MELINTA THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
ASSETS
|
|
|
|
|
|
|
|
|
CURRENT ASSETS:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
12,193
|
|
|
$
|
11,409
|
|
Receivables
|
|
|
7,525
|
|
|
|
454
|
|
Inventory
|
|
|
5,997
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
2,304
|
|
|
|
3,226
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
28,019
|
|
|
|
15,089
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
1,538
|
|
|
|
1,101
|
|
Restricted cash
|
|
|
200
|
|
|
|
|
|
Intangible assets
|
|
|
7,500
|
|
|
|
|
|
Other assets
|
|
|
903
|
|
|
|
444
|
|
|
|
|
|
|
|
|
|
|
TOTAL ASSETS
|
|
$
|
38,160
|
|
|
$
|
16,634
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT
|
|
|
|
|
|
|
|
|
CURRENT LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
12,443
|
|
|
$
|
5,136
|
|
Accrued expenses
|
|
|
16,310
|
|
|
|
6,360
|
|
Notes payable, current portion
|
|
|
|
|
|
|
11,075
|
|
Accrued interest on note payable
|
|
|
275
|
|
|
|
174
|
|
Preferred stock warrants
|
|
|
339
|
|
|
|
674
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
29,367
|
|
|
|
23,419
|
|
|
|
|
|
|
|
|
|
|
LONG-TERM LIABILITIES:
|
|
|
|
|
|
|
|
|
Notes payable, net of current
|
|
|
38,887
|
|
|
|
12,647
|
|
Convertible promissory notes (See Note 3)
|
|
|
73,101
|
|
|
|
45,127
|
|
Deferred revenues
|
|
|
10,008
|
|
|
|
9,008
|
|
Accrued notes payable exit fee
|
|
|
319
|
|
|
|
1,050
|
|
Other long-term liabilities
|
|
|
|
|
|
|
491
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
122,315
|
|
|
|
68,323
|
|
|
|
|
|
|
|
|
|
|
COMMITMENTS AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
CONVERTIBLE PREFERRED STOCK:
|
|
|
|
|
|
|
|
|
Total convertible preferred stock (See Note 6)
|
|
|
217,220
|
|
|
|
218,343
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS DEFICIT:
|
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 350,000,000 shares authorized; 1,161,583 and 1,291,526 shares
issued and outstanding at December 31, 2016 and September 30, 2017, respectively
|
|
|
1
|
|
|
|
1
|
|
Additional
paid-in
capital
|
|
|
223,137
|
|
|
|
220,291
|
|
Accumulated deficit
|
|
|
(553,880
|
)
|
|
|
(513,743
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders deficit
|
|
|
(330,742
|
)
|
|
|
(293,451
|
)
|
|
|
|
|
|
|
|
|
|
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS DEFICIT
|
|
$
|
38,160
|
|
|
$
|
16,634
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
2
MELINTA THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
REVENUE:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
|
|
$
|
|
|
|
$
|
|
|
|
$
|
19,905
|
|
|
$
|
|
|
Contract research
|
|
|
3,191
|
|
|
|
|
|
|
|
9,728
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
3,191
|
|
|
$
|
|
|
|
$
|
29,633
|
|
|
$
|
|
|
OPERATING EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
10,884
|
|
|
|
9,888
|
|
|
|
37,876
|
|
|
|
33,489
|
|
Selling, general and administrative
|
|
|
10,304
|
|
|
|
4,114
|
|
|
|
25,976
|
|
|
|
14,824
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
21,188
|
|
|
|
14,002
|
|
|
|
63,852
|
|
|
|
48,313
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(17,997
|
)
|
|
|
(14,002
|
)
|
|
|
(34,219
|
)
|
|
|
(48,313
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME (EXPENSE), NET:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
7
|
|
|
|
7
|
|
|
|
25
|
|
|
|
24
|
|
Interest expense
|
|
|
(2,381
|
)
|
|
|
(1,156
|
)
|
|
|
(5,765
|
)
|
|
|
(2,928
|
)
|
Loss on early extinguishment of debt
|
|
|
|
|
|
|
|
|
|
|
(607
|
)
|
|
|
|
|
Change in fair value of tranche assets and liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,313
|
)
|
Change in fair value of warrant liability
|
|
|
701
|
|
|
|
436
|
|
|
|
335
|
|
|
|
845
|
|
Other income
|
|
|
34
|
|
|
|
49
|
|
|
|
95
|
|
|
|
135
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expense, net
|
|
|
(1,639
|
)
|
|
|
(664
|
)
|
|
|
(5,917
|
)
|
|
|
(3,237
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NET LOSS
|
|
$
|
(19,636
|
)
|
|
$
|
(14,666
|
)
|
|
$
|
(40,136
|
)
|
|
$
|
(51,550
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of convertible preferred stock dividends
|
|
|
(5,720
|
)
|
|
|
(5,335
|
)
|
|
|
(17,161
|
)
|
|
|
(15,782
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to common stockholders
|
|
$
|
(25,356
|
)
|
|
$
|
(20,001
|
)
|
|
$
|
(57,297
|
)
|
|
$
|
(67,332
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and diluted
|
|
$
|
(19.63
|
)
|
|
$
|
(19.94
|
)
|
|
$
|
(45.26
|
)
|
|
$
|
(67.13
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares, basic and diluted
|
|
|
1,292
|
|
|
|
1,003
|
|
|
|
1,266
|
|
|
|
1,003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
MELINTA THERAPEUTICS, INC.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
|
2016
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(40,136
|
)
|
|
$
|
(51,550
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation expense
|
|
|
368
|
|
|
|
380
|
|
Change in fair value of tranche assets and liabilities
|
|
|
|
|
|
|
1,313
|
|
Loss on early extinguishment of debt
|
|
|
607
|
|
|
|
|
|
Non-cash
interest expense
|
|
|
4,174
|
|
|
|
1,069
|
|
Stock-based compensation
|
|
|
1,628
|
|
|
|
1,851
|
|
Change in fair value of warrant liability
|
|
|
(335
|
)
|
|
|
(845
|
)
|
Loss on disposal of assets
|
|
|
14
|
|
|
|
|
|
Write-off
of deferred equity financing costs
|
|
|
|
|
|
|
969
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Tax credit receivable
|
|
|
35
|
|
|
|
82
|
|
Other receivables
|
|
|
(7,106
|
)
|
|
|
(11
|
)
|
Inventory
|
|
|
(5,997
|
)
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
922
|
|
|
|
(1,611
|
)
|
Accrued interest on notes payable
|
|
|
101
|
|
|
|
|
|
Accounts payable
|
|
|
7,303
|
|
|
|
1,192
|
|
Accrued expenses
|
|
|
4,278
|
|
|
|
(1,372
|
)
|
Deferred revenues
|
|
|
1,000
|
|
|
|
|
|
Other
non-current
assets and liabilities
|
|
|
(459
|
)
|
|
|
615
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(33,603
|
)
|
|
|
(47,918
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchases of property and equipment
|
|
|
(791
|
)
|
|
|
(444
|
)
|
Purchases of intangible assets
|
|
|
(3,500
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(4,291
|
)
|
|
|
(444
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of convertible preferred stock
|
|
|
|
|
|
|
13,625
|
|
Payment of preferred stock issuance costs
|
|
|
|
|
|
|
(9
|
)
|
Proceeds from the issuance of notes payable
|
|
|
40,000
|
|
|
|
|
|
Proceeds from the issuance of convertible notes payable
|
|
|
24,526
|
|
|
|
27,845
|
|
Proceeds from the exercise of stock options
|
|
|
95
|
|
|
|
|
|
Repayment of notes payable
|
|
|
(24,503
|
)
|
|
|
(2,717
|
)
|
Fees paid upon repayment of notes payable
|
|
|
(1,240
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
38,878
|
|
|
|
38,744
|
|
|
|
|
|
|
|
|
|
|
NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH
|
|
|
984
|
|
|
|
(9,618
|
)
|
CASH, CASH EQUIVALENTS AND RESTRICED CASH, beginning of the year
|
|
|
11,409
|
|
|
|
30,158
|
|
|
|
|
|
|
|
|
|
|
CASH, CASH EQUIVALENTS AND RESTRICTED CASH, end of the period
|
|
$
|
12,393
|
|
|
$
|
20,540
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
1,376
|
|
|
$
|
1,852
|
|
Cash received from exchange of state tax credits
|
|
$
|
142
|
|
|
$
|
207
|
|
Supplemental
non-cash
flow information:
|
|
|
|
|
|
|
|
|
Accrued purchases of intangible assets
|
|
$
|
4,000
|
|
|
$
|
|
|
Accrued purchases of fixed assets
|
|
$
|
15
|
|
|
$
|
14
|
|
Accrued notes payable issuance costs
|
|
$
|
1,156
|
|
|
$
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
4
MELINTA THERAPEUTICS, INC.
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(In thousands, except share and per share data)
NOTE 1 BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING POLICIES
Melinta Therapeutics, Inc. (the Company or Melinta), a Delaware corporation, was formed in October 2000. Melinta is a commercial-stage
biopharmaceutical company developing new antibiotics to overcome drug-resistant, life-threating infections. The Company has a commercially ready product, Baxdela
®
, which is being advanced for
acute bacterial skin and skin structure infections (ABSSSI) and other serious infections. The Company also has a proprietary drug discovery platform, enabling a unique understanding of how antibiotics combat infection and has generated a
pipeline spanning multiple phases of research and clinical development. In June 2017, Melinta received approval from the U.S. Food and Drug Administration (FDA) to sell Baxdela for the treatment of adults with ABSSSI.
On August 8, 2017, Melinta entered into a definitive agreement to merge with a subsidiary of Cempra, Inc. (Cempra) in an
all-stock
transaction (the Merger). The Merger closed on November 3, 2017. In connection with the closing of the Merger, Cempra issued shares of Cempra common stock to Melintas former
stockholders such that Melintas former stockholders now own approximately 52% of the combined company, and the Cempra stockholders own approximately 48% of the combined company. Upon closing, the combined company was renamed Melinta
Therapeutics, Inc. See Note 12 for additional discussion of the Merger.
These unaudited condensed consolidated financial statements are prepared in
accordance with accounting principles generally accepted in the United States of America (U.S. GAAP). In accordance with U.S. GAAP requirements for interim financial statements, these condensed consolidated financial statements
do not include certain information and note disclosures that are normally included in annual financial statements prepared in conformity with U.S. GAAP. Accordingly, these condensed consolidated financial statements should be read in
conjunction with the audited consolidated financial statements as of December 31, 2016 and 2015, and for the years ended December 31, 2016, 2015 and 2014, and the notes thereto filed with the SEC on Form
8-K
on December 5, 2017 (2016 Annual Report). In the opinion of the Company, the condensed consolidated financial statements contain all adjustments (which are of a normal, recurring nature)
necessary to present fairly, in all material respects, the financial position as of September 30, 2017, and the results of operations and cash flows for the three and nine months ended September 30, 2017 and 2016, in conformity with
U.S. GAAP. Interim results may not be indicative of results that may be realized for the full year.
The Company has incurred losses from operations
since its inception and had an accumulated deficit of $553,880 as of September 30, 2017. In addition, at September 30, 2017, the Company had $73,101 of outstanding convertible promissory notes, including accrued interest, and $40,000 of
outstanding principal balance of notes payable. The Company expects to incur substantial expenses and further losses in the foreseeable future for the research, development, and commercialization of its product candidates. These conditions raise
substantial doubt about the Companys ability to continue as a going concern. And while Melinta had an excess of $155,000 cash on hand at the closing of the Merger, the Company will need to fund its operations through public or private equity
offerings, debt financings, or corporate collaborations and licensing arrangements. There can be no assurance that the Company will be able to raise the capital it requires on favorable terms, in sufficient amounts or at all. The accompanying
financial statements have been prepared on a going-concern basis and do not include any adjustments that might result from the outcome of these uncertainties. During the nine months ended September 30, 2017, the Company raised $84,525 through
equity and debt financing and licensing activities. Of that, $40,000 was a new debt arrangement that replaced the debt arrangement in place at December 31, 2016. See Note 3 for additional discussion.
Significant Accounting Policies
Revenue
Recognition
The Company recognizes revenue under Accounting Standards Codification (ASC) 605,
Revenue Recognition
. In Note 2 to the Companys audited consolidated financial statements for the year ended
December 31, 2016, the
5
Company disclosed that it was expecting to adopt Accounting Standards Update
2014-09,
Revenue From Contracts With Customers, as amended
(ASU
2014-09)
,
as of January 1, 2017. Subsequent to the issuance of those
financial statements, the Company amended its planned adoption date for ASU
2014-09
to January 1, 2018 to align the adoption date of ASU
2014-09
with that of
Cempra.
The Companys revenue arrangements consist of licensing and collaboration revenue related to
non-refundable
upfront fees, reimbursement of research and development expenses, milestone payments and royalties on future product sales by the licensee. Revenue is recognized when the following criteria are
met: (1) persuasive evidence that an arrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectability is reasonably assured.
For arrangements that involve the delivery of more than one element, each product, service and/or right to use assets is evaluated to determine whether it
qualifies as a separate unit of accounting. This determination is based on whether the deliverable has stand-alone value to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of
accounting based on the relative selling prices of each deliverable. The consideration allocated to each unit of accounting is recognized as the related goods and services are delivered, limited to the consideration that is not contingent upon
future deliverables. When an arrangement is accounted for as a single unit of accounting, the Company determines the period over which the performance obligations will be performed and revenue recognized.
Milestone payments are recognized when earned, provided that the milestone event is substantive and there is no ongoing performance obligation related to the
achievement of the milestone earned. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment is
non-refundable;
achievement of the milestone was not
reasonably assured at the inception of the arrangement; substantive effort is involved to achieve the milestone; and the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement, and the
related risk associated with the achievement of the milestone. Contingent-based payments the Company may receive under a license agreement will be recognized when received.
See Note 8 for discussion related to revenue recognized under the Companys licensing agreement signed in 2017.
The Company plans to adopt the guidance in Accounting Standards Update (ASU)
2014-09,
Revenue From
Contracts With Customers
, on January 1, 2018, using the modified retrospective method. This pronouncement outlines a single comprehensive model to use in accounting for revenue arising from contracts with customers and supersedes most
current revenue recognition guidance. The core principle of the guidance is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects
to be entitled in exchange for those goods or
services. To date, the Company has (1) performed an initial assessment of the its revenue streams;
(2) substantially completed its inventory of all outstanding contracts; and (3) begun the process of applying the five-step model to those revenue streams and contracts to evaluate the quantitative and qualitative impacts the new statement
will have on its business and reported revenues.
Restricted Cash
In November 2016, the FASB issued ASU
2016-18,
Restricted Cash
, which clarifies guidance on the classification and presentation of restricted cash in the statement of cash flows. The ASU states that an entity (1) should include amounts
deemed to be restricted cash in its cash and cash-equivalent balances in the statement of cash flows; (2) should present a reconciliation between the statement of financial position and statement of cash flows when the statement of financial
position includes more than one line item for cash or cash equivalents; (3) must not present changes in restricted cash that result from transfers between unrestricted and restricted cash as cash flow activities in the statement of cash flows;
and (4) must disclose information about material amounts of restricted cash. ASU
2016-18
is effective for public entities for fiscal years beginning after December 15, 2017, including interim
periods, but allows for early adoption. The Company adopted this guidance as of January 1, 2017. Prior to 2017, the Company did not have any restricted cash balances. Accordingly, there was no retrospective impact from the adoption of this
standard.
6
Inventory
Inventory is stated at the lower of cost or estimated net realizable value. The Company
currently uses actual costing to determine the cost basis for its inventory. Inventory is valued on
a first-in, first-out
basis and consists primarily of
third-party manufacturing costs, overhead and related transportation costs. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on managements judgment, future commercialization is
considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. The company reviews inventories on hand at least quarterly and records provisions for estimated excess, slow-moving and obsolete
inventory, as well as inventory with a carrying value in excess of net realizable value.
As of September 30, 2017, inventory on the Companys
balance sheet represented the cost of certain raw material and
work-in-process
inventory that the Company incurred after the FDA approval of Baxdela on June 19,
2017. At September 30, 2017, the Company had incurred other costs for manufacturing this inventory; however, such costs were incurred prior to the FDA approval of Baxdela and, therefore, were recognized as research and development expense in
earlier periods. Consequently, profit margins reported from the initial sales of Baxdela will not be representative of margins the Company expects to achieve after the first commercial batches of inventory are consumed. Costs of drug product to be
consumed in any current or future trials will continue to be recognized as research and development expense.
Intangible Assets
The
Companys intangible assets consisted of intellectual property rights acquired for currently approved products (amortized intangibles). All of the Companys intangible assets were recorded in connection with post-approval
milestones payable under the Companys license agreements. The Company amortizes these intangible assets over their estimated useful lives, which correlates with the period of time over which the intangible assets are estimated to contribute to
future cash flows. The Company amortizes finite-lived intangible assets using the straight-line method.
Industry Segment and Geographic
Information
The Company operates in a single industry segmentthe discovery and development of antibiotics for the treatment of drug-resistant, life threatening infections. The Company had no foreign-based operations during any of the
periods presented. Although all of the revenue reported for the three and nine months ended September 30, 2017, was generated from an agreement with one company that is domiciled in Italy, Melinta did not operate in Italy, nor do we have any
significant assets there. The contract research revenue was reimbursement for
US-based
research activities. See Note 8 for further discussion of the license and contract research revenue.
Business Combinations
In January 2017, the FASB issued ASU
2017-01,
Business Combinations (Topic 805)
Clarifying the Definition of a Business
, which narrows the definition of a business and requires an entity to evaluate if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group
of similar identifiable assets, which would not constitute the acquisition of a business. The guidance also requires a business to include at least one substantive process and
narrows the definition of outputs. This guidance is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal
years, with early adoption permitted. The Company will adopt this guidance as of January 1, 2018. We do not expect the adoption will have a material impact on our condensed consolidated financial statements.
NOTE 2 BALANCE SHEET COMPONENTS
Cash, Cash
Equivalents and Restricted Cash
Cash, cash equivalents and restricted cash, as presented on the Statement of Cash Flows, consisted of the following (we did not have any restricted cash at September 30, 2016):
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
Cash and cash equivalents
|
|
$
|
12,193
|
|
|
$
|
11,409
|
|
Restricted cash
|
|
|
200
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash, cash equivalents and restricted cash shown in the Statement of Cash Flows
|
|
$
|
12,393
|
|
|
$
|
11,409
|
|
|
|
|
|
|
|
|
|
|
7
Prepaid and Other Current Assets
Prepaid and other current assets consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
Prepaid contracted services
|
|
$
|
1,423
|
|
|
$
|
2,483
|
|
Other prepaid expenses
|
|
|
881
|
|
|
|
743
|
|
|
|
|
|
|
|
|
|
|
Total prepaid and other current assets
|
|
$
|
2,304
|
|
|
$
|
3,226
|
|
|
|
|
|
|
|
|
|
|
Inventory
Inventory consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
Raw materials
|
|
$
|
2,432
|
|
|
$
|
|
|
Work in process
|
|
|
3,565
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total inventory
|
|
$
|
5,997
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
Property and Equipment, Net
Property and equipment, net consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
Laboratory equipment
|
|
$
|
3,332
|
|
|
$
|
3,332
|
|
Office equipment
|
|
|
575
|
|
|
|
434
|
|
Purchased software
|
|
|
860
|
|
|
|
932
|
|
Furniture and fixtures
|
|
|
390
|
|
|
|
219
|
|
Leasehold improvements
|
|
|
4,869
|
|
|
|
4,588
|
|
Assets in development
|
|
|
370
|
|
|
|
166
|
|
|
|
|
|
|
|
|
|
|
Gross property and equipment
|
|
|
10,396
|
|
|
|
9,671
|
|
Less-accumulated depreciation
|
|
|
(8,858
|
)
|
|
|
(8,570
|
)
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
$
|
1,538
|
|
|
$
|
1,101
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense relating to property and equipment was $113 and $125 for the three months ended September 30, 2017
and 2016, respectively, and $368 and $380 for the nine months ended September 30, 2017 and 2016, respectively.
Accrued Expenses
Accrued
expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
Accrued contracted services
|
|
$
|
4,616
|
|
|
$
|
2,564
|
|
Payroll related expenses
|
|
|
2,572
|
|
|
|
1,825
|
|
Professional fees
|
|
|
479
|
|
|
|
1,540
|
|
Accrued license milestone payments
|
|
|
4,000
|
|
|
|
|
|
Accrued other expenses
|
|
|
4,643
|
|
|
|
431
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
16,310
|
|
|
$
|
6,360
|
|
|
|
|
|
|
|
|
|
|
Accrued contracted services are primarily composed of amounts owed to third-party clinical research organizations and contract
manufacturers for research and development work performed on behalf of the Company. Accrued other expenses are primarily legal and other professional fees associated with the Merger.
Accrued expenses represent the Companys best estimate of amounts owed through
period-end,
based on all
information available. Such estimates are subject to change as additional information becomes available.
8
NOTE 3 NOTES PAYABLE
The Companys outstanding debt balances consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
December 31,
2016
|
|
Principal balance
|
|
$
|
40,000
|
|
|
$
|
24,502
|
|
Debt discount and deferred financing costs
|
|
|
(1,113
|
)
|
|
|
(780
|
)
|
|
|
|
|
|
|
|
|
|
Net balance
|
|
|
38,887
|
|
|
|
23,722
|
|
Less: current maturities, including deferred financing costs and debt discount
|
|
|
|
|
|
|
(11,075
|
)
|
|
|
|
|
|
|
|
|
|
Long-term balance
|
|
|
38,887
|
|
|
|
12,647
|
|
|
|
|
|
|
|
|
|
|
Principal outstanding under Convertible Promissory Notes
|
|
|
68,636
|
|
|
|
44,111
|
|
Interest outstanding under Convertible Promissory Notes
|
|
|
4,465
|
|
|
|
1,016
|
|
|
|
|
|
|
|
|
|
|
Total Convertible Promissory Notes
|
|
|
73,101
|
|
|
|
45,127
|
|
|
|
|
|
|
|
|
|
|
Total long-term debt, net of current maturities
|
|
$
|
111,988
|
|
|
$
|
57,774
|
|
|
|
|
|
|
|
|
|
|
2014 Loan Agreement
In
December 2014, the Company entered into the 2014 Loan Agreement with a lender pursuant to which it borrowed an initial term loan amount of $20,000. In December 2015, pursuant to the achievement of certain milestones with respect to the terms in the
2014 Loan Agreement, the Company borrowed an additional term loan advance in the amount of $10,000.
The Company was obligated to make monthly payments in
arrears of interest only, at a rate of the greater of 8.25% or the sum of 8.25% plus the prime rate minus 4.5% per annum, commencing on January 1, 2015, and continuing on the first day of each successive month thereafter through and including
June 1, 2016. Commencing on July 1, 2016, and continuing on the first day of each month through and including June 1, 2018, the Company was to make consecutive equal monthly payments of principal and interest. All unpaid principal and
accrued and unpaid interest with respect to the 2014 Loan Agreement were to be due and payable in full on June 1, 2018.
The loan was collateralized
by substantially all of the Companys assets, excluding its intellectual property. In connection with the 2014 Loan Agreement, the Company entered into a negative pledge arrangement in which the Company has agreed not to encumber its
intellectual property. The Company paid a $195 facility fee at the inception of the loan, which was recorded as debt discount and was being recognized as additional interest expense over the term of the loan. Subject to certain limited exceptions,
amounts prepaid in relation to the 2014 Loan Agreement were subject to a prepayment fee on the then outstanding balance of 3% in the first year, 2% in the second year, and 1% thereafter. In addition, upon repayment of the total amounts borrowed, the
Company was required to pay an exit fee equal to 3.5% of the total of the amount borrowed. The amount of the exit fee was $1,050 as of both December 31, 2016 and 2015, and was recorded as a debt discount and included in
non-current
liabilities. The accrued exit fee was amortized as a
non-cash
component of interest expense over the term of the loan.
Under the terms of the 2014 Loan Agreement, the Company was subject to operational covenants, including limitations on the Companys ability to incur
liens or additional debt, pay dividends, redeem stock, make specified investments and engage in merger, consolidation or asset sale transactions, among other restrictions. The Company was subject to a covenant that required specified minimum levels
of liquidity, which commenced July 1, 2015 and was initially $13,000, subject to reduction or termination upon the achievement of certain milestones. In April 2016, the minimum liquidity financial covenant was reduced to $5,000, and in December
2016, it was eliminated altogether.
2017 Loan Agreement
On May 2, 2017, the Company entered into a Loan and Security Agreement with a new lender (the 2017 Loan Agreement). Under the 2017 Loan
Agreement, the lender has made available to the Company up to $80,000 in debt financing and up to
9
$10,000 in equity financing. The Company is eligible for up to four tranches of debt, each under a separate promissory note, of $30,000, $10,000, $20,000 and $20,000. No amounts under any of the
tranches were available to the Company until after the New Drug Application (NDA) approval of Baxdela, on June 19, 2017. In addition, the availability of the third tranche is subject to the modification of certain of the
Companys license agreements to ensure the new lenders rights under the 2017 Loan Agreement (the License Modification). The Company has not yet attained the License Modification, and it can give no assurances it will actually
occur. Subject to the contingencies referenced previously, after the funding of the first tranche of $30,000, the Company has the right to draw the second and third tranches through the earlier of the
18-month
anniversary of the funding of the first tranche and December 31, 2018. In addition to the NDA approval and License Modification, the fourth tranche is available only upon the successful achievement of certain sales milestones on or prior to
September 30, 2019 (such sales milestones can be extended to December 31, 2019, if certain conditions are met). Each note has its own maturity date of seven years after the respective promissory notes funding date.
The 2017 Loan Agreement bears an annual interest rate equal to the greater of 8.25% or the sum of 8.25% plus the prime rate minus 4.5%. The Company is also
required to pay the lender an end of term fee upon the termination of the arrangement. If the outstanding principal is at or below $40,000, the 2017 Loan Agreement requires interest-only monthly payments for 18 months from the funding of the first
tranche, at which time the Company has the option to pay the principal due or convert the outstanding loan to an interest plus royalty-bearing note. If, at any time, the principal exceeds $40,000 under the 2017 Loan Agreement, the promissory notes
automatically convert to an interest plus royalty arrangement. Under this arrangement, the lender will receive a royalty, based on net sales, of between 1.02% and 2.72% depending on the balance of notes outstanding. Specifically, the royalty is
1.02% for the first tranche, 0.34% for the second tranche, 0.68% for the third tranche and 0.68% for the fourth tranche. These additional payments will be applied to either accrued interest or principal based on stated rates of return that vary with
time. The principal for each note must be repaid by the seventh anniversary of the respective promissory note, along with
end-of-term
fees that vary with time. There are
no financial covenants under the agreement; however, the Company is obligated to provide certain financial information each month, quarter and fiscal year. The loan is collateralized by substantially all of the Companys assets.
Under the terms of the 2017 Loan Agreement, the lender has the right to participate in future debt or equity financings of the Company totaling $10,000. The
lender committed to $5,000 of this investment upon the funding of the first loan advance, in the form of any other debt or equity securities issued by the Company on or prior to the funding of the first tranche of the 2017 Loan Agreement.
On June 28, 2017, the Company drew the first tranche of financing under the 2017 Loan Agreement, the gross proceeds of which were $30,000. The Company
used the proceeds to retire a loan entered into in 2014, including payment of outstanding principal and a $1,050 exit fee. In connection with the retirement of the 2014 Loan Agreement, the Company recognized $607 as a loss on the extinguishment of
debt, which was comprised of unamortized debt discounts of $417 and prepayment penalties and fees of $190. Net proceeds under the 2017 Loan Agreement were $9,995 after the retirement of the 2014 Loan Agreement (including the exit fee) and other debt
settlement fees of $190. In August 2017, Melinta drew the second tranche of financing, receiving $10,000. As of September 30, 2017, the $40,000 was recorded as a long-term note payable, offset by debt issuance costs. The Company is amortizing
the debt issuance costs of $1,156 over the seven-year term of the first tranche. In addition, the Company is accreting the $1,750
end-of-term
fee as additional interest
expense over the period between the draw of the tranches and December 27, 2018; this
end-of-term
fee would become due if the Company were to repay the total
outstanding balance under the 2017 Loan Agreement prior to its conversion into an interest plus royalty-bearing note. On June 30, 2017, the Company received the committed $5,000 investment and issued a Convertible Promissory Note to the
Companys lender under the terms of the May 2017 Notes (discussed above).
In September 2017, Melinta entered into an amendment to the 2017 Loan
Agreement (the Amendment) to allow for a short-term bridge option for the $20,000 third tranche of the financing arrangement. Under the Amendment, Melinta may draw the third tranche in multiple installments of either $5,000 or $10,000.
If Melinta draws and repays amounts under the third tranche by
10
December 31, 2017, the third tranche again becomes available under the original terms of the 2017 Loan Agreement. If the Company does not repay the amounts drawn under the third tranche
before December 31, 2017, then all outstanding instruments under the 2017 Loan Agreement may convert into the interest plus royalty arrangement. The Amendment was conditional on Melinta being a private company; the Merger effectively canceled
the Amendment. As of December 5, 2017, the Company had not drawn any amounts under the Amendment.
Convertible Promissory Notes
In July 2016, the Company entered into an agreement with certain of its investors to issue $20,000 in Convertible Promissory Notes (the July
Notes), under which it issued $10,000 in July 2016 and $10,000 in August 2016. In September 2016, the Company entered into an additional agreement with these investors to issue an additional $19,990 in Notes (the September Notes),
under which it issued $7,845 in September 2016, $2,150 in October and $9,995 in November 2016.
Both the July Notes and the September Notes (collectively,
the Notes), are unsecured and subordinated in right of payment to the 2014 Loan Agreement and bear an annual interest rate of 8%. Under the terms of the Notes, if the Company completes a preferred stock or common stock financing prior to
June 2, 2018, all outstanding principal and accrued interest will automatically convert into shares of the stock issued in the financing based on the price per share of the financing. If the Company does not complete an equity financing prior
to June 2, 2018, the note holders have the right to demand repayment of principal and accrued interest or convert all outstanding principal and accrued interest into shares of Series 4 preferred stock at the Series 4 preferred stock price per
share of $1.044687. In addition, the September Notes include the right, at the discretion of the investors, to purchase, at fair value, certain assets of the Company using some or all of the September Notes, and other compensation, to complete the
purchase.
In January 2017, the Company entered into an agreement with certain investors to issue an additional $18,194 in Convertible Promissory Notes
(the January 2017 Notes). The January 2017 Notes are unsecured and subordinated in right of payment to the 2017 Loan Agreement and bear an annual interest rate of 8%. The terms of the January 2017 Notes are similar to those of notes
previously issued in 2016; however, in the event of an IPO (the definition of which includes a reverse merger), the January 2017 Notes will convert to common shares at a discount of up to 15% of the IPO price. The Company received advanced funding
of $4,120 related to the January 2017 Notes in December 2016, and it received $1,945, $6,065 and $6,065 in January 2017, February 2017 and April 2017, respectively.
In May 2017, the Company entered into a new agreement with certain investors to issue additional Convertible Promissory Notes up to $16,353 (the May
2017 Notes). The May 2017 Notes are unsecured and subordinated in right of payment to the 2017 Loan Agreement and bear an annual interest rate of 8%. The terms of the May 2017 Notes are similar to those of the January 2017 Notes, including, in
the event of an IPO (the definition of which includes a reverse merger), the May 2017 Notes will convert to common shares at a discount of up to 15% of the IPO price. The Company received $5,451 in May 2017 under these notes. The Company also
received $5,000 for a Convertible Promissory Note issued under the 2017 Loan Agreement.
On November 3, 2017, in connection with the Merger, all of
the Convertible Promissory Notes, with accumulated interest, were exchanged for 3,766,311 shares of Cempra common stock.
NOTE 4 INTEREST
EXPENSE
Interest expense for the three and nine months ended September 30, 2017 and 2016, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Cash interest expense
|
|
$
|
705
|
|
|
$
|
605
|
|
|
$
|
1,591
|
|
|
$
|
1,859
|
|
Noncash interest expense
|
|
|
1,676
|
|
|
|
551
|
|
|
|
4,174
|
|
|
|
1,069
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest expense
|
|
$
|
2,381
|
|
|
$
|
1,156
|
|
|
$
|
5,765
|
|
|
$
|
2,928
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
NOTE 5 FAIR VALUE MEASUREMENTS
The provisions of the accounting standard for fair value define fair value as the price that would be received to sell an asset or paid to transfer a liability
in an orderly transaction between market participants at the measurement date. The transaction of selling an asset or transferring a liability is a hypothetical transaction at the measurement date, considered from the perspective of a market
participant who holds the asset or owes the liability. Therefore, the objective of a fair value measurement is to determine the price that would be received when selling an asset or paid to transfer a liability (an exit price) at the measurement
date. This standard classifies the inputs used to measure fair value into the following hierarchy:
Level
1
Unadjusted
quoted prices in active markets for identical assets or liabilities.
Level
2
Unadjusted quoted prices in active markets
for similar assets or liabilities, or unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are observable for the asset or liability.
Level
3
Unobservable inputs for the asset or liability.
The following table lists the Companys assets and liabilities that are measured at fair value and the level of inputs used to measure their fair value
at September 30, 2017.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2017
|
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
|
Total
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market fund
|
|
$
|
1,815
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
1,815
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets at fair value
|
|
$
|
1,815
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
1,815
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock warrants
|
|
$
|
|
|
|
$
|
|
|
|
$
|
339
|
|
|
$
|
339
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
|
|
|
$
|
|
|
|
$
|
339
|
|
|
$
|
339
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The preferred stock warrants were valued using a Black-Scholes option-pricing model and Level 3 unobservable inputs. The
significant unobservable inputs include the value of the Companys convertible preferred stock, the risk-free interest rate, remaining contractual term, and expected volatility. Significant increases or decreases in any of these inputs in
isolation would result in a significantly different fair value measurement. An increase in the risk-free interest rate, and/or an increase in the remaining contractual term or expected volatility, would result in an increase in the fair value of the
warrants.
The following table summarizes the changes in fair value of the Companys Level 3 assets for the nine months ended September 30,
2016 (there were no Level 3 assets during the nine months ended September 30, 2017):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 3 Assets
|
|
Fair Value at
December 31,
2015
|
|
|
Realized
Gains
(Losses)
|
|
|
Change in
Unrealized
Gains
(Losses)
|
|
|
Issuances
(Settlements)
|
|
|
Net Transfer
In (Out) of
Level 3
|
|
|
Fair Value at
September 30,
2016
|
|
Preferred stock tranche assets
|
|
$
|
1,313
|
|
|
$
|
|
|
|
$
|
(1,313
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets at fair value
|
|
$
|
1,313
|
|
|
$
|
|
|
|
$
|
(1,313
|
)
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12
The following tables summarize the changes in fair value of the Companys Level 3 liabilities for the
nine months ended September 30, 2017 and 2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 3 Liabilities
|
|
Fair Value at
December 31,
2016
|
|
|
Realized
Gains
(Losses)
|
|
|
Change in
Unrealized
Gains
(Losses)
|
|
|
(Issuances)
Settlements
|
|
|
Net Transfer
In (Out) of
Level 3
|
|
|
Fair Value at
September 30,
2017
|
|
Preferred stock warrants
|
|
$
|
(674
|
)
|
|
$
|
|
|
|
$
|
335
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(339
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
(674
|
)
|
|
$
|
|
|
|
$
|
335
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(339
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 3 Liabilities
|
|
Fair Value at
December 31,
2015
|
|
|
Realized
Gains
(Losses)
|
|
|
Change in
Unrealized
Gains
(Losses)
|
|
|
(Issuances)
Settlements
|
|
|
Net Transfer
In (Out) of
Level 3
|
|
|
Fair Value at
September 30,
2016
|
|
Preferred stock warrants
|
|
$
|
(1,456
|
)
|
|
$
|
|
|
|
$
|
845
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(611
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
(1,456
|
)
|
|
$
|
|
|
|
$
|
845
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
(611
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 6 CONVERTIBLE PREFERRED STOCK
Under the Companys amended and restated certificate of incorporation, the Companys convertible preferred stock was recorded at fair value as of the
date of issuance, net of issuance costs. Outstanding convertible preferred stock as of September 30, 2017, and December 31, 2016, consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of September 30, 2017
|
|
|
|
Shares
|
|
|
Carrying
|
|
|
Liquidation
|
|
|
|
Designated
|
|
|
Outstanding
|
|
|
Values
|
|
|
Preference
|
|
Series 1 Convertible Preferred Stock
|
|
|
9,090,635
|
|
|
|
9,090,635
|
|
|
$
|
1,034
|
|
|
$
|
19,371
|
|
Series
2-A(1)
Convertible Preferred Stock
|
|
|
20,781,845
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2-A(2)
Convertible Preferred Stock
|
|
|
4,677,457
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Series
2-A
Convertible Preferred Stock
|
|
|
25,459,302
|
|
|
|
25,459,302
|
|
|
|
16,716
|
|
|
|
26,771
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2-B(1)
Convertible Preferred Stock
|
|
|
27,709,127
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2-B(2)
Convertible Preferred Stock
|
|
|
39,346,310
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Series
2-B
Convertible Preferred Stock
|
|
|
67,055,437
|
|
|
|
67,055,437
|
|
|
|
48,625
|
|
|
|
115,067
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series 3 Convertible Preferred Stock
|
|
|
80,225,978
|
|
|
|
78,843,653
|
|
|
|
71,125
|
|
|
|
89,955
|
|
Series
3-B
Convertible Preferred Stock
|
|
|
5,262,373
|
|
|
|
5,262,373
|
|
|
|
5,991
|
|
|
|
17,306
|
|
Series 4 Convertible Preferred Stock
|
|
|
68,000,000
|
|
|
|
67,603,974
|
|
|
|
73,729
|
|
|
|
83,109
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Convertible Preferred Stock
|
|
|
255,093,725
|
|
|
|
253,315,374
|
|
|
$
|
217,220
|
|
|
$
|
351,579
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2016
|
|
|
|
Shares
|
|
|
Carrying
|
|
|
Liquidation
|
|
|
|
Designated
|
|
|
Outstanding
|
|
|
Values
|
|
|
Preference
|
|
Series 1 Convertible Preferred Stock
|
|
|
9,363,187
|
|
|
|
9,363,187
|
|
|
$
|
1,433
|
|
|
$
|
18,822
|
|
Series
2-A(1)
Convertible Preferred Stock
|
|
|
20,781,845
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2-A(2)
Convertible Preferred Stock
|
|
|
5,107,484
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Series
2-A
Convertible Preferred Stock
|
|
|
25,889,329
|
|
|
|
25,889,329
|
|
|
|
17,027
|
|
|
|
25,683
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2-B(1)
Convertible Preferred Stock
|
|
|
27,709,127
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series
2-B(2)
Convertible Preferred Stock
|
|
|
39,919,846
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Series
2-B
Convertible Preferred Stock
|
|
|
67,628,973
|
|
|
|
67,628,973
|
|
|
|
49,038
|
|
|
|
112,254
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series 3 Convertible Preferred Stock
|
|
|
80,225,978
|
|
|
|
78,843,653
|
|
|
|
71,125
|
|
|
|
84,863
|
|
Series
3-B
Convertible Preferred Stock
|
|
|
5,262,373
|
|
|
|
5,262,373
|
|
|
|
5,991
|
|
|
|
16,326
|
|
Series 4 Convertible Preferred Stock
|
|
|
67,603,974
|
|
|
|
67,603,974
|
|
|
|
73,729
|
|
|
|
78,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Convertible Preferred Stock
|
|
|
255,973,814
|
|
|
|
254,591,489
|
|
|
$
|
218,343
|
|
|
$
|
336,353
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During the nine months ended September 30, 2017, the Company purchased and retired Convertible Preferred Stock for
approximately 100 dollars, as follows:
|
|
|
|
|
Security
|
|
Number of
Shares
Repurchased
|
|
Series 1 Convertible Preferred Stock
|
|
|
272,552
|
|
Series
2-A(2)
Convertible Preferred Stock
|
|
|
430,027
|
|
Series
2-B(2)
Convertible Preferred Stock
|
|
|
573,536
|
|
|
|
|
|
|
Total
|
|
|
1,276,115
|
|
|
|
|
|
|
The carrying value of the retired shares was $1,123, which approximated the gain on the retirement of the shares. This gain
was recorded as a credit to Additional
Paid-in
Capital.
On November 3, 2017, in connection with the Merger,
all outstanding Convertible Preferred Stock, with accumulated interest, was exchanged for 7,638,816 shares of Cempra common stock.
NOTE 7
STOCK-BASED COMPENSATION
A summary of the stock option activity for the nine months ended September 30, 2017, under the 2001 Stock Option and
Incentive Plan (2001 Plan) and the 2011 Equity Incentive Plan (2011 Plan) is presented in the table below:
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2001 Plan
|
|
|
2011 Plan
|
|
|
|
Options
|
|
|
Weighted-
Average
Exercise
Price
|
|
|
Options
|
|
|
Weighted-
Average
Exercise
Price
|
|
Outstanding as of January 1, 2017
|
|
|
210
|
|
|
$
|
1,196.55
|
|
|
|
26,033,257
|
|
|
$
|
0.62
|
|
Granted
|
|
|
|
|
|
|
|
|
|
|
7,977,355
|
|
|
$
|
0.48
|
|
Exercised/released
|
|
|
|
|
|
|
|
|
|
|
(131,899
|
)
|
|
$
|
0.72
|
|
Forfeited
|
|
|
(4
|
)
|
|
$
|
1,261.72
|
|
|
|
|
|
|
|
|
|
Expired
|
|
|
(88
|
)
|
|
$
|
1,417.67
|
|
|
|
(3,060,036
|
)
|
|
$
|
0.51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding as of September 30, 2017
|
|
|
118
|
|
|
$
|
1,029.45
|
|
|
|
30,818,677
|
|
|
$
|
0.59
|
|
Exercisable as of September 30, 2017
|
|
|
118
|
|
|
$
|
1,029.45
|
|
|
|
16,031,640
|
|
|
$
|
0.59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable and expected to vest as of September 30, 2017
|
|
|
118
|
|
|
$
|
1,029.45
|
|
|
|
30,818,677
|
|
|
$
|
0.59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-Based Compensation
The Company uses a Black-Scholes option-pricing model for determining the estimated fair
value for stock-based awards. The Black-Scholes option-pricing model requires the use of the subjective assumptions in order to determine the fair value of stock-based awards.
The weighted-average assumptions used to value stock option grants awarded during the nine months ended September 30, 2017 and 2016, were as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
|
2016
|
|
Risk-free interest rate
|
|
|
1.96
|
%
|
|
|
1.49
|
%
|
Weighted-average volatility
|
|
|
75.4
|
%
|
|
|
66.60
|
%
|
Expected term - employee awards (in years)
|
|
|
6.0
|
|
|
|
6.0
|
|
Forfeiture rate
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Dividend yield
|
|
|
|
|
|
|
|
|
Stock-based compensation reported in the Companys statements of operations for the three and nine months ended
September 30, 2017 and 2016, was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Nine Months Ended September 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Research and development
|
|
$
|
176
|
|
|
$
|
231
|
|
|
$
|
447
|
|
|
$
|
840
|
|
Selling, general and administrative
|
|
|
372
|
|
|
|
347
|
|
|
|
1,181
|
|
|
|
1,011
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stock-based compensation expense
|
|
$
|
548
|
|
|
$
|
578
|
|
|
$
|
1,628
|
|
|
$
|
1,851
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No related tax benefits associated with stock-based compensation expense has been recognized and no related tax benefits have
been realized from the exercise of stock options due to the Companys net operating loss carryforwards.
Total aggregate unrecognized stock-based
compensation cost for the 2001 Plan and 2011 Plan was $0 and $5,044, respectively. The unrecognized stock-based compensation will be recognized over a weighted-average period of 2.7 years.
15
In August 2017, Melintas board of directors authorized an increase in the common shares available for grant
under the 2011 Plan to 35,000,000 (an increase of 2,835,014 shares). All options under the 2001 Plan and 2011 Plan converted to 732,499 options to purchase post-merger shares of Melinta Therapeutics, Inc. upon the successful closing of the merger on
November 3, 2017, based upon the terms of the merger agreement.
NOTE 8 LICENSE AGREEMENTS
In February 2017, the Company executed a license agreement with A. Menarini Industrie Farmaceutiche Riunite S.r.l. (Menarini), a leading
pharmaceutical company in western Europe, under which the Company licensed rights to commercialize Baxdela in certain European, Asia-Pacific (except for Japan) and other
rest-of-world
territories (the Agreement). Pursuant to the terms and conditions of the Agreement, Menarini is entitled to exclusive rights to obtain product
approval, procure supply from the Company and to commercialize Baxdela in the licensed territories, and the Company is entitled to receive regulatory, commercial and sales-based milestones as well as sales-based royalties on future net sales of
Baxdela. In addition, Menarini and the Company agreed to share jointly in the future development cost of Baxdela. The Company received $19,905 upon the execution of the Agreement. Going forward, the Company will receive reimbursement for 50% of the
costs incurred for efforts to expand the applicable indications for Baxdela, and it may receive up to approximately 90,000 for regulatory, commercial and sales-based milestones as well as sales-based royalties on future sales of Baxdela.
At the time the agreement was entered into, the Company identified two deliverables: the delivery of the Baxdela license to Menarini and the right to a
related sublicense. While the Company is also providing development services in connection with the expansion of applicable indications for Baxdela, the Company is under no obligation to perform such services. In the event that the Company
performs development services related to other indications of Baxdela, Menarini has the option to obtain the results of such services by reimbursing the Company for 50 percent of its related costs, and the Company has determined that
Menarinis option is not priced at a significant and incremental discount. To the extent that the Company is reimbursed for development services, such amounts will be recognized separately from the initial license.
The agreement also states a separate Supply Agreement will be entered into at a future date under which Menarini will purchase Baxdela products from the
Company until it can commence its own manufacturing. The pricing of Baxdela products under the Supply Agreement will not be at a significant, incremental discount. And, under the terms of the agreement, the Company is entitled to receive up to
approximately 90,000 for regulatory, commercial and sales-based milestones as well as royalties on future sales of Baxdela. As the Company has completed all of its performance obligations under the agreement during the first quarter of 2017,
the Company will recognize any future milestone payment received as revenue when Menarini achieves the milestone.
For immediate use of the license and
right to the sublicense, Menarini is able to leverage the information contained within the Baxdela NDAs, which were filed by Melinta with the FDA in October 2016 for ABSSSI, to prepare the regulatory filings in the licensed territories. And, while
the FDA approval was received in June 2017, regulatory approval in many of the licensed territories is not contingent upon U.S. FDA approval. The Company recognized $19,905, the consideration that was fixed and determinable at the inception of the
agreement, upon delivery of the license and right to the sublicense in the first quarter of 2017, and the Company will recognize revenue associated with the development services as they are provided to Menarini. In the nine months ended
September 30, 2017, the Company recognized revenue totaling $9,728 related to the development services. Of the $9,728, the Company has received $2,858 in cash payments; the balance of $6,870 is recorded in Receivables as of September 30,
2017.
In connection with the Agreement, the Company paid Wakunaga $1,590, which was credited toward the Companys future payment obligations to
Wakunaga under the license agreement the Company has with Wakunaga for certain intellectual property underlying
16
Baxdela. This expense was recorded in general and administrative expense, which is where the Company records all expenses related to intellectual property that are generated by events and
activities outside the Companys research and development activities. In this case, the payment was triggered by the receipt of upfront licensing fees from Menarini.
Receiving FDA approval of Baxdela triggered milestones of $6,000 and $1,500 due to Wakunaga and CyDex Pharmaceuticals, Inc. (now a wholly owned
subsidiary of Ligand Pharmaceuticals Incorporated, both hereafter referred to as Ligand), respectively. Melinta paid $2,000 to Wakunaga and $1,500 to Ligand in June 2017. The remaining $4,000 due to Wakunaga is recorded in Accrued Expenses and will
be paid in the next nine months.
Melinta has a distribution and supply agreement with Eurofarma, which gives Eurofarma the right to seek approval for and
commercialize Baxdela in Brazil. In August 2017, Melinta and Eurofarma entered into an amendment to the distribution and supply agreement to extend the licensed territory to substantially all of Central America and South America for consideration of
$1,000 (the Amendment). Because the Amendment did not significantly change the nature of the deliverables under the arrangement, management concluded that it did not constitute a material modification of the original arrangement. As
such, the $9,000 of deferred revenue recorded in connection with the original agreement is appropriately deferred as of September 30, 2017 as the Company has not yet commenced commercial supply of Baxdela for the territory (Brazil).
In addition, because the Amendment was negotiated at arms length, it was deemed to be a separate arrangement from the original contract. The Amendment
has multiple elements, including the delivery of the license and the exclusive supply of Baxdela with respect to the licensed territories. The Company concluded that there was no standalone value for the delivered license in the amendment;
accordingly, the consideration was recorded as deferred revenue as of September 30, 2017. We will commence recognition of the revenue when we begin to deliver under the supply agreement.
NOTE 9 COMMITMENTS AND CONTINGENCIES
The Company
may become subject to claims and assessments from time to time in the ordinary course of business. Such matters are subject to many uncertainties. The Company accrues liabilities for such matters when it is probable that future expenditures will be
made and such expenditures can be reasonably estimated. As of September 30, 2017, and December 31, 2016, the Company does not believe that any such matters, individually or in the aggregate, will have a material adverse effect on the
Companys business, financial condition, results of operations, or cash flows.
In May 2017, in connection with the commercial launch of Baxdela in
early 2018, the Company entered into a fleet agreement with Automotive Rentals, Inc. (ARI) under which it will lease vehicles for certain field-based employees. Under the fleet agreement, each vehicle will be leased under a separate
agreement for a term of up to four years. In connection with the fleet agreement, in June 2017 the Company issued to ARI a $200 letter of credit, which auto-renews annually. As of September 30, 2017, the Company had vehicles under lease with
annual minimum lease payments totaling approximately $70. The Company has completed its analysis of the leases, and because (i) the Company has no right to purchase the vehicles at any time, (ii) the future minimum lease payments are less
than 90% of the fair value of the vehicles at the time of lease and (iii) the Companys use of the vehicles does not exceed 75% of the vehicles useful lives, the Company has determined that they are operating leases under current GAAP.
Accordingly, the Company is recognizing the lease payments as expense as incurred.
Legal Proceedings
As discussed in Note 12, on November 3, 2017, the Company merged with Cempra, Inc. in a business combination. Prior to the merger, on November 4,
2016, a securities class action lawsuit was commenced in the United States District Court for the Middle District of North Carolina, Durham Division, naming Cempra, Inc. (now known as Melinta Therapeutics, Inc.) (for purposes of this Legal
Proceedings section, Cempra) and certain of Cempras officers as defendants, and alleging violations of the Securities Exchange Act of 1934 in connection with allegedly false and misleading statements made by the defendants between
May 1, 2016 and November 1, 2016 (the Class Period). The plaintiff seeks to represent a class comprised of purchasers of Cempras common
17
stock during the Class Period and seeks damages, costs and expenses and such other relief as determined by the Court. Two substantially similar lawsuits were filed in the United States
District Court, Middle District of North Carolina on November 22, 2016 and December 30, 2016, respectively, seeking to assert claims on behalf of all purchasers of Cempras common stock from July 7, 2015 through December 29,
2016, inclusive. Pursuant to the Private Securities Litigation Reform Act, on July 6, 2017, the court consolidated the three lawsuits into a single action and appointed a lead plaintiff and
co-lead
counsel in the consolidated case. On August 16, 2017, the plaintiffs in the case filed a consolidated amended complaint. On September 29, 2017, the defendants in the case filed a motion to dismiss the consolidated amended complaint.
On November 13, 2017, the plaintiffs in the case filed an opposition to the defendants motion to dismiss the consolidated amended complaint. Cempra believes it has meritorious defenses and intends to defend the lawsuits vigorously. It is
possible that similar lawsuits may yet be filed in the same or other courts that name the same or additional defendants.
On December 21, 2016, a
shareholder derivative lawsuit was commenced in the North Carolina Durham County Superior Court, naming certain of Cempras former and current officers and directors as defendants and Cempra as a nominal defendant, and asserting claims for
breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement, and corporate waste. A substantially similar lawsuit was filed in the North Carolina Durham County Superior Court on February 16, 2017. The complaints are
based on similar allegations as asserted in the putative securities class action described above, and seek unspecified damages and attorneys fees. Both cases were served and transferred to the North Carolina Business Court as mandatory complex
business cases. The Business Court has consolidated the two derivative cases into a single action and appointed lead counsel in the consolidated case. On July 6, 2017, the court entered an order staying the consolidated action pending
resolution of the putative securities class action.
On August 3, 2017, a shareholder derivative lawsuit was commenced in the Court of Chancery of
the State of Delaware, naming certain of Cempras former and current officers and directors as defendants and Cempra as nominal defendant, and asserting claims for breach of fiduciary duty, unjust enrichment, and corporate waste. The complaint
is based on similar allegations as asserted in the putative securities class action described above, and seeks unspecified damages and attorneys fees. On October 23, 2017, the defendants in the case filed a motion to dismiss the
complaint, which was supported by an opening brief filed on November 9, 2017. It is possible that similar lawsuits may yet be filed in the same or other courts that name the same or additional defendants.
On September 15, 2017, a shareholder derivative lawsuit was commenced in the United State District Court for the Middle District of North Carolina,
Durham Division, naming certain of Cempras former and current officers and directors as defendants and Cempra as nominal defendant, and asserting claims for breach of fiduciary duty, unjust enrichment, abuse of control, gross mismanagement,
corporate waste, and alleged violation of Section 14(a) of the Exchange Act. The complaint is based on similar allegations as asserted in the putative securities class action described above, and seeks unspecified damages and attorneys
fees. On December 1, 2017, the parties filed a joint motion seeking to stay the shareholder derivative lawsuit pending resolution of the putative securities class action. It is possible that similar lawsuits may yet be filed in the same or
other courts that name the same or additional defendants.
On September 27, 2017, a putative class action complaint was filed against Cempra and the
members of its board of directors on behalf of the public stockholders of Cempra in the United States District Court for the Middle District of North Carolina. The complaint alleges that the preliminary proxy statement issued in connection with the
proposed merger between Cempra and Melinta Therapeutics, Inc. (now known as Melinta Subsidiary Corp.) (for purposes of this Legal Proceedings section, Melinta) omitted material information in violation of Sections 14(a) and 20(a) of the
Exchange Act, rendering the preliminary proxy statement false and misleading. Among other remedies, the action sought to enjoin the merger unless and until additional disclosures are provided, damages, and attorneys fees. Cempra believes that
the action is without merit and that certain supplemental disclosures to the preliminary proxy statement made by Cempra have rendered the action moot. Nevertheless, counsel for plaintiff may file an application seeking recovery of attorneys
fees.
On October 6, 2017, a putative class action complaint was filed against Cempra and the members of its board of directors on behalf of the
public stockholders of Cempra in the United States District Court for the Middle District of North Carolina. The complaint, filed
18
after a definitive proxy statement was issued on October 5, 2017 in connected with the proposed merger between Cempra and Melinta alleges that the preliminary proxy statement omitted
material information in violation of Sections 14(a) and 20(a) of the Exchange Act, rendering the preliminary proxy statement false and misleading. The Complaint also asserted a claim under Section 20(a) of the Exchange Act against Melinta.
Among other remedies, the action sought enjoin the merger unless and until additional disclosures are provided, damage and attorneys fees. Cempra and Melinta believe that the action is without merit and that certain supplemental disclosures to
the preliminary proxy statement made by Cempra have rendered the action moot. Nevertheless, counsel for plaintiff may file an application seeking recovery of attorneys fees.
Other than as described above, Cempra is not a party to any legal proceedings and is not aware of any claims or actions pending or threatened against Cempra.
In the future, Cempra might from time to time become involved in litigation relating to claims arising from its ordinary course of business.
Other than
as described above, Melinta is not a party to any legal proceedings and is not aware of any claims or actions pending or threatened against Melinta. In the future, Melinta might from time to time become involved in litigation relating to claims
arising from its ordinary course of business.
NOTE 10 BENEFIT PLAN
The Company has a 401(k) Plan in which all of the Companys employees are eligible to participate. Each year, although not required, the Company may
make matching contributions to the 401(k) Plan. The Company made contributions of $105 and $65 for the three months ended September 30, 2017 and 2016, respectively, and $334 and $261 for the nine months ended September 30, 2017 and
2016, respectively.
NOTE 11 RELATED PARTY TRANSACTIONS
The Company uses various software tools in the research and development discovery process. These tools are licensed at market rates from a company owned by
Dr. William Jorgensen. Dr. Jorgensen is a founder of the Company and is the spouse of the Companys Chief Scientific Officer. The Company paid fees of $40 to Dr. Jorgensens company during the three and nine months ended
September 30, 2017. The Company paid fees of $43 to Dr. Jorgensens company during the nine-month period ended September 30, 2016; it did not pay any fees during the three months ended September 30, 2016.
Dr. Thomas Koestler is the Companys Chairman of the Board and is employed by the Companys lead investor. Dr. Koestler received
compensation for his role in the amount of $38 and $113 for the three and nine month periods ended September 30, 2017, and $38 and $113 for the three- and nine-month periods ended September 30, 2016, respectively.
The Company issued Convertible Promissory Notes to certain of its investors. See Note 3 for discussion of these notes.
NOTE 12 MERGER
On August 8, 2017, Melinta
entered into a definitive agreement to merge with a subsidiary of Cempra, Inc. (Cempra) in an
all-stock
transaction. On August 8, 2017, Melinta stockholders adopted the merger agreement and
approved the merger and related transactions, and on September 6, 2017, Melinta stockholders approved the merger agreement amendment, adopted the merger agreement, as amended, and approved the merger and related transactions, pursuant to the
terms of the merger agreement, as amended. The Cempra shareholders approved the merger in a meeting on November 3, 2017. On November 3, 2017, the merger closed.
19
On November 3, 2017, in connection with the closing of the merger, each outstanding share of Melintas
common stock (including shares of Melinta common stock issued upon the conversion, immediately prior to the effective time of the Merger, of Melintas then-outstanding convertible notes and preferred stock) automatically converted into the
right to receive 0.0229 shares of Cempras common stock. At the effective time of the Merger, each outstanding option, whether or not vested, to purchase Melinta common stock and each outstanding warrant to purchase Melinta common stock or
Melinta preferred stock unexercised prior to the effective time of the Merger was converted into an option or warrant to purchase post-merger common stock. Immediately after the
Merger, pre-closing Melinta
stockholders owned, on a fully-diluted basis as calculated under the treasury stock method, approximately 52% of post-merger common stock
and pre-closing Cempra
stockholders owned approximately 48% of post-merger common stock.
NOTE 13
SUBSEQUENT EVENTS
The Company evaluated subsequent events through the date that these financial statements were available for issuance, or
December 5, 2017. Any significant events that occurred after September 30, 2017, have been presented in other notes to these September 30, 2017, financial statements and are identified as subsequent events.
On November 28, 2017, Melinta entered into the acquisition agreement with The Medicines Company under which Melinta will acquire a group of antibiotic
drug businesses of The Medicines Company and certain other assets known, collectively, as the Infectious Disease Businesses (IDB). Melinta will pay $165,000 in cash and common stock with a fair value of $55,555 at the time of the closing
and will be committed to further payments of $25,000 each on the
12-
and
18-month
anniversaries of the closing date. In addition, Melinta will be obligated to make
contingent milestone and sales-based royalty payments to The Medicines Company based on future events. The Company expects that this transaction will close in the first quarter of 2018.
In connection with the Acquisition, Melinta received commitment letters for both a new financing agreement, the Senior Secured Credit Facility (the
Credit Facility) and $30,000 in additional equity financing from existing investors. The Credit Facility will provide up to $240,000 in debt and equity financing, with a term of six years. The lender will initially make $190,000 of the
total $240,000 financing available. The interest rate on the debt portion of this initial financing will be 11.75%. The additional $50,000 of debt is available after the Company has achieved certain revenue thresholds, and, if drawn, will bear an
interest rate of 14.75%. The Credit Facility will also provide for the lender to obtain a warrant for the purchase of Melinta common stock. Details of the Credit Facility and equity financing arrangement were not final as of the date of this report.
The proceeds of these arrangements will be used to fund the Acquisition, retire the 2017 Loan Agreement, and fund continuing operations of the Compan
y.
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Exhibit 99.3
MELINTAS MANAGEMENTS DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction with Melintas 2016 audited consolidated financial statements
included elsewhere in this document. This discussion and analysis contains forward-looking statements based upon current beliefs, plans and assumptions, such as statements regarding Melintas intentions, plans, objectives, expectations,
forecasts and projections. Melintas actual results and the timing of selected events could differ materially from those anticipated in these forward-looking statements.
Melinta Corporate Overview
Melinta
(we, us, our, the Company) was incorporated in the State of Delaware and commenced operations in October 2000. We have previously operated under the names
Rib-X
Designs, Inc. and
Rib-X
Pharmaceuticals, Inc., and in October 2013,
Rib-X
Pharmaceuticals, Inc. changed its name to Melinta Therapeutics, Inc. Melintas operations
to date have primarily focused on the discovery and development of antibiotics to combat resistant, life-threatening infections. We have also conducted activities related to business planning, organizing and staffing Melinta, raising capital and
other business development activities. In November 2012, the Company was recapitalized, and Vatera Healthcare Partners LLC became the lead investor in Melinta. On November 3, 2017, Melinta completed a merger with Cempra, Inc.
(Cempra) in which Melinta became Melinta Subsidiary Corp., a wholly-owned subsidiary of Cempra. Cempra was
re-named
Melinta Therapeutics, Inc. as part of the merger.
On June 19, 2017, the Company received approval from the Food and Drug Administration (FDA) to sell our first antibiotic,
Baxdela
®
, for treatment of advanced skin and skin structure infections (ABSSSI). The Company is completing plans to begin sales of Baxdela in early 2018.
To date, Melinta has principally financed its operations through sales of preferred stock, the issuance of convertible notes, loans from
financial institutions, and funds received from collaborations and business development transactions. Total cash generated through equity financings since our recapitalization through September 30, 2017, was $222.1 million, and our cash
balance at September 30, 2017, was $12.2 million.
Melinta has never been profitable. As of September 30, 2017, we had an
accumulated deficit of $553.9 million, and Melintas net losses were $40.1 million and $73.9 million for the nine months ended September 30, 2017, and the year ended December 31, 2016, respectively. Substantially all of
our losses have resulted from costs incurred in connection with our development and discovery programs as well as from general and administrative costs associated with the Companys operations.
We expect to continue to incur significant expenses as we advance the organization, including manufacturing drug product; establishing a
commercial organization; establishing marketing and distribution functions; completing our Phase 3 clinical study for community-acquired bacterial pneumonia (CABP); investing in additional indications for Baxdela; and advancing our
discovery programs. After the merger (discussed below) is consummated, Melintas expenses, evaluated as a stand-alone company, will further increase as a result of costs associated with being a public company, such as the hiring of financial
personnel and adding operational, financial and management information systems.
Recent Developments
On August 8, 2017, the Company entered into a definitive agreement to merge with a subsidiary of Cempra, Inc. (Cempra) in an
all-stock
transaction. On August 8, 2017, Melinta stockholders adopted the merger agreement and approved the merger and related transactions, and on September 6, 2017, Melinta stockholders approved the
merger agreement amendment, adopted the merger agreement, as amended, and approved the merger and related transactions, pursuant to the terms of the merger agreement, as amended. The Cempra shareholders approved the merger in a meeting on
November 3, 2017. On November 3, 2017, the merger closed and on November 6, 2017, Melinta began trading on the NASDAQ under the ticker symbol MLNT.
1
On November 28, 2017, Melinta entered into the acquisition agreement with The Medicines
Company under which Melinta will acquire a group of antibiotic drug businesses of The Medicines Company and certain other assets known, collectively, as the Infectious Disease Businesses (IDB). Melinta will pay $165.0 million in
cash and in common stock with a fair value of $55.6 million at the time of the closing and will be committed to further payments of $25.0 million each on the
12-
and
18-month
anniversaries of the closing date. In addition, Melinta will assume certain contingent milestone payment liabilities and will make sales-based royalty payments to The Medicines Company based on future
events.
In connection with the Acquisition, Melinta received commitment letters for both a new financing agreement, the Senior Secured
Credit Facility (the Credit Facility), and $30,000 in additional equity financing from existing investors. The Credit Facility will provide up to $240 million in debt and equity financing, with a term of six years. The lender will
initially make $190,000 of the total $240,000 financing available. The interest rate on the debt portion of this initial financing will be 11.75%. The additional $50,000 of debt is available after the Company has achieved certain revenue thresholds,
and, if drawn, will bear an interest rate of 14.75%. The Credit Facility will also provide for the lender to obtain a warrant for the purchase of Melinta common stock. Details of the Credit Facility and equity financing arrangement were not final as
of the date of this report. The proceeds of these arrangements will be used to fund the Acquisition, retire the 2017 Loan Agreement, and fund continuing operations of the Company.
Financial Overview
Revenue
To date, Melinta has not generated any product revenue or royalties from the sale of commercial products. Baxdela has been approved for
commercial sale in the United States, and we intend to commercialize Baxdela in the United States with a targeted sales force. The Company anticipates that it will not recognize meaningful revenue from sales of this product before 2018.
For markets outside of the United States, we have partnered with leading multi-national pharmaceutical companies around the world to optimize
the global commercial potential of Baxdela. Currently, commercial agreements exist in Europe, Asia-Pacific (excluding Japan), Central and South America and the Middle East and Africa regions.
In December 2014, we entered into distribution and supply agreements for Baxdela with Eurofarma, a leading pharmaceutical company in Brazil.
Under the terms of these arrangements, Eurofarma will be responsible for filing for approval for Baxdela in Brazil and, if approved, will commercialize Baxdela in that territory. Upon entering into this arrangement, Melinta received a
$15.0 million payment, $6.0 million was recorded as an equity investment and $9.0 million of deferred revenue was recorded as a liability in January 2015, when the transaction was funded. The ability to recognize this revenue is
dependent upon receiving regulatory and pricing approval in Brazil and the successful commercialization of the product by Melintas partner. Should regulatory and pricing approval be obtained, the recognition of the deferred revenue will
commence upon our initial shipments of Baxdela to Eurofarma. In August 2017, Melinta entered into an amendment to the distribution and supply agreement to extend the licensed territory to substantially all of Central America and South America for
consideration of $1.0 million. Under the terms of this amendment, we have the ability to earn additional milestones up to $3.6 million based on regulatory approval in several countries.
In August 2015, Melinta entered into supply and distribution agreements with Malin, a principal investor of Melinta with a more than 5%
ownership interest, which Malin subsequently assigned to its affiliate Altan Pharma Limited, or Altan. Pursuant to the terms and conditions of the supply and distribution agreements, Altan is entitled to exclusive rights to obtain product approval,
procure supply from Melinta and commercialize Baxdela in Africa and the Middle East. In connection with the supply and distribution agreements, Melinta is entitled to receive a royalty based on Altans net sales of Baxdela. No upfront payments
were received or paid in connection with these agreements.
2
In February 2017, Melinta executed a license agreement with Menarini, a leading pharmaceutical
company based in Europe, under which Melinta licensed rights to commercialize Baxdela in certain European, Asia-Pacific (excluding Japan) and other
rest-of-world
territories. Pursuant to the terms and conditions of the arrangement, Menarini is entitled to exclusive rights to obtain product approval, procure supply from Melinta and commercialize Baxdela in the licensed territories, and Melinta may earn
additional commercial and regulatory milestones of approximately 90.0 million and is entitled to receive a tiered royalty, in the low double digits, based on Menarinis net sales of Baxdela and the country of sale. In addition,
Menarini and Melinta agreed to share jointly in the future development cost of Baxdela, including the current CABP Phase 3 clinical trial and, potentially, other future studies initiated for additional indications. At the onset of this arrangement,
we received $19.9 million, and, going forward, we are entitled to reimbursement of 50% of the development costs incurred for our
in-process
CABP Phase 3 clinical trial. The Company recognized
$19.9 million of revenue associated with the delivery of the license to Menarini in the first quarter of 2017 and is recognizing revenue related to the reimbursement of development costs as the services are performed.
During the nine months ended September 30, 2017, we recognized revenue from the Menarini agreement of $29.6 million, of which
$19.9 million related to the license and $9.7 million related to the cost-sharing arrangement for expenses incurred during the first half of 2017.
To the extent that the Company does not find additional partners for the commercialization of Baxdela outside the United States, or to the
extent that our existing partners are not successful in the commercialization of Baxdela, we may or may not receive additional milestones, royalties or other collaboration related revenue in the future.
Research and Development Expenses
The majority of our operating expenses to date have been incurred for discovery, research and development costs relating to our drug
candidates. The Companys business model is dependent upon its continued investment in discovery, research and development. Melintas discovery, research and development costs consist primarily of:
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external development expenses incurred under arrangements with third parties such as: fees paid to contract research organizations (CROs) in connection with Melintas clinical trials, costs of acquiring
and evaluating clinical trial data such as investigator grants, patient screening fees, laboratory work, statistical compilation and fees paid to consultants;
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external discovery expenses incurred under arrangements with third parties to conduct research and testing related to our ESKAPE pathogen program;
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employee-related expenses, including salaries, benefits, travel and stock-based compensation expense;
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costs to acquire, develop and manufacture clinical trial materials, including fees paid to contract manufacturers;
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expenses, including milestone payments, related to licensed products and technologies until regulatory approval of the products;
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compliance costs and fees related to drug development regulatory requirements; and
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facilities, depreciation, rent, maintenance, insurance, laboratory and other supplies.
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expense research and development costs as incurred. Discovery, clinical trial and other development costs incurred by third parties are recognized as expense as the contracted services are performed. We accrue for incurred expenses as the services
are being provided by monitoring the status of the clinical trial or project and the corresponding invoices and other input received from Melintas external service providers. Expenses for certain development activities are recognized based on
an evaluation of the progress to completion of specific tasks using information and data provided by Melintas vendors and its clinical sites. We adjust our accrual as actual costs become known.
3
We anticipate that we will continue to incur significant research, development and manufacturing
expenses in connection with the completion of our Phase 3 trial testing the intravenous and oral formulations of Baxdela for patients with CABP and evaluating the results of that trial. If we achieve positive results, we will incur additional
expenses related to the CABP indication to support the process for obtaining marketing approval. The Company also anticipates incurring significant research and development expenses as it pursues additional indications for Baxdela. Further, we
intend to advance a lead candidate from our novel drug discovery program focused on resistant pathogens into the clinical stage, which will lead to the incurrence of significant development expenses for this program. Additionally, we have
collaborated with a third-party research organization to develop its radezolid drug candidate, and the Company may decide to
opt-in
to the radezolid acne program or initiate additional radezolid indications,
which would increase the costs borne by Melinta for this product.
The successful development of Melintas product candidates is
highly uncertain due to the numerous risks and uncertainties associated with developing drugs, including:
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the scope, rate of progress and expense of our discovery, research and development activities;
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our ability to market, commercialize and achieve market acceptance of Baxdela or any other product candidate we may develop in the future;
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the results of our clinical trials;
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the terms and timing of regulatory approvals; and
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the expense of filing, prosecuting, defending and enforcing patent claims and other intellectual property rights.
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A change in the outcome of any of these variables with respect to the development of any product candidate that we may develop could mean a
significant change in the costs and timing associated with the development of the product candidates. For example, if the FDA or other regulatory authority were to require Melinta to conduct clinical trials beyond those which we currently anticipate
will be required for the completion of clinical development of Baxdela for CABP or other product candidates, or if we experience significant delays in clinical trial enrollment in any clinical trial, we could be required to expend significant
additional financial resources and time on the completion of clinical development.
Selling, General and Administrative Expenses
Selling, general and administrative expenses (SG&A) consist primarily of salaries and benefits-related expenses for personnel,
including stock-based compensation expense, in our executive, finance, sales, marketing and business development functions. SG&A costs also include facility costs for the Companys administrative offices and professional fees relating to
legal, intellectual property, human resources, information technology, accounting and consulting services.
We expect to incur increased
expenses associated with expanding our marketing function and building a U.S. commercial team in connection with the commercial launch of Baxdela. We started incurring these expenses in the second half of 2016 in anticipation of the marketing
approval of Baxdela in the second quarter of 2017. These expenses will increase substantially in the fourth quarter of 2017 and first quarter of 2018 as the Company completes the development of its sales team. We also expect to support the growth in
our business with increased headcount and infrastructure costs. We expect that our general and administrative expenses will increase in the future as we expand our operating activities, maintain and expand our patent portfolio, and incur additional
costs associated with the merger through which we became a public company.
Interest Income and Expense
Melintas excess cash balances are invested in money market funds, which generate a minimal amount of interest income. Melinta expects to
continue this investment philosophy for excess cash as additional funds are received.
4
We have utilized notes payable and convertible promissory notes as sources of funding. We record
interest on the effective interest method in relation to outstanding notes.
Critical Accounting Policies and Significant Judgments and Estimates
Melintas managements discussion and analysis of its financial condition and results of operations is based on its
financial statements, which Melinta has prepared in accordance with GAAP. The preparation of these financial statements requires Melinta to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the
disclosure of contingent assets and liabilities in Melintas financial statements. On an ongoing basis, Melinta evaluates its estimates and judgments, including those related to accrued expenses and stock-based compensation described in greater
detail below. Melinta bases its estimates on historical experience, known trends and events, and various other factors that Melinta believes are reasonable under the circumstances, the results of which form the basis for making judgments about the
carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Melintas significant accounting policies are described in more detail in Note 2 to Melintas audited consolidated financial
statements appearing elsewhere in this Current Report on Form
8-K.
However, Melinta believes that the following accounting policies are the most critical to aid you in fully understanding and evaluating
Melintas financial condition and results of operations:
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Accrued research and development expenses
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Stock-based compensation
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Preferred stock warrants
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Revenue Recognition
Melinta recognizes revenue under ASC 605, Revenue Recognition. Melintas revenue arrangements consist of licensing revenue related to
non-refundable
upfront fees, reimbursement of research and development expenses, milestone payments and royalties on future product sales by the licensee. Revenue is recognized when the following criteria are met:
(1) persuasive evidence that an arrangement exists; (2) delivery of the products and/or services has occurred; (3) the selling price is fixed or determinable; and (4) collectability is reasonably assured.
For arrangements that involve the delivery of more than one element, significant contract interpretation is sometimes required to determine
the appropriate accounting, including whether the deliverables specified in a multiple-element arrangement should be treated as separate units of accounting for revenue recognition purposes and, if so, how the aggregate contract value should be
allocated among the deliverable elements and when to recognize revenue for each element under ASC 605. Each product, service and/or right to use assets is evaluated to determine whether it qualifies as a separate unit of accounting. This
determination is based on whether the deliverable has stand-alone value to the customer. The consideration that is fixed or determinable is then allocated to each separate unit of accounting based on the relative fair values of each
deliverable. The consideration allocated to each unit of accounting is recognized as the related goods and services are delivered, limited to the consideration that is not contingent upon future deliverables. When an arrangement is accounted for as
a single unit of accounting, Melinta determines the period over which the performance obligations will be performed and revenue recognized.
Under the Menarini license agreement, discussed in Note 8 to Melintas unaudited condensed consolidated financial statements included in
this Current Report on Form
8-K,
at the time the agreement was entered into, Melinta identified two
5
deliverables: the delivery of the Baxdela license to Menarini and the right to a related sublicense. While Melinta is also providing development services in connection with the expansion of
applicable indications for Baxdela, Melinta is under no obligation to perform such services. In the event that Melinta performs development services related to other indications of Baxdela, Menarini has the option to obtain the results of such
services by reimbursing Melinta for 50 percent of its related costs, and Melinta has determined that Menarinis option is not priced at a significant and incremental discount. As such, Melinta has not recognized any revenue related to the
potential cost reimbursement at the contract execution date. To the extent that Melinta is reimbursed for development services, such amounts will be recognized separately from the initial license.
The agreement also states a separate supply agreement will be entered into at a future date under which Menarini will purchase Baxdela
products from Melinta until it can commence its own manufacturing. The pricing of Baxdela products under the supply agreement will not be at a significant, incremental discount. And, under the terms of the agreement, Melinta may receive up to
approximately 90 million for regulatory, commercial and sales-based milestones as well as low, double-digit royalties on future sales of Baxdela. Melinta will recognize any future milestone payment received as revenue when Menarini
achieves the milestone.
For immediate use of the license and right to sublicense, Menarini is able to leverage the information contained
within the Baxdela NDAs, which were filed by Melinta with the FDA in October 2016 for ABSSSI, to prepare the regulatory filings in the licensed territories. And, while the FDA approval was received in June 2017, regulatory approval in many of the
licensed territories is not contingent upon U.S. FDA approval. Melinta recognized $19.9 million, the consideration that was fixed and determinable at the inception of the agreement, upon delivery of the license and right to sublicense in the
first quarter of 2017, and Melinta will recognize revenue associated with the development services as they are provided to Menarini. In the six months ended June 30, 2017, Melinta recognized revenue totaling $6.5 million related to the
development services.
In December 2014, Melinta entered into a supply agreement and a distribution agreement, together referred to as the
commercial agreements, and a stock purchase agreement with Eurofarma. The overall purpose of these agreements was to establish a relationship with Eurofarma to distribute Baxdela in Brazil. Upon entering the agreements, Melinta received a
$1.0 million milestone payment for consideration of the rights granted in the commercial agreements. Simultaneously, Eurofarma purchased $14.0 million of Series
3-B
Convertible Preferred Stock at a
negotiated valuation of $2.660397 per share.
Because the Eurofarma agreements were entered into on a concurrent basis, Melinta determined
that accounting for this transaction required an analysis of the relative fair values of the agreements and that the total consideration received should be allocated to the various components based on the relative fair values. In the analysis,
Melinta determined that it would record $6.0 million as the fair value of the equity investment and $9.0 million as deferred revenue relating to the commercial agreements. The determination of these amounts required significant estimates
by management.
The value of shares purchased by Eurofarma was determined by management with input from an independent external valuation
expert based on the Probability Weighted Expected Return Model, or PWERM, model, as described under Common Stock Valuation below, as of December 31, 2014. This model required estimates of the future value of Melinta under various funding,
acquisition and liquidation scenarios. These scenarios were developed by management based on comparative market data and internal fund raising objectives. The PWERM model also included assumptions regarding discount rate, new option grants,
volatility and a discount for lack of marketability.
The values of the commercial agreements, which essentially represent the
distribution rights for Baxdela in Brazil, were determined using a comparative business valuation method (often referred to as the
with-and-without
method).
Melinta prepared an expected value analysis assuming a commercial entry into Brazil without a partner versus the scenario of working with Eurofarma as a partner. The difference in expected values in these two scenarios was used to determine the
relative value of the commercial agreements. This comparative business model valuation method required assumptions regarding product launch timing, market size, market share, market uptake, pricing, research and development costs, commercialization
costs, tax rates and the discount rate applied. In developing the assumptions regarding product launch timing, market size, market share and market uptake, Melinta used estimates included in the commercial agreements, which estimates may ultimately
change based on actual results. Changes in any of Melintas assumptions may have had a material impact on the distribution of relative values between equity and deferred revenue.
6
The value assigned to the equity component of this transaction was included in the balance sheet
as convertible preferred stock. The value assigned to the commercial agreements was recorded as deferred revenue and will be recognized over the applicable patent lives, commencing upon the initial shipments of Baxdela.
Accrued Research and Development Expenses
As part of the process of preparing Melintas financial statements, Melinta estimates its accrued research and development expenses. The
process involves reviewing quotations and contracts, identifying services that have been performed on Melintas behalf and estimating the level of service performed and the associated cost incurred for the service when Melinta has not yet been
invoiced or otherwise notified of the actual cost. The majority of Melintas service providers invoice Melinta monthly in arrears for services performed or when contract milestones are achieved. Melinta makes estimates of its accrued expenses
as of each balance sheet date in its financial statements based on the facts and circumstances known to Melinta at that time. Melinta periodically confirms the accuracy of its estimates with the service providers and make adjustments as necessary.
The significant estimates in Melintas accrued research and development expenses are related to costs incurred by its partners, such as CROs, in connection with research and development activities for which Melinta has not yet been invoiced.
Expenses relating to CROs are the most significant component of Melintas research and development accruals.
Melinta recognizes
expenses related to CROs based on Melintas estimates of the services received and efforts expended pursuant to quotes and contracts with the CROs. The financial terms of these agreements are subject to negotiation, vary from contract to
contract and may result in uneven payment flows. There may be instances in which payments made to Melintas vendors will exceed the level of services provided at the time of payment and result in a prepayment of the research and development
expense. If the actual timing of the performance of services or the level of effort varies from Melintas estimate, Melinta adjusts the accrual or prepaid expense accordingly.
Stock-Based Compensation
Melinta
accounts for stock-based compensation using the fair value method. The fair value of awards granted is estimated at the date of grant and recognized as expense on a straight-line basis over the requisite service period with the offsetting credit to
additional
paid-in
capital. Stock options granted typically fully vest over four years from the grant date and expire after 10 years.
Stock options are granted at exercise prices not less than the estimated fair value of Melintas common stock at the date of grant.
Melinta utilizes the Black-Scholes option-pricing model for determining the estimated fair value of awards. Key inputs and assumptions include the expected term of the option, stock price volatility, risk-free interest rate, dividend yield,
estimated fair value of Melintas common stock, and exercise price. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of stock-based compensation expense. Melinta adjusts
stock-based compensation expense for forfeitures when actual forfeitures occur.
Stock options granted to nonemployees are valued using
the Black-Scholes option-pricing model. Stock options granted to nonemployees are subject to periodic revaluation over their vesting terms. As a result, the charge to operating expenses for nonemployee options with vesting is affected each reporting
period by changes in the fair value of the stock options.
Melinta has historically granted common stock options to members of management.
The majority of options outstanding as of September 30, 2017, were granted under the 2011 Equity Incentive Plan in December 2013 or later. (As of September 30, 2017, 118 stock options are outstanding under the 2001 Stock Option and
Incentive Plan.) While the majority of options are held by management and other employees, Melintas founders and some members of the Board of Directors have also been granted options. As Melinta continues to expand its headcount in support of
pursuing additional clinical programs and building a commercial
7
organization, Melinta expects to make additional option grants, which will result in additional stock-based compensation expense. Since Melinta has not been a publicly traded company, the fair
value of Melintas common stock has historically been determined by management with input from an independent external valuation expert. The intent of management is to ensure that the exercise price of issued options is not less than fair value
at the date of the grant.
The following table summarizes the weighted-average assumptions, other than the estimated fair value of
Melintas common stock (which is discussed under Common Stock Valuation below), used in the Black-Scholes model to value stock option grants for the nine months ended September 30, 2017.
|
|
|
|
|
|
|
Nine Months Ended
|
|
|
|
September 30, 2017
|
|
Risk-free interest rate
|
|
|
1.96
|
%
|
Weighted-average volatility
|
|
|
75.4
|
%
|
Expected termemployee awards (in years)
|
|
|
6.0
|
|
Forfeiture rate
|
|
|
0.00
|
%
|
Dividend yield
|
|
|
|
|
Risk-free Interest Rate
The risk-free interest rate assumptions are based on
zero-coupon
U.S. Treasury instruments that have terms consistent with the expected term for Melintas stock option grants.
Expected Dividend Yield
Melinta has never declared or paid any cash dividends and do not presently plan to pay cash dividends in
the future.
Expected Volatility
Due to Melintas limited operating history and lack of its specific historical and
implied volatility rates, the expected volatility rate used to value stock option grants is estimated based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group is updated at least annually
based on companies in the pharmaceutical and biopharmaceutical industry with a specific therapeutic focus and at a similar stage of development.
Forfeiture Rate
Under the Financial Accounting Standards Board, or FASB, ASC 718 Compensation Stock Compensation, or FASB
ASC Topic 718, prior to January 1, 2016, Melinta was required to estimate the level of forfeitures expected to occur and record share-based compensation expense only for those awards that Melinta ultimately expects will vest. Due to the lack of
historical forfeiture activity of its plan, Melinta estimated the forfeiture rate based on data from a representative group of companies with similar characteristics to Melinta. In March 2016, the FASB issued Accounting Standards Update
2016-09,
Improvements to Employee Share-Based Payment Accounting, which simplified several aspects of the accounting for employee share-based payment transactions, including the accounting for income taxes,
forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. On January 1, 2016, Melinta adopted this guidance on a modified retrospective basis and changed its accounting policy for
forfeitures of stock-based compensation to recognize such forfeitures as they occur rather than estimating an expected amount of forfeitures. The impact of this change to the financial statements was not significant and, therefore, Melinta did not
record an adjustment to its beginning accumulated deficit as of January 1, 2016.
Common Stock Valuation
Options outstanding as of September 30, 2017, granted under the 2011 Stock Option Plan, the fair value of the common stock at each grant
date, and the grant date fair value of the options are summarized in the following table:
8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Option Grant Date
|
|
Number of Options
Granted &
Outstanding
|
|
|
Exercise
Price
|
|
|
Fair Value of
Common
Stock
|
|
|
Grant Date Fair
Value of Options
|
|
|
Total Grant Date
Fair Value of
Options
|
|
December 2013
|
|
|
5,631,717
|
|
|
$
|
0.39
|
|
|
$
|
0.39
|
|
|
$
|
0.22
|
|
|
$
|
1,238,978
|
|
April 2014
|
|
|
5,939,668
|
|
|
$
|
0.63
|
|
|
$
|
0.63
|
|
|
$
|
0.37
|
|
|
$
|
2,197,677
|
|
May 2014
|
|
|
168,951
|
|
|
$
|
0.63
|
|
|
$
|
0.63
|
|
|
$
|
0.37
|
|
|
$
|
62,512
|
|
June 2014
|
|
|
743,951
|
|
|
$
|
0.63
|
|
|
$
|
0.63
|
|
|
$
|
0.37
|
|
|
$
|
275,262
|
|
September 2015
|
|
|
3,558,208
|
|
|
$
|
0.83
|
|
|
$
|
0.83
|
|
|
$
|
0.55
|
|
|
$
|
1,957,014
|
|
November 2015
|
|
|
795,072
|
|
|
$
|
0.87
|
|
|
$
|
0.87
|
|
|
$
|
0.58
|
|
|
$
|
461,142
|
|
December 2015
|
|
|
196,665
|
|
|
$
|
0.87
|
|
|
$
|
0.87
|
|
|
$
|
0.58
|
|
|
$
|
114,066
|
|
March 2016
|
|
|
3,344,194
|
|
|
$
|
0.87
|
|
|
$
|
0.81
|
|
|
$
|
0.52
|
|
|
$
|
1,738,981
|
|
September 2016
|
|
|
2,057,835
|
|
|
$
|
0.50
|
|
|
$
|
0.50
|
|
|
$
|
0.30
|
|
|
$
|
617,351
|
|
October 2016
|
|
|
608,875
|
|
|
$
|
0.50
|
|
|
$
|
0.22
|
|
|
$
|
0.10
|
|
|
$
|
60,888
|
|
January 2017
|
|
|
594,782
|
|
|
$
|
0.50
|
|
|
$
|
0.27
|
|
|
$
|
0.15
|
|
|
$
|
89,217
|
|
April 2017
|
|
|
1,019,300
|
|
|
$
|
0.50
|
|
|
$
|
0.27
|
|
|
$
|
0.14
|
|
|
$
|
142,702
|
|
August 2017
|
|
|
6,171,679
|
|
|
$
|
0.48
|
|
|
$
|
0.48
|
|
|
$
|
0.32
|
|
|
$
|
1,974,937
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,830,897
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
10,930,727
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Since inception, Melinta has been a private company with no active public market for Melintas common
stock. Therefore, Melinta has utilized a third-party valuation expert to assist management in periodically determining the per share fair value of Melintas various classes of equity. These valuations were prepared in compliance with the
Statement on Standards for Valuation Services No. 1 of the American Institute of Certified Public Accountants. Since the November 2012 recapitalization of Melinta, valuations have been prepared as of November 15,
2012, September 30, 2013, March 21, 2014, December 31, 2014, and quarterly thereafter through June 30, 2017.
In conducting these valuations, with input from the board of directors and third-party valuation specialists, Melinta considered objective and
subjective factors that Melinta believed to be relevant for each valuation conducted, including Melintas best estimate of its business condition, prospects and operating performance at each valuation date. For the valuations performed, Melinta
used a range of factors and assumptions. The significant factors include:
|
|
|
the rights, preferences and privileges of Melintas convertible preferred stock as compared to those of Melintas common stock, including liquidation preferences and dividend rights of Melintas
convertible preferred stock;
|
|
|
|
potential future issuances of stock, warrants or options;
|
|
|
|
Melintas results of operations, financial position and the status of research and development efforts;
|
|
|
|
the lack of liquidity of Melintas common and preferred stock as a private company;
|
|
|
|
Melintas stage of development and business strategy and the material risks related to Melintas business and industry;
|
|
|
|
the likelihood of achieving a liquidity event for the holders of Melintas equity, such as an initial public offering, or IPO, or a sale of Melinta given the prevailing market conditions, or a chance of clinical
failure and subsequent liquidation of Melinta;
|
|
|
|
the achievement of corporate objectives, including entering into business development transactions;
|
|
|
|
the valuation of publicly traded companies in the life sciences and biotechnology sectors, as well as recently completed mergers and acquisitions of peer companies;
|
9
|
|
|
any external market conditions affecting the life sciences and biotechnology industry sectors;
|
|
|
|
the state of the IPO market for similarly situated privately held biotechnology companies;
|
|
|
|
general U.S. economic conditions; and
|
|
|
|
Melintas most recent valuations prepared with the assistance of its independent valuation specialist.
|
Melinta and its third-party valuation specialist considered several different valuation methodologies for estimating the value of the
enterprise and evaluated several models for allocating that value to the various classes of equity.
Melinta selected the PWERM method to
allocate the equity value among the various classes of equity given Melintas stage of development, the availability of relevant data and Melintas expectation that Melinta is able to forecast distinct future liquidity scenarios as of each
valuation date. Furthermore, the PWERM approach was deemed to be the valuation model investors would likely use to value Melintas company. Under a PWERM approach, the value of various equity securities are estimated based upon an analysis of
future values for the enterprise assuming various future outcomes, as well as the rights of various classes of equity. Melintas future outcomes were modeled based on various scenarios for initial public offerings, various company sale
scenarios and a liquidation scenario. These scenarios were developed by management based on comparative market data and internal fundraising objectives.
The PWERM analyses underlying each scenario represent Level 3 unobservable inputs. Management makes assumptions and uses judgment to
estimate the following inputs into Melintas PWERM model (listed in order of significance):
|
1)
|
The Value and Timing of Future Liquidity Events
. Melinta estimates the value of future liquidity events under three scenarios: an IPO scenario, a sale of Melinta and a liquidation scenario. The IPO and
Melinta sale scenarios each include high, middle and low range values. Each scenario and value point within each scenario is assigned a probability based on managements assessment of the likelihood of occurrence of a liquidity event of that
type for the indicated valuation amount. The timing of the various events is determined by management based on Melintas intentions at that valuation date. The values for the IPO scenario are determined by comparison to similar stage companies
and managements calculations based on current valuations and future anticipated financings. Melinta sale scenarios are based on average change in control premiums for similar companies and analysis of specific relevant transactions. While
multiple scenarios were considered, in order to reflect a range of possible future values, the greatest weighting was applied to the IPO scenarios, which management deemed to be the most likely form of liquidity event as of each valuation date.
During the period over which Melinta has prepared valuations, Melinta has applied between
60-85%
of the weighting to the IPO scenarios and
10-35%
to Melinta sale
scenarios. Significant increases or decreases in these inputs in isolation would result in a significantly different fair value measurement.
|
|
2)
|
Discount Rate.
The discount rates used to determine the valuation are estimated using the Capital Asset Pricing Model, or CAPM. Melinta evaluates quantitative and qualitative factors at each valuation date
that help Melinta assess the level of risk in Melintas assumptions and Melinta adjusts its discount rates accordingly. Melinta applies discreet discount rates by series and tranche of stock.
|
|
3)
|
Discount for Lack of Marketability
. The Discount for Lack of Marketability, or DLOM, factors for Melintas preferred and common stock are estimated using both quantitative and qualitative methods and
have generally declined as Melinta approaches a potential liquidity event. Melinta applies a separately determined DLOM for each series of preferred stock as well as for common stock.
|
Preferred Stock Warrants
In
connection with a loan and security agreement entered into during 2014 with Hercules Growth Technologies, Melinta issued preferred stock warrants. Melinta accounts for the freestanding warrants to purchase shares of convertible preferred stock at
fair value as liabilities in the balance sheets, as such warrants provide the holders with down-round protection and can be settled
10
on a net basis. Melinta uses a Black-Scholes model to estimate the fair value of the preferred stock warrant
liability based on the estimated fair value of Melintas Series 3 preferred shares derived from the PWERM (discussed above in Common Stock Valuation). The value of the preferred stock warrant liability is adjusted to its estimated fair value at
each reporting period. During the nine months ended September 30, 2017, Melinta recorded $0.3 million in net unrealized gains related to decreases in the fair value of this liability. As of September 30, 2017, the fair value of the
preferred stock warrant liability was $0.3 million.
Inventory
Inventory is stated at the lower of cost or estimated net realizable value. We currently use actual costing to determine the cost basis for its
inventory. Inventory is valued on
a first-in, first-out
basis and consists primarily of third-party manufacturing costs, overhead and related transportation
costs. We capitalize inventory costs associated with our products upon regulatory approval when, based on managements judgment, future commercialization is considered probable and the future economic benefit is expected to be realized;
otherwise, such costs are expensed. We review inventories on hand at least quarterly and record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value.
As of September 30, 2017, inventory on the Companys balance sheet represented the cost of certain raw material and
work-in-process
inventory that the Company incurred after the FDA approval of Baxdela on June 19, 2017. At September 30, 2017, the Company had incurred other costs
for manufacturing this inventory; however, such costs were incurred prior to the FDA approval of Baxdela and, therefore, were recognized as research and development expense in earlier periods. Consequently, profit margins reported from the initial
sales of Baxdela will not be representative of margins the Company expects to achieve after the first commercial batches of inventory are consumed. Costs of drug product to be consumed in any current or future trials will continue to be recognized
as research and development expense.
Results of Operations (all amounts in thousands)
Comparison of the Three Months Ended September 30, 2017 and 2016
The following table summarizes Melintas results of operations for the three months ended September 30, 2017 and 2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Increase (Decrease)
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percent
|
|
Revenue
|
|
$
|
3,191
|
|
|
$
|
|
|
|
$
|
3,191
|
|
|
|
100
|
%
|
Research and development
|
|
$
|
10,884
|
|
|
$
|
9,888
|
|
|
$
|
996
|
|
|
|
10.1
|
%
|
Selling, general and administrative
|
|
$
|
10,304
|
|
|
$
|
4,114
|
|
|
$
|
6,190
|
|
|
|
150.5
|
%
|
Total other expense, net
|
|
$
|
1,639
|
|
|
$
|
664
|
|
|
$
|
975
|
|
|
|
146.8
|
%
|
Revenue
During the three months ended September 30, 2017, Melinta recognized revenue from the Menarini agreement of $3.2 million related to
the cost-sharing arrangement for expenses incurred during the third quarter of 2017. Because we are delivering development services over a period of time as the clinical trials progress, we expect to continue to recognize cost-sharing revenue under
this arrangement for the next few years over the estimated development period.
11
Research and development expenses
Our research and development expenses for the three months ended September 30, 2017 and 2016 were $10.9 million and
$9.9 million, respectively. There have been two primary areas of focus for us in the three months ended September 30, 2017 and 2016. The first area of focus and the primary cost driver has been the clinical development and FDA
approval of Baxdela, our lead product candidate. The second area of focus has been the
pre-clinical
activity (Discovery) for the ESKAPE pathogen program as we work to select a lead program candidate with an
optimal efficacy and safety profile.
We do not allocate personnel-related costs, including stock-based compensation or other indirect
costs, to specific programs as they are deployed across multiple projects under development and, as such, are included as other development or discovery expenses in the table below. The following table summarizes our research, development and
discovery costs by clinical program for the three months ended September 30, 2017 and 2016, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
|
Increase/(Decrease)
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Research and Development Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phase 3 ABSSSI Intravenous/Oral study
|
|
$
|
|
|
|
$
|
175
|
|
|
$
|
(175
|
)
|
|
|
(100.0
|
%)
|
Phase 3 CABP study
|
|
|
5,530
|
|
|
|
1,300
|
|
|
|
4,230
|
|
|
|
325.4
|
%
|
Other development expenses
|
|
|
2,890
|
|
|
|
5,133
|
|
|
|
(2,243
|
)
|
|
|
(43.7
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total development research and development expenses
|
|
|
8,420
|
|
|
|
6,608
|
|
|
|
1,812
|
|
|
|
27.4
|
%
|
Discovery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
External expenses
|
|
|
742
|
|
|
|
1,361
|
|
|
|
(619
|
)
|
|
|
(45.5
|
%)
|
Other discovery expenses
|
|
|
1,722
|
|
|
|
1,919
|
|
|
|
(197
|
)
|
|
|
(10.3
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total discovery research and development expenses
|
|
|
2,464
|
|
|
|
3,280
|
|
|
|
(816
|
)
|
|
|
(24.9
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses
|
|
$
|
10,884
|
|
|
$
|
9,888
|
|
|
$
|
996
|
|
|
|
10.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In total, our research and development costs increased in 2017 over 2016 by $1.0 million, or 10.1%. The
increase is due primarily to $4.2 million of incremental expense for our Phase 3 clinical study of Baxdela for CABP, which was partially offset by reduced expense due to the conclusion of the Phase 3 ABSSSI clinical study and lower expenses
related to the development of the ESKAPE pathogen program.
Development expenses for our Phase 3 clinical study for ABSSSI, testing the
intravenous and oral forms of Baxdela, decreased in 2017 versus 2016 by $0.2 million. The study was completed in 2016 and no costs were incurred in 2017. We do not expect to incur any additional costs related to this study.
Development expenses for the Phase 3 CABP clinical trial increased by $4.2 million, or 325.4%, in 2017 from 2016, driven by steady
patient enrollment during 2017. While the study was active for the entire year of 2016, we did not ramp up study activity until late in 2016 with the first patient enrollment in December 2016. As such, we expect that in 2017 and 2018 we will incur a
significant level of expenses associated with this study.
12
Other development costs decreased in the three months ended September 30, 2017, by
$2.2 million, or 43.7%, versus 2016. This decrease was due to lower expense of $0.6 million for drug production as the costs of manufacturing were capitalized in inventory after the June 2017 FDA approval of Baxdela, and
NDA-related
expenses of $1.4 million incurred in 2016 that were not repeated in 2017.
External
costs for our discovery program represent research and support work performed by third parties. These costs decreased $0.6 million, or 45.5%, year over year due to the use of lower cost vendors for external analysis in 2017 as compared to 2016
as well as shifting some work previously done externally to internal personnel.
Other discovery costs represents internal costs of
research, including salaries, benefits, other compensation, laboratory expenses and facility costs, as well as expenses to maintain our interests in antibiotic candidates. These costs decreased by $0.2 million, or 10.3%, in 2017 over 2016 due
principally to lower external testing expense.
Selling, general and administrative expenses
SG&A expenses were $10.3 million and $4.1 million for the three months ended September 30, 2017 and 2016, respectively. The
increase of $6.2 million, or 150.5%, was primarily driven by a $3.5 million increase in marketing and other costs to support our commercial launch of Baxdela, revenue-sharing payments associated with the license of rights to Baxdela to
Menarini of $1.6 million, increases in legal expenses of $0.9 million and increases in administrative personnel-related costs of $0.7 million. These increases were partially offset by lower finance-related fees of $0.5 million.
Other expense (income)
For the
three months ended September 30, 2017, we recognized other expense of $1.6 million as compared with the three months ended September 30, 2016, when we recognized other expense of $0.7 million, driven by the following:
|
|
|
Interest expense
Interest expense for the three months ended September 30, 2017 and 2016, was $2.4 million and $1.2 million, respectively. Interest expense includes both cash and
non-cash
components of interest expense. The cash portion of interest expense was $0.7 million in 2017, an increase of $0.1 million, due to higher debt balances. The
non-cash
portion of interest was $1.7 million in 2017, an increase of $1.1 million, driven primarily by $68.6 million in convertible promissory notes that we issued in the second half of 2016
and first half of 2017. This interest is categorized as
non-cash
because in the next round of equity financing, all outstanding principal, as well as accrued interest, will convert into shares of our stock. In
addition and to a lesser extent,
non-cash
interest includes the amortization of debt issuance costs.
|
|
|
|
Change in fair value of warrant liability
We adjust the carrying value of the warrant liability to the estimated fair value at each reporting period. Increases or decreases in the fair value of the warrant
liability are recorded within other expense (income) in the statement of operations. We recognized $0.7 million and $0.4 million of other income in the three months ended September 30, 2017 and 2016, respectively.
|
|
|
|
Other
The Company participates in a Connecticut tax credit program whereby we can claim either cash payments or future tax credits based on qualifying expenditures. We have historically chosen the cash
payment incentive and expect to continue to do so in future periods as the tax code allows. This tax credit comprises the majority of the other income for both periods.
|
Comparison of the Nine Months Ended September 30, 2017 and 2016
The following table summarizes Melintas results of operations for the nine months ended September 30, 2017 and 2016:
13
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
Increase (Decrease)
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percent
|
|
Revenue
|
|
$
|
29,633
|
|
|
|
|
|
|
$
|
29,633
|
|
|
|
100.0
|
%
|
Research and development
|
|
$
|
37,876
|
|
|
$
|
33,489
|
|
|
$
|
4,387
|
|
|
|
13.1
|
%
|
Selling, general and administrative
|
|
$
|
25,976
|
|
|
$
|
14,824
|
|
|
$
|
11,152
|
|
|
|
75.2
|
%
|
Total other expense, net
|
|
$
|
5,917
|
|
|
$
|
3,237
|
|
|
$
|
2,680
|
|
|
|
82.8
|
%
|
Revenue
During the nine months ended September 30, 2017, we recognized revenue from the Menarini agreement of $29.6 million, of which
$19.9 million related to an upfront licensing fee and $9.7 million related to the cost-sharing arrangement for expenses incurred during the first half of 2017.
Research and development expenses
Our
research and development expenses for the nine months ended September 30, 2017 and 2016, were $37.9 million and $33.5 million, respectively. There have been two primary areas of focus for us in the nine months ended
September 30, 2017 and 2016. The first area of focus and the primary cost driver has been the clinical development and FDA approval of Baxdela, our lead product candidate. The second area of focus has been the
pre-clinical
activity for the ESKAPE pathogen program as Melinta works to select a lead program candidate with an optimal efficacy and safety profile.
14
We do not allocate personnel-related costs, including stock-based compensation or other indirect
costs, to specific programs as they are deployed across multiple projects under development and, as such, are included as other development or discovery expenses in the table below. The following table summarizes our research, development and
discovery costs by clinical program for the nine months ended September 30, 2017 and 2016, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
Increase/(Decrease)
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Research and Development Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phase 3 ABSSSI Intravenous/Oral study
|
|
$
|
|
|
|
$
|
3,395
|
|
|
$
|
(3,395
|
)
|
|
|
(100.0
|
%)
|
Phase 3 CABP study
|
|
|
17,675
|
|
|
|
4,968
|
|
|
|
12,707
|
|
|
|
255.8
|
%
|
Other development expenses
|
|
|
12,629
|
|
|
|
14,285
|
|
|
|
(1,656
|
)
|
|
|
(11.6
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total development research and development expenses
|
|
|
30,304
|
|
|
|
22,648
|
|
|
|
7,656
|
|
|
|
33.8
|
%
|
Discovery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
External expenses
|
|
|
2,030
|
|
|
|
3,471
|
|
|
|
(1,441
|
)
|
|
|
(41.5
|
%)
|
Other discovery expenses
|
|
|
5,542
|
|
|
|
7,370
|
|
|
|
(1,828
|
)
|
|
|
(24.8
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total discovery research and development expenses
|
|
|
7,572
|
|
|
|
10,841
|
|
|
|
(3,269
|
)
|
|
|
(30.2
|
%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development expenses
|
|
$
|
37,876
|
|
|
$
|
33,489
|
|
|
$
|
4,387
|
|
|
|
13.1
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In total, our research and development costs increased in 2017 over 2016 by $4.4 million, or 13.1%. The
increase is due primarily to $12.7 million of incremental expense for our Phase 3 clinical study of Baxdela for CABP, which was partially offset by reduced expense due to the conclusion of the Phase 3 ABSSSI clinical study and lower expenses
related to the development of the ESKAPE pathogen program.
Development expenses for our Phase 3 clinical study for ABSSSI, testing the
intravenous and oral forms of Baxdela, decreased in 2017 versus 2016 by $3.4 million. The study was completed in 2016 and no costs were incurred in 2017. We do not expect to incur any additional costs related to this study.
Development expenses for the Phase 3 CABP clinical trial increased by $12.7 million, or 255.8%, in 2017 from 2016, driven by steady
patient enrollment during 2017. While the study was active for the entire year of 2016, we did not ramp up study activity until late in 2016 with the first patient enrollment in December 2016. As such, we expect that in 2017 and 2018 it will incur a
significant level of expenses associated with this study.
Other development costs decreased in the nine months ended September 30,
2017, by $1.7 million, or 11.6%, versus 2016. This decrease was due principally to expenses of $2.4 million related to preparation of the NDA for Baxdela incurred in 2016 that were not incurred in 2017. These decreases were partially
offset by higher expenses for Health Economics and Outcomes Research (HEOR), surveillance and automated susceptibility testing as we prepared for the launch of Baxdela.
15
External costs for our discovery program represent research and support work performed by third
parties. These costs decreased $1.4 million, or 41.5%, year over year due to the use of lower cost vendors for external analysis in 2017 as compared to 2016 as well as shifting some work previously done externally to internal personnel.
Other discovery costs represents internal costs of research, including salaries, benefits, other compensation, laboratory expenses and
facility costs, as well as expenses to maintain our interests in antibiotic candidates. These costs decreased by $1.8 million, or 24.8%, in 2017 over 2016 due to an option fee that we paid in 2016 in connection with our radezolid program of
$0.9 million that was not repeated in 2017, and lower external testing expense.
Selling, general and administrative expenses
SG&A expenses were $26.0 million and $14.8 million for the nine months ended September 30, 2017 and 2016, respectively. The
increase of $11.2 million, or 75.2%, was primarily driven by a $6.2 million increase in marketing and other costs to support the commercial launch of Baxdela, revenue-sharing payments associated with the license of rights to Baxdela to
Menarini of $1.6 million, increases in legal expenses of $1.3 million (driven by expenses related to the merger), increases in patent-related expenses of $0.7 million and increases in administrative personnel-related costs of
$0.8 million.
Other expense (income)
For the nine months ended September 30, 2017, we recognized other expense of $5.9 million as compared with the nine months ended
September 30, 2016, when we recognized other expense of $3.2 million, driven by the following:
|
|
|
Interest expense
Interest expense for the nine months ended September 30, 2017 and 2016, was $5.8 million and $2.9 million, respectively. Interest expense includes both cash and
non-cash
components of interest expense. The cash portion of interest expense was $1.6 million in 2017, a decrease of $0.3 million, due to declining balance of the 2014 Loan Agreement as we made principal
payments during 2016 and 2017. The
non-cash
portion of interest was $4.2 million in 2017, an increase of $3.1 million, driven primarily by $68.6 million in convertible promissory notes that we
issued in the second half of 2016 and first half of 2017. This interest was categorized as
non-cash
because in the next round of equity financing, all outstanding principal, as well as accrued interest, would
convert into shares of our stock. In addition and to a lesser extent,
non-cash
interest includes the amortization of debt issuance costs.
|
|
|
|
Change in fair value of tranche assets and liabilities
We adjust the carrying value of the Convertible Preferred Stock tranche obligations to the estimated fair value at each reporting period. Increases or
decreases in the fair value of tranche obligations are recorded within other income (expense) in the statement of operations. We recognized $1.3 million of expense in the nine months ended September 30, 2016, upon issuance of the final
tranche of Series 4 preferred stock in March 2016. We have not recorded a tranche asset or liability since that date.
|
|
|
|
Change in fair value of warrant liability
We adjust the carrying value of the warrant liability to the estimated fair value at each reporting period. Increases or decreases in the fair value of the warrant
liability are recorded within other expense (income) in the statement of operations. We recognized $0.3 million and $0.8 million of income in the nine months ended September 30, 2017 and 2016, respectively.
|
|
|
|
Other
The Company participates in a Connecticut tax credit program whereby we can claim either cash payments or future tax credits based on qualifying expenditures. We have historically chosen the cash
payment incentive and expect to continue to do so in future periods as the tax code allows. This tax credit comprises the majority of the other income for both periods.
|
Liquidity and Capital Resources
Prior to November 2012, Melinta was primarily capitalized through the sale of convertible notes and preferred stock. In November 2012, the
Company was recapitalized under the ownership of a new lead investor. The convertible notes and preferred stock issued prior to November 2012 were restructured at the time of the recapitalization. Since the November 2012 recapitalization through
September 30, 2017, we have obtained funding primarily through sales of convertible preferred stock, loans and business development transactions. As of September 30, 2017, we held cash and cash equivalents of $12.4 million to fund
operations.
16
We have also funded our operations with debt financing. As of September 30, 2017, we had
$40.0 million in outstanding debt under a Loan and Security Agreement, dated as of May 2, 2017, (2017 Loan Agreement) under which the lender has made available up to $80.0 million in debt financing in four separate
tranches and up to $10.0 million in equity financing (see Note 3 to the unaudited condensed consolidated financial statements).
On
November 3, 2017, Melinta completed the merger with Cempra. The combined company has cash and cash equivalents in excess of $155.0 million, which, in managements view, is adequate to fund operations within the next 12 months,
including
on-going
research & development, the production of commercial quantities of Baxdela, and the launch of our commercial strategy for Baxdela. The company expects to begin selling Baxdela in
early 2018, which will provide a new, and growing, source of cash. The company also intends to secure additional operating funds, as needed, through new equity financings and/or new debt. However, there can be no assurance that adequate financing
under acceptable terms will be available as needed.
In the event that the Company closes the Acquisition entered into on
November 28, 2017, we will fund the transaction with a combination of debt and equity, such that funding for
on-going
operations, discussed above, will not be affected.
17
The following table provides a summary of our cash position as of each of the
period-end
dates and the cash flows for each of the periods presented below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2017
|
|
|
2016
|
|
|
|
(unaudited)
|
|
Cash, cash equivalents and restricted cash as of end of the period
|
|
$
|
12,393
|
|
|
$
|
20,540
|
|
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
Operating activities
|
|
|
(33,603
|
)
|
|
|
(47,918
|
)
|
Investing activities
|
|
|
(4,291
|
)
|
|
|
(444
|
)
|
Financing activities
|
|
|
38,878
|
|
|
|
38,744
|
|
Operating Activities
Net cash used in operating activities for the nine months ended September 30, 2017 and 2016, was $33.6 million and
$47.9 million, respectively. For both periods presented, the primary use of cash was to fund development and discovery research activities for our product candidates and to support our selling, general and administrative functions. We used
$14.3 million less in operations during the 2017 period due primarily to amounts received from Menarini and Eurofarma under the license arrangements, partially offset by higher cash-based operating expenses, the net of which was
$12.1 million. In addition, the decrease in cash used in operations was due to favorable changes in working capital accounts year over year totaling $2.2 million.
Investing Activities
Net cash used in
investing activities was $4.3 million and $0.4 million for the nine months ended September 30, 2017 and 2016, respectively. Subsequent to the FDA approval of Baxdela in June 2017, we made $3.5 million in milestone payments for
intellectual property rights in connection with the FDA approval of Baxdela. These payments were capitalized as intangible assets and will be amortized over the estimated useful life of the related intellectual property. Other cash used in investing
activities in both of these periods was primarily for capital expenditures for facility improvements, lab equipment, software and office furniture and equipment.
Financing Activities
Net cash provided
by financing activities for the nine months ended September 30, 2017 and 2016, was $38.9 million and $38.7 million, respectively. During the nine months ended September 30, 2017, cash provided by financing activities related
primarily to the issuance of convertible promissory notes totaling $24.5 million and the refinancing of the 2014 Loan Agreement, replacing it with the 2017 Loan Agreement, under which the Company borrowed $40.0 million. During the
nine months ended September 30, 2016, cash provided by financing activities was comprised primarily of the issuance of notes payable of $27.8 million and preferred stock financing of $13.6 million, partially offset by repayments
of notes payable of $2.7 million.
Funding Sources and Requirements
We expect to launch Baxdela in the United States in early 2018, from which we expect to generate significant product sales and associated cash
in 2018. In addition, Melinta receives reimbursement from Menarini under the license agreement for a portion of Melintas ongoing Phase 3 CABP clinical trial development expenses. We receive such reimbursement within one quarter of the
18
recognition of the expenses. Through September 30, 2017, we were entitled to total reimbursement of $9.7 million, of which Melinta had received $2.8 million. In addition, the
Company is exploring other partnerships and collaborations to assist it with funding certain of its early-stage research and development programs.
We do not expect to generate revenue from any other product candidates under development unless and until we successfully commercialize our
products or enter into additional collaborative agreements with third parties.
We expect to continue to incur significant losses for the
foreseeable future and expect the losses to increase as we continue the development of, and seek regulatory approvals for, our product candidates, continue to advance products generated from the ESKAPE pathogen program platform and commercialize any
approved products. We are also subject to the risks associated with the development of new therapeutic products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect
Melintas business operations. Additionally, upon completion of the merger, we expect to incur additional costs associated with operating as a public company and may need substantial additional funding in connection with Melintas
continuing operations, commercial, discovery and product development activities.
The Company believes that, after the merger, existing
cash balances and other sources of cash, discussed above, will be sufficient to fund our operations requirements for at least the next 12 months. However, we may need to raise additional funds sooner to support the working capital requirements of a
commercialized product and to fund further development of the other product candidates.
We intend to use our combined cash and cash
equivalents, as follows:
|
|
|
to fund the activities supporting the commercialization for Baxdela for the treatment of ABSSSI;
|
|
|
|
to fund the Phase 3 trial and advance its product candidate Baxdela for the treatment of hospital treated CABP;
|
|
|
|
to fund the
scale-up
of manufacturing operations and manufacture Baxdela to meet both commercial and clinical demand;
|
|
|
|
to pursue additional indications for Baxdela;
|
|
|
|
to fund research activities for preclinical product candidates,
IND-enabling
studies and development activities for the ESKAPE pathogen program; and
|
|
|
|
the remainder for working capital, general and administrative expenses, future internal research and development expenses and other general corporate purposes.
|
In addition, we may also use a portion of our cash and cash equivalents for the acquisition of, or investment in, companies, technologies,
products or assets that complement our business. In December 2014, we entered into a license agreement with a CRO to develop a molecule, radezolid, for dermatological applications. Under the terms of the agreement, development of the product is
funded by the CRO. We, however, retain the right, at certain agreed upon milestones, to agree to
co-develop
or take full responsibility for the development program based on
pre-determined
payments to the CRO. In March 2016 and February 2017, we paid $0.9 million and $0.5 million, respectively, in license payments to the CRO under this agreement. In addition, in November
we entered into an agreement to acquire the IDB of The Medicines Company (see Recent Developments section above).
Until we can generate a
sufficient amount of revenue from our products, if ever, we expect to finance our future cash needs through public or private equity or debt financings, or through other sources such as potential collaboration and license agreements. In any event,
we do not expect to achieve significant revenue from product sales prior to 2018.
Off-Balance
Sheet
Arrangements
During the periods presented, we did not have, nor do we currently have, any
off-balance
sheet arrangements as defined under the applicable rules of the SEC.
19
Contractual Obligations and Commitments
During the nine months ended September 30, 2017, there have been no material changes to our contractual obligations and commitments
outside the ordinary course of business from those specified in our 2016 Annual Report.
Quantitative and Qualitative Disclosures about Market Risk
Interest Rate Fluctuation Risk
The primary objective of our investment activities is to preserve our capital to fund its operations. We also seek to maximize income from its
cash and cash equivalents without assuming significant risk. To achieve these objectives, we invest our cash and cash equivalents in money market funds. We do not enter into investments for trading or speculative purposes. We do not believe that an
immediate 1% increase in interest rates would have a material effect on the fair value of our cash equivalents, and therefore, we do not expect its operating results or cash flows to be materially affected to any degree by a sudden change in market
interest rates.
On September 30, 2017, we had $40.0 million aggregate principal amount outstanding under its loan agreement
with Oberland Capital. The loan bears interest at a rate of the greater of 8.25% or the sum of 8.25% plus the prime rate minus 4.5% per annum, and as such is variable based on fluctuations in the prime rate. As a result, increases in interest
rates may increase the cost of servicing the loan agreement and could materially reduce its profitability and cash flows. As September 30, 2017, the prime rate was approximately 25 basis points below the rate necessary for the interest rate on
the loan agreement to exceed the 8.25% minimum interest rate described above. As a result, the fair value of the loan agreement will not change significantly until the prime rate exceeds 4.5%. A 1.0% increase in the prime rate would result in an
additional $0.3 million in interest expense in the first year of the loan.
Foreign Currency Exchange Rate Fluctuations
To date, the vast majority of our contractual obligations have been denominated in U.S. dollars. In the future, we may contract with
organizations such as CROs or contract manufacturers in foreign countries. We may therefore become subject to fluctuations in foreign currency exchange rates in connection with these agreements.
Melintas agreement with Menarini requires that they pay commercial and regulatory milestones of approximately 90.0 million
over time as the milestones are achieved. The cash we receive from these payments is subject to fluctuations in foreign currency exchange rates between the Euro and U.S. dollar. The agreement establishes a fixed exchange rate such that the U.S.
dollars that we will receive will not fluctuate with market exchange rates unless and until the market rate varies by more than 10% from the rate established in the agreement. As of September 30, 2017, if Menarini had met the first
5.0 million milestone, we would have received $5.3 million, which is based on the contractual rate in the agreement. If the 5.0 million milestone was met and paid based on the actual exchange rate as of September 30,
2017, the milestone payment in U.S. dollars would have been higher by $0.6 million.
Inflation
Inflation generally affects us by increasing its cost of labor and clinical trial costs. We do not believe that inflation has had a material
effect on its business, financial condition or results of operations during the periods presented.
20
Exhibit 99.4
UNAUDITED PRO FORMA COMBINED FINANCIAL STATEMENTS
Melinta Therapeutics, Inc. Unaudited Pro Forma Combined Financial Information
The unaudited pro forma combined financial statements give effect to the merger with Cempra, Inc. that closed on November 3, 2017 (the
Merger). The term the combined company as used in this proxy statement refers to the new Melinta Therapeutics, Inc. following the Merger. The unaudited pro forma combined financial information was prepared in accordance with
the regulations of the SEC.
The following unaudited pro forma combined financial information gives effect to the merger of a wholly-owned
subsidiary of Cempra, Inc., or Cempra, with and into Melinta Therapeutics, Inc., or Melinta, who survived as a wholly-owned subsidiary of Cempra in a transaction that was accounted for as a reverse acquisition under the acquisition method of
accounting in accordance with GAAP. For accounting purposes, Melinta acquired Cempra, even though legally Cempra was the issuer of the common stock in the merger.
The unaudited pro forma combined balance sheet at September 30, 2017, and the unaudited pro forma combined statement of operations for
the nine months ended September 30, 2017, and the year ended December 31, 2016, presented herein are based on the historical financial statements of Melinta and Cempra after giving effect to the acquisition (for accounting purposes) of
Cempra by Melinta and the assumptions and adjustments described in the accompanying notes to these unaudited pro forma combined financial information.
Melinta was determined to be the accounting acquirer after consideration of the terms of the merger agreement and other factors, including:
(i) Melinta security holders owned approximately 52% of the voting interests of the combined company immediately following the closing of the transaction and (ii) directors of Melinta were responsible for electing the chairman of the board
for the combined company. Accordingly, the merger transaction has been accounted for by Melinta as a reverse merger acquisition under the acquisition method of accounting for business combinations.
Accordingly, the acquisition consideration is based on Cempras share price and shares of common stock outstanding as more fully
described in the accompanying notes to the unaudited pro forma combined financial information. Under the reverse acquisition method of accounting, the total purchase price is allocated to the acquired tangible and intangible assets and assumed
liabilities of Cempra based on their estimated fair values as of the merger closing date. The excess of the purchase price over the fair value of assets acquired and liabilities assumed, if any, is allocated to goodwill. Alternatively, a bargain
purchase gain is recognized if the aggregate fair value of the identifiable assets acquired and liabilities assumed exceeds the purchase price for the acquisition. The assets and liabilities and results of operations of Cempra will be consolidated
into the results of operations of Melinta as of the effective date of the merger. The pro forma adjustments reflecting the completion of the merger are based upon the acquisition method of accounting in accordance with GAAP and upon the assumptions
set forth in the accompanying notes to the unaudited pro forma combined financial information.
The unaudited pro forma combined balance
sheet as of September 30, 2017, gives effect to the merger as if it occurred on September 30, 2017, and reflects the acquisition of Cempra by Melinta. The unaudited pro forma combined statements of operations for the nine months ended
September 30, 2017, and for the year ended December 31, 2016, are presented as if the merger was consummated on January 1, 2016, and combines the historical results of Melinta and Cempra for the nine months ended September 30,
2017, and the year ended December 31, 2016.
Pro Forma Basis and Presentation
The unaudited pro forma combined financial information does not give effect to the potential impact of current financial conditions, regulatory
matters, operating efficiencies or other savings or expenses that may be associated with the Merger or the Acquisition, or with the integration of the companies. The unaudited pro forma combined financial information has been prepared for
illustrative purposes only and is not necessarily indicative of the financial position or results of operations in future periods or the results that would have been realized had Melinta been a combined company during the specified periods.
The historical financial information has been adjusted to give pro forma effect to events that
are (i) directly attributable to the Merger, (ii) factually supportable, and (iii) with respect to the statement of operations, expected to have a continuing impact on the combined results. The application of the acquisition method of
accounting is dependent upon certain valuations that have yet to be completed. Accordingly, the pro forma adjustments are preliminary and based on managements estimates of the fair value and useful lives of the assets acquired and liabilities
assumed and have been prepared to illustrate the estimated effect of the acquisition and certain other adjustments. Therefore, pro forma adjustments reflected in the unaudited pro forma combined financial information are subject to further revision
as additional information becomes available and additional analyses are performed, and have been made solely for the purpose of providing the unaudited pro forma combined financial information. Differences between the preliminary adjustments
reflected in the unaudited pro forma combined financial information and the final application of the acquisition method of accounting, which is expected to be completed as soon as practicable after the closing of the merger and acquisition, may
arise and those differences could have a material impact on the accompanying unaudited pro forma combined financial information and the combined companys future results of operations and financial position. The amounts of acquisition
consideration, assets acquired and liabilities assumed that will be used in acquisition accounting will be based on their respective fair values as determined at the time of closing, and may differ significantly from these estimates.
The unaudited pro forma combined financial information, including the notes thereto, should be read in conjunction with the Melinta historical
audited consolidated financial statements for the year ended December 31, 2016, and the unaudited condensed and consolidated financial statements for the nine months ended September 30, 2017, included on Form
8-K
filed with the SEC on December 5, 2017. They should also be read in conjunction with the Cempra historical audited consolidated financial statements included in its Annual Report on
Form 10-K
for the year ended December 31, 2016, as amended by Amendment No. 1 on Form
10-K/A,
both of which have been filed with the SEC, and its historical
unaudited consolidated financial statements included in its Quarterly Report on
Form 10-Q
for the nine months ended September 30, 2017, which has also been filed with the SEC.
Unaudited Pro Forma Condensed Combined Balance Sheet
As of September 30, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(In thousands)
|
|
Historical
Melinta
|
|
|
Historical
Cempra
|
|
|
Pro Forma
Adjustments
|
|
|
Notes
|
|
Melinta
Unaudited Pro
Forma
Combined
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
12,193
|
|
|
$
|
176,134
|
|
|
$
|
(10,555
|
)
|
|
(A)
|
|
$
|
177,757
|
|
|
|
|
|
|
|
|
|
|
|
|
(15
|
)
|
|
(B)
|
|
|
|
|
Receivables
|
|
|
7,525
|
|
|
|
2,803
|
|
|
|
|
|
|
|
|
|
10,328
|
|
Inventory
|
|
|
5,997
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,997
|
|
Prepaid expenses and other current assets
|
|
|
2,304
|
|
|
|
833
|
|
|
|
|
|
|
|
|
|
3,137
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
28,019
|
|
|
|
179,770
|
|
|
|
(10,570
|
)
|
|
|
|
|
197,219
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net
|
|
|
1,538
|
|
|
|
27
|
|
|
|
|
|
|
|
|
|
1,565
|
|
Developed product rights, net
|
|
|
|
|
|
|
|
|
|
|
29,200
|
|
|
(C)
|
|
|
29,200
|
|
Other intangible assets
|
|
|
7,500
|
|
|
|
|
|
|
|
11,200
|
|
|
(C)
|
|
|
18,700
|
|
Goodwill
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets
|
|
|
1,103
|
|
|
|
83
|
|
|
|
|
|
|
|
|
|
1,186
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
38,160
|
|
|
$
|
179,880
|
|
|
$
|
29,830
|
|
|
|
|
$
|
247,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
12,443
|
|
|
$
|
6,665
|
|
|
$
|
|
|
|
|
|
$
|
19,108
|
|
Accrued expenses
|
|
|
16,310
|
|
|
|
2,322
|
|
|
|
10,725
|
|
|
(D)
|
|
|
29,357
|
|
Accrued interest on note payable
|
|
|
275
|
|
|
|
|
|
|
|
|
|
|
|
|
|
275
|
|
Long-term debt, current portion
|
|
|
|
|
|
|
6,667
|
|
|
|
(6,667
|
)
|
|
(A)
|
|
|
|
|
Contingent purchase price - current portion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock warrants
|
|
|
339
|
|
|
|
|
|
|
|
(339
|
)
|
|
(E)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
29,367
|
|
|
|
15,654
|
|
|
|
3,719
|
|
|
|
|
|
48,740
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long term liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes payable
|
|
|
39,206
|
|
|
|
|
|
|
|
|
|
|
|
|
|
39,206
|
|
Convertible promissory notes
|
|
|
73,101
|
|
|
|
|
|
|
|
(73,101
|
)
|
|
(F)
|
|
|
|
|
Deferred revenue
|
|
|
10,008
|
|
|
|
16,987
|
|
|
|
|
|
|
|
|
|
26,995
|
|
Deferred purchase price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, net of current
|
|
|
|
|
|
|
3,682
|
|
|
|
(3,682
|
)
|
|
(A)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
151,682
|
|
|
|
36,323
|
|
|
|
(73,064
|
)
|
|
|
|
|
114,941
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convertible preferred stock
|
|
|
217,220
|
|
|
|
|
|
|
|
(217,220
|
)
|
|
(G)
|
|
|
|
|
Shareholders Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock
|
|
|
1
|
|
|
|
53
|
|
|
|
(53
|
)
|
|
(H)
|
|
|
22
|
|
|
|
|
|
|
|
|
|
|
|
|
11
|
|
|
(I)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10
|
|
|
(J)
|
|
|
|
|
Additional
paid-in
capital
|
|
|
223,137
|
|
|
|
626,001
|
|
|
|
(626,001
|
)
|
|
(H)
|
|
|
640,526
|
|
|
|
|
|
|
|
|
|
|
|
|
(15
|
)
|
|
(B)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
339
|
|
|
(E)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,101
|
|
|
(F)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
217,220
|
|
|
(G)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
126,754
|
|
|
(I)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10
|
)
|
|
(J)
|
|
|
|
|
Accumulated other comprehensive (loss) income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated deficit
|
|
|
(553,880
|
)
|
|
|
(482,497
|
)
|
|
|
482,497
|
|
|
(H)
|
|
|
(507,619
|
)
|
|
|
|
|
|
|
|
|
|
|
|
(206
|
)
|
|
(A)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(10,725
|
)
|
|
(D)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,192
|
|
|
(K)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total shareholders (deficit) equity
|
|
|
(330,742
|
)
|
|
|
143,557
|
|
|
|
320,114
|
|
|
|
|
|
132,929
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders (deficit) equity
|
|
$
|
38,160
|
|
|
$
|
179,880
|
|
|
$
|
29,830
|
|
|
|
|
$
|
247,870
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unaudited Pro Forma Condensed Combined Statement of Operations
For the nine months ended September 30, 2017
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
Melinta
|
|
|
Historical
Cempra
|
|
|
Pro Forma
Adjustments
|
|
|
Notes
|
|
|
Melinta
Unaudited
Pro
Forma
Combined
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
|
|
$
|
19,905
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
$
|
19,905
|
|
Collaboration
|
|
|
9,728
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,728
|
|
Contract research
|
|
|
|
|
|
|
7,449
|
|
|
|
|
|
|
|
|
|
|
|
7,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
29,633
|
|
|
$
|
7,449
|
|
|
|
|
|
|
|
|
|
|
$
|
37,082
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
37,876
|
|
|
|
28,338
|
|
|
|
|
|
|
|
|
|
|
|
66,214
|
|
General and administrative
|
|
|
25,976
|
|
|
|
21,291
|
|
|
|
(6,532
|
)
|
|
|
(L)
|
|
|
|
44,468
|
|
|
|
|
|
|
|
|
|
|
|
|
3,733
|
|
|
|
(M)
|
|
|
|
|
|
Restructuring charge
|
|
|
|
|
|
|
3,553
|
|
|
|
|
|
|
|
|
|
|
|
3,553
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
$
|
63,852
|
|
|
$
|
53,182
|
|
|
$
|
(2,799
|
)
|
|
|
|
|
|
$
|
114,235
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
$
|
(34,219
|
)
|
|
$
|
(45,733
|
)
|
|
$
|
2,799
|
|
|
|
|
|
|
$
|
(77,153
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
25
|
|
|
|
896
|
|
|
|
|
|
|
|
|
|
|
|
921
|
|
Interest expense
|
|
|
(5,765
|
)
|
|
|
(677
|
)
|
|
|
4,126
|
|
|
|
(N)
|
|
|
|
(2,316
|
)
|
Loss on extinguishment of debt
|
|
|
(607
|
)
|
|
|
|
|
|
|
(206
|
)
|
|
|
(N)
|
|
|
|
(813
|
)
|
Change in fair value of warrant liability
|
|
|
335
|
|
|
|
|
|
|
|
(335
|
)
|
|
|
(O)
|
|
|
|
|
|
Other income
|
|
|
95
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
$
|
(5,917
|
)
|
|
$
|
219
|
|
|
$
|
3,585
|
|
|
|
|
|
|
$
|
(2,113
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes
|
|
$
|
(40,136
|
)
|
|
$
|
(45,514
|
)
|
|
$
|
6,384
|
|
|
|
|
|
|
$
|
(79,266
|
)
|
Benefit for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$
|
(40,136
|
)
|
|
$
|
(45,514
|
)
|
|
$
|
6,384
|
|
|
|
|
|
|
$
|
(79,266
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of preferred dividends
|
|
|
(17,161
|
)
|
|
|
|
|
|
|
17,161
|
|
|
|
(P)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common shareholders
|
|
$
|
(57,297
|
)
|
|
$
|
(45,514
|
)
|
|
$
|
23,545
|
|
|
|
|
|
|
$
|
(79,266
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss attributable to common shareholders per share
|
|
$
|
(45.26
|
)
|
|
$
|
(0.87
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(3.63
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average shares outstanding
|
|
|
1,266
|
|
|
|
52,471
|
|
|
|
(31,887
|
)
|
|
|
(Q)
|
|
|
|
21,850
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro Forma Condensed Combined Statement of Operations
For the year ended December 31, 2016
(in thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Historical
Melinta
|
|
|
Historical
Cempra
|
|
|
Pro Forma
Adjustments
|
|
|
Notes
|
|
|
Melinta
Unaudited
Pro Forma
Combined
|
|
Revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License
|
|
$
|
|
|
|
$
|
4,339
|
|
|
|
|
|
|
|
|
|
|
$
|
4,339
|
|
Contract research
|
|
|
|
|
|
|
13,677
|
|
|
|
|
|
|
|
|
|
|
|
13,677
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue
|
|
$
|
|
|
|
$
|
18,016
|
|
|
|
|
|
|
|
|
|
|
$
|
18,016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
49,791
|
|
|
|
81,686
|
|
|
|
|
|
|
|
|
|
|
|
131,477
|
|
General and administrative
|
|
|
19,410
|
|
|
|
53,538
|
|
|
|
7,467
|
|
|
|
(M)
|
|
|
|
80,415
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
$
|
69,201
|
|
|
$
|
135,224
|
|
|
$
|
7,467
|
|
|
|
|
|
|
$
|
211,892
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(69,201
|
)
|
|
|
(117,208
|
)
|
|
|
(7,467
|
)
|
|
|
|
|
|
|
(193,876
|
)
|
Other income (expenses)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
30
|
|
|
|
475
|
|
|
|
|
|
|
|
|
|
|
|
505
|
|
Interest expense
|
|
|
(4,406
|
)
|
|
|
(1,228
|
)
|
|
|
2,244
|
|
|
|
(N)
|
|
|
|
(3,390
|
)
|
Change in fair value of tranche assets and liabilities
|
|
|
(1,313
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,313
|
)
|
Change in fair value of warrant liability
|
|
|
781
|
|
|
|
|
|
|
|
(781
|
)
|
|
|
(O)
|
|
|
|
|
|
Other
|
|
|
177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
$
|
(4,731
|
)
|
|
$
|
(753
|
)
|
|
$
|
1,463
|
|
|
|
|
|
|
$
|
(4,021
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income taxes
|
|
$
|
(73,932
|
)
|
|
$
|
(117,961
|
)
|
|
$
|
(6,004
|
)
|
|
|
|
|
|
$
|
(197,897
|
)
|
Benefit for income taxes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss
|
|
$
|
(73,932
|
)
|
|
$
|
(117,961
|
)
|
|
$
|
(6,004
|
)
|
|
|
|
|
|
$
|
(197,897
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accretion of preferred dividends
|
|
|
(21,117
|
)
|
|
|
|
|
|
|
21,117
|
|
|
|
(P)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common shareholders
|
|
$
|
(95,049
|
)
|
|
$
|
(117,961
|
)
|
|
$
|
15,113
|
|
|
|
|
|
|
$
|
(197,897
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss attributable to common shareholders per share
|
|
$
|
(94.29
|
)
|
|
$
|
(2.34
|
)
|
|
|
|
|
|
|
|
|
|
$
|
(9.26
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted-average shares outstanding
|
|
|
1,008
|
|
|
|
50,314
|
|
|
|
(29,943
|
)
|
|
|
(Q)
|
|
|
|
21,379
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTES TO UNAUDITED PRO FORMA COMBINED
FINANCIAL INFORMATION
1. Description
of Transactions and Basis of Presentation
Description of Transaction
On August 8, 2017, Cempra entered into a merger agreement with Melinta. On November 3, 2017, pursuant to the terms and subject to the
conditions set forth in the merger agreement, Melinta was merged into a subsidiary of Cempra and survived as a wholly-owned subsidiary of Cempra (the Merger). Cempra was
re-named
Melinta
Therapeutics, Inc. in connection with the Merger.
Immediately prior to the completion of the Merger, the principal and interest
under outstanding convertible promissory notes and all outstanding shares of preferred stock, including dividends of Melinta were converted into shares of Melinta common stock. As part of the completion of the Merger, each outstanding share of the
common stock of Melinta was converted into the right to receive that number of shares of Cempra common stock as determined pursuant to the exchange ratios described in the merger agreement (except that stockholders of Melinta who are not
accredited investors under U.S. securities laws or who held fractional shares received cash), and all options, warrants or other rights to purchase shares of capital stock of Melinta, were exchanged for rights to acquire Cempra common
stock. No fractional shares of Cempra common stock were issued in connection with the Merger, and holders of Melinta capital stock were entitled to receive cash in lieu thereof.
Upon completion of the Merger, Melinta security holders beneficially own shares of Cempras common stock representing an aggregate of
approximately 52 percent on a fully-diluted basis as calculated under the treasury stock method.
Basis of Presentation
The accompanying pro forma condensed combined financial information was prepared in accordance with Article 11 of Regulation
S-X
and present the pro forma consolidated financial position and results of operations of the combined company based upon the historical financial information of Melinta and Cempra after giving effect to the Merger
and the adjustments described in these notes, and are intended to reflect the impact of the combinations on Melintas consolidated financial information.
The Merger will be accounted for under the acquisition method of accounting in accordance with ASC Topic 805, Business
Combinations (ASC 805). For accounting purposes, Melinta is considered to be acquiring Cempra even though legally Cempra will be the issuer of the common stock in the merger.
The Cempra identifiable assets acquired and liabilities assumed will be recorded at the acquisition-date fair values and added to
Melintas balance sheet. The pro forma adjustments are preliminary and based on managements estimates of the fair value and useful lives of the assets acquired and liabilities assumed and have been prepared to illustrate the estimated
effect of the acquisition. These estimates are based on the most recently available information. To the extent there are significant changes to the combined companys business following completion of the Merger, the assumptions and estimates
set forth in the unaudited pro forma combined financial statements could change significantly. The allocations are dependent upon certain valuations and other studies that have not been completed for the Merger. Accordingly, the pro forma purchase
price adjustments are subject to further adjustments as additional information becomes available and as additional analyses and final valuations are conducted. There can be no assurances that these additional analyses and final valuations will not
result in material changes to the estimates of fair value. In addition, differences between the preliminary and final amounts will likely occur as a result of changes in the estimated fair values of tangible and intangible assets acquired and
liabilities assumed, including any goodwill or bargain purchase gains recognized, as of the dates that the Merger was completed.
The
unaudited pro forma condensed combined balance sheet data gives effect to the Merger as if they occurred on September 30, 2017. The unaudited pro forma combined statement of operations for the nine months ended September 30, 2017, combine
the unaudited historical statements of operations of Cempra and Melinta for their respective nine-month periods ended September 30, 2017, and gives pro forma effect to the Merger as if they had been completed on January 1, 2016. The
unaudited pro forma combined statement of operations for the year ended December 31, 2016, combine the historical statements of operations of Cempra and Melinta for their respective year ended December 31, 2016, and gives pro forma effect
to the Merger as if they had been completed on January 1, 2016.
2. Purchase Price
The purchase price for the merger with Cempra is as follows (in thousands, except share data):
|
|
|
|
|
Number of Cempra shares outstanding as of November 3, 2017
|
|
|
10,502,477
|
|
10-day
weighted average Cempra common stock price as of
November 3, 2017
|
|
|
12.07
|
|
|
|
|
|
|
Total estimated purchase price
|
|
|
126,765
|
|
|
|
|
|
|
For pro forma purposes, the fair value of consideration transferred was determined based on the
closing price of Cempra common stock of $12.07 per share based on the closing price of Cempra common stock on November 3, 2017, the closing date of the Merger. The combined company will expense all transaction costs as incurred.
The preliminary allocation of the purchase price to acquired tangible and intangible assets and liabilities assumed based on their estimated
fair values as of September 30, 2017, comprises (in thousands):
|
|
|
|
|
Cash and cash equivalents
|
|
|
176,134
|
|
Receivables and other assets
|
|
|
3,746
|
|
Intangible assets
|
|
|
40,400
|
|
Accounts payable, accrued expenses and other liabilities
|
|
|
(36,323
|
)
|
|
|
|
|
|
Net assets acquired
|
|
|
183,957
|
|
Less: estimated purchase price
|
|
|
(126,765
|
)
|
|
|
|
|
|
Bargain purchase gain
|
|
|
57,192
|
|
|
|
|
|
|
The allocation of the purchase price is preliminary. The final determination of the purchase price allocation
will be based on the fair values of assets, including identifiable intangible assets acquired, and the fair values of liabilities assumed as of the date that the Merger is completed. Cempra and Melinta believe that the historical values of
Cempras current assets and current liabilities approximate their fair value based on the short-term nature of such items. Cempras property and equipment consists of assets whose historical cost, less depreciation, is deemed to
approximate its fair value. The estimated fair values of the assets acquired and liabilities assumed will remain preliminary until the combined company completes a valuation of significant identifiable intangible assets acquired and determines the
fair values of other assets and liabilities. Based on such preliminary valuations, the excess of the purchase price over the fair value of assets acquired and liabilities assumed, if any, is allocated to goodwill. Alternatively, a bargain purchase
gain is recognized if the aggregate fair value of the identifiable assets acquired and liabilities assumed exceeds the purchase price for the acquisition. Based on preliminary estimates of the fair value of the assets acquired and liabilities
assumed as of September 30, 2017, and the purchase price (based on the closing price of Cempra common stock as of November 3, 2017), the combined company would recognize a bargain purchase gain as of September 30, 2017. The bargain
purchase gain of $57,192 is primarily the result of the decrease in the market value of the Cempra common stock since the date that the merger agreement was announced. The bargain purchase gain has not been reflected in the pro forma condensed
combined statement of operations as it is directly attributable to the merger and will not have a continuing impact on the operating results of the combined organization.
3. Pro Forma Adjustments
The unaudited
pro forma adjustments included in the pro forma condensed combined balance sheet are as follows:
|
A.
|
Represents the
pay-off
of Cempras long-term debt by Cempra as the debt will not be legally assumed by the combined company as part of the merger agreement. There was $10,555
of principal and $206 in unamortized debt issuance costs, resulting in a net reduction of long-term debt of $10,349 as of September 30, 2017.
|
|
B.
|
Represents shares repurchased by Cempra.
|
|
C.
|
Represents the preliminary estimated fair value of the intangible assets of Cempra acquired by Melinta as part of the proposed merger. These amounts include $29,200 for
in-process
research and development related to Solithromycin and Fusidic Acid. The fair value of IPR&D acquired through a business combination is capitalized as an indefinite-lived intangible asset until the completion or abandonment of the related
research and development activities. When the related research and development is completed, the asset will be assigned a useful life and amortized. An additional $11,200 of intangibles is related to the
non-compete
agreements related to the executives that will be amortized over 18 months.
|
|
D.
|
Represents estimated transaction costs payable in cash of $7,037 and $3,688 that have not been incurred as of September 30, 2017, for Cempra and Melinta, respectively. These pro forma adjustments are not reflected
in the unaudited pro forma condensed combined statements of operations as these amounts are not expected to have a continuing effect on the operating results of the combine company.
|
|
E.
|
Represents the conversion of Melinta preferred stock warrants into Cempra common stock warrants, eliminating the terms that caused the preferred stock warrants to be accounted for as a liability, and the elimination of
the historical changes in the estimated fair value of the warrants that were recognized on the related statements of operations.
|
|
F.
|
Represents the conversion of Melintas convertible bridge notes payable and accrued interest to 3,766,311 shares of Cempra common stock, after applying the conversion of Melinta to Cempra shares, in connection with
the merger.
|
|
G.
|
Represents the conversion of Melintas preferred stock to Cempra common stock, after applying the conversion of Melinta common stock to Cempra common stock, in connection with the merger.
|
|
H.
|
Represents the elimination of Cempras historical stockholders equity.
|
|
I.
|
Represents the estimated purchase consideration transferred to Cempra stockholders.
|
|
J.
|
Represents an increase in the par value of common stock based on the par value of Cempra common stock to be issued to Melinta shareholders (dollar amounts in thousands, except per share amounts):
|
|
|
|
|
|
Estimated shares of Cempra common stock issued to Melinta shareholders upon close of the
transaction
|
|
|
11,433,532
|
|
Multiplied by par value per share of Cempra common stock
|
|
|
0.001
|
|
|
|
|
|
|
Par value of Cempra common stock issued to Melinta shareholders (in thousands)
|
|
|
11
|
|
Less historical par value of Melinta common stock
|
|
|
(1
|
)
|
|
|
|
|
|
Net pro forma adjustment to common stock
|
|
|
10
|
|
|
|
|
|
|
|
K.
|
Represents the preliminary bargain purchase gain as a result of the transaction, which is subject to change based on information received before transaction closing.
|
The unaudited pro forma adjustments included in the pro forma condensed combined statements of operation are as follows:
|
L.
|
Represents the elimination of transaction-related expenses incurred by Melinta and Cempra during the period. These amounts have been eliminated on a pro forma basis, as they are not expected to have a continuing effect
on the operating results of the combined company.
|
|
M.
|
Represents the amortization of other intangible assets.
|
|
N.
|
Represents the elimination of interest expense on the conversion of Melintas convertible notes into Cempra common stock, as well as the payoff of the long-term debt for Cempra due to the requirements of the merger
agreement.
|
|
O.
|
Represents the conversion of Melinta preferred stock warrants into Cempra common stock warrants, eliminating the terms that caused the preferred stock warrants to be accounted for as a liability, and the elimination of
the historical changes in the estimated fair value of the warrants that were recognized on the related statements of operations.
|
|
P.
|
Represents the elimination of the accretion of preferred stock dividends as all outstanding Melinta preferred stock was assumed to be converted to common stock in connection with the merger.
|
|
Q.
|
Represents the issuance of Cempra shares to Melinta stockholders in connection with the merger, adjusted for Melintas historical weighted-average outstanding shares.
|
EXHIBIT B
Quarterly Report of Melinta (formerly known as Cempra, Inc.) on Form
10-Q
for the fiscal quarter
ended September 30, 2017.
See attached.
EXHIBIT C
Annual Report of Melinta (formerly known as Cempra, Inc.) on Form
10-K
for the fiscal year ended December 31, 2016.
See attached.
Exhibit D
Combined Carve-out Financial Statements for the
Infectious Disease Businesses of The Medicines Company
The attached document contains preliminary unaudited condensed combined
carve-out
financial statements
for the Infectious Disease Businesses, the Company or Company. During the periods presented, the Company was wholly-owned and controlled by The Medicines Company, Medicines.
These condensed combined
carve-out
financial statements may not be representative of the
Companys future performance, and may not necessarily reflect the condensed combined results of operations, financial position and cash flows of the Company, if it had been operated as a separate entity apart from Medicines during the periods
presented.
Exhibit D
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
Combined
Carve-out
Financial Statements
For the Years Ended December 31, 2015 and 2016
Table of Contents
CARVE-OUT
FINANCIAL STATEMENTS FOR THE YEARS ENDED DECEMBER 31, 2015 AND 2016
Report of Independent Auditors
The Board of Directors of The Medicines Company
We have
audited the accompanying combined financial statements of The Infectious Disease Businesses of The Medicines Company, which comprise the combined balance sheets as of December 31, 2015 and 2016, and the related combined statements of operations,
comprehensive loss, equity and cash flows for the years then ended, and the related notes to the combined financial statements.
Managements
Responsibility for the Financial Statements
Management is responsible for the preparation and fair presentation of these financial statements in
conformity with U.S. generally accepted accounting principles; this includes the design, implementation and maintenance of internal control relevant to the preparation and fair presentation of financial statements that are free of material
misstatement, whether due to fraud or error.
Auditors Responsibility
Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with auditing standards
generally accepted in the United States. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement.
An audit involves performing procedures to obtain audit evidence about the amounts and disclosures in the financial statements. The procedures selected depend
on the auditors judgment, including the assessment of the risks of material misstatement of the financial statements, whether due to fraud or error. In making those risk assessments, the auditor considers internal control relevant to the
entitys preparation and fair presentation of the financial statements in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the entitys
internal control. Accordingly, we express no such opinion. An audit also includes evaluating the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluating the
overall presentation of the financial statements.
We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis
for our audit opinion.
Opinion
In our opinion, the
financial statements referred to above present fairly, in all material respects, the combined financial position of The Infectious Disease Businesses of The Medicines Company at December 31, 2015 and 2016, and the combined results of its operations
and its cash flows for the years then ended in conformity with U.S. generally accepted accounting principles.
The Infectious Disease Businesses of The
Medicines Companys Ability to Continue as Going Concern
The accompanying combined financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 2 to the combined financial statements, the Company has recurring losses from operations and has insufficient capital to fund its operations. There can be no assurances that the
Companys parent, The Medicines Company, will continue to have the ability to financially support the operations of the Company given substantial doubt exists about The Medicines Companys ability to continue as a going concern. These
conditions raise substantial doubt about the Companys ability to continue as a going
4
concern. Managements plans in regard to these matters are also described in Note 2. The combined financial statements do not include any adjustments that might result from the outcome of
these uncertainties. Our opinion is not modified with respect to this matter.
/s/ Ernst & Young LLP
Iselin, New Jersey
November 3, 2017
5
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
COMBINED BALANCE SHEETS
(USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2015
|
|
|
2016
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Accounts receivable, net of allowances
|
|
$
|
3,350
|
|
|
$
|
3,916
|
|
Inventory, net
|
|
|
23,105
|
|
|
|
42,411
|
|
BARDA receivable
|
|
|
6,585
|
|
|
|
4,190
|
|
Prepaid expenses and other current assets
|
|
|
1,596
|
|
|
|
1,492
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
34,636
|
|
|
|
52,009
|
|
Fixed assets, net
|
|
|
743
|
|
|
|
1,799
|
|
Developed product rights, net
|
|
|
112,346
|
|
|
|
104,416
|
|
In-process research and development
|
|
|
188,620
|
|
|
|
188,620
|
|
Goodwill
|
|
|
83,303
|
|
|
|
83,303
|
|
Restricted cash
|
|
|
180
|
|
|
|
186
|
|
Other assets
|
|
|
13
|
|
|
|
13
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
419,841
|
|
|
$
|
430,346
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
12,521
|
|
|
$
|
8,060
|
|
Accrued expenses
|
|
|
24,432
|
|
|
|
35,162
|
|
Current portion of contingent purchase price
|
|
|
18,400
|
|
|
|
55,000
|
|
Deferred revenue
|
|
|
1,563
|
|
|
|
2,467
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
56,916
|
|
|
|
100,689
|
|
Contingent purchase price
|
|
|
60,757
|
|
|
|
66,957
|
|
Deferred tax liabilities
|
|
|
66,019
|
|
|
|
66,019
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
183,692
|
|
|
|
233,665
|
|
Equity:
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive loss
|
|
|
(1,707
|
)
|
|
|
(1,533
|
)
|
Net parent investment
|
|
|
237,856
|
|
|
|
198,214
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
236,149
|
|
|
|
196,681
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$
|
419,841
|
|
|
$
|
430,346
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to combined financial statements.
6
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
COMBINED STATEMENTS OF OPERATIONS
(USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2015
|
|
|
2016
|
|
Net revenue
|
|
$
|
14,460
|
|
|
$
|
24,973
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
15,905
|
|
|
|
11,247
|
|
Research and development
|
|
|
37,662
|
|
|
|
51,841
|
|
Selling, general and administrative
|
|
|
82,432
|
|
|
|
139,443
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
135,999
|
|
|
|
202,531
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(121,539
|
)
|
|
|
(177,558
|
)
|
Other income (expense)
|
|
|
199
|
|
|
|
(19
|
)
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(121,340
|
)
|
|
|
(177,577
|
)
|
|
|
|
|
|
|
|
|
|
Benefit from income taxes
|
|
|
12,809
|
|
|
|
206
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(108,531
|
)
|
|
$
|
(177,371
|
)
|
|
|
|
|
|
|
|
|
|
See accompanying notes to combined financial statements.
7
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
COMBINED STATEMENTS OF COMPREHENSIVE LOSS
(USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2015
|
|
|
2016
|
|
Net loss
|
|
$
|
(108,531
|
)
|
|
$
|
(177,371
|
)
|
Other comprehensive (loss) income:
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
(875
|
)
|
|
|
174
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive (loss) income
|
|
|
(875
|
)
|
|
|
174
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(109,406
|
)
|
|
$
|
(177,197
|
)
|
|
|
|
|
|
|
|
|
|
See accompanying notes to combined financial statements.
8
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
COMBINED STATEMENTS OF EQUITY
(USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Parent
Investment
|
|
|
Accumulated Other
Comprehensive Loss
|
|
|
Total Equity
|
|
Balance at January 1, 2015
|
|
$
|
191,222
|
|
|
$
|
(832
|
)
|
|
$
|
190,390
|
|
Net loss
|
|
|
(108,531
|
)
|
|
|
|
|
|
|
(108,531
|
)
|
Net transfers from parent
|
|
|
155,165
|
|
|
|
|
|
|
|
155,165
|
|
Currency translation adjustment
|
|
|
|
|
|
|
(875
|
)
|
|
|
(875
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2015
|
|
|
237,856
|
|
|
|
(1,707
|
)
|
|
|
236,149
|
|
Net loss
|
|
|
(177,371
|
)
|
|
|
|
|
|
|
(177,371
|
)
|
Net transfers from parent
|
|
|
137,729
|
|
|
|
|
|
|
|
137,729
|
|
Currency translation adjustment
|
|
|
|
|
|
|
174
|
|
|
|
174
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2016
|
|
$
|
198,214
|
|
|
$
|
(1,533
|
)
|
|
$
|
196,681
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to combined financial statements.
9
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
COMBINED STATEMENTS OF CASH FLOWS
(USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2015
|
|
|
2016
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(108,531
|
)
|
|
$
|
(177,371
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
6,986
|
|
|
|
8,262
|
|
Reserve for excess or obsolete inventory
|
|
|
4,228
|
|
|
|
212
|
|
Non-cash
stock compensation
|
|
|
8,584
|
|
|
|
9,931
|
|
Change in contingent purchase price
|
|
|
(1,519
|
)
|
|
|
53,249
|
|
Deferred tax liabilities
|
|
|
(12,621
|
)
|
|
|
|
|
Other
|
|
|
13
|
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(3,322
|
)
|
|
|
(566
|
)
|
Inventory, net
|
|
|
(14,917
|
)
|
|
|
(19,519
|
)
|
BARDA receivable
|
|
|
(3,832
|
)
|
|
|
2,395
|
|
Prepaid expenses and other current assets
|
|
|
(738
|
)
|
|
|
104
|
|
Accounts payable
|
|
|
(763
|
)
|
|
|
(4,461
|
)
|
Accrued expenses
|
|
|
4,998
|
|
|
|
10,730
|
|
Payments on contingent purchase price
|
|
|
(1,854
|
)
|
|
|
(929
|
)
|
Deferred revenue
|
|
|
(6,392
|
)
|
|
|
904
|
|
Other
|
|
|
2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(129,678
|
)
|
|
|
(117,059
|
)
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
Purchases of fixed assets
|
|
|
(562
|
)
|
|
|
(1,256
|
)
|
Change in restricted cash
|
|
|
35
|
|
|
|
(6
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(527
|
)
|
|
|
(1,262
|
)
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Net parent investment
|
|
|
145,709
|
|
|
|
127,841
|
|
Payments on contingent purchase price
|
|
|
(15,504
|
)
|
|
|
(9,520
|
)
|
Net cash provided by financing activities
|
|
|
130,205
|
|
|
|
118,321
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS
|
|
|
|
|
|
|
|
|
Change in cash and cash equivalents
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the beginning of the period
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the end of the period
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to combined financial statements.
10
The accompanying combined financial statements and notes present
the combined balance sheets, statements of operations, statements of comprehensive loss, statements of equity and statements of cash flows of The Infectious Disease Businesses, (The Company), of The Medicines Company, (Medicines). The Infectious
Disease Businesses consist of two operating subsidiaries, Rempex Pharmaceuticals Inc., (Rempex), and Targanta Therapeutics Corporation, (Targanta), through which Medicines has historically operated its infectious disease business.
The Company is primarily comprised of the infectious disease activities related to Minocin IV, Orbactiv, and Vabomere, and other preclinical
product candidates. The Companys marketed product portfolio has Minocin
®
, (minocycline), for injection Orbactiv
®
, (oritavancin)
and Vabomere. The Company also has a pipeline of products in development. The Company manages its business and operations as one segment and believes that its products and products in development possess favorable attributes that competitive
products do not provide, can satisfy unmet medical needs in the intensive care hospital product market and offer, or, in the case of its products in development, have the potential to offer, improved performance to hospital businesses.
2.
|
Significant Accounting Policies
|
Basis of Presentation
The accompanying combined financial statements have been prepared in accordance with accounting principles generally accepted in the United
States (GAAP) and are comprised of the Companys activities distributed across multiple legal entities of Medicines. All intercompany balances and transactions have been eliminated in the accompanying combined financial statements.
These combined financial statements have been extracted from the accounting records of Medicines. The historical results of operations,
financial position, and cash flows may not be indicative of what the Company would actually have been had the Company been a separate stand-alone entity, nor are they indicative of what the results of operations, financial position and cash flows
may be in the future.
The accompanying combined financial statements reflect the assets and liabilities that are directly attributable to
the Company. The assets and liabilities excluded from the accompanying combined financial statements consist of:
|
|
|
Cash that has been swept into a centralized cash management system. For most of the entities constituting its business, including the Company, Medicines uses a centralized approach to cash management and financing of
its operations. Accordingly, none of the cash or cash equivalents, or debt, including interest thereon not directly related to the Company, has been reflected in these combined financial statements.
|
|
|
|
Other assets and liabilities at Medicines subsidiary companies which are not directly related to, or are not specifically owned by, or commitments of the Company, including fixed assets shared by the Company with
other products/businesses of Medicines.
|
|
|
|
Medicines third-party debt and the related interest expense have not been allocated to these combined financial statements as the Company was not the legal obligor of the third-party debt and Medicines
borrowings were not directly attributable to the Company.
|
Earnings per share data has not been presented in the combined
financial statements because the Company does not operate as a separate legal entity with its own capital structure.
Revenue and costs
directly related to the Company have been entirely attributed to the Company in the accompanying combined financial statements. The Company also receives services and support from other functions of Medicines. The Companys operations are
dependent upon the ability of these other businesses and functions to provide these services and support. The costs associated with these services and support
11
have been allocated to the Company using methodologies based on proportionate headcount of the Company, as compared to the headcount of Medicines as a whole, which the Company believes is the
most appropriate method of allocation. These allocated costs are primarily related to corporate administrative expenses, employee related costs, including salaries and other benefits, for corporate and shared employees, depreciation expense on
shared assets, and rental and usage fees for shared assets for the following functional groups: information technology; legal; accounting and finance; human resources; marketing and product support; product development; facility; and other corporate
and infrastructural services.
These allocated costs are recorded in Research and Development (R&D) and Selling, General and
Administrative (SG&A) expenses in the combined statements of operations. Income taxes have been accounted for using the separate return method in the accompanying combined financial statements as described below.
The Company believes the assumptions and allocations underlying the combined financial statements are reasonable and appropriate under the
circumstances.
Going Concern
Since inception, the Company has incurred significant net losses. The Company incurred net losses of $108.5 million and
$177.4 million for the years ended December 31, 2015 and 2016, respectively. The Company has not been capitalized with sufficient funding to conduct its operations. Since the Company has no available cash or credit facilities, the Company is
dependent upon Medicines and its affiliates to provide services and funding to support the operations of the Company until, at least, such time as external financing is completed. The Company expects to incur significant expenses and operating
losses for the foreseeable future as it continues its efforts to seek regulatory approvals for product candidates it acquires or develops and to sell, market and distribute Orbactiv, Minocin IV, and Vabomere. If the Company is unable to grow its
revenue from Orbactiv, Minocin IV and Vabomere, it may never become profitable.
Additional financing will be needed by the Company to fund
its ongoing activities, particularly as it pursues marketing approval for product candidates it may develop as well as the continued commercialization activities with respect to Orbactiv, Minocin IV and Vabomere. The Company may raise this
additional funding through the sale of equity, debt financings or other capital sources, including potential collaborations with other companies or other strategic transactions and funding under government contracts. The Company may be unable to
raise additional funds or enter into such other arrangements or arrangement when needed on favorable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, the Company could be forced to delay, reduce or
eliminate certain of the Companys commercialization efforts and research and development programs. There can be no assurances that other sources of financing would be available or that Medicines will continue to have the ability to financially
support the operations of the Company given that substantial doubt exists about Medicines ability to continue as a going concern. Due to these uncertainties, there is substantial doubt about the Companys ability to continue as a going
concern.
The accompanying combined financial statements have been prepared under the assumption that the Company will continue as on a
going concern. The combined financial statements do not include any adjustments relating to the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result from the outcome of the
uncertainties discussed above.
The Companys future operations are highly dependent on a combination of factors, including
(i) the timely and successful completion of additional financing discussed above; (ii) the success of its research and development programs; (iii) the development of competitive therapies by other biotechnology and pharmaceutical
companies, (iv) the Companys ability to manage growth of the organization; (v) the Companys ability to protect its proprietary technology; and ultimately (vi) regulatory approval and market acceptance of the Companys
product candidates.
12
Use of Estimates
The preparation of the combined financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that
affect the amounts that are reported in the combined financial statements and accompanying disclosures. Such estimates include, but are not limited to contingent consideration, inventory reserves, costs of revenue and other assets, liabilities,
revenue and expenses. Actual amounts may be different.
Inventory
The Company records inventory upon the transfer of title from our vendors. Inventory is stated at the lower of cost or market value and valued
using
first-in,
first-out
methodology. Orbactiv and Minocin IV bulk substance are classified as raw materials and their costs are determined using acquisition costs from
the Companys contract manufacturers. The Company records
work-in-progress
costs of filling, finishing and packaging against specific product batches.
Fixed Assets
Fixed
assets are stated at cost. Depreciation is calculated using the straight-line method based on estimated useful lives or, in the case of leasehold improvements, over the lesser of the useful lives or the lease terms. Repairs and maintenance costs are
expensed as incurred.
Intangible Assets with Definite Useful Lives
Intangible assets with definite useful lives are amortized on a straight line basis over their estimated useful lives and reviewed for
impairment if certain events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
In-Process
Research and Development
The cost of
in-process
research and development (IPR&D) acquired directly in a transaction other than a business combination is capitalized if the projects have an alternative future use; otherwise it is expensed. The fair values of IPR&D projects acquired in
business combinations are capitalized.
Several methods may be used to determine the estimated fair value of the IPR&D acquired in a
business combination. The Company utilizes the income method, which applies a probability weighting that considers the risk of development and commercialization to the estimated future net cash flows that are derived from projected sales
revenues and estimated costs. These projections are based on factors such as relevant market size, patent protection, historical pricing of similar products and expected industry trends. The estimated future net cash flows are then discounted to the
present value using an appropriate discount rate. This analysis is performed for each project independently. The Company also considers qualitative factors such as development of competing drugs, status in the development cycle of the product,
regulatory developments and other qualitative factors.
These assets are treated as indefinite-lived intangible assets until completion or
abandonment of the projects, at which time the assets are amortized over the remaining useful life or written off, as appropriate. These assets are tested at least annually or when a triggering event occurs that could indicate a potential
impairment. See Note 6 Intangible Assets and Goodwill for further details. Based on the Companys analysis, there was no impairment of indefinite lived intangible assets in connection with the annual impairment tests that were
performed during 2015 and 2016.
Goodwill
The Company assesses the recoverability of goodwill annually, at the beginning of the fourth quarter of each year, and between annual tests if
an event occurs or circumstances change that would indicate that it is more
13
likely than not that the fair value of the reporting unit may have been reduced below its carrying amount. Impairment testing for goodwill is done at a reporting unit level. A reporting unit is
defined as an operating segment or one level below the operating segment, called a component. However, two or more components of an operating segment will be aggregated and deemed a single reporting unit if the components have similar economic
characteristics.
The Company is able to first assess qualitative factors to determine whether it is necessary to perform the more detailed
two-step
quantitative goodwill impairment test. The Company may elect to bypass the qualitative assessment and proceed directly to the quantitative test for any reporting unit. The quantitative goodwill
impairment test, if necessary, is a
two-step
process. The first step is to identify the existence of a potential impairment by comparing the fair value of a reporting unit with its carrying amount, including
goodwill. If the fair value of a reporting unit exceeds its carrying amount, the reporting units goodwill is considered not to be impaired and performance of the second step of the quantitative goodwill impairment test is unnecessary. However,
if the carrying amount of a reporting unit exceeds its fair value, the second step of the quantitative goodwill impairment test is performed to measure the amount of impairment loss to be recorded, if any. The second step of the quantitative
goodwill impairment test compares the implied fair value of a reporting units goodwill with the carrying amount of that goodwill. If the carrying amount of a reporting units goodwill exceeds its implied fair value, an impairment loss is
recognized in an amount equal to that excess. The implied fair value of goodwill is determined using the same approach as employed when determining the amount of goodwill that would be recognized in a business combination. That is, the fair value of
the reporting unit is allocated to all of its assets and liabilities as if the reporting unit had been acquired in a business combination and the fair value was the purchase price paid to acquire the reporting unit.
For the 2015 and 2016 annual goodwill impairment test, the Company elected to first assess qualitative factors to determine whether it was more
likely than not that the fair value of its reporting unit was less than its carrying amount as a basis for determining whether it was necessary to perform the
two-step
goodwill impairment test. In evaluating
whether it was more likely than not that the fair value of its reporting unit was less than its carrying amount, the Company assessed relevant events and circumstances including industry and market conditions, macroeconomic conditions, trends in
product costs and financial performance of the Companys businesses. After assessing these events and circumstances, the Company determined that it was not more likely than not that the fair value of its reporting unit was less than its
carrying amount and concluded that the quantitative goodwill impairment test was not required.
Impairment of Long-Lived Assets
Long-lived assets, such as property, plant and equipment and certain other long-term assets are reviewed for impairment whenever
events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset or asset group to the estimated
undiscounted future cash flows expected to be generated by the asset or asset group. If the carrying amount of the assets exceed their estimated future undiscounted net cash flows, an impairment charge is recognized for the amount by which the
carrying amount of the assets exceed the fair value of the assets.
Contingent Purchase Price from Business Combinations
Subsequent to the acquisition date, the Company measures the fair value of the acquisition-related contingent consideration at each reporting
period, with changes in fair value recorded in selling, general and administrative expenses in the accompanying combined statements of operations. Changes to contingent consideration obligations can result from adjustments to discount rates and
periods, updates in the assumed achievement or timing of any development or commercial milestone or changes in the probability of certain clinical events, the passage of time and changes in the assumed probability associated with regulatory
approval. The fair value measurement is based on significant inputs not observable in the market and thus represents a Level 3 measurement as defined in fair value measurement accounting.
14
Risks and Uncertainties
The Company is subject to risks common to companies in the pharmaceutical industry including, but not limited to, uncertainties related to
commercialization of products, regulatory approvals, dependence on key products, dependence on key customers and suppliers, and protection of intellectual property rights.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk include accounts receivable. The Company currently
sells Minocin IV and Orbactiv in the United States to a sole source distributor, Integrated Commercialization Solutions, Inc. (ICS). ICS accounted for 100% of the Companys net revenue during the years ended December 31, 2015 and 2016. At
December 31, 2015 and 2016, amounts due from ICS represented approximately $3.7 million and $4.8 million, respectively, or 100% of gross accounts receivable.
Contingencies
The
Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company continually assesses litigation to determine if an unfavorable outcome would lead to a probable loss or reasonably
possible loss which could be estimated. In accordance with the guidance of the Financial Accounting Standards Board (FASB) on accounting for contingencies, the Company accrues for all contingencies at the earliest date at which the Company deems it
probable that a liability has been incurred and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely than another, the Company accrues the minimum of
the range. In the cases where the Company believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation, including an estimable range, if possible.
Revenue Recognition
Product Sales.
The Company distributes Orbactiv and Minocin IV in the United States through a sole source distribution model with ICS.
The Company recognizes sales from Orbactiv under a deferred revenue model. Under its deferred revenue model, the Company invoices ICS upon product shipment, records deferred revenue at gross invoice sales price, classifies the cost basis of the
product held by ICS as finished goods inventory held by others and includes such cost basis amount within prepaid expenses and other current assets on its combined balance sheets. The Company currently recognizes the deferred revenue when hospitals
purchase product and will do so until such time that the Company has sufficient information to develop reasonable estimates of expected returns and other adjustments to gross revenue. The Company had deferred revenue of $1.4 million and
$2.3 million associated with sales in the United States of Orbactiv as of December 31, 2015 and 2016, respectively. The Company recognized $9.1 million and $16.0 million of revenue associated with Orbactiv during the years ended
December 31, 2015 and 2016, respectively, related to purchases by hospitals.
Under the same sole source distribution model with ICS, the
Company records revenue upon shipment of Minocin IV to ICS. ICS then primarily sells these products to a limited number of national medical and pharmaceutical wholesalers with distribution centers located throughout the United States. Under the
terms of this
fee-for-service
agreement, ICS places orders with the Company for sufficient quantities of Minocin IV and Orbactiv to maintain an appropriate level of
inventory based on Medicines customers historical purchase volumes. ICS assumes all credit and inventory risks, is subject to the Companys standard return policy and has sole responsibility for determining the prices at which it
sells these products, subject to specified limitations in the agreement. The agreement terminates on February 28, 2019 and will automatically renew for additional
one-year
periods unless either party gives
notice at least 90 days prior to the automatic extension. Either party may terminate the agreement at any time and for any reason upon 180
15
days prior written notice to the other party. The Company does not recognize revenue from product sales until there is persuasive evidence of an arrangement, delivery has occurred, the price is
fixed or determinable, the buyer is obligated to pay the Company, the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the
product, the amount of returns can be reasonably estimated and collectability is reasonably assured. The company recognized $5.4 million and $8.9 million of revenue associated with Minocin IV during the years ended December 31, 2015 and
2016, respectively.
The Company records allowances for chargebacks and other discounts or accruals for product returns, rebates and
fee-for-service
charges at the time of sale, and reports revenue net of such amounts. In determining the amounts of certain allowances and accruals, the Company must make
significant judgments and estimates. For example, in determining these amounts, the Company estimates hospital demand, buying patterns by hospitals and group purchasing organizations from wholesalers and the levels of inventory held by wholesalers
and by ICS. Making these determinations involves estimating whether trends in past wholesaler and hospital buying patterns will predict future product sales. The Company receives data periodically from ICS and wholesalers on inventory levels and
levels of hospital purchases and the Company considers this data in determining the amounts of these allowances and accruals.
The specific
considerations the Company uses in estimating these amounts related to sales associated with Minocin IV are as follows:
Product
returns.
The Companys customers have the right to return any unopened product during the
18-month
period beginning six months prior to the labeled expiration date and ending 12 months after the
labeled expiration date. As a result, in calculating the accrual for product returns, the Company must estimate the likelihood that product sold might not be used within six months of expiration and analyze the likelihood that such product will be
returned within 12 months after expiration. The Company considers all of these factors and adjusts the accrual periodically throughout each quarter to reflect actual experience. When customers return product, they are generally given credit against
amounts owed. The amount credited is charged to the Companys product returns accrual.
In estimating the likelihood of product being
returned, the Company relies on information from ICS and wholesalers regarding inventory levels, measured hospital demand as reported by third-party sources and internal sales data. The Company also considers the past buying patterns of ICS and
wholesalers, the estimated remaining shelf life of product previously shipped, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products.
At December 31, 2015 and 2016, the Companys accrual for product returns was $1.2 million, and $0.3 million, respectively.
Chargebacks and rebates.
Although the Company primarily sells products to ICS in the United States, the Company typically enters into
agreements with hospitals, either directly or through group purchasing organizations acting on behalf of their hospital members, in connection with the hospitals purchases of products.
Based on these agreements, most of the Companys hospital customers have the right to receive a discounted price for products and
volume-based rebates on product purchases. In the case of discounted pricing, the Company typically provides a credit to ICS, or a chargeback, representing the difference between ICSs acquisition list price and the discounted price. In the
case of the volume- based rebates, the Company typically pays the rebate directly to the hospitals.
As a result of these agreements, at
the time of product shipment, the Company estimates the likelihood that product sold to ICS might be ultimately sold to a contracting hospital or group purchasing organization. The Company also estimates the contracting hospitals or group
purchasing organizations volume of purchases.
The Company bases its estimates on industry data, hospital purchases and the historic
chargeback data it receives from ICS, most of which ICS receives from wholesalers, which details historic buying patterns and
16
sales mix for particular hospitals and group purchasing organizations, and the applicable customer chargeback rates and rebate thresholds.
The Companys allowance for chargebacks was $0.2 million and $0.7 million as of December 31, 2015 and 2016, respectively. The
Companys allowance for rebates was not material as of December 31, 2015 and 2016.
Fees-for-service.
The Company offers discounts to certain wholesalers and ICS based on contractually determined rates for certain services. The Company estimates its
fee-for-service
accruals and allowances based on historical sales, wholesaler and distributor inventory levels and the applicable discount rate. The Companys discounts are accrued at the time of sale
and are typically settled within 60 days after the end of each respective quarter. The Companys
fee-for-service
accruals and allowances were $0.1 million, and
$0.2 million at December 31, 2015 and 2016, respectively.
The Company has adjusted its allowances for chargebacks and accruals for
product returns, rebates and
fees-for-service
in the past based on actual sales experience, and the Company will likely be required to make adjustments to these
allowances and accruals in the future. The Company continually monitors its allowances and accruals and makes adjustments when it believes actual experience may differ from its estimates.
The following table provides a summary of activity with respect to the Companys sales allowances and accruals during 2015 and 2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash
Discounts
|
|
|
Returns
|
|
|
Chargebacks
|
|
|
Rebates
|
|
|
Fees-
for-
Service
|
|
|
|
In thousands
|
|
Balance as of December 31, 2014
|
|
$
|
7
|
|
|
$
|
773
|
|
|
$
|
286
|
|
|
$
|
|
|
|
$
|
83
|
|
Allowances for sales during 2015
|
|
|
207
|
|
|
|
538
|
|
|
|
860
|
|
|
|
66
|
|
|
|
247
|
|
Actual credits issued for prior years sales
|
|
|
(7
|
)
|
|
|
(94
|
)
|
|
|
(286
|
)
|
|
|
|
|
|
|
(83
|
)
|
Actual credits issued for sales during 2015
|
|
|
(132
|
)
|
|
|
|
|
|
|
(645
|
)
|
|
|
(16
|
)
|
|
|
(103
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2015
|
|
|
75
|
|
|
|
1,217
|
|
|
|
215
|
|
|
|
50
|
|
|
|
144
|
|
Allowances for sales during 2016
|
|
|
441
|
|
|
|
(854
|
)
|
|
|
2,886
|
|
|
|
44
|
|
|
|
821
|
|
Actual credits issued for prior years sales
|
|
|
(75
|
)
|
|
|
(86
|
)
|
|
|
(115
|
)
|
|
|
(50
|
)
|
|
|
(144
|
)
|
Actual credits issued for sales during 2016
|
|
|
(344
|
)
|
|
|
|
|
|
|
(2,243
|
)
|
|
|
(29
|
)
|
|
|
(584
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2016
|
|
$
|
97
|
|
|
$
|
277
|
|
|
$
|
743
|
|
|
$
|
15
|
|
|
$
|
237
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of Revenue
Cost of revenue consisted of expenses in connection with the manufacture of Orbactiv and Minocin IV, royalty expenses under the Companys
agreements with Eli Lilly (Lilly) related to Orbactiv and the logistics costs related to Orbactiv and Minocin IV including distribution, storage and handling costs. Amounts billed for shipping and handling are recorded as revenue. Shipping and
handling expenses are recorded as a component of cost of revenue.
Advertising Costs
The Company expenses advertising costs as incurred. Advertising costs were approximately $0.9 million and $0.02 million during the
years ended December 31, 2015 and 2016, respectively.
Research and Development
Research and development costs are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts
and adjusted as necessary based upon an ongoing review of the level of
17
effort and costs actually incurred. Payments for a product license prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are
expensed in the period incurred as research and development. Milestone payments made in connection with regulatory approvals are capitalized and amortized to cost of revenue over the remaining useful life of the asset.
The Company recognizes reimbursements under research contracts when a contract has been executed, the contract price is fixed or determinable,
delivery of services or products has occurred and collection of the contract price is reasonably assured. The reimbursements are classified as an offset to research and development expenses. Payments received in advance of work performed are
deferred. See Note 13 Reimbursement Agreements for further details on these contracts.
Share-Based Compensation
Medicines recognizes expense using the accelerated expense attribution method in an amount equal to the fair value of all share-based awards
granted to employees. Medicines estimates the fair value of its options on the date of grant using the Black-Scholes closed-form option-pricing model.
Expected volatilities are based principally on historic volatility of Medicines common stock. Medicines uses historical data to estimate
forfeiture rate. The expected term of options represents the period of time that options granted are expected to be outstanding. Medicines has made a determination of expected term by analyzing employees historical exercise experience. The
risk-free interest rate is based on the U.S. Treasury yield in effect at the time of grant corresponding with the expected life of the options.
The Company recognizes compensation expense for grants under Medicines share-based compensation plans to employees of the Company.
Foreign Currencies
Targanta Canada is the only entity within the Companys business contributing to foreign currency translation impact. The combined
financial statements are presented in U.S. Dollars. The financial statements of the Companys operations whose functional currency is not U.S. Dollar are translated to U.S. Dollars. The Companys assets and liabilities are
translated using the current exchange rate as of the balance sheet date. Net parent investment is translated using historical exchange rates. Revenues and expenses and other items of income are translated using a weighted average exchange rate over
the period ended on the balance sheet date. Adjustments resulting from the translation of the financial statements of the Companys foreign subsidiaries into U.S. dollars are excluded from the determination of net loss and included in
accumulated other comprehensive income (loss).
Income Taxes
Medicines files consolidated income tax returns that include the Company. For purposes of these combined financial statements, the
Companys taxes are computed and reported using a separate return method, or as though the Company filed a separate return for jurisdictions in which its operations are included in consolidated returns filed by Medicines. The
Company also records income taxes for jurisdictions in which any of the Companys combined subsidiaries file separate returns. Income taxes as presented herein allocate current and deferred income taxes of Medicines to the Company in a manner
that is systematic, rational and consistent with the asset and liability method. Tax receivable and tax payable balances are settled through net parent investment. The sum of the amounts allocated to the
carve-out
tax provisions may not equal the historical consolidated provision. Under the separate return method, deferred tax assets and liabilities are recognized for the future tax consequences attributable
to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss carry forwards.
18
The Company accounts for income taxes under the asset and liability method, which requires
the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined based on the
differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and
liabilities is recognized in income in the period that includes the enactment date.
The Company records net deferred tax assets to the
extent it believes these assets will more likely than not be realized. On a periodic basis, the Company evaluates the realizability of its deferred tax assets net of deferred tax liabilities and adjusts such amounts in light of changing facts and
circumstances, including but not limited to its level of past and future taxable income, and the current and future expected utilization of tax benefit carryforwards. The Company considers all available evidence, both positive and negative, to
determine whether, based on the weight of that evidence, a valuation allowance is required to reduce the net deferred tax assets to the amount that is more likely than not to be realized in future periods.
The Companys annual effective tax rate is based on
pre-tax
earnings adjusted for differences
between GAAP and income tax accounting, existing statutory tax rates, limitations on the use of net operating loss and tax credit carryforwards and tax planning opportunities available in the jurisdictions in which it operates.
The Company records uncertain tax positions on the basis of a
two-step
process whereby (1) it
determines whether it is more likely than not that a tax position will be sustained upon examination, including resolution of any related appeals or litigation processes, based on the technical merits of the position; and (2) for tax positions
that meet the
more-likely-than-not
recognition threshold, the Company recognizes the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement with the relevant tax
authority. Significant judgment is required in evaluating the Companys tax position. Settlement of filing positions that may be challenged by tax authorities could impact the income tax position in the year of resolution. The Companys
liability for uncertain tax positions is reflected as a reduction to its deferred tax assets on its combined balance sheet.
Comprehensive loss
Comprehensive loss comprises net loss and other comprehensive (loss) income. Other comprehensive (loss) income solely consists of foreign
currency translation adjustments. Accumulated other comprehensive income is recorded as a component of equity on the Companys balance sheets.
Recent Accounting Pronouncements
In May 2014, the FASB issued a comprehensive new revenue recognition Accounting Standards Update (ASU), Revenue from Contracts with
Customers (Topic 606) (ASU
No. 2014-09).
ASU
No. 2014-09
provides guidance to clarify the principles for recognizing revenue. This guidance includes the
required steps to achieve the core principle that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in
exchange for those goods or services. In August 2015, the FASB deferred the effective date of the revenue recognition guidance to reporting periods beginning after December 15, 2017. Early adoption of the standard is permitted but not before the
original effective date, which was for reporting periods beginning after December 15, 2016. The FASB has further amended guidance related to recording revenue on a gross versus a net basis and on identifying performance obligations and licensing.
The FASB has also revised certain SEC guidance primarily related to ASC Topic 815, Derivatives and Hedging, and has issued additional improvements and practical expedients to the standard.
The Company has begun to form a project team to analyze the impacts of ASU
No. 2014-09
on its
revenue streams, specifically focusing on its product revenues. The Companys assessment included a review of
19
current accounting policies and practices to identify potential differences that would result from applying the guidance. Currently, the Company uses a deferred revenue model for certain products
where the price is not fixed or determinable. Under the new standard, such arrangements will be accounted for as variable consideration, which may result in revenue being recognized earlier provided the Company can reliably estimate the ultimate
price expected to be realized from the customer. The Company will continue to assess new customer contracts throughout 2017 and any impact the standard will have on its processes, systems and controls. While the Companys assessment of the
impacts of ASU
No. 2014-09
is still in process, the adoption of the guidance is not expected to have a material impact on the Companys combined financial statements. However, it is likely that the
Company will be required to provide additional disclosures in the notes to the combined financial statements upon adoption. The Company currently intends to adopt the standard using the modified retrospective method.
In August 2014, the FASB issued ASU
No. 2014-15,
Presentation of Financial
StatementsGoing Concern (Subtopic
310-40):
Disclosure of Uncertainties about an Entitys Ability to Continue as a Going Concern (ASU
No. 2014-15),
which provides guidance on determining when and how to disclose going-concern uncertainties in the financial statements. This new ASU requires management to perform interim and annual assessments of an entitys ability to continue as a going
concern within one year of the date the financial statements are issued. An entity must provide certain disclosures if conditions or events raise substantial doubt about the entitys ability to continue as a going concern.
The Company adopted this guidance for the year ended December 31, 2016. The adoption did not have an impact on the financial position or
results of operations and the related disclosures are included in the Basis of Presentation disclosure above.
In February
2016, the FASB issued ASU
No. 2016-02,
Leases (Topic 842) (ASU
No. 2016-02).
ASU
No. 2016-02
will
require organizations that lease assets with lease terms of more than 12 months to recognize assets and liabilities for the rights and obligations created by those leases on their balance sheets. The ASU will also require new qualitative and
quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU
No. 2016-02
will be effective
for public companies for fiscal years, and interim periods within those fiscal years, beginning after Dec. 15, 2018, with early adoption permitted. The Company expects to adopt this guidance when effective and is currently evaluating the effect that
the updated standard will have on its combined balance sheets and related disclosures.
In August 2016, the FASB issued ASU
No. 2016-15,
Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (ASU
No. 2016-15).
This guidance clarifies
how certain cash receipts and payments should be presented in the statement of cash flows and is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company does not believe that
this guidance will have an impact on the combined financial statements and related disclosures.
In November 2016, the FASB issued ASU
2016-18,
Statement of Cash Flows (Topic 230): Restricted Cash (ASU
No. 2016-18).
This amends the guidance in ASC 230, including providing additional guidance
related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. ASU
2016-18
is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The Company is currently evaluating the impact of
adoption on its combined financial statements.
20
The major classes of inventory, net consisted of the following at
December 31, 2015 and 2016:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Raw material
|
|
$
|
18,662
|
|
|
$
|
38,245
|
|
Work-in-progress
|
|
|
4,373
|
|
|
|
3,637
|
|
Finished goods
|
|
|
70
|
|
|
|
529
|
|
|
|
|
|
|
|
|
|
|
Total inventory, net
|
|
$
|
23,105
|
|
|
$
|
42,411
|
|
|
|
|
|
|
|
|
|
|
The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts
based on expected volume and provides reserves against the carrying amount of inventory as appropriate. If annual volume is less than expected, the Company may be required to make additional allowances for excess or obsolete inventory in the future.
The Company recorded inventory obsolescence charges of $4.2 million, and $0.2 million as of December 31, 2015 and 2016,
respectively. The Company recorded a charge of $1.5 million for potential losses on future inventory purchase commitments for 2015.
4.
|
Prepaid expenses and other current assets
|
Prepaid expenses and other current assets
consisted of the following at December 31, 2015 and 2016:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Prepaid expenses
|
|
|
1,533
|
|
|
|
1,320
|
|
Prepaid inventory
|
|
|
7
|
|
|
|
69
|
|
Other
|
|
|
56
|
|
|
|
103
|
|
Total prepaid expenses and other current assets
|
|
$
|
1,596
|
|
|
$
|
1,492
|
|
Fixed assets, net consisted of the following at December 31, 2015 and
2016:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated
Life (Years)
|
|
|
2015
|
|
|
2016
|
|
|
|
|
|
|
(In thousands)
|
|
Furniture, fixtures and equipment
|
|
|
3-7
|
|
|
$
|
2,454
|
|
|
$
|
3,758
|
|
Computer hardware
|
|
|
3
|
|
|
|
202
|
|
|
|
203
|
|
Leasehold improvements
|
|
|
12
|
|
|
|
87
|
|
|
|
82
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,743
|
|
|
|
4,043
|
|
Less: Accumulated depreciation
|
|
|
|
|
|
|
(2,000
|
)
|
|
|
(2,244
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total fixed assets, net
|
|
|
|
|
|
$
|
743
|
|
|
$
|
1,799
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense was approximately $0.2 million and $0.3 million for the years ended December 31, 2015 and
2016, respectively.
21
6.
|
Intangible Assets and Goodwill
|
The following information details the carrying amounts
and accumulated amortization of the Companys intangible assets subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2015
|
|
|
As of December 31, 2016
|
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Net
Carrying
Amount
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Net
Carrying
Amount
|
|
|
|
(In thousands)
|
|
Amortizable intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed product rights
(1)
|
|
$
|
120,560
|
|
|
$
|
(8,214
|
)
|
|
$
|
112,346
|
|
|
$
|
120,560
|
|
|
$
|
(16,144
|
)
|
|
$
|
104,416
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortizable intangible assets
|
|
$
|
120,560
|
|
|
$
|
(8,214
|
)
|
|
$
|
112,346
|
|
|
$
|
120,560
|
|
|
$
|
(16,144
|
)
|
|
$
|
104,416
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets not subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development
|
|
$
|
188,620
|
|
|
$
|
|
|
|
$
|
188,620
|
|
|
$
|
188,620
|
|
|
$
|
|
|
|
$
|
188,620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets not subject to amortization:
|
|
|
188,620
|
|
|
|
|
|
|
|
188,620
|
|
|
|
188,620
|
|
|
|
|
|
|
|
188,620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$
|
309,180
|
|
|
$
|
(8,214
|
)
|
|
$
|
300,966
|
|
|
$
|
309,180
|
|
|
$
|
(16,144
|
)
|
|
$
|
293,036
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
The Company amortizes intangible assets related to developed product rights over the remaining life of the patents.
|
In the second quarter of 2015, the Company reclassified $36.1 million of IPR&D assets to developed product rights due to the approval
of Minocin IV in the United States and commenced amortization over their respective useful lives. Amortization expense was $6.8 million and $7.9 million for the years ended December 31, 2015 and 2016, respectively. The Company expects
annual amortization expense related to these intangible assets to be $12.4 million for the year ending December 31, 2017 and $21.4 million for each of the years ending December 31, 2018, 2019, 2020 and 2021 with the balance of
$195.0 million being amortized thereafter. Amortization of developed product rights is recorded in cost of revenue in the accompanying combined statements of operations.
There were no changes to the Companys goodwill amounts during 2015 and 2016.
Accrued expenses consisted of the following at December 31, 2015 and
2016:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Royalties
|
|
$
|
339
|
|
|
$
|
450
|
|
Research and development services
|
|
|
5,036
|
|
|
|
20,404
|
|
Compensation related
|
|
|
8,819
|
|
|
|
10,030
|
|
Product return, rebates, and other fees
|
|
|
1,351
|
|
|
|
476
|
|
Legal, accounting and other
|
|
|
8,270
|
|
|
|
2,252
|
|
Manufacturing, logistics and related fees
|
|
|
328
|
|
|
|
747
|
|
Sales and marketing
|
|
|
289
|
|
|
|
803
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
24,432
|
|
|
$
|
35,162
|
|
|
|
|
|
|
|
|
|
|
8.
|
Share-Based Compensation
|
Stock Plans
Medicines adopted the 2013 Stock Incentive Plan (the 2013 Plan).
22
The 2013 Plan provides for the grant of stock options, other stock-based awards (including
restricted stock awards, restricted stock units and stock appreciation rights) and cash-based awards to employees, officers, directors, consultants and advisors of Medicines and its subsidiaries, including any individuals who have accepted an offer
of employment. Stock option grants have an exercise price equal to the fair market value of Medicines common stock on the date of grant and generally, for employee grants, have a
10-year
term and vest
25% one year after grant and thereafter in equal monthly installments over a three-year period. The fair value of stock option grants is recognized, net of an estimated forfeiture rate, using an accelerated method over the vesting period of the
options, which is generally four years for employee grants and one year for director grants.
During the years ended December 31, 2015 and
2016, certain employees of the Company were eligible to participate in the 2013 Plan. The Company recorded approximately $8.6 million and $9.9 million of share-based compensation expense, including approximately $7.4 million and
$8.5 million, allocated for employees of Medicines that are not employees of the Company, related to the options for the years ended December 31, 2015 and 2016, respectively.
As discussed in Note 2 Significant Accounting Policies, the
Company was historically included in Medicines consolidated U.S. federal income tax return; the Companys income taxes are computed and reported herein under the separate return method. Use of the separate return method may
result in differences when the sum of the amounts allocated to separate tax provisions are compared with amounts presented in Medicines combined financial statements. In that event, the related deferred tax assets and liabilities could be
significantly different from those presented herein. The benefit from income taxes for the years ended December 31, 2015 and 2016 consists of current and deferred federal, state and foreign taxes based on income as follows:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Current:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
|
|
|
$
|
|
|
State
|
|
|
(6
|
)
|
|
|
(6
|
)
|
Foreign
|
|
|
193
|
|
|
|
212
|
|
|
|
|
|
|
|
|
|
|
|
|
|
187
|
|
|
|
206
|
|
Deferred:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
12,621
|
|
|
$
|
|
|
State
|
|
|
1
|
|
|
|
|
|
Foreign
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,622
|
|
|
|
|
|
Total benefit from taxes
|
|
$
|
12,809
|
|
|
$
|
206
|
|
|
|
|
|
|
|
|
|
|
The components of loss before income taxes consisted of:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Domestic
|
|
$
|
(119,709
|
)
|
|
$
|
(178,571
|
)
|
International
|
|
|
(1,631
|
)
|
|
|
994
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
(121,340
|
)
|
|
$
|
(177,577
|
)
|
|
|
|
|
|
|
|
|
|
23
The difference between tax expense and the amount computed by applying the statutory federal
income tax rate of 35% in 2015 and 2016 to income before income taxes is as follows:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Statutory rate applied to
pre-tax
loss
|
|
$
|
(42,469
|
)
|
|
$
|
(62,152
|
)
|
Add (deduct):
|
|
|
|
|
|
|
|
|
State taxes
|
|
|
4
|
|
|
|
4
|
|
Foreign
|
|
|
377
|
|
|
|
(560
|
)
|
Revaluation of contingent purchase price
|
|
|
(532
|
)
|
|
|
18,637
|
|
Credits
|
|
|
(484
|
)
|
|
|
(604
|
)
|
Other
|
|
|
68
|
|
|
|
72
|
|
Valuation allowances
|
|
|
30,227
|
|
|
|
44,397
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit
|
|
$
|
(12,809
|
)
|
|
$
|
(206
|
)
|
|
|
|
|
|
|
|
|
|
The significant components of the Companys deferred tax assets and liabilities are as follows at
December 31, 2015 and 2016:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Deferred tax assets:
|
|
|
|
|
|
|
|
|
Net operating losses
|
|
$
|
(146,509
|
)
|
|
$
|
(189,013
|
)
|
Credits
|
|
|
(2,238
|
)
|
|
|
(2,842
|
)
|
Deferred revenue
|
|
|
(547
|
)
|
|
|
(864
|
)
|
Other
|
|
|
(1,916
|
)
|
|
|
(1,102
|
)
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
(151,210
|
)
|
|
|
(193,821
|
)
|
Valuation allowance
|
|
|
119,043
|
|
|
|
163,148
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets, net of valuation allowance
|
|
|
(32,167
|
)
|
|
|
(30,673
|
)
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Intangibles
|
|
$
|
32,139
|
|
|
$
|
30,659
|
|
Indefinite lived intangibles
|
|
|
66,019
|
|
|
|
66,019
|
|
fixed Assets
|
|
|
28
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax liability
|
|
|
98,186
|
|
|
|
96,692
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax liability
|
|
$
|
66,019
|
|
|
$
|
66,019
|
|
|
|
|
|
|
|
|
|
|
During 2016, the Company recorded a net increase to its valuation allowance of $44.1 million. At
December 31, 2015 and 2016, the Company recorded a valuation allowance of $119.0 million and $163.1 million, respectively, principally against net operating loss carryforwards in domestic and foreign jurisdictions. The Company
considered positive and negative evidence including its level of past and future operating income, the utilization of carryforwards, and other factors in arriving at its decision to recognize its deferred tax assets. The Company continues to
evaluate the realizability of its deferred tax assets and liabilities on a periodic basis and will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation,
rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory approval of products currently under development. Any additional changes to the valuation allowance recorded on deferred tax assets in the future would impact
the Companys income taxes.
On February 26, 2009, Medicines acquired 100% of the stock of Targanta and became a successor to certain
of its net operating loss and tax credit carryforwards. During 2013, Medicines acquired the stock of Rempex and became the successor of certain net operating losses and tax credit carryforwards. These tax attributes are also subject to a limitation
under Internal Revenue Code Section 382 and these amounts, combined with those of the Company in the table below, have been reduced appropriately for such utilization limitations. In
24
addition, utilization of these net operating loss and tax credit carryforwards is dependent upon the Company achieving profitable results. To the extent the Companys use of net operating
loss and tax credit carryforwards is further limited by Section 382 as a result of any future ownership changes, the Companys income would be subject to cash payments of income tax earlier than it would if the Company was able to fully
use its net operating loss and tax credit carryforwards in the United States. The Company may also be subject to United States alternative minimum tax.
At December 31, 2016, the Company had federal net operating loss carryforwards available to reduce taxable income and federal research and
development tax credit carryforwards available to reduce future tax liabilities. They expire approximately as follows:
|
|
|
|
|
|
|
|
|
Years of Expiration
|
|
Federal Net
Operating Loss
Carryforwards
|
|
|
Federal Research and
Development Tax
Credit Carryforwards
|
|
|
|
(In thousands)
|
|
2025
|
|
$
|
317
|
|
|
$
|
|
|
2026
|
|
|
9,531
|
|
|
|
|
|
2027
|
|
|
30,725
|
|
|
|
|
|
2028
|
|
|
38,954
|
|
|
|
|
|
2029
|
|
|
36,595
|
|
|
|
|
|
2030
|
|
|
2,932
|
|
|
|
|
|
2031
|
|
|
7,753
|
|
|
|
161
|
|
2032
|
|
|
20,570
|
|
|
|
387
|
|
2033
|
|
|
39,748
|
|
|
|
984
|
|
2034
|
|
|
81,497
|
|
|
|
660
|
|
2035
|
|
|
120,714
|
|
|
|
605
|
|
2036
|
|
|
122,276
|
|
|
|
755
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
511,612
|
|
|
$
|
3,552
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2016, the Company had foreign net operating losses of approximately $33.6 million expiring
between 2017 and 2036.
The Company does not anticipate a significant change in its unrecognized tax benefits in the next twelve months.
However applicable taxing authorities can review and adjust net operating loss or tax credit carryforwards originating in a closed tax year if utilized in an open tax year. While tax examinations are often complex, as tax authorities may disagree
with the treatment of items reported requiring several years to resolve, the Company believes that it has adequately provided for all uncertain tax provisions for open tax years by tax jurisdiction. The Company classifies interest and penalties
related to unrecognized tax benefits in income tax expense. The Company has not accrued any interest or penalties as of December 31, 2016. The total amount of unrecognized tax benefits that, if recognized, would affect the Companys effective
tax rate was $0.6 million and $0.7 million as of December 31, 2015 and 2016, respectively.
A reconciliation of the beginning and
ending amount of gross unrecognized tax benefits is as follows:
|
|
|
|
|
|
|
Gross Unrecognized Tax
Benefit
|
|
|
|
(In thousands)
|
|
Balance at January 1, 2015
|
|
$
|
438
|
|
Additions related to current year tax positions
|
|
|
121
|
|
|
|
|
|
|
Balance at December 31, 2015
|
|
|
559
|
|
Additions related to current year tax positions
|
|
|
151
|
|
|
|
|
|
|
Balance at December 31, 2016
|
|
$
|
710
|
|
|
|
|
|
|
The Company provides income taxes on the earnings of foreign subsidiaries to the extent those earnings are
taxable or are expected to be remitted. As of December 31, 2016, the Company has had no accumulated
25
foreign unremitted earnings. The Companys policy is to invest indefinitely its unremitted foreign earnings outside the United States.
10.
|
Fair Value Measurements
|
The Company applies a fair value framework in order to measure
and disclose its financial liabilities which include contingent purchase prices related to acquisitions. The Company determines fair value based on quoted prices when available or through the use of alternative approaches when market quotes are not
readily accessible or available.
The standard describes three levels of inputs that may be used to measure fair value:
Level 1 Quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Fair values are determined by utilizing quoted prices for similar assets
and liabilities in active markets or other market observable inputs such as interest rates and yield curves.
Level 3 Unobservable
inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The Companys Level 3 liabilities consist of the contingent purchase prices associated with the
Companys business combinations. The fair value of certain development or regulatory milestone based contingent purchase prices were determined in a discounted cash flow framework by probability weighting the future contractual payment with
managements assessment of the likelihood of achieving these milestones and present valuing them using a risk-adjusted discount rate. Certain sales milestone based payments were determined in a discounted cash flow framework where risk-adjusted
revenue scenarios were estimated using Monte Carlo simulation models to compute contractual payments which were present valued using a risk- adjusted discount rate.
The following table sets forth the Companys liabilities that were measured at fair value on a recurring basis as of December 31, 2015 and
2016 by level within the fair value hierarchy. Financial assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Companys
assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Balance at
December 31, 2015
|
|
|
|
(In thousands)
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price
|
|
$
|
|
|
|
$
|
|
|
|
$
|
79,157
|
|
|
$
|
79,157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
|
|
|
$
|
|
|
|
$
|
79,157
|
|
|
$
|
79,157
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Balance at
December 31, 2016
|
|
|
|
(In thousands)
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price
|
|
$
|
|
|
|
$
|
|
|
|
$
|
121,957
|
|
|
$
|
121,957
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
|
|
|
$
|
|
|
|
$
|
121,957
|
|
|
$
|
121,957
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Level 3 Disclosures
The Company measures its contingent purchase price at fair value based on significant inputs not observable in the market, which causes it to
be classified as a Level 3 measurement within the fair value hierarchy. The
26
valuation of the contingent purchase price uses assumptions and estimates the Company believes would be made by a market participant in making the same valuation. The Company assesses these
assumptions and estimates on an
on-going
basis as additional data impacting the assumptions and estimates are obtained. Changes in the fair value related to updated assumptions and estimates are recognized
within selling, general and administrative expenses in the accompanying combined statements of operations.
The contingent purchase price
may change significantly as additional data is obtained, impacting the Companys assumptions regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability. In evaluating this
information, considerable judgment is required to interpret the market data used to develop the assumptions and estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange.
Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact the Companys results of operations in future
periods.
The following table provides quantitative information associated with the fair value measurement of the Companys
Level 3 inputs:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value as of
December 31,
2015
|
|
|
Valuation Technique
|
|
Unobservable Input
|
|
Range
(Weighted Average)
|
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
|
Targanta:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
|
|
Contingent purchase price
|
|
$
|
5,857
|
|
|
discounted cash flow
|
|
Probability of success
|
|
|
20%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period in which milestone is expected to be achieved
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
11%
|
|
Rempex:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price:
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
|
|
Event-based milestones
|
|
$
|
63,000
|
|
|
discounted cash flow
|
|
Probabilities of successes
|
|
|
11% - 95% (56%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
|
2016 - 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
3.6% - 6.0%
|
|
Contingent purchase
price:
|
|
|
|
|
|
Risk-adjusted revenue
|
|
|
|
|
|
|
Sales-based milestones
|
|
$
|
10,300
|
|
|
simulation
|
|
Probabilities of successes
|
|
|
11% - 63% (30%)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
|
2018 - 2022
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
5.5% - 6.7%
|
|
27
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value as of
December 31,
2016
|
|
|
Valuation Technique
|
|
Unobservable Input
|
|
Range
(Weighted Average)
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
Targanta
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
Contingent purchase price
|
|
$
|
5,857
|
|
|
discounted cash flow
|
|
Probability of success
|
|
20%
|
|
|
|
|
|
|
|
|
Period in which milestone is expected to be achieved
|
|
2021
|
|
|
|
|
|
|
|
|
Discounted rate
|
|
11%
|
Rempex:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price:
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
Event-based milestones
|
|
$
|
95,800
|
|
|
discounted cash flow
|
|
Probabilities of successes
|
|
18% - 95%(79%)
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2017 - 2024
|
|
|
|
|
|
Contingent purchase price:
|
|
|
|
|
|
Risk-adjusted revenue
|
|
Discount rate
|
|
5.2% - 8.5%
|
Sales-based milestones
|
|
$
|
20,300
|
|
|
simulation
|
|
Probabilities of successes
|
|
16% - 65%(56%)
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2018 - 2022
|
|
|
|
|
|
|
|
|
Discount rate
|
|
6.6% - 8.2%
|
The fair value of the contingent purchase price represents the fair value of the Companys liabilities for
all potential payments under the Companys acquisition agreements for Targanta and Rempex. The significant unobservable inputs used in the fair value measurement of these liabilities are the probabilities of successful achievement of
development, regulatory and sales milestones, which would trigger payments to be made under the Targanta and Rempex agreements, probabilities as to the periods in which the milestones are expected to be achieved and a discount rate. Significant
changes in any of the probabilities of success or periods in which milestones will be achieved would result in a significantly higher or lower fair value measurement.
The changes in fair value of the Companys Level 3 contingent purchase price during the year ended December 31, 2015 and 2016
were as follows:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Balance at the beginning of the period
|
|
$
|
98,034
|
|
|
$
|
79,157
|
|
Settlements
|
|
|
(17,358
|
)
|
|
|
(10,449
|
)
|
Fair Value adjustment to contingent purchase price included in net loss
|
|
|
(1,519
|
)
|
|
|
53,249
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period
|
|
$
|
79,157
|
|
|
$
|
121,957
|
|
|
|
|
|
|
|
|
|
|
No changes in valuation techniques or inputs occurred during the years ended December 31, 2015 and 2016.
11.
|
Commitments and Contingencies
|
The Companys long-term contractual obligations
include commitments and estimated purchase obligations entered into in the normal course of business. These obligations include commitments related to purchases of inventory, research and development service agreements, operating leases, consisting
of the companies leased office space in San Diego, California, and selling, general and administrative obligations.
28
Future estimated contractual obligations as of December 31, 2016 are:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contractual Obligations¹
|
|
Less than 1
Year
|
|
|
1-3 years
|
|
|
4-5 years
|
|
|
More than 5 years
|
|
|
Total
|
|
|
|
(In thousands)
|
|
Inventory related commitments
|
|
$
|
9,330
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
9,330
|
|
Research and development
|
|
|
22,498
|
|
|
|
11,331
|
|
|
|
303
|
|
|
|
|
|
|
|
34,132
|
|
Operating leases
|
|
|
1,121
|
|
|
|
5,566
|
|
|
|
5,905
|
|
|
|
22,706
|
|
|
|
35,298
|
|
Selling, general and administrative
|
|
|
1,596
|
|
|
|
400
|
|
|
|
|
|
|
|
|
|
|
|
1,996
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations
|
|
$
|
34,545
|
|
|
$
|
17,297
|
|
|
$
|
6,208
|
|
|
$
|
22,706
|
|
|
$
|
80,756
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
This table does not include any milestone payments which may become payable to third parties for which the timing and likelihood of such payments are not known, as discussed below.
|
All of the inventory related commitments included above are
non-cancellable.
Included within the
inventory related commitments above are purchase commitments as of December 31, 2016 totaling $8.9 million for Orbactiv bulk drug substances and $0.4 million for Minocin IV. Included in research and development commitments are clinical
research organization costs, validation batch manufacturing for Vabomere and other committed clinical materials and services. Of the total estimated contractual obligations for research and development, and selling, general and administrative,
$16.9 million are
non-cancellable.
On October 1, 2014, Rempex entered into an agreement to
lease 63,000 square feet of office space with
ARE-SD
Region No. 35, LLC for new office and laboratory space in San Diego. This lease has a term of 144 months. The commencement date is February 2017. The
lease qualifies for operating lease treatment with recorded annual rent expense from commencement date to expiration. The Companys expected total obligation for this space is $35.3 million.
Aggregate rent expense under the Companys property leases that are applicable to the Company only was approximately $1.4 million and
$1.7 million as of December 31, 2015 and 2016, respectively.
In addition to the amounts shown in the above table, the Company is
contractually obligated to make potential future success-based development, regulatory and commercial milestone payments and royalty payments in conjunction with acquisitions it has entered into with third-parties. These contingent payments include
milestone payments with respect Orbactiv, Minocin IV, Vabomere and other preclinical royalty and/or product candidates.
As of December 31,
2016, the Company may have to make these significant contingent cash payments in connection with its acquisition and licensing activities upon the achievement of specified regulatory, sales and other milestones as follows:
|
|
|
$49.4 million due to the former equityholders of Targanta and up to $25.0 million in additional payments to other third parties related to the Targanta transaction; and
|
|
|
|
$289.2 million for the Rempex transaction.
|
Given the nature of these events, it is
unclear when, if ever, the Company may be required to pay such amounts. Accordingly, these contingent payments have not been included in the table above as the timing of any future payment is not reasonably estimable.
Contingencies
The
Company may be, from time to time, a party to various disputes and claims arising from normal business activities. The Company accrues for loss contingencies when information available indicates that it is probable that a liability has been incurred
and the amount of such loss can be reasonably estimated.
Currently, the Company is not party to any legal proceedings.
29
12.
|
Employee Benefit Plan
|
Medicines has an employee savings and retirement plan which is
qualified under Section 401(k) of the Internal Revenue Code in which certain employees of the Company are eligible to participate. Medicines made matching contributions to these certain employees of the Company during the years ended December
31, 2015 and 2016 of $0.7 million and $0.5 million, respectively.
13.
|
Related Party Transactions and Shared Service Costs
|
Transactions entered into between
the Company and Medicines have been adjusted to net parent investment as they represent an investment to the Company. The Company receives services and support from other functions of Medicines. The Companys operations are dependent upon the
ability of these other businesses and functions to provide these services and support. The costs associated with these services and support have been allocated to the Company using methodologies based on proportionate headcount of the Company, as
compared to the headcount of Medicines as a whole, which the Company believes is the most appropriate method of allocation. These allocated costs are primarily related to corporate administrative expenses, employee related costs, including salaries
and other benefits, for corporate and shared employees, depreciation expense on shared assets, and rental and usage fees for shared assets for the following functional groups: information technology; legal; accounting and finance; human resources;
marketing and product support; product development; facility; and other corporate and infrastructural services.
The total costs allocated
to the Company for these services were $29.0 million and $31.6 million for the years ended December 31, 2015 and 2016, respectively. These amounts are included in the accompanying combined statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
2015
|
|
|
2016
|
|
|
|
(In thousands)
|
|
Research and development
|
|
$
|
1,072
|
|
|
$
|
2,106
|
|
Selling, general and administrative
|
|
|
27,896
|
|
|
|
29,519
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
28,968
|
|
|
$
|
31,625
|
|
|
|
|
|
|
|
|
|
|
Transactions entered into between the Company and Medicines are considered related party transactions.
14.
|
Reimbursement Agreements
|
Agreements with Biomedical Advanced Research and
Development Authority (BARDA)
2016 BARDA OTA Agreement.
In September 2016, the Company entered into an agreement with BARDA, of
the U.S. Department of Health and Human Services, (HHS). This agreement, which the Company refers to as the BARDA OTA agreement, was established under HHSs Other Transaction Authority, known as OTA. Under the BARDA OTA agreement, the Company
has the potential to receive up to $132.0 million in funding to support the development of early and late stage antibacterial candidates. The BARDA OTA agreement is a cost-sharing arrangement that consisted of an initial base period and four
option periods that BARDA may exercise in its sole discretion pursuant to the agreement. The BARDA OTA agreement provides for an initial commitment by BARDA of $32.0 million for the base period, and up to an additional $100.0 million if
the remaining four options are exercised by BARDA. Under this cost-sharing arrangement, the Company will be responsible for a portion of the costs associated with each period of work. If all option periods are exercised by BARDA, the estimated
period of performance is expected to end in 2021, unless extended by the parties. Either party is entitled to terminate the agreement for convenience, in whole or in part upon 90 days written notice, and BARDAs future period obligations are
subject to congressionally approved annual appropriations. The Company expects to use the total award under the BARDA OTA agreement to support
non-clinical
development activities, nonclinical toxicology,
clinical studies, manufacturing, program management, and associated regulatory activities designed to advance Vabomere and a portfolio of potential new antibiotic drug candidates targeting drug resistant bacteria.
30
2014 BARDA Agreement.
In February 2014, Rempex entered into a cost-sharing agreement
with BARDA, which the Company refers to as the 2014 BARDA agreement. The 2014 BARDA agreement is a cost-sharing arrangement that consisted of an initial base period and seven option periods to be exercised at BARDAs sole discretion. Under the
2014 BARDA agreement, as modified, Rempex had the potential to receive up to $91.8 million in funding to support the development of Vabomere. As of September 2016, when the Company entered into the BARDA OTA Agreement, BARDA had exercised a
base period and three option periods under the 2014 BARDA agreement and committed to total of $55.8 million under the 2014 BARDA agreement. As of December 31, 2016, approximately $9.9 million of funds obligated during the exercised option
periods remain available for reimbursement under the 2014 BARDA agreement. As a result of entering into the BARDA OTA agreement in September 2016, the Company does not expect at this time that BARDA will exercise additional option periods under the
2014 BARDA agreement, although activities relating to Vabomere development will continue to be funded under its terms. Under the 2014 BARDA agreement, Rempex is responsible for a portion of the costs associated with each period of work. The
estimated period of performance for the base period and the exercised option periods is anticipated to continue until 2019. BARDA is entitled to terminate the agreement, including the projects under the 2014 BARDA agreement for convenience, in whole
or in part, at any time. The Company expects to use the remaining award under the 2014 BARDA agreement to support clinical studies, manufacturing and associated regulatory activities designed to obtain marketing approval of Vabomere in the United
States for treatment of serious gram-negative infections.
Under the terms of the Companys agreement with Rempex, the Company agreed
to pay former Rempex equityholders on a quarterly basis, as part of the Companys development milestones, a specified percentage of amounts actually received by the Company from BARDA. The Company recorded approximately $22.5 million and
$15.8 million for the years ended December 31, 2015 and 2016, respectively.
On August 30, 2017, the Company announced that the U.S. Food and
Drug Administration (FDA) has approved Vabomere for injection for the treatment of adult patients with complicated urinary tract infections. The Company expects Vabomere to be commercialized in the fourth quarter of 2017. The FDA approval triggered
a $40 million milestone payment obligation to the former equityholders of Rempex, which was paid in September 2017.
The Company
evaluated subsequent events through November 3, 2017, the date on which these combined financial statements were available to be issued, to ensure that these combined financial statements include appropriate disclosure of events both recognized in
the combined financial statements as of December 31, 2016 and events which occurred subsequently but were not recognized in the combined financial statements.
31
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
Unaudited Condensed Combined
Carve-out
Financial Statements
As of September 30, 2017, and for the Nine Months Ended
September 30, 2016 and 2017
Table of Contents
UNAUDITED CONDENSED
CARVE-OUT
FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2017 AND FOR THE NINE MONTHS ENDED SEPTEMBER
30, 2016 AND 2017
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
CONDENSED COMBINED BALANCE SHEETS
(Unaudited, USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
|
September 30,
2017
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Accounts receivable, net of allowances
|
|
$
|
3,916
|
|
|
$
|
4,223
|
|
Inventory, net
|
|
|
42,411
|
|
|
|
42,850
|
|
BARDA receivable
|
|
|
4,190
|
|
|
|
4,119
|
|
Prepaid expenses and other current assets
|
|
|
1,492
|
|
|
|
558
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
52,009
|
|
|
|
51,750
|
|
Fixed assets, net
|
|
|
1,799
|
|
|
|
5,726
|
|
Developed product rights, net
|
|
|
104,416
|
|
|
|
285,965
|
|
In-process
research and development
|
|
|
188,620
|
|
|
|
|
|
Goodwill
|
|
|
83,303
|
|
|
|
83,303
|
|
Restricted cash
|
|
|
186
|
|
|
|
177
|
|
Other assets
|
|
|
13
|
|
|
|
14
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
430,346
|
|
|
$
|
426,935
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND EQUITY
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
8,060
|
|
|
$
|
2,869
|
|
Accrued expenses
|
|
|
35,162
|
|
|
|
46,656
|
|
Current portion of contingent purchase price
|
|
|
55,000
|
|
|
|
28,700
|
|
Deferred revenue
|
|
|
2,467
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
100,689
|
|
|
|
78,225
|
|
Contingent purchase price
|
|
|
66,957
|
|
|
|
34,183
|
|
Deferred tax liabilities
|
|
|
66,019
|
|
|
|
|
|
Other liabilities
|
|
|
|
|
|
|
3,944
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
233,665
|
|
|
|
116,352
|
|
Equity:
|
|
|
|
|
|
|
|
|
Accumulated other comprehensive loss
|
|
|
(1,533
|
)
|
|
|
(1,127
|
)
|
Net parent investment
|
|
|
198,214
|
|
|
|
311,710
|
|
|
|
|
|
|
|
|
|
|
Total equity
|
|
|
196,681
|
|
|
|
310,583
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and equity
|
|
$
|
430,346
|
|
|
$
|
426,935
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed combined financial statements.
34
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
CONDENSED COMBINED STATEMENTS OF OPERATIONS
(Unaudited, USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2016
|
|
|
2017
|
|
Net revenue
|
|
$
|
16,904
|
|
|
$
|
23,635
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
8,488
|
|
|
|
12,681
|
|
Research and development
|
|
|
30,633
|
|
|
|
37,399
|
|
Selling, general and administrative
|
|
|
103,562
|
|
|
|
94,527
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
142,683
|
|
|
|
144,607
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(125,779
|
)
|
|
|
(120,972
|
)
|
Other expense
|
|
|
(148
|
)
|
|
|
(820
|
)
|
|
|
|
|
|
|
|
|
|
Loss before income taxes
|
|
|
(125,927
|
)
|
|
|
(121,792
|
)
|
|
|
|
|
|
|
|
|
|
(Provision) benefit for income taxes
|
|
|
(12
|
)
|
|
|
66,006
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(125,939
|
)
|
|
$
|
(55,786
|
)
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed combined financial statements.
35
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
CONDENSED COMBINED STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited, USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended
September 30,
|
|
|
|
2016
|
|
|
2017
|
|
Net loss
|
|
$
|
(125,939
|
)
|
|
$
|
(55,786
|
)
|
Other comprehensive income:
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment
|
|
|
267
|
|
|
|
406
|
|
|
|
|
|
|
|
|
|
|
Total other comprehensive income
|
|
|
267
|
|
|
|
406
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(125,672
|
)
|
|
|
(55,380
|
)
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed combined financial statements.
36
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
CONDENSED COMBINED STATEMENT OF EQUITY
(Unaudited, USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Parent
Investment
|
|
|
Accumulated Other
Comprehensive
(Loss) Income
|
|
|
Total Equity
|
|
Balance at January 1, 2017
|
|
$
|
198,214
|
|
|
$
|
(1,533
|
)
|
|
$
|
196,681
|
|
Net loss
|
|
|
(55,786
|
)
|
|
|
|
|
|
|
(55,786
|
)
|
Net transfers from parent
|
|
|
169,282
|
|
|
|
|
|
|
|
169,282
|
|
Currency translation adjustment
|
|
|
|
|
|
|
406
|
|
|
|
406
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2017
|
|
$
|
311,710
|
|
|
|
(1,127
|
)
|
|
|
310,583
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed combined financial statements.
37
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
CONDENSED COMBINED STATEMENTS OF CASH FLOWS
(Unaudited, USD in thousands)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30,
|
|
|
|
2016
|
|
|
2017
|
|
CASH FLOWS FROM OPERATING ACTIVITIES
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(125,939
|
)
|
|
$
|
(55,786
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
6,225
|
|
|
|
7,802
|
|
Non-cash
stock compensation
|
|
|
7,385
|
|
|
|
12,449
|
|
Change in contingent purchase price
|
|
|
42,161
|
|
|
|
3,544
|
|
Deferred tax benefit
|
|
|
|
|
|
|
(66,019
|
)
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(213
|
)
|
|
|
(307
|
)
|
Inventory, net
|
|
|
(13,055
|
)
|
|
|
(439
|
)
|
BARDA receivable
|
|
|
3,951
|
|
|
|
71
|
|
Prepaid expenses and other current assets
|
|
|
163
|
|
|
|
935
|
|
Accounts payable
|
|
|
(3,742
|
)
|
|
|
(5,192
|
)
|
Accrued expenses
|
|
|
(3,387
|
)
|
|
|
11,494
|
|
Payments on contingent purchase price
|
|
|
(773
|
)
|
|
|
(52,499
|
)
|
Deferred revenue
|
|
|
811
|
|
|
|
(2,467
|
)
|
Other liabilities
|
|
|
(1
|
)
|
|
|
3,944
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(86,414
|
)
|
|
|
(142,470
|
)
|
CASH FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
Proceeds from sale of fixed assets
|
|
|
|
|
|
|
72
|
|
Purchases of fixed assets
|
|
|
(51
|
)
|
|
|
(4,503
|
)
|
Change in restricted cash
|
|
|
(10
|
)
|
|
|
10
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(61
|
)
|
|
|
(4,421
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
Net parent investment
|
|
|
94,513
|
|
|
|
157,010
|
|
Payments on contingent purchase price
|
|
|
(8,038
|
)
|
|
|
(10,119
|
)
|
Net cash provided by financing activities
|
|
|
86,475
|
|
|
|
146,891
|
|
|
|
|
|
|
|
|
|
|
CASH AND CASH EQUIVALENTS
|
|
|
|
|
|
|
|
|
Change in cash and cash equivalents
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the beginning of the period
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at the end of the period
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to condensed combined financial statements.
38
THE INFECTIOUS DISEASE BUSINESSES OF THE MEDICINES COMPANY
NOTES
TO CONDENSED COMBINED FINANCIAL STATEMENTS (Unaudited)
The accompanying condensed combined financial statements and notes present the
condensed combined balance sheets, statements of operations, statements of comprehensive loss, statement of equity and statements of cash flows of The Infectious Disease Businesses, (The Company), of The Medicines Company, (Medicines). The
Infectious Disease Businesses consist of two operating subsidiaries, Rempex Pharmaceuticals Inc., (Rempex), and Targanta Therapeutics Corporation, (Targanta), through which Medicines has historically operated its infectious disease business.
The Company is primarily comprised of the infectious disease activities related to Minocin IV, Orbactiv, and Vabomere, and other preclinical product
candidates. The Companys marketed product portfolio has Minocin
®
, (minocycline), for injection, Orbactiv
®
, (oritavancin) and
Vabomere. The Company also has a pipeline of products in development. The Company manages its business and operations as one segment and believes that its products and products in development possess favorable attributes that competitive
products do not provide, can satisfy unmet medical needs in the intensive care hospital product market and offer, or, in the case of its products in development, have the potential to offer, improved performance to hospital businesses.
2.
|
Significant Accounting Policies
|
Basis of Presentation
The accompanying condensed combined financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in
the United States (GAAP) for interim financial information and are comprised of the Companys activities distributed across multiple legal entities of Medicines. Certain information and footnote disclosures normally included in financial
statements prepared in accordance with GAAP have been condensed or omitted pursuant to instructions, rules and regulations prescribed by the United States Securities and Exchange Commission (SEC). Accordingly, they do not include all of the
information and disclosures required by GAAP for complete financial statements. The Company believes that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited condensed combined financial
statements are read in conjunction with the December 31, 2016 audited combined financial statements. In the opinion of management, the accompanying unaudited condensed combined financial statements include all adjustments, consisting solely of
normal recurring adjustments, considered necessary for a fair presentation of the Companys financial position, results of operations, comprehensive loss, and cash flows for the periods presented. All intercompany balances and transactions have
been eliminated in the accompanying condensed combined financial statements.
These condensed combined financial statements have been extracted from the
accounting records of Medicines. The historical results of operations, financial position, and cash flows may not be indicative of what the Company would actually have been had the Company been a separate stand-alone entity, nor are they indicative
of what the results of operations, financial position and cash flows may be in the future.
The accompanying condensed combined financial statements
reflect the assets and liabilities that are directly attributable to the Company. The assets and liabilities excluded from the accompanying condensed combined financial statements consist of:
|
|
|
Cash that has been swept into a centralized cash management system. For most of the entities constituting its business, including the Company, Medicines uses a centralized approach to cash management and financing of
its operations. Accordingly, none of the cash or cash equivalents, or debt, including interest thereon not directly related to the Company, has been reflected in these combined financial statements.
|
39
|
|
|
Other assets and liabilities at Medicines subsidiary companies which are not directly related to, or are not specifically owned by, or commitments of the Company, including fixed assets shared by the Company with
other products/businesses of Medicines.
|
|
|
|
Medicines third-party debt and the related interest expense have not been allocated to these combined financial statements as the Company was not the legal obligor of the third-party debt and Medicines
borrowings were not directly attributable to the Company.
|
Earnings per share data has not been presented in the condensed combined
financial statements because the Company does not operate as a separate legal entity with its own capital structure.
Revenue and costs directly related
to the Company have been entirely attributed to the Company in the accompanying condensed combined financial statements. The Company also receives services and support from other functions of Medicines. The Companys operations are dependent
upon the ability of these other businesses and functions to provide these services and support. The costs associated with these services and support have been allocated to the Company using methodologies based on proportionate headcount of the
Company, as compared to the headcount of Medicines as a whole, which the Company believes is the most appropriate method of allocation. These allocated costs are primarily related to corporate administrative expenses, employee related costs,
including salaries and other benefits, for corporate and shared employees, depreciation expense on shared assets, and rental and usage fees for shared assets for the following functional groups: information technology; legal; accounting and finance;
human resources; marketing and product support; product development; facility; and other corporate and infrastructural services.
These allocated costs
are recorded primarily in Research and Development (R&D), and Selling, General and Administrative (SG&A) expenses in the condensed combined statements of operations. Income taxes have been accounted for using the separate return method in
the accompanying condensed combined financial statements as described below.
The Company believes the assumptions and allocations underlying the
condensed combined financial statements are reasonable and appropriate under the circumstances.
Going Concern
Since inception, the Company has incurred significant net losses. The Company incurred net losses of $125.9 million and $55.8 million for the nine
months ended September 30, 2016 and 2017, respectively. The Company has not been capitalized with sufficient funding to conduct its operations. Since the Company has no available cash or credit facilities, the Company is dependent upon Medicines and
its affiliates to provide services and funding to support the operations of the Company until, at least, such time as external financing is completed. The Company expects to incur significant expenses and operating losses for the foreseeable future
as it continues its efforts to seek regulatory approvals for product candidates it acquires or develops and to sell, market and distribute Orbactiv, Minocin IV, and Vabomere. If the Company is unable to grow its revenue from Orbactiv, Minocin IV and
Vabomere, it may never become profitable.
Additional financing will be needed by the Company to fund its ongoing activities, particularly as it pursues
marketing approval for product candidates it may develop as well as the continued commercialization activities with respect to Orbactiv, Minocin IV and Vabomere. The Company may raise this additional funding through the sale of equity, debt
financings or other capital sources, including potential collaborations with other companies or other strategic transactions and funding under government contracts. The Company may be unable to raise additional funds or enter into such other
arrangements or arrangement when needed on favorable terms, or at all. If the Company is unable to raise capital when needed or on attractive terms, the Company could be forced to delay, reduce or eliminate certain of the Companys
commercialization efforts and research and development programs. There can be no assurances that other sources of financing would be available or that Medicines will
40
continue to have the ability to financially support the operations of the Company given that substantial doubt exists about Medicines ability to continue as a going concern. Due to these
uncertainties, there is substantial doubt about the Companys ability to continue as a going concern.
The accompanying condensed combined financial
statements have been prepared under the assumption that the Company will continue as a going concern. The condensed combined financial statements do not include any adjustments relating to the recoverability and classification of recorded asset
amounts or classification of liabilities that might result from the outcome of the uncertainties discussed above.
Use of Estimates
The preparation of the condensed combined financial statements in accordance with GAAP requires management to make estimates and assumptions that affect the
amounts that are reported in the combined financial statements and accompanying disclosures. Such estimates include, but are not limited to contingent consideration, inventory reserves, costs of revenue and other assets, liabilities, revenue and
expenses. Actual amounts may be different.
Revenue Recognition
Product Sales for Orbactiv.
Prior to September 1, 2017, the Company recognized sales from Orbactiv under a deferred revenue model as it did not have
sufficient information to develop estimates of expected returns and other adjustments to gross revenue. Under the deferred revenue model, the Company did not recognize revenue upon product shipment of Orbactiv to Integrated Commercialization
Solutions (ICS). Instead, upon product shipment, the Company invoiced ICS, recorded deferred revenue at gross invoice sales price, classified the cost basis of the product held by ICS as finished goods inventory held by others and included such cost
basis amount within prepaid expenses and other current assets on the combined balance sheets. The Company recognized revenue when hospitals purchased the products and the transaction consideration became fixed or determinable. Beginning September 1,
2017, the Company has sufficient market information to reasonably estimate its chargebacks, returns and other adjustments to gross revenues associated with Orbactiv and recognizes sales upon shipment to ICS. This change in estimate resulted in a
$1.6 million and $0.4 million increase to net product revenues and cost of product revenues, respectively, for the nine months ended September 30, 2017.
Contingencies
The Company may be, from time to time, a
party to various disputes and claims arising from normal business activities. The Company continually assesses litigation to determine if an unfavorable outcome would lead to a probable loss or reasonably possible loss which could be estimated. In
accordance with the guidance of the Financial Accounting Standards Board (FASB) on accounting for contingencies, the Company accrues for all contingencies at the earliest date at which the Company deems it probable that a liability has been incurred
and the amount of such liability can be reasonably estimated. If the estimate of a probable loss is a range and no amount within the range is more likely than another, the Company accrues the minimum of the range. In the cases where the Company
believes that a reasonably possible loss exists, the Company discloses the facts and circumstances of the litigation, including an estimable range, if possible.
Currently, the Company is not party to any legal proceedings.
Research and Development
Research and development costs
are expensed as incurred. Clinical study costs are accrued over the service periods specified in the contracts and adjusted as necessary based upon an ongoing review of the level of effort and costs actually incurred. Payments for a product license
prior to regulatory approval of the product and payments for milestones achieved prior to regulatory approval of the product are expensed in the period incurred as research and development. Milestone payments that do not represent payments of
contingent purchase price from business combinations that are made in connection with regulatory approvals are capitalized and amortized to cost of revenue over the remaining useful life of the asset.
41
The Company recognizes reimbursements under research contracts when a contract has been executed, the
contract price is fixed or determinable, delivery of services or products has occurred and collection of the contract price is reasonably assured. The reimbursements are classified as an offset to research and development expenses. Payments received
in advance of work performed are deferred. See Note 13 Reimbursement Agreements for further details on these contracts.
Recent Accounting
Pronouncements
In May 2014, the FASB issued a comprehensive new revenue recognition Accounting Standards Update (ASU), Revenue from Contracts
with Customers (Topic 606) (ASU
No. 2014-09).
ASU
No. 2014-09
provides guidance to clarify the principles for recognizing revenue. This guidance includes
the required steps to achieve the core principle that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in
exchange for those goods or services. In August 2015, the FASB deferred the effective date of the revenue recognition guidance to reporting periods beginning after December 15, 2017. Early adoption of the standard is permitted but not before the
original effective date, which was for reporting periods beginning after December 15, 2016. The FASB has further amended guidance related to recording revenue on a gross versus a net basis and on identifying performance obligations and licensing.
The FASB has also revised certain SEC guidance primarily related to ASC Topic 815, Derivatives and Hedging, and has issued additional improvements and practical expedients to the standard.
The Company has begun to form a project team to analyze the impacts of ASU
No. 2014-09
on its revenue streams,
specifically focusing on its product revenues. The Companys assessment included a review of current accounting policies and practices to identify potential differences that would result from applying the guidance. The Company will continue to
assess new customer contracts throughout 2017 and any impact the standard will have on its processes, systems and controls. While the Companys assessment of the impacts of ASU
No. 2014-09
is still
in process, the adoption of the guidance is not expected to have a material impact on the Companys combined financial statements. However, it is likely that the Company will be required to provide additional disclosures in the notes to the
combined financial statements upon adoption. The Company currently intends to adopt the standard using the modified retrospective method.
In February
2016, the FASB issued ASU
No. 2016-02,
Leases (Topic 842) (ASU
No. 2016-02).
ASU
No. 2016-02
will
require organizations that lease assets with lease terms of more than 12 months to recognize assets and liabilities for the rights and obligations created by those leases on their balance sheets. The ASU will also require new qualitative and
quantitative disclosures to help investors and other financial statement users better understand the amount, timing, and uncertainty of cash flows arising from leases. ASU
No. 2016-02
will be effective
for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted. The Company expects to adopt this guidance when effective and is currently evaluating the effect
that the updated standard will have on its combined financial statements and related disclosures.
In August 2016, the FASB issued ASU
No. 2016-15,
Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments (ASU
No. 2016-15).
This guidance clarifies
how certain cash receipts and payments should be presented in the statement of cash flows and is effective for interim and annual reporting periods beginning after December 15, 2017, with early adoption permitted. The Company does not believe that
this guidance will have an impact on the combined financial statements and related disclosures.
In November 2016, the FASB issued ASU
2016-18,
Statement of Cash Flows (Topic 230): Restricted Cash (ASU
No. 2016-18).
This amends the guidance in ASC 230, including providing additional guidance
related to transfers between cash and restricted cash and how entities present, in their statement of cash flows, the cash receipts and cash payments that directly affect the restricted cash accounts. ASU
2016-18
is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption
42
permitted. The Company does not believe that this guidance will have an impact on the combined financial statements and related disclosures.
In January 2017, the FASB issued ASU
2017-01,
Business Combinations (Topic 805): Clarifying the Definition of a
Business, which clarifies the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. ASU
2017-01
is effective for annual reporting periods beginning after December 15, 2017, and interim periods within those years, with early adoption permitted. The Company will apply the guidance to applicable
transactions after the adoption date. The impact on the Companys combined financial statements will depend on the facts and circumstances of any specific future transactions.
In January 2017, the FASB issued ASU
2017-04,
Intangibles-Goodwill and Other, Simplifying the Test for Goodwill
Impairment, which eliminates Step 2 from the goodwill impairment test. Under the revised test, an entity should perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An
entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting units fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. This
ASU is effective for any interim or annual impairment tests for fiscal years beginning after December 15, 2019, with early adoption permitted. The Company does not believe that this guidance will have an impact on the combined financial statements
and related disclosures.
The major classes of inventory consisted of the following at December 31, 2016 and
September 30, 2017:
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
|
September 30,
2017
|
|
|
|
(In thousands)
|
|
Raw material
|
|
$
|
38,245
|
|
|
$
|
40,656
|
|
Work-in-progress
|
|
|
3,637
|
|
|
|
1,390
|
|
Finished goods
|
|
|
529
|
|
|
|
804
|
|
|
|
|
|
|
|
|
|
|
Total inventory, net
|
|
$
|
42,411
|
|
|
$
|
42,850
|
|
|
|
|
|
|
|
|
|
|
The Company reviews inventory, including inventory purchase commitments, for slow moving or obsolete amounts based on expected
volume and provides reserves against the carrying amount of inventory as appropriate. If annual volume is less than expected, the Company may be required to make additional allowances for excess or obsolete inventory in the future.
4.
|
Prepaid and Other Current Assets
|
Prepaid expenses and other current assets consisted of the following
at December 31, 2016 and September 30, 2017:
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
|
September 30,
2017
|
|
|
|
(In thousands)
|
|
Prepaid expenses
|
|
|
1,320
|
|
|
|
444
|
|
Prepaid inventory
|
|
|
69
|
|
|
|
|
|
Other
|
|
|
103
|
|
|
|
114
|
|
|
|
|
|
|
|
|
|
|
Total prepaid expenses and other current assets
|
|
$
|
1,492
|
|
|
$
|
558
|
|
|
|
|
|
|
|
|
|
|
43
Fixed assets, net consisted of the following at December 31, 2016 and September 30, 2017:
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated
Life (Years)
|
|
December 31,
2016
|
|
|
September 30,
2017
|
|
|
|
|
|
(In thousands)
|
|
Furniture, fixtures and equipment
|
|
5
|
|
$
|
3,758
|
|
|
$
|
3,428
|
|
Computer hardware
|
|
3
|
|
|
203
|
|
|
|
169
|
|
Leasehold improvements
|
|
12
|
|
|
82
|
|
|
|
4,859
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,043
|
|
|
|
8,456
|
|
Less: Accumulated depreciation
|
|
|
|
|
(2,244
|
)
|
|
|
(2,730
|
)
|
|
|
|
|
|
|
|
|
|
|
|
Total fixed assets
|
|
|
|
$
|
1,799
|
|
|
$
|
5,726
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation expense was approximately $277 thousand and $731 thousand for the nine months ended September 30, 2016
and 2017, respectively.
6.
|
Intangible Assets and Goodwill
|
The following information details the carrying amounts and accumulated
amortization of the Companys intangible assets subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2016
|
|
|
As of September 30, 2017
|
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
and other
charges
|
|
|
Net
Carrying
Amount
|
|
|
Gross
Carrying
Amount
|
|
|
Accumulated
Amortization
|
|
|
Net
Carrying
Amount
|
|
Amortizable intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developed product rights
(1)
|
|
$
|
120,560
|
|
|
$
|
(16,144
|
)
|
|
$
|
104,416
|
|
|
$
|
309,180
|
|
|
$
|
(23,215
|
)
|
|
$
|
285,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortizable intangible assets
|
|
$
|
120,560
|
|
|
$
|
(16,144
|
)
|
|
$
|
104,416
|
|
|
$
|
309,180
|
|
|
$
|
(23,215
|
)
|
|
$
|
285,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets not subject to amortization:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In-process
research and development
|
|
$
|
188,620
|
|
|
$
|
|
|
|
$
|
188,620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets not subject to amortization:
|
|
|
188,620
|
|
|
|
|
|
|
|
188,620
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$
|
309,180
|
|
|
$
|
(16,144
|
)
|
|
$
|
293,036
|
|
|
$
|
309,180
|
|
|
$
|
(23,215
|
)
|
|
$
|
285,965
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
The Company amortizes intangible assets related to developed product rights over the remaining life of the patents.
|
In the third quarter of 2017, the Company reclassified $188.6 million of IPR&D assets to developed product rights due to the approval of Vabomere in
the United States and commenced amortization over its estimated useful life.
The Company recognized amortization expense of approximately
$5.9 million and $7.1 million during the nine months ended September 30, 2016 and 2017, respectively. The Company expects amortization expense related to its intangible assets to be approximately $5.4 million for the last three months
of 2017. The Company expects annual amortization expense related to its intangible assets to be approximately $21.4 million, $21.4 million, $21.4 million, $21.4 million and $21.4 million for the years ending December 31,
2018, 2019, 2020, 2021 and 2022, respectively, with the balance of $173.6 million being amortized thereafter. The Company records amortization expense in cost of revenue in the accompanying condensed combined statements of operations.
44
There were no changes to the Companys goodwill amounts for the nine months ended September 30, 2017.
Accrued expenses consisted of the following at December 31, 2016 and September 30,
2017:
|
|
|
|
|
|
|
|
|
|
|
December 31,
2016
|
|
|
September 30,
2017
|
|
|
|
(In thousands)
|
|
Royalties
|
|
$
|
450
|
|
|
$
|
669
|
|
Research and development services
|
|
|
20,404
|
|
|
|
7,095
|
|
Compensation related
|
|
|
10,030
|
|
|
|
11,187
|
|
Product return, rebates, and other fees
|
|
|
476
|
|
|
|
1,159
|
|
Legal, accounting and other
|
|
|
2,252
|
|
|
|
1,123
|
|
Manufacturing, logistics and related fees
|
|
|
747
|
|
|
|
20,892
|
|
Sales and marketing
|
|
|
803
|
|
|
|
4,531
|
|
|
|
|
|
|
|
|
|
|
Total accrued expenses
|
|
$
|
35,162
|
|
|
$
|
46,656
|
|
|
|
|
|
|
|
|
|
|
8.
|
Share-Based Compensation
|
Stock Plans
Medicines adopted the 2013 Stock Incentive Plan (the 2013 Plan).
The 2013 Plan provides for the grant of stock options, other stock-based awards (including restricted stock awards, restricted stock units and stock
appreciation rights) and cash-based awards to employees, officers, directors, consultants and advisors of Medicines and its subsidiaries, including any individuals who have accepted an offer of employment. Stock option grants have an exercise price
equal to the fair market value of Medicines common stock on the date of grant and generally, for employee grants, have a
10-year
term and vest 25% one year after grant and thereafter in equal monthly
installments over a three-year period. The fair value of stock option grants is recognized, net of an estimated forfeiture rate, using an accelerated method over the vesting period of the options, which is generally four years for employee grants
and one year for director grants.
During the nine months ended September 30, 2016 and 2017, certain employees of the Company were eligible to participate
in the 2013 Plan. The Company recorded approximately $7.4 million and $12.4 million of share-based compensation expense, including approximately $6.3 million and $10.9 million, allocated for employees of Medicines that are not
employees of the Company, related to the options for the nine months ended September 30, 2016 and 2017, respectively.
For the nine months ended September 30, 2016 and 2017, the Company recorded a provision
for income taxes of $0.01 million and a benefit for income taxes of $66 million, respectively. The worldwide effective income tax rates for the Company for the nine months ended September 30, 2016 and 2017 were (0.1)% and 54.2%,
respectively. For the nine months ended September 30, 2017, the Companys benefit for income taxes is primarily attributable to a reduction in the Companys recorded valuation allowance against its deferred tax assets as a result of the
commencement of amortization of IPR&D associated with Vabomere upon approval by the FDA, which resulted in a discrete benefit of $66.0 million.
The Company considers all available evidence, both positive and negative, to determine whether, based on the weight of that evidence, a valuation allowance is
needed to reduce its deferred tax assets to the amount that is more likely than not to be realized. The Company placed significant weight on the fact that the Company expects to be in a cumulative net book loss for the three-year period ending
December 31, 2017 in recording valuation allowances on substantial portions of its deferred tax assets as of September 30, 2017.
45
The Company will continue to evaluate its ability to realize its deferred tax assets on a periodic basis and
will adjust such amounts in light of changing facts and circumstances including, but not limited to, future projections of taxable income, tax legislation, rulings by relevant tax authorities, the progress of ongoing tax audits and the regulatory
approval of products currently under development. Any additional changes to the valuation allowance recorded on deferred tax assets in the future would impact the Companys income taxes.
10.
|
Fair Value Measurements
|
The Company applies a fair value framework in order to measure and disclose its
financial liabilities which include contingent purchase prices related to acquisitions. The Company determines fair value based on quoted prices when available or through the use of alternative approaches when market quotes are not readily
accessible or available.
The standard describes three levels of inputs that may be used to measure fair value:
Level 1 Quoted prices in active markets for identical assets or liabilities.
Level 2 Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not
active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Fair values are determined by utilizing quoted prices for similar assets and liabilities in
active markets or other market observable inputs such as interest rates and yield curves.
Level 3 Unobservable inputs that are supported by little
or no market activity and that are significant to the fair value of the assets or liabilities. The Companys Level 3 liabilities consist of the contingent purchase prices associated with the Companys business combinations. The fair
value of certain development or regulatory milestone based contingent purchase prices were determined in a discounted cash flow framework by probability weighting the future contractual payment with managements assessment of the likelihood of
achieving these milestones and present valuing them using a risk-adjusted discount rate. Certain sales milestone based payments were determined in a discounted cash flow framework where risk-adjusted revenue scenarios were estimated using Monte
Carlo simulation models to compute contractual payments which were present valued using a risk- adjusted discount rate.
The following table sets forth
the Companys liabilities that were measured at fair value on a recurring basis as of December 31, 2016 and September 30, 2017 by level within the fair value hierarchy. Financial liabilities measured at fair value are classified in their
entirety based on the lowest level of input that is significant to the fair value measurement. The Companys assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers
factors specific to the liability:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Balance at
December 31, 2016
|
|
|
|
(In thousands)
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price
|
|
$
|
|
|
|
$
|
|
|
|
$
|
121,957
|
|
|
$
|
121,957
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
|
|
|
$
|
|
|
|
$
|
121,957
|
|
|
$
|
121,957
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
(Level 3)
|
|
|
Balance at
September 30, 2017
|
|
|
|
(In thousands)
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price
|
|
$
|
|
|
|
$
|
|
|
|
$
|
62,883
|
|
|
$
|
62,883
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities at fair value
|
|
$
|
|
|
|
$
|
|
|
|
$
|
62,883
|
|
|
$
|
62,883
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
46
Level 3 Disclosures
The Company measures its contingent purchase price at fair value based on significant inputs not observable in the market, which causes it to be classified as
a Level 3 measurement within the fair value hierarchy. The valuation of the contingent purchase price uses assumptions and estimates the Company believes would be made by a market participant in making the same valuation. The Company assesses
these assumptions and estimates on an
on-going
basis as additional data impacting the assumptions and estimates are obtained. Changes in the fair value related to updated assumptions and estimates are
recognized within selling, general and administrative expenses in the accompanying condensed combined statements of operations.
The contingent purchase
price may change significantly as additional data is obtained, impacting the Companys assumptions regarding probabilities of successful achievement of related milestones used to estimate the fair value of the liability. In evaluating this
information, considerable judgment is required to interpret the market data used to develop the assumptions and estimates. The estimates of fair value may not be indicative of the amounts that could be realized in a current market exchange.
Accordingly, the use of different market assumptions and/or different valuation techniques may have a material effect on the estimated fair value amounts, and such changes could materially impact the Companys results of operations in future
periods.
The following table provides quantitative information associated with the fair value measurement of the Companys Level 3 inputs:
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value as
December 31,
2016
|
|
|
Valuation Technique
|
|
Unobservable Input
|
|
Range
(Weighted Average)
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
Targanta:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
Contingent purchase price
|
|
$
|
5,857
|
|
|
discounted cash flow
|
|
Probability of success
|
|
20%
|
|
|
|
|
|
|
|
|
Period in which milestone is expected to be achieved
|
|
2021
|
|
|
|
|
|
|
|
|
Discount rate
|
|
11%
|
Rempex:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price:
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
Event-based
milestones
|
|
$
|
95,800
|
|
|
discounted cash flow
|
|
Probabilities of successes
|
|
18% - 95% (78%)
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2017 - 2024
|
|
|
|
|
|
|
|
|
Discount rate
|
|
5.2% - 8.5%
|
Contingent purchase price:
|
|
|
|
|
|
Risk-adjusted revenue
|
|
|
|
|
Sales-based
milestones
|
|
$
|
20,300
|
|
|
simulation
|
|
Probabilities of successes
|
|
16% - 65% (56%)
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2018 - 2022
|
|
|
|
|
|
|
|
|
Discount rate
|
|
6.6% - 8.2%
|
47
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2017
|
|
|
Valuation Technique
|
|
Unobservable Input
|
|
Range
(Weighted Average)
|
|
|
(In thousands)
|
|
|
|
|
|
|
|
Targanta:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
Contingent purchase price
|
|
$
|
1,584
|
|
|
discounted cash flow
|
|
Probability of success
|
|
5%
|
|
|
|
|
|
|
|
|
Period in which milestone is expected to be achieved
|
|
2021
|
|
|
|
|
|
|
|
|
Discount rate
|
|
11%
|
Rempex:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent purchase price:
|
|
|
|
|
|
Probability-adjusted
|
|
|
|
|
Event-based
milestones
|
|
$
|
47,200
|
|
|
discounted cash flow
|
|
Probabilities of successes
|
|
18% - 90% (71%)
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2018 - 2024
|
|
|
|
|
|
|
|
|
Discount rate
|
|
4.4% - 7.3%
|
Contingent purchase price:
|
|
|
|
|
|
Risk-adjusted
revenue
|
|
|
|
|
Sales-based
milestones
|
|
$
|
14,100
|
|
|
simulation
|
|
Probabilities of successes
|
|
15% - 85% (72%)
|
|
|
|
|
|
|
|
|
Period in which milestones are expected to be achieved
|
|
2020 - 2022
|
|
|
|
|
|
|
|
|
Discount rate
|
|
5.5% - 6.7%
|
The fair value of the contingent purchase price represents the fair value of the Companys liabilities for all potential
payments under the Companys acquisition agreements for Targanta and Rempex. During the first quarter of 2017, the Company made a $20.0 million payment to the former equity holders of Rempex upon acceptance of the NDA for Vabomere. During
the third quarter of 2017, the Company made a $40.0 million payment to the former equity holders of Rempex upon approval of Vabomere in the United States. There were no other changes to the potential future payments under the Companys
acquisition agreements. As of September 30, 2017, the remaining potential future payments to the former equity holders of Rempex and Targanta were $224.7 million and $49.4 million, respectively. The significant unobservable inputs used in
the fair value measurement of these liabilities are the probabilities of successful achievement of development, regulatory and sales milestones, which would trigger payments to be made under the Targanta and Rempex agreements, probabilities as to
the periods in which the milestones are expected to be achieved and discount rates. Significant changes in any of the probabilities of success or periods in which milestones will be achieved would result in a significantly higher or lower fair value
measurement.
The changes in fair value of the Companys Level 3 contingent purchase price during the nine months ended September 30, 2016 and
2017 were as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine months ended
September 30, 2016
|
|
|
Nine months ended
September 30, 2017
|
|
|
|
(In thousands)
|
|
Balance at the beginning of the period
|
|
$
|
79,157
|
|
|
$
|
121,957
|
|
|
|
|
Payments
|
|
|
(8,811
|
)
|
|
|
(62,618
|
)
|
Fair Value adjustment to contingent purchase price included in net loss
|
|
|
42,161
|
|
|
|
3,544
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period
|
|
|
112,507
|
|
|
$
|
62,883
|
|
|
|
|
|
|
|
|
|
|
No other changes in valuation techniques or inputs occurred during the nine months ended September 30, 2016 and 2017.
48
11.
|
Related Party Transactions and Shared Service Costs
|
Transactions entered into between the Company and
Medicines have been adjusted to net parent investment as they represent an investment to the Company. The Company receives services and support from other functions of Medicines. The Companys operations are dependent upon the ability of these
other businesses and functions to provide these services and support. The costs associated with these services and support have been allocated to the Company using methodologies based on proportionate headcount of the Company, as compared to the
headcount of Medicines as a whole, which the Company believes is the most appropriate method of allocation. These allocated costs are primarily related to corporate administrative expenses, employee related costs, including salaries and other
benefits, for corporate and shared employees, depreciation expense on shared assets, and rental and usage fees for shared assets for the following functional groups: information technology; legal; accounting and finance; human resources; marketing
and product support; product development; facility; and other corporate and infrastructural services.
The total costs allocated to the Company for these
services were $23.3 million and $34.2 million for the nine months ended September 30, 2016 and 2017, respectively. These amounts are included in the accompanying condensed combined statements of operations as follows:
|
|
|
|
|
|
|
|
|
|
|
Nine months ended
September 30, 2016
|
|
|
Nine months ended
September 30, 2017
|
|
|
|
(In thousands)
|
|
Research and development
|
|
$
|
1,807
|
|
|
$
|
1,401
|
|
Selling, general and administrative
|
|
|
21,521
|
|
|
|
32,804
|
|
|
|
|
|
|
|
|
|
|
Balance at the end of the period
|
|
$
|
23,328
|
|
|
$
|
34,205
|
|
|
|
|
|
|
|
|
|
|
Transactions entered into between the Company and Medicines are considered related party transactions.
On November 29, 2017, Medicines announced it entered into a definitive agreement with
Melinta Therapeutics, Inc. to sell the Company for $270 million in upfront consideration and guaranteed payments, tiered royalty payments of
5%-25%
on worldwide net sales of Vabomere, Orbactiv and Minocin
IV, and the assumption by Melinta Therapeutics, Inc. of all royalty, milestone and other payment obligations related to those products. The transaction is expected to close in the first quarter of 2018, subject to satisfaction of customary
conditions, including approval by the stockholders of Melinta Therapeutics, Inc.
The Company evaluated subsequent events through November 29, 2017, the
date on which these condensed combined financial statements were available to be issued, to ensure that these condensed combined financial statements include appropriate disclosure of events both recognized in the condensed combined financial
statements as of September 30, 2017 and events which occurred subsequently but were not recognized in the condensed combined financial statements.
49
EXHIBIT E
Quarterly Report of Melinta (formerly known as Cempra, Inc.) on Form
10-Q
for the fiscal quarter
ended March 31, 2017.
See attached.
EXHIBIT F
Quarterly Report of Melinta (formerly known as Cempra, Inc.) on Form
10-Q
for the fiscal quarter
ended June 30, 2017.
See attached.
EXHIBIT G
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on March 6, 2017.
See attached.
EXHIBIT H
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on March 13, 2017.
See attached.
EXHIBIT I
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on March 28, 2017.
See attached.
EXHIBIT J
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on April 28, 2017.
See attached.
EXHIBIT K
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on April 28, 2017.
See attached.
EXHIBIT L
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on June 28, 2017.
See attached.
EXHIBIT M
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on August 9, 2017.
See attached.
EXHIBIT N
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on August 10,
2017.
See attached.
EXHIBIT O
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on September 7,
2017.
See attached.
EXHIBIT P
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on September 11,
2017.
See attached.
EXHIBIT Q
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on September 28,
2017.
See attached.
EXHIBIT R
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on October 31,
2017.
See attached.
EXHIBIT S
Current Report of Melinta (formerly known as Cempra, Inc.) on Form
8-K
filed on November 1,
2017.
See attached.
EXHIBIT T
Current Report of Melinta on Form
8-K
filed on November 3, 2017.
See attached.
EXHIBIT U
Current Report of Melinta on Form
8-K
filed on November 9, 2017.
See attached.
EXHIBIT V
Current Report of Melinta on Form
8-K
filed on November 29, 2017.
See attached.
EXHIBIT W
Current Report of Melinta on Form
8-K
filed on December 1, 2017.
See attached.
EXHIBIT X
Current Report of Melinta on Form
8-K
filed on December 4, 2017
See attached.
Annex A
EXECUTION VERSION
PURCHASE AND SALE AGREEMENT
dated as of November 28, 2017
by and between
THE
MEDICINES COMPANY
and
MELINTA THERAPEUTICS, INC.
TABLE OF CONTENTS
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Page
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ARTICLE I. DEFINITIONS
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A-1
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1.1.
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Definitions
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A-1
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1.2.
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Construction
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A-19
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1.3.
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Performance of Obligations by Affiliates
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A-20
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ARTICLE II. PURCHASE AND SALE
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A-20
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2.1.
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Agreement to Purchase and Sell
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A-20
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2.2.
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Excluded Assets
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A-22
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2.3.
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Assumed Liabilities
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A-23
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2.4.
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Excluded Liabilities
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A-24
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2.5.
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Procedures for Assignments
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A-25
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2.6.
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Purchase Price
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A-26
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2.7.
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Transferability of Royalty Rights
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A-28
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2.8.
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Net Sales Reporting; Royalty Payment Mechanics
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A-29
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2.9.
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Commercialization Efforts; Royalty Covenants
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A-30
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2.10.
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Ticking Fee
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A-31
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2.11.
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Purchase Price Allocation
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A-31
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2.12.
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Withholding
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A-32
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ARTICLE III. CLOSING
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A-32
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3.1.
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Closing
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A-32
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3.2.
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Transactions at Closing
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A-33
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3.3.
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Post-Closing Adjustment
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A-33
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ARTICLE IV. REPRESENTATIONS AND WARRANTIES OF SELLER
Parent
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A-35
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4.1.
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Qualification, Organization, etc.
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A-36
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4.2.
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Capitalization of the Transferred Group
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A-36
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4.3.
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Authority; Binding Effect
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A-37
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4.4.
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No Conflicts; Consents
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A-37
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4.5.
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Financial Information; Absence of Undisclosed Liabilities; Indebtedness
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A-37
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4.6.
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Title to Assets
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A-38
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4.7.
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Environmental Matters and Regulations
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A-38
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4.8.
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Employee Benefits
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A-39
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4.9.
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Labor Matters
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A-40
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4.10.
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Real Property
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A-41
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4.11.
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Absence of Certain Changes or Events
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A-41
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4.12.
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Material Contracts
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A-41
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4.13.
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Orders; Litigation
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A-43
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4.14.
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Compliance with Laws; Permits; Regulatory Matters
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A-43
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4.15.
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Consents and Governmental Approvals
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A-45
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4.16.
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Tax Matters
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A-45
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4.17.
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Intellectual Property
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A-47
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4.18.
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Required Vote
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A-48
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4.19.
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Insurance
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A-48
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4.20.
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Sufficiency of Assets
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A-49
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4.21.
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Brokers
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A-49
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4.22.
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Inventory
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A-49
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4.23.
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Disclosure
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A-49
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4.24.
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No Other Representations
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A-49
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-i-
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Page
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ARTICLE V. REPRESENTATIONS AND WARRANTIES OF
BUYER
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A-49
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5.1.
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Qualification, Organization, etc.
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A-49
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5.2.
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Authority; Binding Effect
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A-50
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5.3.
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No Conflicts; Consents
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A-50
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5.4.
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Capitalization
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A-50
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5.5.
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Orders; Litigation
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A-51
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5.6.
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Compliance with Law
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A-51
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5.7.
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Consents and Governmental Approvals
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A-51
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5.8.
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Buyer SEC Reports; Financial Statements
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A-51
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5.9.
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Absence of Certain Changes or Events
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A-52
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5.10.
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Required Vote
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A-52
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5.11.
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Investment Intent
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A-52
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5.12.
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Sufficient Funds
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A-52
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5.13.
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Brokers
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A-53
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5.14.
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Condition of the Business
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A-53
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ARTICLE VI. COVENANTS
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A-54
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6.1.
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Conduct of the Business Prior to the Closing
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A-54
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6.2.
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Antitrust Filings and Actions
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A-56
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6.3.
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Reasonable Best Efforts
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A-58
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6.4.
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Access; Confidentiality
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A-58
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6.5.
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Shared Contracts
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A-59
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6.6.
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Financing
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A-59
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6.7.
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Intercompany Accounts; Cash
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A-61
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6.8.
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Pre-Closing
Restructuring of the Excluded Business
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A-61
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6.9.
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Termination of Intercompany Arrangements
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A-61
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6.10.
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Proxy Statement; Special Meeting
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A-62
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6.11.
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Listing of Buyer Common Stock
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A-62
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6.12.
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Spin-Off
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A-62
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6.13.
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Cooperation in Prosecution and Litigation
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A-62
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6.14.
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Intellectual Property License
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A-63
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ARTICLE VII. EMPLOYEE MATTERS
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A-64
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7.1.
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Transfer of Employees
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A-64
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7.2.
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Compensation and Benefits
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A-65
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7.3.
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Service Credit
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A-65
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7.4.
|
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Welfare Plans
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A-65
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7.5.
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Paid Time Off
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A-66
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7.6.
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Defined Contribution Plans
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A-66
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7.7.
|
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Flexible Spending Accounts
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A-66
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7.8.
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WARN Act
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A-66
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7.9.
|
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No Third Party Beneficiaries
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A-67
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ARTICLE VIII. TAX MATTERS
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A-67
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8.1.
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Transfer Taxes
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A-67
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8.2.
|
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Tax Returns
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A-67
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8.3.
|
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Straddle Period Taxes
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A-68
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8.4.
|
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Tax Cooperation and Contests
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A-68
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8.5.
|
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Tax Refund
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A-68
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8.6.
|
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Section 338(h)(10) Election
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A-69
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-ii-
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Page
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8.7.
|
|
Miscellaneous
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A-69
|
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8.8.
|
|
Tax Provision Priority
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A-69
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ARTICLE IX. OTHER AGREEMENTS
|
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A-69
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9.1.
|
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Books and Records; Access; Assistance
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A-69
|
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9.2.
|
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Privileged Matters
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A-70
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9.3.
|
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Wrong Pocket Assets
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A-71
|
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9.4.
|
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Products Received by Sellers
|
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A-71
|
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9.5.
|
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Guarantees; Commitments
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A-71
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9.6.
|
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Retained Marks
|
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A-72
|
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9.7.
|
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Employee
Non-Solicit
|
|
|
A-73
|
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9.8.
|
|
Financial Information
|
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A-73
|
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9.9.
|
|
Insurance
|
|
|
A-73
|
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9.10.
|
|
Director and Officer Indemnification
|
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|
A-74
|
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9.11.
|
|
Resignations
|
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|
A-74
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9.12.
|
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Contingent Payment Contracts
|
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A-74
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9.13.
|
|
No Waiver of Transfer Restrictions
|
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A-74
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ARTICLE X. CONDITIONS TO CLOSING
|
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A-74
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10.1.
|
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Conditions to Each Partys Obligations
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A-74
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10.2.
|
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Conditions to Sellers Obligations
|
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|
A-75
|
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10.3.
|
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Conditions to Buyers Obligations
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A-75
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10.4.
|
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Frustration of Closing Conditions
|
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|
A-76
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ARTICLE XI. TERMINATION
|
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A-76
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11.1.
|
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Termination
|
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|
A-76
|
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11.2.
|
|
Procedure and Effect of Termination
|
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A-76
|
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|
|
ARTICLE XII. INDEMNIFICATION
|
|
|
A-77
|
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|
12.1.
|
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Survival; Effect of Materiality Qualifiers; Losses
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|
A-77
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12.2.
|
|
Indemnification by Seller Parent
|
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|
A-77
|
|
12.3.
|
|
Indemnification by Buyer
|
|
|
A-78
|
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12.4.
|
|
Third Party Claims
|
|
|
A-79
|
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12.5.
|
|
Direct Claims
|
|
|
A-80
|
|
12.6.
|
|
Adjustments to Losses
|
|
|
A-80
|
|
12.7.
|
|
Characterization of Indemnification Payments
|
|
|
A-81
|
|
12.8.
|
|
Exclusive Remedy
|
|
|
A-81
|
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12.9.
|
|
Duty to Mitigate
|
|
|
A-81
|
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12.10.
|
|
Investigation
|
|
|
A-81
|
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|
|
ARTICLE XIII. MISCELLANEOUS
|
|
|
A-82
|
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|
|
|
13.1.
|
|
Assignment
|
|
|
A-82
|
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13.2.
|
|
Public Announcements
|
|
|
A-82
|
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13.3.
|
|
Confidentiality
|
|
|
A-82
|
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13.4.
|
|
Expenses
|
|
|
A-83
|
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13.5.
|
|
Severability
|
|
|
A-83
|
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13.6.
|
|
Entire Agreement; Amendment
|
|
|
A-83
|
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13.7.
|
|
No Third-Party Beneficiaries
|
|
|
A-83
|
|
13.8.
|
|
Waiver
|
|
|
A-84
|
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13.9.
|
|
Governing Law
|
|
|
A-84
|
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13.10.
|
|
Consent to Jurisdiction; Waiver of Jury Trial
|
|
|
A-84
|
|
-iii-
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Page
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13.11.
|
|
Specific Performance
|
|
|
A-85
|
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13.12.
|
|
Representation by Counsel
|
|
|
A-85
|
|
13.13.
|
|
Bulk Transfers
|
|
|
A-85
|
|
13.14.
|
|
Counterparts; Signature Pages
|
|
|
A-85
|
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13.15.
|
|
Notices
|
|
|
A-86
|
|
SCHEDULES
Schedule 1.1(a)
Business Contracts
Schedule 1.1(b) Schedule of Business Employees
Schedule 1.1(c) Business Leased Real Property
Schedule
1.1(d) Contingent Payment Contracts
Schedule 1.1(e) Products
Schedule 2.1(b)(iv)(A) Patents
Schedule 2.1(b)(iv)(B)
Licensed Patents
Schedule 2.1(b)(iv)(C) Marks
Schedule 2.1(b)(iv)(D) Licensed Marks
Schedule
2.1(b)(vi)(A) Permits
Schedule 2.1(b)(vi)(B) Regulatory Registrations
Schedule 2.1(b)(xii) Other Assets
Schedule 6.5
Shared Contracts
EXHIBITS
Exhibit A
Assignment and Assumption Agreement
Exhibit B Bill of Sale
Exhibit C Intellectual Property Assignment Agreements
Exhibit D Transition Services Agreement
Exhibit E
Form of Closing Statement
Exhibit F Restrictive Legend
Exhibit G Form of Registration Rights Agreement
Exhibit H
Royalty Payments
ANNEX
Annex
I Royalty Payments
-iv-
PURCHASE AND SALE AGREEMENT
This Purchase and Sale Agreement (this
Agreement
), dated as of November 28, 2017, is entered into by and between
Melinta Therapeutics, Inc., a Delaware corporation (
Buyer
), and The Medicines Company, a Delaware corporation (
Seller Parent
). Seller Parent and the Subsidiaries of Seller Parent that are party to any Transfer
Document are referred to in this Agreement each as a
Seller
and collectively as
Sellers
(which definition, for the avoidance of doubt, excludes the Transferred Group). Seller Parent and Buyer sometimes are
referred to in this Agreement collectively as the
Parties
and individually as a
Party
.
WHEREAS,
Sellers and the Transferred Group are engaged in, among other things, the Business; and
WHEREAS, Seller Parent wishes to sell, and to
cause the other Sellers to sell, to Buyer, and Buyer wishes to purchase, the Business through the purchase from Sellers of all of the Acquired Assets, consisting of the Transferred Shares and Transferred Assets, and Buyer wishes to assume the
Assumed Liabilities, each upon the terms and conditions set forth herein, and in connection therewith, the Parties wish to enter into the transactions contemplated by this Agreement and by the Ancillary Agreements (collectively, the
Transactions
).
NOW, THEREFORE, in consideration of the premises and mutual covenants, agreements and provisions herein
contained, the Parties agree as follows:
ARTICLE I.
DEFINITIONS
1.1.
Definition
s
. In addition to the terms defined above and other terms defined in other Sections of this Agreement, the following capitalized terms have the following meanings when used herein:
Accounting Principles
means (a) any amounts not in U.S. Dollars shall be converted into U.S. Dollars using the spot
rate of exchange as quoted by Bloomberg at 12:00 p.m., New York time, on the Closing Date and (b) GAAP as applied by Seller Parent in the Audited Financial Statements, except as set forth on
Exhibit E
.
Acquired Assets
has the meaning set forth in
Section
2.1
.
Adverse Law or Order
means (a) any Law shall have been enacted, promulgated or enforced by any Governmental Authority
of competent jurisdiction which restrains, prohibits or makes illegal the consummation of the Transactions or (b) any Order restraining, prohibiting or making illegal the consummation of the Transactions, whether preliminary or final.
Affiliate
means, with respect to any Person, any other Person which, at the time of determination, directly or indirectly
controls, is controlled by, or is under common control with, such Person. For purposes of this definition,
control
(including, with correlative meanings, the terms controlled by and under common control
with), as used with respect to any Person, means (a) the possession of the power to vote 50% or more of the securities or other equity interests of such Person having ordinary voting power, or (b) the possession, directly or
indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by Contract or otherwise.
Agreement
has the meaning set forth in the preamble hereof.
Alternative Financing
has the meaning set forth in
Section
6.6(c)
.
A-1
Allocation Laws
means Sections 1060 and 338 of the Code, the Treasury
regulations promulgated thereunder, and any other applicable Tax laws that the Parties must satisfy with respect to the allocation of the Purchase Price for U.S. federal income tax purposes.
Allocation Schedule
has the meaning set forth in
Section
2.11(a)
.
Ancillary Agreements
means the Registration Rights Agreement, the Transfer Documents and the Transition Services Agreement.
Antitrust Division
has the meaning set forth in
Section
6.2(a)
.
Antitrust Laws
means any antitrust, competition or trade regulation Laws that are designed or intended to prohibit,
restrict or regulate actions having the purpose or effect of monopolization or restraint of trade or lessening competition through merger or acquisition, including the HSR Act.
Assignment and Assumption Agreement
means the assignment and assumption agreement to be entered into between Sellers and
Buyer substantially in the form of
Exhibit A
attached hereto, evidencing the assignment by Sellers and assumption by Buyer of the Assumed Liabilities.
Assumed Liabilities
has the meaning set forth in
Section
2.3
.
Audited Financial
Statements
has the meaning set forth in
Section
4.5(a)
.
Base Consideration
has the meaning set forth in
Section
2.6(a)(i)
.
Benefit Plan
means any employee benefit plan, employment or severance agreement or other compensation, employment or
benefit plan, program, policy, agreement or arrangement, including (a) any profit-sharing, deferred compensation, commission, incentive, equity inducement, independent contractor, bonus, equity-based, tax
gross-up,
pension, retirement, retention, severance or change of control plan, program, policy, agreement or arrangement, (b) any plan, program, policy, agreement or arrangement providing for fringe
benefits or perquisites, (c) any hospitalization, health, welfare, post-retirement medical, vision, dental, disability, vacation, sick leave, or other benefit plan, program, policy, agreement or arrangement or (d) any other
employee benefit plan within the meaning of Section 3(3) of ERISA (whether or not subject to ERISA);
provided
that in no event shall a Benefit Plan include any multiemployer plan (as defined in Section 3(37)
of ERISA).
Bill of Sale
means a bill of sale to be entered into between Sellers and Buyer substantially in the form of
Exhibit B
attached hereto, evidencing the transfer of the Transferred Assets to Buyer.
Books and Records
means
original or true and complete copies of all of the books, records, files, work papers, data, documents and information (including all payroll and personnel records of Continuing Employees to the extent permitted by Law, customer, distributor and
supplier lists, pricing, promotional, and research and development data, summaries of financial and accounting records, purchase orders and invoices, sales orders and sales order log books, credit and collection records, inventory records, product
specifications, cost and pricing information, quality control records and manuals, product development files, records and stability and clinical studies and manufacturing processes, marketing studies, consultant reports, physician databases,
correspondence, complaint files, adverse drug experience files and miscellaneous records with respect to customers, distributors or suppliers) in the possession or control of Sellers or any of their Affiliates or to which they have access from a
third party storage provider, in each case primarily related to or used primarily in connection with the Business (including the Continuing Employees), the Transferred Assets, the Transferred Group or the Transferred Group Assets.
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Business
means the business, operations and activities of Seller Parent
and its Subsidiaries conducted as of the date of this Agreement and at the Closing relating to researching, developing and commercializing antibiotics to treat infections, including with respect to the Products, but excluding, for the avoidance of
doubt, the Retained Business.
Business Benefit Plan
has the meaning set forth in
Section
4.8(a)
.
Business Contracts
means all Contracts primarily related to or used
primarily in connection with the Business (other than any Shared Contract), including the Contracts identified on
Schedule 1.1(a)
.
Business Day
means any day, other than Saturday or Sunday, on which commercial banks in New York City, New York are
generally open for business.
Business Employee
means (i) each individual identified on
Schedule 1.1(b)
who
is primarily employed in connection with the Business and (ii) each other individual employed by Seller Parent or any of its Subsidiaries listed on
Schedule
1.1(b)
(in each case, as it may be updated from time to time
by mutual agreement of Buyer and Sellers, the
Schedule of Business Employees
).
Business Intellectual
Property
has the meaning set forth in
Section
4.17(a)
.
Business Leased Real
Property
means the real property located in San Diego, California identified in
Schedule 1.1(c)
.
Buyer
has the meaning set forth in the preamble hereof.
Buyer 401(k) Plan
has the meaning set forth in
Section
7.6
.
Buyer Capital Stock
has the meaning set forth in
Section
5.4(a)
.
Buyer Common Stock
means the common stock, par value $0.001 per share, of Buyer.
Buyer Disclosure Letter
has the meaning set forth in the introductory paragraph to
ARTICLE V
.
Buyer Financial Statements
has the meaning set forth in
Section
5.8
.
Buyer Fundamental Representations
means the representations and warranties in
Sections 5.1
(Qualification,
Organization, etc.),
5.2
(Authority; Binding Effect),
5.3
(No Conflicts; Consents),
5.4
(Capitalization),
5.12
(Sufficient Funds) and
5.13
(Brokers).
Buyer Indemnified Parties
has the meaning set forth in
Section
12.2(a)
.
Buyer
Information
has the meaning set forth in
Section
13.3(b)
.
Buyer Material Adverse Effect
means any Effect that, individually or in the aggregate together with all other Effects:
(x) has a material adverse effect on the financial condition, business or results of operations of Buyer and its Subsidiaries, in each case taken as a whole, or (y) materially impairs the ability of Buyer to consummate, or prevents or
materially delays, the Transactions;
provided
,
however
, that, in the case of clause (x), no Effects resulting from the following shall be deemed to constitute a Buyer Material Adverse Effect or shall be taken into account when
determining whether a Buyer Material Adverse Effect has occurred or would reasonably be expected to occur: (a) general legal, tax, economic, political or regulatory conditions (or changes therein) in the markets in which Buyer operates,
including any changes affecting financial, credit or capital market conditions; (b) conditions (or changes therein) in the market for branded pharmaceutical products,
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infectious disease pharmaceutical products or the pharmaceutical industry generally; (c) any changes in financial, banking or securities markets in general, including any disruption thereof
and any decline in the price of any security or any market index or any change in prevailing interest or exchange rates; (d) acts of war (whether or not declared), armed hostilities, cyber-attack or terrorism, or the escalation or worsening
thereof; (e) compliance by Buyer and its Subsidiaries with the terms of this Agreement or any action taken (or omitted to be taken) with the written consent of or at the written request of Seller Parent; (f) any changes or prospective
changes in applicable Laws or accounting rules or principles (including GAAP) or the enforcement, implementation or interpretation thereof; (g) the announcement of, or the pendency of, this Agreement or consummation of the Transactions,
including the identity of Seller Parent; (h) any natural or
man-made
disaster or acts of God; (i) the failure to meet any financial or other plan, estimate, budget or projection (
provided
that
the underlying cause of such failure, to the extent not otherwise excluded herein, may be taken into account in making a determination as to whether a Buyer Material Adverse Effect has occurred or would reasonably be expected to occur); or
(j) any change in Buyers stock price or trading volume (
provided
that the underlying cause of such change, to the extent not otherwise excluded herein, may be taken into account in making a determination as to whether a Buyer
Material Adverse Effect has occurred or would reasonably be expected to occur), except to the extent (and only to the extent) any such Effect described in clauses (a), (b), (c), (d), (f) or (h) is disproportionately adverse on the
financial condition, business or results of operations of Buyer, in each case taken as a whole, as compared to participants in the life science industry.
Buyer Preferred Stock
has the meaning set forth in
Section
5.4(a)
.
Buyer SEC Reports
means all reports, schedules, forms, and exhibits required to be filed by Buyer with the SEC pursuant to
the reporting requirements of the Exchange Act and all exhibits included therein and financial statements and schedules thereto, in each case to the extent required to be filed since January 1, 2015.
Buyer Stockholder Approval
means the approval by the stockholders of Buyer of the issuance of Buyer Common Stock pursuant
to this Agreement and in the Financing by a majority of the votes cast on the proposal in accordance with NASDAQ Rule 5635 (including, for the avoidance of doubt, the issuance of any warrants related to the Financing).
Buyers Knowledge
means the actual knowledge of the persons listed in Section 1.1(a) of the Buyer Disclosure
Letter.
Cadwalader
means Cadwalader, Wickersham & Taft LLP.
Cap
means Twenty Four Million Dollars ($24,000,000).
Claim
means any claim, demand, cause of action, chose in action, suit, litigation, Proceeding, arbitration, mediation,
hearing or investigation against any Person.
Claim Notice
has the meaning set forth in
Section
12.4(a)
.
Closing
has the meaning set forth in
Section
3.1
.
Closing Adjustment Amount
means either (a) the Closing Date Working Capital Excess, if any, or (b) the
Closing Date Working Capital Shortfall, if any, expressed as a negative number.
Closing Cash Consideration
has the
meaning set forth in
Section
2.6(a)(i)
.
Closing Date
has the meaning set forth in
Section
3.1
.
Closing Date Tax Return
has the meaning set forth in
Section
8.2(a)
.
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Closing Date Working Capital
means (a) the total Current Assets
minus
(b) the total Current Liabilities, in each case as of the Closing.
Closing Date Working Capital
Excess
means the amount, if any, by which the Closing Date Working Capital is in excess of the Target Working Capital Amount.
Closing Date Working Capital Shortfall
means the amount, if any, by which the Closing Date Working Capital is less than the
Target Working Capital Amount.
Closing Payment
has the meaning set forth in
Section
2.6(a)(i)
.
Closing Statement
has the meaning set forth in
Section
3.3(a)
.
Closing Stock Consideration
has the meaning set forth in
Section
2.6(a)(i)
.
Code
means the United States Internal Revenue Code of 1986, as amended.
Commitment Letters
has the meaning set forth in
Section
5.12
.
Confidentiality Agreement
means the Confidentiality Agreement, dated October 24, 2017, by and between Seller Parent
and Buyer relating to certain confidentiality obligations, as amended.
Consent
means any consent, approval,
ratification, authorization, waiver, grant, agreement, license, certificate, exemption, order, registration, declaration, filing or notice of, with or to any Person.
Consolidated Tax Returns
means any Tax Returns with respect to Consolidated Taxes.
Consolidated Taxes
means all federal, state, provincial, local or foreign income Taxes that are paid on an affiliated,
consolidated, combined, unitary or similar basis with respect to Tax Returns that include one or more members of the Transferred Group, on the one hand, and Seller Parent or any of its Affiliates (other than any members of the Transferred Group), on
the other hand.
Contingent Payment Contracts
means all Contracts to make royalty, milestone or deferred payments or
any other contingent payments to third parties in connection with the Business or the Products, which Contracts are identified on
Schedule
1.1(e)
.
Continuing Employee
has the meaning set forth in
Section
7.1
.
Contract
means any written or oral contract, agreement, lease, instrument, note, indenture, mortgage, guarantee, bond,
legally binding commitment, license or sublicense.
Copyrights
has the meaning set forth in the definition of
Intellectual Property.
Current Assets
means the current assets of the Transferred Group and any other
Transferred Assets constituting current assets as determined in accordance with the Accounting Principles, as set forth on the line items to the Form of Closing Statement under the heading Current Assets.
Current Liabilities
means the current liabilities of the Transferred Group and any other Assumed Liabilities constituting
current liabilities as determined in accordance with the Accounting Principles, as set forth on the line items to the Form of Closing Statement under the heading Current Liabilities.
De Minimis Amount
means One Hundred Fifty Thousand Dollars ($150,000).
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Debt Commitment Letter
has the meaning set forth in
Section
5.12
.
Debt Financing
means the debt financing set forth in the Debt Commitment
Letter.
Debt Financing Sources
has the meaning set forth in
Section
5.12
.
Deductible
means One Million Nine Hundred Eighty Seven Thousand Five Hundred Dollars ($1,987,500).
Deferred Payments
has the meaning set forth in
Section
2.6(a)(iv)
.
Definitive Agreement
has the meaning set forth in
Section
6.6(b)
.
DGCL
means the Delaware General Corporation Law, as amended from time to time, and any successor statute.
Direct Claim
has the meaning set forth in
Section
12.5
.
Disclosure Information
has the meaning set forth in
Section
13.3(b)
.
Dispute Notice
has the meaning set forth in
Section
3.3(b)
.
Disputed Item
has the meaning set forth in
Section
3.3(b)
.
Effect
means any change, effect, development, circumstance, condition or occurrence.
Environmental Laws
means all applicable international, federal, state, or local Laws which (a) regulate or relate to
the protection or cleanup of the environment; the use, treatment, storage, transportation, handling, disposal or release of Hazardous Materials, the preservation or protection of waterways, groundwater, drinking water, air, wildlife, plants or other
natural resources; or the health and safety of persons or property, including protection of the health and safety of employees or (b) impose Liability or responsibility with respect to any of the foregoing, including the Comprehensive
Environmental Response, Compensation and Liability Act (42 U.S.C. §9601
et
seq
.), the Occupational Safety and Health Act (29 U.S.C. § 651
et
seq
.), the Resource Conservation and Recovery Act (42 U.S.C.
§ 6901
et
seq
.) or any other Law of similar effect.
Environmental Permits
means all Permits
required under or issued pursuant to all applicable Environmental Laws.
Equipment
has the meaning set forth in
Section
2.1(b)(iii)
.
Equity Commitment Letters
has the meaning set forth in
Section
5.12
.
Equity Financing Sources
has the meaning set forth in
Section
5.12
.
ERISA
means the Employee Retirement Income Security Act of 1974, as amended.
ERISA Affiliate
has the meaning set forth in
Section
4.8(d)
.
Estimated Closing Adjustment Amount
has the meaning set forth in
Section
2.6(a)(i)
.
Estimated Closing Statement
has the meaning set forth in
Section
2.6(a)(ii)
.
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Exchange Act
means the Securities Exchange Act of 1934, as amended, and
the rules and regulations promulgated with respect thereto.
Excluded Assets
has the meaning set forth in
Section
2.2
.
Excluded Business
means the business, operations and activities of researching,
discovering and developing
pre-clinical
and developmental assets, including without limitation the preclinical product candidates Oravance (oral beta-lactam/BLI combination) and Omnivance (broad spectrum
carbapenemase inhibitors), the
pre-clinical
polymyxin programs, and all other
pre-clinical
and developmental programs being conducted at or in connection with the
Business Leased Real Property.
Excluded Business IP
has the meaning set forth in
Section
6.14
.
Excluded Liabilities
has the meaning set forth in
Section
2.4
.
Exclusivity Period
means, with respect to a given Product and a given country,
the period beginning on the date of First Commercial Sale of such Product in such country and ending on the later of: (a) the expiration of the last to expire Valid Claim of any Patents or Licensed Patents that covers such Product in such
country and (b) the expiration of the Regulatory Exclusivity Period with respect to such Product in such country, but in no event less than ten (10) years following the date of First Commercial Sale of such Product in such country.
FDA
means the U.S. Food and Drug Administration.
FDCA
means the Federal Food, Drug and Cosmetic Act (21 U.S.C. §§ 301
et
seq
.), as amended from
time to time, and any successor statute.
Final Closing Adjustment Amount
has the meaning set forth in
Section
3.3(j)
.
Final Closing Statement
has the meaning set forth in
Section
3.3(j)
.
Final Determination
means (a) with respect to U.S. federal income
Taxes, a determination as defined in Section 1313(a) of the Code or execution of an IRS Form
870-AD
(or successor form) and (b) with respect to Taxes other than U.S. federal income Taxes,
any final determination of liability in respect of a Tax that, under applicable Law, is not subject to further appeal, review or modification through Proceedings or otherwise, including the expiration of a statute of limitations or a period for the
filing of claims for refunds, amended Tax Returns or appeals from adverse determinations.
Final Ticking Fee
means an
amount in cash equal to the Weekly Ticking Fee multiplied by a fraction: (A) the numerator of which is the number of days which have elapsed between the date that the most recent Weekly Ticking Fee became due and the Ticking Fee End Date and
(B) the denominator of which is seven (7).
Financial Statements
has the meaning set forth in
Section
4.5(a)
.
Financing
has the meaning set forth in
Section
5.12
.
Financing Assignee
has the meaning set forth in
Section
2.7
.
Financing Source
means, in its capacity as such, any Person providing or
proposing to provide the financing pursuant to the Commitment Letters or any Alternative Financing or any Affiliates, employees, officers, directors, agents or advisors of any such Person.
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First Commercial Sale
means the first sale of any Product in a country
constituting Net Sales by or under the authority of the applicable Selling Entity after all required Regulatory Approvals for commercial sale of such Product (including Pricing Approval, to the extent required for sale of such Product, and any
necessary labeling negotiations that may be required after Regulatory Approval and such Pricing Approval) have been obtained in such country;
provided
that First Commercial Sale will not include any transfer, disposition, sale or
other distribution of a sample or for charitable purposes (including, without limitation, pursuant to an early access, compassionate use, emergency use, named patient, indigent access or patient assistance program), or for preclinical, clinical or
regulatory purposes or solely for
so-called
treatment investigational new drug sales.
First Deferred Payment
has the meaning set forth in
Section
2.6(a)(iii)
.
Foreign Antitrust Laws
has the meaning set forth in
Section
4.15
.
Form of Closing Statement
has the meaning set forth in
Section
2.6(a)(ii)
.
FTC
has the meaning set forth in
Section
6.2(a)
.
GAAP
means accounting principles generally accepted in the United States.
Generic Product
means a pharmaceutical preparation which (i) either (x) is not produced, licensed, or owned by Buyer
or any of Buyers Controlled Affiliates, successors, assigns, or its or their respective
sub-licensees
or (y) is not authorized by Buyer or any of Buyers Controlled Affiliates or its or their
respective successors, assigns, or sublicensees by license, covenant not to sue, settlement agreement, release or by any other arrangement or means (including with respect to ANDAs), and (ii) is automatically substitutable for the branded
Product at the retail pharmacy level or is approved in reliance on the prior approval of the Product as determined by the applicable Regulatory Authority(ities) in any country on the basis of being comparable to and substitutable for the Product;
provided
that Generic Product shall in no event include any pharmaceutical preparation that is marketed, distributed and sold by or on behalf of Buyer or any of Buyers Controlled Affiliates, successors, assigns, or its or their
respective
sub-licensees
(e.g., an authorized generic).
GMPs
mean the current
principles, standards and guidelines of Good Manufacturing Practice for medicinal products and medical devices for human use including the sourcing or manufacture of active substances, as required by applicable Law including EC Directive 2003/94/EEC
and 21 CFR Parts 210 and 211, in each case as amended from time to time.
Government Antitrust Authority
has the
meaning set forth in
Section
6.2(d)
.
Governmental Approvals
means all licenses, consents,
permits, certificates, filings, registrations, notifications, franchises, concessions, authorizations, approvals, ratifications, permissions, clearances, confirmations, endorsements, waivers, designations or qualifications issued, granted, given or
otherwise made available by or under the authority of any Governmental Authority or pursuant to any requirement under the applicable Laws of any Governmental Authority.
Governmental Authority
means (a) any nation or government, including any federal, state, local or foreign
municipality, principality, commonwealth, province, territory, county, district or other jurisdiction of any nature or other political subdivision thereof; or (b) any entity, department, commission, bureau, agency, authority, board, court,
official or officer, domestic or foreign, exercising executive, judicial, regulatory, administrative, judicial, police, military, or taxing governmental functions, or any mediator, arbitrator, or arbitral body.
Guaranteed Payments
has the meaning set forth in
Section
2.6(a)(iv)
.
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Hazardous Materials
means (a) any hazardous substance,
pollutant, contaminant, hazardous waste, regulated substance, hazardous chemical or toxic chemical as designated, listed or defined (whether expressly or by reference) in any
Environmental Law, (b) any other pollutant, chemical, substance, toxic, infectious, carcinogenic, reactive, corrosive, ignitable or flammable chemical, or chemical compound, or hazardous substance, material or waste, whether solid, liquid or
gas, that is subject to regulation, control or remediation under any Environmental Laws, including any quantity of asbestos in any form, urea, formaldehyde, polychlorinated biphenyls (PCBs), radon gas, petroleum, waste oil, crude oil, or any
fraction thereof, all forms of natural gas, petroleum products or
by-products
or derivatives and (c) any compound, mixture, solution, product or other substance or material that contains any hazardous
substance or material referred to in clauses (a) and (b) above.
Health Care Laws
has the meaning set forth in
Section
4.14(i)
.
HIPAA
has the meaning set forth in
Section
4.14(h)
.
HSR Act
means the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as
amended.
HSR Filing
has the meaning set forth in
Section
6.2(a)
.
Indebtedness
means (a) all indebtedness, whether or not contingent, for borrowed money, (b) all obligations
evidenced by notes, bonds, debentures, loan agreements or other similar instruments, (c) that portion of obligations with respect to capital leases that is properly classified as a liability on a balance sheet in conformity with GAAP,
(d) all payment obligations, contingent or otherwise, under acceptance, letters of credit, bank guarantees, surety bonds or similar facilities, (e) net obligations under any interest rate, swap, currency swap, forward currency or interest
rate contracts or other interest rate or currency hedging arrangements, (f) any guarantee (other than customary
non-recourse
carve-out
or badboy
guarantees) of any of the foregoing, whether or not evidenced by a note, mortgage, bond, indenture or similar instrument,
provided
that Indebtedness shall not include any performance guarantee or any other guarantee that is not a guarantee of
other Indebtedness, and (g) all interest, any premiums payable or any other costs or charges (including prepayment penalties) on any instruments or obligations described in clauses (a) through (f) hereof, all as the same may be payable
upon the complete and final payoff thereof, regardless of whether such payoff occurs prior to or simultaneously with the Closing.
Indemnifiable Liabilities
has the meaning set forth in
Section
6.6(e)
.
Indemnified Party
has the meaning set forth in
Section
12.3(a)
.
Indemnifying Party
has the meaning set forth in
Section
12.4(a)
.
Independent Accountant
means an independent accounting firm that Seller Parent and Buyer shall mutually agree upon, and, if
Seller Parent and Buyer cannot agree, mutually chosen by their respective independent accounting firms.
Intellectual
Property
means intellectual property or other proprietary rights anywhere in the world, including registered, unregistered, applied for and pending rights, arising out of or related to: (a) ideas, discoveries, inventions, patents,
patent applications, including provisional applications, statutory invention registrations, inventions, discoveries and invention disclosures (whether or not patented), and related continuations,
continuations-in-part,
divisions, reissues,
re-examinations,
substitutions, and extensions thereof (collectively,
Patent Rights
); (b) indicia of
source, brands, trademarks, service marks, trade names, trade dress, corporate names, logos, internet domain names, social media accounts, URLs, in each case whether or not registered, together with derivations and combinations thereof, and common
law rights thereto, and the goodwill associated with the foregoing, and applications (including intent to use applications), registration and renewals of
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the foregoing (collectively,
Trademark Rights
); (c) published and unpublished works of authorship including computer software programs, applications, source code and object
code, and databases, copyrights in and to the foregoing, together with common law rights and moral rights therein, rights of publicity and privacy, and any applications and registrations therefor, including extensions, renewals, restorations,
reversions, derivatives, translations, localizations, adaptations and combinations of the above (collectively,
Copyrights
); (d) mask works and any applications, registrations and renewals for any of the foregoing; and
(e) data, databases, trade secrets techniques,
non-public
information (proprietary or otherwise), processes, including any trade secrets under applicable Law (collectively,
Trade
Secrets
).
Intellectual Property Assignment Agreements
means the assignments of Sellers right, title
and interest in and to the registrations and applications related to the Transferred Intellectual Property substantially in the form of
Exhibit C
hereto, assigning such right, title and interest in and to such Transferred Intellectual
Property to Buyer, as appropriate.
Interim
Financial
Statements
has the meaning set forth in
Section
4.5(a)
.
Inventory
means, as of the Closing, (a) all inventory of finished
Product owned by Seller Parent or any of its Subsidiaries, whether or not Labeled, (b) all Product
work-in-progress
owned by Seller Parent or any of its
Subsidiaries and (c) all other inventory primarily related to or used primarily in connection with the Business, including raw materials, active pharmaceutical ingredients, excipients, intermediaries, reagents, packaging,
work-in-process,
finished goods, spare parts and shop and production supplies, in each case whether imported, provided from contract manufacturers or otherwise and whether
located at a facility of Seller Parent or any of its Subsidiaries, at a wholesaler or in transit.
IRS
means the United
States Internal Revenue Service.
Know-How
means all
non-public
information, proprietary or otherwise, owned or held by or licensed to Seller Parent or any of its Subsidiaries as of the date of this Agreement or at Closing.
Labeling
(and the correlative terms
Label
and
Labeled
) shall be as defined in
Section 201(k), (m) of the FDCA (21 U.S.C. § 321(k), (m)) and other comparable foreign Law relating to the subject matter thereof, including the applicable Products label, packaging and package inserts accompanying such Product,
and any other written, printed, or graphic materials accompanying such Product, including patient instructions or patient indication guides.
Law
means each provision of any national, supranational, federal, state, provincial, local, municipal or foreign, civil and
criminal law, common law, constitution, statute, regulation, legislation, ordinance, Order, code, proclamation, treaty, convention, rule, ruling, directive, requirement, determination, decision, opinion or interpretation, promulgated, adopted,
enacted, implemented, issued, passed, approved, or otherwise put into effect by or under the authority of any Governmental Authority.
Liability
means, with respect to any Person, any debt, liability, duty or obligation of such Person, whether known or
unknown, absolute or contingent, accrued or unaccrued, matured or unmatured, disputed or undisputed, liquidated or unliquidated, secured or unsecured, joint or several, due or to become due, vested or unvested, executory, determined, determinable or
otherwise, and whether or not the same is required to be accrued on the financial statements of such Person, including those arising under any Law or Order or any Contract.
Licensed Marks
has the meaning set forth in
Section
2.1(b)(iv)
.
Licensed Patents
has the meaning set forth in
Section
2.1(b)(iv)
.
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Lien
means any lien, encumbrance, mortgage, security interest, pledge,
conditional sale agreement or other title retention agreement, or other charge or encumbrance of any nature whatsoever on any property or property interest.
Litigation Matters
means all Proceedings that have been or may be asserted by a third party against, or otherwise adversely
affect, Seller Parent and its Subsidiaries, on the one hand, and the Business, on the other hand.
Losses
has the
meaning set forth in
Section
12.1(b)
.
Mailing Date
has the meaning set forth in
Section
6.10(a)
.
Marks
has the meaning set forth in
Section
2.1(b)(iv)
.
Material Adverse Effect
means any Effect that, individually or in the
aggregate together with all other Effects: (x) has a material adverse effect on the Acquired Assets, the Transferred Group or the financial condition, business or results of operations of the Business, in each case taken as a whole or
(y) materially impairs the ability of Sellers to consummate, or prevents or materially delays, the Transactions;
provided
,
however
, that in the case of clause (x), no Effects resulting from the following shall be deemed to
constitute a Material Adverse Effect or shall be taken into account when determining whether a Material Adverse Effect has occurred or would reasonably be expected to occur: (a) general legal, tax, economic, political or regulatory conditions
(or changes therein) in the markets in which the Business operates, including any changes affecting financial, credit or capital market conditions; (b) conditions (or changes therein) in the market for branded pharmaceutical products,
infectious disease pharmaceutical products or the pharmaceutical industry generally; (c) any changes in financial, banking or securities markets in general, including any disruption thereof and any decline in the price of any security or any
market index or any change in prevailing interest or exchange rates; (d) acts of war (whether or not declared), armed hostilities, cyber-attack or terrorism, or the escalation or worsening thereof; (e) compliance by Seller Parent and its
Subsidiaries with the terms of this Agreement or any action taken (or omitted to be taken) with the written consent of or at the written request of Buyer; (f) any changes or prospective changes in applicable Laws or accounting rules or
principles (including GAAP) or the enforcement, implementation or interpretation thereof; (g) the announcement of, or the pendency of, this Agreement or consummation of the Transactions, including the identity of Buyer; (h) the results of
any
pre-clinical
or clinical testing sponsored by Seller Parent or any of its Subsidiaries, any of their competitors or any of their respective collaboration partners; (i) any change or prospective change
in reimbursement or payor rules or policies applicable to any product or product candidates of Seller Parent or any of its Subsidiaries or the products or product candidates of any of their competitors; (j) any natural or
man-made
disaster or acts of God; (k) the failure to meet any financial or other plan, estimate, budget or projection (
provided
that the underlying cause of such failure, to the extent not otherwise
excluded herein, may be taken into account in making a determination as to whether a Material Adverse Effect has occurred or would reasonably be expected to occur); or (l) any change in Seller Parents stock price or trading volume
(
provided
that the underlying cause of such change, to the extent not otherwise excluded herein, may be taken into account in making a determination as to whether a Material Adverse Effect has occurred or would reasonably be expected to
occur), except to the extent (and only to the extent) any such Effect described in clauses (a), (b), (c), (d), (f) or (j) is disproportionately adverse on the Acquired Assets or the financial condition, business or results of operations of the
Business, in each case taken as a whole, as compared to participants in the life science industry.
Material Contract
has the meaning set forth in
Section
4.12(b)
.
NASDAQ
means the Nasdaq Global Select Market,
but if the Nasdaq Global Select Market is not then the principal U.S. trading market for Buyer Common Stock, then Nasdaq shall be deemed to mean the principal U.S. national securities exchange registered under the Exchange Act on which
Buyer Common Stock is then traded.
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Net Sales
means, with respect to any applicable period:
(a) for any Product sold in the U.S., the gross invoiced amount of such Product sold in respect of such period to any third party that is not
an Affiliate of the Selling Entity by Buyer, its Controlled Affiliates or any licensees, sublicensees or transferees to which Buyer or its Controlled Affiliates has granted or otherwise transferred rights to sell such Product or granted a license
under or sold any patents or pending patent applications included in the Acquired Assets in respect of such Product, including, for the avoidance of doubt, any licensees, sublicensees or transferees of such licensees, sublicensees or transferees
(each a
Selling Entity
) for sale to unrelated third parties in bona fide arms length transactions; or
(b) for
any Product sold outside of the U.S., the gross invoiced amount of such Product sold in respect of such period to any third party that is not an Affiliate of the Selling Entity by Buyer or its Controlled Affiliates; or
(c) for any Product sold outside of the U.S., in the event any Product is marketed or sold by a Selling Entity other than Buyer or its
Controlled Affiliates, Net Sales shall include all income, revenue and other consideration in respect of such Product or any related patents or patent applications in whatever manner received by Buyer or a Controlled Affiliate of Buyer, as
applicable, through any arrangement between Buyer or any of its Controlled Affiliates, on the one hand, and such Selling Entity or any of its Affiliates, on the other hand, including in connection with any sale, licensing, sublicensing, distribution
or other transaction relating to such Product or any patents or patent applications, including, without limitation, upfront payments, royalties, milestone payments, technology transfer payments, issue fees, any lump sum payments, and any and all
other similar fees and payments, but excluding any amounts (x) received by Buyer or any of its Controlled Affiliates as
bona fide
reimbursement for research, development, manufacturing or similar services conducted for such Product after
the date of the sale, licensing, sublicensing, distribution or other transaction referred to above or for patent, patent prosecution or other
out-of-pocket
expenses
relating to such Product incurred after the date of the sale, licensing, sublicensing, distribution or other transaction referred to above or (y) received by Buyer or any of its Controlled Affiliates from a Person to which Buyer has transferred
its rights to sell Products outside the U.S. and which Person, in connection with such transfer, has not also assumed Buyers obligation to make all milestone payments to a third party with respect to such Products but is contractually
obligated to pay to Buyer an amount in respect of or equal to such milestone payments, solely to the extent that Buyer is required to, and does, following receipt of such amounts, promptly pay such amounts to such third party to whom such milestone
payments are owed;
less
, in each of clauses (a) and (b), the following deductions, in each case related specifically to such Product, to the
extent reasonable and customary, and actually allowed and not otherwise recovered by or reimbursed to the Selling Entity: (i) refunds, allowance or credits for recalls, breakage, rejected, or returned products, (ii) excise, use, value
added, and sales Taxes (other than income Taxes) included in the invoiced amounts, (iii) tariffs, import/export duties, customs duties, and other imposts actually paid by the Selling Entity, (iv) quantity, trade, and cash discounts,
including those allowed under group purchasing organization or other commercial customer or payor contracts, stocking incentives and patient assistance programs, (v) price reductions, chargebacks or rebates, retroactive or otherwise, to the
extent required by applicable Law, including Medicaid, managed care rebates and Medicare rebates, Department of Veterans Affairs and Department of Defense discounts and Public Health Service Act rebates and (vi) distribution or any other
similar service fees. With respect to each relevant period for which Net Sales are calculated hereunder, there shall be included appropriate accruals for all of the items listed in clauses (i) through (vi) of the immediately preceding
sentence, calculated according to GAAP, and adjustments to accruals as increases or decreases to Net Sales (as applicable) by the difference between actual paid amounts and accruals for all such items in the prior measurement period. All of the
foregoing (including each of the components with the Net Sales calculation) and the recording of a sale of a Product is deemed to occur and shall be calculated in accordance with GAAP and the normal revenue recognition policies of Buyer during the
relevant period with respect to the sale of the applicable Products;
provided
that, with respect to Net Sales outside of the U.S. under clause (b) above, allowances shall be calculated in accordance with the local
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GAAP and revenue recognition policies applicable to the relevant counterparty. In the case of each of clauses (a) and (b) above, if a Product is sold in combination with any one or more
other products that were not combined with the Product as of the Closing Date and, if such Product is also sold separately on a commercial basis, then the portion of Net Sales attributable to sales of such Product in such combination product sales
shall be determined according to the ratio of (A) the invoiced amount at which the Product is sold separately to (B) the invoiced amount of any such combination of products sold in which the Product is included.
Net Sales Statement
has the meaning set forth in
Section
2.8(a).
Non-Business
Employee
means each Person who is employed by a Seller or by a
Subsidiary of a Seller and who is not a Business Employee.
Order
means any writ, judgment, edict, decree, injunction,
ruling, pronouncement, order, decision, determination, verdict, award or other binding obligation of, or settlement or other similar agreement with, any Governmental Authority (whether preliminary or final).
Ordinary Course of Business
means the operation of the Business by Seller Parent and its Subsidiaries in the usual and
customary way and consistent with their past practices through the date of this Agreement.
Organizational Documents
means, with respect to any Person, collectively, its organizational documents, including any certificate of incorporation, notarial deed of incorporation, certificate of formation, articles of organization, articles of association, business rules
and regulations, bylaws, operating agreement, certificate of limited partnership, partnership agreement, equityholders agreement and/or certificates of existence, or any foreign equivalent of any of the foregoing, as applicable.
Outside Date
has the meaning set forth in
Section
11.1(b)
.
Parties
or
Party
has the meaning set forth in the preamble hereof.
Patent Rights
has the meaning set forth in the definition of Intellectual Property.
Patents
has the meaning set forth in
Section
2.1(b)(iv)
.
Permits
means all permits, licenses, registrations, certificates, franchises, variances, exemptions, orders and other
Governmental Approvals, Consents and authorizations necessary or desirable for the past or present conduct of the Business or used in connection with the Business by Seller Parent or its Subsidiaries, other than Regulatory Registrations.
Permitted Lien
means (a) Liens for Taxes that are not yet due and payable or that are being contested in good faith by
appropriate proceedings and for which appropriate reserves have been established in accordance with GAAP, (b) Liens of carriers, warehousemen, mechanics, repairmen and materialmen and other like Liens arising in the Ordinary Course of Business
for sums not yet due and payable or that are being contested in good faith by appropriate proceedings and for which appropriate reserves have been established in accordance with GAAP, none of which are, individually or in the aggregate, material to
the Business, (c) restrictions under the leases, subleases and similar agreements with respect to the Business Leased Real Property, none of which, individually or in the aggregate, materially interferes with the ordinary conduct of the
Business as a whole and to the extent such leases, subleases and similar agreements have been made available to Buyer, (d) pledges and deposits made in the Ordinary Course of Business in compliance with workers compensation, unemployment
insurance and other social security laws or regulations, (e) deposits to secure the performance of bids, trade contracts, leases, statutory obligations, surety and appeal bonds, performance bonds and other obligations of a like nature incurred
in the Ordinary Course of Business, (f) defects of title, easements,
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rights-of-way,
restrictions and other similar charges or encumbrances that, individually or in the aggregate, are
not detracting in any material respect from the value of real property or interfering in any material respect with the ordinary conduct of the Business, (g) zoning, building and other generally applicable land use restrictions which are imposed
by any Governmental Authority having jurisdiction over the applicable real property and which are not violated by the current use or occupancy of such real property or the operation of the Business, (h) Liens resulting from any facts or
circumstances relating to Buyer or its Controlled Affiliates, and (i) restrictions on transfer under applicable securities Laws.
Person
means any natural person, individual, corporation (including any
non-profit
corporation), partnership, joint venture, limited liability company, estate, trust, cooperative, foundation, society, political party, union, other unincorporated organization, joint stock company or Governmental Authority.
Personally Identifiable Information
means any information of or about a Person that (a) under Law or Contract requires
specific handling or protection requirements, (b) under Law or Contract requires any Person to be notified if such information is lost, misused, wrongly accessed, wrongly acquired or compromised, (c) alone or in combination with other
information can be used to identify an individual Person or (d) constitutes health or other sensitive information of an individual Person.
Post-Closing Tax Period
means any taxable period (or portion of a Straddle Period) beginning after the Closing Date.
Pre-Closing
Period
has the meaning set forth in
Section
6.1(a)
.
Pricing Approval
means the first approval, agreement, determination or
decision from a Governmental Authority establishing the price and/or reimbursement for a product for sale in any given country or regulatory jurisdiction, as required by applicable Law in such country or regulatory jurisdiction prior to the sale of
such product in such country or regulatory jurisdiction.
Pre-Closing
Separate Tax
Return
has the meaning set forth in
Section
8.2(a)
.
Pre-Closing
Taxes
means (a) any Taxes imposed on or with respect to the
Acquired Assets, the Business, any member of the Transferred Group or the Transferred Group Assets with respect to a
Pre-Closing
Tax Period, including the portion of any Straddle Period ending on or before the
close of the Closing Date as determined pursuant to
Section
8.2
, (b) any Taxes of any member (other than any member of the Transferred Group) of an affiliated, consolidated, combined or unitary group of which any member of
the Transferred Group is or was a member on or prior to the Closing Date, including pursuant to Treasury regulations
Section 1.1502-6
and
1.1502-78
or any analogous
or similar state, local, or foreign Law or regulation, and (c) any Taxes of any Person imposed on or with respect to the Transferred Group, the Transferred Group Assets, the Acquired Assets, or the Business as a transferee or successor in
respect of a transaction occurring on or before the Closing Date, by law, contract, or otherwise;
provided
that,
Pre-Closing
Taxes shall not include any amounts to the extent that such
amounts have already been taken into account under this Agreement, including, without limitation, in Closing Date Working Capital.
Pre-Closing
Tax Period
means any taxable period (or portion of a Straddle Period)
ending on or before the end of the Closing Date.
Privacy Obligations
has the meaning set forth in
Section
4.17(j)
.
Privileged Information
means, with respect to each Party, information
regarding such Party or its Subsidiaries, or any of its operations, assets or liabilities (whether in documents or stored in any other form or known to its employees or agents) that is protected from disclosure pursuant to the attorney-client
privilege, the work product doctrine or another applicable legal privilege, in each case that the other Party or its Subsidiaries may come into possession of or obtain access to in connection with this Agreement or the Ancillary Agreements.
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Proceeding
or
Proceedings
means any Claim, action,
arbitration, mediation, audit, hearing, inquiry, prosecution, contest, examination, proceeding, investigation, litigation, suit (whether civil, criminal, administrative, or investigative or appellate proceeding) commenced, brought, conducted, or
heard by or before, or otherwise involving any Governmental Authority, arbitrator or arbitration panel.
Products
means
those products listed on
Schedule 1.1(e)
.
Product Transfer
has the meaning set forth in
Section
2.9(b)
.
Property Taxes
means all real property Taxes, personal property Taxes,
intangible property Taxes and similar ad valorem Taxes.
Proxy Statement
has the meaning set forth in
Section
6.10(a)
.
Purchase Price
has the meaning set forth in
Section
2.6(a)
.
Qualifying Country
has the meaning set forth in
Section
2.6(a)(v)
.
Registered IP
has the meaning set forth in
Section
4.17(c)
.
Registration Rights Agreement
means that certain registration rights
agreement between Buyer and Seller Parent to be entered into at Closing substantially in the form attached hereto as
Exhibit G
.
Regulatory Approval
means, with respect to a country, any and all approvals, licenses, registrations or authorizations of
any Regulatory Authority necessary in order to develop, manufacture, use, commercialize, store, import, transport, sell, and/or otherwise exploit a Product in such country.
Regulatory Authority
means any Governmental Authority that is responsible for issuing technical, medical, scientific,
Labeling and similar licenses, registrations, authorizations, permits, certifications, variances, exemptions, orders and approvals necessary for the testing, manufacture, commercialization, Labeling, distribution, use, storage, import, export,
transport, advertising, promotion, marketing or sale of the Products.
Regulatory Documentation
means (a) all
regulatory filings and supporting documents (including copies of all correspondence between Seller Parent or any of its Subsidiaries and the applicable Regulatory Authority), chemistry, manufacturing and controls data and documentation, and
preclinical and clinical studies and tests, (b) all regulatory files and foreign equivalents related thereto, current approved packaging and any other existing files and dossiers, including the underlying data or information used to support,
maintain or obtain marketing authorization of the underlying Product, (c) all records maintained under record keeping or reporting Laws of the FDA or any other Governmental Authority including all applications, annual and safety reports, drug
master files, FDA warning letters, FDA notices of adverse finding letters, FDA audit reports (including Establishment Inspection Reports (EIR) and any responses to such reports), any correspondence with the Office of Prescription Drug Promotion,
periodic safety update reports, complaint files, and annual product quality reviews, (d) the complete complaint, adverse event and medical inquiry filings with respect to the Products as required by applicable Laws, including the Regulatory
Registrations and (e) all equivalent, comparable or analogous documentation with respect to any other country outside the United States.
Regulatory Exclusivity Period
means, with respect to a given Product and given country, a period of exclusivity (other than
patent exclusivity), granted or afforded by applicable Laws or by a Regulatory Authority in such country, that confers exclusive marketing rights with respect to such Product in such country and prevents the initial market entry of a Generic Product
with respect to such Product. In the event that such exclusivity is not available with respect to a Product in a country, the Regulatory Exclusivity Period for such Product in such country shall be deemed to expire upon the First Commercial
Sale of a Generic Product in such country.
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Regulatory Registrations
means the premarket notifications or premarket
approvals issued by the FDA, European Union Conformity Marking (CE marks) issued by a European Union Notified Body, and all other technical, medical, scientific, Labeling and similar licenses, registrations, authorizations, permits, certifications,
franchises, variances, exemptions, orders, approvals, amendments and renewals of the Products (including marketing authorizations and Labeling approvals) issued by the Regulatory Authorities of any country and held or pending (including any
applications) as of the Closing Date by Seller Parent or any of its Subsidiaries or third-party distributors (under rights of reservation of Seller Parent or any of its Subsidiaries) that are required for the manufacture, commercialization,
Labeling, distribution, use, storage, import, export, transport, marketing or sale of the Products within any country.
Representatives
means, with respect to any Person, any officers, directors, employees, attorneys, investment bankers,
financial advisors, agents and other representatives of such Person.
Required Financial Information
means (i)(a) the
audited balance sheets of the Infectious Disease Business of The Medicines Company as at December 31, 2015 and December 31, 2016 and (b) the unaudited balance sheet of the Infectious Disease Business of The Medicines Company as at
September 30, 2017, (ii)(a) the audited income statements of the Infectious Disease Business of The Medicines Company for the years ended December 31, 2015 and December 31, 2016 and (b) the unaudited income statements of the
Infectious Disease Business of The Medicines Company for the nine month periods ended September 30, 2016 and September 30, 2017 and (iii)(a) the unaudited pro forma balance sheet of the Business (which excludes the Excluded Business) as at
September 30, 2017 and (b) the unaudited pro forma income statement of the Business (which excludes the Excluded Business) for the year ended December 31, 2016 and the nine months ended September 30, 2017.
Restricted Person
has the meaning set forth in
Section
9.7(b)
.
Retained Business
means the business,
Know-How,
Intellectual Property, operations
and activities of Seller Parent and its Subsidiaries relating to the Retained Products or not otherwise included in the definition of Acquired Assets, including Seller Parents and its Subsidiaries cardiovascular care and surgery and
perioperative care businesses and the Excluded Business.
Retained Marks
has the meaning set forth in
Section
9.6(a)
.
Retained Products
means each product of Seller Parent and its Subsidiaries
that is not a Product, including without limitation Angiomax, Ionsys, Inclisiran and
MDCO-700.
Royalty Payment
has the meaning set forth in
Section
2.6(a)(v)
.
Sarbanes-Oxley Act
means the Sarbanes-Oxley Act of 2002, as amended, together with the rules and regulations promulgated
thereunder.
Schedule of Business Employees
has the meaning set forth in the definition of Business
Employees.
SEC
means the United States Securities and Exchange Commission.
Second Deferred Payment
has the meaning set forth in
Section
2.6(a)(iv)
.
Section
338(h)(10) Election
has the meaning set forth in
Section
8.6
.
Securities Act
means the Securities Act of 1933, as amended, and the rules and regulations promulgated with respect
thereto.
Seller
and
Sellers
have the meaning set forth in the preamble hereof.
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Seller Benefit Plan
has the meaning set forth in
Section
4.8(a)
.
Seller Disclosure Letter
has the meaning set forth in the introductory
paragraph to
ARTICLE IV
.
Seller Fundamental Representations
means
Section
4.1
(Qualification, Organization, etc.),
Sections 4.2(a)
and
4.2(b)
(Capitalization of the Transferred Group),
Section
4.3
(Authority; Binding Effect),
Section
4.4(a)
(No Conflicts;
Consents) and
Section
4.21
(Brokers).
Seller Guarantees
has the meaning set forth in
Section
9.5(a)
.
Seller Indemnified Parties
has the meaning set forth in
Section
12.3(a)
.
Seller Parent
has the meaning set forth in the preamble hereof.
Seller Parents Knowledge
means the actual knowledge of the Persons listed in Section 1.1(a) of the Seller
Disclosure Letter.
Seller 401(k) Plan
has the meaning set forth in
Section
7.6.
Selling Entity
has the meaning set forth in the definition of Net Sales.
Setoff Amount
has the meaning set forth in
Section
12.6(e)
.
Shared Contracts
means any Contract that relates to both the Business and the Retained Business, which Contracts are listed
on
Schedule 6.5
.
Special Meeting
has the meaning set forth in
Section
6.10
.
Straddle Period
means any taxable period that includes (but does not end on) the Closing Date.
Subject Entities
has the meaning set forth in
Section
8.6
.
Subsidiary
or
Subsidiaries
means, with respect to any Person, any corporation, entity or other
organization, whether incorporated or unincorporated, of which (a) such first Person directly or indirectly owns or controls at least a majority of the securities or other interests having by their terms ordinary voting power to elect a
majority of the board of directors or others performing similar functions or (b) such first Person is or controls a general partner or managing member of such organization or directly or indirectly owns or controls any securities or other
interests of such organization and is allocated a majority of such organizations gains or losses. For the avoidance of doubt, prior to the Closing, the Subsidiaries of Seller Parent shall include each member of the Transferred Group unless the
context expressly requires otherwise.
Target Working Capital Amount
means
negative
Twenty Four Million Three
Hundred Seventy One Thousand Five Hundred Ninety One Dollars ($(24,371,591)).
Tax Claim
has the meaning set forth in
Section
8.4(b)
.
Tax Return
means any return (including estimated returns), declaration,
election, filing, report, claim for refund, information return or other statement relating to Taxes, including any schedule or attachment thereto and any amendment thereof.
Taxes
means (a) all federal, state, local and foreign taxes, assessments, charges, duties, fees, levies or other
similar amounts of any kind whatsoever, including all income, gross receipts, franchise, profits, capital
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gains, capital stock, excise, premium, escheat, unclaimed property, transfer, sales, use, occupation, property, excise, severance, windfall profits, stamp, stamp duty reserve, license, payroll,
withholding, ad valorem, value added, alternative minimum, environmental, customs, social security (or similar), employment, unemployment, sick pay, disability, registration and other taxes, assessments, charges, duties, fees, levies or other
similar amounts, whether disputed or not, together with all estimated taxes, deficiency assessments, additions to tax, penalties and interest with respect thereto, and (b) any liability for the payment of any amounts of the type described in
the foregoing clause (a) as a result of being a member of an affiliated, consolidated, combined or unitary group, as a result of any tax sharing or tax allocation agreement, arrangement or understanding, or as a result of being liable for
another Persons taxes as a transferee or successor, by contract or otherwise.
Taxing Authority
means any
Governmental Authority exercising any authority to impose, regulate or administer the imposition of Taxes.
Third Party
Claim
has the meaning set forth in
Section
12.4(a)
.
Ticking Fee
means a Weekly
Ticking Fee or the Final Ticking Fee, as applicable.
Ticking Fee End Date
has the meaning set forth in
Section
2.10
.
Ticking Fee Start Date
has the meaning set forth in
Section
2.10
.
Trade Secrets
has the meaning set forth in the definition of
Intellectual Property.
Trademark Rights
has the meaning set forth in the definition of Intellectual
Property.
Trading Day
means any day on which NASDAQ is open for trading;
provided
that a Trading
Day only includes those days that have a scheduled closing time of 4:00 PM New York City time.
Transaction
Arbitrator
has the meaning set forth in
Section
3.3(c)
.
Transactions
has the
meaning set forth in the recitals hereof.
Transfer Date
has the meaning set forth in
Section
7.1
Transfer Documents
means, collectively, any and all agreements, assignments,
deeds, notarial forms, certificates and other instruments of sale, conveyance, transfer, assignment and/or assumption, as the case may be, between a Seller and Buyer as necessary under the Law of the relevant jurisdiction or contemplated by this
Agreement in order to transfer all right, title and interest of such Seller in and to the Acquired Assets, and for the Assumed Liabilities to be effectively assumed by and transferred to Buyer, in accordance with the terms hereof, including the Bill
of Sale, the Assignment and Assumption Agreement and the Intellectual Property Assignment Agreements.
Transfer Taxes
means any federal, state, county, local, foreign and other sales, use, transfer, excise, stamp, conveyance, value added, documentary transfer, recording, registration, filing or other similar Taxes imposed with respect to the Transactions.
Transferred Assets
has the meaning set forth in
Section
2.1(b)
.
Transferred Entities
means Rempex Pharmaceuticals, Inc. and Targanta Therapeutics Corporation.
Transferred Entity Insurance Policies
has the meaning set forth in
Section
9.9
.
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Transferred Group
means, individually and collectively, each of the
Transferred Entities and each of their direct and indirect Subsidiaries.
Transferred Group Assets
means the assets,
properties, rights or interests (in each case, tangible or intangible) of the Transferred Group.
Transferred Intellectual
Property
has the meaning set forth in
Section
2.1(b)(iv)
.
Transferred Shares
means
all of the outstanding capital stock of the Transferred Entities.
Transition Services Agreement
means the transition
services agreement to be entered into at Closing substantially in the form attached hereto as
Exhibit D
.
United
States
and
U.S.
mean the United States of America (including its territories and possessions).
Unresolved Items
has the meaning set forth in
Section
3.3(c)
.
Valid Claim
means (a) a claim of any issued and unexpired patent that (i) has not been dedicated to the public,
disclaimed, revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction from which no appeal can be taken, or a decision of a court or governmental agency of competent jurisdiction that can be
appealed, but with respect to which an appeal has not been taken within the time allowed for appeal, and (ii) has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise; or (b) a claim of
any pending patent application that (i) has not been cancelled, withdrawn or abandoned, without being
re-filed
in another application in the applicable jurisdiction, (ii) has not been finally
rejected by an administrative agency or other governmental action from which no appeal can be taken and (iii) has not been pending or filed more than seven (7) years from the earliest possible priority date for such patent application;
provided
,
however
, that if such pending patent application results in an issued patent after such seven (7) year period has elapsed, such patent derived from such application shall represent a Valid Claim.
VWAP
means, for any Trading Day, the volume-weighted average price per share of Buyer Common Stock on NASDAQ (as reported
by Bloomberg L.P. or, if not reported therein, in another authoritative source mutually selected by Buyer and Seller Parent).
WARN
has the meaning set forth in
Section
7.8
.
Weekly
Ticking Fee
means an amount in cash equal to One Million Seven Hundred Thousand Dollars ($1,700,000).
1.2.
Construction
. The table of contents, articles, titles and headings to sections herein are inserted
for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. Unless expressly specified otherwise, whenever used in this Agreement, the terms Article,
Exhibit, Schedule and Section refer to articles, exhibits, schedules and sections of this Agreement (and, for the avoidance of doubt, do not refer to appendices, articles, sections, schedules and exhibits of any
Ancillary Agreement). Whenever used in this Agreement, the terms hereby, hereof, herein and hereunder and words of similar import refer to this Agreement as a whole, including all articles, sections,
schedules and exhibits hereto. Whenever used in this Agreement, the terms include, includes and including mean include, without limitation, includes, without limitation and including,
without limitation, respectively. The word or is not exclusive. Whenever the context of this Agreement permits, the masculine, feminine or neuter gender, and the singular or plural number, are each deemed to include the others.
Days means calendar days unless otherwise specified. Unless expressly specified otherwise, all payments to be made in accordance with or under
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this Agreement (or any Ancillary Agreement) shall be made in U.S. Dollars (USD$). References in this Agreement to particular sections of a Law shall be deemed to refer to such sections or
provisions as they may be amended after the date of this Agreement. All references to a willful and material breach refer to a material breach of this Agreement that is the consequence of an action or omission that the breaching party
takes or omits to take with the knowledge that such action or omission will cause a material breach this Agreement. The Parties have participated jointly in the negotiation and drafting of this Agreement and in the event an ambiguity or question of
intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party (or any Affiliate thereof) by virtue of the authorship of any
of the provisions of this Agreement.
1.3.
Performance of Obligations by Affiliate
s
. Any
obligation of a Seller under or pursuant to this Agreement may be satisfied, met or fulfilled, in whole or in part, at Seller Parents sole and exclusive option, either by Seller Parent directly or by any Controlled Affiliate or designee of
Seller Parent that Seller Parent causes to satisfy, meet or fulfill such obligation, in whole or in part. Any obligation of Buyer under or pursuant to this Agreement may be satisfied, met or fulfilled, in whole or in part, at Buyers sole and
exclusive option, either by Buyer directly or by any Affiliate or designee of Buyer that Buyer causes to satisfy, meet or fulfill such obligation, in whole or in part. With respect to any particular action, the use of the words Seller Parent
shall, Seller Parent agrees to, Sellers shall, Seller shall, and any similar variation with respect to any action, also means Seller Parent shall cause the particular action to be performed, and
the use of the words Buyer shall, Buyer agrees to and any similar variation with respect to any action, also means Buyer shall cause the particular action to be performed, because Seller Parent and Buyer each
understand, agree and acknowledge that they are entering into this Agreement on behalf of themselves and certain of their respective Affiliates. Seller Parent guarantees the performance of all actions, agreements and obligations to be performed by
any Subsidiaries or Affiliates of Seller Parent under the terms and conditions of this Agreement, and Buyer guarantees the performance of all actions, agreements and obligations to be performed by any Controlled Affiliates of Buyer under the terms
and conditions of this Agreement, regardless of whether or not any such Person is a party hereto. In case Seller Parent undertakes any actions, agreements and obligations that should be performed by any Subsidiaries or Affiliates of Seller Parent
under the terms and conditions of this Agreement, Seller Parent shall be deemed to be acting on behalf of such Subsidiaries or Affiliates.
ARTICLE II.
PURCHASE AND SALE
2.1.
Agreement to Purchase and Sel
l
. At the Closing, in accordance with and pursuant to the terms and conditions of this Agreement, for the consideration specified in
Section
2.6
, Seller Parent and its
Subsidiaries shall grant, sell, transfer, convey, assign and deliver to Buyer, and Buyer shall purchase and accept from Seller Parent and its Subsidiaries, all right, title and interest of Seller Parent and its Subsidiaries, as of the Closing, in
and to the following (collectively, the Acquired Assets):
(a) the Transferred Shares, free and clear of all Liens, other than
the Permitted Liens described in clauses (h) and (i) of the definition thereof; and
(b) the following assets, properties, rights and
interests, except if specifically identified as Excluded Assets, free and clear of all Liens, other than Permitted Liens (collectively, the
Transferred Assets
):
(i) all Products;
(ii) all Inventory;
(iii) all of the rights to the fixed and other tangible personal property and equipment primarily related to or used primarily
in connection with the Business, including materials, prototypes, tools, supplies, vehicles, furniture, fixtures, improvements to property and other tangible assets whether
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owned or leased by Sellers or any of their Affiliates, other than any of the foregoing located at the Business Leased Real Property (collectively, the
Equipment
);
provided
,
however
, that any such Equipment necessary for Seller Parent to provide any services under the Transition Services Agreement shall be transferred to Buyer at such time(s) set forth in the Transition Services Agreement;
provided
further
, that the expense of moving any such Equipment shall be borne by Buyer;
(iv) all
Intellectual Property owned by Seller Parent or any of its Subsidiaries and primarily used or held for use in connection with the conduct of the Business, including, without limitation to the foregoing, the following Intellectual Property (all of
the Intellectual Property in this
Section
2.1(b)(iv)
, the
Transferred Intellectual Property
):
(A) the patents and patent applications listed on
Schedule 2.1(b)(iv)(A)
and all other Patent Rights owned by Seller
Parent or any of its Subsidiaries primarily related to the Business (the
Patents
);
(B) the patents and
patent applications listed on
Schedule 2.1(b)(iv)(B)
and all other Patent Rights
in-licensed
by Seller Parent or any of its Subsidiaries primarily related to the Business (the
Licensed
Patents
);
(C) the Trademark Rights listed on
Schedule
2.1(b)(iv)(C)
and all other
Trademark Rights, applications and registrations, owned by Seller Parent or any of its Subsidiaries primarily related to the Business, together with all common law rights and goodwill associated therewith (the
Marks
);
(D) the Trademark Rights listed on
Schedule 2.1(b)(iv)(D)
and all other Trademark Rights
in-licensed
by Seller Parent or any of its Subsidiaries primarily related to the Business, together with all common law rights and goodwill associated therewith (the
Licensed Marks
);
(E) all trade dress, logos, packaging design, slogans and Copyrights owned by Seller Parent or any of its Subsidiaries
primarily related to the Business; and
(F) all Trade Secrets owned by Seller Parent or any of its Subsidiaries primarily
related to the Business;
(v) subject to
Section
2.5
, the Business Contracts, and all rights,
benefits and interests thereunder from and after the Closing;
provided
,
however
, that such Business Contracts which Seller Parent requires in order to provide transition services to Buyer pursuant to the Transition Services Agreement
shall be transferred or assigned to Buyer at such time(s) set forth in the Transition Services Agreement or otherwise agreed in writing by the Parties;
(vi) (A) all Permits (including any applications that are in process) primarily related to or used primarily in connection with
the Business or any Acquired Asset or Transferred Group Asset, including those listed on
Schedule
2.1(b)(vi)(A)
, that are legally transferrable, and (B) all Regulatory Registrations (including any applications that are
in process) primarily related to or used primarily in connection with the Business or any Acquired Asset or Transferred Group Asset, including those listed on
Schedule 2.1(b)(vi)(B)
, and, with respect to each of (A) and (B), supported by
and including: (x) the original documents under the possession of Seller Parent and its Subsidiaries evidencing the Regulatory Registrations issued to and held by Seller Parent and its Subsidiaries by the Regulatory Authorities (or if the
original is not available, copies of the portions thereof related to the Products); (y) all related Regulatory Documentation (
provided
,
however
, that, if any Regulatory Documentation also covers the manufacturing, marketing or sale of
the Retained Products, Seller Parent and its Subsidiaries may elect to redact those portions of Regulatory Documentation that pertain to such other products, or deliver copies of such materials unredacted, but such materials shall be subject to the
confidentiality provisions of this Agreement, shall remain the property of Seller Parent and its Subsidiaries and Buyer shall have no rights with respect to such information); and (z) all of Seller Parent and its Subsidiaries rights of
reservation in any such Regulatory Registrations under any agreement pursuant to which any such
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Regulatory Registrations are held in the name of a third party;
provided
,
however
, that in each of (A) and (B) above, any Permit or Regulatory Registration that is necessary
for Seller Parent to provide any services under the Transition Services Agreement shall be transferred to Buyer at such time(s) set forth in the Transition Services Agreement. Seller Parent and its Subsidiaries shall deliver to Buyer the originals
or, if applicable, copies of such Regulatory Registrations issued to and held directly by Seller Parent and its Subsidiaries (x) as soon as reasonably possible after the Closing Date, with respect to the Regulatory Registrations issued to and
held directly by Seller Parent and its Subsidiaries that Seller Parent and its Subsidiaries do not need to retain to perform their respective obligations under the Transition Services Agreement or otherwise agreed in writing by the Parties; and
(y) at such time(s) set forth in the Transition Services Agreement with respect to Regulatory Registrations issued to and held directly by Seller Parent and its Subsidiaries that Seller Parent and its Subsidiaries need to retain to perform
their respective obligations under the Transition Services Agreement or otherwise agreed in writing by the Parties;
(vii)
all Books and Records;
provided
,
however
, that, if any Books and Records contain any information of Seller Parent or any of its Subsidiaries not primarily related to the Business or the employment of the Business Employees, Sellers may
elect to redact those portions of such Books and Records to the extent pertaining to such other information or, in Sellers sole and absolute discretion, Sellers may deliver unredacted copies of such Books and Records containing information not
primarily related to the Business or the employment of Business Employees but such information shall be subject to the confidentiality provisions of this Agreement, shall remain the property of Sellers, and Buyer shall have no rights with respect to
such information;
(viii) all rights, claims and credits of any kind of Seller Parent or any of its Subsidiaries primarily
related to the Business, any Acquired Asset or Transferred Group Asset or any Assumed Liability, including all actions, claims, causes of action, rights of recovery, choses in action, rights of set off or recoupment, guarantees, warranties,
indemnities, rights to payment or to enforce payment and similar rights in favor of Seller Parent and its Subsidiaries, in each case primarily related to the Business, any Acquired Asset or Transferred Group Asset or any Assumed Liability;
(ix) any Business Benefit Plan and any assets thereunder;
(x) all goodwill of the Business as a going concern;
(xi) the Current Assets at Closing, to the extent reflected as such in the Final Closing Statement;
(xii) the Transferred Entity Insurance Policies;
(xiii) those assets listed on
Schedule
2.1(b)(xiii)
; and
(xiv) any other asset, property or right of Seller Parent and its Subsidiaries, whether real or personal, tangible or
intangible, primarily related to or used primarily in connection with the Business,
in each case set forth in this
Section
2.1(b)
, only to the extent such items are not already transferred by way of the sale of the Transferred Shares.
2.2.
Excluded Asset
s
. Notwithstanding anything to the contrary in this Agreement, Sellers shall
not grant, sell, transfer, convey, assign or deliver, and Buyer shall not, nor shall Buyer have any right to, purchase, accept or otherwise acquire, any right, title or interest in any of the following assets, properties, rights or interests of
Sellers or any of Sellers Affiliates, which are expressly excluded from the Transferred Assets and are not to be acquired by Buyer pursuant to this Agreement (the
Excluded Assets
):
(a) any assets, properties, rights or interests primarily related to the Retained Business, including the Retained Products;
(b) any assets, properties, rights or interests primarily related to the Excluded Business (including materials, prototypes, tools, supplies,
vehicles, furniture, fixtures, information technology assets, improvements to property and other tangible assets located at the Business Leased Real Property);
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(c) any Shared Contracts;
(d) rights of Sellers arising under this Agreement or the Ancillary Agreements or from the consummation of the Transactions;
(e) all Tax refunds, credits, offsets, recoveries and similar benefits related to the Transferred Assets for a
Pre-Closing
Tax Period or relating to the other Excluded Assets for all periods;
(f) any
wholesale supply agreement for pharmaceutical products;
(g) cash, cash equivalents, bank deposits and marketable securities on hand and
in transit of Sellers;
(h) the corporate books and records of Seller Parent and its Subsidiaries (other than the Transferred Group);
(i) the Business Leased Real Property (including without limitation the lease contracts relating thereto), and all rights, title and interest
in, to and under all structures, facilities or improvements located thereon and all easements, licenses, rights and appurtenances related to the foregoing;
(j) all current and prior insurance policies (other than the Transferred Entity Insurance Policies), and all rights of any nature with respect
thereto, including all insurance recoveries thereunder and rights to assert claims with respect to any such insurance recoveries; and
(k)
any Seller Benefit Plan and any assets thereunder.
2.3.
Assumed Liabilitie
s
. At the Closing,
in accordance with and pursuant to the terms and conditions of this Agreement, Buyer shall assume and agree to satisfy and discharge only the following Liabilities, except to the extent specifically identified as Excluded Liabilities (collectively,
the
Assumed Liabilities
):
(a) all Liabilities of the Transferred Group arising or accruing after the Closing;
(b) all Liabilities arising out of or relating to any Transferred Asset or the operation of the Business, to the extent arising or accruing
after the Closing, including all Liabilities arising after the Closing out of or relating to the design, manufacture, testing, marketing, Labeling, distribution, use or sale of any Products;
(c) all Liabilities in respect of any Proceedings, to the extent arising out of or relating to any Transferred Asset or the operation of the
Business after the Closing;
(d) all Liabilities to suppliers for materials and services related to the Business ordered prior to the
Closing, but scheduled to be delivered or provided and paid for thereafter (including all orders for active pharmaceutical ingredients primarily related to the Products), and all Liabilities to customers under purchase orders received for Products
that have not yet been shipped or delivered at Closing;
(e) all Liabilities under any Business Contracts, in each case except to the
extent that such Liabilities relate to any failure to perform or other breach, default or violation by Seller Parent or any of its Subsidiaries under any such Business Contract prior to the Closing;
(f) all Liabilities with respect to Products sold on or after the Closing, including all Liabilities for any returns, credits, rebates,
refunds or other amounts payable in respect of, or Claims with respect to, any such Product;
(g) all Liabilities with respect to
(i) the Continuing Employees in respect of service on and after the Closing and (ii) the Business Benefit Plans, in each case, except as set forth in
Article VII
;
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(h) all Liabilities under any Permits or Regulatory Registrations included in the
Transferred Assets to the extent arising after the Closing;
(i) all Liabilities to make royalty, milestone or deferred payments or any
other contingent payments to third parties after the Closing in connection with the Business or the Products, including pursuant to the terms of the Contingent Payment Contracts;
(j) the Current Liabilities at Closing, to the extent reflected as such in the Final Closing Statement; and
(k) all Liabilities for (i) fifty percent (50%) of the Transfer Taxes of Buyer as described in
Section
8.1
and
(ii) Taxes (other than Transfer Taxes) attributable to the Transferred Assets or the operations or the income of the Business for any Post-Closing Tax Period, including the portion of any Straddle Period beginning after the Closing Date borne
by Buyer as determined pursuant to
Section
8.2
.
2.4.
Excluded
Liabilitie
s
. Notwithstanding anything to the contrary in this Agreement or otherwise, neither Buyer nor any of its Affiliates shall assume, nor shall they be or become responsible for, any Liabilities of the Business or of Seller Parent
or any of its Subsidiaries other than the Assumed Liabilities (collectively, the
Excluded Liabilities
). Without limiting the generality of the foregoing, the following shall constitute the Excluded Liabilities notwithstanding any
other provision of this Agreement:
(a) except for the Assumed Liabilities described in
Sections 2.3(d)
,
2.3(e)
,
2.3(f)
,
2.3(g)
and
2.3(j)
, all Liabilities of the Transferred Group arising or accruing before the Closing;
(b)
except for the Assumed Liabilities described in
Sections 2.3(d)
,
2.3(e)
,
2.3(f)
,
2.3(g)
and
2.3(j)
, all Liabilities arising out of or relating to any Transferred Asset, Transferred Group Asset or the operation of
the Business, to the extent arising or accruing prior to the Closing or resulting from the ownership, operation or control of the Business or the Transferred Assets or Transferred Group Assets prior to the Closing;
(c) all Liabilities to the extent relating to the Excluded Assets;
(d) all Liabilities under any Business Contracts, in each case to the extent such Liabilities relate to any failure to perform or other
breach, default or violation by Seller Parent or any of its Subsidiaries under any such Business Contract prior to the Closing;
(e) all
Liabilities with respect to Products sold prior to the Closing, including all Liabilities for any returns, credits, rebates, refunds or other amounts payable in respect of or Claims with respect to any such Product;
(f) all Liabilities for (i) fifty percent (50%) of the Transfer Taxes of Seller Parent as described in
Section
8.1
and
(ii) Pre-Closing
Taxes (other than Transfer Taxes), including any Taxes arising out of or relating to the separation and/or sale of the Excluded Business
(including any restructuring related thereto);
(g) all Liabilities arising out of or relating to the Retained Business;
(h) all Liabilities arising out of or relating to the separation and/or sale of the Excluded Business (including any restructuring related
thereto), including claims from purchasers related thereto;
(i) all Liabilities to make Milestone Payments in respect of Milestone #s 6
(subject to
Section
6.5
), 13, 14, 15, 16 and 17 (each, as defined in the Rempex Merger Agreement as defined in
Schedule 1.1(d)
) which relate to the Excluded Business or Retained Business;
(j) (i) all Liabilities with respect to
change-in-control,
transaction, retention and other similar bonuses or payments, severance or similar payments or benefits payable by a Seller or any Subsidiary of a Seller or any
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member of the Transferred Group to any employee, independent contractor, officer, or director of a Seller, any Subsidiary of a Seller or any member of the Transferred Group, including any
Business Employee or Continuing Employee, arising from or incurred solely in connection with this Agreement or the Transactions, other than as set forth in the Transition Services Agreement; (ii) all Liabilities related to the Seller Benefit
Plans, any Business Employee who does not become a Continuing Employee or to any
Non-Business
Employees or to any current or former employee, independent contractor, officer, or director of a Seller, any
Subsidiary of a Seller or any member of the Transferred Group (other than any Continuing Employee, but only to the extent provided for in
ARTICLE VII
), other than as set forth in the Transition Services Agreement; (iii) all Liabilities
(including severance costs) arising out of the employment of the Continuing Employees by a Seller or any Subsidiary of a Seller or any member of the Transferred Group at and prior to the Closing, or relating to any current or former employee,
independent contractor, officer, or director of a Seller, any Subsidiary of a Seller or any member of the Transferred Group (other than the Continuing Employees), including, for the avoidance of doubt, all employment-related Liabilities relating to
any
pre-Closing
restructuring with respect to the Business Employees who are employed by an entity within the Transferred Group as of immediately prior to the Closing; (iv) all Liabilities relating to any
equity or equity-based awards granted by Seller Parent; and (v) the employer portion of any employment Taxes or other costs arising from any of the foregoing;
(k) all Liabilities relating to rights to indemnification now existing in favor of the current or former directors or officers of the
Transferred Group provided in the Organizational Documents of the Transferred Group, as the case may be, relating to any
pre-Closing
facts or circumstances;
(l) all Liabilities (other than Assumed Liabilities) arising out of or related to Indebtedness of the Transferred Group existing at the
Closing; and
(m) all Liabilities that are transaction expenses of Sellers arising out of this Agreement, including the separation and/or
sale of the Excluded Business;
2.5.
Procedures for Assignments
. (a) Notwithstanding anything
to the contrary contained herein, this Agreement shall not constitute an agreement to assign or transfer any Transferred Asset if an assignment or transfer thereof, without the Consent of a Person, would constitute a breach or violation thereof and
such Consent is not obtained at or prior to the Closing. Sellers will use reasonable best efforts to obtain any Consent necessary to the assignment or transfer of any Transferred Asset prior to the Closing and, if the Parties are not successful in
obtaining any such Consent at or prior to the Closing, then the Parties agree that on and after the Closing, Sellers will continue to use reasonable best efforts to obtain such Consent;
provided
,
however
, that, except to the
extent that Buyer agrees to reimburse such Seller, in no event shall any Seller be required to pay any monies to obtain such Consent prior to or after the Closing. Subject to compliance with the immediately preceding sentence and the terms and
provisions of
Section
6.3
, the fact of a failure to obtain any such Consent shall not result in a breach of this Agreement in any manner except to the extent inconsistent with the representations and warranties of Seller
Parent contained in
Section
4.4
and Section 4.4 of the Seller Disclosure Letter.
(b) If the Parties are
not successful in transferring or assigning any Transferred Asset or right, benefit or obligation thereunder or resulting therefrom at or prior to the Closing in accordance with
Section
2.5(a)
and the Closing proceeds
without such transfer or assignment, then following the Closing and pending the receipt of such Consent, the Parties shall cooperate with each other in any mutually agreeable, reasonable and lawful arrangements designed to provide Buyer with the
benefits and burdens of any such Transferred Assets and any right, benefit or obligation thereunder or resulting therefrom as if the appropriate Consent had been obtained, including provision of the consideration and other economic benefits to be
received by Buyer in and under every Transferred Asset and right, benefit or obligation thereunder or resulting therefrom, which consideration shall be held for the benefit of, and shall be promptly delivered to, Buyer and refrain from agreeing to
any amendment, supplement, waiver or other modification of any Transferred Asset, right, benefit or obligation thereunder or resulting therefrom, as applicable, without Buyers prior written consent. Once the applicable Consent for the
assignment or transfer of any such Transferred Asset not assigned or transferred at the Closing is obtained,
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Sellers shall assign and transfer such Transferred Asset to Buyer at no additional cost. To the extent that any such Transferred Asset cannot be transferred or the full benefits and burdens of
use of any such Transferred Asset cannot be provided to Buyer following the Closing pursuant to this
Section
2.5
, then Buyer and Seller Parent shall enter into such arrangements (including subleasing, sublicensing or
subcontracting) to provide to the Parties the economic (taking into account Tax costs and benefits) and operational equivalent, to the extent permitted, of obtaining such Consent (
provided
that, with respect to any such asset that is a
Contract, such obligation shall continue for only so long as the applicable Contract is in effect). Seller Parent shall hold in trust for and pay to Buyer promptly upon receipt thereof, all income, proceeds and other monies received by Sellers or
any of their Affiliates in connection with the use of any asset in connection with the arrangements under this
Section
2.5
. To the extent that Buyer is provided the benefits of any Transferred Asset or right, benefit or
obligation thereunder or resulting therefrom referred to herein (whether from Sellers or otherwise) as if the appropriate Consent had been obtained, Buyer shall arrange to discharge and perform the Liabilities of Sellers thereunder or in connection
therewith, as applicable, to the same extent as if the appropriate Consent had been obtained.
(c) Notwithstanding the foregoing, neither
Party nor any of its respective Affiliates shall have any obligation to (i) pay sums of money or provide any guarantee or other consideration, or agree to any undertaking, in connection with obtaining the Consents referred to in this
Section
2.5
or otherwise agree to any action that would adversely affect any Party or its Affiliates, or any Partys or its Affiliates businesses or operations, or any right or obligation of such Party or any of
its Affiliates under any Contract related to such Consents, (ii) waive or discharge any liabilities or obligations owing to either Party or its Affiliates by any counterparty under any such Contract, (iii) waive any rights of any Party or
its Affiliates under any such Contracts or (iv) amend, modify, supplement or otherwise change in any material respect (including any change that adversely affects pricing) the terms of any such Contract.
2.6.
Purchase Price
. (a) In consideration for the sale and transfer of the Acquired Assets, and
subject to the terms and conditions of this Agreement, Buyer shall assume the Assumed Liabilities at the Closing, as provided in
Section
2.3
, and shall pay to Seller Parent the following amounts (collectively, as adjusted
pursuant to
Section
3.3
, the
Purchase Price
):
(i) At the Closing, Buyer shall
pay to Seller Parent an amount equal to:
(A) One Hundred Sixty Five Million Dollars ($165,000,000), in cash (the
Closing Cash
Consideration
); and
(B) the number of shares of Buyer Common Stock equal to: (1) Fifty Million Dollars ($50,000,000)
divided by
(2) ninety percent (90%) of the VWAP for the ten (10) Trading Day period ending three (3) Trading Days prior to Closing (it being understood that each share of Buyer Common Stock issued to Seller Parent hereunder
will reflect the restrictive legends set forth in
Exhibit F
at the Closing) (the
Closing Stock Consideration
and, together with the Closing Cash Consideration, the
Base Consideration
).
(The Amounts described in clauses (A) and (B) above (as adjusted pursuant to
Section
2.6(a)(ii))
, shall
constitute the
Closing Payment
).
(ii) Not less than three (3) Business Days nor more than five
(5) Business Days prior to the Closing Date, Seller Parent shall deliver to Buyer a written statement (the
Estimated Closing Statement
) setting forth, in reasonable detail, Seller Parents good faith estimate of the
Closing Adjustment Amount (the
Estimated Closing Adjustment Amount
). The Estimated Closing Statement shall be prepared in the format of
Exhibit
E
(the
Form of Closing Statement
) using
GAAP applied in a manner consistent with the Accounting Principles. If the Estimated Closing Adjustment Amount is positive, then the Closing Payment shall be increased by the Estimated Closing Adjustment Amount. If the Estimated Closing Adjustment
Amount is negative, then the Closing Payment shall be reduced by the Estimated Closing Adjustment Amount. If the Estimated Closing Adjustment Amount is zero (0), then the Closing Payment shall not be adjusted pursuant to this
Section
2.6(a)(ii)
.
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(iii) On the first Business Day following the twelve (12) month
anniversary of the Closing Date, Buyer shall pay to Seller Parent an amount equal to Twenty Five Million Dollars ($25,000,000) (the
First Deferred Payment
).
(iv) On the first Business Day following the eighteen (18) month anniversary of the Closing Date, Buyer shall pay to
Seller Parent an amount equal to Twenty Five Million Dollars ($25,000,000) (the
Second Deferred Payment
and, together with the First Deferred Payment, the
Deferred Payments
and, together with the Closing
Payment, the
Guaranteed Payments
).
(v) For the rights and assets acquired by Buyer hereunder with
respect to the Products, in addition to the Guaranteed Payments, Buyer shall (or shall cause one of its Affiliates to) pay to Seller Parent in accordance with
Section
2.8
, during the Exclusivity Period in each applicable
country on a
country-by-country
basis (any such country during its Exclusivity Period, a
Qualifying Country
) (except as provided in paragraph
(C) below), on an annual calendar year basis, royalty payments, in cash (the
Royalty Payments
) equal to:
(A) For any Vabomere sold in the U.S.:
(1) on the amount of Net Sales of Vabomere in the U.S. (for so long as it is a Qualifying Country) that is less than or equal
to fifty million dollars ($50,000,000) during such calendar year, the percentage of such Net Sales during such calendar year set forth in Annex
I-A,
plus
(2) on the amount of Net Sales of Vabomere in the U.S. (for so long as it is a Qualifying Country) that is greater than fifty
million dollars ($50,000,000) and less than or equal to one hundred million dollars ($100,000,000) during such calendar year, the percentage of such Net Sales during such calendar year set forth in Annex
I-A,
plus
(3) on the amount of Net Sales of Vabomere in the U.S. (for so long as it is a Qualifying Country) that is
greater than one hundred million dollars ($100,000,000) and less than or equal to two hundred million dollars ($200,000,000) during such calendar year, the percentage of such Net Sales during such calendar year set forth in Annex
I-A,
plus
(4) on the amount of Net Sales of Vabomere in the U.S. (for so long as
it is a Qualifying Country) that is greater than two hundred million dollars ($200,000,000) and less than or equal to five hundred million dollars ($500,000,000) during such calendar year, the percentage of such Net Sales during such calendar year
set forth in Annex
I-A,
plus
(5) on the amount of Net Sales of Vabomere in
the U.S. (for so long as it is a Qualifying Country) that is greater than five hundred million dollars ($500,000,000) during such calendar year, the percentage of such Net Sales during such calendar year set forth in Annex
I-A.
(B) For any Orbactiv and Minocin IV sold in the U.S.:
(1) on the amount of Net Sales of such Products in the U.S. (for so long as it is a Qualifying Country) that is less than or
equal to one hundred million dollars ($100,000,000) during such calendar year, the percentage of such Net Sales during such calendar year set forth in Annex
I-B,
plus
(2) on the amount of Net Sales of such Products in the U.S. (for so long as it is a Qualifying Country) that is greater than
one hundred million dollars ($100,000,000) during such calendar year, the percentage of such Net Sales during such calendar year set forth in Annex
I-B.
(C) for any Product in any Qualifying Country sold outside of the U.S., on the amount of Net Sales of the Products in such
Qualifying Countries, the percentage of such Net Sales during such calendar year set forth in Annex
I-C,
it being understood and agreed that Royalty Payments on Net Sales described in paragraph (c) of the
definition thereof shall be calculated and payable irrespective of whether any country to which Net Sales relate is a Qualifying Country.
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(vi) an illustrative example of the Royalty Payments described in
Section
2.6(a)(v)
is set forth in
Exhibit H
.
(vii) Notwithstanding the foregoing, with
respect to any Product in any given country, if: (A) the Regulatory Exclusivity Period with respect to such Product in such country shall have expired, (B) fewer than ten (10) years shall have elapsed since the date of First
Commercial Sale of such Product in such country, and (C) a Generic Product with respect to such Product shall have been approved for sale in such country by a Governmental Authority having the authority to approve sales of such Generic Product
in such country, the royalty rates applicable to such Product in such country (1) shall, commencing with the calendar quarter immediately following the satisfaction of the conditions set forth in clauses (A)-(C) of this
Section
2.6(a)(vii)
, be reduced by fifty percent (50%), (2) shall thereafter be reduced to an amount equal to twenty five percent (25%) of their original amounts as of the first day of the calendar quarter following a
calendar quarter for which the Net Sales of such Product during such calendar quarter in such country, together with the Net Sales of such Product in such country during the immediately preceding three calendar quarters, total less than fifty
percent (50%) of the Net Sales of such Product in such country for the twelve calendar month period ending as of the first day of the calendar month during which the condition described in clause (C) above shall first be satisfied in such
country, and (3) shall thereafter be reduced to zero percent (0%) as of the first day of the calendar quarter following a calendar quarter for which the Net Sales of such Product in such country during such calendar quarter, together with the
Net Sales of such Product in such country during the immediately preceding three calendar quarters, total less than twenty five percent (25%) of the Net Sales of such Product in such country for the twelve calendar month period ending as of the
first day of the calendar month during which the condition described in clause (C) above shall first be satisfied in such country;
provided
,
however
, that if Buyer or the applicable Selling Entity receives any damages, amounts
paid in settlement or other consideration (excluding amounts paid in reimbursement of
out-of-pocket
legal costs and expenses) in connection with an actual or threatened
Proceeding challenging the legality or validity of the existence of the matter underlying the condition described in clause (C) above, then Seller Parent shall be entitled to receive a percentage of such damages, amounts paid in settlement or
other consideration (after applying any such amounts to reimburse
out-of-pocket
legal costs and expenses incurred by Buyer or the applicable Selling Entity in connection
therewith, to the extent not reimbursed as part of such award or settlement) equal to the effective royalty percentage on aggregate Net Sales which was payable in the calendar quarter immediately preceding the calendar quarter in which the condition
described in clause (C) above first was satisfied;
provided
,
further
, that, if the condition described in clause (C) above shall cease to be satisfied at any time, the reductions in royalty rates payable with respect to such
Product in such country described in clauses (1)-(3) of this
Section
2.6(a)(vii)
shall no longer apply with respect to subsequent calendar quarters, to the extent applicable (and, for the avoidance of doubt, the increase in
royalty rates shall not affect the amounts paid or payable during any such reduction in royalty rates);
provided
,
further
, that this
Section
2.6(a)(vii)
shall not apply to any Royalty Payments based on Net
Sales described in paragraph (c) of the definition thereof.
2.7.
Transferability of Royalty
Rights
. The right to receive the Royalty Payments or any portion thereof, if payable pursuant to the terms and conditions of this Agreement, together with the related inspection and audit rights set forth in
Section
2.8(b)
and
Section
2.8(c)
, may be sold, assigned, pledged as security, contributed, conveyed, granted, declared in trust or otherwise transferred (including any transfer by operation of
Law) or financed, monetized or securitized by Seller Parent to or by any Person without the prior written consent of Buyer, subject to the conditions set forth below. Seller Parent will provide written notice to Buyer within ten (10) days of
any such sale, assignment, pledge, contribution, conveyance, grant, declaration or other transfer, financing, monetization or securitization, which written notice will include the name, contact, address and telephone number of any such purchaser,
assignee, pledgee, contributee, conveyee, grantee or other transferee or party to any financing, monetization or securitization (each, a
Financing Assignee
), and written authorization to direct the payment of Royalty Payments (or
portion thereof) to such Financing Assignee, rather than Seller Parent. Buyer acknowledges that Seller Parent intends to consider, subject to market conditions and other factors, entering into a negotiated financing transaction with respect to the
Royalty Payments. Buyer shall, at Seller
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Parents expense, cooperate and provide reasonable assistance to Seller Parent and any Financing Assignee in connection with any assignment by Seller Parent or any Financing Assignee
pursuant to this
Section
2.7
. Such cooperation shall include without limitation (a) acknowledging such assignments to respective Financing Assignees from time to time, (b) executing and delivering such
assignments, agreements and other instruments and documents (including amendments hereto) as may be reasonably requested by Seller Parent or any Financing Assignee in order to transfer the right to receive the Royalty Payments and (c) agreeing
to deliver Net Sales Statements, and pay interest payments as required pursuant to
Section
2.8(f)
, directly to a Financing Assignee, if so instructed in writing by Seller Parent. Buyer consents that Seller Parent and any
Financing Assignee shall be entitled to disclose the terms of this Agreement, Net Sales Statements, and other documentation material to a potential transaction with a Financing Assignee;
provided
that in advance of, and as a condition to, any
such disclosure, such potential Financing Assignee shall have entered into a
non-disclosure
agreement. Buyer acknowledges that the covenants contained in this
Section
2.7
are material
conditions of Seller Parents willingness to enter into this Agreement and consummate the Transactions, and Seller Parent shall be entitled to preliminary and permanent injunctive relief against any breach or threatened breach of any such
covenants. This
Section
2.7
shall be binding upon, and inure to the benefit of, Buyer and its successors and permitted assigns.
2.8.
Net Sales Reporting; Royalty Payment Mechanics
.
(a) Within ten (10) days following the end of each calendar quarter during the period during which Royalty Payments may be payable
hereunder, Buyer will provide Seller Parent with a report (the
Net Sales Statement
) containing the following information with respect to any Net Sales of any applicable Product during such calendar quarter: (i) the number of
units of such Product sold in the applicable territory, (ii) gross sales in the applicable territory, (iii) the deductions therefrom, (iv) any consideration received by Buyer or any of its Controlled Affiliates in respect of any
Product Transfer (whether upfront payments, royalty payments, milestone payments or otherwise), (v) the resulting calculation of Net Sales and (vi) in the case of any Net Sales Statement in respect of a calendar year end, the resulting
calculation of the Royalty Payments owed to Seller Parent. With respect to each calendar quarter (or portion thereof), the relevant Royalty Payments for such calendar quarter shall be paid on the tenth
(10
th
) Business Day after such calendar quarter (i.e. the tenth (10
th
) Business Day of the following calendar quarter), with such payment to be
calculated based on gross cash receipts for such calendar quarter;
provided
that all payments in respect of any calendar quarter (or portion thereof) shall be subject to reconciliation based on the final Net Sales for the applicable calendar
quarter (or portion thereof) on the payment date for the subsequent calendar quarter, with such reconciliation being prepared by Buyer and delivered to Seller Parent in the form of an updated and revised Net Sales Statement on such payment date, and
thereafter subject to final reconciliation based on the final Net Sales for the applicable calendar year in which such calendar quarter occurs based on the audited financial statements for such calendar year, with such final reconciliation to be
prepared by Buyer and delivered to Seller Parent no later than one hundred fifty (150) days after the end of such fiscal year. With respect to each reconciliation, any overpayments shall be credited against, and any underpayments shall be added
to, the subsequent payments in respect of any Royalty Payments.
(b) Upon Seller Parents reasonable request, Buyer shall provide to
Seller Parent
back-up
information used to prepare any Net Sales Statement. Buyer shall keep such records (and shall require its Controlled Affiliates, licensees, sublicensees, assignees and other transferees
to keep such records) as shall be reasonably necessary to support the calculations of Net Sales as set forth in each Net Sales Statement. Such records shall be available for inspection and audit by Seller Parent or its authorized Representatives, at
reasonable times and on reasonable advance notice, for a period of three (3) years after Seller Parents receipt of any Net Sales Statement to which such records relate. Each Net Sales Statement and all records of Buyer, its Controlled
Affiliates, licensees, sublicensees, assignees and other transferees subject to inspection pursuant to this
Section
2.8(b)
shall be deemed to be Buyer Information subject to the confidentiality obligations of
Section
13.3
.
(c) If, as a result of any such audit or inspection, Seller Parent reasonably concludes that
Buyer has underreported the Net Sales for any audited period, Seller Parent shall inform Buyer of the Net Sales for such
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audited period as calculated by Seller Parent in a written notice setting forth Seller Parents calculation of such Net Sales in reasonable detail. In the event Buyer disputes Seller
Parents calculation of Net Sales as set forth in such notice within thirty (30) days after receipt of such notice, Buyer will so notify Seller Parent in writing within such thirty (30) day period and the Parties will attempt
thereafter to resolve such dispute amicably and, if they cannot do so by the end of such thirty (30) day period, they will (unless the Parties mutually agree in writing to continue their efforts to resolve such dispute) submit the dispute for
resolution by the Transaction Arbitrator, with the procedures set forth in
Sections
3.3(c)-(h)
relating to the selection and payment of the Transaction Arbitrator and the resolution of Unresolved Items applying
mutatis
mutandis
to disputes over Net Sales Statements and Royalty Payments. If Buyer does not dispute Seller Parents calculation of Net Sales set forth in such notice within the thirty (30) day period set forth above, Net Sales for such
audited period shall be deemed to be the amount set forth in such notice and if, based upon such calculation, any additional amounts are due to Seller Parent in accordance with
Section
2.6
, Buyer shall pay such amounts to
Seller Parent in cash by wire transfer of immediately available funds into an account designated by Seller Parent within five (5) Business Days after the expiration of the thirty (30) day period set forth above.
(d) Each Royalty Payment shall be made by electronic transfer in immediately available funds via either a bank wire transfer, an ACH
(automated clearing house) mechanism, or any other means of electronic funds transfer, at Buyers election, to such bank account as Seller Parent or, if applicable, the Financing Assignee shall designate in a notice at least five
(5) Business Days before the payment is due.
(e) All Royalty Payments due under this Agreement shall be made in United States
dollars. Whenever, for the purposes of calculating Royalty Payments, conversion from any foreign currency will be required, all amounts will first be calculated in the currency of sale or other compensation and then converted into United States
dollars by applying the monthly average rate of exchange calculated by using the foreign exchange rates published in Bloomberg during the applicable month starting two (2) Business Days before the beginning of such month and ending two
(2) Business Days before the end of such month, in accordance with generally accepted accounting principles, fairly applied and as employed on a consistent basis throughout Buyers operations. For the avoidance of doubt, for all purposes
in this Agreement, any hedging or derivatives transaction engaged in by Buyer with respect to sales of Products shall be disregarded.
(f)
If any Royalty Payment owed to Seller Parent under this Agreement is not paid by Buyer within a reasonable amount of time, in any event not to exceed thirty (30) days, following the due date of such payment, then Buyer shall pay interest on the
undisputed and unpaid portion thereof at the Prime Rate as published in the Wall Street Journal (New York edition), or if lower, the maximum interest rate permitted under applicable Law, such interest to run from the date upon which payment of such
undisputed amount became due until payment in full of the undisputed and unpaid portion thereof.
2.9.
Commercialization Efforts; Royalty Covenants
. (a) From and after the Closing, Buyer shall, and shall cause its Subsidiaries to, (i) use commercially reasonable efforts to develop, promote, market, sell, distribute and commercialize
Vabomere, Orbactiv and Minocin IV in the United States with a view towards maximizing Net Sales of such Products in the United States and, with respect to Products sold outside the United States, use commercially reasonable efforts to pursue
agreements with third parties with a view towards maximizing Net Sales of such Products outside the United States and (ii) not take any action, or omit to take any action, a primary purpose of which is to reduce the amount of Royalty Payments
otherwise due to Seller Parent. It is understood and agreed that a Product Transfer (as defined below) will not relieve Buyer of its obligation under this
Section
2.9(a)
;
provided
, that, for purposes of this
Section
2.9(a)
, the activities of Buyer and each transferee in a Product Transfer shall be attributed to Buyer for the purposes of determining Buyers satisfaction of the foregoing obligations.
(b) Buyer and its Affiliates may not, directly or indirectly, by a sale or swap of assets, merger, reorganization, joint venture, lease,
license, sublicense or any other transaction or arrangement, sell, transfer, license, sublicense, convey or otherwise dispose of all or a portion of their respective rights in and to Vabomere,
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Orbactiv or Minocin IV to a third party (other than Buyer or its Affiliates) (collectively, a
Product Transfer
), unless the contract for such sale, transfer, license,
conveyance or other disposition (which Buyer shall take all commercially reasonable actions necessary to enforce in all material respects) shall require the transferee to comply with the covenants in
Sections 2.7
,
2.8
,
2.9(a)
and
2.9(b)
, and to provide Buyer with all information necessary to calculate Net Sales with respect to such Product.
(c) Buyer
shall give Seller Parent written notice of any Product Transfer or distribution arrangement within ten (10) Business Days after consummation thereof, which notice shall include a reasonably detailed description of such Product Transfer or
distribution arrangement, including the products and countries or territories subject to such Product Transfer or distribution arrangement and all consideration, whether guaranteed or contingent, paid or payable to or on behalf of Buyer and its
Affiliates in connection therewith.
(d) Buyer (and its Controlled Affiliates and permitted successors and assigns) shall not engage in
any Product Transfer that would result in the sale, conveyance, transfer or other disposition of all or substantially all of Buyers and its Affiliates rights covering Vabomere, Orbactiv or Minocin IV to an unaffiliated third party,
through one or more transactions or a series of transactions (including by merger or consolidation or otherwise by operation of law), unless, and as a condition thereto, the transferee or successor assumes and succeeds to all of the obligations of
Buyer set forth in this
Section
2.9
,
Section
2.6(a)(v)
and
Section
2.8
and prior to or simultaneously with such transaction delivers to Seller Parent an instrument of
assumption for the benefit of Seller Parent and its Affiliates, and in form reasonably acceptable to Seller Parent, effecting such assumption and succession. Any such Product Transfer will not release Buyer from its obligations under this
Section
2.9
,
Section
2.6(a)(v)
and
Section
2.8
.
(e) For
purposes of this
Section
2.9
,
Section
2.7
,
Section
2.8
and
Section
2.6
(and any definition used therein), Products,
Vabomere, Orbactiv and Minocin IV mean, collectively, the Products, Vabomere, Orbactiv or Minocin IV, as the case may be, and any alternate forms or formulations thereof developed after the Closing Date by Buyer
or any of its Affiliates or any of their respective licensees, sublicensees or other transferees based on or derived in any material respect from the Transferred Intellectual Property or Intellectual Property of the Transferred Group.
2.10.
Ticking Fe
e
. If the conditions set forth in
Section 10.3
(other than those
conditions which are to be satisfied at the Closing) have been satisfied or waived and the Closing Date does not occur on or prior to the date which is sixty (60) days following the date that Seller Parent delivers the Required Financial
Information to Buyer (the
Ticking Fee Start Date
), on the first (1
st
) Business Day following such Ticking Fee Start Date, Buyer shall pay to Seller Parent the Weekly Ticking
Fee. Buyer shall continue to pay the Weekly Ticking Fee every seventh (7th) calendar day following the Ticking Fee Start Date (unless such date is not a Business Day, in which case the relevant Weekly Ticking Fee will be paid on the first Business
Day following the date upon which the Weekly Ticking Fee becomes due and payable) until the earlier of (i) the Closing Date or (ii) the date upon which this Agreement is terminated pursuant to ARTICLE XI (such earlier date, the
Ticking Fee End Date
). If the Ticking Fee End Date is the Closing Date, at the Closing, Buyer shall pay the Final Ticking Fee in accordance with
Section
3.2(b)(iii)
. If the Ticking Fee End Date is not the
Closing Date, Buyer shall pay the Final Ticking Fee on the second (2nd) Business Day following the Ticking Fee End Date. If the Closing Date occurs fewer than seven (7) calendar days following the Ticking Fee Start Date, the Closing Payment
shall be reduced by an amount equal to one seventh (1/7th) of the Weekly Ticking Fee
multiplied
by the number obtained by
subtracting
(A) the number of days which have elapsed between the Ticking Fee Start Date and the Closing
Date (inclusive) from (B) seven (7). All Ticking Fees shall be paid by wire transfer of immediately available funds to an account designated by Seller Parent not less than two (2) Business Days prior to the date upon which the relevant
Ticking Fee becomes due and payable.
2.11.
Purchase Price Allocation
.
(a) The Parties agree that the Purchase Price and the Assumed Liabilities (plus other relevant items) will be allocated to the Acquired Assets
in a manner consistent with the Allocation Laws. Seller Parent will
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complete a draft schedule (the
Allocation Schedule
) (A) that allocates the Purchase Price and Assumed Liabilities (plus other relevant items) consistent with Section 1060
of the Code (i) to the Acquired Assets (other than the Transferred Entities) and (ii) to each of the Transferred Entities, and (B) that further allocates the amount allocated to each Transferred Entity among the assets of the
Transferred Group consistent with Sections 338 and 1060 of the Code, if applicable. Seller Parent shall provide a copy of the Allocation Schedule to Buyer at least sixty (60) days prior to the due date for filing any form with respect to the
Allocation Schedule.
(b) Unless Buyer notifies Seller Parent in writing within thirty (30) days after the receipt of the draft
Allocation Schedule, Buyer shall be deemed to have agreed to the Allocation Schedule as prepared by Seller Parent. If Buyer disputes any portion of the Allocation Schedule, Buyer shall provide an alternative draft Allocation Schedule together with
reasons for the deviations from the draft Allocation Schedule prepared by Seller Parent. The Parties shall attempt to resolve any disagreement in good faith. If Seller Parent and Buyer fail to reach agreement as to an alternative allocation in the
ten (10) days following such notice, the dispute with respect to the Allocation Schedule shall be presented on the next Business Day to the Independent Accountant. The Independent Accountants review shall be final and binding on all
parties. Buyer and Seller Parent, in respect of Sellers, shall each bear the respective fees and costs incurred by the Parties in connection with the matters set forth in this
Section
2.11(b)
, except that the fees and
disbursements of the Independent Accountant shall be paid by Buyer or Seller Parent in proportion to those matters submitted to the Independent Accountant that are resolved against Buyer or Seller Parent, as applicable, as such fees and
disbursements are allocated by the Independent Accountant pursuant to the foregoing.
(c) Buyer and Seller Parent each shall report all
Taxes and file all Tax Returns (including amended Tax Returns and claims for refund) consistent with the Allocation Schedule and shall take no position inconsistent therewith (including in any audits or examinations by any Taxing Authority), unless,
and then only to the extent, required by a Final Determination. Buyer and Seller Parent shall exchange completed and executed forms required by applicable Law with respect to the allocation (including IRS Form 8594) at least thirty (30) days
prior to the due date for filing such forms and shall cooperate in the filing of any such forms, including any amendments to such forms required as a result of any adjustment to the Purchase Price pursuant to this Agreement.
(d) With respect to any payments made hereunder after the Allocation Schedule shall have become final (including, without limitation, payments
of the Deferred Payments and any Royalty Payment), Buyer and Seller Parent shall cooperate to prepare additional schedules setting forth adjustments to the Allocation Schedule. The same procedures and obligations that are imposed hereunder with
respect to the Allocation Schedule shall apply to such additional schedules.
2.12.
Withholding
.
Buyer and any other applicable withholding agent shall be entitled to deduct and withhold from any amounts payable pursuant to or as contemplated by this Agreement any withholding Taxes or other amounts required under the Code or any applicable Law
to be deducted or withheld. To the extent that any such amounts are so deducted or withheld, such amounts shall be treated for all purposes of this Agreement as having been paid to the Person in respect of which such deduction and withholding was
made.
ARTICLE III.
CLOSING
3.1.
Closin
g
. The closing of the Transactions (the
Closing
) shall take place
in accordance with and pursuant to the terms and conditions of this Agreement at the offices of Cadwalader, Wickersham & Taft LLP, 200 Liberty Street, New York, New York 10281, or remotely via electronic exchange of documents and
signatures, no later than three (3) Business Days following the satisfaction or waiver of all of the conditions set forth in
ARTICLE X
(other than those conditions to be satisfied by the delivery of documents or the taking of
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actions at the Closing itself, but subject to such conditions being satisfied or duly waived at the Closing) or at such other time, date or place as Seller Parent and Buyer may mutually agree in
writing (the
Closing Date
).
3.2.
Transactions at Closing
. At the Closing,
subject to the terms and conditions hereof:
(a)
Sellers
Actions and Deliveries
. In accordance with and pursuant
to the terms and conditions of this Agreement, at the Closing, Seller Parent shall:
(i) deliver to Buyer share
certificates representing the Transferred Shares, free and clear of all Liens, other than the Permitted Liens described in clauses (h) and (i) of the definition thereof, which certificates shall be accompanied by duly executed stock powers;
(ii) execute and deliver, or cause to be executed and delivered, to Buyer (or to such Affiliates of Buyer as instructed in
writing by Buyer prior to the Closing Date) the Ancillary Agreements that call for a Sellers signature;
(iii)
deliver to Buyer a properly executed affidavit prepared in accordance with Treasury Regulations
Section 1.1445-2(b)
certifying each applicable domestic Sellers
non-foreign
status for U.S. federal income Tax purposes;
(iv) execute and deliver
to Buyer a cross-receipt for the Closing Payment; and
(v) execute and deliver, or cause to be executed and delivered, to
Buyer such other documents as Buyer may reasonably request and that Seller Parent agrees are reasonably necessary to consummate the Transactions.
(b)
Buyer
s Actions and Deliveries
. In consideration for the transfer of the Acquired Assets, and in accordance with
and pursuant to the terms and conditions of this Agreement, at the Closing, Buyer shall:
(i) pay, or cause to be paid, the
Closing Payment to Seller Parent by wire transfer of immediately available funds or delivery of book-entry shares, as applicable, in accordance with written instructions provided by Seller Parent at least two (2) Business Days in advance of the
Closing Date;
(ii) execute and deliver, or cause to be executed and delivered, to Seller Parent (and/or to such Affiliates
of Seller Parent as instructed by Seller Parent in writing to Buyer prior to the Closing Date) the Ancillary Agreements that call for Buyers signature;
(iii) pay, or cause to be paid, the Final Ticking Fee to Seller Parent by wire transfer of immediately available funds in
accordance with written instructions provided by Seller Parent at least two (2) Business Days in advance of the Closing Date;
(iv) execute and deliver to Seller Parent a cross-receipt for the Acquired Assets; and
(v) execute and deliver, or cause to be executed and delivered, to Seller Parent such other documents as Seller Parent may
reasonably request and that Buyer agrees are reasonably necessary to consummate the Transactions.
3.3.
Post-Closing Adjustment
.
(a) Within ninety (90) days after the Closing Date, Buyer shall prepare and deliver to Seller Parent
a statement (the
Closing Statement
) setting forth in reasonable detail Buyers calculation of the Closing Date Working Capital and its resulting calculation of the Closing Adjustment Amount. The Closing Statement shall be
prepared in the format of the Form of Closing Statement using the Accounting Principles.
(b) If Seller Parent disputes the Closing
Statement prepared by Buyer, Seller Parent shall deliver to Buyer within sixty (60) days after receipt of the Closing Statement a notice setting forth Seller Parents calculation of the Closing Date Working Capital and its resulting
calculation of the Closing Adjustment Amount
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(which shall be calculated in accordance with
Section
3.3(a)
) and describing in detail the basis for the determination of such different amount (such notice, the
Dispute Notice
, and each item in dispute, a
Disputed Item
). Buyer and Seller Parent shall use reasonable efforts to resolve the Disputed Items for a period of thirty (30) days after Seller Parent has given
the Dispute Notice.
(c) If Buyer and Seller Parent have not resolved all of the Disputed Items (any such unresolved items, the
Unresolved Items
) within thirty (30) days after Seller Parent has given the Dispute Notice, then, within fifteen (15) days after the expiration of such period, Buyer and Seller Parent shall submit the Unresolved Items to
a jointly appointed independent and impartial certified public accountant who is a partner at a neutral nationally recognized accounting firm in the United States that is not the auditor or independent accounting firm of, and is otherwise
independent of, the Parties and any of their respective Affiliates (the
Transaction Arbitrator
) for final and binding arbitration. If the Parties are unable to timely appoint a Transaction Arbitrator within fifteen (15) days
of the expiration of the thirty (30) day resolution period described above, either Buyer or Seller Parent may request that the American Arbitration Association appoint the Transaction Arbitrator. Buyer and Seller Parent shall each bear the
respective fees and costs incurred by it and its respective Affiliates in connection with the matters set forth in this
Section
3.3(c)
, except that the fees and disbursements of the Transaction Arbitrator shall be paid by
Buyer or Seller Parent in proportion to those matters submitted to the Transaction Arbitrator that are resolved against Buyer or Seller Parent, as applicable, as such fees and disbursements are allocated by the Transaction Arbitrator pursuant to the
foregoing.
(d) The Transaction Arbitrator shall review and determine the Unresolved Items, and only the Unresolved Items, in a manner
consistent with this
Section
3.3(d)
and the Accounting Principles. The review and determination shall be based solely on the grounds presented by Buyer and Seller Parent. In no event shall the Transaction Arbitrators
determination of an Unresolved Item be for an amount outside the ranges proposed by Buyer and Seller Parent in the Closing Statement and the Dispute Notice, respectively.
(e) Within ten (10) days after the appointment of the Transaction Arbitrator, Buyer and Seller Parent shall provide to the Transaction
Arbitrator a copy of the Closing Statement and Dispute Notice, and shall each provide to the Transaction Arbitrator, with a copy to the other Party, a written report that states for each Unresolved Item the dollar amount in dispute, a narrative
description of how the dollar amount was calculated or derived by such Party, if applicable, and an explanation of the rationale for such Partys position;
provided
that each such report shall be consistent with the Closing Statement (in
the case of Buyer) and the Dispute Notice (in the case of Seller Parent). Buyer and Seller Parent shall reasonably cooperate with the Transaction Arbitrator and shall provide to the Transaction Arbitrator and to each other, upon the request of the
Transaction Arbitrator and in each case to the extent required to complete its review of the Unresolved Items, any
non-privileged
information and documentation, including any accountants work papers or
internal accounting records, and make reasonably available to the Transaction Arbitrator employees of Buyer, on the one hand, and Seller Parent, on the other hand, in each case that have been involved in the preparation or review of the Closing
Statement and Dispute Notice;
provided
,
however
, that the
independent accountants of Seller Parent or Buyer shall not be obligated to make any working papers available to the Transaction Arbitrator unless and until the
Transaction Arbitrator has signed a customary confidentiality and hold harmless agreement relating to such access to working papers in form and substance reasonably acceptable to such independent accountants. Neither Buyer, on the one hand, nor
Seller Parent, on the other hand, shall disclose to the Transaction Arbitrator, and the Transaction Arbitrator shall not consider for any purpose, any settlement discussions or settlement offer made by Buyer, on the one hand, or Seller Parent, on
the other hand, with respect to any objection under this
Section
3.3
, unless otherwise agreed in writing by Buyer and Seller Parent.
(f) The place of arbitration shall be New York, New York.
(g) Buyer and Seller Parent shall use their reasonable best efforts to cause the Transaction Arbitrator to issue its final written award
regarding the Unresolved Items within thirty (30) days after such items are submitted for review, and otherwise as soon as practicable. The award shall include a reasonably detailed explanation of the
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changes, if any, required to be made to the Closing Statement. The award shall be governed by the Federal Arbitration Act, 9 U.S.C. § 1. The award shall be final and binding
upon the Parties and may be enforced in any court having jurisdiction;
provided
,
however
, that within seven (7) days after transmittal by the Transaction Arbitrator of the award, either Party may request in writing with a copy to
the other Party, that the Transaction Arbitrator correct any clerical, typographical or computational errors in the award. The other Party shall have seven (7) days to respond and the Transaction Arbitrator shall dispose of the request within
five (5) days after such seven (7) day period, after which the Closing Statement shall be revised.
(h) Each Party shall provide
promptly to the other Party all
non-privileged
information and reasonable access to employees as such other Party shall reasonably request to the extent required to complete its review of the Closing Statement
or the Dispute Notice, as the case may be, including all work papers of the accountants who audited, compiled or reviewed such statements or notices, and shall otherwise cooperate in good faith with such other Party to arrive at a final
determination of the Closing Statement;
provided
,
however
, that the independent accountants of the
non-requesting
Party shall not be obligated to make any working papers available to the
requesting Party unless and until such requesting Party has signed a customary confidentiality and hold harmless agreement relating to such access to working papers in form and substance reasonably acceptable to such independent accountants.
(i) The Parties agree that the procedures set forth in this
Section
3.3
for resolving disputes with respect to the
Closing Statement shall be the sole and exclusive method for resolving any such disputes,
provided
that this provision shall not prohibit any Party from instituting litigation to enforce the ruling of the Transaction Arbitrator.
(j) If Buyer and Seller Parent resolve the Disputed Items during the thirty (30) day period referred to in
Section
3.3(b)
, the Closing Adjustment Amount agreed to by the Parties shall be deemed to be the
Final Closing Adjustment Amount
and the Closing Statement agreed to by the Parties shall be deemed to be
the
Final Closing Statement
. If Buyer and Seller Parent do not so resolve the Disputed Items and the Unresolved Items are submitted to the Transaction Arbitrator, the Closing Adjustment Amount determined by the Transaction
Arbitrator pursuant to the terms of this
Section
3.3
shall be deemed to be the
Final Closing Adjustment Amount
and the Closing Statement so determined by the Transaction Arbitrator shall be deemed to be
the
Final Closing Statement
. If Seller Parent does not timely deliver a Dispute Notice to Buyer, then the Closing Adjustment Amount proposed by Buyer in its Closing Statement shall be deemed to be the
Final Closing
Adjustment Amount
and shall be conclusive and binding on the Parties, absent fraud or manifest error.
(k) If the Final Closing
Adjustment Amount is less than the Estimated Closing Adjustment Amount, then Seller Parent shall pay to Buyer an amount equal to the difference between the Estimated Closing Adjustment Amount and the Final Closing Adjustment Amount. If the Final
Closing Adjustment Amount is greater than the Estimated Closing Adjustment Amount, then Buyer shall pay to Seller Parent an amount equal to the difference between the Final Closing Adjustment Amount and the Estimated Closing Adjustment Amount. If
the Final Closing Adjustment Amount is equal to the Estimated Closing Adjustment Amount, then no payment shall be due under this
Section
3.3(k)
. Any amounts due pursuant to this
Section
3.3(k)
shall be paid promptly by the relevant party (and in any event within five (5) Business Days) after the final determination thereof in cash in U.S. Dollars by wire transfer of immediately available funds to an account designated by Seller
Parent or Buyer (as applicable) at least two (2) Business Days in advance.
ARTICLE IV.
REPRESENTATIONS AND WARRANTIES OF SELLER PARENT
Except as disclosed in the disclosure letter delivered by Seller Parent to Buyer immediately prior to the execution of this Agreement (the
Seller Disclosure Letter
) (it being agreed that disclosure of any item in any
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section of the Seller Disclosure Letter shall be deemed disclosure with respect to any other section of this Agreement to which the relevance of such item is reasonably apparent on its face),
Seller Parent represents and warrants to Buyer as set forth below.
4.1.
Qualification, Organization,
etc.
(a)
Sellers
. Each Seller is (i) a legal entity duly organized, validly existing and in good standing under the Laws
of its respective jurisdiction of organization and has all requisite corporate or similar power and authority to own, lease and operate its properties and assets (including the Acquired Assets) and to carry on its business (including the Business)
as presently conducted and (ii) qualified to do business and is in good standing as a foreign corporation or other entity in each jurisdiction where the ownership, leasing or operation of its assets or properties or conduct of its business
requires such qualification, except, solely in the case of the foregoing clause (ii), where the failure to be so qualified or in good standing has not had and would not reasonably be expected to have, individually or in the aggregate, a Material
Adverse Effect.
(b)
Transferred Group
. Each of the entities comprising the Transferred Group is (i) a legal entity duly
organized, validly existing and in good standing under the Laws of its respective jurisdiction of organization and has all requisite corporate or similar power and authority to own, lease and operate its properties and assets (including the
Transferred Group Assets) and to carry on its business as presently conducted and (ii) qualified to do business and is in good standing as a foreign corporation or other entity in each jurisdiction where the ownership, leasing or operation of
its assets or properties or conduct of its business requires such qualification, except, solely in the case of the foregoing clause (ii), where the failure to be so qualified or in good standing has not had and would not reasonably be expected to
have, individually or in the aggregate, a Material Adverse Effect. True and complete copies of the Organizational Documents of each member of the Transferred Group have been provided to Buyer or its Representatives prior to the date hereof, the same
are in full force and effect and each such member of the Transferred Group is not in violation of its Organizational Documents.
4.2.
Capitalization of the Transferred Group
. (a) The Transferred Shares are duly authorized, validly issued, fully paid and nonassessable and owned by Seller Parent, free and clear of all Liens other than the Permitted Liens
described in clauses (h) and (i) of the definition thereof. All of the equity interests of each other entity comprising the Transferred Group are duly authorized, validly issued, fully paid and
non-assessable
and wholly owned by a Transferred Entity or another member of the Transferred Group, free and clear of all Liens other than the Permitted Liens described in clauses (h) and (i) of the
definition thereof.
(b) The capitalization, including the number of authorized and outstanding shares and the holder thereof, of each of
the Transferred Entities and each of their respective Subsidiaries and their respective jurisdictions of organization is set forth in Section 4.2(b) of the Seller Disclosure Letter. Except for the Transferred Shares and any interest held by a
Transferred Entity or a wholly owned Subsidiary thereof, there are no shares of common stock, preferred stock or other equity interests of any member of the Transferred Group issued and outstanding. With respect to the Transferred Shares and the
equity interests of each other entity comprising the Transferred Group, there are no preemptive or other outstanding rights, subscriptions, rights of first refusal, options, warrants, stock appreciation rights, redemption rights, repurchase rights,
restrictions on transfer other than under applicable securities laws, convertible, exercisable, or exchangeable securities or other ownership interest in any member of the Transferred Group or any other securities or obligations convertible or
exchangeable into or exercisable for, or giving any Person a right to subscribe for or acquire, any securities of any member of the Transferred Group, and no securities evidencing such rights are authorized, issued or outstanding. None of the
Transferred Entities or any of their Subsidiaries has any outstanding bonds, debentures, notes or other obligations that provide the holders thereof the right to vote (or are convertible or exchangeable into or exercisable for securities having the
right to vote) with the stockholders of such Person on any matter. There are no outstanding or authorized appreciation, phantom, profit participation or similar rights with respect to any member of the Transferred Group.
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(c) Except for other members of the Transferred Group as set forth in Section 4.2(b) of
the Seller Disclosure Letter, no member of the Transferred Group (i) owns, directly or indirectly, any equity interest in any Person or (ii) is a party to any joint venture, partnership or similar relationship, or
buy-sell
agreement, stockholders agreement or similar Contract. There is no Contract to which Seller Parent or any of its Subsidiaries is a party or by which any member of the Transferred Group is otherwise
bound requiring any member of the Transferred Group to make any investment (in the form of a loan, capital contribution or otherwise) in any Person.
4.3.
Authority; Binding Effect
. (a) Seller Parent has all requisite corporate power and authority
to execute and deliver this Agreement and each Ancillary Agreement to which it is or will be a party, to perform its obligations hereunder and thereunder and to consummate the applicable Transactions. The execution and delivery by Seller Parent of
this Agreement and each such Ancillary Agreement, the performance by Seller Parent of its obligations hereunder and thereunder and the consummation by Seller Parent of the Transactions, have been duly authorized by all requisite corporate action,
and no other proceedings on the part of Seller Parent or any equityholder (direct or indirect) or director thereof are necessary to authorize such execution, delivery, performance and consummation.
(b) Each other Seller has all requisite corporate power and authority to execute and deliver each Ancillary Agreement to which it is or will
be a party, to perform its obligations thereunder and to consummate the applicable Transactions. The execution and delivery by each other Seller of each Ancillary Agreement to which it is or will be a party, the performance by such Seller of its
obligations hereunder and thereunder and the consummation by such Seller of the applicable Transactions, have been, or will have been at the Closing, duly authorized by all requisite corporate or similar action on behalf of such Seller, and no other
proceedings on the part of such Seller or any equityholder (direct or indirect) or director thereof are necessary to authorize such execution, delivery, performance and consummation.
(c) This Agreement has been duly executed and delivered by Seller Parent and constitutes a valid and binding obligation of Seller Parent, and
each Ancillary Agreement will be, prior to the Closing, duly executed and delivered by each Seller that is or will be a party thereto and will, at and after the Closing, constitute a valid and binding obligation of each such Seller, in each case
enforceable against Seller Parent or the applicable other Seller in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting
creditors rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in equity or law).
4.4.
No Conflicts; Consent
s
. The execution, delivery and performance of this Agreement and the
Ancillary Agreements by Seller Parent and the other Sellers and the consummation of the Transactions by Sellers do not and will not: (a) violate any provision of Seller Parents Organizational Documents or the Organizational Documents of
any of the other Sellers or any member of the Transferred Group; (b) subject to making or obtaining the Consents referred to in Section 4.4 of the Seller Disclosure Letter, (i) conflict with, or result in the breach or violation of,
constitute a default under, result in the termination, cancellation or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation of Sellers or any member of the Transferred Group under, or to a loss of
any benefit of the Business to which any Seller or any member of the Transferred Group is entitled under, in each case any Material Contract, or (ii) create or impose any Lien, other than a Permitted Lien, upon any of the Acquired Assets or
Transferred Group Assets; or (c) subject to making or obtaining the Consents referred to in
Section
4.15
, violate or result in a breach of or constitute a default under any Law to which any Seller or any member of the
Transferred Group is subject, except, with respect to clauses (b) and (c), for violations, breaches, conflicts, defaults, terminations, cancellations or accelerations as has not had and would not reasonably be expected to have, individually or
in the aggregate, a Material Adverse Effect.
4.5.
Financial Information; Absence of Undisclosed
Liabilities; Indebtedness
. (a) Seller Parent has delivered to Buyer the following financial statements: (i) audited balance sheets and the related statements of operations, comprehensive loss, equity and cash flows of the Business, as
of and for the fiscal years ended December 31,
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2016 and 2015, accompanied by an opinion of Ernst & Young LLP, together with the notes thereto (the
Audited Financial Statements
), and (ii) the unaudited combined
balance sheet, and the related unaudited combined statement of operations, comprehensive loss, equity and cash flows of the Business, as of and for the nine-month period ended September 30, 2017 (the
Interim Financial
Statements
and, together with the Audited Financial Statements, the
Financial Statements
). The Financial Statements have been prepared in accordance with GAAP applied on a consistent basis throughout the periods involved
(except as indicated therein or in the notes thereto), present fairly, in all material respects, the financial condition of the Business as of the dates and the results of operations and changes in comprehensive loss, equity and cash flows of the
Business for the periods stated therein (subject in the case of the Interim Financial Statements to
year-end
audit adjustments normal in nature and amount).
(b) Neither Seller Parent nor any of its Subsidiaries has, with respect to the Business or the Acquired Assets, any Liabilities that would be
required in accordance with GAAP to be disclosed on the balance sheet of the Business, except for (a) Liabilities disclosed on the face of the balance sheet included in the Audited Financial Statements for the fiscal year ended
December 31, 2016, (b) Liabilities incurred in the Ordinary Course of Business since December 31, 2016, (c) Liabilities constituting future performance obligations under the Business Contracts, (d) Excluded Liabilities, and
(e) other Liabilities that are not, or would not reasonably be expected to be, individually or in the aggregate, material to the Business, the Acquired Assets, the Transferred Group or the Transferred Group Assets. Neither Seller Parent nor any
of its Subsidiaries has, with respect to the Business, any
off-balance
sheet arrangements (as such term is defined in Item 303(a)(4) of Regulation
S-K
promulgated under the Exchange Act).
(c) Except as set forth on
Section
4.5(c)
of the Seller Disclosure Letter
and other than intercompany obligations which will be settled or terminated prior to Closing, neither Seller Parent nor any of its Subsidiaries has any Liability for Indebtedness with respect to the Business (except to the extent an Excluded
Liability), and no member of the Transferred Group has any Liability for Indebtedness (including, for purposes of this
Section
4.5(c)
, pursuant to any intercompany obligations between any member of the Transferred Group, on
the one hand, and any Seller or other Subsidiary of any Seller, on the other hand, or pursuant to any guarantees directly or indirectly provided by any member of the Transferred Group of any Indebtedness of any Seller or other Subsidiary of any
Seller, in each case that will remain outstanding after the Closing). For each such item of Indebtedness,
Section
4.5(c)
of the Seller Disclosure Letter correctly sets forth the debtor, the guarantor, the Contract governing
the Indebtedness, the principal amount of the Indebtedness as of the date of this Agreement, the creditor, the maturity date, and the collateral, if any, securing the Indebtedness.
4.6.
Title to Assets
. A Seller has good and valid title to, a valid leasehold interest in or a valid
license to use all of the material tangible personal property included in the Transferred Assets, free and clear of all Liens other than Permitted Liens. A member of the Transferred Group has good and valid title to, a valid leasehold interest in or
a valid license to use all of the material tangible personal property included in Transferred Group Assets, free and clear of all Liens other than Permitted Liens.
4.7.
Environmental Matters and Regulation
s
. Except for such matters as would not reasonably be
expected to have, individually or in the aggregate, a Material Adverse Effect: (a) Sellers and their respective Subsidiaries, in respect of the Business, the Transferred Group, the Transferred Group Assets and the Transferred Assets, are now
and have been during the past three (3) years in compliance with all, and have not violated any, applicable Environmental Laws; (b) Sellers and the Transferred Group have all of the Environmental Permits necessary for the conduct and
operation of the Business as now being conducted, and all such Environmental Permits are in good standing; (c) during the past three (3) years, neither Seller Parent nor any of its Subsidiaries has received any written notice, demand
letter, claim, Proceeding or request for information alleging that Seller Parent or any of its Subsidiaries, in respect of the Business, the Transferred Assets or the Transferred Group Assets, may be in violation of or subject to Liability under any
Environmental Law; (d) to Seller Parents Knowledge no property currently or formerly owned or operated in connection with the Business or by any of the Transferred Group has been contaminated with any Hazardous Substance that would
reasonably be expected to require material
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remediation or result in material liability relating to any Environmental Law; and (e) Seller Parent and its Subsidiaries, with respect to the Business, the Transferred Assets and the
Transferred Group Assets, are not subject to any order, decree, injunction or agreement or to Seller Parents Knowledge any investigation, involving any Governmental Authority imposing Liability or obligations relating to any Environmental Law
or any Hazardous Materials.
4.8.
Employee Benefits
. (a) Section 4.8(a) of the Seller
Disclosure Letter sets forth a true and complete list of each Business Benefit Plan and each material Seller Benefit Plan. For purposes of this Agreement,
Business Benefit Plan
means each Benefit Plan that is maintained or
sponsored by a member of the Transferred Group. For purposes of this Agreement,
Seller Benefit Plan
means a Benefit Plan, other than a Business Benefit Plan that a Seller or any Subsidiary of a Seller (other than the Transferred
Group) is a party to or sponsors, maintains or contributes to, or is required to contribute to, or has any Liability for and that benefits any Business Employee. Seller Parent has made available to Buyer true and complete copies (or form thereof) of
each Business Benefit Plan and each material Seller Benefit Plan and, with respect to each Business Benefit Plan, if applicable, (i) the most recent summary plan description and plan document and all amendments or modifications thereto,
(ii) the Form 5500 filed in the most recent plan year, (iii) the most recent determination or opinion letter from the Internal Revenue Service, (iv) the most recent trust agreements or other funding arrangements, (v) the most
recently prepared actuarial reports and financial statements, (vi) current administrative and other service contracts and amendments thereto with third-party services providers, and (vii) any
non-routine
notices, letters or other correspondence received from any Governmental Authority in the past three (3) years.
(b) Each Business Benefit Plan and Seller Benefit Plan is, and during the past three (3) years has been, established, funded, operated
and administered in all material respects in compliance with its terms and all applicable Laws, and there are no pending or, to Seller Parents Knowledge, threatened claims (other than routine claims for benefits) or Proceedings by a
Governmental Authority by, on behalf of, against, or related to any Business Benefit Plan or Seller Benefit Plan or any trust related thereto. To Seller Parents Knowledge, no party to any Business Benefit Plan or Seller Benefit Plan that is a
Business Employee or other service provider to the Business has materially breached or defaulted thereunder.
(c) Each Business Benefit
Plan and Seller Benefit Plan that is intended to be qualified under Section 401(a) of the Code has received a determination from the IRS, or is able to rely on a favorable determination or opinion letter from the IRS, that such Business Benefit
Plan or Seller Benefit Plan, as applicable, is qualified under Section 401(a) of the Code and, to Seller Parents Knowledge, nothing has occurred that would adversely affect the qualification or tax exemption of any such Business Benefit
Plan or Seller Benefit Plan.
(d) None of Sellers nor any ERISA Affiliate of Sellers, nor any member of the Transferred Group (nor any
predecessor of any such entity) sponsors, maintains, administers or contributes to (or has any obligation to contribute to), or has in the past six years sponsored, maintained, administered or contributed to (or had any obligation to contribute to),
or has or is reasonably expected to have any Liability with respect to, (i) any plan subject to Section 412 of the Code or Title IV of ERISA, including any multiemployer plan (as defined in Section 3(37) of ERISA) or any
other defined benefit pension plan, (ii) any multiple employer plan as defined in ERISA or the Code, or (iii) any multiple employer welfare arrangement as defined in Section 3(40) of the ERISA. For purposes of
this Agreement,
ERISA Affiliate
means all Persons (whether or not incorporated) that would, at the relevant time, be treated together with any other Person as a single employer within the meaning of Section 414 of
the Code.
(e) None of Sellers nor their Subsidiaries has any current or projected liability for, and no Business Benefit Plan nor Seller
Benefit Plan provides or promises, any post-employment or post-retirement medical, dental, disability, hospitalization, life or similar benefits to any Business Employee or former employee of the Business, except coverage mandated by applicable Law
for which the Business Employee pays the full cost of coverage.
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(f) Neither the execution of this Agreement nor the consummation of the Transactions (either
alone or together with any other event) will (i) accelerate the time of payment or vesting or increase the amount of compensation or benefits due to any Business Employee, (ii) entitle any Business Employee, or any current or former
officer, consultant, or employee of the Transferred Group to any payment or benefit, (iii) trigger any payment or funding (through a grantor trust or otherwise) of compensation or benefits under, or trigger any other obligation under, any
Business Benefit Plan, (iv) limit or restrict the right of Sellers or, after the Closing, Buyer, to merge, amend or terminate any Business Benefit Plan, or (v) result in any breach or violation of, or default under, any Business Benefit
Plan.
(g) All contributions (including all employer contributions and employee salary reduction contributions) that are due have been
made within the time periods prescribed by ERISA and the Code to each Business Benefit Plan that is an employee pension benefit plan (within the meaning of Section 3(2) of ERISA) and all contributions for any period ending on or
before the Closing Date that are not yet due have been made to each Business Benefit Plan or accrued in accordance with the requirements of GAAP, consistently applied (or, to the extent GAAP does not apply, in accordance with past practice). All
premiums or other payment for all periods ending on or before the Closing Date have been paid with respect to each Business Benefit Plan that is an employee welfare benefit plan (within the meaning of Section 3(1) of ERISA).
(h) None of Seller Parent nor its Subsidiaries is party to any agreement, contract or arrangement that could result, separately or in the
aggregate, in the payment of any excess parachute payments within the meaning of Section 280G of the Code to any Business Employee or any officer, consultant, or former employee of the Transferred Group, in respect of the
Transactions, whether alone or in combination with any other event.
4.9.
Labor Matters
.
(a) None of Sellers nor their Subsidiaries is a party to or subject to, or currently negotiating in connection with entering into, any collective bargaining agreement or other agreement with any labor union, other employee representative body
or any other similar organization. No labor union, other employee representative body or similar organization currently represents any Business Employees with respect to their employment with Sellers or the Subsidiaries of Sellers, and to Seller
Parents Knowledge, no labor union, other employee representative body or similar organization, or any Business Employees have taken any action with respect to organizing any Business Employees (including the filing of any petition or
institution of any proceedings with any labor relations board seeking recognition of a bargaining representative or the making of any demand for recognition). None of Sellers nor their Subsidiaries with respect to any Business Employees has
experienced during the past three (3) years, any strikes, work stoppages, slowdowns, picketing, refusal to cross picket lines, grievances, claims of unfair labor practices, lockouts or other collective bargaining or union, employee
representative body, works council disputes, and, to Seller Parents Knowledge, none is pending or threatened.
(b) Each Seller and
its Subsidiaries (i) is, and during the past three (3) years has been, in compliance in all material respects with all applicable Laws regarding employment and employment practices and those Laws relating to terms and conditions of
employment, including without limitation Laws concerning classification of employees and independent contractors, wages and hours, child labor, employment equity, nondiscrimination,
non-harassment
and
non-retaliation
in employment, immigration occupational safety and health and workers compensation, and (ii) has, and during the past three (3) years has had, no charges or complaints relating to
unfair labor practices or unlawful employment practices pending or, to Seller Parents Knowledge, threatened against it before any Governmental Authority, in each case with respect to any Business Employee.
(c) Neither the execution and delivery of this Agreement nor the Transactions will require the consent of, or advance consultation with or
notification to, any works councils, unions, other employee representative bodies or similar labor organizations.
(d) Seller Parent has
provided a complete and accurate Schedule of Business Employees as of the date hereof, and sets forth for each individual listed on such Schedule the following: (i) employee identification
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number and name; (ii) title or position (including whether full or part time); (iii) employing entity; (iv) hire date; (v) work location; (vi) current annual base compensation
rate; (vii) commission, bonus or other incentive-based compensation; (viii) leave status and (ix) visa status (if applicable). To Seller Parents Knowledge, no Business Employee who is an executive or a key employee, and no group
of Business Employees, has given notice of termination of employment or otherwise disclosed plans to terminate employment within the twelve (12) month period following the date hereof.
4.10.
Real Property
. (a) Neither Seller Parent nor any of its Subsidiaries own any real property
used in or relating to the Business. The lease with respect to the Business Leased Real Property is in full force and effect and a Seller has a valid leasehold interest in the Business Leased Real Property, free and clear of all Liens, other
than Permitted Liens and any encumbrances on the landlords fee title which do not and would reasonably be expected to materially adversely affect the Business present use of such property.
(b) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, there are
no condemnation, expropriation or other proceedings in eminent domain pending, threatened (in writing) or affecting the Business Leased Real Property.
4.11.
Absence of Certain Changes or Events
. (a) From December 31, 2016 through the date of
this Agreement, there has not occurred any Effect that has had, or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(b) From December 31, 2016 through the date of this Agreement, other than with respect to the Transactions and the exploration of
strategic alternatives for the Business, the Business has been conducted in all material respects in the Ordinary Course of Business.
4.12.
Material Contracts
. (a) Except as set forth in Section 4.12(a) of the Seller Disclosure Letter, as of the date of this Agreement, none of the Business Contracts, the other Business Contracts, the Shared Contracts, the
Contingent Payment Contracts or any other Contract to which any member of the Transferred Group is a party:
(i) contains
any
non-compete,
non-solicit
or exclusivity provisions with respect to the Business or, directly or indirectly, any member of the Transferred Group, or upon consummation
of the Transactions, Buyer or its Subsidiaries, in each case, which materially restricts the conduct of the Business or use of the Transferred Assets or Transferred Group Assets;
(ii) relates to a partnership, joint venture or similar arrangement, unless, in each case, immaterial to the Business;
(iii) is a Contract for sale of goods or services that involved the payment of more than $500,000 in the year ended
December 31, 2016 or which Seller Parent reasonably anticipates will involve the payment of more than $500,000 in the year ending December 31, 2017 under such Contract;
(iv) includes an agreement or commitment to purchase a minimum quantity of, or pay a minimum amount for, active
pharmaceutical ingredients or finished drug products, in each case in favor of a party other than the Transferred Group;
(v) is a Contract for (A) the purchase of services, materials, supplies or equipment or (B) any royalty, profit
sharing or contingent payment right or (C) the lease of any tangible personal property (other than in respect of office equipment or equipment used in the research and development of products), which, in each case, involved the payment of more
than $500,000 in the year ended December 31, 2016 or Seller Parent reasonably anticipates will involve the payment of more than $500,000 in the year ending December 31, 2017 and has a remaining term in excess of twelve (12) months,
excluding, in each case such Contracts that are terminable on less than ninety (90) days notice by Seller Parent or its Affiliates without penalty or other material impact;
(vi) is a Contract for capital expenditures or the acquisition or construction of fixed assets which requires aggregate future
payments in excess of $500,000;
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(vii) relates to the manufacture, marketing, sale, licensing or distribution
of any Product pursuant to which Seller Parent and its Subsidiaries have paid or received more than $500,000 in the year ended December 31, 2016 or would reasonably be expected to be paid or receive more than such amount in the year ending
December 31, 2017;
(viii) relates to the conduct of clinical trials of Vabomere, Orbactiv or Minocin IV, including
any such Contract with investigators, contract research organizations, clinical trial sites and clinical trial support services;
(ix) is a Contract in which Seller Parent or any of its Subsidiaries has granted manufacturing, packaging, marketing or
distribution rights relating to any Product;
(x) provides for or evidences Indebtedness for borrowed money or any guaranty
thereof, or imposes or results in the creation of any Lien (other than a Permitted Lien) on any Acquired Asset or Transferred Group Asset;
(xi) is a Contract providing Seller Parent or any of its Subsidiaries the right to use or otherwise exploit any Intellectual
Property rights that are material to the conduct of the Business (as currently conducted or currently planned to be conducted), other than any Contract with respect to
non-exclusive
licenses for
off-the-shelf
software;
(xii) is a Contract
providing any Person with any right or license under any material Transferred Intellectual Property or material Intellectual Property held by any member of the Transferred Group, except for
non-exclusive
rights or licenses granted in the Ordinary Course of Business on terms and conditions that are substantially similar to the terms and conditions that are provided to Buyer prior to the date hereof; or
(xiii) is a Contract providing for any royalty, milestone, contingent or deferred payments or obligations of any kind with
respect to any Products by Seller Parent or any of its Subsidiaries.
(b) Each Contract of the type described above in
Section
4.12(a)
is referred to herein as a
Material Contract
. Except as set forth in the applicable subsection of
Section
4.12(b)
:
(i) each Material Contract is in full force and effect and is valid and binding on the applicable Seller or member of the
Transferred Group, to the extent it is a party thereto, and, to Seller Parents Knowledge, each other party thereto, as applicable;
(ii) no Seller or member of the Transferred Group is in, or, to Seller Parents Knowledge, is alleged to be in, material
violation or breach of, or default under, any of the Material Contracts, and to Seller Parents Knowledge, no other party to any of the Material Contracts has materially violated or breached or defaulted thereunder; and
(iii) since January 1, 2016, neither Seller Parent nor any of its Subsidiaries has received any written notice or other
communication regarding any actual or possible material violation or breach of, or default under, any Material Contract.
(c) As of the
date of this Agreement, neither Seller Parent nor any of its Subsidiaries has received notice in writing from any third party that would reasonably cause Seller Parent nor any of its Subsidiaries to believe that any of the customers, suppliers,
distributors, licensors or other business partners of the Business would be reasonably likely to terminate (or refuse to renew) any Material Contract or materially reduce its relationship with the Business, object to the transfer of the rights under
such Material Contract to a purchaser of the Business (including Buyer) (whether through novation, sublicense, assignment or otherwise), or institute a Proceeding against any Seller, member of the Transferred Group or any assignee or sublicensee of
any of the foregoing in connection with the performance of any such Persons obligations under such Material Contract.
(d) Seller
Parent has prior to the date of this Agreement delivered to, or made available to, Buyer or its Representatives, true and complete copies of each Material Contract.
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4.13.
Orders; Litigation
. As of the date hereof,
(a) there are no Orders issued by any Governmental Authority binding on the Business, the Transferred Group, the Transferred Group Assets or the Transferred Assets, and (b) there are no Proceedings pending (or, to Seller Parents
Knowledge, threatened) against Seller Parent or any of its Subsidiaries with respect to the Acquired Assets, the Transferred Group, the Transferred Group Assets or the Business, except, in the case of clauses (a) and (b), as have not had or
would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
4.14.
Compliance with Laws; Permits; Regulatory Matters
. (a) Seller Parent and its Subsidiaries hold and
are operating in compliance in all material respects with all Permits, including the Regulatory Registrations that are necessary for the conduct of the Business as now being conducted by Seller Parent and its Subsidiaries, and such Permits,
including the Regulatory Registrations are valid and in full effect. There are no Proceedings pending or, to Seller Parents Knowledge, threatened which would reasonably be expected to result in the material limitation, material adverse
modification, revocation, cancellation or suspension of any material Permits or Regulatory Registrations.
(b) Seller Parent and its
Subsidiaries are conducting and have, since January 1, 2015, conducted the Business in compliance in all material respects with all Laws applicable to the Business, the Acquired Assets, the Transferred Group or the Transferred Group Assets,
including all Laws applicable to the nonclinical and clinical testing, manufacturing, ownership, operation, storage, import, export, distribution, marketing, pricing, sale, promotion, warehousing, packaging, Labeling, handling advertising, and
distribution of the Products. Since January 1, 2015, Seller Parent and its Subsidiaries have not received any written notice, including any notice of adverse finding, or notice of deficiency, or similar communication from the FDA or any other
Governmental Authority, (i) contesting the Regulatory Registrations for the Labeling and promotion of any of the Products, (ii) alleging that any of the Products or the ownership, manufacturing, operation, storage, import, export,
distribution, marketing, pricing, sale, promotion, warehousing, packaging, Labeling, advertising, promotion, nonclinical testing, handling and/or testing thereof is in violation in any material respect of any applicable Health Care Law, Regulatory
Registration or Permit, or (iii) otherwise alleging any violation in any material respect of any Health Care Law by Seller Parent or any of its Subsidiaries with respect to the Business and/or Products.
(c) All nonclinical and clinical testing, and other studies and tests conducted by or on behalf of Seller Parent and its Subsidiaries with
respect to the Business or Products have been, and if still pending are being, conducted in compliance in all material respects with research protocols and all applicable Laws, including, but not limited to, the FDCA and comparable foreign Laws
relating to the subject matter thereof. No clinical trial conducted by or, to Seller Parents Knowledge, on behalf of Seller Parent and its Subsidiaries, with respect to the Business or Products has been terminated or suspended prior to
completion due to any Proceeding initiated by a Governmental Authority, and neither the FDA nor any other applicable Governmental Authority, clinical investigator that has participated or is participating in, or institutional review board that has
or has had jurisdiction over, a clinical trial conducted by or, to Seller Parents Knowledge, on behalf of Seller Parent or its Subsidiaries, with respect to the Business or Products has commenced, or, to Seller Parents Knowledge,
threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Seller Parent or any of its Subsidiaries
with respect to the Business or Products.
(d) No manufacturing site owned by Seller Parent or its Subsidiaries, or to Seller
Parents Knowledge, any of their respective contract manufacturers for pharmaceutical products, in each case, with respect to the manufacture of Vabomere, Orbactiv or Minocin IV, (i) is subject to a Governmental Authority (including FDA)
shutdown or import or export prohibition, or (ii) has received any FDA Form 483 (or other governmental entity notice of inspectional observations, warning letters, untitled letters or requests or requirements to make
changes with respect to the Business or Products, or any of Seller Parents, any of the Subsidiaries, or any of their respective contract manufacturers processes or procedures related to the Business or Products), or similar
correspondence or notice from the FDA or other Governmental Authority in respect of the Business or Products and alleging or asserting noncompliance in any material respect with any applicable Law, Permit or such requests
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or requirements of a Governmental Authority, in each case that have not been complied with or closed to the satisfaction of the relevant Governmental Authority, and, to Seller Parents
Knowledge, neither the FDA nor any other Governmental Authority is considering such action.
(e) All manufacturing operations conducted by
or, to Seller Parents Knowledge, on behalf of, or for the benefit of, Seller Parent and its Subsidiaries with respect to Vabomere, Orbactiv or Minocin IV have been and are being conducted in compliance with applicable Laws in all material
respects, including the provisions of the FDAs current good manufacturing practice regulations at 21 C.F.R. Parts
210-211
for pharmaceutical products sold in the United States and comparable foreign Laws
relating to the subject matters thereof.
(f) Seller Parent, its Subsidiaries and, to Seller Parents Knowledge, any contract
manufacturer who manufactures Vabomere, Orbactiv or Minocin IV on behalf of Seller Parent or its Subsidiaries have not conducted or issued any recalls, field notifications, market withdrawals or replacements, warnings, dear doctor
letters, investigator notices, safety alerts, serious adverse event reports or other notice of action relating to an alleged lack of safety or regulatory compliance with respect to the Products.
(g) Seller Parent, its Subsidiaries, and, to Seller Parents Knowledge, any contract manufacturer and, to Seller Parents Knowledge,
any of their respective officers, key employees or agents, are not debarred or have been convicted of any crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Law, including,
without limitation, 21 U.S.C. Section 335a. No claims, actions, proceedings or investigations that would reasonably be expected to result in such a material debarment or exclusion are pending or, to Seller Parents Knowledge, its
Subsidiaries, threatened against Seller Parent or any of its Subsidiaries or any of their respective officers, employees or agents. Neither Seller Parent nor any of its Subsidiaries is a party to any corporate integrity agreement, monitoring
agreement, consent decree, settlement order or similar agreement with or imposed by any Governmental Authority.
(h) Seller Parent and its
Subsidiaries have complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health
Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively
HIPAA
) and (ii) any applicable state privacy Laws.
(i) Seller Parent, its Subsidiaries and their respective directors, offices, employees and agents (while acting in such capacity) are, in good
faith believed to be now, and at all relevant times have been, in compliance in all material respects with all health care Laws applicable to the Business, the Acquired Assets, the Transferred Group and the Transferred Group Assets, including the
federal Anti-kickback Statute (42 U.S.C. §
1320a-7b(b)),
the Anti-Inducement Law (42 U.S.C. §
1320a-7a(a)(5)),
the civil False Claims Act (31 U.S.C.
§§ 3729 et. seq.), the administrative False Claims Law (42 U.S.C. §
1320a-7b(a)),
the exclusion Laws (42 U.S.C. §
1320a-7),
the FDCA, the Medicare
Program (Title XVIII of the Social Security Act), the Medicaid Program (Title XIX of the Social Security Act), HIPAA, the
so-called
federal sunshine law or Open Payments (42 U.S.C. §
1320a-7h),
state Laws regulating or requiring reporting of interactions between pharmaceutical manufacturers and members of the healthcare industry, the regulations promulgated pursuant to such Laws and any other
similar Law, including the collection and reporting requirements and the processing of any applicable rebate, chargeback or adjustment, under applicable rules and regulations relating to the Medicaid Drug Rebate Program (42
U.S.C. § 1396r-8)
and any state supplemental rebate program, Medicare average sales price reporting (42 U.S.C. §
1395w-3a),
the Public Health Service Act
(42 U.S.C. § 256b), the VA Federal Supply Schedule (38 U.S.C. § 8126) or under any state pharmaceutical assistance program or U.S. Department of Veterans Affairs agreement, and any successor government programs (collectively,
Health Care Laws
).
(j) All material documents, reports and notices, including Permits and Regulatory Registrations,
required to be filed with any Governmental Authority by Seller Parent and its Subsidiaries with respect to the Business or any Product have been so filed on a timely basis, and were complete and accurate in all material
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respects as of the date of filing, or were subsequently updated, changed, corrected, or modified. To Seller Parents Knowledge, no such filing with any Governmental Authority contains any
materially false, misleading or otherwise inaccurate statements or information, whether express or due to omission of material information, as of the date of filing.
(k) Notwithstanding anything contained in this
Section
4.14
, no representation or warranty shall be deemed to be
made in this
Section
4.14
in respect of any environmental, employee benefits, labor law, Tax or Intellectual Property matters, which are covered solely by
Sections 4.7
,
Section
4.8,
Section
4.9
,
Section
4.16
and
Section
4.17
, respectively.
4.15.
Consents and Governmental Approval
s
. Assuming the accuracy of
the representations and warranties made by Buyer in
ARTICLE V
, and except for (a) (i) any HSR Filing with the FTC or the Antitrust Division and the expiration or early termination of the waiting period with respect thereto and
(ii) any filing under any other foreign antitrust, competition or similar Laws (
Foreign Antitrust Laws
) and the expiration or early termination of any waiting period with respect thereto or the receipt of any Consents
thereunder, in each case to the extent required, or (b) as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, no Consent to, with or from any Governmental Authority or any other Governmental
Approval is required for Sellers to execute and deliver this Agreement or any Ancillary Agreement or to consummate the Transactions.
4.16.
Tax Matter
s
. Except as would not reasonably be expected to be, individually or in the aggregate, material to the Business, the Acquired Assets, the Transferred Group or the Transferred Group Assets:
(a) all Tax Returns that are required to be filed by or with respect to the Acquired Assets, any member of the Transferred Group and the
Business have been timely filed (taking into account any extension of time within which to file), and all such Tax Returns are true, complete and accurate;
(b) all Taxes due and owing with respect to the Acquired Assets, any member of the Transferred Group and the Business (whether or not shown on
any Tax Return) have been paid, other than Taxes that are being contested in good faith by appropriate proceedings and for which adequate reserves have been established in accordance with GAAP on the financial statements of Sellers or their
respective Affiliates;
(c) no Tax Proceedings are pending, in progress or have been threatened in writing with respect to any Taxes
relating to the Acquired Assets, any member of the Transferred Group or the Business;
(d) there are no Liens for Taxes upon any of the
Acquired Assets or any of the Transferred Group Assets, except for Permitted Liens;
(e) no claim has ever been made by an authority in a
jurisdiction where Seller Parent or its Subsidiaries do not file Tax Returns that a member of the Transferred Group or the Acquired Assets, as applicable, are or may be subject to taxation by that jurisdiction, and, to Seller Parents
Knowledge, there is no basis for any such claim to be made;
(f) all Taxes required to be deducted, withheld or paid by any member of the
Transferred Group, or with respect to the Acquired Assets or the Business, in connection with amounts paid or owing to any employee, independent contractor, creditor, stockholder or other third party, have been deducted, withheld and timely paid to
the appropriate Taxing Authority;
(g) neither Seller Parent or its Subsidiaries (in each case to the extent related to the Acquired
Assets or the Business) nor any member of the Transferred Group has waived any statute of limitations in respect of Taxes or agreed to any extension of time with respect to a Tax assessment or deficiency;
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(h) neither Seller Parent or its Subsidiaries (in each case to the extent related to the
Acquired Assets or the Business) nor any member of the Transferred Group has executed any power of attorney with respect to any Tax with respect to which the relevant statute of limitations has not yet closed, other than powers of attorney that are
no longer in force or powers of attorney executed with respect to any Tax for which there has been a Final Determination;
(i) no closing
agreements, private letter rulings, Tax holidays, technical advice memoranda or similar agreements or rulings related to Taxes have been entered into, issued by or requested from any Taxing Authority with or in respect of the Acquired Assets, the
Business or any member of Transferred Group;
(j) the unpaid Taxes of Seller Parent and its Subsidiaries with respect to the Acquired
Assets and the Business, and the unpaid Taxes of the member of the Transferred Group, (i) as of the date of the Audited Financial Statements did not exceed the reserve for Taxes (excluding any reserve for deferred Taxes established to reflect
timing differences between book and Tax income and any reserve for Taxes to be incurred as a result of the consummation of the Transactions) set forth on the face thereof (rather than in any notes thereto) and (ii) will not, as of the close of
the Closing Date, exceed that reserve as adjusted for the passage of time through the Closing Date in accordance with the past custom and practice of Sellers in filing their Tax Returns;
provided
,
however
, that this representation
shall not take into account any Taxes that will be incurred in connection with the Transactions;
(k) neither Seller Parent or its
Subsidiaries (in each case to the extent related to the Acquired Assets or the Business) nor any member of Transferred Group has participated in any reportable transaction within the meaning of Treasury regulations
Section 1.6011-4
or any tax shelter within the meaning of Code Section 6662;
(l)
(i) no member of the Transferred Group has ever been a member of an affiliated group within the meaning of Code Section 1504(a) filing a consolidated federal income Tax Return (other than the affiliated group as defined
in Code Section 1504(a) the common parent of which is Seller Parent), and (ii) neither Seller Parent or its Subsidiaries (in each case to the extent related to the Acquired Assets or the Business) nor any member of the Transferred Group
(A) is a party to any contractual obligation relating to Tax sharing or Tax allocation, or (B) has any liability for the Taxes of any person under Treasury regulations
Section 1.1502-6
or
1.1502-78
(or any similar provision of state, local or foreign law), as a transferee or successor, by contract or otherwise;
(m) (i) neither Seller Parent or its Subsidiaries (in each case to the extent related to the Acquired Assets or the Business) nor any member
of the Transferred Group is required to make any adjustment pursuant to Code Section 481(a) or any similar provision of state, local or foreign Tax law by reason of any change in any accounting methods, and will not be required to make such an
adjustment as a result of the transactions contemplated by this Agreement, and there is no application pending with any Taxing Authority requesting permission for any changes in any of accounting methods of Sellers or any member of the Transferred
Group for Tax purposes, and (ii) to Seller Parents Knowledge, no Taxing Authority has proposed any such adjustment or change in accounting method;
(n) no member of the Transferred Group will be required, as a result of (i) any installment sale or open transaction disposition made on
or prior to the Closing Date, (ii) any election under Section 108(i) of the Code (or any similar provision of state, local or
non-U.S.
Tax Law) or (iii) the application of Treasury Regulations
Section 1.1502-13
(or any similar provision of state, local or
non-U.S.
Tax Law) to include any item of income in or exclude any item of deduction from taxable income for
any Tax period ending after the Closing Date;
(o) no Transferred Entity has been a United States real property holding corporation within
the meaning of Code Section 897(c)(2) during the period specified in Code Section 897(c)(1)(A)(ii); and
(p) since
January 1, 2015, no member of the Transferred Group has constituted a distributing corporation or a controlled corporation (in each case, within the meaning of Section 355(a)(1)(A) of the Code)
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in a distribution of stock intended to qualify for
tax-free
treatment under Section 355 of the Code (or any similar provision of state, local, or
non-U.S.
Law).
4.17.
Intellectual Property
. (a) The
Transferred Intellectual Property, together with all other Intellectual Property owned by or licensed to the Transferred Group, (collectively, the
Business Intellectual Property
), include all Intellectual Property that are owned
by or licensed to Seller Parent and its Subsidiaries which are material to, or necessary for, the Business as currently conducted. The Transferred Intellectual Property, together with the Intellectual Property owned by or licensed to the Transferred
Group, is all the Intellectual Property that is necessary for the conduct of the Business as currently conducted and as reasonably anticipated to be conducted immediately prior to the Closing, including all Intellectual Property that is required for
use in the use, design, development, manufacturing, quality control, packaging, storage, registration, marketing, distribution or sale of the Products.
(b) Without limiting
Section
4.17(a)
, Seller Parent and its Subsidiaries have sufficient rights to use the Licensed
Patents and the Licensed Marks that are material to the Business, in each case, pursuant to valid and enforceable written Contracts.
(c)
Section 4.17(c) of the Seller Disclosure Letter sets forth a correct and complete list of all Business Intellectual Property that is owned by or exclusively licensed to Seller Parent or any of its Subsidiaries and is issued by, registered with, or
subject to a pending application before any Governmental Authority or internet domain name registrar and is material to the Business (collectively, the
Registered IP
). The Registered IP that is material to the Business is, to
Seller Parents Knowledge, subsisting, valid and enforceable, and free of any Liens (other than Permitted Liens). Neither Seller Parent nor any of its Subsidiaries has taken any action pursuant to which any such Registered IP are reasonably
likely to cease to be valid and enforceable.
(d) Each item of Business Intellectual Property that is material to the Business which is
owned, and to Seller Parents Knowledge, the Business Intellectual Property that is material to the Business licensed to Seller Parent or any of its Subsidiaries, is not subject to any outstanding injunction, judgment, order, decree, or ruling.
(e) To Seller Parents Knowledge, no Proceedings are currently pending and Seller Parent and its Subsidiaries have not, since
January 1, 2015, received any written notice or written Claim by any Person alleging that (i) any Product, the Business or the Business Intellectual Property, or any act by Seller Parent and its Subsidiaries related thereto or the use
thereof, infringes or misappropriates (or in the past infringed or misappropriated) any Intellectual Property of any Person or (ii) any of the Registered IP that is material to the Business is invalid or unenforceable. To Seller Parents
Knowledge, neither the operation of the Business as currently conducted, nor the making, use, import, offer for sale or other disposition of any Product infringes or misappropriates, or has infringed or misappropriated, any Intellectual Property of
any Person.
(f) To Seller Parents Knowledge, there is no, nor has there been any, material infringement or misappropriation by any
Person of any Business Intellectual Property.
(g) Other than office actions pending before the United States Patent and Trademark Office
or the equivalent Governmental Authority in jurisdictions other than the United States, there are no Proceedings pending before any Governmental Authority challenging the scope, ownership, inventorship, validity or enforceability of the Business
Intellectual Property that is owned by Seller Parent or any of its Subsidiaries or, to Seller Parents Knowledge, any other Business Intellectual Property that is licensed to Seller Parent or any of its Subsidiaries, and, to Seller
Parents Knowledge, no such Proceedings have been threatened in writing with respect to any Business Intellectual Property.
(h)
Seller Parent and its Subsidiaries have maintained commercially reasonable practices to protect the confidentiality of Trade Secrets and have required all employees and other Persons with access to Trade Secrets to execute Contracts requiring them
to maintain the confidentiality of such information and use such information
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only for the benefit of the Business. To Seller Parents Knowledge, all current and former employees and contractors of Seller Parent and its Subsidiaries who contributed to Transferred
Intellectual Property or Intellectual Property owned by the Transferred Group that is material to the Business have executed Contracts that assign all of such Persons respective rights, including Intellectual Property, to Seller Parent or one
or more of its Subsidiaries.
(i) To Seller Parents Knowledge, the Trade Secrets that are owned, used, or held by, or licensed to,
Seller Parent or any of its Subsidiaries primarily relating to the Business have not been used, disclosed to or discovered by any Person except pursuant to written, valid and enforceable
non-disclosure
or
license agreements (in each case, with appropriate
non-disclosure
obligations) which have not, to Seller Parents Knowledge, been breached.
(j) Except as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, Seller Parent and its
Subsidiaries have complied with all applicable Laws and contractual and fiduciary obligations relating to the collection, storage, use, protection, transfer and any other processing of any Personally Identifiable Information collected, held, used or
otherwise processed by Seller or any of its Subsidiaries in connection with the Business (collectively,
Privacy Obligations
). Seller Parent and its Subsidiaries have implemented reasonable security measures that protect all
Personally Identifiable Information they receive, process and maintain in connection with the Business against loss and unauthorized access, use, modification, disclosure or other misuse by third parties, and to protect the confidentiality,
integrity and security of their IT Assets from potential unauthorized use, access or interruption by third parties. Seller Parent and its Subsidiaries obligate all third party service providers, outsourcers, or any Person who receives Personally
Identifiable Information from the Business to comply with applicable Privacy Obligations. During the last three (3) years, to Seller Parents Knowledge, (i) no Personally Identifiable Information collected, held, used or otherwise
processed by Seller Parent or any of its Subsidiaries has been lost, inappropriately accessed, misappropriated or misused and (ii) no allegation relating to an improper use or disclosure, or a breach in the security of, any Personally
Identifiable Information or violation of any applicable Privacy Obligation has been made or threatened in writing against the Business, in each case, except as has not had and would not reasonably be expected to have, individually or in the
aggregate, a Material Adverse Effect.
(k) All items of Transferred Intellectual Property owned by Sellers are fully transferable,
assignable, and licensable by Sellers to Buyer without restriction and without payment of any kind to any Person.
(l) No funding,
facilities, or resources of any Governmental Authority or any university, college, or other educational institution or research center were used in the development of the Transferred Intellectual Property owned, controlled or licensed by Sellers,
and no Governmental Authority, university, college, or other educational institution or research center has received from Sellers any ownership in or rights to any Transferred Intellectual Property.
(m) Except as set forth in
Section
4.17(m)
of the Seller Disclosure Letter and for the Contingent Payment Contracts,
no third party or current or former partner, director, officer, or employee of Sellers will, after giving effect to each of the transactions contemplated by this Agreement, own or retain any rights in or to, or have the right to receive any
milestone, royalty or other payment with respect to, any of the Transferred Intellectual Property.
4.18.
Required Vot
e
. No vote of the holders of the common stock or any other equity interests of Seller Parent, any of the other Sellers, or any of the entities comprising the Transferred Group is required for Sellers to enter into or
consummate the Transactions.
4.19.
Insurance
. Seller Parent and its Subsidiaries have all material
policies of insurance covering the Business and the Business Employees, including policies of property, fire, workers compensation, products liability, directors and officers liability, and other casualty and liability insurance,
and such policies are in a
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form and amount which, to Seller Parents Knowledge, is adequate for the operation of the Business as presently conducted, except, in each case, as has not had and would not reasonably be
expected to have, individually or in the aggregate, a Material Adverse Effect. All such insurance policies are in full effect, no written notice of cancellation has been received by Seller Parent or any of its Subsidiaries under such policies, and
there is no existing default or event which, with the giving of notice or lapse of time or both, has had or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
4.20.
Sufficiency of Asset
s
. The Transferred Assets and the Transferred Group Assets, together
with the services to be provided under the Transition Services Agreement to be entered into upon Closing, and other than any wholesaler agreements which may be required, will constitute all assets and rights necessary for the conduct of the Business
immediately following the Closing in all material respects as conducted by Seller Parent and its Subsidiaries as at the date hereof and as of the Closing.
4.21.
Broker
s
. No broker, investment banker, agent, finder or other intermediary acting on behalf
of Seller Parent and its Subsidiaries or under the authority of Seller Parent and its Subsidiaries is or shall be entitled to any brokers or finders fee or any other commission or similar fee directly or indirectly in connection with any
of the Transactions other than Citigroup Global Markets Inc., the fees and expenses of which shall be the sole responsibility of Seller Parent.
4.22.
Inventory
. The Inventory (i) has been produced or manufactured and stored in accordance with
Sellers specifications for the manufacture and storage thereof in all material respects, (ii) has been manufactured in accordance with current GMPs, as set forth in the U.S. Code of Federal Regulations, in all material respects and is
free from any material damage and is not misbranded or adulterated, within the meaning of the FDCA, and (iii) shall have remaining expiration dating of no less than twelve (12) months. The Inventory does not consist of any items held on
consignment. No Seller is under any obligation or liability with respect to accepting returns of items in Inventory in the possession of its customers other than in the Ordinary Course of Business.
4.23.
Disclosure
. The information supplied by Seller Parent and each of its Subsidiaries for inclusion
in the Proxy Statement will not, as of the date of the Proxy Statement, (a) contain any statement that is inaccurate or misleading with respect to any material facts or (b) omit to state any material fact necessary in order to make such
information, in the light of the circumstances under which such information will be provided, not false or misleading.
4.24.
No Other Representations
. Except for the representations and warranties contained in
Article V
, Seller Parent acknowledges that neither Buyer nor any Affiliate or Representative of Buyer makes, and Seller Parent acknowledges
that it has not relied upon or otherwise been induced by, any other express or implied representation or warranty with respect to Buyer or any of its Affiliates or Representatives.
ARTICLE V.
REPRESENTATIONS AND WARRANTIES OF BUYER
Except as disclosed in the applicable section of the disclosure letter delivered by Buyer to Seller Parent immediately prior to the execution
of this Agreement (the
Buyer Disclosure Letter
) (it being agreed that disclosure of any item in any section of the Buyer Disclosure Letter shall be deemed disclosure with respect to any other section of this Agreement to which the
relevance of such item is reasonably apparent on its face), Buyer represents and warrants to Seller Parent as set forth below.
5.1.
Qualification, Organization, et
c
. Buyer is a legal entity duly organized, validly existing and, where relevant, in good standing under the Laws of its jurisdiction of organization and has all requisite corporate or similar
power and authority to own, lease and operate its properties and assets and to carry on its business as
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presently conducted and is qualified to do business and is in good standing as a foreign corporation or other entity in each jurisdiction where the ownership, leasing or operation of its assets
or properties or conduct of its business requires such qualification, except where the failure to be so qualified or, where relevant, in good standing, or to have such power or authority, would not, individually or in the aggregate, reasonably be
expected to prevent or materially delay the consummation of the Transactions.
5.2.
Authority; Binding
Effect
. (a) Buyer has all requisite corporate power and authority to execute and deliver this Agreement and each Ancillary Agreement to which it will be a party and to perform its obligations hereunder and thereunder. The execution and
delivery by Buyer of this Agreement and each such Ancillary Agreement, and the performance by Buyer of its obligations hereunder and thereunder, have been duly authorized by all requisite corporate action.
(b) This Agreement has been duly executed and delivered by Buyer and constitutes a valid and binding obligation of Buyer, and each Ancillary
Agreement will be, prior to the Closing, duly executed and delivered by Buyer and will, after the Closing, constitute a valid and binding obligation of Buyer, in each case enforceable against Buyer in accordance with its terms, except as enforcement
may be limited by bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or similar laws affecting creditors rights generally or by general principles of equity (regardless of whether enforcement is sought in a proceeding in
equity or law).
5.3.
No Conflicts; Consent
s
. The execution, delivery and performance of this
Agreement by Buyer and the consummation of the Transactions do not and will not: (a) violate any provision of Buyers Organizational Documents; (b) subject to obtaining the Consents referred to in Section 5.3 of the Buyer
Disclosure Letter, conflict with, or result in the breach of, constitute a default under, result in the termination, cancellation or acceleration (whether after the giving of notice or the lapse of time or both) of any right or obligation of Buyer
under any Contract to which Buyer is a party; and (c) subject to making or obtaining the Consents referred to in
Section
5.7
, violate or result in a breach of or constitute a default under any Law to which Buyer is
subject; except, with respect to clauses (b) and (c), for any violations, breaches, conflicts, defaults, terminations, cancellations or accelerations as would not, individually or in the aggregate, have a Buyer Material Adverse Effect, or would
not reasonably be expected to prevent or materially delay the consummation of the Transactions.
5.4.
Capitalization
.
(a) The authorized capital stock of Buyer consists of (i) 80,000,000 shares of Buyer Common Stock and (ii)
5,000,000 shares of preferred stock, $0.001 par value per share (
Buyer Preferred Stock
and, together with Buyer Common Stock, the
Buyer Capital
Stock
). Other than Buyer Capital Stock, there are no shares
of capital stock authorized, issued, or outstanding. As of November 26, 2017, there were outstanding (a) 21,942,183 shares of Buyer Common Stock, (b) no shares of Buyer Preferred Stock, (c) 2,104,823 options granted and outstanding under
the (i) Melinta Therapeutics, Inc. 2011 Equity Incentive Plan, as amended and restated, dated December 17, 2013, and amended from time to time, (ii) Cempra, Inc. 2011 Equity Incentive Plan, as amended, (iii) Cempra, Inc. Sixth
Amended and Restated 2006 Stock Plan and (iv) Notice of Stock Option Grant between Buyer and Daniel Mark Wechsler and (d) 385,661 restricted stock units granted and outstanding under the (i) Cempra, Inc. 2011 Equity Incentive Plan, as
amended and (ii) Restricted Stock Unit Award Grant Notice between Buyer and Daniel Mark Wechsler. All outstanding shares of Buyer Capital Stock have been, and all shares of Buyer Capital Stock that may be issued pursuant to any stock plan of
Buyer or other compensation plan or arrangement will be, when issued in accordance with the respective terms thereof, duly authorized and validly issued and are fully paid and nonassessable.
(b) The number of shares of Buyer Common Stock to be issued in the Financing shall consist of (i) a number of shares of Buyer Common
Stock equal to 9.985% of the number of shares of Buyer Common Stock outstanding immediately following the Closing (inclusive of such shares) for a purchase price per share equal to 90% of the closing price for the Buyer Common Stock immediately
prior to execution of the Debt Commitment Letter, (ii) up to $30 million of shares of Buyer Common Stock for a purchase price per share equal to 90% of the
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closing price for the Buyer Common Stock immediately prior to execution of the Equity Commitment Letters and (iii) up to $10 million of shares of Buyer Common Stock for a purchase price
per share equal to ninety percent (90%) of the VWAP for the ten (10) Trading Day period ending three (3) Trading Days prior to Closing.
5.5.
Orders; Litigation
. (a) There are no Orders issued by any Governmental Authority binding on Buyer,
and (b) there are no Proceedings pending (or, to Buyers Knowledge, threatened) against Buyer, which, in the case of clauses (a) or (b), would reasonably be expected to prevent or materially delay the consummation of the Transactions.
5.6.
Compliance with La
w
. Buyer and each of its Subsidiaries are in compliance with and are
not in default under or in violation of any Laws, applicable to Buyer, such Subsidiaries or any of their respective properties or assets, except where such noncompliance, default or violation would not, individually or in the aggregate, have a Buyer
Material Adverse Effect, or would not reasonably be expected to prevent or materially delay the consummation of the Transactions.
5.7.
Consents and Governmental Approvals
. Assuming the accuracy of the representations and warranties made by Seller Parent in Article IV, and except for (a) (i) any HSR Filing with the FTC or the Antitrust Division and the
expiration or early termination of the waiting period with respect thereto and (ii) any filing under any other Foreign Antitrust Laws identified in Section 5.7 of the Buyer Disclosure Letter and the expiration or early termination of any
waiting period with respect thereto or the receipt of any Consents thereunder, in each case to the extent required, or (b) as would not reasonably be expected to prevent or materially delay the consummation of the Transactions, no Consent to,
with or from any Governmental Authority is required for Buyer to execute and deliver this Agreement or any Ancillary Agreement or to consummate the Transactions.
5.8.
Buyer SEC Reports; Financial Statements
. (a) Buyer has filed or furnished, as applicable, on a
timely basis all Buyer SEC Reports. Each Buyer SEC Report, at the time of its filing or being furnished complied in all material respects with the applicable requirements of the Exchange Act, the Securities Act and the Sarbanes-Oxley Act, and any
rules and regulations promulgated thereunder applicable to the Buyer SEC Reports. As of their respective dates (or, if amended prior to the date hereof, as of the date of such amendment), the Buyer SEC Reports did not contain any untrue statement of
a material fact or omit to state a material fact required to be stated therein or necessary to make the statements made therein, in light of the circumstances in which they were made, not misleading. Each of the audited consolidated balance sheets,
statements of income and statements of cash flows of Buyer and its consolidated Subsidiaries included in or incorporated by reference into the Buyer SEC Reports (including any related notes and schedules) (the
Buyer Financial
Statements
): (i) have been prepared in accordance with GAAP applied on a consistent basis during the periods involved; and (ii) present fairly, in all material respects, Buyers and its consolidated Subsidiaries
financial position as of the specified dates and Buyers and its consolidated Subsidiaries results of operations and cash flows for the specified periods.
(b) Buyer maintains and has maintained a standard system of accounting established and administered in accordance with GAAP. Buyer maintains a
system of internal accounting controls sufficient to provide reasonable assurance that (i) transactions are executed in accordance with managements general or specific authorizations, (ii) transactions are recorded as necessary to
permit preparation of financial statements in conformity with GAAP and to maintain accountability for assets, (iii) access to assets is permitted only in accordance with managements general or specific authorizations and (iv) the
recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
(c) In the past three (3) years, neither Buyer, Buyers Subsidiaries nor, to Buyers Knowledge, any Representative of Buyer or
its Subsidiaries, has received or otherwise had or obtained knowledge of any complaint, allegation, assertion or claim, whether written or oral, regarding the accounting or auditing practices, procedures, methodologies or methods of Buyer or any of
its Subsidiaries or their respective internal accounting
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controls, including any complaint, allegation, assertion or claim that Buyer or any of its Subsidiaries has engaged in questionable accounting or auditing practices, in each case, that reasonably
would be expected to result in a restatement to the Buyer Financial Statements. In the past three (3) years, no attorney representing Buyer or any of Buyers Subsidiaries has reported evidence of a material violation of applicable
securities laws, breach of fiduciary duty or similar violation by Buyer or any of its Subsidiaries or any of their respective officers, directors, employees or agents to the Board of Directors (or similar body) or any committee thereof or to any
director or officer of Buyer or its Subsidiaries. In the past three (3) years, neither Buyer or any of its Subsidiaries has conducted an internal investigation regarding accounting practices or policies.
(d) Neither Buyer nor any of its Subsidiaries is a party to, or has any commitment to become a party to, any joint venture or
off-balance
sheet partnership agreement (including any agreement or arrangement relating to any transaction or relationship between or among Buyer and any of its Subsidiaries, on the one hand, and any unconsolidated
Affiliate, including any structured finance, special purpose or limited purpose entity or Person, on the other hand, or any
off-balance
sheet arrangements (as defined in Item 303(a) of
Regulation
S-K
of the SEC)).
5.9.
Absence of Certain Changes or
Events
. From December 31, 2016 through the date of this Agreement, there has not occurred any Effect that has had, or would reasonably be expected to have, individually or in the aggregate, a Buyer Material Adverse Effect.
5.10.
Required Vot
e
. Except for the Buyer Stockholder Approval, no vote or consent of the holders
of any class or series of capital stock of Buyer is necessary to approve this Agreement or the transactions contemplated hereby. The Voting Agreement entered into by Seller Parent and certain stockholders of Buyer pertains to
fifty-one
percent (51%) of the outstanding Buyer Common Stock as of the date hereof.
5.11.
Investment Intent
. Buyer is acquiring the Transferred Shares for investment for its own account and not with a view to the distribution of any part thereof in violation of the Securities Act of 1933, as amended, or any other
applicable Law. Buyer acknowledges that the Transferred Shares have not been registered under U.S. federal or any applicable state securities laws or the laws of any other jurisdiction and cannot be resold without registration under such laws or an
exemption therefrom. Buyer further acknowledges that it has knowledge and experience in financial and business matters, that it is capable of evaluating the merits and risks of an investment in the Transferred Shares, and that it can bear the
economic risk of an investment in the Transferred Shares.
5.12.
Sufficient Fund
s
. Buyer has
delivered to Seller Parent true, correct and complete copies of (i) the executed equity commitment letters, dated as of the date hereof, among Buyer and Vatera Healthcare Partners LLC and JWC
Rib-X,
LLC,
respectively (together with their respective officers, employees, directors, affiliates, partners, controlling parties, advisors, agents and representatives, the
Equity Financing Sources
) (including any replacement or amendment
thereof (that does not adversely affect or delay in any material respect the ability of Buyer to fund the Purchase Price at Closing), the
Equity Commitment Letters
), (ii) the executed commitment letter, dated as of the date
hereof, among Deerfield Private Design Fund IV, L.P. (together with its officers, employees, directors, affiliates, partners, controlling parties, advisors, agents and representatives, the
Debt Financing Sources
and, together with
the Equity Financing Sources, the
Financing Sources
) and Buyer, together with each related fee letter (with customary redactions only with respect to fee amounts and the economic terms of the market flex provisions and
nothing which would affect the amount or availability of the Debt Financing) (collectively, the
Debt Commitment Letter
and, together with the Equity Commitment Letters, the
Commitment Letters
), and
(iii) all registration rights agreements and other agreements entered into by the Equity Financing Sources in connection with the Transactions. The Commitment Letters will provide financing in an aggregate amount set forth therein, and subject
to the terms and conditions set forth therein (the
Financing
). The Equity Commitment Letters provide that Seller Parent is a third-party beneficiary thereof. As of the date of this Agreement, the Commitment Letters have not
been amended or modified in any manner, and, to Buyers Knowledge, no amendment or modification of the Commitment Letters is contemplated. As of the date of this Agreement, the Commitment Letters have not been terminated, reduced,
withdrawn or rescinded in
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any respect and, to Buyers Knowledge, as of the date of this Agreement, no such termination, reduction, withdrawal or rescission is contemplated. Buyer has paid in full any all fees,
expenses and other amounts in connection with the Commitment Letters that are payable on or prior to the date of this Agreement and, as of the date of this Agreement, the Commitment Letters are in full force and effect and are the valid, binding and
enforceable (in accordance with their terms) obligations of Buyer and, to Buyers Knowledge, as of the date hereof, the other parties thereto, subject to applicable bankruptcy, insolvency, reorganization, moratorium and similar Laws affecting
creditors rights and remedies generally. Buyer is unaware of any fact or occurrence existing on the date of this Agreement that would reasonably be expected to make any of the assumptions or any of the statements set forth in the Commitment
Letters to be incorrect or ineffective. Assuming compliance by Sellers of their obligations under this Agreement (including cooperation and assistance by Sellers with respect to the Debt Financing) and based upon facts and events known by Buyer as
of the date of this Agreement, Buyer believes that the conditions to the funding contemplated by the Commitment Letters will be satisfied, and Buyer is not aware of the existence of any fact or event as of the date of this Agreement that would
reasonably be expected to cause such conditions to funding not to be satisfied. There are no conditions precedent to the funding of the full amount of the Financing, other than as set forth in the Commitment Letters. The net proceeds
contemplated by the Commitment Letters, together with available cash on hand at Buyer and its Controlled Affiliates, will, in the aggregate, be sufficient for Buyer to pay all of the Guaranteed Payments and all related fees and expenses required to
be paid as of the Closing by Buyer. As of the date of this Agreement, there are no side letters, understandings or other agreements, contracts or arrangements of any kind relating to the Commitment Letters that could affect the amount or
availability of the Financing contemplated by the Commitment Letters. There are no conditions precedent or other contingencies related to the funding of the full amount (or any portion) of the Financing (including any condition relating to the
availability of the Debt Financing relating to any flex provision), other than as expressly set forth in the Commitment Letters delivered to Seller Parent pursuant to this
Section
5.12
. As of the date of this
Agreement and assuming the satisfaction or waiver (to the extent permitted by Law) of the conditions to Buyers obligation to consummate the Transactions, (a) no event has occurred which (with or without notice, lapse of time or both)
could constitute a default or breach or failure to satisfy a condition by Buyer under the terms and conditions of the Commitment Letters and (b) Buyer does not have any reason to believe that any of the conditions to the Financing will not be
satisfied by Buyer on a timely basis or that the Financing will not be available to Buyer on the date of the Closing. For the avoidance of doubt, it is not a condition to Closing under this Agreement for Buyer to obtain the Financing or any
Alternative Financing.
5.13.
Broker
s
. No broker, investment banker, agent, finder or other
intermediary acting on behalf of Buyer or under the authority of Buyer is or shall be entitled to any brokers or finders fee or any other commission or similar fee directly or indirectly in connection with any of the Transactions.
5.14.
Condition of the Business
. Buyer acknowledges that it is a sophisticated purchaser and, together
with its Controlled Affiliates and Representatives, has made its own investigation, review and analysis regarding the Business, the Transferred Group, the Acquired Assets, the Assumed Liabilities and the Transactions. Buyer acknowledges that none of
Seller Parent, its Affiliates or Representatives is making, and Buyer is not relying on, any statement, representation or warranty, oral or written, express or implied, regarding the Business, the Transferred Group, the Acquired Assets or the
Assumed Liabilities, except as expressly set forth in
Article IV
. Buyer is not relying on, and none of Seller Parent or any of its Affiliates or Representatives shall have any liability to Buyer or any of its Controlled Affiliates or
Representatives pursuant to this Agreement in connection with the use of, any information, documents or materials made available to Buyer or its Controlled Affiliates or Representatives, whether orally or in writing, in any confidential information
memoranda, virtual data rooms, management presentations, projections, due diligence discussions, or in any other form in expectation of the Transactions, except to the extent representations with respect to such information, documents or
materials are expressly made in
ARTICLE IV
.
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ARTICLE VI.
COVENANTS
6.1.
Conduct of the Business Prior to the Closing
. (a) Unless Buyer consents in writing (which consent shall not be unreasonably withheld, delayed or conditioned), or except (i) as required by Order or Law or expressly
contemplated by this Agreement or the Ancillary Agreements to which a Seller is a party, or (ii) with respect to the Excluded Assets or the Excluded Liabilities, from and after the date of this Agreement until the earlier of (A) the
Closing Date, or (B) the termination of this Agreement pursuant to
Section
11.1
(the
Pre-Closing
Period
), Seller Parent shall, and shall cause its Subsidiaries
engaged in the Business (including the Transferred Group) to, conduct the Business only in the Ordinary Course of Business, including using commercially reasonable efforts to preserve and maintain intact the Business, the Transferred Assets, the
Transferred Group Assets and the existing relationships of the Business and the Transferred Group with customers, lenders, suppliers, regulators, employees and others having significant business relationships with the Business.
(b) Without limiting the generality of
Section
6.1(a)
, unless Buyer consents in writing (which consent shall not be
unreasonably withheld, delayed or conditioned), or except (i) as required by Order or Law or expressly contemplated by this Agreement or the Ancillary Agreements, (ii) with respect to the Excluded Assets or the Excluded Liabilities or
(iii) as set forth in Section 6.1(b) of the Seller Disclosure Letter, during the
Pre-Closing
Period, Seller Parent shall not, and shall cause each of its Subsidiaries engaged in the Business
(including the Transferred Group) or holding Transferred Assets to not, take any of the following actions:
(i) transfer,
sell, assign, lease, sublease, enter into any sale lease back (or similar arrangement), license, sublicense, pledge or otherwise convey or dispose of or grant any option or rights in, to or under, or create any Liens on (1) the Transferred
Shares or (2) any of the Transferred Assets or the Transferred Group Assets, other than, in the case of this clause (2), (A) Permitted Liens made in the Ordinary Course of Business and (B) Ordinary Course of Business sales of obsolete
equipment or Inventory;
(ii) with respect to the Business Employees, (A) increase the annual salary or wage rate
payable or to become payable to such employees, or (B) grant or increase any bonus, incentive, compensation, severance, change of control, tax
gross-up,
retention or termination pay to any Business
Employee; provided, however, the restrictions in this Section 6.1(b)(ii) shall not apply to any Business Employee who is not listed on the notice contemplated by the first sentence of Section 7.1 on and after the date on which such notice
is delivered to Seller;
(iii) negotiate, enter into, amend, or extend a collective bargaining agreement or other Contract
with any labor union or other employee representative body, with respect to Business Employees;
(iv) except in the
Ordinary Course of Business, abandon, cancel, fail to maintain or otherwise allow to lapse or expire any Business Intellectual Property;
(v) make any change in accounting principles materially affecting the reporting of the Acquired Assets, any member of the
Transferred Group, the Transferred Group Assets or the Business, other than as required by Law, a Governmental Authority, GAAP or any interpretation thereof;
(vi) revalue any Transferred Assets or Transferred Group Assets, including writing down or writing off the value of Inventory
or writing off notes or accounts receivable other than in the Ordinary Course of Business;
(vii) (A) terminate any
Material Contract or material Business Contract, or make any material amendment to or waive any material right or remedy under any such Material Contract or material Business Contract, (B) enter into any Contract that is material to the
Business or (C) amend or waive any material right or remedy under any Permit;
(viii) (A) discharge, settle,
compromise, satisfy or consent to any entry of any judgment with respect to, any Claim that (1) results in any material restriction on the Business or any Product or
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(2) results in a Liability of the Business after the Closing greater than $250,000 individually or $500,000 in the aggregate, (B) cancel any Indebtedness owed to the Business to the
extent such Indebtedness would constitute a Transferred Asset or a Transferred Group Asset, or (C) waive, release or assign any material Claims or rights of the Business;
(ix) incur any Indebtedness, or enter into any financing or guarantee arrangement, agreement or undertaking with any customer
of the Business or any financial institution, leasing company or similar business, which would constitute an Assumed Liability or a Liability of the Transferred Group other than in the Ordinary Course of Business;
(x) make any commitment for capital expenditures with respect to the Business or for which a member of the Transferred Group
shall be liable which are in excess of $250,000 individually or $500,000 in the aggregate in any twelve (12) month period;
(xi) except in the Ordinary Course of Business, offer any rebates, discounts, promotions or credits, make any change to any
promotional programs or make any change in the manner in which Seller Parent and its Subsidiaries generally extend rebates, discounts or credit to, or otherwise similarly deal with, customers with respect to the Products or the Business;
(xii) (1) amend or propose to amend the Organizational Documents of any member of the Transferred Group, or (2) split,
combine or reclassify the outstanding capital stock of any member of the Transferred Group;
(xiii) (1) issue, sell, pledge
or dispose of, or agree to issue, sell, pledge or dispose of, any additional shares of, or any options, warrants or rights of any kind to acquire any shares of, the capital stock of or any other equity interests of any member of the Transferred
Group or any debt or equity securities which are convertible into or exchangeable for such capital stock or other equity interests, or (2) declare, set aside or pay any
non-cash
dividends on or make any
other
non-cash
distributions in respect of any shares of capital stock or other equity interests of any member of the Transferred Group;
(xiv) permit any member of the Transferred Group to dissolve, merge or consolidate with any other Person or adopt a plan of
complete or partial liquidation;
(xv) vary any inventory practices with respect to any Product (including Inventory held
by or on behalf of any wholesaler of Seller Parent and its Subsidiaries) in any respect materially inconsistent with past practice;
(xvi) solely with respect to the Business, the Transferred Assets or the Transferred Group, make, change or revoke any Tax
election, elect or change any method of accounting for Tax purposes, change any annual Tax accounting period, settle any audit, assessment, dispute, proceeding or investigation in respect of Taxes, surrender any right to claim a Tax refund, file any
amended Tax Return, or enter into any contractual obligation in respect of Taxes with any Taxing Authority;
(xvii)
establish, adopt, amend or terminate any Business Benefit Plan;
(xviii) hire, engage, or terminate (other than for cause)
the employment or engagement of any Business Employee;
provided
,
however
, that Seller Parent and its Subsidiaries may terminate any Business Employee who is not listed on the notice delivered to Sellers as contemplated by the first
sentence of
Section
7.1
on and after the date such notice is delivered to Sellers;
(xix)
purchase, sell, make any short sale of, acquire or grant any option for the purchase of, or enter into any hedging or similar transaction having the same economic effect as any of the foregoing with respect to, any Buyer Common Stock or direct or
encourage any third party to take any of the foregoing actions; or
(xx) agree, in writing or otherwise, to take any of the
foregoing actions.
(c) Nothing contained in this Agreement shall give Buyer, directly or indirectly, the right to control or direct
Seller Parents or any of its Subsidiaries operations prior to the Closing. Prior to the Closing, the
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management of Seller Parent shall exercise, consistent with and in accordance with the terms and conditions of this Agreement, complete control and supervision over the operations of Seller
Parent and its Subsidiaries.
6.2.
Antitrust Filings and Actions
.
(a)
Filings and Other Action
s
. Subject to the other terms of this Agreement, Seller Parent and Buyer shall cooperate with each
other and use (and shall cause their respective Controlled Affiliates to cooperate and use) their respective reasonable best efforts to take or cause to be taken all reasonable actions, and to do or cause to be done all reasonable things necessary,
proper or advisable on its part under this Agreement and applicable Law to consummate and make effective the Transactions as soon as reasonably practicable, including preparing and filing as promptly as reasonably practicable and advisable all
documentation to effect all necessary notices, reports and other filings and to obtain as promptly as reasonably practicable all Consents necessary or advisable to be obtained from any Person, including any Governmental Authority, and to lift any
injunction or other legal bar in order to consummate the Transactions. Without limiting the foregoing, each of Seller Parent and Buyer undertakes and agrees to file (or cause their respective Controlled Affiliates to file, as applicable) as soon as
reasonably practicable and advisable, and in any event not later than five (5) Business Days after the date of this Agreement, a Notification and Report Form regarding the Transactions as and to the extent required by the HSR Act (the
HSR Filing
) with each of the U.S. Federal Trade Commission (the
FTC
) and the Antitrust Division of the U.S. Department of Justice (the
Antitrust Division
) and to as soon as reasonably
practicable and advisable submit any other filings required to be made under any Foreign Antitrust Laws. Each of Seller Parent and Buyer shall (and shall cause their respective Controlled Affiliates to) (i) respond as promptly as reasonably
practicable and advisable to any inquiries received from any Governmental Authority for additional information or documentation and to all inquiries and requests received from any Governmental Authority in connection with antitrust matters and
(ii) not extend any waiting period under the HSR Act or any Foreign Antitrust Laws or enter into any agreement with any Governmental Authority to delay the Transactions, except with the prior written consent of the other Party. Buyer and Seller
Parent shall (and shall cause each of their respective Controlled Affiliates to) to take all steps requested by the FTC, the Antitrust Division or other Governmental Authority to avoid or eliminate impediments under any Antitrust Law that may be
asserted by a Governmental Authority with respect to the Transactions so as to enable the Closing to occur as soon as reasonably practicable, and in any event prior to the Outside Date, and shall defend through litigation on the merits any Claim in
respect of Antitrust Laws asserted in any court by any Governmental Authority, including appeals. Without limiting the foregoing, Buyer shall (and shall cause each of its Controlled Affiliates to) propose, negotiate and offer to commit and effect
(and, if such offer is accepted, commit to and effect) by consent decree, hold separate Order, or otherwise, the sale, divestiture, licensing or other disposition of or restriction on such assets or businesses of Buyer (or such Controlled
Affiliates) or of any of the Acquired Assets, terminate any existing relationships or contractual rights of Buyer or the Acquired Assets, amend or terminate any licenses or other intellectual property agreements of Buyer or the Acquired Assets, or
otherwise offer to take or offer to commit to take any action and, if the offer is accepted, commit to take and take such action that limits its freedom of action with respect to, or its ability to retain, any of the businesses, services or assets
of Buyer (or such Controlled Affiliates) or any of the Acquired Assets, in each case, to the extent necessary so as to permit and cause the condition set forth in
Section
10.1(b)
to be satisfied as soon as reasonably
practicable, and in any event prior to the Outside Date. Notwithstanding the foregoing, in no event shall Buyer or any of its Controlled Affiliates be required to take or agree to take any such action that is not conditioned on the occurrence of the
Closing or that, individually or together with any other such actions, would reasonably be expected to have a Buyer Material Adverse Effect, it being understood and agreed that, for purposes of this sentence, the reference to Buyer and its
Subsidiaries in clause (x) of the definition of Buyer Material Adverse Effect shall be deemed to include Buyer, its Subsidiaries and the Acquired Assets, taken as a whole. Each of Buyer and Seller Parent shall promptly notify the
other of any written communication to that Party from a Governmental Authority or any other Person (whether or not a Governmental Authority) in connection with antitrust matters relating to the Transactions and, subject to applicable Law, and the
instructions of any Governmental Authority, permit the other to review in advance any material proposed written communication to any of the foregoing.
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(b)
Cooperation
. Buyer shall control all communications with any Governmental
Authority relating to Antitrust Laws, and determine and direct the strategy and process by which the Parties will seek required approvals relating to Antitrust Laws, strategy or process. Each of Buyer and Seller Parent shall, upon request by the
other, furnish the other (or its outside counsel, where appropriate) with all information concerning itself, its Controlled Affiliates and their respective directors, officers and stockholders and such other matters as may be reasonably necessary or
advisable in connection with any statement, filing, notice or application made by or on behalf of a Party or any of their respective Controlled Affiliates to any Person, including any Governmental Authority, in connection with the Transactions
insofar as they pertain to antitrust matters. Buyer shall consult with Seller Parent in connection with any communication, statement, filing, notice or application contemplated by this Section 6.2(b) and take into consideration in good faith
any comments that Seller Parent may provide with respect thereto.
(c)
Notification
. Subject to applicable Law and the instructions
of any Governmental Authority, and except as necessary to preserve any applicable legal privilege, each of Buyer and Seller Parent shall keep the other apprised of the status of matters in connection with Antitrust Laws relating to consummation of
the Transactions, including promptly furnishing the other with copies of notices or other communications received by it, or by any of its Controlled Affiliates, from any Person, including any Governmental Authority, with respect to the Transactions
insofar as they pertain to antitrust matters.
(d)
Meetings
. Subject to applicable Law, neither Seller Parent nor Buyer (nor any of
their respective Controlled Affiliates) shall, nor shall they permit any of their respective Representatives to, participate in any substantive meeting or discussion with any Governmental Authority with jurisdiction over enforcement of any
applicable Antitrust Law (
Government Antitrust Authority
) in respect of any filings, investigation or other inquiry unless it consults with the other Party in advance and, to the extent permitted by such Government Antitrust
Authority, gives the other Party the opportunity to attend and participate.
(e)
Other Actions
. Without limiting the generality of
the undertakings pursuant to this
Section
6.2
, each Party agrees to take or cause to be taken the following actions: (i) the prompt provision to each and every foreign, federal, state or local court or any other
Governmental Authority of
non-privileged
information and documents reasonably requested by any of them or that are necessary, proper or advisable to permit consummation of the Transactions; and (ii) the
use of its reasonable best efforts to avoid the entry of any permanent, preliminary or temporary injunction or other Order, decree, decision, determination or judgment that would restrain, prevent, enjoin or otherwise prohibit consummation of the
Transactions by the Outside Date. The Parties obligations under this
Section
6.2
shall include the obligation to use its reasonable best efforts to defend against any lawsuits or other legal Proceedings, whether
judicial or administrative, challenging the consummation of the Transactions, including seeking to have any stay or other injunctive relief which would prevent or impair the consummation of the Transactions by the Outside Date entered by any court
or other Governmental Authority reversed on appeal or vacated. The Parties agree that, if advisable to facilitate obtaining the Consent of any Governmental Authority that is a condition to Closing, the Parties shall promptly meet and use their good
faith efforts to agree to a modification or modifications to the terms of this Agreement and/or any Ancillary Agreement that the Parties agree will facilitate obtaining such Consent,
provided
such modifications in the aggregate shall not
alter the economic value of the Transactions other than in immaterial respects.
(f)
No Adverse Actions
. Buyer and Seller Parent
shall not, and each shall cause its Subsidiaries not to, directly or indirectly, acquire, purchase, lease or license (or agree to acquire, purchase, lease or license), by merging with or into or consolidating with, or by purchasing a substantial
portion of the assets of or equity in, or by any other manner, any business or any corporation, partnership, association or other business organization or division or part thereof, or any securities or collection of assets, if doing so would
reasonably be expected to: (i) impose any material delay in the obtaining of, or materially increase the risk of not obtaining, any Consent, approval or exemption of any Governmental Authority necessary to consummate the Transactions or the
expiration or termination of any applicable waiting period under applicable Law; (ii) materially increase the risk of any Governmental Authority entering any judgment, decree, injunction or other Order prohibiting the
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Transactions; (iii) materially increase the risk of not being able to remove any such judgment, decree, injunction or other Order on appeal or otherwise; or (iv) restrict, prevent,
prohibit, impede or delay the consummation of the Transactions.
(g)
Fees and Expenses
. Buyer shall be responsible for the payment
of all filing fees in connection with the filings made pursuant to this
Section
6.2
.
6.3.
Reasonable Best Efforts
. (a) Subject to the terms and conditions of this
Agreement and without limiting the express obligations hereunder, each of the Parties agrees to cooperate fully with each other and to use its reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done, all
things necessary, proper or advisable to consummate and make effective, at the time and in the manner contemplated by this Agreement, and the Transactions, including to (i) make and obtain all Consents required under applicable Laws, and
(ii) execute and deliver such documents and other papers and any other agreements, in each case as may be necessary to, as soon as practicable, carry out the provisions of this Agreement and consummate and make effective the Transactions. At
the Closing, Buyer shall, and shall cause each of its applicable Subsidiaries to, execute and deliver each Ancillary Agreement, and Seller Parent shall, and shall cause each of its applicable Subsidiaries to, execute and deliver each Ancillary
Agreement, in each case to which it is a party.
(b) From time to time following the Closing, as and when requested by a Party, the other
Party shall, and shall cause its Controlled Affiliates to, at the requesting Partys expense (except as otherwise expressly provided in this Agreement), execute such Transfer Documents (including such instruments of assignment as may be
necessary in order to have the assignment of the Transferred Intellectual Property recorded in the name of Buyer or a Controlled Affiliate of Buyer at the relevant patent and trademark offices) and take such further actions as may be reasonably
required to carry out the provisions hereof and consummate and evidence the Transactions, including executing and delivering or causing to be executed and delivered to such Party such Transfer Documents as such Party or its counsel may reasonably
request as necessary for such purpose and using reasonable best efforts remove any Permitted Liens described in clause (a) or (b) of such definition on any Transferred Assets.
6.4.
Access; Confidentialit
y
. During the
Pre-Closing
Period, Seller Parent and its Subsidiaries shall and shall cause their Representatives to, upon reasonable prior notice, free of charge, give Buyer and its authorized Representatives reasonable access during normal business hours to the Contracts,
Books and Records, analysis, projections, plans, systems, management and other personnel, Seller Parent and its Subsidiaries Representatives, offices and other facilities and properties, in each case to the extent related to the Business
(including the Business Employees), the Transferred Group, the Transferred Group Assets, the Acquired Assets or the Assumed Liabilities;
provided
that Buyer and its Representatives shall not interfere unreasonably with the business and
operations of Sellers and the Transferred Group. The terms of the Confidentiality Agreement shall apply to any information provided to Buyer and its Representatives pursuant to this
Section
6.4
. Notwithstanding anything to
the contrary set forth herein, no Seller shall be required to provide access to, or to disclose information, where such access or disclosure would (a) jeopardize the attorney-client or other legal privilege of such Seller, (b) contravene
any applicable Law (including any applicable law related to the confidentiality of individual performance or evaluation records, medical histories or other personnel-related information), or (c) give a third party the right to terminate or
accelerate the rights under a Contract to which Seller Parent or any of its Subsidiaries is a party or otherwise bound;
provided
that in each case, Seller Parent shall: (i) give reasonable notice to Buyer of the fact that it is
restricting or otherwise prohibiting access to any documents or information pursuant to this
Section
6.4
, (ii) inform Buyer with sufficient detail of the reason for such restriction or prohibition, and (iii) cause the
applicable Seller to use its reasonable best efforts to cause the documents or information that are subject to such restriction or prohibition to be provided in a manner that would not reasonably be expected to violate such restriction or
prohibition, including using reasonable best efforts to obtain a waiver of any such Liability or third party right.
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6.5.
Shared Contracts
.
(a) Subject to
Section
6.5(b)
below, for a period of ninety (90) days following the Closing Date, Seller Parent
shall, and shall cause its Subsidiaries to, reasonably cooperate with Buyer to the extent reasonably requested by Buyer to cause the counterparty to any Shared Contract material to the Business to enter into a new agreement with Buyer (or, at
Buyers option, the Transferred Group, as appropriate) with respect to the matters addressed by such Shared Contract that are related to the Business;
provided
, that neither Seller Parent nor any of its Subsidiaries shall be required to
compromise any right, asset or benefit or expend any amount or incur any liabilities or provide any other consideration in connection therewith.
(b) With respect to the Shared Contract set forth on
Schedule 6.5(b)
, for a period of one (1) year following the Closing Date,
Buyer and Seller Parent shall, and shall cause their respective Subsidiaries to, reasonably cooperate with each other to the extent reasonably necessary to cause the counterparty to such Shared Contract to enter into a new agreement with Buyer (or,
at Buyers option, the Transferred Group, as appropriate) with respect to the provisions of such contract that are related to Vabomere;
provided
, that neither Seller Parent nor any of its Subsidiaries shall be required to compromise any
right, asset or benefit or expend any amount or incur any liabilities or provide any other consideration in connection therewith; provided, that, in the event that the counterparty to such Shared Contract enters into a new agreement with Buyer (or,
at Buyers option, the Transferred Group, as appropriate) with respect to the provisions of such contract that are related to Vabomere, any remaining obligation to make the Milestone Payment in respect of Milestone #6 (as defined in the Rempex
Merger Agreement as defined in
Schedule 1.1(d)
) shall, from and after the date of such agreement, be deemed an Assumed Liability hereunder.
6.6.
Financing
.
(a) Buyer shall use reasonable best efforts to take, or cause to be taken, all actions and do, or cause to be done, all things necessary,
proper or advisable to consummate and obtain the Financing on the terms and conditions described in the Commitment Letters and shall not permit any amendment or modification to be made to, any replacement of all or a portion of any facilities (or
commitments thereof) described in, or any waiver of any provisions under, the Commitment Letters without the prior written consent of Seller Parent, if such amendment, modification, replacement or waiver (i) reduces the aggregate amount of the
Financing to an amount below the amount required, to consummate the Transactions, including the payment of all fees, premiums and expenses associated therewith, (ii) imposes additional conditions or any contingencies or otherwise expands upon,
amends or otherwise modifies any of the conditions to the receipt of any portion of the Financing in a manner that would or would reasonably be expected to make any portion of the funding of the Financing (or satisfaction of the conditions to
obtaining the Financing) less likely to be obtained, (iii) prevents, impedes or delays the occurrence of Closing, (iv) adversely impacts the ability of Buyer to enforce its rights against any other party to any Commitment Letter or the
Definitive Agreements or (v) adversely impacts the ability of Buyer to consummate the Transactions. For purposes of this Agreement, (1) the term Financing shall be deemed to include the financing contemplated by the Commitment
Letters as amended, modified or replaced pursuant to this
Section
6.6
(including any Alternative Financing used to satisfy the obligations under this Agreement), and (2) the term Commitment
Letters
shall be deemed to include the Commitment Letters as may be amended or modified pursuant to this
Section
6.6
and any commitment letters with respect to the Alternative Financing. Buyer acknowledges and agrees that neither
the obtaining of the Financing or any Alternative Financing is a condition to Buyers obligations to consummate the Transactions and the other transactions contemplated by this Agreement.
(b) Buyer shall comply with the interim operating covenants described in Section 3 of the Debt Commitment Letter and use its reasonable
best efforts to take, or cause to be taken, all actions and do, or cause to be done, all things necessary, proper or advisable to consummate and obtain the Financing on the terms and conditions described in the Commitment Letters, including using
reasonable best efforts to (i) maintain in effect the Commitment Letters pursuant to their terms (except for amendments not prohibited by
Section
6.6(a))
until the Transactions are consummated or this Agreement is
terminated in accordance with its terms, (ii) negotiate
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and enter into definitive agreements with respect to the Financing on the terms and conditions contained in the Commitment Letters (including any flex provisions) or on other terms
not materially less favorable, in the aggregate, to Buyer (as determined in the reasonable judgment of Buyer) than the terms and conditions contained in the Commitment Letters (such definitive agreements, the
Definitive
Agreements
), and do not expand upon the conditions precedent set forth in the Commitment Letters in a manner that would reasonably be expected to make any portion of the funding of the Financing less likely to be obtained or prevent,
impede or delay the funding of the Financing and, upon execution thereof, deliver a copy thereof to Seller Parent, (iii) satisfy (or, if deemed advisable by Buyer, seek a waiver on a timely basis of) all covenants, other obligations and
conditions to funding in the Commitment Letters that are required to be satisfied by it and, in the event that all conditions to funding in the Commitment Letters and the Definitive Agreements are satisfied at or prior to the Closing, consummate the
Financing at the Closing in accordance with the terms and conditions of the Commitment Letters as in effect at or prior to the Closing and (iv) enforce its rights, including through litigation, under the Commitment Letters and the Definitive
Agreements in the event of a failure to fund by the Financing Sources that prevents, impedes or delays the Closing. Buyer shall provide the funding notice specified in Section 12 of Annex I to Annex A of the Debt Commitment Letter not later
than the Mailing Date.
(c) In the event any portion of the Financing becomes unavailable on the terms and conditions contemplated in the
Commitment Letters or Buyer becomes aware of any event or circumstance that makes any portion of the Financing unavailable, in each case, on the terms and conditions contemplated in the Commitment Letters and such portion is reasonably required to
consummate the Transactions and the other transactions contemplated by this Agreement, Buyer shall promptly notify Seller Parent and shall use its reasonable best efforts to arrange alternative financing as promptly as practicable from the same or
alternative sources in an amount sufficient to consummate the transactions contemplated under this Agreement (the
Alternative Financing
) and all references to Financing shall be deemed to include such Alternative Financing and all
references to the Commitment Letters and Definitive Agreements shall include the applicable documents for the Alternative Financing;
provided
,
however
, that (x) Buyer shall not be required to obtain financing which includes terms
and conditions less favorable (taking into account any market flex provision) to Buyer, taken as a whole, relative to those in the Financing being replaced and (y) such Alternative Financing shall comply with the provisions of
Section
6.6(a)
. Buyer shall give Seller Parent prompt oral and written notice of any material breach or default by any party to any Commitment Letter or Definitive Agreement of which Buyer becomes aware or any termination
or waiver, amendment or other modification of any Commitment Letter or Definitive Agreement. Buyer shall keep Seller Parent reasonably informed of the status of its effort to arrange the Financing and shall provide to Seller Parent copies of all
material, final definitive documents related to the Financing (excluding fee letters, except to the extent that such documents contain any conditions to funding or other substantive provisions regarding the terms and conditions of the Financing). In
the event that Buyer commences an enforcement action to enforce its rights under any Commitment Letter or Definitive Agreement and/or cause any Financing Source to fund the Financing, Buyer shall keep Seller Parent reasonably informed of the status
of such enforcement action.
(d) During the
Pre-Closing
Period, Seller Parent will use its
commercially reasonable efforts to provide, and cause its Affiliates to provide, to Buyer all cooperation reasonably requested by Buyer that is necessary in connection with obtaining the Financing and causing the conditions in the Commitment Letters
to be satisfied, including in (i) preparing and furnishing to Buyer and the Financing Sources as promptly as practicable all customary information and disclosures relating to the Business as may be reasonably requested by Buyer, and
(ii) cooperating with Buyer to satisfy the conditions precedent to the Financing or set forth in any Definitive Agreement, to the extent within the control of Seller Parent or its Affiliates, and taking all corporate or other entity actions
reasonably requested by Buyer to permit the consummation of the Financing. Notwithstanding the foregoing, (1) such requested cooperation shall not unreasonably interfere with the ongoing business and operations of Seller Parent or any of its
Affiliates, (2) none of Seller Parent or any of its Affiliates or any of its and its respective Affiliates respective officers, directors, employees, accountants, consultants, legal counsel, agents, investment bankers and other
representatives shall be required to bear any cost or expense, pay any commitment or other fee or incur any other liability or obligation or agree to provide any indemnity in
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connection with the Financing (except to the extent Buyer promptly reimburses (in the case of ordinary course
out-of-pocket
costs and expenses) or provides the funding (in all other cases) to Seller Parent or such Affiliate therefor), (3) none of Seller Parent or any of its
Affiliates or any of its and its respective Affiliates respective officers, directors or employees shall be required to execute or enter into or perform any agreement, document or instrument, deliver any certificate or opinion or take any
corporate or other organizational action (including the adoption of any resolutions) to authorize the execution, entering into or performance of any such agreement, document or instrument, in either case, with respect to the Financing, (4) such
assistance shall not include any actions that cause any representation, warranty, covenant or other obligation in this Agreement to be breached by Seller Parent, or any condition to the Closing hereunder to fail to be satisfied by such parties,
(5) such assistance shall not cause any director, officer or employee of Seller Parent or any of its Affiliates to incur any personal liability, (6) such assistance shall not conflict with or violate any Laws or require Seller Parent or
any of its Affiliates to disclose information subject to any attorney-client, attorney work product or other legal privilege, and (7) such assistance shall not conflict with or violate Seller Parents or any of its Affiliates
Organizational Documents or result in the contravention of, or that would reasonably be expected to result in the violation or breach of, or a default under, any contract (including any confidentiality agreement) to which Seller Parent or any of its
Affiliates is a party.
(e) Buyer shall promptly (i) upon request by Seller Parent, reimburse Seller Parent for all reasonable
out-of-pocket
costs (including reasonable attorneys fees) incurred by Seller Parent, any of Seller Parents Affiliates or their respective Representatives in
connection with the cooperation of Seller Parent and its Subsidiaries and their Representatives contemplated by this
Section
6.6
and (ii) indemnify and hold harmless Seller Parent, Seller Parents Affiliates and
their respective Representatives from and against any and all liabilities, losses, damages, claims, costs, expenses, interest, awards, judgments and penalties (collectively, the
Indemnifiable Liabilities
) suffered or incurred by
any of them in connection with any claims asserted by the Financing Sources in connection with the arrangement of the Financing (other than to the extent such Indemnifiable Liabilities arise from the willful misconduct of or breach of this Agreement
by Seller Parent, any of Seller Parents Affiliates or their respective Representatives) and any information used in connection therewith. All
non-public
or other confidential information provided by
Seller Parent to Buyer, its Representatives or its Financing Sources pursuant to this
Section
6.6
shall be kept confidential in accordance with the Confidentiality Agreement. The obligations under this
Section
6.6(e)
shall survive the termination of this Agreement.
6.7.
Intercompany Accounts; Cas
h
. At or prior to the Closing, (a) all intercompany accounts between Seller Parent and/or any of its Affiliates (other than the Transferred Group), on the one hand, and any member of the Transferred
Group, on the other hand, shall be settled or otherwise eliminated, and (b) any and all cash and cash equivalents may be extracted by Seller Parent from the Transferred Group, in each case in such a manner as Seller Parent shall determine in
its sole discretion (but in any event, in a manner that would not reasonably be expected to impair the operation of the Business), and no party shall have any further liability with respect thereto. Intercompany accounts between and among members of
the Transferred Group shall not be affected by this provision.
6.8.
Pre-Closing
Restructuring of the Excluded Business
. Prior to the Closing, Seller Parent shall, or shall cause its Affiliates to, transfer, convey, assign or distribute all assets and liabilities
primarily relating to the Excluded Business from the Transferred Group, as applicable, to an Affiliate of Seller, and such Affiliate shall assume all such liabilities, in each case pursuant to documentation that is reasonably acceptable in form and
substance to Buyer.
6.9.
Termination of Intercompany Arrangements
. Effective at the Closing, other
than any intercompany accounts governed by
Section
6.7
, all arrangements, understandings or Contracts, including all obligations to provide goods, services or other benefits, by Seller Parent and/or any of its Affiliates
(other than the Transferred Group), on the one hand, and any member of the Transferred Group, on the other hand, including any and all such arrangements set forth in
Section
4.21
of the Seller Disclosure Letter, shall be
terminated without any party
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having any continuing obligations or liability to the other, except for this Agreement and the Ancillary Agreements.
6.10.
Proxy Statement; Special Meeting
. (a) Buyer shall, in accordance with applicable Law and
Buyers Organizational Documents: (i) prepare and file with the SEC no later than five (5) Business Days following the date of this Agreement, a preliminary proxy statement relating to the solicitation of proxies from the stockholders
of Buyer for the Buyer Stockholder Approval and (A) respond promptly to any comments made by the SEC with respect to the preliminary proxy statement and cause a definitive proxy statement (the
Proxy Statement
) to be mailed to
Buyers stockholders no later than the later of (x) the expiration of the ten
(10)-day
period required by SEC Rule
14a-6
and (y) if the SEC advises Buyer
that it will review the preliminary proxy statement, the day following the SEC staffs clearance of the preliminary proxy statement (the
Mailing Date
) and (B) solicit proxies from its stockholders for the Buyer
Stockholder Approval and (ii) cause a special meeting of its stockholders (the
Special Meeting
) to be duly called, noticed and held no later than the twelfth (12th) day following the Mailing Date for the purpose of obtaining
the Buyer Stockholder Approval. The Proxy Statement shall include the recommendation of the Board of Directors of Buyer that stockholders vote in favor of the issuance of Buyer Common Stock pursuant to this Agreement and the Financing. The Proxy
Statement shall not incorporate by reference any information from any other filing made with the SEC. Seller Parent shall furnish to Buyer all information concerning Seller Parent and its Subsidiaries as Buyer may reasonably request in connection
with the preparation of the Proxy Statement. Prior to filing the Proxy Statement or mailing the Proxy Statement (or any amendment or supplement thereto) or responding to any comments of the SEC with respect thereto, Buyer shall provide Seller Parent
with an opportunity to review and comment on such document or response.
(b) Buyer shall comply with all applicable provisions of and
rules under the Exchange Act and all applicable provisions of the DGCL in the preparation, filing and distribution of the Proxy Statement, the solicitation of proxies thereunder, and the calling and holding of the Special Meeting. Without limiting
the foregoing, Buyer shall ensure that the Proxy Statement will not, as of the filing date of the Proxy Statement (or any amendment or supplement thereto) or as of the date of the Special Meeting, contain any untrue statement of a material fact or
omit to state a material fact necessary in order to make the statements made, in the light of the circumstances under which they were made, not misleading (
provided
that Buyer shall not be responsible for the accuracy or completeness of any
information relating to Seller Parent furnished by Seller Parent for inclusion in the Proxy Statement).
(c) Neither Buyer nor the Board
of Directors of Buyer shall (i) fail to (A) call, notice or hold the Special Meeting, (B) prepare and file with the SEC the preliminary or definitive Proxy Statement and include in the Proxy Statement the recommendation of the Board
of Directors of Buyer that stockholders vote in favor of the issuance of Buyer Common Stock, all as required and pursuant to this Agreement, (C) solicit proxies from its stockholders for the Buyer Stockholder Approval or (ii) withdraw,
modify or qualify, or propose publicly to withdraw, modify or qualify, in a manner adverse to Seller Parent, its recommendation that Buyers stockholders approve the issuance of Buyer Common Stock pursuant to this Agreement and the Financing in
accordance with NASDAQ Rule 5635.
6.11.
Listing of Buyer Common Stock
. Buyer shall use its best
efforts to cause Buyer Common Stock to be issued pursuant to this Agreement to be approved for listing on NASDAQ, subject only to official notice of issuance, prior to the Closing.
6.12.
Spin-Off
. To the extent Seller Parent shall determine to
spin-off
or otherwise dispose of the Excluded Assets following the Closing, Buyer will in good faith evaluate participation in the financing of such enterprise.
6.13.
Cooperation in Prosecution and Litigation
.
(a)
Cooperation in Prosecution
. From and after the Closing Date, Sellers shall cooperate with Buyer and its Affiliates in the
prosecution and maintenance of the Transferred Intellectual Property. Each Seller shall
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use commercially reasonable efforts to make available to Buyer (or to Buyers authorized attorneys, agents or representatives) the employees, agents or consultants of such Seller or its
Affiliates to the extent reasonably necessary to enable Buyer to prepare, file, prosecute and maintain all Transferred Intellectual Property. In addition, if requested by Buyer, each Seller shall perform, and shall cause its Affiliates to perform,
such commercially reasonable acts (including signing or causing to have signed all documents necessary) for Buyer and its Affiliates to prepare, file, prosecute and maintain all such Transferred Intellectual Property.
(b)
Cooperation in Litigation
. From and after the Closing Date, Sellers and Buyer shall reasonably cooperate with each other in the
defense or prosecution of any Proceedings, examination or audit instituted prior to the Closing or that may be instituted thereafter against or by either Party relating to or arising out of the conduct of the Business, the Products, or the
Transferred Intellectual Property prior to or after the Closing (other than Actions between a Seller and Buyer or their respective Affiliates arising out of this Agreement and the Ancillary Agreements, with respect to which applicable rules of
discovery shall apply). In connection therewith, from and after the Closing Date, each of Sellers and Buyer shall, and shall cause its Controlled Affiliates to, make available to the other during normal business hours and upon reasonable prior
written notice, but without unreasonably disrupting its business, all records to the extent relating to the Business, Acquired Assets, the Assumed Liabilities, the Excluded Assets (to the extent related to the Business), and the Excluded Liabilities
(to the extent related to the Business) held by it and reasonably necessary to permit the defense or investigation of any such Proceedings, examination or audit (other than Actions between a Seller and Buyer or their respective Affiliates arising
out of this Agreement or the Ancillary Agreements, with respect to which applicable rules of discovery shall apply), and shall, and shall cause its Controlled Affiliates to, preserve and retain all such records for the length of time contemplated by
its standard record retention policies and schedules;
provided
that neither Sellers nor Buyer shall be obligated pursuant to this
Section
6.13
to disclose any document or information, the disclosure of which would
violate the terms of any binding confidentiality agreements the disclosing Party is subject to or violate the attorney-client privilege of the disclosing Party. In addition, with respect to Proceedings relating to the Transferred Intellectual
Property, including Proceedings related to the filing of ANDAs or Section 505(b)(2) NDAs related to the Products or any similar actions before any Governmental Authority or Regulatory Authority, Sellers shall reasonably cooperate with Buyer by
(i) providing reasonable access to Buyer (and its Affiliates and counsel) to the records and information of Sellers and their Affiliates that are reasonably relevant to such Proceedings, (ii) providing reasonable access to the employees
and contractors of Sellers and their Affiliates for providing information that is reasonably relevant to such Proceedings, including making a reasonable number of employees and/or contractors available to appear at depositions and/or trial in such
Proceedings, and (iii) to execute all necessary and proper papers and instruments, and to make all rightful oaths and declarations, as may be necessary in such Proceedings, in each of cases (i), (ii) and (iii) to the extent within
Sellers control and at Buyers expense.
(c) The Party requesting cooperation pursuant to this
Section
6.13
shall pay the reasonable
out-of-pocket
costs and expenses of providing such cooperation (including reasonable legal fees and
disbursements and reasonably necessary costs of any redactions required in the event requested materials are mixed with other sensitive information of the disclosing party) incurred by the Party providing such cooperation and by its Representatives.
6.14.
Intellectual Property License
.
(a) To the extent that the Transferred Intellectual Property includes Patent Rights and Trade Secrets which are necessary for the Excluded
Business (
Excluded Business IP
), Buyer hereby grants to Seller Parent and its Affiliates (such grant to become effective at the Closing) a perpetual, royalty-free, fully paid up,
non-exclusive,
non-transferable
and
non-sublicensable
(except as provided in
sub-paragraph
(c) below) license to use and otherwise exploit the Excluded Business IP solely in connection with the operation of the Excluded Business.
(b) Seller Parent agrees not to disclose to any third party any Trade Secrets or other confidential information included in the Excluded
Business IP, treating such Excluded Business IP in the same manner (but in
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no event using less than a commercially reasonable degree of care) as Seller Parent treats other similarly sensitive Intellectual Property owned by Seller Parent;
provided
,
however
that Seller Parent may make such information available (i) to potential acquirors, licensees or transferees in connection with the proposed sale, license or other transfer of all or any part of the Excluded Business or (ii) to any third
party vendor, in each case provided that such information is made available to such Person pursuant to a customary confidentiality agreement and provided that Seller Parent remains liable to Buyer for any breach of such confidentiality agreements.
(c) The license granted to Seller Parent pursuant to this
Section
6.14
may not be assigned, sublicensed or
otherwise transferred by Seller Parent without the prior written consent of Buyer, which consent shall not be unreasonably withheld, conditioned or delayed;
provided
, that without such consent, Seller Parent may assign, sublicense or
otherwise transfer its rights and obligations under this
Section
6.14
to an Affiliate or to a third party in connection with a sale or transfer of substantially all of the assets related to the Excluded Business (whether by
sale of assets, stock, merger or otherwise) and the license may be sublicensed to third party vendors performing research, development, supply or similar activities for the Excluded Business as are customary in the industry. The license granted
pursuant to this
Section
6.14
shall be binding upon and inure to the benefit of the parties hereto and their respective permitted successors and permitted assigns. Any attempted assignment or transfer in violation of this
license granted pursuant to this
Section
6.14
shall be void
ab initio
.
ARTICLE VII.
EMPLOYEE MATTERS
7.1.
Transfer of Employee
s
. Prior to the Closing, but effective as of the Closing, Buyer shall, or shall cause one of its Controlled Affiliates to, make an offer of employment to each Business Employee that is identified by Buyer
in a notice delivered to Sellers not more than thirty (30) days after the date hereof and in any event at least fifteen (15) days prior to the Closing, conditioned on such Business Employee satisfactorily completing Buyers standard
hiring procedures (as determined in good faith), including any
pre-employment
background checks or other onboarding requirements, for a position consistent with such Business Employees position as of
immediately prior to the Closing and on terms consistent with those set forth in this
ARTICLE VII
, effective immediately following the Closing;
provided
that, unless required by applicable Law, any such offer of employment to a
Business Employee who is not actively at work as of the Closing due to an approved leave of absence will be effective on the date after the Closing on which such Business Employee returns to active employment (the
Transfer Date
),
so long as such date is within six (6) months following the Closing Date. Effective as of the Closing or the Transfer Date, as applicable, Sellers and their Affiliates, as applicable, shall (i) treat each Business Employee who accepts an
offer of employment from Buyer or any of its Controlled Affiliates as having resigned his or her employment and (ii) transfer the employment of each employee of any member of the Transferred Group who is not a Business Employee and of any
Business Employee who is employed by any member of the Transferred Group who is not listed on the notice delivered to Seller as contemplated in the immediately preceding sentence, in each case, to Seller Parent or any of its Affiliates, other than
any member of the Transferred Group. Buyer shall provide Seller Parent with a form of offer letter to be used to make such offers of employment a reasonable time prior to the distribution of offer letters, and Buyer shall consider Seller
Parents reasonable comments to such form in good faith. None of Buyer or its Affiliates (including, on or following the Closing, any entity within the Transferred Group) shall have any Liability for severance pay or benefits with respect to
any Business Employee who does not become a Continuing Employee hereunder (including, for the avoidance of doubt, any Business Employee who does not receive or rejects an offer of employment with Buyer or its Affiliates) and each employee of any
member of the Transferred Group who is not a Business Employee. Sellers shall cooperate with Buyer with respect to the offer process described in this
Section
7.1
. For the purposes of this Agreement, each Business Employee
who accepts employment with Buyer or its Controlled Affiliates or otherwise becomes employed by Buyer or its Controlled Affiliates as of the Closing or the Transfer Date, as applicable (including, on or following the Closing, any entity within the
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Transferred Group), shall be a
Continuing Employee
. As of the Closing, the Transferred Group shall employ no
Non-Business
Employees.
Immediately as of the Closing or the Transfer Date, as applicable, the Continuing Employees shall cease to participate in or accrue further benefits under any Seller Benefit Plan and none of Buyer or its Affiliates (including, on or following the
Closing, any entity within the Transferred Group) shall assume or be transferred the sponsorship of any Seller Benefit Plan or any Liability with respect thereto in connection with the transactions contemplated by this Agreement or otherwise. To the
extent necessary for any Continuing Employee to perform services in connection with such Continuing Employees employment with Buyer, Seller Parent or its Affiliates shall release each Continuing Employee from any existing
non-competition,
non-solicitation
or confidentiality obligation solely with respect to any confidential information of the Business owed to Seller Parent or any of its
Affiliates.
7.2.
Compensation and Benefit
s
. Effective as of the Closing or the Transfer
Date, as applicable, and through the first anniversary of the Closing, Buyer shall provide, or shall cause its Controlled Affiliates to provide, to each Continuing Employee who remains employed by Buyer or one of its Controlled Affiliates,
(a) a base salary or wage rate that is not less than the base salary or wage rate in effect for such Continuing Employee immediately prior to the Closing, (b) annual cash bonus opportunities (excluding
change-in-control,
transaction and retention-related bonus opportunities) that, in the aggregate, are no less favorable than those provided to similarly-situated employees of Buyer or its Controlled
Affiliates, (c) severance pay and benefits that would have been applicable to such Continuing Employee under the Seller Benefit Plan in effect as of immediately prior to the Closing and disclosed on
Schedule 7.2
and (d) employee
benefits (excluding severance, bonus, change in control, transaction, equity or equity-based, deferred compensation arrangements, retiree health and welfare benefits, defined benefit pension plans and retention-related benefits) that are, in the
aggregate, substantially comparable to those provided to such Continuing Employees immediately prior to the Closing or consistent with those provided to similarly situated employees of Buyer.
7.3.
Service Credit
. Effective as of the Closing or the Transfer Date, as applicable, and thereafter,
Buyer shall, or shall cause a Controlled Affiliate to, use commercially reasonable efforts to recognize for each Continuing Employee those periods of employment with a Seller or any Affiliate of a Seller to the same extent such service was
recognized by Sellers or their Affiliates for vesting and eligibility and level of benefits purposes under all Benefit Plans maintained by Buyer or its Controlled Affiliates, including vacation or other
paid-time-off
plans or arrangements, 401(k), pension or other retirement plans and any severance or health or welfare plans (other than for purposes of determining any accrued benefit under any defined benefit
pension plan, or for purposes of vesting for equity-based awards);
provided
,
however
, that such service will not be credited: (a) to the extent such service credit would result in a duplication of benefits; (b) where such
service was not recognized under a comparable Benefit Plan maintained by Seller or any Affiliate of Seller immediately prior to the Closing; or (c) to the extent employees of Buyer and its Controlled Affiliates (other than any member of the
Transferred Group) who are similarly situated to the Continuing Employees are not provided such credit for service;
provided
,
further
,
however
, clauses (b) and (c) of this sentence shall not apply to the severance pay and
benefits contemplated by
Section
7.2(c)
.
7.4.
Welfare Plans
. Effective as
of the Closing or the Transfer Date, as applicable, and thereafter, Buyer shall, or shall cause a Controlled Affiliate to, use commercially reasonable efforts to (a) ensure that no eligibility waiting periods,
actively-at-work
requirements or
pre-existing
condition limitations or exclusions shall apply with respect to the Continuing Employees under the applicable health and
welfare benefits plan of Buyer or any of its Controlled Affiliates (except to the extent such terms are applicable under the Seller Benefit Plans that such Continuing Employees participated in immediately prior to the Closing), (b) waive any
and all evidence of insurability requirements with respect to the Continuing Employees to the extent such evidence of insurability requirements were not applicable to the Continuing Employees under the Seller Benefit Plans that such Continuing
Employees participated in immediately prior to the Closing, and (c) credit each Continuing Employee with all deductible payments,
out-of-pocket
or other
co-payments
paid by such Continuing Employee under the Seller Benefit Plans that each such Continuing Employee participated in prior to the Closing during the year in which the Closing occurs for the purpose of
determining the extent to which any such employee has satisfied his
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or her deductible and whether he or she has reached the
out-of-pocket
maximum under any health benefit plan of
Buyer or any of its Controlled Affiliates for such year. As soon as practicable, but in no event later than ten (10) Business Days following, the Closing Date, Seller or Sellers applicable insurance carrier shall provide Buyer or
Buyers group health plan (in a format useable by Buyers insurance carrier) with a report or other documentation setting forth as of the Closing Date all deductible payments,
out-of-pocket
or other copayments toward
out-of-pocket
maximums paid by Continuing
Employees for the plan year in which the Closing occurs under the Benefit Plans that are employee welfare benefit plans.
7.5.
Paid Time Off
. Seller or one of its Affiliates shall make a payment to each Continuing Employee in respect of his or her accrued but unused paid time off immediately prior to the Closing without any Liability to Buyer and Buyer shall
not be required to credit such Continuing Employee with accrued but unused paid time off.
7.6.
Defined
Contribution Plan
s
. Buyer shall use commercially reasonable efforts to cause each Continuing Employee who is a participant in a Seller Benefit Plan intended to qualify under Section 401(a) of the Code that includes a cash or deferred
arrangement intended to satisfy the provisions of Section 401(k) of the Code (the
Seller 401(k) Plan
) to be allowed to participate, effective as of the Closing or the Transfer Date, as applicable, in a tax qualified plan
which includes a cash or deferred arrangement intended to satisfy the provisions of Section 401(k) of the Code that is sponsored and maintained by Buyer or an Affiliate thereof (the
Buyer 401(k) Plan
). In addition, to the
extent permitted by the terms of the Buyer 401(k) Plan, Buyer shall cause the Buyer 401(k) Plan to accept rollover contributions of eligible rollover distributions (within the meaning of Section 401(a)(31) of the Code, inclusive of
loans) from the Seller 401(k) Plan.
7.7.
Flexible Spending Accounts
. To the extent any Continuing
Employee is participating in a Seller Benefit Plan that provides for qualified flexible spending accounts for medical or dependent care expenses as of the Closing, Buyer shall use commercially reasonable efforts to permit each such Continuing
Employee, effective as of the Closing Date or the Transfer Date, as applicable, and to the extent there exist a similar Buyer Benefit Plan, to be eligible to participate in an employee benefit plan maintained by Buyer or its Controlled Affiliates
that provides for qualified flexible spending accounts for medical or dependent care expenses, as applicable. Buyer shall credit such accounts with the amount (positive or negative) credited as of the Closing Date or the Transfer Date, as
applicable, under comparable accounts maintained under Seller Benefit Plans from the beginning of the applicable plan year to the Closing Date or the Transfer Date, as applicable. As soon as practicable after the Closing Date or the Transfer Date,
as applicable, (a) Seller Parent shall pay to Buyer in cash the amount, if any, by which aggregate contributions made by Continuing Employees to flexible spending accounts under Seller Benefit Plans exceeded the aggregate benefits provided to
Continuing Employees as of the Closing or the Transfer Date, as applicable, or (b) Buyer shall pay to Seller Parent in cash the amount, if any, by which aggregate benefits provided to Continuing Employees under flexible spending accounts under
Seller Benefit Plans exceeded the aggregate contributions made by Continuing Employees as of the Closing or the Transfer Date, as applicable.
7.8.
WARN Ac
t
. At or prior to the Closing, Seller Parent agrees to provide any required notice to
Business Employees under the U.S. Worker Adjustment and Retraining Notification Act or any other similar displaced worker notification Laws (
WARN
). Seller Parent shall indemnify and hold harmless Buyer and its Affiliates with
respect to any Liability under WARN arising from the actions (or inactions) of Seller Parent or its Affiliates prior to or at the Closing (including, for the avoidance of doubt, any Liability under WARN with respect to any Business Employee who does
not become a Continuing Employee hereunder (including, for the avoidance of doubt, any Business Employee who does not receive or rejects an offer of employment with Buyer or its Affiliates) and each employee of any member of the Transferred Group
who is not a Business Employee). At the Closing, Seller Parent will provide to Buyer a list of the name and site of employment of any employees of Sellers or their Affiliates who have experienced or will experience an employment loss or layoff (as
defined in WARN) within ninety (90) days prior to the Closing and who are located at a site of employment where Continuing Employees will be located following the Closing, along with the date of the employment loss or
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layoff. Following the Closing, Buyer or its Controlled Affiliates, as applicable, will be responsible for providing any required notice to Business Employees under WARN. Buyer shall indemnify and
hold harmless Sellers and their Affiliates with respect to any Liability under WARN arising from the actions (or inactions) of Buyer or its Affiliates after the Closing, except to the extent resulting from any error or omission in the list provided
by Sellers pursuant to the second sentence of this
Section
7.8
.
7.9.
No Third
Party Beneficiarie
s
. Nothing contained in this Agreement, whether express or implied, shall: (a) be treated as an amendment or modification of any Benefit Plan; (b) without limiting the generality of
Section
13.7
, give any Person (including, without limitation, any current or former employee, any Business Employee or any other individual associated therewith or any Benefit Plan or trustee thereof) other than a Party,
any right to enforce the provisions of this
ARTICLE VII
; (c) modify the
at-will
nature of any employees employment; or (d) obligate any Seller or Buyer or any of their respective
Affiliates to (i) maintain any particular Benefit Plan, (ii) refrain from amending or terminating any particular Benefit Plan, (iii) retain the employment of any particular employee or (iv) refrain from changing the terms and
conditions of employment.
ARTICLE VIII.
TAX MATTERS
8.1.
Transfer Taxe
s
. All Transfer Taxes shall be borne fifty percent (50%) by Buyer and fifty percent (50%) by Seller. Seller Parent and Buyer shall cooperate to timely prepare any Tax Returns relating to such Transfer Taxes,
including any claim for exemption or exclusion from the imposition of any Transfer Taxes. The party responsible under applicable Law will file any Tax Returns with respect to Transfer Taxes, and promptly following the filing thereof, any such party
will furnish to the other party a copy of such Tax Return and a copy of a receipt showing payment of any such Transfer Tax. The
non-filing
party shall pay to the filing party, not later than five
(5) Business Days before the due date for payment of such Transfer Taxes, an amount equal to fifty percent (50%) of the Transfer Taxes shown on such Tax Return, and the filing party will furnish to the
non-filing
party a copy of such Tax Return and a copy of a receipt showing payment of any such Transfer Tax.
8.2.
Tax Returns
. (a) In accordance with past practice (except as otherwise required by applicable
Law, the Section 338(h)(10) Election, and the Allocation Schedule), Sellers will prepare and timely file all Tax Returns with respect to the members of the Transferred Group, the Acquired Assets (other than the Transferred Group) and the
Business (other than any Tax Return relating to Transfer Taxes governed by
Section
8.1
) that are required to be filed (taking into account any applicable extensions) after the Closing Date and (i) are Consolidated Tax
Returns, or (ii) are required to be filed by or with respect to any member of the Transferred Group on a separate Tax Return basis for any taxable period ending on or before the Closing Date (the Tax Returns referenced in clause (ii), the
Pre-Closing
Separate Tax Returns
), except that, to the extent Buyer is required by applicable Law to file such
Pre-Closing
Separate Tax Return,
Sellers shall deliver a draft of such Tax Return to Buyer for Buyers review and comment at least fifteen (15) days prior to the due date for filing such Tax Return (taking into account any applicable extensions). Sellers shall reflect on
such Tax return any reasonable comments submitted by Buyer at least five (5) days before the due date of such Tax Return, and Buyer shall timely file such Tax Return as revised. All Tax Returns with respect to the Transferred Group, Acquired
Assets (other than the Transferred Entities) or the Business that are required to be filed on a separate Tax Return basis for any Straddle Period shall be filed on the basis that the relevant taxable period ended as of the close of the Closing Date
(
Closing Date Tax Return
), unless the relevant Taxing Authority will not accept a Closing Date Tax Return. Sellers will prepare and timely file all Closing Date Tax Returns with the relevant Taxing Authority. In accordance with
past practice (except as otherwise required by applicable Law, the Section 338(h)(10) Election, and the Allocation Schedule), Buyer will prepare and timely file all other such Tax Returns for a Straddle Period on a basis consistent with past
practice, and Buyer will deliver to Sellers at least fifteen (15) days prior to the due date for the filing of any such Tax Return (taking into account any applicable extensions) a statement setting forth the amount of Tax for which Sellers are
responsible consistent with
Section
8.2
and a copy of such Tax
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Return. Buyer will reflect on such Tax Return any reasonable comments submitted by Sellers at least five (5) days prior to the due date of such Tax Return.
(b)
Sellers will pay all
Pre-Closing
Taxes
. At least three (3) days prior to the due date
for a
Pre-Closing
Separate Tax Return prepared by Sellers and filed by Buyer pursuant to Section 8.2(a), Sellers will pay Buyer an amount equal to the Taxes that are
Pre-Closing
Taxes shown on such Tax Return. At least three (3) days prior to the due date for a Tax Return for a Straddle Period prepared and filed by Buyer, Sellers will pay their portion of the Taxes
that are
Pre-Closing
Taxes due with respect to such Tax Return to Buyer, as determined under
Section
8.2
.
8.3.
Straddle Period Taxe
s
. In any case where the relevant Taxing Authority will not accept a
Closing Date Tax Return, the Taxes of Sellers and Buyer shall be allocated between the
Pre-Closing
Tax Period and the Post-Closing Tax Period as follows: (i) in the case of any Property Taxes, Taxes
attributable to the
Pre-Closing
Tax Period shall equal the Property Taxes for such Straddle Period multiplied by a fraction, the numerator of which is the number of days during the Straddle Period that are in
the
Pre-Closing
Tax Period and the denominator of which is the number of days in the Straddle Period; and (ii) all other Taxes attributable to the
Pre-Closing
Tax
Period shall be computed as if the Straddle Period ended as of the close of the Closing Date.
8.4.
Tax
Cooperation and Contests
. (a) Subject to
Section
9.1
, Buyer and Sellers agree to furnish or cause their Affiliates to furnish, to each other, upon request, as promptly as practicable, such information and
assistance relating to the Acquired Assets, the Business, or the Transferred Group as is reasonably necessary for the filing of all Tax Returns and other Tax filings, the preparation for any audit by any Taxing Authority and the defense of any Claim
or Proceeding relating to Taxes of the Acquired Assets, the Business, or the Transferred Group;
provided
that Buyer will not be permitted to inspect or otherwise review any Consolidated Tax Return and that Seller Parent and its Affiliates
will not be permitted to inspect or otherwise review any Tax Return reflecting the activities or operations of any Person other than the members of the Transferred Group.
(b) Buyer shall promptly notify Seller Parent in writing of the commencement of any audit or examination of any
Pre-Closing
Separate Tax Return and any other proposed change, adjustment, claim, dispute, arbitration or litigation that, if sustained, would reasonably be expected to give rise to a claim for indemnification
in respect of Taxes under this Agreement (each, a
Tax Claim
);
provided
,
however
, that any failure by Buyer to so notify Seller Parent shall not relieve Seller Parent of any of its indemnification obligations under
this Agreement, except to the extent that Seller Parent is actually prejudiced as a result of such failure. Such notice shall describe the asserted Tax Claim in reasonable detail and shall include copies of any notices and other documents
received from any Taxing Authority in respect of any such asserted Tax Claim. Seller Parent shall have the right to control any audit, examination, or other proceeding relating to a Tax Claim that arises in connection with a
Pre-Closing
Separate Tax Return;
provided
,
however
, that (i) Seller Parent shall inform Buyer of the status and progress of such proceedings, (ii) Buyer shall have the opportunity to
participate in such proceedings at its expense, and (iii) Seller Parent shall not settle any Tax Claim (either at the audit or examination stage or thereafter) without first obtaining Buyers consent (which consent shall not be
unreasonably withheld, conditioned or delayed). Buyer and Seller Parent shall have the right to control jointly any audit, examination, or other proceeding relating to a Tax Claim that arises in connection with a Straddle Period Tax Return. In the
event that Seller Parent does not exercise its control rights set forth in this
Section
8.4(b)
, Buyer shall have the right to control such Tax Claim.
8.5.
Tax Refund
. Any Tax refunds and credits related to the Acquired Assets, the Business or Transferred
Group (including any interest paid or credited with respect thereto) for any
Pre-Closing
Tax Period shall be the property of Seller Parent. Buyer shall cause the amount of such refund or credit (net of any Tax
or reasonable third-party costs of Buyer or its Affiliates solely attributable to obtaining and receiving such benefit) to be paid to Seller Parent within thirty (30) days after receipt thereof. To the extent such refund or credit is
subsequently disallowed or required to be returned to the applicable Governmental Authority, Seller Parent agrees to promptly repay the amount of such refund, together with any interest, penalties or other additional amounts imposed by such
Governmental Authority, to Buyer or its Affiliates, as applicable.
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8.6.
Section 338(h)(10) Electio
n
. At the
request of Buyer, Seller Parent or its Affiliates shall join with Buyer in making an election under Section 338(h)(10) of the Code (and any corresponding elections under state or local Tax law) (collectively, a
Section
338(h)(10) Election
) with respect to the transfer of the interests in the members of the Transferred Group that are taxable as domestic corporations (such members, the
Subject
Entities
) under the Code pursuant to this Agreement. In the event that a Section 338(h)(10) Election is made, (a) Seller Parent and Buyer agree to take all actions necessary or appropriate, including properly completing and
executing IRS Form 8023 and all other forms and documents required by applicable Law, to make the Section 338(h)(10) Election with respect to the sale of the interests of each Subject Entity with respect to which a Section 338(h)(10)
Election is made pursuant to this Agreement, (b) Seller Parent and Buyer will exchange completed and executed copies of IRS Forms 8023 and all other relevant forms and documents, not later than thirty (30) days prior to the due date, and
(c) Seller Parent and Buyer will report the sale of the interests of each Subject Entity with respect to which a Section 338(h)(10) Election is made pursuant to this Agreement consistent with such Section 338(h)(10) Election and shall
take no position contrary thereto unless, and then only to the extent, required by a Final Determination.
8.7.
Miscellaneous
.
After the Closing, except as required under applicable Law, Buyer shall not,
and shall not cause or permit any of its Affiliates to (a) make, change or revoke any Tax election with respect to any member of the Transferred Group, the Acquired Assets or the Business that could increase the amount of
Pre-Closing
Taxes, or (b) grant an extension of any applicable statute of limitations that relates to Taxes with respect to any member of the Transferred Group, the Acquired Assets or the Business that relates
to a
Pre-Closing
Tax Period, without the prior written consent of Seller Parent, such consent not to be unreasonably withheld, delayed or conditioned. Buyer shall not, and shall not cause or permit any
Affiliate (including any Transferred Entity) to, take any action on the Closing Date other than in the ordinary course of business. Buyer shall not, without the prior written consent of Seller Parent, make or file an election under
Section 338(g) of the Code (and any corresponding elections under state or local Tax law) with respect to any member of the Transferred Group.
8.8.
Tax Provision Priority
. To the extent that this
Article VIII
conflicts with any other
provision in this Agreement, this
Article VIII
shall govern.
ARTICLE IX.
OTHER AGREEMENTS
9.1.
Books and Records; Access; Assistance
. (a) Subject to any limitations imposed by Law, including limitations that are required to preserve any applicable attorney-client privilege, and subject to
Section
13.3
, after the Closing, as applicable, Buyer and Sellers shall, at no cost to the other, make reasonably available (x) to each other and their respective Affiliates and Representatives, as reasonably requested
and, in the case of Sellers, only in connection with the preparation of Tax Returns, the preparation of financial statements, or any investigations or litigation brought by a Governmental Authority, and (y) to any Taxing Authority or any other
Governmental Authority, in each case all books and records to the extent related to the Business, the Transferred Group, the Transferred Group Assets, the Acquired Assets or the Assumed Liabilities for all periods prior to the Closing Date (other
than any Consolidated Tax Returns) and shall use reasonable best efforts to preserve, for at least six (6) years after the Closing Date or, if applicable and later, the expiration of the applicable statutes of limitations or extensions thereof:
(i) all such books and records, (ii) Tax Returns solely pertaining to the Business, the Transferred Group, the Transferred Group Assets, the Acquired Assets or the Products (other than any Consolidated Tax Returns) and
(iii) government Contract information, records or documents, to the extent relating to the Business, the Transferred Group, the Transferred Group Assets, the Acquired Assets or the Assumed Liabilities, for the required retention period. Buyer
and Sellers shall also make available to each other for such period, during normal business hours when reasonably requested and, in the case of Sellers, only in connection with the preparation of Tax Returns, the preparation of financial statements,
or any investigations or
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litigation brought by a Governmental Authority, personnel responsible for preparing or maintaining such information, records and documents, in each case as it relates to the Business, including
product Liability and general insurance Liability. Sellers shall have the right to retain copies of all information and documents provided by Sellers to Buyer pursuant to
Section
2.1
, subject to
Section
13.3
. The right to access provided by this
Section
9.1
shall include the right to make copies of accessed documents,
provided
that all such copies shall be at the sole cost and
expense of the requesting Party. The Party providing access under this
Section
9.1
shall have the right to reasonably redact all such documents.
(b) Notwithstanding the foregoing, this
Section
9.1
shall not provide Buyer or any Seller (or Representatives of any
thereof) any access rights to documents or information of the other Party (i) which access would violate any Laws or obligations regarding the confidentiality thereof (unless any such violation could be and is avoided by the recipients
execution and delivery of an appropriate confidentiality agreement), (ii) with respect to individual performance or evaluation records, medical histories or other personnel-related information, the disclosure of which would, in a Partys good
faith opinion, subject the Party or any of its Affiliates to risk of Liability, (iii) which access would waive any attorney-client, work product, or like privilege, or (iv) for the purpose of use in connection with potential or actual
litigation, arbitration or mediation between Buyer or any Affiliate of Buyer, on the one hand, and any Seller or any Affiliate of any Seller, on the other hand (nor, for the avoidance of doubt, shall Buyer or any Seller or any of their respective
Affiliates have any right to use any document or information obtained from the other pursuant to this
Section
9.1
in any such Proceeding).
9.2.
Privileged Matters
. (a) Each Party acknowledges that: (i) each Party and its Affiliates
has or may obtain Privileged Information; (ii) there are and/or may be a number of Litigation Matters affecting both of Buyer and Seller Parent; (iii) both Buyer and Seller Parent have a common legal interest in Litigation Matters, in the
Privileged Information and in the preservation of the confidential status of the Privileged Information, in each case relating to the Business; and (iv) both Buyer and Seller Parent intend that the Transactions and any transfer of Privileged
Information in connection therewith shall not operate as a waiver of any potentially applicable privilege.
(b) Following the Closing,
each of Buyer and Seller Parent agrees, on behalf of itself and each of its Subsidiaries, not to disclose or otherwise waive any privilege attaching to any Privileged Information relating to the Business, the Transferred Group, the Transferred Group
Assets or the Transferred Assets without providing prompt written notice to and obtaining the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned or delayed and shall not be withheld, conditioned
or delayed if the other Party certifies that such disclosure is to be made in response to a likely threat of suspension or debarment or similar action;
provided
,
however
, that Buyer shall not be required to give such notice or obtain
any such consent and may make such disclosure or waiver with respect to Privileged Information if such Privileged Information relates solely to the Business, the Transferred Group, the Transferred Group Assets or the Transferred Assets (unless such
information relates to matters for which Sellers may have indemnification obligations under this Agreement or the Ancillary Agreements). In the event of a disagreement concerning the reasonableness of withholding such consent, no disclosure shall be
made prior to a resolution of such disagreement by a court of competent jurisdiction,
provided
that the limitations in this sentence shall not apply in the case of disclosure required by Law and so certified as provided in the first sentence
of this paragraph.
(c) After the Closing, upon receipt of any subpoena or other compulsory disclosure notice from a court, other
Governmental Authority or otherwise which requests disclosure of Privileged Information relating to the Business, the Transferred Group, the Transferred Group Assets or the Transferred Assets, to the extent permitted by Law, Seller Parent or Buyer
(only in the case of information relating to matters for which Seller Parent may have indemnification obligations under this Agreement or the Ancillary Agreements, or in the case of Privileged Information not primarily related to the Business, the
Transferred Group, the Transferred Group Assets or the Transferred Assets and in which a Seller may have an interest), as applicable, shall as promptly as practicable provide to the other Party (in accordance with the notice provisions set forth
herein) a copy of such notice, the intended response, and all materials or information that might be disclosed and the proposed date of disclosure.
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In the event of a disagreement as to the intended response or disclosure, unless and until the disagreement is resolved as provided in
Section
9.2(b)
, the disclosing
party shall, at the other partys expense, cooperate to the extent such other party seeks to limit such disclosure and take all reasonable steps to resist or avoid such disclosure, except as otherwise required by a court Order requiring such
disclosure.
(d) Buyer (on its behalf and on behalf of its Affiliates) further agrees that, notwithstanding anything in this Agreement to
the contrary, as to all communications between Cadwalader and any of Sellers or the Transferred Group (including any of their respective directors, officers or employees) that occur prior to the Closing that relate exclusively to this Agreement or
the transactions contemplated hereby, including the Transactions (including the preceding sale process by Seller Parent), the attorney-client privilege and the expectation of client confidence belongs to Sellers and shall be controlled by Sellers
and shall not pass to or be claimed by Buyer, the Transferred Group or any of their respective Affiliates. Notwithstanding the foregoing, in the event that a dispute arises between Buyer, the Transferred Group or any of their respective Affiliates
and a third party, other than a party to this Agreement, after the Closing, Buyer and/or a member of the Transferred Group may assert the attorney-client privilege to prevent disclosure of confidential communications by Cadwalader to such third
party.
9.3.
Wrong Pocket Assets
. (a) Subject to
Section
2.5
, if any
Transferred Asset remains vested in any Seller or any of their respective Affiliates following Closing, such Seller shall (or shall cause its applicable Affiliate to) transfer such Transferred Asset, at Seller Parents sole expense, as soon as
reasonably practicable to Buyer or its designee for no additional consideration with any necessary prior third party consent or approval (it being acknowledged and agreed that Buyer shall have already paid good consideration for all Transferred
Assets by paying the Purchase Price), and such Seller and Buyer shall (or shall cause the applicable Affiliate or designee to) as soon as reasonably practicable execute such documents or instruments of conveyance or assumption and take such further
acts which are reasonably necessary or desirable to effect the transfer of such asset to Buyer. Seller Parent shall notify Buyer as soon as reasonably practicable upon becoming aware that that there are any Transferred Assets in its possession or
control or that of any Affiliate of any Seller.
(b) If any Excluded Asset is vested in Buyer or any of its Controlled Affiliates
following Closing, Buyer shall (or shall cause its applicable Controlled Affiliate to) transfer such Excluded Asset, at Seller Parents sole expense, as soon as reasonably practicable to Seller Parent or its designee for no consideration with
any necessary prior third party consent or approval (it being acknowledged and agreed that the Parties have not agreed to sell such Excluded Asset), and Buyer and Seller Parent shall (or shall cause the applicable Affiliate or designee to) as soon
as reasonably practicable execute such documents or instruments of conveyance or assumption and take such further acts which are reasonably necessary or desirable to effect the transfer of such asset back to Seller Parent. Buyer shall notify Seller
Parent as soon as reasonably practicable upon becoming aware that that there are any Excluded Assets in its possession or control.
9.4.
Products Received by Seller
s
. If Products are received by any Seller after the Closing, such Seller shall ship those products to Buyer, or to Buyers stated Representative, at Buyers cost. Within fifteen
(15) days after notification from a Seller, Buyer shall reimburse such Seller for all customer claims made against such Seller in the form of invoice deductions for amounts associated with such returned products which are received by such
Seller or such Sellers Representative after the Closing.
9.5.
Guarantees; Commitments
.
(a) From and after the Closing until the expiration of the applicable statute of limitations, Buyer and the Transferred Group, jointly and severally, shall indemnify, defend and hold harmless Seller Parent and any of its Affiliates against any
Liabilities that Seller Parent or any of its Affiliates suffer, incur or are liable for that accrue or arise after the Closing by reason of or arising out of or in consequence of (i) Seller Parent or any of its Affiliates issuing, making
payment under, being required to pay or reimburse the issuer of, or being a party to, any guarantee, indemnity, surety bond, letter of credit, letter of comfort or other similar obligation relating to the Business or the Transferred Group that was
obtained or given by Seller Parent or any of its Affiliates prior to the date hereof or, with the prior written consent of Buyer, after the date hereof
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(collectively, the
Seller Guarantees
), (ii) any claim or demand for payment made on Seller Parent or any of its Affiliates with respect to any of the Seller Guarantees that
result from post-Closing facts or circumstances or (iii) any Proceeding by any Person who is or claims to be entitled to the benefit of or claims to be entitled to payment, reimbursement or indemnity with respect to any Seller Guarantees as a
result of post-Closing facts or circumstances, and shall reimburse Seller Parent for any
out-of-pocket
expenses incurred in connection with any of the foregoing.
(b) Without limiting
Section
9.5(a)
in any respect, Buyer shall use its commercially reasonable efforts to cause
itself or one of its Controlled Affiliates to be substituted in all respects for Seller Parent and any of its Affiliates, and for Seller Parent and its Affiliates to be released, effective as of the Closing, in respect of, or otherwise terminate
(and cause Seller Parent and its Affiliates to be released in respect of), all obligations of Seller Parent and any of its Affiliates under each of the Seller Guarantees. For any of the Seller Guarantees for which Buyer or an Affiliate thereof is
not substituted in all respects for Seller Parent and its Affiliates (or for which Seller Parent and its Affiliates are not released) effective as of the Closing and that cannot otherwise be terminated effective as of the Closing (with Seller Parent
and its Affiliates to be released in respect thereof), Buyer shall continue to use its commercially reasonable efforts to effect such substitution or termination and release after the Closing. Without limiting the foregoing, neither Buyer nor any of
its Affiliates shall extend or renew any Contract containing or underlying a Seller Guarantee unless, prior to or concurrently with such extension or renewal, Buyer or an Affiliate thereof is substituted in all respects for Seller Parent and any of
its Affiliates, and Seller Parent and its Affiliates are released, in respect of all obligations of Seller Parent and any of its Affiliates under such Seller Guarantee.
9.6.
Retained Marks
. (a) From and after the Closing, except in accordance with the license to Retained
Marks granted to Buyer in
Section
9.6(b)
, neither Buyer nor any of its Controlled Affiliates shall have any right to use any Retained Mark and Buyer shall (and shall cause each of its Controlled Affiliates to) cease all use
of each Retained Mark and not hold itself out as having any affiliations with Seller Parent or any of its Affiliates other than the Transferred Group. Without limitation of the foregoing, Buyer shall cause each of the Transferred Entities to specify
on their websites that the Business is not affiliated with Seller Parent.
Retained Marks
means all business names, trade names, trademarks, trade dress and domain names of Seller Parent or any Affiliate of Seller Parent other than
the Transferred Group, any derivative thereof, or any word that is confusingly similar thereto and, for the avoidance of doubt, shall include all business names, trade names, trademarks and domain names consisting of, or that include, the name
MEDICINES COMPANY or MEDCO;
provided
,
however
, that the Retained Marks shall not include the business names, trade names, trademarks and domain names that are included in the Acquired Assets.
(b) Buyer agrees to use commercially reasonable efforts to convert Labeling for the Products (other than as permitted pursuant to the license
set forth in this
Section
9.6(b)
) to Labeling that does not include Retained Marks promptly following the Closing and to use commercially reasonable efforts to cause any third party manufacturers of such Products under any
Contract included in the Transferred Assets or Transferred Group Assets to implement such changes as promptly as is commercially reasonable. Seller Parent hereby grants to Buyer a royalty-free,
non-exclusive,
worldwide, nontransferable,
non-sublicensable
license under the Retained Marks to (i) use such Retained Marks in connection with distributing, selling and offering to sell existing inventories of Products
included in the Transferred Assets or Transferred Group Assets that bear the Retained Marks and (ii) use such Retained Marks in connection with manufacturing or having manufactured such quantities of the Products that bear Retained Marks that
Buyer, in its reasonable discretion, deems reasonably necessary to prevent a
stock-out
or shortage of any such Products or otherwise reasonably transition from the use of Retained Marks, and to use such
Retained Marks in connection with distributing, marketing, selling and offering to sell any such Product manufactured pursuant to this clause (ii). With respect to any such quantities of the Products that Buyer manufactures or has manufactured after
the Closing, such Products shall be of a quality that is at least equal to the quality of such Products sold by Seller Parent and its Subsidiaries under such marks prior to the Closing Date. If Seller Parent at any time reasonably determines that
any of such Products are not being provided in accordance with such standards of quality, Seller Parent may notify Buyer in writing of such
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deficiencies, and if Buyer fails to correct such deficiencies within forty-five (45) days after receipt of such notice, Seller Parent may, at its reasonable discretion, terminate the license
set forth in this
Section
9.6(b)
effective immediately.
9.7.
Employee
Non-Solicit
. (a) Beginning on the Closing Date, neither Seller Parent nor any of its Subsidiaries shall, prior to the end of the first (1
st
) anniversary of
the Closing Date, directly or indirectly, solicit for purposes of employment, offer to hire, hire or enter into any employment agreement with any Continuing Employee, or otherwise solicit, induce or otherwise encourage any Continuing Employee to
discontinue, or refrain from entering into any employment relationship (contractual or otherwise) with Buyer or its Affiliates;
provided
,
however
, that notwithstanding the foregoing, for purposes of this Agreement, Seller Parent and
its Subsidiaries shall not be prohibited from (i) placing general advertisements or conducting general employment solicitations (including via a search firm inquiry) that are not targeted at any Continuing Employee, or (ii) soliciting or
employing any Continuing Employee who has ceased to serve due to termination other than for cause, and, for a period of at least six (6) continuous months prior to the date of such solicitation or employment, has not served, as a director,
officer or employee of Buyer or any of its Subsidiaries.
(b) Beginning on the Closing Date, neither Buyer nor any of its Subsidiaries
shall, prior to the end of the first (1
st
) anniversary of the Closing Date, directly or indirectly, solicit for purposes of employment, offer to hire, hire or enter into any employment agreement
with any
(i) Non-Business
Employee or (ii) Business Employee who rejects an offer of employment from Buyer or any of its Affiliates or who does not receive an offer of employment prior to the Closing
Date from Buyer or any of its Affiliates (each, a
Restricted Person
), or otherwise solicit, induce or otherwise encourage any such
Non-Business
Employee or Restricted Person to discontinue
or refrain from entering into any employment relationship (contractual or otherwise) with Seller Parent or any Subsidiary of Seller Parent;
provided
,
however
, that notwithstanding the foregoing, for purposes of this Agreement,
Buyer and its Subsidiaries shall not be prohibited from (i) placing general advertisements or conducting general employment solicitations (including via a search firm inquiry) that are not targeted at any
Non-Business
Employee or Restricted Person, or (ii) soliciting or employing any
Non-Business
Employee or Restricted Person who has ceased to serve due to
termination other than for cause, and, for a period of at least six (6) continuous months prior to the date of such solicitation or employment, has not served, as a director, officer or employee of Seller Parent or any Subsidiary of Seller
Parent.
9.8.
Financial Information
. Following the Closing, Buyer shall use commercially reasonable
efforts to provide to Sellers (and their respective auditors, attorneys, financial advisors, bankers and other consultants and advisors) any information reasonably requested and relating to the Business reasonably required by Sellers in
(a) preparing and resolving disputes arising out of the Closing Statement and (b) connection with Seller Parent preparing financial statements of Seller Parent and its Subsidiaries for all fiscal periods that precede or include the Closing
Date.
9.9.
Insuranc
e
. From and after the Closing, the Business shall cease to be insured by
Seller Parent or its Affiliates current and historical insurance policies or programs (other than any third-party insurance policies of the Transferred Group, the sole beneficiaries of which are members of the Transferred Group
(
Transferred Entity Insurance Policies
)) or by any of the current and historical self-insured programs of Seller Parent or its Affiliates, and neither Buyer nor its Controlled Affiliates (including the Transferred Group) shall
have any access, right, title or interest to or in any insurance policies or programs or self-insured programs of Seller Parent and its Affiliates (other than Transferred Entity Insurance Policies) (including to any claims or rights to make claims
or any rights to proceeds). Seller Parent or any of its Affiliates may, to be effective at the Closing, amend any insurance policies and ancillary arrangements in the manner they deem appropriate to give effect to this
Section
9.9
. From and after the Closing, Buyer shall be responsible for securing all insurance it considers appropriate for its operation of the Business and the Transferred Group. Buyer further covenants and agrees not to
seek to assert or to exercise any rights or claims of the Business or the Transferred Group under or in respect of any past or current insurance policy, program or self-insurance program under which the Business, any member of the Transferred Group
or Affiliate thereof is a named insured, other than under or in respect of any Transferred Entity Insurance Policy.
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9.10.
Director and Officer Indemnificatio
n
.
For a period of six (6) years after the Closing, Buyer shall not take or cause, or permit to be taken or caused by any Subsidiary or any of Buyers or its Subsidiaries Representatives, any action to alter or impair any exculpatory or
indemnification provisions now existing in the Organizational Documents of any member of the Transferred Group for the benefit of any individual who served as a director or officer of any member of the Transferred Group at any time prior to the
Closing Date, except for any changes that may be required to conform with changes in applicable Law and any changes that do not affect the application of such provisions to acts or omissions of such individuals prior to the Closing Date.
9.11.
Resignations
. Effective upon the Closing, unless otherwise requested by Buyer in writing, Seller
Parent shall cause all of its own employees, directors and attorneys and all of its Subsidiaries employees, directors and attorneys to resign from the boards of directors of the entities comprising the Transferred Group and from all positions
as executive officers of the entities comprising the Transferred Group.
9.12.
Contingent Payment
Contracts
. Effective upon the Closing, Buyer shall assume, discharge and comply with all covenants, obligations and Liabilities of Seller Parent or any of its Affiliates under the Contingent Payment Contracts (other than to the extent such
Liabilities arise out of or relate to the matters described in clause (a) below), including, without limitation: (a) the Rempex Merger Agreement as defined in
Schedule 1.1(d)
(it being understood that Buyer shall take all actions,
use all efforts and pay any remaining Milestone Payments (as defined therein) required by Section 2.6 thereof, but excluding, for the avoidance of doubt, any obligation to make Milestone Payments in respect of Milestone #s 6 (subject to
Section
6.5
),13, 14, 15, 16 and 17 which relate to the Excluded Business or Retained Business), (b) the Targanta Merger Agreement and Targanta Contingent Payment Rights Agreement, in each case as defined in
Schedule
1.1(d)
(it being understood that Buyer shall (i) make any remaining payments required by Section 2.4 of the Targanta Contingent Payment Rights Agreement and (ii) enter into an amendment to the Targanta Contingent Payment Rights
Agreement evidencing Buyers succession to, and assumption of, the covenants of Seller Parent in the Targanta Contingent Payment Rights Agreement), (c) the Lilly License Agreement and the Intellectual Property Assignment Agreement, in each case
as defined in
Schedule 1.1(d)
(it being understood that Buyer shall take all actions and use all efforts required by Section 7.3 of the Lilly License Agreement and make any remaining milestone and royalty payments required by Sections
3.1 and 3.2 of the Lilly License Agreement) and (d) the Theravance License Agreement as defined in
Schedule 1.1(d)
(it being understood that Buyer shall make any remaining royalty payments and
one-time
payments required by Section 2.1 and Section
2.3 thereof).
9.13.
No Waiver of Transfer Restrictions
. From the date hereof until May 31,
2018, Buyer shall not, nor shall it allow any of its Controlled Affiliates to, waive any
lock-up
provisions or other restrictions on transfer, in each case in existence as of the date hereof, applicable to any
Buyer Common Stock or any other securities or obligations convertible or exchangeable into or exercisable for, any Buyer Common Stock, without the prior written consent of Seller Parent.
ARTICLE X.
CONDITIONS TO CLOSING
10.1.
Conditions to Each Party
s Obligation
s
. The respective obligations of each Party to consummate the Transactions are subject to the satisfaction, at or prior to the Closing, of each of the following
conditions, any and all of which may be waived, in whole or in part, by Seller Parent and Buyer, as the case may be, to the extent permitted by Law:
(a) No Adverse Law or Order shall be in effect and there shall be no pending Proceeding brought by a Governmental Authority of competent
jurisdiction seeking to prohibit, prevent or make illegal the consummation of any of the Transactions.
(b) All applicable waiting periods
(or extensions thereof) or necessary approvals or clearances relating to the Transactions under the HSR Act shall have expired, been terminated or received.
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(c) The Buyer Stockholder Approval shall have been obtained in accordance with the terms of
this Agreement.
10.2.
Conditions to Sellers
Obligation
s
. The obligation
of Sellers to consummate the Transactions is subject to the satisfaction, at or prior to the Closing, of each of the following conditions, unless waived by Seller Parent:
(a) The representations and warranties set forth in
ARTICLE V
shall be true and correct (with such representations read for such
purposes without materiality qualifications) on the date hereof and as of the Closing as if made on the Closing Date (except that representations and warranties that by their terms speak specifically as of the date of this Agreement or some other
date shall be true and correct as of such date), except for inaccuracies that, individually or in the aggregate, would not reasonably be expected to have a Buyer Material Adverse Effect.
(b) Buyer shall have performed in all material respects all covenants and obligations required to be performed by it under this Agreement at
or prior to the Closing.
(c) Since the date of this Agreement, no Effects shall have occurred which have had or would reasonably be
expected to have, individually or in the aggregate, a Buyer Material Adverse Effect.
(d) The Buyer Common Stock shall have been issued
pursuant to this Agreement and shall have been approved for listing on NASDAQ, subject to official notice of issuance.
(e) Buyer shall
have delivered to Seller Parent:
(i) each of the documents and deliveries required pursuant to
Section
3.2(b)
; and
(ii) a certificate dated as of the Closing Date, signed by a duly authorized
officer of Buyer, certifying that the conditions set forth in
Section
10.2(a)
and
Section
10.2(b)
have been duly satisfied.
10.3.
Conditions to Buyer
s Obligation
s
. The obligation of Buyer to
consummate the Transactions is subject to the satisfaction, at or prior to the Closing, of each of the following conditions, unless waived by Buyer:
(a) Each of the (i) Seller Fundamental Representations shall be true and correct in all material respects, in each case on the date hereof
and as of the Closing as if made on the Closing Date (except that representations and warranties that by their terms speak specifically as of the date of this Agreement or some other date shall be true and correct in all material respects as of such
date), and (ii) remaining representations and warranties set forth in
ARTICLE IV
shall be true and correct in all respects (with such representations and warranties read for such purposes without any materiality or Material Adverse
Effect qualifications) on the date hereof and as of the Closing as if made on the Closing Date (except that representations and warranties that by their terms speak specifically as of the date of this Agreement or some other date shall be true and
correct in all respects as of such date), except in the case of this clause (ii) for inaccuracies or breaches that, individually or in the aggregate, have not had and would not reasonably be expected to have a Material Adverse Effect.
(b) Seller Parent and each other Seller shall have performed in all material respects all covenants and obligations required to be performed
by it under this Agreement at or prior to the Closing.
(c) Since the date of this Agreement, no Effects shall have occurred which have
had or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(d) Seller Parent shall have
delivered, or caused the applicable Seller to have delivered, to Buyer:
(i) each of the documents and deliveries required
pursuant to
Section
3.2(a)
; and
(ii) a certificate dated as of the Closing Date, signed by a
duly authorized officer of Seller Parent, certifying that the conditions set forth in
Section
10.3(a)
and
Section
10.3(b)
have been duly satisfied.
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10.4.
Frustration of Closing Conditions
. Except as
required by applicable Law, neither Seller Parent nor Buyer may rely on the failure of any condition set forth in
Section
10.1
,
Section
10.2
or
Section
10.3
, as the case
may be, to be satisfied if such Partys breach of
Section
6.3(a)
has been the cause of, or resulted in, such failure.
ARTICLE XI.
TERMINATION
11.1.
Terminatio
n
. This Agreement may be terminated at any time prior to the Closing:
(a) by the mutual written
agreement of Seller Parent and Buyer;
(b) by Seller Parent or Buyer, by written notice to the other Party, if the Closing has not
occurred by 11:59 p.m., Eastern Time, on May 28, 2018 (the
Outside Date
);
provided
,
however
, that the right to terminate this Agreement pursuant to this
Section
11.1(b)
shall not
be available to any Party whose breach of any representation, warranty, covenant or agreement set forth in this Agreement has been the cause of, or resulted in, the Closing not occurring prior to the Outside Date;
(c) by Seller Parent, by written notice to Buyer, if Buyer shall have breached any of its representations or warranties or failed to comply
with any of its covenants or agreements contained in this Agreement, which breach or failure (i) would give rise to the failure of the conditions set forth in
Section
10.2(a)
or
Section
10.2(b)
and (ii) is incapable of being cured, or is not cured, by Buyer within thirty (30) days following receipt of written notice of such breach or failure to comply from Seller Parent;
provided
,
however
, that the right to terminate this Agreement under this
Section
11.1(c)
shall not be available to Seller Parent if Seller Parent has breached any of its representations or warranties or failed to comply with
any of its covenants or agreements contained in this Agreement such that the conditions set forth in
Section
10.3(a)
or
Section
10.3(b)
could not then be satisfied;
(d) by Buyer, by written notice to Seller Parent, if Seller Parent and its Subsidiaries shall have breached any of their representations or
warranties or failed to comply with any of their covenants or agreements contained in this Agreement, which breach or failure (i) would give rise to the failure of the conditions set forth in
Section
10.3(a)
or
Section
10.3(b)
and (ii) is incapable of being cured, or is not cured, by Sellers within thirty (30) days following receipt of written notice of such breach or failure to comply from Buyer;
provided
,
however
, that the right to terminate this Agreement under this
Section
11.1(d)
shall not be available to Buyer if Buyer has breached any of its representations or warranties or failed to comply with any of its
covenants or agreements contained in this Agreement such that the conditions set forth in
Section
10.2(a)
or
Section
10.2(b)
could not then be satisfied;
(e) by either Seller Parent or Buyer, by written notice to the other, in the event of any final and nonappealable Adverse Law or Order issued
by a Governmental Authority of competent jurisdiction located in the United States; or
(f) by Seller Parent in the event that the Buyer
Stockholder Approval is not obtained at the Special Meeting.
11.2.
Procedure and Effect of
Termination
. In the event of the termination of this Agreement and the abandonment of the Transactions pursuant to
Section
11.1
, written notice thereof shall forthwith be given by the terminating Party to the other
Party, Buyer shall return to Seller Parent or destroy all documents, work papers and other materials of Sellers relating to the Business and to the Transactions, whether so obtained before or after the execution hereof, in each case to the extent
required by the Confidentiality Agreement, and no Party to this Agreement shall have any other Liability under this Agreement to any other Party except for any Liability of any Party for any willful and material breach by such Party of any of its
covenants or agreements set forth in this Agreement; it being understood and agreed that the Confidentiality Agreement,
Section
2.10
and
ARTICLE XIII
(except for
Section
13.3
) hereof shall
remain in full force and effect following such termination.
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ARTICLE XII.
INDEMNIFICATION
12.1.
Survival; Effect of Materiality Qualifiers; Losses
. (a) The representations and warranties of Seller Parent and Buyer contained in this Agreement and the certificates delivered at Closing pursuant to
Section
10.2(e)(ii)
and
Section
10.3(d)(ii)
shall survive the Closing for the period set forth in this
Section
12.1
. All representations and warranties contained in this
Agreement (except for the Seller Fundamental Representations and the Buyer Fundamental Representations) and all claims with respect thereto under this
Article XII
shall terminate on the date that is fifteen (15) months after the Closing
Date. All Seller Fundamental Representations and the representations and warranties set forth in Section 4.16 (Tax Matters), and all Buyer Fundamental Representations, and all claims with respect thereto under this
Article XII
shall
terminate on the date that is thirty (30) days after the expiration of the relevant statutory period of limitations applicable to the underlying claim. All claims with respect to the covenants of Sellers and Buyer which by their terms do not
contemplate performance after the Closing or more than fifteen (15) months after the Closing Date shall terminate on the date that is fifteen (15) months after the Closing Date. All claims with respect to the covenants of Sellers and Buyer
which by their terms contemplate performance beyond fifteen (15) months after the Closing Date shall survive until expiring on the six (6) month anniversary of the date such covenant is performed or observed in accordance with its terms.
In the event that notice of any claim for indemnification under this
ARTICLE XII
has been given pursuant to
Section
12.4
or
Section
12.5
, as the case may be, within the applicable survival
period, the representations and warranties or covenants that are the subject of such indemnification claim (and the right to pursue such claim) shall survive with respect to such claim until such time as such claim is finally resolved, and no
Proceeding shall be required to be commenced in connection therewith in order for such claim to so survive. It is the intention of the Parties that the survival periods and termination date set forth in this
Section
12.1
supersede any statute of limitations applicable to such representations and warranties and covenants or claim with respect thereof.
(b)
The term
Losses
means damages, Liabilities, losses, claims, payments, fines, fees, penalties, charges, judgments, settlements, assessments and costs and expenses (including reasonable attorneys, accountants and other
experts fees and reasonable
out-of-pocket
disbursements);
provided
,
however
, that Losses shall not include consequential or punitive damages or lost
profits, except to the extent required to be paid to a third party not affiliated with the applicable Indemnified Party in connection with a Third Party Claim, or solely in the case of consequential damages and lost profits, except to the extent
reasonably foreseeable, it being understood and agreed that consequential damages and lost profits shall not be deemed reasonably foreseeable to the extent they are based on the conduct of the Business in geographies or with respect to
indications not currently contemplated by the Parties.
(c) Solely for purposes of determining the amount of any Losses in respect of any
breach or inaccuracy of any representation or warranty contained in this Agreement, any express qualifications or limitations set forth in such representation or warranty as to materiality, Material Adverse Effect or other words of similar import
contained therein shall be disregarded.
12.2.
Indemnification by Seller Parent
. (a) From and
after the Closing and subject to the provisions of this
ARTICLE XII
, Seller Parent shall indemnify, defend and hold harmless Buyer, Buyers Affiliates (including, after the Closing, the members of the Transferred Group) and the
respective officers, directors, managers, general partners, employees, agents, successors and permitted assigns of each of the foregoing (collectively, the
Buyer Indemnified Parties
) from, against and in respect of any and all
Losses imposed on, sustained, incurred or suffered by any of the Buyer Indemnified Parties arising out of or resulting from:
(i) the breach of or inaccuracy in any representation or warranty made by Seller Parent in this Agreement or the certificate
delivered by Seller Parent pursuant to
Section
10.3(d)(ii)
of this Agreement;
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(ii) the breach in any material respect of any covenant or agreement made by
Sellers in this Agreement; or
(iii) any Excluded Asset or Excluded Liability (including, for the avoidance of doubt, any
Pre-Closing
Taxes).
(b) Notwithstanding anything to the contrary contained in this Agreement:
(i) Seller Parent shall have no Liability for any claim for indemnification pursuant to
Section
12.2(a)(i)
unless (A) the Losses for which Seller Parent would be responsible for such claim and all related claims exceed the De Minimis Amount and (B) the aggregate amount of Losses in respect of
breaches of or inaccuracies in Sellers representations and warranties (excluding all Losses associated with claims less than the De Minimis Amount) exceeds the Deductible, in which event Seller Parent shall be liable solely for Losses in
excess of the Deductible up to the Cap;
provided
that the limitations set forth in this
Section
12.2(b)(i)
shall not apply to any Losses in respect of breaches of or inaccuracies in any Seller Fundamental
Representations;
(ii) Seller Parents aggregate liability for indemnification under
Section
12.2(a)(i)
shall in no event exceed the Cap;
provided
that the limitations set forth in this
Section
12.2(b)(ii)
shall not apply to any Losses in respect of breaches of or
inaccuracies in any Seller Fundamental Representations;
(iii) The cumulative indemnification obligations of Seller Parent
under
Section
12.2(a)(i)
shall in no event exceed, in the aggregate, the Purchase Price;
provided
, for the avoidance of doubt, that the limitations set forth in this
Section
12.2(b)(iii)
shall
not apply to any Losses in respect of
Section
12.2(a)(ii)
or
Section
12.2(a)(iii)
; and
(iv) The limitations set forth in this
Section
12.2(b)
shall not apply to any Losses in the case of
fraud (as construed in accordance with Delaware law) with respect to the representations and warranties made by Sellers in this Agreement.
(c) In the event that a Buyer Indemnified Party wishes to seek indemnity under this
Article XII
, Buyer shall have the sole and
exclusive power to do all acts or things on behalf of such Buyer Indemnified Party that such Buyer Indemnified Party is obligated to do or has the right to do under this
Article XII
with respect to seeking such indemnity.
12.3.
Indemnification by Buyer
. (a) From and after the Closing and subject to the provisions of
this
ARTICLE XII
, Buyer shall indemnify, defend and hold harmless Sellers, their respective Affiliates and their and their Affiliates respective officers, directors, employees, agents, successors and permitted assigns (collectively, the
Seller Indemnified Parties
, and each of the Buyer Indemnified Parties and the Seller Indemnified Parties, an Indemnified Party) from, against and in respect of any and all Losses imposed on, sustained, incurred or
suffered by any of the Seller Indemnified Parties arising out of or resulting from:
(i) the breach of or inaccuracy in any
representation or warranty made by Buyer in this Agreement or the certificate delivered by Buyer pursuant to
Section
10.2(e)(ii)
of this Agreement;
(ii) the breach in any material respect of any covenant or agreement made by Buyer in this Agreement; or
(iii) any Assumed Liability.
(b) Notwithstanding anything to the contrary contained in this Agreement:
(i) Buyer shall have no Liability for any claim for indemnification pursuant to
Section
12.3(a)(i)
unless (A) the Losses for which Buyer would be responsible for such claim and all related claims exceed the De Minimis Amount and (B) the aggregate amount of Losses in respect of breaches of Buyers representations and warranties
(excluding all Losses associated with claims less than the De
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Minimis Amount) exceeds the Deductible, in which event Buyer shall be liable solely for Losses in excess of the Deductible up to the Cap;
provided
that the limitations set forth in this
Section 12.2(b)(i) shall not apply to any Losses in respect of breaches of or inaccuracies in any Buyer Fundamental Representations; and
(ii) Buyers aggregate liability for indemnification under
Section
12.3(a)(i)
shall in no event
exceed the Cap;
provided
that the limitations set forth in this Section 12.3(b)(ii) shall not apply to any Losses in respect of breaches of or inaccuracies in any Buyer Fundamental Representations;
provided
,
further
, for
the avoidance of doubt, that the limitations set forth in this
Section
12.3(b)(ii)
shall not apply to any Losses in respect of
Section
12.3(a)(ii)
or
Section
12.3(a)(iii)
.
(iii) The limitations set forth in this
Section
12.3(b)
shall not apply to any Losses in the case of
fraud (as construed in accordance with Delaware law) with respect to the representations and warranties made by Buyer in this Agreement.
12.4.
Third Party Claims
. (a) In the event that an Indemnified Party seeks indemnity under this
Article XII
with respect to any claim or demand for which an indemnifying party (an Indemnifying Party) may have
Liability to any Indemnified Party hereunder that is asserted against or sought to be collected from any Indemnified Party by a third party (a Third Party Claim), such Indemnified Party shall promptly, but in no event more than ten
(10) days following such Indemnified Partys receipt of a Third Party Claim, notify the Indemnifying Party in writing of such Third Party Claim, the specific section(s) of this Agreement that form the basis of the claim for
indemnification, the amount or the estimated amount of damages sought under such Third Party Claim to the extent then ascertainable, any other remedy sought thereunder, any relevant time constraints relating thereto and, to the extent practicable,
any other material details pertaining thereto, in each case if such information is known and reasonably available (a Claim Notice);
provided
,
however
, that the failure to timely give a Claim Notice or to include the
foregoing information shall affect the rights of an Indemnified Party hereunder only to the extent that such failure has an actual and material prejudicial effect on the defenses available to the Indemnifying Party with respect to such Third Party
Claim.
(b) Within thirty (30) days after receipt of any Claim Notice, the Indemnifying Party may, upon written notice thereof to the
Indemnified Party, assume control of the defense of the Third Party Claim at the Indemnifying Partys sole cost and expense with counsel reasonably satisfactory to the Indemnified Party, so long as (a) such Third Party Claim does not seek
an injunction or other equitable relief against the Indemnified Party, (b) such Third Party Claim does not relate to or otherwise arise in connection with Taxes or any criminal enforcement action, (c) such Third Party Claim, together with
any other pending Direct Claims and Third Party Claims, would not reasonably be expected to, if successful, result in Seller Parents aggregate liability for indemnification under
Section
12.2(a)(i)
exceeding the
then-remaining Cap, and (d) the Indemnifying Party conducts the defense of such Third Party Claim with reasonable diligence. If the Indemnifying Party does not so assume control of the defense of such claim, the Indemnified Party shall have the
sole power to direct and control such defense with counsel selected by the Indemnified Party. The Party not controlling the defense of such claim shall have the right, but not the obligation, to participate in any such defense and to employ separate
counsel of its choosing at its own cost and expense;
provided
,
however
, that, if the Indemnifying Party assumes control of the defense of such claim and the Indemnifying Party and the Indemnified Party have materially conflicting
interests or different defenses with respect to such claim that cause the Indemnified Party to hire its own separate counsel with respect to such proceeding, the reasonable fees and expenses of counsel to the Indemnified Party shall be considered
Losses for purposes of this Agreement. Neither Party shall, without the prior written consent of the other Party (such consent not to be unreasonably withheld, delayed or conditioned), settle, compromise or agree to the settlement or
compromise of, or the entry of any judgment arising from, any Third Party Claim;
provided
,
however
, that the consent of the Indemnified Party shall not be required with respect to any settlement or judgment if (i) the Indemnifying
Party agrees in writing to pay or cause to be paid any amounts payable pursuant to such settlement or judgment (net of any applicable Deductible), (ii) such settlement or judgement would not restrict the future activity or conduct of the Indemnified
Party or any of its Affiliates, (iii) such settlement or judgment involves no finding or admission of a violation of Law or violation of the rights
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of any Person or admission of Liability by or other obligations on the part of the Indemnified Party or any of its Affiliates, and (iv) such settlement or judgment includes a complete
release of the Indemnified Party and its Affiliates from further Liability.
(c) The Indemnified Party and the Indemnifying Party shall
reasonably cooperate in order to ensure the proper and adequate defense of a Third Party Claim, including by providing access to each others relevant business records and other documents and employees, it being understood that the reasonable
costs and expenses of the Indemnified Party relating thereto shall be considered Losses. The Indemnified Party and the Indemnifying Party shall keep each other fully informed with respect to the status of such Third Party Claim.
(d) The Indemnified Party and the Indemnifying Party shall use reasonable best efforts to avoid production of confidential information
(consistent with applicable Law), and to cause all communications among employees, counsel and others representing any party to a Third Party Claim to be made so as to preserve any applicable attorney-client or work-product privileges.
12.5.
Direct Claim
s
. If an Indemnified Party wishes to make a claim for indemnification
hereunder for a Loss that does not result from a Third Party Claim (a Direct Claim), the Indemnified Party shall notify the Indemnifying Party in writing of such Direct Claim (a
Direct Claim Notice
), the specific
section(s) of this Agreement that form the basis of the claim for indemnification, the amount or the estimated amount of damages sought with respect to such Direct Claim to the extent then ascertainable, any other remedy sought thereunder, any
relevant time constraints relating thereto and, to the extent practicable, any other material details pertaining thereto. The Indemnifying Party shall have a period of thirty (30) days within which to respond to such Direct Claim by either
delivering to the Indemnified Party in writing a response in which the Indemnifying Party will either: (i) agree that the Indemnified Party is entitled to indemnification for all of the Losses at issue in the Direct Claim or (ii) dispute
the Indemnified Partys entitlement to indemnification by delivering to the Indemnified Party a written notice. If the Indemnifying Party does not so respond within such thirty (30) day period, the Indemnifying Party will be deemed to have
irrevocably accepted the Direct Claim. If the Indemnifying Party rejects all or any part of the Direct Claim, the Indemnified Party shall be free to seek enforcement of its rights to indemnification under this Agreement with respect to such Direct
Claim.
12.6.
Adjustments to Losses
.
(a)
Insurance
. In calculating the amount of any Loss, the proceeds actually received by the Indemnified Party under any insurance
policy or pursuant to any claim, recovery, settlement or payment by or against any other Person (after deducting therefrom the full amount of the reasonable fees, costs and expenses incurred by it in procuring such recovery and any Taxes payable
thereon), in each case relating to a Third Party Claim or a Direct Claim for which such Indemnified Party is then being indemnified pursuant to this
Article XII
, shall be deducted before such Loss is paid pursuant to this
Article XII
.
(b)
Taxes
. In calculating the amount of any Loss, there shall be deducted an amount equal to any net Tax benefit actually realized
as a result of such Loss by the Party claiming such Loss, solely for the taxable year of the incurrence, accrual or payment of any such Loss.
(c)
Reimbursement
. If an Indemnified Party recovers an amount from a third party in respect of a Loss that is the subject of
indemnification hereunder after all or a portion of such Loss has been paid by an Indemnifying Party pursuant to this
ARTICLE XII
, the Indemnified Party shall promptly remit to the Indemnifying Party the excess (if any) of (i) the amount
paid by the Indemnifying Party in respect of such Loss,
plus
the amount received from the third party in respect thereof (after deducting therefrom the full amount of the reasonable fees, costs and expenses incurred by it in procuring such
recovery and any Taxes payable thereon),
less
(ii) the full amount of the Loss.
(d)
Other Recovery
. The provisions of
this
ARTICLE XII
are not intended to permit duplicate recoveries on the same matters. To the extent that any payment is made with respect to any particular Loss under
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ARTICLE VIII
or such Loss is reflected on the Final Closing Statement and resulted in a reduction to Final Closing Adjustment Amount, no recovery in respect of the same Claim will be
available under this
ARTICLE XII
.
(e)
Right of Offset
. If a Buyer Indemnified Party incurs or suffers Losses for which
Buyer (subject to the limitations set forth elsewhere in this
ARTICLE XII
) is otherwise entitled to indemnification under
Section
12.2(a)(ii)
or
Section
12.2(a)(iii)
, Buyer may set off
against Deferred Payments otherwise payable under
Section
2.6(a)(iii)
or
Section
2.6(a)(iv)
Buyers good faith estimate of the amount of such indemnifiable Losses (the
Setoff
Amount
). If Buyer exercises its setoff right under this
Section
12.6(e)
, Buyer will provide Seller Parent with a written certificate, signed by Buyers Chief Financial Officer, certifying that the amount set
off by Buyer represents Buyers good faith estimate of such Losses. Notwithstanding the foregoing, if within fifteen (15) days following receipt of such certificate Seller Parent notifies Buyer in writing that it disputes Buyers
assertion that Seller Parent is obligated to indemnify Buyer for such Losses under
Section
12.2(a)(ii)
or
Section
12.2(a)(iii)
or the amount set off by Buyer, then pending the Parties
agreement regarding the appropriate setoff (if any) or a determination by a court of competent jurisdiction of the proper amount that Buyer may set off (if any) in accordance with
Section
13.10
, Buyer will pay the Setoff
Amount into an interest-bearing escrow account established for the purpose at a mutually acceptable bank or trust company pending a decision of such court. If it is finally determined by such court that Buyer has set off an amount that exceeds the
amount of Losses for which Seller Parent is obligated to indemnify Buyer under
Section
12.2(a)(ii)
or
Section
12.2(a)(iii)
, then Buyer will cause the amount of such excess, plus interest earned on
such amount in such escrow account, to be released from the escrow account and paid to Seller Parent. Subject to Buyers compliance with its obligations in this
Section
12.6(e)
, the exercise of such right of setoff by
Buyer in good faith, whether or not ultimately determined to be justified, will not constitute an event of default hereunder. Neither the exercise of nor the failure to exercise such right of setoff will constitute an election of remedies or limit
Buyer in any manner in the enforcement of any other remedies that may be available to it. For the avoidance of doubt, in no event shall Buyer be entitled to set off against any Royalty Payments payable pursuant to
Section
2.6(a)(v)
.
12.7.
Characterization of Indemnification Payments
.
Except as otherwise required by applicable Law, all payments made by an Indemnifying Party to an Indemnified Party in respect of any claim pursuant to
Section
12.2
or
Section
12.3
shall be treated
as adjustments to the purchase price for all applicable Tax purposes.
12.8.
Exclusive Remedy
.
Subject to
Section
13.12
, from and after the Closing, except in the event of fraud (as construed in accordance with Delaware law) with respect to the representations and warranties made by Seller Parent or Buyer in this
Agreement, the exclusive remedy for any Indemnified Party for Losses or other monetary damages arising from a breach of this Agreement shall be the indemnification provided in this
ARTICLE XII
.
12.9.
Duty to Mitigate
. Nothing herein shall relieve any Indemnified Party of its common law duty to
mitigate Losses. Without limiting the foregoing, each Indemnified Party shall take commercially reasonable steps to mitigate all Losses after becoming aware of any event that could reasonably be expected to give rise to any Losses that are
indemnifiable hereunder, in each case to the extent such mitigation is required by Law.
12.10.
Investigation
. The right to indemnification or any other remedy based on representations, warranties, covenants and agreements of a Party in this Agreement, or in any Ancillary Agreement, shall not be affected by any investigation conducted
by any Indemnified Party or any other Person at any time, or any knowledge acquired (or capable of being acquired) by any Indemnified Party or any other Person at any time, whether before or after the execution and delivery of this Agreement and
prior to the Closing, with respect to the accuracy or inaccuracy of, or compliance with, any such representation, warranty, covenant or agreement.
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ARTICLE XIII.
MISCELLANEOUS
13.1.
Assignmen
t
. Subject to
Section
1.3
, this Agreement may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided, however, that
(1) Buyer shall have the right to assign all or certain provisions of this Agreement or any interest herein, without the consent of Sellers, as collateral security to any Financing Sources, but no such collateral assignment shall release Buyer
of its obligations under this Agreement and (2) Seller Parent shall have the right to assign all or any part of its rights to receive the Royalty Payments and its rights set forth in
Section
2.8
and
Section
2.9
, and delegate any of its obligations under this Agreement related thereto (including pursuant to
Section
2.8
and
Section
2.9
), to any third party without the
consent of Buyer, subject to the conditions set forth in
Section
2.7
. Any purported assignment in violation of this
Section
13.1
shall be void
ab initio
.
13.2.
Public Announcement
s
. Neither Party nor any of their respective Affiliates shall issue any
press release or make any public announcement relating to the subject matter of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld, delayed or conditioned;
provided
,
however
, that any Party and any of their respective Affiliates may make any public disclosure (a) it believes in good faith, upon advice of counsel, is required by applicable Law or any listing or trading agreement concerning its
publicly traded securities (in which case the disclosing Party or Affiliate will provide reasonable advance notice, to the extent reasonably practicable, to the other Party prior to making the disclosure and will in good faith consider the
reasonable comments of the other Party on such disclosure) or (b) that is substantially consistent with a prior press release or public announcement made with the consent of the other Party;
provided further
,
however
, that the
Parties shall mutually agree on any press release(s) made with respect to the execution of this Agreement and the Transactions.
13.3.
Confidentialit
y
. Buyer and Seller Parent agree that the Confidentiality Agreement, as it relates to Information, shall, as of the Closing Date, be terminated and of no further force and effect.
(a) Seller Parent agrees that, for a period of five (5) years after the Closing, Sellers and their Representatives shall keep
confidential and exercise the same degree of care with respect to maintaining the confidentiality of any Buyer Information in any of their possession that Sellers exercise with respect to similar types of their own proprietary information, but in no
event less than a reasonable degree of care, except that, if any Buyer Information is required by Law or legal or administrative process to be disclosed, Seller Parent shall promptly (and in any event prior to making such disclosure, to the extent
permitted by Law) notify Buyer of such disclosure requirement so that Buyer or its Affiliates may seek a protective Order or other appropriate remedy. In the event that no such protective Order or other remedy is obtained, or Buyer does not waive
compliance with this
Section
13.3(b)
, and the applicable Seller or its Representatives are nonetheless legally compelled to disclose such Buyer Information, such Seller or its Representatives, as the case may be, will
furnish only that portion of the Buyer Information which such Seller or Representative is advised by counsel is legally required to be furnished and will give Buyer written notice of the Buyer Information to be disclosed as far in advance as
reasonably practicable and exercise all reasonable efforts to obtain reliable assurance that confidential treatment will be accorded the Buyer Information. For purposes of this
Section
13.3(b)
, the term
Buyer
Information
means (i) all information, knowledge and data of Seller Parent and its Affiliates as of immediately prior to the Closing to the extent related to the Business, the Acquired Assets, the Products and/or the Assumed
Liabilities, (ii) all information, knowledge and data provided by Buyer or any of its Affiliates to any Seller in connection with the Transactions, other than any information contemplated by clause (i), and (iii) all analyses,
compilations, forecasts, studies, interpretations, summaries, notes, data and other documents and materials (in any form or medium of communication, whether written, oral, electronic or magnetic), whether prepared by any Seller, such Sellers
Representatives or others, which contain, reflect or are generated from or based upon, in whole or in part, the information referred to in clauses (i) and (ii) of this sentence, other than any such information that (A) only with respect to
(ii) above, is known to any Seller prior to receipt thereof from Buyer or any of its Affiliates, (B) is
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disclosed to a Seller by a third party which has, or is reasonably believed by such Seller to have, a legal right to make such disclosure without requiring such Seller to maintain the
confidentiality thereof, (C) is or becomes part of the public domain through no fault of any Seller, or (D) is independently developed by or for any Seller, without reliance on or reference to any information contemplated by clauses
(i) or (ii) of this sentence.
(b) Notwithstanding the foregoing, Seller Parent shall be permitted to disclose the reports and
information delivered by Buyer pursuant to
Section
2.8
or otherwise related to the Royalty Payments and Net Sales (the
Disclosure Information
) in Seller Parents periodic filings with the SEC,
earnings press releases and investor and analyst conference calls and presentations, as, and to the extent, required, in the reasonable advice of Seller Parents legal counsel, to comply with applicable laws, including the rules and regulations
promulgated by the SEC and applicable stock exchange regulations and requirements. For the avoidance of doubt, Seller Parent shall be permitted to disclose the Disclosure Information in its periodic filings with the SEC, earnings press releases and
investor and analyst conference calls notwithstanding whether Buyer has publicly disclosed such Disclosure Information but only as, and to the extent, required, in the reasonable advice of Seller Parents legal counsel, to comply with
applicable laws, including the rules and regulations promulgated by the SEC and applicable stock exchange regulations and requirements; provided, that, Seller Parent shall provide prior written notice to Buyer of its public disclosure of any
Disclosure Information so as to enable Buyer to determine, to the extent possible, whether to make public disclosure of such Disclosure Information at or about the same time.
13.4.
Expenses
. Whether or not the Transactions are consummated, and except as otherwise specified
herein, including
Section
6.2(g)
, each Party shall bear its own costs and expenses in connection with this Agreement and the Ancillary Agreements and with respect to the Transactions.
13.5.
Severability
. In the event that any provision of this Agreement or the application thereof
becomes or is declared by a Governmental Authority of competent jurisdiction to be illegal, void or unenforceable, the remainder of this Agreement will continue in full force and effect and the application of such provision to other Persons or
circumstances will be interpreted so as reasonably to effect the intent of the Parties. Further, to the extent necessary, the Parties agree to replace such void or unenforceable provision of this Agreement with a valid and enforceable provision that
will achieve, to the extent possible, the economic, business and other purposes of such void or unenforceable provision.
13.6.
Entire Agreement; Amendmen
t
. This Agreement, the Confidentiality Agreement and the Ancillary Agreements (including the Transfer Documents after their execution and delivery hereunder) contain the entire agreement of the
Parties with respect to the Transactions, superseding all negotiations, prior discussions and preliminary agreements made prior to the date hereof with respect to the Transactions. This Agreement may not be amended, supplemented or otherwise
modified except by an instrument in writing signed by all of the Parties. No such supplement, amendment or addition shall be evidence, in and of itself, that the representations and warranties in the corresponding section are no longer true and
correct in all material respects. Notwithstanding the foregoing, any amendment of
Section
13.1
, this
Section
13.6
,
Section
13.7
,
Section
13.10
and the definition of Financing Source and the capitalized terms used therein (or any amendment to any other Section of this Agreement that modifies the terms of
Section
13.1
, this
Section
13.6
,
Section
13.7
,
Section
13.10
and the definition of Financing Source and the capitalized terms used therein) shall not be enforceable against the
Financing Sources without the prior written consent of the Financing Sources and any purported amendment by any party in a manner which does not comply with this
Section
13.6
shall be void.
13.7.
No Third-Party Beneficiarie
s
. This Agreement is solely for the benefit of the Parties and,
to the extent set forth herein, their respective Affiliates and the Indemnified Parties, and no provision of this Agreement shall be deemed to otherwise confer upon any other third parties any remedy, Claim, Liability, reimbursement or other right
in excess of those existing without reference to this Agreement,
provided
that the Financing Sources and their respective successors, legal representatives and permitted assigns shall each be a third party beneficiary with respect to their
respective rights under
Section
13.1
,
Section
13.6
,
Section
13.10
and this
Section
13.7
. None
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of the Debt Financing Sources will have any liability to Seller Parent or its Affiliates relating to or arising out of this Agreement, the Debt Financing or otherwise, whether at law, or equity,
in contract, in tort or otherwise, and neither Seller Parent nor any of its Affiliates will have any rights or claims against any of the Financing Sources hereunder or thereunder.
13.8.
Waiver
. The waiver by a Party of any breach of any of the terms, covenants or conditions of this
Agreement or of any right or privilege conferred by this Agreement shall not be construed as a subsequent waiver of any such terms, covenants, conditions, rights or privileges or as a waiver of any other terms, covenants, conditions, rights or
privileges. No waiver shall be effective unless it is in writing and signed by an authorized Representative of the waiving Party.
13.9.
Governing Law
. This Agreement (and any Claim or controversy arising out of or relating to this Agreement) shall be governed by and construed in accordance with the Laws of the State of Delaware without giving effect to any choice or
conflict of law provision or rule that would cause the application of the Laws of any jurisdiction other than the State of Delaware.
13.10.
Consent to Jurisdiction; Waiver of Jury Trial
. (a) Subject to
Section
2.8
(Net Sales Reporting),
Section
2.11(b)
(Purchase Price Allocation) and
Section
3.3
(Post-Closing Adjustment), each Party hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of any Delaware state court, or federal court of the United States
of America, in each case sitting in the City of Wilmington, County of New Castle, State of Delaware, and any appellate court from any thereof, in any action, suit or proceeding arising out of or relating to this Agreement or any Ancillary Agreement
delivered in connection herewith or the Transactions or for recognition or enforcement of any judgment relating thereto, and each Party hereby irrevocably and unconditionally: (i) agrees not to commence any such action, suit or proceeding
except in such courts; (ii) agrees that any claim in respect of any such action, suit or proceeding may be heard and determined in such Delaware state court or, to the extent permitted by applicable Law, in such federal court;
(iii) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such action, suit or proceeding in any such Delaware state or federal court; and
(iv) waives, to the fullest extent permitted by applicable Law, the defense of an inconvenient forum to the maintenance of such action, suit or proceeding in any such Delaware state or federal court. Each Party agrees that a final judgment in
any such action, suit or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by applicable Law. Each Party irrevocably consents to service of process in the manner
provided for notices in
Section
13.15
. Nothing in this Agreement will affect the right of any Party to serve process in any other manner permitted by applicable Law. Notwithstanding the foregoing, each of the Parties agrees
that it will not bring or support any action, cause of action, claim, cross-claim or third-party claim of any kind or description, whether in law or in equity, whether in contract or in tort or otherwise, against the Debt Financing Sources in any
way relating to this Agreement or any of the transactions contemplated by this Agreement, including, but not limited to, any dispute arising out of or reliant in any way to the Debt Commitment Letter or the performance thereof, in any forum other
than the Commercial Division, New York State Supreme Court and the federal courts, in each case, sitting in the City of New York, borough of Manhattan (and, in each case, the applicable state and federal appeals courts sitting in the City of New
York or, if not available or applicable, the State of New York).
(b) EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY
ARISE UNDER THIS AGREEMENT AND THE ANCILLARY AGREEMENTS IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE IT HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION
DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT AND ANY OF THE ANCILLARY AGREEMENTS DELIVERED IN CONNECTION HEREWITH OR THE TRANSACTIONS, INCLUDING ANY CLAIM, CONTROVERSY, DEMAND, ACTION OR CAUSE OF ACTION AGAINST OR INVOLVING
ANY DEBT FINANCING SOURCE ARISING OUT OF THIS AGREEMENT OR THE DEBT FINANCING OR THE DEBT COMMITMENT
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LETTER. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN
THE EVENT OF LITIGATION, SEEK TO ENFORCE EITHER OF SUCH WAIVERS, (B) IT UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVERS, (C) IT MAKES SUCH WAIVERS VOLUNTARILY, AND (D) IT HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT
BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS
SECTION
13.10(b)
.
13.11.
Specific Performance
. The Parties agree that irreparable damage would occur in
the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached or threatened to be breached. It is accordingly agreed that the Parties shall be entitled (without proof of
actual damages or otherwise or posting or securing any bond) to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement, these being in addition to any other remedy to
which they are entitled at law or in equity. The right to specific performance shall include the right of Seller Parent to cause Buyer to cause the Transactions to be consummated on the terms and subject to the conditions and obligations set forth
in this Agreement. The Parties further agree not to assert that a remedy of specific performance is unenforceable, invalid, contrary to Law or inequitable for any reason, nor to assert that a remedy of monetary damages would provide adequate remedy.
Each of the Parties acknowledges and agrees that the right to specific performance and the other relief contemplated herein is an integral part of the Transactions and without such right, none of the Parties would have entered into this Agreement.
13.12.
Representation by Counse
l
. Each Party represents and agrees with each other that it
has been represented by or had the opportunity to be represented by independent counsel of its own choosing, and that it has had the full right and opportunity to consult with its respective attorney(s), that to the extent, if any, that it desired,
it availed itself of this right and opportunity, that it or its authorized officers (as the case may be) have carefully read and fully understand this Agreement and the Ancillary Agreements in their entirety and have had them fully explained to them
by such Partys respective counsel, that each is fully aware of the contents thereof and their meaning, intent and legal effect, and that it or its authorized officer (as the case may be) is competent to execute this Agreement and has executed
this Agreement free from coercion, duress or undue influence.
13.13.
Bulk Transfers
. Buyer waives
compliance with the provisions of all applicable Laws relating to bulk transfers in connection with the transfer of the Acquired Assets.
13.14.
Counterparts; Signature Pages
. The Parties may execute this Agreement in one or more counterparts, each of which will be deemed an original and all of which, when taken together, will be deemed to constitute one and the same
agreement. Any signature page hereto delivered by facsimile machine or by
e-mail
(including in portable document format (.pdf), as a joint photographic experts group (.jpg) file, or otherwise) shall be binding
to the same extent as an original signature page, with regard to any agreement subject to the terms hereof or any amendment thereto and may be used in lieu of the original signatures for all purposes. Any Party that delivers such a signature page
agrees to later deliver an original counterpart to any Party that requests it.
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13.15.
Notice
s
. All notices or other
communications required or permitted to be given hereunder shall be in writing and may be delivered by hand, by nationally recognized private courier (for delivery in no fewer than two (2) Business Days with return receipt requested), by
facsimile or by email. Except as provided otherwise herein, notices delivered by hand shall be deemed given upon receipt; notices delivered by nationally recognized private courier shall be deemed given upon receipt; notices delivered by facsimile
shall be deemed given on the date of the senders receipt of confirmation of successful transmission; and notices delivered by email shall be deemed given on the date delivered (
provided
confirmation of email receipt is obtained). If a
notice deemed given upon receipt is given after 5:00 p.m. in the place of receipt (the Parties understand and agree that the foregoing applies only to notice and not to copies), such notice will be deemed given on the next succeeding Business Day.
All notices shall be addressed as follows:
If to Seller Parent:
The Medicines Company
8 Sylvan
Way
Parsippany, New Jersey 07054
Attention: Stephen Rodin
Facsimile: (973)
656-9898
E-mail: stephen.rodin@themedco.com
with a copy to (which shall not constitute notice):
Cadwalader, Wickersham & Taft LLP
200 Liberty Street
New York,
New York 10281
Attention: Gregory P. Patti, Jr.
Andrew P. Alin
Facsimile: (212)
504-6666
E-mail: greg.patti@cwt.com
andrew.alin@cwt.com
If to Buyer:
Melinta
Therapeutics, Inc.
300 George Street, Suite 301
New Haven, Connecticut 06511
Attention: Paul Estrem
Facsimile: (224)
377-8030
E-mail: pestrem@melinta.com
with a copy to (which shall not constitute notice):
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York,
New York 10019
Attention: Gordon Caplan
Sean Ewen
Facsimile: (212)
728-8111
E-mail: gcaplan@willkie.com
sewen@willkie.com
and/or to such other respective addresses and/or addressees as may be designated by notice given in accordance with the provisions of this
Section
13.15
.
[remainder of page intentionally left blank]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their
respective duly authorized officers as of the date first above written.
|
|
|
SELLER PARENT
|
|
THE MEDICINES COMPANY
|
|
|
By:
|
|
/s/ Stephen M. Rodin
|
|
|
Name: Stephen M. Rodin
|
|
|
Title: Executive Vice President and General Counsel
|
[Signature Page to Purchase and Sale Agreement]
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|
|
|
BUYER
|
|
MELINTA THERAPEUTICS, INC.
|
|
|
By:
|
|
/s/ Paul Estrem
|
|
|
Name: Paul Estrem
|
|
|
Title: Chief Financial Officer
|
[Signature Page to Purchase and Sale Agreement]
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EXHIBIT A
FORM OF ASSIGNMENT AND ASSUMPTION AGREEMENT
This ASSIGNMENT AND ASSUMPTION AGREEMENT (this
Agreement
), dated as of [●], 2017, has been made and entered into by
and between Melinta Therapeutics, Inc., a Delaware corporation (
Assignee
), The Medicines Company, a Delaware corporation (
Seller Parent
), and [other Sellers] (together with Seller Parent,
Assignors
).
W
I
T
N
E
S
S
E
T
H
:
WHEREAS, Buyer and Seller Parent have entered into a Purchase and Sale Agreement,
dated as of November 28, 2017 (the
Purchase Agreement
); and
WHEREAS, pursuant to the Purchase Agreement,
Assignors have agreed to grant, sell, transfer, convey, assign and deliver the Business Contracts to Assignee, and Assignee has agreed to assume from Assignors the Assumed Liabilities and the Business Contracts, as more fully described in the
Purchase Agreement and upon the terms and conditions set forth therein.
NOW, THEREFORE, in consideration of the mutual benefits to be
derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained in the Purchase Agreement, this Agreement, and the other Ancillary Agreements, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and upon the terms and subject to the conditions set forth herein, the parties hereto hereby agree as follows:
1.
Definitions
. Unless otherwise specifically provided herein, capitalized terms used but not defined herein shall have the respective
meanings ascribed to them in the Purchase Agreement.
2.
Assignment and Assumption
.
(a) As of the Closing, in accordance with the provisions of the Purchase Agreement, Assignors hereby irrevocably and unconditionally grant,
sell, transfer, convey, assign and deliver to Assignee the Business Contracts and all of Assignors right, title and interest in, to and under each Business Contract, free and clear of all Liens, other than Permitted Liens, without any
representations, warranties or other obligations or duties on the part of Assignors, except as set forth in the Purchase Agreement.
(b)
As of the Closing, Assignee hereby irrevocably and unconditionally assumes and agrees to satisfy and discharge, when due or when required to be satisfied or discharged, the Assumed Liabilities and assumes all of Assignors right, title and
interest in, to and under the Business Contracts, except as set forth in the Purchase Agreement.
(c) Notwithstanding
Sections 2(a)
and
(b)
above, with respect to any Business Contract for which a Consent of a third party has not been obtained as of the date hereof (where an assignment or transfer of such Business Contract, without the Consent of such third party,
would constitute a breach or violation thereof), the assignment and assumption of such Business Contract shall be effective only as of the date, if any, such Consent is obtained.
(d) Notwithstanding the foregoing, this Agreement shall not operate to assign any Excluded Liability or any Excluded Asset.
3.
No Modification of the Purchase Agreement
. Notwithstanding any other provision of this Agreement to the contrary, nothing contained
herein shall release Seller Parent or Buyer from any of their respective obligations under the Purchase Agreement or in any way supersede, modify, replace, amend, change, rescind, waive, exceed, expand, enlarge or in any way affect the provisions,
including warranties, covenants, agreements, conditions, representations, or in general any of the rights and remedies or any of the obligations of Buyer or Seller Parent set forth in the Purchase Agreement. In the event of any conflict or
inconsistency between the terms of the Purchase Agreement and the terms hereof, the terms of the Purchase Agreement shall govern.
(b)
General Provisions
. Sections 1.2, 13.1, 13.4, 13.5, 13.7, 13.8, 13.9, 13.10,
13.13, and 13.14 of the Purchase Agreement are each hereby incorporated by reference herein
mutatis mutandis
.
[
Signature Page
Follows
]
-2-
IN WITNESS WHEREOF, each of Assignors and Assignee have caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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THE MEDICINES COMPANY
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By:
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Name:
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Title:
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[OTHER SELLERS]
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-1-
IN WITNESS WHEREOF, each of Assignors and Assignee have caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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MELINTA THERAPEUTICS, INC.
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By:
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Name:
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Title:
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-1-
EXHIBIT B
FORM OF BILL OF SALE
This BILL
OF SALE (this
Bill of Sale
), dated as of [●], 2017, has been made and entered into by and between Melinta Therapeutics, Inc., a Delaware corporation (
Buyer
), The Medicines Company, a Delaware corporation
(
Seller Parent
), and [other Sellers] (together with Seller Parent,
Sellers
).
W
I
T
N
E
S
S
E
T
H
:
WHEREAS, Buyer and Seller Parent have entered into a Purchase and Sale Agreement, dated as of
November 28, 2017 (the
Purchase Agreement
); and
WHEREAS, pursuant to the Purchase Agreement, Seller Parent, on
behalf of itself and its subsidiaries, has agreed to grant, sell, transfer, convey, assign and deliver to Buyer, and Buyer has agreed to purchase and accept from Seller Parent and its subsidiaries, the Acquired Assets, as more fully described in the
Purchase Agreement and upon the terms and conditions set forth therein.
NOW, THEREFORE, in consideration of the mutual benefits to be
derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained in the Purchase Agreement, this Agreement, and the other Ancillary Agreements, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and upon the terms and subject to the conditions set forth herein, the parties hereto hereby agree as follows:
1.
Definitions
. Unless otherwise specifically provided herein, capitalized terms used but not defined herein shall have the respective
meanings ascribed to them in the Purchase Agreement.
2.
Sale
. As of the Closing, in accordance with the provisions of the
Purchase Agreement, Sellers hereby irrevocably and unconditionally grant, sell, transfer, convey, assign and deliver to Buyer all of their right, title and interest in and to the Transferred Assets, free and clear of all Liens, other than Permitted
Liens, without any representations, warranties or other obligations or duties on the part of Sellers, except as set forth in the Purchase Agreement.
(a) As of the Closing, Buyer hereby irrevocably and unconditionally purchases and accepts from Sellers all of Sellers right, title and
interest in and to the Transferred Assets.
(b) Notwithstanding the foregoing, this Bill of Sale shall not operate to grant, sell,
transfer, convey, assign or deliver any of the Excluded Assets.
3.
No Modification of the Purchase Agreement
. Notwithstanding any
other provision of this Agreement to the contrary, nothing contained herein shall release Seller Parent or Buyer from any of their respective obligations under the Purchase Agreement or in any way supersede, modify, replace, amend, change, rescind,
waive, exceed, expand, enlarge or in any way affect the provisions, including warranties, covenants, agreements, conditions, representations, or in general any of the rights and remedies or any of the obligations of Buyer or Seller Parent set forth
in the Purchase Agreement. In the event of any conflict or inconsistency between the terms of the Purchase Agreement and the terms hereof, the terms of the Purchase Agreement shall govern.
4.
General Provisions
. Sections 1.2, 13.1, 13.4, 13.5, 13.7, 13.8, 13.9, 13.10, 13.13, and 13.14 of the Purchase Agreement are each
hereby incorporated by reference herein
mutatis mutandis
.
[
Signature Page Follows
]
IN WITNESS WHEREOF, each of Seller Parent and Buyer has caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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THE MEDICINES COMPANY
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By:
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Name:
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Title:
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[OTHER SELLERS]
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[Signature Page to Bill of Sale]
IN WITNESS WHEREOF, each of Seller Parent and Buyer has caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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MELINTA THERAPEUTICS, INC.
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By:
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Name:
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Title:
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[Signature Page to Bill of Sale]
EXHIBIT
C-1
FORM OF PATENT ASSIGNMENT
THIS PATENT ASSIGNMENT dated as of [●], 2017 (this
Assignment
) is by and among The Medicines Company, a Delaware
corporation (
Seller
Parent
), [other Sellers] (together with Seller Parent, collectively,
Assignors
) and Melinta Therapeutics, Inc. (
Assignee
).
W
I
T
N
E
S
S
E
T
H
:
WHEREAS, Seller Parent and Assignee have entered into a Purchase and Sale Agreement, dated as of
November 28, 2017 (the
Purchase Agreement
);
WHEREAS, pursuant to the Purchase Agreement, Seller Parent, on behalf
of itself and its subsidiaries, has agreed, among other things, to grant, sell, transfer, convey, assign and deliver to Assignee, and Assignee has agreed to purchase and accept from Seller Parent and its subsidiaries, the Patents and Licensed
Patents, as more fully described in the Purchase Agreement and upon the terms and conditions set forth therein.
NOW, THEREFORE, in
consideration of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained in the Purchase Agreement, this Agreement, and the other Ancillary Agreements, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and upon the terms and subject to the conditions set forth herein, the parties hereto hereby agree as follows:
1.
Definitions
. Unless otherwise specifically provided herein, capitalized terms used but not defined herein shall have the respective
meanings ascribed to them in the Purchase Agreement.
2.
Assignment
. In accordance with the provisions of the Purchase Agreement,
Assignors hereby irrevocably and unconditionally grant, sell, transfer, convey, assign and deliver to Assignee all of Assignors right, title and interest in and to the Patents and Licensed Patents, together with all rights and remedies related
to infringement thereof and rights to protection of interests related thereto under all applicable laws, free and clear of all Liens, other than Permitted Liens. Assignors do further consent to the recordation of this Assignment by Assignee with the
United States Patent and Trademark Office.
3.
Further Assurances
. Assignee shall be solely responsible for all actions and all
costs whatsoever, including attorneys fees, arising after the date hereof and associated with the prosecution and the maintenance of the Patents and Licensed Patents, and Assignors shall have no obligation to pay any prosecution costs and/or
maintenance fees which become due for the Patents or Licensed Patents after the date hereof. Assignee shall be responsible for preparing and translating any documents that Assignee records to perfect its right, title and interest in the Patents and
Licensed Patents in any jurisdiction and all costs and fees associated with such recordation documents.
4.
No Modification of the
Purchase Agreement
. Notwithstanding any other provision of this Agreement to the contrary, nothing contained herein shall release Seller Parent or Assignee from any of their respective obligations under the Purchase Agreement or in any way
supersede, modify, replace, amend, change, rescind, waive, exceed, expand, enlarge or in any way affect the provisions, including warranties, covenants, agreements, conditions, representations, or in general any of the rights and remedies or any of
the obligations of Assignee or Seller Parent set forth in the Purchase Agreement. In the event of any conflict or inconsistency between the terms of the Purchase Agreement and the terms hereof, the terms of the Purchase Agreement shall govern.
5.
General Provisions
. Sections 1.2, 6.13, 13.1, 13.4, 13.5, 13.7, 13.8, 13.9, 13.10, 13.13, and 13.14 of the Purchase Agreement are
each hereby incorporated by reference herein
mutatis mutandis
.
[
Signature Page Follows
]
IN WITNESS WHEREOF, each of Assignors and Assignee have caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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THE MEDICINES COMPANY
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By:
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Name:
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Title:
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[other sellers]
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IN WITNESS WHEREOF, each of Assignors and Assignee have caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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MELINTA THERAPEUTICS, INC.
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By:
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Name:
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Title:
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EXHIBIT
C-2
FORM OF TRADEMARK ASSIGNMENT
THIS TRADEMARK ASSIGNMENT dated as of [●], 2017 (this
Assignment
) is by and among The Medicines Company, a Delaware
corporation (
Seller
Parent
), [other Sellers] (together with Seller Parent, collectively,
Assignors
) and Melinta Therapeutics, Inc. (
Assignee
).
W
I
T
N
E
S
S
E
T
H
:
WHEREAS, Seller Parent and Assignee have entered into a Purchase and Sale Agreement,
dated as of November 28, 2017 (the
Purchase Agreement
);
WHEREAS, pursuant to the Purchase Agreement, Seller
Parent, on behalf of itself and its subsidiaries, has agreed, among other things, to grant, sell, transfer, convey, assign and deliver to Assignee, and Assignee has agreed to purchase and accept from Seller Parent and its subsidiaries, the Marks and
Licensed Marks, as more fully described in the Purchase Agreement and upon the terms and conditions set forth therein.
NOW, THEREFORE, in
consideration of the mutual benefits to be derived from this Agreement and of the representations, warranties, conditions, agreements and promises contained in the Purchase Agreement, this Agreement, and the other Ancillary Agreements, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and upon the terms and subject to the conditions set forth herein, the parties hereto hereby agree as follows:
1.
Definitions
. Unless otherwise specifically provided herein, capitalized terms used but not defined herein shall have the respective
meanings ascribed to them in the Purchase Agreement.
2.
Assignment
. In accordance with the provisions of the Purchase Agreement,
Assignors hereby irrevocably and unconditionally grant, sell, transfer, convey, assign and deliver to Assignee all of Assignors right, title and interest in and to the Marks and Licensed Marks, free and clear of all Liens, other than Permitted
Liens. Assignors do further consent to the recordation of this Assignment by Assignee with the United States Patent and Trademark Office.
3.
Further Assurances
. Assignee shall be solely responsible for all actions and all costs whatsoever, including attorneys fees,
arising after the date hereof and associated with the registration and the renewal of the Marks and Licensed Marks, and Assignors shall have no obligation to pay any registration costs and/or renewal fees which become due for such Marks or Licensed
Marks after the date hereof. Assignee shall be responsible for preparing and translating any documents that Assignee records to perfect its right, title and interest in the Marks and Licensed Marks in any jurisdiction and all costs and fees
associated with such recordation documents.
4.
No Modification of the Purchase Agreement
. Notwithstanding any other provision of
this Agreement to the contrary, nothing contained herein shall release Seller Parent or Assignee from any of their respective obligations under the Purchase Agreement or in any way supersede, modify, replace, amend, change, rescind, waive, exceed,
expand, enlarge or in any way affect the provisions, including warranties, covenants, agreements, conditions, representations, or in general any of the rights and remedies or any of the obligations of Assignee or Seller Parent set forth in the
Purchase Agreement. In the event of any conflict or inconsistency between the terms of the Purchase Agreement and the terms hereof, the terms of the Purchase Agreement shall govern.
5.
General Provisions
. Sections 1.2, 6.13, 13.1, 13.4, 13.5, 13.7, 13.8, 13.9, 13.10, 13.13, and 13.14 of the Purchase Agreement are
each hereby incorporated by reference herein
mutatis mutandis
.
[Signature Page Follows]
IN WITNESS WHEREOF, each of Assignors and Assignee have caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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THE MEDICINES COMPANY
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By:
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Name:
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Title:
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[Other Sellers]
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IN WITNESS WHEREOF, each of Assignors and Assignee have caused this instrument to be signed
by its proper and duly authorized officer as of the date and year first written above.
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MELINTA THERAPEUTICS, INC.
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By:
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Name:
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Title:
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EXHIBIT D
FORM OF TRANSITION SERVICES AGREEMENT
This Transition Services Agreement (this
Agreement
), dated as of [[●], 2017], is entered into by and between Melinta
Therapeutics, Inc., a Delaware corporation (
Buyer
), and The Medicines Company, a Delaware corporation (
Seller Parent
). Buyer and Seller Parent are sometimes referred to herein individually as a
Party
and together as the
Parties
.
W
I
T
N
E
S
S
E
T
H
:
WHEREAS, Seller Parent and Buyer have entered into a Purchase and Sale Agreement,
dated as of November 28, 2017 (the
Purchase Agreement
);
WHEREAS, pursuant to the Purchase Agreement, among other
things, Sellers will sell to Buyer, and Buyer will purchase from Sellers, the Acquired Assets, consisting of the Transferred Shares and Transferred Assets, and Buyer will assume the Assumed Liabilities; and
WHEREAS, in order to ensure an orderly transition of the Business, Buyer and Seller Parent have agreed to enter into this Agreement, pursuant
to which Seller Parent will provide, or cause its Affiliates to provide, to Buyer certain services, in each case on a transitional basis and upon the terms and subject to the conditions set forth herein.
NOW THEREFORE, in consideration of the foregoing and the mutual covenants and agreements set forth in this Agreement, the Parties agree as
follows:
1.
Definitions
. As used in this Agreement, the following terms shall have the meanings set forth below and capitalized
terms used herein and not otherwise defined herein shall have the meanings ascribed to such terms in the Purchase Agreement.
1.1
Agreement
has the meaning specified in the Introduction.
1.2
Buyer
has the meaning specified in the
Introduction.
1.3
Compensation Expense
means (i) salary and wages consistent with past practice,
(ii) benefits consistent with past practice, and (iii) subject to prior Buyer approval, not to be unreasonably withheld, conditioned or delayed, reasonable retention payments, to the extent reasonably necessary to provide the Services
without interruption from and after the Closing until the end of the Service Period, in each case, of employees, contractors, agents and other third parties employed or engaged by or on behalf of Seller Parent or its Affiliates in connection with
the performance of any Service.
1.4
Force Majeure
has the meaning specified in
Section
7.12
.
1.5
Parties
has the meaning specified in the Introduction.
1.6
Party
has the meaning specified in the Introduction.
1.7
Purchase Agreement
has the meaning specified in the Recitals.
1.8
Sales Tax
has the meaning specified in
Section
2.6
.
1.9
Seller Parent
has the meaning specified in the Introduction.
1.10
Service Fee
has the meaning specified in
Section
2.5
.
1.11
Service Period
has the meaning specified in
Section
5.1
.
1.12
Services
has the meaning specified in
Section
2.1
.
2.
Services to be Provided
.
2.1
Services Generally
. During the Service Period and with respect to each Service for the period of time specified on
Annex
A
, Seller Parent shall provide (or cause to be provided) to Buyer or its Affiliates the services described on
Annex
A
, solely with respect to the Products and the Business (collectively, the
Services
). Notwithstanding the foregoing, the Parties acknowledge and agree that (i) Buyer may determine from time to time that it does not require all of the Services or that it does not require such Services for the entire
Service Period and (ii) nothing herein is intended to relieve Buyer of its responsibilities under the Purchase Agreement or applicable legal requirements.
2.2
Standards
. The Parties acknowledge and agree that Seller Parent shall use commercially reasonable efforts to conduct the Services
substantially as Seller Parent and/or its Affiliates has customarily conducted such activities with respect to the Products and the Business and in compliance in all material respects with applicable Law. Seller Parent agrees to use commercially
reasonable efforts to assign sufficient resources and qualified personnel as are reasonably required to perform the Services in accordance with the standards set forth in the preceding sentence. Notwithstanding anything to the contrary herein,
(i) neither Seller Parent nor any of its Affiliates will be required to perform or to cause to be performed any of the Services for the benefit of any third party (other than Buyer or its Affiliates) or in a manner (including in terms of volume
and scope) that is inconsistent with the past practices of Seller Parent or its Affiliates, as applicable, and (ii) neither Seller Parent nor any of its Affiliates makes any representations or warranties, expressed or implied, with respect to
the Services.
2.3
Performance by Affiliates and Third Parties
. Seller Parent may discharge its obligations hereunder through any
of its Affiliates or through any third party. Seller Parent hereby guarantees the performance by such Affiliates and third parties of its obligations under this Agreement and shall cause such Affiliates and third parties to comply with the
provisions of this Agreement in connection with such performance.
2.4
Systems Access, Security, and Integrity
. Each Party shall
(and shall cause each Person acting on its behalf to): (i) not attempt to obtain access to, use or interfere with any information technology systems of the other Party or any data owned, used or processed by the other Party, except to the extent
required to do so to receive or provide, as the case may be, the Services or as expressly permitted herein; and (ii) maintain reasonable security measures designed to protect the systems of the other Party to which it has access pursuant to
this Agreement from access by unauthorized third parties, and any back door, time bomb, Trojan Horse, worm, drop dead device, virus or other computer software routine intended
or designed to (1) permit access or use of information technology systems by a third party other than as authorized by the other Party, or (2) disable, damage or erase or disrupt or impair the normal operation of the information technology
systems of the other Party or its Affiliates.
2.5
Service Fees; Invoicing
. Buyer shall pay to Seller Parent, for each Service
provided hereunder, a fee (with respect to each Service, a
Service Fee
) equal to (i) the Compensation Expense with respect to such Service and (ii) any reasonable additional
out-of-pocket
costs and expenses of Seller Parent to provide the Service;
provided
that in the event any individual expenditure of
out-of-pocket
costs exceeds $10,000, Buyer shall have consented to such expenditure. For purposes of calculating the Service Fee for any Service, the allocable
Compensation Expense with respect to any employee or consultant of Seller Parent or any Affiliate thereof for performance of such Service during any period shall be equal to 100% of such persons Compensation Expense
multiplied by
the
proportion of such persons time that is required to be devoted to the performance of such Service during such period on the basis of a
40-hour
work week. Service Fees shall be invoiced by Seller Parent
to and payable by Buyer. Amounts payable pursuant to the terms of this Agreement shall be paid by Buyer to Seller Parent within thirty (30) days after the date of invoice. Service Fees not paid when due shall bear
-2-
interest at the rate of 1.50% per month from the date payment is due until the date payment is received in full by Seller Parent. All costs of collection, including reasonable attorneys
fees and expenses, incurred by or on behalf of Seller Parent in collecting any such invoice shall be recoverable by Seller Parent from Buyer pursuant to
Section
6
.
2.6
Taxes
. The Service Fees payable by Buyer to Seller Parent hereunder shall, in each case, be taken to be exclusive of any sales
Taxes (collectively,
Sales Tax
) properly chargeable in respect of the transactions hereunder, and an amount equal to such Taxes so chargeable shall, subject to receipt of a valid Sales Tax receipt or invoice, be paid by Buyer to
Seller Parent in addition to the fees otherwise payable under this Agreement. In the event that applicable Laws require that any amount in respect of Taxes be withheld from any payment by Buyer under this Agreement, Buyer shall withhold the required
amounts and pay such withheld amounts over to the applicable Governmental Authority in accordance with the requirements of applicable Laws, and, except in the case of any Sales Tax (which amount shall continue to be due and payable to Seller
Parent), any amount so withheld and paid over shall be treated as having been paid to Seller Parent, and Buyer shall not be required to pay any additional amount as a result of or in respect of such withholding.
3.
Cooperation
. Buyer shall cause its employees to, and Seller Parent shall cause its and its Affiliates employees to, cooperate
with the employees of the other Party to enable the provision of Services to Buyer hereunder. Each of Seller Parent and Buyer shall designate a point of contact who shall be responsible for the
day-to-day
implementation of this Agreement, including attempted resolution of any disputes that may arise during the performance of the Parties respective obligations hereunder. The initial point of
contact designated by Seller Parent shall be [●], and the initial point of contact designated by Buyer shall be [●]. Each of Seller Parent and Buyer may change its point of contact by written notice to the other Party.
4.
Confidentiality Obligations
. The Parties acknowledge that the information provided to them and their representatives in connection
with this Agreement is subject to, and the Parties shall, and shall cause their Affiliates and representatives to, comply with their respective obligations under Section 13.3 of the Purchase Agreement.
5.
Term; Termination
.
5.1
Service Period
. The term of this Agreement shall commence on the date hereof and shall expire with respect to each Service on the
last day of the time period set forth for such Service on
Annex A
, unless sooner terminated in accordance with the provisions of this
Section
5
; provided that, notwithstanding the foregoing, Buyer shall be entitled
to extend each such Service for a period equal to the shorter of (i)(A) the number of days set forth on
Annex A
for such Service
multiplied by
(B) two (2) and (ii) 30 days, in each case by written notice to Seller Parent no less
than five (5) Business Days prior to the then scheduled termination of such Service (the
Service Period
).
5.2
Termination for Breach
. A Party may terminate this Agreement immediately in the event that the other Party materially breaches any of its duties or obligations under this Agreement and such material breach is not cured within twenty
(20) days after receipt of written notice from the
non-breaching
Party to such breaching Party specifying the nature of such material breach.
5.3
Termination for Convenience
. Buyer may terminate this Agreement or any individual Service provided hereunder at any time;
provided
that at least thirty (30) days prior written notice of such termination is provided to Seller Parent.
5.4
Effects of Termination
. The expiration or termination of this Agreement shall not affect in any way the survival of any rights, duties or obligations of the Parties set forth in
Section
2.5
,
Section
2.6
,
Section
4
, this
Section
5.4
,
Section
6
or
Section
7
of this Agreement or that are expressly stated
elsewhere in this Agreement to survive such expiration or termination, and, notwithstanding any such expiration or termination or anything to
-3-
the contrary in this Agreement, Buyer shall remain obligated to pay Seller Parent for (i) any invoice for any Service rendered prior to the effectiveness of such termination or expiration,
(ii) subject to the provision by Seller Parent to Buyer of reasonable supporting documentation, any
non-refundable
or
non-cancellable
out-of-pocket
costs or expenses incurred by or on behalf of Seller Parent prior to such expiration or termination in connection with the provision or anticipated
provision of any Service hereunder and (iii) any valid Sales Tax receipt or invoice related to Sales Tax payments due to Seller Parent.
6.
Disclaimers; Limitation of Liability; Indemnification
.
6.1
Disclaimers
. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, THE PARTIES ACKNOWLEDGE AND AGREE THAT THE SERVICES ARE PROVIDED ON
AN AS IS BASIS, WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTIES, CONDITIONS, GUARANTEES OR REPRESENTATIONS, WHETHER EXPRESS OR IMPLIED.
6.2
Limitations of Liability
. SELLER PARENT AND ITS AFFILIATES SHALL HAVE NO LIABILITY TO BUYER AND ITS AFFILIATES WITH RESPECT TO THE
PROVISION OF SERVICES, OTHER THAN IN RESPECT OF ACTS OR OMISSIONS OF SELLER PARENT OR ITS AFFILIATES IN CONNECTION WITH THE PROVISION OF SERVICES THAT CONSTITUTE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT BY SELLER PARENT OR ITS AFFILIATES. NO PARTY,
NOR ANY STOCKHOLDER, OFFICER, DIRECTOR, AGENT, OTHER REPRESENTATIVE, OR AFFILIATE THEREOF, SHALL BE LIABLE TO ANY OTHER PARTY, ANY STOCKHOLDER, OFFICER, DIRECTOR, AGENT, OTHER REPRESENTATIVE, OR AFFILIATE THEREOF OR ANY OTHER THIRD PERSON FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, RELIANCE OR PUNITIVE DAMAGES OR LOST OR IMPUTED PROFITS OR OPERATIONAL RISK RELATED LOSSES, IN EACH CASE, ARISING IN CONNECTION WITH THIS AGREEMENT OR ANY ACTS OR OMISSIONS RELATING TO THE SERVICES,
WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER A PARTY OR ANY AFFILIATE THEREOF HAS BEEN ADVISED OF THE POSSIBILITY OF ANY SUCH LOSS OR
DAMAGE.
6.3
Indemnification
. Buyer shall indemnify, defend and hold harmless Seller Parent or any of its Affiliates from and
against any Losses incurred by Seller Parent or its Affiliates to the extent resulting from any breach of this Agreement by Buyer, except for Losses that are a result of the willful misconduct or gross negligence of Seller Parent, and Seller Parent
shall indemnify, defend and hold harmless Buyer from and against any Losses incurred by Buyer or any of its Affiliates that are a result of the willful misconduct or gross negligence of Seller Parent or its Affiliates in their provision of the
Services. The rights provided to the Parties under this
Section
6.3
shall be the sole and exclusive remedies of the Parties with respect to claims arising under or related to this Agreement or otherwise relating to the
provision of Services hereunder.
7.
Miscellaneous
.
7.1
No Third Party Beneficiaries
. This Agreement is solely for the benefit of the Parties and, to the extent set forth herein, their
respective Affiliates, and no provision of this Agreement shall be deemed to otherwise confer upon any other third parties any remedy, Claim, Liability, reimbursement or other right in excess of those existing without reference to this Agreement.
7.2
Entire Agreement; Amendment
. This Agreement (together with
Annex
A
), the Purchase Agreement, the
Confidentiality Agreement and the other Ancillary Agreements (including the Transfer Documents after their execution and delivery pursuant to the Purchase Agreement) contain the entire agreement of the Parties with respect to the Transactions,
superseding all negotiations, prior discussions and preliminary agreements made prior to the date hereof. This Agreement may not be amended, supplemented or otherwise modified, except by an instrument in writing signed by both Seller Parent and
Buyer.
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7.3
Succession and Assignment
. This Agreement shall be binding upon and inure to the
benefit of the Parties and their respective successors and permitted assigns. Neither Party may assign either this Agreement or any of its rights, interests, or obligations hereunder without the prior written approval of the other Party. Any
purported assignment in violation of the preceding sentence shall be void
ab initio
.
7.4
Counterparts; Signature Pages
. The
Parties may execute this Agreement in two or more counterparts, each of which will be deemed an original and all of which, when taken together, will be deemed to constitute one and the same agreement. Any signature page hereto delivered by facsimile
machine or by
e-mail
(including in portable document format (pdf), as a joint photographic experts group (jpg) file, or otherwise) shall be binding to the same extent as an original signature page, with regard
to any agreement subject to the terms hereof or any amendment thereto and may be used in lieu of the original signatures for all purposes. Any Party that delivers such a signature page agrees to later deliver an original counterpart to any Party
that requests it.
7.5
Notices
. All notices, requests, demands, claims and other communications hereunder shall be in writing and
shall be delivered to the Parties in accordance with Section 13.15 of the Purchase Agreement.
7.6
Waivers
. The waiver by a
Party of any breach of any of the terms, covenants or conditions of this Agreement or of any right or privilege conferred by this Agreement shall not be construed as a subsequent waiver of any such terms, covenants, conditions, rights or privileges
or as a waiver of any other terms, covenants, conditions, rights or privileges. No waiver shall be effective unless it is in writing and signed by an authorized Representative of the waiving Party.
7.7
Severability
. In the event that any provision of this Agreement or the application thereof becomes or is declared by a court of
competent jurisdiction to be illegal, void or unenforceable, the remainder of this Agreement will continue in full force and effect and the application of such provision to other Persons or circumstances will be interpreted so as reasonably to
effect the intent of the Parties. Further, the Parties agree to replace such void or unenforceable provision of this Agreement with a valid and enforceable provision that will achieve, to the extent possible, the economic, business and other
purposes of such void or unenforceable provision.
7.8
Governing Law
. This Agreement (and any Claim or controversy arising out of
or relating to this Agreement) shall be governed by and construed in accordance with the Laws of the State of Delaware without giving effect to any choice or conflict of Law provision or rule that would cause the application of the Laws of any
jurisdiction other than the State of Delaware.
7.9
Submission to Jurisdiction
.
7.9.1 Each Party hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of any Delaware
State court, or Federal court of the United States of America, in each case sitting in the City of Wilmington, County of New Castle, State of Delaware, and any appellate court from any thereof, in any action, suit or proceeding arising out of or
relating to this Agreement delivered in connection herewith or for recognition or enforcement of any judgment relating thereto, and each Party hereby irrevocably and unconditionally: (a) agrees not to commence any such action, suit or
proceeding except in such courts, (b) agrees that any claim in respect of any such action, suit or proceeding may be heard and determined in such Delaware State court or, to the extent permitted by applicable Law, in such Federal court,
(c) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such action, suit or proceeding in any such Delaware State or Federal court and
(d) waives, to the fullest extent permitted by applicable Law, the defense of an inconvenient forum to the maintenance of such action, suit or proceeding in any such Delaware State or Federal court. Each Party agrees that a final judgment in
any such action, suit or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by applicable Law. Each Party irrevocably consents to service of process in the manner
provided for notices in Section 13.15 of the Purchase Agreement. Nothing in this Agreement will affect the right of any Party to serve process in any other manner permitted by applicable Law.
-5-
7.9.2 EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS
AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE IT HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING
TO THIS AGREEMENT OR THE TRANSACTIONS. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION,
SEEK TO ENFORCE EITHER OF SUCH WAIVERS, (B) IT UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVERS, (C) IT MAKES SUCH WAIVERS VOLUNTARILY, AND (D) IT HAS BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS,
THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS
SECTION
7.9.2
.
7.10
Construction
. The articles, titles and
headings to sections herein are inserted for convenience of reference only and are not intended to be part of or to affect the meaning or interpretation of this Agreement. Unless expressly specified otherwise, whenever used in this Agreement, the
terms Annex, and Section refer to annexes and sections of this Agreement. Whenever used in this Agreement, the terms hereby, hereof, herein and hereunder and words of similar
import refer to this Agreement as a whole, including all articles, sections, schedules and exhibits hereto, and not to any particular provision of this Agreement. Whenever used in this Agreement, the terms include, includes
and including mean include, without limitation, includes, without limitation and including, without limitation, respectively. The words either and or are not exclusive. Whenever
the context of this Agreement permits, the masculine, feminine or neuter gender, and the singular or plural number, are each deemed to include the others. Days means calendar days unless otherwise specified. Unless expressly specified
otherwise, all payments to be made in accordance with or under this Agreement shall be made in U.S. Dollars (USD$). References in this Agreement to particular sections of a Law shall be deemed to refer to such sections or provisions as they may be
amended after the date of this Agreement. All references to a willful breach refer to an action or omission that the breaching party takes or omits to take with the intent of breaching this Agreement. The Parties have participated
jointly in the negotiation and drafting of this Agreement and in the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof
shall arise favoring or disfavoring any Party (or any Affiliate thereof) by virtue of the authorship of any of the provisions of this Agreement.
7.11
Independent Contractors
. It is expressly agreed that Buyer and Seller Parent shall be independent contractors and that the
relationship between the Parties hereto shall not constitute a partnership, joint venture, agency or employment relationship. Neither Buyer nor Seller Parent shall have the authority to make any statements, representations or commitments of any
kind, or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party. Nothing in this Agreement shall be construed so as to create an employment relationship between Buyer and any employees,
agents, consultants or contractors of Seller Parent who provide Services. None of the benefits provided by Buyer to its employees, including compensation, insurance and unemployment insurance, shall be available to the employees, agents, consultants
or contractors of Seller Parent by virtue of this Agreement. Seller Parent remains fully responsible for payment of all federal, state and local Taxes or contributions imposed or required under unemployment insurance, social security and income Tax
Laws with respect to the employees, agents, consultants or contractors of Seller Parent who provide Services.
7.12
Force Majeure
.
The Parties shall not be liable for the failure or delay in performing any obligation (other than any payment obligation) under this Agreement if and to the extent such failure or delay is due to: (i) acts of God; (ii) unusually severe
weather condition, fire or explosion; (iii) war, terrorism, invasion, riot or other civil unrest; (iv) the issuance, adoption or enactment of any governmental Laws, Orders, restrictions, actions, embargoes or blockades; (v) national
or regional emergency; (vi) injunctions, strikes, lockouts, labor trouble or other industrial disturbances; (vii) shortage of adequate fuel, power or materials that is beyond the
-6-
reasonable control of the affected Party; or (viii) any other event which is beyond the reasonable control of the affected Party (each such event, a
Force Majeure
);
provided
, that the Party affected shall promptly notify the other of the Force Majeure condition and shall provide the other Party, from time to time, with its best estimate of the duration of such Force Majeure and shall exert all
commercially reasonable efforts at its cost to eliminate, cure or overcome any such causes and to resume performance of its obligations as soon as possible.
[Signature Page Follows.]
-7-
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their
respective duly authorized officers as of the date first above written.
|
|
|
THE MEDICINES COMPANY
|
|
|
By:
|
|
|
|
|
Name:
|
|
|
Title:
|
[Signature Page to Transition Services Agreement]
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their
respective duly authorized officers as of the date first above written.
|
|
|
MELINTA THERAPEUTICS, INC.
|
|
|
By:
|
|
|
|
|
Name:
|
|
|
Title:
|
[Signature Page to Transition Services Agreement]
EXHIBIT E
Form of Closing Statement
|
|
|
|
|
Target Working Capital Amount:
|
|
$
|
(24,371,591
|
)
|
Closing Date Working Capital:
|
|
$
|
[
●
]
|
1
|
Closing Adjustment Amount
|
|
$
|
[
●
]
|
|
1
|
See calculation on
Annex I
.
|
EXHIBIT F
Restrictive Legend
The shares
represented hereby have not been registered under the Securities Act of 1933, as amended, or under the securities laws of any state, and may not be sold, transferred or otherwise disposed of in the absence of an effective registration statement
under such Act and under the securities laws of any applicable state or an opinion of counsel satisfactory to the corporation to the effect that such registrations are not required.
EXHIBIT H
Royalty Payments
1.
|
If the Net Sales of Vabomere in the U.S. in a calendar year are $600,000,000, the Royalty Payment owed to Seller Parent in respect thereof would be an amount equal to $80,000,000. The calculation of such Royalty Payment
is set forth below:
|
|
|
|
|
|
|
|
|
|
Net Sales
|
|
Applicable
Percentage
|
|
|
Royalty
Payment
|
|
$0-50,000,000
|
|
|
0.0
|
%
|
|
$
|
0
|
|
$50,000,001-$100,000,000
|
|
|
5.0
|
%
|
|
$
|
2,500,000
|
|
$100,000,001-
200,000,000
|
|
|
7.5
|
%
|
|
$
|
7,500,000
|
|
$200,000,001-500,000,000
|
|
|
15.0
|
%
|
|
$
|
45,000,000
|
|
Greater than $500,000,000
|
|
|
25.0
|
%
|
|
$
|
25,000,000
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
$
|
80,000,000
|
|
|
|
|
|
|
|
|
|
|
2.
|
If the Net Sales of Orbactiv in the U.S. in a calendar year are $80,000,000 and the Net Sales of Minocin in the U.S. in a calendar year are $60,000,000, combining for a total of $140,000,000, the Royalty Payment owed to
Seller Parent in respect thereof would be an amount equal to $11,000,000. The calculation of such Royalty Payment is set forth below:
|
|
|
|
|
|
|
|
|
|
Net Sales
|
|
Applicable
Percentage
|
|
|
Royalty
Payment
|
|
$0-100,000,000
|
|
|
5.0
|
%
|
|
$
|
5,000,000
|
|
Greater than $100,000,000
|
|
|
15.0
|
%
|
|
$
|
6,000,000
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
$
|
11,000,000
|
|
|
|
|
|
|
|
|
|
|
3.
|
If the Net Sales of Orbactiv in the U.S. in a calendar year are $140,000,000 and the Net Sales of Minocin in the U.S. in a calendar year are $80,000,000, combining for a total of $220,000,000, the Royalty Payment owed
to Seller Parent in respect thereof would be an amount equal to $23,000,000. The calculation of such Royalty Payment is set forth below:
|
|
|
|
|
|
|
|
|
|
Net Sales
|
|
Applicable
Percentage
|
|
|
Royalty
Payment
|
|
$0-100,000,000
|
|
|
5.0
|
%
|
|
$
|
5,000,000
|
|
Greater than $100,000,000
|
|
|
15.0
|
%
|
|
$
|
18,000,000
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
|
|
|
$
|
23,000,000
|
|
|
|
|
|
|
|
|
|
|
4.
|
If the revenues of Vabomere sold in China by a sublicensee of Buyer during the same annual calendar year are $100,000,000, of which Buyer receives a 10% royalty (i.e., $10,000,000), and Buyer also receives a $10,000,000
upfront payment from the sublicensee, the Royalty Payment owed to Seller Parent in respect thereof would be an amount equal to $3,000,000 ($20,000,000 x 15.0%).
|
ANNEX I
Royalty Payments
Annex
I-A
|
|
|
|
|
|
|
|
|
Net Sales
|
|
Applicable
Percentage
|
|
(1)
|
|
Less than or equal to $50,000,000
|
|
|
0.0
|
%
|
(2)
|
|
Greater than $50,000,000 and less than or equal to $100,000,000
|
|
|
5.0
|
%
|
(3)
|
|
Greater than $100,000,000 and less than or equal to $200,000,000
|
|
|
7.5
|
%
|
(4)
|
|
Greater than $200,000,000 and less than or equal to $500,000,000
|
|
|
15.0
|
%
|
(5)
|
|
Greater than $500,000,000
|
|
|
25.0
|
%
|
Annex
I-B
|
|
|
|
|
|
|
|
|
Net Sales
|
|
Applicable
Percentage
|
|
(1)
|
|
Less than or equal to $100,000,000
|
|
|
5.0
|
%
|
(2)
|
|
Greater than $100,000,000
|
|
|
15.0
|
%
|
Annex
I-C
15.0%
Annex B
CONFIDENTIAL
November 28, 2017
Melinta Therapeutics,
Inc.
300 George Street
Suite 301
New Haven, Connecticut 06511
Attention: Paul Estrem, Chief
Financial Officer
Re: Project Grouper Commitment Letter
Senior Secured Credit Facility, Equity Investment and Warrants
Ladies and Gentlemen:
You have advised the
investment funds managed by Deerfield Management Company, L.P. (
Deerfield
) that are signatories hereto (the
Deerfield Funds
) (
we
,
us
or the
Commitment
Party
) that Melinta Therapeutics, Inc. (the
Borrower
or
you
or
your
) seeks financing to (a) fund the purchase price for the proposed acquisition (the
Acquisition
) of the assets (the
Acquired Assets
) of The Medicines Company (the
Seller Parent
) and its subsidiaries (such subsidiaries, collectively with the Parent, the
Seller
) specified in the Purchase and Sale Agreement, dated as of the date hereof, by and between the Borrower and the Seller Parent (the
Acquisition Agreement
), (b) pay fees, costs and expenses in connection
with the Transactions (as defined below), (c) refinance the existing indebtedness of the Borrower under the Loan and Security Agreement dated as of May 2, 2017 (the
Oberland LSA
), as amended, among the Borrower, the lenders
party thereto and Suchard SA LLC (the
Refinancing
) and (d) finance ongoing working capital requirements and other general corporate purposes, all as more fully described in the Summary of Terms and Conditions attached hereto
as
Annex A
(the
Term Sheet Summary
). This Commitment Letter (as defined below) describes the general terms and conditions under which (a) the Commitment Party is willing to provide (i) up to an amount (such
amount, the
Closing Date Loan Amount
) equal to (A) $190 million
minus
(B) the amount of the Equity Investment, of senior secured loans for the Acquisition (the
Closing Date Loans
) and
(ii) up to $50 million in a senior secured delayed draw term loan facility (the
Delayed Draw Term Loan Facility
, and together with the Closing Date Loans, the
Loan Facility
) and (b) (i) the
Borrower will issue to the Commitment Party, on the Closing Date, warrants (the
Warrants
) to purchase a number of shares of the common stock of the Borrower (
Common Stock
) equal to 38.5% of the principal amount
of the Closing Date Loans, divided by $15.00, subject to appropriate adjustment to reflect any Stock Event (as defined in the Term Sheet Summary) that occurs between the date hereof and the date of issuance of the Warrants and (ii) the Borrower
will issue and sell to the Commitment Party a number of shares of Common Stock (the
Shares
) equal to 9.985% of the number of shares of Common Stock outstanding immediately following the Acquisition (including the Shares) for a
purchase price of $13.50, subject to appropriate adjustment to reflect any Stock Event that occurs between the date hereof and the date the Shares are issued to the Commitment Party (the
Equity Investment
, and together with the
Loan Facility and the Warrants, the
Facilities
).
As used herein, the term
Transactions
means,
collectively, the Acquisition, the making of the Closing Date Loans, the providing of the Delayed Draw Term Loan Facility, the issuance of the Warrants on the Closing Date, the Equity Investment, the Refinancing and the payment of fees, costs and
expenses in connection with each of the foregoing. This letter, including the Term Sheet Summary,
Schedule
1
and the Conditions
Annex I
attached hereto and thereto (and
Exhibit
A
attached
thereto) (such
Annex
I
and Exhibit A, the
Conditions Annex
), is herein referred to as the
Commitment Letter
. The date on which the Facilities are closed are referred to as the
Closing Date
, which shall be the date on which all conditions under the Commitment Letter are satisfied (or waived in writing by the Commitment Party in its sole discretion). Capitalized terms used herein without definition shall
have the meaning ascribed to such terms in the Term Sheet Summary or the Conditions Annex.
B-1
1.
Commitment
. Upon the terms and subject only to the conditions set forth in
Section 2 of this Commitment Letter and in the Conditions Annex, the Commitment Party is pleased to advise you of its commitment to provide 100% of the Closing Date Loans (the
Commitment
).
2.
Conditions to Commitment
. The Commitment and undertakings of the Commitment Party hereunder are subject solely to the satisfaction
of the conditions precedent set forth in (A) this Section 2 of this Commitment Letter and (B) the Conditions Annex. Subject to the satisfaction of the conditions set forth in this Section 2 of this Commitment Letter and the
Conditions Annex, (a) the only representations relating to the Acquired Assets, the Borrower and its subsidiaries, the Seller Parent and its subsidiaries and the respective businesses of the Borrower, the Seller Parent and their respective
subsidiaries the accuracy of which shall be a condition to the Commitment Party providing the Loan Facility on the Closing Date shall be (i) such of the representations made by the Seller and/or their affiliates with respect to the Seller, its
affiliates, the Acquired Assets or the related business, financials or entities in the Acquisition Agreement as are material to the interests of the Commitment Party, the Agent and the Lenders, but only to the extent that you or your affiliates have
the right (taking into account any applicable cure provisions) to terminate your or their obligations under the Acquisition Agreement or otherwise decline or refuse to close or consummate the Acquisition as a result of a breach (or failure to be
accurate, true or correct) of any such representations in the Acquisition Agreement (the representations in this clause (i), the
Specified Acquisition Agreement Representations
) and (ii) the Specified Representations (as
defined below) and (b) the terms of the Facilities Documentation (as defined below) shall be in a form such that they do not impair the availability of the Closing Date Loans on the Closing Date if the conditions set forth in this
Section 2 of this Commitment Letter and the Conditions Annex are satisfied (it being understood and agreed that to the extent any security interest in any Collateral (as defined in the Term Sheet Summary) (other than security interests that may
be perfected by (x) the filing of a financing statement under the Uniform Commercial Code, (y) the making of a federal intellectual property filings with the United States Patent and Trademark Office and the United States Copyright Office
and (z) the delivery of certificates, if applicable, evidencing the equity securities of the Loan Parties (other than the Borrower) and any other material subsidiary of the Borrower required to be pledged pursuant to the Term Sheet Summary and
the Facilities Documentation) is not or cannot be perfected on the Closing Date after your use of commercially reasonable efforts to do so, then the perfection of such security interests shall not constitute a condition precedent to the availability
of the Closing Date Loans on the Closing Date, but instead shall be required to be perfected after the Closing Date pursuant to arrangements and timing to be mutually agreed by the Agent and the Borrower acting reasonably (but not to exceed 60 days
after the Closing Date, unless extended by the Agent in its sole discretion)). For purposes hereof,
Specified Representations
means the representations and warranties relating to corporate existence of the Borrower, the Guarantors
and their subsidiaries; good standing of the Borrower and the Guarantors in their jurisdictions of organization; power and authority, due authorization, execution and delivery, legality, validity and enforceability, in each case, relating to the
Borrower and the Guarantors entering into and performance of the Facilities Documentation; no conflicts with or consents needed under the Borrowers or the Guarantors organizational documents or the Acquisition Agreement in connection
with the execution, delivery and performance by the Borrower and the Guarantors under the Facilities Documentation; solvency as of the Closing Date (after giving effect to the Transactions) of the Borrower, the Guarantors and their subsidiaries on a
consolidated basis (in form and scope substantially consistent with the solvency certificate to be delivered in accordance with the Conditions Annex); use of proceeds consistent with this Commitment Letter; no investment company (and no regulation
under the Investment Company Act); no applicability of Federal Power Act, Interstate Commerce Act and state public utilities codes; the PATRIOT Act; OFAC; FCPA; compliance with anti-terrorism laws, anti-money laundering laws and anti-corruption
laws; Federal Reserve margin regulations; the status of the Loan Facility as senior debt; governmental and third party approvals relating to the Facilities Documentation and the transactions contemplated thereby (not including the Acquisition);
creation, validity, priority and, subject to the parenthetical in the immediately preceding sentence, perfection of security interests in the Collateral; capitalization of the Borrower; reservation of authorized Common Stock for issuance upon
exercise of the Warrants; that the shares of Common Stock issued in the Equity Investment or issuable upon exercise of the Warrants will be duly authorized, validly issued, fully paid and nonassessable upon issuance; and that the issuance of such
shares of Common Stock, the Warrants and the shares issuable upon exercise of the Warrants will not be subject to preemptive rights or result in anti-dilution adjustments to any outstanding securities. The provisions of this Section 2 are
collectively referred to as the
Certain Funds Provision
.
B-2
3.
Clear Market; Other Covenants; Exclusivity
. Without the prior written consent of
the Commitment Party, at all times prior to the termination of this letter (or, to the extent the termination of this letter is due to Section 10(b)(i), until immediately after the funding of the Closing Date Loans), the Borrower and its
subsidiaries (not including, for the avoidance of doubt, the Seller) shall not, directly or indirectly, (a) create, incur, assume, guarantee, permit to exist or be liable with respect to any indebtedness or issue any equity securities or
warrants, other than (i) the Facilities, (ii) the Revolving Facility, subject to the terms of the Term Sheet Summary and the effectiveness of the Intercreditor Agreement, (iii) (A) the issuance of (A) equity securities in any
equity financing consummated concurrently with the Acquisition on the Closing Date on no more favorable terms to the investors therein than those provided under the Facilities Documentation (B) up to $50 million of Common Stock to the
Seller (
Seller Equity
) in connection with the consummation of the Acquisition at 90% of the volume weighted average price for the 10 day trading day period immediately prior to the consummation of the Acquisition and (C) up
to $10 million of Common Stock for a purchase price per share equal to ninety percent (90%) of the volume weighted average price for the ten (10) trading day period ending three (3) trading days prior to Closing (clause (iii),
Permitted Equity Issuances
) and (iv) indebtedness that will be paid off on the Closing Date (clauses (i) (iv), the
Permitted Debt and Equity Issuances
), (b) sell, transfer, lease, license, make
distributions of or otherwise dispose of any of the assets or property of the Borrower or any of its subsidiaries (or enter into any agreement to do so), other than in the ordinary course of business, (c) encumber, grant or otherwise convey any
liens or security interests on any assets or property (or enter into any agreement to do so, other than the Facilities Documentation) of the Borrower or any of its subsidiaries, other than Permitted Liens (as defined below), (d) make any dividends
or distributions to any person or entity (or enter into any agreement to do so) in respect of its equity securities (other than dividends or distributions paid in common stock and reimbursement of reasonable and customary shareholder expenses), (e)
make any loans to, or investments in, or acquire any assets or equity of, any person or entity (or enter into any agreement to do so), other than (i) the Acquisition, (ii) investments in money market funds, US treasury obligations, demand
deposit accounts and other cash equivalents in the ordinary course of business, (iii) investments received in connection with the bankruptcy or reorganization of customers or suppliers, (iv) travel advances to employees, officers and
directors in the ordinary course of business in an aggregate amount not to exceed $25,000, (v)
non-cash
loans to employees, officers and directors to finance the acquisition of stock in the Borrower pursuant
to compensation arrangements, (vi) existing joint ventures and existing strategic alliances in the ordinary course of business,
(vii) non-speculative
hedging arrangements and (viii) additional
investments in the ordinary course of business in an aggregate amount not to exceed $600,000, (f) merge with, consolidate with or into, dissolve or liquidate into or convey, transfer, lease or otherwise dispose of (whether in one transaction or in a
series of transactions) all or substantially all of its assets (whether now owned or hereafter acquired) to or in favor of any person or entity (or enter into any agreement to do so), (g) enter into any transactions with affiliates that are not at
arms length and on market terms (or enter into any agreement to do so), other than reimbursement of reasonable and customary shareholder expenses, (h) file for protection under the United States Bankruptcy Code or any similar federal,
state or foreign law for the protection of debtors or be a party as a debtor to any proceeding related thereto or take any action to effectuate any of the foregoing in this clause (h), (i) other than in a manner not materially adverse to
the Commitment Party, the Agent, the Lenders and their affiliates, amend any of its or their organizational documents, (j) engage in any line of business materially different from those lines of business carried on by it on the date of this
letter (or enter into any agreement to do so), (k) take any action that would reasonably be expected to result in the delisting or suspension of the Common Stock from the NASDAQ Global Market; (l) fail to file any reports on Form
10-Q
or
10-K
prior to the date such filings are required to be made under applicable law and regulations (giving effect to any legally permitted extension or grace period
associated therewith) and in accordance with applicable law and regulations, it being agreed that a subsequent amendment of any such filing shall not constitute a breach of this provision so long as the initial filing was otherwise properly filed in
accordance with applicable law and regulations prior to such date (giving effect to any legally permitted extension or grace period associated therewith) and any such subsequent amendment was filed in accordance with applicable law and regulations
prior to the date such amendment is required to be made under applicable law and regulations; or (m) grant registration rights to any person (other than the Commitment Party, the Lenders and their respective affiliates or in connection with any
Permitted Equity Issuances or the issuance of the Seller Equity) in respect of its equity or debt securities. The Borrower shall (i) promptly upon knowledge or notice
B-3
thereof (and, in any event, within one business day thereof), notify Mark Wood and Kristopher Ring at Katten Muchin Rosenman LLP at mark.wood@kattenlaw.com and kristopher.ring@kattenlaw.com, as
counsel to the Commitment Party (but, for the avoidance of doubt, not the Commitment Party itself), of any breaches or defaults under the Acquisition Documents (including, without limitation, providing copies of any documentation evidencing or
claiming such a breach or default) and (ii) promptly upon execution or receipt thereof (and, in any event, within one business day thereof), deliver copies to Mark Wood and Kristopher Ring at Katten Muchin Rosenman LLP at
mark.wood@kattenlaw.com and kristopher.ring@kattenlaw.com, as counsel to the Commitment Party (but, for the avoidance of doubt, not the Commitment Party itself) of any amendments, restatements, supplements, modification, changes, consents or waivers
to the Acquisition Documents.
Permitted Liens
means (a) liens for taxes that are not yet due and payable or that
are being contested in good faith by appropriate proceedings and for which appropriate reserves have been established in accordance with GAAP, (b) liens of carriers, warehousemen, mechanics, repairmen and materialmen and other like liens
arising in the ordinary course of business for sums not yet due and payable or that are being contested in good faith by appropriate proceedings and for which appropriate reserves have been established in accordance with GAAP, none of which are,
individually or in the aggregate, material to the business of the Borrower and its subsidiaries (the
Business
), (c) restrictions under any leases, subleases and similar agreements with respect to leased real property, none of
which, individually or in the aggregate, materially interferes with the ordinary conduct of the Business as a whole, (d) pledges and deposits made in the ordinary course of business in compliance with workers compensation, unemployment
insurance and other social security laws or regulations, (e) deposits to secure the performance of bids, trade contracts, leases, statutory obligations, surety and appeal bonds, performance bonds and other obligations of a like nature incurred
in the ordinary course of business, (f) liens securing the Oberland LSA that will be released on the Closing Date, (g) liens in favor of customs and revenue authorities arising as a matter of law to secure payment of custom duties that are
promptly paid on or before the date they become due, (h) liens on insurance proceeds securing the payment of financed insurance premiums that are promptly paid on or before the date they become due (provided, that such liens extend only to such
insurance proceeds and not to any other property or assets) in the ordinary course of business, (i) statutory and common law rights of
set-off
and other similar rights as to deposits of cash and
securities in favor of banks, other depository institutions and brokerage firms, (j) precautionary liens filed in respect of operating leases, (k) liens on property subject to capital leases securing such capital leases in an aggregate
amount not to exceed $50,000 at any time outstanding and (l) restrictions on transfer under applicable securities laws.
This
letter constitutes a legally binding agreement by you to work exclusively with the Commitment Party for obtaining debt or equity for purposes of consummating (or attempting to consummate) the Acquisition. You shall (and you shall cause your
affiliates to) ensure that at all times prior to the termination of this letter (or after such termination of this letter if caused by the breach of the Borrower or its affiliates of the terms, covenants or provisions of this Commitment Letter), you
and your affiliates shall not enter into, arrange, place, or propose any commercial bank or other credit facilities or other types of debt or issue any equity securities or warrants in connection with the Acquisition, other than the Permitted Debt
and Equity Issuances; provided, that, the obligations under this paragraph shall terminate if the Commitment Party fails to confirm in writing, within ten (10) business days of a written request by the Borrower to the Commitment Party (with
detailed instructions included in such request for how the Commitment Party may respond to the Borrower by email address, phone number, fax number and mailing address included therein), that the Commitment Party intends to comply with the Commitment
upon the satisfaction of the conditions precedent set forth in Section 2 of the Commitment Letter and the Conditions Annex and has not determined, to its knowledge as of the date of its response, that such conditions precedent are not capable
of being satisfied;
provided
further
that the Borrower shall only have the right to make any such request once during any sixty (60) day period (with the delivery of any such request to the Commitment Party commencing the first
day of such sixty (60) day period) and any additional requests made during such sixty (60) day period shall be null and void and the provisions in the immediately preceding proviso in this sentence shall not apply, or be enforceable
against the Commitment Party, in such instance.
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4.
Information; No MNPI
. You represent, warrant and covenant that all written
information and written data (other than forward-looking or projected information and information of a general economic or general industry nature;
provided
that, for the avoidance of doubt, any projections or other forward-looking
information that includes any material
non-public
information has not been shared with the Commitment Party, the Agent, the Lenders or any of their affiliates) concerning the Borrower, the Guarantors, their
affiliates and the Acquired Assets and the Transactions that has been or will be made available to the Agent, the Commitment Party, any of the Lenders or any of their affiliates by you, your affiliates or your or their representatives, including in
the Borrowers filings with the SEC (as defined below) (the
Information
), when taken as a whole (after giving effect to all supplements and updates thereto through the date furnished), (x) is, and in the case of Information
made available after the date hereof, will be, complete and correct in all material respects and (y) does not, and in the case of Information made available after the date hereof, will not, contain any untrue statement of a material fact or
omit to state a material fact necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not materially misleading. Solely as they relate to matters with respect to the Acquired Assets and
the Seller, the foregoing representations, warranties and covenants are made to the best of your knowledge. We will be entitled to use and rely upon, without responsibility to verify independently, the Information. You agree that if at any time
prior to the closing of the Facilities, any of the representations, warranties or covenants in this Section 4 would be incorrect in any material respect if the Information were being furnished, and such representations, warranties or covenants
were being made, at such time, then you will (i) with respect to Information relating to the Borrower, the Guarantors or their affiliates, promptly supplement the Information, and (ii) with respect to Information relating to the Acquired
Assets and the Seller, use commercially reasonable efforts to promptly supplement the Information, as the case may be, so that such representations, warranties and covenants will be true, correct and complete in all material respects under those
circumstances. The accuracy of the foregoing representations in this Section 4, whether or not cured, shall not be a condition precedent to the Commitment unless the inaccuracy results in a condition in Section 2 of this Commitment Letter
or in the Conditions Annex otherwise not having been satisfied.
At or prior to 9:30 a.m. (New York City time) on the third (3rd)
business day following the date of this Commitment Letter, the Borrower shall file a current report on Form
8-K
(the
Announcing Form
8-K
) with
the Securities and Exchange Commission (the
SEC
) describing the terms of the transactions (including, without limitation, the Transactions) contemplated by this Commitment Letter and by the Acquisition Agreement and disclosing any
other material
non-public
information (in the context of United States of America federal securities laws) provided or made available to the Commitment Party, the Agent, the Lender, any of their affiliates or
any of their officers, directors, employees, attorneys, advisors, representatives or agents (all such persons and entities, collectively, the
Applicable Persons
) by the Borrower or any of its subsidiaries or affiliates (not
including, for the purpose of this paragraph, the Seller or any of its subsidiaries or affiliates) or any of its or their respective officers, directors, employees, attorneys, representatives or agents prior to the filing of the Announcing Form
8-K.
The Announcing Form
8-K
shall include as exhibits thereto this Commitment Letter (including the annexes hereto) and the Acquisition Agreement. The Borrower represents and
warrants to the Commitment Party, the Agent, the Lenders and each other Applicable Person that, from and after the filing of the Announcing Form
8-K,
no Applicable Person shall be (or shall be deemed to be) in
possession of any material
non-public
information regarding the Borrower, any of its subsidiaries or affiliates, the Acquisition, the Transactions, the Acquired Assets or the Seller received from the Borrower
or any of its subsidiaries or affiliates (not including, for the purpose of this paragraph, the Seller or any of its subsidiaries or affiliates) or any of its or their respective officers, directors, employees, attorneys, advisors, representatives
or agents. Notwithstanding any affirmative disclosure obligations of the Borrower pursuant to the terms of this Commitment Letter, the Borrower shall not, and shall cause each of its subsidiaries and affiliates (not including, for the purpose of
this paragraph, the Seller or any of its subsidiaries or affiliates) and its and each of their respective officers, directors, employees, attorneys, advisors, representatives and agents to not, provide any of the Applicable Person with any material
non-public
information regarding the Borrower, any of its subsidiaries or affiliates, the Acquisition, the Transactions, the Acquired Assets or Seller from and after the filing of the Announcing Form
8-K
with the SEC without the express prior written consent of the Commitment Party, it being acknowledged and agreed that any such consent given prior to the date hereof shall be ineffective from and after the date
of the Announcing Form
B-5
8-K.
The Borrower hereby acknowledges and agrees that no Applicable Party shall have any duty of trust or confidence with respect to any material
non-public
information provided to any Applicable Party in breach of, or otherwise possessed by any Applicable Party as a result of a breach of, any of the foregoing covenants. Notwithstanding anything to the
contrary contained herein, in the event of a breach of any of the foregoing covenants, in addition to any other remedies available at law or in equity, the Commitment Party and its affiliates shall have the right to make a public disclosure, in the
form of a press release, public advertisement or otherwise, of the applicable material
non-public
information without the prior approval by the Borrower or any other person or entity.
5.
Indemnification
. You agree to indemnify and hold harmless the Agent, the Commitment Party, the Lenders, their affiliates and the
principals, directors, officers, employees, representatives, agents, accountants, attorneys and third party advisors of each of them (each, an
Indemnified Party
) from and against any and all actions, suits, losses, claims,
damages, penalties, liabilities and expenses of any kind or nature (including legal expenses), joint or several, to which such Indemnified Party may become subject or that may be incurred or asserted or awarded against such Indemnified Party, in
each case arising out of or in connection with or by reason of (including, without limitation, in connection with any investigation, litigation, dispute or proceeding or preparation of a defense in connection therewith, in each case, regardless of
whether such Indemnified Party is a party thereto (and regardless of whether such matter is initiated by a third party, you, a Guarantor, your subsidiaries, the Acquired Assets, the Seller or any of your or their respective affiliates)) (a) any
matters contemplated by this Commitment Letter, the Facilities Documentation, the Transactions or any transactions contemplated hereby or thereby (including, without limitation, the execution, delivery and performance of this Commitment Letter and
the Facilities Documentation and the closing of the Transactions) or (b) the use or the contemplated use of the proceeds of the Loan Facilities, and will reimburse each Indemnified Party for all reasonable and documented
out-of-pocket
expenses (including reasonable and documented attorneys fees, expenses and charges (but limited, in the case of legal fees and expenses, to the reasonable
and documented
out-of-pocket
fees, disbursements and other charges of one counsel to all Indemnified Parties (taken as a whole), one local counsel in each relevant
jurisdiction and one regulatory counsel to all such Indemnified Parties, taken as a whole, and in the event of a conflict of interest, one additional counsel (and, if necessary, one regulatory counsel and one local counsel in each relevant
jurisdiction) to each group of similarly situated affected Indemnified Parties)) actually incurred in connection with any of the foregoing;
provided
that no Indemnified Party will have any right to indemnification for any of the foregoing to
the extent that the same is found by a final,
non-appealable
judgment of a court of competent jurisdiction resulting directly and primarily from such Indemnified Partys (A) own bad faith, gross
negligence or willful misconduct or (B) material breach of its funding obligations to the Borrower under this Commitment Letter at a time when neither you nor your affiliates have breached your obligations in this Commitment Letter in any
material respect or (C) a dispute solely among Indemnified Parties (other than a dispute involving any Commitment Party solely in its capacity as the Agent or any other similar role in connection with this Commitment Letter, the Facilities, the
Transactions or any related transactions contemplated hereby or thereby or any use or intended use of the proceeds of the Facilities) not arising out of any act or omission on the part of you or your affiliates. In the case of an investigation,
litigation or proceeding to which the indemnity in the immediately preceding sentence applies, such indemnity shall be effective whether or not such investigation, litigation or proceeding is brought by you, your equity holders, affiliates or
creditors or an Indemnified Party, whether or not an Indemnified Party is otherwise a party thereto and whether or not the transactions contemplated hereby are consummated. Neither you nor any Indemnified Party will be liable for any indirect,
consequential, special or punitive damages in connection with this Commitment Letter, the Facilities Documentation or any other element of the Transactions. You shall not, without the prior written consent of each Indemnified Party affected thereby,
settle any threatened or pending claim or action that would give rise to the right of any Indemnified Party to claim indemnification hereunder unless such settlement (x) includes a full and unconditional release of all liabilities arising out
of such claim or action against such Indemnified Party, (y) does not include any statement as to or an admission of fault, culpability or failure to act by or on behalf of such Indemnified Party and (z) requires no action on the part of
the Indemnified Party other than its consent.
B-6
6.
Expenses
. Regardless of whether the Facilities close or the Closing Date occurs,
you agree to pay to the Agent, the Commitment Party, the Lenders and their affiliates all reasonable and documented fees and expenses (including, but not limited to, all reasonable and documented costs and
out-of-pocket
expenses of one (1) legal counsel and, to the extent necessary, one (1) local counsel in each relevant jurisdiction and one (1) regulatory counsel if reasonably required for all
of the Agent, the Commitment Party, the Lenders and their affiliates) incurred by them in connection with this Commitment Letter, the Facilities, the Transactions and the Facilities Documentation (including, without limitation, the preparation,
negotiation, execution and delivery of this Commitment Letter and the Facilities Documentation and any costs, expenses and legal fees incurred prior to, on and after the date hereof);
provided
that the maximum amount of such legal costs
incurred prior to the Closing Date in connection with the Facilities Documentation by the Agent, the Commitment Party and the Lenders that is required to be paid by the Borrower is $500,000. Such amounts in this Section 6 shall be due and
payable on the Closing Date or otherwise (either before or after the Closing Date) prior to the 30th day after demand is made therefor by the Agent, the Commitment Party, the Lender or any of their affiliates.
7.
Fees
. As consideration for the Commitment and agreements of the Commitment Party hereunder, you agree to pay, or you agree to cause
to be paid, the fees described in the fee portions of the Term Sheet Summary on the terms and subject to the conditions set forth therein.
8.
Confidentiality
. Subject to the second paragraph of Section 4, the Commitment Party shall treat all written information
received from the Borrower regarding the Seller or the Acquired Assets that is marked (or is disclosed as being) confidential in a confidential manner (the
Seller Confidential Information
); provided, however, that
nothing herein shall prevent the Commitment Party from disclosing any such Seller Confidential Information (a) subject to the final proviso of this sentence, to the Agent, any Lender, any assignee or participant or prospective Lender or
participant (in each case, other than any known direct competitor of the Borrower or the Seller), (b) to the extent compelled by legal process in, or reasonably necessary to, the defense of such legal, judicial or administrative proceeding, in any
legal, judicial or administrative proceeding or otherwise as required by applicable law, rule or regulation (in which case the Commitment Party shall, to the extent permitted by law, rule, regulation or proceed, use commercially reasonable efforts
to (i) inform you promptly thereof and (ii) ensure that any such Seller Confidential Information so disclosed is accorded confidential treatment), (c) upon the request or demand of any governmental, regulatory or self-regulatory authority
having jurisdiction over the Commitment Party or its affiliates (in which case the Commitment Party shall except with respect to any audit or examination conducted by bank accountants or any governmental, regulatory or self-regulatory authority
exercising examination or regulatory authority, to the extent permitted by law, rule or regulation, use commercially reasonable efforts to (i) notify you promptly thereof and (ii) ensure that any such Seller Confidential Information so
disclosed is accorded confidential treatment), (d) to its affiliates and its and its affiliates directors, officers, employees, accountants, attorneys, other professional advisors, agents and representatives who have been advised of their
obligation to maintain the confidentiality of the Seller Confidential Information for the purpose of evaluating, negotiating or entering into the Facilities and the other Transactions, (e) to the extent any such Seller Confidential Information
becomes publicly available other than by reason of disclosure by the Commitment Party, its affiliates or its or their respective directors, officers, employees, accountants, attorneys or other professional advisors in material breach of this
Section 8, or is independently developed by the Commitment Party, its affiliates or its or their respective directors, officers, employees, accountants, attorneys, other professional advisors, agents or representatives without the use of any
confidential information involving Seller Confidential Information, (f) to the extent applicable and reasonably necessary or advisable, for purposes of establishing a due diligence defense and (g) to the extent any such Seller
Confidential Information becomes available to the Commitment Party, its affiliates or its or their respective directors, officers, employees, accountants, attorneys, other professional advisors, agents or representatives from a source which is not
known by the Commitment Party to be subject to any contractual or fiduciary confidentiality obligation owing to the Seller with respect to the Seller Confidential Information. The provisions of this paragraph shall automatically terminate on the
date that is two years following the date of this Commitment Letter unless earlier superseded by the relevant Facilities Documentation.
B-7
9.
Other Services
.
(a) Nothing contained herein shall limit or preclude the Commitment Party, the Agent, any Lender or any of their affiliates from carrying on
any business with, providing banking or other financial or equity services to, or from participating in any capacity, including as an equity investor, in any party whatsoever, including, without limitation, any competitor, supplier or customer of
you, the Seller or any of your or its affiliates, or any other party, person or entity that may have interests different than or adverse to such parties, persons or entities. The Borrower (i) acknowledges and consents to the Commitment Party,
the Agent, the Lenders or any of their affiliates providing any Seller Bridge Financing or any other loans or commitments to the Seller and (ii) acknowledges and agrees that the providing thereof does not constitute a breach of this Commitment
Letter or any Facilities Documentation. The Borrower agrees that the Commitment Party, the Agent and the Lenders have no obligation to inform the Borrower of any Seller Bridge Financing or any other loans or commitments provided to the Seller from
time to time.
(b) In connection with all aspects of the Transactions, you acknowledge and agree that: (i) the Facilities and any
related services contemplated in this Commitment Letter constitute an
arms-length
commercial transaction between you, on the one hand, and the Commitment Party, the Agent and the Lenders, on the other
hand, and you are capable of evaluating and understanding and understand and accept the terms, risks and conditions of the Transactions, (ii) in connection with the process leading to the Transactions, the Commitment Party, the Agent and the
Lenders are and have been acting solely as a principal and not as a financial advisor, agent or fiduciary, for you or any of your management, affiliates, equity holders, directors, officers, employees, creditors or any other party, person or entity,
(iii) none of the Commitment Party, the Agent, any Lender or any of their affiliates has assumed or will assume an advisory, agency or fiduciary responsibility in your or your affiliates favor with respect to any of the Transactions or
the process leading thereto (irrespective of whether the Commitment Party, the Agent, the Lenders or any of their affiliates have advised or are currently advising you or your affiliates on other matters) and none of the Commitment Party, the Agent
the Lenders or their affiliates have any obligation to you or your affiliates with respect to the Transactions except the Commitment solely of the Commitment Party based on the terms, and subject to the conditions and covenants, set forth in the
this Commitment Letter, (iv) the Commitment Party, the Agent, the Lenders and their affiliates may be engaged in a broad range of transactions that involve interests that differ from yours and those of your affiliates and none of the Commitment
Party, the Agent, any Lender or any of their affiliates shall have any obligation to disclose any of such interests, and (v) none of the Commitment Party, the Agent, the Lenders or any of their affiliates have provided any legal, accounting,
regulatory or tax advice with respect to any of the Transactions and you have consulted your own legal, accounting, regulatory and tax advisors to the extent you have deemed appropriate. The Borrower waives and releases, to the fullest extent
permitted by law, any claims that it may have against Deerfield, the Deerfield Funds, the Commitment Party, the Agent, the Lenders and their respective affiliates with respect to any breach of fiduciary duty or alleged breach of fiduciary duty as a
consequence of this Commitment Letter and the Facilities Documentation.
10.
Acceptance/Expiration of Commitment
.
(a) This Commitment Letter and the Commitment of the Commitment Party set forth herein shall automatically terminate at 11:59 p.m. (New York
Time) on November 30, 2017 (the
Acceptance Deadline
), without further action or notice unless signed counterparts of this Commitment Letter (and all components thereof) shall have been fully delivered by electronic mail to
the Commitment Party by such time to the attention of Jonathan Leff at jleff@deerfield.com.
(b) If this Commitment Letter is accepted by
you as provided above, the Commitment and the undertakings of the Commitment Party set forth herein will automatically terminate without further action or notice upon the earliest to occur of (i) the funding of the Closing Date Loans,
(ii) the consummation of any portion of the Acquisition (with or, unless a court of competent jurisdiction has found by a final,
non-appealable
judgment that the Commitment Party has materially breached
its funding obligations under this Commitment Letter at a time
B-8
when neither you nor your affiliates have breached your obligations under this Commitment Letter in any material respect, without the use of any of the Closing Date Loans or the other
Facilities), (iii) the termination of the Acquisition Agreement and (iv) 11:59 p.m. (New York time) on May 28, 2018.
(c) Each of the parties hereto agrees that this Commitment Letter, if accepted by the Borrower prior to the Acceptance Deadline as provided
above, is a binding and enforceable agreement (subject to the effects of bankruptcy, insolvency, fraudulent conveyance, reorganization and other similar laws relating to or affecting creditors rights generally and general principles of equity
(whether considered in a proceeding in equity or law)) with respect to the subject matter contained herein (including an agreement to negotiate in good faith the Facilities Documentation by the parties in a manner consistent with this Commitment
Letter), it being acknowledged and agreed by the parties that the Commitment and the funding of the Closing Date Loans is subject to the conditions set forth in Section 2 of this Commitment Letter and the Conditions Annex.
11.
Survival
. The Sections and provisions of this Commitment Letter and the Term Sheet Summary relating to Clear Market, Other
Covenants, Exclusivity, Indemnification, Expenses, Confidentiality, Other Services, Survival and Governing Law and Capital Commitment Fee shall survive any termination or expiration of this Commitment Letter;
provided
that your
obligations under this Commitment Letter (other than your obligations with respect to the sections of this Commitment Letter relating to Clear Market, Other Covenants, Confidentiality, Other Services, Survival and Governing Law) shall be superseded
by the provisions of the Facilities Documentation upon the initial funding thereunder.
12.
Governing Law; Jury Trial Waiver
.
THIS COMMITMENT LETTER AND ANY CLAIM, CONTROVERSY OR DISPUTE ARISING UNDER OR RELATED HERETO OR THERETO (INCLUDING, WITHOUT LIMITATION, ANY CLAIMS SOUNDING IN CONTRACT LAW OR TORT LAW ARISING OUT OF THE SUBJECT MATTER HEREOF OR THEREOF), SHALL BE
GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH, THE LAWS OF THE STATE OF NEW YORK
(INCLUDING SECTION
5-1401
AND SECTION
5-1402
OF THE GENERAL OBLIGATIONS LAW OF THE STATE OF NEW YORK), WITHOUT REFERENCE TO ANY OTHER CONFLICTS OR CHOICE OF LAW PRINCIPLES THEREOF
;
PROVIDED
,
HOWEVER
, THAT
(A)
THE INTERPRETATION OF THE DEFINITION OF MATERIAL ADVERSE EFFECT (AND WHETHER OR NOT A MATERIAL ADVERSE EFFECT HAS OCCURRED), (B) THE DETERMINATION OF THE ACCURACY OF ANY SPECIFIED ACQUISITION AGREEMENT
REPRESENTATIONS AND WHETHER AS A RESULT OF ANY INACCURACY, UNTRUTHFULNESS OR INCORRECTNESS OF ANY SPECIFIED ACQUISITION AGREEMENT REPRESENTATION THERE HAS BEEN A FAILURE OF A CONDITION PRECEDENT TO YOUR OBLIGATION TO CONSUMMATE THE ACQUISITION OR
SUCH FAILURE GIVES YOU THE RIGHT TO TERMINATE YOUR OBLIGATIONS (OR TO DECLINE OR REFUSE TO CLOSE OR CONSUMMATE THE ACQUISITION) UNDER THE ACQUISITION AGREEMENT AND (C)
THE DETERMINATION OF WHETHER THE ACQUISITION HAS BEEN
CONSUMMATED IN ACCORDANCE WITH THE TERMS OF THE ACQUISITION AGREEMENT SHALL, IN EACH CASE, BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF DELAWARE WITHOUT GIVING EFFECT TO ANY CHOICE OR CONFLICT OF LAW PROVISION OR RULE
THAT WOULD CAUSE THE APPLICATION OF THE LAWS OF ANY JURISDICTION OTHER THAN THE STATE OF DELAWARE
. THE PARTIES HEREBY WAIVE ANY RIGHT TO TRIAL BY JURY WITH RESPECT TO ANY CLAIM OR ACTION ARISING OUT OF THIS COMMITMENT LETTER.
13.
Venue and Submission to Jurisdiction
. The parties hereto irrevocably consent and agree that the Commercial Division, New York State
Supreme Court and the federal courts, in each case, sitting in the City of New York, borough of Manhattan (and, in each case, the applicable state and federal appeals courts sitting in the City of New York or, if not available or applicable, the
State of New York), shall have exclusive jurisdiction to hear and determine any claims or disputes between or among any of the parties hereto pertaining to this
B-9
Commitment Letter, the Facilities, the Transactions, any other transaction relating hereto or thereto, and any investigation, litigation, or proceeding in connection with, related to or arising
out of any such matters. The parties hereto expressly and irrevocably submit and consent in advance to such jurisdiction in any action or suit commenced in any such court, and hereby irrevocably waive any objection, which each of the parties may
have based upon lack of personal jurisdiction, improper venue or inconvenient forum.
14.
Patriot Act
. The Commitment Party, the
Agent and the Lenders hereby notify you that pursuant to the requirements of the USA PATRIOT Act, Title III of Pub. L.
107-56
(signed into law October 26, 2001) (the
PATRIOT Act
), the
Commitment Party, the Agent and each Lender may be required to obtain, verify and record information that identifies the Borrower and each Guarantor, which information includes the name, address, tax identification number and other information
regarding the Borrower and each Guarantor that will allow the Commitment Party, the Agent or such Lender to identify the Borrower and each Guarantor in accordance with the PATRIOT Act. This notice is given in accordance with the requirements of the
PATRIOT Act and is effective as to the Commitment Party, the Agent and each Lender.
15.
Miscellaneous
. This Commitment Letter
embodies the entire agreement among the Commitment Party and you with respect to the specific matters set forth above and supersede all prior agreements and understandings relating to the subject matter hereof (including, without limitation, any
prior proposal letter or term sheet related to the Facilities or the Transactions). No person or entity has been authorized by the Commitment Party to make any oral or written statements inconsistent with this Commitment Letter. This Commitment
Letter shall not be assignable by you without the prior written consent of the Commitment Party, and any purported assignment without such consent shall be absolutely void
ab initio
. The Commitment of the Commitment Party may be assigned to
any of the other Deerfield Funds and any other Deerfield managed investment funds and their affiliates and such persons and entities may become Lenders or the Agent under the Facilities and a Commitment Party,
we or us under this Commitment Letter, in each case, without the consent of the Borrower or any other person or entity. This Commitment Letter is not intended to benefit or create any rights in favor of any person or entity
other than the parties hereto and other Deerfield Funds and Deerfield managed investment funds and their affiliates that are assigned any portion of the Commitment and that become a Commitment Party, we or us
under this Commitment Letter and, with respect to indemnification, each Indemnified Party. This Commitment Letter may be executed in separate counterparts and delivery of an executed signature page of this Commitment Letter by facsimile or
electronic mail shall be effective as delivery of manually executed counterpart hereof. This Commitment Letter (and any components thereof) may only be amended, restated, modified or superseded by an agreement in writing signed by you and the
Commitment Party. The division of this Commitment Letter into Sections and the use of headings and captions is for convenience of reference only and shall not modify or affect the interpretation or construction of this Commitment Letter or any of
its provisions.
[Signature Pages Follow]
B-10
If you are in agreement with the foregoing, please indicate acceptance of the terms hereof
by signing a counterpart of this Commitment Letter and returning it to the Commitment Party, together with the Term Sheet Summary and the Conditions Annex (and the Exhibits) attached to it, by no later than the Acceptance Deadline.
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Sincerely,
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Commitment Party:
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DEERFIELD PRIVATE DESIGN FUND IV, L.P.
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By:
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Deerfield Mgmt IV, L.P., General Partner
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By:
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J.E. Flynn Capital IV, LLC, General Partner
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By:
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/s/ James E. Flynn
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Name:
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James E. Flynn
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Title:
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President
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Agreed to and accepted as of the date first above written:
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MELINTA THERAPEUTICS, INC.
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By:
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/s/ Paul Estrem
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Name:
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Paul Estrem
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Title:
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Chief Financial Officer
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B-11
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
Capitalized Terms used herein without definition shall have the meanings assigned to them in the commitment letter (such commitment letter, together with
the below-defined Term Sheet Summary,
Schedule
1
and the Conditions Annex I attached hereto and thereto (and
Exhibit
A
attached thereto) (such
Annex
I
and
Exhibit
A
, the
Conditions Annex
), the
Commitment Letter
) to which this Summary of Terms and Conditions (this
Term Sheet Summary
) is attached, or if not defined
therein, in
Annex I
attached to this Term Sheet Summary.
Loan Facility Terms
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Borrower
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Melinta Therapeutics, Inc., a Delaware corporation (the
Borrower
)
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Guarantors
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Each of the Borrowers existing and future domestic subsidiaries other than Excluded Foreign Subsidiaries (as defined below)
(collectively the
Guarantors
) (the Borrower and the Guarantors referred to herein as the
Loan Parties
)
Excluded Foreign Subsidiary
means, for any taxable year of such foreign subsidiary to which Section 956(a) of the Code (as defined
below) applies with respect to the domestic Loan Party of which such foreign subsidiary is a subsidiary, any foreign subsidiary which is a controlled foreign corporation (as defined in the Internal Revenue Code of 1986, as amended (the
Code
), and any Treasury Regulations promulgated thereunder) that has not guaranteed or pledged any of its assets to secure, or with respect to which there shall not have been pledged
two-thirds
or more of the voting equity interests to secure, any indebtedness (other than the Loan Facility) of a Loan Party. For the avoidance of doubt, a foreign subsidiary shall not be (or, if it previously
was, shall cease to be) an Excluded Foreign Subsidiary from and after the effective date of any change in law making Section 956 of the Code inapplicable to its domestic parent.
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Lenders
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(a) Deerfield Private Design Fund IV, L.P. (
DPDF IV
) or any other investment funds managed by Deerfield or any of their affiliates and (b) other persons and entities reasonably acceptable to the Agent and the
Borrower (the persons and entities in clauses (a) and (b), together with its successors and assigns, collectively, the
Lenders
). It is currently anticipated that DPDF IV will be the sole Lender on the Closing Date.
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Agent
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DPDF IV, as collateral agent for the Lenders (in such capacity, together with its successors and assigns in such capacity, the
Agent
).
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Closing Date Loans
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Loans to be made on the Closing Date in an amount equal to the Closing Date Loan Amount, upon satisfaction of the conditions set forth in Section 2 in the Commitment Letter and the Conditions Annex (the
Closing Date
Loans
).
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Delayed Draw Term Loan Facility
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A delayed draw term loan facility (the
DDTL Facility
) of up to $50 million, under which loans (each, a
Delayed Draw Term Loan
, and together with the Closing Date Loans, the
Loans
) will be made available to the Borrower after (but not including) the Closing Date until (but not including) the second annual
anniversary of the Closing Date (the
DDTL Commitment Expiration Date
), subject only to the following terms and conditions:
(i) conditioned upon (both immediately before and after giving effect to the making of any such Delayed Draw Term Loan): (A) the Borrower achieving annualized
net
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B-12
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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sales of $75 million based upon the actual net sales amounts for the first two fiscal quarters preceding the making of the first
Delayed Draw Term Loan (but reflecting net sales generated by the Acquired Assets on a pro forma basis for any such fiscal quarter occurring prior to the Closing Date), (B) pro forma compliance with the financial covenants, (C) compliance with use
of proceeds provisions of the Facilities Documentation, (D) truthfulness, correctness and completeness of all representations and warranties in the Facilities Documentation (including, without limitation, the solvency representation), (E) delivery
of a borrowing notice request in form and substance satisfactory to the Agent and the Lenders, (F) no default or event of default existing under the Facilities Documentation, (G) the Borrower providing notice of any request for a Delayed Draw Term
Loan to the Agent and the Lenders at least fifteen (15) business days prior to the proposed funding date of such Delayed Draw Term Loan pursuant to a borrowing notice that is in form reasonably acceptable to the Agent and the Lenders and (H) such
other conditions to be agreed in the Facilities Documentation;
(ii) the DDTL
Facility may be funded in up to 5 separate draws before the DDTL Commitment Expiration Date;
(iii) the DDTL Facility will bear interest at 14.75% per annum, payable quarterly in arrears in accordance with the terms set forth in clause (ii) of the
Interest section below, and otherwise similar to the payment of the Closing Date Loans;
(iv) the minimum amount of any Delayed Draw Term Loan request shall be at least $10 million;
(v) the maturity date of all Delayed Draw Term Loans will be sixth anniversary of the
date when the first Delayed Draw Term Loan is made under the DDTL Facility (the
DDTL Maturity Date
);
(vi) amounts repaid on the DDTL Facility may not be reborrowed;
(vii) proceeds of the DDTL Facility shall be used for general corporate and working capital purposes (including Permitted Acquisitions (as defined below)) and
in compliance with the use of proceeds provisions in the Facility Agreement; and
(viii) the other terms of the DDTL Facility shall be either (A) consistent with the Closing Date Loans (taking into account the later maturity date for pushing
out the applicability of certain terms, such as, among other things, prepayment premiums, amortization (measured from such first draw under the DDTL Facility), upfront fees and other fees and collateral) or (B) as otherwise agreed.
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Interest
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(i)
On the Closing Date Loans, 11.75% per annum, payable quarterly in arrears. The Borrower will have the right to make any
interest payments on the Closing Date Loans only in cash or freely tradable shares of Common Stock or in a combination of cash and freely tradable shares of Common Stock (subject, in the case of payment in shares of Common Stock, to price, quantity,
9.985% beneficial ownership limitations and liquidity conditions set forth in the Facilities Documentation).
(ii)
On any Delayed Draw Term Loans, 14.75% per annum, payable quarterly in arrears. The Borrower will have the right to make any interest payments on
the Delayed Draw Term Loans only in cash or freely tradable shares of Common Stock or
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B-13
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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in a combination of cash and freely tradable shares of Common Stock (subject, in the case of payment in shares of Common Stock, to price, quantity, 9.985% beneficial ownership limitations and liquidity conditions set forth in the
Facilities Documentation).
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Default Rate; Late Payment Fee
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Additional interest of 2% upon the existence of any event of default, which shall (a) for payment and bankruptcy events of defaults, apply immediately and automatically and (b) for all other events defaults, be exercisable at the
sole election of the Agent or any Lender, which election shall apply retroactively from the date such event of default first occurred. With respect to any late payment of principal, interest or other amounts, other than to the extent arising from an
acceleration (except for an acceleration due (completely or partially) to a payment event of default that is not caused by an automatic acceleration from a bankruptcy event of default) or bankruptcy, a 10% fee on such overdue amounts to be paid in
cash.
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Maturity Date and Amortization
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Any outstanding Closing Date Loans shall be repaid in cash on the sixth anniversary date of the Closing Date. Any outstanding Delayed Draw
Term Loans shall be repaid in cash on the DDTL Maturity Date.
The aggregate
principal amount of the Loans shall be repaid in cash in equal monthly cash payments between the fourth anniversary and the sixth anniversary of
(i)
in respect of Closing Date Loans, the Closing Date, and
(ii)
in respect of any Delayed
Draw Term Loans, the date that the first Delayed Draw Term Loan is made under the DDTL Facility.
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Use of Proceeds
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The proceeds of
(i)
the Closing Date Loans will be used to finance (a) the purchase price of the Acquisition, including the refinancing of existing indebtedness (to the extent agreed to by the Lenders to be repaid with the
proceeds thereof), payment of fees, costs and expenses incurred in connection with the consummation of the Acquisition and the Facilities and (b) ongoing working capital requirements and other general corporate purposes and
(ii)
the
DDTL Facility will be used to finance general corporate and working capital purposes;
provided
, however, that the amount of funds disbursed for the aforementioned uses shall be pursuant to the conditions in the Facilities Documentation
(including, without limitation, those set forth in Section 2 of the Commitment Letter and in the Conditions Annex and, with respect to the DDTL Facility, those set forth in the Delayed Draw Term Loan Facility section above in this
Term Sheet Summary).
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Optional Prepayments
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The Loans may be prepaid, in whole or in part, in cash at the option of the Borrower at any time upon three (3) business days notice
subject to the payment by the Borrower to the Lenders (based on their pro rata share of such Loans) of
(i)
an exit fee equal to 2% of the amount of Loans paid, repaid or prepaid, which shall be due and payable in cash upon each such repayment
of the applicable tranche of Loans, and
(ii)
the fees outlined below (any such fee, a
Prepayment Fee
) to be paid in cash, if paid, repaid or prepaid:
(a) after (but not including) the third anniversary, and on or before the fourth
anniversary, of the Closing Date (with respect to the Closing Date Loans) or the date that the first Delayed Draw Term Loan is made (with respect to the Delayed Draw
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B-14
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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Term Loans), as applicable, upon cash payment of a premium equal to 75% of the total annual interest payment amount on all principal of
the applicable Loans being paid, repaid or prepaid (without giving effect to the principal payment, repayment or prepayment when calculating the 75%), which, by way of example, (i) for the Closing Date Loans, the principal thereof that was
outstanding immediately prior to any such payment, repayment or prepayment would be multiplied by 11.75% and then multiplied by 75% and (ii) for the Delayed Draw Term Loans, the principal thereof that was outstanding immediately prior to any such
payment, repayment or prepayment would be multiplied by 14.75% and then multiplied by 75%;
(b) after (but not including) the fourth anniversary, and on or before the fifth anniversary, of the Closing Date (with respect to the Closing Date Loans) or
the date that the first Delayed Draw Term Loan is made (with respect to the Delayed Draw Term Loans), as applicable, upon cash payment of a premium equal to 50% of the total annual interest payment amount on all principal of the applicable Loans
being paid, repaid or prepaid (without giving effect to the principal payment, repayment or prepayment when calculating the 50%); and
(c) after (but not including) the fifth anniversary of the Closing Date (with respect to the Closing Date Loans) or the date that the first Delayed Draw Term
Loan is made (with respect to the Delayed Draw Term Loans), as applicable, upon cash payment of a premium equal to 25% of the total annual interest payment amount on all principal of the applicable Loans being paid, repaid or prepaid (without giving
effect to the principal payment, repayment or prepayment when calculating the 75%).
For the avoidance of doubt, the principal amount of the Loans shall not be permitted to be paid, repaid or prepaid on or prior to the third anniversary of the
Closing Date (with respect to the Closing Date Loans) or the date that the first Delayed Draw Term Loan is made (with respect to the Delayed Draw Term Loans).
All prepayments of the Loans shall be applied pro rata to the outstanding principal balance of the Closing Date Loans and then the outstanding principal
balance of the Delayed Draw Term Loans, but within each such tranche of Loans, any voluntary prepayments shall be applied as directed by the Borrower and any acceleration payments shall be applied as determined by the Agent and the Lenders in their
sole discretion.
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Yield Enhancement Fee
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A yield enhancement fee shall be paid in cash by the Borrower to the Lenders funding such Loans in the amount of 2% of the principal amount of
(i)
the Closing Date Loans, which shall be due and payable in cash on
the Closing Date, and
(ii)
each Delayed Draw Term Loan, which shall be due and payable in cash on the date such Delayed Draw Term Loan is made. Each such fee shall be paid in cash directly to the funding Lenders based upon their pro
rata share of the principal amount of the Loan being funded.
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Upfront Fee
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An upfront fee shall be paid in cash by the Borrower to the Lenders funding such Loans in the amount of 2% of the principal amount of (i) the Closing Date Loans, which shall be due and payable in cash on the Closing Date, and
(ii) each Delayed Draw Term Loan, which shall be due and payable in cash on the date such Delayed
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B-15
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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Draw Term Loan is made. Each such fee shall be paid in cash directly to the funding Lenders based upon their pro rata share of the principal amount of the Loan being funded.
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Capital Commitment Fee
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A fee in the amount of $3 million shall be paid in cash by the Borrower to the Lenders on the date (the
Capital Commitment Fee Payment Date
) that is the earlier of (x) the one year anniversary of the date
of the Commitment Letter and (y) the date that is 5 (five) business days following the termination of the Acquisition Agreement, in each case solely to the extent that the Closing Date has not occurred prior to such Capital Commitment Fee
Payment Date (other than to the extent the failure of the Closing Date to have occurred by such Capital Commitment Fee Payment Date is found by a final,
non-appealable
judgment of a court of competent
jurisdiction to have directly and primarily resulted from the Commitment Party failing to fund the Closing Date Loans when (i) all of the conditions set forth in Section 2 of the Commitment Letter and the Conditions Annex had been satisfied and
(ii) the Commitment Letter was still in full force and effect at such time). This Section of this Term Sheet Summary shall survive the termination of the Commitment Letter and the Borrower shall still be obligated to pay such amounts in such
instance.
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Availability
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The
(i)
Closing Date Loans shall be made on the Closing Date subject solely to the conditions in Section 2 of the Commitment
Letter and in the Conditions Annex and
(ii)
the Delayed Draw Term Loans may be borrowed by the Borrower subject to the terms and conditions set forth in this Term Sheet Summary, including the Delayed Draw Term Loan Facility
section above in this Term Sheet Summary.
Repayments and prepayments of the Loan
Facility may not be reborrowed.
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Collateral; Ranking
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Subject to the Certain Funds Provision, the Facilities (and all obligations thereunder) shall be secured by a first priority perfected
lien (subject to the immediately succeeding paragraph below) on all of the Loan Parties tangible and intangible assets (the
Collateral
), subject to standard exclusions and carve-outs. The Collateral shall include, among
other assets, the stock of each of the Borrowers existing and future subsidiaries (or, in the case of first tier Excluded Foreign Subsidiaries, 65% of the voting and 100% of the
non-voting
equity
interests), other than the extent such stock pledge is not permitted by law or requires regulatory approval.
While the Collateral shall be subjected to a first priority perfected lien of the Agent (for the benefit of the Agent, the Lenders and the other secured
parties), the Borrower may enter into a revolving credit facility of up to $20 million (the
Revolving Facility
) that may have lien priority over the Facilities subject to entering into an intercreditor agreement that is
reasonably satisfactory to the Agent and the Lenders (the
Intercreditor Agreement
); provided that, for the avoidance of doubt, (a) the Facilities shall not be payment subordinated to the Revolving Facility and the Intercreditor
Agreement shall not include any payment subordination and (b) the Borrower and its subsidiaries can only have one revolving credit facility combined and it shall be the Revolving Facility and subject to the terms and conditions set forth in the
Commitment Letter and the Facilities Documentation. To the extent any Revolving Facility is outstanding (or will be outstanding) on any such date of determination, then the Intercreditor Agreement shall be part of the Facilities
Documentation.
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B-16
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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Representations and Warranties
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The representations and warranties included in the Facility Agreement will be limited to the following (subject to materiality thresholds,
baskets and other exceptions and qualifications to be mutually agreed):
Compliance
with, no violation of and effectiveness of, organizational documents; no default or event of default; paying debts as they become due, solvency and no dissolution, liquidation, etc.; no liens; valid existence, good standing and foreign
qualifications, power and authority; no governmental actions proceedings or threats; absence of litigation, threats, injunctions, orders, investigations, etc.; due authorization, execution and delivery; duly authorized, validly issued, fully paid
and
non-assessable
Shares and Warrant shares (upon exercise), valid and binding obligations and enforceability; no conflict or creation of liens with agreements, organizational documents, law or judgments,
governmental orders, etc.; no consent, authorizations or filings required (other than shareholder approval only for purpose of NASDAQ requirement and other consents, authorizations and filings obtained or made); compliance with law, regulations,
etc.; compliance with authorizations, licenses, permits, governmental orders, etc. and validity and effectiveness thereof; real estate; ownership of property; leases; intellectual property; no default or breach under agreements, etc.; taxes; no
exclusive rights agreements regarding services; governmental compliance and authorizations; SEC filings, reportings, compliance, etc.; financial condition and financial statements (including, without limitation, with respect to acquired persons,
entities and businesses and predecessors), and reports; no material adverse effect; internal and disclosure controls; ERISA; subsidiaries; share issuances, warrants, stockholder agreements and other stock limitations, restrictions and compliance;
delivery of correct and complete organizational documents; use of proceeds; environmental and hazardous materials; no investment company (and no regulation under the Investment Company Act); no applicability of Federal Power Act, Interstate Commerce
Act, state public utilities codes or any other federal or state statute, etc. limiting its ability to incur debt, pledge assets or perform obligations under the Facilities Documentation; labor relations; jurisdiction or organization, legal name,
organizational identification number and location of chief executive office; deposit and other accounts; accuracy of information; compliance with OFAC, money laundering, Patriot Act and other anti-terrorism laws and anti-corruption laws;
capitalization of the Borrower; Shares, Warrants and Warrant shares are not subject to preemptive rights and the issuance thereof will not result in any anti-dilution adjustment of outstanding securities; reservation of authorized Common Stock for
issuance upon exercise of the Warrants; compliance with Sarbanes-Oxley Act; no shell company; eligibility for registering the Shares and Warrant shares for resale; no general solicitation of securities; no offers or sales of securities
requiring registration under Securities Act; registration of the Common Stock; listing on NASDAQ, and no suspension of trading or violation of stock market rules and regulations; clearance and eligibility of the Common Stock through DTC, DWAC, DRS,
etc.; inapplicability of anti-takeover provisions in organizational documents and law and no poison pill adoption; derivatives and short sales and purchases and hedging; Warrant acknowledgments and representations; placement, broker and
adviser commissions; Acquisition, Acquisition Agreement and related documents and compliance therewith and receipt of necessary consents and approvals with respect thereto; Revolving Facility and documents and compliance related thereto and receipt
of necessary consents and approvals; collateral and lien creation, perfection actions and lien priority; and healthcare.
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B-17
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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Affirmative Covenants
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The affirmative covenants included in the Facility Agreement will be limited to the following (subject to materiality thresholds, baskets
and other exceptions and qualifications to be agreed):
Preservation of
organizational existence and jurisdiction qualifications; compliance with laws; licenses and permits; maintenance of property; insurance; taxes (including calculation and allocation of original issue discount to debt, warrants and equity provided in
connection with the Facilities Documentation); default and event of default notices; copies of documents, notices, defaults and breaches under the Revolving Facility; notices of material events and events regarding the Acquisition and related
documents (and copies thereof); reports sent to certain other investors and parties; financial statements and other financial deliverables; notices and deliverables related to the Acquisition and the Acquisition Agreement (including, without
limitation, any breaches or defaults under, and any amendments, restatements, changes, consents, waivers, etc. to the Acquisition Agreement and other related documents (collectively, the
Acquisition Documents
); the perfection
certificates and compliance certificate deliverables; GAAP compliance; compliance with SEC reporting requirements; additional information requests; inspection of property and books and records; truth and accuracy of representations, warranties and
other information and additional disclosures; control agreements on deposit and other accounts; collateral deliverables and further assurances (including provision of additional collateral and guaranties); real estate; ERISA; Form D filings;
exemptions or qualification under applicable laws for securities; blue Sky law compliance and filings; active listing of Common Stock with NASDAQ; SEC filings with respect to information on Facilities and Transactions; restrictions on
providing material
non-public
information to the Agent, the Lenders and their affiliates; notices and acknowledgments related to securities; options and convertible securities; public company covenants;
anti-layering; royalty-related covenants; obligation to reserve for issuance authorized and unissued shares of Common Stock as shall be sufficient for the exercise of the Warrant in full; healthcare; and any post-closing obligations (including,
without limitation, any that are required pursuant to the Certain Funds Provision).
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Negative Covenants
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The negative covenants included in the Facility Agreement will be limited to the following (subject to materiality thresholds, baskets and
other exceptions and qualifications to be agreed):
Limitations on: consolidations,
mergers, dissolutions and liquidations; formation or acquisition of subsidiaries; partnership, joint venture, profit-sharing or royalty agreements with certain affiliates; management service arrangements and management and related fees, expenses and
indemnities; dividends, distributions and restricted payments; liens; asset dispositions; indebtedness; investments; issuances and sales of controlling or management interests in equity of the Loan Parties or their subsidiaries (other than permitted
under the Warrants); transactions with affiliates; ERISA; nature and line of business; amendments to organizational documents, Acquisition Documents, Revolving Facility documents and other material documents; changes to accounting and reporting
practices and fiscal periods; changes to legal name, jurisdiction of organization, chief executive office, entity structure and entity identity; prepayments of indebtedness; negative pledge and restrictions on dividends and distributions, asset
sales, management fees and certain other actions;
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B-18
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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noncompliance with OFAC, money laundering, Patriot Act and other anti-terrorism laws and anti-corruption laws; sale leaseback, synthetic leases and similar transactions; environmental violations and hazardous materials;
investment companies and registration under the Investment Company Act; Revolving Facility; royalties; no material operations or revenue of
Rib-X
Therapeutics Limited; and healthcare violations.
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Permitted Acquisitions
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The Borrower will be permitted to make acquisitions with an aggregate purchase price (including, without limitation, costs and expenses,
deferred purchase price and indebtedness assumed and/or incurred in connection therewith) not in excess of $50,000,000 (excluding the purchase price of the Acquisition from such capped amount) from and after the Closing Date, in each case, for all
acquisition targets organized in the United States of America or of assets which are located in the United States of America; provided that all of the conditions specified in the Credit Documentation have been fully satisfied, including, without
limitation the following:
(a) receipt of (i) material acquisition documents;
provided that, on the third (3rd) business day following the date of such acquisition documents, the Borrower shall file a current report on Form
8-K
with the SEC describing the terms of the transactions
contemplated by such acquisition documents and disclosing any other material
non-public
information (in the context of United States of America federal securities laws), and (ii) to the extent required in the
acquisition documents, all required consents and approvals;
(b) (i) granting to the
Agent of a first priority perfected security interest in all acquired assets to the extent required by the Facilities Documentation and (ii) providing for any target entity to become a Loan Party under the Facilities Documentation and having such
target entity provide a first priority perfected security interest in all of its tangible and intangible assets that are Collateral;
(c) after giving effect to such acquisition and all other transactions contemplated by the applicable acquisition documents, pro forma compliance with the
financial covenants;
(d) such acquisition is consensual (not hostile),
and, if applicable, has been approved by the acquisition targets board of directors;
(e) EBITDA (to be mutually defined) of target will be accretive and target will not have a negative impact on EBITDA; and
(f) at the time of, and after giving effect to, such acquisition and all other
transactions contemplated by the applicable acquisition documents, (i) all representations and warranties in the Facilities Documentation and in the applicable acquisition documents are true, correct and complete and (ii) no breach, default or event
of default has occurred under the Facilities Documents or the applicable acquisition documents.
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Financial Covenants
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The financial performance covenants included in the Facility Agreement will be limited to the following, each with definitions to be
agreed upon:
1.
minimum cash balance of $25 million;
and
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B-19
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
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2.
minimum level of annual net sales per the
following: $45 million for 2018; $75 million for 2019; and $100 million for 2020 and each year thereafter.
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Events of Default
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The Facility Agreement will contain only the following events of default (subject to materiality thresholds, grace periods, baskets and
other exceptions and qualifications to be agreed):
Failure to pay principal,
interest or any other amount when due; failure to comply with covenants in the Facilities Documentation; representations and warranties incorrect or incomplete in any material respect when made or deemed made (and no supplement thereof after the
fact or later scheduling thereof shall cure any such event of default); bankruptcy or insolvency; judgments, orders, settlements, etc.; governmental authorizations related to Facilities Documentation not given or withdrawn; actual or asserted
invalidity or impairment of any part of the Facilities Documentation (including the failure of any lien to remain perfected and having the necessary priority) or impairment thereof; cross-default to other indebtedness (including, without limitation,
the Revolving Facility); invalidity of intercreditor and subordination provisions; ERISA; and change of ownership or control.
A transaction described in clause (i), (ii), (iii) or (iv) of the definition of Major Transaction under the Warrant Terms, at the option of the
holders of the Warrants, shall cause a mandatory prepayment of the Loan Facility.
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Expenses and Indemnification; Governing Law and Forum; and Miscellaneous
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The Facilities Documentation will include (a) customary expense reimbursement, indemnification and other provisions as are usual and customary for facilities of this kind; (b) a waiver of consequential and punitive damages and
right to a jury trial, (c) customary agency and
set-off
provisions, (d) New York governing law, jurisdiction and venue, (e) secured party rights and remedies provisions and (f) other customary miscellaneous
provisions.
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Vabomere Royalty
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DPDF IV (or its designee) will receive annual cash payments equal to (with definitions of the financial terms to be agreed upon): (i) $0 for the first $75 million in Vabomere U.S. annual net sales and (ii) 3% on the
increment of Vabomere U.S. annual net sales between $75 million and $500 million. Such payment right will have a term of 7 years regardless of whether the Loan Facility is paid off and the Loan commitments thereunder are terminated;
provided
that the 3% payment rate in clause (ii) in the sentence above will reduce to 2% after the repayment in full in cash of the Loan Facility and the termination of the Loan commitments thereunder.
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Counsel to Deerfield
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Katten Muchin Rosenman LLP
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B-20
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
Warrant Terms
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Issuer
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Melinta Therapeutics, Inc. (
Borrower
)
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Investors
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Deerfield Private Design Fund IV, L.P.
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Warrant Strike
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$16.50, subject to equitable and proportionate adjustment to reflect any Stock Event (as defined below) that becomes effective between the close of trading on the last trading day prior to the signing of the Commitment Letter and
the date of issuance of the Warrant. The holder of the Warrant (the
Holder
) will be entitled to exercise the Warrant for cash, by cashless exercise or through the reduction of principal outstanding under the Closing Date
Loans.
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Warrant Term
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7 years
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Number of Shares
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A number of shares of the common stock of the Borrower (
Common Stock
) equal to 38.5% of the principal amount of the Closing Date Loans divided by $15.00, subject to equitable and proportionate adjustment to
reflect any Stock Event that becomes effective between the close of trading on the last trading day prior to the signing of the Commitment Letter and the date of issuance of the Warrant. No fractional shares shall be issued upon any exercise of the
Warrant. The number of shares of Common Stock issuable upon such exercise shall be rounded down to the nearest whole number and the Holder shall receive no consideration in lieu of fractional shares.
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Ownership Limits
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The Warrant will contain a provision restricting the exercise thereof to the extent that, upon such exercise, the Holder (or any group of which the Holder is a member) would beneficially own greater than 9.985% of the
outstanding shares of Common Stock (the
9.985% Cap
). No changes to the 9.985% Cap shall be made without the prior written consent of Borrower.
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Major Transaction
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|
Major Transaction
will be defined to include: (i) a consolidation, merger, exchange of shares, recapitalization, reorganization, business combination or other similar event that results in a change in
control of the Borrower (
i.e.
, current stockholders no longer hold at least 50% of the Common Stock or no longer have the ability to elect a majority of the Board of Directors of Borrower); (ii) a sale or transfer of assets in one transaction
or a series of related transactions for a purchase price of more than 50% of Borrowers enterprise value or a sale or transfer of all or substantially all of the Borrowers assets (an
Asset Sale
); (iii) a purchase,
tender or exchange offer made to the holders of outstanding shares of Common Stock, such that following the completion of such purchase, tender or exchange offer a change of control shall have occurred (
i.e.
, current stockholders no longer
hold at least 50% of the Common Stock or no longer have the ability to elect a majority of the Board of Directors of Borrower); (iv) an issuance or series of issuances by the Borrower after the date of the Warrant (other than to the Holder and its
affiliates), of an aggregate number of shares of Common Stock equal to 50% or more of the Borrowers outstanding Common Stock as of the date of such issuance; (v) the liquidation, bankruptcy, insolvency, dissolution or
winding-up
(or the occurrence of any analogous proceeding) affecting the Borrower; (vi) the shares of Common Stock cease to be listed, traded or publicly
|
B-21
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
|
|
|
|
|
quoted on the NASDAQ Global Market and are not promptly
re-listed
or requoted on either the New
York Stock Exchange, the NYSE American, the NASDAQ Global Select Market or the NASDAQ Capital Market; or (vii) the Common Stock ceases to be registered under Section 12 of the Exchange Act.
In the case of a Major Transaction pursuant to clause (i) or (ii) of the definition in which the Common Stock are converted into the right to receive cash
or other assets or in which the Company has announced its intention to liquidate and distribute its assets to stockholders, the Holder will be entitled to convert the Warrant into an amount of the applicable transaction consideration equal in value
to the Black-Scholes Value (as defined below) of the Warrant upon consummation of the Major Transaction. With respect to all other Major Transactions, the Holder will be entitled to exercise the Warrant following the announcement or consummation of
a Major Transaction for an amount of Common Stock (valued in accordance with the Warrant) equal to the Black-Scholes Value of the Warrant.
Alternatively, the Holder will also be entitled to require that the Warrant be assumed by any successor (or its parent company) in a Major Transaction pursuant
to instruments and agreements reasonably acceptable to the Holder that (A) in the case of a successor entity (or parent company) that has publicly traded or quoted common stock (or equivalent equity securities),
provide
that the Warrant
is exercisable for the appropriate number of shares of the successor entitys (or parents) capital stock (without regard to the 9.985% Cap or any other restriction or limitation on exercise; provided, that such instruments and agreements
shall contain a limitation on exercise comparable to the 9.985% Cap) at an exercise price that has been adjusted to reflect the Major Transaction and otherwise entitles the Holder to rights equivalent to the Holders rights under the Warrant
(e.g., registration rights and rights upon Major Transactions); or (B) in the case of any other successor entity, provide that the Warrant shall be exercisable for the kind and amount of securities, cash and/or other property which a holder of
the number of shares of Common Stock issuable upon exercise immediately prior to such Major Transaction would have been entitled to receive pursuant to such Major Transaction. For the avoidance of doubt, there shall be no requirement that any
successor in a Major Transaction have publicly traded securities.
|
|
|
Stock Events
|
|
The Warrant will provide for equitable and proportionate adjustment of the Strike Price and the number of shares issuable upon exercise of
the Warrant to reflect any subdivision of outstanding Common Stock, combination of outstanding Common Stock, reclassification or other similar transaction of such character that shares of Common Stock shall be changed into or become exchangeable for
a larger or smaller number of shares of Common Stock (a
Stock Event
).
The Warrant will not contain price-based anti-dilution provisions.
|
|
|
Dividends
|
|
The Holder will be entitled to receive such dividends paid, and distributions of any kind made, to the holders of Common Stock to the same extent as if the Holder had exercised the Warrant in full (without regard to any
limitations on exercise (e.g., the 9.985% Cap) and without regard to whether or not a sufficient number of shares are authorized and reserved to effect any such exercise and issuance) and had held shares of Common Stock issuable upon such exercise
on the record date for the dividends and distributions. Payments under the preceding sentence will be made concurrently with the dividend or distribution to the holders of Common Stock.
|
B-22
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
|
|
|
Reservation of Shares
|
|
The Borrower will be obligated to reserve for issuance such number of authorized and unissued shares of Common Stock (or other securities substituted therefor in accordance with the Warrant) as shall be sufficient for the
exercise of the Warrant in full (assuming a cash exercise of the Warrant, and disregarding any limitations on exercise (e.g., the 9.985% Cap).
|
|
|
Registration Rights
|
|
The Borrower and the Holder will enter into a Registration Rights Agreement (the
Registration Rights Agreement
) upon
execution of the Facilities Documentation. Among other things the Registration Rights Agreement will provide that the Borrower will register for resale on an initial registration statement all Common Stock issuable upon the exercise of, or otherwise
pursuant to the terms of, the Warrant within an agreed timeframe. The Registration Rights Agreement will also provide the Holders with customary demand (limited to two (2) demand registrations within any
12-month
period and with a minimum proceeds requirement of $10 million) and customary piggy back registration rights, subject to customary
black-out
periods and, in
the event the Company conducts an underwritten public offering,
lock-up
periods.
The Registration Rights Agreement will also include appropriate liquidated damage provisions for failures by the Borrower to timely comply with its
obligations, similar to those contained in the Warrant.
|
|
|
Liquidated Damages
|
|
If an
Event of Failure
(as will be defined in the Warrant) occurs, the Borrower will agree to pay (as partial
liquidated damages) to the Holder an amount determined by reference to 15% per annum (or the maximum rate permitted by applicable law, whichever is less) of the Black-Scholes Value of the remaining portion of the Warrant. Such amount will be
payable, at the Borrowers option, either (i) in cash or (ii) in shares of Common Stock (subject to the 9.985% Cap) that will be valued based on the volume weighted average price of the shares of Common Stock on the date of such
calculation in the manner further described in the Warrant.
If an
Event of
Default
(as will be defined in the Warrant) occurs and the Holder delivers a notice of default under the Warrant, the Borrower will be entitled to redeem the remaining portion of the Warrant by paying to the Holder an amount in cash equal
to the Black-Scholes Value of the remaining portion of the Warrant in full satisfaction of its obligations thereunder. If the Borrower does not redeem the remaining portion of the Warrant, the Holder will be entitled to elect to exercise the
remaining portion of the Warrant from time to time for a number of shares of Common Stock (which shares shall be valued at 95% of the volume weighted average price for the five (5) consecutive trading days immediately prior to the date of the
applicable default notice) equal to the greater of (i) the Black-Scholes Value of the remaining unexercised portion of the Warrant (or such portion thereof subject to such exercise) as of the date of the default notice and (ii) the
Black-Scholes Value of the remaining unexercised portion of the Warrant (or such portion thereof subject to such exercise) on the trading day immediately preceding the date that the shares of Common Stock in respect of such exercise are issued to
the Holder.
|
|
|
Black Scholes Value
|
|
Black-Scholes Value
will be defined as the Black-Scholes value of the Warrant or applicable portion thereof as determined by use of the Black-Scholes Option Pricing Model using the criteria that will be set
forth in Schedule 1 to this this Term Sheet.
|
B-23
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
|
|
|
Shareholder Rights
|
|
Other than with respect to dividends and other distributions, the Warrant shall not entitle the Holder, prior to the exercise of the Warrant, to rights as a shareholder of Borrower.
|
B-24
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
Schedule 1
Black-Scholes Value
|
|
|
|
|
|
|
Calculation for Major Transactions
|
|
Calculation For Failure/Default Payments
|
Remaining Term
|
|
Number of calendar days from date of public announcement of the Major Transaction until the last date on which the Warrant may be exercised.
|
|
Number of calendar days from date of the Event of Failure until the last date on which the Warrant may be exercised.
|
|
|
|
Interest Rate
|
|
A risk-free interest rate corresponding to the US$ LIBOR/Swap rate for a period equal to the remaining term.
|
|
A risk-free interest rate corresponding to the US$ LIBOR/Swap rate for a period equal to the remaining term.
|
|
|
|
Cost to Borrow
|
|
Zero
|
|
Zero
|
|
|
|
Volatility
|
|
If the first public announcement of the Major Transaction is made at or prior to 4:00 p.m., New York City time, the arithmetic mean of the
historical volatility for the 10, 30 and 50 trading day periods ending on the date of such first public announcement, obtained from the HVT or similar function on Bloomberg.
If the first public announcement of the Major Transaction is made after 4:00 p.m., New York City time, the arithmetic mean of the historical volatility for the
10, 30 and 50 trading day periods ending on the next succeeding trading day following the date of such first public announcement, obtained from the HVT or similar function on Bloomberg.
|
|
The arithmetic mean of the historical volatility for the 10, 30 and 50 trading day periods ending on the date of such determination, obtained from the HVT or similar function on Bloomberg.
|
|
|
|
Stock Price
|
|
The greater of (1) the closing price of the Common Stock on NASDAQ, or, if that is not the principal trading market for the Common Stock, such principal market on which the Common Stock is traded or listed (the Closing
Market Price) on the trading day immediately preceding the date on which a Major Transaction is consummated, (2) the first Closing Market Price following the first public announcement of a Major Transaction, or (3) the Closing Market
Price as of the date immediately preceding the first public announcement of the Major Transaction.
|
|
The volume weighted average price on the date of such calculation.
|
B-25
ANNEX A
SUMMARY OF TERMS AND CONDITIONS
|
|
|
|
|
|
|
Calculation for Major Transactions
|
|
Calculation For Failure/Default Payments
|
Dividends
|
|
Zero.
|
|
Zero.
|
|
|
|
Strike Price
|
|
The initial Strike Price, as adjusted in accordance with the Warrant.
|
|
The initial Strike Price, as adjusted in accordance with the Warrant.
|
B-26
ANNEX I
CONDITIONS
The
availability and initial funding of the Closing Date Loans and the effectiveness of the Facilities Documentation shall be subject solely to the satisfaction (or waiver in writing by the Commitment Party) of the following conditions and the
conditions in Section 2 of the Commitment Letter. Capitalized terms used but not otherwise defined herein have the meanings assigned to such terms in the Commitment Letter (or, if not defined therein, in
Annex A
thereto) to which this
Annex I
is attached.
1. The definitive facility agreement evidencing the Facilities (the
Facility Agreement
),
the Warrants, the Registration Rights Agreement, the Shares, shareholder waivers and consents, promissory notes, disbursement letter (and funds flow), schedules, exhibits and the other documents and certificates executed or delivered in connection
therewith (collectively, the
Facilities Documentation
), which (a) shall be consistent, in each case, with the Commitment Letter and the Term Sheet Summary, (b) shall give due regard to any similar documentation for
similar facilities used for other similarly situated borrower clients of the Agent and the Lenders, (c) shall otherwise be satisfactory to the Agent, the Lenders and the Borrower and (d) shall have been executed and delivered by the
Borrower and each other Loan Party party thereto to the Agent and the Lenders. The Agent and the Lenders shall have received (i) executed legal opinions and resolutions in form and substance reasonably satisfactory to the Agent and the Lenders,
(ii) lien searches in the jurisdiction of organization (and at the location of the chief executive office, where applicable and appropriate) of the Borrower and each Guarantor, (iii) a certificate of the chief financial officer (or other
officer with reasonably equivalent responsibilities) of the Borrower in the form attached as
Exhibit A
hereto, certifying that the Borrower and its subsidiaries, taken as a whole, after giving effect to the consummation of the Acquisition and
the other Transactions and the incurrence of the Closing Date Loans, are solvent, (iv) customary officers and secretarys certificates attaching the organizational documents of the Borrower and each Guarantor, (v) payoff
documents and lien terminations and (vi) documents (including, without limitation insurance certificates and
UCC-1
financing statements) effecting the requirements of clause 8 of this Annex I (subject to
the limitations set forth therein). The perfection actions mentioned in Section 2 of the Commitment Letter shall have been performed.
2. The Specified Acquisition Agreement Representations shall be true and correct to the extent required by the Certain Funds Provision.
3. The Specified Representations shall be true and correct in all material respects (unless such Specified Representations are already subject
to materiality, and in such event, in all respects) as of the Closing Date or, to the extent any such Specified Representation specifically relates to an earlier date, as of such earlier date.
4. The Borrower shall be in compliance with all of the covenants set forth in Section 3 of the Commitment Letter, in all material
respects (unless such covenants are already subject to materiality, and in such event, in all respects).
5. Substantially concurrently
with the execution and delivery of the Facilities Documentation, the Acquisition shall be consummated in accordance with the terms of that certain Purchase and Sale Agreement, dated as of the date of the Commitment Letter, by and between the
Borrower and the Seller Parent, and the schedules and exhibits thereto, each in the form that was delivered to Katten Muchin Rosenman LLP on November 28, 2017 at 8:26 p.m. (New York time), and all conditions therein shall have been satisfied
(without giving effect to any waiver thereof) as of such time, but, in each case, without giving effect to (a) any amendments, modifications or supplements thereof or (b) waivers or consents (including, for the avoidance of
CONDITIONS
ANNEX I PAGE 1
B-27
doubt, waivers or consents to deviations of any of the conditions set forth in Section 10.1 or 10.3 of the Purchase and Sale Agreement) thereunder by the Borrower or its affiliates (but not,
for the avoidance of doubt, the Seller and its affiliates), in the case of each of clauses (a) and (b) above in this Section 5, that are materially adverse to the interests of the Agent and the Lenders and that have not been consented to
in writing (such consent not to be unreasonably withheld) by the Agent and the Lenders; it being understood that any change in (i) the purchase price (other than (A) an increase funded solely by equity of the existing direct and indirect
equity holders of the Borrower and (B) a decrease in the purchase price so long as 100% of such reduction is allocated to reduce (y) first, the Closing Date Loans and (z) then, the DDTL Facility) and (ii) the definition of
Material Adverse Effect, in each case, in such Purchase and Sale Agreement shall be deemed materially adverse to the interests of the Agent and the Lenders.
6. Since the date of the Acquisition Agreement, no change, effect, development, circumstance, condition or occurrence shall have occurred
which has had or would reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect (as defined in the Acquisition Agreement on the date hereof).
7. On the Closing Date, after giving effect to the funding of the Closing Date Loans, none of the Borrower nor any of its Subsidiaries shall
have any third party indebtedness for borrowed money other than the Loan Facility, the Revolving Facility and indebtedness permitted under the Facilities Documentation;
provided
that no indebtedness for borrowed money shall be senior or pari
passu with to the Senior Credit Facility (other than the Revolving Facility in accordance with the terms of the Term Sheet Summary and the Facilities Documentation) without the written consent of the Agent.
8. All actions necessary to establish that the Agent (for the benefit of itself, the Lenders and the other secured parties under the
Facilities Documentation) will have perfected first priority security interests (subject to certain to be agreed liens permitted under the Facilities Documentation, including the liens with respect to the Revolving Facility pursuant to the terms of
the Term Sheet Summary and the Facilities Documentation) in the Collateral under the Facilities shall have been taken;
provided
,
however
, that, the condition in this
paragraph 7
shall be subject in all respects to the Certain
Funds Provision.
9. All expenses and fees required to be paid on the Closing Date pursuant to the Commitment Letter (including, without
limitation, the Term Sheet Summary) shall have been paid in cash (which amounts may be offset against the proceeds of the Loan Facility);
provided
that, in the case of expenses only, to the extent invoiced at least two (2) business days
prior to the Closing Date.
10. The Lenders shall have received at least five (5) business days prior to the Closing Date all
documentation and other information required by regulatory authorities under applicable know your customer and anti-money laundering rules and regulations, including, without limitation, the PATRIOT Act, that has been reasonably
requested by the Agent or any Lender at least ten (10) days in advance of the Closing Date.
11. The shareholders of the Borrower
shall have approved the issuance of all of the shares of Common Stock being issued in the Acquisition and to the Lenders (including all of the shares underlying the Warrants) and any other person or entity providing equity financing in connection
with the Acquisition for purposes of satisfying the NASDAQ listing requirement.
12. The Closing Date Loans shall have been requested in a
writing by the Borrower to the Agent and the Lenders at least fifteen (15) calendar days prior to the Closing Date pursuant to a borrowing notice that is in form reasonably acceptable to the Agent and the Lenders, which notice may be revoked in
writing by the Borrower at
CONDITIONS
ANNEX I PAGE 2
B-28
any time, it being understood that such notice may provide that the Closing Date may occur on or after a date certain (within a range of reasonably estimated dates), rather than specifying a
Closing Date.
13. Solely to the extent the Revolving Facility will be outstanding on, or as of, the Closing Date, then the Intercreditor
Agreement (and, solely to the extent such documentation evidencing the Revolving Facility was not reasonably approved by the Commitment Party at the closing of the Revolving Facility (which, for the avoidance of doubt, shall permit the Transactions
and the other transactions contemplated by the Commitment Letter, the Facilities Documentation and the Acquisition Agreement), such documentation evidencing the Revolving Facility) shall be in form and substance reasonably satisfactory to the Agent
and the Lenders.
CONDITIONS
ANNEX I PAGE 3
B-29
Exhibit A to Annex I
FORM OF SOLVENCY CERTIFICATE
,
20
This Solvency Certificate (this
Certificate
) is being executed and delivered pursuant to Section
[ ] of the Facility Agreement, dated as of the date hereof (as amended, restated, amended and restated, supplemented or otherwise modified from time to time, the
Facility Agreement
),
by and among Melinta Therapeutics, Inc., a Delaware corporation (the
Borrower
), the other [Loan Parties] party thereto (together with the Borrower, the
Loan Parties
), the Lenders party
thereto (the
Lenders
) and Deerfield Private Design Fund IV, L.P., as collateral agent for itself, the Lenders and the other [Secured Parties] (in such capacity,
Agent
). Capitalized terms used but not defined
herein shall have the meanings ascribed to them in the Facility Agreement.
The undersigned, solely in such undersigneds capacity as
[Chief Financial Officer/title of equivalent officer] of the Borrower, and not individually, hereby certifies to Agent and the Lenders, on behalf of the Loan Parties and their subsidiaries, as follows:
1. The undersigned is familiar with the business and financial position of the Loan Parties and their subsidiaries. In reaching the conclusions
set forth in this Certificate, the undersigned has made, or has caused to be made under such undersigneds supervision, such other examinations, investigations and inquiries as is reasonable and necessary to enable the undersigned to express an
informed opinion as to the matters referred to herein, having taken into account the nature of the particular business anticipated to be conducted by the Loan Parties and their subsidiaries after consummation of the transactions contemplated by the
Facility Agreement.
2. Both before and immediately after giving effect to (a) the [Facilities], (b) the consummation of
[Acquisition], the other [Transactions] and the other transactions contemplated by the Facility Agreement to occur on the date hereof, (c) the application of the proceeds of the [Loans] made on the date hereof to or as directed by the Borrower
and (d) the payment of all estimated legal, accounting and other fees and expenses in connection with the foregoing, the following is true with respect to the Loan Parties and their subsidiaries, taken as a whole, as of the date hereof:
|
(A)
|
the present fair salable value of the assets of the Loan Parties and their subsidiaries, taken as a whole (determined on a going concern basis), is greater than (i) the total amount of debts and liabilities
(including subordinated, contingent and
un-liquidated
liabilities) of the Loan Parties and their subsidiaries, taken as a whole and (ii) the amount that will be required to pay the probable liability, on
a consolidated basis, of their debts and other liabilities as such debts and liabilities become absolute and matured;
|
|
(B)
|
the Loan Parties and their subsidiaries, taken as a whole, are able to pay all debts and liabilities (including subordinated, contingent and
un-liquidated
liabilities) as such
debts and liabilities become absolute and matured; and
|
|
(C)
|
the Loan Parties and their subsidiaries, taken as a whole, do not have unreasonably small capital with which to conduct the business in which they are engaged as such business is now conducted and is proposed to be
conducted following the date hereof.
|
For purposes of this Certificate, in computing the amount of contingent or
unliquidated liabilities at any time, such liabilities shall be computed at the amount that, in light of all the facts and circumstances existing at such time, represents the amount that can reasonably be expected to become an actual or matured
liability.
[
Remainder of Page Intentionally Left Blank
]
CONDITIONS
EXHIBIT A TO ANNEX PAGE 1
B-30
IN WITNESS WHEREOF, I have executed this Certificate on the date first written above.
|
|
|
|
|
By:
|
|
|
|
|
Name:
[
●
]
|
Title:
[Chief Financial Officer/equivalent officer].
|
SOLVENCY CERTIFICATE
EXHIBIT A TO ANNEX I PAGE 3
B-31
Annex C
CONFIDENTIAL
November 28, 2017
Melinta Therapeutics, Inc.
300 George Street
Suite 301
New Haven, CT 06511
Re:
Equity Financing Commitment
Ladies and Gentlemen:
Reference is made to that
certain Purchase and Sale Agreement, dated as of the date hereof (as amended, supplemented or modified from time to time, the
Purchase Agreement
), by and among Melinta Therapeutics, Inc., a Delaware Corporation
(
Buyer
), and The Medicines Company, a Delaware corporation (
Seller Parent
), pursuant to which, upon the terms and subject to the conditions set forth therein, among other things, on the Closing Date, Seller
Parent will sell, and cause the other Sellers to sell, to Buyer, and Buyer will purchase, the Business through the purchase from Sellers of all of the Acquired Assets, consisting of the Transferred Shares and Transferred Assets, and Buyer will
assume the Assumed Liabilities (together with the other transactions contemplated by the Purchase Agreement and the transactions contemplated by the Ancillary Agreements upon the terms and conditions set forth herein and therein, the
Transactions
). Except as otherwise set forth herein, capitalized terms used and not defined herein but defined in the Purchase Agreement shall have the meanings ascribed to them in the Purchase Agreement. This letter is being
delivered by the undersigned equity investor (the
Equity Investor
) to Buyer in connection with the execution of the Purchase Agreement.
1.
Commitment
. This letter confirms the commitment of the Equity Investor, subject to the conditions set forth in the next sentence of
this
Section
1
, to purchase (or cause an assignee permitted by the terms of
Section
3
hereof to purchase), prior to or substantially contemporaneously with the Closing, directly or indirectly
through one or more intermediate entities, 2,000,000 shares of Buyer Common Stock (the
Subject Equity Securities
) for an aggregate purchase price equal to Twenty-Seven Million Dollars ($27,000,000) (such commitment, the
Equity Commitment
) solely for the purpose of funding (i) the Purchase Price and the other payments under Article II and Article III of the Purchase Agreement (including any amounts payable by Buyer pursuant to
Section 3.3(k) of the Purchase Agreement, if any), (ii) any and all fees, premiums and expenses required to be paid by Buyer in connection with the Transactions, and (iii) all other payment obligations of Buyer contemplated under the
Purchase Agreement, in each case, in accordance with, and subject in all respects to, the terms of the Purchase Agreement and this letter, and not for any other purpose, it being understood that the Equity Investor (together with its successors and
permitted assigns) shall not under any circumstances be obligated to purchase any equity of, or make any other payment to or investment in, Buyer other than the purchase of the Subject Equity Securities pursuant to the terms hereof for an aggregate
purchase price equal to the Equity Commitment. Notwithstanding anything herein to the contrary, the aggregate liability of the Equity Investor under this letter shall at no time exceed the Equity Commitment. The obligation of the Equity Investor (or
its successors and permitted assigns) to fund the Equity Commitment (a) is subject in all respects to the satisfaction (or waiver by Buyer) of all of the conditions precedent to Buyers obligations to consummate the Transactions set forth
in Sections 10.1 and 10.3 of the Purchase Agreement (other than those conditions to be satisfied by the delivery of documents or the taking of actions at the Closing itself, but subject to such conditions being satisfied or duly waived at the
Closing) and (b) subject to the foregoing clause (a), will occur prior to or contemporaneously with the Closing.
2.
Termination
. The Equity Investors obligation to fund the Equity Commitment shall terminate automatically and immediately upon the earliest to occur of: (i) the valid termination of the Purchase Agreement in accordance with its
terms, (ii) 30 days following the Outside Date if the Closing has not occurred unless, in the
C-1
case of each of clauses (i) and (ii), a claim has been brought hereunder or under the Purchase Agreement pursuant to and in accordance with the terms and conditions hereof or thereof prior
to, in the case of clause (i), such termination or, in the case of clause (ii), such
30-day
anniversary;
provided
, that if such claim is brought, then the obligations of the Equity Investor to fund the
Equity Commitment pursuant to the terms hereof shall not terminate pursuant to clause (i) or (ii), as the case may be, unless any of the following occurs: (x) a final,
non-appealable
resolution of
such claim in favor of Buyer and/or the Equity Investor; (y) performance by the Equity Investor of all obligations imposed on it pursuant to a final,
non-appealable
resolution of such claim that is not in
favor of Buyer or the Equity Investor; or (z) a written agreement signed by the Equity Investor, Buyer and Seller Parent terminating this letter, (iii) the assertion or commencement, directly or indirectly, of any Proceeding by Seller
Parent or any of its Affiliates against the Equity Investor or any Specified Person (as defined below) relating to this letter, the Purchase Agreement, any Ancillary Agreement or any of the transactions contemplated hereby or the Transactions
(including in respect of any oral representations made or alleged to be made in connection herewith or therewith), other than any claim by Seller Parent against the Equity Investor to enforce the Equity Investors obligation to fund the Equity
Commitment in accordance with, and solely to the extent permitted under, the terms and conditions hereof, and (iv) consummation of the Closing. Upon such termination pursuant to this
Section
2
, the Equity Investor
shall not have any further obligation or liability hereunder with respect to the Equity Commitment, which shall become null and void ab initio. For the avoidance of doubt, nothing herein shall prevent or limit Seller Parents right to bring a
claim at law or in equity against Buyer pursuant to and in accordance with the Purchase Agreement, the Confidentiality Agreement, or any other Ancillary Agreement to which Buyer is a party, it being understood and agreed that no such claim shall
affect the Equity Investors Equity Commitment hereunder.
3.
Assignment
. Neither the Equity Investor nor Buyer may assign or
delegate (whether by operation of law, merger, consolidation or otherwise) their respective rights, interests or obligations hereunder to any other Person without the prior written consent of each of the other parties hereto and Seller Parent,
except for any such assignment made in connection with the assignment of Buyers rights, obligations and liabilities under the Purchase Agreement pursuant to, and in accordance with, the provisions set forth in Section 13.1 thereof;
provided
, that notwithstanding the foregoing, the rights provided pursuant to
Section
14
shall be automatically assigned to any Assignee (as defined below), without the prior written consent of the other parties
hereto and Seller Parent, in respect of the Subject Equity Securities and Purchase Option Shares acquired by such Assignee upon the assignment of all or a portion of the Equity Investors obligation to fund the Equity Commitment or its right to
exercise all or a portion of the Purchase Option (as defined below), as applicable, to such Assignee. Seller Parents rights under this
Section
3
,
Section
5(b)
and
Section
8
and Seller Parents obligations under
Section
6
of this letter shall not be assigned without the prior written consent of the Equity Investor. Any attempted assignment not in
accordance with the foregoing shall be null and void and of no force or effect. Notwithstanding the foregoing, the Equity Investor may assign all or a portion of its obligation to fund the Equity Commitment or its right to exercise all or a portion
of the Purchase Option to one or more affiliated investment funds or other
co-investors
(which
co-investors
may include, for the avoidance of doubt, third party
investors that are not affiliated with the Equity Investor or its Affiliates) (any such assignee, an
Assignee
) without obtaining the prior written consent of the other parties hereto and Seller Parent, but no such assignment shall
relieve the Equity Investor of its obligations hereunder.
4.
No Third Party Beneficiaries
. Except to the extent set forth in
Section
5
, this letter shall be binding solely on, and inure solely to the benefit of, the parties hereto and their respective successors and permitted assigns, and nothing set forth in this letter, express or implied,
shall be construed to confer upon or give to any Person, other than the parties hereto and their respective successors and permitted assigns, any benefits, rights or remedies under or by reason of, or any rights to enforce or cause Buyer to enforce,
the Equity Commitment or any provisions of this letter.
5.
Limited Recourse; Enforcement
.
(a) Notwithstanding anything that may be expressed or implied in this letter or any document or instrument delivered in connection herewith,
Buyer, by its acceptance of the benefits of the Equity Commitment
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provided herein, covenants, agrees and acknowledges (i) that no Person other than the Equity Investor (and its respective successors and permitted assigns) shall have any obligation
hereunder or in connection with the transactions contemplated hereby, (ii) in no event shall Buyer seek, and Buyer shall cause each of its Affiliates not to seek, any damages or any other recovery, judgment, or remedies of any kind, including
special, exemplary, consequential, indirect or punitive damages, or damages arising from loss of profits, business opportunities or goodwill, diminution in value or any other losses or damages, whether at law, in equity, in contract, in tort or
otherwise, against the Equity Investor or any Specified Person, in each case, other than seeking specific performance of Buyers right to cause the Equity Investor to fund the Equity Commitment in accordance with, and solely to the extent
permitted under, the terms and conditions hereof (together with any claim by Seller Parent against the Equity Investor to enforce the Equity Investors obligation to fund the Equity Commitment in accordance with, and solely to the extent
permitted under, the terms and conditions hereof, the
Non-Prohibited
Claims
), and (iii) that, notwithstanding that the Equity Investor may be, or any of its successors and permitted
assigns may be, a limited partnership, neither it nor any Specified Person shall have any right of recovery against, and no recourse shall be had against, and no personal liability shall attach to, any of the former, current or future direct or
indirect equity holders, controlling persons, stockholders, directors, officers, employees, agents, general or limited partners, managers, members, Affiliates, attorneys or other Representatives of the Equity Investor or any of the Equity
Investors successors or assigns or any former, current or future director, officer, employee, direct or indirect equity holder, equity or other financing source, portfolio company, management company, controlling person, agent, general or
limited partner, manager, member, stockholder, Affiliate, attorney or other Representative or successor or assign of any of the foregoing (in each case, other than Buyer, Seller Parent, and the Equity Investor, and any Person to whom any of the
foregoing has assigned its obligations hereunder in accordance with the terms hereof, a
Specified Person
and together, the
Specified Persons
), hereunder or under any documents or instruments delivered in
connection herewith or in respect of any oral representations made or alleged to have been made in connection herewith or therewith, whether by or through attempted piercing of the corporate (or limited liability company or limited partnership)
veil, by or through a Proceeding (whether at law, in equity, in contract, in tort or otherwise) by or on behalf of the Equity Investor against any Specified Person, by the enforcement of any assessment or by any legal or equitable Proceeding, by
virtue of any applicable Law, or otherwise, except, for the avoidance of doubt, for its rights to recover from the Equity Investor and its successors and permitted assigns (but not any other Person) under and to the extent provided in this letter
and any other claims that are
Non-Prohibited
Claims; it being agreed and acknowledged that, except with respect to the
Non-Prohibited
Claims, no personal liability
whatsoever shall attach to, be imposed on or otherwise be incurred by any Specified Person for any obligations of the Equity Investor or any of its successors or permitted assigns under this letter, the Purchase Agreement, any Ancillary Agreement or
any documents or instruments delivered in connection herewith or therewith, in respect of any transaction contemplated hereby or thereby or in respect of any representations made or alleged to have been made in connection herewith or therewith or
for any claim (whether at law, in equity, in contract, in tort or otherwise) based on, in respect of, or by reason of such obligations or their creation.
(b) Subject to
Section
5(d)
, this letter may only be enforced by Buyer, and none of Buyers creditors and no
other Person that is not a party to this letter shall have any right to enforce this letter or to cause Buyer to enforce this letter;
provided
,
however
, that notwithstanding the foregoing, Seller Parent is hereby made an express
third party beneficiary of this letter with respect to Buyers right to directly seek specific performance of the Equity Investors obligation to fund the Equity Commitment hereunder at the Closing if and when required pursuant to
Section
1
, if and only in the event each of the conditions set forth in Section 10.1 and 10.3 of the Purchase Agreement has been satisfied or waived by Buyer (other than those conditions to be satisfied by the delivery
of documents or the taking of actions at the Closing itself, but subject to such conditions being satisfied or duly waived at the Closing), subject to the terms and conditions set forth in this letter applicable to Buyer, including this
Section
5
, and for no other purpose (including any claim for monetary damages hereunder or under the Purchase Agreement except as expressly set forth herein and therein), and by its acceptance of the benefits of such
rights, Seller Parent shall be subject to the terms and conditions set forth in this letter applicable to Seller Parent or Buyer, including this
Section
5
. In addition, nothing herein shall limit Seller Parents right
under the Purchase Agreement to bring an action against Buyer to enforce Buyers rights under this letter to cause the
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Equity Investor to fund the Equity Commitment pursuant to the terms and conditions hereof. The Equity Investor agrees that irreparable damage would occur in the event that any of the provisions
of this letter were not performed in accordance with their specific terms or were otherwise breached or threatened to be breached and that neither Buyer nor Seller Parent shall be required to provide proof of actual damages or otherwise post or
secure any bond in connection with or as a condition to obtaining specific performance as described in this
Section
5(b)
.
(c) Other than as expressly set forth in
Section
5(b)
, and except with respect to the
Non-Prohibited
Claims, Seller Parents remedies against the Equity Investor under this letter shall, and are intended to, be Seller Parents sole and exclusive direct or indirect remedies (whether at
law, in equity, in contract, in tort or otherwise) available to Seller Parent and its Affiliates against the Equity Investor or any of the Specified Persons for any liability, loss, damage or recovery of any kind (including special, exemplary,
consequential, indirect or punitive damages or damages arising from loss of profits, business opportunities or goodwill, diminution in value or any other losses or damages, whether at law, in equity, in contract, in tort or otherwise) arising under
or in connection with any breach of the Purchase Agreement or any Ancillary Agreement (in each case whether willfully, intentionally, unintentionally or otherwise) or of the failure of the Transactions to be consummated for any reason or otherwise
in connection with the transactions contemplated hereby or contemplated by the Ancillary Agreements and thereby or in respect of any representations or warranties made or alleged to have been made in connection herewith or therewith (whether or not
Buyers breach is caused by the breach by the Equity Investor of its obligations under this letter).
(d) The Specified Persons are
express third-party beneficiaries of this
Section
5
.
6.
Confidentiality
. This letter shall be treated as
confidential and is being provided to Buyer solely in connection with the Transactions. This letter may not be used, circulated, quoted or otherwise referred to in any document (other than the Purchase Agreement, any SEC filing made in connection
with the Transactions or any proxy statement prepared in connection with the Transactions), except with the written consent of the Equity Investor;
provided
that no such written consent shall be required for the provision of a copy of this
letter to Seller Parent in connection with the execution of the Purchase Agreement and Seller Parent is agreeing, by its acceptance thereof, to treat this letter as confidential on the terms contained in this
Section
6
;
provided
,
further
, that any party hereto may disclose the existence of this letter to the extent required by any Governmental Authority or applicable Law, so long as the disclosing party (a) promptly notifies the Equity
Investor in reasonable detail of the circumstances giving rise to such required disclosure, (b) uses its reasonable best efforts to seek to limit such disclosure and maintain the confidentiality of this letter and the terms and conditions
hereof and (c) uses its reasonable best efforts to give the Equity Investor an opportunity to comment on such disclosure and to incorporate such comments therein.
7.
Governing Law; Consent to Jurisdiction
.
(a) This letter (and any Claim or controversy arising out of or relating to this letter) shall be governed by and construed in accordance with
the Laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule that would cause the application of the Laws of any jurisdiction other than the State of Delaware.
(b) Each party hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of any Delaware
state court, or federal court of the United States of America, in each case sitting in the City of Wilmington, County of New Castle, State of Delaware, and any appellate court from any thereof, in any action, suit or proceeding arising out of or
relating to this letter or the transactions contemplated hereby or for recognition or enforcement of any judgment relating thereto, and each party hereby irrevocably and unconditionally: (i) agrees not to commence any such action, suit or
proceeding except in such courts; (ii) agrees that any claim in respect of any such action, suit or proceeding may be heard and determined in such Delaware state court or, to the extent permitted by applicable Law, in such federal court;
(iii) waives, to the fullest extent it
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may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such action, suit or proceeding in any such Delaware state or federal court; and
(iv) waives, to the fullest extent permitted by applicable Law, the defense of an inconvenient forum to the maintenance of such action, suit or proceeding in any such Delaware state or federal court. Each party agrees that a final judgment in
any such action, suit or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by applicable Law.
8.
Entire Agreement; Amendments and Waivers
. This letter, together with the Purchase Agreement, the Registration Rights Agreements (as
defined below), the Ancillary Agreements, the other Commitment Letters and the Confidentiality Agreement, constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior written or oral
and all contemporaneous oral agreements and understandings between any of the parties hereto with respect to the subject matter hereof and thereof. This letter may not be amended, and no provision hereof waived or modified, except by an instrument
signed by each of the parties hereto and, except for any such amendment made (i) in connection with an assignment by the Equity Investor of all or a portion of its obligations to fund the Equity Commitment pursuant to this letter or
(ii) in connection with an assignment of Buyers rights, obligations and liabilities under the Purchase Agreement pursuant to, and in accordance with Section 13.1 thereof, Seller Parent, and in the case of a waiver, by the party
against whom the waiver is to be effective.
9.
Interpretation
. The titles and captions in this letter are for reference purposes
only, and shall not in any way define, limit, extend or describe the scope of this letter otherwise affect the meaning or interpretation of this letter. The words including or any variation thereof means including, without
limitation, and shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it.
10.
Counterparts
. This letter may be executed in one or more counterparts for the convenience of the parties hereto, each of which
shall be deemed an original and all of which together will constitute one and the same instrument, and this letter shall become effective when one or more counterparts have been signed by each of the parties hereto and delivered to the other parties
hereto. Delivery of an executed counterpart of a signature page to this letter by facsimile or electronic transmission shall be effective as delivery of a mutually executed counterpart to this letter.
11.
WAIVER OF JURY TRIAL
. EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS LETTER IS LIKELY TO
INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE IT HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS LETTER OR THE
TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK
TO ENFORCE EITHER OF SUCH WAIVERS, (B) IT UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVERS, (C) IT MAKES SUCH WAIVERS VOLUNTARILY, AND (D) IT HAS BEEN INDUCED TO ENTER INTO THIS LETTER BY, AMONG OTHER THINGS, THE MUTUAL
WAIVERS AND CERTIFICATIONS IN THIS
SECTION 11
.
12.
Severability
. If any term or other provision of this letter is invalid,
illegal or incapable of being enforced by any rule of Law or public policy, all other conditions and provisions of this letter shall nevertheless remain in full force and effect so long as the economic or legal substance of the transactions
contemplated hereby is not affected in any manner materially adverse to any party hereto;
provided
, however, that this letter may not be enforced (a) without giving effect to the provisions in Sections
1
,
2
,
3
,
5(a)
,
5(c)
and
5(d)
of this letter (including by giving effect to any maximum dollar amounts set forth therein), or (b) if this letter would require the Equity Commitment to be funded at any time prior to the closing when
required pursuant to
Section
1
or for any
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purposes other than as expressly set forth in
Section
1
. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the
parties shall negotiate in good faith to modify this letter so as to effect the original intent of the parties as closely as possible to the fullest extent permitted by applicable Law in an acceptable manner to the end that the transactions
contemplated hereby are fulfilled to the extent possible.
13.
Representations and Warranties
. The Equity Investor hereby
represents and warrants to Buyer that:
(a) it has all limited partnership power and authority required to execute, deliver and perform
this letter;
(b) the execution, delivery and performance of this letter has been duly and validly authorized and approved by all
necessary action and do not contravene any provision of the Equity Investors charter, partnership agreement, operating agreement or similar organizational documents or any Law binding on the Equity Investor;
(c) all consents, approvals, authorizations, permits of, filings with and notifications to, any Governmental Entity necessary for the due
execution, delivery and performance of this letter by the Equity Investor have been obtained or made and all conditions thereof have been duly complied with, and no other action by, and no notice to or filing with, any Governmental Entity is
required in connection with the execution, delivery or performance of this letter;
(d) this letter constitutes a legal, valid and binding
obligation of the Equity Investor enforceable against the Equity Investor in accordance with its terms, except as may be limited by any bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance or other similar laws affecting the
enforcement of creditors rights generally or by general principles of equity;
(e) the Equity Commitment is less than the maximum
amount that the Equity Investor is permitted to invest in any one portfolio investment pursuant to the terms of its organizational or governing documents; and
(f) the Equity Investor has uncalled capital commitments or otherwise has available funds (including lines of credit) in excess of the Equity
Commitment hereunder and all of its other unfunded contractually binding equity commitments that are currently outstanding and all funds necessary for it to fulfill all of its obligations under this letter will be available to it for so long as this
letter shall remain in effect.
14.
Registration Rights
. The Equity Investor and any Assignee shall be entitled to registration
rights in respect of the Subject Equity Securities and Purchase Option Shares acquired by the Equity Investor and such Assignee, as applicable, pursuant to this letter, on the same terms and pursuant to and in accordance with any Registration Rights
Agreement, to which Buyer, such Assignee and/or the Equity Investor is a party (as amended, each a
Registration Rights Agreement
and together, the
Registration Rights Agreements
). Buyer hereby acknowledges and
agrees that the Registration Rights Agreement to which the Equity Investor or any Assignee is a party shall apply with respect to the Subject Equity Securities and Purchase Option Shares held by the Equity Investor or such Assignee, as applicable,
and such Subject Equity Securities and Purchase Option Shares shall constitute Registrable Securities (as defined in the applicable Registration Rights Agreement) under the applicable Registration Rights Agreement,
mutatis mutandis
.
15.
Option to Purchase Additional Shares
. The Equity Investor shall have the option, exercisable in its sole discretion, to purchase
from Buyer at the Closing, and Buyer does hereby agree to issue and sell to the Equity Investor at the Closing, up to the Maximum Option Amount of shares of Buyer Common Stock (which shares shall be in addition to the Subject Equity Securities
purchased by the Equity Investor pursuant to this letter in exchange for funding the Equity Commitment, such additional shares,
Purchase Option Shares
), in exchange for the payment by the Equity Investor to Buyer of an amount in
cash equal to the Aggregate Option Price (the
Purchase Option
). If the Equity Investor so desires to exercise the Purchase Option pursuant to this
Section
15
, the Equity Investor shall deliver to Buyer a
written notice no later than two (2) Trading Days prior to the Closing,
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which written notice shall specify the number of shares of Buyer Common Stock (up to the Maximum Option Amount) that the Equity Investor would like to purchase, the Aggregate Option Price and the
Per Share Option Price. Such written notice delivered by the Equity Investor to Buyer exercising the Purchase Option shall be irrevocable. For purposes of this letter, (a)
Maximum Option Amount
means the quotient of (i)
$10,000,000,
divided
by (ii) the Aggregate Option Price, (b)
Aggregate Option Price
means the product of (i) the number of shares of Buyer Common Stock that the Equity Investor elects to purchase pursuant to the
Purchase Option,
multiplied
by (ii) the Per Share Option Price, and (c)
Per Share Option Price
means ninety percent (90%) of the VWAP for the ten (10) Trading Day period ending three (3) Trading Days prior to
Closing. For the avoidance of doubt, the Aggregate Option Price is not, and shall not be deemed, a part of the Equity Commitment. The Aggregate Option Price shall be paid by the Equity Investor only in the event that the Equity Investor exercises
the Purchase Option pursuant to this
Section
15
and such amount shall be paid in addition to the Equity Commitment pursuant to, and in accordance with, the terms hereof.
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Very truly yours,
|
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EQUITY INVESTOR
:
|
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VATERA HEALTHCARE PARTNERS LLC
|
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By:
|
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Vatera Holdings LLC, as manager
|
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By:
|
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/s/ Kevin Ferro
|
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Name: Kevin Ferro
|
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Title: CEO
|
Signature Page to Vatera Equity Commitment Letter
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Accepted and acknowledged:
Buyer
:
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MELINTA THERAPEUTICS, INC.
|
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By:
|
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/s/ Paul Estrem
|
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Name: Paul Estrem
|
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Title: Chief Financial Officer
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Signature Page to Vatera Equity Commitment Letter
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Annex D
CONFIDENTIAL
November 28, 2017
Melinta Therapeutics, Inc.
300 George Street
Suite 301
New Haven, CT 06511
Re:
|
Equity Financing Commitment
|
Ladies and Gentlemen:
Reference is made to that certain Purchase and Sale Agreement, dated as of the date hereof (as amended, supplemented or modified from time to
time, the
Purchase Agreement
), by and among Melinta Therapeutics, Inc., a Delaware Corporation (
Buyer
), and The Medicines Company, a Delaware corporation (
Seller Parent
), pursuant to which,
upon the terms and subject to the conditions set forth therein, among other things, on the Closing Date, Seller Parent will sell, and cause the other Sellers to sell, to Buyer, and Buyer will purchase, the Business through the purchase from Sellers
of all of the Acquired Assets, consisting of the Transferred Shares and Transferred Assets, and Buyer will assume the Assumed Liabilities (together with the other transactions contemplated by the Purchase Agreement and the transactions contemplated
by the Ancillary Agreements upon the terms and conditions set forth herein and therein, the
Transactions
). Except as otherwise set forth herein, capitalized terms used and not defined herein but defined in the Purchase Agreement
shall have the meanings ascribed to them in the Purchase Agreement. This letter is being delivered by the undersigned equity investor (the
Equity Investor
) to Buyer in connection with the execution of the Purchase Agreement.
1.
Commitment
. This letter confirms the commitment of the Equity Investor, subject to the conditions set forth in the next sentence of
this
Section
1
, to purchase (or cause an assignee permitted by the terms of
Section
3
hereof to purchase), prior to or substantially contemporaneously with the Closing, directly or indirectly
through one or more intermediate entities, 222,222 shares of Buyer Common Stock (the
Subject Equity Securities
) for an aggregate purchase price equal to Three Million Dollars ($3,000,000) (such commitment, the
Equity
Commitment
) solely for the purpose of funding (i) the Purchase Price and the other payments under Article II and Article III of the Purchase Agreement (including any amounts payable by Buyer pursuant to Section 3.3(k) of the
Purchase Agreement, if any), (ii) any and all fees, premiums and expenses required to be paid by Buyer in connection with the Transactions, and (iii) all other payment obligations of Buyer contemplated under the Purchase Agreement, in each
case, in accordance with, and subject in all respects to, the terms of the Purchase Agreement and this letter, and not for any other purpose, it being understood that the Equity Investor (together with its successors and permitted assigns) shall not
under any circumstances be obligated to purchase any equity of, or make any other payment to or investment in, Buyer other than the purchase of the Subject Equity Securities pursuant to the terms hereof for an aggregate purchase price equal to the
Equity Commitment. Notwithstanding anything herein to the contrary, the aggregate liability of the Equity Investor under this letter shall at no time exceed the Equity Commitment. The obligation of the Equity Investor (or its successors and
permitted assigns) to fund the Equity Commitment (a) is subject in all respects to the satisfaction (or waiver by Buyer) of all of the conditions precedent to Buyers obligations to consummate the Transactions set forth in
Sections 10.1 and 10.3 of the Purchase Agreement (other than those conditions to be satisfied by the delivery of documents or the taking of actions at the Closing itself, but subject to such conditions being satisfied or duly waived at the
Closing) and (b) subject to the foregoing clause (a), will occur prior to or contemporaneously with the Closing.
2.
Termination
. The Equity Investors obligation to fund the Equity Commitment shall terminate automatically and immediately upon the earliest to occur of: (i) the valid termination of the Purchase Agreement in accordance with its
terms, (ii) 30 days following the Outside Date if the Closing has not occurred unless, in the case of each of clauses (i) and (ii), a claim has been brought hereunder or under the Purchase Agreement
D-1
pursuant to and in accordance with the terms and conditions hereof or thereof prior to, in the case of clause (i), such termination or, in the case of clause (ii), such
30-day
anniversary;
provided
, that if such claim is brought, then the obligations of the Equity Investor to fund the Equity Commitment pursuant to the terms hereof shall not terminate pursuant to clause
(i) or (ii), as the case may be, unless any of the following occurs: (x) a final,
non-appealable
resolution of such claim in favor of Buyer and/or the Equity Investor; (y) performance by the
Equity Investor of all obligations imposed on it pursuant to a final,
non-appealable
resolution of such claim that is not in favor of Buyer or the Equity Investor; or (z) a written agreement signed by the
Equity Investor, Buyer and Seller Parent terminating this letter, (iii) the assertion or commencement, directly or indirectly, of any Proceeding by Seller Parent or any of its Affiliates against the Equity Investor or any Specified Person (as
defined below) relating to this letter, the Purchase Agreement, any Ancillary Agreement or any of the transactions contemplated hereby or the Transactions (including in respect of any oral representations made or alleged to be made in connection
herewith or therewith), other than any claim by Seller Parent against the Equity Investor to enforce the Equity Investors obligation to fund the Equity Commitment in accordance with, and solely to the extent permitted under, the terms and
conditions hereof, and (iv) consummation of the Closing. Upon such termination pursuant to this
Section
2
, the Equity Investor shall not have any further obligation or liability hereunder with respect to the Equity
Commitment, which shall become null and void ab initio. For the avoidance of doubt, nothing herein shall prevent or limit Seller Parents right to bring a claim at law or in equity against Buyer pursuant to and in accordance with the Purchase
Agreement, the Confidentiality Agreement, or any other Ancillary Agreement to which Buyer is a party, it being understood and agreed that no such claim shall affect the Equity Investors Equity Commitment hereunder.
3.
Assignment
. Neither the Equity Investor nor Buyer may assign or delegate (whether by operation of law, merger, consolidation or
otherwise) their respective rights, interests or obligations hereunder to any other Person without the prior written consent of each of the other parties hereto and Seller Parent, except for any such assignment made in connection with the assignment
of Buyers rights, obligations and liabilities under the Purchase Agreement pursuant to, and in accordance with, the provisions set forth in Section 13.1 thereof. Seller Parents rights under this
Section
3
,
Section
5(b)
and
Section
8
and Seller Parents obligations under
Section
6
of this letter shall not be assigned without the prior written consent of the Equity
Investor. Any attempted assignment not in accordance with the foregoing shall be null and void and of no force or effect. Notwithstanding the foregoing, the Equity Investor may assign all or a portion of its obligation to fund the Equity Commitment
to one or more affiliated investment funds or other
co-investors
(which
co-investors
may include, for the avoidance of doubt, third party investors that are not
affiliated with the Equity Investor or its Affiliates) without obtaining the prior written consent of the other parties hereto and Seller Parent, but no such assignment shall relieve the Equity Investor of its obligations hereunder.
4.
No Third Party Beneficiaries
. Except to the extent set forth in
Section
5
, this letter shall be binding
solely on, and inure solely to the benefit of, the parties hereto and their respective successors and permitted assigns, and nothing set forth in this letter, express or implied, shall be construed to confer upon or give to any Person, other than
the parties hereto and their respective successors and permitted assigns, any benefits, rights or remedies under or by reason of, or any rights to enforce or cause Buyer to enforce, the Equity Commitment or any provisions of this letter.
5.
Limited Recourse; Enforcement
.
(a) Notwithstanding anything that may be expressed or implied in this letter or any document or instrument delivered in connection herewith,
Buyer, by its acceptance of the benefits of the Equity Commitment provided herein, covenants, agrees and acknowledges (i) that no Person other than the Equity Investor (and its respective successors and permitted assigns) shall have any
obligation hereunder or in connection with the transactions contemplated hereby, (ii) in no event shall Buyer seek, and Buyer shall cause each of its Affiliates not to seek, any damages or any other recovery, judgment, or remedies of any kind,
including special, exemplary, consequential, indirect or punitive damages, or damages arising from loss of profits, business opportunities or goodwill, diminution in value or any other losses or damages, whether at law, in equity, in contract, in
tort or
D-2
otherwise, against the Equity Investor or any Specified Person, in each case, other than seeking specific performance of Buyers right to cause the Equity Investor to fund the Equity
Commitment in accordance with, and solely to the extent permitted under, the terms and conditions hereof (together with any claim by Seller Parent against the Equity Investor to enforce the Equity Investors obligation to fund the Equity
Commitment in accordance with, and solely to the extent permitted under, the terms and conditions hereof, the
Non-Prohibited
Claims
), and (iii) that, notwithstanding that the Equity
Investor may be, or any of its successors and permitted assigns may be, a limited partnership, neither it nor any Specified Person shall have any right of recovery against, and no recourse shall be had against, and no personal liability shall attach
to, any of the former, current or future direct or indirect equity holders, controlling persons, stockholders, directors, officers, employees, agents, general or limited partners, managers, members, Affiliates, attorneys or other Representatives of
the Equity Investor or any of the Equity Investors successors or assigns or any former, current or future director, officer, employee, direct or indirect equity holder, equity or other financing source, portfolio company, management company,
controlling person, agent, general or limited partner, manager, member, stockholder, Affiliate, attorney or other Representative or successor or assign of any of the foregoing (in each case, other than Buyer, Seller Parent, and the Equity Investor,
and any Person to whom any of the foregoing has assigned its obligations hereunder in accordance with the terms hereof, a
Specified Person
and together, the
Specified Persons
), hereunder or under any documents
or instruments delivered in connection herewith or in respect of any oral representations made or alleged to have been made in connection herewith or therewith, whether by or through attempted piercing of the corporate (or limited liability company
or limited partnership) veil, by or through a Proceeding (whether at law, in equity, in contract, in tort or otherwise) by or on behalf of the Equity Investor against any Specified Person, by the enforcement of any assessment or by any legal or
equitable Proceeding, by virtue of any applicable Law, or otherwise, except, for the avoidance of doubt, for its rights to recover from the Equity Investor and its successors and permitted assigns (but not any other Person) under and to the extent
provided in this letter and any other claims that are
Non-Prohibited
Claims; it being agreed and acknowledged that, except with respect to the
Non-Prohibited
Claims, no
personal liability whatsoever shall attach to, be imposed on or otherwise be incurred by any Specified Person for any obligations of the Equity Investor or any of its successors or permitted assigns under this letter, the Purchase Agreement, any
Ancillary Agreement or any documents or instruments delivered in connection herewith or therewith, in respect of any transaction contemplated hereby or thereby or in respect of any representations made or alleged to have been made in connection
herewith or therewith or for any claim (whether at law, in equity, in contract, in tort or otherwise) based on, in respect of, or by reason of such obligations or their creation.
(b) Subject to
Section
5(d)
, this letter may only be enforced by Buyer, and none of Buyers creditors and no
other Person that is not a party to this letter shall have any right to enforce this letter or to cause Buyer to enforce this letter;
provided
,
however
, that notwithstanding the foregoing, Seller Parent is hereby made an express
third party beneficiary of this letter with respect to Buyers right to directly seek specific performance of the Equity Investors obligation to fund the Equity Commitment hereunder at the Closing if and when required pursuant to
Section
1
, if and only in the event each of the conditions set forth in Section 10.1 and 10.3 of the Purchase Agreement has been satisfied or waived by Buyer (other than those conditions to be satisfied by the delivery
of documents or the taking of actions at the Closing itself, but subject to such conditions being satisfied or duly waived at the Closing), subject to the terms and conditions set forth in this letter applicable to Buyer, including this
Section
5
, and for no other purpose (including any claim for monetary damages hereunder or under the Purchase Agreement except as expressly set forth herein and therein), and by its acceptance of the benefits of such
rights, Seller Parent shall be subject to the terms and conditions set forth in this letter applicable to Seller Parent or Buyer, including this
Section
5
. In addition, nothing herein shall limit Seller Parents right
under the Purchase Agreement to bring an action against Buyer to enforce Buyers rights under this letter to cause the Equity Investor to fund the Equity Commitment pursuant to the terms and conditions hereof. The Equity Investor agrees that
irreparable damage would occur in the event that any of the provisions of this letter were not performed in accordance with their specific terms or were otherwise breached or threatened to be breached and that neither Buyer nor Seller Parent shall
be required to provide proof of actual damages or otherwise post or secure any bond in connection with or as a condition to obtaining specific performance as described in this
Section
5(b)
.
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(c) Other than as expressly set forth in
Section
5(b)
, and except
with respect to the
Non-Prohibited
Claims, Seller Parents remedies against the Equity Investor under this letter shall, and are intended to, be Seller Parents sole and exclusive direct or indirect
remedies (whether at law, in equity, in contract, in tort or otherwise) available to Seller Parent and its Affiliates against the Equity Investor or any of the Specified Persons for any liability, loss, damage or recovery of any kind (including
special, exemplary, consequential, indirect or punitive damages or damages arising from loss of profits, business opportunities or goodwill, diminution in value or any other losses or damages, whether at law, in equity, in contract, in tort or
otherwise) arising under or in connection with any breach of the Purchase Agreement or any Ancillary Agreement (in each case whether willfully, intentionally, unintentionally or otherwise) or of the failure of the Transactions to be consummated for
any reason or otherwise in connection with the transactions contemplated hereby or contemplated by the Ancillary Agreements and thereby or in respect of any representations or warranties made or alleged to have been made in connection herewith or
therewith (whether or not Buyers breach is caused by the breach by the Equity Investor of its obligations under this letter).
(d)
The Specified Persons are express third-party beneficiaries of this
Section
5
.
6.
Confidentiality
. This
letter shall be treated as confidential and is being provided to Buyer solely in connection with the Transactions. This letter may not be used, circulated, quoted or otherwise referred to in any document (other than the Purchase Agreement, any SEC
filing made in connection with the Transactions or any proxy statement prepared in connection with the Transactions), except with the written consent of the Equity Investor;
provided
that no such written consent shall be required for the
provision of a copy of this letter to Seller Parent in connection with the execution of the Purchase Agreement and Seller Parent is agreeing, by its acceptance thereof, to treat this letter as confidential on the terms contained in this
Section
6
;
provided
,
further
, that any party hereto may disclose the existence of this letter to the extent required by any Governmental Authority or applicable Law, so long as the disclosing party
(a) promptly notifies the Equity Investor in reasonable detail of the circumstances giving rise to such required disclosure, (b) uses its reasonable best efforts to seek to limit such disclosure and maintain the confidentiality of this
letter and the terms and conditions hereof and (c) uses its reasonable best efforts to give the Equity Investor an opportunity to comment on such disclosure and to incorporate such comments therein.
7.
Governing Law; Consent to Jurisdiction
.
(a) This letter (and any Claim or controversy arising out of or relating to this letter) shall be governed by and construed in accordance with
the Laws of the State of Delaware without giving effect to any choice or conflict of law provision or rule that would cause the application of the Laws of any jurisdiction other than the State of Delaware.
(b) Each party hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of any Delaware
state court, or federal court of the United States of America, in each case sitting in the City of Wilmington, County of New Castle, State of Delaware, and any appellate court from any thereof, in any action, suit or proceeding arising out of or
relating to this letter or the transactions contemplated hereby or for recognition or enforcement of any judgment relating thereto, and each party hereby irrevocably and unconditionally: (i) agrees not to commence any such action, suit or
proceeding except in such courts; (ii) agrees that any claim in respect of any such action, suit or proceeding may be heard and determined in such Delaware state court or, to the extent permitted by applicable Law, in such federal court;
(iii) waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any such action, suit or proceeding in any such Delaware state or federal court; and
(iv) waives, to the fullest extent permitted by applicable Law, the defense of an inconvenient forum to the maintenance of such action, suit or proceeding in any such Delaware state or federal court. Each party agrees that a final judgment in
any such action, suit or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by applicable Law.
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8.
Entire Agreement; Amendments and Waivers
. This letter, together with the Purchase
Agreement, the Ancillary Agreements, the other Commitment Letters and the Confidentiality Agreement, constitute the entire agreement between the parties hereto with respect to the subject matter hereof and supersede all prior written or oral and all
contemporaneous oral agreements and understandings between any of the parties hereto with respect to the subject matter hereof and thereof. This letter may not be amended, and no provision hereof waived or modified, except by an instrument signed by
each of the parties hereto and, except for any such amendment made (i) in connection with an assignment by the Equity Investor of all or a portion of its obligations to fund the Equity Commitment pursuant to this letter or (ii) in
connection with an assignment of Buyers rights, obligations and liabilities under the Purchase Agreement pursuant to, and in accordance with Section 13.1 thereof, Seller Parent, and in the case of a waiver, by the party against whom the
waiver is to be effective.
9.
Interpretation
. The titles and captions in this letter are for reference purposes only, and shall
not in any way define, limit, extend or describe the scope of this letter otherwise affect the meaning or interpretation of this letter. The words including or any variation thereof means including, without limitation, and
shall not be construed to limit any general statement that it follows to the specific or similar items or matters immediately following it.
10.
Counterparts
. This letter may be executed in one or more counterparts for the convenience of the parties hereto, each of which
shall be deemed an original and all of which together will constitute one and the same instrument, and this letter shall become effective when one or more counterparts have been signed by each of the parties hereto and delivered to the other parties
hereto. Delivery of an executed counterpart of a signature page to this letter by facsimile or electronic transmission shall be effective as delivery of a mutually executed counterpart to this letter.
11.
WAIVER OF JURY TRIAL
. EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY WHICH MAY ARISE UNDER THIS LETTER IS LIKELY TO
INVOLVE COMPLICATED AND DIFFICULT ISSUES, AND THEREFORE IT HEREBY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS LETTER OR THE
TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK
TO ENFORCE EITHER OF SUCH WAIVERS, (B) IT UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVERS, (C) IT MAKES SUCH WAIVERS VOLUNTARILY, AND (D) IT HAS BEEN INDUCED TO ENTER INTO THIS LETTER BY, AMONG OTHER THINGS, THE MUTUAL
WAIVERS AND CERTIFICATIONS IN THIS
SECTION 11
.
12.
Severability
. If any term or other provision of this letter is invalid,
illegal or incapable of being enforced by any rule of Law or public policy, all other conditions and provisions of this letter shall nevertheless remain in full force and effect so long as the economic or legal substance of the transactions
contemplated hereby is not affected in any manner materially adverse to any party hereto;
provided
, however, that this letter may not be enforced (a) without giving effect to the provisions in Sections
1
,
2
,
3
,
5(a)
,
5(c)
and
5(d)
of this letter (including by giving effect to any maximum dollar amounts set forth therein), or (b) if this letter would require the Equity Commitment to be funded at any time prior to the closing when
required pursuant to
Section
1
or for any purposes other than as expressly set forth in
Section
1
. Upon such determination that any term or other provision is invalid, illegal or incapable of being
enforced, the parties shall negotiate in good faith to modify this letter so as to effect the original intent of the parties as closely as possible to the fullest extent permitted by applicable Law in an acceptable manner to the end that the
transactions contemplated hereby are fulfilled to the extent possible.
13.
Representations and Warranties
. The Equity Investor
hereby represents and warrants to Buyer that:
(a) it has all limited partnership power and authority required to execute, deliver and
perform this letter;
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(b) the execution, delivery and performance of this letter has been duly and validly
authorized and approved by all necessary action and do not contravene any provision of the Equity Investors charter, partnership agreement, operating agreement or similar organizational documents or any Law binding on the Equity Investor;
(c) all consents, approvals, authorizations, permits of, filings with and notifications to, any Governmental Entity necessary for the due
execution, delivery and performance of this letter by the Equity Investor have been obtained or made and all conditions thereof have been duly complied with, and no other action by, and no notice to or filing with, any Governmental Entity is
required in connection with the execution, delivery or performance of this letter;
(d) this letter constitutes a legal, valid and binding
obligation of the Equity Investor enforceable against the Equity Investor in accordance with its terms, except as may be limited by any bankruptcy, insolvency, reorganization, moratorium, fraudulent conveyance or other similar laws affecting the
enforcement of creditors rights generally or by general principles of equity;
(e) the Equity Commitment is less than the maximum
amount that the Equity Investor is permitted to invest in any one portfolio investment pursuant to the terms of its organizational or governing documents; and
(f) the Equity Investor has uncalled capital commitments or otherwise has available funds (including lines of credit) in excess of the Equity
Commitment hereunder and all of its other unfunded contractually binding equity commitments that are currently outstanding and all funds necessary for it to fulfill all of its obligations under this letter will be available to it for so long as this
letter shall remain in effect.
[
The remainder of this page is intentionally left blank
]
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|
|
Very truly yours,
EQUITY INVESTOR
:
JWC
RIB-X
LLC
|
|
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By:
|
|
/s/ Christopher Eklund
|
|
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Name: Christopher Eklund
Title: Managing Director
|
Signature Page to JWC Equity Commitment Letter
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Accepted and acknowledged:
Buyer
:
MELINTA THERAPEUTICS, INC.
|
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By:
|
|
/s/ Paul Estrem
|
|
|
Name: Paul Estrem
Title: Chief Financial Officer
|
Signature Page to JWC Equity Commitment Letter
D-8
Annex E
VOTING AGREEMENT
This
Voting Agreement (this
Agreement
) is made and entered into as of November 28, 2017, between The Medicines Company, a Delaware corporation (
MedCo
), and the Persons whose names appear on the signature pages
hereto (each such Person, a
Stockholder
and, collectively, the
Stockholders
). Capitalized terms used but not otherwise defined herein shall have the respective meanings ascribed to such terms in the Purchase
Agreement (as defined below).
RECITALS
A. Promptly after the execution of this Agreement, MedCo and Melinta Therapeutics, Inc., a Delaware corporation (the
Company
), intend to enter into a Purchase and Sale Agreement containing terms materially consistent with those set forth in the Letter of Intent attached hereto as
Exhibit A
(the
Purchase Agreement
),
pursuant to which the Company will acquire certain assets of, and assume certain related liabilities of, MedCo, all upon the terms and subject to the conditions set forth therein.
B. The Stockholders agree to enter into this Agreement with respect to shares of Voting Stock (as defined below) held by the Stockholders.
C. As of the date hereof, the Stockholders are the owners of, and have either sole or shared voting power over, such number of shares of
Voting Stock as are indicated opposite each of their names on
Schedule A
attached hereto.
E. Each of MedCo and the Stockholders
have determined that it is in its best interests to enter into this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the
respective representations, warranties, covenants and agreements set forth below and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, do
hereby agree as follows:
1.
Definitions
. When used in this Agreement, except as set forth in the Preamble hereto, the following
terms in all of their tenses, cases and correlative forms shall have the meanings assigned to them in this
Section
1
or elsewhere in this Agreement.
Affiliate
of any particular Person means any other Person controlling, controlled by or under common control
with such Person. The term
control
means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by
contract or otherwise. The terms
controlled
,
controlling
, and
under common control with
have meanings correlative thereto. Notwithstanding the foregoing, no Stockholder shall be deemed an
Affiliate of the Company or MedCo, and vice versa.
Beneficially Own
,
Beneficial
Owner
or
Beneficial Ownership
shall have the meaning (or the correlative meaning, as applicable) set forth in Rule
13d-3
and Rule
13d-5(b)(i)
of the rules and regulations promulgated under the Securities Exchange Act.
Expiration Time
shall mean (a) in the event that the Company and Medco execute the Purchase Agreement,
the earlier to occur of (i) the Closing Date and (ii) such date and time as the Purchase Agreement shall be terminated in accordance with its terms and (b) in the event that the Company and Medco do not execute the Purchase Agreement,
the earlier to occur of (i) December 31, 2017 and (ii) the date that Medco enters into a definitive agreement with a third party, other than the Company or its Affiliates, regarding the sale or other disposition of those certain
assets of MedCo contemplated by the Letter of Intent attached hereto as Exhibit A.
E-1
Hedging Activities
means any forward sale, hedging or
similar transaction involving any Voting Stock, including any transaction by which any economic risks and/or rewards or ownership of, or voting rights with respect to, any such Voting Stock are Transferred or affected.
Joinder Agreement
means a joinder to this Agreement reasonably satisfactory to MedCo evidencing a
transferees agreement to be bound by and subject to the terms and provisions hereof to the same effect as each Stockholder.
SEC
shall mean the United States Securities and Exchange Commission.
Securities Exchange Act
shall mean the Securities Exchange Act of 1934, as amended, and the rules and
regulations promulgated thereunder.
Term
means the period from the date hereof until the Expiration
Time.
Transfer
shall mean any direct or indirect sale, assignment, encumbrance, pledge, hypothecation,
disposition, loan or other transfer, or entry into any Contract with respect to any sale, assignment, encumbrance, pledge, hypothecation, disposition, loan or other transfer, excluding entry into this Agreement and the Purchase Agreement and the
consummation of the transactions contemplated hereby and thereby.
Voting Stock
shall mean, any Company
Common Stock or any securities convertible into, exchangeable for or otherwise exercisable to acquire Company Common Stock or any other securities having (or being convertible into, exchangeable for or otherwise exercisable to acquire any securities
having) the ordinary power to vote in the election of members of the Board of Directors of the Company, or any right to acquire within sixty days any of the foregoing, whether now owned or hereafter acquired.
2.
Subject Shares
. Each Stockholder agrees that any Voting Stock that such Stockholder Beneficially Owns or owns of record shall be
subject to the terms and conditions of this Agreement so long as such Voting Stock is Beneficially Owned or owned of record by such Stockholder.
3.
Restrictions Prior to Expiration Time
.
3.1
No Transfer of Voting Stock
. Until the Expiration Time, each Stockholder agrees not to: (x) Transfer any Voting Stock,
(y) directly or indirectly engage in any Hedging Activities or (z) deposit any Voting Stock into a voting trust or enter into a voting agreement with respect to Voting Stock or grant any proxy, consent or power of attorney with respect
thereto (other than pursuant to this Agreement); provided that any Stockholder may Transfer any such Voting Stock to any other Stockholder or any Affiliate of any such Stockholders if such Affiliate transferee executes a Joinder Agreement (each, a
Permitted Transferee
).
3.2 The limitations set forth in
Section
3.1
shall not apply to
(x) any Transfer as to which MedCo gives its prior written consent or (y) any Transfer to another Stockholder or any of their respective Affiliates who has executed a Joinder Agreement.
3.3
Non-permitted
Transfers
. Any Transfer or attempted Transfer of any Voting Stock in
violation of this
Section
3
shall, to the fullest extent permitted by applicable Law, be null and void
ab initio
.
4.
Agreement to Consent and Approve Prior to Expiration Time
.
4.1 Until the Expiration Time, no Stockholder shall enter into any tender, voting or other agreement, or grant a proxy or power of attorney,
with respect to the Voting Stock that is inconsistent with this Agreement or otherwise take any other action with respect to the Voting Stock that would in any way restrict, limit or interfere with the performance of such Stockholders
obligations hereunder or the transactions contemplated hereby, including the receipt of the Buyer Stockholder Approval and the consummation of the transactions contemplated by the Purchase Agreement.
E-2
4.2 Until the Expiration Time, at any meeting of the stockholders of the Company, however
called, or at any postponement or adjournment thereof, called to seek the affirmative vote of the holders of the outstanding shares of Voting Stock to approve the transactions contemplated by the Purchase Agreement (including any financing related
thereto) or in any other circumstances upon which a vote, consent or other approval with respect to the Purchase Agreement or the transactions contemplated by the Purchase Agreement is sought, each Stockholder shall vote (or cause to be voted) all
shares of Voting Stock currently or hereinafter owned by such Stockholder in favor of the foregoing.
4.3 Until the Expiration Time, at
any meeting of the stockholders of the Company, however called, or at any postponement or adjournment thereof or in any other circumstances upon which any Stockholders vote, consent or other approval (including by written consent) is sought,
each Stockholder shall vote (or cause to be voted) all shares of Voting Stock (to the extent such Voting Stock are then entitled to vote thereon), currently or hereinafter owned by such Stockholder against and withhold consent with respect to
(i) any action or agreement that has or would be reasonably likely to result in any conditions to Medcos or the Companys obligations under Article X of the Purchase Agreement not being fulfilled, (ii) any amendments to the
Companys certificate of incorporation or bylaws if such amendment would reasonably be expected to prevent or delay the consummation of the Closing or (iii) any other action or agreement that is intended, or could reasonably be expected,
to impede, interfere with, delay, or postpone the transactions contemplated by the Purchase Agreement or change in any manner the voting rights of any class of stock of the Company. No Stockholder shall commit or agree to take any action
inconsistent with the foregoing that would be effective prior to the Expiration Time.
5.
Litigation
. Each Stockholder agrees not
to commence, join in, facilitate, assist or encourage, and agrees to take all actions necessary to opt out of any class in any class action with respect to, any claim, derivative or otherwise, against the Company, MedCo or any of their respective
successors or directors (a) challenging the validity of, or seeking to enjoin the operation of, any provision of this Agreement or (b) alleging a breach of any fiduciary duty of any Person in connection with the evaluation, negotiation or
entry into this Agreement or the Purchase Agreement.
6.
Legend on Securities; Stop Transfer Order
.
(a) MedCo and the Company may make a notation on its records or give instructions to any transfer agents or registrars for the
Voting Stock in order to implement the restrictions on Transfer set forth in this Agreement.
(b) In connection with any
Transfer of shares of Voting Stock, the transferor shall provide MedCo with such certificates, opinions and other documents as MedCo may reasonably request to assure that such Transfer complies fully with this Agreement.
(c) In furtherance of this Agreement, from and after the Closing Date, the Stockholders shall and hereby do authorize MedCo to
notify MedCos transfer agent that there is a stop transfer order with respect to all Voting Stock subject to this Agreement (and that this Agreement places limits on the transfer of the Voting Stock). The Stockholders further agree to permit
MedCo, from and after the Closing, not to register the transfer of any certificate representing any of the Voting Stock unless such transfer is made in accordance with the terms of this Agreement.
7.
Representations and Warranties of the Stockholders
. Each Stockholder hereby represents and warrants to MedCo as follows:
7.1
Organization
. If such Stockholder is a corporation, partnership, limited liability company, limited liability partnership,
syndicate, trust, association, organization or other entity, such Stockholder is duly organized, validly existing, and in good standing under the laws of the State of its respective jurisdiction.
7.2
Due Authority
. Such Stockholder has the full power and authority to make, enter into and carry out the terms of this Agreement.
This Agreement has been duly and validly executed and delivered by such
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Stockholder and constitutes a valid and binding agreement of such Stockholder enforceable against it in accordance with its terms, except to the extent enforceability may be limited by the effect
of applicable bankruptcy, reorganization, insolvency, moratorium or other applicable Law affecting the enforcement of creditors rights generally and the effect of general principles of equity, regardless of whether such enforceability is
considered in a proceeding at law or in equity.
7.3
Ownership of the Voting Stock
. As of the date hereof, such Stockholder is the
owner of the shares of Voting Stock indicated on
Schedule A
hereto opposite such Stockholders name, free and clear of any and all Liens, other than those created by this Agreement. Such Stockholder has and will have until the Expiration
Time either sole or shared voting power (including the right to control such vote as contemplated herein), power of disposition, power to issue instructions with respect to the matters set forth in this Agreement and power to agree to all of the
matters applicable to such Stockholder set forth in this Agreement, in each case, over all shares of Voting Stock currently or hereinafter owned by such Stockholder. As of the date hereof, such Stockholder does not own any capital stock or other
voting securities of the Company, other than the shares of Voting Stock set forth on
Schedule A
opposite such Stockholders name. As of the date hereof, such Stockholder does not own any rights to purchase or acquire any shares of
capital stock or other equity securities of the Company, except as set forth on
Schedule A
opposite such Stockholders name.
7.4
No Conflict; Consents
.
(a) The execution and delivery of this Agreement by such Stockholder does not, and the performance by such Stockholder of the
obligations under this Agreement and the compliance by such Stockholder with any provisions hereof do not and will not: (i) conflict with or violate any applicable Law applicable to such Stockholder, (ii) contravene or conflict with, or
result in any violation or breach of, any provision of any charter, certificate of incorporation, articles of association,
by-laws,
operating agreement or similar formation or governing documents and
instruments of such Stockholder, or (iii) result in any material breach of or constitute a material default (or an event that with notice or lapse of time or both would become a material default) under, or give to others any rights of
termination, amendment, acceleration or cancellation of, or result in the creation of a Lien on any of the shares of Voting Stock owned by such Stockholder pursuant to any Contract to which such Stockholder is a party or by which such Stockholder is
bound, except, in the case of clause (i) or (iii), as would not reasonably be expected, either individually or in the aggregate, to materially impair the ability of such Stockholder to perform its obligations hereunder or to consummate the
transactions contemplated hereby.
(b) No consent, approval, order or authorization of, or registration, declaration or
filing with, any Governmental Authority or any other Person is required by or with respect to such Stockholder in connection with the execution and delivery of this Agreement or the consummation by such Stockholder of the transactions contemplated
hereby.
7.5
Absence of Litigation
. As of the date hereof, there is no Legal Proceeding pending against, or, to the knowledge of
such Stockholder, threatened against such Stockholder that would reasonably be expected to materially impair the ability of such Stockholder to perform such Stockholders obligations hereunder or to consummate the transactions contemplated
hereby.
7.6
Absence of Other Voting Agreement
. Except for this Agreement and the Purchase Agreement, such Stockholder has not:
(i) entered into any voting agreement, voting trust or similar agreement with respect to any Voting Stock or other equity securities of the Company owned by such Stockholder, or (ii) granted any proxy, consent or power of attorney with
respect to any Voting Stock owned by such Stockholder (other than as contemplated by this Agreement or with another Stockholder who has executed this Agreement).
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8.
Representations and Warranties of MedCo
. MedCo hereby represents and warrants to
the Stockholders as follows:
8.1
Organization
. MedCo is duly organized, validly existing, and in good standing under the laws of
its state of incorporation.
8.2
Due Authority
. MedCo has the full power and authority to make, enter into and carry out the terms
of this Agreement. The execution and delivery of this Agreement by MedCo and the consummation by MedCo of the transactions contemplated hereby have been duly and validly authorized by all necessary action on the part of MedCo. This Agreement has
been duly and validly executed and delivered by MedCo and constitutes a valid and binding agreement of MedCo enforceable against it in accordance with its terms, except to the extent enforceability may be limited by the effect of applicable
bankruptcy, reorganization, insolvency, moratorium or other applicable Law affecting the enforcement of creditors rights generally and the effect of general principles of equity, regardless of whether such enforceability is considered in a
proceeding at law or in equity.
8.3
No Conflict; Consents
.
(a) The execution and delivery of this Agreement by MedCo does not, and the performance by MedCo of the obligations under this
Agreement and the compliance by MedCo with any provisions hereof do not and will not: (i) conflict with or violate any applicable Law applicable to MedCo, (ii) contravene or conflict with, or result in any violation or breach of, any
provision of any charter, certificate of incorporation, articles of association,
by-laws,
operating agreement or similar formation or governing documents and instruments of MedCo, or (iii) result in any
material breach of or constitute a material default (or an event that with notice or lapse of time or both would become a material default) under any Contract to which MedCo is a party or by which MedCo is bound, except, in the case of clause
(i) or (iii), as would not reasonably be expected, either individually or in the aggregate, to materially impair the ability of MedCo to perform its obligations hereunder or to consummate the transactions contemplated hereby.
(b) No consent, approval, order or authorization of, or registration, declaration or filing with, any Governmental Authority
or any other Person is required by or with respect to MedCo in connection with the execution and delivery of this Agreement or the consummation by MedCo of the transactions contemplated hereby, except for filings with the SEC of such reports under
the Securities Exchange Act as may be required in connection with this Agreement and the consummation of the transactions contemplated hereby.
8.4
Absence of Litigation
. As of the date hereof, there is no Legal Proceeding pending against, or, to the knowledge of MedCo,
threatened against MedCo that would reasonably be expected to materially impair the ability of MedCo to perform the obligations of MedCo hereunder or to consummate the transactions contemplated hereby.
9.
Fiduciary Duties
. The covenants and agreements set forth herein shall not prevent any of the Stockholders designees serving on
the board of directors of MedCo or the Company from taking any action while acting in such designees capacity as a director of MedCo or the Company. Each Stockholder is entering into this Agreement solely in its capacity as the owner of such
Stockholders shares of Voting Stock.
10.
Further Assurances
. The Stockholders shall, without further consideration, from
time to time, execute and deliver, or cause to be executed and delivered, such additional or further consents, documents and other instruments as MedCo may reasonably request in order to vest, perfect, confirm or record the rights granted to MedCo
under this Agreement.
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11.
Joinder; Certain Events
.
11.1 During the Term, in the event any Stockholder Transfers any shares of Voting Stock to a Person as permitted by and in accordance with
this Agreement, such transferee shall be required, as a condition to such Transfer, to execute and deliver to MedCo a Joinder Agreement.
11.2 Except as provided in
Section
11.1
, the Stockholders agree that this Agreement and the obligations hereunder
shall attach to the shares of Voting Stock referenced in
Section
2
and shall be binding on any Person to which legal or beneficial ownership of such shares of Voting Stock shall pass, whether by operation of Law or
otherwise. In the event of any stock split, stock dividend, merger, amalgamation, reorganization, recapitalization or other change in the capital structure of the Company or, after the Closing Date, MedCo, affecting the Voting Stock, the number of
shares of Voting Stock shall be deemed adjusted appropriately and this Agreement and the obligations hereunder shall attach to any additional shares of Voting Stock so issued to or acquired by the Stockholders.
12.
Termination
. Except as set forth herein with respect to specific provisions hereof, this Agreement shall not terminate and shall
remain in full force and effect until the end of the Term;
provided
that nothing herein shall relieve any party from liability for any intentional breach of this Agreement prior to such termination.
13.
No Ownership Interest
. Nothing contained in this Agreement shall be deemed to vest in MedCo any direct or indirect ownership or
incidence of ownership of or with respect to the Stockholders shares of Voting Stock. All rights, ownership and economic benefits of and relating to the Stockholders shares of Voting Stock shall remain vested in and belong to the
Stockholders, and MedCo shall have no authority to direct the Stockholders in the voting or disposition of any of the shares of Voting Stock except as otherwise provided herein.
14.
Miscellaneous
.
14.1
Severability
. The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision
shall not affect the validity or enforceability of the other provisions hereof. If any provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid or unenforceable, (a) a suitable and equitable
provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision; and (b) the remainder of this Agreement and the application of such
provision to other Persons or circumstances shall not be affected by such invalidity or unenforceability, nor shall such invalidity or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other
jurisdiction.
14.2
Non-survival
of Representations and Warranties
. None of the
representations and warranties in this Agreement or in any schedule, instrument or other document delivered pursuant to this Agreement shall survive the Closing Date or the termination of this Agreement. This
Section
14.2
shall not limit any covenant or agreement contained in this Agreement that by its terms is to be performed in whole or in part after the Closing Date or the termination of this Agreement.
14.3
Assignment
. Neither this Agreement nor any of the rights, interests or obligations under this Agreement may be assigned or
delegated, in whole or in part, by operation of law or otherwise, by any of the parties hereto without the prior written consent of the other parties, and any such assignment without such prior written consent shall be null and void. Subject to the
preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the parties and their respective successors and assigns.
14.4
Amendment and Modification
. This Agreement may not be amended, modified or supplemented in any manner, whether by course of
conduct or otherwise, except by an instrument in writing specifically designated as an amendment hereto, signed on behalf of each party.
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14.5
Enforcement
. The parties hereto agree that irreparable damage would occur in
the event that any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. Accordingly, each of the parties hereto shall be entitled to specific performance of the terms hereof,
including an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in the Court of Chancery of the State of Delaware (or, if such court lacks subject matter
jurisdiction, in the Superior Court of the State of Delaware or the United States District Court for the District of Delaware), this being in addition to any other remedy to which such party is entitled at law or in equity. Each of the parties
hereby further waives (a) any defense in any action for specific performance that a remedy at law would be adequate and (b) any requirement under any law to post security as a prerequisite to obtaining equitable relief.
14.6
Notices
. All notices and other communications hereunder shall be in writing and shall be deemed duly given (a) on the date
of delivery if delivered personally, (b) on the first Business Day following the date of dispatch if delivered utilizing a
next-day
service by a recognized
next-day
courier or (c) on the earlier of confirmed receipt or the fifth Business Day following the date of mailing if delivered by registered or certified mail, return receipt requested, postage prepaid. All notices hereunder shall be delivered to the
addresses set forth below, or pursuant to such other instructions as may be designated in writing by the party to receive such notice:
(i) if to any Stockholder, to the address set forth on such Stockholders signature page attached hereto:
with a concurrent copy to (which shall not be considered notice):
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York,
NY 10019
Telephone: (212)
728-8000
Fax: (212)
728-9867
Attention: Gordon Caplan, Esq.
Sean M. Ewen, Esq.
(ii) if to MedCo, to:
The Medicines Company
8 Sylvan
Way
Parsippany, New Jersey 07054
Attention: Stephen Rodin
Facsimile: (973)
656-9898
E-mail:
stephen.rodin@themedco.com
with a concurrent copy to (which shall not be considered notice):
Cadwalader, Wickersham & Taft LLP
200 Liberty Street
New York,
New York 10281
Attention: Gregory P. Patti, Jr.
Andrew P. Alin
Facsimile: (212)
504-6666
E-mail:
greg.patti@cwt.com
andrew.alin@cwt.com
14.7
Governing Law; Submission to Jurisdiction
. This Agreement and all disputes or controversies arising out of or relating to this Agreement or the transactions contemplated hereby shall be governed by, and construed in accordance with, the
internal laws of the State of Delaware, without regard to the laws of any other jurisdiction that might be applied because of the conflicts of laws principles of the State of
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Delaware. Each of the parties irrevocably agrees that any legal action or proceeding arising out of or relating to this Agreement brought by the other party or its successors or assigns shall be
brought and determined in the Court of Chancery of the State of Delaware (or, if such court lacks subject matter jurisdiction, in the Superior Court of the State of Delaware or the United States District Court for the District of Delaware), and each
of the parties hereby irrevocably submits to the exclusive jurisdiction of the aforesaid courts for itself and with respect to its property, generally and unconditionally, with regard to any such action or proceeding arising out of or relating to
this Agreement and the transactions contemplated hereby. Each of the parties agrees not to commence any action, suit or proceeding relating thereto except in the courts described above in Delaware, other than actions in any court of competent
jurisdiction to enforce any judgment, decree or award rendered by any such court in Delaware as described herein. Each of the parties further agrees that notice as provided herein shall constitute sufficient service of process and the parties
further waive any argument that such service is insufficient. Each of the parties hereby irrevocably and unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim or otherwise, in any action or proceeding
arising out of or relating to this Agreement or the transactions contemplated hereby, (a) any claim that it is not personally subject to the jurisdiction of the courts in Delaware as described herein for any reason, (b) that it or its
property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment
or otherwise) and (c) that (i) the suit, action or proceeding in any such court is brought in an inconvenient forum, (ii) the venue of such suit, action or proceeding is improper or (iii) this Agreement, or the subject matter hereof,
may not be enforced in or by such courts.
14.8
WAIVER OF JURY TRIAL
. EACH OF THE PARTIES TO THIS AGREEMENT HEREBY IRREVOCABLY
WAIVES ALL RIGHT TO A TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
14.9
Entire Agreement; Third-Party Beneficiaries
. This Agreement constitutes the entire agreement, and supersedes all prior written
agreements, arrangements, communications and understandings and all prior and contemporaneous oral agreements, arrangements, communications and understandings among the parties hereto with respect to the subject matter hereof. Nothing in this
Agreement, express or implied, is intended to or shall confer upon any Person other than the parties and their respective successors and permitted assigns any legal or equitable right, benefit or remedy of any nature under or by reason of this
Agreement.
14.10
Counterparts; Facsimile Signature
. This Agreement may be executed in two or more counterparts, all of which
shall be considered one and the same instrument and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other party. This Agreement may be executed by facsimile signature or other
electronic signature and such signature shall constitute an original for all purposes.
14.11
Effect of Headings
. Headings of the
articles and sections of this Agreement and the table of contents, schedules and exhibits are for convenience of the parties only and shall be given no substantive or interpretative effect whatsoever.
14.12
No Presumption Against Drafting Party
. The parties hereto have participated jointly in the negotiation and drafting of this
Agreement. Each of the parties hereto acknowledges that each party to this Agreement has been represented by counsel in connection with this Agreement and the transactions contemplated by this Agreement. Accordingly, any rule of law or any legal
decision that would require interpretation of any claimed ambiguities in this Agreement against the drafting party has no application and is expressly waived.
14.13
Expenses
. Except as otherwise provided herein or in the Purchase Agreement, all fees and expenses incurred in connection with or
related to this Agreement and the transactions contemplated hereby shall be paid by the party incurring such fees or expenses, whether or not such transactions are consummated. In the
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event of termination of this Agreement, the obligation of each party to pay its own expenses will be subject to any rights of such party arising from a breach of this Agreement by the other.
14.14
No Recourse
. Notwithstanding anything to the contrary contained herein or otherwise, but without limiting any provision in the
Purchase Agreement, this Agreement may only be enforced against, and any claims or causes of action that may be based upon, arise out of or relate to this Agreement, or the negotiation, execution or performance of this Agreement or the transactions
contemplated hereby, may only be made against the entities and Persons that are expressly identified as parties to this Agreement in their capacities as such and no former, current or future stockholders, equity holders, controlling persons,
directors, officers, employees, general or limited partners, members, managers, agents or affiliates of any party hereto, or any former, current or future direct or indirect stockholder, equity holder, controlling person, director, officer,
employee, general or limited partner, member, manager, agent or affiliate of any of the foregoing (each, a
Non-Recourse
Party
) shall have any liability for any obligations or liabilities of
the parties to this Agreement or for any claim (whether in tort, contract or otherwise) based on, in respect of, or by reason of, the transactions contemplated hereby or in respect of any oral representations made or alleged to be made in connection
herewith. Without limiting the rights of any party against the other parties hereto, in no event shall any party or any of its affiliates seek to enforce this Agreement against, make any claims for breach of this Agreement against, or seek to
recover monetary damages from, any
Non-Recourse
Party.
[Remainder of Page Intentionally Left
Blank]
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In witness whereof, the parties hereto have caused this Agreement to be executed as of the
date first set forth above.
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THE MEDICINES COMPANY
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By:
|
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/s/ Stephen M. Rodin
|
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Name: Stephen M. Rodin
|
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Title: Executive Vice President and
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General Counsel
|
[Signature page to Voting Agreement]
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STOCKHOLDERS:
VATERA HEALTHCARE PARTNERS LLC
|
By: Vatera Holdings LLC, as manager
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By:
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|
/s/ Kevin Ferro
|
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Name: Kevin Ferro
|
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Title: CEO
|
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Notice Address:
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c/o Vatera
Holdings LLC
499 Park Avenue 23rd Floor
|
New York, NY 10022
|
[Signature page to Voting Agreement]
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LUPA GmbH
|
|
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By:
|
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/s/ Bernhard Muller
|
Name:
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Title:
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Notice Address:
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[Signature page to Voting
Agreement]
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JWC
RIB-X
LLC
|
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By:
|
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/s/ Christopher
Eklund
|
Name: Christopher Eklund
|
Title: Managing Director
|
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Notice Address:
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[Signature page to Voting
Agreement]
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MALIN LIFE SCIENCES HOLDINGS LIMITED
|
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By:
|
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/s/ Sean E. Murphy
|
Name: Sean E. Murphy
|
Title: Executive VP
|
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Notice Address:
|
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[Signature page to Voting
Agreement]
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FALCON FLIGHT LLC
By: TDM VENTURES LLC,
its Managing
Member
|
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By:
|
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/s/ Erik S. Akhund
|
Name: Eric S. Akhund
|
Title: Managing Member
|
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Notice Address:
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[Signature page to Voting
Agreement]
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QUAKER BIOVENTURES II, LP
By: Quaker Bioventures II, L.P., its General Partner
By: Quaker Bioventures II, LLC, its General Partner
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By:
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/s/ P. Sherrill
Neff
|
Name: P. Sherrill Neff
|
Title: Executive Manager
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Notice Address:
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[Signature page to Voting
Agreement]
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VOTING AGREEMENT
This Voting Agreement (this
Agreement
) is made and entered into as of November 28, 2017, between The Medicines
Company, a Delaware corporation (
MedCo
), and the Persons whose names appear on the signature pages hereto (each such Person, a
Stockholder
and, collectively, the
Stockholders
). Capitalized
terms used but not otherwise defined herein shall have the respective meanings ascribed to such terms in the Purchase Agreement (as defined below).
RECITALS
A. Promptly
after the execution of this Agreement, MedCo and Melinta Therapeutics, Inc., a Delaware corporation (the
Company
), intend to enter into a Purchase and Sale Agreement containing terms materially consistent with those set forth in
the Letter of Intent attached hereto as
Exhibit A
and provided that under no circumstances shall such Purchase and Sale Agreement impose any obligations or liabilities of any kind (including but not limited to any restrictive covenant or
indemnities) on the Stockholder or any of its Affiliates (the
Purchase Agreement
), pursuant to which the Company will acquire certain assets of, and assume certain related liabilities of, MedCo, all upon the terms and subject to
the conditions set forth therein.
B. The Stockholders agree to enter into this Agreement with respect to shares of Voting Stock (as
defined below) held by the Stockholders.
C. As of the date hereof, the Stockholders are the owners of, and have either sole or shared
voting power over, such number of shares of Voting Stock as are indicated opposite each of their names on
Schedule A
attached hereto.
E. Each of MedCo and the Stockholders have determined that it is in its best interests to enter into this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the respective representations, warranties, covenants and agreements set forth below and
for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows:
1.
Definitions
. When used in this Agreement, except as set forth in the Preamble hereto, the following terms in all of their tenses,
cases and correlative forms shall have the meanings assigned to them in this
Section
1
or elsewhere in this Agreement.
Affiliate
of any particular Person means any other Person controlling, controlled by or under common control
with such Person. The term
control
means possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by
contract or otherwise. The terms
controlled
,
controlling
, and
under common control with
have meanings correlative thereto. Notwithstanding the foregoing, no Stockholder shall be deemed an
Affiliate of the Company or MedCo, and vice versa.
Beneficially Own
,
Beneficial
Owner
or
Beneficial Ownership
shall have the meaning (or the correlative meaning, as applicable) set forth in Rule
13d-3
and Rule
13d-5(b)(i)
of the rules and regulations promulgated under the Securities Exchange Act.
Expiration Time
shall mean (a) in the event that the Company and Medco execute the Purchase Agreement,
the earlier to occur of (i) the Closing Date (ii) such date and time as the Purchase Agreement shall be terminated in accordance with its terms and (iii) May 28, 2018 and (b) in the event that the Company and Medco do not
execute the Purchase Agreement, the earlier to occur of (i) December 31, 2017 and (ii) the date that Medco enters into a definitive agreement with a third party, other than the Company or its Affiliates, regarding the sale or other
disposition of those certain assets of MedCo contemplated by the Letter of Intent attached hereto as Exhibit A.
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Hedging Activities
means any forward sale, hedging or
similar transaction involving any Voting Stock, including any transaction by which any economic risks and/or rewards or ownership of, or voting rights with respect to, any such Voting Stock are Transferred or affected.
Joinder Agreement
means a joinder to this Agreement reasonably satisfactory to MedCo evidencing a
transferees agreement to be bound by and subject to the terms and provisions hereof to the same effect as each Stockholder.
SEC
shall mean the United States Securities and Exchange Commission.
Securities Exchange Act
shall mean the Securities Exchange Act of 1934, as amended, and the rules and
regulations promulgated thereunder.
Term
means the period from the date hereof until the Expiration
Time.
Transfer
shall mean any direct or indirect sale, assignment, encumbrance, pledge, hypothecation,
disposition, loan or other transfer, or entry into any Contract with respect to any sale, assignment, encumbrance, pledge, hypothecation, disposition, loan or other transfer, excluding entry into this Agreement and the Purchase Agreement and the
consummation of the transactions contemplated hereby and thereby.
Voting Stock
shall mean, any Company
Common Stock or any securities convertible into, exchangeable for or otherwise exercisable to acquire Company Common Stock or any other securities having (or being convertible into, exchangeable for or otherwise exercisable to acquire any securities
having) the ordinary power to vote in the election of members of the Board of Directors of the Company, or any right to acquire within sixty days any of the foregoing, whether now owned or hereafter acquired.
2.
Subject Shares
. Each Stockholder agrees that any Voting Stock that such Stockholder Beneficially Owns or owns of record shall be
subject to the terms and conditions of this Agreement so long as such Voting Stock is Beneficially Owned or owned of record by such Stockholder.
3.
Restrictions Prior to Expiration Time
.
3.1
No Transfer of Voting Stock
. Until the Expiration Time, each Stockholder agrees not to: (x) Transfer any Voting Stock,
(y) directly or indirectly engage in any Hedging Activities or (z) deposit any Voting Stock into a voting trust or enter into a voting agreement with respect to Voting Stock or grant any proxy, consent or power of attorney with respect
thereto (other than pursuant to this Agreement); provided that any Stockholder may Transfer any such Voting Stock to any other transferee so long as such transferee executes a Joinder Agreement (each, a
Permitted Transferee
).
3.2 The limitations set forth in
Section
3.1
shall not apply to (x) any Transfer as to which MedCo gives its
prior written consent or (y) any Transfer to another Stockholder or any of their respective Affiliates who has executed a Joinder Agreement.
3.3
Non-permitted
Transfers
. Any Transfer or attempted Transfer of any Voting Stock in
violation of this
Section
3
shall, to the fullest extent permitted by applicable Law, be null and void
ab initio
.
4.
Agreement to Consent and Approve Prior to Expiration Time
.
4.1 Until the Expiration Time, no Stockholder shall enter into any tender, voting or other agreement, or grant a proxy or power of attorney,
with respect to the Voting Stock that is inconsistent with this Agreement or otherwise take any other action with respect to the Voting Stock that could reasonably be expected in any way to restrict, limit or interfere with the performance of such
Stockholders obligations hereunder or the transactions contemplated hereby.
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4.2 Until the Expiration Time, at any meeting of the stockholders of the Company, however
called, or at any postponement or adjournment thereof, called to seek the affirmative vote of the holders of the outstanding shares of Voting Stock to approve the transactions contemplated by the Purchase Agreement (including any financing related
thereto) or in any other circumstances upon which a vote, consent or other approval with respect to the Purchase Agreement or the transactions contemplated by the Purchase Agreement is sought, each Stockholder shall vote (or cause to be voted) all
shares of Voting Stock currently or hereinafter owned by such Stockholder in favor of the foregoing.
4.3 Until the Expiration Time, at
any meeting of the stockholders of the Company, however called, or at any postponement or adjournment thereof or in any other circumstances upon which any Stockholders vote, consent or other approval (including by written consent) is sought,
each Stockholder shall vote (or cause to be voted) all shares of Voting Stock (to the extent such Voting Stock are then entitled to vote thereon), currently or hereinafter owned by such Stockholder against and withhold consent with respect to
(i) any action or agreement that has or would be reasonably likely to result in any conditions to Medcos or the Companys obligations under Article X of the Purchase Agreement not being fulfilled, (ii) any amendments to the
Companys certificate of incorporation or bylaws if such amendment would reasonably be expected to prevent or delay the consummation of the Closing or (iii) any other action or agreement that is intended, or could reasonably be expected,
to impede, interfere with, delay, or postpone the transactions contemplated by the Purchase Agreement or change in any manner the voting rights of any class of stock of the Company. No Stockholder shall commit or agree to take any action
inconsistent with the foregoing that would be effective prior to the Expiration Time.
5.
RESERVED.
6.
Legend on Securities; Stop Transfer Order
.
(a) MedCo and the Company may make a notation on its records or give instructions to any transfer agents or registrars for the
Voting Stock in order to implement the restrictions on Transfer set forth in this Agreement.
(b) In connection with any
Transfer of shares of Voting Stock, the transferor shall provide MedCo with such certificates, opinions and other documents as MedCo may reasonably request to assure that such Transfer complies fully with this Agreement.
(c) In furtherance of this Agreement, from and after the Closing Date, the Stockholders shall and hereby do authorize MedCo to
notify MedCos transfer agent that there is a stop transfer order with respect to all Voting Stock subject to this Agreement (and that this Agreement places limits on the transfer of the Voting Stock). The Stockholders further agree to permit
MedCo, from and after the Closing, not to register the transfer of any certificate representing any of the Voting Stock unless such transfer is made in accordance with the terms of this Agreement.
7.
Representations and Warranties of the Stockholders
. Each Stockholder hereby represents and warrants to MedCo as follows:
7.1
Organization
. If such Stockholder is a corporation, partnership, limited liability company, limited liability partnership,
syndicate, trust, association, organization or other entity, such Stockholder is duly organized, validly existing, and in good standing under the laws of the State of its respective jurisdiction.
7.2
Due Authority
. Such Stockholder has the full power and authority to make, enter into and carry out the terms of this Agreement.
This Agreement has been duly and validly executed and delivered by such Stockholder and constitutes a valid and binding agreement of such Stockholder enforceable against it in accordance with its terms, except to the extent enforceability may be
limited by the effect of applicable bankruptcy, reorganization, insolvency, moratorium or other applicable Law affecting the enforcement of creditors rights generally and the effect of general principles of equity, regardless of whether such
enforceability is considered in a proceeding at law or in equity.
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7.3
Ownership of the Voting Stock
. As of the date hereof, such Stockholder is the
owner of the shares of Voting Stock indicated on
Schedule A
hereto opposite such Stockholders name, free and clear of any and all Liens, other than those created by this Agreement. Such Stockholder has and will have until the Expiration
Time either sole or shared voting power (including the right to control such vote as contemplated herein), power of disposition, power to issue instructions with respect to the matters set forth in this Agreement and power to agree to all of the
matters applicable to such Stockholder set forth in this Agreement, in each case, over all shares of Voting Stock currently or hereinafter owned by such Stockholder. As of the date hereof, such Stockholder does not own any capital stock or other
voting securities of the Company, other than the shares of Voting Stock set forth on
Schedule A
opposite such Stockholders name. As of the date hereof, such Stockholder does not own any rights to purchase or acquire any shares of
capital stock or other equity securities of the Company, except as set forth on
Schedule A
opposite such Stockholders name.
7.4
No Conflict; Consents
.
(a) The execution and delivery of this Agreement by such Stockholder does not, and the performance by such Stockholder of the
obligations under this Agreement and the compliance by such Stockholder with any provisions hereof do not and will not: (i) conflict with or violate any applicable Law applicable to such Stockholder, (ii) contravene or conflict with, or
result in any violation or breach of, any provision of any charter, certificate of incorporation, articles of association,
by-laws,
operating agreement or similar formation or governing documents and
instruments of such Stockholder, or (iii) result in any material breach of or constitute a material default (or an event that with notice or lapse of time or both would become a material default) under, or give to others any rights of
termination, amendment, acceleration or cancellation of, or result in the creation of a Lien on any of the shares of Voting Stock owned by such Stockholder pursuant to any Contract to which such Stockholder is a party or by which such Stockholder is
bound, except, in the case of clause (i) or (iii), as would not reasonably be expected, either individually or in the aggregate, to materially impair the ability of such Stockholder to perform its obligations hereunder or to consummate the
transactions contemplated hereby.
(b) No consent, approval, order or authorization of, or registration, declaration or
filing with, any Governmental Authority or any other Person is required by or with respect to such Stockholder in connection with the execution and delivery of this Agreement or the consummation by such Stockholder of the transactions contemplated
hereby.
7.5
Absence of Litigation
. As of the date hereof, there is no Legal Proceeding pending against, or, to the knowledge of
such Stockholder, threatened against such Stockholder that would reasonably be expected to materially impair the ability of such Stockholder to perform such Stockholders obligations hereunder or to consummate the transactions contemplated
hereby.
7.6
Absence of Other Voting Agreement
. Except for this Agreement and the Purchase Agreement, such Stockholder has not:
(i) entered into any voting agreement, voting trust or similar agreement with respect to any Voting Stock or other equity securities of the Company owned by such Stockholder, or (ii) granted any proxy, consent or power of attorney with
respect to any Voting Stock owned by such Stockholder (other than as contemplated by this Agreement or with another Stockholder who has executed this Agreement).
8.
Representations and Warranties of MedCo
. MedCo hereby represents and warrants to the Stockholders as follows:
8.1
Organization
. MedCo is duly organized, validly existing, and in good standing under the laws of its state of incorporation.
8.2
Due Authority
. MedCo has the full power and authority to make, enter into and carry out the terms of this Agreement. The execution
and delivery of this Agreement by MedCo and the consummation by
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MedCo of the transactions contemplated hereby have been duly and validly authorized by all necessary action on the part of MedCo. This Agreement has been duly and validly executed and delivered
by MedCo and constitutes a valid and binding agreement of MedCo enforceable against it in accordance with its terms, except to the extent enforceability may be limited by the effect of applicable bankruptcy, reorganization, insolvency, moratorium or
other applicable Law affecting the enforcement of creditors rights generally and the effect of general principles of equity, regardless of whether such enforceability is considered in a proceeding at law or in equity.
8.3
No Conflict; Consents
.
(a) The execution and delivery of this Agreement by MedCo does not, and the performance by MedCo of the obligations under this
Agreement and the compliance by MedCo with any provisions hereof do not and will not: (i) conflict with or violate any applicable Law applicable to MedCo, (ii) contravene or conflict with, or result in any violation or breach of, any
provision of any charter, certificate of incorporation, articles of association,
by-laws,
operating agreement or similar formation or governing documents and instruments of MedCo, or (iii) result in any
material breach of or constitute a material default (or an event that with notice or lapse of time or both would become a material default) under any Contract to which MedCo is a party or by which MedCo is bound, except, in the case of clause
(i) or (iii), as would not reasonably be expected, either individually or in the aggregate, to materially impair the ability of MedCo to perform its obligations hereunder or to consummate the transactions contemplated hereby.
(b) No consent, approval, order or authorization of, or registration, declaration or filing with, any Governmental Authority
or any other Person is required by or with respect to MedCo in connection with the execution and delivery of this Agreement or the consummation by MedCo of the transactions contemplated hereby, except for filings with the SEC of such reports under
the Securities Exchange Act as may be required in connection with this Agreement and the consummation of the transactions contemplated hereby.
8.4
Absence of Litigation
. As of the date hereof, there is no Legal Proceeding pending against, or, to the knowledge of MedCo,
threatened against MedCo that would reasonably be expected to materially impair the ability of MedCo to perform the obligations of MedCo hereunder or to consummate the transactions contemplated hereby.
9.
Fiduciary Duties
. The covenants and agreements set forth herein shall not prevent any of the Stockholders designees serving on
the board of directors of MedCo or the Company from taking any action while acting in such designees capacity as a director of MedCo or the Company. Each Stockholder is entering into this Agreement solely in its capacity as the owner of such
Stockholders shares of Voting Stock.
10.
Further Assurances
. The Stockholders shall, without further consideration, from
time to time, execute and deliver, or cause to be executed and delivered, such additional or further consents, documents and other instruments as MedCo may reasonably request in order to vest, perfect, confirm or record the rights granted to MedCo
under this Agreement.
11.
Joinder; Certain Events
.
11.1 During the Term, in the event any Stockholder Transfers any shares of Voting Stock to a Person as permitted by and in accordance with
this Agreement, such transferee shall be required, as a condition to such Transfer, to execute and deliver to MedCo a Joinder Agreement.
11.2 Except as provided in
Section
11.1
, the Stockholders agree that this Agreement and the obligations hereunder
shall attach to the shares of Voting Stock referenced in
Section
2
and shall be binding on any Person to which legal or beneficial ownership of such shares of Voting Stock shall pass, whether by operation of Law or
otherwise. In the event of any stock split, stock dividend, merger, amalgamation,
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reorganization, recapitalization or other change in the capital structure of the Company or, after the Closing Date, MedCo, affecting the Voting Stock, the number of shares of Voting Stock shall
be deemed adjusted appropriately and this Agreement and the obligations hereunder shall attach to any additional shares of Voting Stock so issued to or acquired by the Stockholders.
12.
Termination
. Except as set forth herein with respect to specific provisions hereof, this Agreement shall not terminate and shall
remain in full force and effect until the end of the Term;
provided
that nothing herein shall relieve any party from liability for any intentional breach of this Agreement prior to such termination.
13.
No Ownership Interest
. Nothing contained in this Agreement shall be deemed to vest in MedCo any direct or indirect ownership or
incidence of ownership of or with respect to the Stockholders shares of Voting Stock. All rights, ownership and economic benefits of and relating to the Stockholders shares of Voting Stock shall remain vested in and belong to the
Stockholders, and MedCo shall have no authority to direct the Stockholders in the voting or disposition of any of the shares of Voting Stock except as otherwise provided herein.
14.
Miscellaneous
.
14.1
Severability
. The provisions of this Agreement shall be deemed severable and the invalidity or unenforceability of any provision
shall not affect the validity or enforceability of the other provisions hereof. If any provision of this Agreement, or the application thereof to any Person or any circumstance, is invalid or unenforceable, (a) a suitable and equitable
provision shall be substituted therefor in order to carry out, so far as may be valid and enforceable, the intent and purpose of such invalid or unenforceable provision; and (b) the remainder of this Agreement and the application of such
provision to other Persons or circumstances shall not be affected by such invalidity or unenforceability, nor shall such invalidity or unenforceability affect the validity or enforceability of such provision, or the application thereof, in any other
jurisdiction.
14.2
Non-survival
of Representations and Warranties
. None of the
representations and warranties in this Agreement or in any schedule, instrument or other document delivered pursuant to this Agreement shall survive the Closing Date or the termination of this Agreement. This
Section
14.2
shall not limit any covenant or agreement contained in this Agreement that by its terms is to be performed in whole or in part after the Closing Date or the termination of this Agreement.
14.3
Assignment
. Neither this Agreement nor any of the rights, interests or obligations under this Agreement may be assigned or
delegated, in whole or in part, by operation of law or otherwise, by any of the parties hereto without the prior written consent of the other parties, and any such assignment without such prior written consent shall be null and void. Subject to the
preceding sentence, this Agreement will be binding upon, inure to the benefit of, and be enforceable by, the parties and their respective successors and assigns.
14.4
Amendment and Modification
. This Agreement may not be amended, modified or supplemented in any manner, whether by course of
conduct or otherwise, except by an instrument in writing specifically designated as an amendment hereto, signed on behalf of each party.
14.5
Enforcement
. The parties hereto agree that irreparable damage would occur in the event that any of the provisions of this
Agreement were not performed in accordance with their specific terms or were otherwise breached. Accordingly, each of the parties hereto shall be entitled to specific performance of the terms hereof, including an injunction or injunctions to prevent
breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement in the Court of Chancery of the State of Delaware (or, if such court lacks subject matter jurisdiction, in the Superior Court of the State of Delaware
or the United States District Court for the District of Delaware), this being in addition to any other remedy to which such party is entitled at law or in equity. Each of the parties hereby further waives (a) any defense in any action for
specific performance that a remedy at law would be adequate and (b) any requirement under any law to post security as a prerequisite to obtaining equitable relief.
E-22
14.6
Notices
. All notices and other communications hereunder shall be in writing and
shall be deemed duly given (a) on the date of delivery if delivered personally, (b) on the first Business Day following the date of dispatch if delivered utilizing a
next-day
service by a recognized
next-day
courier or (c) on the earlier of confirmed receipt or the fifth Business Day following the date of mailing if delivered by registered or certified mail, return receipt requested, postage prepaid. All
notices hereunder shall be delivered to the addresses set forth below, or pursuant to such other instructions as may be designated in writing by the party to receive such notice:
(i) if to any Stockholder, to the address set forth on such Stockholders signature page attached hereto:
with a concurrent copy to (which shall not be considered notice):
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York,
NY 10019
Telephone: (212)
728-8000
Fax: (212)
728-9867
Attention: Gordon Caplan, Esq.
Sean M. Ewen, Esq.
(ii) if to MedCo, to:
The Medicines Company
8 Sylvan
Way
Parsippany, New Jersey 07054
Attention: Stephen Rodin
Facsimile: (973)
656-9898
E-mail:
stephen.rodin@themedco.com
with a concurrent copy to (which shall not be considered notice):
Cadwalader, Wickersham & Taft LLP
200 Liberty Street
New York,
New York 10281
Attention: Gregory P. Patti, Jr.
Andrew P. Alin
Facsimile: (212)
504-6666
E-mail:
greg.patti@cwt.com
andrew.alin@cwt.com
14.7
Governing Law; Submission to Jurisdiction
. This Agreement and all disputes or controversies arising out of or relating to this
Agreement or the transactions contemplated hereby shall be governed by, and construed in accordance with, the internal laws of the State of Delaware, without regard to the laws of any other jurisdiction that might be applied because of the conflicts
of laws principles of the State of Delaware. Each of the parties irrevocably agrees that any legal action or proceeding arising out of or relating to this Agreement brought by the other party or its successors or assigns shall be brought and
determined in the Court of Chancery of the State of Delaware (or, if such court lacks subject matter jurisdiction, in the Superior Court of the State of Delaware or the United States District Court for the District of Delaware), and each of the
parties hereby irrevocably submits to the exclusive jurisdiction of the aforesaid courts for itself and with respect to its property, generally and unconditionally, with regard to any such action or proceeding arising out of or relating to this
Agreement and the transactions contemplated hereby. Each of the parties agrees not to commence any action, suit or proceeding relating thereto except in the courts described above in Delaware, other than actions in any court of competent
jurisdiction to enforce any judgment, decree or award rendered by any such court in Delaware as described herein. Each of the parties further agrees that notice as provided herein shall constitute sufficient service of process and the parties
further waive any argument that such service is
E-23
insufficient. Each of the parties hereby irrevocably and unconditionally waives, and agrees not to assert, by way of motion or as a defense, counterclaim or otherwise, in any action or proceeding
arising out of or relating to this Agreement or the transactions contemplated hereby, (a) any claim that it is not personally subject to the jurisdiction of the courts in Delaware as described herein for any reason, (b) that it or its
property is exempt or immune from jurisdiction of any such court or from any legal process commenced in such courts (whether through service of notice, attachment prior to judgment, attachment in aid of execution of judgment, execution of judgment
or otherwise) and (c) that (i) the suit, action or proceeding in any such court is brought in an inconvenient forum, (ii) the venue of such suit, action or proceeding is improper or (iii) this Agreement, or the subject matter hereof,
may not be enforced in or by such courts.
14.8
WAIVER OF JURY TRIAL
. EACH OF THE PARTIES TO THIS AGREEMENT HEREBY IRREVOCABLY
WAIVES ALL RIGHT TO A TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
14.9
Entire Agreement; Third-Party Beneficiaries
. This Agreement constitutes the entire agreement, and supersedes all prior written
agreements, arrangements, communications and understandings and all prior and contemporaneous oral agreements, arrangements, communications and understandings among the parties hereto with respect to the subject matter hereof. Nothing in this
Agreement, express or implied, is intended to or shall confer upon any Person other than the parties and their respective successors and permitted assigns any legal or equitable right, benefit or remedy of any nature under or by reason of this
Agreement.
14.10
Counterparts; Facsimile Signature
. This Agreement may be executed in two or more counterparts, all of which
shall be considered one and the same instrument and shall become effective when one or more counterparts have been signed by each of the parties and delivered to the other party. This Agreement may be executed by facsimile signature or other
electronic signature and such signature shall constitute an original for all purposes.
14.11
Effect of Headings
. Headings of the
articles and sections of this Agreement and the table of contents, schedules and exhibits are for convenience of the parties only and shall be given no substantive or interpretative effect whatsoever.
14.12
No Presumption Against Drafting Party
. The parties hereto have participated jointly in the negotiation and drafting of this
Agreement. Each of the parties hereto acknowledges that each party to this Agreement has been represented by counsel in connection with this Agreement and the transactions contemplated by this Agreement. Accordingly, any rule of law or any legal
decision that would require interpretation of any claimed ambiguities in this Agreement against the drafting party has no application and is expressly waived.
14.13
Expenses
. Except as otherwise provided herein or in the Purchase Agreement, all fees and expenses incurred in connection with or
related to this Agreement and the transactions contemplated hereby shall be paid by the party incurring such fees or expenses, whether or not such transactions are consummated. In the event of termination of this Agreement, the obligation of each
party to pay its own expenses will be subject to any rights of such party arising from a breach of this Agreement by the other.
14.14
No Recourse
. Notwithstanding anything to the contrary contained herein or otherwise, but without limiting any provision in the Purchase Agreement, this Agreement may only be enforced against, and any claims or causes of action that may be
based upon, arise out of or relate to this Agreement, or the negotiation, execution or performance of this Agreement or the transactions contemplated hereby, may only be made against the entities and Persons that are expressly identified as parties
to this Agreement in their capacities as such and no former, current or future stockholders, equity holders, controlling persons, directors, officers, employees, general or limited partners, members, managers, agents or affiliates of any party
hereto, or any former, current or future direct or indirect stockholder, equity holder, controlling person, director, officer, employee, general or
E-24
limited partner, member, manager, agent or affiliate of any of the foregoing (each, a
Non-Recourse
Party
) shall have any liability for
any obligations or liabilities of the parties to this Agreement or for any claim (whether in tort, contract or otherwise) based on, in respect of, or by reason of, the transactions contemplated hereby or in respect of any oral representations made
or alleged to be made in connection herewith. Without limiting the rights of any party against the other parties hereto, in no event shall any party or any of its affiliates seek to enforce this Agreement against, make any claims for breach of this
Agreement against, or seek to recover monetary damages from, any
Non-Recourse
Party.
[Remainder of
Page Intentionally Left Blank]
E-25
In witness whereof, the parties hereto have caused this Agreement to be executed as of the
date first set forth above.
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THE MEDICINES COMPANY
|
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By:
|
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/s/ Stephen M. Rodin
|
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Name: Stephen M. Rodin
|
|
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Title: Executive Vice President and General
Counsel
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E-26
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WARBURG PINCUS NETHERLANDS PRIVATE EQUITY VIII C.V. I
|
By: Warburg Pincus Partners, L.P., its general partner
|
By: Warburg Pincus Partners GP LLC, its general partner
|
By: Warburg Pincus & Co., its managing member
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By:
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/s/ Steven Glenn
|
Name: Steven Glenn
|
Title: Partner
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WP-WPVIII
INVESTORS, L.P.
|
By:
WP-WPVIII
Investors GP L.P., its general partner
|
By: WPP GP LLC, its general partner
|
By: Warburg Pincus Partners, L.P., its general partner
|
By: Warburg Pincus Partners GP LLC, its general partner
|
By: Warburg Pincus & Co., its managing member
|
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By:
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/s/ Steven Glenn
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Name: Steven Glenn
|
Title: Partner
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WARBURG PINCUS PRIVATE EQUITY VIII, L.P.
|
By: Warburg Pincus Partners, L.P., its general partner
|
By: Warburg Pincus Partners GP LLC, its general partner
|
By: Warburg Pincus & Co., its managing member
|
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By:
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/s/ Steven Glenn
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Name: Steven Glenn
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Title: Partner
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Notice Address:
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E-27
Annex F
REGISTRATION RIGHTS AGREEMENT
This REGISTRATION RIGHTS AGREEMENT, dated as of [●], 2017 (this
Agreement
), is made between Melinta Therapeutics,
Inc., a Delaware corporation (the
Company
) and The Medicines Company, a Delaware Corporation (the
Shareholder
).
A. On November 28, 2017, the Company and the Shareholder entered into a Purchase and Sale Agreement (as may be further amended from time
to time, the
Purchase Agreement
), pursuant to which the Shareholder and certain of its subsidiaries sold certain assets and the capital stock of certain subsidiaries to the Company (the
Purchase
).
B. In connection with the Purchase and pursuant to the Purchase Agreement the Shareholder acquired Buyer Common Stock (as defined in the
Purchase Agreement) (
Company Common Stock
).
C. In order to induce the Shareholder to adopt and approve the Purchase
Agreement and approve the Purchase and other transactions contemplated in the Purchase Agreement, the Company has agreed to provide the registration rights set forth in this Agreement.
D. Except as otherwise expressly set forth herein, capitalized terms used in this Agreement and set forth in Section 9 are used as
defined in Section 9.
Now, therefore, the parties hereto agree as follows:
1
. Mandatory Shelf Registration.
(a) The Company agrees to (i) file with the SEC on the date hereof, but in no event later than two business days following the date
hereof, a shelf Registration Statement on Form
S-3
or such other form under the Securities Act then available to the Company that covers all Registrable Securities then outstanding for an offering to be made
on a delayed or continuous basis pursuant to Rule 415 under the Securities Act or any successor rule thereto (the
Mandatory Shelf Registration Statement
) and (ii) use its best efforts to cause the Mandatory Shelf Registration
Statement to be declared effective by the SEC as soon as reasonably practical thereafter, but in no event later than 90 calendar days after the initial date of filing thereof; provided, that, notwithstanding the foregoing, if, during the period
beginning on February 14, 2018 and ending on March 16, 2018 (the
Effectiveness Grace Period
), the Mandatory Shelf Registration Statement has otherwise satisfied all requirements for the declaration of its effectiveness
under applicable SEC regulations and the Company has not filed its Form
10-K
for the fiscal year ended December 31, 2017 (the
2017 Form
10-K
),
the Company shall not be in breach of its obligations under this clause (ii) for so long as the Company qualifies as a Loss Corporation within the meaning of Section 382 of the IRC and uses commercially reasonable efforts to
file the 2017 Form
10-K
by February 28, 2018, but in no event later than the end of the Effectiveness Grace Period. The Company shall consult with the Shareholder if it intends to include in the Mandatory
Shelf Registration Statement securities held by other securityholders of the Company and, if requested by the Shareholder, the Mandatory Shelf Registration Statement will not include such other securities.
(b) The Company shall use its commercially reasonable efforts to cause the Mandatory Shelf Registration Statement to remain continuously
effective until the earliest of (A) the sale pursuant to a registration statement of all of the Registrable Securities covered by the Mandatory Shelf Registration Statement, (B) the sale, transfer or other disposition pursuant to Rule 144
of all of the Registrable Securities covered by the Mandatory Shelf Registration Statement, (C) such time as all of the Registrable Securities covered by the Mandatory Shelf Registration Statement have been sold to the Company or any of its
subsidiaries or (D) the fifth anniversary of the effective date of the Mandatory Shelf Registration Statement. The Mandatory Shelf Registration Statement
F-1
shall provide for the resale of Registrable Securities from time to time, and pursuant to any method or combination of methods legally available to, and requested by, the Shareholder, including
an underwritten offering. The Company will pay all Registration Expenses incurred in connection with any registration pursuant to this Section 1.
(c) If the Shareholder intends to distribute Registrable Securities under the Mandatory Shelf Registration Statement by means of an
underwritten resale offering (an
Offering
), the Shareholder will so advise the Company by written notice (the
Offering Notice
). In such event, the Shareholder will have the right to select one managing
underwriter for the Offering, provided that such managing underwriter is reasonably satisfactory to the Company and the Company shall cause there to be Full Cooperation. The Offering Notice shall specify the amount of Registrable Securities to be
included in the Offering and the intended method or methods of disposition. If at the time the Shareholder provides an Offering Notice it is reasonably expected that other securityholders of the Company intend to effect an underwritten resale
offering of Company securities and the underwriter for the Offering or an underwriter for the offerings to be conducted by other securityholders of the Company advise the Company that, in its reasonable opinion, the number of Registrable Securities
to be sold by all securityholders of the Company is greater than the amount that can be offered without adversely affecting the marketability of the Offering (taking into consideration any intended distribution by the Prior Holders or Deerfield
Holders in a concurrent underwritten resale offering), including the price at which such securities can be sold, the Company will include in such Offering the maximum number of securities that in the opinion of such underwriters can be sold without
adversely affecting the marketability of the Offering, including the price at which such securities can be sold, and shall be allocated among the Registrable Securities, Prior Holder Securities and Deerfield Holder Securities, as applicable, pro
rata among the holders thereof on the basis of the number of securities so requested to be included in such Offering owned by each such holder or in such other manner as they agree. The Shareholder shall be entitled to no more than four
(4) Offerings pursuant to an Offering Notice under the Mandatory Shelf Registration Statement.
2
. Piggyback Registrations.
(a)
Right to Piggyback
. At any time after the date hereof, whenever the Company proposes to register shares of Company Common
Stock (
Common Shares
) (other than pursuant to (i) registrations on Form
S-8
or any similar form(s) solely for registration of securities in connection with an employee benefit plan or
dividend reinvestment plan, (ii) registrations on Form
S-4
or any similar form(s) solely for registration of securities in connection with a business combination, (iii) a Mandatory Shelf Registration
Statement, or (iv) a shelf registration statement filed for Vatera Healthcare Partners LLC pursuant to the Prior Registration Rights Agreements or for affiliates of Deerfield Management Company L.P. (the
Deerfield
Holders
) pursuant to the Debt Commitment Letter (as defined in the Purchase Agreement)), whether for its own account or for the account of one or more securityholders of the Company, and the registration form to be filed may be used for
the registration or qualification for distribution of Registrable Securities, the Company will give prompt written notice to the Shareholder of its intention to effect such a registration and will include in such registration all Registrable
Securities with respect to which the Company has received a written request for inclusion therein within 15 days after the date of the Companys notice (a
Piggyback Registration
). Once the Shareholder has made such a written
request, it may withdraw its Registrable Securities from such Piggyback Registration by giving written notice to the Company and the managing underwriter, if any, on or before the fifth (5th) day prior to the anticipated effective date of such
Piggyback Registration. The Company may terminate or withdraw any registration initiated by it and covered by this Section 2 prior to the effectiveness of such registration, whether or not the Shareholder has elected to include Registrable
Securities in such registration, and except for the obligation to pay Registration Expenses pursuant to Section 2(c) the Company will have no liability to the Shareholder in connection with such termination or withdrawal.
(b)
Underwritten Registration
. If the registration referred to in Section 2(a) is proposed to be underwritten, the Company will so
advise the Shareholder in the written notice given pursuant to Section 2(a). In such event, the right of the Shareholder to registration pursuant to this Section 2 will be conditioned upon the Shareholders
F-2
participation in such underwriting and the inclusion of the Shareholders Registrable Securities in the underwriting, and the Shareholder will (together with the Company and the other
holders distributing their securities through such underwriting) enter into an underwriting agreement in customary form with the underwriter or underwriters selected for such underwriting by the Company. If the Shareholder disapproves of the terms
of the underwriting, it may elect to withdraw therefrom by written notice to the Company and the managing underwriter.
(c)
Piggyback
Registration Expenses
. Except to the extent prohibited by applicable law, the Company will pay all Registration Expenses in connection with any Piggyback Registration, whether or not any registration or prospectus becomes effective or final.
(d)
Priority on Primary Registrations
. If a Piggyback Registration relates to an underwritten primary offering on behalf of the
Company, and the managing underwriters advise the Company that in their opinion the number of securities requested to be included in such registration exceeds the number which can be sold without adversely affecting the marketability of the
offering, including the price at which such securities can be sold, the Company will include in such registration the maximum number of securities that in the opinion of such underwriters can be sold without adversely affecting the marketability of
the offering, including the price at which such securities can be sold, which securities will be so included in the following order of priority: (i) first, the securities the Company proposes to sell, (ii) second, the Registrable
Securities and Prior Holder Securities requested to be included in such registration, pro rata among the Shareholder and the Prior Holders of such securities on the basis of the number of Registrable Securities and Prior Holder Securities so
requested to be included therein owned by each such holder or in such other manner as they may agree, and (iii) third, other securities requested to be included in such registration.
(e)
Priority on Secondary Registrations
. If a Piggyback Registration relates solely to an underwritten secondary registration on behalf
of other holders of the Companys securities, and the managing underwriters advise the Company that in their opinion the number of securities requested to be included in such registration exceeds the number which can be sold without adversely
affecting the marketability of the offering, including the price at which such securities can be sold, the Company will include in such registration the maximum number of securities that in the opinion of such underwriters can be sold without
adversely affecting the marketability of the offering, including the price at which such securities can be sold, which securities will be so included in the following order of priority: (i) first, the securities requested to be included therein
by the holders requesting such registration, (ii) second, (A) to the extent none of the securities in subsection (i) above are Registrable Securities, Deerfield Holder Securities or Prior Holder Securities then Registrable Securities,
Deerfield Holder Securities and Prior Holder Securities pro rata among the holders thereof on the basis of the number of securities so requested to be included therein owned by each such holder or in such other manner as they agree, (B) to the
extent the securities requested in subsection (i) are Registrable Securities then Prior Holder Securities and Deerfield Holder Securities pro rata among the holders thereof on the basis of the number of securities so requested to be included
therein owned by each such holder or in such other manner as they may agree or (C) to the extent the securities requested in subsection (i) are Prior Holder Securities then Registrable Securities and Deerfield Holder Securities pro rata
among the holders thereof on the basis of the number of securities so requested to be included therein owned by each such holder or in such other manner as they may agree so requested to be included therein and (iii) third, other securities
requested to be included in such registration.
3
.
Registration Procedures
. Whenever the Shareholder has requested that any
Registrable Securities be registered pursuant to this Agreement (or in connection with the Mandatory Shelf Registration Statement), the Company will use its commercially reasonable efforts to effect the registration and sale of such Registrable
Securities in accordance with the intended method of disposition thereof. Without limiting the generality of the foregoing, the Company will, as expeditiously as commercially reasonable:
(a) prepare and (except with respect to the Mandatory Shelf Registration Statement) file with the SEC a Registration Statement with respect to
such Registrable Securities, make all required filings with FINRA and
F-3
thereafter use its commercially reasonable efforts to cause such Registration Statement to become effective; provided, that before filing a Registration Statement or any amendments or supplements
thereto, the Company will furnish to one firm of counsel selected by the Shareholder copies of all such documents proposed to be filed. The Company will not file any Registration Statement or amendments or post-effective amendments or supplement to
such Registration Statement to which such counsel will have reasonably objected in writing on the grounds that such amendment or supplement does not comply in all material respects with the requirements of the 1933 Act or of the rules and
regulations thereunder.
(b) prepare and file with the SEC such amendments and supplements to such Registration Statement as may be
necessary to keep such Registration Statement effective for a period of either (i) not less than six months or, if such Registration Statement relates to an underwritten offering, such longer period as in the opinion of counsel for the
underwriters a prospectus is required by law to be delivered in connection with sales of Registrable Securities by an underwriter or dealer or (ii) such shorter period as will terminate when all of the securities covered by such Registration
Statement have been disposed of in accordance with the intended methods of disposition by the Shareholder set forth in such Registration Statement (but in any event not before the expiration of any longer period required under the 1933 Act), and to
comply with the provisions of the 1933 Act with respect to the disposition of all securities covered by such Registration Statement until such time as all of such securities have been disposed of in accordance with the intended methods of
disposition by the Shareholder set forth in such Registration Statement;
(c) furnish to the Shareholder such number of copies, without
charge, of such Registration Statement, each amendment and supplement thereto, including each preliminary prospectus, final prospectus, all exhibits and other documents filed therewith and such other documents as the Shareholder may reasonably
request in order to facilitate the disposition of the Registrable Securities owned by the Shareholder;
(d) use its commercially
reasonable efforts to register or qualify such Registrable Securities under such other securities or blue sky laws of such jurisdictions as the Shareholder reasonably requests and do any and all other acts and things that may be necessary or
reasonably advisable to enable the Shareholder to consummate the disposition in such jurisdictions of the Registrable Securities owned by the Shareholder (provided, that the Company will not be required to (i) qualify generally to do business
in any jurisdiction where it would not otherwise be required to qualify but for this subsection, (ii) subject itself to taxation in any such jurisdiction or (iii) consent to general service of process in any such jurisdiction);
(e) use its commercially reasonable efforts to cause all Registrable Securities covered by such Registration Statement to be registered with
or approved by such other governmental agencies, authorities or self-regulatory bodies as may be necessary or reasonably advisable in light of the business and operations of the Company to enable the Shareholder to consummate the disposition of such
Registrable Securities in accordance with the intended method or methods of disposition thereof;
(f) immediately notify the Shareholder
and any underwriter(s), at any time when a prospectus relating thereto is required to be delivered under the 1933 Act, of the occurrence of any event which will have the result that, the prospectus contains an untrue statement of a material fact or
omits to state any fact necessary to make the statements therein not misleading in the light of the circumstances under which they were made;
(g) notify the Shareholder (i) when the prospectus or any prospectus supplement or post-effective amendment has been filed and, with
respect to such Registration Statement or any post-effective amendment, when the same has become effective, (ii) of any request by the SEC for amendments or supplements to such registration statement or to amend or to supplement such prospectus
or for additional information and (iii) of the issuance by the SEC of any stop order suspending the effectiveness of such registration statement or the initiation of any proceedings for any of such purposes;
(h) use its commercially reasonable efforts to cause all such Registrable Securities to be listed on each securities exchange on which Common
Shares are then listed;
F-4
(i) provide a transfer agent and registrar for all such Registrable Securities not later
than the effective date of such Registration Statement;
(j) enter into such customary agreements (including underwriting agreements with
customary provisions) and take all such other actions as the Shareholder or the underwriters, if any, reasonably requests in order to expedite or facilitate the disposition of such Registrable Securities;
(k) otherwise use its commercially reasonable efforts to comply with all applicable rules and regulations of the SEC, and make available to
its security holders, as soon as reasonably practicable, an earnings statement covering the period of at least twelve months beginning with the first day of the Companys first full calendar quarter after the effective date of the Registration
Statement, which earnings statement will satisfy the provisions of Section 12(a) of the 1933 Act and Rule 158 thereunder;
(l) make
available for inspection by the Shareholder, any underwriter participating in any disposition pursuant to such Registration Statement and any attorney, accountant or other agent retained by the Shareholder or underwriter, all financial and other
records, pertinent corporate documents and documents relating to the business of the Company, and cause the Companys officers, directors, employees and independent accountants to supply all information reasonably requested by the Shareholder
or any such underwriter, attorney, accountant or agent in connection with such Registration Statement; provided, that the Shareholder will, and will use its commercially reasonable efforts to cause each such underwriter, accountant or other agent to
enter into a customary confidentiality agreement in form and substance reasonably satisfactory to the Company; provided further, that such confidentiality agreement will not contain terms that would prohibit any such Person from complying with its
obligations under applicable law or Nasdaq rules;
(m) in the event of the issuance of any stop order suspending the effectiveness of a
Registration Statement, or of any order suspending or preventing the use of any related prospectus or ceasing trading of any securities included in such Registration Statement for sale in any jurisdiction, use its commercially reasonable efforts
promptly to obtain the withdrawal of such order;
(n) enter into such agreements and take such other actions as the Shareholder or the
underwriters reasonably request in order to expedite or facilitate the disposition of such Registrable Securities, including, without limitation, preparing for and participating in such number of road shows and all such other customary
selling efforts as the underwriters reasonably request in order to expedite or facilitate such disposition;
(o) prepare and deliver for
inclusion in the prospectus pro forma financial statements with respect to the Purchase in compliance with Regulation
S-X
of the 1933 Act and, if such registration relates to an underwritten offering, obtain a
comfort letter, addressed to the Shareholder (and, if such registration includes an underwritten public offering to the underwriters of such offering), signed by the Companys independent public accountants in customary form and covering such
matters of the type customarily covered by comfort letters;
(p) if such registration relates to an underwritten offering, provide a legal
opinion of the Companys outside counsel, addressed to the underwriters of any underwritten public offering, with respect to the Registration Statement and prospectus in customary form and covering such matters of the type customarily covered
by legal opinions of such nature;
(q) if such registration relates to an underwritten offering, furnish to the Shareholder such
information and assistance as the Shareholder may reasonably request in connection with any due diligence effort which the Shareholder deems appropriate; and
(r) use its commercially reasonable efforts to take or cause to be taken all other actions, and do and cause to be done all other things,
necessary or reasonably advisable to effect the registration of such Registrable Securities contemplated hereby.
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The Company agrees not to file or make any amendment to any Registration Statement with
respect to any Registrable Securities, or any amendment of or supplement to the prospectus used in connection therewith, that refers to the Shareholder by name, or otherwise identifies the Shareholder as the holder of any securities of the Company,
without the consent of the Shareholder, such consent not to be unreasonably withheld or delayed; unless such disclosure is required by law.
The Company may require the Shareholder to furnish the Company with such information regarding the Shareholder and pertinent to the disclosure
requirements relating to the registration and the distribution of such securities as the Company may from time to time reasonably request in writing.
4
. Registration Expenses.
(a) Except as otherwise provided for herein, all expenses incidental to the Companys performance of or compliance with this Agreement,
including, without limitation, all registration and filing fees (including SEC registration and FINRA filing fees), fees and expenses of compliance with securities or blue sky laws, word processing, duplicating and printing expenses, messenger and
delivery expenses, transfer agent
s and registrars fees, cost of distributing prospectuses in preliminary and final form, as well as any supplements thereto, and fees and disbursements of counsel for the Company and all independent
certified public accountants, underwriters and other Persons retained by the Company (all such expenses,
Registration Expenses
), will be borne by the Company. In addition, the Company will, in any event, pay its internal expenses
(including, without limitation, all salaries and expenses of its officers and employees performing legal or accounting duties), the expenses of any annual audit or quarterly review, the expenses of any liability insurance and the expenses and fees
for listing the securities to be registered on each securities exchange or automatic quotation system on which similar securities issued by the Company are then listed (including Nasdaq). Notwithstanding the foregoing and subject to
Section 4(b), all Selling Expenses in connection with the sale of Registrable Securities will be borne by the Shareholders.
(b) In
connection with the Mandatory Shelf Registration Statement and each Piggyback Registration, the Company will reimburse the Shareholder for reasonable fees and disbursements, in an amount not to exceed $25,000, of one law firm, chosen by the
Shareholder.
5
. Indemnification.
(a) The Company agrees to indemnify and hold harmless, and hereby does indemnify and hold harmless, the Shareholder, its affiliates and their
respective officers, directors and partners and each Person who controls the Shareholder (within the meaning of the 1933 Act) against, and pay and reimburse such holder, affiliate, director, officer or partner or controlling person for any losses,
claims, damages, expenses, liabilities, joint or several, to which such holder or any such affiliate, director, officer or partner or controlling person may become subject under the 1933 Act or otherwise, insofar as such losses, claims, damages or
liabilities (or actions or proceedings, whether commenced or threatened, in respect thereof) arise out of or are based upon (i) any untrue or alleged untrue statement of material fact contained in any Registration Statement, prospectus or
preliminary prospectus or any amendment thereof or supplement thereto, or any issuer free writing prospectus (as defined in 1933 Act Rule 433), (ii) any omission or alleged omission of a material fact required to be stated therein or
necessary to make the statements therein not misleading, (iii) any violation or alleged violation by the Company of any rule or regulation promulgated under the 1933 Act, the 1934 Act, FINRA or any state securities laws applicable to the
Company and relating to action or inaction required of the Company in connection with any such registration, and the Company will pay and reimburse the Shareholder and each such affiliate, director, officer, partner and controlling person for the
legal fees and expenses of one counsel, and any other nonlegal expenses, actually and reasonably incurred by them in connection with investigating, defending or settling any such loss, claim, liability, action or proceeding or (iv) the failure
to include, at the time of pricing any offering, the information required by Sections 12(a)(2) and 17(a)(2) of the 1933 Act; provided, that the Company will not be liable in any such case to the extent that any such loss, claim, damage, expense,
liability (or action or proceeding in respect thereof) or
F-6
expense arises out of or is based upon an untrue statement or alleged untrue statement, or omission or alleged omission, made in such Registration Statement, any such prospectus or preliminary
prospectus or any amendment or supplement thereto, or in any application, in reliance upon, and in conformity with, written information prepared and furnished to the Company by the Shareholder expressly for use therein or by the Shareholders
failure to deliver, to the extent required by law and except to the extent such failure results from a failure by the Company to comply with Section 3(f), a copy of the Registration Statement or prospectus or any amendments or supplements
thereto after the Company has furnished the Shareholder with a sufficient number of copies of the same. In connection with an underwritten offering, the Company, if requested, will indemnify such underwriters, their officers and directors and each
Person who controls such underwriters (within the meaning of the 1933 Act) to at least the same extent as provided above with respect to the indemnification of the Shareholder.
(b) In connection with any Registration Statement in which the Shareholder is participating, the Shareholder will furnish to the Company in
writing such information as required by law for use in connection with any such Registration Statement or prospectus and will indemnify and hold harmless the Company, its directors and officers, each other Person who controls the Company (within the
meaning of the 1933 Act) and each underwriter (to the extent required by such underwriter) against any losses, claims, damages, expenses, liabilities (or actions or proceedings, whether commenced or threatened, in respect thereof), joint or several,
to which the Company or any such director or officer, any such underwriter or controlling person may become subject under the 1933 Act or otherwise, insofar as such losses, claims, damages, liabilities, actions or proceedings arise out of or are
based upon (i) any untrue or alleged untrue statement of material fact contained in the Registration Statement, prospectus or preliminary prospectus or any amendment thereof or supplement thereto or in any application or (ii) any omission
or alleged omission of a material fact required to be stated therein or necessary to make the statements therein not misleading, and the Shareholder will reimburse the Company and each such director, officer, underwriter and controlling Person for
any legal or any other expenses actually and reasonably incurred by them in connection with investigating, defending or settling any such loss, claim, liability, action or proceeding, but in each case only to the extent, that such untrue statement
(or alleged untrue statement) or omission (or alleged omission) is made in reliance upon and in conformity with written information furnished to the Company by the Shareholder and stated to be specifically for use therein; provided, that the
obligation to indemnify and hold harmless will be individual and several to the Shareholder and will be limited to the amount of net proceeds (after giving effect to underwriters discounts and commissions) received by the Shareholder from the
sale of Registrable Securities pursuant to such Registration Statement.
(c) Any Person entitled to indemnification hereunder will
(i) give prompt written notice to the indemnifying party of any claim with respect to which it seeks indemnification and (ii) unless in such indemnified partys reasonable judgment a conflict of interest between such indemnified and
indemnifying parties exists with respect to such claim, permit such indemnifying party to assume the defense of such claim with counsel reasonably satisfactory to the indemnified party. If such defense is assumed, the indemnifying party will not be
subject to any liability for any settlement made by the indemnified party without its prior written consent (but such consent will not be unreasonably withheld or delayed). An indemnifying party who is not entitled to, or elects not to, assume the
defense of a claim will not be obligated to pay the fees and expenses of more than one counsel for all parties indemnified by such indemnifying party with respect to such claim, unless in the reasonable judgment of any indemnified party a conflict
of interest exists between such indemnified party and any other of such indemnified parties with respect to such claim. Failure to give prompt written notice shall not release the indemnifying party from its obligations hereunder except to the
extent that such indemnifying party is materially prejudiced as a result of such failure to give notice.
(d) The indemnification provided
for under this Agreement will remain in full force and effect regardless of any investigation made by or on behalf of the indemnified party or any officer, director or controlling Person of such indemnified party and will survive the registration
and sale of any securities by any Person entitled to any indemnification hereunder and the expiration or termination of this Agreement.
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(e) If the indemnification provided for in this Section 5 is held by a court of
competent jurisdiction to be unavailable to an indemnified party with respect to any loss, liability, claim, damage or expense referred to herein, then the indemnifying party, in lieu of indemnifying such indemnified party hereunder, will contribute
to the amount paid or payable by such indemnified party as a result of such loss, liability, claim, damage or expense in such proportion as is appropriate to reflect the relative fault of the indemnifying party on the one hand and of the indemnified
party on the other hand in connection with the statements or omissions which resulted in such loss, liability, claim, damage or expense as well as any other relevant equitable considerations. The relevant fault of the indemnifying party and the
indemnified party will be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or the omission to state a material fact relates to information supplied by the indemnifying party or by the
indemnified party and the parties relative intent, knowledge, access to information and opportunity to correct or prevent such statement or omission. Notwithstanding the foregoing, the amount the Shareholder will be obligated to contribute
pursuant to this Section 5(e) will be limited to an amount equal to the net proceeds to the Shareholder of the Registrable Securities sold pursuant to the registration statement which gives rise to such obligation to contribute (less the
aggregate amount of any damages which the Shareholder has otherwise been required to pay in respect of such loss, claim, damage, expense, liability or action or any substantially similar loss, claim, damage, expense, liability or action arising from
the sale of such Registrable Securities).
6
. Participation in Underwritten Registrations.
(a) The Shareholder may not participate in any registration hereunder that is underwritten unless it (i) agrees to sell its Registrable
Securities on the basis provided in any underwriting arrangements approved by the Person or Persons entitled hereunder to approve such arrangements (including, without limitation, pursuant to the terms of any over-allotment or green shoe
option requested by the managing underwriter(s); provided, that the Shareholder will not be required to sell more than the number of Registrable Securities that it has requested the Company to include in any registration), (ii) completes and
executes all questionnaires, powers of attorney, underwriting agreements and other documents reasonably required under the terms of such underwriting arrangements, and (iii) cooperates with the Companys reasonable requests in connection
with such registration or qualification (it being understood that the Companys failure to perform its obligations hereunder, which failure is caused by the Shareholders failure to cooperate, will not constitute a breach by the Company of
this Agreement, provided that the Company delivers a certificate by the Chief Executive Officer or Chief Financial Officer of the Company to the Shareholder that, in its opinion, the Shareholders failure to cooperate has frustrated the
Companys ability to comply with this Agreement). Notwithstanding the foregoing, the Shareholder will not be required to agree to any indemnification obligations on the part of the Shareholder that are materially greater than its obligations
pursuant to Section 6(b).
(b) The Shareholder agrees that, if it is participating in any registration hereunder, upon receipt of any
notice from the Company of the happening of any event of the kind described in subsection 3(f) above, the Shareholder will forthwith discontinue the disposition of its Registrable Securities pursuant to the Registration Statement until it receives
copies of a supplemented or amended prospectus as contemplated by such Section 3(f). In the event the Company gives any such notice, the applicable time period during which a Registration Statement is to remain effective will be extended by the
number of days during the period from and including the date of the giving of such notice pursuant to this Section 6(b) to and including the date when the Shareholder will have received the copies of the supplemented or amended prospectus
contemplated by Section 3(f).
7
. Rule 144; Legend Removal.
(a)
Facilitation of Sales Pursuant to Rule 144
. The Company covenants to the Shareholder, the Company shall use its commercially
reasonable efforts to (i) timely file the reports required to be filed by it under the 1934 Act or the 1933 Act (including the reports under Sections 13 and 15(d) of the 1934 Act referred to in subparagraph (c)(1) of Rule 144), and
(ii) make and keep public information available as those terms are understood and defined in Rule 144 under the 1933 Act, all to the extent required from time to time to enable the
F-8
Shareholder to sell Registrable Securities without registration under the Securities Act within the limitations of the exemption provided by Rule 144. Upon the request of the Shareholder in
connection with its sale pursuant to Rule 144, the Company shall deliver to the Shareholder a written statement as to whether it has complied with such requirements.
(b)
Availability of Rule 144 Not Excuse for Obligations
. The fact that the Shareholder may become eligible to sell its Registrable
Securities pursuant to Rule 144 shall not (i) cause such Securities to cease to be Registrable Securities or (ii) excuse the Companys obligations set forth in this Agreement.
(c) Upon request of the Shareholder, upon receipt by the Company of an opinion of counsel reasonably satisfactory to the Company to the effect
that such legend is no longer required under the 1933 Act and applicable state laws, the Company shall promptly cause any legend affixed to any Registrable Securities to be removed from any certificate for any Registrable Securities, including by
providing any opinion of counsel to the Company that may be reasonably required by the transfer agent to effect such removal.
8
.
Term. This Agreement will be effective as of the date hereof and will continue in effect thereafter until the earliest of (a) its termination by the consent of the Shareholder or its successor(s) in interest, (b) the fifth anniversary of
the effective date of the Mandatory Shelf Registration Statement and (c) the dissolution, liquidation or winding up of the Company.
9
.
Lock-Up
Restrictions. During the
Lock-Up
Period, the
Shareholder agrees not to Transfer any of the
Lock-Up
Shares except (i) as a
bona fide
gift; (ii) to any wholly-owned subsidiary thereof; (iii) pursuant to any take-over bid, acquisition,
sale or merger involving the Company or the Shareholder; (iv) transactions relating to shares of Common Stock or other securities acquired in open market transactions after the completion of the Purchase; (v) sale of
Lock-Up
Shares to satisfy any tax liability associated with the Registrable Securities; (vi) any forward sale, hedging or similar transaction, including but not limited to any transaction by which any economic
risks and/or rewards or ownership of, or voting rights with respect to, any such
Lock-Up
Shares are affected; or (vii) with the prior written consent of the Company provided that in each case to the
extent practicable such transferees agree to be bound by the restrictions set forth in Section 9. Any Transfer or attempted Transfer in violation of this
Section
9
shall, to the fullest extent permitted by applicable
law, be null and void
ab initio
.
10
. Additional Covenants of the Company; Certain Restrictions.
(a) The Company covenants to do all that is necessary to comply with its obligations hereunder including, but not limited to, obtaining the
requisite consents of the Prior Holders in accordance with the Prior Registration Rights Agreements.
(b)
Suspension
.
i. Notwithstanding any provision of this Agreement to the contrary, if the Board of Directors of the Company determines in good faith that it
is in the best interests of the Company to suspend the use of any or all registration statements covering shares of common stock held by any securityholder of the Company, the Company, by written notice to the Shareholder, may direct the Shareholder
to suspend sales of the Registrable Shares pursuant to the Mandatory Shelf Registration Statement for such time as the Company reasonably may determine is necessary and advisable, but in no event for more than thirty (30) consecutive days (the
Suspension Period
), but only if either of the following events will occur: (A) there is material
non-public
information regarding the Company that (1) the Board of Directors of the
Company determines not to be in the Companys best interest to disclose, (2) would, in the good faith determination of the Board of Directors of the Company, require any revision to the Mandatory Shelf Registration Statement so that it
will not contain any untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading and
(3) the
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Company is not otherwise required to disclose such material nonpublic information pursuant to SEC reporting obligations at the time a Suspension Notice (as defined below) is delivered to the
Shareholder; or (B) the distribution of Registrable Securities would materially impede, delay or interfere with, or require premature disclosure of, (1) a proposed acquisition or disposition of assets by the Company (other than in the
ordinary course of business) or any proposed material merger, consolidation, tender offer or other similar transaction or (2) a proposed material debt or equity financing of the Company and, upon consummation of any such transaction set forth
in subclause (B)(1) would require the Company to disclose pro forma financial information pursuant to Article 11 of Regulation
S-X;
provided, however, that (x) the Company may only cause two
(2) Suspension Periods to occur in any
12-month
period; provided, however, that if the Effectiveness Grace Period is used by the Company then the Company may only cause one (1) Suspension Period to
occur in the first
12-month
period beginning on the effective date of the Mandatory Shelf Registration Statement, (y) at least 90 calendar days shall have elapsed between any two Suspension Periods and
(z) no Suspension Period shall begin for at least 30 calendar days after the effective date of the Mandatory Shelf Registration Statement or, to the extent applicable, at least 30 calendar days after the end of the Effectiveness Grace Period.
ii. The Company will use its best efforts to promptly amend or supplement the Mandatory Shelf Registration Statement on a post-effective
basis, if necessary, or to take such action as is necessary to make resumed use of the Mandatory Shelf Registration Statement so as to permit the Shareholder to resume sales of the Registrable Shares promptly upon the earlier to occur of
(i) the Company delivering to the Shareholder an End of Suspension Notice (as defined below), and (ii) the end of the Suspension Period.
iii. In the case of an event described in Section 10(b)(i) that causes the Company to suspend the use of the Mandatory Shelf Registration
Statement (a
Suspension Event
), the Company will give written notice (a
Suspension Notice
) to the Shareholder to suspend sales of the Registrable Shares, and such notice will state generally the basis for such
suspension and that such suspension will continue only for so long as the Suspension Event or its effect is continuing and the Company is making its best efforts to terminate suspension of the effectiveness of the Mandatory Shelf Registration
Statement as promptly as possible. The Shareholder will not effect any sales of the Registrable Shares pursuant to the Mandatory Shelf Registration Statement (or such filings) at any time after it has received a Suspension Notice from the Company
and prior to receipt of an End of Suspension Notice (as defined below) and the Company will not permit any securityholder of the Company to effect any such sales pursuant to any shelf registration statement filed by the Company. The Shareholder may
recommence effecting sales of the Registrable Shares pursuant to the Mandatory Shelf Registration Statement on the earlier of (i) the date that notice to such effect (an
End of Suspension Notice
) is delivered by the Company
to the Shareholder, which End of Suspension Notice will be given by the Company to the Shareholder in the manner described above reasonably promptly following the conclusion of any Suspension Event and its effect and (ii) the end of the
Suspension Period.
(c)
Offering
Lock-Up
. In connection with any underwritten public
offering of equity securities by the Company pursuant to which the Shareholder has the ability to include at least 50% of its Registrable Securities in such offering pursuant to Section 2(a) after giving effect to any
cut-back
in Section 2(e) (a
Specified Offering
), the Shareholder agrees to execute a
lock-up
agreement in favor of the Companys
underwriters covering the Registrable Securities not included in the Specified Offering on the terms and conditions required by the underwriters in a
lock-up
agreement (subject to customary exceptions and
exclusions) for such Specified Offering, including with respect to the duration of the
lock-up.
The provisions of this Section 10(c) will no longer apply to the Shareholder once the Shareholder ceases to
hold Registrable Securities or 5% or less of the outstanding equity securities of the Company.
11
. Defined Terms. Capitalized
terms when used in this Agreement have the following meanings:
1933 Act
means the Securities Act of 1933, as amended.
1934 Act
means the Securities Exchange Act of 1934, as amended.
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Affiliate
means, with respect to any Person, any other Person directly or
indirectly controlling, controlled by, or under common control with such Person, provided that, for purposes of this Agreement, the Company shall not be deemed an Affiliate of the Shareholder, and the Shareholder shall not be deemed an Affiliate of
the Company. For purposes of this definition, when used with respect to any Person, control means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting securities,
by contract or otherwise, and the terms controlling and controlled have correlative meanings.
Business
Day
means any day, except a Saturday, Sunday or legal holiday on which banking institutions in The City of New York are authorized or obligated to close.
Deerfield Holder Securities
means those securities with registration rights issued to Deerfield Holders in connection with
the financing arrangement with the Company with the proceeds from such financing arrangement being used to finance the Purchase.
FINRA
means the Financial Industry Regulatory Authority.
Full Cooperation
means, in connection with any underwritten offering, where, in addition to the cooperation otherwise
required by this Agreement, (a) members of senior management of the Company (including the chief executive officer and chief financial officer) reasonably cooperate with the underwriter(s) in connection therewith and make themselves reasonably
available to participate in road-shows and other customary marketing activities in such locations (domestic and foreign) as reasonably recommended by the underwriter(s) (including
one-on-one
meetings with prospective purchasers of the Registrable Securities) and (b) the Company prepares preliminary and final prospectuses for use in connection therewith containing such additional
information as reasonably requested by the underwriter(s) (in additional to the minimum amount of information required by law, rule or regulation).
IRC
means the International Revenue Code of 1986, as amended.
Lock-Up
Period
shall mean the period from the Closing Date to the date that is 180
days after the Closing Date.
Lock-Up
Shares
means [●]
1
shares of Buyer Common Stock delivered to the Shareholder by the Company on the Closing Date.
Person
means an individual, a partnership, a joint venture, a corporation, a limited liability company, a trust, an
unincorporated organization or a government or department or agency thereof.
Prior Holder
means a Holder
as defined in the Prior Registration Rights Agreements.
Prior Holder Securities
means those securities that constitute
Registrable Securities under the Prior Registration Rights Agreements.
Prior Registration Rights
Agreements
means (i) the Registration Rights Agreement, dated February 12, 2012, by and among Cempra, Inc. and the persons set forth on Exhibit A attached thereto and (ii) the Registration Rights Agreement, dated as of
November 3, 2017, by and among Cempra, Inc., Vatera Healthcare Partners LLC and the other shareholders set forth on the signature pages thereto.
Register
, registered and registration refers to a registration effected by preparing and filing a
Registration Statement in compliance with the 1933 Act, and the declaration or ordering of the effectiveness of such Registration Statement, and compliance with applicable state securities laws of such states in which the Shareholder notifies the
Company of its intention to offer Registrable Securities.
1
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Number of shares equal to 50% of the equity consideration.
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F-11
Registrable Securities
means (i) any Common Shares issued or
delivered to the Shareholder pursuant to the Purchase Agreement or otherwise acquired by the Shareholder and (ii) any Common Shares issued or issuable with respect to the shares referred to in the foregoing clause (i) by way of a share
dividend or share split or in exchange for or upon conversion of such shares or otherwise in connection with a combination of shares, recapitalization, reclassification, merger, amalgamation, arrangement, consolidation or other reorganization. As to
any particular securities constituting Registrable Securities, such securities will cease to be Registrable Securities when (x) they have been effectively registered or qualified for sale by prospectus filed under the 1933 Act and disposed of
in accordance with the Registration Statement covering them, (y) subject to Section 7(b), such Registrable Security has been sold by the Shareholder pursuant to Rule 144 under circumstances in which any legend borne by such Registrable
Security relating to restrictions on transferability thereof, under the 1933 Act or otherwise, is removed by the Company; or (z) such Registrable Security shall cease to be outstanding. For purposes of this Agreement, a Person will be deemed to
be a holder of Registrable Securities whenever such Person has the right to acquire directly or indirectly such Registrable Securities (upon conversion, exercise or exchange in connection with a transfer of securities or otherwise, but disregarding
any restrictions or limitations upon the exercise of such right), whether or not such acquisition has actually been effected.
Registration Statement
means the prospectus and other documents filed with the SEC to effect a registration under the 1933
Act.
Rule 144
means Rule 144 under the 1933 Act or any successor or similar rule as may be enacted by the SEC from
time to time, as in effect from time to time.
SEC
means the Securities and Exchange Commission.
Selling Expenses
means all underwriting discounts, fees, selling commissions and transfer taxes applicable to the sale of
Registrable Securities hereunder and, to the extent agreed upon by the Shareholder and underwriters pursuant to an underwriting agreement, related
out-of-pocket
expenses
of underwriters and such underwriters counsel applicable to the sale of the Registrable Securities.
Transfer
means any direct or indirect sale, assignment, encumbrance, pledge, hypothecation, disposition, loan or other transfer, or entry into any contract with respect to any sale, assignment, encumbrance, pledge, hypothecation, disposition, loan or other
transfer, excluding entry into this Agreement and the Purchase Agreement and the consummation of the transactions contemplated hereby and thereby.
12
. Miscellaneous.
(a)
No Inconsistent Agreements
. The Company will not, without the consent of the Shareholder, hereafter enter into any agreement and has not entered into any agreement, in each case with respect to its securities, that is more favorable or is
inconsistent or conflicts with or violates the registration rights granted to the Shareholder pursuant to Sections 1 and 2 of this Agreement and notwithstanding anything to the contrary herein (but subject to the proviso of this clause (a)), for the
avoidance of doubt, solely for purposes of determining whether such agreement is more favorable or is inconsistent or conflicts with or violates such registration rights, Sections 9 and 10 shall be disregarded; provided, that, the Company may enter
into such agreement without the consent of the Shareholder if the Company delivers a written notice thereof to the Shareholder offering the Shareholder the option to elect to have the benefit of the demand registration rights and piggyback
registration rights granted under such agreement with respect to the Registrable Securities,
mutatis mutandis
.
(b)
Remedies
. The parties hereto agree and acknowledge that money damages may not be an adequate remedy for any breach of the provisions of this Agreement and that any party hereto will have the right to equitable relief, including specific
performance and injunctive relief, in addition to all of its other rights and remedies at law or in equity, to enforce the provisions of this Agreement.
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(c)
Amendments and Waivers
. Except as otherwise provided herein, the provisions of
this Agreement may be amended or waived only by the written consent of the Company and the Shareholder.
(d)
Successors and
Assigns
. This Agreement shall be binding upon and shall inure to the benefit of the parties hereto and their respective successors and permitted assigns; provided, that the Shareholder may assign or otherwise transfer its rights or obligations
under this Agreement, in whole or in part, to any other Person who acquires at least 25% of the Registrable Securities held by the Shareholder as of the date hereof from the Shareholder without the prior written consent of the Company; provided,
further, that no such assignment or transfer shall relieve such assigning or transferring shareholder of its obligations hereunder, unless such transferee delivers a written instrument to the Company in which it agrees to be bound by all of the
terms and conditions applicable to the Shareholder of the Registrable Securities.
(e)
Severability
. Whenever possible, each
provision of this Agreement will be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement is held to be invalid, illegal or unenforceable in any respect under any applicable law or rule
in any jurisdiction, such invalidity, illegality or unenforceability will not affect any other provision or the effectiveness or validity of any provision in any other jurisdiction, and this Agreement will be reformed, construed and enforced in such
jurisdiction as if such invalid, illegal or unenforceable provision had never been contained herein.
(f)
Counterparts
. This
Agreement may be executed simultaneously in two or more counterparts, any one of which need not contain the signatures of more than one party, but all such counterparts taken together will constitute one and the same Agreement.
(g)
Descriptive Headings
. The descriptive headings of this Agreement are inserted for convenience only and do not constitute a part of
this Agreement.
(h)
Governing Law
. This Agreement and the rights and duties of the parties hereto hereunder shall be governed by
and construed in accordance with laws of the State of Delaware, without giving effect to its principles or rules of conflict of laws to the extent such principles or rules are not mandatorily applicable by statute and would require or permit the
application of the laws of another jurisdiction. Any suit, action or proceeding seeking to enforce any provision of, or based on any matter arising out of or in connection with, this Agreement or the transactions contemplated hereby may be brought
in the Court of Chancery of the State of Delaware, or, to the extent such court does not have subject matter jurisdiction, the Superior Court of the State of Delaware or the United States District Court for the District of Delaware, and each of the
parties hereby consents to the jurisdiction of such courts (and of the appropriate appellate courts therefrom) in any such suit, action or proceeding and irrevocably waives, to the fullest extent permitted by law, any objection which it may now or
hereinafter have to the laying of the venue of any such suit, action or proceeding which is brought in any such court has been brought in an inconvenient forum. Process in any such suit, action or proceeding may be served on any party anywhere in
the world, whether within or without the jurisdiction of any such court. Without limiting the foregoing, each party agrees that service of process on such party as provided in Section 12(j) shall be deemed effective service of process on such
party.
EACH OF THE PARTIES HERETO HERBY IRREVOCABLY WAIVES ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR
RELATED TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY.
(i)
Further Assurances
. Each of the parties hereto shall
execute such documents and other papers and perform such further acts as may be reasonably required or advisable to carry out the provisions of this Agreement and the transactions contemplated hereby.
(j)
Notices
. All notices, demands or other communications to be given or delivered under or by reason of the provisions of this
Agreement will be in writing and shall be deemed to have been given (a) when personally
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delivered, (b) when transmitted via facsimile to the number set out below, if the sender on the same day sends a confirming copy of such notice by a recognized overnight delivery service
(charges prepaid), (c) the day following the day (except if not a Business Day then the next Business Day) on which the same has been delivered prepaid to a reputable national overnight air courier service, (d) when transmitted via
e-mail
(including via attached pdf document) to the
e-mail
address set out below, if the sender on the same day sends a confirming copy of such notice by a recognized
overnight delivery service (charges prepaid) or (e) the third Business Day following the day on which the same is sent by certified or registered mail, postage prepaid, in each case to the respective parties as applicable, at the address,
facsimile number or
e-mail
address set forth below:
To the Company
:
Melinta Therapeutics, Inc.
300
George Street, Suite 301
New Haven, Connecticut 06511
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Attention:
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[●]
|
Facsimile:
|
|
[●]
|
E-mail:
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|
[●]
|
with a copy (which shall not constitute notice to the Company) to
:
Willkie Farr & Gallagher LLP
787 Seventh Avenue
New York, New
York 10019
|
|
|
Attention:
|
|
Gordon Caplan
|
|
|
Sean Ewen
|
Facsimile:
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|
(212)
728-8111
|
E-mail:
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gcaplan@willkie.com
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sewen@willkie.com
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To the Shareholder
:
The Medicines Company
8 Sylvan
Way
Parsippany, New Jersey 07054
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|
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Attention:
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Stephen Rodin
|
Facsimile:
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|
(973)
656-9898
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E-mail:
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|
stephen.rodin@themedco.com
|
with a copy (which shall not constitute notice to the Shareholder) to
:
Cadwalader, Wickersham & Taft LLP
200 Liberty Street
New York, New
York 10281
|
|
|
Attention:
|
|
Gregory P. Patti, Jr.
|
|
|
Andrew P. Alin
|
Facsimile:
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|
(212)
504-6666
|
E-mail:
|
|
greg.patti@cwt.com
|
|
|
andrew.alin@cwt.com
|
; or to such other address as the party to whom notice is given may have previously furnished to the others in
writing in the manner set forth above.
(k)
Entire Agreement
. This Agreement, together with the Organizational Documents, contains
the entire agreement among the parties hereto with respect to the subject matter hereof and supersedes and replaces all other prior agreements, written or oral, among the parties hereto with respect to the subject matter hereof.
F-14
(l)
No Waivers; Third Party Beneficiary Rights
. No failure or delay by any party in
exercising any right, power or privilege hereunder shall operate as a waiver thereof nor shall any single or partial exercise thereof preclude any other or further exercise thereof or the exercise of any other right, power or privilege. The rights
and remedies herein provided shall be cumulative and not exclusive of any rights or remedies provided by law. Nothing in this Agreement, express or implied, is intended to confer on any Person (other than the parties hereto and any permitted
transferee under Section 12(d) hereof) its heirs, successors, legal representatives or permitted assigns, any rights, remedies, obligations or liabilities under this Agreement
[Remainder of this page left intentionally blank.]
F-15
IN WITNESS WHEREOF, the undersigned have set their hands and seals as of the above date.
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MELINTA THERAPEUTICS,
INC.
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Shareholder
|
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THE MEDICINES COMPANY
|
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By:
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Name:
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Title:
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F-16
Melinta IMPORTANT SPECIAL MEETING INFORMATION 000004 ENDORSEMENT_LINE SACKPACK MR A SAMPLE DESIGNATION (IF ANY)
ADD 1 ADD 2 ADD 3 ADD 4 MMMMMMMMM ADD 5 ADD 6 MMMMMMMMMMMM MMMMMMMMMMMMMMM C123456789 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext 000000000.000000 ext Electronic
Voting Instructions Available 24 hours a day, 7 days a week! Instead of mailing your proxy, you may choose one of the voting methods outlined below to vote your proxy. VALIDATION DETAILS ARE LOCATED BELOW IN THE TITLE BAR. Proxies submitted by the
Internet or telephone must be received by 1:00 a.m., Eastern Time, on [●], 2017. Vote by Internet Go to www.investorvote.com/MLNT Or scan the QR code with your smartphone Follow the steps outlined on
the secure website Vote by telephone Call toll free
1-800-652-VOTE
(8683) within the USA, US
territories & Canada on a touch tone telephone Follow the instructions provided by the recorded message Using a black ink pen, mark your votes with an X as shown in this example. Please do not write outside the
designated areas. Special Meeting Proxy Card 1234 5678 9012 345 A Proposals The Board of Directors recommends a vote FOR Proposals 1 2. 1. To approve the issuance of Melinta common stock
pursuant to The Medicines Company purchase agreement, the Deerfield commitment letter and the equity commitment letters, and the issuance of the Deerfield warrant (and the shares issuable upon exercise of such warrant) as contemplated by the
Deerfield commitment letter. For Against Abstain 2. To adjourn the Special Meeting, if necessary, if a quorum is present, to solicit additional proxies, in the event that there are not sufficient votes
at the time of the Special Meeting to approve Proposal 1.For Against Abstain C 1234567890 J N T MR A SAMPLE (THIS AREA IS SET UP TO ACCOMMODATE 140 CHARACTERS) MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE
AND MR A SAMPLE AND MR A SAMPLE AND MMMMMMM 1UPX3476391MR A SAMPLE AND MR A SAMPLE AND MR A SAMPLE AND 02OF4E PRELIMINARY - SUBJECT TO COMPLETION and as may be further amended from time to time