If the securities being registered on this Form
are being offered in connection with the formation of a holding company and there is compliance with General Instruction G, check the following box. ☐
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act of 1933, as amended, check the
following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. ☐
If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same offering. ☐
Indicate by check mark
whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated
filer, a smaller reporting company, or an emerging growth company. See the definitions of large accelerated
filer, accelerated filer, smaller reporting company, and emerging growth company in Rule
12b-2
of the Exchange Act. (Check one):
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
If applicable, place an X in the box to designate the appropriate rule provision relied upon in conducting this transaction:
Summary
This summary highlights selected information contained or incorporated by reference in this proxy statement/prospectus and may not contain all of the
information that is important to you. This summary is not intended to be complete and reference is made to, and this summary is qualified in its entirety by, the more detailed information contained or incorporated by reference in this proxy
statement/prospectus and the annexes attached to this proxy statement/prospectus. You should read carefully the entire proxy statement/prospectus and the additional documents referenced in it to understand fully the merger agreement and the merger.
You may obtain the information incorporated by reference into this proxy statement/prospectus without charge by following the instructions in the section entitled Where you can find more information. Page references have been included
parenthetically to direct you to a more complete description of the topics presented in this summary.
The companies (see page 44)
Intrexon Corporation
Intrexon believes it is a
leader in the field of synthetic biology, an emerging and rapidly evolving discipline that applies engineering principles to biological systems to enable rational, design-based control of cellular functions for a specific purpose. Using its suite of
proprietary and complementary technologies, Intrexon designs, builds and regulates gene programs, which are DNA sequences that consist of key genetic components. A single gene program or a complex, multi-genic program is fabricated and stored within
a DNA vector. Vectors are segments of DNA used as a vehicle to transmit genetic information. DNA vectors can, in turn, be introduced into cells in order to generate a simple or complex cellular system, which are the basic and complex cellular
activities that take place within a cell and the interaction of those systems in the greater cellular environment. It is these genetically modified cell systems that can be used to produce biological effector molecules, or be employed directly to
enable the development of new and improved products and manufacturing processes across a variety of end markets, including health, food, energy, environment and consumer. Intrexons synthetic biology capabilities include the ability to
precisely control the amount, location and modification of biological molecules to control the function and output of living cells and optimize for desired results at an industrial scale.
Working with its collaborators, Intrexon seeks to create more effective, less costly and more sustainable solutions than can be provided through current
industry practices. Intrexon believes its approach to synthetic biology can enable new and improved biotherapeutics, increase the productivity and quality of food crops and livestock, create sustainable alternative energy sources and chemical
feedstocks utilize biologically-based applications for the delivery of innovative consumer products and provide for a diverse set of environmental solutions. Intrexons business model is to commercialize its technologies through exclusive
channel collaborations, referred to herein as ECCs, with collaborators that have industry expertise, development resources and sales and marketing capabilities to bring new and improved products and processes to market.
Intrexon is incorporated in Virginia. Intrexons common stock is traded on the NYSE under the symbol XON. The principal executive offices of
Intrexon are located at 20374 Seneca Meadows Parkway, Germantown, Maryland 20876, and its telephone number is (301)
556-9900.
For more information regarding Intrexons business, see the section entitled Description of Intrexons business in this proxy
statement/prospectus, Item 1 of Intrexons Annual Report on Form
10-K
for its 2016 fiscal year and the other documents incorporated by reference into this proxy statement/prospectus.
GenVec, Inc.
GenVec is a clinical-stage biopharmaceutical company with an entrepreneurial focus on leveraging its proprietary AdenoVerse gene delivery platform to
develop a pipeline of cutting-edge therapeutics and vaccines. GenVec is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVecs lead product
candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, GenVec also focuses on opportunities to license
its proprietary technology platform, including vectors and production cell lines, to potential collaborators in the biopharmaceutical industry for the development and manufacture of therapeutics and vaccines.
GenVec is incorporated in Delaware. GenVecs common stock is traded on NASDAQ under the symbol GNVC. The principal executive offices of
GenVec are located at 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878, and its telephone number is (240)
632-0740.
For more information regarding GenVecs business, see the section entitled Description of GenVecs business.
Intrexon GV Holding, Inc.
Merger Sub is a wholly
owned subsidiary of Intrexon formed solely for the purpose of effecting the merger. Merger Sub is incorporated in Delaware.
Merger Sub has not conducted
any activities other than those incidental to its formation and the matters contemplated by the merger agreement. The principal executive offices of Merger Sub are located at 20374 Seneca Meadows Parkway, Germantown, Maryland 20876, and its
telephone number is (301)
556-9900.
7
The merger (see page 45)
Pursuant to the terms and subject to the conditions of the merger agreement, at the closing of the proposed transactions contemplated by the merger agreement,
Merger Sub will be merged with and into GenVec. GenVec will continue as the surviving corporation of the merger, but it will become a wholly owned subsidiary of Intrexon.
Merger consideration (see page 72)
At the effective time
of the merger, each share of GenVec common stock (other than shares with respect to which appraisal rights are properly exercised or shares owned by Intrexon, any of its subsidiaries or GenVec) will be converted into the right to receive 0.297 of a
share of Intrexon common stock and one CPR. For more information on the CPRs, see the section entitled Contingent payment rights agreement.
GenVec shareholders will not receive any fractional shares of Intrexon common stock in the merger. Instead, any shareholder who would otherwise be entitled to
a fractional share of Intrexon common stock will be entitled to receive an amount in cash, without interest, equal to the product of such fraction multiplied by the last reported sale price of Intrexon common stock on the NYSE on the last complete
trading day prior to the effective time of the merger.
Treatment of GenVec stock options and warrants (see page 72)
Each outstanding, unvested GenVec stock option will fully vest upon the approval of the merger proposal by the GenVec shareholders. In connection with the
merger, each outstanding GenVec stock option may be exercised (including net exercise) for a period of at least 15 days prior to the effective time of the merger. Each share of GenVec common stock resulting from the exercise of an option during this
exercise window will be treated as a share of GenVec common stock issued and outstanding immediately prior to the effective time of the merger and will be eligible to receive the merger consideration. Any GenVec stock option that is not exercised
and remains outstanding at the effective time of the merger will be automatically cancelled for no consideration.
At the effective time of the merger,
each outstanding, unexpired and unexercised warrant to purchase shares of GenVec common stock will be assumed by Intrexon and converted into a warrant to purchase, at an aggregate exercise price equal to the aggregate exercise price of the warrant
as of immediately prior to the effective time of the merger, and in lieu of the shares of GenVec common stock otherwise issuable upon exercise of such warrant, the applicable merger consideration (including shares of Intrexon common stock and CPRs)
that would have been receivable upon consummation of the merger by the holder of such warrant if such warrant had been exercised immediately prior to the effective time of the merger. The other
pre-existing
terms of the warrants will continue to apply in accordance with their terms following the merger. See the section entitled The merger agreementTreatment of GenVec stock options and warrants.
Contingent payment rights agreement (see page 82)
Each
share of GenVec common stock outstanding at the effective time of the merger (including through exercise of a GenVec stock option), and each share of GenVec common stock underlying a warrant that is converted into a warrant to purchase merger
consideration, will, upon the effective time of the merger, or with respect to a warrant, upon the exercise of such warrant, entitle the holder to receive one CPR. Each CPR represents the right to receive an amount equal to (i) 50% of (a) all
milestone payments, if any, received by Intrexon or GenVec for milestones that are achieved or occur under the NVS License Agreement within 36 months after the effective time of the merger and (b) all royalty payments, if any, received by
Intrexon or GenVec under the NVS License Agreement within such
36-month
period,
divided by
(ii) the total number of CPRs outstanding at such time. To the extent any applicable milestone or royalty
payment is received by Intrexon or GenVec, each holder of a CPR will receive a payment equal to the amount described in the foregoing sentence multiplied by the number of CPRs held by such holder at the applicable time. Payments to holders of CPRs
will be made in cash, except under certain circumstances, where payments will be made in the form of shares of Intrexon common stock. See the section entitled Contingent payment rights agreement Form of CPR payments.
The GenVec special meeting (see page 41)
Date,
time and place
The special meeting will be held at [●]:[●][●], Eastern Daylight Time, on [●] [●], 2017, at
GenVecs office located at 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878.
Purpose of the special meeting
At the special meeting you will be asked:
|
|
|
to consider and vote upon the merger proposal;
|
|
|
|
to consider and vote upon the merger-related compensation proposal; and
|
|
|
|
to consider and vote upon the adjournment proposal.
|
GenVec may also conduct any other business properly
brought before the special meeting and any adjournment or postponement thereof.
8
Record date; stock entitled to vote
The GenVec board of directors has fixed the close of business on [●], 2017 as the record date for the determination of shareholders entitled to notice
of, and to vote at, the special meeting and at any adjournment or postponement of the special meeting.
At the close of business on the record date, there
were [●] shares of GenVec common stock outstanding and entitled to vote held by [●] holders of record. As of the record date, the directors and executive officers of GenVec and their affiliates as a group owned and were entitled to vote
[●] shares of GenVec common stock, or approximately [●]% of the shares of GenVec common stock outstanding and entitled to vote as of that date.
Vote required
The votes required for each
proposal are as follows:
|
|
|
Proposal 1.
|
|
The merger proposal requires the affirmative vote of the holders of a majority of the outstanding shares of GenVec common stock.
|
|
|
Proposal 2.
|
|
The merger-related compensation proposal requires the affirmative vote of the holders of a majority of shares of GenVec common stock present in person or by proxy at the special meeting and entitled to vote on the
matter.
|
|
|
Proposal 3.
|
|
The adjournment proposal requires the affirmative vote of the holders of a majority of shares of GenVec common stock present in person or by proxy at the special meeting and entitled to vote on the matter.
|
If you vote ABSTAIN on the merger proposal, the merger-related compensation proposal or the adjournment proposal,
it will have the same effect as voting AGAINST such proposal.
If you are a shareholder of record and do not vote by completing your proxy
card, by telephone or in person at the special meeting, your shares will not be voted. This will have the same effect as voting AGAINST the merger proposal, but it will have no effect on the outcome of the merger-related compensation
proposal or the adjournment proposal.
If your shares are held in street name and you do not provide your broker, bank or other nominee with instructions
as to how to vote your shares on a particular proposal, your shares will not be voted on that proposal. This will have the same effect as voting AGAINST the merger proposal, but it will have no effect on the outcome of the merger-related
compensation proposal or the adjournment proposal.
Recommendations of the GenVec board of directors (see page 41)
The GenVec board of directors unanimously recommends that GenVecs shareholders vote
FOR
the merger proposal,
FOR
the merger-related compensation proposal and
FOR
the adjournment proposal.
GenVecs reasons for the merger (see page 51)
In the course of reaching its decision to adopt the merger agreement and to recommend that GenVec shareholders vote to approve the merger proposal,
GenVecs board of directors consulted with its senior management, financial advisor and legal counsel, reviewed a significant amount of information and considered a number of factors, including, among others, those contained in the section
entitled The Merger Recommendation of the GenVec board of directors; GenVecs reasons for the merger.
Opinion of Roth Capital
Partners (see page 54)
GenVecs board of directors received an opinion, dated January 24, 2017, from Roth Capital Partners, LLC,
referred to herein as Roth, that, as of that date and based on and subject to assumptions, factors, qualifications and limitations set forth therein, the consideration to be received by holders of GenVec common stock in the merger was fair, from a
financial point of view, to such holders. The full text of Roths written opinion, which sets forth, among other things, the procedures followed, assumptions made, qualifications and limitations on the review undertaken and other matters
considered by Roth in rendering its opinion, is attached as
Annex E
to this proxy statement/prospectus. The opinion was prepared for the information of the GenVec board of directors and addresses only the fairness, from a financial point of
view, to holders of GenVec common stock of the consideration to be received by such holders in the merger. The opinion does not address any other aspect of the proposed merger and does not constitute a recommendation to the GenVec board of directors
or to any other persons in respect of the proposed merger, including as to how any holder of shares of GenVec common stock should vote or act in respect of the proposed merger.
Interests of GenVecs directors and executive officers in the merger (see page 61)
In considering the recommendation of the GenVec board of directors to approve the merger proposal, GenVec shareholders should be aware that GenVecs
directors and executive officers may have interests in the merger that are different from, or in addition to, the interests of shareholders generally. The GenVec board of directors was aware of and considered these potential interests, among other
things, in adopting the merger agreement and approving the merger, and in recommending that the merger agreement be adopted by shareholders. These interests include accelerated vesting of certain outstanding GenVec equity awards held by the
directors and the executive officers of GenVec in connection with the merger, potential continued
9
employment of executive officers following the merger, potential severance payments and benefits if the employment of the executive officers is terminated in connection with or following the
merger, and the continuation, for a period of six years following the effective time of the merger, of indemnification and insurance coverage of the directors and executive officers.
Appraisal rights (see page 101)
GenVec shareholders who
do not vote in favor of the adoption of the merger agreement and comply precisely with the applicable requirements of Section 262 of the DGCL will be entitled to seek appraisal rights in connection with the merger. The text of the applicable
provisions of Delaware law is included as
Annex D
to this proxy statement/prospectus.
Regulatory approvals required for the merger (see page
68)
Intrexon and GenVec are not aware of any material governmental approvals, waivers or actions that are required to complete the merger. If any such
governmental approvals, waivers or actions are required, Intrexon and GenVec have agreed to use reasonable best efforts to obtain those approvals, waivers or actions. There can be no assurance, however, that any waivers, approvals or actions will be
obtained.
The merger agreement (see page 72)
A copy
of the merger agreement is attached as
Annex A
to this proxy statement/prospectus. You are encouraged to read the entire merger agreement carefully because it is the principal legal document governing the merger.
Conditions to completion of the merger (see page 79)
Mutual conditions
Each partys obligation to
complete the merger is subject to the satisfaction or waiver of certain conditions, including:
|
|
|
the merger agreement shall have been adopted by the affirmative vote of the holders of a majority of the outstanding shares of GenVecs common stock;
|
|
|
|
the consummation of the merger shall not then be restrained, enjoined or prohibited by any order of any governmental authority and there shall not be in effect any law enacted or promulgated by any governmental
authority that prevents or makes illegal the consummation of the merger;
|
|
|
|
the shares of Intrexon common stock issuable to the holders of GenVec common stock pursuant to the merger agreement shall have been approved for listing on NYSE, subject to official notice of issuance;
|
|
|
|
the Registration Statement on Form
S-4
shall have been declared effective by the SEC, no stop order suspending the effectiveness of such Registration Statement shall be in effect
and no proceedings for such purpose shall be pending before the SEC; and
|
|
|
|
holders of no more than 20% of the outstanding shares of GenVecs common stock shall have validly exercised their appraisal, dissenters or similar rights under applicable law.
|
Conditions to the obligations of GenVec
The
obligations of GenVec to complete the merger are subject to the satisfaction or waiver of certain additional conditions, including:
|
|
|
the representations and warranties of Intrexon shall be, with certain exceptions, true and correct as of the date of the merger agreement and as of the effective time of the merger, as though made at such time,
generally subject to a material adverse effect standard; and
|
|
|
|
Intrexon shall have performed in all material respects the covenants and agreements required to be performed by it under the merger agreement prior to the closing of the merger.
|
Conditions to the obligations of Intrexon and Merger Sub
The obligations of Intrexon and Merger Sub to complete the merger are subject to the satisfaction or waiver of certain conditions, including
|
|
|
the representations and warranties of GenVec shall be, with certain exceptions, true and correct as of the date of the merger agreement and as of the effective time of the merger, as though made at such time, generally
subject to a material adverse effect standard;
|
|
|
|
GenVec shall have performed in all material respects the covenants and agreements required to be performed by it under the merger agreement prior to the closing of the merger;
|
|
|
|
since January 24, 2017, there shall not have been any change, event, development, condition, occurrence or effect that has had or would reasonably be expected to have a material adverse effect on GenVec; and
|
10
|
|
|
GenVec shall have delivered to Intrexon a statement satisfying the requirements of certain U.S. treasury regulations certifying that interests in GenVec are not United States real property interests within
the meaning of Section 897(c) of the Internal Revenue Code of 1986, as amended, which we refer to as the Code.
|
No solicitation by GenVec
(see page 77)
Subject to certain exceptions, the merger agreement precludes GenVec from soliciting from a third party, or engaging in discussions or
negotiations with a third party with respect to, a proposal for an alternative transaction, including the acquisition of a significant interest in GenVecs equity or assets. Notwithstanding such restrictions, the merger agreement provides that,
prior to approval of the merger proposal by GenVecs shareholders, under certain specified circumstances, if GenVec receives an unsolicited proposal from a third party for an alternative transaction that its board of directors determines in
good faith could reasonably be expected to result in a proposal that is superior to the merger, GenVec may furnish information, including
non-public
information, to that third party and engage in discussions
or negotiations regarding an alternative transaction with that third party. GenVecs board of directors may change its recommendation to GenVecs shareholders to approve the merger proposal, and, as described below under
Termination of the merger agreement, GenVec may terminate the merger agreement, if GenVec has received a proposal for an alternative transaction that its board of directors determines in good faith to be superior to the merger and
certain other conditions are met, including GenVecs provision to Intrexon of notice of such a proposal and an opportunity to negotiate revisions to the terms of the merger agreement.
In addition, under certain circumstances, GenVecs board of directors may change its recommendation to GenVecs shareholders to approve the merger
proposal in response to an event that was not known to the board, and could not reasonably be expected to have been known to the board, on or prior to the date of the merger agreement. The merger agreement refers to this as an intervening event.
However, the board of directors of GenVec may only change its recommendation in response to an intervening event if (i) the board determines in good faith that such intervening event has occurred and is continuing, (ii) the board
determines that failure to change its recommendation would breach or would reasonably be expected to breach the boards fiduciary duties, and (iii) certain other conditions are met, including GenVecs provision to Intrexon of notice
of such intervening event and an opportunity to negotiate revisions to the terms of the merger agreement.
Termination of the merger agreement (see
page 80)
The merger agreement may be terminated under certain circumstances, including:
|
|
|
by mutual written consent of Intrexon and GenVec;
|
|
|
|
by either GenVec or Intrexon, if GenVec shall have failed to obtain the requisite affirmative vote of its shareholders to adopt the merger agreement;
|
|
|
|
by either GenVec or Intrexon, if a governmental authority shall have issued a final and
non-appealable
order that permanently restrains, enjoins or prohibits consummation of the
merger, or if any law is in effect that prevents or makes illegal consummation of the merger;
|
|
|
|
by either GenVec or Intrexon, if the merger is not consummated on or before July 24, 2017;
|
|
|
|
by Intrexon, prior to the approval of the merger proposal by the shareholders of GenVec, if the board of directors of GenVec shall have effected a change in its recommendation to GenVecs shareholders to adopt the
merger agreement;
|
|
|
|
by GenVec, prior to the approval of the merger proposal by its shareholders, in order to accept a superior proposal, provided that GenVec has complied with the provisions of the merger agreement that prohibit
solicitation of alternative acquisition proposals (as described above under No solicitation by GenVec) and met certain other conditions, including payment to Intrexon of the termination fee discussed below; or
|
|
|
|
by either party if there shall have been a breach of any of the covenants or agreements or any of the representations or warranties in the merger agreement by the other party that is not cured (or is not capable of
cure) within the timeframe specified in the merger agreement, which breach or misrepresentation would prevent the satisfaction of certain conditions to closing.
|
Termination fee
GenVec shall pay Intrexon a
termination fee of $550,000, if the merger agreement is terminated:
|
|
|
by Intrexon, prior to the approval of the merger proposal by the shareholders of GenVec, due to the board of directors of GenVec effecting a change in its recommendation to GenVecs shareholders to adopt the merger
agreement;
|
|
|
|
by GenVec, prior to the adoption of the merger proposal by its shareholders, in order to accept a superior proposal; or
|
|
|
|
by Intrexon or GenVec because the merger is not consummated on or before July 24, 2017 or by Intrexon because there has been an uncured breach by GenVec of any covenant or agreement in the merger agreement, which
breach would prevent the satisfaction of certain conditions to closing, and (i) an acquisition proposal has been publicly announced or made to GenVec after the date of the merger agreement (but prior to the termination of the merger agreement)
and has not been withdrawn prior to the date of termination of the merger agreement, and (ii) within twelve months of such termination, GenVec enters into a letter of intent or agreement with respect to, or consummates, an acquisition proposal.
|
11
In addition, GenVec shall pay to Intrexon, in an amount not to exceed $400,000, the reasonable costs, fees
and expenses incurred by Intrexon in connection with the investigation, due diligence, negotiation and documentation of the merger agreement, in the event Intrexon (i) terminates the merger agreement because there has been an uncured breach by
GenVec of any covenant or agreement in the merger agreement, which breach would prevent the satisfaction of certain conditions to closing and (ii) within six months after the date of such termination, GenVec enters into a definitive agreement
with a third party in respect of an acquisition proposal. In addition to such expense reimbursement (and only when such expense reimbursement is due), GenVec will also be obligated to pay Intrexon an additional $200,000 if GenVec willfully breached
in any material respect the provisions of the merger agreement prohibiting solicitation of alternative acquisition proposals (as described above under No solicitation by GenVec). In the event that GenVec reimburses Intrexons
expenses as described in this paragraph and the termination fee thereafter becomes payable, the termination fee will be reduced by the expenses so reimbursed (as well as by the additional $200,000 paid by GenVec as described in the previous
sentence, if applicable).
Ownership of Intrexon after the merger
Based on the number of shares of GenVec common stock outstanding as of April 19, 2017 (including the number of shares of GenVec common stock potentially
issuable upon the exercise of stock options and warrants), Intrexon expects to issue approximately 696,281 shares of its common stock to GenVec shareholders in connection with the closing of the merger. The CPRs are to be paid in cash unless such
payment would prevent the transactions contemplated by the merger agreement from being treated as a tax free reorganization, in which case Intrexon would issue shares of its common stock in lieu of payment in cash of such amounts determined to be
payable under the contingent payment rights agreement. The actual number of shares of Intrexon common stock to be issued as stock consideration will be determined at the completion of the merger based on the number of GenVec common shares
outstanding at such time, and the actual number of shares of Intrexon common stock to be issued in connection with the CPRs (if any) will ultimately depend on the aggregate amount of any milestone payments received based on milestones that are
achieved or occur, and on the aggregate amount of any royalty payments received, within 36 months after the closing of the merger under the NVS License Agreement.
Immediately after the consummation of the merger, and based on the number of shares of Intrexon common stock outstanding as of the record date, it is expected
that former GenVec shareholders will own approximately [●]% of the [●] shares of Intrexon common stock then outstanding.
Directors and
management after the merger (see page 68)
Upon completion of the merger, the board of directors and executive officers of Intrexon are expected to
remain unchanged.
Material U.S. federal income tax consequences of the merger (see page 87)
It is intended, and each of Intrexon and GenVec expect, the merger will qualify as a reorganization within the meaning of Section 368(a) of the
Code. Moreover, assuming the merger is treated as a reorganization and a closed transaction, (i) a United States holder will recognize gain, but not loss, with respect to the receipt of merger consideration other than Intrexon
voting common stock (
e.g.
, CPRs and cash) and (ii) will recognize no gain or loss with respect to the Intrexon voting common stock received in the merger in exchange for GenVec common stock. Qualification as a reorganization is dependent
on various requirements, including the requirement that the value of Intrexon common stock received by holders of GenVec common stock constitute a certain percentage of the total consideration, including the fair market value of the CPRs received
and any cash received. If the merger does not qualify as a reorganization, the receipt of the merger consideration by a United States holder in exchange for shares of GenVec common stock will be a taxable transaction for United States federal income
tax purposes. For a more complete discussion of the tax consequences of the merger, see the section entitled Material U.S. federal income tax consequences of the merger.
Tax matters are very complicated, and the tax consequences of the merger to a particular GenVec shareholder will depend in part on such shareholders
circumstances. Accordingly, you are urged to consult your own tax advisor for a full understanding of the tax consequences of the merger to you, including the applicability and effect of federal, state, local and foreign income and other tax laws.
Accounting treatment (see page 68)
In
accordance with accounting principles generally accepted in the United States, Intrexon will account for the merger using the acquisition method of accounting for business combinations.
Procedure for receiving the merger consideration (see page 73)
Intrexon has appointed American Stock Transfer & Trust Company, LLC, referred to herein as AST, as its exchange agent to coordinate the payment of the
stock consideration following the merger. If you own shares of GenVec common stock that are held in street name, meaning that your shares are held by a broker, bank or other nominee, you will receive instructions from your broker, bank
or other nominee as to how to surrender your street name shares and receive stock for those shares. If you are the record holder of book-entry shares or hold certificated shares, the exchange agent will send you written instructions for
surrendering your book-entry shares or certificates and obtaining the stock consideration at or about the date on which GenVec completes the merger.
Do not send in your share certificates now.
Intrexon has also appointed AST as its rights agent to coordinate the payment of cash and/or shares of Intrexon common stock in connection with the CPRs.
Holders of GenVec common stock will receive one CPR for each share of GenVec common stock
12
outstanding immediately prior to the effective time of the merger. The amount of cash and/or shares of Intrexon common stock ultimately payable in connection with the CPRs will be determined
pursuant to the terms of the contingent payment rights agreement entered into by Intrexon and AST, the form of which is included as
Annex B
to this proxy statement/prospectus. Pursuant to the terms of the agreement, Intrexon will, on or
before certain specified dates, provide notice to AST indicating, among other things, the amount of cash and/or shares of Intrexon common stock payable to the holders of the CPRs.
Comparison of Intrexon and GenVec shareholder rights (see page 92)
The rights of Intrexon shareholders are currently governed by the Virginia Stock Corporation Act, which we refer to as the VSCA, and the articles of
incorporation and bylaws of Intrexon. The rights of GenVec shareholders are currently governed by the DGCL, and the certificate of incorporation and bylaws of GenVec. Upon completion of the merger, GenVec shareholders will become Intrexon
shareholders. GenVec shareholders will have different rights as shareholders of Intrexon than as shareholders of GenVec, because the VSCA and the articles of incorporation and bylaws of Intrexon contain provisions that are different from the
provisions contained in the DGCL and the certificate of incorporation and bylaws of GenVec.
Risk factors (see page 21)
The merger (including the possibility that the merger may not be consummated) poses a number of risks to GenVec shareholders. In addition, GenVec shareholders
will be receiving shares of Intrexon common stock in the merger. Intrexon is subject to various risks associated with its business and a number of risks exist with respect to an investment in Intrexon common stock.
13
Intrexon selected historical financial and other data
The following table sets forth Intrexons selected historical consolidated financial data for the periods and as of the dates indicated. The consolidated
statement of operations data for the years ended December 31, 2016, 2015, 2014, 2013 and 2012 and the consolidated balance sheet data as of December 31, 2016, 2015, 2014, 2013 and 2012 are derived from Intrexons audited consolidated
financial statements. You should read the following selected consolidated financial data together with the financial statements that are included in Intrexons annual reports on Form
10-K
incorporated by
reference into this document, including their accompanying notes and managements discussion and analysis of operations and financial condition contained in such reports. See the section entitled Where you can find more information.
Intrexons audited consolidated financial statements have been prepared in U.S. dollars in accordance with U.S. GAAP.
Intrexons historical results for any prior period are not necessarily indicative of results to be expected in any future period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
|
2013
|
|
|
2012
|
|
|
|
(In thousands, except share and per share amounts)
|
|
Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and licensing revenues
|
|
$
|
109,871
|
|
|
$
|
87,821
|
|
|
$
|
45,212
|
|
|
$
|
23,525
|
|
|
$
|
13,706
|
|
Product revenues
|
|
|
36,958
|
|
|
|
41,879
|
|
|
|
11,481
|
|
|
|
164
|
|
|
|
|
|
Service revenues
|
|
|
43,049
|
|
|
|
42,923
|
|
|
|
14,761
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
190,926
|
|
|
|
173,605
|
|
|
|
71,930
|
|
|
|
23,760
|
|
|
|
13,774
|
|
Total operating expenses
|
|
|
316,092
|
|
|
|
320,469
|
|
|
|
141,892
|
|
|
|
81,783
|
|
|
|
88,931
|
|
Operating loss
|
|
|
(125,166
|
)
|
|
|
(146,864
|
)
|
|
|
(69,962
|
)
|
|
|
(58,023
|
)
|
|
|
(75,157
|
)
|
Net loss
|
|
|
(190,274
|
)
|
|
|
(87,994
|
)
|
|
|
(85,616
|
)
|
|
|
(40,908
|
)
|
|
|
(81,874
|
)
|
Net loss attributable to noncontrolling interests
|
|
|
3,662
|
|
|
|
3,501
|
|
|
|
3,794
|
|
|
|
1,928
|
|
|
|
|
|
Net loss attributable to Intrexon
|
|
|
(186,612
|
)
|
|
|
(84,493
|
)
|
|
|
(81,822
|
)
|
|
|
(38,980
|
)
|
|
|
(81,874
|
)
|
Accretion of dividends on redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18,391
|
)
|
|
|
(21,994
|
)
|
Net loss attributable to common shareholders
|
|
|
(186,612
|
)
|
|
|
(84,493
|
)
|
|
|
(81,822
|
)
|
|
|
(57,371
|
)
|
|
|
(103,868
|
)
|
Net loss attributable to common shareholders per share, basic and diluted
|
|
$
|
(1.58
|
)
|
|
$
|
(0.76
|
)
|
|
$
|
(0.83
|
)
|
|
$
|
(1.40
|
)
|
|
$
|
(18.77
|
)
|
Weighted average shares outstanding, basic and diluted
|
|
|
117,983,836
|
|
|
|
111,066,352
|
|
|
|
99,170,653
|
|
|
|
40,951,952
|
|
|
|
5,533,690
|
|
14
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2016
|
|
|
2015
(4)
|
|
|
2014
(3)
|
|
|
2013
(2)
|
|
|
2012
|
|
|
|
(In thousands)
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
62,607
|
|
|
$
|
135,782
|
|
|
$
|
27,466
|
|
|
$
|
49,509
|
|
|
$
|
10,403
|
|
Short-term and long-term investments
|
|
|
180,595
|
|
|
|
207,975
|
|
|
|
115,608
|
|
|
|
188,561
|
|
|
|
260
|
|
Equity securities
|
|
|
23,522
|
|
|
|
83,653
|
|
|
|
164,889
|
|
|
|
141,525
|
|
|
|
83,116
|
|
Investment in preferred stock
|
|
|
129,545
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
|
949,068
|
|
|
|
982,046
|
|
|
|
576,272
|
|
|
|
469,472
|
|
|
|
151,646
|
|
Deferred revenue, current and
non-current
|
|
|
310,142
|
|
|
|
197,729
|
|
|
|
113,209
|
|
|
|
73,571
|
|
|
|
58,636
|
|
Other liabilities
(1)
|
|
|
69,678
|
|
|
|
79,431
|
|
|
|
53,774
|
|
|
|
14,558
|
|
|
|
7,904
|
|
Redeemable convertible preferred stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
406,659
|
|
Total Intrexon shareholders equity (deficit)
|
|
|
560,237
|
|
|
|
694,078
|
|
|
|
384,761
|
|
|
|
366,722
|
|
|
|
(321,553
|
)
|
Noncontrolling interests
|
|
|
9,011
|
|
|
|
10,808
|
|
|
|
24,528
|
|
|
|
14,621
|
|
|
|
|
|
Total equity (deficit)
|
|
|
569,248
|
|
|
|
704,886
|
|
|
|
409,289
|
|
|
|
381,343
|
|
|
|
(321,553
|
)
|
(1)
|
Other liabilities include $7,948, $8,528, $10,369 and $1,653 of long term debt as of December 31, 2016, 2015, 2014 and 2013, respectively; and $8,801, $15,629 and $20,485 of deferred consideration as of
December 31, 2016, 2015 and 2014, respectively.
|
(2)
|
In 2013, Intrexon acquired ownership interests in AquaBounty Technologies, Inc., referred to herein as AquaBounty, and Biological & Popular Culture, Inc., or BioPop, which resulted in its gaining control over
these entities, resulting in consolidation effective on the respective acquisition dates.
|
(3)
|
In 2014, Intrexon acquired Medistem, Inc. and Trans Ova and began including the results of their operations effective on the respective acquisition dates.
|
(4)
|
In 2015, Intrexon acquired ActoGeniX NV, or ActoGeniX, Okanagan, and Oxitec and began including the results of their operations effective on the respective acquisition dates.
|
15
GenVec selected historical financial and other data
The following table sets forth GenVecs selected historical financial data for the periods and as of the dates indicated. The statement of operations
data for the years ended December 31, 2016 and 2015 and the balance sheet data as of December 31, 2016 and 2015 are derived from GenVecs audited financial statements included elsewhere in this proxy statement/prospectus. The
statement of operations data for the years ended December 31, 2014, 2013 and 2012 and the balance sheet data as of December 31, 2014, 2013 and 2012 are derived from GenVecs audited financial statements that are not included or
incorporated by reference in this proxy statement/prospectus, but which have previously been filed with the SEC and are publicly available. See the section entitled Where you can find more information. You should read the following
selected financial data together with the section entitled GenVec managements discussion and analysis of financial conditions and results of operations and with GenVecs audited financial statements and related notes included
elsewhere in this proxy statement/prospectus.
GenVecs audited financial statements have been prepared in U.S. dollars in accordance with U.S. GAAP.
All share and per share amounts set forth in the following tables have been retroactively adjusted to reflect the reverse stock split.
GenVecs
historical results for any prior period are not necessarily indicative of results to be expected in any future period.
Selected Statement of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
|
2013
|
|
|
2012
|
|
|
|
(in thousands, except share and per share amounts)
|
|
Revenues
|
|
$
|
511
|
|
|
$
|
885
|
|
|
$
|
6,041
|
|
|
$
|
3,682
|
|
|
$
|
9,353
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative
|
|
$
|
5,227
|
|
|
$
|
4,901
|
|
|
$
|
6,314
|
|
|
$
|
8,484
|
|
|
$
|
9,102
|
|
Research and development
|
|
$
|
2,499
|
|
|
$
|
2,551
|
|
|
$
|
2,264
|
|
|
$
|
5,492
|
|
|
$
|
14,348
|
|
Total operating expenses
|
|
$
|
7,726
|
|
|
$
|
7,452
|
|
|
$
|
8,578
|
|
|
$
|
13,976
|
|
|
$
|
23,450
|
|
Operating loss
|
|
$
|
(7,215
|
)
|
|
$
|
(6,567
|
)
|
|
$
|
(2,537
|
)
|
|
$
|
(10,294
|
)
|
|
$
|
(14,097
|
)
|
Other income, net
|
|
$
|
1,428
|
|
|
$
|
22
|
|
|
$
|
22
|
|
|
$
|
275
|
|
|
$
|
42
|
|
Net loss
|
|
$
|
(5,787
|
)
|
|
$
|
(6,545
|
)
|
|
$
|
(2,515
|
)
|
|
$
|
(10,019
|
)
|
|
$
|
(14,055
|
)
|
Basic and diluted net loss per share
|
|
$
|
(2.78
|
)
|
|
$
|
(3.90
|
)
|
|
$
|
(1.59
|
)
|
|
$
|
(7.74
|
)
|
|
$
|
(10.86
|
)
|
Shares used in computation of basic and diluted net loss per share
|
|
|
2,080,089
|
|
|
|
1,677,812
|
|
|
|
1,582,698
|
|
|
|
1,294,824
|
|
|
|
1,293,994
|
|
Selected Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
|
2013
|
|
|
2012
|
|
|
|
(in thousands)
|
|
Cash, cash equivalents, and short-term investments
|
|
$
|
7,165
|
|
|
$
|
8,676
|
|
|
$
|
14,692
|
|
|
$
|
6,105
|
|
|
$
|
15,255
|
|
Working capital
|
|
$
|
5,611
|
|
|
$
|
7,393
|
|
|
$
|
13,014
|
|
|
$
|
3,999
|
|
|
$
|
12,741
|
|
Total assets
|
|
$
|
7,707
|
|
|
$
|
9,463
|
|
|
$
|
15,609
|
|
|
$
|
7,254
|
|
|
$
|
17,430
|
|
Accumulated deficit
|
|
$
|
(290,627
|
)
|
|
$
|
(284,840
|
)
|
|
$
|
(278,295
|
)
|
|
$
|
(275,780
|
)
|
|
$
|
(265,761
|
)
|
Total shareholders equity
|
|
$
|
4,705
|
|
|
$
|
7,680
|
|
|
$
|
13,298
|
|
|
$
|
4,610
|
|
|
$
|
13,743
|
|
16
Comparative market price and dividend information
Intrexon common stock is listed and traded on the NYSE under the symbol XON. GenVec common stock is listed and traded on NASDAQ under the symbol
GNVC. The following table sets forth, for the respective periods indicated, the high and low sale prices per share of Intrexon common stock (as reported on the NYSE) and GenVec common stock (as reported on NASDAQ), as well as dividend
information. The sale prices per share of GenVec common set forth in the table below have been retroactively adjusted to reflect the reverse stock split.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intrexon
|
|
|
GenVec
|
|
|
|
High
|
|
|
Low
|
|
|
Dividend
|
|
|
High
|
|
|
Low
|
|
|
Dividend
|
|
Year Ended December 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Second Quarter (through April 19, 2017)
|
|
$
|
20.43
|
|
|
$
|
18.41
|
|
|
|
|
|
|
$
|
6.25
|
|
|
$
|
5.44
|
|
|
|
|
|
First Quarter
|
|
$
|
26.95
|
|
|
$
|
18.55
|
|
|
|
|
(1)
|
|
$
|
10.44
|
|
|
$
|
3.17
|
|
|
|
|
|
Year Ended December 31, 2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter
|
|
$
|
32.90
|
|
|
$
|
24.01
|
|
|
|
|
|
|
$
|
4.70
|
|
|
$
|
2.70
|
|
|
|
|
|
Third Quarter
|
|
$
|
30.56
|
|
|
$
|
22.88
|
|
|
|
|
|
|
$
|
7.60
|
|
|
$
|
4.52
|
|
|
|
|
|
Second Quarter
|
|
$
|
38.60
|
|
|
$
|
22.81
|
|
|
|
|
|
|
$
|
14.00
|
|
|
$
|
5.71
|
|
|
|
|
|
First Quarter
|
|
$
|
40.24
|
|
|
$
|
18.52
|
|
|
|
|
|
|
$
|
18.50
|
|
|
$
|
3.50
|
|
|
|
|
|
Year Ended December 31, 2015
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter
|
|
$
|
43.76
|
|
|
$
|
27.52
|
|
|
|
|
|
|
$
|
36.90
|
|
|
$
|
15.10
|
|
|
|
|
|
Third Quarter
|
|
$
|
69.45
|
|
|
$
|
28.39
|
|
|
|
|
|
|
$
|
35.00
|
|
|
$
|
20.00
|
|
|
|
|
|
Second Quarter
|
|
$
|
51.44
|
|
|
$
|
37.30
|
|
|
|
|
(2)
|
|
$
|
30.80
|
|
|
$
|
17.90
|
|
|
|
|
|
First Quarter
|
|
$
|
50.98
|
|
|
$
|
25.23
|
|
|
|
|
|
|
$
|
46.70
|
|
|
$
|
20.40
|
|
|
|
|
|
Year Ended December 31, 2014
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fourth Quarter
|
|
$
|
28.78
|
|
|
$
|
16.13
|
|
|
|
|
|
|
$
|
23.00
|
|
|
$
|
16.11
|
|
|
|
|
|
Third quarter
|
|
$
|
26.62
|
|
|
$
|
17.35
|
|
|
|
|
|
|
$
|
27.60
|
|
|
$
|
18.20
|
|
|
|
|
|
Second quarter
|
|
$
|
26.60
|
|
|
$
|
13.13
|
|
|
|
|
|
|
$
|
30.10
|
|
|
$
|
19.80
|
|
|
|
|
|
First quarter
|
|
$
|
38.50
|
|
|
$
|
22.53
|
|
|
|
|
|
|
$
|
42.50
|
|
|
$
|
21.80
|
|
|
|
|
|
(1)
|
As further described under the section entitled Dividend policy below, on January 18, 2017, Intrexon distributed 1,776,557 shares of AquaBounty common stock to its shareholders.
|
(2)
|
As further described under the section entitled Dividend policy below, in June 2015 Intrexon distributed 17,830,305 shares of common stock of ZIOPHARM Oncology, Inc., referred to herein as ZIOPHARM, to its
shareholders.
|
The following table sets forth the closing sale prices per share of Intrexon common stock and GenVec common stock as of
January 23, 2017 (as reported on the NYSE and NASDAQ, respectively), the last trading day prior to the public announcement of the proposed merger, and as of April 19, 2017 the most recent practicable trading day prior to the date of this
proxy statement/prospectus. The table also includes the market value of GenVec common stock on an equivalent price per share basis, as determined by reference to the stock consideration to be received in respect of each share of GenVec common stock
in the merger. These equivalent prices per share reflect the fluctuating value of the Intrexon common stock that GenVec shareholders would receive in exchange for each share of GenVec if the merger was completed on either of these dates, applying an
exchange ratio of 0.297 shares of Intrexon common stock for each share of GenVec common stock. Immediately prior to the public announcement of the transaction, the exchange ratio represented an implied value of $7.00 per share of GenVec common stock
based on Intrexons
five-day
volume weighted average price as of January 23, 2017, the last trading day before the first public announcement of the proposed merger. The exchange ratio, and resulting
equivalent value of GenVec common stock, do not give effect to any payment under the contingent payment rights agreement.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intrexon
Common Stock
|
|
|
GenVec
Common
Stock
|
|
|
Exchange Ratio
|
|
|
Equivalent Value
of GenVec
Common Stock (Excluding the
Value of Contingent Payment
Rights)
|
|
January 23, 2017
|
|
$
|
22.09
|
|
|
$
|
4.54
|
|
|
|
0.297
|
|
|
$
|
6.56
|
|
April 19, 2017
|
|
$
|
20.12
|
|
|
$
|
6.07
|
|
|
|
0.297
|
|
|
$
|
5.98
|
|
The above table shows only historical comparisons, and these comparisons may not provide meaningful information to GenVec
shareholders in determining whether to adopt the merger agreement. The value of Intrexon common stock is subject to fluctuation and the consideration to GenVec shareholders will depend on the market value of Intrexon common stock at the time the
merger is completed. GenVec shareholders are urged to obtain current market quotations for Intrexon common stock and GenVec common stock and to review carefully the other information contained in this proxy statement/prospectus or incorporated by
reference into this proxy statement/prospectus in considering whether to adopt the merger agreement.
Dividend policy
Intrexon has never declared or paid any cash dividends on its capital stock. Intrexon currently intends to retain earnings, if any, to finance the growth and
development of its business. It does not expect to pay any cash dividends on its common stock in the foreseeable future. Intrexon has on two occasions distributed equity securities of other companies it owned to its shareholders as a special stock
dividend: 17,830,305 shares of ZIOPHARM common stock were distributed in June 2015 and 1,776,557 shares
17
of AquaBounty common stock were distributed in January 2017. Payment of future dividends, if any, will be at the discretion of Intrexons board of directors and will depend on its financial
condition, results of operations, capital requirements, restrictions contained in current or future financing instruments, provisions of applicable law and other factors that its board of directors deems relevant.
GenVec has never declared or paid any cash dividends on its capital stock and does not anticipate paying any cash dividends in the foreseeable future.
18
Comparative historical and unaudited pro forma per share data
The following table sets forth selected historical and unaudited pro forma per share information for Intrexon and GenVec for the year ended
December 31, 2016. The unaudited pro forma combined and pro forma combined equivalent net loss attributable to common shareholders per share information set forth in the following table reflects the merger as though it had occurred on
January 1, 2016. The unaudited pro forma book value and pro forma combined equivalent book value per common share at December 31, 2016 reflects the merger as though it had occurred on December 31, 2016. The information in the tables
is based on, and should be read together with, the historical financial information that Intrexon has presented in its filings with the SEC and the financial statements of GenVec and notes thereto included elsewhere in this proxy
statement/prospectus. See the section entitled Where you can find more information.
The pro forma data in the table assume that the merger is
accounted for using the acquisition method of accounting and represent current estimates based on available information of the combined companys results of operations for the periods presented. As of the date of this document, Intrexon has not
completed the detailed valuation studies necessary to arrive at the required estimates of the fair value of the GenVec assets to be acquired and liabilities to be assumed and the related allocations of purchase price, nor has it identified all the
adjustments necessary to conform GenVecs data to Intrexons accounting policies. However, Intrexon has made certain adjustments to the historical book values of the assets and liabilities of GenVec as of December 31, 2016 to reflect
certain preliminary estimates of the fair values necessary to prepare the unaudited pro forma combined and pro forma combined equivalent data. The fair value adjustments included in the unaudited pro forma combined and pro forma combined equivalent
data represent managements estimate of these adjustments based upon currently available information. The preliminary purchase price allocation assigned value to certain identifiable intangible assets, including GenVecs developed
technology and
know-how.
The pro forma information is preliminary and is subject to change once Intrexon has determined the final purchase price for GenVec and has completed the detailed valuation studies
necessary to finalize the pro forma combined and pro forma combined equivalent amounts included in this section, which changes could be material.
The unaudited pro forma combined and pro forma combined equivalent data per share data is presented for illustrative purposes only and is not necessarily
indicative of actual or future financial position or results of operations that would have been realized if the proposed merger had been completed as of the dates indicated or will be realized upon the completion of the proposed merger. All share
and per share amounts set forth in the following table with respect to GenVec common stock have been retroactively adjusted to reflect the reverse stock split.
|
|
|
|
|
|
|
Year ended December 31,
2016
|
|
Intrexon historical data:
|
|
|
|
|
Net loss attributable to common shareholders per share, basic and diluted
|
|
$
|
(1.58
|
)
|
Book value per common share
(1)
|
|
$
|
4.72
|
|
|
|
GenVec historical data:
|
|
|
|
|
Net loss per common share, basic and diluted
|
|
$
|
(2.78
|
)
|
Book value per common share
(1)
|
|
$
|
2.07
|
|
|
|
Unaudited pro forma combined:
(2)
|
|
|
|
|
Net loss attributable to common shareholders per share, basic and diluted
(3)
|
|
$
|
(1.63
|
)
|
Book value per common share
(1)
|
|
$
|
4.81
|
|
|
|
Unaudited pro forma combined equivalent data:
(4)
|
|
|
|
|
Net loss attributable to common shareholders per share, basic and diluted
|
|
$
|
(0.48
|
)
|
Book value per common share
|
|
$
|
1.43
|
|
(1)
|
The historical book value per common share is computed by dividing shareholders equity by the number of shares of common stock outstanding as of December 31, 2016. The unaudited pro forma combined book value
per share is computed by dividing the pro forma combined shareholders equity by the pro forma number of shares of Intrexon common stock outstanding as of December 31, 2016, assuming the merger had occurred as of that date. As of
December 31, 2016, there were 118,688,770 shares of Intrexon common stock outstanding.
|
19
(2)
|
The unaudited pro forma combined amounts for the year ended December 31, 2016 have been developed from the (i) historical financial information that Intrexon has presented in its filings with the SEC and
(ii) the financial statements of GenVec and notes thereto included elsewhere in this proxy statement/prospectus. As of December 31, 2016, there were 2,273,632 shares of GenVec common stock outstanding.
|
(3)
|
Unaudited pro forma net loss attributable to common shareholders per share, basic and diluted has been calculated as of December 31, 2016, after giving effect to the issuance of 696,281 shares assumed to be issued
in the merger.
|
This reflects (i) 675,269 shares of Intrexon common stock issued in exchange for the 2,273,632 shares of
GenVec common stock outstanding as of December 31, 2016, (ii) 21,012 shares of Intrexon common stock issuable pursuant to the exercise of the outstanding stock options of GenVec with an exercise price that is less than the implied price of
$7.00 per share of GenVec common stock in the merger, (iii) no shares of Intrexon common stock issuable pursuant to outstanding stock options of GenVec with an exercise price that is equal to, or in excess of, the implied price of $7.00 per
share of GenVec common stock in the merger, and (iv) no shares of Intrexon common stock issuable pursuant to the warrants to purchase shares of GenVec common stock as the exercise price per share is in excess of the implied price of $7.00 per
share of GenVec common stock in the merger.
The foregoing also assumes (x) the closing price of Intrexons common stock of
$20.12 as reported on the NYSE on April 19, 2017, and (y) any payment made in respect of the CPRs is made in cash and not shares of Intrexon common stock.
(4)
|
The unaudited pro forma combined equivalent data is calculated by multiplying the unaudited pro forma combined data amounts by the exchange ratio of 0.297.
|
20
Risk factors
By voting in favor of the merger proposal, GenVec shareholders will be choosing to invest in Intrexon common stock following the consummation of the
merger. An investment in Intrexon common stock involves a high degree of risk. In addition to the other information included and incorporated by reference in this proxy statement/prospectus, including the matters addressed in the section entitled
Cautionary note regarding forward-looking statements, you should carefully consider the following risks described below in evaluating whether to vote to approve the merger proposal. In addition, you should read carefully and consider the
risks associated with the businesses of each of Intrexon and GenVec because these risks will also affect the combined company. Information on risks associated with GenVecs business can be found below. Information on risks associated with
Intrexons business can be found in Intrexons Annual Report on Form
10-K
for the year ended December 31, 2016 as updated by any subsequent Quarterly Reports on Form
10-Q
and Current Reports on Form
8-K,
which are filed with the SEC and incorporated by reference into this proxy statement/prospectus. For further information regarding the
documents incorporated into this proxy statement/prospectus by reference, see the section entitled Where you can find more information. Realization of any of the risks described below, any of the events described under Cautionary
note regarding forward-looking statements or any of the risks or events described in the documents incorporated by reference could have a material adverse effect on Intrexons, GenVecs, or the combined companys businesses,
financial condition, cash flows and results of operations and could result in a decline in the trading prices of their respective common units.
Risks related to the merger
Failure to consummate
the merger could negatively impact the stock price and the future business and financial results of Intrexon and GenVec.
The merger agreement contains a number of customary conditions to closing, including the accuracy of Intrexons and GenVecs representations and
warranties to varying standards, the performance of each companys covenants, the absence of any legal prohibitions to closing, the adoption of the merger agreement by GenVec shareholders and certain other conditions. Many of the conditions to
closing are not within either Intrexons or GenVecs control and neither company can predict when or if these conditions will be satisfied.
If
any condition to the merger is not satisfied or waived, it is possible that the merger will not be consummated in the expected time frame or at all. In addition, Intrexon and GenVec may terminate the merger agreement under certain circumstances even
if the merger agreement is adopted by GenVec shareholders, including if the merger has not been completed, subject to certain conditions, on or before July 24, 2017. If the merger is not completed for any reason, the ongoing businesses of
Intrexon and GenVec may be adversely affected and the companies will be subject to several risks, including the following:
|
|
|
having to pay all of the fees and expenses incurred in connection with the proposed merger;
|
|
|
|
GenVec having to pay, under certain circumstances, a termination fee equal to $550,000;
|
|
|
|
GenVec having to reimburse, under certain circumstances, Intrexon for reasonable
out-of-pocket
expenses in an amount of up to $400,000 and
to pay, in certain circumstances, an additional expense amount equal to $200,000; and
|
|
|
|
focusing each companys management on the proposed merger instead of on pursuing other opportunities that could be beneficial to Intrexon and GenVec, without realizing any of the benefits of having the proposed
merger completed.
|
If the merger agreement is terminated, Intrexon or GenVec may be unable to find another party willing to engage in a
similar transaction on terms as favorable as those set forth in the merger agreement, or at all. The negative publicity that could accompany such a termination could adversely impact GenVecs ability to find an alternate partner for a strategic
transaction or to obtain required financing for any such transaction.
In addition, although Intrexon and GenVec are not aware of any material
governmental approvals, waivers or actions that are required to complete the merger, if any such approvals, waivers or actions are required, there can be no assurance, that any such waivers, approvals or actions will be obtained.
Failure to complete the merger could result in a decrease in the market price of GenVec common stock to the extent that the current market price of those
shares reflects a market assumption that the merger will be completed. In addition, neither company would realize any of the expected benefits of having completed the merger. Further, failure to complete the merger could result in damage to
GenVecs reputation and business relationships. GenVec could also be subject to litigation related to any failure to consummate the merger or related to any enforcement proceedings commenced against GenVec to perform its obligations under the
merger agreement.
Therefore, a failure to consummate the merger could materially and adversely affect Intrexons or GenVecs business,
financial results and stock price, and could limit each companys ability to pursue its strategic goals.
GenVec has suffered recurring losses
from operations and has an accumulated deficit, which raises substantial doubt about its ability to continue as a going concern, and, if the merger is not consummated, absent additional financing, GenVec may be unable to remain a going concern.
GenVec has suffered recurring losses from operations and has an accumulated deficit. If the merger is not consummated and GenVec is unsuccessful
in its efforts to raise additional capital, based on GenVecs current levels of operating expenses, GenVecs current capital is not expected to fund its operations for the next twelve months. These conditions raise substantial
21
doubt about GenVecs ability to continue as a going concern. The Report of Independent Registered Public Accounting Firm at the beginning of the GenVecs audited financial statements
included in this proxy statement/prospectus includes an explanatory paragraph about GenVecs ability to continue as a going concern.
The
financial statements of GenVec included herein were prepared on the basis of a going concern, which contemplates that GenVec will be able to realize its assets and discharge liabilities in the normal course of business. GenVecs financial
statements do not include any adjustments that might be necessary if GenVec is unable to continue as a going concern. In addition, GenVecs financial situation and the presence of an explanatory paragraph about GenVecs ability to
continue as a going concern could make it more difficult to raise the capital necessary to address GenVecs current needs.
Because the market
price of Intrexon common stock will fluctuate, you cannot be sure of the market value of the shares of Intrexon common stock you will receive in the merger.
Upon completion of the merger, each share of GenVec common stock that you hold will be converted into the right to receive the per share merger consideration
consisting of (i) 0.297 shares of Intrexon common stock plus (ii) one CPR. There will be no adjustment to the per share merger consideration due to changes in the market price of either shares of GenVec common stock or shares of Intrexon common
stock and the merger agreement does not provide for any price-based termination right. Accordingly, the market value of the shares of Intrexon common stock that you will be entitled to receive upon completion of the merger will depend on the market
value of the shares of Intrexon common stock at the time of the completion of the merger and could vary significantly from the market value on the date of this proxy statement/prospectus or the date of the special meeting. In addition, the market
value of the shares of Intrexon common stock that you will be entitled to receive in the merger with respect to the stock consideration also will continue to fluctuate after the completion of the merger and you could lose the value of your
investment in Intrexon common stock.
Such variations could be the result of changes in the business or operations of GenVec or Intrexon prior to the
merger and Intrexon following the merger, market assessments of the likelihood that the merger will be completed or the timing of the completion of the merger, general market and economic conditions and other factors both within and beyond the
control of GenVec or Intrexon. Because the merger will be completed after the special meeting, at the time of the meeting you will not know the value of the merger consideration that you will receive upon completion of the merger.
The contingent payment rights may not result in payments to holders.
Under the terms of the merger agreement, each share of GenVec common stock issued and outstanding immediately prior to the effective time of the merger (other
than shares with respect to which appraisal rights are properly exercised or shares owned by Intrexon, any of its subsidiaries or GenVec), and each share of GenVec common stock underlying a warrant to purchase shares of GenVec common stock that is
converted into a warrant to purchase merger consideration in connection with the merger, will, upon the effective time of the merger or, with respect to a warrant, upon the exercise of such warrant, be converted into the right to receive 0.297 of a
share of Intrexon common stock and a CPR that entitles the holder to receive, without interest and subject to applicable withholding tax, a portion of (i) milestone payments received by Intrexon or the surviving corporation for milestones that
are achieved or occur, and (ii) royalty payments received by Intrexon or the surviving corporation, in each case, under the NVS License Agreement within 36 months after the closing of the merger. As of the date hereof, the first four
development and regulatory milestones under the NVS License Agreement have been met. As of the date hereof, GenVec has not received any royalty payments from Novartis under the NVS License Agreement. GenVec cannot determine whether any milestones
will be achieved or occur within the
36-month
period after the closing of the merger, and it does not expect that any royalty payments will be made during that period. Accordingly, neither Intrexon nor GenVec
can assure you that any milestone or royalty payments will be received by Intrexon or the surviving corporation after the date hereof. If these payment events do not occur, no payments will be made under the contingent payment rights agreement.
Accordingly, the CPRs may ultimately have no value and expire without yielding any payments to holders of CPRs. It is difficult to value the CPRs, and the amount of actual payments on the CPRs is highly speculative.
You will not be able to determine the amount of payment (if any) to be received under the contingent payment rights until certain milestone or royalty
payments have been made by Novartis.
If any payment is made on the CPRs, it will not be made until certain milestones are achieved or occur or
certain royalty payments are earned under the NVS License Agreement and Intrexon or the surviving corporation has received payments for such milestones or royalties. GenVec cannot determine whether any milestones will be achieved or occur within the
36-month
period after closing of the merger, and it does not expect that any royalty payments will be made during that period. After receipt of such amounts (if any), the holders of the CPRs would collectively
be entitled to receive 50% of the amounts received by Intrexon or the surviving corporation in respect of such milestone or royalty payments. There is no guarantee that any milestones will be achieved or occur or that any milestone or royalty
payments will be made under the NVS License Agreement.
The contingent payment rights are not registered and may not be transferred except in
certain limited circumstances.
The CPRs that will be issued as part of the merger consideration, or upon exercise of each warrant to purchase
shares of GenVec common stock that is converted into a warrant to purchase merger consideration in connection with the merger, will not be registered under the Securities Act and will not be listed on any exchange. Intrexon does not intend to, and
is not obligated to, register the CPRs or list them on an exchange. Subject to certain limited exceptions, holders of CPRs will not be able to transfer
22
or sell the CPRs. As a result, GenVec shareholders should anticipate holding the CPRs until such time as they expire. In addition, until such time as any royalty or milestone payments are made
under the NVS License Agreement (if any), the CPRs will be difficult to value and may not ultimately result in any additional amounts being payable to the GenVec shareholders.
The U.S. federal income tax treatment of the contingent payment rights is unclear.
Although Intrexon and GenVec intend to treat the merger as a reorganization under Section 368(a) of the Code, the tax treatment of CPRs could impact whether
or not the merger will qualify as a reorganization under Section 368(a) of the Code. In that regard, there is no legal authority directly addressing the U.S. federal income tax classification of a CPR or the treatment of payments that may be
received pursuant to a CPR. Accordingly, the impact of CPRs on the tax treatment of the merger and the amount, timing and character of any gain, income or loss with respect to the CPRs are uncertain. Due to the legal and factual uncertainties
regarding the tax treatment of CPRs, GenVec shareholders are urged to consult their own tax advisers to determine the timing and characterization of income, gain or loss resulting from receipt of payments (if any) pursuant to the CPRs. See the
section entitled Material U.S. federal income tax consequences of the merger.
Tax matters are very complicated, and the tax consequences of
the merger to a particular GenVec shareholder will depend in part on such shareholders circumstances. Accordingly, you are urged to consult your own tax advisor for a full understanding of the tax consequences of the merger to you, including
the applicability and effect of federal, state, local and foreign income and other tax laws.
If the merger is consummated, Intrexon may not realize
the anticipated benefits of the merger.
The success of the GenVec acquisition, if completed, will depend, in part, on Intrexons ability to
realize the anticipated benefits from combining GenVecs business with Intrexons business, including the ability to expand on GenVecs expertise in adenoviral vectors and the current Good Manufacturing Practices, which we refer to as
cGMP, of the U.S. Food and Drug Administration, which we refer to as the FDA, drug product manufacturing to enhance Intrexons gene transfer capabilities and to expedite the design and production of vectors that complement Intrexons
multigene programming and focus on safety with limited
off-target
effect. The combined company will require additional resources to accomplish Intrexons goals for the merger, and Intrexon may not have
the resources to accomplish these goals, or may choose to spend those resources on other business opportunities.
Integrating operations will be complex
and will require significant efforts and expenditures on the part of both Intrexon and GenVec. Intrexons management might have its attention diverted while trying to integrate operations and corporate and administrative infrastructures. GenVec
will continue to operate independently of Intrexon until the closing of the acquisition, which is expected to take place in the second quarter of 2017. The integration process could result in the loss of key employees, the disruption of each
companys ongoing businesses, tax costs or inefficiencies, or inconsistencies in standards, controls, information technology systems, procedures and policies, any of which could adversely affect Intrexons and GenVecs ability to
maintain relationships with customers, employees or other third parties or Intrexons ability to achieve the anticipated benefits of the GenVec acquisition and could harm Intrexons financial performance.
If Intrexon is unable to successfully or timely integrate the operations of GenVecs business into Intrexons business, Intrexon may be unable to
realize the anticipated benefits resulting from the proposed acquisition and its business and results of operations could be adversely affected.
The pendency of the merger could adversely affect the business and operations of each of Intrexon and GenVec.
Some customers and collaborators of each of Intrexon and GenVec may delay or defer decisions because of uncertainties or lack of understanding about the
mergers potential effect on their businesses, which could negatively impact the revenues, earnings, cash flows and expenses of Intrexon and/or GenVec, regardless of whether the merger is completed. Similarly, current and prospective employees
of Intrexon and GenVec may experience uncertainty about their roles with the combined company following the merger, which may materially adversely affect the ability of each of Intrexon and GenVec to attract, retain and motivate key personnel during
the pendency of the merger and which may materially adversely divert attention from the daily activities of Intrexon and GenVecs existing employees.
Intrexon will incur significant transaction costs as a result of the merger.
Intrexon expects to incur significant
one-time
transaction costs related to the merger. These transaction costs
include legal and accounting fees and expenses and filing fees, printing expenses and other related charges. Intrexon may also incur additional unanticipated transaction costs in connection with the merger. A portion of the transaction costs related
to the merger will be incurred regardless of whether the merger is completed. Additional costs will be incurred in connection with integrating the two companies businesses. Costs in connection with the merger and integration may be higher than
expected. These costs could adversely affect Intrexons financial condition, operating results or prospects of the combined company.
The
merger agreement limits GenVecs ability to pursue alternatives to the merger.
Under the merger agreement, GenVec agreed not to, beginning
on the date of the merger agreement, (i) solicit alternative acquisition proposals or (ii) engage or participate in discussions or negotiations with, or provide
non-public
information to, any person
relating to any such alternative acquisition proposal, subject to certain limited exceptions. Intrexon generally has an opportunity to offer to modify the terms of the proposed merger in response to any competing acquisition proposal that may be
made before the GenVec board of directors may withdraw or change its recommendation to GenVecs shareholders.
23
If the merger agreement is terminated in certain circumstances, GenVec would be required to pay Intrexon a
termination fee equal to $550,000. See the section entitled The merger agreement Covenants regarding alternative acquisition proposals and The merger agreement Termination fee. In addition, if the merger
agreement is terminated under certain circumstances, GenVec would be required to compensate Intrexon for its actual reasonable
out-of-pocket
costs and expenses up to
$400,000, plus an additional expense amount equal to $200,000. See the section entitled The merger agreement Costs and expenses.
These
provisions could discourage a third party that might have an interest in acquiring all or a significant part of GenVec from considering or proposing such an acquisition, even if it were prepared to pay consideration with a higher per share cash or
market value than that market value proposed to be received or realized in the merger, or could result in a third party proposing to pay a lower price than it might otherwise have proposed to pay because of the added expense of the termination fee
(or the expense reimbursement and additional expense amount) that becomes payable to Intrexon in certain circumstances.
If the merger agreement is
terminated and GenVec decides to seek another business combination, it may not be able to negotiate a transaction with another party on terms comparable to, or better than, the terms of the merger.
Under the terms of the merger agreement, GenVec is subject to certain restrictions on its business activities.
The merger agreement generally requires GenVec to operate its business in the ordinary course pending consummation of the merger, and restricts GenVec from
taking certain specified actions until the merger is completed. These restrictions may prevent GenVec from making desirable expenditures, including capital expenditures, pursuing otherwise attractive business opportunities and making other changes
to its business prior to completion of the merger or termination of the merger agreement. See the section entitled The merger agreement Covenants Interim conduct of GenVecs business.
Certain executive officers and directors of GenVec may have interests in the merger that may differ from, or are in addition to, the interests of GenVec
shareholders.
Executive officers of GenVec negotiated the terms of the merger agreement and the GenVec board of directors unanimously determined
that the merger agreement, the merger and the other transactions contemplated by the merger agreement are fair and advisable to, and in the best interest of, GenVec and its shareholders, unanimously approved the execution, delivery and performance
by GenVec of the merger agreement and the consummation of the merger and the other transactions contemplated by the merger agreement, and unanimously recommended that the GenVec shareholders vote in favor of the adoption and approval of the merger
agreement. In considering these facts and the other information contained in this proxy statement/prospectus, you should be aware that GenVecs executive officers and directors may have interests in the merger that are different from, or in
addition to, the interests of GenVec shareholders generally. For a detailed discussion of the special interests that GenVecs directors and executive officers may have in the merger, see the section entitled The MergerInterests of
GenVecs directors and executive officers in the merger.
The market price of Intrexon common stock after the merger may be affected by
factors different from those currently affecting the financial condition, results of operations and business of GenVec.
Upon completion of the
merger, holders of GenVec common stock will become holders of Intrexon common stock. Intrexons business differs from that of GenVec in important respects, and, accordingly, the financial condition and operating results of the combined company
and the market price of Intrexon common stock after the completion of the merger may be affected by factors different from those currently affecting the financial condition and operating results of GenVec.
The issuance of Intrexon common stock in connection with the merger could decrease the market price of Intrexon common stock.
At the completion of the merger, Intrexon expects to issue up to approximately 696,281 shares of Intrexon common stock, or approximately [●]% of the
number of shares of Intrexon common stock outstanding as of the record date, to GenVec shareholders in the merger. The issuance of the Intrexon common stock may result in fluctuations in the market price of Intrexon common stock, including a stock
price decline.
The foregoing assumes that no shares of Intrexon common stock are issued to holders of CPRs. If shares of Intrexon common stock are issued
to holders of CPRs, such additional issuances may result in further fluctuations in the market price of Intrexon common stock.
The shares of
Intrexon common stock to be received by GenVec shareholders as a result of the merger will have different rights from the shares of GenVec common stock.
Upon completion of the merger, GenVec shareholders will become Intrexon shareholders and their rights as shareholders will be governed by Intrexons
amended and restated articles of incorporation, Intrexons amended and restated bylaws, and Virginia law. Certain of the rights associated with GenVec common stock are different from, and may be viewed as more favorable than, the rights
associated with Intrexon common stock. See the section entitled Comparison of rights of shareholders of Intrexon and GenVec for a discussion of the different rights associated with Intrexon common stock.
24
The issuance of additional equity securities by Intrexon in capital raising transactions or strategic
transactions after completion of the merger would result in additional dilution to existing shareholders.
To the extent Intrexon raises
additional capital by issuing equity securities, including in a debt financing where Intrexon issues convertible notes or notes with warrants, or issues additional equity in a strategic transaction, Intrexons shareholders may experience
substantial dilution. Intrexon may, from time to time, issue common stock in one or more transactions at prices and in a manner it determines. If Intrexon issues common stock, existing shareholders may be materially diluted. In addition, new
investors could gain rights superior to existing shareholders, such as liquidation and other preferences.
GenVec shareholders will have a reduced
ownership and voting interest in Intrexon as compared with their interest in GenVec and will exercise less influence over management.
GenVec
shareholders currently have the right to vote in the election of directors of GenVec and on certain other matters affecting GenVec. Based on the number of GenVec shares of common stock outstanding as of April 19, 2017, Intrexon expects to issue
approximately 696,281 shares of its common stock to GenVec shareholders in the merger (assuming no shares of Intrexon common stock are issued to the holders of CPRs). The actual number of shares of Intrexon common stock to be issued in the merger
will be determined at the completion of the merger based on the number of GenVec shares outstanding at the time of the consummation of the merger, subject to adjustment as described herein. Immediately after the consummation of the merger, and based
on the number of shares of Intrexon common stock outstanding as of the record date, it is expected that former GenVec shareholders will own approximately [●]% of the [●] shares of Intrexon common stock then outstanding. Because of this,
GenVecs shareholders will have substantially less influence on the management and policies of Intrexon than they now have with respect to the management and policies of GenVec.
If the proposed merger is not completed, GenVec will have incurred substantial costs that could adversely affect GenVecs financial results and
operations and the market price of GenVec common stock.
If the merger is not completed, the
on-going
business of GenVec may be adversely affected. Without having realized any of the benefits of the merger, GenVec will be subject to a number of risks, including:
|
|
|
GenVec will be required to pay its costs relating to the proposed merger if the merger is not completed;
|
|
|
|
GenVec may be required to pay a termination fee to Intrexon or to reimburse Intrexon for certain transaction-related expenses as described in the sections entitled The merger agreementTermination fee
and The merger agreementCosts and expenses;
|
|
|
|
the merger agreement provides for certain restrictions on the operations of GenVecs business prior to the completion of the merger, which may affect GenVecs ability to execute certain of its business
strategies; and
|
|
|
|
matters relating to the merger will require substantial commitments of time and resources by GenVecs management team, and GenVecs management team will not have devoted as much time and resources to other
opportunities that may have been beneficial to GenVec as a stand-alone company.
|
GenVec may also be subject to litigation related to any
failure to complete the merger. If the merger is not completed, these risks may materialize and may adversely affect GenVecs business and financial results and the market price of GenVec common stock.
If the proposed merger is not completed, GenVecs ability to continue as a stand-alone company may be uncertain.
GenVecs ability to continue as a stand-alone company, including its ability to secure necessary funding for its operations, may face uncertainty if the
merger is not completed. GenVecs ability to execute on its operating strategy may also be affected by the failure to complete the merger. For example, potential licensees or other collaborators may be reluctant to enter into arrangements with
GenVec on terms that are acceptable to it, or at all, because of any concerns regarding GenVecs long-term stability and plans raised by entering into the merger agreement and then failing to complete the merger. Accordingly, GenVec may not be
able to successfully execute its operating strategy.
In addition, if the merger is not completed and the GenVec board of directors seeks another merger
or business combination, GenVec shareholders cannot be certain that GenVec will be able to find a party willing to offer equivalent or more attractive consideration than the per share merger consideration Intrexon has agreed to provide in the
merger.
The integration of GenVec and other acquired businesses may present significant challenges to Intrexon.
Achieving the anticipated benefits of the merger will depend in part upon whether GenVec and Intrexon can integrate their businesses in an efficient and
effective manner. The combination of two independent businesses is a complex, costly and time-consuming process. The integration of GenVec and any future businesses that Intrexon may acquire involves a number of risks, including, but not limited to:
|
|
|
the diversion of managements attention from the management of daily operations to the integration of operations;
|
25
|
|
|
higher integration costs than anticipated;
|
|
|
|
failure to achieve anticipated synergies, cost savings, business opportunities and growth prospects from the combination;
|
|
|
|
difficulties in assimilating and retaining employees and in attracting key personal;
|
|
|
|
difficulties in developing GenVecs AdenoVerse technology platform; and
|
|
|
|
difficulties in the integration of departments, systems, including accounting systems, technologies, books and records, and procedures, as well as in maintaining uniform standards, controls, including internal control
over financial reporting required by the Sarbanes-Oxley Act of 2002, and related procedures and policies.
|
Many of these factors are outside
of the control of Intrexon and GenVec, and will be outside the control of the combined company, and any one of them could result in increased costs, decreased expected revenues and diversion of management time and energy, which could materially
impact the business, financial condition and results of operations of the combined company. In addition, even if the operations of the businesses of Intrexon and GenVec are integrated successfully, the full benefits of the merger may not be
realized, including, among others, the synergies, cost savings or sales or growth opportunities that are expected. These benefits may not be achieved within the anticipated time frame, or at all. Further, additional unanticipated costs may be
incurred in the integration of the businesses of Intrexon and GenVec. All of these factors could cause dilution to the earnings per share of the combined company, decrease or delay the expected accretive effect of the merger, and negatively impact
the price of the combined company ordinary shares. As a result, it cannot be assured that the combination of Intrexon and GenVec will result in the full realization of the benefits anticipated from the transaction within the anticipated time frames
or at all.
Risks related to Intrexon and its business
You should read and consider the risk factors specific to Intrexons business that will also affect the combined company after the merger. These risks are
described in Part I, Item 1A of Intrexons Annual Report on Form
10-K
for the fiscal year ended December 31, 2016, and in other documents that are incorporated by reference into this proxy
statement/prospectus. See the section entitled Where you can find more information for the location of information incorporated by reference in this proxy statement/prospectus.
Risks related to GenVec and its business
GenVec
has a history of losses and anticipates future losses.
GenVec has incurred net losses in each year since its inception in December 1992,
including a net loss of $5.8 million for the year ended December 31, 2016. As of December 31, 2016, GenVec had an accumulated deficit of approximately $290.6 million. GenVec is unsure if or when it will become profitable. The
size of GenVecs net losses will depend on its revenues and its expenses.
GenVec has derived its revenues primarily from payments from
collaborations with corporations and government entities and expects to do so for the foreseeable future. It may be years, if ever, before GenVec recognizes revenue from product candidate sales or royalties. While GenVec has taken efforts to control
costs throughout 2016 and into 2017, a large portion of its expenses are fixed, including expenses related to facilities, equipment and personnel, and GenVecs ability to continue to meaningfully reduce costs is limited. In addition, GenVec
expects to continue to spend significant amounts to fund research and development to advance its programs and to enhance its core technologies. As a result of its operating expenses, GenVec will need to generate significant additional revenue to
achieve profitability. Even if GenVec does achieve profitability, it may not be sustainable.
GenVec is a biopharmaceutical company deploying
unproven technologies, and it may never be able to develop, obtain regulatory approval of, or market any of its product candidates.
Gene-based
products are new and rapidly evolving medical approaches, which have not been shown to be effective on a widespread basis. Only a limited number of gene-based products have been successfully developed and commercialized to date. In addition, no gene
therapy product has received regulatory approval in the U.S. None of GenVecs product candidates has been approved for sale in the U.S. or elsewhere. Gene-based products may be susceptible to various risks, including undesirable and unintended
side effects from genes or the delivery systems, unintended immune responses, inadequate therapeutic efficacy, or other characteristics that may prevent or limit their approval or commercial use. Successful products require significant development
and investment, including a lengthy and uncertain period of testing to show their safety and effectiveness before their regulatory approval or commercialization. Other than GenVecs limited conditional approval with respect to its
foot-and-mouth
disease (which we refer to as FMD) vaccine, GenVec has not proven its ability to develop, obtain regulatory approval of, or commercialize gene-based medicines
or vaccines.
26
If GenVec or its collaborators fail to adequately show the safety and efficacy of GenVecs
product candidates, GenVec will not be able to obtain FDA approval of its product candidates.
GenVec faces the risk of failure involved in
developing therapies based on new technologies and the difficulties generally associated with drug development. CGF166 is the only product candidate that GenVec and its collaborators currently have in clinical trials. Novartis initiated dosing in a
Phase 1/2 clinical trial of CGF166 in October 2014. On January 8, 2016, GenVec was notified by Novartis that enrollment in the clinical trial had been paused, based on a review of data by the trials Data Safety Monitoring Board,
referred to herein as its DSMB, in accordance with criteria in the trial protocol, and the FDA placed the clinical trial on hold. The FDA lifted the clinical hold on July 25, 2016 and the Phase 1/2 clinical trial of CGF166 is currently ongoing.
In February 2017, GenVec was notified that the first patient in the fourth cohort of the trial had been dosed.
Significant additional research and animal
testing, referred to as preclinical testing, will need to be conducted before any of GenVecs other product candidates currently under active development can advance to clinical trials. It may take GenVec many years to complete preclinical
testing or trials, and GenVec expects that doing so will be dependent on its ability to enter into collaborations. Drug development is an uncertain scientific and medical endeavor, and failure could occur at any stage of development. Acceptable
results in early testing or trials might not be repeated later. Not all products in preclinical testing or early stage clinical trials will become approved products, and historically there is a high rate of attrition for product candidates in
preclinical and clinical trials due to scientific feasibility, safety, efficacy, changing standards of medical care and other variables. Before an application can be filed with the FDA for product approval, GenVec or its collaborators must show that
a particular product candidate is safe and effective. Even with respect to product candidates that advance to clinical trials, GenVec or its collaborators must demonstrate the safety and efficacy of those product candidates before FDA approval can
be secured. The failure to adequately show the safety and effectiveness of GenVecs product candidates would prevent FDA approval of its products. Any one of GenVecs product candidates could fail at any time, as clinical development of
drug candidates presents numerous unpredictable and significant risks and is very uncertain at all times prior to regulatory approval by the FDA or health authorities in other major markets.
Because regulatory approval must be obtained to market GenVecs products, GenVec cannot predict whether or when its products will be
commercialized; failure to comply with applicable regulations can also harm its business and operations.
Biologic products are subject to
stringent regulation by a wide range of governmental authorities. GenVec cannot predict whether GenVec or its collaborators will obtain regulatory approval for any of GenVecs products. No one can market a biologic product in the U.S. until it
has completed rigorous preclinical testing, clinical trials, and an extensive regulatory approval process implemented by the FDA. To date, the FDA has not approved a gene therapy product for sale in the U.S. Satisfaction of regulatory requirements
typically takes many years, is dependent upon the type, complexity, and novelty of the product, and requires the expenditure of substantial resources. Of particular significance are the requirements covering research and development, testing,
manufacturing, quality control, labeling, and promotion of drugs for human use.
Before commencing clinical trials, GenVec or its collaborators must
submit an investigatory new drug application, which we refer to as an IND application, to the FDA and wait for the IND to become effective 30 days following its receipt by the FDA. Even after an IND becomes effective, however, a clinical trial is
subject to continuing oversight by an Institutional Review Board, referred to herein as an IRB, and the FDA, and in some cases by a DSMB, or a Data Monitoring Committee, referred to herein as a DMC.
Clinical trials are also subject to:
|
|
|
Good clinical practices regulations, which include a requirement for each subjects informed consent; and
|
|
|
|
Potential suspension or termination by GenVec conducting the clinical trial, the IRB, or the FDA at any time if, among other reasons, it is believed that the subjects participating in these trials are being exposed to
unacceptable health risks or if the FDA finds deficiencies in the IND or the conduct of the trials.
|
Delays or rejections in the regulatory
approval process may be encountered because of additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials, or FDA regulatory review.
Failure to comply with applicable FDA or other regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products,
total or partial suspension of production, or injunction, as well as other regulatory action against GenVecs product candidates or GenVec. If regulatory approval of a product is granted, this approval will be limited to those disease
indications for which the product has been shown through clinical trials to be safe and effective. Even if approved, a product may not be approved for the indications that are necessary or desirable for successful commercialization, or the FDA may
impose restrictions on distribution of the product that may materially impact GenVecs operations. The FDA also strictly regulates promotion and labeling after approval. Outside the U.S., the ability to market a product is also contingent upon
receiving clearances from the appropriate regulatory authorities. This
non-U.S.
regulatory approval process includes risks similar to those associated with FDA clearance described above and is subject to the
independent judgments, policies, priorities and decisions of the applicable regulatory authorities, which may differ from those of the FDA.
27
GenVec or its collaborators may experience delays in conducting GenVecs clinical trials.
Clinical trials may be delayed or prematurely terminated by many factors, including: (i) limited number of, and competition for, suitable
patients for the particular clinical trial; (ii) slower than expected rate of patient recruitment and enrollment; (iii) failure of patients to complete the trial; (iv) inability to obtain sufficient quantities of acceptable materials
for use in clinical trials; (v) delay or failure in reaching agreement on contract terms with prospective study sites or other third-party vendors who are supporting GenVecs clinical trials; (vi) inability to reach agreement with the
FDA on a trial design that GenVec is able to execute; (vii) difficulty in adequately following up with patients after treatment; and (viii) changes in laws, regulations, regulatory policy or clinical practices. GenVecs ability or the
ability of its collaborators to enroll appropriate patients for any clinical trials for GenVecs product candidates also may be adversely affected by trials being conducted by GenVecs competitors for similar disease indications. The
failure of any clinical trials to meet applicable regulatory standards, or the standards of the relevant reviewing bodies could cause such trials to be delayed, suspended or terminated, which could further delay the development of any of
GenVecs product candidates. Any such delays increase GenVecs product development costs, with the possibility that GenVec could be required to raise additional funds. Delays in one clinical trial also can adversely affect GenVecs
ability and the ability of its collaborators to launch clinical trials for similar or different indications. Consequently, if such delays are significant they could negatively affect GenVecs financial results and the commercial prospects for
its products.
Additionally, clinical trials may be suspended or terminated at any time by the FDA, an IRB, a DSMB or DMC, other regulatory authorities,
or by GenVec for a variety of reasons, including safety. In January 2016, Novartis paused enrollment in the clinical trial of CGF166, based on a review of data by the trials DSMB in accordance with criteria in the trial protocol, and the FDA
placed the clinical trial on hold. The FDA lifted the clinical hold on July 25, 2016, and the Phase 1/2 clinical trial of CGF166 is currently ongoing. In February 2017, GenVec was notified that the first patient in the fourth cohort of the
trial had been dosed. Any failure or significant delay in completing clinical trials for GenVecs product candidates could harm its financial results and commercial prospects for its product candidates.
Any clinical trial may fail to produce results satisfactory to the FDA. Preclinical and clinical data can be interpreted in different ways, and the FDA may
not agree with GenVecs interpretations, which could delay, limit or prevent regulatory approval. Negative or inconclusive results or adverse medical events during a clinical trial could cause a trial to be delayed or repeated or a program to
be terminated.
GenVec does not currently have any late stage clinical trials in its therapeutic product or vaccine development programs and,
therefore, GenVec does not have any near-term prospects of generating revenues from the commercial sale of its therapeutic or vaccine products.
GenVec does not currently have any therapeutic products or vaccines in late stage clinical programs, and the one product of GenVecs that has received
some approval is its FMD vaccine, for which a conditional license was issued that is applicable in certain emergency or similar situations. Accordingly, GenVec does not have any near-term prospects of generating revenues from the commercial sale of
its product candidates in its therapeutic product or vaccine programs. In October 2014 Novartis initiated dosing in a Phase 1/2 clinical trial of CGF166. In January 2016, Novartis paused enrollment in the clinical trial, and the FDA placed the
clinical trial on hold. The FDA lifted the clinical hold on July 25, 2016. The Phase 1/2 clinical trial of CGF166 is currently ongoing. However, there can be no assurance that CGF166 will successfully complete that trial, much less enter or
successfully complete any other clinical trial. There also can be no assurance that any of GenVecs other therapeutic products or its vaccines will enter or successfully complete the clinical trials required for commercialization.
GenVec does not know if its strategy will be successful.
GenVecs operating strategy focuses on working with leading companies and organizations such as Novartis and the U.S. government to leverage
GenVecs proprietary gene-delivery technologies to address the prevention and treatment of significant health concerns. This strategy includes working with Novartis to facilitate the development of
first-in-class
products for the treatment of hearing and balance disorders, developing a sustainable revenue base by licensing rights to GenVecs proprietary vector and cell line technologies to
additional companies and organizations, licensing its preclinical vaccine candidates for the prevention of respiratory syncytial virus, which we refer to as RSV, and the treatment of herpes simplex virus 2, which we refer to as
HSV-2,
infection, and minimizing its cash burn by operating its business in a cost-efficient manner. This operating strategy may not be successful, and is largely dependent on the success of GenVecs
collaboration agreement with Novartis, of which there can be no assurance, and GenVecs ability to enter into additional collaborations, which GenVec has only been able to do to a limited extent.
A central aspect of GenVecs business strategy is to enter into collaborations with other companies to develop, obtain regulatory approval of, and
commercialize its potential products, and if GenVec is unable to find collaborators or sustain existing relationships, GenVec may not be able to generate revenue and advance its products.
A central aspect of GenVecs business strategy is to enter into collaborations to support the development of its products. GenVecs lead program, in
the field of regenerative medicine and licensed to Novartis, is for the development of novel treatments for hearing loss and balance disorders. In addition to this program, GenVec intends to license rights to its proprietary vector and cell line
technologies to additional companies and organizations and license its preclinical vaccine candidates for the prevention of RSV and the treatment of
HSV-2
infection. There can be no assurance that GenVec will
be able to enter into licensing and other collaboration agreements on terms that are acceptable to GenVec, or at all. If GenVec is not able to enter into and sustain
28
license or other collaboration agreements, it would not be able to develop a sustainable revenue base, and it would need to raise additional funds for the development and commercialization of
GenVecs product candidates and technologies and develop additional capabilities in testing, manufacturing, marketing and sales, among other areas. If GenVec is not able to enter into successful collaborations or obtain additional funds through
other means, it would have to delay, curtail or abandon the development and commercialization of certain product candidates and technologies.
GenVec intends to continue to seek support for its government funded contracts and collaborations for the development of new vaccines, but GenVecs
existing agreements are subject to termination and uncertain future funding and there is no certainty that GenVec will be able to enter into new agreements.
In addition to corporate collaborations, GenVec has historically entered into agreements with U.S. government agencies, such as the National Institute of
Allergy and Infectious Diseases of the National Institutes of Health, the U.S. Department of Homeland Security, the U.S. Department of Agriculture, herein referred to as USDA, and the U.S. Naval Medical Research Center to support GenVecs
vaccine research. These and similar agreements have historically accounted for a substantial portion of GenVecs revenues, and GenVec intends to continue entering into these agreements in the future. GenVecs business strategy is partially
dependent on collaboration agreements with U.S. government agencies and on the ability of these government agencies to perform under these agreements, which performance depends on adequate continued funding of the agencies and their programs.
GenVec has no control over the resources and funding government agencies may devote to any collaboration agreements with GenVec, which may be subject to
annual renewal and which generally may be terminated by the government agencies at any time. Any significant reductions in the funding of U.S. government agencies or in the funding areas targeted by GenVecs business could materially and
adversely affect its business, results of operations, and financial condition. If GenVec was to fail to satisfy its contractual obligations to deliver in the manner required by a collaboration agreement with a U.S. government agency, the applicable
Federal Acquisition Regulations allow the agency to cancel the agreement in whole or in part, and GenVec may be required to perform corrective actions, including but not limited to delivering to the government any uncompleted or partially completed
work. The performance of these corrective actions could have a material adverse impact on GenVecs financial results in the period or periods affected. Government agencies may fail to perform their responsibilities under these agreements, which
could materially impact GenVecs financial results.
In addition, GenVecs contract-related costs and fees, including allocated indirect costs,
are subject to audits and adjustments by negotiation between GenVec and the U.S. government. As part of the audit process, the government audit agency verifies that all charges made by a contractor against a contract are legitimate and appropriate.
Audits may result in recalculation of contract revenues and
non-reimbursement
of some contract costs and fees. Any audits of GenVecs contract-related costs and fees could result in material adjustments
to its revenues. In addition, U.S. government contracts are conditioned upon the continuing availability of Congressional appropriations. Congress usually appropriates funds on a fiscal year basis even though contract performance may take several
years. Consequently, at the outset of a major program, the contract is usually incrementally funded and additional funds are normally committed to the contract by the procuring agency as appropriations are made by Congress for future fiscal years.
Any failure of such agencies to continue to fund such contracts could have a material adverse effect on GenVecs business, results of operations, and financial condition.
GenVec applies for and has received funding from government agencies under Small Business Technology Transfer and Small Business Innovation Research grants.
Eligibility of public companies to receive such grants is based on size and ownership criteria that are under review by the Small Business Administration. As a result, its eligibility may change in the future and additional funding from this source
may not be available.
GenVec depends, and anticipates depending further, on corporate collaborators for the development of GenVecs product
candidates.
When GenVec signs a collaboration agreement, license agreement or similar agreement with a collaborator to develop a product
candidate, it will generally expect the collaborator to further the development of the product candidate, which could include the design and conduct of clinical trials, the preparation and filing of documents necessary to obtain regulatory approval,
and the manufacturing, sale, marketing and other commercialization of the product if it obtains regulatory approval. GenVec may also grant the collaborator certain rights. For example, under the terms of the NVS License Agreement, GenVec granted
Novartis certain exclusive, worldwide rights in specified intellectual property related to GenVecs atonal gene program and atonal adenovectors, as well as
non-exclusive,
world-wide rights to certain
other intellectual property related to GenVecs hearing loss and balance disorders program and its adenovector platform related to the atonal gene. Novartis has the right to develop and commercialize any products related to the licensed
intellectual property. GenVecs dependence on a corporate collaborator, such as Novartis, subjects GenVec to a number of risks, including that:
|
|
|
GenVec may not be able to control the amount and timing of resources that the collaborator devotes to the development or commercialization of product candidates or to their marketing and distribution;
|
|
|
|
the collaborator may not be successful in its efforts to obtain regulatory approvals in a timely manner, or at all;
|
|
|
|
the collaborator may not properly maintain or defend GenVecs intellectual property rights or may use its proprietary information in such a way as to invite litigation that could jeopardize or invalidate its
proprietary information or expose GenVec to potential litigation;
|
29
|
|
|
the collaborator may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new
formulation of a product candidate for clinical testing;
|
|
|
|
changes in the collaborators business strategy may also adversely affect its willingness or ability to complete its obligations under any arrangement;
|
|
|
|
GenVecs agreement with the collaborator may fail to provide GenVec with significant protection, or may not be effectively enforced, if a collaborator fails to perform;
|
|
|
|
the collaboration may be terminated or allowed to expire, which would delay the development and may increase the cost of developing GenVecs product candidates;
|
|
|
|
the collaborator could have the ability to unilaterally terminate agreements, or have extension or renewal rights, in instances that GenVec believes are not commercially reasonable or consistent with GenVecs
current business strategy; or
|
|
|
|
the collaborator may not be able to pay GenVec as expected.
|
Given these risks, the success of GenVecs
current and future collaborations is highly unpredictable and can have a substantial negative or positive impact on its business. If GenVecs collaborations fail, its product development or commercialization of product candidates could be
delayed or cancelled, which would negatively impact GenVecs business, results of operations and financial condition.
Collaborations might
produce conflicts that could delay or prevent the development or commercialization of GenVecs potential product candidates and negatively impact its business and financial condition.
An important part of GenVecs strategy involves conducting multiple product development programs. GenVec may pursue opportunities in fields that conflict
with those of its collaborators. In addition, disagreements with GenVecs collaborators could develop over rights to its intellectual property or rights to technology developed with its collaborators. The resolution of such conflicts and
disagreements may affect ownership of intellectual property to which GenVec believes GenVec is entitled. In addition, any disagreement or conflict with GenVecs collaborators could reduce GenVecs ability to obtain future collaboration
agreements and negatively impact GenVecs relationship with existing collaborators. Such a conflict or disagreement could also lead to delays or termination of collaborative research, development, regulatory approval, or commercialization of
various products or could require or result in litigation or arbitration, which would be time consuming, expensive, lead to a diversion of management attention and resources and could have a significant negative impact on GenVecs business,
financial condition, and results of operations.
GenVecs collaboration agreements may prohibit GenVec from conducting research in areas that
may compete with GenVecs collaboration products, while its collaborators may not be limited to the same extent. This could negatively affect GenVecs ability to develop products and, ultimately, prevent GenVec from achieving a continuing
source of revenues.
GenVec anticipates some of its corporate or academic collaborators will be conducting multiple product development efforts
within each disease area that is the subject of their collaborations with GenVec. In certain circumstances GenVec has agreed not to conduct independently, or with any third party, certain research and development activities that are competitive with
the research and development activities conducted under GenVecs collaborations. Therefore, GenVecs collaborations may limit the areas of research and development GenVec may pursue alone or with others. Some of GenVecs
collaborators, however, may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of their collaborations with GenVec. In addition, competing products,
either developed by the collaborators or to which the collaborators have rights, may result in their withdrawing support for GenVecs product candidates.
Agreements with government agencies may lead to claims against GenVec under the Federal False Claims Act, and these claims could result in substantial
fines and other penalties.
The biopharmaceutical industry is, and in recent years has been, under heightened scrutiny as the subject of
government investigations and enforcement actions. GenVecs agreements with U.S. government agencies or any arrangement that implicates the payment of government funds may be subject to substantial financial penalties under the Federal Civil
Monetary Penalties Act and the federal False Claims Act. Under the False Claims Acts whistleblower provisions, private enforcement of fraud claims against businesses on behalf of the U.S. government has increased due in part to
amendments to the False Claims Act that encourage private individuals to sue on behalf of the government. These whistleblower suits, known as qui tam actions, may be filed by private individuals, including present and former employees. The federal
False Claims Act provides for treble damages and civil penalties of up to $11,000 per false claim. If GenVecs operations are found to be in violation of any of these laws, or any other governmental regulations that apply to GenVec, GenVec may
be subject to penalties, damages, fines, exclusion from federal healthcare programs like Medicare and Medicaid, and the curtailment or restructuring of GenVecs operations. Any penalties, damages, fines, exclusions, curtailment or restructuring
of GenVecs operations could adversely affect its ability to operate its business and its financial results.
30
If successful large-scale manufacturing of gene-based medicines is not possible, GenVec or its
collaborators may be unable to manufacture enough of GenVecs product candidates to achieve regulatory approval or market its products.
Few
companies to date have demonstrated successful large-scale manufacturing of gene-based medicines, including those that have had significantly more resources than GenVec does and it is anticipated that significant challenges will be faced in the
scale-up
of GenVecs manufacturing process for commercial production. There are a limited number of contract manufacturers qualified to perform large-scale manufacturing of gene-based medicines. GenVec or its
collaborators may be unable to manufacture commercial-scale quantities of gene-base medicines or receive appropriate government approvals on a timely basis or at all. Failure to successfully manufacture or obtain appropriate government approvals on
a timely basis or at all would prevent GenVec from achieving its business objectives.
If regulatory approvals are not obtained for a manufacturing
facility for GenVecs products, GenVec may experience delays, be unable to meet demand, and may lose potential revenues.
Completion of
clinical trials for and commercialization of GenVecs product candidates require access to, or development of, facilities to manufacture a sufficient supply of its product candidates. GenVec has limited experience manufacturing any of its
gene-based products in the volumes that will be necessary to support large-scale clinical trials or commercial sales, and GenVec expects that it will rely on its collaborators for manufacturing capabilities. Before GenVec or its collaborators can
begin commercial manufacturing of any of its product candidates, GenVec or its collaborators must obtain regulatory approval of the manufacturing facility and process. Manufacturing of GenVecs proposed products must comply with cGMP
requirements and similar
non-U.S.
regulatory requirements. The cGMP requirements govern, among other things, personnel, buildings and facilities, equipment, control of components and drug product containers
and closures, production and process controls, packaging and labeling controls, holding and distribution, laboratory controls and records and reports. Among other things, complying with cGMP and comparable
non-U.S.
regulatory requirements will require GenVec to expend time, money and effort in production, record keeping, and quality control to ensure the product meets applicable specifications and other
requirements. GenVec or its collaborators must also pass a preapproval inspection before FDA approval. Significant capital will likely need to be expended on the development of manufacturing capacity for a product candidate even before GenVec knows
if the FDA will approve the product for commercialization. Furthermore, if GenVec or its collaborators materially fail to comply with these requirements, its product candidates likely would not be approved. If GenVec or its collaborators fail to
comply with these requirements after approval, GenVec would be subject to possible regulatory action (including warning letters, restrictions on the product, product recalls, suspension or withdrawal of approval, seizures, injunctions, civil fines,
and criminal sanctions), and GenVec may be limited in the jurisdictions in which GenVec is permitted to sell its products. The FDA and
non-U.S.
regulatory authorities generally have the authority to perform
unannounced periodic inspections of manufacturing facilities to ensure compliance with cGMP and
non-U.S.
regulatory requirements.
GenVec relies on a limited number of suppliers for some of its manufacturing materials. Any problems experienced by any of these suppliers could
negatively impact GenVecs operations.
GenVec relies on third-party suppliers and vendors for some of the materials used in the manufacture
of GenVecs product candidates. Some of these materials are available from only one supplier or vendor. For supply of early clinical trial materials, GenVec relies on one supplier, Thermo Fisher Scientific Corporation, for its cell culture
medium and another supplier, Lonza Walkersville, Inc., for custom buffers. The cell culture medium is used to grow the cells within which GenVecs product candidates are produced. GenVec does not currently have supply agreements with any of its
suppliers. Any significant problem experienced by one of GenVecs suppliers could result in a delay or interruption in the supply of materials to GenVec until such supplier resolves the problem or an alternative source of supply is located.
GenVec has limited experience with alternative sources of raw materials. Any delay or interruption would likely lead to a delay or interruption of manufacturing operations, which could negatively affect GenVecs operations.
GenVec faces substantial competition from other companies and research institutions that are developing products to treat the same diseases that
GenVecs product candidates target, and GenVec may not be able to compete successfully.
GenVec competes with pharmaceutical and
biotechnology companies pursuing other forms of treatment for the health concerns GenVecs product candidates target. GenVec may also face competition from companies that may develop competing technology internally or acquire it from the
government, universities or other research institutions. As these companies develop their technologies, they may develop proprietary positions, which may prevent or limit GenVecs product commercialization efforts.
Some of GenVecs competitors are established companies with greater financial and other resources than GenVecs. GenVecs competitors may
succeed in:
|
|
|
Identifying important genes or delivery mechanisms before GenVec does;
|
|
|
|
Developing products or product candidates earlier than GenVec does;
|
|
|
|
Forming collaborations before GenVec does or precluding GenVec from forming collaborations with others;
|
31
|
|
|
Obtaining approvals from the FDA or other regulatory agencies for such products more rapidly than GenVec does;
|
|
|
|
Developing and validating manufacturing processes more rapidly than GenVec does;
|
|
|
|
Obtaining patent protection to other intellectual property rights that would limit or preclude GenVecs ability to use its technologies or develop products; or
|
|
|
|
Developing products that are safer or more effective than those GenVec develops or proposes to develop.
|
While
GenVec seeks to expand its technological capabilities to remain competitive, research and development by others may render its technology or product candidates obsolete or noncompetitive or result in treatments or cures superior to any therapy
developed by GenVec.
In addition, GenVecs products, if approved, may subsequently face competition from biosimilar products that are approved via
an abbreviated process on the basis of a showing that the product is highly similar to its approved product. The Biologics Price Competition and Innovation Act provides periods of exclusivity during which abbreviated applications may not be
submitted to, or approved by, the FDA, but the statute then allows approval by an abbreviated pathway and, if certain standards are met, a finding by the FDA that the biosimilar product is interchangeable with the reference product. A similar
abbreviated approval process for biosimilars (but without the possibility of an interchangeability determination) is available in Europe. If competitors are able to obtain marketing approval for biosimilars under an abbreviated regulatory approval
process in the U.S. or Europe, GenVecs products may become subject to additional competition with the attendant pricing pressure. GenVec also could face or be forced to bring litigation with respect to the validity or scope of patents relating
to GenVecs products.
If GenVec is unable to adequately protect its intellectual property rights, its competitors may be able to take
advantage of its research and development efforts to compete with GenVec.
GenVecs commercial success will depend, in part, on obtaining
patent protection for GenVecs products and other technologies and successfully defending these patents against third party challenges. GenVecs patent position, like that of other biotechnology firms, is highly uncertain and involves
complex legal and factual questions. The laws, rules, and regulations affecting biotechnology patent protection in the U.S. and other countries are uncertain and are currently undergoing review and revision. Changes in, or different interpretations
of, patent laws in the U.S. and other countries might allow others to use GenVecs discoveries or to develop and commercialize its products without any compensation to GenVec.
GenVecs ability to develop and protect a proprietary position based on biotechnological innovations and technologies involving genes and gene delivery
systems, methods of use, production, formulations, and the like is particularly uncertain. The U.S. Patent and Trademark Office, as well as patent offices in other countries, have often required that patent applications concerning
biotechnology-related inventions be limited or narrowed substantially. GenVecs disclosures in its patent applications may not be sufficient to meet the statutory requirements for patentability in all cases. In addition, other companies or
institutions possess issued patents and have filed and will file patent applications that cover or attempt to cover genes, vectors, cell lines, and methods of making and using gene therapy products that are the same as or similar to the subject
matter of GenVecs patent applications. For example, although GenVec has pending patent applications pertaining to particular adenovectors that cannot reproduce themselves and adenovectors modified to alter cell binding characteristics, GenVec
is aware of issued patents and pending patent applications of other companies and institutions relating to the same subject matter. Patents and patent applications of third parties may have priority over GenVecs issued patents and its pending
or yet to be filed patent applications. Proceedings before the U.S. Patent and Trademark Office and other patent offices to determine who properly lays claim to inventions are costly and time consuming, and GenVec may not win in any such
proceedings.
The issued patents GenVec already has or may obtain in the future may not provide commercially meaningful protection against competitors.
Other companies or institutions may challenge GenVecs or its collaborators patents in the U.S. and in other countries. In the event a company, institution or researcher infringes upon GenVecs or its collaborators patent
rights, enforcing these rights may be difficult, expensive and time consuming, with no guarantee that GenVecs or its collaborators patent rights will be upheld. Others may be able to design around these patents or develop unique products
providing effects similar to GenVecs products. In addition, GenVecs competitors may legally challenge GenVecs patents, and they may be considered invalid. For example, GenVec is also aware of issued patents and pending patent
applications of third parties relating to aspects of production, purification, quality assessment, and formulation technology. It could be alleged that GenVecs production, purification, quality assessment, and formulation technology conflict
with such existing or future patents.
Various components used in developing gene therapy products, such as particular genes, vectors, promoters, cell
lines, and construction methods, used by others and by GenVec, are available to the public. As a result, GenVec is unable to obtain patent protection with respect to such components, and third parties can freely use such components. Third parties
may develop products using such components that compete with GenVecs potential products. Also, with respect to some of GenVecs patentable inventions, GenVec or its collaborators have decided not to pursue patent protection outside the
U.S. Accordingly, GenVecs competitors could develop, and receive
non-U.S.
patent protection for, gene therapies or technologies for which GenVec or its collaborators have or are seeking U.S. patent
protection. GenVecs competitors may be free to use these gene therapies or technologies outside the U.S. in the absence of patent protection.
GenVec also relies to a limited extent on trade secrets to protect its technology. However, trade secrets are difficult to protect. While GenVec has entered
into confidentiality agreements with employees and collaborators, it may not be able to prevent the disclosure or use of GenVecs trade secrets. In addition, other companies or institutions may independently develop substantially equivalent
information and techniques.
32
If GenVecs technologies and potential products conflict with intellectual property rights of
competitors, universities, or others, then GenVec may be prevented from licensing those technologies, developing those product candidates or both.
Other companies and institutions have issued patents and have filed or will file patent applications that may issue into patents that cover or attempt to
cover genes, vectors, cell lines, and methods of making and using gene and gene-based therapy products used in or similar to GenVecs product candidates and technologies. GenVec also is aware of other issued patents and pending patent
applications that relate to various aspects of GenVecs manufacture of its product candidates and systems, and it could be alleged that GenVecs manufacture of these product candidates or licensure of those technologies conflicts with
these patents. GenVec has not conducted
freedom-to-use
patent searches on all aspects of GenVecs technologies, product candidates or potential product candidates,
and GenVec may be unaware of relevant patents and patent applications of third parties. In addition, the
freedom-to-use
patent searches that have been conducted may not
have identified all relevant issued patents or pending patent applications that could issue into patents, particularly in view of the characterizations of the subject matter of issued patents and pending patent applications, as well as the fact that
pending patent applications can be maintained in secrecy for a period of time and, in some circumstances, until issuance as patents.
An issued patent
gives rise to a rebuttable presumption of validity under U.S. law and under the laws of some other countries. The holder of a patent to which GenVec or its collaborators do not hold a license could bring legal actions against GenVecs
collaborators or GenVec for damages or to stop GenVec or its collaborators from using the affected technology, which could limit or preclude its ability to license its technologies or to develop and commercialize its product candidates. If any of
GenVecs potential products are found to infringe a patent of a competitor or third party, GenVec or its collaborators may be required to pay damages and to either obtain a license in order to continue to develop and commercialize the potential
products or, at the discretion of the competitor or third party, to stop development and commercialization of the potential products. Similarly, if any of GenVecs
out-licensed
technologies are found to
infringe a patent of a competitor or third party, GenVec or its collaborators may be required to pay damages and to either obtain a license in order to continue to utilize the technologies or, at the discretion of the competitor or third party, to
stop utilizing the technologies. Since GenVec has concentrated its resources on licensing certain of its technologies and developing only a limited number of products, the inability to license one of its technologies or to market one of its products
would disproportionately affect GenVec as opposed to a competing company with many products in development.
GenVec believes there will be significant
litigation in its industry regarding intellectual property rights. Many of GenVecs competitors have expended and are continuing to expend significant amounts of time, money and management resources on intellectual property litigation. If
GenVec becomes involved in litigation, it could consume a substantial portion of GenVecs resources and could adversely affect its business, financial condition and results of operations, even if GenVec ultimately is successful in such
litigation.
If GenVec loses its rights to use intellectual property it licenses from others, or those rights are not enforceable, then
GenVecs ability to develop and commercialize its product candidates will be harmed.
GenVec relies, in part, on licenses to use some
technologies material to its business. For example, to create GenVecs product candidates GenVec combines its adenovectors with genes intended to produce therapeutic proteins. In most instances GenVec does not own the patents or patent
applications that cover these genes and certain methods of use thereof which underlie these licenses. For these genes, GenVec does not control the enforcement of the patents. GenVec relies upon its licensors to properly prosecute and file those
patent applications and defend and enforce any issued patents.
While many of the licenses under which GenVec has rights provide it with exclusive rights
in specified fields, the scope of GenVecs rights under these and other licenses may be subject to dispute by its licensors or third parties. In addition, GenVecs rights to use these technologies and practice the inventions claimed in the
licensed patents and patent applications are subject to GenVecs licensors abiding by the terms of those licenses and not terminating them. Any of GenVecs licenses may be terminated by the licensor if GenVec is in breach of a term or
condition of the license agreement or in certain other circumstances. In addition, some of GenVecs licenses are contingent upon its achievement of specific development milestones.
Legal proceedings to obtain, enforce, and defend patents, and litigation of third-party claims of intellectual property infringement could require
GenVec to spend money and could impair GenVecs operations.
GenVecs success will depend, in part, on GenVecs ability to obtain
patent protection for its products and processes, both in the U.S. and in other countries. The patent positions of biotechnology and pharmaceutical companies, however, can be highly uncertain and can involve complex legal and factual questions.
Therefore, it is difficult to predict the breadth of claims allowed in the biotechnology and pharmaceutical fields.
Protecting intellectual property
rights can be expensive and time consuming. Litigation may be necessary to enforce patents issued to GenVec or to determine the scope and validity of third party proprietary rights. Moreover, if a competitor were to file a patent application
claiming technology also invented by GenVec, GenVec would have to participate in an interference proceeding before the U.S. Patent and Trademark Office to determine the priority of invention. GenVec may be drawn into interferences with third parties
or may have to provoke interferences by itself to challenge third-party patent rights to allow GenVec or its licensees to commercialize products based on GenVecs technologies. Litigation could result in substantial costs and diversion of
management efforts regardless of the results of the litigation. An unfavorable result in litigation could subject GenVec to significant liabilities to third parties, require disputed rights to be licensed, or require GenVec to cease using some
technologies.
33
GenVecs products and processes may infringe, or be found to infringe, patents not owned or controlled
by GenVec. Patents held by others may require GenVec to alter its products or processes, obtain licenses or stop activities. If relevant claims of third-party patents are upheld as valid and enforceable, GenVec could be prevented from practicing the
subject matter claimed in the patent. In addition, GenVec may be required to obtain licenses, redesign its products or processes to avoid infringement or pay money damages. As a result, GenVecs business may suffer if GenVec is not able to
obtain licenses at all or on commercially reasonable terms to GenVec or GenVec is required to redesign its products or processes to avoid infringement.
GenVec is exposed to potential product liability claims.
GenVecs business exposes GenVec to potential product liability risks inherent in the clinical testing and manufacturing and marketing of pharmaceutical
products, and GenVec may not be able to avoid significant product liability exposure. A product liability claim or recall could be detrimental to GenVecs business. Although GenVec currently maintains product liability and clinical trial
insurance, GenVecs present product liability and clinical trial insurance may be inadequate. Any successful product liability claim may prevent GenVec from obtaining adequate product liability and clinical trial insurance in the future on
commercially desirable or reasonable terms. In addition, product liability and clinical trial coverage may cease to be available in sufficient amounts or at an acceptable cost. An inability to obtain sufficient insurance coverage at an acceptable
cost or otherwise to protect against potential product liability claims could prevent or inhibit the commercialization of GenVecs products. A successful product liability claim could have a material adverse effect on GenVecs reputation,
business, financial condition and results of operations.
Adverse events in the field of gene therapy may negatively affect regulatory approval or
public perception of GenVecs products or product candidates.
Most of GenVecs product candidates under development could be broadly
described as recombinant DNA therapies. A number of clinical trials are being conducted by other biotechnology and pharmaceutical companies involving related therapies, including compounds similar to or competitive with, GenVecs product
candidates. The announcement of adverse results from these clinical trials, such as serious adverse events or unexpected side effects attributable to the treatment, or any response by the FDA or other similar regulatory authority to such clinical
trials, may impede the timing of GenVecs clinical trials, delay or prevent GenVec from obtaining regulatory approval, impede GenVecs ability to secure additional funding, or negatively influence public perception of its product
candidates. As a result, these conditions could harm GenVecs business and results of operations.
The commercial success of GenVecs product
candidates will depend, in part, on public acceptance of the use of gene therapies for the prevention or treatment of significant health concerns. Public attitudes may be influenced by claims that gene therapy is unsafe, and gene therapy may not
gain the acceptance of the public or the medical community. Negative public reaction to gene therapy could result in greater government regulation and stricter clinical trial oversight and commercial product labeling requirements of gene therapy
products and could cause a decrease in the demand for any products GenVec may develop.
GenVecs product candidates involve new technologies and
therapeutic approaches in the field of gene therapy, which is a new and evolving field. As discussed above, no gene therapy product has received regulatory approval in the U.S., and adverse events in this field may negatively affect public
perception of GenVecs product candidates. Even if GenVecs product candidates attain regulatory approval, its success will depend upon the medical community, patients, and third-party payers accepting gene therapy products in general, and
its product candidates in particular, as medically useful, cost-effective, and safe. In particular, GenVecs success will depend upon whether physicians who specialize in the diseases GenVecs product candidates target decide to prescribe
treatments that involve the use of GenVecs product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available. Even if the clinical safety and efficacy of
GenVecs product candidates is established, physicians may elect not to recommend its products for a variety of reasons, including the reimbursement policies of government and third-party payers. Furthermore, third-party payers, such as health
insurance plans, may be reluctant to authorize and pay for new forms of treatment they may deem expensive and less proven than existing treatments. Even if gene therapy products, and GenVecs product candidates in particular, are accepted by
the medical community and third-party payers, the public in general, or patients in particular, may be uncomfortable with new therapies, including GenVecs product candidates, and it could take substantial time for them to accept gene therapy
products as a viable treatment alternative, if ever. If gene therapy and GenVecs product candidates do not gain widespread acceptance, GenVec may be unable to generate significant revenues, if any, which would adversely affect its results of
operations. In addition, even if GenVecs product candidates achieve market acceptance, GenVec may not be able to maintain that market acceptance over time if new products or technologies are introduced that are more favorably received than
GenVecs product candidates or that render them obsolete.
GenVec uses hazardous biological materials in GenVecs business; any liability
or disputes relating to improper handling, storage or disposal of these materials could be time consuming and costly.
GenVecs research and
development processes involve the use of hazardous biological materials. Such materials include human and animal cell lines and viruses, such as adenoviruses and animals infected with human viruses. Some of the biological material may be novel,
including viruses with novel properties. GenVec cannot eliminate the risk of accidental contamination or discharge or injury from these materials. Federal, state and local laws and regulations govern the use, manufacture, storage, handling and
disposal of these materials. GenVec could be subject to civil damages in the event of an improper or unauthorized release of, or exposure of individuals to, these hazardous materials. In addition, claimants may sue GenVec for injury or contamination
that results from GenVecs use or the use by third parties of these materials, and GenVecs liability may exceed its total assets.
34
Although GenVec has general liability insurance, these policies contain exclusions from insurance against
claims arising from pollution from chemical or radioactive materials. GenVecs collaborators are working with these types of hazardous materials in connection with its collaborations. In the event of a lawsuit or investigation, GenVec could be
held responsible for any injury it or its collaborators cause to persons or property by exposure to, or release of, any hazardous materials. Although GenVec believes it is currently in compliance with all applicable environmental and occupational
health and safety regulations, compliance with environmental laws and regulations may be expensive and current or future environmental regulations may impair its research, development, or production efforts.
GenVecs revenue is primarily derived from GenVecs collaboration agreements, which can result in significant fluctuation in GenVecs
revenue from period to period, and GenVecs past revenue is therefore not necessarily indicative of GenVecs future revenue.
GenVecs revenue is primarily derived from GenVecs collaboration agreements with corporate partners, institutions, and governmental entities under
which GenVec may receive grants, milestone payments based on clinical progress, regulatory progress or net sales achievements, royalties, manufacturing revenue or payment for GenVecs development activities on behalf of third parties. GenVec is
particularly dependent on its agreement with Novartis, pursuant to which GenVec is facilitating the development of
first-in-class
products for the treatment of hearing
and balance disorders. On February 11, 2014, Novartis informed GenVec that the third milestone under GenVecs agreement with Novartis had been achieved after Novartis filed an IND with the FDA for the clinical development of CGF166, the
lead product candidate under the collaboration between GenVec and Novartis. The IND was deemed effective on February 7, 2014, triggering a $2 million milestone payment to GenVec. On October 28, 2014, the fourth milestone under
GenVecs agreement with Novartis was achieved after the first patient was dosed in the Phase 1/2 clinical trial of CGF166, triggering a $3 million milestone payment to GenVec. Significant variations in the timing of receipt of cash
payments and GenVecs recognition of revenue can result from the timing of clinical, regulatory or sales events which result in milestone payments and the timing and success of the commercial launch of new products by GenVecs
collaboration partners. The amount of GenVecs revenue derived from collaboration agreements in any given period will depend on a number of unpredictable factors, including GenVecs ability to find and maintain suitable collaboration
partners, the timing of the negotiation and conclusion of collaboration agreements with such partners, whether and when GenVec or its collaboration partner achieve clinical, regulatory and sales milestones, whether the collaboration is exclusive or
whether GenVec can seek other partners, the timing of regulatory approvals in one or more major markets and the market introduction of new products or generic versions of the approved product, as well as other factors.
GenVec depends on a limited number of collaborators for a significant portion of its revenues, and the loss of or significant reduction in business with
those business partners could materially adversely affect GenVecs business and operating results.
Novartis and the U.S. government
accounted for approximately 80% and 83% of GenVecs revenues for the years ended December 31, 2016 and 2015, respectively. While the concentration of GenVecs business with a small number of collaborators may provide certain benefits
to us, it also exposes GenVec to adverse effects in the event of a disruption in GenVecs relationship with any of them. GenVec is particularly dependent on its agreement with Novartis. If Novartis or the U.S. government decreases business with
GenVec, fails to fulfill its obligations to GenVec, or terminates its relationship with GenVec, GenVec could experience material adverse effects on its business, operating results and financial condition.
Changes in healthcare law and implementing regulations, including those based on recently enacted legislation, as well as changes in healthcare policy,
may impact GenVecs business in ways that GenVec cannot currently predict, and these changes could have a material adverse effect on GenVecs business and financial condition if GenVec is able to commercialize its candidate products.
Healthcare costs have risen significantly over the past decade. The Patient Protection and Affordable Care Act, as amended by the Health Care and
Education Reconciliation Act of 2010, which we refer to collectively as PPACA, substantially changes the way health care is financed by both governmental and private insurers and significantly impacts the pharmaceutical industry. PPACA contains a
number of provisions that are expected to impact GenVecs business and operations, in some cases in ways GenVec cannot currently predict. Changes that may affect GenVecs business include those governing enrollment in federal and private
healthcare programs, increased rebates and taxes on pharmaceutical products, and revised fraud and abuse and enforcement requirements. These changes will impact existing government healthcare programs and will result in the development of new
programs.
GenVec anticipates that if and when it or its collaborators commercialize GenVecs products in the U.S., a significant portion of
GenVecs revenue and the revenue from its collaborators from sales of its products will be derived from government payers, including Medicare, Medicaid, and Department of Defense, referred to herein as DoD, programs. Reimbursement rates to
purchasers of GenVecs drugs and its net revenues for sales of drugs used by these programs can be altered by legislation or regulation. PPACA and other federal law require rebates on certain drugs utilized under Medicare, Medicaid, and DoD
programs and require discounts on certain drugs furnished to Medicare beneficiaries. For example, as part of PPACAs provisions closing a funding gap that currently exists in the Medicare Part D prescription drug program (commonly known as the
donut hole), once GenVec or its collaborators participate in the Medicare program, it or its collaborators will be required to provide a 50% discount on branded prescription drugs dispensed to beneficiaries within this donut hole.
35
PPACA also made changes to the Medicaid drug rebate program, discussed further herein, including changing
the definition of AMP, expanding rebate liability from
fee-for-service
Medicaid utilization to include the utilization of Medicaid managed care organizations as well,
and increasing the minimum rebate from 15.1% to 23.1% of the AMP for most innovator products and from 11% to 13% for
non-innovator
products. GenVec expects that the increased minimum rebate of 23.1% will apply
to GenVecs products following commercialization, if successful, in the U.S. Furthermore, PPACA requires pharmaceutical manufacturers of branded prescription drugs to pay a branded prescription drug fee to the federal government. Each
individual pharmaceutical manufacturer pays a prorated share of the branded prescription drug fee of $4.0 billion in 2017, based on the dollar value of its branded prescription drug sales to certain federal programs identified in the law.
The effects of reforms under PPACA will be shaped significantly by implementing regulations and by state government decisions. On February 1, 2016, the
Centers for Medicare and Medicaid Services, referred to herein as CMS, the federal agency that administers the Medicare and Medicaid programs, issued a final regulation to implement the changes to the Medicaid drug rebate program under PPACA. This
regulation became effective on April 1, 2016. Many states have not chosen to expand their Medicaid programs by raising the income limit to 133% of the federal poverty level, as is permitted by PPACA. It is unclear whether these states will
choose to expand their programs in the future and whether there will be more uninsured patients than anticipated when Congress passed PPACA. For each state that does not choose to expand its Medicaid program as permitted by PPACA, there will be
fewer insured patients overall. The reduction in the number of insured patients could impact the sales, business and financial condition following the commercialization, if successful, of GenVecs products in the U.S.
PPACA also expanded the Public Health Services 340B drug pricing discount program. A pharmaceutical manufacturer must participate in the 340B drug
pricing program in order for federal funds to be available to pay for the pharmaceutical manufacturers drugs under Medicaid and Medicare Part B. Under this program, the participating pharmaceutical manufacturer agrees to charge
statutorily-defined covered entities no more than the 340B discounted ceiling price for the pharmaceutical manufacturers covered outpatient drugs. PPACA obligates the Secretary of the Department of Health and Human Services to create
regulations and processes to improve the integrity of the program and to ensure the agreement that manufacturers must sign to participate in the program obligates a manufacturer to offer the ceiling price to covered entities if the manufacturer
makes the drug available to any other purchaser at any price and to report to the government the ceiling prices for its drugs. In addition, legislation may be introduced that, if passed, could further expand the 340B drug pricing program to include
additional covered entities or could require participating manufacturers to agree to provide 340B discounted pricing on drugs used in the inpatient setting. To the extent that PPACA and subsequent legislation, as discussed above, causes the
statutory and regulatory definitions of AMP and the Medicaid rebate amount to change, these changes also impact the 340B discounted ceiling price.
Legislative changes to PPACA and new or revised regulations remain possible and appear likely in the 115th Congress and under the Trump Administration. These
changes could affect all of the PPACA-related policies discussed above and could have a significant effect on the number of insured patients in the U.S., the breadth of coverage under insurance plans, financing of healthcare, and reimbursement
rates, which could impact GenVecs sales, business, and financial condition following the commercialization, if successful, of GenVecs products in the U.S. GenVec expects that PPACA, as currently enacted or as it may be amended in the
future, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on GenVecs industry generally and on its ability to successfully commercialize its product candidates, if approved.
In addition to PPACA, there will continue to be proposals by legislators at both the federal and state levels, regulators and third-party payers to keep these
costs down while expanding individual healthcare benefits. Certain of these changes could impose limitations on the prices GenVec will be able to charge for any product candidates that are approved or the amounts of reimbursement available for these
products from governmental agencies or third-party payers, or may increase the tax obligations on life sciences companies such as GenVecs.
The
healthcare industry, and thus GenVecs business, continues to be subject to extensive federal, state, local and foreign regulation. Some of the pertinent laws have not been definitively interpreted by the regulatory authorities or the courts,
and their provisions are open to a variety of interpretations. In addition, these laws and their interpretations are subject to change. Applicable federal and state health care fraud and abuse laws and regulations may affect GenVecs ability to
operate GenVecs business, particularly once third-party reimbursement becomes available for one or more of GenVecs products. These laws and regulations include, but are not limited to:
|
|
|
The federal Anti-Kickback Law, which prohibits, among other things, knowingly or willingly offering, paying,
soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any health care items or service for which
payment may be made, in whole or in part, by federal healthcare programs such as Medicare and Medicaid. This statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and prescribers, purchasers and formulary
managers on the other. Further, PPACA clarified that liability may be established under the federal Anti-Kickback Law without proving actual knowledge of the statute or specific intent to violate it. In addition, PPACA amended the Social Security
Act to provide that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Law constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although
there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Law protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions
|
36
|
and safe harbors are drawn narrowly, and practices that involve remuneration to those who prescribe, purchase, or recommend pharmaceutical and biological products, including certain discounts, or
engaging such individuals as speakers or consultants, may be subject to scrutiny if they do not fit squarely within an exemption or safe harbor. GenVecs practices may not in all cases meet all of the criteria for safe harbor protection from
anti-kickback liability. Moreover, there are no safe harbors for many common practices, such as educational and research grants or patient assistance programs.
|
|
|
|
The federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or
knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay
money to the federal government. Many healthcare companies have been investigated and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged improper activities including
causing false claims to be submitted as a result of the marketing of their products for unapproved and thus
non-reimbursable
uses, inflating prices reported to private price publication services which are used
to set drug payment rates under government healthcare programs and other interactions with customers including those that may have affected their billing or coding practices and submission to the federal government. In addition, PPACA amended
federal law to provide that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Law constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
Pharmaceutical and other healthcare companies also are subject to other federal false claim laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to
non-government
health benefit programs.
|
|
|
|
The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act, among other things, imposes criminal and civil liability for
executing a scheme to defraud any healthcare benefit program or making false statements in connection with the delivery of or payment for healthcare benefits, items or services, and also imposes obligations with respect to safeguarding the privacy,
security and transmission of individually identifiable health information. HIPAA also prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or
representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
|
|
|
|
Numerous federal and state laws and regulations that address privacy and data security, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection
laws (e.g., Section 5 of the FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information. Failure to comply with data protection laws and regulations could result in government enforcement
actions and create liability for GenVec (which could include civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect GenVecs operating results and business.
|
|
|
|
The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, which requires certain pharmaceutical and biological manufacturers to engage in extensive tracking of payments or transfers of
value to physicians and teaching hospitals and public reporting of the payment data. Pharmaceutical and biological manufacturers with products for which payment is available under Medicare, Medicaid or the State Childrens Health Insurance
Program are required to have started tracking such payments on August 1, 2013, and must submit a report on or before the 90th day of each calendar year disclosing reportable payments made in the previous calendar year.
|
|
|
|
Analogous state laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed under Medicaid and other state programs or, in several states, regardless of the
payer. Some state laws also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to certain health care providers in those states. Some of these
states also prohibit certain marketing-related activities including the provision of gifts, meals, or other items to certain health care providers. In addition, California, Connecticut, Nevada, and Massachusetts require pharmaceutical companies to
implement compliance programs or marketing codes of conduct.
|
|
|
|
The federal Foreign Corrupt Practices Act of 1997 and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of
foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by
U.S. regulators, with more frequent and aggressive investigations and enforcement proceedings by both the Department of Justice and the SEC. A determination that GenVecs operations or activities are not, or were not, in compliance with United
States or foreign laws or regulations could result in the imposition of substantial fines, interruptions of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits, and other legal or
equitable sanctions. Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow.
|
If GenVecs operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to GenVec, GenVec
may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government-funded healthcare programs like Medicare and Medicaid, and the curtailment or
37
restructuring of GenVecs operations, any of which could adversely affect its ability to operate its business and its financial results. Although compliance programs can mitigate the risk of
investigation and prosecution for violations of these laws, the risks cannot be entirely eliminated. Any action against GenVec for violation of these laws or regulations, even if GenVec successfully defends against it, could cause GenVec to incur
significant legal expenses and divert its managements attention from the operation of its business. Moreover, achieving and sustaining compliance with applicable federal and state privacy, security and fraud laws could result in government
enforcement actions and create liability for GenVec (which could include civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect GenVecs operating results and business.
If third party payers do not provide coverage or reimbursement for GenVecs products, those products will not be widely accepted, which would have
a negative impact on GenVecs business, results of operations and financial conditions.
Even if a product of GenVecs receives
regulatory approval, GenVecs success will depend, in part, on the extent to which coverage and reimbursement will be available from third party payers such as Medicare, Medicaid, other government health programs, private health insurers,
managed care programs, and other organizations. Third party payers are increasingly challenging the price and cost-effectiveness of medical products and services, and this trend is expected to continue. Therefore, significant uncertainty exists as
to the pricing approvals for, and the coverage or reimbursement status of, newly approved healthcare products. Additional federal or state health care legislation may be adopted in the future, any products that GenVec seeks to commercialize may not
be considered cost-effective, and limitations on coverage and the amount of reimbursement for GenVecs products could be imposed. Adequate third-party insurance coverage may not be available for GenVec to establish and maintain price levels
that are sufficient for realization of an appropriate return on GenVecs investment in product development. Moreover, the existence or threat of cost control measures, including a reduction in reimbursement rates could cause potential corporate
collaborators to be less willing or able to pursue research and development programs related to GenVecs product candidates. GenVec cannot be certain that, if and when GenVecs products become commercialized, the pertinent reimbursement
amounts or formulary status for GenVecs products will be sufficient to enable GenVec to market and sell its products.
GenVecs business
involves animal testing and changes in laws, regulations, accepted clinical procedures, or social pressures could restrict GenVecs use of animals in testing and adversely affect its research and development efforts.
Many of the research and development efforts GenVec sponsors involve the use of laboratory animals. Changes in laws, regulations, or accepted clinical
procedures may adversely affect these research and development efforts. Social pressures that would restrict the use of animals in testing or actions against GenVec or its partners by groups or individuals opposed to testing using animals could also
adversely affect these research and development efforts. In addition, preclinical animal studies conducted by GenVec or third parties on its behalf may be subject to the FDAs Good Laboratory Practices regulations and the USDA regulations for
certain animal species. Failure to comply with applicable regulations could extend or delay clinical trials conducted for its drug candidates.
GenVec depends on its key technical and management personnel to advance its technology and implement its business strategy, and the loss of these
personnel could impair the development of its products and business.
GenVec relies, and will continue to rely, on its key management and
scientific staff, all of whom are employed at will. GenVecs success depends upon the ability of its senior management to implement its business strategy. The loss of key personnel could have a material adverse effect on GenVecs business
and results of operations. There is intense competition from other companies, research and academic institutions and other organizations for qualified personnel. GenVec may not be able to continue to attract and retain the qualified personnel
necessary for the development of its business. If GenVec does not succeed in retaining and recruiting necessary personnel or developing this expertise, its business could suffer significantly. Furthermore, changes in its senior management may lead
to instability for its Company which could cause its business to suffer significantly.
38
Cautionary note regarding forward-looking statements
This proxy statement/prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange
Act with respect to the businesses, strategies and plans of Intrexon and GenVec, their expectations relating to the merger and their future financial condition and performance. Forward-looking statements generally relate to future events or future
financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as may, will, should, would, expects, plans,
anticipates, could, intends, target, projects, contemplates, believes, estimates, predicts, potential or continue or
the negative of these words or other similar terms or expressions that concern Intrexons and GenVecs expectations, strategies, plans or intentions. Intrexons and GenVecs expectations and beliefs regarding these matters may
not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including but not limited to:
|
|
|
the risk that GenVec shareholders may fail to approve the merger proposal;
|
|
|
|
the risk that Intrexon and GenVec will be unable to consummate the merger on the terms set forth in the merger agreement for any reason, including under circumstances that could require GenVec to pay a termination fee
(or an expense reimbursement and additional expense amount) to Intrexon;
|
|
|
|
the possibility that costs, difficulties or disruptions related to the integration of GenVecs operations into Intrexon will be greater than expected;
|
|
|
|
the length of time necessary to consummate the proposed transaction may be longer than anticipated;
|
|
|
|
the proposed transaction may involve unexpected costs;
|
|
|
|
the parties may be unable to meet expectations regarding the timing, completion and accounting and tax treatments of the transaction (including the tax treatment of the CPRs);
|
|
|
|
the businesses of Intrexon and GenVec may suffer as a result of uncertainty surrounding the proposed transaction;
|
|
|
|
the ability of GenVec to reach the milestones under the NVS License Agreement and trigger the rights to payments under the contingent payment rights agreement;
|
|
|
|
the risk that growth opportunities will not be realized or realized to the extent anticipated;
|
|
|
|
the risk that Intrexon following the merger will not realize on its financing or operating strategies;
|
|
|
|
the price of, the market for, and the potential market price volatility of Intrexons common stock;
|
|
|
|
the risk that litigation in respect of either company or the merger could adversely impact either company;
|
|
|
|
the risk that disruption caused by the merger could make it difficult to maintain certain strategic relationships;
|
|
|
|
the sufficiency of Intrexons cash and cash equivalents to meet its liquidity needs following the merger, whether caused by unanticipated increases in capital expenditures or otherwise;
|
|
|
|
the effect of the announcement of the merger on Intrexons and GenVecs business relationships, employees, customers, suppliers, vendors, other partners, operating results and businesses generally;
|
|
|
|
Intrexons current and future ECCs, license agreements and other collaborations;
|
|
|
|
developments concerning Intrexons collaborators and licensees;
|
|
|
|
Intrexons ability to successfully enter new markets or develop additional products, whether with its collaborators or independently;
|
|
|
|
changes in laws and regulations applicable to GenVec and/or Intrexon;
|
|
|
|
competition from existing technologies and products or new technologies and products that may emerge;
|
|
|
|
actual or anticipated variations in Intrexons operating results;
|
|
|
|
actual or anticipated fluctuations in Intrexons competitors or its collaborators and licensees operating results or changes in their respective growth rates;
|
|
|
|
Intrexons cash position;
|
|
|
|
market conditions in the industry;
|
|
|
|
Intrexons ability, and the ability of its collaborators and licensees, to protect their intellectual property and other proprietary rights and technologies;
|
|
|
|
Intrexons ability, and the ability of its collaborators and licensees, to adapt to changes in laws or regulations and policies;
|
39
|
|
|
the ability of Intrexons collaborators and licensees to secure any necessary regulatory approvals to commercialize any products developed under the ECCs, license agreements and joint ventures;
|
|
|
|
the ability of Intrexons collaborators and licensees to develop and successfully commercialize products enabled by Intrexons technologies;
|
|
|
|
the rate and degree of market acceptance of any products developed by a collaborator under an ECC or through a joint venture or license under a license agreement;
|
|
|
|
Intrexons ability to retain and recruit key personnel;
|
|
|
|
the result of litigation proceedings that Intrexon or GenVec faces currently or may face in the future;
|
|
|
|
Intrexons estimates regarding expenses, future revenue, capital requirements and needs for additional financing;
|
|
|
|
diversion of the attention of Intrexon and GenVec management from ongoing business concerns;
|
|
|
|
limitations placed on the ability of GenVec to operate its business by the merger agreement and the limitations put on GenVecs ability to pursue alternatives to the merger pursuant to the merger agreement;
|
|
|
|
decisions GenVec makes with respect to its future and strategic direction;
|
|
|
|
GenVecs product candidates being in the early stages of development;
|
|
|
|
GenVecs ability to find collaborators and, if it finds collaborators, to mutually agree on terms for its collaborations;
|
|
|
|
GenVecs reliance on collaborators;
|
|
|
|
the timing, amount, and availability of revenues from GenVecs government-funded vaccine programs;
|
|
|
|
uncertainties with, and unexpected results and related analyses relating to, preclinical development and clinical trials of GenVecs product candidates;
|
|
|
|
the timing and content of future FDA regulatory actions related to GenVec, its product candidates, or its collaborators;
|
|
|
|
GenVecs financial condition, the sufficiency of its existing cash, cash equivalents, investments, and cash generated from operations, and its ability to lower its operating costs;
|
|
|
|
the scope and validity of patent protection for GenVecs product candidates and its ability to commercialize technology and products without infringing the patent rights of others;
|
|
|
|
the listing of GenVecs common stock on NASDAQ; and
|
|
|
|
the other factors discussed in the sections entitled Risk factors and in Intrexons and GenVecs filings with the SEC.
|
Forward-looking statements may also concern Intrexons expectations relating to its subsidiaries and other affiliates. Intrexon and GenVec also caution
you that the foregoing list may not contain all of the forward-looking statements made in this proxy statement/prospectus.
Due to these risks and
uncertainties, there can be no assurances that the results anticipated by the forward-looking statements of Intrexon or GenVec will occur, that their respective judgments or assumptions will prove correct or that unforeseen developments will not
occur. Furthermore, if these forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you are cautioned not to place undue reliance upon any
forward-looking statements of Intrexon or GenVec, which speak only as of the date made. Intrexon and GenVec undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changed
circumstances or otherwise, except as required by law.
40
The GenVec special meeting
This section contains information about the special meeting of GenVec shareholders that has been called to consider and vote on the merger proposal, the
merger-related compensation proposal and the adjournment proposal. This proxy statement/prospectus is being furnished to GenVec shareholders in connection with the solicitation of proxies by the GenVec board of directors for use at the special
meeting and any postponements or adjournments of such special meeting.
This proxy statement/prospectus and the enclosed proxy card are first being mailed
to GenVec shareholders on or about [●][●], 2017. This proxy statement/prospectus provides GenVec shareholders with information about the special meeting and should be read carefully in its entirety.
Date, time and place of the special meeting
The special
meeting will be held on [●][●], 2017, at [●], Eastern Daylight Time, at 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878.
Purpose of the special meeting
At the special meeting
you will be asked to consider and vote upon:
|
|
|
Proposal 1.
|
|
a proposal to adopt the Agreement and Plan of Merger, dated as of January 24, 2017, among GenVec, Intrexon, and Merger Sub, as it may be amended from time to time, a copy of which is included as
Annex A
to this proxy
statement/prospectus, which proposal we refer to as the merger proposal;
|
|
|
Proposal 2.
|
|
a proposal to approve, on a
non-binding,
advisory basis, compensation that will or may become payable to GenVecs named executive officers in connection with the merger, which proposal
we refer to as the merger-related compensation proposal; and
|
|
|
Proposal 3.
|
|
a proposal to adjourn the special meeting, if necessary or appropriate, to solicit additional proxies in favor of the merger proposal, which proposal we refer to as the adjournment proposal.
|
At the special meeting, GenVec may also conduct any other business properly brought before the special meeting and any
adjournment or postponement thereof.
Recommendations of the GenVec board of directors
The GenVec board of directors reviewed and considered the terms and conditions of the merger agreement and the transactions contemplated thereby, including the
merger and, after careful consideration, has unanimously:
|
|
|
determined that the merger agreement, the merger and the other transactions contemplated by the merger agreement are fair and advisable to, and in the best interests of, GenVec and its shareholders;
|
|
|
|
approved the execution, delivery and performance by GenVec of the merger agreement and the consummation of the merger and the other transactions contemplated by the merger agreement; and
|
|
|
|
resolved to recommend the adoption and approval of the merger agreement to GenVecs shareholders.
|
The
GenVec board of directors unanimously recommends that GenVecs shareholders vote
FOR
the merger proposal,
FOR
the merger-related compensation proposal and
FOR
the adjournment proposal.
Record date; stock entitled to vote
The GenVec
board of directors has fixed the close of business on [●], 2017 as the record date for the determination of shareholders entitled to notice of, and to vote at, the special meeting and at any adjournment or postponement of the special meeting.
At the close of business on the record date, there were [●] shares of GenVec common stock outstanding and entitled to vote held by [●] holders of record. As of the record date, the directors and executive officers of GenVec and their
affiliates as a group owned and were entitled to vote [●] shares of GenVec common stock, or approximately [●]% of the shares of GenVec common stock outstanding and entitled to vote as of that date.
A list of shareholders of record of GenVec entitled to vote at the special meeting will be available for ten days prior to the special meeting at
GenVecs office at 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878, for inspection by shareholders of GenVec during ordinary business hours for any purpose germane to the special meeting.
Quorum
A quorum is necessary to conduct business at the
special meeting. The presence, in person or by proxy, of the holders of a majority of the outstanding shares of GenVec common stock entitled to vote is necessary to constitute a quorum for action on any subject matter at the special meeting.
Shareholders of record who are present at the special meeting in person or by proxy and who abstain from voting are considered present and count toward the
quorum. If your shares are held in street name, meaning that your shares are held by a broker, bank or other nominee, your broker, bank or other nominee may not vote your shares on
non-routine
matters without
41
instructions from you. As each of the proposals to be voted upon at the special meeting is considered
non-routine,
your broker, bank or other
nominee does not have discretion to vote on any proposal for which they do not receive instructions from you. As a result, if you fail to provide your broker, bank or other nominee with any instructions regarding how to vote your shares, your shares
will not be considered present at the special meeting, will not be counted for purposes of determining the presence of a quorum and will not be voted on any of the proposals. If you provide instructions to your broker, bank or other nominee that
indicate how to vote your shares with respect to certain proposals but not with respect to a particular proposal, your shares will be considered present at the special meeting and will be counted for purposes of determining the presence of a quorum,
but they will not be voted with respect to that particular proposal (this is referred to as a broker
non-vote).
Required vote
|
|
|
Proposal 1.
|
|
The merger proposal requires the affirmative vote of the holders of a majority of the outstanding shares of GenVec common stock.
|
|
|
Proposal 2.
|
|
The merger-related compensation proposal requires the affirmative vote of the holders of a majority of shares of GenVec common stock present in person or by proxy at the special meeting and entitled to vote on the
matter.
|
|
|
Proposal 3.
|
|
The adjournment proposal requires the affirmative vote of the holders of a majority of shares of GenVec common stock present in person or by proxy at the special meeting and entitled to vote on the matter.
|
Voting rights
Each
GenVec shareholder is entitled to one vote on each matter to be acted upon at the special meeting for each share of GenVec common stock owned by such shareholder as of the record date.
Abstentions and broker
non-votes
If you are a shareholder of record and vote ABSTAIN on the merger proposal, the merger-related compensation proposal or the adjournment proposal,
it will have the same effect as voting AGAINST such proposal. Likewise, if your shares are held in street name, meaning that your shares are held by a broker, bank or other nominee, and you instruct your broker, bank or other
nominee to vote ABSTAIN on the merger proposal, the merger-related compensation proposal or the adjournment proposal, it will have the same effect as voting AGAINST such proposal.
If you are a shareholder of record and do not vote by completing your proxy card, by telephone or in person at the special meeting (as described below in the
section entitled Voting at the special meeting), your shares will not be voted. This will have the same effect as voting AGAINST the merger proposal, but it will have no effect on the outcome of the merger-related
compensation proposal or the adjournment proposal.
If your shares are held in street name and you do not provide your broker, bank or other nominee with
instructions as to how to vote your shares on a particular proposal, your shares will not be voted on that proposal (as noted above, this is referred to as a broker
non-vote).
This will have the
same effect as voting AGAINST the merger proposal, but it will have no effect on the outcome of the merger-related compensation proposal or the adjournment proposal.
Voting at the special meeting
Whether or not you plan to
attend the special meeting, please promptly vote your shares of GenVec common stock by proxy or, if you hold your shares in street name, instruct your broker, bank or other nominee how to vote, to ensure your shares are represented at the meeting.
You may also vote in person at the special meeting.
Voting in person
If you plan to attend the special meeting and wish to vote in person, you will be given a ballot at the special meeting. Please note, however, that if your
shares of GenVec common stock are held in street name, meaning that your shares are held by a broker, bank or other nominee, and you wish to vote in person at the special meeting, you must bring to the special meeting (i) a letter,
account statement or other evidence from such broker, bank or other nominee indicating that you were the beneficial owner of the shares on the record date for the special meeting and (ii) a legal proxy from the record holder of the shares of
GenVec common stock (i.e., your broker, bank or nominee) authorizing you to vote at the special meeting.
Voting by proxy; voting instructions
Shareholders of Record
: You should vote your proxy even if you plan to attend the special meeting. You can always change your vote at the
special meeting. Registered shareholders may vote by mail or by telephone.
|
|
|
To vote by mail, please complete, sign, date and mail your proxy card in the postage prepaid envelope provided. Proxies should be mailed sufficiently in advance to ensure receipt prior to the special meeting.
|
|
|
|
To vote by telephone, call toll-free at (800)
776-9437
from any touch-tone telephone and follow the instructions. Have your proxy card available when you call. If you vote by
phone, you do not need to mail your proxy card. Telephone voting is available until 11:59 p.m., Eastern Daylight Time, on [●] [●], 2017.
|
42
Your enclosed proxy card includes specific instructions for voting your shares of GenVec common stock. When
the accompanying proxy card is returned properly executed, the shares of GenVec common stock represented by it will be voted at the special meeting or any adjournment thereof in accordance with the instructions contained in the proxy card.
If you return your signed proxy card without indicating how you want your shares of GenVec common stock to be voted with regard to a particular proposal, your
shares will be voted as recommended by the GenVec board of directors. The GenVec board of directors has unanimously recommended that GenVecs shareholders vote
FOR
the merger proposal,
FOR
the
merger-related compensation proposal and
FOR
the adjournment proposal. Proxy cards that are returned without a signature will not be counted as present at the special meeting and cannot be voted.
If the special meeting is postponed or adjourned for any reason, at any subsequent reconvening of the special meeting all proxies will be voted in the same
manner as the proxies would have been voted at the original convening of the special meeting, except for any proxies that have at that time effectively been revoked or withdrawn, even if the proxies had been effectively voted on the same or any
other matter at a previous meeting.
Shares Held in Street Name
: If your shares are held of record in street name, meaning that your
shares are held by a broker, bank or other nominee, you should follow the separate instructions that such broker, bank or other nominee provides to you. Although most banks and brokers now offer telephone and Internet voting, availability and
specific processes will depend on their voting arrangements.
Revocation of proxies or voting instructions
If you are a registered holder and give your proxy card to GenVec or vote by telephone, you have the power to revoke your proxy or change your vote by taking
any of the following actions before your proxy is voted at the special meeting:
|
|
|
voting again by telephone any time prior to 11:59 p.m., Eastern Daylight Time, on [●] [●], 2017;
|
|
|
|
notifying the Corporate Secretary of GenVec in writing no later than the beginning of the special meeting of your revocation;
|
|
|
|
delivering to the Corporate Secretary of GenVec no later than the beginning of the special meeting a revised signed proxy card bearing a later date; or
|
|
|
|
attending the special meeting and voting in person, which will automatically cancel any proxy previously given, or revoking your proxy in person (but your attendance alone will not revoke any proxy that you have
previously given).
|
If your shares are held in street name by your broker, bank or other nominee, you should contact them to change your
vote.
Notice of revocation or your new proxy must be delivered to GenVecs Corporate Secretary at 910 Clopper Road, Suite 220N, Gaithersburg,
Maryland 20878, Attention: Corporate Secretary.
Other matters
As of the date of this proxy statement/prospectus, the GenVec board of directors is not aware of any other business to be presented for consideration at the
special meeting.
Solicitation of proxies
The GenVec
board of directors is soliciting proxies to provide an opportunity to all GenVec shareholders to vote on agenda items at the special meeting, whether or not the shareholders are able to attend the special meeting or an adjournment or postponement
thereof. GenVec will pay all costs incurred in connection with the solicitation of proxies from its shareholders on behalf of its board of directors. In addition to solicitation by mail, the directors, officers and regular employees of GenVec may,
without any additional compensation for their services, solicit proxies from shareholders in person or by telephone, facsimile or otherwise.
Arrangements
also will be made with brokers, banks, trustees and other custodians, nominees and fiduciaries for the forwarding of solicitation material to the beneficial owners of stock held of record by such persons, and GenVec will reimburse such custodians,
nominees and fiduciaries for their reasonable
out-of-pocket
expenses in connection therewith.
GenVec has retained Saratoga to assist it in the solicitation of proxies. The fee payable to Saratoga in connection with the proxy solicitation is $12,500 and
an additional fee of $4.00 per telephonic contact, plus reimbursement for reasonable
out-of-pocket
expenses.
Additional questions
If you have questions about the
merger agreement, the merger or the merger proposal or the other matters to be voted on at the special meeting or desire additional copies of this proxy statement/prospectus or additional proxy cards, please contact Saratoga by calling toll-free at
(888)
368-0379.
Banks, brokerage firms, and other nominees may call collect at (212)
257-1311.
43
The companies
Intrexon Corporation
Intrexon
believes it is a leader in the field of synthetic biology, an emerging and rapidly evolving discipline that applies engineering principles to biological systems to enable rational, design-based control of cellular functions for a specific purpose.
Using its suite of proprietary and complementary technologies, Intrexon designs, builds and regulates gene programs, which are DNA sequences that consist of key genetic components. A single gene program or a complex, multi-genic program is
fabricated and stored within a DNA vector. Vectors are segments of DNA used as a vehicle to transmit genetic information. DNA vectors can, in turn, be introduced into cells in order to generate a simple or complex cellular system, which are the
basic and complex cellular activities that take place within a cell and the interaction of those systems in the greater cellular environment. It is these genetically modified cell systems that can be used to produce biological effector molecules, or
be employed directly to enable the development of new and improved products and manufacturing processes across a variety of end markets, including health, food, energy, environment and consumer. Intrexons synthetic biology capabilities include
the ability to precisely control the amount, location and modification of biological molecules to control the function and output of living cells and optimize for desired results at an industrial scale.
Working with its collaborators, Intrexon seeks to create more effective, less costly and more sustainable solutions than can be provided through current
industry practices. Intrexon believes its approach to synthetic biology can enable new and improved biotherapeutics, increase the productivity and quality of food crops and livestock, create sustainable alternative energy sources and chemical
feedstocks, utilize biologically-based applications for the delivery of innovative consumer products and provide for a diverse set of environmental solutions. Intrexons business model is to commercialize its technologies through ECCs with
collaborators that have industry expertise, development resources and sales and marketing capabilities to bring new and improved products and processes to market.
Intrexon is incorporated in Virginia. Intrexons common stock is traded on the NYSE under the symbol XON. The principal executive offices of
Intrexon are located at 20374 Seneca Meadows Parkway, Germantown, Maryland 20876, and its telephone number is (301)
556-9900.
For more information regarding Intrexons business, see Item 1 of Intrexons Annual Report on Form
10-K
for
its 2016 fiscal year and the other documents incorporated by reference into this proxy statement/prospectus. For information on how you can view Intrexons Annual Report on Form
10-K
and other documents
incorporated by reference into this proxy statement/prospectus, see the section entitled Where you can find more information.
GenVec, Inc.
GenVec is a clinical-stage biopharmaceutical company with an entrepreneurial focus on leveraging its proprietary AdenoVerse gene delivery
platform to develop a pipeline of cutting-edge therapeutics and vaccines. GenVec is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVecs lead
product candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to its internal and partnered pipeline, GenVec also focuses on opportunities to
license its proprietary technology platform, including vectors and production cell lines, to potential collaborators in the biopharmaceutical industry for the development and manufacture of therapeutics and vaccines.
GenVec is incorporated in Delaware. GenVecs common stock is traded on NASDAQ under the symbol GNVC. The principal executive offices of
GenVec are located at 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878, and its telephone number is (240)
632-0740.
For more information regarding GenVecs business, see the section entitled Description of GenVecs business.
Intrexon GV Holding, Inc.
Merger Sub is a wholly owned
subsidiary of Intrexon formed solely for the purpose of effecting the merger. Merger Sub is incorporated in Delaware.
Merger Sub has not conducted any
activities other than those incidental to its formation and the matters contemplated by the merger agreement, including the preparation of applicable regulatory filings in connection with the merger. The principal executive offices of Merger Sub are
located at 20374 Seneca Meadows Parkway, Germantown, Maryland 20876, and its telephone number is (301)
556-9900.
44
The merger
(Proposal 1)
Effects of the merger
The shareholders of GenVec are being asked to adopt the Agreement and Plan of Merger, dated as of January 24, 2017, by and among GenVec,
Intrexon, and Merger Sub.
Pursuant to the terms and subject to the conditions of the merger agreement, at the closing of the proposed transactions
contemplated by the merger agreement, Merger Sub will be merged with and into GenVec. GenVec will continue as the surviving corporation of the merger, but it will become a wholly owned subsidiary of Intrexon. At the effective time of the merger,
each share of GenVec common stock (other than shares with respect to which appraisal rights are properly exercised or shares owned by Intrexon, any of its subsidiaries or GenVec) will be converted into the right to receive 0.297 of a share of
Intrexon common stock (with cash paid in lieu of fractional shares) and one CPR. For information regarding the treatment of GenVec stock options and warrants in the merger, see the section entitled The merger agreementTreatment of GenVec
stock options and warrants.
The merger agreement does not contain any provision that would adjust the exchange ratio that applies to the stock
consideration based on fluctuations in the market value of Intrexons common stock. Because of this, the implied value of the stock consideration to GenVec shareholders will fluctuate between now and the completion of the merger and will depend
on the market value of Intrexon common stock at the time the merger is completed. For information regarding the CPRs, see the section entitled Contingent payment rights agreement.
Background of the merger
Introduction
GenVec is a biopharmaceutical company whose business had been developing novel, gene-based therapeutic drugs and vaccines. In March 2010, GenVec discontinued a
pivotal Phase 3 clinical trial for TNFerade, its then lead and only clinical stage human therapeutic product candidate. As a result of discontinuing that trial and the early stage nature of GenVecs other programs, GenVec began reevaluating its
business strategy. In June 2010, GenVec retained Wells Fargo Securities, LLC to conduct a comprehensive review of strategic alternatives aimed at enhancing shareholder value. As part of that process, GenVec solicited proposals for strategic
transactions, including for the disposition of some or all of GenVecs assets, or for the sale or merger of the entire entity. When GenVec did not receive acceptable proposals for strategic transactions by November 2010, the board of directors
of GenVec announced that it would continue to explore strategic opportunities while focusing on GenVecs core business.
Despite GenVecs
efforts to seek strategic opportunities, between November 2010 and April 2013, it had no programs that offered any near-term prospects for significant revenues or meaningful value-creating achievements. By April 2013, GenVec had begun taking
significant steps to reduce its cash burn rate, including by cutting back on development programs, employee headcount and related expenses. Regardless, GenVec continued to lack prospects to achieve significant revenues in the near term and had
limited prospects to achieve significant additional revenues before GenVec would use its existing capital resources. Without meaningful prospects, in May 2013 the GenVec board of directors held a meeting for the purpose of considering the
liquidation and dissolution of GenVec. At this meeting, the GenVec board of directors unanimously determined that the liquidation and dissolution of GenVec was fair and in the best interests of GenVec and its shareholders.
On August 8, 2013, GenVec filed a preliminary proxy statement pursuant to Section 14(a) of the Exchange Act for the purpose of giving notice of a special
meeting of the shareholders to approve the liquidation and dissolution of GenVec. However, on September 4, 2013, GenVec announced that the GenVec board of directors unanimously withdrew the plan of complete liquidation and dissolution for
GenVec that was previously adopted on May 24, 2013, announcing that it would instead pursue a strategy focused on maximizing the value of its technology and assets, including its collaboration with Novartis to develop a novel gene-therapy
treatment for hearing loss and balance disorders.
Over the next three years GenVec focused its efforts on assisting Novartis with developing CGF166, an
adenoviral vector engineered to express the human atonal gene for patients with severe hearing loss, and engaging third parties, including governmental entities and universities, to research and develop new therapies in collaboration with GenVec
using its proprietary adenovirus vector technology. Additionally, GenVec continued to support its operations through equity financings.
In December 2013,
GenVec announced approval of the protocol for initiation of a Phase 1 study of CGF166. Between December 2013 and January 2016, GenVec and Novartis continued clinical development of CGF166.
Prior to and during this period, GenVec and Intrexon were in communication at several points regarding various potential collaborations and transactions. For
example, prior to the decision to pursue a dissolution in 2013, GenVec and Intrexon had shared information in consideration of a potential strategic transaction. In January 2014, Intrexon and GenVec entered into a material transfer agreement
pursuant to which GenVec would incorporate certain transgenes developed by Intrexon into GenVecs proprietary adenovirus based vectors for gene delivery applications for Intrexons oncology programs. However, subsequent to entering into
the material transfer agreement, Intrexon elected not to pursue the research covered under the agreement. During 2014, GenVec was approached by Intrexon regarding the possibility of amending the material transfer
45
agreement to instead focus on animal health applications of GenVecs proprietary gene delivery technology. Following these discussions, the parties were not able to agree to mutually
acceptable terms and negotiations ended in December 2014. In August 2015 GenVec was approached by Intrexon regarding a potential exclusive channel collaboration with respect to a product concept being explored by Intrexon not related to
GenVecs proprietary technology platform. On August 14, 2015, GenVec and Intrexon entered into a confidentiality agreement to permit the parties to engage in discussions regarding this potential collaboration. Following these discussions,
GenVec notified Intrexon that it did not wish to pursue the project and discussions ended in September 2015.
During this period, GenVec continued its
business development efforts and, on March 23, 2015, it announced a new collaboration with TheraBiologics, Inc. to develop cancer therapeutics leveraging both GenVecs proprietary gene delivery platform and TheraBiologics proprietary
neural stem cell technology. In order to further ongoing business development efforts, in December 2015, GenVecs board of directors approved the establishment of a business development committee to review, evaluate and recommend to
GenVecs board of directors business development transactions. Despite its extensive business development and clinical research efforts, GenVec was unable to establish any major pipeline programs outside of its Novartis collaboration that
provided GenVec the potential for substantial revenues in the near term.
On January 8, 2016, Novartis notified GenVec that it was pausing enrollment
in the Phase 1/2 trial of CGF166 to conduct a safety review of patient data, based on the recommendation of the trials data safety monitoring board. Following the public announcement of the clinical hold on January 11, 2016, the price of
GenVecs common stock dropped from a closing price of $1.72 on the Nasdaq Capital Market (which price does not take into account the reverse stock split) on January 8, 2016, the day prior to the announcement, to a closing price of $0.72 on
the trading day of the announcement. As a result of this price drop, on February 24, 2016 GenVec received notice from NASDAQ that the minimum bid price of its common stock had remained below $1.00 for 30 consecutive business days, and it
therefore was not in compliance with the minimum bid price requirement for continued listing.
In May 2016, GenVec announced that it expected that the
trial of CGF166 would resume, and GenVec undertook capital raising efforts to address its cash needs. On May 4, 2016, GenVec entered into a Securities Purchase Agreement with certain investors for the sale of approximately 547,196 shares of
GenVecs common stock (as adjusted for the reverse stock split), at a purchase price of $9.1375 per share and the concurrent sale of warrants to purchase approximately 410,397 shares of common stock for aggregate gross proceeds of approximately
$5 million.
On July 25, 2016, Novartis notified GenVec that the FDA had lifted the clinical hold on the trial.
In order to regain compliance with the minimum bid price requirement, effective December 1, 2016 GenVec effected a
one-for-ten
reverse stock split of its outstanding common stock. After the reverse stock split, on December 15, 2016 GenVec received notice from the Listing Qualifications Department of NASDAQ stating
that it had regained compliance with the $1.00 minimum bid price requirement for continued listing.
Through the first half of May 2016, GenVec continued
with its business development and clinical research efforts, but did not enter into any agreements or identify any opportunities that were likely to result in opportunities in the near term.
Detailed Timeline of Events
On May 18, 2016, Thomas
Reed, Ph.D., Founder and Chief Science Officer of Intrexon, contacted Douglas Swirsky, President and Chief Executive Officer of GenVec, asking for a meeting with Mr. Swirsky. The next day, Mr. Swirsky and Dr. Reed met to discuss the
possibility of a strategic transaction between GenVec and Intrexon. On the following day, Mr. Swirsky
e-mailed
Dr. Reed a
non-confidential
presentation
regarding GenVecs AdenoVerse technology platform. Dr. Reed and Mr. Swirsky then corresponded regarding the differences between GenVecs AdenoVerse technology platform and the delivery platform of a third party.
On May 26, 2016, Dr. Reed requested a meeting between the GenVec and Intrexon teams to discuss GenVecs technology, programs and capabilities;
in response, Mr. Swirsky provided support for the meeting and confirmed that the confidentiality agreement entered into by the parties in August 2015 remained effective. The meeting was held at Intrexons offices in Germantown,
Maryland on June 3, 2016. Following this meeting, Dr. Reed and Mr. Swirsky exchanged
e-mails
regarding GenVecs technology, experience and capabilities in human and animal health vaccines.
Dr. Reed and Mr. Swirsky met in Palm Beach, Florida on June 22, 2016, at which time Dr. Reed reiterated Intrexons interest in a
strategic transaction involving GenVec. However, Dr. Reed also explained that Intrexon had certain competing interests and priorities that would delay further discussions between the parties for several weeks.
Despite the delay in further negotiations, on August 14, 2016 GenVec and Intrexon executed an amendment to the confidentiality agreement previously
entered into in August 2015 to extend confidentiality obligations thereunder until August 14, 2017.
Between August and November of 2016, consistent
with its strategic plan, GenVec continued to engage in discussions with third parties regarding potential business development and capital raising transactions. On September 2, 2016, based on potential business development opportunities with
other parties Mr. Swirsky sent Dr. Reed an
e-mail
stating that a strategic transaction was no longer a preferred outcome for GenVec and inquiring as to Intrexons interest in a more focused
collaboration.
GenVec continued to pursue other business development opportunities. However, GenVecs business development efforts during this time
did not eventually result in any near-term developments, and, on November 2, 2016, Mr. Swirsky contacted Dr. Reed via
e-mail
to follow up on prior discussions. That same day, Dr. Reed and
Mr. Swirsky spoke about GenVecs business
46
development efforts that were maturing at a slow pace relative to its capital needs and Mr. Swirsky expressed a willingness to revisit a possible strategic transaction with Intrexon. On this
call Dr. Reed requested that Mr. Swirsky provide an outline of the licensing transactions for the AdenoVerse technology that GenVec was exploring. Mr. Swirsky provided a redacted version of this outline to Dr. Reed on
November 6, 2016.
After these initial discussions with Mr. Swirsky, Dr. Reed introduced Mr. Swirsky via
e-mail
to Nir Nimrodi, Intrexons Senior Vice President of Corporate Development. On November 9, 2016, Mr. Swirsky spoke with Mr. Nimrodi to discuss logistics for Intrexons evaluation of
GenVecs technology, programs and capabilities. The following day Mr. Swirsky sent Mr. Nimrodi an overview of GenVecs financial projections to provide information on GenVecs cost structure. For information regarding the
treatment of GenVecs financial projections, see the section entitled The merger agreement Certain financial projections of GenVecs management.
Over the following few weeks, Intrexon continued to review GenVecs technology, programs, capabilities and financial outlook and to assess a potential
strategic transaction between the two companies. On November 22, 2016, Intrexon delivered to GenVec a letter expressing interest in pursuing a strategic transaction with GenVec and requesting that the two companies negotiate an exclusivity
agreement to provide Intrexon with an exclusive period of time to evaluate the opportunity and to conduct due diligence on GenVec.
On November 25,
2016, the GenVec board of directors met by telephone to consider the request for the exclusive negotiating period requested by Intrexon. The GenVec board of directors discussed the scope of the exclusivity requested, the time period during which the
exclusive due diligence and negotiating period would apply, and the potential that another transaction would need to be considered within this period. Following these discussions, the GenVec board of directors authorized Mr. Swirsky to enter
into the exclusivity agreement, but to negotiate the shortest period that Intrexon would be willing to agree to for the period of the agreement.
On
November 29, 2016, GenVec and Intrexon executed an exclusivity agreement, which provided that, between November 29, 2016 and January 23, 2017, GenVec would refrain from (i) soliciting or accepting any offers for the acquisition
of 20% or more of its outstanding securities or all of its assets, (ii) disclosing any
non-public
information to any entity with respect to such offers or (iii) entering into any agreement relating
to such offers. Under the terms of this agreement, GenVec was permitted to request Intrexons confirmation that it was pursuing a transaction in good faith and, if Intrexon did not make such confirmation, GenVec could terminate the exclusivity
at any time after December 26, 2016.
Immediately after executing the exclusivity agreement, Intrexon sent to GenVecs outside counsel, Hogan
Lovells US LLP, referred to herein as Hogan Lovells, Intrexons preliminary due diligence request list. On December 8, 2016, Mr. Swirsky sent GenVecs responses to the preliminary due diligence request list to Intrexon. The
following day, multiple members of the Intrexon business and technical teams were granted access to GenVecs virtual data room.
On December 9,
2016, executives from Intrexon, including Dr. Reed; Donald Lehr, Chief Legal Officer; Mr. Nimrodi; Christian Ulrich, Chief M&A Counsel and several members of the scientific team at Intrexon, attended in person meetings at GenVecs
headquarters. This meeting was led by Mr. Swirsky, who was joined by members of GenVecs corporate and scientific teams, including Douglas Brough, Ph.D., Chief Scientific Officer, Bryan Butman, Ph.D., Executive Vice President, Development,
and James Lambert, Senior Director, Accounting & Financing, as well as representatives of Hogan Lovells. At this meeting, GenVecs executive team presented its responses to Intrexons technical and
non-technical
diligence questions and answered additional questions from the Intrexon team. Additionally, Intrexons scientific team was offered the opportunity to tour GenVecs facilities.
Between December 9 and December 21, the parties engaged in a due diligence process with respect to GenVecs scientific, legal and financial
matters. On December 13, Mr. Swirsky sent Mr. Nimrodi an
e-mail
confirming that GenVec had added a significant amount of information to the virtual data room and had opened the technical and
scientific portion of the virtual data room. Mr. Ulrich then sent Mr. Swirsky on December 16 a list of supplemental due diligence requests based on Intrexons preliminary review of the documents uploaded to the virtual data room.
GenVec sent Intrexon responses to the supplemental requests on December 20 and 21.
On December 28, 2016, GenVec received a
non-binding
proposal from Intrexon to acquire 100% of the issued and outstanding stock of GenVec, in a
stock-for-stock
transaction, at
an implied price of between $3.75 and $3.85 per share.
The board of directors of GenVec convened a telephonic meeting on December 30, 2016 at which
all directors were in attendance, as well as representatives of Hogan Lovells. Mr. Swirsky opened this meeting by describing the background of discussions with Intrexon to date and then discussed the letter of intent provided by Intrexon. A
representative of Hogan Lovells then provided background on discussions with Intrexons legal department. Mr. Swirsky highlighted for the GenVec board of directors managements views on the limited business development and strategic
transaction opportunities. The GenVec board of directors members agreed that it was not in the best interests of GenVec or its shareholders to accept the proposal from Intrexon and authorized Mr. Swirsky to respond to Mr. Nimrodi
indicating the same. Additionally, the GenVec board of directors authorized Mr. Swirsky to request that Intrexon release GenVec from exclusivity on the basis that the offer was not acceptable to the GenVec board of directors. The GenVec board
of directors also approved enabling a business development committee to engage in future strategic discussions with Intrexon and other parties, if any. Following the meeting of the GenVec board of directors, Mr. Swirsky sent Mr. Nimrodi a
letter stating that GenVec believed that the parties were too far apart on perceived deal value to continue discussions and requested an early termination of the exclusivity period given the valuation gap.
47
On January 5, 2017, Mr. Nimrodi contacted Mr. Swirsky by email to schedule a telephone call,
and they spoke later that day. During the conversation, Mr. Nimrodi stated that Intrexon intended to submit another offer rather than provide early termination of the exclusivity agreement.
In connection with the annual J.P. Morgan Healthcare Conference, both Mr. Swirsky and Dr. Reed were in San Francisco in the first part of January
2017. They met for dinner on January 8, 2017 and were joined by Dr. Brough. During dinner, Dr. Reed indicated that the Intrexon team was working on a revised proposal and the parties discussed the complementary technologies of the two
companies.
Between January 9 and January 12, 2017, Mr. Swirsky, Dr. Brough, and members of GenVecs business development team
met with various potential business development and strategic partners who were also in San Francisco for meetings related to the J.P. Morgan Healthcare Conference in San Francisco. In parallel, GenVec continued to engage in discussions with third
parties with respect to financing opportunities for GenVec through the capital markets.
After failing to receive a new offer from Intrexon by
January 10, 2017, and with no business development transactions expected to occur in the near term, GenVecs management determined that GenVec should engage in capital raising efforts both in order to meet its near-term cash needs and also
to potentially help make GenVec a more attractive partner in business development efforts. On January 12, 2017, after discussions with management, the GenVec board of directors delegated full authority of the GenVec board of directors to a
pricing committee to take actions necessary to authorize and issue up to $10 million of common stock at no less than $4.00 per share, together with warrants.
While GenVec was proceeding with capital raising efforts, at the direction of management, on January 13, 2017, representatives of Hogan Lovells contacted
Mr. Lehr to inquire as to the status of Intrexons interest. Mr. Lehr indicated again that Intrexon was planning on presenting an offer to GenVec, but that Intrexon had not yet determined the proposed terms.
On January 17, 2017, GenVec concluded that the revised proposal discussed by Intrexon was unlikely, and entered into an engagement letter with an
investment bank to assist GenVec with an offering of equity securities. As part of the engagement and at the recommendation of the bank, GenVec authorized the bank to contact potential investors for a private placement of preferred stock and
warrants. During the afternoon of January 19, 2017, GenVec began negotiations with an institutional investor in connection with the proposed private placement transaction. GenVec and the potential investors continued negotiations throughout the
evening of January 19, 2017 with the goal of announcing a transaction prior to the market opening on Friday, January 20, 2017. However, GenVec and the investors were unable to reach agreement on the transaction terms for the private
placement prior to market open on January 20 and the parties agreed to continue to negotiate with the intent of announcing the financing during
intra-day
trading if the terms could be resolved. By
mid-day
on January 20, the investor had agreed to the terms of a private placement that would have provided GenVec with gross proceeds of approximately $6.5 million, before fees and expenses. In the
private placement, GenVec would have issued 6,500 shares of a newly created series of convertible preferred stock at $1,000 per share (and convertible into GenVec common stock at an initial conversion price of $5.00 per share) and warrants to
purchase up to 1,300,000 shares of common stock at an exercise price of $5.00 per share. Assuming the issuance of common stock on conversion of the preferred stock and the full exercise of the warrants, the securities issued in the offering would
have represented approximately 53% of the outstanding shares of common stock of GenVec.
Prior to executing documents with respect to the private
placement, on the afternoon of January 20, 2017, Mr. Nimrodi delivered to Mr. Swirsky a
non-binding
proposal from Intrexon to acquire 100% of the issued and outstanding stock of GenVec at a
price of $6.00 per share delivered in the form of Intrexon common stock plus a contingent payment right covering the next milestone to be received under the NVS License Agreement. Upon receiving this offer, Mr. Swirsky convened a telephonic
meeting of the available members of the GenVec board of directors. The directors available for the meeting agreed that Mr. Swirsky should negotiate with Intrexon to improve the terms of the offer while maintaining the possibility of completing
the financing transaction.
In accordance with the GenVec board of directors direction, Mr. Swirsky responded to Intrexons offer
indicating that the GenVec board of directors would be more likely to approve the transaction at a price of $8.00 per share plus up to $15 million in contingent payments based on the achievement of the milestones under the NVS License
Agreement. Mr. Nimrodi responded to Mr. Swirsky stating that Intrexon was willing to increase the offer to a value of $7.00 per share payable in Intrexon common stock, but with no contingent payments. Mr. Swirsky then spoke with
Randal Kirk, Chairman and Chief Executive Officer of Intrexon, regarding the potential strategic transaction and reached agreement on the key terms of the offer. Shortly after this discussion, Mr. Nimrodi formally communicated an offer of
Intrexon common stock having a value of $7.00 per share of GenVec common stock plus 50% of the milestone payments received under the NVS License Agreement during the next 36 months. Mr. Swirsky responded to Mr. Nimrodi indicating that he
thought that the companies should move forward on negotiating transactions documents under those terms and that he would meet with the GenVec board of directors the next morning. Mr. Nimrodi informed Mr. Swirsky that Intrexon wanted to
execute a definitive agreement and to announce the transaction prior to the opening of the stock markets on Monday, January 23, 2017.
Mr. Swirsky reached out to the investors in the private placement following discussions with Intrexon to confirm that GenVec did not intend to sign the
private placement transaction on January 20, 2017.
On the morning of January 21, 2017, the GenVec board of directors convened to discuss the status
of discussions with Intrexon regarding the proposed strategic transaction and parallel discussions with the investors in the proposed financing transaction. The GenVec board of directors discussed the alternatives of a strategic transaction and a
financing transaction, and asked Mr. Swirsky to discuss where GenVec stood with its other ongoing business development efforts. Following the discussion, the GenVec board of directors
48
determined that, based on several factors, including the additional dilution to existing GenVec shareholders associated with a financing transaction and the limited prospects of completing an
alternative business development transaction in the near-term, it was in the best interests of the GenVec shareholders to continue discussions with Intrexon regarding the potential strategic transaction. In discussing the financing transaction and
the substantial dilution that would result, the GenVec board of directors considered the impact of the dilution on the existing stockholders, that the implied price of a share of common stock in the financing was at a lower value than that implied
by the offer price in the strategic transaction, and that if there were a strategic transaction in the future, then the value paid by any third party would be split among a greater number of shareholders, which would require a greater overall
premium to be paid in order to provide the same value to the existing shareholders. The GenVec board of directors also noted that the financing transaction would result in the existing and new shareholders having continued exposure to the uncertain
outcome of GenVecs research and development activities, while at the same time providing less of a benefit to existing shareholders from any ultimate upside of those activities. Also in attendance at this meeting were representatives of Hogan
Lovells who discussed with the GenVec board of directors its legal obligations associated with a strategic transaction with Intrexon. The GenVec board of directors then discussed engaging a financial advisor to assess the proposed transaction with
Intrexon, in order to deliver to GenVec an opinion as to the financial fairness of the transaction. Following this discussion, the GenVec board of directors formally approved resolutions to form a special committee, comprised of Stefan D. Loren,
Ph.D., Marc R. Schneebaum and Michael Richman, authorized to consider the terms of and negotiate the Intrexon transaction. Additionally, the GenVec board of directors formally authorized Mr. Swirsky to engage Roth as GenVecs financial
advisor to provide a fairness opinion with respect to the transaction. Mr. Swirsky then left the meeting so that the GenVec board of directors could meet in an executive session. During the executive session, the representatives of Hogan
Lovells advised the GenVec board of directors of its considerations in connection with a potential conflict of interest if Intrexon were to offer the executives of GenVec employment with Intrexon prior to the closing of the transaction with
Intrexon.
That afternoon, Mr. Swirsky contacted representatives of Roth to discuss whether Roth would prepare an analysis and opinion for the
GenVec board of directors as to the fairness, from a financial point of view, of the per share merger consideration to be received by the holders of GenVec common stock in the merger based on the proposed terms of the agreement and its analysis
thereof. Roth agreed to perform such analysis and to render an opinion to the GenVec board of director with respect to the fairness, from a financial point of view, of the per share merger consideration to be received by the holders of GenVec common
stock in the merger.
In the afternoon on January 21, 2017, Mr. Swirsky contacted the GenVec board of directors to update them on the proposed
key terms of the transaction and to inform them that he expected to receive a draft merger agreement from Intrexon that evening. Mr. Swirsky also scheduled calls with the special committee of the GenVec board of directors and with the entire
board of directors at 10:00 a.m., and 10:00 p.m., respectively, on January 22, to discuss the status of the transaction.
Later that evening of
January 21, 2017, Mr. Ulrich sent Hogan Lovells a draft of the merger agreement, which included a number of open discussion items. Intrexon indicated that it planned on sharing a draft contingent payment rights agreement the next day.
During the evening of January 21, 2017, GenVec and Hogan Lovells began reviewing the merger agreement and preparing disclosure schedules.
On the
morning of January 22, 2017, the strategic transaction committee of the GenVec board of directors met via telephone conference, with representatives of Hogan Lovells in attendance, to discuss the material issues in the merger agreement.
Representatives of Hogan Lovells summarized the material terms of the merger agreement, including the proposal by Intrexon that the purchase price of the GenVec common stock be determined using an exchange ratio calculated based on the
20-day
volume weighted average price, referred to herein as VWAP, of Intrexons common stock as of the close of business on January 20, 2017 (which valued each share of Intrexon common stock at $24.716 per
share), and that the exchange ratio would be fixed and therefore the value to be received by GenVecs shareholder would float based on the value of a share of Intrexon common stock. The strategic transaction committee then discussed
with counsel those terms, as well as others, including termination rights, the ability of GenVec to entertain offers from third parties following signing, circumstances under which GenVec would be required to pay the expenses of Intrexon and the
importance of ensuring the certainty of the purchase price and the closing of the merger. Of additional discussion among the committee members were provisions with respect to employment matters, treatment of outstanding options and warrants and
GenVecs ability to operate its business between signing and closing. The transaction committee then provided guidance to GenVecs management and outside counsel regarding the material outstanding terms, particularly pricing, termination
rights, termination fee, expense reimbursement and closing certainty provisions.
In accordance with the directives from the strategic transaction
committee, representatives of Hogan Lovells held a telephone conference with Mr. Lehr, Mr. Ulrich and representatives of Thompson Hine LLP, referred to herein as Thompson Hine, outside counsel to Intrexon, to discuss the material open
issues in the merger agreement from GenVecs point of view. Specifically, representatives of Hogan Lovells proposed a
go-shop
provision that would have provided GenVec the ability to seek
alternative proposals after signing of the transaction with a termination fee of $250,000, an exchange ratio with a floor of $6.50 per share using the closing price of Intrexons common stock on January 21, 2017, a termination
fee of $450,000 and no repayment of expenses in the event that the shareholders of GenVec do not approve the merger.
During the afternoon of
January 22, 2017, GenVec received a draft of the proposed contingent payment rights agreement as well as a draft press release with respect to the merger.
Mr. Lehr and representatives of Hogan Lovells had further conversations with respect to the terms of the transaction throughout the afternoon, and in the
evening the Intrexon team communicated revised terms, confirming that Intrexon was willing to discuss decreasing the termination fee from $1.25 million to $1 million, but was not amenable to a
go-shop
provision or a price floor, and that it required an expense reimbursement of up to $750,000 in the event of termination in certain circumstances, including if the GenVec shareholders did
not approve the merger.
Later in the evening of January 22, 2017, representatives of Hogan Lovells held a telephone conference with the entire
GenVec board of directors to further consider the proposed transaction and to provide feedback from the telephone calls with Intrexon. Representatives of Hogan Lovells reported on the discussion with Intrexon and its counsel and the revised terms
that Intrexon had communicated. The GenVec board of directors discussed the pricing of the transaction, and particularly the relative importance of certainty around the price per share under the merger agreement. The GenVec board of directors agreed
that a
49
fixed price per share would provide GenVecs shareholders with greater certainty regarding the payments under the merger agreement, but that it would be reasonable to accept a floating
exchange ratio, particularly in light of the view of the GenVec board of directors of the potential benefits from a combination of the two companies. The GenVec board of directors also discussed the historical volatility of both Intrexon and
GenVecs common stock and concluded that it would be willing to determine the value of Intrexon common stock based on a shorter VWAP period, such as a
five-day
period ending on the day prior to signing
the merger agreement.
The GenVec board of directors further discussed the termination provisions, concluding that the strategic value of the combination
made it such that a
go-shop
provision was not necessary, but that it was still appropriate to have the reasonable ability to terminate the merger agreement if GenVec received a superior proposal,
including by ensuring that any termination fee was reasonable. The GenVec board of directors agreed that a termination fee of $1 million or more was unacceptable and emphasized that it must be decreased in order for the GenVec board of
directors to approve and recommend the transaction. The GenVec board of directors then discussed the proposals regarding the CPRs and that a structure using cash for the payment of those rights would make it difficult for the transaction to qualify
as a tax free reorganization. Prior to adjourning the meeting, the directors agreed to meet again in the evening of January 23, 2017 to discuss the status of the transaction after further negotiations.
In the morning on January 23, 2017, Hogan Lovells delivered revised drafts of the merger agreement and the contingent payment rights agreement and
initial drafts of ancillary documents. The revised draft of the merger agreement proposed a price based on the
five-day
VWAP of Intrexons common stock, provisions relating to employee benefit
arrangements, a termination fee of $450,000, an expense reimbursement for termination for GenVecs breach of its covenants of up to $250,000 (but not on a
no-vote
by GenVecs shareholders), and
carve-outs from the material adverse effect definition for certain events with respect to GenVecs programs that are outside of GenVecs control.
In the evening of January 23, 2017, Thompson Hine sent further revised drafts of the merger agreement and related documents to Hogan Lovells. After
reviewing the material revisions to the documents, representatives of Hogan Lovells and Thompson Hine, Mr. Lehr and Mr. Ulrich met via teleconference to discuss the open items in the agreements. During the call, the parties agreed to
setting the exchange ratio based on the
five-day
VWAP, which would result in a fixed exchange ratio of 0.297 of a share of Intrexon common stock, plus a CPR. However, the parties were unable to agree with
respect to certain provisions relating to termination of the merger agreement, including an associated
break-up
fee and expense reimbursement, and left the call to meet with their respective business teams.
Following the call with the legal teams, the GenVec board of directors convened a meeting to discuss the status of the transaction. Representatives of
Hogan Lovells updated the GenVec board of directors on the agreed pricing and the differences between the parties with respect to termination provisions. The GenVec board of directors discussed the various termination provisions and agreed that the
representatives of Hogan Lovells should continue discussions with the Intrexon representatives, including to limit GenVecs exposure in the event that the merger is not consummated. After providing specific guidance to the Hogan Lovells team,
the GenVec board of directors scheduled a call at 6:30 a.m. on January 24, 2017 and Mr. Swirsky informed the members of the GenVec board of directors that representatives of Roth had indicated that they would be available at that time to
present their fairness opinion, if requested.
Later that evening, after further discussions with Intrexons legal representatives, Hogan Lovells
sent further revised drafts of the merger agreement and related documents to Thompson Hine. The draft of the merger agreement proposed a termination fee of $550,000, an expense reimbursement of up to $400,000 for termination for breach by GenVec and
an additional $200,000 expense reimbursement if GenVec willfully breaches the
non-solicitation
provision. The draft did not include an expense reimbursement in the event that the GenVec shareholders did not
approve the transaction. And, it provided that the GenVec board of directors could, in certain circumstances, terminate the merger agreement if it had a change of recommendation. After further discussions through the night, Intrexon agreed to the
material terms of the draft provided by Hogan Lovells.
That same night, Mr. Swirsky and Dr. Stefan Loren, a director of GenVec, engaged in
discussions with Mr. Lehr and Mr. Rick L. Sterling, Intrexons Chief Financial Officer, regarding certain diligence matters with respect to Intrexon.
Throughout the night of January 23 and into the early morning of January 24, the parties continued finalizing the documents for the transaction.
On the morning of January 24, 2017, the GenVec board of directors met, with representatives of Roth and Hogan Lovells in attendance at various
points in the meeting, to consider approving the merger, pending results of the latest updates from its advisors regarding the negotiations of the material terms of the merger agreement. Representatives of Hogan Lovells updated the GenVec board of
directors with respect to the current status of certain terms of the merger agreement that remained open as of the prior GenVec board of directors meeting, including that Intrexon had made material concessions with respect to termination fees.
Representatives of Hogan Lovells then answered questions from the GenVec board of directors regarding the terms of the merger agreement and summarized the material terms of the other documents included in the transactions contemplated by the merger
agreement.
Roth then joined the meeting and reviewed with the GenVec board of directors its financial analysis of the merger consideration and rendered
an oral opinion, confirmed by the delivery of a written opinion, dated January 24, 2017, to the GenVec board of directors to the effect that, as of such date and based on and subject to various assumptions made, procedures followed, matters
considered and limitations and qualifications on the review undertaken, the merger consideration to be received by the holders of GenVec common stock pursuant to the merger agreement and contingent payment rights agreement was fair, from a financial
point of view, to such holders.
50
Following the foregoing discussion, representatives of Hogan Lovells reviewed proposed resolutions approving
the merger and the other transactions contemplated by the merger agreement. In addition to approving the execution, delivery and performance of the merger agreement, the resolutions contained, among other matters, resolutions approving the
contingent payment rights agreement and other ancillary matters. At this point, Mr. Swirsky left the meeting, so that the GenVec board of directors could meet in an executive session. During the executive session, the GenVec board of directors
considered that, as a result of the merger, Mr. Swirsky will be entitled to certain benefits, including acceleration of options held by Mr. Swirsky and a potential
18-month
severance package if he
experiences a qualifying termination of employment in the
two-year
period following the merger. The GenVec board of directors acknowledged that Mr. Swirskys interests may be viewed as different than
the other shareholders, but the GenVec board of directors agreed that Mr. Swirsky had not acted inconsistent with the best interests of the shareholders taken as a whole. Mr. Swirsky then rejoined the meeting.
The GenVec board of directors, following a review of the proposed resolutions, unanimously adopted resolutions and, among other things, (i) determined
that the merger agreement, the merger, and the other transactions contemplated by the merger agreement were fair and advisable to, and in the best interests of, GenVec and its shareholders, (ii) approved the execution, delivery and performance
by GenVec of the merger agreement and the consummation of the merger and the other transactions contemplated by the merger agreement, (iii) approved the contingent payment rights agreement and (iv) resolved to recommend that the
shareholders of GenVec adopt and approve the merger agreement.
On the morning of January 24, 2017, GenVec, Intrexon and Merger Sub signed the merger
agreement and GenVec and Intrexon issued a joint press release announcing the merger prior to the opening of regular trading on the NASDAQ Capital Market.
Recommendation of the GenVec board of directors; GenVecs reasons for the merger
The GenVec board of directors, at a meeting held on January 24, 2017, unanimously:
|
|
|
determined that the merger agreement, the merger and the other transactions contemplated by the merger agreement are fair and advisable to, and in the best interests of, GenVec and its shareholders;
|
|
|
|
approved the execution, delivery and performance by GenVec of the merger agreement and the consummation of the merger and the other transactions contemplated by the merger agreement;
|
|
|
|
directed that a proposal to adopt the merger agreement be submitted to a vote at a meeting of the GenVec shareholders; and
|
|
|
|
recommended that the GenVec shareholders vote to adopt and approve the merger agreement.
|
In evaluating the
merger, the GenVec board of directors consulted with GenVecs senior management and outside legal advisors, considered the limited available alternatives to enhance GenVecs competitive position in the pharmaceutical industry and to
increase shareholder value and considered a number of factors that it believed supported its decision to enter into the merger agreement and consummate the merger. These discussions included executive sessions with outside legal advisors without
management and financial advisors present.
In that process, the GenVec board of directors considered, among other things, the following factors (not in
any relative order of importance) as generally supporting its decision to approve the merger agreement and recommend that GenVec shareholders approve the merger proposal:
Financial Considerations
|
|
|
the per share stock consideration, having a value of 0.297 of a share of Intrexon common stock, without regard to the value of the CPR, which represented $7.00 per share of GenVecs common stock based on
Intrexons
five-day
VWAP as of January 23, 2017, which was an approximately 54% premium to GenVecs closing stock price of $4.54 per share on January 23, 2017;
|
|
|
|
in addition to the initial payment of Intrexon common stock, each GenVec shareholder will receive a CPR, which provides GenVecs shareholders an opportunity to realize additional value to the extent certain
milestones are achieved or occur and/or certain royalties are earned under the NVS License Agreement, through an additional payment of cash, or, under some circumstances, Intrexon common stock;
|
|
|
|
that based on the forecasts of GenVecs management, as well as the assumptions made by Roth based upon Roths analysis of GenVecs weighted average cost of capital and Roths experience and
professional judgment, Roth calculated the net present value of a CPR to be approximately $0.49 as of January 24, 2017 and the combined value, on a per share basis, of the $7.00 of stock consideration per share of GenVecs common stock and
the calculated net present value of a CPR to be $7.49, which represented an approximately 65% premium to the closing price of GenVecs common stock as of January 23, 2017;
|
|
|
|
the belief of the GenVec board of directors that, as a result of extensive
arms-length
negotiations, it and its advisors had obtained Intrexons best and final offer,
and that, as of the date of the merger agreement, the per share merger consideration represented the highest consideration per share of GenVec common stock reasonably obtainable;
|
51
|
|
|
the consideration to be received by GenVec shareholders will consist of Intrexon common stock, providing GenVec shareholders the opportunity to participate as shareholders in the potential appreciation in the stock of
the combined company, in light of perceived benefits of the proposed merger, including increased opportunities to pursue strategic collaborations using both GenVec and Intrexon technology;
|
|
|
|
Intrexon common stock issued in the merger will be registered with the SEC and listed on the NYSE, and therefore holders of GenVec common stock who wish to obtain liquidity with respect to their merger consideration
will have the opportunity to do so;
|
|
|
|
the fact that, in order to proceed on a stand-alone basis, the GenVec board of directors and members of GenVecs senior management believed that GenVec would need to raise additional funding to finance ongoing
operations, which, if available, would likely result in further significant dilution to GenVecs shareholders, including based on the financing terms that GenVec had most recently negotiated;
|
|
|
|
the financial analyses reviewed by Roth with the GenVec board of directors, and Roths oral opinion to the GenVec board of directors (which was confirmed in writing by Roths written opinion dated
January 24, 2017), with respect to the fairness, from a financial point of view, of the per share merger consideration to be received by the holders of GenVec common stock in the merger, as of January 24, 2017, based upon and subject to
the procedures followed, assumptions made, qualifications and limitations on the review undertaken and other matters considered by Roth in preparing its opinion (See The Merger Opinion of Roth Capital Partners as GenVecs financial
advisor);
|
Strategic Considerations
|
|
|
the fact that, in the months leading up to GenVecs decision to engage in discussions with Intrexon regarding a strategic transaction on November 2, 2016, GenVec had encountered limited success in negotiating
collaborations or partnerships;
|
|
|
|
the fact that GenVec has only one product, CGF166, under development and that its cash position limits its ability to acquire or invest in other indications, products, technologies or businesses;
|
|
|
|
the relatively slow pace of the development of CGF166, and that GenVec did not have the ability to change the pace of development;
|
|
|
|
the consideration by the GenVec board of directors of the current and historical financial condition, results of operations, business, competitive position, properties, assets and prospects of GenVec, including the risk
factors set forth in GenVecs Annual Report on Form
10-K
for the fiscal year ended December 31, 2015, subsequent quarterly reports on Form
10-Q
and current
reports on Form
8-K,
as well as the significant risk associated with GenVecs reliance on its collaboration with Novartis, and its limited prospects for capital raising efforts;
|
Transaction Terms and Other Considerations
|
|
|
the terms of the merger agreement, including the merger exchange ratio, were the result of extensive
arms-length
negotiations between representatives of Intrexon and GenVec;
|
|
|
|
the likelihood that the merger would be consummated based on, among other things:
|
|
|
|
the absence of any financing or due diligence condition to the completion of the merger;
|
|
|
|
the conditions to closing of the merger being specific and limited in scope;
|
|
|
|
the covenants contained in the merger agreement obligating each of the parties to use reasonable best efforts to take all actions necessary, proper or advisable to consummate and make effective the merger and the other
transactions as promptly as practicable; and
|
|
|
|
GenVec being entitled to specific performance to prevent breaches of the merger agreement and to enforce specifically the terms of the merger agreement;
|
|
|
|
other terms of the merger agreement, including:
|
|
|
|
the GenVec board of directors ability, at any time prior to obtaining GenVec shareholder approval, if prior to taking such actions the GenVec board of directors determines, after consultation with outside legal
counsel, that the failure to take such actions would breach, or would reasonably be expected to breach, its fiduciary duties to the GenVec shareholders, (i) to consider and respond to an unsolicited written proposal concerning any business
combination, sale of at least 20% of GenVecs assets or acquisition of at least 20% of GenVecs outstanding voting equity interests, (ii) to furnish information to the person making such proposal and (iii) to participate in
discussions or negotiations with the person making such proposal;
|
|
|
|
the GenVec board of directors ability, under certain circumstances, to (i) withdraw, change, qualify, withhold or modify, or publicly propose to withdraw, change, qualify, withhold or modify, in a manner
adverse to Intrexon, the GenVec board of directors recommendation to GenVec shareholders that they vote in favor of the adoption of the merger agreement, or (ii) adopt, approve or recommend, or publicly propose to adopt, approve or
recommend, an alternative acquisition proposal;
|
52
|
|
|
GenVecs ability, under certain circumstances, to terminate the merger agreement in order to enter into a merger agreement, acquisition agreement, letter of intent, memorandum of understanding or other similar
agreement relating to a superior proposal, after paying to Intrexon a termination fee of $550,000; and
|
|
|
|
the availability of appraisal rights under the DGCL to GenVec shareholders who comply with all of the required procedures under the DGCL, which allows such holders to seek appraisal of the fair value of their shares of
GenVec common stock as determined by the Delaware Court of Chancery;
|
|
|
|
the view of the GenVec board of directors that the terms of the merger agreement, including the parties mutual representations, warranties, covenants and conditions to closing, are reasonable;
|
|
|
|
the fact that the merger was unanimously approved by the GenVec board of directors, none of the members of which is affiliated with Intrexon;
|
|
|
|
the risk that pursuing other potential alternatives could have resulted in the loss of an opportunity to consummate a transaction with Intrexon; and
|
|
|
|
the fact that the merger is designed to qualify as a reorganization within the meaning of Section 368 of the Internal Revenue Code.
|
In the course of its deliberation, the GenVec board of directors also considered the following risk factors relating to entering into the merger agreement and
consummating the merger and the other transactions contemplated thereby, but determined that the benefits of the transactions substantially outweighed such risks:
|
|
|
the fact that the milestones and royalties necessary to trigger payments under the CPRs may not be achieved, and, if any such milestones or royalties are not achieved prior to the date that is 36 months following the
closing of the merger, no payments would be made pursuant to the CPRs with respect to such milestones or royalties;
|
|
|
|
the fact that the CPRs are not freely transferable and, accordingly, will not be registered with the SEC or listed on any securities exchange;
|
|
|
|
the possibility that, if the merger is not consummated, under certain circumstances, GenVec may be required to pay up to $600,000 in Intrexons expenses or a termination fee of $550,000, as more fully described in
the sections entitled The merger agreementTermination fee and The merger agreementCosts and expenses, which could discourage other third parties from making an alternative proposal with respect to GenVec;
|
|
|
|
the possibility that the public announcement of the merger agreement could have an adverse effect on GenVec, including effects on GenVecs customers, operating results and share price, and GenVecs ability to
attract and retain key management and personnel;
|
|
|
|
the potential impact of the restrictions under the merger agreement on GenVecs ability to take certain actions during the period between execution of the merger agreement and the consummation of the transactions,
generally requiring the company to conduct business only in the ordinary course or, if not in the ordinary course, to first seek and obtain Intrexons consent (which could delay or prevent GenVec from undertaking business opportunities that may
arise pending completion of the transactions);
|
|
|
|
the possibility that the merger may be delayed or not occur at all, due to a failure of certain conditions, and the risks and costs to GenVec if the merger is delayed or does not occur at all, including the potential
negative impact on GenVecs ability to retain key employees and the potential disruptive effects on GenVecs
day-to-day
operations and GenVecs
relationships with third parties;
|
|
|
|
the risk that the merger and the other transactions contemplated by the merger agreement may divert management attention and resources away from other strategic opportunities and from operational matters;
|
|
|
|
the potential risks associated with achieving anticipated synergies and successfully integrating GenVecs business, operations and workforce with those of Intrexon;
|
|
|
|
the fact that the consideration to be received by GenVecs shareholders will consist of Intrexon common stock, and therefore, if the risks described in the preceding item materialize, the long-term value of the
merger consideration may be materially less than the value of such consideration expected as of the date that the merger agreement was signed;
|
|
|
|
the fact that the price of Intrexon common stock determined at the time of closing of the merger could be lower than the price of such stock as of the time of signing the merger agreement, and accordingly, the value of
the consideration received by the GenVec shareholders in the merger could be materially less than the value of such stock consideration as of the date that the merger agreement was signed;
|
|
|
|
the risk of incurring substantial expenses related to the merger, including in connection with any litigation resulting from the announcement of the pendency of the merger; and
|
|
|
|
the other risks described in the section entitled Risk factors.
|
In addition, the GenVec board of
directors was aware of and considered the interests of its directors and executive officers that are different from, or in addition to, the interests of GenVec shareholders generally, including the treatment in the merger of GenVec stock options and
other equity awards described in the section entitled Interests of GenVecs directors and executive officers in the merger and Intrexons agreement to indemnify GenVec directors and officers against certain claims and
liabilities.
53
The foregoing discussion of information and factors considered by the GenVec board of directors is not
exhaustive, but includes the material factors considered by the GenVec board of directors, including factors that support the merger and the other transactions contemplated by the merger agreement as well as those against them. In view of the wide
variety of factors considered by the GenVec board of directors in connection with its evaluation of the merger and the other transactions and the complexity of these matters, the GenVec board of directors did not consider it practical to, nor did it
attempt to, quantify, rank or otherwise assign relative weights to the specific factors that it considered in reaching its decision. Rather, the GenVec board of directors based its recommendation on the totality of the information presented to and
considered by it. The GenVec board of directors evaluated the factors described above with the assistance of GenVecs senior management and legal advisors. In considering the factors described above, individual members of the GenVec board of
directors may have given different weights to other or different factors.
This explanation of the factors considered by the GenVec board of directors is
in part forward-looking in nature, and, therefore, should be read in light of the factors discussed in the sections of this proxy statement/prospectus entitled Cautionary statement on forward-looking statements and Risk
factors.
After careful consideration, the GenVec board of directors unanimously determined that the merger agreement, the merger and the other
transactions contemplated by the merger agreement are fair and advisable to, and in the best interests of, GenVec and its shareholders, and approved the execution, delivery and performance by GenVec of the merger agreement and the consummation of
the merger and the other transactions contemplated by the merger agreement.
Accordingly, the GenVec board of directors unanimously recommends that GenVec
shareholders vote
FOR
the merger proposal,
FOR
the merger-related compensation proposal and
FOR
the adjournment proposal.
Opinion of Roth Capital Partners as GenVecs financial advisor
The GenVec board of directors retained Roth on January 21, 2017 to render an opinion as to the fairness, from a financial point of view, to the holders of
GenVec common stock of the consideration to be received by such holders in the merger.
On January 24, 2017, Roth rendered its oral opinion to the
GenVec board of directors (which was subsequently confirmed in writing by delivery of Roths written opinion dated the same date) to the effect that, based upon and subject to the assumptions, factors, qualifications and limitations set forth
in the written opinion described herein, as of January 24, 2017, the consideration to be received by the holders of GenVec common stock in the merger was fair, from a financial point of view, to such holders.
Roths opinion was prepared for the information of the GenVec board of directors for its use in connection with its consideration of the merger and only
addressed the fairness, from a financial point of view, to the holders of GenVec common stock of the consideration to be received by such holders in the merger. Roth was not requested to opine as to, and Roths opinion does not address, the
relative merits of the merger or any alternatives to the merger, GenVecs underlying decision to proceed with or effect the merger, or any other aspect of the merger. Roths opinion does not address the fairness of the merger to the
holders of any other class of securities, creditors or other constituencies of GenVec and is not a valuation of GenVec or its assets or any class of its securities. Roth did not express an opinion about the fairness of the amount or nature of any
compensation payable or to be paid to any of the officers, directors or employees, of GenVec, whether or not relative to the merger.
The summary of
Roths opinion in this proxy statement/prospectus is qualified in its entirety by reference to the full text of its written opinion, which is included as
Annex E
to this proxy statement/prospectus and sets forth the procedures followed,
assumptions made, qualifications and limitations on the review undertaken and other matters considered by Roth in preparing its opinion. Roths opinion was prepared for the information of the GenVec board of directors for its use in connection
with its consideration of the merger. Neither Roths written opinion nor the summary of its opinion and the related analyses set forth in this proxy statement/prospectus are intended to be, and they do not constitute, advice or a recommendation
to any shareholder as to how such shareholder should act or vote with respect to any matter relating to the merger or any other matter.
In
connection with rendering the opinion described above and performing its related financial analyses, Roth, among other things:
|
|
|
reviewed a draft of the merger agreement;
|
|
|
|
reviewed certain information, including financial forecasts, relating to the business, earnings, cash flow, assets, liabilities and prospects of GenVec that were furnished to Roth by GenVec;
|
|
|
|
conducted discussions with members of senior management and representatives of GenVec concerning the matters described in the prior clause;
|
|
|
|
reviewed publicly available information relating to the businesses of GenVec and Intrexon;
|
|
|
|
discussed the past and current operations and financial condition and the prospects of GenVec with members of senior management of GenVec;
|
54
|
|
|
reviewed the financial terms, to the extent publicly available, of certain acquisition and financing transactions that Roth deemed relevant; and
|
|
|
|
performed such other analyses and considered such other factors as Roth deemed appropriate for the purpose of rendering its opinion.
|
In arriving at its opinion, Roth relied upon and assumed, without independent verification, the accuracy and completeness of all information that was publicly
available or was furnished, or otherwise made available to Roth or discussed with or reviewed by or for Roth, and further assumed that the financial information provided to Roth had been prepared on a reasonable basis in accordance with industry
practice, and that management of GenVec was not aware of any information or facts that would make any information provided to Roth incomplete or misleading.
With respect to the financial forecasts, estimates and other forward-looking information reviewed by Roth, Roth assumed that such information had been
reasonably prepared based on assumptions reflecting the best currently available estimates and judgments of GenVecs management as to the expected future results of operations and financial condition of GenVec. Roth was not engaged to assess
the achievability of any such financial forecasts, estimates or forward-looking information or the assumptions on which they were based, and Roth expressed no opinion as to such information or assumptions. In addition, Roth did not assume any
responsibility for, and did not perform, any appraisals or valuation of any specific assets or liabilities (fixed, contingent or other) of GenVec, nor was Roth furnished or provided with any such appraisals or valuations. Without limiting the
generality of the foregoing, Roth was not engaged to perform, and did not undertake, any independent analysis of any pending or threatened litigation, regulatory action, possible unasserted claims or other contingent liabilities, to which GenVec or
any of their respective affiliates is a party or may be subject, and at the direction of the GenVec board of directors and with its consent, Roths opinion made no assumption concerning, and did not consider, the possible assertion of claims,
outcomes or damages arising out of any such matters.
Roth relied upon and assumed, without independent verification, that the representations and
warranties of all parties set forth in the merger agreement and all related documents and instruments that are referred to therein are true and correct, that each party will fully and timely perform all of the covenants and agreements required to be
performed by such party, that the merger will be consummated pursuant to the terms of the merger agreement, without amendment, and that all conditions to the consummation of the merger will be satisfied without waiver thereof. Roth further assumed
that the merger agreement was in all material respects identical to the draft of the merger agreement provided to Roth. Finally, Roth also assumed that all the necessary regulatory approvals and consents required for the merger, including the
approval of the shareholders of GenVec, will be obtained in a manner that will not adversely affect GenVec or the contemplated benefits of the merger.
In
connection with its opinion, Roth assumed and relied upon, without independent verification, the accuracy and completeness of all of the financial, legal, regulatory, tax, accounting and other information provided to, discussed with or reviewed by
it. Roths opinion does not address any legal, regulatory, tax or accounting issues. Roths fairness opinion was approved by its fairness committee prior to delivering it to GenVec.
Roths opinion is necessarily based upon the information available to Roth and facts and circumstances as they existed and were subject to evaluation as
of January 24, 2017, which is the date of the Roth opinion. Although events occurring after the date of the Roth opinion could materially affect the assumptions used in preparing the opinion, Roth does not have any obligation to update, revise
or reaffirm its opinion and Roth expressly disclaims any responsibility to do so. Roth did not express any opinion as to the price at which shares of Intrexon common stock may trade following announcement of the merger or at any future time.
The consideration to be paid by GenVec in the merger was determined through negotiations between GenVec and Intrexon. Roth did not provide advice to the
GenVec board of directors during these negotiations, and the decision to enter into the merger agreement was solely that of the GenVec board of directors. Roths opinion and its presentation to the GenVec board of directors was one of many
factors taken into consideration by the GenVec board of directors in connection with its consideration of the merger. Consequently, the analyses as described herein should not be viewed as determinative of the opinion of the GenVec board of
directors with respect to the consideration to be received by holders of GenVec common stock in the merger or of whether the GenVec board of directors would have been willing to agree to different consideration.
The following is a summary of the material financial analyses performed by Roth in connection with the preparation of its fairness opinion, which opinion was
rendered orally to the GenVec board of directors (and subsequently confirmed in writing by delivery of Roths written opinion dated the same date) on January 24, 2017. The preparation of analyses and a fairness opinion is a complex
analytic process involving various determinations as to the most appropriate and relevant methods of financial analysis and the application of those methods to the particular circumstances and, therefore, such an opinion is not readily susceptible
to summary description and this summary does not purport to be a complete description of the analyses performed by Roth or the delivery of Roths opinion to the GenVec board of directors.
In furnishing its opinion, Roth did not attempt to combine the analyses described herein into one composite valuation range, nor did Roth assign any
quantitative weight to any of the analyses or the other factors considered. Furthermore, in arriving at its opinion, Roth did not attribute any particular weight to any analysis or factor considered by it, but rather made qualitative judgments as to
the significance and relevance of each analysis and factor in light of one another. Accordingly, Roth has stated that it believes that its analyses must be considered as a whole and that considering any portion of its analyses, without considering
all of the analyses, could create a misleading or incomplete view of the process underlying its opinion or the conclusions to be drawn therefrom.
55
This summary includes information presented in tabular format. In order to fully understand the financial
analyses presented by Roth, the tables must be read together with the text of each analysis summary and considered as a whole. The tables alone do not constitute a complete summary of the financial analyses. Considering any portion of such analyses
and of the factors considered, without considering all analyses and factors, could create a misleading or incomplete view of the process underlying Roths opinion.
In conducting the analysis as to the fairness, from a financial point of view, to the holders of GenVec common stock of the consideration to be received by
such holders in the merger, Roth evaluated the equity valuation of GenVec using a number of valuation metrics. Roth also estimated the value of the CPRs to be received by holder of GenVec common stock. Roth then compared the total consideration to
be paid by Intrexon to an estimate of the equity value of GenVec.
The results of the application by Roth of each of the valuation methodologies utilized
in connection with its fairness opinion are summarized below. The order in which such valuation methodologies are described below does not represent the relative importance or weight given to those methodologies by Roth. Except as otherwise noted,
the following quantitative information, to the extent that it is based on market data, is based on market data as it existed on January 23, 2017.
Estimated GenVec equity valuation
Roth evaluated
the value of GenVec using the following valuation methodologies:
|
|
|
public market valuation;
|
|
|
|
public comparable analysis;
|
|
|
|
precedent M&A premiums analysis; and
|
|
|
|
discounted cash flow analysis of GenVecs CGF166 and FMD programs.
|
Utilizing these valuation
methodologies, Roth estimated equity valuations of GenVec as follows: (i) $4.40 per share to $5.95 per share utilizing the Public Market Valuation; (ii) $7.33 per share to $8.89 per share utilizing the Public Comparable Analysis; (iii) $6.64 per
share to $7.00 per share utilizing the Precedent M&A Premiums Analysis; and (iv) $4.64 per share to $4.77 per share utilizing the Discounted Cash Flow Analysis. Roth determined that these estimates resulted in an average equity valuation of
$5.75 per share to $6.65 per share.
56
The results of Roths analyses are summarized as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GenVec Inc. Valuation Summary
($ in millions unless on a per share basis)
|
|
|
|
|
|
|
|
Implied
|
|
|
Implied
|
|
|
Implied Equity
|
|
|
|
Enterprise Value
|
|
|
Equity Value
1
|
|
|
Value Per Share
2
|
|
Methodology
|
|
Low
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
|
Low
|
|
|
High
|
|
GenVec Public Market Valuation
|
|
$
|
3.7
|
|
|
$
|
7.3
|
|
|
$
|
10.3
|
|
|
$
|
13.9
|
|
|
$
|
4.40
|
|
|
$
|
5.95
|
|
Public Comparable Analysis
|
|
$
|
10.6
|
|
|
$
|
14.2
|
|
|
$
|
17.2
|
|
|
$
|
20.8
|
|
|
$
|
7.33
|
|
|
$
|
8.89
|
|
Precedent M&A Premiums Analysis
|
|
$
|
9.0
|
|
|
$
|
9.8
|
|
|
$
|
15.6
|
|
|
$
|
16.4
|
|
|
$
|
6.64
|
|
|
$
|
7.00
|
|
Discounted Cash Flow
Analaysis
3
|
|
$
|
4.3
|
|
|
$
|
4.6
|
|
|
$
|
10.9
|
|
|
$
|
11.2
|
|
|
$
|
4.64
|
|
|
$
|
4.77
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
$
|
6.9
|
|
|
$
|
9.0
|
|
|
$
|
13.5
|
|
|
$
|
15.6
|
|
|
$
|
5.75
|
|
|
$
|
6.65
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Notes: (1) Equity Value assumes a net cash position of $6.6 million
(2) Based on fully-diluted share count of 2,344,381.6 shares
(3) Enterprise value based on the discounted cash flow analysis of the CGF166 and FMD programs; For the purposes of the analysis,
GenVecs assets in the discovery or preclinical development stages were not included in the Discounted Cash Flow Analysis due to the early nature of the programs and lack of strategic partner validation
Public market valuation
Roth noted that since
January 1, 2016, the price of GenVec common stock had declined 75%, closing on January 23, 2017 at $4.54, reflecting a public market valuation of $10.3 million.
Utilizing the
five-day
high ($6.13 on January 17, 2017) and
five-day
low
($4.54 on January 23, 2017) of the price of GenVec common stock, and assuming a net cash position of $6.6 million, Roth determined that GenVecs implied enterprise value ranged from $3.7 million to $7.3 million.
Public comparable analysis
Roth reviewed the total
enterprise values of publicly traded companies that Roth deemed comparable to GenVec. The comparable companies analysis uses data from comparable companies to develop a measure of current value for GenVec. The rationale for using a public
comparable analysis is that companies in the same industry with similar operating characteristics should have certain valuation benchmarks in common. The goal of the analysis is to develop a premise for relative value, which when coupled with other
valuation approaches, presents a foundation for determining a range of values for a company.
Although none of the following companies is identical to
GenVec, Roth selected these companies because they had publicly traded equity securities and were deemed to be similar to GenVec in one or more respects, including their businesses, their size and their operating characteristic. Roth obtained the
following publicly available information for each selected company from
57
Biomed Tracker, Capital IQ, and Evaluate Pharma and, as reflected below, determined that the selected companies had a median and mean enterprise value of $10.6 million and
$14.2 million, respectively:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Company
|
|
Ticker
|
|
1/23/2017
Price
|
|
|
52 Week
High
|
|
|
52 Week
Low
|
|
|
Market
Cap ($M)
|
|
|
Enterprise
Value ($M)
|
|
ImmunoVaccine Inc.
|
|
IMV
|
|
$
|
0.51
|
|
|
$
|
0.64
|
|
|
$
|
0.29
|
|
|
$
|
60.2
|
|
|
$
|
58.0
|
|
Auris Medical Holding AG
|
|
EARS
|
|
$
|
1.15
|
|
|
$
|
5.45
|
|
|
$
|
0.84
|
|
|
$
|
39.5
|
|
|
$
|
12.8
|
|
Vical Incorporated
|
|
VICL
|
|
$
|
2.22
|
|
|
$
|
4.80
|
|
|
$
|
2.20
|
|
|
$
|
24.5
|
|
|
($
|
12.9
|
)
|
Heat Biologics, Inc.
|
|
HTBX
|
|
$
|
0.93
|
|
|
$
|
3.61
|
|
|
$
|
0.40
|
|
|
$
|
23.9
|
|
|
$
|
18.3
|
|
Benitec Biopharma Limited
|
|
BLT
|
|
$
|
0.11
|
|
|
$
|
0.22
|
|
|
$
|
0.06
|
|
|
$
|
18.6
|
|
|
$
|
8.4
|
|
Opexa Therapeutics, Inc.
|
|
OPXA
|
|
$
|
0.93
|
|
|
$
|
4.93
|
|
|
$
|
0.50
|
|
|
$
|
6.6
|
|
|
$
|
0.8
|
|
|
|
|
|
|
|
|
|
|
Mean
|
|
|
|
|
|
|
$
|
28.9
|
|
|
$
|
14.2
|
|
|
|
|
|
|
|
|
|
|
Median
|
|
|
|
|
|
|
$
|
24.2
|
|
|
$
|
10.6
|
|
Although the selected companies were used for comparison purposes, no selected company was either identical or directly
comparable to GenVecs business. Accordingly, Roths comparison of selected companies to GenVec and analysis of the results of such comparisons was not purely mathematical, but instead necessarily involved complex considerations and
judgments concerning differences in financial and operating characteristics and other factors that could affect the relative values of the selected companies and GenVec.
Precedent M&A premiums analysis
The precedent
M&A premiums analysis uses data from selected public M&A transactions to evaluate the premiums paid for comparable companies. The rationale for using a precedent M&A premiums analysis is that the premiums paid for public companies in the
same industry with similar operating characteristics should have some level of comparability. The goal of the analysis is to develop a premise for relative value, which when coupled with other valuation approaches, presents a foundation for
determining a range of values for a company.
Roth examined precedent transactions, from March 30, 2015 through September 14, 2016, involving
public life science companies that it viewed as similar to GenVec with available transaction values. Roth selected these entities on the basis of the nature of their businesses, their size and their operating characteristics. Roth limited
transactions to those with a transaction value of less than $1.0 billion. The data publicly available on these transactions, due in part to their size, is limited and was obtained by Roth from Evaluate Pharma and company press releases. Roth
examined the data points set out in the table below for the selected precedent transactions, including, for each transaction, the transaction value and the premium of the offer price in the transaction over the target companys closing stock
price one day prior to the announcement of the transaction:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock Price Premium
|
|
Date
1
|
|
Target Company
|
|
Acquiroring Company
|
|
Transaction
Value (M)
|
|
|
1-Day Prior
Announcement
|
|
09/14/16
|
|
Vitae Pharmaceuticals
|
|
Allergan
|
|
$
|
639.0
|
|
|
|
159%
|
|
09/12/16
|
|
Raptor Pharmaceutical
|
|
Horizon Pharma
|
|
$
|
800.0
|
|
|
|
21%
|
|
07/11/16
|
|
Sagent Pharmaceuticals
|
|
Nichi-Iko
Pharmaceutical
|
|
$
|
736.0
|
|
|
|
40%
|
|
07/01/16
|
|
BIND Therapeutics
|
|
Pfizer
|
|
$
|
38.0
|
|
|
|
78%
|
|
05/23/16
|
|
XenoPort
|
|
Arbor Pharmaceuticals
|
|
$
|
467.0
|
|
|
|
60%
|
|
05/02/16
|
|
Symmetry Surgical
|
|
Consortium of Investors
|
|
$
|
140.3
|
|
|
|
26%
|
|
11/09/15
|
|
Ocata Therapeutics
|
|
Astellas Pharma
|
|
$
|
359.8
|
|
|
|
79%
|
|
09/15/15
|
|
InSite Vision
|
|
Sun Pharmaceutical Industries
|
|
$
|
48.0
|
|
|
|
30%
|
|
09/02/15
|
|
Synergetics USA
|
|
Valeant Pharmaceuticals International
|
|
$
|
166.0
|
|
|
|
71%
|
|
07/13/15
|
|
Unilens Vision
|
|
Valeant Pharmaceuticals International
|
|
$
|
28.0
|
|
|
|
24%
|
|
06/04/15
|
|
DARA BioSciences
|
|
Midatech Pharma
|
|
$
|
24.0
|
|
|
|
51%
|
|
04/23/15
|
|
Ridley
|
|
Alltech
|
|
$
|
412.9
|
|
|
|
20%
|
|
03/30/15
|
|
Cellular Dynamics International
|
|
FUJIFILM Holdings
|
|
$
|
307.0
|
|
|
|
108%
|
|
|
|
|
|
|
|
|
Mean
|
|
|
|
59%
|
|
|
|
|
|
|
|
|
Median
|
|
|
|
51%
|
|
Note: (1) As of transaction announcement
As reflected in the table above, Roth determined that the selected precedent M&A premiums had a median and mean transaction premium of 51% and 59%,
respectively. Applying the median and mean transaction premiums to GenVecs market capitalization of $10.3 million, Roth determined that the implied equity value of GenVec ranged from $15.6 million to $16.4 million and, assuming
a net cash position of $6.6 million, the implied enterprise value ranged from $9.0 million to $9.8 million.
58
No company or transaction utilized in the precedent M&A premiums analysis is identical to GenVec or to
the merger. In evaluating the precedent transactions, Roth made judgments and assumptions concerning differences in financial and operating characteristics and other factors that could affect the relative values of the companies or transactions to
which GenVec or the merger were compared.
Discounted cash flow analysis
The discounted cash flow analysis is a forward looking methodology and is based on projected future cash flows to be generated by GenVec which are
then discounted back to the present. This methodology has three primary components: (1) the present value of projected unlevered cash flows for a determined period; (2) the present value of the terminal value of cash flows based on the
declining growth method (representing a companys value beyond the time horizon on the projections); (3) the weighted average cost of capital (WACC) used to discount such future cash flows and terminal value back to the present. In
the discounted cash flow analysis, Roth used unlevered free cash flow projections from GenVec management and then applied a probability of success adjustment based on the estimated probabilities of clinical success of its CGF166 and FMD
programs as provided by GenVec management. The future cash flows plus the terminal value of such cash flows are discounted by the WACC, to derive a present value. For the purposes of the Discounted Cash Flow Analysis, GenVecs assets in the
discovery or preclinical development stages were not included due to the early nature of the programs and lack of strategic partner validation.
In
conducting its discounted cash flow analysis for the purpose of determining the enterprise value of GenVec, Roth applied the projected unlevered free cash flow that GenVec is expected to generate during fiscal years 2017 to 2039 from GenVecs
CGF166 and FMD programs based upon financial projections prepared by GenVec management. Terminal values based on declining cash flow at a rate of 3.0% to 7.0% were applied to managements cash flow estimates in year 2039 to complete the basis
for calculating the present value of future free cash flows. The future free cash flows are then discounted by the WACC, to derive a present value. In selecting an appropriate discount rate, Roth took into account the industrys unlevered
equity beta of 1.22, GenVecs debt to equity ratio of 0.05%, levered beta of 1.22%, the equity risk premium of 19% based on Duff & Phelps 2015 Valuation Handbook, the risk free rate of 2.4% for
10-year
U.S. treasury securities,
pre-tax
cost of debt of 3.3% (average of comparable companies), GenVecs tax rate assumption of 34.0%, GenVecs equity to
total capitalization of 100.0% and its debt to total capitalization of 0.0%. Application of the foregoing principles resulted in a 25.6% WACC. Roth performed a sensitivity analysis using discount rates from 24.6% to 26.6% to arrive at a range of
present values.
Based on the foregoing, Roth computed an enterprise value range of $4.3 million to $4.6 million. In evaluating the foregoing,
it should be noted that the WACC does not take into consideration the specific firm risks such as bankruptcy. As a result, GenVecs true WACC may be higher when taking into consideration the risks of default and negative operating profit
history of the business which would have the effect of reducing the enterprise value range. By conducting an analysis of a range of discount rates rather than relying one specific WACC, Roth is comfortable that the analysis is appropriate.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GenVec Inc.
|
|
Discounted Cash Flow Analysis - CGF166 & FMD Programs
|
|
|
|
|
|
|
|
|
|
|
($ in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2018
|
|
|
2019
|
|
|
2020
|
|
|
2021
|
|
|
2022
|
|
|
2023
|
|
|
2024
|
|
Revenue Projections
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
10.9
|
|
|
$
|
15.4
|
|
YoY Growth
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
41
|
%
|
|
|
|
|
|
|
|
|
|
Net Income - CGF166
1
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
7.6
|
|
|
$
|
10.8
|
|
Probability of Success Adjustment
2
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
Net Income (Risk Adjusted)
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.4
|
|
|
$
|
0.5
|
|
|
|
|
|
|
|
|
|
|
First Indication Milestones -
CGF166
1
|
|
$
|
0.0
|
|
|
$
|
5.0
|
|
|
$
|
0.0
|
|
|
$
|
10.0
|
|
|
$
|
20.0
|
|
|
$
|
10.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
Probability of Success Adjustment
2
|
|
|
100.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
17.5
|
%
|
|
|
5.3
|
%
|
|
|
5.3
|
%
|
|
|
5.3
|
%
|
|
|
5.3
|
%
|
First Indication Milestones (Risk Adjusted)
|
|
$
|
0.0
|
|
|
$
|
1.8
|
|
|
$
|
0.0
|
|
|
$
|
1.8
|
|
|
$
|
1.1
|
|
|
$
|
0.5
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
|
|
|
|
|
|
|
|
Second Indication Milestones -
CGF166
1
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
1.0
|
|
|
$
|
5.0
|
|
|
$
|
0.0
|
|
|
$
|
15.0
|
|
Probability of Success Adjustment
2
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
100.0
|
%
|
|
|
28.0
|
%
|
|
|
11.2
|
%
|
|
|
11.2
|
%
|
|
|
2.7
|
%
|
Second Indication Milestones (Risk Adjusted)
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.3
|
|
|
$
|
0.6
|
|
|
$
|
0.0
|
|
|
$
|
0.4
|
|
|
|
|
|
|
|
|
|
|
Concept of Milestone Payment - FMD
1
|
|
$
|
0.3
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
Probability of Success Adjustment
2
|
|
|
80
|
%
|
|
|
80
|
%
|
|
|
80
|
%
|
|
|
80
|
%
|
|
|
80
|
%
|
|
|
80
|
%
|
|
|
80
|
%
|
|
|
80
|
%
|
Concept of Milestone Payment (Risk Adjusted)
|
|
$
|
0.2
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
|
$
|
0.0
|
|
Cash Flows (Risk Adjusted)
|
|
$
|
0.2
|
|
|
$
|
1.8
|
|
|
$
|
0.0
|
|
|
$
|
1.8
|
|
|
$
|
1.3
|
|
|
$
|
1.1
|
|
|
$
|
0.4
|
|
|
$
|
0.9
|
|
Note: (1) Figures are based on GenVecs estimates
(2) Probability of Success (PoS) adjustment based on GenVecs estimates
59
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2025
|
|
|
2026
|
|
|
2027
|
|
|
2028
|
|
|
2029
|
|
|
2030
|
|
|
2031
|
|
|
2032
|
|
Revenue Projections
|
|
$
|
20.5
|
|
|
$
|
28.3
|
|
|
$
|
52.4
|
|
|
$
|
58.8
|
|
|
$
|
63.1
|
|
|
$
|
4.3
|
|
|
$
|
4.7
|
|
|
$
|
5.1
|
|
YoY Growth
|
|
|
33
|
%
|
|
|
38
|
%
|
|
|
85
|
%
|
|
|
12
|
%
|
|
|
7
|
%
|
|
|
-93
|
%
|
|
|
10
|
%
|
|
|
9
|
%
|
|
|
|
|
|
|
|
|
|
Net Income - CGF166
1
|
|
$
|
14.3
|
|
|
$
|
19.8
|
|
|
$
|
36.7
|
|
|
$
|
41.1
|
|
|
$
|
44.2
|
|
|
$
|
3.0
|
|
|
$
|
3.3
|
|
|
$
|
3.6
|
|
Probability of Success Adjustment
2
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
Cash Flows (Risk Adjusted)
|
|
$
|
0.72
|
|
|
$
|
1.0
|
|
|
$
|
1.8
|
|
|
$
|
2.1
|
|
|
$
|
2.2
|
|
|
$
|
0.2
|
|
|
$
|
0.2
|
|
|
$
|
0.2
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2033
|
|
|
2034
|
|
|
2035
|
|
|
2036
|
|
|
2037
|
|
|
2038
|
|
|
2039
|
|
Revenue Projections
|
|
$
|
5.6
|
|
|
$
|
3.6
|
|
|
$
|
4.0
|
|
|
$
|
4.4
|
|
|
$
|
3.4
|
|
|
$
|
3.7
|
|
|
$
|
2.5
|
|
YoY Growth
|
|
|
9
|
%
|
|
|
-35
|
%
|
|
|
10
|
%
|
|
|
10
|
%
|
|
|
-24
|
%
|
|
|
11
|
%
|
|
|
-34
|
%
|
|
|
|
|
|
|
|
|
Net Income - CGF166
1
|
|
$
|
3.9
|
|
|
$
|
2.6
|
|
|
$
|
2.8
|
|
|
$
|
3.1
|
|
|
$
|
2.4
|
|
|
$
|
2.6
|
|
|
$
|
1.7
|
|
Probability of Success Adjustment
2
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
|
|
5.0
|
%
|
Cash Flows (Risk Adjusted)
|
|
$
|
0.20
|
|
|
$
|
0.1
|
|
|
$
|
0.1
|
|
|
$
|
0.2
|
|
|
$
|
0.1
|
|
|
$
|
0.1
|
|
|
$
|
0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Declining Growth Terminal Value
Methodology
|
|
|
Declining Growth Method
|
|
|
|
NPV of
|
|
|
PV of Terminal Value
|
|
|
|
|
|
|
Cash Flows
|
|
|
Declining Growth Method
|
|
|
NPV+Terminal Value
|
|
Discount Rate
|
|
(2017-2039)
|
|
|
3%
|
|
|
5%
|
|
|
7%
|
|
|
3%
|
|
|
5%
|
|
|
7%
|
|
24.6%
|
|
$
|
4.6
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
4.6
|
|
|
$
|
4.6
|
|
|
$
|
4.6
|
|
25.1%
|
|
$
|
4.5
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
4.5
|
|
|
$
|
4.5
|
|
|
$
|
4.5
|
|
25.6%
|
|
$
|
4.4
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
4.4
|
|
|
$
|
4.4
|
|
|
$
|
4.4
|
|
26.1%
|
|
$
|
4.4
|
|
|
$
|
0.002
|
|
|
$
|
0.002
|
|
|
$
|
0.001
|
|
|
$
|
4.4
|
|
|
$
|
4.4
|
|
|
$
|
4.4
|
|
26.6%
|
|
$
|
4.3
|
|
|
$
|
0.002
|
|
|
$
|
0.001
|
|
|
$
|
0.001
|
|
|
$
|
4.3
|
|
|
$
|
4.3
|
|
|
$
|
4.3
|
|
Note: (1) Figures are based on GenVecs estimates
(2) Probability of Success (PoS) adjustment based on GenVecs estimate
Contingent payment right analysis
Using the
results of its discounted cash flow analysis described above, Roth estimated the value range of the CPRs issuable to holders of GenVec common stock as $1.1 million to $1.2 million. The average of the estimated range of the CPRs was
$1.1 million or $0.49 per share, based on the 2,344,381.6 shares of GenVec common stock outstanding on a fully-diluted basis as of January 23, 2017.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GenVec Inc.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discounted Cash Flow Analysis - CPRs (CGF166)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in millions)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2017
|
|
|
2018
|
|
|
2019
|
|
|
2020
|
|
First Indication Milestones
1
|
|
$
|
0.0
|
|
|
$
|
2.5
|
|
|
$
|
0.0
|
|
|
$
|
5.0
|
|
Probability of Success Adjustment
2
|
|
|
100.0
|
%
|
|
|
35.0
|
%
|
|
|
35.0
|
%
|
|
|
17.5
|
%
|
Cash Flows (Risk Adjusted)
|
|
$
|
0.0
|
|
|
$
|
0.9
|
|
|
$
|
0.0
|
|
|
$
|
0.9
|
|
|
|
|
|
|
|
|
NPV of Cash Flows
|
|
Discount Rate
|
|
(2017-2020)
|
|
24.6%
|
|
$
|
1.2
|
|
25.1%
|
|
$
|
1.1
|
|
25.6%
|
|
$
|
1.1
|
|
26.1%
|
|
$
|
1.1
|
|
26.6%
|
|
$
|
1.1
|
|
Note: (1) FY2017 - FY2020 figures are based on GenVecs estimates
(2) Probability of Success (PoS) adjustment based on GenVecs estimates
Consideration analysis
Based on the exchange
ratio in the merger agreement of 0.297 of a share of Intrexon common stock for each share of GenVec common stock, Roth evaluated the consideration to be received by holders of GenVec common stock in the merger.
Roth noted that the closing price of GenVec common stock was $4.54 per share on January 23, 2017. Based on the value of $7.00 per share represented by
the exchange ratio and Roths estimate of the net present value of the CPRs, Roth estimated that each holder of GenVec common stock would receive consideration in the merger of approximately $7.49 per share, based
60
on the 2,344,381.6 shares of GenVec common stock outstanding on a fully-diluted basis as of January 23, 2017. Roth concluded that the $7.49 per share consideration being paid by Intrexon was
greater than the estimated equity value range of $5.75 to $6.65 attributed to GenVec and that the average of the estimated equity value range attributed to GenVec was $6.20 per share based on the midpoint of the valuation range attributed to GenVec.
As discussed above, Roth performed a variety of financial and comparative analyses for the purpose of rendering its opinion. While the preceding summary
describes several analyses and examinations that Roth deems material to its evaluation and opinion, they are not a comprehensive description of all analyses and examinations actually conducted by Roth.
General
Roth is a nationally recognized
investment banking firm that provides financial advisory services and is continually engaged in the valuation of businesses and their securities in connection with mergers and acquisitions, negotiated underwritings, secondary distributions of listed
and unlisted securities, private placements and valuations for estate, corporate and other purposes. The GenVec board of directors retained Roth to render an opinion as to the fairness, from a financial point of view, to the holders of GenVec common
stock of the consideration to be received by such holders in the merger pursuant to the merger agreement based upon the foregoing qualifications, experience and expertise.
GenVec paid Roth a fee of $175,000 for rendering its fairness opinion delivered in connection with the merger. The opinion fee was not contingent in whole or
in part on the success of the merger, or on the results of Roths evaluation and analysis or upon the conclusions reached in Roths opinion. In addition, GenVec agreed to reimburse Roth up to $25,000 for its reasonable
out-of-pocket
expenses, including reasonable fees and disbursements of its counsel. GenVec has also agreed to indemnify Roth against certain liabilities and other items that
may arise out of GenVecs engagement of Roth. The GenVec board of directors did not limit Roth in any way in the investigations it made or the procedures it followed in rendering its opinion.
Roth in the past has provided and may in the future provide investment banking and other financial services to GenVec and its affiliates for which Roth and
its affiliates have received, or, in the case of future services, may receive, compensation. Roth has not, however, had a material relationship with, nor otherwise received fees from, GenVec or any other parties to the merger during the two years
preceding the date of Roths opinion. Roth is a full service securities firm engaged in securities trading and brokerage activities, as well as providing investment banking and other financial services. In the ordinary course its business, Roth
and its affiliates may acquire, hold or sell, for its and its affiliates own accounts and for the accounts of customers, equity, debt and other securities and financial instruments (including bank loans and other obligations) of GenVec and the
other parties to the merger, and, accordingly, may at any time hold a long or a short position in such securities. In the future, Roth may provide financial advisory and investment banking services to Intrexon and its affiliates for which Roth would
expect to receive compensation.
Consistent with applicable legal and regulatory requirements, Roth has adopted policies and procedures to establish and
maintain the independence of its research departments and personnel. As a result, Roths research analysts may hold views, make statements or investment recommendations and/or publish research reports with respect to GenVec, Intrexon and/or the
merger that differ from the views of its investment banking personnel.
Interests of GenVecs directors and executive officers in the merger
In considering the recommendation of the GenVec board of directors to approve the merger proposal, GenVec shareholders should be aware that
GenVecs directors and executive officers may have interests in the merger that are different from, or in addition to, the interests of shareholders generally. The GenVec board of directors was aware of and considered these potential interests,
among other things, in adopting the merger agreement and approving the merger, and in recommending that the merger agreement be adopted by shareholders. See The mergerGenVecs reasons for the merger and recommendation of the GenVec
board of directors. These interests are described in further detail below, and certain of them are quantified in the narrative and table below. All share amounts relating to GenVec stock options, and the exercise prices of each such option,
described in this section have been retroactively adjusted to reflect the reverse stock split.
Treatment of outstanding GenVec stock options
GenVec has stock options outstanding under the GenVec, Inc. 2002 Stock Incentive Plan, which we refer to as the 2002 Plan, a CEO Inducement Award,
and the GenVec, Inc. 2015 Omnibus Incentive Plan (which amended and restated the GenVec, Inc. 2011 Omnibus Incentive Plan), which we refer to as the 2015 Plan. All stock options granted under the 2002 Plan and the CEO Inducement Award previously
vested in accordance with their terms. Pursuant to the applicable stock option award agreements, all unvested stock options under the 2015 Plan will fully vest upon a change in control. A change in control will occur under
the 2015 Plan both upon the approval of the merger proposal by the GenVec shareholders and the consummation of the merger.
Under the terms of the merger agreement, contingent on and subject to the closing of the merger, each outstanding, unvested stock option to purchase shares of
GenVec common stock will fully vest and will become immediately exercisable for a period of 15 days prior to the effective time of the merger, which period we refer to as the exercise window, and each holder of outstanding GenVec stock options will
be permitted to exercise such stock options during the exercise window. Each share of GenVec common stock purchased as a result of the exercise of a GenVec stock option during the exercise window will be treated as a share of GenVec common stock
issued and outstanding immediately prior to the effective time of the merger and will be eligible to receive the merger consideration as described under the headings The merger agreementMerger consideration and The merger
agreementTreatment of GenVec stock options and warrantsTreatment of stock options. At the effective time of the merger, each then-outstanding, unexercised GenVec stock option will automatically, and without any required action on
the part of the holder thereof, be cancelled for no consideration.
61
Under the 2002 Plan, the per share exercise price of stock options ranges from $41.00 to $410.00, and
the weighted average exercise price is $120.71. Under the CEO Inducement Award, the per share exercise price is $25.40. Under the 2015 Plan, the per share exercise price of stock options ranges from $3.80 to $39.60, and the weighted average exercise
price is $19.65. As of April 19, 2017, the per share closing price of GenVec common stock on the NASDAQ was $6.07. As a result, GenVec anticipates that many outstanding GenVec stock options, while vested or vesting in connection with the
merger, will not be exercised in connection with the merger and will be cancelled for no consideration as of the closing of the merger.
The
following tables set forth, for each of the GenVec directors and executive officers (i) the number of shares of GenVec common stock underlying previously-vested GenVec stock options, and (ii) the number of shares of GenVec common stock
underlying unvested GenVec stock options that will vest in connection with the merger, and (iii) the per share exercise price of each such GenVec stock option, in each case assuming the director or executive officer continues employment or
service through the approval of the merger proposal by GenVecs shareholders.
Non-Employee
Directors
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Vested Options
(1)
|
|
|
Unvested Options
(2)
|
|
|
Exercise Price ($)
|
|
Wayne T. Hockmeyer, Ph.D.
|
|
|
150
|
|
|
|
|
|
|
|
283.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
147.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
82.39
|
|
|
|
|
150
|
|
|
|
|
|
|
|
53.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
28.20
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
23.80
|
|
|
|
|
2,250
|
|
|
|
|
|
|
|
20.90
|
|
|
|
|
2,250
|
|
|
|
|
|
|
|
19.50
|
|
|
|
|
|
|
|
|
1,500
|
|
|
|
3.80
|
|
|
|
|
|
William N. Kelley, Ph.D.
|
|
|
150
|
|
|
|
|
|
|
|
283.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
147.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
82.39
|
|
|
|
|
150
|
|
|
|
|
|
|
|
53.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
28.20
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
23.80
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
20.90
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
19.50
|
|
|
|
|
|
|
|
|
1,500
|
|
|
|
3.80
|
|
|
|
|
|
Stefan D. Loren, Ph.D.
|
|
|
1,500
|
|
|
|
500
|
|
|
|
8.40
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
16.30
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
20.90
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
19.50
|
|
|
|
|
|
|
|
|
1,500
|
|
|
|
3.80
|
|
|
|
|
|
Quinterol J. Mallette, M.D.
|
|
|
2,500
|
|
|
|
1,000
|
|
|
|
20.90
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
19.50
|
|
|
|
|
|
|
|
|
1,500
|
|
|
|
3.80
|
|
|
|
|
|
Michael Richman
|
|
|
1,000
|
|
|
|
1,000
|
|
|
|
29.70
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
19.50
|
|
|
|
|
|
|
|
|
2,250
|
|
|
|
3.80
|
|
|
|
|
|
Marc Schneebaum
|
|
|
150
|
|
|
|
|
|
|
|
283.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
147.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
82.39
|
|
|
|
|
150
|
|
|
|
|
|
|
|
53.00
|
|
|
|
|
150
|
|
|
|
|
|
|
|
28.20
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
23.80
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
20.90
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
19.50
|
|
|
|
|
|
|
|
|
1,500
|
|
|
|
3.80
|
|
(1)
|
This amount includes previously-vested GenVec stock options and excludes unvested GenVec stock options that will vest in connection with the merger. The number of previously-vested GenVec stock options assumes an
effective date of the approval of the merger proposal by GenVecs shareholders as of June 30, 2017 and includes the number of GenVec stock options anticipated to vest in the ordinary course, in accordance with the existing vesting schedule, up
to June 30, 2017.
|
62
(2)
|
This amount includes the unvested GenVec stock options that will vest in connection with the merger, assuming an effective date of approval of the merger proposal by GenVecs shareholders as of June 30, 2017.
|
Executive Officers
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Vested Options
(1)
|
|
|
Unvested Options
(2)
|
|
|
Exercise Price ($)
|
|
Douglas E. Brough
|
|
|
250
|
|
|
|
|
|
|
|
179.00
|
|
|
|
|
400
|
|
|
|
|
|
|
|
218.00
|
|
|
|
|
400
|
|
|
|
|
|
|
|
41.00
|
|
|
|
|
1,250
|
|
|
|
|
|
|
|
220.00
|
|
|
|
|
350
|
|
|
|
|
|
|
|
179.00
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
57.00
|
|
|
|
|
7,500
|
|
|
|
|
|
|
|
24.90
|
|
|
|
|
8,500
|
|
|
|
|
|
|
|
15.60
|
|
|
|
|
4,271
|
|
|
|
729
|
|
|
|
39.60
|
|
|
|
|
5,437
|
|
|
|
3,563
|
|
|
|
29.70
|
|
|
|
|
4,604
|
|
|
|
8,396
|
|
|
|
5.60
|
|
|
|
|
|
Bryan T. Butman
|
|
|
1,750
|
|
|
|
|
|
|
|
179.00
|
|
|
|
|
2,250
|
|
|
|
|
|
|
|
41.00
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
220.00
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
57.00
|
|
|
|
|
6,000
|
|
|
|
|
|
|
|
24.90
|
|
|
|
|
7,500
|
|
|
|
|
|
|
|
15.60
|
|
|
|
|
3,417
|
|
|
|
583
|
|
|
|
39.60
|
|
|
|
|
3,625
|
|
|
|
2,375
|
|
|
|
29.70
|
|
|
|
|
2,125
|
|
|
|
3,875
|
|
|
|
5.60
|
|
|
|
|
|
James V. Lambert
|
|
|
150
|
|
|
|
|
|
|
|
179.00
|
|
|
|
|
200
|
|
|
|
|
|
|
|
119.00
|
|
|
|
|
400
|
|
|
|
|
|
|
|
41.00
|
|
|
|
|
400
|
|
|
|
|
|
|
|
220.00
|
|
|
|
|
250
|
|
|
|
|
|
|
|
50.17
|
|
|
|
|
650
|
|
|
|
|
|
|
|
57.00
|
|
|
|
|
1,000
|
|
|
|
|
|
|
|
24.90
|
|
|
|
|
1,000
|
|
|
|
|
|
|
|
15.60
|
|
|
|
|
854
|
|
|
|
146
|
|
|
|
39.60
|
|
|
|
|
625
|
|
|
|
375
|
|
|
|
20.90
|
|
|
|
|
1,812
|
|
|
|
1,188
|
|
|
|
29.70
|
|
|
|
|
1,416
|
|
|
|
2,584
|
|
|
|
5.60
|
|
|
|
|
|
Douglas J. Swirsky
|
|
|
1,500
|
|
|
|
|
|
|
|
179.00
|
|
|
|
|
2,250
|
|
|
|
|
|
|
|
41.00
|
|
|
|
|
1,500
|
|
|
|
|
|
|
|
220.00
|
|
|
|
|
2,000
|
|
|
|
|
|
|
|
57.00
|
|
|
|
|
6,000
|
|
|
|
|
|
|
|
24.90
|
|
|
|
|
12,500
|
|
|
|
|
|
|
|
15.60
|
|
|
|
|
6,406
|
|
|
|
1,094
|
|
|
|
39.60
|
|
|
|
|
12,083
|
|
|
|
7,917
|
|
|
|
29.70
|
|
|
|
|
8,854
|
|
|
|
16,146
|
|
|
|
5.60
|
|
(1)
|
This amount includes previously-vested GenVec stock options and excludes unvested GenVec stock options that will vest in connection with the merger. The number of previously-vested GenVec stock options assumes an
effective date of the approval of the merger proposal by GenVecs shareholders as of June 30, 2017 and includes the number of GenVec stock options anticipated to vest in the ordinary course, in accordance with the existing vesting schedule, up
to June 30, 2017.
|
(2)
|
This amount includes the unvested GenVec stock options that will vest in connection with the merger, assuming an effective date of the approval of the merger proposal by GenVecs shareholders as of June 30, 2017.
|
63
Salary Continuation and Change in Control Agreements
GenVec has entered into (i) salary continuation agreements with Mr. Swirsky and Drs. Brough and Butman, and (ii) a change in control agreement
with Mr. Swirsky, in each case pursuant to which the executive officer may become entitled to certain payments or benefits upon a qualifying termination of employment. To the extent that Mr. Swirsky becomes entitled to benefits under his
change in control agreement, his salary continuation agreement will be superseded, and he will not receive any benefit under that agreement. Mr. Lambert is not party to a salary continuation agreement or a change in control agreement with
GenVec.
Salary Continuation Agreements
Under the
terms of each salary continuation agreement, if GenVec terminates the employment of the executive officer without cause (as defined below) and other than by reason of death or disability, GenVec will provide the executive officer with
(i) continuation of the executive officers regular base salary for a period of 12 months, paid in installments over such
12-month
period consistent with GenVecs then-current payroll practices,
(ii) continued life insurance and health insurance under GenVecs employee benefit plans and policies for 12 months, and (iii) a lump sum cash payment equal to the product of (a) the annual bonus paid to the executive officer for
the fiscal year preceding the termination date,
divided by
12,
multiplied by
(b) the number of months of service during the year of termination.
Under the terms of the salary continuation agreements, cause is generally defined to include:
|
|
|
the willful and continued failure of the executive officer to substantially perform his duties;
|
|
|
|
the willful engaging by the executive officer in illegal conduct or gross misconduct that is materially and demonstrably injurious to GenVec;
|
|
|
|
personal dishonesty or breach of fiduciary duty to GenVec that results in or was intended to result in personal profit to the executive officer at the expense of GenVec; or
|
|
|
|
the willful violation of any law, rule, regulation, or order (other than traffic violations, misdemeanors or similar offenses) in a manner that is materially and demonstrably injurious to GenVec.
|
Each salary continuation agreement includes (i) a mutual
non-disparagement
restriction in perpetuity, (ii) a
non-compete
restriction during employment and for a period of 12 months following termination of employment, (iii) a
non-solicitation
of employees restriction for a
period of 12 months following termination of employment, and (iv) a confidentiality restriction in perpetuity.
Change in Control Agreement
Under the terms of the change in control agreement with Mr. Swirsky, if GenVec terminates the employment of Mr. Swirsky without
cause (as defined in the salary continuation agreements described above) and other than as a result of his death or disability, or if Mr. Swirsky resigns for good reason (as defined below), in each case within the
two-year
period following a change in control (such as the merger), GenVec will provide Mr. Swirsky with (i) a lump sum cash severance payment equal to (A) 18, multiplied by (B) the sum of
his monthly base salary and average monthly bonus, (ii) continued life insurance and health insurance for 18 months, (iii) a lump sum cash payment equal the product of (a) Mr. Swirskys highest annual base salary for the
year of termination,
divided by
12,
multiplied by
(b) Mr. Swirskys target bonus percentage,
multiplied by
(c) the number of months (including fractions) of service during the year of termination, and
(iv) to the extent that the preceding fiscal years bonus has not yet been determined and paid, a lump sum cash payment equal to (a) Mr. Swirskys highest annual base salary for the preceding fiscal year,
multiplied
by
(b) Mr. Swirskys highest target bonus percentage for the preceding fiscal year. The payments are payable on the date of termination, but if such payments are not determinable as of the date of termination, GenVec will pay an
estimated minimum amount of such payments on the date of termination and will pay the remainder (together with interest) as soon as practicable but no later than 30 days following the date of termination.
For purposes of Sections 280G and 4999 of the Code, the change in control agreement includes a modified cutback provision and an excise tax
gross-up
payment. In the event that it is determined that any of the payments and benefits described above or any other payments would subject Mr. Swirsky to excise taxes under Section 4999 of the Code
because such payments and benefits due would constitute a parachute payment under Section 280G of the Code, payments to Mr. Swirsky under the change in control agreement will be reduced so that no portion is subject to the
excise taxes. But, if the foregoing reduction would exceed $10,000, GenVec will not reduce the payments and instead will pay to Mr. Swirsky an additional amount equal to the excise tax on the payments and benefits, which additional amount we
refer to as the
gross-up
payment, plus an amount equal to any federal income taxes and FICA and Medicare withholding taxes payable on such
gross-up
payment. Based on the
estimates and assumptions discussed below, GenVec currently estimates that Mr. Swirsky will not be eligible to receive a
gross-up
payment in connection with the merger.
In addition, the change in control agreement provides for GenVecs reimbursement of certain legal costs incurred by Mr. Swirsky related to the
enforcement of the agreement or in connection with any tax audit or proceeding to the extent applicable to the application of Section 4999 of the Code and the payments or benefits under the change in control agreement.
Under the terms of the change in control agreement, good reason is generally defined as the occurrence of any of the following events without the
consent of Mr. Swirsky, unless, if correctable, such circumstances are fully corrected with 30 days of the
64
notice of resignation given by Mr. Swirsky in respect thereof (which notice of resignation must be given within 90 days of the occurrence):
|
|
|
the assignment to Mr. Swirsky of any duties inconsistent in any material respect with his position, authority, duties, or responsibilities, as they were immediately prior to the change in control;
|
|
|
|
the diminution in any material respect in Mr. Swirskys position, authority, duties, or responsibilities as they were immediately prior to a change in control;
|
|
|
|
a material reduction by GenVec in Mr. Swirskys annual base salary;
|
|
|
|
a relocation of more than 35 miles from where Mr. Swirskys office or location was immediately prior to a change in control;
|
|
|
|
the failure by GenVec to continue any compensation plan in which Mr. Swirsky participates immediately prior to a change in control that is material to Mr. Swirskys total compensation (unless an equitable
arrangement has been made with respect to such plan), or the continuation of such plan under materially less favorable terms than existed immediately prior to a change in control;
|
|
|
|
the failure by GenVec to pay to Mr. Swirsky any material deferred compensation when due under any deferred compensation plan or agreement applicable to Mr. Swirsky; or
|
|
|
|
a material breach by GenVec of the terms and provisions of the change in control agreement.
|
To constitute
good reason for purposes of the change in control agreement, the resignation by Mr. Swirsky must occur within two years following the initial occurrence of the event constituting the good reason.
To the extent that Mr. Swirsky becomes entitled to benefits under the change in control agreement, his salary continuation agreement (described above) is
superseded, and he will not receive any benefit under that agreement.
Severance Plan
Under the terms of the merger agreement, prior to the consummation of the merger, GenVec will adopt a severance plan, in which all employees of GenVec as of
the consummation of the merger, including Mr. Lambert but excluding Mr. Swirsky and Drs. Brough and Butman (who are already parties to a salary continuation agreement and/or a change in control agreement with GenVec, as discussed above),
will be eligible to participate.
Under the terms of the severance plan, if an eligible employees employment is terminated by GenVec, Intrexon, or
one of their affiliates without cause (as defined in the salary continuation agreements described above, with the use of employee instead of executive officer) or if the eligible employee resigns due to the
material reduction of his or her base salary or wages, in each case within the one year period following the consummation of the merger, the eligible employee shall be eligible to receive (i) a lump sum cash payment equal to not less than 12
weeks of base salary or wages, to be paid in the next regularly-scheduled payroll cycle following the employees termination of employment (but no later than 30 days following such termination) and (ii) fully employer-subsidized medical
plan continuation for not less than 12 weeks.
Indemnification and Insurance
Pursuant to the terms of the merger agreement, GenVecs current and former directors and executive officers and each employee who serves as a fiduciary of
GenVecs employee benefit plan will be entitled to certain ongoing indemnification following the merger. In addition, GenVecs current directors and executive officers will be entitled to certain coverage following the merger under
directors and officers liability insurance and fiduciary liability policies to be purchased by GenVec prior to the effective time of the merger. Such indemnification and insurance coverage is further described in the section entitled
The merger agreementCovenantsIndemnification and insurance.
Employment Offers by Intrexon
On April 20, 2017, Intrexon made employment offers to Drs. Brough and Butman. Subject to negotiation and acceptance, a summary of the material terms of their
employment arrangements is expected to be set forth in this proxy statement/prospectus prior to the time the Registration Statement of which this combined proxy statement/prospectus forms a part is declared effective. The salary continuation
agreements to which each are subject are not expected to be continued after completion of the merger, such that each will cease to be in effect 12 months after completion of the merger. In addition, on April 19, 2017, Intrexon notified Mr. Swirsky
that it does not anticipate that he will continue as an employee of Intrexon or the surviving company upon completion of the merger. As of the date of this proxy statement/prospectus, Intrexon has not had any conversations with Mr. Lambert regarding
his employment following the completion of the merger.
Quantification of potential payments to GenVec executive officers in connection with the
merger
The following table and related footnotes set forth information required by Item 402(t) of
Regulation S-K
regarding certain compensation that each of GenVecs named executive officers may receive that is based on, or that otherwise relates to, the merger. For purposes of this
disclosure, GenVecs named executive officers consist of Mr. Swirsky and Drs. Brough and Butman. The figures in the table are estimated based on compensation and benefit levels as of the date of this proxy statement/prospectus and an
assumed effective date of June 30, 2017 for both the merger and the termination of the named executive officers employment. The amounts reported below are estimates based on multiple assumptions that may or may not actually occur or be
accurate on the relevant date, including an assumption that the employment of each of GenVecs named executive officers will terminate upon consummation of the merger and other assumptions described in this proxy statement/prospectus. The
actual amounts, if any, to be received by a named executive officer may materially differ from the amounts set forth below. The merger-related compensation payable to GenVecs named executive officers is subject to a
non-binding
advisory vote of GenVecs shareholders, as described under the section of this proxy statement/prospectus captioned Advisory vote on merger-related compensation. For additional details
regarding the terms of the payments described below, see the discussion under the caption Interests of GenVecs directors and executive officers in the merger. All share amounts relating to GenVec stock options, and the
exercise prices of each such option, set forth in the following table or the notes thereto have been retroactively adjusted to reflect the reverse stock split.
65
Golden Parachute Compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name
|
|
Cash
($)
|
|
|
Equity
($)
(1)
|
|
|
Perquisites /
Benefits
($)
(2)
|
|
|
Tax
Reimbursements
($)
(3)
|
|
|
Total
($)
(4)
|
|
Douglas J. Swirsky
|
|
|
998,750
|
(5) (6)
|
|
|
13,923
|
|
|
|
27,465
|
|
|
|
0
|
|
|
|
1,040,138
|
|
Douglas E. Brough
|
|
|
357,248
|
(7)
|
|
|
7,240
|
|
|
|
32,795
|
|
|
|
0
|
|
|
|
397,283
|
|
Bryan T. Butman
|
|
|
327,750
|
(8)
|
|
|
3,342
|
|
|
|
35,081
|
|
|
|
0
|
|
|
|
366,173
|
|
(1)
|
In accordance with the terms of the merger agreement as described under Interests of GenVecs directors and executive officers in the merger, all outstanding, unvested GenVec stock options held by
the named executive officers shall fully vest in connection with the merger. All amounts in this column are determined by multiplying (i) the number of GenVec stock options that will be accelerated in connection with the merger, by
(ii) the excess of (a) the per share price of GenVec common stock of $6.41 (which, as required by applicable SEC rules, is the average closing market price of GenVec common stock over the first five business days following the public
announcement of the merger prior to the market opening on January 24, 2017) over (b) the per share exercise price of each such accelerated GenVec stock option. The amount shown is based on the following holdings of GenVec stock options
that would be accelerated and that have a per share exercise price less than $6.41: (i) 17,188 GenVec stock options for Mr. Swirsky, with an exercise price per share of $5.60, (ii) 8,938 GenVec stock options for Dr. Brough, with an
exercise price per share of $5.60, and (iii) 4,125 GenVec stock options for Dr. Butman, with an exercise price per share of $5.60. No value has been attributed to the acceleration of out of the money GenVec stock options (that is,
where the per share exercise price of GenVec stock options equals or exceeds the per share price of GenVec common stock of $6.41). Each amount is attributable to a single trigger arrangement. The actual amounts, if any, that would be
realized by the named executive officers upon exercise of stock options in connection with the merger will be dependent on the value of the stock options at the time of exercise.
|
(2)
|
In accordance with the terms of Mr. Swirskys change in control agreement as described under Interests of GenVec directors and executive officers in the merger, assuming for purposes of
amounts reported in the table that Mr. Swirskys employment is terminated without cause or that Mr. Swirsky resigns for good reason upon consummation of the merger (or otherwise within the
two-year
period following the merger), this amount represents the gross premiums to be paid by GenVec to provide Mr. Swirsky with continued life and health insurance substantially similar to the coverage
provided as of the date of this proxy statement/prospectus for an
18-month
period. In accordance with the terms of Dr. Broughs and Dr. Butmans salary continuation agreements as described
under Interests of GenVecs directors and executive officers in the merger, assuming for purposes of amounts reported in the table that Dr. Broughs and Dr. Butmans employment is terminated without
cause upon consummation of the merger (or otherwise following the merger), this amount represents the gross premiums to be paid by GenVec to provide the named executive officer with continued life and health insurance substantially
similar to the coverage provided as of the date of this proxy statement/prospectus for a
12-month
period. Each amount is attributable to a double trigger arrangement.
|
(3)
|
In accordance with the terms of Mr. Swirskys change in control agreement as described under Interests of GenVec directors and executive officers in the merger, Mr. Swirsky could become
eligible to receive a
gross-up
payment in certain situations. Based on the estimates and assumptions listed above and throughout, GenVec currently estimates that Mr. Swirsky will not trigger, and thus
will not be eligible to receive, a
gross-up
payment in connection with the merger.
|
(4)
|
Portions of the total amounts reported are attributable to single trigger arrangements and portions are attributable to double trigger arrangements, as follows: (i) Mr. Swirsky -
$13,923 attributable to single trigger arrangements and $1,026,215 attributable to double trigger arrangements, (ii) Dr. Brough - $7,240 attributable to single trigger arrangements and $390,043
attributable to double trigger arrangements, and (iii) Dr. Butman - $3,342 attributable to single trigger arrangements and $362,831 attributable to double trigger arrangements.
|
(5)
|
In accordance with the terms of Mr. Swirskys change in control agreement as described under Interests of GenVec directors and executive officers in the merger, assuming for purposes of
amounts reported in the table that Mr. Swirskys employment is terminated without cause or Mr. Swirsky resigns for good reason upon consummation of the merger on June 30, 2017 (or otherwise within the
two-year
period following the merger), this amount represents the sum of: (i) a lump sum cash payment of $892,500, which is equal to (a) 18,
multiplied by
(b) the sum of Mr. Swirskys
monthly base salary and average monthly bonus, and (ii) a lump sum cash payment of $106,250, which represents the product of (a) Mr. Swirskys current annual base salary of $425,000,
divided by
12,
multiplied by
(b) Mr. Swirskys current target bonus percentage of 50%,
multiplied by
(c) the number of months of service during 2017 through June 30, 2017. Each amount is attributable to a double trigger arrangement. This
amount does not include (i) Mr. Swirskys annual base salary or other benefits earned and accrued prior to the date of termination or (ii) an amount attributable to Mr. Swirskys bonus for the preceding fiscal year
because such bonus was paid on February 15, 2017.
|
66
(6)
|
This amount assumes that the applicable amount is paid on Mr. Swirskys date of termination and excludes any potential interest payments. Pursuant to Mr. Swirskys change in control agreement, the
payments are payable on the date of termination, but if such payments are not determinable as of the date of termination, GenVec shall pay an estimated minimum amount of such payments on the date of termination and shall pay the remainder (together
with interest) as soon as practicable but no later than 30 days following the date of termination.
|
(7)
|
In accordance with the terms of Dr. Broughs salary continuation agreement as described under Interests of GenVec directors and executive officers in the merger, assuming for purposes of
amounts reported in the table that Dr. Broughs employment is terminated without cause upon consummation of the merger on June 30, 2017 (or otherwise following the merger), this amount represents the sum of: (i) salary
continuation payments of $310,650, which is equal to 12 months of Dr. Broughs current annual base salary, and (ii) a lump sum cash payment of $46,598, which represents the product of (a) Dr. Broughs 2016 annual bonus
payment of $93,195,
divided by
12,
multiplied by
(b) the number of months of service during 2017 through June 30, 2017. Each amount is attributable to a double trigger arrangement. This amount does not include
Dr. Broughs annual base salary or other benefits earned and accrued prior to the date of termination.
|
(8)
|
In accordance with the terms of Dr. Butmans salary continuation agreement as described under Interests of GenVec directors and executive officers in the merger, assuming for purposes of
amounts reported in the table that Dr. Butmans employment is terminated without cause upon consummation of the merger on June 30, 2017 (or otherwise following the merger), this amount represents the sum of: (i) salary
continuation payments of $285,000, which is equal to 12 months of Dr. Butmans current annual base salary, and (ii) a lump sum cash payment of $42,750, which represents the product of (a) Dr. Butmans 2016 annual bonus
payment of $85,500,
divided by
12,
multiplied by
(b) the number of months of service during 2017 through June 30, 2017. Each amount is attributable to a double trigger arrangement. This amount does not include
Dr. Butmans annual base salary or other benefits earned and accrued prior to the date of termination.
|
Intrexons
reasons for the merger
The board of directors of Intrexon unanimously approved the merger agreement and the transactions contemplated by the merger
agreement, including the merger. In evaluating the merger agreement and the transactions contemplated thereby, including the merger, the board of directors of Intrexon consulted with the management of Intrexon and outside legal advisors for
Intrexon.
In determining to approve the merger agreement and the transactions contemplated thereby, including the merger, the board of directors of
Intrexon considered a number of factors, including the following:
|
|
|
the belief that the acquisition of GenVec fits within Intrexons strategy to grow its business and further develop synthetic biology technologies and to seek to develop and commercialize innovative products;
|
|
|
|
the belief that Intrexon would be able to use its existing expertise in order to develop GenVecs technology;
|
|
|
|
the substantial experience of GenVecs management team and employees in designing, testing and manufacturing adenoviral-based product candidates;
|
|
|
|
the fact that the CPRs will require Intrexon to pay additional consideration only if milestone and/or royalty payments are received from Novartis by Intrexon or GenVec under the NVS License Agreement;
|
|
|
|
the overall terms and conditions of the merger agreement; and
|
|
|
|
current industry, economic and market conditions and trends, including Intrexons and GenVecs respective positions in the market.
|
The board of directors of Intrexon also considered a number of potentially negative factors in its deliberations regarding the merger, including the
following:
|
|
|
the ability of Intrexon to integrate GenVecs operations with Intrexons existing operations;
|
|
|
|
the possible disruption to Intrexons business as a result of the merger, including the time necessary from members of Intrexons management team and the costs associated with the merger;
|
|
|
|
the impact of the announcement of the merger agreement and the transactions contemplated thereby, including the merger, on the market prices for Intrexon common stock and GenVec common stock as well as their respective
businesses and operations;
|
|
|
|
the risks that the potential benefits, synergies and costs savings sought in the merger may not be realized or may not be realized within the expected time frame; and
|
67
|
|
|
the other risks set forth in the section entitled Risk factors.
|
The board of directors of
Intrexon conducted an overall analysis of the factors described above, including through discussions with, and inquiry of, the management of Intrexon and the legal advisors to Intrexon regarding certain of the factors described above. In view of the
wide variety of factors considered in connection with its evaluation of the merger and the complexity of these matters, the board of directors of Intrexon did not find it useful, and did not attempt, to quantify, rank, or otherwise assign any
relative or specific weights to the factors that it considered in reaching its determination to approve the merger agreement and the transactions contemplated thereby, including the merger. Individual members of the board of directors of Intrexon
may have given differing weights to the foregoing factors.
Directors and management after the merger
Upon completion of the merger, the board of directors and executive officers of Intrexon are expected to remain unchanged.
Accounting treatment
The merger will be accounted for
using the acquisition method of accounting for business combinations. Intrexon will record net tangible and identifiable intangible assets acquired and liabilities assumed from GenVec at their respective fair values at the date of the completion of
the merger. Any excess of the purchase price over the net fair value of such assets and liabilities will be recorded as goodwill.
The financial condition
and results of operations of Intrexon after completion of the merger will reflect GenVecs balances and results after completion of the transaction but will not be restated retroactively to reflect the historical financial condition or results
of operations of GenVec. The earnings of Intrexon following the completion of the merger will reflect acquisition accounting adjustments, including the effect of changes in the carrying value for assets and liabilities on depreciation and
amortization expense. Intangible assets with indefinite useful lives and goodwill will not be amortized but will be tested for impairment at least annually, and all long-lived assets, including goodwill, will be tested for impairment when certain
indicators are present. If in the future, Intrexon determines that tangible or intangible assets (including goodwill) are impaired, Intrexon would record an impairment charge at that time.
Regulatory approvals required for the merger
Intrexon
and GenVec are not aware of any material governmental approvals, waivers or actions that are required to complete the merger. If any such governmental approvals, waivers or actions are required, Intrexon and GenVec have agreed to use reasonable best
efforts to obtain those approvals, waivers or actions. There can be no assurance, however, that any waivers, approvals or actions will be obtained.
In
addition, at any time before or after the completion of the merger, any state or foreign country could take action to enjoin the merger under antitrust laws as it deems necessary or desirable in the public interest, or any private party could seek
to enjoin the merger on anti-competitive grounds. Although the parties believe that completion of the merger would not violate any antitrust law, there can be no assurance that a challenge to the merger on antitrust grounds will not be made or, if a
challenge is made, what the result will be. Intrexon and GenVec have determined that no filing under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 is required in connection with the proposed merger.
Exchange of shares in the merger
Intrexon has appointed
AST as its exchange agent to handle the exchange of shares of GenVec common stock for the shares of Intrexon common stock (and, if applicable, cash in lieu of fractional shares of Intrexon common stock) that each GenVec shareholder is entitled to
receive under the merger agreement. Promptly following the effective time of the merger, the exchange agent will mail to each person that was, as of immediately prior to the effective time, a record holder of GenVec common stock a letter of
transmittal and instructions for effecting the exchange of GenVec common stock certificates or book-entry shares for the merger consideration.
Upon
(i) in the case of shares of GenVec common stock represented by certificates, surrender of such certificates along with the executed letter of transmittal and any other documents described in the instructions, (ii) in the case of
book-entry shares of GenVec common stock (other than book-entry shares held through The Depository Trust Company, referred to herein as DTC), receipt of an executed letter of transmittal, or (iii) in the case of book-entry shares held through
DTC, receipt of an agents message, a GenVec shareholder will receive (1) the per share stock consideration, (2) one CPR for each share of GenVec stock surrendered, and (3) if applicable, cash in lieu of fractional
shares of Intrexon common stock (as well as any dividends or distributions with respect to Intrexon common stock to which such holder is entitled pursuant to the merger agreement). The shares of Intrexon common stock you receive in the merger will
be issued in book-entry form, unless you request a physical certificate or a physical certificate is otherwise required under applicable law. The CPRs you receive in the merger will not be evidenced by a certificate or other instrument, but will be
recorded in a register maintained by the rights agent under the contingent payment rights agreement. The exchange agent and Intrexon are entitled to deduct and withhold any applicable taxes from any merger consideration that would otherwise be
payable.
After the effective time of the merger, GenVec will not register any transfers of the shares of GenVec common stock. Shares of GenVec common
stock will no longer be outstanding, will automatically be cancelled, and will cease to exist. Certificates or evidence of shares in book-entry form that, in each case, previously represented shares of GenVec common stock will represent
68
only the right to receive the merger consideration as described above (or, in the case of shares with respect to which appraisal rights are properly exercised, the right to receive payment of the
fair value of such shares in accordance with and to the extent provided by Section 262 of the DGCL, as further described in the section entitled Appraisal rights).
GenVec shareholders should not return their stock certificates with the enclosed proxy card and should not forward stock certificates to the exchange agent
without a letter of transmittal.
Appraisal rights
GenVec shareholders who do not vote in favor of the merger proposal and who precisely follow certain procedural steps will be entitled to appraisal rights
under Section 262 of the DGCL. For more information regarding appraisal rights, see the section entitled Appraisal rights. In addition, a copy of Section 262 of the DGCL is attached as
Annex D
to this proxy statement.
Listing of Intrexon common stock
Intrexons
common stock currently trades on the NYSE under the stock symbol XON. It is a condition to the completion of the merger that the Intrexon common stock issuable in the merger be approved for listing on the NYSE, subject to official notice
of issuance. Intrexon has agreed to use its reasonable best efforts to cause the shares of Intrexon common stock issuable in connection with the merger to be approved for listing on the NYSE and expects to obtain the NYSEs approval to list
such shares prior to completion of the merger, subject to official notice of issuance.
Delisting and deregistration of GenVec common stock
If the merger is completed, the GenVec common stock will be delisted from NASDAQ and deregistered under the Exchange Act, and GenVec will no longer file
periodic reports with the SEC relating to the GenVec common stock.
Restrictions on the shares of Intrexon common stock received in the merger
The shares of Intrexon common stock to be issued in connection with the merger will be freely transferable under the Securities Act and the Exchange Act,
except for shares issued to any shareholder who may be deemed to be an affiliate of Intrexon for purposes of Rule 144 under the Securities Act. Persons who may be deemed to be affiliates include individuals or entities that control, are
controlled by, or under the common control with Intrexon and may include the executive officers, directors and significant shareholders of Intrexon.
Certain financial projections of GenVecs management
GenVec does not, as a matter of course, publicly release long-term projections regarding its expectations of future financial performance, given, among other
things, the uncertainty of the underlying assumptions and estimates. However, for internal purposes and in connection with the process leading up to entering into the merger agreement, GenVecs management prepared certain projections regarding
the anticipated future cash flows of GenVec on a stand-alone,
pre-transaction
basis for the fiscal years ending December 31, 2016 through 2019. These projections were prepared and delivered on
November 10, 2016 and are referred to herein as the GenVec projections.
The GenVec projections were not prepared with a view toward public
disclosure or with a view toward complying with the published guidelines of the SEC, the guidelines established by the American Institute of Certified Public Accountants with respect to prospective financial information, or U.S. GAAP. However, in
the view of GenVecs management, such projections were prepared on a reasonable basis, reflect the best then-available estimates and judgments, and present, to the best of managements knowledge and belief, the expected course of action
and the expected future cash flows of GenVec on a stand-alone basis, provided, however, that management assumed, rather than expected, that an additional milestone under the NVS License Agreement would be achieved in 2018. Because the GenVec
projections were prepared on a stand-alone basis without giving effect to the merger, the GenVec projections do not give effect to the merger or any changes to GenVecs operations or strategy that may be implemented after the consummation of
the merger, including potential synergies realized as a result of the merger or any costs related to the merger. These projections are not fact and should not be relied upon as necessarily indicative of actual future performance or results, and
readers of this proxy statement/prospectus are cautioned not to place undue reliance on the GenVec projections.
No independent registered public
accounting firm has examined, compiled or performed any procedures with respect to the GenVec projections and, accordingly, no independent registered public accounting firm expresses an opinion or any other form of assurance with respect to such
projections or the achievability of the performance or results reflected therein. No independent registered public accounting firm assumes any responsibility for such projections. The reports of independent registered public accounting firms
included in (or incorporated by reference into) this proxy statement/prospectus relate only to GenVecs and Intrexons historical financial information, respectively, and no such report extends to the GenVec projections or should be read
to do so.
GenVecs management provided the GenVec projections to Intrexons management in connection with Intrexons due diligence review
of GenVec. A summary of the GenVec projections is included below not to influence GenVec shareholders decision on whether to vote in favor of the merger proposal, but rather to give shareholders access to certain
non-public
unaudited projections that were provided to Intrexon in connection with the merger. While the GenVec projections were provided to Intrexons management, the board of directors of Intrexon did
not consider the GenVec projections to be a significant factor in its
69
overall analysis of the merger. GenVec cautions that these projections are subjective in many respects and uncertainties are inherent in prospective financial information of any kind. Although
the GenVec financial projections have been prepared in good faith, no assurance can be given regarding future events. Neither GenVec nor Intrexon nor any of their respective affiliates, officers, directors, advisors or other representatives has made
or makes any representation or can give any assurance to any shareholder or any other person regarding the ultimate performance of GenVec, Intrexon or the combined companies.
The unaudited prospective financial information included in the GenVec projections covers multiple years. Such information, by its nature, becomes less
predictive with each successive year. In addition, GenVec has not updated or otherwise revised, and does not intend to update or otherwise revise, such prospective financial information to reflect circumstances existing or arising since its
preparation or to reflect the occurrence of unanticipated events, even where any or all of the underlying assumptions are shown to be in error, except to the extent required by law. GenVec also does not intend to update or revise such prospective
financial information to reflect changes in general economic or industry conditions. Since the date the GenVec projections were prepared, GenVec has made publicly available its audited financial statements, including an audited statement of cash
flows, for the fiscal year ended December 31, 2016. Such financial statements are included in this proxy statement/prospectus; you are encouraged to review such audited financial statements.
The internal financial forecasts of GenVec, which were used as a basis for preparing the GenVec projections, are inherently uncertain. Although considered
reasonable by GenVecs management as of the date of their preparation, such internal financial forecasts are subject to a wide variety of significant business, economic, competitive and regulatory risks and uncertainties that could cause actual
cash flows to differ materially from those contained in the GenVec projections. Although the GenVec projections were prepared with numerical specificity, such projections reflect numerous and varying assumptions made by the management of GenVec,
including various estimates and assumptions that may not be realized, and are subject to significant variables, uncertainties and contingencies, all of which are difficult or impossible to predict and many of which are beyond the control of GenVec,
Intrexon and the combined companies. The risk that these uncertainties and contingencies could cause the estimates or assumptions not to reflect actual performance or results is further increased given the duration in the future over which these
estimates and assumptions apply. The estimates and assumptions in early periods have a compounding effect on the projections shown for later periods. Thus, any failure of an estimate or assumption to be reflective of actual performance or results in
an early period would have a greater effect on projected cash flows failing to be reflective of actual events in later periods. Important factors that may affect or cause the information below to materially vary from actual performance or results
include, but are not limited to, industry performance, general business, economic, political, regulatory, market and financial conditions, and other matters such as those referenced in the sections entitled Cautionary note regarding
forward-looking statements and Risk factors elsewhere in this proxy statement/prospectus. These projections are forward-looking statements, and in light of the uncertainties inherent in forward-looking information of any kind,
GenVec cautions you against relying on this information. There can be no assurance that the assumptions made in preparing the internal financial forecasts upon which the projections set forth below were based will be realized; that the prospective
cash flows are necessarily indicative of the future performance of GenVec, Intrexon or the combined companies; or that actual cash flows will not differ materially from those presented in the GenVec projections. Inclusion of the GenVec projections
in this proxy statement/prospectus should not be regarded as a representation by any person that the cash flows reflected in the GenVec projections will actually be realized or will not be significantly lower or higher than actual cash flows.
Summary of GenVec Projections
(in dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Projected
Total 2016
|
|
|
Projected
Total 2017
|
|
|
Projected
Total 2018
|
|
|
Projected
Total 2019
|
|
Revenue
|
|
|
656,136
|
(1)
|
|
|
500,000
|
|
|
|
5,500,000
|
(2)
|
|
|
500,000
|
|
Expenses
|
|
|
(6,842,837
|
)
|
|
|
(6,520,663
|
)
|
|
|
(6,595,740
|
)
|
|
|
(6,745,170
|
)
|
Financing Activity
|
|
|
4,515,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Burn
(3)
|
|
|
(1,670,714
|
)
|
|
|
(6,020,663
|
)
|
|
|
(1,095,740
|
)
|
|
|
(6,245,170
|
)
|
Beginning Cash and Cash Equivalents
|
|
|
8,773,009
|
|
|
|
7,102,295
|
|
|
|
1,081,632
|
|
|
|
(14,108
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending Cash and Cash Equivalents
|
|
|
7,102,295
|
|
|
|
1,081,632
|
|
|
|
(14,108
|
)
|
|
|
(6,259,277
|
)
|
(1)
|
Projected total revenue in 2016 includes $5,325 from sales of equipment.
|
(2)
|
Projected total revenue in 2018 includes an assumed $5 million from receipt of a milestone payment under the NVS License Agreement.
|
(3)
|
Cash burn is a
non-GAAP
financial measure. For purposes of GenVec managements projections, GenVec defined this measure to mean the net increase (or decrease) in cash and
cash equivalents (as determined in accordance with GAAP).
|
70
In preparing the projections summarized above, GenVecs management assumed, among other things, that
GenVec would continue to receive annual revenue from grants, as well as annual revenue from financial support under its programs with Novartis, that would generally be consistent with prior receipts. GenVecs management also assumed that an
additional milestone under the NVS License Agreement would be achieved in 2018. These assumptions may be beyond the control of GenVec. In addition, GenVecs management did not include in the GenVec projections any cash flows relating to
possible new collaborations that were being explored at the time the GenVec projections were prepared, including because such cash flows were considered too uncertain and speculative to estimate.
The projections summarized above were prepared by GenVecs management for internal purposes and in connection with the process leading up to entering
into the merger agreement.
Non-GAAP
financial measures should not be considered a substitute for, or superior to, financial measures determined or calculated in accordance with GAAP.
***
GENVEC HAS NOT UPDATED OR REVISED, NOR
DOES IT INTEND TO UPDATE OR REVISE, THESE PROJECTIONS TO REFLECT CIRCUMSTANCES EXISTING SINCE THEIR PREPARATION OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS EVEN IN THE EVENT THAT ANY OR ALL OF THE UNDERLYING ASSUMPTIONS ARE SHOWN TO BE IN
ERROR, EXCEPT TO THE EXTENT REQUIRED BY LAW
.
71
The merger agreement
The following description describes the material terms of the merger agreement. This description does not purport to be complete and may not contain all of
the information about the merger agreement that is important to you. The rights and obligations of the parties are governed by the express terms and conditions of the merger agreement and not by this description or any other information contained in
this proxy statement/prospectus. This description of the merger agreement is qualified in its entirety by reference to the full text of the merger agreement, which is attached as
Annex A
to this proxy statement/prospectus and is incorporated
herein by reference. The merger agreement has been included to provide you with information regarding its terms. GenVec encourages you to read the entire merger agreement, as well as this proxy statement/prospectus, before making any decisions
regarding the merger.
The merger
Each of the
GenVec board of directors and Intrexon board of directors has approved the merger agreement, which provides that, at the closing of the proposed transactions contemplated by the merger agreement, Merger Sub will be merged with and into GenVec.
GenVec will continue as the surviving corporation of the merger, but it will become a wholly owned subsidiary of Intrexon. As a result, following the merger, GenVec will no longer be a publicly traded corporation.
Merger consideration
At the effective time of the
merger, each share of GenVec common stock (other than shares with respect to which appraisal rights are properly exercised or shares owned by Intrexon, Merger Sub or GenVec) will be converted into the right to receive consideration equal to (i)
0.297 shares of Intrexon common stock, subject to adjustment as described below, referred to herein as the exchange ratio, and (ii) one CPR (as described more fully below under the section entitled Contingent payment rights
agreement).
GenVec shareholders will not receive any fractional shares of Intrexon common stock in the merger. Instead, each GenVec shareholder
otherwise entitled to a fraction of a share of Intrexon common stock will be entitled to receive in cash the dollar amount, without interest, determined by multiplying such fraction by the last reported sale price of Intrexon common stock on the
NYSE on the last complete trading day prior to the effective time of the merger.
The exchange ratio and merger consideration are subject to adjustment to
reflect (i) the effect of any stock split, reverse stock split, stock dividend (including any dividend or distribution of securities convertible into or exchangeable for shares of GenVecs common stock), recapitalization, reclassification
or other similar change with respect to GenVec common stock, or (ii) any reduction in the assets or property of Intrexon or any of its subsidiaries resulting from any direct or indirect distribution of such assets or property to the
shareholders of Intrexon, in each case, occurring after the date of the merger agreement but before the effective time of the merger.
Treatment of
GenVec stock options and warrants
Treatment of stock options
Each outstanding, unvested GenVec stock option will fully vest upon the approval of the merger proposal by the GenVec shareholders. In connection with the
merger, each outstanding GenVec stock option may be exercised (including net exercise) for a period of 15 days prior to the effective time of the merger. Each share of GenVec common stock resulting from the exercise of any GenVec stock option during
such time will be treated as a share of GenVec common stock issued and outstanding immediately prior to the effective time of the merger, and will be eligible to receive the merger consideration in accordance with the terms of the merger agreement.
As of the effective time of the merger, each outstanding unexercised GenVec stock option shall be canceled for no consideration.
Treatment of
warrants
At the effective time of the merger, each outstanding, unexpired and unexercised warrant to purchase shares of GenVec common stock will
be assumed by Intrexon and converted into a warrant to purchase, at an aggregate exercise price equal to the aggregate exercise price of the warrant as of immediately prior to the effective time of the merger, and in lieu of the shares of GenVec
common stock otherwise issuable upon exercise of such warrant, the merger consideration that would have been receivable upon consummation of the merger by the holder of such warrant if such warrant had been exercised immediately prior to the
effective time of the merger. Specifically, each such warrant to purchase shares of GenVec common stock will be converted into a warrant to purchase (i) a number of shares of Intrexon common stock equal to the product of (a) the exchange
ratio and (b) the number of shares of GenVec common stock underlying such warrant, and (ii) a number of CPRs (as described more fully below under the section entitled Contingent payment rights agreement) equal to the number of
shares of GenVec common stock underlying such warrant. Warrantholders will not be entitled to receive CPRs until they exercise their warrants, nor will warrantholders be entitled to any portion of the amounts payable to CPR holders prior to the date
on which such warrantholders exercise their warrants and purchase the CPRs subject to them. Please see the section entitled Contingent payment rights agreement for a discussion of the contingent payment period under, and term of, the
contingent payment rights agreement. The other
pre-existing
terms of the warrants will continue to apply in accordance with their terms following the merger.
72
Appraisal rights
GenVec shareholders who do not vote in favor of the merger proposal and who precisely follow certain procedural steps will be entitled to appraisal rights
under Section 262 of the DGCL. For more information regarding appraisal rights, see the section entitled Appraisal rights. In addition, a copy of Section 262 of the DGCL is attached as
Annex D
to this proxy statement.
A condition to Intrexons and Merger Subs obligation to complete the merger is that holders representing no more than 20% of GenVecs
outstanding shares of common stock have exercised statutory rights of appraisal under Delaware law.
Completion of the merger
The merger agreement requires the parties to complete the merger after all of the conditions to the completion of the merger contained in the merger agreement
are satisfied or waived, including the approval of the merger proposal by the shareholders of GenVec. The merger will become effective upon the filing of the certificate of merger with the Secretary of State of the State of Delaware, or at such
later time as is agreed to by Intrexon, Merger Sub and GenVec and specified in the certificate of merger.
Intrexon and GenVec expect to complete the
merger during the second quarter of 2017 if the approval of the merger proposal is obtained, assuming the other conditions to the consummation of the merger that are set forth in the merger agreement are satisfied or waived. However, it is possible
that the merger will not be consummated within that timeframe or at all.
Conversion of shares; exchange of certificates
The merger agreement provides that Intrexon will select a bank or trust company, reasonably acceptable to GenVec, to act as the exchange agent. Intrexon has
appointed AST to act as exchange agent. The merger agreement provides that at or prior to the effective time of the merger, Intrexon will deposit with the exchange agent evidence of a sufficient number of shares of Intrexon common stock to provide
for the issuance of the stock consideration, and a sufficient amount of cash to make payments in lieu of fractional shares to which holders of GenVec common stock are entitled pursuant to the terms of the merger agreement. In addition, the merger
agreement provides that after the effective time of the merger, until such time as holders of GenVec common stock surrender their shares of GenVec common stock in exchange for shares of Intrexon common stock, Intrexon will deposit with the exchange
agent any dividends or other distributions with respect to Intrexon common stock to which such holders are entitled pursuant to the terms of the merger agreement. The exchange agent will be entitled to deduct and withhold from the cash amounts
payable to any GenVec shareholder the amounts it is required to deduct and withhold under any federal, state, local or foreign tax law. If the exchange agent withholds any amounts and remits them to applicable tax authorities, these amounts will be
treated for all purposes of the merger as having been paid to the shareholders from whom they were withheld.
Promptly, but not later than three business
days, following the effective time of the merger, the exchange agent will mail to each person that was, as of immediately prior to the effective time, a record holder of GenVec common stock a letter of transmittal and instructions for surrendering
and exchanging the record holders GenVec stock certificates or book-entry shares. Upon (i) in the case of shares of GenVec common stock represented by a certificate, surrender of such certificate for exchange to the exchange agent,
together with a duly signed and completed letter of transmittal and such other documents as may reasonably be required pursuant to the instructions, (ii) in the case of book-entry shares of GenVec common stock (other than book-entry shares held
through DTC), receipt by the exchange agent of a duly signed and completed letter of transmittal, or (iii) in the case of book-entry shares of GenVec common stock held through DTC, receipt of an agents message, the holder of
the GenVec stock certificate or book-entry shares will be entitled to receive merger consideration and any other amounts to which such holder is entitled for fractional shares of Intrexon common stock or in respect of any dividends or other
distributions payable with respect to Intrexon common stock as set forth in the merger agreement.
After the effective time of the merger, shares of
GenVec common stock will no longer be outstanding, will automatically be cancelled, and will cease to exist. All holders of shares of GenVec common stock (whether such shares are represented by certificates or held in book-entry form) that were
outstanding immediately prior to the completion of the merger will cease to have any rights as shareholders of GenVec, other than the right to receive the merger consideration and cash in lieu of fractional shares of Intrexon common stock (or, in
the alternative, the appraisal rights described under the heading Appraisal rights, if so elected), as well as any rights to dividends or other distributions payable with respect to Intrexon common stock as set forth in the merger
agreement. In addition, no transfer of GenVec common stock after the effective time of the merger will be registered on the stock transfer books of GenVec.
If any GenVec stock certificate has been lost, stolen or destroyed, the exchange agent will issue in exchange for such lost, stolen or destroyed stock
certificate the merger consideration upon the delivery of an affidavit by the owner of such stock certificate claiming that such stock certificate has been lost, stolen or destroyed. However, Intrexon may, in its discretion and as a condition to the
payment of cash or the issuance of any shares of Intrexon common stock in exchange therefor, also require the owner of such lost, stolen or destroyed stock certificate to deliver a bond as indemnity against any claim that may be made with respect to
that stock certificate against Intrexon, Merger Sub, the surviving corporation or the exchange agent.
Stock certificates should be sent only pursuant
to instructions set forth in the letters of transmittal, which the merger agreement provides will be mailed to GenVec shareholders promptly following the effective time of the merger, but in no event later than three business days following the
effective time of the merger. In all cases, shares of Intrexon common stock, cash in lieu of fractional shares and any dividends or other distributions payable to GenVec shareholders in respect of Intrexon common stock will be delivered only in
accordance with the procedures set forth in the letter of transmittal.
73
Representations and warranties
The merger agreement contains representations and warranties made by GenVec to Intrexon and Merger Sub and made by Intrexon and Merger Sub to GenVec. The
assertions embodied in the representations and warranties may be subject to important qualifications and limitations agreed to by the parties to the merger agreement in connection with negotiating its terms. In particular, in your review of the
representations and warranties contained in the merger agreement, it is important to bear in mind that the representations and warranties were negotiated for the purpose of allocating contractual risk among the parties to the merger agreement, and
in some cases, the representations and warranties are qualified by information in confidential disclosure schedules that the parties exchanged in connection with signing the merger agreement. Although none of GenVec, Intrexon, or Merger Sub believe
that the disclosure schedules contain information that the U.S. federal securities laws require to be publicly disclosed, the disclosure schedules do contain information that modifies, and creates exceptions to, the representations and warranties
set forth in the merger agreement. In addition, the representations and warranties may also be subject to a standard of materiality or material adverse effect different from those generally applicable to investors and reports and documents filed
with the SEC and in some cases may be qualified by disclosures made by one party to the other, which are not necessarily reflected in the merger agreement. In addition, the representations and warranties in the merger agreement may be subject to
knowledge qualifications, which means that those representations and warranties would not be deemed untrue or incorrect as a result of matters that were not actually known to certain officers or employees of the party making those representations
and warranties. Moreover, information concerning the subject matter of the representations and warranties, which do not purport to be accurate as of the date of this proxy statement/prospectus, may have changed since the date of the merger
agreement, and subsequent developments or new information qualifying a representation or warranty may have been included in or incorporated by reference into this proxy statement/prospectus. For the foregoing reasons, the representations, warranties
and covenants or any descriptions of those provisions should be read only in conjunction with the other information provided elsewhere in this document or incorporated by reference into this proxy statement/prospectus.
In the merger agreement, GenVec, Intrexon and Merger Sub each made representations and warranties relating to, among other things:
|
|
|
due organization, good standing and corporate power and authority to own, lease and operate properties and carry on their respective businesses;
|
|
|
|
corporate power and authority to execute and deliver the merger agreement, to perform the obligations under the merger agreement and to consummate the merger and the transactions contemplated by the merger agreement,
and the enforceability of the merger agreement;
|
|
|
|
absence of any conflict with or violation of corporate charter documents, applicable law or contracts as a result of the execution and delivery of the merger agreement and consummation of the transactions contemplated
by the merger agreement;
|
|
|
|
compliance with federal securities laws, including filing all registration statements, prospectuses, forms, reports, schedules and other documents required to be filed under the Securities Act or Exchange Act, since
January 1, 2014;
|
|
|
|
accuracy and GAAP compliance (subject to customary exceptions) of the financial statements contained in the SEC filings;
|
|
|
|
absence of liabilities or obligations that would be required by GAAP to be reflected or reserved against on such persons balance sheet, except as disclosed in SEC filings, incurred in the ordinary course, incurred
in connection with the merger or that would not reasonably be expected to have a material adverse effect;
|
|
|
|
absence of untrue statements of material fact or omissions of material facts in all information supplied for inclusion in the proxy statement/prospectus to be filed with the SEC in connection with the merger;
|
|
|
|
absence of certain types of litigation, except as disclosed in SEC filings or the disclosure schedules to the merger agreement;
|
|
|
|
the absence of any brokers or finders fees; and
|
|
|
|
limitation of representations and warranties to those made in the merger agreement.
|
In the merger agreement,
Intrexon and Merger Sub also each made representations and warranties relating to:
|
|
|
ownership of Merger Sub by Intrexon;
|
|
|
|
no shareholder vote required to adopt the merger agreement and consummate the transactions; and
|
|
|
|
the availability of sufficient funds to perform their obligations under the merger agreement.
|
In the merger
agreement, GenVec also made representations and warranties relating to:
|
|
|
accuracy of its governing documents;
|
74
|
|
|
intellectual property matters;
|
|
|
|
accuracy of tax returns, timely filing of tax returns and timely payment of taxes;
|
|
|
|
compliance with laws, permits and certain regulatory requirements;
|
|
|
|
absence of any event that would reasonably be expected to have a material adverse effect since January 1, 2016;
|
|
|
|
compliance with the U.S. Foreign Corrupt Practices Act of 1977, as amended, and other similar anti-corruption laws;
|
|
|
|
compliance with the sanction programs of the Office of Foreign Assets Control of the U.S. Department of the Treasury;
|
|
|
|
operation of its business in the ordinary course and the absence of past actions that would have constituted a breach of certain covenants in the merger agreement (if such covenants had applied at the time of such
actions);
|
|
|
|
employees, employee relations and employee benefit plans;
|
|
|
|
labor and other employment matters;
|
|
|
|
valid ownership and possession of properties;
|
|
|
|
environmental liabilities and compliance with environmental laws;
|
|
|
|
insurance maintained by GenVec;
|
|
|
|
opinion of GenVecs financial advisor; and
|
|
|
|
vote required to adopt the merger agreement and consummate the transactions.
|
Material adverse effect
Several of the representations, warranties, and closing conditions in the merger agreement are qualified by a material adverse effect standard. For
the purposes of the merger agreement, material adverse effect, with respect to Intrexon or Merger Sub, is defined to mean any change, event, condition, occurrence, state of facts, development or effect that, individually or in the
aggregate, prevents or materially impairs or delays the consummation by Intrexon or Merger Sub of the merger. For purposes of the merger agreement, material adverse effect, with respect to GenVec, is defined to mean any change, event,
condition, occurrence, state of facts, development or effect that, individually or in the aggregate, (i) has a material adverse effect on the business, properties, assets, condition or results of operations of GenVec, taken as a whole, or
(ii) would prevent or materially impair or delay the consummation by GenVec of the merger.
However, the first prong of the definition of
material adverse effect with respect to GenVec (described in clause (i) of such definition above) is subject to certain specified exclusions. In particular, no change, event, condition, state of facts, development or effect arising
out of or attributable to any of following will constitute or will be deemed to contribute to, or will otherwise be taken into account in determining whether there has been or would reasonably be expected to be, a material adverse effect with
respect to GenVec under such first prong:
|
|
|
changes or proposed changes in applicable laws or in GAAP, except to the extent any such change disproportionately impacts GenVec relative to other companies operating in the same industries;
|
|
|
|
changes in general economic, business, labor or regulatory conditions, changes in securities, credit or other financial markets, or changes generally affecting the industries in which GenVec operates, except to the
extent any such change disproportionately impacts GenVec relative to other companies operating in the same industries;
|
|
|
|
changes in global or national political conditions, including the outbreak or escalation of war, changes due to natural disasters, changes in the weather or changes due to the outbreak or worsening of an epidemic or
other health crisis, except to the extent any such change disproportionately impacts GenVec relative to other companies operating in the same industries;
|
|
|
|
the announcement of the merger agreement or the pendency of the transactions contemplated thereby;
|
|
|
|
any shareholder litigation relating to the merger agreement or the transactions contemplated thereby;
|
|
|
|
any changes in the trading price or volume of GenVec common stock or any suspension of trading, provided that the underlying facts or circumstances giving rise to such changes may be taken into account;
|
|
|
|
any failure to meet any internal or third party estimates of revenue or other financial projections or forecasts, provided that the underlying facts or circumstances giving rise to such failure may be taken into
account;
|
|
|
|
the performance of the merger agreement or any action taken or omitted to be taken at the request of or with the prior consent of Intrexon or Merger Sub; or
|
|
|
|
certain other regulatory and contractual matters.
|
75
Covenants
Interim conduct of GenVecs business
Under
the merger agreement, GenVec agreed, subject to certain exceptions, to:
|
|
|
conduct its operations in the ordinary course; and
|
|
|
|
use its commercially reasonable efforts to keep available the services of the current officers, employees and consultants of GenVec and preserve the current relationships of GenVec with customers, suppliers and other
business relations.
|
Additionally, during the pendency of the merger, GenVec agreed, subject to certain exceptions, not to:
|
|
|
amend its certificate of incorporation, its bylaws or equivalent organizational documents;
|
|
|
|
issue, sell, pledge, dispose of, grant, transfer or encumber any shares of GenVec common stock, or securities convertible into, or exchangeable or exercisable for, any shares of such common stock, or any options,
warrants or other rights of any kind to acquire any shares of such common stock, other than the issuance of shares of GenVec common stock upon the exercise of GenVec stock options outstanding as of the date of the merger agreement;
|
|
|
|
sell, pledge, dispose of, transfer, lease, license, guarantee or encumber any property or assets of GenVec (other than intellectual property), except (i) pursuant to the express terms of any material contract in
effect as of the date of the merger agreement, (ii) the sale or disposition of property or assets with a fair market value not in excess of $10,000 individually or $25,000 in the aggregate, or (iii) the sale of inventory in the ordinary
course of business;
|
|
|
|
sell, assign, pledge, transfer, license, abandon, or otherwise dispose of any GenVec intellectual property, except (i) the abandonment, in the ordinary course of business, of intellectual property owned by GenVec
that in GenVecs reasonable business judgment is no longer used or useful in its business, and (ii) the
non-exclusive
licensing or sublicensing of GenVec intellectual property to affiliates,
distributors, and customers in the ordinary course of business;
|
|
|
|
declare, set aside, make or pay any dividend or other distribution (whether payable in cash, stock, property or a combination thereof) with respect to any of its capital stock or other equity interests;
|
|
|
|
reclassify, combine, split, subdivide or amend the terms of, or redeem, purchase or otherwise acquire, directly or indirectly, any of its capital stock or other equity interests, except the acceptance of shares of
GenVec common stock as payment for the exercise price of GenVec stock options or for withholding taxes incurred in connection with the exercise of GenVec stock options;
|
|
|
|
merge or consolidate GenVec with any entity or adopt a plan of complete or partial liquidation or resolutions providing for a complete or partial liquidation, dissolution, restructuring, recapitalization or other
reorganization of GenVec;
|
|
|
|
acquire (including by merger, consolidation, or acquisition of stock or assets) any entity (or any business line or division thereof) or assets, other than acquisitions of inventory, raw materials and other property in
the ordinary course of business;
|
|
|
|
incur any indebtedness for borrowed money or issue any debt securities or assume, guarantee or endorse, or otherwise as an accommodation become responsible for (whether directly, contingently or otherwise), the
obligations of any third party for borrowed money, except (i) in connection with refinancings of existing indebtedness on terms no less favorable to GenVec than (and in an aggregate principal amount not in excess of) such existing indebtedness,
(ii) for borrowings under GenVecs existing credit facilities or issuances of commercial paper for working capital and general corporate purposes in the ordinary course of business, and (iii) other indebtedness not to exceed $10,000
in the aggregate;
|
|
|
|
make any loans, advances or capital contributions to, or investments in, any third party;
|
|
|
|
terminate, cancel or renew, or agree to any material amendment to or waiver under, any material contract, or enter into or amend any contract that, if existing on the date of the merger agreement, would be a material
contract, in each case other than in the ordinary course of business;
|
|
|
|
make any capital expenditure in excess of GenVecs capital expenditure budget as disclosed to Intrexon prior to the date of the merger agreement, other than capital expenditures that are not, in the aggregate, in
excess of $10,000
|
|
|
|
except as required by the existing terms of any GenVec benefit plan or as required by law, (i) materially increase the compensation or benefits payable to any service provider, other than in the ordinary course of
business, (ii) amend, establish or adopt any GenVec benefit plan, (iii) waive any performance or vesting criteria or accelerate vesting, exercisability or funding under any GenVec benefit plan, (iv) pay or award any bonus or incentive
compensation (other than annual bonuses payable in the ordinary course of business); (v) grant any equity-based awards; (vi) enter into any collective bargaining agreement; (vii) hire or terminate the employment of any officer (other than
for cause); or (viii) promote any officers or employees except in the ordinary course of business;
|
76
|
|
|
make any change in accounting policies, practices, principles, methods or procedures, other than as required by GAAP or by a governmental authority;
|
|
|
|
compromise, settle or agree to settle any proceeding, other than compromises, settlements or agreements of proceedings (excluding proceedings brought by GenVec shareholders relating to the merger agreement or the
transactions contemplated thereby) in the ordinary course of business that involve only the payment of monetary damages not in excess of $10,000 individually or $50,000 in the aggregate, in any case without the imposition of equitable relief on, or
the admission of wrongdoing by, GenVec;
|
|
|
|
(i) make, change or revoke any material tax election, (ii) change any of its material methods of reporting income or deductions for tax purposes (or file a request to make any such change), (iii) settle or
compromise any material tax liability, claim, audit or dispute, (iv) surrender any right to claim a material tax refund, (v) file any amended tax return with respect to any material tax, (vi) enter into any tax allocation, sharing,
indemnity or closing agreement, or (vii) waive or extend the statute of limitations with respect to any tax other than pursuant to extensions of time to file tax returns obtained in the ordinary course of business;
|
|
|
|
enter into any new line of business or materially alter any existing line of business, other than in the ordinary course of business;
|
|
|
|
voluntarily cancel, terminate or fail to renew (in a form and amount consistent with past practice) any material insurance policies covering GenVec or any of its business, assets or properties; or
|
|
|
|
authorize or enter into any contract or otherwise make any commitment to do any of the foregoing.
|
Other
covenants
The merger agreement also contains covenants relating to:
|
|
|
the filing of this proxy statement/prospectus and other SEC filings;
|
|
|
|
the holding of a meeting of GenVec shareholders;
|
|
|
|
access to information and confidentiality;
|
|
|
|
taking appropriate action to consummate the merger, obtaining any necessary consents, making applicable filings, defending proceedings that challenge the merger, executing additional instruments necessary to consummate
the merger, complying with information requests and notifying the other party of certain actions by governmental authorities;
|
|
|
|
providing notice of certain events;
|
|
|
|
coordination of public announcements with respect to the transactions contemplated by the merger agreement;
|
|
|
|
the delisting of GenVec common stock from NASDAQ;
|
|
|
|
cooperating with respect to shareholder litigation;
|
|
|
|
obligations of Merger Sub; and
|
|
|
|
other matters as described further below.
|
Covenants regarding alternative acquisition proposals
The merger agreement contains detailed provisions regarding GenVec seeking or entertaining alternative acquisition proposals.
No solicitation
Effective as of the date of the merger
agreement, and until the effective time of the merger, GenVec (i) is required to (and is required to cause its representatives to) immediately cease and terminate any discussions or negotiations with any persons that may have been ongoing on
the date of the merger agreement with respect to any acquisition proposal (as defined below), and as promptly as practicable thereafter deliver a written notice to each such person indicating that GenVec is ending all discussions and negotiations
with such person with respect to any acquisition proposal, effective immediately and (ii) is prohibited from (and must prohibit its representatives from) initiating, soliciting, facilitating or knowingly encouraging any acquisition proposal or
participating in any discussions with any third party regarding any acquisition proposal.
Until the time GenVec obtains
shareholder approval of the merger proposal, if the board of directors of GenVec in good faith, and without breaching the foregoing obligations, determines that an acquisition proposal from a third party would be, or could reasonably be expected to
result in, a superior proposal (as defined below), and that the failure to consider such proposal would breach, or would reasonably be expected to breach, the fiduciary duties of the board of directors of GenVec, then GenVec may furnish information
to the party making such proposal and participate in discussions or negotiations with the party making such proposal, provided that any
non-public
information provided to such party shall, to the extent not
previously provided to Intrexon, be provided to Intrexon.
77
No change in recommendation or alternative acquisition agreement
Except as otherwise described below, neither the board of directors of GenVec nor any committee thereof may (i) withdraw, change, qualify, withhold or
modify (or publicly propose to withdraw, change, qualify, withhold or modify) the recommendation of GenVecs board of directors in favor of the merger proposal, (ii) fail to include the recommendation of GenVecs board of directors in
favor of the merger proposal in this proxy statement/prospectus, (iii) in the event a tender offer that constitutes an acquisition proposal subject to Regulation 14D of the Exchange Act is commenced, fail to recommend against such acquisition
proposal in any solicitation or recommendation statement within 10 business days of such commencement, (iv) adopt, approve or recommend, or publicly propose to adopt, approve or recommend, any acquisition proposal, (v) approve, authorize
or cause or permit GenVec to enter into any merger agreement, acquisition agreement, letter of intent, memorandum of understanding or other similar agreement relating to any acquisition proposal, or (vi) resolve or agree to do any of the
foregoing.
The issuance by GenVec or its board of directors of a stop, look and listen statement pending disclosure of its position with
respect to an acquisition proposal, as contemplated by Rules
14d-9
and
14e-2(a)
promulgated under the Exchange Act, shall not constitute a change in recommendation by
the board of directors of GenVec.
Permitted changes in recommendation and opportunity to modify the merger agreement
Notwithstanding the above, until the time GenVec obtains shareholder approval of the merger proposal, and provided that GenVec has not breached the covenants
regarding acquisition proposals contained in the merger agreement (as described above), the board of directors of GenVec may, under certain circumstances, change its recommendation to GenVecs shareholders with respect to the merger proposal in
favor of an alternative acquisition proposal (and GenVec may terminate the merger agreement to enter into such alternative acquisition proposal, as described below in the section entitled Termination of the merger agreement).
However, GenVecs board of directors may only change its recommendation if the board first determines in good faith (after consultation with its financial advisor and outside legal counsel) that (i) such alternative acquisition proposal
constitutes a superior proposal, and (ii) the failure to change the boards recommendation would breach or would reasonably be expected to breach the boards fiduciary duties under applicable law. In addition, after making such
determinations, before the GenVec board of directors may change its recommendation, GenVec must first provide at least three business days notice to Intrexon, which notice must include, among other things, the material terms of the alternative
acquisition proposal and be accompanied by certain documents relating to the alternative acquisition proposal. Intrexon will then have the opportunity, during this
three-business-day
period, to negotiate with
GenVec regarding amendments and modifications to the merger agreement intended to cause the alternative acquisition proposal to no longer constitute a superior proposal. Following this
three-business-day
period, if the GenVec board of directors determines in good faith that, after giving effect to any such amendments or modifications proposed by Intrexon, the alternative acquisition proposal is still a superior proposal, the GenVec board of
directors may change its recommendation with respect to the merger proposal in favor of the alternative acquisition proposal. In the event that the alternative acquisition proposal is materially amended, the foregoing process will be repeated.
In addition, until the time GenVec obtains shareholder approval of the merger proposal, and provided that GenVec has not breached the covenants regarding
acquisition proposals contained in the merger agreement (as described above), the board of directors of GenVec may, under certain circumstances, change its recommendation to GenVecs shareholders with respect to the merger proposal in response
to an intervening event (as defined below). However, GenVecs board of directors may only change its recommendation in response to an intervening event if the board first determines in good faith (after consultation with outside legal counsel)
that (i) such intervening event has occurred and is continuing, and (ii) the failure to change the boards recommendation with respect to the merger proposal would breach or would reasonably be expected to breach the boards
fiduciary duties under applicable law. In addition, after making such determinations, before the GenVec board of directors may change its recommendation, GenVec must first provide at least three business days notice to Intrexon. Intrexon will
then have the opportunity, during this
three-business-day
period, to negotiate with GenVec regarding amendments or modifications to the merger agreement intended to enable the GenVec board of directors to
continue to recommend the merger proposal. Following this
three-business-day
period, if the GenVec board of directors determines in good faith, after considering any such amendments or modifications proposed
by Intrexon, that the failure to change its recommendation with respect to the merger proposal in response to the intervening event would reasonably be expected to breach the boards fiduciary duties under applicable law, the GenVec board of
directors may change its recommendation with respect to the merger proposal.
Definitions of acquisition proposal, superior proposal and intervening
event
For purposes of this summary of the merger agreement, an acquisition proposal shall mean any inquiry, offer or proposal from a third party
concerning any (i) merger, consolidation, recapitalization, dissolution or other business combination or similar transaction involving GenVec, (ii) sale, lease or other disposition by merger, consolidation, business combination, share
exchange, joint venture or otherwise, of assets of GenVec representing 20% or more of the asset of GenVec, based on their fair market value as determined in good faith by the GenVec board of directors, (iii) issuance or acquisition of
(including by way of merger, consolidation, business combination or share exchange) equity interests representing 20% or more of the voting power of GenVec or (iv) any combination of the foregoing (in each case, other than the merger).
For purposes of this summary of the merger agreement, a superior proposal means a bona fide written acquisition proposal (except that the phrase 20% or
more in the definition of acquisition proposal shall be replaced with the phrase 50% or more for purposes of this definition) that is not solicited or received in violation, or resulting from any breach, of the terms of the merger
agreement, which the GenVec board of directors determines in good faith (after consultation with its financial advisor and outside legal counsel) (i) would, if consummated, be more favorable to GenVecs shareholders from a financial point
of view than the merger proposal and (ii) is reasonably likely of being consummated in accordance with its terms.
78
For purposes of this summary of the merger agreement, an intervening event means any event, change, effect,
development, state of facts, condition or occurrence that is material to GenVec that (i) was not known to or by the board of directors of GenVec and could not reasonably be expected to have been known to or by the board of directors of GenVec
as of or prior to the date of the merger agreement (or if known, the magnitude or material consequences of which were not known and could not reasonably be expected to have been known to or by the board of directors of GenVec as of or prior to the
date of the merger agreement), and (ii) does not involve or relate to the receipt, existence or terms of an acquisition proposal.
Employee
matters
The merger agreement provides that, at closing, the employment agreements with certain employees of GenVec and GenVecs severance
plan will be assumed and honored by Intrexon or one of its affiliates.
Indemnification and insurance
The merger agreement provides that, from and after the effective time of the merger, Intrexon will indemnify each present and former director and officer of
GenVec, as well as each GenVec employee who serves as a fiduciary of a GenVec benefit plan, against any losses incurred in connection with any proceeding or investigation arising out of such directors, officers or fiduciarys
position with GenVec at or prior to the effective time of the merger, in each case to the extent provided in GenVecs certificate of incorporation, bylaws and indemnification agreements with such directors, officers and fiduciaries in effect as
of the date of the merger agreement.
The merger agreement provides that Intrexon will cause the surviving corporation to honor and fulfill in all
respects the obligations of GenVec with respect to the indemnification of GenVecs current and former directors and officers, as well as with respect to the indemnification of each GenVec employee who serves as a fiduciary of a GenVec benefit
plan, under GenVecs certificate of incorporation, bylaws and indemnification agreements with such officers, directors and fiduciaries for six years after the effective time of the merger.
The merger agreement provides that GenVec will procure prepaid directors and officers liability insurance and fiduciary liability insurance for
GenVecs directors and officers, with a claims period of six years following the effective time of the merger, which policies may be no less favorable in the aggregate to the directors and officers of GenVec than GenVecs current policy.
Conditions to complete the merger
Mutual
conditions
The respective obligations of the parties to complete the merger are subject to satisfaction or waiver of the following conditions:
|
|
|
the merger agreement shall have been adopted by the affirmative vote of the holders of a majority of the outstanding shares of GenVecs common stock;
|
|
|
|
the consummation of the merger shall not then be restrained, enjoined or prohibited by any order of any governmental authority and there shall not be in effect any law enacted or promulgated by any governmental
authority that prevents or makes illegal the consummation of the merger;
|
|
|
|
the shares of Intrexons common stock issuable to GenVecs shareholders in the merger shall have been approved for listing on the NYSE, subject to official notice of issuance;
|
|
|
|
the Registration Statement on Form
S-4
shall have been declared effective by the SEC, no stop order suspending the effectiveness of such Registration Statement shall be in effect,
and no proceedings for such purpose shall be pending before the SEC; and
|
|
|
|
holders representing no more than 20% of GenVecs shares of common stock shall have exercised appraisal, dissenters or similar rights under applicable law.
|
Conditions to Obligations of Intrexon and Merger Sub
In
addition, the obligations of Intrexon and Merger Sub to effect the merger are subject to satisfaction or waiver of the following conditions:
|
|
|
the representations and warranties of GenVec (i) with respect to capitalization shall be true and correct in all respects (except for de minimis inaccuracies) as of the date of the merger agreement and as of the
effective time of the merger as though made at such time (except to the extent any representations and warranties address matters only as of a particular date or time, in which case they shall be true and correct as of such date or time), (ii) with
respect to corporate organization, authority, execution, delivery and enforceability of the merger agreement, and brokers fees shall be true and correct in all material respects as of the date of the merger agreement and as of the effective
time of the merger as though made at such time (except to the extent any representations and warranties address matters only as of a particular date or time, in which case they shall be true and correct as of such date or time), and (iii) with
respect to all other representations and warranties, shall be true and correct in all respects without giving effect to any materiality or material adverse effect qualifications, as of the date of the merger agreement and as of the effective time of
the merger as though made at such time (except to the extent any representations and warranties address matters only as of a particular date or time, in which case they shall be true and correct as of such date or time), except as has not had and
would not be reasonably expected to have, individually or in the aggregate, a material adverse effect with respect to GenVec; and Intrexon shall have received a certificate of an executive officer of GenVec to that effect;
|
79
|
|
|
GenVec shall have performed in all material respects the covenants and agreements required to be performed by it under the merger agreement, and Intrexon shall have received a certificate of an executive officer of
GenVec to that effect;
|
|
|
|
there shall not have occurred since the date of the merger agreement any change, event, development, condition, occurrence or effect that has had, or would reasonably be expected to have, a material adverse effect with
respect to GenVec; and
|
|
|
|
GenVec shall have delivered to Intrexon a statement satisfying the requirements of Treasury Regulations Section
1.897-2(h)
and
1.1445-2(c)(3)
certifying that interests in GenVec are not United States real property interests.
|
Conditions to Obligations of GenVec
In addition, the
obligations of GenVec to effect the merger are subject to the satisfaction or waiver of the following conditions:
|
|
|
the representations and warranties of Intrexon and Merger Sub (i) with respect to capitalization shall be true and correct in all respects (except for de minimis inaccuracies) as of the date of the merger agreement
and as of the effective time of the merger as though made at such time (except to the extent any representations and warranties address matters only as of a particular date or time, in which case they shall be true and correct as of such date or
time) and (ii) with respect to all other representations and warranties, shall be true and correct in all respects without giving effect to any materiality or material adverse effect qualifications, as of the date of the merger agreement and as
of the effective time of the merger as though made at such time (except to the extent any representations and warranties address matters only as of a particular date or time, in which case they shall be true and correct as of such date or time),
except as has not had and would not be reasonably expected to have, individually or in the aggregate, a material adverse effect with respect to Intrexon; and GenVec shall have received a certificate of a duly authorized officer of Intrexon to that
effect; and
|
|
|
|
Intrexon and Merger Sub shall have performed in all material respects the covenants and agreements required to be performed by each of them under the merger agreement, and GenVec shall have received a certificate of a
duly authorized officer of Intrexon to such effect.
|
Termination of the merger agreement
The merger agreement may be terminated upon the following occurrences:
|
|
|
by mutual written consent of Intrexon and GenVec;
|
|
|
|
by either Intrexon or GenVec, if GenVec shall have failed to obtain the requisite affirmative vote of its shareholders to adopt the merger agreement;
|
|
|
|
by either Intrexon or GenVec, if a governmental authority shall have issued a final and
non-appealable
order that permanently restrains, enjoins or prohibits consummation of the
merger, or if any law is in effect that prevents or makes illegal consummation of the merger, unless the issuance of, or failure to resolve or have vacated or lifted, such order was primarily due to breach of any obligation under the merger
agreement by the party seeking to terminate the merger agreement;
|
|
|
|
by either Intrexon or GenVec, if the merger is not consummated on or before July 24, 2017, unless the party seeking to terminate the merger agreement is in breach of the merger agreement and such breach has
primarily caused or resulted in the failure of the closing to occur by such date;
|
|
|
|
by Intrexon, prior to the approval of the merger proposal by the shareholders of GenVec, if the board of directors of GenVec shall have effected a change in its recommendation with respect to the merger proposal;
|
|
|
|
by GenVec, prior to the approval of the merger proposal by the shareholders of GenVec, if the board of directors of GenVec shall have effected a change in its recommendation with respect to the merger proposal, or
determined to effect such a change in its recommendation, in order to accept a superior proposal, provided that GenVec (i) complied with the provisions of the merger agreement prohibiting solicitation of acquisition proposals (as described
above in the section entitled Covenants regarding alternative acquisition proposals), (ii) shall have approved, and substantially concurrently with the termination of the merger agreement entered into, a letter of intent or
agreement with respect to such superior proposal, and (iii) concurrently with such termination, GenVec shall have paid Intrexon the termination fee discussed below; or
|
|
|
|
by either party, if there shall have been a breach of any of the covenants or agreements or any of the representations or warranties in the merger agreement by the other party that is not cured (or is not capable of
cure) within the timeframe specified in the merger agreement, which breach or misrepresentation would prevent the satisfaction of certain conditions to closing, provided that neither party shall have the right to terminate pursuant to this provision
if it is in material breach of its representations, warranties, covenants or agreements contained in the merger agreement.
|
80
Termination fee
GenVec shall pay Intrexon a termination fee of $550,000 if the merger agreement is terminated:
|
|
|
by GenVec, prior to the approval of the merger proposal by the shareholders of GenVec, in order to accept a superior proposal;
|
|
|
|
by Intrexon, prior to the approval of the merger proposal by the shareholders of GenVec, because the board of directors of GenVec shall have effected a change in recommendation with respect to the merger proposal;
|
GenVec shall also pay to Intrexon a termination fee of $550,000 if the merger agreement is terminated (i) by Intrexon or GenVec
because the merger is not consummated on or before July 24, 2017, or (ii) by Intrexon based solely on a breach by GenVec of any covenant or agreement in the merger agreement that is not cured (or is not capable of cure) within the
timeframe specified in the merger agreement, which breach would prevent the satisfaction of certain conditions to closing, and, in either case, (a) an acquisition proposal is publicly announced or made to GenVec after the date of the merger
agreement but prior to termination of the merger agreement (and such acquisition proposal has not been withdrawn prior to such termination) and (b) GenVec enters into a letter of intent or an agreement for, or consummates, an acquisition
proposal within 12 months of such termination, provided that for purposes of this summary only, references to 20% in the definition of acquisition proposal set forth above shall be deemed to be references to 50%.
In circumstances where the termination fee is due, Intrexons receipt of the termination fee will be Intrexons sole and exclusive remedy against
GenVec for all losses and damages suffered as a result of the failure to consummate the merger and the other transactions contemplated by the merger agreement, as well as for any breach or failure to perform under the merger agreement.
Costs and expenses
GenVec shall reimburse Intrexon for
the reasonable costs, fees and expenses of Intrexon, its affiliates and their representatives incurred in connection with the investigation, due diligence, negotiation and documentation of the merger agreement, up to a maximum of $400,000, if the
merger agreement is terminated by Intrexon because of a breach by GenVec of any covenant or agreement in the merger agreement that is not cured (or is not capable of cure) within the timeframe specified in the merger agreement, which breach would
prevent the satisfaction of certain conditions to closing, and within 6 months after the date of such termination, GenVec enters into a definitive agreement with a third party in respect of any acquisition proposal (regardless of when GenVec
received such acquisition proposal). In addition to such expense reimbursement (and only when such expense reimbursement is due), GenVec will also be obligated to pay Intrexon an added $200,000 if GenVec willfully breached in any materially respect
the provisions of the merger agreement prohibiting solicitation of acquisition proposals (as described above in the section entitled Covenants regarding alternative acquisition proposals). In the event that GenVec reimburses
Intrexons expenses as described in this paragraph and the termination fee thereafter becomes payable, the termination fee will be reduced by the expenses so reimbursed (as well as by the additional $200,000 paid by GenVec as described in the
previous sentence, if applicable).
In circumstances where the expense reimbursement is due, Intrexons receipt of such expense reimbursement
(together with the additional $200,000 paid by GenVec as described in the previous paragraph, if applicable) will be Intrexons sole and exclusive remedy against GenVec for all losses and damages suffered as a result of the failure to
consummate the merger and the other transactions contemplated by the merger agreement, as well as for any breach or failure to perform under the merger agreement.
Specific performance
In addition to any other remedy to
which the parties to the merger agreement are entitled at law or in equity, the parties thereto will be entitled to an injunction or injunctions to prevent breaches of the merger agreement and to enforce specifically the terms and provisions hereof
in any court of the United States or any state having jurisdiction.
Amendment, waiver and extension of the merger agreement
The merger agreement may be amended by the parties at any time prior to the effective time of the merger. After approval of the merger proposal by the
shareholders of GenVec, no amendment may be made that, by law or in accordance with the rules of any relevant stock exchange, requires further approval by such shareholders. The merger agreement may not be amended except by an instrument in writing
signed by the parties.
At any time prior to the effective time of the merger, the parties may (i) extend the time for the performance of any of the
obligations or other acts of the other party, (ii) waive any inaccuracies in the representations and warranties and (iii) waive compliance with any of the agreements or satisfaction of any conditions;
provided, however
, that after
approval of the merger proposal by the shareholders of GenVec, there may not be any extension or waiver of the merger agreement that decreases the merger consideration or that adversely affects the rights of GenVecs shareholders without the
approval of such shareholders. Any such extension or waiver will be valid only if set forth in an instrument in writing signed by the party to be bound thereby, but such extension or waiver or failure to insist on strict compliance with an
obligation, covenant, agreement or condition shall not operate as a waiver of, or estoppel with respect to, any subsequent or other failure.
Governing
law
The merger agreement is governed by, and will be construed in accordance with, the laws of the State of Delaware without regard to laws applicable
under conflicts of laws principles.
81
Contingent payment rights agreement
The following description describes the material terms of the contingent payment rights agreement executed by Intrexon and the rights agent. This
description is qualified in its entirety by reference to the contingent payment rights agreement, a copy of which is attached hereto as
Annex B
and incorporated herein by reference. Each shareholder should read the contingent payment
rights agreement carefully and in its entirety.
Pursuant to the terms of the NVS License Agreement, GenVec has licensed to Novartis certain of its
intellectual property in exchange for, among other things, the payment to GenVec of certain milestone and royalty amounts based on development, regulatory and sales results, as further described below.
CPRs
The CPRs are not evidenced by a certificate or any
other instrument. AST has agreed to act as rights agent and will serve as the initial CPR registrar and will maintain a record of issued CPR holdings as well as any permitted transfers.
Eligibility
Each share of GenVec common stock
outstanding at the effective time of the merger (including through exercise of a GenVec stock option), and each share of GenVec common stock underlying a warrant that is converted into a warrant to purchase merger consideration, will, upon the
effective time of the merger, or with respect to a warrant, upon the exercise of such warrant, entitle the holder to receive one CPR. Each CPR represents the right to receive an amount equal to (i) 50% of the applicable milestone or royalty payments
received by Intrexon or GenVec
divided by
(ii) the total number of CPRs outstanding at such time. To the extent any applicable milestone or royalty payment is received by Intrexon or GenVec, each holder of a CPR will receive a payment
equal to the amount described in the foregoing sentence multiplied by the number of CPRs held by such holder at the applicable time, referred to herein as a CPR Payment.
Achievement of milestones
CPR holders will collectively
be entitled to receive 50% of the actual amounts received by Intrexon or GenVec under the NVS License Agreement with respect to the achievement or occurrence of certain development, regulatory and sales milestones as more fully described in the NVS
License Agreement. The description of the milestones and royalty payments under the NVS License Agreement is qualified in its entirety by reference to the NVS License Agreement which has previously been filed with the SEC by GenVec. The first four
development and regulatory milestones under the NVS License Agreement have previously been achieved. Although it is highly uncertain whether any further milestones will be achieved or occur during the
36-month
contingent payment period covered by the contingent payment rights agreement (or at all), GenVec estimates that the most likely milestones to be achieved or occur during such period, if any, would be first patient first visit in a phase IIb clinical
trial with respect to the first indication of a product covered by the NVS License Agreement, achievement of which would trigger a milestone payment from Novartis to GenVec of $5 million, and first patient first visit in a phase III clinical
trial with respect to the first indication of a product covered by the NVS License Agreement, achievement of which would trigger a milestone payment from Novartis to GenVec of $10 million. However, achievement or occurrence of either of these
milestones, or any other milestone(s), under the NVS License Agreement is not guaranteed and is highly speculative. GenVec does not expect there to be any royalty payments during the
36-month
contingent
payment period. Novartis may also make other payments to GenVec and Intrexon to compensate for research, personnel and other administrative costs. The CPRs do not represent the right to share in such payments, and CPR Payments will not include the
amount of those payments made to GenVec or Intrexon.
Payment mechanics
If the first two milestones under the NVS License Agreement are achieved or occur during the
36-month
period after the
effective time of the merger and milestone payments are received by Intrexon or GenVec, Intrexon will notify the rights agent within 30 days of receipt of each such payment. The rights agent will then make the applicable CPR Payments to the
appropriate CPR holders within 10 business days. With respect to all other milestone payments received by Intrexon or GenVec on account of milestones that are achieved or occur during the
36-month
period after
the effective time of the merger, and with respect to all royalty payments received by Intrexon or GenVec under the NVS License Agreement during such
36-month
period, Intrexon will notify the rights agent
within 30 days of the end of such
36-month
period, such date referred to herein as final notice date. The rights agent will then make the applicable CPR Payments to the appropriate CPR holders within 10
business days.
Form of CPR payments
CPR Payments
will be made in cash, except that, to the extent such payment would cause the merger to fail to qualify as a
tax-free
reorganization (taking into account for such determination the value of Intrexon common
stock at both the time of such CPR Payment and at the effective time of the merger), CPR Payments will be made in shares of Intrexon common stock with a view to preserving the
tax-free
reorganization status of
the merger. However, in no event will shares of Intrexon common stock be issued to holders of CPRs if:
|
|
|
such shares, when aggregated with all other shares of Intrexon common stock issued in connection with the merger, would exceed 19.9% of all then-issued and outstanding shares of Intrexon common stock; or
|
82
|
|
|
such shares, when aggregated with all other shares of Intrexon common stock issued pursuant to the contingent payment rights agreement, would exceed the number of shares of Intrexon common stock issued to GenVec
shareholders at the effective time of the merger.
|
Thus, it is possible that the merger would not be treated as a tax-free reorganization if
the maximum value of all Intrexon shares issued pursuant to the merger is less than 80% of the total value of all of the merger consideration. See the section entitled Material U.S. federal income tax consequences of the mergerExchange
of GenVec common stock for Intrexon voting common stock, cash in lieu of fractional shares, and CPRs.
For purposes of determining the value of
shares of Intrexon common stock for these purposes, such shares will be valued based on the VWAP for the five trading days immediately preceding the applicable measurement date.
Non-transferability
CPRs will not be evidenced by a certificate or other instrument and, subject to certain limited exceptions, may not be sold or otherwise transferred or
disposed of.
Rights of holders of CPRs
The CPRs
alone do not represent any equity, dividend or voting interests in Intrexon or GenVec and are limited to the rights expressly provided for in the contingent payment rights agreement.
The holders of CPRs, by written consent of holders holding a majority of the then-outstanding CPRs, may direct the rights agent to enforce any of the
holders rights pursuant to the contingent payment rights agreement. The rights agent is not under any obligation, however, to institute any action, suit or proceeding or take any other action likely to result in the incurrence of material
expenses by the rights agent unless the holders indemnify the rights agent for any material expense incurred in enforcing such rights.
Once during the
one-year
period following the expiration of the
36-month
contingent payment period, upon reasonable notice of holders holding a majority of the then-outstanding CPRs, holders
of CPRs may appoint an independent accounting firm, reasonably acceptable to Intrexon, to have reasonable access to the books and records of Intrexon and GenVec to audit the milestone and royalty payments made by Novartis and the CPR Payments made
by Intrexon to determine compliance with the contingent payment rights agreement. The fees of such independent accountant will be borne by the holders of CPRs, unless Intrexon is found to have made underpayments with respect to the CPR Payments
greater than 5% of the required amount, in which case the fees of such independent accountant will be borne by Intrexon.
Amendment of contingent
payment rights agreement
The contingent payment rights agreement may be amended without the consent of the holders of CPRs by Intrexon and the rights
agent as follows:
|
|
|
to evidence the succession of another person as a successor rights agent and the assumption by any successor of the covenants and obligations of the rights agent pursuant to the terms of the contingent payment rights
agreement;
|
|
|
|
to add to the covenants of Intrexon such further covenants, restrictions, conditions or provisions as Intrexon and the rights agent will consider to be for the protection of the holders of CPRs; provided that, in each
case, such provisions do not materially adversely affect the interests of the holders of CPRs;
|
|
|
|
to cure any ambiguity, to correct or supplement any provision in the contingent payment rights agreement that may be defective or inconsistent with any other provision of the contingent payment rights agreement, or to
make any other provisions with respect to matters or questions arising under the contingent payment rights agreement; provided that, in each case, such provisions do not materially adversely affect the interests of the holders of CPRs;
|
|
|
|
as may be necessary or appropriate to ensure that the CPRs are not subject to registration under the Securities Act or the Exchange Act; provided that, in each case, such provisions do not materially adversely affect
the interests of the holders of CPRs; or
|
|
|
|
any other amendments hereto for the purpose of adding, eliminating or changing any provisions of the contingent rights agreement, unless such addition, elimination or change is materially adverse to the interests of the
holders of CPRs.
|
In addition, the contingent payment rights agreement may be amended with the consent of Intrexon, the rights agent and
holders holding a majority of the then-outstanding CPRs, regardless of whether such amendment is materially adverse to the interests of the holders of CPRs.
Termination of contingent payment rights agreement
The
contingent payment rights agreement will automatically terminate upon the earlier to occur of (i) the payment of all CPR Payments required to be paid or potentially payable as contemplated by the terms of the contingent payment rights agreement
and (ii) 45 days after the final notice date. Except for the payment of any CPR Payments earned during, or payable in connection with milestones that are achieved or occur during, the
36-month
contingent
payment period, upon termination of the contingent payment rights agreement, Intrexon and GenVec will have no further responsibility or obligation to make any CPR Payments.
83
Risks associated with CPRs
For a discussion of the risks associated with the CPRs, see the section entitled Risk factors.
84
Amendment to the rights agreement
The following description describes the material terms of the rights agreement, as amended by the amendment to the rights agreement, executed by GenVec and
the rights agent. This description is qualified in its entirety by reference to the rights agreement, a copy of which was filed as Exhibit 4.1 to GenVecs Current Report on Form
8-K,
filed with the SEC on
August 12, 2011, and the amendment to the rights agreement, a copy of which is attached hereto as Annex C and which was filed as Exhibit 4.1 to GenVecs Current Report on Form
8-K,
filed with
the SEC on January 24, 2017. Each shareholder should read the rights agreement and the amendment to the rights agreement carefully and in its entirety.
The rights agreement
On August 11, 2011, GenVec
entered into a Rights Agreement, referred to herein as the rights agreement, between GenVec and AST, as rights agent.
In connection with entering into
the rights agreement, on August 11, 2011 the board of directors of GenVec declared a distribution of one preferred share purchase right, which we refer to as a Right, for each outstanding share of GenVecs common stock, to shareholders of
record at the close of business on September 7, 2011, and for each share of common stock issued (including shares distributed from treasury) by GenVec thereafter and prior to the Distribution Date (as described below). As a result of the
reverse stock split, there are now 10 Rights associated with each outstanding share. Each Right entitles the registered holder, subject to the terms of the rights agreement, to purchase from GenVec one
one-thousandth
of a share of Series B Junior Participating Preferred Stock, $0.001 par value per share at a purchase price of $32.00 per one
one-thousandth
of a share,
subject to adjustment, referred to herein as the Purchase Price.
Initially, no separate rights certificates were distributed and instead the Rights were
attached to all certificates representing shares of outstanding common stock, or, with respect to common stock in book-entry form, to the outstanding shares of common stock evidenced by the balances indicated in the book-entry account system of the
transfer agent for the common stock. The Rights will separate from the common stock and the Distribution Date will occur upon the earlier of (i) ten business days following a public announcement that a person or group of affiliated
or associated persons has become an Acquiring Person, or (ii) ten business days (or such later date as may be determined by the board of directors prior to such time as any person becomes an Acquiring Person) following the
commencement of a tender offer or exchange offer that would result in a person or group of affiliated and associated persons beneficially owning 20% or more of the shares of common stock then outstanding. Until the Distribution Date, (i) the
Rights will be evidenced by the balances indicated in the book-entry account system of the transfer agent for the common stock registered in the names of the holders thereof or, in the case of certificated shares, by common stock certificates, and
will be transferred with and only with such underlying shares of common stock, (ii) confirmation and account statements sent to holders of common stock in book-entry form or, in the case of certificated shares, certificates, representing such
shares of common stock, issued after the Record Date (including shares distributed from treasury) will contain a notation incorporating the rights agreement by reference, and (iii) the transfer of any shares of outstanding common stock will
also constitute the transfer of the Rights associated with such shares of common stock.
As used in the rights agreement, an Acquiring Person
means a person or group of affiliated or associated persons that has acquired, obtained the right to acquire, or otherwise obtained beneficial ownership of 20% or more of the shares of common stock then outstanding. The following, however, are not
Acquiring Persons: GenVec, its subsidiaries, any employee benefit plan of GenVec or any of its subsidiaries, or any entity holding shares of common stock pursuant to the terms of any such plan. Moreover, no person or affiliated persons will be
deemed to be an Acquiring Person as a result of the following: (i) an acquisition of common stock by GenVec, which, by reducing the number of shares of common stock outstanding, increases the percentage of the shares of common stock that such
person, or group of affiliated or associated persons, beneficially owns to 20% or more of the shares of common stock then outstanding, (ii) any unilateral grant of any security by GenVec to such person, (iii) through the exercise of any
options, warrants, rights or similar interests (including restricted stock) granted by GenVec to its directors, officers and employees or (iv) being the beneficial owner of 20% or more of the shares of common stock then outstanding as of the
date of the rights agreement or prior to the first public announcement of the adoption of the rights agreement.
Notwithstanding the foregoing, if the
board of directors of GenVec determines that a person, or group of affiliated or associated persons, who would otherwise be an Acquiring Person, has become so inadvertently (either because such person, or group of persons, was unaware that it
beneficially owned the requisite percentage of outstanding common stock or because it had no actual knowledge of the consequences of such beneficial ownership under the rights agreement), and such person, or group of affiliated or associated
persons, promptly divests a sufficient number of shares of common stock so that it would no longer be an Acquiring Person, then such person or group of affiliated or associated persons shall not be deemed to be or to have become an Acquiring Person
for any purposes of the rights agreement.
The Rights are not exercisable until the Distribution Date and will expire at the close of business on
September 7, 2021 unless earlier redeemed or exchanged by GenVec.
In the event that a person, or group of affiliated or associated persons, becomes
an Acquiring Person, then each holder of a Right will thereafter have the right to receive, upon exercise, shares of common stock (or, in certain circumstances, shares of Preferred Stock, other securities, cash, property, or a combination thereof)
having a value equal to two times the exercise price of the Right. The exercise price is the Purchase Price multiplied by the number of one
one-thousandth
of a share of Preferred Stock issuable upon exercise
of a Right prior to the events described in the paragraph below.
85
In the event that, at any time after a person or group becomes an Acquiring Person, (i) GenVec
is acquired in a merger or other business combination with another company and GenVec is not the surviving corporation, (ii) another company consolidates or merges with GenVec and all or part of the common stock is converted or exchanged for
other securities, cash, or property, or (iii) 50% or more of the consolidated assets or earning power of GenVec and its subsidiaries is sold or transferred to another company, then each holder of a Right (except Rights that previously have been
voided as described above) shall thereafter have the right to receive, upon exercise, common stock or other equity interest of the ultimate parent of such other company having a value equal to two times the exercise price of the Right.
Notwithstanding any of the foregoing, following the time any person or group becomes an Acquiring Person, all Rights that are, or under certain circumstances
specified in the rights agreement were, beneficially owned by any Acquiring Person or its affiliates or associates will be null and void.
Any of the
provisions of the rights agreement may be amended without the approval of the holders of Rights in order to cure any ambiguity, defect, inconsistency or to make any other changes that the board of directors may deem necessary or desirable. After any
person or group of affiliated or associated persons becomes an Acquiring Person, the provisions of the rights agreement may not be amended in any manner that would adversely affect the interests of the holders of Rights excluding the interests of
any Acquiring Person.
Amendment to rights agreement
On January 24, 2017, prior to the execution of the merger agreement, the board of directors of GenVec approved Amendment No. 1 to the Rights
Agreement, referred to herein as the amendment to the rights agreement. The amendment to the rights agreement was executed on January 24, 2017, immediately prior to the execution of the merger agreement.
The amendment to the rights agreement renders the rights agreement inapplicable to the merger agreement and the transactions contemplated thereby.
Specifically, the amendment to the rights agreement provides, among other things, that: (i) none of Intrexon, Merger Sub, or any of their respective affiliates or associates shall become an Acquiring Person as a result of (a) the approval,
execution, delivery, performance or public announcement of the merger agreement (including any amendments, modifications or supplements thereto), (b) the consummation of the merger, (c) the execution, delivery or performance of the contingent
payment rights agreement to be entered into in connection with the merger or (d) consummation of any other transactions contemplated by the merger agreement or the contingent payment rights agreement, including, but not limited to, the
potential future payments thereunder, collectively referred to herein as exempted transactions; (ii) a Distribution Date shall not be deemed to occur as a result of the exempted transactions; (iii) the Rights of the GenVecs
shareholders shall not be adjusted as a result of the exempted transactions; and (iv) the right to obtain shares of common stock of an Acquiring Person under the rights agreement in the event of a merger shall not be applicable to the exempted
transactions.
In addition, the amendment to the rights agreement provides that Section 13(a)(i) of the rights agreement, providing for the conversion of
each Right into one
one-thousandth
of a share of Series B Junior Participating Preferred Stock, will not apply to the merger and will not apply to Intrexon or Merger Sub as an other Person,
provided that neither becomes an Acquiring Person (as such terms are defined in the rights agreement).
Accordingly, no rights will be issued
as a result of the execution of the merger agreement and the transactions contemplated thereby, including the merger.
86
Material U.S. federal income tax consequences of the merger
The following discussion sets forth the material U.S. federal income tax consequences of the merger to GenVec and to the United States
holders (as that term is defined below) of GenVec common stock. This discussion is based upon provisions of the Internal Revenue Code, referred to herein as the Code, U.S. Treasury Regulations, and administrative rulings and court decisions, all as
in effect or in existence on the date of this filing and all of which are subject to change or differing interpretations by the Internal Revenue Service, referred to herein as the IRS, or a court, possibly with retroactive effect. Changes in these
authorities may cause the tax consequences of the merger to vary substantially from the consequences described below.
This discussion addresses only
those United States holders (as defined below) of GenVec common stock that hold such stock as a capital asset within the meaning of Section 1221 of the Code (generally, property held for investment), and does not address all the United States
federal income tax consequences that may be relevant to GenVec or to any United States holders of GenVec common stock in light of their individual circumstances such as (i) beneficial owners of GenVec common stock subject to special tax rules
(e.g., banks or other financial institutions, real estate investment trusts, regulated investment companies, insurance companies, broker-dealers, traders that elect to
mark-to-market
for U.S. federal income tax purposes,
tax-exempt
organizations and retirement plans, individual retirement
accounts and
tax-deferred
accounts, or former citizens or long-term residents of the United States) or to persons that hold GenVec common stock as part of a straddle, hedge, conversion, constructive sale, or
other integrated transaction for U.S. federal income tax purposes, (ii) partnerships or other entities classified as partnerships for U.S. federal income tax purposes or their partners, (iii) United States holders that have a functional
currency other than the U.S. dollar, (iv) United States holders of stock rights, options, or warrants with respect to GenVec common stock, or (v) United States holders of GenVec common stock that acquired their GenVec common stock as
compensation, all of whom may be subject to tax rules that differ significantly from those summarized below. If a partnership or other entity classified as a partnership for U.S. federal income tax purposes holds GenVec common stock, the tax
treatment of its partners generally will depend upon the status of the partner, the activities of the partnership and certain determinations made at the partner level. If you are a partner in a partnership holding GenVec common stock, you should
consult your own tax advisor regarding the tax consequences to you of the partnerships ownership of GenVec common stock.
This discussion does not
discuss (i) the U.S. federal income tax consequences to a United States holder of GenVec common stock who dissents and exercises appraisal rights, (ii) any state or local, foreign, estate, gift or alternative minimum tax considerations
concerning the merger, or (iii) any information regarding a
non-United
States holder. A
non-United
States holder is a holder that is not a United States holder. If
you are not a United States holder you should consult with your own tax advisor as to the United States federal, state, local, and foreign tax laws with respect to the merger.
Except as noted, this discussion assumes that the any payments received pursuant to the CPR will be made in cash.
Accordingly, each beneficial owner of GenVec common stock is urged to consult its own tax advisors regarding the U.S. federal, state, local, foreign, and
other tax consequences to them of the merger.
For purposes of this discussion, a United States holder is a beneficial owner of GenVec
common stock that:
|
|
|
is an individual U.S. citizen or resident (as determined for U.S. federal income tax purposes),
|
|
|
|
a corporation (or other entity that is classified as a corporation for U.S. federal income tax purposes) organized under the laws of the United States or any of its political subdivisions,
|
|
|
|
an estate the income of which is subject to U.S. federal income taxation regardless of its source, or
|
|
|
|
a trust if (i) a court within the United States is able to exercise primary supervision over the administration of the trust and one or more United States persons (as defined in the Code) have the
authority to control all substantial decisions of the trust or (ii) the trust has a valid election in effect under current U.S. Treasury Regulations to be treated as a United States person.
|
Exchange of GenVec common stock for Intrexon voting common stock, cash in lieu of fractional shares, and CPRs
It is intended, and each of Intrexon and GenVec expect that the merger will qualify as a reorganization within the meaning of Section 368(a) of the
Code. The qualification of the merger as a reorganization depends on compliance with numerous technical requirements of these provisions of the Code, including whether holders of GenVec common stock will receive a sufficient amount of Intrexon
voting common stock to satisfy the control test set forth in Section 368(a)(2)(E) of the Code, and whether after the merger the surviving corporation is regarded as holding substantially all of the assets of GenVec and the merged
subsidiary, which is referred to as the substantially all test.
The control test requires that, in the transaction, the holders of GenVec stock exchange,
for an amount of Intrexon voting stock, stock possessing control of GenVec. For purposes of Section 368(a)(2)(E) of the Code, control is defined as ownership of stock possessing at least 80% of the total combined voting power
of all classes of stock entitled to vote and at least 80% of the total number of shares of all other classes of stock of the corporation. Satisfaction of the control test will depend on the value, as of the closing of the merger, of the Intrexon
voting common stock received by holders of GenVec common stock in exchange for GenVec common stock relative to the value of the consideration other than Intrexon voting common stock (including the fair market value of the CPRs and cash consideration
paid to GenVec shareholders receiving appraisal rights) received by holders of
87
GenVec common stock in exchange for shares of GenVec common stock in connection with the merger. At this time, neither Intrexon nor GenVec is able to ascertain with certainty whether the value of
the Intrexon voting common stock to be received by holders of GenVec common stock in connection with the merger will be sufficient to satisfy the control test. Accordingly, although Intrexon and GenVec have structured the merger, including the CPRs,
with the intent that the control test will be satisfied, due to uncertainties surrounding the amount of cash issued to shareholders exercising appraisal rights and limitations on the total number of Intrexon shares that may be issued in the merger,
they anticipate that it will not be possible to make this determination with certainty until after the closing of the merger and the expiration of the
36-month
CPR payment period.
Intrexon and GenVec believe that the merger should satisfy the other technical requirements to qualify as a reorganization within the meaning of
Section 368(a)(2)(E) of the Code, including the continuity of interest requirement, the continuity of business enterprise requirement, the substantially all requirement, and the requirement that the merger must be
undertaken for reasons pertaining to the continuance of the business of a corporation that is a party to the transaction. However, Intrexon and GenVec have not sought and will not seek any ruling from the IRS regarding any matter affecting the
merger or any of the United States federal income tax consequences discussed herein, and have not sought and will not seek any opinion from their respective legal counsel regarding the qualification of the merger as a reorganization
within the meaning of Section 368(a) of the Code. Thus, there can be no assurance that the IRS will ultimately conclude that the merger does meet the control test or any of the other requirements for qualification as a
reorganization within the meaning of Section 368(a) of the Code or that any of the other statements made herein would not be challenged by the IRS and, if so challenged, sustained upon review in a court.
If the merger is treated as a reorganization within the meaning of Section 368(a) of the Code, and the transaction is treated as a closed rather
than an open transaction for federal income tax purposes (as discussed more fully below), then, subject to the limitations and qualifications referred to herein, the following U.S. federal income tax consequences should result:
|
|
|
A United States holder of GenVec common stock will recognize gain (but not loss), with respect to its shares of GenVec common stock held, in an amount equal to the lesser of (i) any gain realized with respect to
such shares or (ii) the fair market value of consideration other than Intrexon voting common stock received such as the fair market value of the CPRs received (subject to the discussion below under the section entitled
Treatment of Receipt, Holding and Disposition of CPRs), determined as of the effective time of the merger. A United States holders gain realized will be equal to the difference between (i) the sum of the fair
market value of the Intrexon voting common stock and CPRs received and (ii) such United States holders tax basis in the GenVec common stock surrendered (less any basis allocable to fractional shares as described below). Any such gain
recognized by a United States holder of GenVec common stock with respect to the receipt of the CPRs should be capital gain, long-term or short-term depending on the United States holders holding period for the GenVec common stock.
|
|
|
|
The aggregate adjusted tax basis of the Intrexon voting common stock received in the transaction (including any fractional interest) by a United States holder of GenVec common stock will be equal to the aggregate
adjusted tax basis of such holders GenVec common stock exchanged therefor, decreased by the fair market value of the cash and CPRs received by such United States holder and increased by any gain recognized by such United States holder.
|
|
|
|
The holding period for Intrexon common stock received in the transaction by a United States holder of GenVec common stock will include the holding period of such United States holders GenVec common stock exchanged
therefor.
|
|
|
|
The aggregate adjusted tax basis of the CPRs received in the transaction by a United States holder of GenVec common stock will be equal to their fair market value as of the effective time of the merger, and the holding
period for CPRs received will begin the day after the effective time of the transaction.
|
|
|
|
A United States holder of GenVec common stock who receives cash instead of a fractional share of Intrexon common stock will generally recognize capital gain or loss based on the difference between the amount of the cash
so received and the holders adjusted tax basis in such fractional share.
|
|
|
|
Capital gain or loss recognized on receipt of cash in lieu of fractional shares will constitute long-term capital gain or loss if the holding period of the United States holder of GenVec common stock is greater than one
year as of the date of the consummation of the transaction. The deductibility of capital losses is subject to limitations.
|
If the merger
does not qualify as a reorganization within the meaning of Section 368(a) of the Code, and again provided that the transaction is treated as a closed rather than an open transaction for federal income tax purposes (as
discussed more fully below), then the merger generally will be a taxable transaction. In general, a United States holder will recognize capital gain or loss on the exchange in an amount equal to the difference, if any, between (i) the sum of
the fair market value of Intrexon voting common stock and the fair market value of other merger consideration (for example CPRs and cash) received and (ii) the United States holders adjusted tax basis in the GenVec common stock exchanged
in the merger. Gain or loss, as well as the holding period, will be determined separately for each block of shares exchanged pursuant to the merger. Such gain or loss will be long-term capital gain or loss provided that the United States holder has
held (or is treated as having held) his or her GenVec common stock for more than one year as of the date of the merger. Otherwise, the recognized gain or loss generally will be a short-term capital gain or loss.
The deductibility of capital
losses may be subject to limitations, so United States holders are urged to consult with their own tax advisors about their particular tax consequences, including the potential deductibility of their capital losses, if any.
The United States
holder will have an adjusted tax basis in the Intrexon voting common stock and CPRs received equal to their respective fair market value, and the holding period of the Intrexon voting common stock received by a United States holder pursuant to the
merger will generally start anew. Additionally, if the merger is a taxable transaction, then the backup withholding rules would apply as well (see the section entitled Backup Withholding below).
88
Treatment of receipt, holding and disposition of CPRs
In general, the characteristics of the CPRs may cause the receipt of the merger consideration in the merger to be treated as an open transaction
rather than a closed transaction for United States federal income tax purposes. There is no authority directly on point addressing whether a sale of property for, in whole or in part, CPRs with characteristics similar to the CPRs should
be treated as an open transaction or closed transaction and such question is inherently factual in nature. Accordingly, United States holders are urged to consult their tax advisors regarding this issue. The installment
method of reporting any gain attributable to the receipt of a CPR will not be available because GenVec common stock is traded on an established securities market. However, if the transaction were treated as an open transaction, gain
recognition with respect to the CPRs may nevertheless be deferred.
The following sections discuss the possible tax consequences if the receipt of the
merger consideration is treated as an open transaction or a closed transaction for federal income tax purposes. Intrexon and GenVec urge you to consult your tax advisor with respect to the proper characterization of the
receipt of the CPRs.
Open transaction treatment
The receipt of the CPRs would generally be treated as part of an open transaction if the value of the CPRs cannot be reasonably
ascertained. If the receipt of CPRs were treated as an open transaction for United States federal income tax purposes, a United States holder will not immediately take the CPRs into account in determining its capital gain (or loss,
if allowed and applicable) on the receipt of CPRs upon consummation of the merger and a United States holder would take no tax basis in the CPRs.
Rather,
subject to the Section 483 rules discussed below, the United States holder would recognize gain as payments in cash with respect to the CPRs are received or deemed received in accordance with the United States holders regular method of
accounting, but only to the extent the sum of (i) such payments (and all previous payments under the CPRs), and (ii) the fair market value the Intrexon voting common stock received upon consummation of the merger (if the merger does not
qualify as a reorganization under Section 368(a) of the Code), exceeds such United States holders adjusted tax basis in the GenVec common stock surrendered pursuant the merger. To the extent that all or a portion of any payments received with
respect to the CPRs are paid in Intrexon voting common stock, it is possible that such payments should be treated as additional
tax-free
merger consideration. An adjustment to the tax basis in Intrexon voting
common stock received would be made once it becomes known how many shares (if any) the holders of a CPR is entitled to receive. It is unclear how this adjustment should be made, particularly if the holder no longer retains all the Intrexon voting
common stock or CPRs received in the merger. The IRS has not issued guidelines on how a shareholder should make this adjustment. A United States holder of GenVec common stock could recalculate its basis in any remaining Intrexon voting common stock
or additional Intrexon voting common stock received from the CPRs without recalculating the basis that had been allocated to any disposed merger consideration. Alternatively, a United States holder of GenVec common stock could recalculate its basis
in all of its Intrexon voting common stock, including additional Intrexon voting common stock received from the CPRs, even if the shareholder has disposed of some of its Intrexon voting common stock. Each United States holder of GenVec common stock
should consult its own tax advisor as to the treatment of the receipt of any additional shares of Intrexon voting stock pursuant to the CPRs and the allocation of its tax basis among the Intrexon voting common stock.
Subject to the Section 483 rules discussed below, if the merger does not qualify as a reorganization under Section 368(a) of the Code, a United States
holder who does not receive cumulative consideration having a fair market value at least equal to such United States holders adjusted tax basis in the GenVec common stock surrendered pursuant the merger, will recognize a capital loss in
the year that the United States holders right to receive further payments under the CPRs terminates. As noted above, a United States holder will not be able to recognize such a capital loss if the merger is treated as a reorganization under
Section 368(a) of the Code. The deductibility of any such capital losses may also be subject to applicable limitations.
If the transaction is treated as
an open transaction, a payment pursuant to a CPR to a United States holder thereof should be treated as a payment under a contract for the sale or exchange of GenVec common stock to which Section 483 of the Code applies, or the
Section 483 rules. The Section 483 rules will apply regardless of whether the transaction qualifies as a reorganization under section 368 of the Code. Under the Section 483 rules, a portion of the payments made pursuant to a CPR will
be treated as interest, which will be ordinary income to the United States holder of a CPR. The interest amount will equal the excess of the amount received over its present value at the consummation of the merger, calculated using the applicable
federal rate as the discount rate. The United States holder of a CPR must include in its taxable income interest pursuant to the Section 483 rules using such United States holders regular method of accounting. The portion of the payment
pursuant to a CPR that is not treated as interest under the Section 483 rules will generally be treated as a payment with respect to either the sale or exchange of GenVec common stock, as discussed above.
Closed transaction treatment
If the value of the
CPRs can be reasonably ascertained, the transaction should generally be treated as closed for U.S. federal income tax purposes, and the receipt of the CPRs will be as set forth above in the section entitled Exchange of
GenVec Common Stock for Intrexon Voting Common Stock, Cash in lieu of Fractional Shares, and CPRs. A United States holders initial tax basis in the CPRs will equal the fair market value of the CPRs on the date of the consummation of the
merger. The holding period of the CPRs will begin on the day following the date of the consummation of the merger.
89
There is no direct authority with respect to the tax treatment of holding and receiving payments with
respect to the CPRs. Accordingly, the amount, timing, and character of any gain, income or loss with respect to the CPRs are uncertain. It is possible that payments received with respect to a CPR, up to the amount of the holders adjusted tax
basis in the CPR, may be treated as a
non-taxable
return of a United States holders adjusted tax basis in the CPR, with any amount received in excess of basis treated as gain from the disposition of the
CPR. Moreover, to the extent that all or a portion of any payments received with respect to the CPRs are paid in Intrexon voting common stock and the United States holder did not recognize gain upon the receipt of any CPR, it is possible that such
payments should be treated as additional
tax-free
merger consideration. However, in the event a United States holder recognized gain upon the receipt of a CPR and subsequently receives all or a portion of any
payments with respect to such CPR in Intrexon voting common stock, the U.S. federal income tax consequences are unclear. An adjustment to the tax basis in Intrexon voting common stock received would be made once it becomes known how many shares (if
any) the holders of a CPR is entitled to receive. It is unclear how this adjustment should be made, particularly if the holder no longer retains all the Intrexon voting common stock or CPRs received in the merger. The IRS has not issued guidelines
on how a shareholder should make this adjustment. A United States holder of GenVec common stock could recalculate its basis in any remaining Intrexon voting common stock or additional Intrexon voting common stock received from the CPRs without
recalculating the basis that had been allocated to any disposed merger consideration. Alternatively, a United States holder of GenVec common stock could recalculate its basis in all of its Intrexon voting common stock, including additional Intrexon
voting common stock received from the CPRs, even if the shareholder has disposed of some of its Intrexon voting common stock. Each United States holder of GenVec common stock should consult its own tax advisor as to the treatment of the receipt of
any additional shares of Intrexon voting stock pursuant to the CPRs and the allocation of its tax basis among the Intrexon voting common stock.
Additionally, a portion of any payment received with respect to a CPR may constitute imputed interest and therefore be taxed as ordinary income under the
Section 483 rules. If not treated as described above, payments with respect to a CPR may be treated as either (i) payments with respect to a sale of a capital asset, including an option or a debt instrument, (ii) ordinary income
(including interest income), or (iii) dividends. Finally, upon the expiration of the
36-month
CPR payment period, it is possible that a United States holder may be permitted to recognize a loss to the
extent a United States holder has not received payments with respect to a CPR up to the amount of the United States holders adjusted tax basis in the CPR.
Medicare tax
A United States holder that is an
individual or estate, or a trust that does not fall into a special class of trusts that is exempt from such tax, will generally be subject to a 3.8% tax on the lesser of (i) the U.S. Holders net investment income for a taxable
year and (ii) the excess of the U.S. Holders modified adjusted gross income for such taxable year over $200,000 ($250,000 in the case of joint filers). For these purposes, net investment income may include any gain realized or
amounts received with respect to their shares of GenVec common stock or their CPRs not held in connection with certain trades or businesses, but will be reduced by any deductions properly allocable to such income or net gain. GenVec shareholders
should consult their own tax advisors with respect to the applicability of this additional 3.8% tax on any payments received by such shareholder.
Reporting requirements
Each United States holder
of GenVec common stock that receives Intrexon voting common stock, CPRs, and/or cash in the transaction will be required to file a statement with his, her or its U.S. federal income tax return setting forth his, her or its basis in the GenVec common
stock surrendered and the fair market value of the Intrexon voting common stock, CPRs and cash, if any, received in the transaction, and to retain permanent records of these facts relating to the merger.
Backup withholding
Certain
non-corporate
United States holders of GenVec common stock may be subject to backup withholding, currently at a 28% rate, on cash payments received in connection with the transaction. Backup withholding generally
will not apply, however, to a United States holder of GenVec common stock who:
|
|
|
furnishes a correct taxpayer identification number and certifies that he, she or it is not subject to backup withholding on the substitute Internal Revenue Service Form
W-9
(or
successor form) included in the letter of transmittal to be delivered to the United States holders of GenVec common stock following the consummation of the transaction; or
|
|
|
|
is otherwise exempt from backup withholding.
|
Any amounts withheld under the backup withholding rules will be
allowed as a refund or credit against a United States holders U.S. federal income tax liability, provided the holder furnishes the required information to the IRS.
90
Description of Intrexon capital stock
A description of Intrexons capital stock is contained in Intrexons Registration Statement on Form
8-A,
filed with the SEC on August 5, 2013, and in other documents that are incorporated by reference into this proxy statement/prospectus. See the section entitled Where you can find more information for the location of information
incorporated by reference in this proxy statement/prospectus.
91
Comparison of rights of shareholders of Intrexon and GenVec
GenVec is incorporated under the laws of the State of Delaware and, accordingly, the rights of GenVecs shareholders are currently governed by
the DGCL. Intrexon is incorporated under the laws of the Commonwealth of Virginia and, accordingly, the rights of Intrexons shareholders are currently governed by the VSCA. Upon completion of the merger, the GenVec shareholders will receive
shares of Intrexon common stock in exchange for their shares of GenVec common stock pursuant to the terms of the merger agreement and will become Intrexon shareholders. The rights of the former GenVec shareholders and the Intrexon shareholders will
therefore be governed by the VSCA and by Intrexons amended and restated articles of incorporation and Intrexons amended and restated bylaws.
The table below summarizes material differences between the rights of GenVecs shareholders and those of Intrexons shareholders pursuant to the
DGCL, the VSCA and their respective constitutive documents as they are currently in effect. While Intrexon and GenVec believe that the summary table includes the material differences between the rights of their respective shareholders prior to the
merger, this summary does not include a complete description of all the differences between the rights of Intrexons shareholders and those of GenVecs shareholders, nor does it include a complete description of the specific rights of the
respective shareholders discussed. The inclusion of differences in the rights in the table is not intended to indicate that all of such differences should necessarily be considered material by you or that other differences that you may consider
equally important do not exist.
Each of Intrexon and GenVec urge you to carefully read this entire proxy statement/prospectus, the relevant provisions of
the VSCA, and the other documents to which Intrexon and GenVec refer in this proxy statement/prospectus for a more complete understanding of the differences between being a shareholder of GenVec and being a shareholder of Intrexon. Copies of
Intrexons amended and restated articles of incorporation, as currently in effect, referred to herein as Intrexons articles of incorporation, and Intrexons amended and restated bylaws, as currently in effect, referred to herein as
Intrexons bylaws, are attached as Exhibits 3.1 and 3.2, respectively, to the Registration Statement on Form
S-4
of which this proxy statement/prospectus is a part. GenVec has filed with the SEC its
amended and restated certificate of incorporation, as amended from time to time, referred to herein as GenVecs certificate of incorporation, the certificate of designation of its Series A Junior Participating Preferred Stock, par value $0.001
per share, referred to herein as the certificate of designation of Series A Preferred, the certificate of designation of its Series B Junior Participating Preferred Stock, par value $0.001 per share, referred to herein as the certificate of
designation of Series B Preferred, and its amended and restated bylaws, referred to herein as GenVecs bylaws, each referenced in this summary of shareholder rights, and will send copies of these documents to you, free of charge, upon your
request. See the section entitled Where you can find more information.
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
Corporate Governance
|
|
Upon completion of the merger, the rights of Intrexon shareholders and former GenVec shareholders will be governed by the VSCA, Intrexons articles of incorporation, and Intrexons bylaws.
|
|
The rights of GenVec shareholders are governed by the DGCL and GenVecs certificate of incorporation and GenVecs bylaws.
|
|
|
|
Authorized Capital Stock
|
|
Intrexons authorized capital stock consists of 200,000,000 shares of common stock, no par value per share, and 25,000,000 shares of
preferred stock, no par value per share.
As of [the GenVec record date], there were
[●] shares of common stock issued and outstanding and [no] shares of preferred stock issued and outstanding.
|
|
GenVecs authorized capital stock consists of 55,000,000 shares of common stock, $0.001 par value per share, and 5,000,000 shares of
preferred stock, $0.001 par value per share, of which 30,000 of which are designated as Series B Participating Preferred.
As of [the GenVec record date], there were [●] shares of common stock issued and outstanding and no shares of preferred stock issued and
outstanding.
|
|
|
|
Special Meetings of Shareholders
|
|
Intrexons bylaws provide that a special meeting may be called by the board of directors, the chairman of the board of directors or the chief executive officer. Intrexons bylaws also provide that the vote of 25% of its
shareholders is required to call a special meeting, and that its shareholders may only conduct business at special meetings of its shareholders that was specified in the notice of the meeting.
|
|
A special meeting of the shareholders may be called only by the president of GenVec, or by the board of directors pursuant to a resolution adopted by a majority of the members of the board of directors then in office or by written
consent executed by all of the members of the board of directors. In accordance with the DGCL and GenVecs bylaws, written notice of the place, date and hour, and purpose of the special meeting must be given not less than ten (10) nor more
than sixty (60) days before the date of the meeting.
|
|
|
|
Shareholder Nominations and Shareholder Proposals
|
|
Intrexons bylaws provide that nominations for the election of directors may be made at an annual shareholder meeting only (i) pursuant to Intrexons notice of meeting (or any supplement thereto), (ii) by or at the
direction of the board or (iii) by any shareholder of Intrexon who (a) was a shareholder of record of Intrexon (and, with respect to any beneficial owner, if different, on whose behalf such nominations or proposal of other business are
made, only if such
|
|
GenVecs bylaws provide that proposals for a shareholder vote must include (i) the names and business addresses of the shareholder submitting the proposal, referred to herein as the Proponent, and all persons or entities
acting in concert with the Proponent; (ii) the names and addresses of the Proponent and the persons or entities identified in clause (i) above, as they appear on GenVecs books (if they so appear); (iii) the class and number
of
|
92
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
beneficial owner was the beneficial owner of shares of Intrexon) at the time the notice provided for in its bylaws is delivered to the
Secretary and at the time of the annual meeting, (b) is entitled to vote at the meeting, and (c) complies with the notice procedures set forth in its bylaws.
To comply with the notice procedures set forth in Intrexons bylaws, a shareholder must have given notice thereof in writing to the Secretary and any such
proposed business other than the nominations of persons for election to the board must constitute a proper matter for shareholder action. To be timely, a shareholders notice shall be delivered to the Secretary at Intrexons principal
executive offices not later than the close of business on the 90th day nor earlier than the close of business on the 120th day prior to the first anniversary of the preceding years annual meeting; provided, however, that in the event that the
date of the annual meeting is more than 30 days before or more than 70 days after such anniversary date, notice by such shareholder must be so delivered not earlier than the close of business on the 120th day prior to such annual meeting and not
later than the close of business on the later of the 90th day prior to such annual meeting or the 10th day following the day on which public announcement of the date of such meeting is first made by Intrexon.
To be in proper form, a s shareholders notice to the Secretary must:
(i) set forth, as to the shareholder giving the notice and the beneficial owner, if any,
on whose behalf the nomination or proposal is made:
(a) the name
and address of such shareholder, as they appear on Intrexons books, and of such beneficial owner, if any;
(b) (1) the class or series and number of shares of Intrexon which are, directly or indirectly owned beneficially and of record by such
shareholder rand such beneficial owner;
(2) any option, warrant, convertible security,
stock appreciation right, or similar right with an exercise or conversion privilege or a settlement payment or mechanism at a price related to any class or series of shares of Intrexon or with a value derived in whole or in part from the value of
any class or series of shares of Intrexon, whether or not such instrument or right shall be subject to settlement in the underlying class or series of capital stock of Intrexon or otherwise, referred to herein as a Derivative Instrument, directly or
indirectly owned beneficially by such shareholder and such beneficial owner and any other direct or indirect opportunity to profit or share in any profit derived from any increase or decrease in the value of shares of Intrexon;
(3) any proxy, contract, arrangement, understanding, or relationship pursuant to which
such shareholder and such beneficial owner has a right to vote any shares of any security of Intrexon;
(4) any short interest in any security of Intrexon;
(5) any rights to dividends on the shares of Intrexon owned beneficially by such shareholder and such beneficial owner that are separated or separable from the
underlying shares of Intrexon;
(6) any proportionate interest in shares of Intrexon or
Derivative Instruments held, directly or indirectly, by a general or limited partnership in which such shareholder and such beneficial owner is a general partner or, directly or indirectly, beneficially owns an interest in a general
partner;
|
|
shares beneficially owned by the Proponent and the persons and entities identified in clause (i); (iv) a description of the proposal
containing all material information relating thereto; and (v) such other information as the board of directors reasonably determines is necessary or appropriate to enable the board of directors and shareholders of GenVec to consider the
proposal.
GenVecs bylaws also provide that nominations for the election of
directors shall be made by written notice, which shall set forth:
(i) as to each
individual nominated,
(A) the name, date of birth, business
address and residence address of such individual;
(B) the business
experience during the past five years of such nominee, including his or her principal occupations and employment during such period, the name and principal business of any corporation or other organization in which such occupations and employment
were carried on and such other information as to the nature of his responsibilities and level of professional competence as may be sufficient to permit assessment of his prior business experience;
(C) whether the nominee is or has ever been at any time a director,
officer or owner of more than five percent (5%) or more of any class of capital stock, partnership interests or other equity interest of any corporation, partnership or other entity;
(D) any directorships held by such nominee in any company with a class
of securities registered pursuant to Section 12 of the Exchange Act, as amended, or subject to the requirements of Section 15(d) of such Act or any company registered as an investment company under the Investment Company Act of 1940, as amended;
and
(E) whether, in the last five years, such nominee has been
convicted in a criminal proceeding or has been subject to a judgment, order, finding or decree of any federal, state or other governmental entity, concerning any violation of federal, state or other law, or any proceeding in bankruptcy, which
conviction, judgment, order, finding, decree or proceeding may be material to an evaluation of the ability or integrity of the nominee; and
(ii) as to the shareholder nominating such director candidate, and any persons or entities acting in concert with such nominating shareholder,
(x) the names and business addresses of such nominating shareholder
and such persons or entities,
(y) the names and addresses of such
nominating shareholder and such persons or entities as they appear on GenVecs books (if they so appear), and
(z) the class and number of shares of GenVec which are beneficially owned by such nominating shareholder and such persons and entities.
In addition, a written consent to being named in a proxy statement as a nominee, and to
serve as a director if elected, signed by the nominee, shall be filed with any nomination notice. If the presiding officer at any shareholders meeting determines that a nomination was not made in accordance with the procedures prescribed by
GenVecs bylaws, such officer will so declare to the meeting and the defective nomination will be disregarded.
|
93
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
(7) any performance-related fees (other than an asset-based fee) that such shareholder and such beneficial owner is entitled to based on
any increase or decrease in the value of shares of Intrexon or Derivative Instruments, if any, as of the date of such notice, including without limitation any such interests held by members of such shareholder and such beneficial owners
immediate family sharing the same household (which information shall be supplemented by such shareholder and beneficial owner, if any, not later than 10 days after the record date for the meeting to disclose such ownership as of the record
date);
(c) any other information relating to such shareholder and beneficial owner, if
any, that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for, as applicable, the proposal and/or for the election of directors in a contested election pursuant
to Section 14 of the Exchange Act and the rules and regulations promulgated thereunder;
(d) a statement whether such shareholder or any other person known to the shareholder will deliver a proxy statement and form of proxy to holders of at least
the percentage of Intrexons voting shares required under applicable law to carry the proposal; and
(e) a representation that the shareholder is a holder of record of stock of Intrexon entitled to vote at such meeting and intends to appear in person or by
proxy at the meeting to make the nomination or propose such business specified in the notice before the meeting;
(ii) if the notice relates to any business other than a nomination of a director or directors that the shareholder proposes to bring before the meeting, set
forth:
(a) a brief description of the business desired to be brought before the
meeting, the reasons for conducting such business at the meeting and any material interest of such shareholder and beneficial owner, if any, in such business;
(b) the complete text of any resolutions intended to be presented at the meeting and in the event that such business includes a proposal to amend the bylaws of
Intrexon, the language of the proposed amendment; and
(c) a description of all
agreements, arrangements and understandings between such shareholder and beneficial owner, if any, and any other person or persons (including their names) in connection with the proposal of such business by such shareholder;
(iii) set forth, as to each person, if any, whom the shareholder proposes to nominate for
election or reelection to the Intrexon board of directors:
(a) all information
relating to such person that would be required to be disclosed in a proxy statement or other filings required to be made in connection with solicitations of proxies for election of directors in a contested election pursuant to Section 14 of the
Exchange Act and the rules and regulations promulgated thereunder (including such persons written consent to being named in the proxy statement as a nominee and to serving as a director if elected) and;
(b) a description of all direct and indirect compensation and other material monetary
agreements, arrangements and understandings during the past three years, and any other material relationships, between or among such shareholder and the beneficial owner, if any, and their respective affiliates and associates, or others acting in
concert therewith, on the
|
|
Nomination notices and shareholder proposals for an annual shareholders meeting must be delivered to GenVecs secretary at its principal executive offices not less than one hundred twenty (120) days nor more than one hundred
fifty (150) days prior to the anniversary of the mailing date of GenVecs proxy materials for the preceding annual meeting of shareholders; provided, however, that in the event that the annual meeting is called for a date that is not within
thirty (30) days before or after the anniversary date of such meeting, notice by the shareholder to be timely must be so delivered not later than the close of business on the tenth (10th) day following the day on which notice of the date of the
annual meeting was mailed to shareholders or public disclosure of the date of the annual meeting was made, whichever first occurs. The public announcement of an adjournment of an annual meeting will not commence a new time period for the giving of a
shareholders notice as described above.
|
94
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
one hand, and each proposed nominee, and his or her respective affiliates and associates, or others acting in concert therewith, on the other
hand, including, without limitation all information that would be required to be disclosed pursuant to Rule 404 promulgated under Regulation
S-K
under the Exchange Act if the shareholder making the nomination
and any beneficial owner on whose behalf the nomination is made, if any, or any affiliate or associate thereof or person acting in concert therewith, were the registrant for purposes of such rule and the nominee were a director or
executive officer of such registration; and
(iv) with respect to each nominee for
election or reelection to the board, include a completed and signed questionnaire, representation and agreement as required by the bylaws.
|
|
|
|
|
|
Shareholder Action by Written Consent
|
|
The VSCA allows action by written consent to be made by the shareholders in lieu of a shareholders meeting if the action is adopted or
taken by all the shareholders entitled to vote on the action. Under the VSCA, the corporations articles of incorporation may authorize action by shareholders by less than unanimous written consent provided that the taking of such action is
consistent with any requirements that may be set forth in Intrexons articles of incorporation, the bylaws, or the VSCA.
Intrexons bylaws do not provide for action by shareholders by less than unanimous written consent.
|
|
GenVecs certificate of incorporation provides that no action that is required or permitted to be taken by the shareholders may be effected by written consent in lieu of a meeting of shareholders.
|
|
|
|
Number of Directors
|
|
Intrexons bylaws provide that the number of directors constituting the board shall be designated by resolution of the board, but shall
not be more than ten (10); provided that no decrease in the number of directors shall shorten or terminate the term of any incumbent director. Intrexons articles of incorporation provide that the board of directors shall consist of a number of
directors as shall be specified in accordance with the bylaws.
There are currently
eight (8) directors serving on the Intrexon board of directors.
|
|
GenVecs bylaws provide that the board of directors shall be the number from time to time fixed exclusively by a vote of a majority of
the board of directors then in office, which number shall not be less than one (1).
There are currently seven (7) directors serving on the GenVec board of directors.
|
|
|
|
Election of Directors
|
|
Intrexons bylaws provide that a nominee for director shall be elected to the board if the votes cast for such nominees election
exceed the votes cast against such nominees election; provided, however, that such directors shall be elected by a plurality of the votes cast at any meeting of the shareholders for which (i) the Secretary receives a notice that
shareholder has nominated a person for election to the board in compliance with the advance notice requirements for shareholder nominees for director set forth in the bylaws, and (ii) such nomination has not been withdrawn by such shareholder
on or prior to the 10th day preceding the date Intrexon first mails its notice of meeting for such meeting to the shareholders.
If directors are to be elected by a plurality of the votes cast, the shareholders shall not be permitted to vote against a nominee.
|
|
GenVecs certificate of incorporation provides that the board of directors shall be divided into three classes, with each class to be as
nearly equal in number as reasonably possible, and with each class to serve staggered three year terms. If the number of directors is changed, any increase or decrease shall be apportioned among the classes so as to maintain or attain, if possible,
the number of directors in each class as nearly equal as reasonably possible, but in no case will a decrease in the number of directors shorten the term of any incumbent director.
GenVecs bylaws provide that the board of directors may from time to time increase or
decrease the number of directors to any number not less than one, provided that the number of directors shall not be increased by 50% or more in any
12-month
period without the approval of at least 80% of the
members of the board of directors then in office.
GenVecs bylaws provide that
all elections for directors shall be decided by a plurality of the votes of shares present in person or represented by proxy at the meeting and entitled to vote in the election of directors. Abstentions shall not be considered to be votes cast.
Further, vacancies and newly created directorships resulting from any increase in the
authorized number of directors may be filled only by a majority of the remaining directors then in office, although less than a quorum, or by a sole remaining director, and the directors so chosen shall hold office until the
next
|
95
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
|
|
election of the class for which such directors have been chosen and until their successors are duly elected and qualified. If at any time
there are no directors in office, by reason of death, resignation or other cause, then any shareholders or any executor or administrator or other fiduciary entrusted with like responsibility for the estate of a shareholder may call a special meeting
of the shareholders to elect the directors. If at the time of filling any vacancy or any newly created directorship, the directors then in office shall constitute less than a majority of the board of directors (as constituted immediately prior to
any such increase), the Court of Chancery of the State of Delaware may, upon application of any shareholder or shareholders holding at least ten percent of the total number of the shares outstanding at the time and having the right to vote for such
directors, summarily order an election to be held to fill any such vacancies or newly created directorships, or to replace the directors chosen by the directors then in office.
Notwithstanding anything to the contrary in the above paragraphs, the certificate of designation of the Series B Preferred provides that, under certain limited
circumstances arising when dividends on any Series B Preferred shares are in arrears, the holders of the Series B Preferred have the right to elect up to two directors.
|
|
|
|
Removal of Directors
|
|
The VSCA provides that shareholders may remove directors with or without cause by the affirmative vote of the holders of at least a majority of the stock entitled to vote generally in the election of directors unless the
corporations articles of incorporation provide that directors may only be removed with cause. Intrexons articles of incorporation provide that, subject to the rights of preferred shareholders, directors may be removed only with cause and
only by the affirmative vote of a majority of the votes entitled to be cast by each voting group that is entitled to vote generally in the election of directors.
|
|
Subject to the rights given to the holders of shares of Series B Preferred pursuant to the certificate of designation of the Series B Preferred, GenVecs certificate of incorporation provides that any director may be removed
only for cause by the affirmative vote of the holders of at least 80% of the voting power of all of the shares of GenVecs capital stock then entitled to vote generally in the election of directors, voting together as a single class.
|
|
|
|
Limitation on Liability of Directors
|
|
The VSCA provides that in any proceeding brought by or in the right of a corporation or brought by or on behalf of shareholders of a corporation, the damages assessed against an officer or director arising out of a single
transaction, occurrence or course of conduct may not exceed the lesser of (i) the monetary amount, including the elimination of liability, specified in the corporations articles of incorporation or, if approved by the shareholders, in the
bylaws as a limitation on or elimination of the liability of the officer or director or (ii) the greater of (a) $100,000 or (b) the amount of cash compensation received by the officer or director from the corporation during the 12 months
immediately preceding the act or omission for which liability was imposed. The liability of an officer or director is not limited under the VSCA or the corporations articles of incorporation and bylaws if the officer or director engaged in
willful misconduct or a knowing violation of the criminal law or of any federal or state securities law.
|
|
The DGCL provides that a provision eliminating or limiting the personal liability of a director to the corporation or its shareholders for
monetary damages for breach of fiduciary duty as a director, provided that such provision shall not eliminate or limit the liability of a director: (i) for any breach of the directors duty of loyalty to the corporation or its
shareholders; (ii) for acts or omissions not in good faith or which involve intentional misconduct or a knowing violation of law; (iii) under Section 174 of the DGCL; or (iv) for any transaction from which the director derived an
improper personal benefit. No such provision shall eliminate or limit the liability of a director for any act or omission occurring prior to the date when such provision becomes effective.
|
|
|
|
|
|
Intrexons articles of incorporation provide that, to the fullest extent that the VSCA, as it exists or as it may hereafter be amended, permits the limitation or elimination of the liability of directors and officers in a
proceeding brought by or in the right of Intrexon or brought by or on behalf of the Intrexon shareholders, a director or officer of Intrexon shall not be liable to Intrexon or its shareholders for monetary damages arising out of a single transaction
occurrence or course of conduct in excess of $1.00. Notwithstanding the foregoing, the liability of a director or officer shall not be eliminated if the director or officer engaged in willful
|
|
GenVecs certificate of incorporation provides that a director shall, to the maximum extent permitted by the laws of Delaware, have no personal liability to GenVec or its shareholders for monetary damages for breach of
fiduciary duty as a director, provided that this limitation on liability shall not eliminate or reduce the liability of a director in any case where such elimination or reduction is not permitted by
law.
|
96
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
misconduct or a knowing violation of criminal law or of any federal or state securities law, including without limitation, any claim of unlawful insider trading or manipulation of the market for any security.
|
|
|
|
|
|
Indemnification of Directors and Officers
|
|
Under the VSCA, unless limited by its articles of incorporation, a corporation must indemnify a director or officer who entirely prevails in
the defense of any proceeding to which he was a party because he is or was a director or officer of the corporation against reasonable expenses incurred by him in connection with the proceeding. The VSCA permits a corporation to indemnify, after a
determination has been made that indemnification of the director is permissible in the circumstances because he has met the following standard of conduct, an individual made a party to the proceeding because he is or was a director against liability
incurred in the proceeding if (i) he conducted himself in good faith; (ii) he believed that his official conduct was in the best interest of the corporation and all other
non-official
conduct was not
opposed to the corporations best interest; and (iii) in the case of a criminal proceeding, he had no reasonable basis to believe his conduct was unlawful.
Under the VSCA, corporation may not indemnify a director or officer in connection with a proceeding by or in which the director or officer is adjudged liable
on the basis that he received an improper personal benefit. A director or officer also cannot be indemnified in connection with a proceeding by or in the right of the corporation in which the director or officer was adjudged liable to the
corporation. In addition, under the VSCA, any corporation may indemnify, including an indemnity with respect to a proceeding by or in the right of the corporation, and may provide for advances or reimbursement of expenses to, any director, officer,
employee or agent that is authorized by the corporations articles of incorporation or any bylaw approved by the shareholders or any resolution adopted before or after the subject event by the shareholders, except an indemnity against willful
misconduct or a knowing violation of criminal law.
Intrexons articles of
incorporation require indemnification of directors and officers with respect to certain liabilities, expenses, and other amounts imposed on them by reason of having been a director or officer, except in the case of willful misconduct or a knowing
violation of criminal law.
Unless ordered by a court of competent jurisdiction, any
indemnification pursuant to Intrexons articles of incorporation shall be made by Intrexon only as authorized in the specific case upon a determination that indemnification of the individual is permissible in the circumstances because he or she
met the standard of conduct that warrants indemnification, as discussed above. Such determination shall be made: (i) if there are two or more disinterested directors, by the board by a majority vote of all disinterested directors, a majority of
whom shall constitute a quorum; or by a majority vote of a committee consisting of two or more disinterested directors appointed by such a vote; or (ii) by special legal counsel selected by the board or its committee in the manner heretofore
provided or, if there are fewer than two disinterested directors, selected by a majority vote of the board (in which selection directors who do not qualify as disinterested directors may participate); or (iii) by the shareholders, but shares
owned by or voted under the control of individuals who at the time do not qualify as disinterested directors may not be voted on the determination. Authorization of indemnification, evaluation as to reasonableness of expenses and determination and
authorization of advancements for
|
|
Under the DGCL, a corporation may indemnify any directors, officers, employees and agents of the corporation, or any person who is or was
serving at the request of the corporation as a director, officer, employee or agent of another entity, against expenses and liabilities actually and reasonably incurred by such person in connection with any action, suit or proceeding (except in the
case of an action by or in the right of the corporation) involving such person by reason of the fact that the person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a
director, officer, employee or agent of another entity, provided that (i) such person acted in good faith and in a manner the person reasonably believed to be in or not opposed to the best interests of the corporation, and, with respect to any
criminal action or proceeding, such person had no reasonable cause to believe his conduct was unlawful and (ii) in the case of an action by or in the right of the corporation, no indemnification of expenses may be made in respect of any matter
as to which such person is adjudged liable to the corporation unless and only to the extent such indemnification is approved by a court. The DGCL mandates such indemnification of expenses to the extent that a present or former director or officer of
the corporation has been successful in defense of any proceeding described above, and permits advancement of expenses to a director or officer if the corporation receives an undertaking that the amount advanced will be repaid if it is determined
that such person is not entitled to indemnification. The DGCL also provides that the permitted indemnifications described above are not exclusive.
GenVecs certificate of incorporation provides that each person who was or is made a party or is threatened to be made a party to or is otherwise involved
in any action, suit or proceeding, whether civil, criminal, administrative or investigative, by reason of the fact:
(a) that he or she is or was a director or officer of GenVec, or
(b) that he or she, being at the time a director or officer of GenVec, is or was serving at the request of GenVec as a director, trustee,
officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan,
whether either in case (a) or in case (b) the basis of such proceeding is alleged action or inaction (x) in an official capacity as a director
or officer of GenVec, or as a director, trustee, officer, employee or agent of such other enterprise, or (y) in any other capacity related to GenVec or such other enterprise while so serving as a director, trustee, officer, employee or agent,
shall be indemnified and held harmless by GenVec to the fullest extent not prohibited by Section 145 of the DGCL (or any successor provision or provisions) as the same exists or may hereafter be amended (but, in the case of any such amendment,
with respect to actions taken prior to such amendment, only to the extent that such amendment permits GenVec to provide broader indemnification rights than permitted prior thereto), against all expense, liability and loss (including, without
limitation, attorneys fees, judgments, fines, ERISA excise taxes or penalties and
|
97
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
expenses shall be made in the same manner as the determination that indemnification is permissible, except that if there are fewer than two
disinterested directors or if the determination is made by special legal counsel, authorization of indemnification and evaluation as to reasonableness of expenses shall be made by those selecting such counsel.
Notwithstanding the foregoing, in the event there has been a change in the composition of
a majority of the board after the date of the alleged act or omission with respect to which indemnification is claimed, any determination as to indemnification and advancement of expenses with respect to any claim for indemnification made pursuant
to Intrexons articles of incorporation shall be made by special legal counsel agreed upon by the board and the applicant. If the board and the applicant are unable to agree upon such special legal counsel the board and the applicant each shall
select a nominee, and the nominees shall select such special legal counsel
|
|
amounts paid in settlement) incurred or suffered by such person in connection therewith. Such indemnification as to such alleged action or inaction shall continue as to an indemnitee who has after such alleged action or inaction
ceased to be a director or officer of GenVec, or director, officer, employee or agent of another enterprise; and shall inure to the benefit of the indemnitees heirs, executors, administrators, and personal or legal representatives, provided,
however, that except for proceedings to enforce rights to indemnification, GenVec shall not be obligated to indemnify any director of officer (or his or her heirs, executors, administrators, or personal or legal representatives) in connection with a
proceeding (or part thereof) initiated by such person unless such proceeding (or part thereof) was authorized or consented to by the board of directors. The right to indemnification conferred in GenVecs certificate of incorporation
(i) shall be a contract right; (ii) shall not be affected adversely as to any indemnitee by any amendment of GenVecs certificate of incorporation with respect to any action or inaction occurring prior to such amendment; and
(iii) shall, subject to any requirements imposed by law, GenVecs certificate of incorporation or GenVecs bylaws, include the right to have paid by GenVec the expenses incurred in defending any such proceeding in advance of its final
disposition.
|
|
|
|
Amendments to Certificate/Articles of Incorporation
|
|
The VSCA generally requires that any amendment to a corporations articles of incorporation be approved by each voting group entitled to
vote on the proposed amendment by at least
two-thirds
of all the votes entitled to be cast by that voting group, unless the VSCA otherwise requires a greater vote or such corporations articles of
incorporation provide for a greater or lesser vote, or a vote by separate voting groups, so long as the vote provided for is not less than a majority of all the votes cast on the amendment by each voting group entitled to vote.
Intrexons articles of incorporation provide that an amendment or restatement of its
articles of incorporation for which the VSCA requires shareholder approval shall be approved by a majority of the votes entitled to be cast by each voting group that is entitled to vote on the matter, unless in submitting any such matter to the
shareholders the board shall require a greater vote.
|
|
The DGCL provides that an amendment to GenVecs certificate of incorporation must be adopted by the board of directors through a
resolution setting forth the proposed amendment, declaring its advisability and either calling a special meeting of the shareholders or directing that the amendment proposed be considered at the next annual meeting of the shareholders. At the
meeting, the shareholders must approve the amendment by a majority of outstanding shares entitled to vote (and a majority of the outstanding shares of each class entitled to vote, if any). Additionally, if the amendment adversely affects any class
of shares, the shareholders holding a majority of the outstanding shares of such class must affirmatively vote to adopt the amendment.
GenVecs certificate of incorporation provides that any amendment, alteration, change or repeal of Articles V, VI, XI, XII and XIII of GenVecs
certificate of incorporation shall require the affirmative vote of the holders of at least 80% of the voting power of all of the shares of capital stock of GenVec then entitled to vote generally in the election of directors, voting together as a
single class. Any other amendment, alteration, change or repeal of any other provision of GenVecs certificate of incorporation requires the affirmative vote of both (a) a majority of the members of the board of directors then in office
and (b) a majority of the voting power of all of the shares of capital stock of GenVec entitled to vote generally in the election of directors, voting together as a single class.
|
|
|
|
Amendments to Bylaws
|
|
Under the VSCA, unless other provision is made in a corporations articles of incorporation or bylaws, a majority of the directors or a
majority of the shareholders present and entitled to vote may adopt, amend or repeal the bylaws.
Intrexons articles of incorporation provides that the board of directors is expressly authorized and empowered to adopt, amend or repeal the bylaws,
provided, however, that bylaws adopted by the board pursuant to this power may be altered, amended or repealed by the board or by the shareholders having voting power with respect thereto. In the case of any such action by shareholders, the
affirmative vote of the
|
|
The DGCL provides that the shareholders, and, when provided for in the corporations certificate of incorporation, the board of
directors of the corporation, have the power to adopt, amend and repeal the bylaws of a corporation.
GenVecs certificate of incorporation provides that any proposed amendment, alteration, change or repeal of, or any proposed adoption of GenVecs
bylaws inconsistent with any of Sections 2.3, 2.9, 2.11, 3.2, or 3.3 or Article VIII therein shall require the affirmative vote of at least eighty percent (80%) of the voting power of all shares of capital stock of GenVec then entitled to vote
generally in the election of directors voting as a single class.
|
98
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
holders of a majority of the voting power of the then outstanding voting stock, voting together as a single voting group, shall be required in order for the shareholders to alter, amend or repeal any provision of the bylaws or to
adopt any additional bylaw.
|
|
|
|
|
|
Vote on Certain Fundamental Issues
|
|
The VSCA provides that, unless a corporations articles of incorporation provide for a higher or lower vote, specified significant
corporate actions must be approved by the affirmative vote of the holders of at least
two-thirds
of the votes entitled to be cast on the matter. Corporate actions requiring at least a
two-thirds
vote include an amendment to a corporations articles of incorporation, adoption of plans of merger or exchange, sales of all or substantially all of the corporations assets other than in the
ordinary course of business and adoption of plans of dissolution. The VSCA provides that a corporations articles may either increase the vote required to approve these actions or may decrease the required vote to not less than a majority of
the votes entitled to be cast.
Intrexons articles of incorporation provide that
such fundamental actions for which the VSCA requires shareholder approval shall be approved by a majority of the votes entitled to be cast by each voting group that is entitled to vote on the matter, unless in submitting any such matter to the
shareholders the board shall require a greater vote.
|
|
Under the DGCL, the board of directors of each corporation which desires to merge or consolidate shall adopt a resolution approving an
agreement of merger or consolidation and declaring its advisability. The agreement shall then be submitted to the shareholders of each constituent corporation at an annual or special meeting for the purpose of acting on the agreement. Such
corporation must give notice of such meeting to each shareholder at least 20 days prior to the date of the meeting. If a majority of the outstanding stock of the corporation entitled to vote thereon shall be voted for the adoption of the agreement,
that fact shall be certified on the agreement by the secretary or assistant secretary of the corporation, provided that such certification on the agreement shall not be required if a certificate of merger or consolidation is filed in lieu of filing
the agreement. If the agreement shall be so adopted and certified by each constituent corporation, it shall then be filed and shall become effective, in accordance with § 103 of the DGCL.
GenVecs bylaws provide that, except as otherwise provided by statute or by
GenVecs certificate of incorporation, any corporate action, other than the election of directors, to be taken by vote of the shareholders, shall be authorized by a majority of votes cast at the meeting of shareholders by the holders of shares
entitled to vote thereon. GenVecs certificate of incorporation does not address the issue.
|
|
|
|
Certain Business Combinations Restrictions
|
|
The VSCA contains provisions governing affiliated transactions. In general, these provisions prohibit a corporation from engaging in
affiliated transactions with any holder of more than 10 percent of any class of its outstanding voting shares, or an interested shareholder, for a period of three years following the date that such person became an interested shareholder
unless:
a majority of (but not fewer than two) disinterested directors of
Intrexon and the holders of
two-thirds
of the voting shares, other than the shares beneficially owned by the interested shareholder, approve the affiliated transaction; or
before or on the date the person became an interested shareholder, a
majority of disinterested directors approved the transaction that resulted in the shareholder becoming an interested shareholder.
Affiliated transactions subject to this approval requirement include mergers, share exchanges, material dispositions of corporate assets not in the ordinary
course of business, any dissolution of Intrexon proposed by or on behalf of an interested shareholder or any reclassification, including reverse stock splits, recapitalizations or mergers of the corporation with its subsidiaries, which increases the
percentage of voting share owned beneficially by an interested shareholder by more than five percent.
The VSCA permits a corporation to exempt itself from this statutory provision by placing a statement to that effect in its articles of incorporation.
Intrexons articles of incorporation do not specifically address the VSCA regarding affiliated transactions; therefore, Intrexon is subject to this provision.
|
|
Under the DGCL, except under certain circumstances, a corporation is not permitted to engage in a business combination with any interested shareholder for a period of three years following the date such shareholder became an
interested shareholder. An interested shareholder is (i) is the owner of 15% or more of the outstanding voting stock of the corporation, or (ii) is an affiliate or associate of the corporation and was the owner of 15% or more of the
outstanding voting stock of the corporation at any time within the three-year period immediately prior to the date on which it is sought to be determined whether such person is an interested shareholder, and the affiliates and associates of such
person. The DGCL permits a corporation to opt out of the application of these business combinations provisions by so providing in the corporations certificate of incorporation; GenVec has not opted out of these provisions.
|
|
|
|
Exclusive Forum Provision
|
|
Intrexons bylaws provide that unless Intrexon consents in writing to the selection of an alternative forum, the United States District Court for the Eastern District of Virginia, Alexandria Division, or in the event that
court
|
|
Neither of GenVecs certificate of incorporation nor bylaws provide for an exclusive forum for shareholder litigation.
|
99
|
|
|
|
|
|
|
Rights of Intrexon Shareholders
|
|
Rights of GenVec Shareholders
|
|
|
lacks subject matter jurisdiction to hear such action, the Circuit Court of the County of Fairfax, Virginia, shall be the sole and exclusive forum of (i) any derivative action or proceeding brought on behalf of Intrexon,
(ii) any action for breach of duty to Intrexon or the shareholders by any current or former officer or other employee or agent or director of Intrexon, (iii) any action against Intrexon or any current or former officer or other employee or
agent or director of Intrexon arising pursuant to any provision of the VSCA or Intrexons articles of incorporation or Intrexons bylaws, or (iv) any action against Intrexon or any current or former officer or other employee or agent
or director of Intrexon governed by the internal affairs doctrine.
|
|
|
|
|
|
Shareholder Rights Plan
|
|
Intrexon has no shareholder rights plan.
|
|
GenVec has entered into a rights agreement, as amended, which provides that the board of directors of GenVec may grant each shareholder a right to receive, upon exercise, common stock or other equity interest of the ultimate parent
of an acquirer of GenVec, valued at two times the exercise price of such right. The amendment to the rights agreement provides that such rights described in the previous sentence will not be applicable to the merger and any transaction related
thereto. See the section entitled Amendment to the rights agreement for a full description of the rights granted under the rights agreement, as amended.
|
|
|
|
Rights of Preferred Stock
|
|
Under Intrexons articles of incorporation, the Intrexon board of directors has the authority, without shareholder action, to establish the relative rights and preferences of the shares of the preferred stock, including the
applicable dividend rate, amounts payable upon a liquidation or dissolution of Intrexon, redemption rights and conversion rights.
|
|
Subject to the certificate of designation of the Series B Preferred and the DGCL, GenVecs certificate of incorporation grants the GenVec board of directors the authority to establish the relative rights and preferences of the
shares of the preferred stock, including the applicable dividend rate, redemption rights, conversion rights, voting rights, restrictions on transfer, and rights upon a liquidation or dissolution of GenVec.
|
|
|
|
Dividends and Other Distributions
|
|
Intrexons articles of incorporation provide that, if any shares of preferred stock are outstanding, Intrexon cannot declare and pay or set apart for payment any dividends (other than dividends payable in common stock or other
stock of Intrexon raking junior to the preferred stock as to dividends) or make any other distribution on such junior stock if, at the time of making such declaration, payment or distribution, Intrexon is in default with respect to any dividend
payable, or any obligation to redeem any shares of preferred stock.
|
|
Subject to any preferences that may be applicable to any preferred stock outstanding at the time, GenVecs certificate of incorporation provides that the holders of common stock (i) have the right to receive dividends
when, as and if properly declared by the GenVec board of directors in its sole discretion and (ii) to receive ratably all the assets of GenVec remaining after payment to creditors of GenVec upon the liquidation, dissolution or winding up of
GenVec.
|
100
Appraisal rights
Under Delaware law, holders of GenVec common stock who do not wish to accept the merger consideration provided for in the merger agreement have the right to
seek appraisal of their shares of GenVec common stock in the Delaware Court of Chancery and to receive payment in cash for the fair value of those shares (exclusive of any element of value arising from the accomplishment or expectation
of the merger), as determined by the Delaware Court of Chancery, together with interest, if any, to be paid upon the amount so determined to be fair value. These rights are known as appraisal rights. Shareholders may only exercise these appraisal
rights by strictly complying with the provisions of Section 262 of the DGCL. Any GenVec shareholders who properly exercise these appraisal rights and are awarded fair value for their shares will receive payment of such fair value in
cash, together with interest, if any, in lieu of the right to receive the merger consideration.
The following is intended as a brief summary of the
material provisions of the Delaware statutory procedures required to be followed by a shareholder in order to dissent from the merger and perfect its appraisal rights. This summary, however, is not a complete statement of all applicable requirements
and is qualified in its entirety by reference to Section 262 of the DGCL, the full text of which appears in
Annex D
to this proxy statement/prospectus. All references in Section 262 of the DGCL and in this summary to a
shareholder are to a record holder of shares of GenVec common stock. Failure to precisely follow any of the statutory procedures set forth in Section 262 of the DGCL may result in a termination or waiver of your appraisal rights.
This summary does not constitute legal or other advice, nor does it constitute a recommendation that holders of GenVec common stock exercise their appraisal rights.
Under Section 262 of the DGCL, GenVec is required to notify each of its shareholders (as determined on the record date for notice of the special meeting)
of the availability appraisal rights not less than 20 days prior to the special meeting. Such notice must include a copy of Section 262 of the DGCL. This proxy statement/prospectus constitutes the notification to GenVec shareholders of the
availability of appraisal rights in connection with the merger in compliance with the requirements of Section 262 of the DGCL, and a copy of Section 262 of the DGCL is attached to this proxy statement/prospectus as
Annex D
. If you
wish to consider exercising your appraisal rights or to preserve your right to do so, you should carefully review the text of Section 262 of the DGCL contained in
Annex D
to this proxy statement/prospectus. Failure to strictly
comply with the requirements of Section 262 of the DGCL in a timely and proper manner will result in the loss of your appraisal rights under Delaware law.
Holders of shares of GenVec common stock who desire to exercise their appraisal rights must do ALL of the following: (i) not vote in favor of the merger,
(ii) deliver a written demand for appraisal of his or her shares of GenVec common stock to the Corporate Secretary of GenVec before the vote on the merger at the special meeting, (iii) continuously hold the shares from the date of making
the demand through the effective time of the merger and (iv) file, or cause the surviving corporation to file, a petition in the Delaware Court of Chancery requesting a determination of the fair value of the shares within 120 days after the
effective time of the merger. A demand for appraisal must reasonably inform GenVec of the identity of the shareholder and that such shareholder intends thereby to demand appraisal of the shares of GenVec common stock held by such shareholder. All
demands for appraisal should be addressed to GenVec, Inc., 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878, Attention: Corporate Secretary, and should be executed by, or on behalf of, the record holder of shares of GenVec common stock.
ALL DEMANDS MUST BE RECEIVED BY GENVEC BEFORE THE VOTE ON THE MERGER AT THE SPECIAL MEETING AT [
●
]:[
●
][
●
] A.M. EASTERN DAYLIGHT TIME ON
[
●
] [
●
], 2017.
Because a proxy that is signed and submitted but does not
otherwise contain voting instructions will, unless revoked, be voted as recommended by the GenVec board of directors, and because the GenVec board of directors has recommended that shareholders vote in favor of adoption of the merger agreement, if a
shareholder votes by proxy and wishes to exercise his, her or its appraisal rights, such shareholder must vote against the adoption of the merger or abstain from voting his, her or its shares. Voting, in person or by proxy, against, abstaining from
voting on or failing to vote on the adoption of the merger agreement will not constitute a written demand for appraisal as required by Section 262 of the DGCL. The written demand for appraisal must be in addition to and separate from any proxy
or vote.
If you fail to deliver a written demand for appraisal within the time period specified above and the merger is completed, you will be entitled
to receive the merger consideration for your shares of GenVec common stock as provided for in the merger agreement, but you will have no appraisal rights with respect to your shares of GenVec common stock.
To be effective, a demand for appraisal by a holder of shares of GenVec common stock must be made by, or in the name of, the registered shareholder, fully and
correctly, as the shareholders name appears in GenVecs stock ledger.
Beneficial owners who do not also hold the shares of record may not directly make appraisal demands to GenVec. The beneficial owner must, in these cases, have the
registered owner, such as a broker, bank or other custodian, submit the required demand in respect of those shares.
If shares are owned of record in a fiduciary capacity, such as by a trustee, guardian or custodian, execution of a demand for
appraisal should be made by or for the fiduciary; and if the shares are owned of record by more than one person, as in a joint tenancy or tenancy in common, the demand should be executed by or for all joint owners. An authorized agent, including an
authorized agent for two or more joint owners, may execute the demand for appraisal for a shareholder of record; however, the agent must identify the record owner or owners and expressly disclose the fact that, in executing the demand, he or she is
acting as agent for the record owner. A record owner, such as a broker, who holds shares as a custodian for others, may exercise the record owners right of appraisal with respect to the shares held for one or more beneficial owners, while not
exercising this right for other beneficial owners. In that case, the written demand should state the number of shares as to which appraisal is sought. Where no number of shares is expressly mentioned, the demand will be presumed to cover all shares
held in the name of the record owner. In addition, the shareholder must continuously hold the shares of record from the date of making the demand through the completion of the merger.
101
IF YOU HOLD YOUR SHARES OF GENVEC COMMON STOCK IN A BROKERAGE ACCOUNT OR IN OTHER CUSTODIAN FORM AND YOU
WISH TO EXERCISE APPRAISAL RIGHTS, YOU SHOULD CONSULT WITH YOUR BANK, BROKER OR OTHER CUSTODIAN, AS APPLICABLE, TO DETERMINE THE APPROPRIATE PROCEDURES FOR THE MAKING OF A DEMAND FOR APPRAISAL BY THE CUSTODIAN. YOU MUST ACT PROMPTLY SO THAT YOUR
BANK, BROKER OR OTHER CUSTODIAN, AS APPLICABLE, IS ABLE TO FOLLOW PROPERLY AND IN A TIMELY MANNER THE STEPS NECESSARY TO PERFECT YOUR APPRAISAL RIGHTS.
If the merger is completed, within 10 days after the effective time of the merger, the surviving corporation must give written notice of the date on which the
merger became effective to each shareholder who did not vote in favor of the merger agreement and who properly and timely filed a written demand for appraisal in accordance with Section 262 of the DGCL. At any time within 60 days after the
completion of the merger, any shareholder who has demanded an appraisal has the right to withdraw the demand and accept the terms of the merger by delivering a written withdrawal of the shareholders demand for appraisal. If, following a demand
for appraisal, you have withdrawn your demand for appraisal in accordance with Section 262 of the DGCL, you will have the right to receive the merger consideration for your shares of GenVec common stock.
Within 120 days after the effective date of the merger, any shareholder who has delivered a demand for appraisal in accordance with Section 262 of the
DGCL will, upon written request to the surviving corporation, be entitled to receive a written statement setting forth the aggregate number of shares not voted in favor of the merger agreement and with respect to which demands for appraisal rights
have been received and the aggregate number of holders of these shares. This written statement will be mailed to the requesting shareholder within 10 days after the shareholders written request is received by the surviving corporation or
within 10 days after expiration of the period for delivery of demands for appraisal, whichever is later.
Within 120 days after the effective date of the
merger, either the surviving corporation or any shareholder who has delivered a demand for appraisal in accordance with Section 262 of the DGCL may file a petition in the Delaware Court of Chancery demanding a determination of the fair value of
the shares held by all such shareholders. Any shareholder that is the beneficial owner of shares held in a voting trust or by a bank, broker or other custodian on such shareholders behalf may, in his, her or its name, file an appraisal
petition or request from the surviving corporation the statement described in the foregoing paragraph. Upon the filing of the petition by a shareholder, service of a copy of the petition must be made upon the surviving corporation. The surviving
corporation has no obligation to file a petition in the Delaware Court of Chancery in the event there are dissenting shareholders, and the surviving corporation has no present intent to file a petition in the Delaware Court of Chancery. Accordingly,
the failure of a shareholder to file a petition within the period specified could nullify the shareholders previously written demand for appraisal.
If a petition for appraisal is duly filed by a shareholder and a copy of the petition is delivered to the surviving corporation, the surviving corporation
will then be obligated, within 20 days after receiving service of a copy of the petition, to provide the Delaware Court of Chancery with a duly verified list containing the names and addresses of all shareholders who have demanded an appraisal of
their shares and with whom agreements as to the value of their shares have not been reached by the surviving corporation. After notice to dissenting shareholders who demanded appraisal of their shares, the Delaware Court of Chancery is empowered to
conduct a hearing upon the petition, and to determine those shareholders who have complied with Section 262 of the DGCL and who have become entitled to the appraisal rights provided thereby. The Delaware Court of Chancery may require the
shareholders who have demanded appraisal for their shares and who hold stock represented by certificates to submit their stock certificates to the Register in Chancery for notation thereon of the pendency of the appraisal proceedings; and if any
shareholder fails to comply with that direction, the Delaware Court of Chancery may dismiss the proceedings as to that shareholder.
After determination
of the shareholders entitled to appraisal of their shares, the Delaware Court of Chancery will appraise the fair value, as of the effective time of the merger, of the shares of GenVec common stock held by dissenting shareholders . This
value will be exclusive of any element of value arising from the accomplishment or expectation of the merger, but will include a fair rate of interest, if any, upon the amount determined to be the fair value.
At any time prior to the entry of judgment in the proceedings, the surviving corporation may pay to each holder of GenVec common stock entitled to appraisal
an amount in cash, in which case interest shall accrue thereafter only upon the sum of (i) the difference, if any, between the amount so paid and the fair value of the GenVec common stock as determined by the Delaware Court of Chancery, and
(ii) interest theretofore accrued, unless paid at that time. Unless the Delaware Court of Chancery in its discretion determines otherwise for good cause shown, interest from the effective time of the merger through the date of payment of the
judgment will be compounded quarterly and will accrue at 5% over the Federal Reserve discount rate (including any surcharge) as established from time to time during the period between the effective time of the merger and the date of payment of the
judgment. The Delaware Court of Chancery must dismiss the proceedings as to all holders of GenVec common stock who are otherwise entitled to appraisal rights unless (a) the total number of shares of GenVec common stock entitled to appraisal
exceeds 1% of the outstanding shares of GenVec common stock and (b) the value of consideration provided in the merger for such total number of shares of GenVec common stock exceeds $1.0 million.
When the value is determined, the Delaware Court of Chancery will direct the payment of the value, with interest thereon accrued during the pendency of the
proceeding, if the Delaware Court of Chancery so determines, to the shareholders entitled to receive the same. In the case of any shareholder who holds shares in book-entry form, such payment must be made immediately. In the case of any shareholder
who holds shares represented by certificates, such payment must be made upon surrender of the
102
certificates representing the shares. In determining fair value, and, if applicable, a fair rate of interest, the Delaware Court of Chancery is required to take into account all relevant factors.
In Weinberger v. UOP, Inc., the Delaware Supreme Court discussed the factors that could be considered in determining fair value in an appraisal proceeding, stating that proof of value by any techniques or methods which are generally considered
acceptable in the financial community and otherwise admissible in court should be considered, and that [f]air price obviously requires consideration of all relevant factors involving the value of a company. The Delaware Supreme
Court has stated that, in making this determination of fair value, the court must consider market value, asset value, dividends, earnings prospects, the nature of the enterprise and any other factors which could be ascertained as of the date of the
merger regarding future prospects of the merged corporation.
Section 262 of the DGCL provides that fair value is to be exclusive of any
element of value arising from the accomplishment or expectation of the merger. In Cede & Co. v. Technicolor, Inc., the Delaware Supreme Court stated that this exclusion is a narrow exclusion [that] does not encompass known
elements of value, but which rather applies only to the speculative elements of value arising from such accomplishment or expectation. In Weinberger, the Delaware Supreme Court construed Section 262 of the DGCL to mean that elements
of future value, including the nature of the enterprise, which are known or susceptible of proof as of the date of the merger and not the product of speculation, may be considered. However, an opinion of an investment banking firm as to the
fairness from a financial point of view of the consideration payable in a merger is not an opinion as to, and does not in any manner address, fair value under Section 262 of the DGCL.
You should be aware that the fair value of your shares as determined under Section 262 of the DGCL could be more than, the same as, or less than the
value that you are entitled to receive under the terms of the merger agreement. Intrexon does not anticipate offering more than the per share merger consideration to any shareholder exercising appraisal rights and reserves the right to assert, in
any appraisal proceeding, that, for purposes of Section 262 of the DGCL, the fair value of a share of GenVec common stock is less than the per share merger consideration. In addition, you should be aware that Delaware courts have
decided that the statutory appraisal remedy, depending on factual circumstances, may or may not be a dissenters exclusive remedy.
Costs of the
appraisal proceeding may be determined by the Delaware Court of Chancery and may be imposed upon the surviving corporation and the shareholders participating in the appraisal proceeding by the Delaware Court of Chancery as the Court deems equitable
in the circumstances. However, costs do not include attorneys and expert witness fees. Upon the application of a shareholder, the Delaware Court of Chancery may order all or a portion of the expenses incurred by any shareholder in connection with
the appraisal proceeding, including, without limitation, reasonable attorneys fees and the fees and expenses of experts, to be charged pro rata against the value of all shares entitled to appraisal. In the absence of such a determination of
assessment, each party bears its own expenses.
Any shareholder who has demanded appraisal rights will not, after the completion of the merger, be
entitled to vote shares subject to that demand for any purpose or to receive payments of dividends or any other distribution with respect to those shares, other than with respect to payment as of a record date prior to the completion; however, if no
petition for appraisal is filed within 120 days after the completion of the merger, or if the shareholder delivers a written withdrawal of his or her demand for appraisal and an acceptance of the terms of the merger within 60 days after the
completion of the merger, then the right of that shareholder to appraisal will cease and that shareholder will be entitled to receive the merger consideration for his or her shares of GenVec common stock pursuant to the merger agreement. Any
withdrawal of a demand for appraisal made more than 60 days after the completion of the merger may only be made with the written approval of the surviving corporation, and no appraisal proceeding in the Delaware Court of Chancery will be dismissed
as to any shareholder without the approval of the Delaware Court of Chancery. Such approval may be conditioned on terms the Delaware Court of Chancery deems just; however, this limitation will not affect the right of any shareholder who has not
commenced an appraisal proceeding or joined such proceeding as a named party to withdraw such shareholders demand for appraisal and to accept the terms offered in the merger within 60 days. If you fail to perfect or withdraw or otherwise lose
the appraisal right, your shares will be converted into the right to receive the merger consideration, without interest thereon, less any withholding taxes.
Failure to follow the steps required by Section 262 of the DGCL for perfecting appraisal rights may result in the loss of appraisal rights. In that
event, you will be entitled to receive the merger consideration for your shares in accordance with the merger agreement. In view of the complexity of Section 262 of the DGCL, shareholders who may wish to dissent from the merger and pursue
appraisal rights should consult their legal advisors.
THE PROCESS OF DEMANDING AND EXERCISING APPRAISAL RIGHTS REQUIRES STRICT COMPLIANCE WITH
TECHNICAL PREREQUISITES. IF YOU WISH TO EXERCISE YOUR APPRAISAL RIGHTS, YOU SHOULD CONSULT WITH YOUR OWN LEGAL COUNSEL IN CONNECTION WITH COMPLIANCE UNDER SECTION 262 OF THE DGCL. TO THE EXTENT THERE ARE ANY INCONSISTENCIES BETWEEN THE FOREGOING
SUMMARY AND SECTION 262 OF THE DGCL, THE DGCL WILL GOVERN.
103
Description of Intrexons business
Intrexons business is described in Part I, Item 1 of Intrexons Annual Report on Form
10-K
for the fiscal
year ended December 31, 2016 and in other documents that are incorporated by reference into this proxy statement/prospectus. See the section entitled Where you can find more information for the location of information incorporated
by reference in this proxy statement/prospectus.
104
Intrexon managements discussion and analysis of financial
condition and results of operations
A discussion and analysis of Intrexons financial condition and results of operations is described in Part
II, Item 7 of Intrexons Annual Report on Form
10-K
for the fiscal year ended December 31, 2016 and in other documents that are incorporated by reference into this proxy statement/prospectus. See the
section entitled Where you can find more information for the location of information incorporated by reference in this proxy statement/prospectus. The discussion and analysis of Intrexons financial condition and results of
operations should be read together with Selected consolidated financial data and Intrexons consolidated financial statements and the related notes. In addition to historical information, the discussion and analysis contains
forward-looking statements that involve risks, uncertainties and assumptions. Intrexons actual results may differ materially from those discussed in the discussion and analysis. Factors that could cause or contribute to such differences
include, but are not limited to, those identified in the discussion and analysis, and those discussed in the section entitled Risk factors.
105
Intrexon management
A description of Intrexons executive officers and directors, board and committee composition, director independence, and related matters are described
in Intrexons Definitive Proxy Statement relating to its 2016 Annual Meeting of Shareholders and in other documents that are incorporated by reference into this proxy statement/prospectus. See the section entitled Where you can find more
information for the location of information incorporated by reference in this proxy statement/prospectus.
106
Intrexon executive compensation
A description of Intrexons executive compensation and related matters are described in Intrexons Definitive Proxy Statement relating to its 2016
Annual Meeting of Shareholders and in other documents that are incorporated by reference into this proxy statement/prospectus. See the section entitled Where you can find more information for the location of information incorporated by
reference in this proxy statement/prospectus.
107
Certain relationships and related party transactions of
Intrexon
A description of certain of Intrexons relationship, related party transactions and related matters are described in Intrexons
Definitive Proxy Statement relating to its 2016 Annual Meeting of Shareholders and in other documents that are incorporated by reference into this proxy statement/prospectus. See the section entitled Where you can find more information
for the location of information incorporated by reference in this proxy statement/prospectus.
108
Intrexon s
ecurity ownership of certain beneficial owners and
management
The following table sets forth information regarding beneficial ownership of Intrexons share capital as of March 31, 2017
by (1) each of Intrexons directors, (2) each of Intrexons named executive officers, (3) all of Intrexons directors and executive officers as a group, and (4) each person, or group of affiliated persons, known by
Intrexon to beneficially own more than five percent of Intrexons shares of common stock.
The percentage ownership information is based on an
aggregate 119,552,674 shares of common stock outstanding as of March 31, 2017.
Except as otherwise noted below, the address for each person or
entity listed in the table is c/o Intrexon Corporation, 20374 Seneca Meadows Parkway, Germantown, Maryland 20876.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Name of Beneficial Owner
|
|
Outstanding Shares
Beneficially Owned
(1)
|
|
|
Right to Acquire
Beneficial Ownership
(2)
|
|
|
Total Shares
Beneficially Owned
|
|
|
Percentage of Shares
Beneficially Owned
|
|
Directors/director nominees
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cesar Alvarez
|
|
|
37,010
|
|
|
|
93,889
|
|
|
|
130,899
|
|
|
|
*
|
|
Steven Frank
|
|
|
43,041
|
|
|
|
93,889
|
|
|
|
136,930
|
|
|
|
*
|
|
Fred Hassan
|
|
|
9,706
|
|
|
|
30,060
|
|
|
|
39,766
|
|
|
|
*
|
|
Jeffrey Kindler
|
|
|
66,322
|
|
|
|
90,926
|
|
|
|
157,248
|
|
|
|
*
|
|
Dean Mitchell
|
|
|
13,103
|
|
|
|
90,921
|
|
|
|
104,024
|
|
|
|
*
|
|
Robert Shapiro
(3)
|
|
|
123,273
|
|
|
|
90,926
|
|
|
|
214,199
|
|
|
|
*
|
|
James Turley
|
|
|
9,595
|
|
|
|
92,413
|
|
|
|
102,008
|
|
|
|
*
|
|
Named executive officers
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Randal Kirk
(4)
|
|
|
62,301,326
|
|
|
|
|
|
|
|
62,301,326
|
|
|
|
52.1
|
%
|
Rick Sterling
|
|
|
6,369
|
|
|
|
220,759
|
|
|
|
227,128
|
|
|
|
*
|
|
Thomas Bostick
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Geno Germano
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Andrew Last
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*
|
|
Executive officers and directors as a group (18 persons)
|
|
|
63,209,839
|
|
|
|
2,463,371
|
|
|
|
65,673,210
|
|
|
|
54.9
|
%
|
Greater than 5% shareholders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FMR, LLC
(5)
|
|
|
6,459,001
|
|
|
|
|
|
|
|
6,459,001
|
|
|
|
5.4
|
%
|
*
|
Represents beneficial ownership of less than 1 percent of Intrexons outstanding shares of common stock
|
(1)
|
Beneficial ownership is determined in accordance with the rules and regulations of the SEC and includes sole or shared voting or investment power with respect to shares of Intrexons common stock. The information
set forth in the table above is not necessarily indicative of beneficial ownership for any other purpose, and the inclusion of any shares deemed beneficially owned in this table does not constitute an admission of beneficial ownership of those
shares. Except as otherwise noted, to Intrexons knowledge, the persons and entities named in the table above have sole voting and investment power with respect to all of the shares of common stock beneficially owned by them, subject to
community property laws, where applicable.
|
(2)
|
Consists of shares of common stock subject to stock options exercisable as of, or within 60 days of March 31, 2017. Shares of common stock subject to stock options that are exercisable as of or within 60 days
of March 31, 2017 are deemed to be outstanding and beneficially owned by the person holding the option for the purpose of calculating the percentage ownership of that person, but are not deemed outstanding for the purpose of calculating the
percentage ownership of any other person.
|
(3)
|
Includes 80,116 shares held in the Robert B. Shapiro Revocable Trust, an affiliate of Robert Shapiro.
|
(4)
|
Includes shares held by the following entities over which Mr. Kirk (or an entity over which he exercises exclusive control) exercises exclusive control: 213,805 shares held by ADC 2010, LLC, 139,052 shares held by
JPK 2008, LLC, 720,562 shares held by JPK 2009, LLC, 843,044 shares held by JPK 2012, LLC, 6,649,997 shares held by Kapital Joe, LLC, 135,033 shares held by Kellie L. Banks (2009) Long Term Trust, 1,403 shares held by Lotus Capital (2000)
Company Inc., 5,483,957 shares held by Mascara Kaboom, LLC, 140,007 shares held by MGK 2008, LLC, 850,355 shares held by MGK 2009, LLC, 940,426 shares held by MGK 2011, LLC, 22,636,052 shares held by New River Management V, LP, 13,340,645
shares held by NRM VI Holdings I, LLC, 243,001 shares held by NRM VII Holdings I, LLC, 5,325,535 shares held by R.J. Kirk Declaration of Trust, 678,323 shares held by Third Security Incentive 2010 LLC, 19,711 shares held by Third Security
Incentive 2006 LLC, 59,133 shares held by Third Security Staff 2006 LLC, 118,266 shares held by Third Security Senior Staff 2006 LLC, 1,356,648 shares held by Third Security Senior Staff 2008 LLC, 58,800 shares held by Third Security Senior Staff
LLC, 311,287 shares held by Third Security Staff 2001 LLC, 1,356,648 shares held by Third Security Staff 2010 LLC, 489,771 shares held by Third Security, LLC, 114,181 shares held by ZSK 2008 LLC, and 75,684 shares held by ZSK 2009 LLC.
|
(5)
|
Information is based solely on the Schedule 13G/A that was filed with the SEC on February 14, 2017 by FMR LLC. FMR LLC reports that it is the beneficial owner of 6,459,001 shares of Intrexons common stock and has
sole voting power with respect to 687,303 shares of Intrexons common stock and sole dispositive power with respect to 6,459,001 shares of Intrexons common stock as of December 31, 2016. The address of FMR, LLC is 245 Summer Street,
Boston, Massachusetts 02210.
|
109
(4)
|
Geno J. Germano resigned from Intrexon effective March 10, 2017.
|
(5)
|
Information is based solely on the Schedule 13G/A that was filed with the SEC on February 14, 2017 by FMR LLC. FMR LLC reports that it is the beneficial owner of 6,459,001 shares of Intrexon common stock and has
sole voting power with respect to 687,303 shares of Intrexon common stock and sole dispositive power with respect to 6,459,001 shares of Intrexon common stock as of December 31, 2016. The address of FMR, LLC is 245 Summer Street, Boston,
Massachusetts 02210.
|
110
Description of GenVec business
OVERVIEW
GenVec is a clinical-stage biopharmaceutical
company with an entrepreneurial focus on leveraging its proprietary AdenoVerse gene delivery platform to develop a pipeline of cutting-edge therapeutics and vaccines. GenVec is a pioneer in the design, testing and manufacture of
adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVecs lead product candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and
balance disorders. In addition to GenVecs internal and partnered pipeline, GenVec also focuses on opportunities to license its proprietary technology platform, including vectors and production cell lines, to potential collaborators in the
biopharmaceutical industry for the development and manufacture of therapeutics and vaccines.
A key component of GenVecs strategy is to develop and
commercialize its product candidates through collaborations.
GenVec is working with prominent companies and organizations such as Novartis, Merial (a unit of Boehringer Ingelheim), which we refer to herein as Merial, Washington University in
St. Louis, and the U.S. government, as well as promising young companies such as TheraBiologics, to support a portfolio of programs that addresses the prevention and treatment of a number of significant human and animal health concerns.
GenVecs combination of internal and partnered development programs address therapeutic areas such as hearing loss and balance disorders, oncology, bleeding disorders, as well as vaccines against infectious diseases, including RSV, herpes
simplex virus, which we refer to herein as HSV, and malaria, and in the area of animal health, vaccines against FMD.
GenVecs
AdenoVerse gene
delivery technology has the important advantage of localizing protein delivery in the body. This is accomplished by using GenVecs adenovector platform to locally deliver genes to cells, which then direct production of the desired protein. This
approach reduces side effects typically associated with systemic delivery of proteins. For therapeutics, the goal is for the protein produced to have a meaningful effect in treating the cause, manifestation, or progression of the disease. For
vaccines, the goal is to induce an immune response against a target protein or antigen. This is accomplished by using an adenovector to deliver a gene that causes production of an antigen, which then stimulates the desired immune reaction by the
body.
GenVecs research and development activities yield product candidates that utilize GenVecs technology platform and represent potential
commercial opportunities. For example, preclinical research in hearing loss and balance disorders indicates that the delivery of the atonal gene using GenVecs adenovector technology may have the potential to restore hearing and balance
function. GenVec is currently working with Novartis on the development of novel treatments for hearing loss and balance disorders that emerged from these research and development efforts. There are currently no effective therapeutic treatments
available for patients who have lost all balance function, and hearing loss remains a major unmet medical problem.
GenVec has multiple vaccine candidates
that leverage GenVecs core adenovector technology including GenVecs vaccine candidates for the prevention or treatment of RSV and HSV. GenVec also has a program to develop a vaccine for malaria, a program in which it is currently working
in collaboration with the Laboratory of Malaria Immunology and Vaccinology, referred to herein as LMIV, of the National Institute of Allergy and Infectious Diseases, National Institutes of Health.
On February 24, 2016, GenVec received notification that it would be afforded 180 calendar days, or until August 22, 2016, to regain compliance with
NASDAQs minimum bid price requirement, referred to herein as the Bid Price Requirement, and on August 23, 2016, GenVec received notice that it had been afforded a second 180 calendar day grace period, or until February 21, 2017, to
regain compliance.
To regain compliance with the Bid Price Requirement, the closing bid price of GenVecs common stock was required to meet or exceed $1.00 per share for at least 10 consecutive business days. On November 30, 2016,
GenVec effected a reverse stock split, referred to herein as the reverse stock split, of its outstanding common stock at a ratio of
one-for-ten,
whereby each 10 shares
of common stock were combined into one share of common stock. The reverse stock split was intended to enable GenVec to regain compliance with the Bid Price Requirement. On December 15, 2016, GenVec received a notice from NASDAQ stating that
GenVec had regained compliance.
As a biopharmaceutical company, GenVecs business and its ability to execute its strategy to achieve GenVecs
corporate goals are subject to numerous risks and uncertainties. Material risks and uncertainties relating to GenVecs business and its industry are described in Risk Factors Risks Related to GenVec and its business herein.
The description of GenVecs business in this Registration Statement on Form
S-4
should be read in conjunction with the information in Risk Factors Risks Related to GenVec and its
business as well as GenVec Financial Statements in this Registration Statement on Form
S-4,
which includes additional financial information, including information about GenVecs total
assets, revenue, and measures of profit and loss.
GENVECS STRATEGY
GenVecs primary objective is to leverage its proprietary technology through partnerships to develop and commercialize products that address significant
unmet medical needs. GenVec plans to achieve this objective through the following strategies:
Working with GenVecs collaborators to facilitate
the development of
first-in-class
products for the treatment of significant unmet medical needs including:
|
|
|
hearing and balance disorders through GenVecs collaboration with Novartis;
|
|
|
|
vaccines against FMD through GenVecs collaboration with Merial;
|
111
|
|
|
bleeding disorders through GenVecs collaboration with Washington University in St. Louis;
|
|
|
|
glioma and other brain cancers through GenVecs collaboration with TheraBiologics; and
|
|
|
|
vaccines against Malaria through GenVecs collaboration with LMIV.
|
Entering into new collaborations
for the development of product candidates utilizing GenVecs technology.
GenVec is engaged in seeking strategic collaborations, partnerships and licensing arrangements to further develop and potentially commercialize therapeutic and vaccine
product candidates that utilize its technology. GenVec continues to seek corporate partnerships in the following programs and areas:
|
|
|
vaccine against RSV, which is the most common viral cause of lower respiratory infections in infants and young children;
|
|
|
|
vaccine against HSV, which is the virus responsible for most cases of genital herpes; and
|
|
|
|
other therapeutic and prophylactic applications of GenVecs human and
non-human
adenoviral vectors together with the related platform technology and packaging cell lines.
|
Exploring new applications of GenVecs technology to address the treatment and prevention of major unmet medical needs.
GenVec
intends to continue to enhance its core technologies and product pipeline through internal research as well as external collaborations, licensing arrangements and possible acquisitions. In the past, GenVec has received peer-reviewed external funding
from the U.S. government and from nonprofit foundations to improve its technology platform for vaccine and gene delivery applications. GenVec intends to further strengthen its technologies relating to vector performance, process development,
formulation, and manufacturing through GenVecs existing and future relationships. GenVec intends to explore the use of its AdenoVerse technology in the following areas:
|
|
|
therapeutic gene delivery;
|
|
|
|
immunotherapy (including cellular immunotherapy);
|
|
|
|
nucleic acid therapeutics;
|
HEARING AND BALANCE DISORDERS PROGRAM
Overview.
In collaboration with Novartis, GenVecs hearing and balance disorders program is focused on the restoration of hearing and balance
function through the regeneration of critical cells of the inner ear. GenVecs lead product candidate, CGF166, emerged from research and development performed as part of the collaboration. In October 2014, the first patient was treated in
a Phase 1/2
proof-of-concept
trial of CGF166 in patients with severe to profound hearing loss. As discussed in Collaboration with Novartis below, the
trial was temporarily paused for a portion of 2016, but has since restarted. In February 2017, GenVec was notified that the first patient in the fourth cohort of the trial had been dosed.
Background.
Sensorineural hearing loss and vestibular dysfunction may result from destruction of inner ear sensory hair cells. Humans are born with
approximately 30,000 sensory hair cells, which are located in the cochlea, vestibular canals, utricle, and saccule of the ear. Sensory hair cells, located in the cochlea are critical for auditory function, while those located in the vestibular
canals, utricle, and saccule provide the basis for vestibular function.
Sensory hair cells can be damaged or destroyed by pharmacological agents,
infections, loud noises, or simply aging. Because these cells do not naturally regenerate, any damage to or destruction of them is permanent.
Patients
whose sensory hair cells have been damaged or destroyed may experience hearing loss. According to the National Institute on Deafness and Other Communication Disorders, referred to herein as the NIDCD, among adults aged 70 and older with hearing loss
who could benefit from hearing aids, fewer than one in three (30%) has ever used them. Even fewer adults aged 20 to 69 who could benefit from wearing hearing aids have ever used them (approximately 15%). Also according to the NIDCD, as of December
2012, approximately 324,200 patients worldwide have received cochlear implants in the United States, roughly 58,000 devices have been implanted in adults and 38,000 in children. Although cochlear implants improve hearing, they require
invasive surgery, do not discriminate pitch, and require ongoing maintenance and patient training.
Patients whose sensory hair cells have been damaged or
destroyed may also experience more severe vestibular dysfunction, which may result in debilitating vertigo and nausea. There is currently no known therapy other than rehabilitation to facilitate the acquisition of environmental signals to compensate
for vestibular dysfunction.
GenVec believes that because there are no therapeutic options available to regenerate sensory hair cells to restore auditory
or balance function, there is a significant and unmet medical need in the area of sensorineural hearing loss and vestibular dysfunction.
112
During embryonic development, an atonal gene (Atoh1) induces the generation of sensory cells in the inner
ear required for hearing and balance. In multiple animal models, GenVec has demonstrated formation of new inner ear sensory hair cells and the restoration of hearing and balance function using its AdenoVerse technology to deliver the Atoh1 gene to
the inner ear.
The lead product emerging from GenVecs hearing program is an advanced adenoviral vector engineered to deliver the human atonal gene
under the control of a tissue specific promoter. Novartis has designated this product candidate as CGF166.
Collaboration with Novartis.
In January
2010, GenVec entered into a research collaboration and license agreement with Novartis to discover and develop novel treatments for hearing loss and balance disorders. Under the terms of the agreement, GenVec licensed the world-wide rights to its
preclinical hearing loss and balance disorders program to Novartis. GenVec received a $5.0 million upfront payment and Novartis purchased $2.0 million of its common stock.
GenVec was eligible, from the inception of the agreement, to receive up to an additional $206.6 million in milestone payments if certain clinical,
regulatory, and sales milestones were met, including: up to $0.6 million for the achievement of preclinical development activities; up to $26.0 million for the achievement of clinical milestones (including
non-rejection
of an investigational new drug application, referred to herein as an IND, with respect to a covered product, the first patient visit in Phase I, Phase IIb and Phase III clinical trials); up to
$45.0 million for the receipt of regulatory approvals; and up to $135.0 million for sales-based milestones.
From September 2010 through October
2014, GenVec achieved four milestones resulting in aggregate payments from Novartis of $5.6 million. There were no milestones achieved in 2016 or 2015.
The achieved milestones are as follows:
|
|
|
|
|
|
|
Milestone Event
|
|
Date
|
|
Amount
|
|
Successful completion of certain preclinical development activities
|
|
September 2010
|
|
$
|
300,000
|
|
Successful completion of certain preclinical development activities
|
|
December 2011
|
|
|
300,000
|
|
Non-rejection
by the FDA of the IND filed by Novartis for
CGF166
|
|
February 2014
|
|
|
2,000,000
|
|
First patient treated in a clinical trial with CGF166
|
|
October 2014
|
|
|
3,000,000
|
|
As of February 28, 2017, milestones remaining available under the agreement include $21.0 million of additional
clinical milestones, $45.0 million in regulatory milestones, and $135.0 million of sales-based milestones.
Additionally, if a product is
commercialized, GenVec is also entitled to tiered royalties on the annual net sales of licensed products, on a
product-by-product
and
country-by-country
basis, at percentage rates that range based on annual net sales from the
mid-single
digits to the low double digits until the earlier of (i) the
expiration of the last valid claim with respect to applicable patent rights and (ii) January 1 following a year in which annual net sales of the product declined by a specified percentage of the highest level of prior annual net sales
where the decline is reasonably attributable in part to the marketing or sale of a competing product in the country. For the five years thereafter, in the applicable country, GenVec is entitled to tiered royalties of below 1% on annual net sales.
The collaboration and license agreement is terminable for convenience upon notice by either party or for uncured material breach.
In addition, the
agreement allows GenVec to receive funding from Novartis for a research program focused on developing additional adenovectors for hearing loss. GenVec recognized approximately $0.1 million and $0.2 million in 2016 and 2015, respectively,
for services performed under this agreement.
In January 2016, GenVec was notified by Novartis that enrollment was paused in the clinical study for
CGF166. This pause was based on a review of data by the trials Data Safety Monitoring Board, referred to herein as DSMB, in accordance with criteria in the trial protocol. In April 2016, GenVec was notified by Novartis, based on a review of
safety and efficacy data from the nine patients currently enrolled in the study, that the DSMB recommended that the trial continue, subject to approval by the FDA. In July 2016, GenVec was notified by Novartis that FDA had lifted the clinical hold
on the trial. In February 2017, GenVec was notified that the first patient in the fourth cohort of the trial had been dosed.
In August 2010, GenVec
signed an agreement for the supply of services relating to development materials with Novartis, related to GenVecs collaboration in hearing loss and balance disorders. Under this agreement, valued at $14.9 million, GenVec agreed to
manufacture clinical trial material for up to two lead product candidates. The Company recognized approximately $0.1 million and $0.2 million in 2016 and 2015, respectively, for services performed under this agreement. As of
December 31, 2016, GenVec had recognized a total of $14.8 million under this agreement.
CELL THERAPY PROGRAM
In March 2015, GenVec
entered into a collaboration with TheraBiologics, Inc. to develop cancer therapeutics by leveraging GenVecs AdenoVerse gene
delivery platform and TheraBiologics proprietary neural stem cell technology. GenVec
will contribute technology,
know-how,
vector construction, and technical and regulatory support to the program.
TheraBiologics will be responsible for all other development costs. Depending on the manner of commercialization, GenVec
will be entitled to profit sharing and/or royalty and milestone payments for the products being developed under the
collaboration.
113
PULMONARY ENDOTHELIAL CELL DELIVERY PROGRAM
In December 2016, GenVec
entered into an exclusive option agreement with Washington University in St. Louis, referred to herein as WUSTL, to license
intellectual property and technology related to gene editing and pulmonary endothelial cell, referred to herein as PEC, delivery. If the option is exercised, the license will allow broad utilization of technology developed by David T. Curiel, M.D.,
Ph.D., Professor of Radiation Oncology at Washington University School of Medicine. In connection with the option agreement, GenVec executed a sponsored research agreement with WUSTL to further advance the optioned technology. PEC delivery has been
designed to leverage the lung, the second largest organ in the body, as a surrogate production site for proteins. GenVec and WUSTL plan to initially focus on research utilizing the technology to develop treatments for hemophilia.
VACCINE PROGRAMS
GenVec has developed vaccine candidates
using its AdenoVerse technology. GenVec believes that its AdenoVerse vectors have superior properties to deliver antigens and stimulate an effective innate and adaptive immune response against pathogens of interest. GenVecs vaccine candidates
include preventative vaccines against RSV and malaria, and a therapeutic vaccine for HSV.
Many vectors used in developing vaccines are susceptible to
pre-existing
immunity that neutralizes and has the effect of preventing the vaccine from generating the desired immunological response; this is referred to as vector-specific immunity. GenVecs most promising
vectors for vaccine applications are derived from
non-human
primate adenovirus types, which GenVec believes can circumvent neutralizing antibodies, or vector-specific immunity, in order to generate the desired
immunologic response of the vaccine.
Respiratory Syncytial Virus.
GenVec is seeking a partner to continue the development of its GV2311 vaccine
against RSV, the single most important viral cause of lower respiratory infections in infants and young children.
According to information published by
the Centers for Disease Control and Prevention, referred to herein as CDC, in 2014, each year, on average, in the United States, RSV leads to 57,527 hospitalizations among children younger than 5 years old; 100,000 to 126,000 hospitalizations among
children younger than 1 year old; 2.1 million outpatient visits among children younger than 5 years old; and 177,000 hospitalizations and 14,000 deaths among adults older than 65 years.
In March 2012, data were presented on GenVecs RSV vaccine program at the Keystone Symposium on Viral Immunity and Host Gene Influence,
which took place in Keystone, Colorado. Data presented at the conference demonstrated encouraging preclinical
proof-of-principle
findings generated in
non-human
primates. Specifically, the data showed GenVecs vaccine technology induced neutralizing antibody and significant T cell responses with a single administration. The immune responses were consistent
with protective responses without disease potentiation and multiple administrations increased the neutralizing antibody responses.
In
September 2012, data were presented on GenVecs RSV vaccine program at the International Respiratory Syncytial Virus Symposium, which took place in Santa Fe, New Mexico. Data presented at the conference demonstrated that GenVecs
universal RSV vaccine candidate, GV2311, is highly immunogenic and produces durable and broad protection from a single intramuscular administration. Protection in cotton rat and mouse models was characterized by functional RSV neutralizing
antibodies, and no disease potentiation was observed. GenVecs RSV vaccine candidate utilizes a proprietary adenovirus that is capable of generating a broad immune response while avoiding the problems of vector specific immunity that has
hampered other vectored vaccines.
In November 2014, data exploring the immune responses generated by GV2311 were presented at the 9th International
Respiratory Syncytial Virus Symposium held in South Africa. In the experiments described in the presentation, RSV immunized mice had no detectable virus following low dose challenge, while breakthrough RSV replication in both lungs and noses was
rapidly controlled upon high dose challenge. GV2311 immunization fully protected the lungs at both challenge doses with partial protection in noses. The studies also confirmed the major protective mechanism is through induction of antibodies against
RSV, although antigen specific T cells contribute to viral clearance in the absence of antibody. GV2311 was previously shown to induce protective immunity to RSV in a dose-dependent manner in established animal models.
GenVec
is not engaging in significant development for RSV while GenVec
seeks to partner this program.
Herpes Simplex Virus.
GenVec is seeking a partner to continue the development of its GV2207 vaccines for the treatment of HSV including
HSV-2,
the virus responsible for most cases of genital herpes. According to the World Health Organization, referred to herein as the WHO, an estimated 417 million people aged
14-49
(11%) worldwide have
HSV-2
infections. According to the CDC, genital herpes is common in the United States one of every six people aged
14-49
is infected. All
HSV-2
infections are permanent and result in periodic virus shedding. The CDC notes that herpes infections are most contagious when symptoms are
present, but can still be transmitted to others in the absence of symptoms. Of added concern, infection with
HSV-2
increases the risk of acquiring and transmitting HIV infection. There is no approved vaccine
for
HSV-2
in the United States. Although antiviral regimens have become a standard of care, their inconvenience, cumulative cost and potential for drug resistance further underscore the need for safe, new
approaches to reducing
HSV-2
lesions, virus shedding, and transmission. Estimated costs of treating HSV in the United States alone are close to $1 billion, primarily for drugs and outpatient medical care.
Data on GenVecs HSV vaccine program has shown that a single administration of GenVecs genetic vaccine was effective against
HSV-2
in two industry-accepted HSV disease models. Specifically, immunization was shown to reduce viral shedding, and the recurrence and severity of lesions.
GenVec is not engaging in significant development for HSV while GenVec
seeks to partner this program.
114
Malaria.
GenVec has worked with collaborators in recent years, including with the NIAID, to generate
vaccine candidates for the prevention of malaria. According to the Malaria Fact Sheet available through the WHO, about 3.2 billion people almost half of the worlds population are at risk for malaria. Young children, pregnant
women and
non-immune
travelers from malaria-free areas are particularly vulnerable to the disease. Despite advances in prevention and treatment, per WHO estimates, released in December 2015, there were
214 million cases of malaria in 2015 and 438,000 deaths.
In April 2010, encouraging clinical and preclinical malaria vaccine data were
presented regarding safety, tolerability, immunogenicity, and efficacy data from the Phase 1/2a malaria trial using GenVec technology. Data indicate malaria vaccines given to
malaria-naïve
adults were
found to be safe and well-tolerated with minimal local or systemic reactions and no serious vaccine-related adverse reactions. Sterile protection, a complete absence of parasites in the blood, was seen in 4 out of 15 volunteers that had been
inoculated with the vaccine and subsequently challenged with the malaria parasite.
In March 2012, GenVec
received a grant from NIAID to
support GenVecs malaria vaccine program. This grant, valued at approximately $600,000, is being used to identify novel highly protective antigens for malaria vaccine development. Revenue recognized under this grant amounted to
$0.2 million in 2016 and $0.1 million in both 2015 and 2014.
In November 2012, data were presented highlighting GenVecs success in
identifying novel antigens for use in its malarial vaccine development program. Using a proprietary screening technology, GenVec identified new antigens that are as protective as the gold standard, circumsporozoite protein, or CSP, in an
industry-accepted mouse model of malaria. Recent data suggest that new antigens are needed and that CSP, used in vaccines being developed by others, may not be sufficient to generate a protective response in an adequate percentage of people. Data
presented at the conference also highlighted GenVecs proprietary
non-human
primate adenoviral vectors that are capable of generating broad immune responses while avoiding the problems of vector-specific
immunity which has limited the development of other adenoviruses as vectors for vaccines.
In April 2015, GenVec
announced a research collaboration
with LMIV. The collaboration utilized GenVecs proprietary gorilla adenovirus vectors to deliver a number of novel antigens discovered at the LMIV in order to create and test a variety of malaria vaccine candidates. GenVec will construct
vaccine candidates at its laboratories and provide them to LMIVs Vaccine Development Unit for preclinical testing. The purpose of this collaboration is to devise vaccines that block the transmission of the deadliest malaria-causing parasite,
Plasmodium falciparum, by triggering the production of antibodies that are taken up by a mosquito when it bites a vaccinated individual. This approach, which is different from traditional vaccine approaches, is designed to launch an attack on the
parasite while it is in its mosquito carrier and could potentially help stop the spread of the disease to subsequent bite victims.
ANIMAL HEALTH
PRODUCT DEVELOPMENT PROGRAM
GenVec is exploring applications of its technology to treat and prevent diseases that affect livestock and other animals.
With its collaborators, GenVec is developing vaccine and anti-viral candidates for the prevention and containment of FMD outbreaks. FMD is a highly contagious viral disease affecting cows and other animals with cloven hooves. GenVecs novel FMD
vaccine approach utilizes GenVecs proprietary adenovector technology and is manufactured on a proprietary GenVec cell line that is capable of producing antigens without the use of highly contagious FMD virus. Because the vaccine is produced
without using killed virus materials, it can be produced cost effectively in the U.S. and around the world. While the United States has not had an outbreak of FMD since 1929, the highly contagious nature of FMD, and the grave economic consequences
of an outbreak, has made developing a vaccine and anti-viral candidates a high priority of the U.S. government. Initial testing of a vaccine against FMD showed that inoculated cattle challenged with the virus causing FMD did not develop symptoms.
In June 2012, the U.S. Department of Agricultures Animal and Plant Health Inspection Service, referred to herein as APHIS, issued a
conditional license for GenVecs FMD vaccine for use in cattle. APHIS issued the conditional license to Antelope Valley Bios, Inc., who manufactured the vaccine under a contract with GenVec. This is the first FMD vaccine licensed by USDA Center
for Veterinary Biologics. Under the conditional license, the product may be distributed as authorized by Federal emergency management officials within USDA, should the need for the product arise. APHIS issues conditional licenses in the event of an
emergency situation, limited market or other special circumstance. In this case, the special circumstance was the need for an FMD vaccine that was capable of being manufactured in the U.S. that allowed for the differentiation between infected and
vaccinated animals. The vaccine is available to agriculture officials in the event of an FMD emergency situation.
In December 2010, GenVec
entered into a collaboration with Merial to develop and commercialize GenVecs proprietary vaccine technology for use against FMD. Merial is the leading FMD vaccine producer in the world, with leading positions in all key markets. Under the
agreement, Merial will be responsible for all costs related to the development and commercialization of FMD vaccines developed through the collaboration. If the program results in a commercial product, GenVec
will receive development
milestones and royalties on sales. In May 2011, GenVec
entered into a second agreement with Merial. Under the agreement, Merial has the right to evaluate GenVec technology for applications in other areas of animal health. This agreement
expired in April 2016.
In September 2016, GenVec
entered into an amendment to its previously disclosed license agreement with Merial. Under the
terms of the amendment, GenVec will provide Merial with certain biological materials and grant Merial the right to use the underlying GenVec technology to further develop and advance FMD vaccine product candidates.
In February 2010, GenVec
signed a contract with the U.S. Department of Homeland Security to continue the development of adenovector-based vaccines
against FMD. This agreement covered the use of GenVecs adenovector technology to develop additional
FMD-serotype
candidate vaccines and explore methods to increase the potency and simplify the production
process of adenovector-based FMD vaccines. This agreement was completed in February 2015.
115
TECHNOLOGY PLATFORM
GenVec is a pioneer in the gene therapy field, with experience progressing therapeutics and vaccines from the research stage to the product candidate stage and
into clinical development. GenVecs AdenoVerse technology can be used to deliver genes precisely to target cells in order to elicit the desired biological response, as exemplified by the delivery of CGF166 to the inner ear in GenVecs
hearing loss and balance disorder program. In addition, GenVecs technology can be used to deliver one or more antigens to elicit immune responses to the target disease. GenVec believes it is also a leader in adenovector design and testing,
with experience in
scale-up
and manufacture. GenVecs technology platform includes a broad array of proprietary adenovirus vectors for gene delivery for therapeutics and vaccines, as well as proven
scale-up
and production methodologies and proprietary manufacturing cell lines.
GenVecs highly potent AdenoVerse
vectors include human and
non-human
low-seroprevalence
serotypes, such as GenVecs monkey and gorilla adenovectors, and are designed for superior performance by
providing what GenVec believes is the ability to avoid the
pre-existing
immunity issues that can hamper gene delivery using some other adenovector constructs.
When compared to standard vaccine approaches GenVecs gorilla adenovectors provide what GenVec believes are other distinct advantages for molecular
vaccines, including the induction of both durable high-level antibody and T cell responses. GenVecs gorilla adenovectors have been shown to induce increased antigen-specific immune responses on repeat administration. GenVec believes that its
technology platform can be used to develop product candidates that address a variety of disease challenges.
GenVecs manufacturing cell lines have
been used to produce therapeutics and vaccines in accordance with cGMP with high yields for numerous clinical studies. GenVecs track record includes the successful design and manufacture of novel adenovectors containing single or multiple
genes for the production of therapeutic proteins or antigens that GenVec has been able to scale up for clinical manufacturing. Therapeutics and vaccines designed by GenVec and produced using is high-yield cell lines have been tested in over 3,000
study subjects in clinical trials conducted in the U.S., Europe, Africa and the Middle East.
Adenovirus Vector Technology.
GenVec
utilizes
a collection of differentiated, proprietary technologies to create product candidates with what GenVec believes are superior attributes. GenVecs product candidates are developed with GenVecs proprietary adenovector technology, which uses
modified adenoviruses to deliver genes to cells. Adenoviruses are naturally occurring viruses that reproduce in certain tissues and can cause ailments such as mild respiratory infections. GenVec
designs its vectors so they cannot replicate or
cause diseases. This limits toxicity, including unwanted effects on target cells and the surrounding tissues. GenVecs product candidates consist of adenovectors that contain one or more inserted gene(s). GenVec has multiple proprietary
adenovectors to suit different applications in therapeutic and vaccine products.
When administered to tissues, GenVecs vectors enter target cells,
leading the cells to produce the protein encoded by the inserted gene. The vector is then naturally eliminated from cells and tissues.
GenVec believes
adenovectors are desirable gene delivery vehicles because they efficiently deliver genes, can be readily modified, and are generally well tolerated.
GenVec believes its differentiated gene delivery technology enables it to:
|
|
|
improve the efficiency of discovering new therapies and vaccines;
|
|
|
|
rapidly construct and screen product candidates;
|
|
|
|
identify novel antigens in a quick, and cost-effective manner;
|
|
|
|
minimize interference from antibodies to adenoviruses;
|
|
|
|
put genes or antigens rapidly into vectors to evaluate function and usefulness in therapy;
|
|
|
|
deliver GenVecs product candidates to specific organs or cell types to avoid systemic exposure;
|
|
|
|
achieve efficient delivery of gene to, and stimulate protein expressions in, target cells;
|
|
|
|
control the amount and duration of therapeutic protein production to allow flexibility in treating different diseases; and
|
|
|
|
scale GenVecs manufacturing process for commercial production.
|
GenVec believes
its adenovector technology is a preferred approach for therapeutic and vaccine products:
|
|
|
for local delivery and expression of therapeutic genes;
|
|
|
|
for cell type specific delivery and expression;
|
116
|
|
|
for rational vaccine design;
|
|
|
|
for high level antibody and cellular based vaccine responses;
|
|
|
|
for vaccine production without exposure to contagious pathogens; and
|
|
|
|
for the manufacture of new products that cannot be produced using standard technologies.
|
Local Delivery
and Expression of Genes.
To achieve local production of proteins, GenVec
can administer its product candidates directly to the site of disease using standard medical devices such as syringes. Direct administration of GenVecs product
candidates into diseased tissue allows it to increase effectiveness by achieving high concentrations of the protein at disease sites while improving safety by avoiding systemic exposure throughout the body.
Control of Gene Expression.
GenVecs
technology also allows it to modify the location, duration, and rate of therapeutic gene expression.
GenVec
alters gene expression by inserting a sequence of DNA, called a promoter, into GenVecs vectors adjacent to the target gene. GenVec
tailors its technology to the therapeutic or vaccine product need. For some diseases,
long-term expression of the therapeutic gene is required to achieve a clinical benefit while high level antigen expression from GenVecs molecular vaccines is preferred. Moreover, GenVecs adenovector technology allows multiple antigens or
therapeutic genes to be efficiently expressed for therapeutic benefit. GenVec has also shown that local production of therapeutic proteins by regulating expression via insertion of a specific proprietary promoter that either limits expression to
specific cell types or can regulate expression after specific treatments can be preferred.
New Adenovector Platforms.
GenVec has generated vectors
based on different types of adenovirus. These vectors have the potential to avoid neutralizing antibodies, and for vaccine applications can improve vaccine potency and generate desired immune responses to combat against an infectious agent or
illicit desired therapeutic responses to treat an underlying infection.
Emerging Applications.
The AdenoVerse platform offers numerous
advantages that could be beneficial for a variety of emerging therapeutic approaches such as gene editing, cell therapy, immunotherapy, regenerative medicine, and others. The flexibility of the AdenoVerse platform allows for the customized design of
vectors capable of addressing the unique needs and limitations of each of these different applications. GenVecs expertise in vector construction can be leveraged to construct vectors with specific performance characteristics necessary for the
successful delivery and expression of the genetic material applicable in these emerging fields, and GenVec intends to further explore these opportunities.
Proprietary Cell Lines.
GenVecs established and proven ORF6 and M2A cell lines are used to produce all of GenVecs proprietary adenovectors.
GenVecs cell lines perform excellently in serum-free, animal protein-free suspension culture and efficiently complement for the growth of even the most complex human-origin and nonhuman-origin adenovector constructs. These include vectors
bearing the genes for multiple antigens, vectors bearing targeted expression cassettes, and vectors containing inserts that encode for proteins which interfere with the host cell metabolism and therefore pose challenges for
scale-up
and manufacture. GenVecs cell lines produce high-concentration, stable adenovector lots that meet the rigorous manufacturing standards of GenVecs corporate and governmental collaborators as well
as regulatory agencies.
RESEARCH AND DEVELOPMENT
As
a biopharmaceutical company developing biologic products, and to support the activities discussed above, GenVec has significant research and development expenditures each year. For the years ended December 31, 2016, 2015 and 2014, GenVecs
research and development expenses were $2.5 million, $2.6 million and $2.3 million, respectively. These expenses for the years ended December 31, 2016, 2015 and 2014 were divided between GenVecs research and development
programs in the following manner:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31,
|
|
|
2016
|
|
|
2015
|
|
|
2014
|
|
|
(in
millions)
|
|
Therapeutic
|
|
$
|
1.7
|
|
|
$
|
0.5
|
|
|
$
|
|
|
Vaccines
|
|
|
0.5
|
|
|
|
1.0
|
|
|
|
1.1
|
|
Hearing loss and balance disorders
|
|
|
0.3
|
|
|
|
1.0
|
|
|
|
1.1
|
|
Other programs
|
|
|
|
|
|
|
0.1
|
|
|
|
0.1
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2.5
|
|
|
$
|
2.6
|
|
|
$
|
2.3
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INTELLECTUAL PROPERTY
GenVec
endeavors to protect and enhance its proprietary technology, inventions, and improvements that are commercially important to the development and
sustainability of its business. GenVec
generally seeks patent protection for its technology and product candidates in the U.S. and abroad as well as maintain and defend its patent rights whether developed internally or
117
licensed from third parties. GenVec
also relies on trade secrets relating to its proprietary technology platform and on
know-how,
continuing
technology innovation, and
in-licensing
of opportunities to strengthen, develop and maintain GenVecs proprietary position in the field of gene therapy that may be important for the development and
sustainability of GenVecs business.
GenVecs commercial success may depend in part on its ability to obtain and maintain patent and other
proprietary protection for commercially important technology, inventions and
know-how
related to its business; defend and enforce its patents; preserve the confidentiality of its trade secrets; and operate
without infringing the valid enforceable patents and proprietary rights of third parties.
Patent Rights and Licenses.
GenVec
and its
licensors have patents and continue to seek patent protection for technologies that relate to its product candidates, as well as technologies that may prove useful for future product candidates. GenVecs
proprietary intellectual
property, including patent and
non-patent
intellectual property, is generally directed to, for example, matters such as the composition of GenVecs adenovector-based product candidates, its proprietary
technologies and processes related to its product development candidates, certain genes and methods of transferring genetic material into cells, and its processes to manufacture and test its adenovector-based product candidates.
As of December 31, 2016, GenVec
holds or has licenses to 150 issued, allowed or pending patents worldwide, 40 of which are issued or allowed in
the U.S. These patents and patent applications pertain to, among other things: the composition of matter of its vectors; genes that encode therapeutic proteins; expression control elements that regulate the production of the therapeutic proteins by
such genes and targeting technology for enhanced target cell selectivity of its product candidates; cell lines used to manufacture its product candidates; methods of constructing, producing (including purification, quality control, and assay
techniques), storing and shipping its product candidates; methods of administering its product candidates; and methods of treating disease using its product candidates.
Hearing Loss Program.
GenVec has licensed the Atoh1 gene from the Baylor College of Medicine. This license is worldwide and is exclusive for gene
therapy applications. GenVec
licensed its rights to this gene to Novartis as part of GenVecs worldwide collaboration with Novartis to develop treatments for hearing loss and balance disorders. Patents or patent applications covering
GenVecs product candidate are directed to composition of matter for the Atoh1 gene therapy vectors, as well as, compositions and methods of using the candidates emerging from this program. Issued patents that cover the product candidate begin
to expire in 2024 and if patents are issued from the pending applications and if the appropriate maintenance, renewal, annuity or other governmental fees are paid for issued patents, GenVec
expects coverage to expire in 2035 (worldwide,
excluding possible patent term extensions).
Proprietary Vectors.
GenVec has issued patents and patent applications covering GenVecs
proprietary AdenoVerse technology platform. GenVec has filed patent applications that cover the composition of matter of its new
non-human
primate vectors, including those based on adenovirus isolated from
mountain gorilla that if issued from the pending patent applications and if the appropriate maintenance, renewal annuity, or other governmental fees are paid are projected to expire in 2032 (excluding possible patent term extensions). Issued patents
that cover the composition and use of GenVecs proprietary technology platform began to expire in 2015 and extend through 2033 if appropriate maintenance, renewal, annuity, or other governmental fees are paid.
In 2016, GenVec announced progress on the intellectual property front that GenVec believes will help secure its interests to fully explore the potential of
some of its newer adenovirus vectors. In January 2016 a U.S. patent that provides broad protection for GenVecs gene delivery vectors derived from mountain gorillas was issued. Based on the preclinical data GenVec has seen to
date, GenVec believes these gorilla vectors have a strong potential in the molecular vaccines space as well as other applications. In addition, GenVec was notified U.S. and European patents were issued in 2015 that cover GenVecs monkey
adenovirus vector technology.
In May 1998, GenVec
entered into an Amended and Restated Exclusive License Agreement, which we refer to as the
Cornell agreement, with the Cornell Research Foundation, which we refer to as Cornell, which was subsequently amended. Pursuant to the Cornell agreement, GenVec
licenses certain proteins, genes, gene vectors, and similar biological materials
that relate to GenVecs adenovector platform. GenVec is obligated to pay Cornell a yearly maintenance fee of $50,000 (creditable against any royalty payable in that year). No royalty payments have been made to date, and prior to
commercialization of a licensed product, GenVec has no royalty obligations to Cornell. The Cornell agreement may be terminated by Cornell or by GenVec in the event of an uncured material breach by the other party or by GenVec for any reason with
prior written notice. The Cornell agreement continues in full force until the expiration of all patents or applications covered thereby, unless otherwise terminated. The latest expiring patent under the Cornell agreement expires in 2020.
Licenses to Genes.
To create GenVecs product candidates, GenVec
combines its vectors with genes intended to produce proteins with therapeutic potential. GenVec has secured licenses to applicable genes for this purpose. GenVec
often seeks to obtain exclusivity, consistent with its business needs, when
securing such licenses. In return for the rights GenVec
receives under its gene licenses, GenVec
typically is required to pay royalties based on any commercial sales of the applicable product during a specified time period, as well as
provide additional compensation, including
up-front
license fees and product development-related milestone payments.
Any of GenVecs licenses may be terminated by the licensor if it is in material breach of a term or condition of the particular license agreement, or if
GenVec
becomes insolvent. In addition, some of GenVecs licenses require it to achieve specific milestones.
118
Production, Purification, Quality Assessment and Formulation Technology.
GenVec
holds issued
patents expiring beginning in 2019 and has pending patent applications pertaining to the production, purification, quality assessment, and formulation of GenVecs product candidates, and if patents are issued from the pending applications and
if the appropriate maintenance, renewal, annuity, or other governmental fees are paid for issued patents, GenVec
expects coverage to expire in 2033 (worldwide, excluding possible patent term extensions). In particular, GenVec
holds
issued patents covering the process for manufacturing its product candidates, the purification of its product candidates applicable to both research and commercial scales, methods of assessing and confirming the quality and purity of its product
candidates for clinical testing and commercialization, and product formulations that improve the stability of product candidates and allow its product candidates to be conveniently stored, shipped, and used. GenVec is aware, however, of issued
patents and pending patent applications of third parties relating to these and other aspects of production, purification, quality assessment, and formulation technology. It could be alleged that GenVecs production, purification, quality
assessment, and formulation technology conflict with such existing or future patents.
GenVec
anticipates that it, and its current and future
licensors, will continue to seek to improve existing technologies, develop new technologies and, when appropriate, secure patent protection for such improvements and new technologies.
Certain patents pertaining to GenVecs product candidates may be eligible for Patent Term Extension under 35 U.S.C. §156. The term of any patent
that claims a human drug product (including human biological products), a method of using a drug product, or a method of manufacturing a drug product is eligible for an extension to restore that portion of the patent term that has been lost as a
result of FDA review subject to certain limitations.
Trade Secrets.
To a more limited extent, GenVec
relies on trade secret protection and
confidentiality agreements to protect its interests. It is GenVecs
policy to require its employees, consultants, contractors, manufacturers, collaborators, and other advisors to execute confidentiality agreements upon the commencement
of employment, consulting or collaborative relationships with us. GenVec
also requires signed confidentiality agreements from any entity that is to receive confidential data. With respect to employees, consultants, and contractors, the
agreements generally provide that all inventions made by the individual while rendering services to GenVec shall be assigned to GenVec as its property.
MANUFACTURING AND SUPPLY
Technology for Production,
Purification, Quality Assessment and Formulation.
GenVec believes its proprietary production technology and
know-how
facilitate the production, purification, quality assessment, and formulation of
GenVecs product candidates. The structure of GenVecs vectors and the procedures for their production and purification enable GenVec to minimize the presence of contaminants. GenVec believes its proprietary positions provide a competitive
advantage in the following areas:
|
|
|
Production and
Scale-Up.
GenVec
produces its adenovectors using cell lines grown in culture under standardized and controlled conditions. GenVec has
developed specialized proprietary cell lines for production of its vectors. GenVec
employs materials that are free of animal-derived components. GenVec has designed its production processes to be scalable for commercial production and to
reduce the potential for contamination.
|
|
|
|
Purification.
GenVec has proprietary methods for the purification of is vectors that GenVec believes are scalable to commercial levels as well as suitable for small-scale use in discovery and testing of
new product candidates.
|
|
|
|
Quality Assessment.
GenVec has established proprietary methods to assess and confirm the quality and purity of vectors for research purposes and clinical testing. GenVec
uses advanced
techniques to determine the physical characteristics of its product candidates as a means to establish product consistency and purity. GenVec has an issued U.S. patent covering this technology. GenVec believes these methods are also suitable for
quality assessment of commercial production.
|
|
|
|
Formulation.
GenVec has developed a novel product formulation that improves the stability of its vectors and is covered by issued U.S. patents. GenVecs formulation allows products to be
stored, shipped, and used in a controlled manner that assures activity for the duration of the product shelf-life. For research purposes, GenVecs formulation enhances the ease and reproducibility of testing.
|
Manufacturing Strategy.
GenVec has historically relied on third-party manufacturers or GenVecs collaborators for cGMP production for clinical
trials. GenVec has significant experience working with contract manufacturers and GenVec has successfully transferred manufacturing processes to several collaborators and contract manufacturers. GenVecs research and development facility is
located in Gaithersburg, Maryland, where GenVec has established laboratories and staff to support the
non-cGMP
production and characterization methods for GenVecs product candidates. Many of the
production and assay technologies developed for GenVecs hearing restoration, GenVecs now discontinued TNFerade clinical study, and those developed under GenVecs now terminated HIV vaccine contract with the National Institutes of
Health (NIH), are suitable for GenVecs other product development programs.
GenVec
currently has two suppliers for its clinical manufacturing components, one for human health and one for animal health candidates. GenVec
procures raw materials, including specialized components known as resins, for GenVecs product purification and testing methods from a limited number of suppliers. GenVec
also procures nutrients used to support the growth of
microorganisms or other cells from Thermo Fischer Scientific Corporation and another supplier, Lonza Walkersville, Inc., for custom buffers.
119
GENVECS COMPETITION
Competition in the discovery and development of new methods for treating and preventing disease is intense. GenVec
faces, and will continue to face,
substantial competition from pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies both in the U.S. and abroad. GenVec
faces competition from organizations pursuing the same or
similar technologies used by GenVec in its drug discovery efforts and from organizations that are competitive with GenVecs potential therapeutic and vaccine product candidates.
Many of GenVecs competitors, either alone or together with their collaborative partners, have substantially greater financial resources and larger
research and development organizations. In addition, GenVecs experience in clinical trials, obtaining FDA and other regulatory approvals, manufacturing, and commercialization of products may be more limited. GenVec
also competes in
recruiting and retaining highly qualified scientific personnel and consultants. GenVecs ability to compete successfully depends on adequate funding and collaborators who can supplement its capabilities.
GenVec is aware of products under development by its competitors that target the same prevention or treatment of disease. There are several development-stage
and established entities, including major pharmaceutical and biotechnology companies that are actively engaged in infectious disease vaccine research and development. These include Sanofi S.A., Novartis, GlaxoSmithKline plc, MedImmune, Inc., (a
wholly owned subsidiary of AstraZeneca), Merck & Co., Inc., Pfizer Inc., Crucell N.V. (part of the Janssen Pharmaceutical Companies of Johnson & Johnson), Bavarian Nordic A/S, Okairos Srl (acquired by GlaxoSmithKline), Genocea
BioSciences Inc., Vical Incorporated, Emergent Biosolutions Inc., and Novavax Inc. among others.
GenVec believes its competitive success will be based on
the efficacy and safety of its products, as well as its ability to create and maintain scientifically advanced technology, attract and retain skilled scientific and management personnel, obtain patents or other protection for its products and
technology, obtain regulatory approvals, and successfully commercialize its products either independently or through collaborators.
Hearing Loss and
Balance Disorders.
The market for hearing loss treatments is dominated by devices such as hearing aids or cochlear implants, which are the current standard of care. There are no
FDA-approved
drug
therapies. Several biotechnology and pharmaceutical companies have announced research programs into therapies for either the restoration of function or for the protection of hearing function. These therapies are in various stages of development.
RSV Vaccine.
There are a number of companies pursuing the development of a RSV vaccine. These include but are not limited to MedImmune Inc.,
Sanofi S.A., Bavarian Nordic A/S, Crucell N.V., Novavax Inc., NanoBio Corporation, and Okairos Srl.
HSV Vaccine.
HSV vaccines are currently under
development by Genocea BioSciences Inc., Sanofi S.A., and Vical Incorporated, and Admedus Vaccines.
FMD Vaccine.
Vaccine manufacturers include
Merial, Intervet Inc., a subsidiary of Merck & Co. Inc., Bayer AG, Indian Immunological Ltd. and other local vaccine producers around the world, including government producers as well as those pursuing the development of new vaccines.
Malaria Vaccine.
There are currently no vaccines approved for the prevention of malaria. Companies developing malaria vaccines include
GlaxoSmithKline plc, Sanofi S.A., Crucell N.V., Genocea BioSciences Inc., Sanaria, and Okairos S.r.l.
GOVERNMENT REGULATION
Regulation of Biologic Products.
The research, development, testing, manufacture, quality, safety, effectiveness, labeling, packaging, storage,
approval, distribution, marketing, record keeping, advertising and promotion, and import and export of any biologic products developed by GenVec or its collaborators are subject to regulation by federal, state, local, and foreign governmental
authorities. In the U.S., new drugs are subject to extensive regulation under the Federal Food, Drug, and Cosmetic Act, and biologic products, such as therapeutic products and vaccines, are subject to regulation both under provisions of that Act and
under the Public Health Service Act. The process of obtaining FDA approval for a new product is costly and time-consuming, and the outcome is not guaranteed. If approved, drug products are subject to ongoing regulation, and compliance with
appropriate federal, state, local, and foreign statutes and regulations will require the expenditure of substantial time and financial resources.
Biologic Product Candidates for Human Health
The
steps required before GenVecs proposed investigational biologic products may be marketed in the U.S. (other than for veterinary biologics, including its FMD vaccine product candidate, which are discussed below), include:
|
|
|
performance of preclinical (animal and laboratory) tests;
|
|
|
|
submission to FDA of an IND, which must become effective before human clinical trials may commence;
|
|
|
|
performance of adequate and well-controlled human clinical trials to establish the safety and efficacy in the intended target population for each indication for which approval is sought;
|
|
|
|
performance of a consistent and reproducible manufacturing process intended for commercial use;
|
|
|
|
submission to the FDA of a Biologics License Application, referred to herein as a BLA; and
|
120
|
|
|
FDA approval of the BLA before any commercial sale or shipment.
|
Preclinical studies may take several years to
complete. The results of these studies, together with manufacturing information and analytical data, are submitted to the FDA as part of an IND. The FDA must review the IND prior to the commencement of human clinical trials. Unless the FDA raises
concerns (such as concerns that human research subjects will be exposed to unreasonable risks), the IND will become effective 30 days following its receipt by the FDA, and the clinical trials covered by the IND may commence.
Clinical trials typically are conducted in three sequential but often overlapping phases. In Phase 1, a drug is typically studied in a small number of healthy
volunteers or patients to test the drug for safety or adverse effects, dosage tolerance, absorption, metabolism, excretion and clinical pharmacology. Phase 2 involves clinical trials in the targeted patient population to determine the effectiveness
of the drug for specific, targeted indications, to determine dosage tolerance and optimal dosage, and to gather additional safety data. Phase 3 clinical trials are commonly referred to as pivotal, or registrational, studies and are conducted to
further evaluate dosage, to provide substantial evidence of clinical efficacy and to further test for safety in an expanded and diverse patient population. Each phase may take several years to complete.
The conduct of the clinical trials is subject to extensive regulation, including compliance with good clinical practice regulations and guidelines, obtaining
informed patient consent, sponsor monitoring, auditing of the clinical, laboratory and product manufacturing sites, and review and approval of each study by an independent institutional review board, referred to herein as the IRB, for each site
proposing to conduct the clinical trial. The FDA, the IRB, a DSMB or Data Monitoring Committee, or the sponsor may, at its discretion, suspend or terminate a clinical trial at any time on various grounds, including a finding that the subjects or
patients are being exposed to an unacceptable health risk.
In addition to the regulations discussed above, there are a number of additional standards
that apply to clinical trials involving the use of gene therapy. The FDA has issued various guidance documents regarding gene therapies, which outline additional factors the FDA will consider at each of the above stages of development and relate to,
among other things: the proper preclinical assessment of gene therapies; the chemical, manufacturing and control information that should be included in an IND; the proper design of tests to measure product potency in support of an IND or BLA; and
measures to observe potential delayed adverse effects in subjects who have been exposed to investigational gene therapies when the risk of such effects is high. Further, the FDA usually recommends that sponsors observe subjects for potential gene
therapy-related delayed adverse events for a
15-year
period, including a minimum of five years of annual examinations followed by 10 years of annual queries, either in person or by questionnaire.
Promising data in early-stage clinical trials do not necessarily assure success in later-stage clinical trials. The FDA may request that additional clinical
trials be conducted as a condition to product approval. Additionally, new government requirements may be established that could delay or prevent regulatory approval of products under development.
After the completion of the required clinical trials, if GenVec believes the data indicate the biologic product is safe and effective, GenVec
would
prepare a BLA and submit it to the FDA. This process takes substantial time and effort. The FDA may refuse to file the BLA and request additional information, in which case, the application must be resubmitted with the supplemental information. Once
a BLA is deemed filed by the FDA, there is no guarantee the FDA will approve the BLA. The FDA has substantial discretion in the approval process and may disagree with GenVecs interpretation of the preclinical or clinical data and request
additional data and information, which could significantly delay, limit, or even prevent regulatory approval.
As part of this review, the FDA may refer
the BLA to an appropriate advisory committee, typically a panel of physicians, for review, evaluation, and an approval recommendation. Although the FDA is not bound by the opinion of the advisory committee, advisory committee discussions may further
delay, limit, or prevent approval. The FDA also may conclude that as part of the BLA, the sponsor must develop a risk evaluation and mitigation strategy, referred to herein as a REMS, to ensure that the benefits of the drug outweigh the risks. A
REMS may have different components, including a package insert directed to patients, a plan for communication with healthcare providers, restrictions on a drugs distribution, or a medication guide to provide better information to consumers
about the drugs risks and benefits.
If its evaluations of the BLA are favorable and the agency concludes the standards for approval have been met,
the FDA will issue an approval letter. If the FDA believes the BLA is deficient in some way that precludes approval, it will issue a Complete Response Letter that generally identifies the deficiencies, which can be minor, such as requiring labeling
changes, or major, such as requiring additional preclinical or clinical studies. The Complete Response Letter may also include recommended actions the applicant might take to place the BLA in a condition for approval. If a Complete Response Letter
is issued, the applicant may either resubmit the BLA, addressing all of the deficiencies identified in the letter, or withdraw the BLA. If the deficiencies have been addressed to the FDAs satisfaction, the FDA may issue an approval letter.
Even if the requested information and data are submitted, however, the FDA may ultimately decide the BLA does not satisfy the criteria for approval.
Prior to granting approval, the FDA generally conducts an inspection of the facilities, including third-party contract facilities that will be involved in the
manufacture, production, packaging, testing, and control of the drug substance and finished drug product for compliance with current cGMP. The FDA will not approve the BLA unless cGMP compliance is satisfactory. In addition, each manufacturing
establishment must be registered with the FDA and is subject to periodic FDA inspection. In order to supply products for use either inside or outside the U.S., including for investigation in clinical trials, domestic and foreign manufacturing
establishments, including third-party facilities, must comply with cGMP regulations and are subject to periodic inspection by the corresponding regulatory agencies in their home country, often under reciprocal agreements with the FDA or by the FDA.
121
After a biologic product is approved, it is subject to significant ongoing regulation and must comply with
requirements relating to manufacturing, labeling, packaging, adverse event reporting, storage, advertising, promotion, distribution, and recordkeeping. As a condition of BLA approval, the FDA may require post-approval testing (referred to as Phase 4
clinical trials) and surveillance to monitor the products safety or efficacy. In addition, the holder of an approved BLA is required to keep extensive records; to report certain adverse reactions, production deviations, and other problems to
the FDA; to provide updated safety and efficacy information, and to comply with requirements concerning advertising and promotional labeling for their products. Generally, a company can promote a product only for those claims relating to safety and
efficacy that are consistent with the labeling approved by the FDA and supported by substantial evidence. Failure to comply with the regulatory requirements of the FDA and other applicable U.S. and foreign regulatory authorities could result in
administrative or judicially imposed sanctions or other setbacks, including warning letters, restrictions on the product, product recalls, suspension or withdrawal of approval, seizures, injunctions, civil fines, and criminal sanctions.
If the FDA becomes aware of new safety information, it may require post-approval studies or clinical trials to investigate known serious risks or signals of
serious risks or in response to the occurrence of unexpected serious risks identified following approval. If a post-approval study is required, periodic status reports must be submitted to the FDA. Failure to conduct such post-approval studies in a
timely manner may result in substantial civil fines. In addition, newly discovered or developed safety or efficacy data may require changes to an approved products distribution or labeling, including the addition of new warnings,
contraindications or a REMS, or suspended marketing or withdrawal of the product.
A biologic product is also subject to regulatory approval in other
countries in which it is intended to be marketed. No such product can be marketed in a country until the regulatory authorities of that country have approved an appropriate license application. FDA approval does not assure approval by other
regulatory authorities. In many countries, the government is involved in the pricing of the product. In such cases, a pricing review period often begins after market approval is granted.
Under the Biologics Price Competition and Innovation Act of 2009, referred to herein as BPCIA, there is an abbreviated approval pathway for biologic products
that are biosimilar to a previously approved biologic product, which is called the reference product. This abbreviated approval pathway is intended to permit a biosimilar product to come to market more quickly and less
expensively than if a full BLA were submitted, by relying to some extent on the FDAs previous review and approval of the reference product. If a proposed biosimilar product meets the statutory standards for approval (which include
demonstrating that it is highly similar to the reference product and there are no clinically meaningful differences in safety, purity or potency between the products), the proposed biosimilar product may be approved on the basis of an application
that is different from the standard BLA. In addition, a biosimilar product may be approved as interchangeable with the reference product if the proposed product application meets standards intended to ensure that the biosimilar product can be
expected to produce the same clinical result as the reference product.
The BPCIA provides exclusivity periods during which a product approved under a BLA
cannot be relied on as a reference product. No biosimilar application may be submitted to the FDA for a period of four years after the reference product was approved, and no biosimilar application may be approved until 12 years after the reference
products approval. If pediatric studies with the reference product are performed and accepted by the FDA, the
12-year
exclusivity period will be extended for an additional six months. Additionally, the
first biosimilar product approved as interchangeable with a reference product will be granted an exclusivity period of varying length, depending on the factual circumstances. The contours of the BPCIA are being defined as the statute is implemented
over a period of years. Some issues may be resolved through regulation or agency guidance, but other interpretations may develop on an ad hoc basis as the FDA confronts them in the context of specific applications. The FDA has to date issued
various guidance documents and other materials indicating the agencys thinking regarding a number of issues implicated by the BPCIA. Additionally, the FDAs approval in 2015 of the first biosimilar application helps define the
agencys approach to certain issues.
Biologic Product Candidates for Animal Health
GenVecs FMD vaccine product candidate is subject to a separate regulatory regime. In the U.S., governmental regulation of animal health products is
primarily provided by two agencies: APHIS within the USDA, and the Center for Veterinary Medicine within the FDA. Vaccines for animals are considered veterinary biologics and are regulated by the Center for Veterinary Biologics of USDA under the
auspices of the Virus-Serum-Toxin Act. The USDA licensing process involves the submission of several data packages. These packages include information on how the product will be manufactured, information on the efficacy and safety of the product in
laboratory and target animal studies, and information on performance of the product in field conditions. The USDA may issue one of two types of licenses: a full license or a conditional license. Conditional licenses are used to meet an emergency
condition, limited market, local situation or other special circumstance and do not permit the general commercialization of the product. Conditionally licensed products are required to be pure and safe, and have a reasonable expectation of efficacy.
Conditional licenses are effective for a finite time period and distribution of conditionally licensed products in each state is limited to authorized recipients designated by proper state officials. Conditional licenses may be renewed if the
applicant demonstrates a good-faith effort toward obtaining full licensure.
In June 2012, APHIS issued a conditional license for GenVecs FMD
vaccine for use in cattle. The conditional license was issued because of the need for an FMD vaccine that is capable of being manufactured in the United States that allows for the differentiation between infected and vaccinated animals. The vaccine
is available to agriculture officials in the event of an FMD emergency situation. The conditional license was renewed in 2014 and 2016 and is effective until 2018. GenVec
expects to seek a further renewal in 2018 when the current conditional
license expires.
122
Reimbursement of Biologic Products.
If and when GenVecs products reach commercialization,
insurance companies, health maintenance organizations, other third-party payers, and federal and state governments will be the primary payers for GenVecs products. The largest payer in this group will probably be the Centers for Medicare and
Medicaid Services, referred to herein as CMS, the federal agency that administers the Medicare and Medicaid programs. Under Medicare, there are different reimbursement methodologies for certain drugs and biological products that depend on the site
of service. These methodologies generally use average sales price, which we refer to as ASP, information. Manufacturers, including us, if and when GenVec
or its collaborators commercialize GenVecs products in the U.S., are required to
provide ASP information for certain products to CMS on a quarterly basis if GenVec
participates in the Medicaid program. If a manufacturer is found to have made a misrepresentation in the reporting of ASP, the statute provides for civil
monetary penalties of up to $12,856 for each misrepresentation for each day in which the misrepresentation was applied. Additional civil monetary penalties apply for reporting false information or reporting required information late. ASP is used to
compute Medicare payment rates, updated quarterly based on this ASP information. Until enough ASP data are available to calculate a payment rate, reimbursement is wholesale acquisition cost plus 6%. There also is a mechanism for comparison of the
ASP for a product to the widely available market price and the Medicaid Average Manufacturer Price, which we refer to as AMP, for the product. When the ASP for a product exceeds the products AMP by a specified percentage, the products
ASP may be disregarded and an
AMP-based
reimbursement rate may be applied instead, which could cause further decreases in Medicare payment rates.
For covered physician-administered drugs and biological products furnished in a physicians office, if the physician purchases the drug or biological
product, CMS will reimburse the physician based upon that drug or biological products ASP plus 6% (reduced by sequestration, as discussed below). The ASP is determined by CMS based upon information reported by manufacturers. Medicare also has
several reimbursement methodologies for drugs and biological products administered in hospital outpatient departments. New drugs and biologicals whose cost is not insignificant in relation to payment for related procedures are granted
pass-through status and are reimbursed at ASP plus 6% for the first two to three years of payment under the Medicare hospital outpatient prospective payment system. For many other drugs and biological products that do not qualify for
pass-through status but have an average cost per day greater than $110, the current Medicare payment to a hospital outpatient department is ASP plus 6%. Drugs and biological products with an average cost per day equal to or less than $110 are not
separately reimbursed; payment for these products is included in payment for the associated procedure. Payment levels for drugs without pass-through status and the $110 threshold are subject to change through regulation each calendar year.
In addition, Congress may change Medicare reimbursement amounts or methods by statute. For example, Medicare payments for all items and services, including
drugs and biologicals, have been reduced by 2% under the sequestration (automatic spending reductions) required by the Budget Control Act of 2011, as amended by the American Taxpayer Relief Act of 2012. Subsequent legislation extended the 2%
reduction, on average, to 2025, unless Congress modifies the sequestration in the future. In addition, Congress or CMS could change
ASP-based
reimbursement amounts through statute or regulation for the
physician office or hospital outpatient settings, respectively. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, referred to herein together as PPACA, also requires CMS to test
new payment methodologies that would bundle payment for physician and hospital services and supplies, including drugs and biological products, for an episode of care. Changes to the calculation of ASP or Medicare reimbursement methodologies could
affect reimbursement for GenVecs products and could negatively impact GenVecs results of operations, if and when GenVec
begins to commercialize products that could be reimbursed by the Medicare program.
Medicare Part D provides Medicare beneficiaries with drug coverage for self-administered drugs and biological products and other drugs and biological products
not covered by Medicare, including many vaccines. This voluntary benefit is being implemented through private plans under contractual arrangements with the federal government. Currently, these plans negotiate directly with pharmaceutical
manufacturers for rebates on drugs dispensed to Medicare Part D beneficiaries. Like pharmaceutical coverage through private health insurance, Medicare Part D plans establish formularies and use other utilization management tools when determining the
drugs and biological products that are offered by each plan. These formularies can change on an annual basis, subject to federal governmental review. These plans may also require beneficiaries to provide
out-of-pocket
payments for such products. Private Medicare Part D plans pay physicians one payment that includes both the administration cost and the cost of the vaccine for those vaccines that are not
already covered by law under a different component of the Medicare program. PPACA requires manufacturers to pay rebates of 50% on all drugs dispensed to beneficiaries, other than
low-income
beneficiaries, in
the Medicare Part D coverage gap, often referred to as the donut hole. It is possible that future health reform legislation would require the government to negotiate Medicare Part D rebates directly, which could result in much higher
rebate amounts than those currently negotiated with the plans. In addition, although certain treatments are currently included in CMSs protected classes of drugs for purposes of Medicare Part D formularies, which generally ensures inclusion on
plan formularies, it is possible that future regulatory or legislative changes could change that status.
Federal law requires pharmaceutical manufacturers to pay rebates on covered outpatient drugs reimbursed by the Medicaid program as a condition of having
federal funds being made available to pay for those drugs under Medicaid and Medicare Part B. Rebate amounts for a product are determined by a statutory formula that is based on prices defined by statute: AMP, which must be calculated for all
products that are covered outpatient drugs under the Medicaid program, and best price, which must be calculated only for those covered outpatient drugs that are innovator products, such as biological products and products approved under new drug
applications. A pharmaceutical manufacturer is required to report AMP and best price for each of its covered outpatient drugs to the government on a regular basis. AMP is reported quarterly and monthly, and best price is reported quarterly.
123
Various states have adopted mechanisms under Medicaid that seek to control drug reimbursement, including by
disfavoring certain higher priced drugs and by seeking supplemental rebates from manufacturers. PPACA and subsequent legislation made significant changes to the Medicaid drug rebate program, including changing the definition of AMP, increasing the
minimum rebate percentage, changing the rebate calculation for new formulations of existing products, capping the rebate amount at 100% of AMP, and expanding rebate liability from
fee-for-service
Medicaid utilization to include the utilization of Medicaid managed care organizations as well. GenVec
expects, if and when GenVec
or its
collaborators commercialize GenVecs products in the U.S., a significant portion of GenVecs revenue and the revenue of its collaborators from sales of GenVecs products will be obtained through government payers, including Medicare,
Medicaid and Department of Defense, referred to herein as DoD, programs, and any failure to qualify for reimbursement for GenVecs products under those programs would have a material adverse effect on future revenues from sales of GenVecs
products.
A pharmaceutical manufacturer must also participate in the 340B drug pricing program in order for federal funds to be available to pay for the
pharmaceutical manufacturers drugs under Medicaid and Medicare Part B. Under this program, the participating pharmaceutical manufacturer agrees to charge statutorily-defined covered entities no more than the 340B discounted ceiling price for
the pharmaceutical manufacturers covered outpatient drugs. The formula for determining the discounted purchase price is defined by statute and is based on the AMP and rebate amount for a particular product as calculated under the Medicaid drug
rebate program, discussed above. PPACA also obligates the Secretary of the Department of Health and Human Services to create regulations and processes to improve the integrity of the 340B drug pricing program and to ensure the agreement that
manufacturers must sign to participate in the program obligates manufacturers to offer the ceiling price to covered entities if the manufacturer makes the drug available to any other purchaser at any price and report to the government the ceiling
prices for its drugs. In addition, legislation may be introduced that, if passed, could further expand the 340B drug pricing program to include additional covered entities or could require participating manufacturers to agree to provide 340B
discounted pricing on drugs used in the inpatient setting. To the extent that PPACA and subsequent legislation, as discussed above, causes the statutory and regulatory definitions of AMP and the Medicaid rebate amount to change, these changes also
impact the 340B discounted ceiling price.
In order to be eligible to have GenVecs products paid for with federal funds under the Medicaid and
Medicare Part B programs and purchased by certain federal agencies and grantees, GenVec
anticipates that it will participate in the Department of Veterans Affairs Federal Supply Schedule, referred to herein as the VA FSS, pricing program,
established by Section 603 of the Veterans Health Care Act of 1992. Under this program, GenVec
will be obligated to make its products available for procurement on an FSS contract and charge prices to four federal agencies VA, DoD,
Public Health Service and Coast Guard that are no higher than the statutory Federal Ceiling Price, referred to herein as the FCP. The FCP is based on the
non-federal
average manufacturer price, referred
to herein as
Non-FAMP,
which GenVec
will be required to calculate and report to VA on a quarterly and annual basis.
To the extent GenVecs other products become available in the retail pharmacy setting if and when they are commercialized, GenVec
would be subject
to Section 703 of the National Defense Authorization Act for Fiscal Year 2008. DoD has established a program under which it seeks
FCP-based
rebates from drug manufacturers on TRICARE retail utilization of
covered drugs. Under this authority, DoD asserts an entitlement to rebates on TRICARE Retail Pharmacy utilization unless DoD grants a waiver or compromise of amounts due. Rebates are computed by subtracting the applicable FCP from the corresponding
annual
Non-FAMP.
DoD has asserted the right to apply offsets and/or proceed under the Debt Collection Act in the event that a company does not pay rebates or request a waiver of rebate liability in a timely
fashion. Any company that wants its covered drugs to be eligible for favorable positioning on DoDs Uniform Formulary must enter into a Section 703 Agreement with the Defense Health Agency under which the company agrees to pay the
quarterly rebates.
If and when GenVec
begins commercializing its products, GenVec
expects to experience pricing pressures in the United
States in connection with the sale of these products due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative proposals. GenVec is unable to predict what additional
legislation, regulations or policies, if any, relating to the healthcare industry or third-party coverage and reimbursement may be enacted in the future or what effect such legislation, regulations or policies would have on GenVecs business.
Any cost containment measures, including those listed above, or other healthcare system reforms that are adopted could have a material adverse effect on GenVecs ability to operate profitably.
In addition to the changes discussed above, PPACA substantially changes the way healthcare is financed by both governmental and private insurers and
significantly impacts the pharmaceutical industry in other ways as well. PPACA contains a number of provisions that are expected to impact GenVecs business and operations, in some cases in ways GenVec
cannot currently predict. Changes
that may affect GenVecs business if and when its products are commercialized in the U.S. include those governing expanded enrollment in federal and private healthcare programs, new Medicare reimbursement methods and rates, increased rebates
and taxes on pharmaceutical products, and revised fraud and abuse and enforcement requirements. These changes will impact existing government healthcare programs and will result in the development of new programs.
The effects of reforms under PPACA will be shaped significantly by implementing regulations and by state government decisions. On February 1, 2016, CMS
issued a final regulation to implement the changes to the Medicaid drug rebate program under PPACA. This regulation became effective on April 1, 2016. Many states chose not to expand their Medicaid programs by raising the income limit to 133%
of the federal poverty level, as permitted by PPACA. It is unclear whether these states will choose to expand their programs in the future and whether there will be more uninsured patients than anticipated when Congress passed PPACA. For each state
that does not choose to expand its Medicaid program as permitted by PPACA, there will be fewer insured patients overall. The reduction in the number of insured patients could impact GenVecs sales, business and financial condition following the
commercialization, if successful, of GenVecs products in the U.S.
124
Moreover, legislative changes to PPACA and new or revised regulations remain possible and appear likely in
the 115th U.S. Congress and under the Trump Administration. These changes could affect all of the PPACA-related policies discussed above and could have a significant effect on the number of insured patients in the U.S., the breadth of coverage under
insurance plans, financing of healthcare, and reimbursement rates, which could impact GenVecs sales, business and financial condition following the commercialization, if successful, of GenVecs products in the U.S. GenVec
expects
that PPACA, as currently enacted or as it may be amended in the future, and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on GenVecs industry generally and on its ability to
successfully commercialize its product candidates, if approved.
Other Laws and Regulations.
GenVecs business may be subject to healthcare fraud and abuse regulation and enforcement by both the federal government and the states in which GenVec
conducts its business, particularly once third-party reimbursement becomes available for one or more of its products. The healthcare fraud and abuse laws and regulations that may affect GenVecs ability to operate include but are not
limited to:
|
|
|
The federal Anti-Kickback Law, which prohibits, among other things, knowingly or willingly offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward the
purchasing, leasing, ordering or arranging for or recommending the purchase, lease or order of any health care items or service for which payment may be made, in whole or in part, by federal healthcare programs such as Medicare and Medicaid. This
statute has been interpreted to apply to arrangements between pharmaceutical companies on one hand and prescribers, purchasers and formulary managers on the other. Further, PPACA clarified that liability may be established under the federal
Anti-Kickback Law without proving actual knowledge of the statute or specific intent to violate it. In addition, PPACA amended the Social Security Act to provide that the government may assert that a claim including items or services resulting from
a violation of the federal Anti-Kickback Law constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Although there are a number of statutory exemptions and regulatory safe harbors to the federal Anti-Kickback Law
protecting certain common business arrangements and activities from prosecution or regulatory sanctions, the exemptions and safe harbors are drawn narrowly, and practices that involve remuneration to those who prescribe, purchase, or recommend
pharmaceutical and biological products, including certain discounts, or engaging such individuals as speakers or consultants, may be subject to scrutiny if they do not fit squarely within an exemption or safe harbor. GenVecs practices may not
in all cases meet all of the criteria for safe harbor protection from anti-kickback liability. Moreover, there are no safe harbors for many common practices, such as educational and research grants or patient assistance programs.
|
|
|
|
The federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds or
knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay
money to the federal government. Many healthcare companies have been investigated and have reached substantial financial settlements with the federal government under the civil False Claims Act for a variety of alleged improper activities including
causing false claims to be submitted as a result of the marketing of their products for unapproved and thus
non-reimbursable
uses, inflating prices reported to private price publication services which are used
to set drug payment rates under government healthcare programs, and other interactions with customers including those that may have affected their billing or coding practices and submission to the federal government. In addition, PPACA amended
federal law to provide that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Law constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act.
Pharmaceutical and other healthcare companies also are subject to other federal false claims laws, including, among others, federal criminal healthcare fraud and false statement statutes that extend to
non-government
health benefit programs.
|
|
|
|
The Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act, among other things, imposes criminal and civil liability for
executing a scheme to defraud any healthcare benefit program or making false statements in connection with the delivery of or payment for healthcare benefits, items or services, and also imposes obligations with respect to safeguarding the privacy,
security and transmission of individually identifiable health information. HIPAA also prohibits knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or
representation, or making or using any false writing or document knowing the same to contain any materially false, fictitious or fraudulent statement or entry in connection with the delivery of or payment for healthcare benefits, items or services.
|
|
|
|
Numerous federal and state laws and regulations that address privacy and data security, including state data breach notification laws, state health information privacy laws, and federal and state consumer protection
laws (e.g., Section 5 of the FTC Act), govern the collection, use, disclosure and protection of health-related and other personal information. Failure to comply with data protection laws and regulations could result in government enforcement
actions and create liability for GenVec (which could include civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect GenVecs operating results and business.
|
|
|
|
The federal Physician Payment Sunshine Act, being implemented as the Open Payments Program, which requires certain pharmaceutical and biological manufacturers to engage in extensive tracking of payments or transfers of
value to physicians
|
125
|
and teaching hospitals and public reporting of the payment data. Pharmaceutical and biological manufacturers with products for which payment is available under Medicare, Medicaid or the State
Childrens Health Insurance Program are required to have started tracking such payments on August 1, 2013, and must submit a report on or before the 90th day of each calendar year disclosing reportable payments made in the previous
calendar year.
|
|
|
|
Analogous state laws and regulations, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed under Medicaid and other state programs or, in several states, regardless of the
payer. Some state laws also require pharmaceutical companies to report expenses relating to the marketing and promotion of pharmaceutical products and to report gifts and payments to certain health care providers in those states. Some of these
states also prohibit certain marketing-related activities including the provision of gifts, meals, or other items to certain health care providers. In addition, California, Connecticut, Nevada and Massachusetts require pharmaceutical companies to
implement compliance programs or marketing codes of conduct.
|
|
|
|
The federal Foreign Corrupt Practices Act of 1997 and similar anti-bribery laws in other jurisdictions generally prohibit companies and their intermediaries from providing money or anything of value to officials of
foreign governments, foreign political parties or international organizations with the intent to obtain or retain business or seek a business advantage. Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S.
regulators, with more frequent and aggressive investigations and enforcement proceedings by both the Department of Justice and the U.S. Securities and Exchange Commission. A determination that GenVecs operations or activities are not, or were
not, in compliance with U.S. or foreign laws or regulations could result in the imposition of substantial fines, interruptions of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits
and other legal or equitable sanctions. Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow.
|
If GenVecs operations are found to be in violation of any of the laws described above or any other governmental regulations that apply to us, GenVec
may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from government-funded healthcare programs like Medicare and Medicaid, and the curtailment or restructuring of GenVecs
operations, any of which could adversely affect is ability to operate its business and its financial results. Although compliance programs can mitigate the risk of investigation and prosecution for violations of these laws, the risks cannot be
entirely eliminated. Any action against GenVec for violation of these laws or regulations, even if GenVec
successfully defends against it, could cause GenVec to incur significant legal expenses and divert its managements attention from
the operation of its business. Moreover, failure to achieve and sustain compliance with applicable federal and state privacy, security and fraud laws could result in government enforcement actions and create liability for GenVec (which could include
civil and/or criminal penalties), private litigation and/or adverse publicity that could negatively affect GenVecs operating results and business.
GenVecs business is also subject to regulation under various state and federal environmental laws, including the Occupational Safety and Health Act, the
Resource Conservation and Recovery Act and the Toxic Substances Control Act. These and other laws govern GenVecs use, handling, and disposal of various biological, chemical and radioactive substances used in and wastes generated by
GenVecs operations. GenVec is not aware of any costs or liabilities in connection with any environmental laws that will have a material adverse effect on GenVecs business or financial condition.
EMPLOYEES
As of February 28, 2017, GenVec
had 15 full-time employees, three of whom hold Ph.D. degrees and four of whom hold other advanced degrees. Of GenVecs total workforce, five are engaged primarily in research and development activities and 10 are engaged primarily in
business development, finance, marketing, and administration functions. None of GenVecs employees is represented by a labor union or covered by a collective bargaining agreement, and GenVec
considers its employee relations to be good.
PRINCIPAL EXECUTIVE OFFICES
GenVec was incorporated
in Delaware in 1992. GenVecs principal executive offices are located at 910 Clopper Road, Suite 220N, Gaithersburg, Maryland 20878. GenVecs telephone number at that location is (240)
632-0740.
126
Description of GenVecs properties
GenVecs corporate offices and research and development laboratories are located at a facility at 910 Clopper Road, Gaithersburg, Maryland, where GenVec
leases space. The lease was amended effective July 1, 2016 to add 4,457 square feet of leased space, and GenVec now leases space in the facility totaling 13,969 square feet. The term of the lease expires on June 30, 2021. GenVec currently
believes this facility is sufficient to meet its present needs. The leased space includes unused space GenVec can utilize to accommodate future growth.
GenVecs legal proceedings
On March 28, 2017 and April 6, 2017, putative stockholder class actions were filed in the United States District Court for the District of Delaware styled,
respectively,
Parshall v. GenVec, Inc.
, et. al., Case No. 1:17-cv-00338 (D.Del.) and
Mussman v. GenVec, Inc.
, et al., Case No. 1:99-mc-09999 (D.Del.). Additionally, on April 10, 2017, an action was filed in the United States District
Court for the District of Maryland styled
Hoose v. GenVec, Inc. et al
., Case No. 8:17-cv-00987 (which, together with the
Parshall
and
Mussman
actions, is referred to herein as the Stockholder Actions). The Stockholder Actions
assert claims against GenVec and members of GenVecs Board of Directors, referred to herein as Individual Defendants. The
Parshall
action also named, and the
Hoose
action purports to name, Intrexon and Merger Sub as defendants.
The complaints in the Stockholder Actions allege that GenVec and the Individual Defendants violated Section 14(a) of the Securities Exchange Act of 1934, and Rule 14a-9 promulgated thereunder, by failing to disclose in the draft proxy statement
included in the Registration Statement on Form S-4, filed by Intrexon on March 17, 2017, in connection with the merger certain information regarding alleged potential conflicts of interest, events leading up to the signing of the merger agreement
with Intrexon and Merger Sub, certain financial data regarding GenVec, and certain inputs regarding Roths fairness opinion. The complaints in the Stockholder Actions also allege the Individual Defendants violated Section 20(a) of the
Securities Exchange Act of 1934 as control persons who had the ability to prevent the Registration Statement from being false and misleading. The
Parshall
and
Hoose
actions also allege that Intrexon and Merger Sub violated Section
20(a) of the Exchange Act. The actions seek, among other things, an injunction preventing consummation of the merger with Merger Sub, an award of damages, and an award of costs and expenses, including attorneys fees. On April 18, 2017,
the defendants in the
Hoose
action filed a letter seeking leave to file a motion to transfer that action to the United States District Court for the District of Delaware. On April 19, 2017, the plaintiffs in the
Parshall
and
Mussman
actions voluntarily dismissed their claims. Intrexon, GenVec and the Individual Defendants believe the
Hoose
action is without merit and intend to vigorously defend it.
127
GenVec managements discussion and analysis of
financial condition and results of operations
The following discussion and analysis should be read in conjunction with the GenVec selected historical financial and other data section of
this proxy statement/prospectus and GenVecs financial statements and related notes included in this proxy statement/prospectus. All share and per share amounts relating to the common stock, stock options or warrants to purchase common stock,
and the respective exercise prices of each such option or warrant, set forth in this section have been retroactively adjusted to reflect the reverse stock split.
In addition, the following discussion and analysis contains forward-looking statements that involve risks, uncertainties, judgment and assumptions.
GenVecs actual results and timing of selected events may differ materially from those anticipated in these forward-looking statements as a result of many factors, including those described under Risks related to GenVec and its
business and elsewhere in this proxy statement/prospectus.
OVERVIEW
GenVec is a clinical-stage biopharmaceutical company with an entrepreneurial focus on leveraging its proprietary AdenoVerse gene delivery platform to
develop a pipeline of cutting-edge therapeutics and vaccines. GenVec is a pioneer in the design, testing and manufacture of adenoviral-based product candidates that can deliver on the promise of gene-based medicine. GenVecs lead product
candidate, CGF166, is licensed to Novartis and is currently in a Phase 1/2 clinical study for the treatment of hearing loss and balance disorders. In addition to GenVecs internal and partnered pipeline, GenVec also focuses on opportunities to
license its proprietary technology platform, including vectors and production cell lines, to potential collaborators in the biopharmaceutical industry for the development and manufacture of therapeutics and vaccines.
A key component of GenVecs strategy is to develop and commercialize its product candidates through collaborations. GenVec is working with prominent
companies and organizations such as Novartis, Merial, Washington University in St. Louis, and the U.S. government, as well as promising young companies such as TheraBiologics, to support a portfolio of programs that address the prevention and
treatment of a number of significant human and animal health concerns. GenVecs combination of internal and partnered development programs addresses therapeutic areas such as hearing loss and balance disorders, oncology, bleeding disorders, as
well as vaccines against infectious diseases including RSV, HSV, malaria, and in the area of animal health, vaccines against FMD.
GenVecs
AdenoVerse gene delivery technology has the important advantage of localizing protein delivery in the body. This is accomplished by using GenVecs adenovector platform to locally deliver genes to cells, which then direct production of the
desired protein. This approach reduces side effects typically associated with systemic delivery of proteins. For therapeutics, the goal is for the protein produced to have a meaningful effect in treating the cause, manifestation, or progression of
the disease. For vaccines, the goal is to induce an immune response against a target protein or antigen. This is accomplished by using an adenovector to deliver a gene that causes production of an antigen, which then stimulates the desired immune
reaction by the body.
GenVecs research and development activities yield product candidates that utilize its technology platform and represent
potential commercial opportunities. For example, preclinical research in hearing loss and balance disorders indicates that the delivery of the atonal gene using GenVecs adenovector technology may have the potential to restore hearing and
balance function. GenVec is currently working with Novartis on the development of novel treatments for hearing loss and balance disorders that emerged from these research and development efforts. There are currently no effective therapeutic
treatments available for patients who have lost all balance function, and hearing loss remains a major unmet medical problem.
GenVec has multiple vaccine
candidates that leverage its core adenovector technology, including its preclinical vaccine candidates for the prevention or treatment of RSV and HSV. GenVec also has a program to develop a vaccine for malaria, a program in which it is currently
working in collaboration with
LMIV.
GenVecs business strategy is focused on entering into collaborative arrangements with third parties
to complete the development and commercialization of its product candidates. In the event that third parties take over the development for one or more of GenVecs product candidates, the estimated completion date would largely be under the
control of that third party rather than GenVec. GenVec cannot forecast with any degree of certainty which proprietary products or indications, if any, will be subject to future collaborative arrangements, in whole or in part, or how such
arrangements would affect GenVecs development plan or capital requirements. GenVecs programs may also benefit from subsidies, grants, or government or agency-sponsored studies that could reduce GenVecs development costs.
An element of GenVecs business strategy is to pursue, as resources permit, the research and development of a range of product candidates for a variety
of indications. This is intended to allow GenVec to diversify the risks associated with its research and development expenditures. To the extent GenVec is unable to maintain a broad range of product candidates, its dependence on the success of one
or a few product candidates would increase.
On February 24, 2016, GenVec received notification from NASDAQ that the minimum bid price of
GenVecs common stock had remained below $1.00 per share for 30 consecutive business days, and GenVec therefore was not in compliance with the minimum bid price requirement for continued listing set forth in Marketplace Rule 5550(a)(2). The
notification letter stated that GenVec would be afforded 180 calendar days, or until August 22, 2016, to regain compliance with the minimum bid price
128
requirement. On August 23, 2016, GenVec received notification from NASDAQ that GenVec had been afforded a second 180 calendar day grace period, or until February 21, 2017, to regain
compliance. To regain compliance, the closing bid price of GenVecs common stock had to meet or exceed $1.00 per share for at least ten consecutive business days. On October 20, 2016, GenVecs shareholders approved an amendment to
GenVecs Amended and Restated Certificate of Incorporation to effect a reverse stock split of GenVecs common stock at a ratio within the range of
one-for-three
to
one-for-ten,
as determined by GenVecs board of directors. On
December 1, 2016, GenVec effected the reverse stock split at a ratio of
one-for-ten,
whereby each 10 shares of common stock were combined into one share of common
stock. The reverse stock split was intended to enable GenVec to regain compliance with the bid price requirement. On December 15, 2016, GenVec received a notice from NASDAQ stating that GenVec had regained compliance.
On January 24, 2017, GenVec, Intrexon and Merger Sub entered into the merger agreement, pursuant to which, and on the terms and conditions set forth in
the merger agreement, Merger Sub will merge with and into GenVec. GenVec will survive the merger as a wholly owned subsidiary of Intrexon. For more information regarding the merger and the merger agreement, see the sections entitled The
merger and The merger agreement.
Subject to the terms and conditions set forth in the merger agreement, at the effective time of the
merger, each share of common stock of GenVec issued and outstanding immediately prior to the effective time of the merger (other than shares held directly by Intrexon or Merger Sub and shares owned by GenVec shareholders who have properly exercised
their appraisal rights under Delaware law) will be converted into the right to receive merger consideration consisting of (i) 0.297 validly issued, fully paid and
non-assessable
shares of Intrexons
common stock, plus (ii) an amount equal to half of certain payments actually received by GenVec or its successor or any of their affiliates from or on behalf of Novartis under the NVS License Agreement, on account of milestone payments or
royalties due in relation to the period ending 36 months after the closing date divided by the number of shares of GenVec common stock having rights to the merger consideration, including any warrants that are exercised, in each case, subject to any
withholding of taxes required by applicable law. For more information regarding the merger consideration, see the sections entitled The merger agreementMerger consideration and Contingent payment rights agreement. The
exchange ratio for the stock portion of the merger consideration represents $7.00 per share of GenVec common stock based on the
five-day
VWAP of Intrexon common stock as of January 23, 2017.
The merger agreement may be terminated by mutual written consent of Intrexon and GenVec, and by either party if (i) the requisite GenVec shareholder
approval has not been obtained at the special meeting of GenVecs shareholders, (ii) any governmental order restraining or prohibiting the merger becomes final and
non-appealable,
(iii) the
merger is not consummated by July 24, 2017, or (iv) the other party breaches any of its representations, warranties, covenants or agreements in the merger agreement such that conditions to close the merger that relate to compliance with
representations and warranties and other obligations under the merger agreement are not reasonably capable of being satisfied while the breach is continuing and the breach is incapable of a cure sufficient to allow satisfaction of the conditions
prior to July 24, 2017. In addition, Intrexon may terminate the merger agreement if the GenVec board of directors effects a change in its recommendation to GenVecs shareholders with respect to the merger proposal, and GenVec may terminate
the merger agreement if the GenVec board of directors effects such a change in its recommendation in respect of a superior proposal and substantially concurrently with termination enters into a definitive agreement with respect to such superior
proposal. For more information regarding termination rights under the merger agreement, see the section entitled The merger agreementTermination of the merger agreement.
If the merger agreement is terminated by either party as a result of a change of recommendation by GenVecs board of directors, then GenVec must pay
Intrexon a termination fee equal to $550,000. The termination fee is also payable if the merger agreement is terminated by (i) either party as a result of the merger not being consummated by July 24, 2017, or (ii) Intrexon in the
event of certain specified breaches of the merger agreement by GenVec, and, in either case, an acquisition proposal has been announced publicly or made to GenVec, and GenVec enters into a letter of intent or an agreement in respect of an acquisition
proposal within 12 months of termination of the merger agreement. GenVec will also be obligated to pay Intrexon an expense reimbursement of up to $400,000 if the merger agreement is terminated by Intrexon because of certain specified breaches of the
merger agreement by GenVec and within six months after the date of such termination GenVec enters into a definitive agreement with a third party in respect of any acquisition proposal. In addition, if GenVec willfully breaches its
non-solicitation
covenants, then in circumstances in which an expense reimbursement is paid, GenVec will also be obligated to pay Intrexon an additional $200,000. If GenVec pays Intrexon the expense reimbursement,
including the additional $200,000 described in the preceding sentence (to the extent applicable), and the termination fee thereafter becomes payable, then the termination fee will be reduced by the amount of the previously paid expense
reimbursement, including such additional $200,000 (to the extent applicable). For more information regarding the termination fee and expense reimbursement, see the sections entitled The merger agreementTermination fee and The
merger agreementCosts and expenses.
129
GenVecs research and development expenses were $2.5 million and $2.6 million for each of the
years ended December 31, 2016 and 2015, respectively. These expenses were divided between GenVecs research and development platforms in the following manner:
|
|
|
|
|
|
|
|
|
|
|
Years ended December 31,
|
|
|
|
2016
|
|
|
2015
|
|
|
|
(in millions)
|
|
Therapeutic
|
|
$
|
1.7
|
|
|
$
|
0.5
|
|
Vaccines
|
|
|
0.5
|
|
|
|
1.0
|
|
Hearing loss and balance disorders
|
|
|
0.3
|
|
|
|
1.0
|
|
Other programs
|
|
|
|
|
|
|
0.1
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
2.5
|
|
|
$
|
2.6
|
|
|
|
|
|
|
|
|
|
|
Therapeutic.
GenVecs therapeutic programs have been funded in part by GenVecs collaborations with both
corporate and governmental entities. Since commencement of these development programs, GenVec has incurred approximately $27.8 million in research and development costs, including an allocation of corporate general and administrative expenses.
Hearing.
Through a collaboration with Novartis, GenVecs hearing loss and balance disorders program is focused on the restoration of hearing
and balance function through the regeneration of critical cells of the inner ear. Since commencement of this development program, GenVec has incurred approximately $24.7 million in research and development costs, including an allocation of
corporate general and administrative expenses, most of which have been funded under the NVS License Agreement.
Vaccines.
GenVecs vaccine
programs have been funded in part by GenVecs collaborations with both corporate and governmental entities. GenVec has worked on developing vaccine candidates against RSV, HSV, and other infectious diseases, as well as an animal health vaccine
for FMD, and continues to work on vaccine candidates for malaria. Since the commencement of these vaccine development programs, GenVec has incurred approximately $121.6 million in research and development costs, including an allocation of
corporate general and administrative expenses, most of which have been funded under GenVecs agreements with its various collaborators. GenVec has a collaboration with Merial to develop and commercialize vaccines for the prevention of a major
animal health problem,
foot-and-mouth
disease. Development efforts for this program were supported by the U.S. Department of Homeland Security, referred to herein as
DHS, and in collaboration with the USDA. GenVec also has a research collaboration with LMIV that will utilize GenVecs proprietary gorilla adenovirus vectors to deliver a number of novel antigens discovered at LMIV in order to create and test a
variety of malaria vaccine candidates.
To date, none of GenVecs proprietary or collaborative programs has resulted in a commercial product;
therefore, GenVec has not received any revenues or royalties from the sale of products. GenVec has funded its operations primarily through public and private placements of equity securities, payments received under collaborative programs with public
and private entities, and debt financings.
GenVecs revenue is primarily derived from its collaboration agreements with corporate partners,
institutions, and government entities under which GenVec may receive grants, milestone payments based on clinical progress, regulatory progress or net sales achievements, royalties, manufacturing revenue, or payment for GenVecs development
activities on behalf of third parties. GenVec is particularly dependent on the NVS License Agreement. The amount of GenVecs revenue derived from collaboration agreements in any given period will depend on a number of unpredictable factors,
including, among other factors, whether and when GenVec or its collaboration partner achieve clinical, regulatory and sales milestones.
GenVec has
incurred operating losses each year since inception and, as of December 31, 2016, had an accumulated deficit of approximately $290.6 million. GenVecs losses have resulted principally from costs incurred in research and development
and from general and administrative activities. Research and development expenses consist primarily of salaries and related personnel costs, sponsored research costs, patent costs, technology access fees, clinical trial costs, and other expenses
related to GenVecs product development and research programs. General and administrative expenses consist primarily of compensation and benefit expenses for executive, finance and other administrative personnel, facility costs, professional
fees, business development costs, insurance premiums, and other general corporate expenditures.
Due to the inherent uncertainties in research and
development and the nature of GenVecs business, GenVec is unable to estimate the duration and completion costs of its research and development projects or when, if ever, and to what extent GenVec will receive cash inflows from the
commercialization and sale of a product. GenVecs inability to complete its research and development projects in a timely manner or its failure to enter into collaborative agreements, when appropriate, could significantly increase GenVecs
capital requirements and could adversely impact its liquidity. These uncertainties could force GenVec to seek additional, external sources of financing from time to time in order to continue with GenVecs business strategy. GenVecs
inability to raise additional capital, or to do so on terms reasonably acceptable to GenVec, would jeopardize the future success of GenVecs business. However, GenVec believes its current cash, cash equivalents and investments and committed and
expected revenues from its strategic collaborations are expected to be sufficient to continue its current research, development and collaborative activities into early 2018.
CRITICAL ACCOUNTING POLICIES AND USE OF ESTIMATES
The
preparation of financial statements in conformity with accounting principles generally accepted in the United States requires GenVecs management to make estimates and assumptions that affect the amounts reported in GenVecs financial
statements and the accompanying notes. On an ongoing basis, GenVec evaluates its estimates using authoritative pronouncements, historical experience, and other assumptions as the basis for making estimates. Actual results could differ from those
estimates. Significant accounting policies are more fully described in Note 2 Summary of Significant Accounting Policies in the notes to GenVecs audited financial statements
included in this proxy statement/prospectus.
130
GenVec has discussed the development, selection, and disclosure of critical accounting policies and
estimates with the audit committee of its board of directors. While GenVec bases estimates and assumptions on its knowledge of current events and actions GenVec may undertake in the future, actual results may ultimately differ from these estimates
and assumptions.
GenVec believes the following accounting policies to be critical because they require significant estimates or judgment on the part of
management.
Revenue Recognition
Revenue is
recognized when all four of the following criteria are met (i) a contract is executed, (ii) the contract price is fixed and determinable, (iii) delivery of the services or products has occurred, and (iv) collectability of the
contract amounts is considered probable.
GenVecs collaborative research and development agreements provide for upfront license fees, research
payments, and/or substantive milestone payments. Upfront
non-refundable
fees associated with license and development agreements where GenVec has continuing involvement in the agreement are recorded as deferred
revenue and recognized over the estimated service period. If the estimated service period is subsequently modified, the period over which the upfront fee is recognized is modified accordingly on a prospective basis. Upfront
non-refundable
license and development fees for which no future performance obligations exist are recognized when collection is assured. Substantive milestone payments are considered performance payments and are
recognized upon achievement of the milestone if all of the following criteria are met: (i) achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; (ii) substantive effort
is involved in achieving the milestone; and (iii) the amount of the milestone payment is reasonable in relation to all of the deliverables and payment terms within the arrangement. Determination of whether a milestone meets the aforementioned
conditions involves the judgment of management.
Research and development revenue from cost-reimbursement and cost-plus
fixed-fee
agreements is recognized as earned based on the performance requirements of the contract. Revisions in revenues, cost, and billing factors, such as indirect rate estimates, are accounted for in the
period of change. Reimbursable costs under such contracts are subject to audit and retroactive adjustment. Contract revenues and accounts receivable reported in the financial statements are recorded at the amount expected to be received. Contract
revenues are adjusted to actual upon final audit and retroactive adjustment. Estimated contractual allowances are provided based on managements evaluation of current contract terms and past experience with disallowed costs and reimbursement
levels. Payments received in advance of work performed are recorded as deferred revenue.
Research and development revenue from fixed-price best efforts
arrangements is recognized as earned based on the performance requirements of the contract. Revenue under these arrangements is recognized when delivery to and acceptance by the customer has been received. Payments received in advance of customer
acceptance are recorded as deferred revenue. Once customer acceptance has been received, revenue and recoverable contract costs are recognized. Over the course of the arrangement, GenVec routinely evaluates whether revenue and profitability should
be recognized in the current period. Any known or probable losses on projects are charged to operations in the period in which such losses are determined.
Stock Based Compensation
GenVec accounts for
stock-based compensation based on the estimated grant date fair value of the stock using the Black-Scholes option-pricing model. The estimated grant date fair value is recognized in earnings over the requisite service period.
RECENT ACCOUNTING PRONOUNCEMENTS
For a discussion of
recently issued accounting pronouncements, refer to the section entitled Recent Accounting Pronouncements within Note 2, Summary of Significant Accounting Policies in the notes to GenVecs audited financial statements
included in this proxy statement/prospectus.
RESULTS OF OPERATIONS FOR THE YEARS ENDED DECEMBER 31, 2016 AND 2015
Revenue
Revenue decreased 42% to $0.5 million in
2016 from $0.9 million in 2015.
Revenues for the twelve-month period ended December 31, 2016 were primarily derived from the collaboration with
Novartis to discover and develop novel treatments for hearing loss and balance disorders. Revenues were also derived from GenVecs funded research and development programs with the National Institutes of Allergy and Infectious Diseases of the
National Institutes of Health, the U.S. Naval Medical Research Center, DHS, and Merial, all of which use GenVecs proprietary adenovector technology for the development of vaccines against malaria or vaccine candidates against FMD for
livestock.
In January 2010, GenVec entered into the NVS License Agreement with Novartis to discover and develop novel treatments for hearing loss and
balance disorders. Under the terms of the NVS License Agreement, GenVec licensed the world-wide rights to its preclinical hearing loss and balance disorders program to Novartis.
131
In addition, the NVS License Agreement allows GenVec to receive funding from Novartis for a research program
focused on developing additional adenovectors for hearing loss. The NVS License Agreement accounted for $0.1 million and $0.2 million of revenue for 2016 and 2015, respectively.
For more information on the NVS License Agreement, its terms and the amounts paid or recognized thereunder through December 31, 2016, see note 6,
Collaborative Agreements in the notes to GenVecs unaudited financial statements included in this proxy statement/prospectus.
In
August 2010, GenVec signed an agreement for the supply of services relating to development materials with Novartis related to their collaboration in hearing loss and balance disorders. Under this agreement, valued at $14.9 million, GenVec
agreed to manufacture clinical trial material for up to two lead product candidates. This agreement accounted for $0.1 million and $0.2 million in revenue in 2016 and 2015, respectively.
The decrease in revenue in 2016 is primarily due to a reduction in requested services performed in connection with GenVecs hearing loss and balance
disorders program in 2016 as compared to the prior year. Also contributing to the reduction was lower revenue earned under GenVecs animal health program. GenVecs work under the contract with DHS related to GenVecs animal health
program was completed in February 2015; as a result GenVec experienced reduced revenues of $0.2 million. This was partially offset by an amended license agreement with Merial for $0.1 million. Also partially offsetting the decrease was an
increase in revenue associated with GenVecs malaria program of $0.1 million.
Operating Expenses
General and administrative
.
General and administrative expenses increased 7% to $5.2 million in 2016 from $4.9 million in 2015.
The increase in general and administrative expenses in 2016 is primarily attributable to higher personnel costs related to the expansion of GenVecs workforce. The increased costs were partially offset by a decrease in professional service
costs in 2016 as compared to 2015. General and administrative expenses include a decrease of approximately $34,000 of stock-based compensation expense in 2016 as compared to the prior year.
Research and development
.
Research and development expenses decreased 2% to $2.5 million in 2016 from $2.6 million in 2015. In
2016, GenVec experienced a slight decrease in professional costs as compared to the prior year. Stock-based compensation expense included in research and development personnel costs decreased approximately by $108,000 in 2016 as compared to the
prior year.
Other Income (Loss)
Other income, net
in 2016 was $1.4 million as compared to $22,000 in 2015. The increases in 2016 were due to a $1.7 million change in the fair value of the warrant liabilities in connection with GenVecs May 10, 2016 registered offering, partially
offset by financing expenses of $250,000 related to the offering.
LIQUIDITY AND CAPITAL RESOURCES
GenVec has experienced significant losses since its inception. As of December 31, 2016, GenVec had an accumulated deficit of $290.6 million. The
process of developing and commercializing GenVecs product candidates requires significant research and development work and clinical trial work, as well as significant manufacturing and process development efforts. These activities, together
with GenVecs general and administrative expenses, are expected to continue to result in significant operating losses for the foreseeable future.
Years Ended December 31, 2016 and 2015
As of
December 31, 2016, GenVecs cash, cash equivalents, and investments totaled $7.2 million, as compared to $8.7 million on December 31, 2015.
For 2016, GenVec used net cash of $6.0 million for operating activities. This consisted of a net loss for the period of $5.8 million, which included
approximately $0.1 million of
non-cash
depreciation and amortization, $0.8 million of
non-cash
stock-based compensation expenses, $0.3 million of
non-cash
adjustments for financing expense associated with GenVecs May 2016 financing, $1.7 million for the change in the fair value of warrant liabilities issued in connection with GenVecs May 2016
financing, and $0.3 million provided by the net change in current assets and liabilities. Net cash was used primarily for GenVecs internally funded research and development programs and general and administrative activities.
Net cash used in investing activities during 2016 was $1.9 million, which included $3.5 million for the purchase of marketable securities, partially
offset by $1.6 million of proceeds from the sale and maturity of investment securities. GenVec also used $19,000 for the purchase of property and equipment.
Net cash provided by financing activities during 2016 was $4.5 million, which represents the proceeds, net of issuance costs, from GenVecs
concurrent offerings of common stock and warrants, described below, completed on May 10, 2016.
As of December 31, 2015, cash, cash equivalents,
and investments totaled $8.7 million, as compared to $14.7 million on December 31, 2014.
For 2015, GenVec used net cash of
$5.9 million for operating activities. This consisted of a net loss for the period of $6.5 million, which included approximately $0.1 million of
non-cash
depreciation and amortization,
$0.9 million of
non-cash
stock-based compensation expenses, $0.5 million used for the net change in current assets and liabilities, and $0.1 million provided by the net change in
non-current
assets. Net cash was used primarily for GenVecs internally funded research and development programs and general and administrative activities.
132
Net cash provided by investing activities during 2015 was $5.0 million, which included
$5.1 million for the net proceeds from the sale of marketable securities and $0.1 million for the purchase of property and equipment.
Net cash
used in financing activities during 2015 was $24,000, which represents the costs of maintaining GenVecs equity distribution agreement with Roth, described under
Capital Resources and Sources of Liquidity
below, in 2015.
NASDAQ Notifications and Reverse Stock Split
On
February 24, 2016, GenVec received notification from NASDAQ that the minimum bid price of GenVecs common stock had remained below $1.00 per share for 30 consecutive business days, and GenVec therefore was not in compliance with the
minimum bid price requirement for continued listing set forth in Marketplace Rule 5550(a)(2). The notification letter stated that GenVec would be afforded 180 calendar days, or until August 22, 2016, to regain compliance with the minimum bid
price requirement. On August 23, 2016, GenVec received notification from NASDAQ that it had been afforded a second 180 calendar day grace period, or until February 21, 2017, to regain compliance. To regain compliance, the closing bid price
of GenVecs common stock had to meet or exceed $1.00 per share for at least ten consecutive business days. On October 20, 2016, GenVecs shareholders approved an amendment to GenVecs Amended and Restated Certificate of
Incorporation to effect a reverse stock split of GenVecs common stock at a ratio within the range of
one-for-three
to
one-for-ten,
as determined by GenVecs board of directors. On December 1, 2016, GenVec effected the reverse stock split at a ratio of
one-for-ten,
whereby each 10 shares of common stock were combined into one share of common stock. The reverse stock split was intended to enable GenVec to regain
compliance with the Bid Price Requirement. On December 15, 2016, GenVec received a notice from NASDAQ stating that GenVec had regained compliance.
Capital Resources and Sources of Liquidity
Since
GenVecs initial public offering, GenVec has raised capital by offering shares of its common stock and warrants to purchase shares of its common stock in a variety of offerings.
Effective September 7, 2011, GenVec entered into the rights agreement with AST, as rights agent. The rights agreement was not adopted in response to any
specific effort to acquire control of GenVec. In connection with the adoption of the rights agreement, GenVecs board of directors declared a dividend of one preferred stock purchase right, which we refer to as a Right, for each outstanding
share of common stock to shareholders of record as of the close of business on September 7, 2011. Initially, the Rights will be represented by GenVecs common stock certificates or book-entry notations, will not be traded separately from
the common stock and will not be exercisable. As a result of the reverse stock split, there are now ten Rights associated with each outstanding share of common stock. In the event that any person acquires beneficial ownership of 20% or more of the
outstanding shares of GenVecs common stock, or upon the occurrence of certain other events, each holder of a Right, other than the acquirer, would be entitled to receive, upon payment of the purchase price, which is initially set at $32 per
Right, a number of shares of GenVec common stock having a value equal to two times such purchase price. GenVecs board of directors is entitled to redeem the Rights at $0.001 per Right at any time before a person or group has acquired 20% or
more of GenVecs common stock. The Rights will expire on September 7, 2021, subject to GenVecs right to extend such date, unless earlier redeemed or exchanged by GenVec or terminated. The Rights will at no time have any voting
rights. GenVec has authorized 30,000 shares of series B junior participating preferred stock in connection with the adoption of the rights agreement. There was no series B junior participating preferred stock issued or outstanding as of
December 31, 2016.
In connection with its execution of the merger agreement with Intrexon and Merger Sub, GenVec amended the rights agreement to
provide that none of Intrexon, Merger Sub or any of their respective associates or affiliates shall become an Acquiring Person (as defined in the rights agreement) under the rights agreement and to otherwise exempt the merger from triggering
provisions or rights under the rights agreement.
On January 23, 2014, GenVec filed a $75.0 million shelf registration statement on Form
S-3,
referred to herein as the 2014 shelf registration statement, with the SEC, which was declared effective February 11, 2014 and allowed GenVec to obtain financing through the issuance of any combination of
common stock, preferred stock or warrants.
On February 11, 2014, GenVec entered into an equity distribution agreement, referred to herein as the
equity distribution agreement, with Roth, pursuant to which GenVec may sell from time to time up to $10.0 million of shares of its common stock, par value $0.001 per share, through Roth. Sales of shares pursuant to the equity distribution
agreement, if any, may be made by any method permitted by law deemed to be an at the market offering as defined in Rule 415 of the Securities Act of 1933, as amended, including without limitation directly on the NASDAQ Capital Market, or
any other existing trading market for the shares or through a market maker, or, if agreed by GenVec and Roth, by any other method permitted by law, including but not limited to in negotiated transactions. Sales under the equity distribution
agreement have been made and will be made pursuant to the 2014 shelf registration statement. As of March 31, 2014, GenVec had sold 72,168 shares pursuant to the equity distribution agreement for gross proceeds of approximately
$2.6 million. GenVec has not sold any shares under the equity distribution agreement since that date.
On March 18, 2014, GenVec sold 287,000
shares of its common stock, par value $0.001, in a registered direct offering pursuant to the 2014 shelf registration statement, at a price of $31.50 per share, resulting in gross proceeds of approximately $9.0 million.
133
On May 10, 2016, in a registered offering pursuant to the 2014 shelf registration statement, GenVec
sold 547,195 shares of its common stock, referred to herein as the May 2016 Shares, at a purchase price of $9.1375 per share. In a private placement concurrent with the sale of the May 2016 Shares, GenVec sold to the investors who purchased the May
2016 Shares warrants to purchase 410,396.8 shares of GenVecs common stock, referred to herein as the May 2016 Warrants. The May 2016 Shares and the May 2016 Warrants were sold pursuant to a securities purchase agreement for aggregate gross
proceeds of $5.0 million. Subject to certain ownership limitations, the May 2016 Warrants became exercisable on November 10, 2016 at an exercise price equal to $8.30 per share of common stock, subject to adjustments as provided under
the terms of the May 2016 Warrants. The May 2016 Warrants are exercisable until November 10, 2022.
In connection with the offering of the May 2016
Shares and May 2016 Warrants, GenVec issued to the placement agent and its designees unregistered warrants to purchase an aggregate of 38,303.7 shares of GenVecs common stock. Such warrants have substantially the same terms as the May 2016
Warrants, except that they will expire on May 4, 2021 and have an exercise price equal to $11.422 per share of common stock.
The net proceeds from
the sale of the May 2016 Shares and the May 2016 Warrants were $4.5 million after deducting certain fees due to the placement agent and GenVecs estimated transaction expenses.
As of December 31, 2016, pursuant to the equity distribution agreement, the March 18, 2014 registered direct offering, and the May 10, 2016
registered offering, GenVec had sold 906,363 shares of its common stock since the 2014 shelf registration statement became effective on February 11, 2014 for gross proceeds of $16.6 million. These sales resulted in proceeds, net of
issuance costs, of approximately $15.1 million. The 2014 shelf registration statement expired on February 11, 2017.
On January 24, 2017,
GenVec, Intrexon and Merger Sub entered into the merger agreement, pursuant to which, and on the terms and conditions set forth therein, Merger Sub will merge with and into GenVec. GenVec will survive the merger as a wholly owned subsidiary of
Intrexon. For more information on the merger and the merger agreement, see the sections entitled The merger and The merger agreement.
Subject to the terms and conditions set forth in the merger agreement, at the effective time of the merger, each share of GenVec common stock issued and
outstanding immediately prior to the effective time of the merger (other than shares held directly by Intrexon or Merger Sub and shares owned by GenVec shareholders who have properly exercised their appraisal rights under Delaware law) will be
converted into the right to receive the merger consideration. For more information on the effects of the merger, see the section entitled The mergerEffects of the merger.
GenVecs estimated future capital requirements are uncertain and could change materially as a result of many factors, including the progress of
GenVecs research, development, clinical, manufacturing, and commercialization activities. GenVec currently estimates it will use between $6.5 million and $7.0 million of cash during the four quarters ending December 31, 2017.
GenVecs estimate includes approximately $0.4 million in contractual obligations.
GenVecs financial statements as of December 31,
2016 have been prepared under the assumption that GenVec will continue as a going concern for the next twelve months. The report of GenVecs independent registered public accounting firm for the year ended December 31, 2016
includes an explanatory paragraph about GenVecs ability to continue as a going concern. If the merger with Intrexon is not consummated, GenVecs ability to continue as a going concern may depend on its ability to raise additional capital,
attain further operating efficiencies, reduce expenditures, and, ultimately, to generate revenue. If GenVec management is unsuccessful in these efforts, GenVecs current capital is not expected to be sufficient to fund GenVecs operations
for the next twelve months. GenVecs financial statements as of December 31, 2016 do not include any adjustments that might result from the outcome of this uncertainty.
OFF-BALANCE
SHEET OBLIGATIONS
GenVec had no
off-balance
sheet obligations other than in connection with its operating leases, as disclosed in Note 7,
Commitments and Contingencies, in the notes to GenVecs audited financial statements
included in this proxy statement/prospectus.
GenVec changes in and disagreements with accountants on accounting and financial disclosures
Not applicable.
GenVecs quantitative and qualitative disclosures about market risk
Not applicable.
134
GenVec security ownership of certain beneficial owners and
management
The following table sets forth certain information as of April 15, 2017 (unless otherwise specified), regarding the beneficial
ownership of GenVecs common stock by (i) each named executive officer of GenVec, (ii) each director of GenVec and (iii) all current directors and executive officers as a group. As of April 15, 2017, there were three persons
known to GenVec to be the beneficial owners of more than 5% of the outstanding shares of common stock.
Beneficial ownership is determined in accordance
with the rules of the SEC for computing the number of shares of common stock beneficially owned by a person and the percentage ownership of that person. Shares of common stock subject to options currently exercisable or exercisable within 60 days
after April 15, 2017 are considered outstanding for the purpose of computing the percentage ownership of the person holding such options, but are not considered outstanding when computing the percentage ownership of each other person. Except as
indicated in the footnotes to this table, each shareholder named in the table below has sole voting and investment power for the shares shown as beneficially owned by them. Percentage of beneficial ownership is based on 2,273,632 shares of common
stock outstanding on April 15, 2017. Unless otherwise specified, the address for each director or executive officer is care of GenVec at its principal office.
|
|
|
|
|
|
|
|
|
Name of Beneficial Owner
(1)
|
|
Total Number of
Shares
Beneficially
Owned
|
|
|
% of
Class
Owned
|
|
Beneficial Owner of More than 5% of the Outstanding Common
Stock:
|
|
|
|
|
|
|
|
|
|
|
|
Aristides Capital, LLC (2)
|
|
|
169,519
|
|
|
|
7.5
|
%
|
Sabby Healthcare Master Fund, LTD (3)
|
|
|
120,544
|
|
|
|
5.3
|
%
|
MMCAP International Inc. SPC (4)
|
|
|
257,272
|
|
|
|
11.3
|
%
|
|
|
|
Directors and Named Executive Officers:
|
|
|
|
|
|
|
|
|
|
|
|
Wayne T. Hockmeyer, Ph.D.
|
|
|
14,550
|
|
|
|
|
*
|
William N. Kelley, Ph.D.
|
|
|
12,800
|
|
|
|
|
*
|
Stefan D. Loren, Ph.D.
|
|
|
6,500
|
|
|
|
|
*
|
Quinterol J. Mallette, M.D.
|
|
|
4,000
|
|
|
|
|
*
|
Michael Richman
|
|
|
2,500
|
|
|
|
|
*
|
Marc R. Schneebaum
|
|
|
12,800
|
|
|
|
|
*
|
Douglas J. Swirsky
|
|
|
77,249
|
|
|
|
3.3
|
%
|
Douglas E. Brough, Ph.D.
|
|
|
48,066
|
|
|
|
2.1
|
%
|
Bryan T. Butman, Ph.D.
|
|
|
37,972
|
|
|
|
1.7
|
%
|
All directors and executive officers as a group (10 persons)
|
|
|
227,009
|
|
|
|
9.4
|
%
|
(1)
|
Includes shares of Common Stock issuable upon exercise of options that are exercisable within 60 days of March 3, 2017 in the following amounts: Dr. Hockmeyer, 6,750 shares; Dr. Kelley, 5,250 shares;
Mr. Loren, 6,000 shares; Dr. Mallette, 4,000 shares; Mr. Richman, 2,500 shares; Mr. Schneebaum, 5,450 shares; Mr. Swirsky, 50,905 shares; Dr. Brough, 33,836 shares; Dr. Butman, 29,500 shares; and directors and
executive officers as a group (10 people), 154,572 shares.
|
(2)
|
Based solely on the Schedule 13G filed on January 31, 2017 by Christopher M. Brown, Aristides Capital, LLC (the General Partner), Aristides Fund QP, LP (the 3c7 Fund) and Aristides Fund LP
(the 3c1 Fund, and together with 3c7 Fund, the Funds) (collectively, the Reporting Persons) and further information provided by the Reporting Persons. Mr. Brown and the General Partner have sole voting and
dispositive power with respect to all of these shares, the 3c7 Fund has sole voting and dispositive power with respect to 34,191 shares, and the 3c1 Fund has sole voting and dispositive power with respect to 135,328 shares.
|
135
The principal business office of the Reporting Persons is c/o Aristides Capital LLC, 25 S.
Huron St. Suite 21, Toledo Ohio 43604.
(3)
|
Based solely on the Schedule 13G/A filed on January 10, 2017 by Sabby Healthcare Master Fund, Ltd. (SHMF), Sabby Volatility Warrant Master Fund, Ltd (SVWMF), Sabby Management, LLC and Hal
Mintz. SMHF has shared voting and dispositive power with respect to 72,719 shares. SVWMF has shared voting and dispositive power with respect to 47,825 shares. Sabby Management, LLC and Mr. Mintz each have shared voting and dispositive power
with respect to 120,544 shares.
|
The address for SHMF and SVWMF is 89 Nexus Way, Camana Bay Grand Cayman
KY1-9007
Cayman Islands and the address for Sabby Management, LLC and Mr. Mintz is 10 Mountainview Road, Suite 205 Upper Saddle River, New Jersey 07458.
(4)
|
Based solely on the Schedule 13G filed on March 14, 2017 by MMCAP International Inc. SPC (MMCAP) and MM Asset Management Inc. (together with MMCAP, the MMCAP Reporting Persons) and the Form 4
filed on March 14, 2017 by MMCAP. The MMCAP Reporting Persons have shared voting and dispositive power with respect to all of these shares.
|
The address for MMCAP International Inc. SPC is P.O. Box 259 George Town Financial Centre Grand Cayman, Cayman Islands
KY1-1208.
The address for MM Asset Management, Inc. is 66 Wellington Street West, Suite 2707 Toronto, Ontario M5K 1H6 Canada.
GenVec equity compensation plan information
The following table provides information as of December 31, 2016 with respect to shares of common stock that may be issued pursuant to outstanding equity
awards under GenVecs existing equity incentive plans, as well as information with respect to shares of common stock that remain available for issuance as of that date under those plans. All share amounts relating to GenVec stock options,
warrants and rights and to securities remaining available for future issuance under GenVec equity compensation plans, and the exercise price or weighted-average exercise price of outstanding options, warrants and rights, set forth in the table below
and in the related notes have been retroactively adjusted to reflect the reverse stock split.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a)
|
|
|
(b)
|
|
|
(c)
|
|
Plan Category
|
|
Number of securities to be
issued upon exercise of
outstanding options,
warrants and
rights
|
|
|
Weighted-average
exercise price of
outstanding options,
warrants and
rights
|
|
|
Number of securities
remaining available for
future issuance under
equity compensation
plans
(excluding
securities reflected in
column (a))
|
|
Equity compensation plans approved by security holders (1)
|
|
|
280,860
|
|
|
$
|
31.11
|
|
|
|
99,379
|
|
Equity compensation plans not approved by security holders (2)
|
|
|
8,333
|
|
|
$
|
25.40
|
|
|
|
0
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
|
289,193
|
|
|
$
|
30.95
|
|
|
|
99,379
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1)
|
This row represents awards granted under the 2002 Plan and the 2015 Plan and shares remaining available for issuance under the 2015 Plan.
|
(2)
|
In May 2012, GenVec granted a CEO Inducement Award to purchase shares of GenVec common stock to GenVecs
then President and Chief Executive Officer. The CEO Inducement Award allowed for the purchase of up to 25,000 shares of GenVec common stock at an exercise price per share equal to $25.40. When GenVecs former President and Chief Executive
Officer departed GenVec, she forfeited her unvested shares as of September 3, 2013, but the exercise
|
136
|
period was extended to the end of the full term of the
10-year
option to May 23, 2022 for those options already vested. Pursuant to the CEO Inducement
Award, the options are subject to the terms of any agreement of merger, liquidation, or reorganization in the event GenVec is subject to such corporate activity.
|
Advisory vote on merger-related compensation
(Proposal 2)
As required by Section 14A
of the Exchange Act and the SECs rules thereunder, GenVec is asking its shareholders to cast a
non-binding,
advisory vote on the compensation that will or may become payable to GenVecs named
executive officers in connection with the merger, as disclosed in the table captioned Golden Parachute Compensation in the section of this proxy statement/prospectus entitled The mergerQuantification of potential payments to
GenVec executive officers in connection with the merger, including in the footnotes to such table and the associated narrative discussion.
In
accordance with these requirements, GenVec is asking its shareholders to vote on the adoption of the following resolution:
RESOLVED, that the
compensation that will or may become payable to the named executive officers of GenVec, Inc. in connection with the merger, as disclosed in the table captioned Golden Parachute Compensation in the section of the proxy
statement/prospectus entitled The mergerQuantification of potential payments to GenVec executive officers in connection with the merger, including the footnotes to such table and the associated narrative discussion, and the
agreements or understandings pursuant to which such compensation will or may become payable, are hereby APPROVED.
The vote on the compensation
payable in connection with the merger is a vote separate and apart from the votes on the other proposals described in this proxy statement/prospectus. You may vote to approve this proposal and vote not to approve the merger proposal, or you may vote
against this proposal and vote to approve the merger proposal. Because the vote on this proposal is advisory in nature only, it will not be binding on GenVec. Accordingly, because GenVec is contractually obligated to pay the compensation covered by
this proposal, such compensation will become payable, subject only to the conditions applicable thereto, if the merger agreement is adopted and the merger is completed, regardless of the outcome of the advisory vote on this proposal.
The GenVec board of directors unanimously recommends that you vote FOR the approval of this proposal.
Approval of this proposal requires the affirmative vote of the holders of a majority of shares of GenVec common stock present in person or represented by
proxy at the special meeting and entitled to vote on this proposal. If you fail to vote, or fail to instruct your broker, bank or other nominee to vote, it will have no effect on this proposal, assuming a quorum is present. If you mark your proxy or
voting instructions to abstain, it will have the same effect as voting against this proposal.
Adjournment of
the meeting
(Proposal 3)
The
special meeting may be adjourned to another time or place, if necessary or appropriate, to permit further solicitation of proxies to obtain additional proxies in favor of the merger proposal.
If the number of shares of GenVec common stock present in person or represented by proxy at the special meeting voting in favor of the merger proposal is
insufficient to approve the merger proposal at the time of the special meeting, then GenVec may move to adjourn the special meeting in order to enable its board of directors to solicit additional proxies in respect of the merger proposal. In that
event, GenVec shareholders will be asked to vote only upon the adjournment proposal, and not on any other proposal, including the merger proposal.
In
this proposal, you are being asked to authorize the holder of any proxy solicited by GenVecs board of directors to vote in favor of any adjournment of the special meeting, if necessary or appropriate, to solicit additional proxies in favor of
the merger proposal. If GenVec shareholders approve this adjournment proposal, GenVec could adjourn the special meeting and any adjourned session of the special meeting and use the additional time to solicit additional proxies, including the
solicitation of proxies from GenVec shareholders that have previously returned properly executed proxy cards or voted by telephone. Among other things, approval of the adjournment proposal could mean that, even if GenVec has received proxies
representing a sufficient number of votes against the approval of the merger proposal such that the proposal would be defeated, GenVec could adjourn the special meeting without a vote on the merger proposal and seek to obtain sufficient votes in
favor of the merger proposal to obtain approval of that proposal.
137
The GenVec board of directors unanimously recommends that you vote FOR the approval of this
proposal.
Approval of this proposal requires the affirmative vote of the holders of a majority of shares of GenVec common stock present in person or
represented by proxy at the special meeting and entitled to vote on this proposal. If you fail to vote, or fail to instruct your broker, bank or other nominee to vote, it will have no effect on this proposal, assuming a quorum is present. If you
mark your proxy or voting instructions to abstain, it will have the same effect as voting against this proposal.
138
Legal matters
The validity of the shares of Intrexon common stock to be issued in the merger will be passed upon by Troutman Sanders LLP.
CONVERSION OF
SECURITIES IN THE MERGER
2.1
Conversion of Securities
. At the Effective Time, by virtue of the
Merger and without any action on the part of Parent, Merger Sub, the Company or the holders of any of the following securities:
(a)
Conversion of Company Shares
. Each share of common stock, par value $0.001 per share, of the Company
(each, a
Company Share
and collectively, the
Company Shares
) issued and outstanding immediately prior to the Effective Time, other than Company Shares to be cancelled or converted pursuant to
Sections
2.1(b)
or
2.1(c)
or Dissenting Shares, shall be automatically converted into and thereafter represent the right to receive (i) 0.297 (as may be adjusted pursuant to
Section
2.7
, the
Exchange
Ratio
) validly issued, fully paid and
non-assessable
shares of Parent common stock, no par value per share (
Parent
A-3
Common Stock
), and cash in lieu of fractional shares of Parent Common Stock as contemplated by
Section
2.8
(the
Stock Consideration
)
plus
(ii) one Contingent Payment Right (a
CPR
), which shall represent the right to receive the CPR Payment Amount (as such term is defined in the Contingent Payment Rights Agreement), if any, at the times provided for
in the Contingent Payment Rights Agreement, without interest (the Stock Consideration plus one CPR is collectively referred to herein as the
Merger Consideration
), subject to any withholding of Taxes required by applicable Law,
upon surrender of the Certificates or Book-Entry Company Shares in accordance with
Section
2.2
. As of the Effective Time, all such Company Shares shall no longer be outstanding and shall automatically be cancelled and
retired and shall cease to exist, and shall thereafter represent only the right to receive the Merger Consideration to be paid in accordance with
Section
2.2
.
(b)
Cancellation of Treasury Shares and Parent-Owned Shares
. Each Company Share held by the Company as treasury
stock or held directly by Parent or Merger Sub, in each case, immediately prior to the Effective Time, shall automatically be cancelled and retired and shall cease to exist, and no consideration or payment shall be delivered in exchange therefor or
in respect thereof.
(c)
Merger Sub Equity Interests
. All outstanding Equity Interests of Merger Sub
held immediately prior to the Effective Time shall be converted into and become (in the aggregate) 100 shares of newly and validly issued, fully paid and
non-assessable
shares of common stock of the Surviving
Corporation.
2.2
Payment for Securities; Surrender of Certificates
.
(a)
Exchange Agent
. At or prior to the Effective Time, Parent shall designate a reputable bank or trust
company to act as the paying and exchange agent (the identity and terms of designation and appointment of which shall be reasonably acceptable to the Company) for purposes of delivering or causing to be delivered to each holder of Company Shares the
Stock Consideration that such holder shall become entitled to receive with respect to such holders Company Shares pursuant to the Merger (the
Exchange Agent
). Parent shall pay, or cause to be paid, the fees and expenses
of the Exchange Agent. At or prior to the Effective Time, Parent shall deposit, or cause to be deposited, with the Exchange Agent (i) evidence of a number of shares of Parent Common Stock in book-entry form equal to the Stock Consideration
and (ii) cash sufficient to make payments in lieu of any fractional shares of Parent Common Stock pursuant to
Section
2.8
(such evidence of book-entry shares of Parent Common Stock and cash deposited with the Exchange
Agent, collectively, the
Exchange Fund
), to which holders of Company Shares shall be entitled at the Effective Time pursuant to this Agreement. In the event the cash portion of the Exchange Fund shall be insufficient to make
cash payments in lieu of any fractional shares of Parent Common Stock, Parent shall promptly deposit, or cause to be deposited, with the Exchange Agent such additional funds to ensure that the Exchange Agent has sufficient funds to make such
payments. In addition, Parent shall deposit or cause to be deposited with the Exchange Agent, as necessary from time to time after the Effective Time, any dividends or other distributions, if any, to which the holders of Company Shares may be
entitled pursuant to
Section
2.9
, with both a record and payment date after the Effective Time and prior to the surrender of the Company Shares in exchange for such Parent Common Stock. If requested by Parent, the cash
portion of the Exchange Fund shall be invested
A-4
by the Exchange Agent as directed by Parent, pending payment thereof by the Exchange Agent to the holders of the Company Shares;
provided
,
however
, that any such investments shall
be in obligations of, or guaranteed by, the United States government or rated
A-1
or
P-1
or better by Moodys Investor Service, Inc. or Standard &
Poors Corporation, respectively. Earnings from such investments shall be the sole and exclusive property of the Surviving Corporation, and no part of such earnings shall accrue to the benefit of holders of Company Shares. Any losses
with respect to such investments shall have no effect upon amounts payable or other consideration due to holders of Company Shares or any other Person hereunder.
(b)
Procedures for Surrender
.
(i)
Certificates
. As soon as practicable after the Effective Time (and in no event later than three
(3) Business Days after the Effective Time), the Surviving Corporation shall cause the Exchange Agent to mail to each Person that was, immediately prior to the Effective Time, a holder of record of Company Shares represented by certificates
(the
Certificates
), which Company Shares were converted into the right to receive the Merger Consideration at the Effective Time pursuant to this Agreement: (A) a letter of transmittal, which shall specify that delivery shall
be effected, and risk of loss and title to the Certificates shall pass, only upon delivery of the Certificates to the Exchange Agent, shall include any certifications Parent may reasonably request relating to any withholding obligations of Parent
under the Code or other applicable Tax law, and shall otherwise be in such form as Parent and the Exchange Agent shall reasonably agree; and (B) instructions for effecting the surrender of the Certificates (or affidavits of loss in lieu of the
Certificates as provided in
Section
2.2(e)
) in exchange for payment of the Merger Consideration. Upon surrender of a Certificate (or affidavit of loss in lieu of the Certificate as provided in
Section
2.2(e)
) to the Exchange Agent or to such other agent or agents as may be appointed by Parent, together with delivery of a letter of transmittal, duly executed and in proper form, with respect to such Certificates,
and such other documents as may be reasonably required pursuant to such instructions, the holder of such Certificates shall be entitled to receive the Merger Consideration for each Company Share formerly represented by such Certificates (without
interest and after giving effect to any required Tax withholdings as provided in
Section
2.6
), and any Certificate so surrendered shall forthwith be cancelled. The Parent Common Stock constituting part of the Merger
Consideration to be delivered in respect of Company Shares formerly represented by such Certificates shall be in uncertificated book-entry form, unless a physical certificate is requested by a holder of such Company Shares formerly represented by
such Certificates or is otherwise required under applicable Law. If payment of the Merger Consideration is to be made to a Person other than the Person in whose name any surrendered Certificate is registered, it shall be a condition precedent
of payment that the Certificate so surrendered shall be properly endorsed or shall be otherwise in proper form for transfer, and the Person requesting such payment shall have paid any transfer and other similar Taxes required by reason of the
payment of the Merger Consideration to a Person other than the registered holder of the Certificate so surrendered and shall have established to the satisfaction of the Surviving Corporation that such Taxes either have been paid or are not required
to be paid. No interest will be paid or accrued on any amount payable upon due surrender of the Certificates. Until surrendered as contemplated hereby, each Certificate shall be deemed at any time after the Effective Time to represent only
the right to receive the Merger Consideration as contemplated by this Agreement, except for Certificates representing
A-5
Company Shares that are Dissenting Shares, which shall be deemed to represent the right to receive payment of the fair value of such Company Shares in accordance with and to the extent provided
by Section 262 of the DGCL. Parent shall, at or prior to the Effective Time, duly authorize, execute, and the deliver the Contingent Payment Rights Agreement.
(ii)
Book-Entry Company Shares
. Notwithstanding anything to the contrary contained in this Agreement,
no holder of
non-certificated
Company Shares represented by book-entry (
Book-Entry Company Shares
) shall be required to deliver a Certificate or, in the case of holders of
Book-Entry Company Shares held through The Depository Trust Company, an executed letter of transmittal to the Exchange Agent to receive the Merger Consideration that such holder is entitled to receive pursuant to
Section
2.1(a)
. In lieu thereof, each holder of record of one or more Book-Entry Company Shares held through The Depository Trust Company whose Company Shares were converted into the right to receive the Merger
Consideration at the Effective Time pursuant to this Agreement shall, upon receipt of an agents message by the Exchange Agent (or such other evidence of transfer or surrender as the Exchange Agent may reasonably request), be
entitled to receive, and Parent shall cause the Exchange Agent to pay and deliver to The Depository Trust Company or its nominee as promptly as practicable after the Effective Time, the Merger Consideration in respect of each such Book-Entry Company
Share pursuant to the provisions of this
Article 2
(after giving effect to any required Tax withholdings as provided in
Section
2.6
), and such Book-Entry Company Shares of such holder shall be cancelled. As soon
as practicable after the Effective Time (and in no event later than three (3) Business Days after the Effective Time), the Surviving Corporation shall cause the Exchange Agent to mail to each Person that was, immediately prior to the Effective
Time, a holder of record of Book-Entry Company Shares not held through The Depository Trust Company: (A) a letter of transmittal, which shall include any certifications Parent may reasonably request relating to any withholding obligations of
Parent under the Code or other applicable Tax law and be in such form as Parent and the Exchange Agent shall reasonably agree; and (B) instructions for returning such letter of transmittal in exchange for the Merger Consideration. Upon
delivery of such letter of transmittal, in accordance with the terms of such letter of transmittal, duly executed, the holder of such Book-Entry Company Shares shall be entitled to receive in exchange therefor the Merger Consideration in respect of
each such Book-Entry Company Share pursuant to the provisions of this
Article 2
(without interest and after giving effect to any required Tax withholdings as provided in
Section
2.6
), and such Book-Entry Company
Shares shall at the Effective Time be cancelled. The Parent Common Stock constituting part of the Merger Consideration to be delivered in respect of any Book-Entry Company Shares shall be in uncertificated book-entry form, unless a physical
certificate is requested by a holder of Book-Entry Company Shares or is otherwise required under applicable Law. Payment and delivery of the Merger Consideration with respect to Book-Entry Company Shares shall only be made to the Person in
whose name such Book-Entry Company Shares are registered. No interest will be paid or accrued on any amount payable upon due surrender of Book-Entry Company Shares. Until paid or surrendered as contemplated hereby, each Book-Entry Company
Share shall be deemed at any time after the Effective Time to represent only the right to receive the Merger Consideration as contemplated by this Agreement, except for Book-Entry Company Shares representing Company Shares that are Dissenting
Shares, which shall be deemed to represent the right to receive payment of the fair value of such Company Shares in accordance with and to the extent provided by Section 262 of the DGCL.
A-6
(c)
Transfer Books; No Further Ownership Rights in Shares
. At
the Effective Time, the stock transfer books of the Company shall be closed and thereafter there shall be no further registration of transfers of Company Shares on the records of the Company. From and after the Effective Time, the holders of
Certificates and Book-Entry Company Shares that represented ownership of Company Shares outstanding immediately prior to the Effective Time shall cease to have any rights with respect to such Company Shares except as otherwise provided for herein or
by applicable Law. If, after the Effective Time, Certificates are presented to the Surviving Corporation for any reason, they shall be cancelled and exchanged as provided in this Agreement.
(d)
Termination of Fund; Abandoned Property; No Liability
. Any portion of the funds in Exchange Fund
(including any interest received with respect thereto) made available to the Exchange Agent that remains unclaimed by the holders of Certificates or Book-Entry Company Shares on the six (6) month anniversary of the Effective Time will
be returned to the Surviving Corporation or an affiliate thereof designated by the Surviving Corporation, upon demand, and any such holder who has not tendered its Certificates or Book-Entry Company Shares for the Merger Consideration in accordance
with
Section
2.2(b)
prior to such time shall thereafter look only to the Surviving Corporation (subject to abandoned property, escheat or other similar Laws) for delivery of the Merger Consideration, without interest and
subject to any withholding of Taxes required by applicable Law, in respect of such holders surrender of their Certificates or Book-Entry Company Shares and compliance with the procedures in
Section
2.2(b)
. Any
Merger Consideration remaining unclaimed by the holders of Certificates or Book-Entry Company Shares immediately prior to such time as such amounts would otherwise escheat to, or become property of, any Governmental Entity will, to the extent
permitted by applicable Law, become the property of the Surviving Corporation or an affiliate thereof designated by the Surviving Corporation, free and clear of any claim or interest of any Person previously entitled thereto. Notwithstanding
the foregoing, none of Parent, Merger Sub, the Surviving Corporation, the Exchange Agent or their respective affiliates will be liable to any holder of a Certificate or Book-Entry Company Shares for Merger Consideration delivered to a public
official pursuant to any applicable abandoned property, escheat or similar Law. Any portion of the Merger Consideration made available to the Exchange Agent pursuant to
Section 2.2(a)
, to pay for Company Shares for which appraisal rights
have been perfected shall be returned to the Surviving Corporation, upon demand.
(e)
Lost, Stolen or Destroyed
Certificates
. In the event that any Certificates shall have been lost, stolen or destroyed, the Exchange Agent shall issue in exchange for such lost, stolen or destroyed Certificates, upon the making of an affidavit of that fact by the
person claiming such Certificates to be lost, stolen or destroyed, the Merger Consideration payable in respect thereof pursuant to
Section
2.1(a)
. Parent may, in its reasonable discretion and as a condition precedent
to the payment of such Merger Consideration, require the owners of such lost, stolen or destroyed Certificates to deliver a bond in a reasonable sum as it may reasonably direct as indemnity against any claim that may be made against Parent, Merger
Sub, the Surviving Corporation or the Exchange Agent with respect to the Certificates alleged to have been lost, stolen or destroyed.
A-7
2.3
Dissenting
Shares
.
Notwithstanding anything in this Agreement to the contrary (but subject to the provisions of this
Section
2.3
), Company Shares outstanding immediately prior
to the Effective Time and held by a holder who did not vote in favor of the adoption of this Agreement, and who is entitled to demand and has properly demanded appraisal for such Company Shares in accordance with, and who complies in all respects
with, Section 262 of the DGCL (such Company Shares, the
Dissenting Shares
) shall not be converted into the right to receive the Merger Consideration. At the Effective Time, all Dissenting Shares shall no longer be
outstanding and shall automatically be cancelled and cease to exist, and the holders of Dissenting Shares shall cease to have any rights with respect thereto, except the rights granted to them under Section 262 of the DGCL. If any such
holder fails to perfect or otherwise waives, withdraws or loses his right to appraisal under Section 262 of the DGCL or other applicable Law, then the right of such holder to be paid the fair value of such Dissenting Shares shall cease and such
Dissenting Shares shall thereupon be deemed to have been converted, as of the Effective Time, into and shall be exchangeable solely for the right to receive the Merger Consideration, without interest and subject to any withholding of Taxes required
by applicable Law in accordance with this
Article 2
and shall not thereafter be deemed to be Dissenting Shares. The Company shall give Parent prompt notice of any demands received by the Company for appraisal of Company Shares and any
other instruments served pursuant to the DGCL and received by the Company relating to rights to be paid the fair value of Dissenting Shares, and Parent shall have the right to participate in and control all negotiations and proceedings with respect
to such demands. Prior to the Effective Time, the Company shall not, except with the prior written consent of Parent, make any payment with respect to, or settle or compromise, any such demands, or approve any withdrawal of any such demands, or
agree to do any of the foregoing, except to the extent required by applicable Law.
2.4
Treatment of
Options
.
(a)
Treatment of Options
. Prior to the Effective Time, contingent on, and subject to the
Closing, each option to purchase Company Shares (each a
Company Option
) shall fully vest and become immediately exercisable for a period of fifteen (15) days prior to the Effective Time (the
Exercise
Window
), and each holder of such Company Options shall be permitted to exercise such Company Options during the Exercise Window, including exercise on a cashless basis (meaning that the Company shall withhold the lowest number
of Company Shares issuable upon exercise of the Company Option sufficient to cover the applicable exercise price and any Taxes required to be withheld, with the Company providing a cash payment in lieu of any excess fractional shares that would not
be issued as a result of such withholding). Each Company Share resulting from exercise of a Company Option during the Exercise Window shall be treated as a Company Share issued and outstanding immediately prior to the Effective Time and shall
be eligible to receive the Merger Consideration, payable in accordance with
Section
2.1
and
Section 2.2.
At the Effective Time, each then-outstanding, unexercised Company Option shall automatically and
without any required action on the part of the holder thereof, be cancelled for no consideration.
(b)
Termination of Company Equity Plans
. As of the Effective Time, the GenVec, Inc. 2002 Stock Incentive
Plan, the GenVec, Inc. 2011 Omnibus Incentive Plan, and the GenVec, Inc. 2015 Omnibus Incentive Plan (each, a
Company Equity Plan
and, collectively, the
Company Equity Plans
) shall be terminated and no further
Company Shares, Company Options, Equity Interests or other rights with respect to Company Shares shall be granted thereunder.
A-8
(c)
Board Actions
. Prior to the Effective Time, the Company
Board (or, if appropriate, any committee thereof) shall adopt appropriate resolutions and take such other actions as are reasonably necessary and appropriate (including using reasonable best efforts to obtain any required consents) to effect the
transactions described in this
Section
2.4
.
2.5
Conversion of Company
Warrants
. At the Effective Time, each outstanding, unexpired and unexercised warrant to purchase Company Shares (each, a
Company Warrant
), whether or not then vested, shall be assumed by Parent
and converted into a warrant to purchase upon exercise thereof (i) the number of shares of Parent Common Stock equal to the product of (x) the Exchange Ratio (as adjusted pursuant to
Section
2.7
) multiplied
by (y) the number of Company Shares underlying such Company Warrant (with the product rounded up to the nearest whole share)
plus
(ii) one CPR for each Company Share underlying such Company Warrant. The exercise price for each
such Company Warrant shall be adjusted to reflect an exercise price per share (rounded up to the nearest cent) equal to the exercise price for each Company Share subject to such Company Warrant as of immediately prior to the Effective Time divided
by the Exchange Ratio. All references to the Company in such Company Warrant shall be deemed to refer to Parent, where appropriate. The other
pre-existing
terms of such Company Warrants shall continue to
apply in accordance with their terms. Each Company Warrant assumed and converted pursuant to the terms of this Section 2.5 shall be referred to as a
Parent Exchange Warrant
. At or prior to the Effective Time, Parent shall
reserve for future issuance a number of shares of Parent Common Stock that will be subject to Parent Exchange Warrants as a result of the actions contemplated by this
Section
2.5
.
2.6
Withholding Rights
. The Company, Parent, Merger Sub, the Surviving Corporation and the Exchange Agent,
as the case may be, shall be entitled to deduct and withhold from any amounts otherwise payable pursuant to this Agreement, such amounts as are required to be deducted and withheld with respect to the making of such payment under the Code, the
Treasury Regulations or any other provision of applicable Law. Any amounts deducted or withheld from any such payment shall be remitted to the applicable Tax Authority and, when so remitted, shall be treated for all purposes of this Agreement
as having been paid to the Person in respect of which such deduction or withholding was made.
2.7
Certain
Adjustments
. In the event that, between the date of this Agreement and the Effective Time, (i) any change in the outstanding Company Shares shall occur as a result of any stock split, reverse stock split, stock dividend (including any
dividend or distribution of Equity Interests convertible into or exchangeable for Company Shares), recapitalization, reclassification, combination, exchange of shares or other similar event, or (ii) any reduction in the assets or property of
(including Equity Interests held by) Parent or any of its Subsidiaries shall occur as a result of any direct or indirect distribution of such assets or property to the shareholders of Parent (including any spinoff of any Subsidiary of Parent), then,
in each case (i) and (ii), the Exchange Ratio and the Merger Consideration shall be equitably adjusted to reflect such event and to provide to holders of Company Shares the same economic effect as contemplated by this Agreement prior to such
event; provided that nothing in this
Section
2.7
shall be deemed to permit or authorize the Company to take any such action or effect any such change that it is not otherwise authorized or permitted to take pursuant to this
Agreement (including
Section
5.1
).
A-9
2.8
Fractional Shares
. No certificates or scrip representing
fractional shares of Parent Common Stock shall be issued upon the conversion of Company Shares pursuant to
Section 2.1(a) or
Section 2.4(a), no dividend or distribution with respect to Parent Common Stock shall be payable on or with respect
to any fractional share and such fractional share interests will not entitle the owner thereof to any rights of a stockholder of Parent. Notwithstanding any other provision of this Agreement, each holder of Company Shares that are converted
pursuant to the Merger who would otherwise have been entitled to receive a fractional share of Parent Common Stock (after taking into account all Company Shares exchanged by such holder) shall receive, in lieu thereof, cash (without interest) in an
amount equal to such fractional amount multiplied by the last reported sale price of Parent Common Stock on NYSE (as reported in The Wall Street Journal or, if not reported therein, in another authoritative source mutually selected by the Company
and Parent) on the last complete trading day prior to the date of the Effective Time. The parties acknowledge that payment of cash in lieu of issuing fractional shares is solely for the purpose of avoiding the expense and inconvenience to
Parent of issuing fractional shares and does not represent separately
bargained-for
consideration
2.9
Distributions with respect to Unsurrendered Shares
. All shares of Parent Common Stock to be issued
pursuant to the Merger shall be deemed issued and outstanding as of the Effective Time and whenever a dividend or other distribution is declared by Parent in respect of the Parent Common Stock, the record date for which is after the Effective Time,
that declaration shall include dividends or other distributions in respect of all shares issuable pursuant to this Agreement. No dividends or other distributions in respect of the Parent Common Stock shall be paid to any holder of any unsurrendered
Company Share until the Certificate (or affidavit of loss in lieu of the Certificate as provided in
Section
2.2(e)
) or Book-Entry Company Share is surrendered for exchange in accordance with
Section
2.2
. Subject to the effect of applicable Laws, following such surrender, there shall be issued or paid to the holder of record of the whole shares of Parent Common Stock issued in exchange for Company Shares in
accordance with this Section 2.2, without interest: (a) at the time of such surrender, the dividends or other distributions with a record date after the Effective Time theretofore payable with respect to such whole shares of Parent Common
Stock and not paid; and (b) at the appropriate payment date, the dividends or other distributions payable with respect to such whole shares of Parent Common Stock with a record date after the Effective Time but with a payment date subsequent to
surrender.
ARTICLE 3
REPRESENTATIONS AND WARRANTIES OF THE COMPANY
Except (a) as set forth in the disclosure schedule delivered by the Company to Parent and Merger Sub (the
Company Disclosure
Schedule
) prior to the execution of this Agreement (with specific reference to the representations and warranties in this
Article 3
to which the information in such schedule relates;
provided
, that, disclosure in the Company
Disclosure Schedule as to a specific representation or warranty shall qualify any other sections of this Agreement to the extent (notwithstanding the absence of a specific cross reference) it is
A-10
reasonably apparent on its face that such disclosure relates to such other sections), and (b) as disclosed in the Company SEC Documents filed since January 1, 2016 and publicly
available at least 24 hours prior to the execution and delivery of this Agreement (other than any disclosures contained in the Forward Looking Statements or Risk Factors sections of such Company SEC Documents, and any other
disclosures contained in such Company SEC Documents to the extent that such other disclosures are predictive, cautionary or forward-looking in nature); provided that, the foregoing clause (b) shall not be applicable to
Section
3.2
or
Section
3.4
, the Company hereby represents and warrants to Parent and Merger Sub as follows:
3.1
Corporate Organization
. The Company is a corporation duly organized, validly existing and in good
standing under the laws of the State of Delaware and has the requisite corporate power and authority to own or lease all of its properties and assets and to carry on its business as it is now being conducted. The Company is duly licensed or
qualified to do business in each jurisdiction in which the nature of the business conducted by it or the character or location of the properties and assets owned or leased by it makes such licensing or qualification necessary, except where the
failure to be so licensed or qualified, has not had and would not reasonably be expected to have a Company Material Adverse Effect. The copies of the Amended and Restated Certificate of Incorporation, as amended (the
Company
Charter
) and Amended and Restated Bylaws (the
Company Bylaws
) of the Company, as most recently filed with the Company SEC Documents, are true, complete and correct copies of such documents as in effect as of the date of
this Agreement. The Company is not in violation of any of the provisions of the Company Charter or the Company Bylaws.
3.2
Capitalization
.
(a) The authorized capital stock of the Company consists of 55,000,000 Company Shares and 5,000,000 shares of preferred
stock, $0.001 par value per share (the
Preferred Stock
), of which 30,000 are designated as Series B Junior Participating Preferred Stock pursuant to the terms of the Rights Agreement. As of January 22, 2017, (i) 2,273,632
Company Shares (other than treasury shares) were issued and outstanding, all of which were validly issued and fully paid, nonassessable and free of preemptive rights, (ii) no Company Shares were held in the treasury of the Company , (iii)
388,572 Company Shares are available for issuance under the Company Equity Plans, of which 287,283 are subject to Company Options and outstanding as of such date, and (iv) no shares of Preferred Stock are issued and outstanding as of such
date. Except for Company Options and Company Warrants, there are no options, warrants or other rights, agreements, arrangements or commitments of any character to which the Company is a party or by which the Company is bound relating to the
issued or unissued capital stock or other Equity Interests of the Company, or securities convertible into or exchangeable for such capital stock or other Equity Interests, or obligating the Company to issue or sell any shares of its capital stock or
other Equity Interests, or securities convertible into or exchangeable for such capital stock of, or other Equity Interests in, the Company. Since December 31, 2016 and through the date of this Agreement, except for the issuance of Company
Shares upon the exercise of Company Options or Company Warrants in accordance with the terms of such Company Options or Company Warrants, the Company has not issued any shares of its capital stock or other Equity Interests, or securities convertible
into or exchangeable for such capital stock or other Equity Interests.
Section 3.2(a)
of the Company
A-11
Disclosure Schedule sets forth, as of the date hereof, a list of the holders of Company Options outstanding as of the date hereof, including, on a holder by holder and grant by grant basis, the
date on which each such Company Option was granted, the type and the number of Company Options granted, the Company Equity Plan pursuant to which such Company Option was granted, the expiration date of such Company Option, the price at which such
Company Option may be exercised, and the vesting schedule and status of each such Company Option. All Company Shares subject to issuance under the Company Equity Plans have been duly reserved for issuance by the Company, and upon issuance prior
to the Effective Time on the terms and conditions specified in the instruments pursuant to which they are issuable, will be duly authorized, validly issued, fully paid, nonassessable and free of preemptive rights.
(b) Each Company Option (x) has been granted or issued under terms intended not to constitute nonqualified
deferred compensation within the meaning of Section 409A of the Code, and (y) has been granted or issued in all material respects in accordance with the terms of the applicable Company Equity Plan and all applicable Laws.
(c) There are no outstanding contractual obligations or other commitments, agreements or arrangements of the Company
(i) restricting the transfer of, (ii) relating to affecting the voting rights of, (iii) requiring the repurchase, redemption, acquisition or disposition of, or containing any right of first refusal with respect to, (iv) requiring
the registration for sale of, or (v) granting any preemptive or antidilutive right with respect to, in each case, any Company Shares or any capital stock of, or other Equity Interests in, the Company. There are no outstanding bonds, debentures,
notes or other indebtedness of the Company having the right to vote (or convertible into or exchangeable for Equity Interests in the Company having the right to vote) on any matters on which the Companys stockholders may vote.
(d) The Company does not hold or have the right or obligation to acquire an Equity Interest in any other Person.
3.3
Authority; Execution and Delivery; Enforceability
.
(a) The Company has all necessary power and authority to execute and deliver this Agreement, to perform and comply with
each of its obligations under this Agreement and, subject to the receipt of the Company Stockholder Approval, to consummate the Transactions. The execution and delivery by the Company of this Agreement, the performance and compliance by the
Company with each of its obligations herein, and the consummation by it of the Transactions have been duly authorized by all necessary corporate action on the part of the Company, subject to receipt of the Company Stockholder Approval, and no other
corporate proceedings on the part of the Company and no other stockholder votes are necessary to authorize this Agreement or the consummation by the Company of the Transactions. The Company has duly and validly executed and delivered this
Agreement and, assuming the due authorization, execution and delivery by Parent and Merger Sub of this Agreement, this Agreement constitutes a legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its
terms, except as may be limited by Laws affecting the enforcement of creditors rights generally and by general equitable principles (whether considered in a Proceeding at law or in equity).
A-12
(b) The Company Board, at a meeting duly called and held, at which all of
the directors were present, unanimously adopted resolutions (i) approving and declaring advisable this Agreement and the consummation of the Transactions, (ii) determining that the terms of the Agreement and the Merger are fair to, and in
the best interests of, the Company and its stockholders, (iii) directing that this Agreement be submitted to the stockholders of the Company at the Company Meeting and (iv) recommending that its stockholders adopt this Agreement (the
Company Board Recommendation
), which resolutions have not been subsequently withdrawn, amended or modified as of the date of this Agreement.
(c) The Company Board has taken all necessary actions so that the restrictions on business combinations set forth in
Section 203 of the DGCL and any other similar Law are not and will not be applicable to this Agreement and the transactions contemplated hereby, including the Merger or the other Transactions. Assuming the accuracy of the representations
and warranties of Parent and Merger Sub set forth in
Section
4.8
, no other takeover, anti-takeover, business combination, moratorium, fair price, control share acquisition or similar Law applies to the Merger or the other
Transactions. The Company Board has also taken all necessary actions so that the Rights Agreement does not apply to this Agreement and the transactions contemplated hereby, including the Merger or the other Transactions. The only vote of holders of
any class or series of Company Shares or other Equity Interests of the Company necessary to adopt this Agreement and approve the Merger is the adoption of this Agreement by the affirmative vote of holders of a majority of the Company Shares
outstanding and entitled to vote thereon at the Company Meeting (the
Company Stockholder Approval
). No other vote of the holders of Company Shares or any other Equity Interests of the Company is necessary to consummate the
Transactions.
3.4
No Conflicts
.
(a) The execution and delivery of this Agreement does not , and the consummation by the Company of the Transactions and
compliance by the Company with any of the terms or provisions hereof will not, (i) assuming the Company Stockholder Approval is obtained, conflict with or violate any provision of the Company Charter or the Company Bylaws, (ii) assuming
that all consents, approvals, authorizations and permits described in
Section 3.4(b)
have been obtained and all filings and notifications described in
Section 3.4(b)
have been made and any waiting periods thereunder have terminated or
expired, conflict with or violate any Law applicable to the Company or by which any property or asset of the Company is bound or affected or (iii) require any consent or approval under, result in any breach or violation of or any loss of any
benefit under, constitute a change of control or default (or an event which with notice or lapse of time or both would become a default) under or give to others any right of termination, vesting, amendment, acceleration or cancellation of, or result
in the creation of a Lien on any property or asset of the Company pursuant to, any Contract or Permit to which the Company is party, except, with respect to clauses (ii) and (iii), for any such conflicts, violations, breaches, defaults or other
occurrences which would not reasonably be expected to have a Company Material Adverse Effect.
(b) The execution
and delivery of this Agreement by the Company does not, and the consummation by the Company of the Transactions and compliance by the Company with any of the terms or provisions hereof will not, require any consent, approval,
A-13
authorization or permit of, or filing with or notification to, any Governmental Entity, except (i) the filing with the SEC of (A) a proxy statement, in preliminary and definitive form,
relating to the Company Meeting (as amended or supplemented from time to time, the
Proxy Statement
), and (B) a registration statement on Form
S-4
pursuant to which the offer and sale of
shares of Parent Common Stock in the Merger will be registered pursuant to the Securities Act and in which the Proxy Statement will be included (together with any amendments or supplements thereto, the
Form
S-4
), (ii) other filings required under, and compliance with other applicable requirements of, the Exchange Act and the rules and regulations of the NASDAQ, (iii) the filing and recordation of
the Certificate of Merger as required by the DGCL and (iv) where failure to obtain such consents, approvals, authorizations or permits, or to make such filings, registrations or notifications, would not reasonably be expected to have a Company
Material Adverse Effect.
3.5
SEC Documents; Financial Statements; Undisclosed Liabilities
.
(a) The Company has timely filed or furnished all reports, schedules, forms, statements, registration statements,
prospectuses and other documents required to be filed or furnished by the Company with the SEC under the Securities Act or the Exchange Act since January 1, 2014 (the
Company SEC Documents
).
(b) As of its respective filing date, and, if amended, as of the date of the last amendment prior to the date of this
Agreement, each Company SEC Document complied in all material respects with the requirements of the Exchange Act, the Securities Act and the Sarbanes-Oxley Act of 2002 and the related rules and regulations promulgated thereunder or under the
Exchange Act (the
Sarbanes-Oxley Act
), as the case may be, and the rules and regulations of the SEC promulgated thereunder applicable to such Company SEC Document and did not contain any untrue statement of a material fact or omit
to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading. The Company has made available to Parent true and complete
copies of all material correspondence between the SEC, on the one hand, and the Company, on the other hand, occurring since January 1, 2014 and prior to the date hereof. As of the date hereof, there are no outstanding or unresolved
comments in comment letters from the SEC staff with respect to any of the Company SEC Documents. To the Knowledge of the Company, as of the date hereof, none of the Company SEC Documents is the subject of ongoing SEC review, outstanding SEC
comment or outstanding SEC investigation.
(c) The financial statements of the Company included in the Company SEC
Documents (including, in each case, any notes or schedules thereto) (the
Company SEC Financial Statements
) fairly present, in all material respects, the financial condition and the results of operations, cash flows and changes in
stockholders equity of the Company as of the respective dates of and for the periods referred to in the Company SEC Financial Statements, and were prepared in accordance with GAAP applied on a consistent basis during the periods involved
(except as may be indicated in the notes thereto), subject, in the case of interim Company SEC Financial Statements, to normal
year-end
adjustments (none of which are material individually or in the aggregate)
and the absence of notes (none of which, if presented, would materially differ from those in the
year-end
Company SEC Financial Statements). The Company SEC Financial Statements were prepared from, and in
accordance with, the books and records of the Company in all material respects, and complied as to form in all material respects with all applicable accounting requirements and with the published rules and regulations of the SEC with respect
thereto.
A-14
(d) The Company has established and maintains disclosure controls and
procedures and internal control over financial reporting (as such terms are defined in paragraphs (e) and (f), respectively, of
Rule 13a-15
and paragraph (e) of
Rule 15d-15
under the Exchange Act) as required by
Rules 13a-15
and
15d-15
under the Exchange Act. The
Companys disclosure controls and procedures are designed to ensure that all information (both financial and
non-financial)
required to be disclosed by the Company in the reports that it files or
furnishes under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that all such information is accumulated and communicated to the Companys management as
appropriate to allow timely decisions regarding required disclosure and to make the certifications required pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act. The Companys management has completed an assessment of the
effectiveness of the Companys disclosure controls and procedures and, to the extent required by applicable Law, presented in any applicable Company SEC Document that is a report on Form
10-K
or Form
10-Q,
or any amendment thereto, its conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by such report or amendment based on such evaluation. Based
on the Companys managements most recently completed evaluation of the Companys internal control over financial reporting, (i) the Company had no significant deficiencies or material weaknesses in the design or operation of its
internal control over financial reporting that would reasonably be expected to adversely affect the Companys ability to record, process, summarize and report financial information and (ii) the Company does not have Knowledge of any fraud,
whether or not material, that involves management or other employees who have a significant role in the Companys internal control over financial reporting. Since January 1, 2014, the Companys principal executive officer and its
principal financial officer have disclosed to the Companys auditors and the audit committee of the Company Board (i) all significant deficiencies and material weaknesses in the design or operation of the Companys internal control
over financial reporting that would reasonably be expected to adversely affect the Companys ability to record, process, summarize and report financial information and (ii) any fraud, whether or not material, that involves management or
other employees who have a significant role in the Companys internal control over financial reporting, and the Company has made available to Parent true and complete copies of any material written materials provided to the Companys
auditors or the audit committee of the Company Board relating to each of the foregoing. The Company has not made any prohibited loans or extensions of credit (within the meaning of Section 402 of the Sarbanes-Oxley Act) to any
executive officer (as defined in Rule
3b-7
under the Exchange Act) or director of the Company.
(e) The Company does not have any liabilities or obligations of any nature (whether absolute or contingent, asserted
or unasserted, known or unknown, primary or secondary, direct or indirect, and whether or not accrued), required by GAAP to be reflected or reserved on a balance sheet of the Company (or the notes thereto) except (i) as reflected or reserved
against in the most recent audited balance sheet included in the Company SEC Financial Statements or the notes thereto, (ii) for liabilities and obligations incurred in the
A-15
ordinary course of business since the date of the most recent audited balance sheet included in the Company SEC Financial Statements , (iii) for liabilities and obligations arising out of or
in connection with this Agreement, the Merger or the Transactions and (iv) for liabilities and obligations that have not had, and would not reasonably be expected to have, a Company Material Adverse Effect.
3.6
Absence of Certain Changes or Events
. Since January 1, 2016 through the date of this Agreement,
(a) the Company has conducted its business in all material respects only in the ordinary course and in a manner consistent with past practice and (b) there has not been any change, event, development, condition or occurrence that has had
or would reasonably be expected to have a Company Material Adverse Effect. Since January 1, 2016 through the date of this Agreement, the Company has not taken any action that would have constituted a breach of, or required Parents
consent pursuant to,
Sections 5.1(d), (e), (f), (g), (h), (k) or (p)
had the covenants therein applied since January 1, 2016.
3.7
Information Supplied
. None of the information supplied or to be supplied by the Company for inclusion or
incorporation by reference in (a) the Proxy Statement will, at the date that the Proxy Statement or any amendment or supplement thereto is mailed to holders of Company Shares and at the time of the Company Meeting, contain any untrue statement
of a material fact or omit to state a material fact necessary to make the statements therein, in light of the circumstances in which they are made, not misleading and (b) the Form
S-4
will, at the time
the Form
S-4
is filed with the SEC, and at any time it is amended or supplemented or at the time it becomes effective under the Securities Act, 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 are made, not misleading (except that no representation or warranty is made by the Company to such portions
of the Proxy Statement and the Form
S-4,
as applicable, that relate to Parent and its Subsidiaries, including Merger Sub, or to statements made therein based on information supplied by or on behalf of Parent
for inclusion or incorporation by reference therein). The Proxy Statement will comply as to form in all material respects with the requirements of the Exchange Act.
3.8
Legal Proceedings
. There are no material Proceedings pending, or to the Knowledge of the Company,
threatened against the Company or any of its assets or properties or, to the Knowledge of the Company, any of the officers or directors of the Company. Neither the Company nor any of its assets or properties is subject to any material
Order.
3.9
Compliance with Laws and Orders
. The Company is, and since January 1, 2014 has been, in
compliance in all material respects with all Laws, Orders and NASDAQ rules and regulations applicable to the Company or any assets owned or used by it. The Company has not received any written communication since January 1, 2014 from a
Governmental Entity that alleges that the Company is in material violation of any such Law or Order. During the past five (5) years, neither the Company, nor, to the Knowledge of the Company, any director, officer, agent, employee or other
Person acting on behalf of the Company, has, in the course of its actions for, or on behalf of, any of them, (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to political
activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated any provision of any applicable Anti-corruption
A-16
Laws; or (iv) made any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any foreign or domestic government official or employee. During the past
five (5) years, the Company has not received any written communication from a Governmental Entity (x) related to any investigation or inquiry with respect to a potential violation by the Company or any Representative thereof of any
Anti-corruption Laws, or (y) that alleges that the Company or any Representative thereof is in violation of any Anti-corruption Laws. During the past five (5) years, the Company has not had a customer or supplier or other business
relationship with, is a party to any Contract with, or has engaged in any transaction with, any Person (i) that is located, organized or domiciled in or that is a citizen of Cuba, Iran, North Korea, Sudan, Syria or the Crimea Region of Ukraine
(including any Governmental Entity within such country or territory) or (ii) that is the target of any international economic or trade sanction administered or enforced by the Office of Foreign Assets Control of the United States Department of
the Treasury (
OFAC
), the United Nations Security Council, the European Union, Her Majestys Treasury, the United Kingdom Export Control Organization or other relevant sanctions authority (including but not limited to being
listed on the Specially Designated Nationals and Blocked Persons List administered by OFAC).
3.10
Permits
. The Company has all governmental licenses, permits, certificates, certifications, approvals,
clearances, consents, franchises, registrations, exemptions and authorizations (
Permits
) necessary for the conduct of its business and the use of its properties and assets, as presently conducted and used, and each of the Permits
is valid, subsisting and in full force and effect, except where the failure to have or maintain such Permit has not had and would not reasonably be expected to have, a Company Material Adverse Effect. The operation of the Company as currently
conducted is not, and has not been since January 1, 2014, in violation of, nor is the Company in default or violation under, any Permit, and, to the Knowledge of the Company, no event has occurred which, with notice or the lapse of time or
both, would reasonably be expected to constitute a default or violation of any term, condition or provision of any Permit, except where such default or violation of such Permit has not had and would not reasonably be expected to have, a Company
Material Adverse Effect. There are no actions pending or, to the Knowledge of the Company, threatened, that seek the revocation, cancellation or modification of any Permit, except where such revocation, cancellation or modification has not had
and would not reasonably be expected to have, a Company Material Adverse Effect. Notwithstanding the foregoing, nothing in this
Section
3.10
addresses Regulatory Permits, which are instead addressed by
Section
3.18
.
3.11
Employee Benefit Plans
.
(a)
Section
3.11(a)
of the Company Disclosure Schedule sets forth a true, correct and
complete list of each (i) employee benefit plan as defined in Section 3(3) of ERISA, whether or not subject to ERISA, (ii) employment, consulting, end of service or severance, termination protection, change in control,
transaction bonus, retention or similar plan, agreement, arrangement, program or policy; or (iii) other benefit or compensation plan, contract, policy or arrangement providing for pension, retirement, profit-sharing, deferred compensation,
stock option, equity or equity-linked compensation, stock purchase, employee stock ownership, tax
gross-up,
vacation, holiday pay or other paid time off, bonus or other incentive plans, medical, retiree
medical, vision, dental or other health plans, life insurance plans, and other
A-17
employee benefit plans, welfare plans or fringe benefit plans, in each case whether or not written, that is sponsored, maintained, administered, contributed to or entered into by the Company,
with respect to any current or former director, officer, employee or individual independent contractor of the Company (each, a
Service Provider
), or for which the Company has any direct or indirect liability (whether actual or
contingent) (each a
Company Benefit Plan
). The term Company Benefit Plan does not, however, include plans or arrangements administered by a Governmental Entity or to which the Company contributes pursuant to
applicable Law or that are Multiemployer Plans (as defined below). Neither the Company, nor to the Knowledge of the Company, any other Person, has any express or implied commitment, whether legally enforceable or not, to (i) modify, change
or terminate any Company Benefit Plan, other than with respect to a modification, change or termination required by ERISA or the Code or (ii) create any additional Company Benefit Plans from the prior three (3) years.
(b) The Company has made available to Parent a true, correct and complete copy of each Company Benefit Plan and the
following related documents, to the extent applicable: (i) the most recent copy of any summary plan description and all written amendments, modifications or supplements applicable to any such Company Benefit Plan (and a summary of any such
amendment, modification or supplement that is not in writing), (ii) the most recent annual report (Form 5500) filed with the U.S. Department of Labor, (iii) the most recently received IRS determination or opinion letter, (iv) each trust,
insurance or administrative agreement relating to any such Company Benefit Plan, (v) the most recent actuarial report with respect to any such Company Benefit Plan, and (vi) all filings, records and notices concerning audits or
investigations by any Governmental Entity.
(c) Each Company Benefit Plan has been established, operated and
administered in all material respects in accordance with its terms and all applicable Laws, including ERISA and the Code, all contributions required to be made for any period in the prior three (3) years through the date hereof to any Company
Benefit Plan by applicable Law, or under the terms of any Company Benefit Plan or under the terms of any other contractual undertaking have been timely made or, if not yet due, have been properly reflected on the most recent balance sheet filed or
incorporated by reference in the Company SEC Documents prior to the date of this Agreement; and all material premiums due or payable for any period in the prior three (3) years through the date hereof with respect to insurance policies funding
any Company Benefit Plan have been timely paid or, if not yet due, have been properly reflected on the most recent balance sheet filed or incorporated by reference in the Company SEC Documents prior to the date of this Agreement. With respect
to the Company Benefit Plans, (i) no event has occurred and, to the Knowledge of the Company, there exists no condition or set of circumstances which would reasonably be expected to result in material liability to the Company and (ii) the
Company has not, within the prior three (3) years, taken corrective action or made a filing under any voluntary correction program of the IRS, the U.S. Department of Labor, or any other Governmental Entity with respect to any Company Benefit
Plan that has not been resolved prior to the date hereof and, to the Companys Knowledge, no Company Benefit Plan defect exists as of the date hereof that would qualify for correction under any such program.
(d) Each Company Benefit Plan which is intended to qualify under Section 401(a) of the Code has either received a
favorable determination letter from the IRS as to
A-18
its qualified status which letter has not been revoked (nor has revocation been threatened in writing) or may rely upon a favorable opinion letter from the IRS, and each trust established in
connection with any Company Benefit Plan which is intended to be exempt from federal income taxation under Section 501(a) of the Code is so exempt, and to the Companys Knowledge no fact or event has occurred that would reasonably be
expected to adversely affect the qualified status of any such Company Benefit Plan or the exempt status of any such trust. No trust funding any Company Benefit Plan is intended to meet the requirements of Section 501(c)(9) of the Code.
(e) Neither the Company, nor any of its ERISA Affiliates, nor, to the Companys Knowledge, any fiduciary whom the
Company has an obligation to indemnify has engaged in any prohibited transaction (within the meaning of Section 406 of ERISA or Section 4975 of the Code and other than a transaction that is exempt under a statutory or
administrative exemption) which would reasonably be expected to subject any of the Company Benefit Plans or their related trusts, the Company, any of its ERISA Affiliates or any Person that the Company has an obligation to indemnify, to a material
liability. No material Proceeding (including any audit or inquiry by the IRS or U.S. Department of Labor (other than routine benefits claims)) is pending, or to the Companys Knowledge is threatened, against or with respect to any Company
Benefit Plan, any fiduciary of a Company Benefit Plan with respect to such fiduciarys duties to the Company Benefit Plan for whom the Company has an obligation to indemnify, or the assets of any trust under any of the Company Benefit Plans.
All tax, annual reporting and other governmental filings required by ERISA and the Code have been timely filed with the appropriate Governmental Entity and all notices and disclosures have been timely provided to participants, except where the
failure to do so has not had and would not reasonably be expected to have a Company Material Adverse Effect.
(f) No Company Benefit Plan is a multiemployer pension plan (as defined in Section 3(37) of ERISA)
(
Multiemployer Plan
) or other pension plan subject to Title IV of ERISA (
Title IV Plan
), and neither the Company, nor any of its ERISA Affiliates sponsors, maintains, participates in, contributes to, or has any
obligation (contingent or otherwise) with respect to, or has sponsored, maintained, participated in, contributed to, or had any obligation (contingent or otherwise) with respect to a Multiemployer Plan or other pension plan subject to Title IV of
ERISA. No material liability under Title IV of ERISA has been incurred by the Company or any of its ERISA Affiliates that has not been satisfied in full, and no condition exists that presents a material risk to the Company or any of its ERISA
Affiliates of incurring or being subject (whether primarily, jointly or secondarily) to a material liability thereunder. The Company has not incurred any material withdrawal liability under Section 4201 of ERISA.
(g) No Company Benefit Plan is, and neither the Company nor any of its ERISA Affiliates sponsors, maintains,
participates in, contributes to, or has any obligation (contingent or otherwise) with respect to, or has sponsored, maintained, participated in, contributed to, or had any obligation (contingent or otherwise), with respect to any multiple employer
plan (within the meaning of Section 413(c) of the Code), or multiple employer welfare arrangement (within the meaning of Section 3(40) of ERISA).
A-19
(h) Each Company Benefit Plan that is a nonqualified deferred
compensation plan (as defined in Section 409A(d)(1) of the Code) and any award thereunder, in each case, that is subject to Section 409A of the Code, has been maintained and operated in documentary and operational compliance with Section 409A
of the Code except as could not reasonably be expected to result in, either individually or in the aggregate, any material liability to the Company or any Service Provider.
(i) Except as set forth on
Section 3.11(i)
of the Company Disclosure Schedule, no amount that has been or could
be received (whether in cash or property or the vesting of property), as a result of the consummation of the Transactions (alone or in conjunction with any other event, including any termination of employment), by any Service Provider of the Company
who is a disqualified individual (as such term is defined in Treasury Regulation Section
1.280G-1)
could be characterized as an excess parachute payment (as defined in Section
280G(b)(1) of the Code). No Company Benefit Plan provides for the
gross-up
or reimbursement of Taxes under Sections 409A or 4999 of the Code.
(j) Except as set forth on
Section 3.11(j)
of the Company Disclosure Schedule, neither the execution of this
Agreement nor the consummation of the Transactions (alone or in conjunction with any other event, including any termination of employment) will (i) entitle any current or former Service Provider to any additional compensation or benefit
(including any increased bonus, retention or severance pay), (ii) accelerate the time of payment or vesting or result in any payment or funding (through a grantor trust or otherwise) of compensation or benefits, increase the amount payable or result
in any other material obligation to, any Service Provider under a Company Benefit Plan, or (iii) limit or restrict the right of the Company or, after the consummation of the Merger or the Transactions, the Surviving Corporation or any of its
affiliates, to merge, amend or terminate any Company Benefit Plan.
(k) Except as set forth on
Section
3.11(k)
of the Company Disclosure Schedule, no Company Benefit Plan provides post-employment, medical, disability or life insurance benefits to any former employee or their dependents, except as required by Section 4980B of the Code, similar
state coverage, or coverage through the end of the calendar month in which a termination of employment occurs.
3.12
Employee and Labor Matters
.
(a) Section 3.12(a) of the Company Disclosure Schedule sets forth a true, correct and complete list as of the date
hereof of the name of each current Service Provider and each such Service Providers (i) position or title, (ii) date of hire, (iii) location of employment or services, (iv) if the Service Provider is full-time or part-time,
(v) if such Service Provider is on a leave of absence, (vi) if such Service Provider is identified as a exempt or
non-exempt
under the Fair Labor Standards Act (
FLSA
) or similar
state laws , (vii) such Service Providers base salary or hourly wage or compensation rate (as applicable), and (viii) current commission or incentive eligibility.
(b) The Company is not a party to, or bound by, any collective bargaining agreement, agreement with any works council,
or labor contract, and the Company is not currently engaged in any negotiation with any labor union, labor organization, works council
A-20
or other employee organization. To the Knowledge of the Company, no labor union, labor organization, works council, or group of employees of the Company has made a pending demand for
recognition or certification. To the Knowledge of the Company, there are no representation or certification proceedings or petitions seeking a representation proceeding presently pending or threatened in writing to be brought or filed with the
National Labor Relations Board or any other labor relations tribunal or authority. To the Knowledge of the Company, there is no material unfair labor practice complaint or material grievance or other material administrative or judicial complaint,
action or investigation pending or threatened in writing against the Company by the National Labor Relations Board or any other Governmental Entity with respect to the Companys Service Providers. There is no labor strike, dispute,
lockout, slowdown or stoppage pending or, to the Companys Knowledge, threatened against or affecting the Company, and no such strike, dispute, lockout, slowdown or stoppage has occurred within the past three (3) years, in any event which
could reasonably be expected to materially interfere with the business activities of the Company.
(c) The Company
has been in material compliance with all applicable Laws respecting employment and employment practices including, without limitation, all Laws respecting terms and conditions of employment, health and safety, wage payment, wages and hours, child
labor, immigration and work authorizations, employment discrimination, disability rights or benefits, equal opportunity, plant closures and layoffs, affirmative action, and labor relations. Notwithstanding the generality of the foregoing, the
Company has properly classified each of its employees under the FLSA and independent contractors under applicable Laws.
(d) To the Companys Knowledge, no Service Provider is in any respect in violation of any term of any employment
agreement, nondisclosure agreement, common law nondisclosure obligation, fiduciary duty, noncompetition agreement, restrictive covenant or other obligation to a former employer of any such employee relating (i) to the right of any such Service
Provider to be employed by the Company or (ii) to the knowledge or use of trade secrets or proprietary information, in each case except as would not reasonably be expected to be material to the Company.
3.13
Environmental Matters
.
(a) The Company (i) is and for the past three years has been in compliance in all material respects with all
Environmental Laws, (ii) has and holds, or has applied for, all material Environmental Permits necessary for the conduct of its business and the use of its properties and assets, as currently conducted and used, and (iii) is and for the
past three years has been in compliance in all material respects with its Environmental Permits.
(b) There are no
material Environmental Claims pending nor, to the Knowledge of the Company, threatened against the Company, and the Company has not received any written notification of any allegation of actual or potential responsibility for any material violation
of, or material liability under, Environmental Laws relating to any Release or threatened Release of any Hazardous Materials.
(c) The Company has not (i) disposed of, arranged for the disposal of, Released, exposed any Person to or
manufactured, sold, or distributed products containing, any
A-21
Hazardous Materials, in each case as would give rise to material liability under Environmental Laws,
(ii) entered into or agreed to any consent decree or consent order or is otherwise subject to any judgment, decree, or judicial or administrative order relating to compliance with Environmental Laws, Environmental Permits or to the
investigation, sampling, monitoring, treatment, remediation, response, removal or cleanup of Hazardous Materials and no Proceeding is pending or, to the Knowledge of the Company, threatened with respect thereto, or (iii) become an indemnitor by
contract or otherwise in connection with Environmental Claim threatened or asserted by any third-party.
3.14
Real Property; Title to Assets
.
(a)
Section 3.14(a)
of the Company Disclosure Schedule sets forth a true and complete list of all real property
owned in fee simple by the Company (collectively, the
Company Owned Real Property
) and the address for each Company Owned Real Property. The Company holds good and valid indefeasible fee simple title to the Company Owned Real
Property, free and clear of all Liens, except for Permitted Liens. The Company has not leased or otherwise granted to any Person the right to use or occupy such Company Owned Real Property or any portion thereof. Other than the rights of
Parent pursuant to this Agreement, there are no outstanding options, rights of first offer or rights of first refusal to purchase such Company Owned Real Property or any portion thereof or interest therein Except as has not had and would not
reasonably be expected to have a Company Material Adverse Effect, to the Knowledge of the Company, all buildings, structures, improvements and fixtures located on the Company Owned Real Property are in a state of good operating condition, subject to
reasonable wear and tear. The Company is not a party to any agreement or option to purchase any real property or interest therein.
(b)
Section 3.14(b)
of the Company Disclosure Schedule sets forth (i) a true and complete list of all real
property leased, licensed subleased or otherwise occupied by the Company (collectively, the
Company Leased Real Property
), (ii) the address for each parcel of Company Leased Real Property, and (iii) a description of the
applicable lease, sublease or other agreement therefore and any and all amendments and modifications relating thereto (the
Company Lease Agreements
). No Company Lease Agreement is subject to any Lien, including any right to
the use or occupancy of any Company Leased Real Property, other than Permitted Liens and Liens encumbering the respective landlords fee interest. The Company has delivered to Parent a true and complete copy of each such Company Lease
Agreement, and in the case of any oral Company Lease Agreement, a written summary of the material terms of such Company Lease Agreement. With respect to each of the Company Lease Agreements: (i) the Companys possession and quiet
enjoyment of the Company Leased Real Property under such Company Lease Agreement has not been disturbed, and to the Knowledge of the Company, there are no material disputes with respect to such Company Lease Agreement; (ii) the Company has not
subleased, licensed or otherwise granted any Person the right to use or occupy such Company Leased Real Property or any portion thereof; and (iii) the Company has not collaterally assigned or granted any other security interest in such Company
Lease Agreement or any interest therein.
(c) The Company Owned Real Property and the Company Leased Real Property
are referred to collectively herein as the
Company Real Property
. The Company Real Property comprises all of the real property used or intended to be used in, or otherwise
A-22
related to, the business of the Company. Except as has not had and would not reasonably be expected to have a Company Material Adverse Effect, (i) each parcel of Company Real Property
is in compliance with all existing Laws applicable to such Company Real Property, and (ii) the Company has not received written notice of any Proceedings in eminent domain, condemnation or other similar Proceedings that are pending, and to the
Companys Knowledge there are no such Proceedings threatened, affecting any portion of the Company Real Property.
(d) The Company has good and marketable title to, or a valid and binding leasehold or other interest in, all tangible
personal property necessary for the conduct of the business of the Company as currently conducted, free and clear of all Liens (except for Permitted Liens) except as has not had and would not reasonably be expected to have a Company Material Adverse
Effect.
3.15
Tax Matters
. Except as has not had or would not reasonably be expected to have a Company
Material Adverse Effect:
(a) all Tax Returns that are required to be filed by or with respect to the Company have
been timely filed with the appropriate Tax Authority (taking into account any extension of time within which to file), and all such Tax Returns are true, complete, and accurate in all respects;
(b) the Company has timely paid all Taxes due and owing by it (whether or not shown on any Tax Return), including any
Taxes required to be withheld from amounts owing to, or collected from, any employee, creditor, or other third party, other than Taxes for which adequate reserves have been established in accordance with GAAP on the financial statements of the
Company;
(c) no deficiencies for Taxes have been claimed, proposed or assessed by any Tax Authority against the
Company except for deficiencies which have been fully satisfied by payment, settled or withdrawn;
(d) there is no
ongoing, pending or, to the Knowledge of the Company, threatened audit, examination, investigation or other proceeding with respect to any Taxes of the Company;
(e) the Company has not waived or extended any statute of limitations with respect to Taxes or agreed to any extension
of time with respect to a Tax assessment or deficiency, nor has any request been made for any such extension or waiver;
(f) the Company has not constituted a distributing corporation or a controlled corporation
(within the meaning of Section 355(a)(1)(A) of the Code) in a distribution of stock intended to qualify for
tax-free
treatment under Section 355(a) of the Code (or any similar provision of state,
local, or
non-U.S.
Law) in the two years prior to the date of this Agreement;
(g) the Company is not, nor has it been, a party to or bound by any Tax allocation, sharing, indemnity, or
reimbursement agreement or similar arrangement;
A-23
(h) the Company has not been a member of an affiliated group
(within the meaning of Section 1504(a) of the Code) filing a federal income Tax Return or any similar group for federal, state, local or foreign Tax purposes, other than a group of which the Company has been the common parent, and the Company does
not have any liability for Taxes of any other person (other than Taxes of the Company) under Treasury Regulations
Section 1.1502-6
(or any similar provision of foreign, state or local Law), as a
transferee or successor, by contract or otherwise;
(i) the Company is not, nor has it been, a United States
real property holding corporation within the meaning of Code Section 897(c)(2) of the Code within the past five (5) years;
(j) there are no Liens for Taxes upon any property or assets of the Company, except for Permitted Liens;
(k) the Company is not, nor has it been, a party to a transaction that is or is substantially similar to any
reportable transaction within the meaning of U.S. Treasury Regulation
Section 1.6011-4(b)
(or any similar provision of state, local or
non-U.S.
Law);
and
(l) no claim has been made by any Tax Authority in a jurisdiction where the Company does not file Tax Returns
that the Company is or may be subject to taxation by that jurisdiction, other than any such claims that have been resolved.
3.16
Material Contracts
.
(a) All Contracts required to be filed as exhibits to the Company SEC Documents have been so filed in a timely manner.
Section 3.16(a)
of the Company Disclosure Schedule sets forth a true and complete list, as of the date hereof, of each of the following Contracts to which the Company is a party or by which the Company or any of its assets are bound (and
any material amendments, supplements and modifications thereto):
(i) any Contract that is a material
contract (as such term is defined in Item 601(b)(10) of
Regulation S-K
of the Exchange Act);
(ii) any Contract (other than a Company Benefit Plan) under which the Company is required to make payments of, or
deliver goods or services having a value of more than $50,000;
(iii) any Contract that materially limits the
ability of the Company to compete or provide services in any line of business or with any Person or in any geographic area;
(iv) any Contract required to be disclosed pursuant to Item 404 of
Regulation S-K
of the Exchange Act;
(v) any Contract that permits
any Person other than the Company to manufacture, market, offer, distribute, or sell any products of the Company, including distribution, sales representative, and similar agreements;
A-24
(vi) any Contract or series of related Contracts (A) relating to
indebtedness of the Company for borrowed money or (B) constituting a guarantee by the Company of the obligations of any other Person for borrowed money;
(vii) any Contract providing for the acquisition, transfer, use, development, sharing or license or grant of any right
in or to any Intellectual Property, with the exception of shrink-wrap, click-wrap, and
off-the-shelf
software licenses, and any other licenses of
un-customized
software that is commercially available to the public generally, in each case with
one-time
or annual license, maintenance, support and other fees of $50,000 or
less;
(viii) any Contract that provides for any material most favored nation provision to which the
Company is subject;
(ix) any Contract with the Companys top ten (10) suppliers (measured by dollar
volume of purchases of the Company during the twelve (12) months ended December 31, 2016);
(x) any
Contract with the Companys the top four (4) customers (measured by volume of spending by the customer during the twelve (12) months ended December 31, 2016);
(xi) any Contract between the Company, on the one hand, and any Governmental Entity, on the other hand, involving the
purchase or sale of goods or the provision of services for the benefit of, or by, any Governmental Entity;
(xii) any purchase, sale or supply contract that contains minimum volume requirements or commitments, exclusive or
preferred purchasing arrangements or promotional requirements;
(xiii) any Company Lease Agreements;
(xiv) any acquisition or divestiture agreement (A) entered into since January 1, 2013 or (B) that
contains any
earn-out
provision or other contingent payment obligation, or any continuing indemnification provision, in each case, that has not been satisfied in full or otherwise expired by its
terms;
(xv) any Contract for any joint venture, partnership or similar arrangement;
(xvi) any single source supply contract pursuant to which goods or materials that are material to the
Company are supplied to the Company from an exclusive source;
(xvii) any Contract that contains a standstill or
similar agreement pursuant to which the Company has agreed not to acquire assets or securities of any other party to such Contract or any of its affiliates; or
A-25
(xviii) any Contract that grants any rights of first refusal or rights of
first offer or similar rights with respect to, or that limits or purports to limit the ability of the Company to own, operate, sell, transfer, pledge or otherwise dispose of, any material amount of the Companys assets or any material portion
of the Companys business.
(b) Except as has not had and would not reasonably be expected to have a Company
Material Adverse Effect, (i) each Contract set forth or required to be set forth in
Section
3.16(a)
of the Company Disclosure Schedule or filed or required to be filed as an exhibit to the Company SEC Documents (the
Company Material Contracts
) is valid and binding on the Company and, to the Knowledge of the Company, each other party thereto, and is and in full force and effect and enforceable by the Company in accordance with its terms,
except as limited by Laws affecting the enforcement of creditors rights generally or by general equitable principles (whether considered in a Proceeding at law or in equity), (ii) the Company has performed all obligations required to be
performed by it under each Company Material Contract, and it is not (with or without notice or lapse of time, or both) in breach or default thereunder and, to the Knowledge of the Company, no other party to any Company Material Contract is (with or
without notice or lapse of time, or both) in breach or default thereunder and, to the Knowledge of the Company, no event has occurred or circumstance exists which (with or without notice or lapse of time, or both) would constitute a breach or
default thereunder, and (iii) since January 1, 2015, the Company has not received written notice of any actual, alleged, possible or potential breach or violation of, default under, or failure to comply with, any term or requirement of any
Company Material Contract, or any written notice of revocation, cancellation or termination of any Company Material Contract.
(c) The Company has made available to Parent true and complete copies of each Company Material Contract (including any
material amendments or modifications thereto) as of the date of this Agreement.
3.17
Intellectual Property
.
(a)
Section 3.17(a)(i)
of the Company Disclosure Schedule sets forth a list of all (i) issued patents
and pending patent applications, (ii) trademark and service mark registrations and applications, (iii) copyright registrations and applications, and (iv) internet domain name registrations, in each case that are owned by the Company
(collectively, the
Company Registered Intellectual Property
) together with the assignment status (if applicable) and the jurisdictions in which any such Company Registered Intellectual Property has been issued or registered or in
which an application for such issuance and registration has been filed, including the respective registration or application numbers and the names of the registered owner or applicant, as applicable. With respect to each item of material
Company Registered Intellectual Property, (i) the Company is the sole owner and possesses all right, title and interest in and to the item, free and clear of all Liens (other than Permitted Liens), (ii) such item is in effect, has not been
abandoned or cancelled, and all necessary fees and filings with respect to any Company Registered Intellectual Property have been timely submitted to the relevant Governmental Entities and domain name registrars to maintain such Company Registered
Intellectual Property in its current status, and (iii) no Proceeding is pending or, to Knowledge of the Company, is threatened, that challenges the legality, validity, enforceability, registration, use or ownership of the item.
A-26
(b) Neither the execution and delivery of this Agreement by the Company,
nor the performance of this Agreement by the Company, will result in the loss, forfeiture, termination, or impairment of, or give rise to a right of any Person to limit, terminate, or consent to the continued use of, any rights of the Company in any
Company Material Intellectual Property.
(c) To the Knowledge of the Company, the Company is not infringing,
misappropriating, diluting, or otherwise violating the Intellectual Property rights of any Person. No Proceeding is pending, or to the Knowledge of the Company is threatened, alleging any such infringement, misappropriation, dilution, or
violation (including any claim that the Company must license or refrain from using any Intellectual Property rights of any Person). To the Knowledge of the Company, no Person is infringing, misappropriating, diluting or otherwise violating any
Company Owned Intellectual Property. The Company has not made or asserted any charge, complaint, claim, demand or notice during the past three (3) years (or earlier, if presently not resolved) alleging that any Person has infringed,
misappropriated, diluted, or otherwise violated any Company Owned Intellectual Property.
(d) All Company Material
Intellectual Property regarded as trade secrets has been maintained in confidence in accordance with protection procedures that are adequate for protection. All current and, to the Knowledge of the Company, former officers, directors,
employees, personnel, consultants, advisors, agents, and independent contractors of the Company, and its predecessors, who have created, contributed to or participated in the conception or development of any Company Material Intellectual Property
have entered into valid and binding proprietary rights agreements with the Company or predecessor, vesting ownership of such Intellectual Property in the Company, and waiving all of such Persons moral rights therein. No such Person has
asserted, and to the Companys Knowledge, no such Person has, any right, title, interest or other claim in, or the right to receive any royalties or other consideration with respect to, any such Intellectual Property.
(e) No Company Owned Intellectual Property is subject to any outstanding judgment, injunction, order, decree or
agreement restricting the ownership or use thereof by the Company, or restricting the sale or licensing thereof to any Person. Except as set forth in
Section 3.17(e)
of the Company Disclosure Schedule, to the Companys Knowledge, at
no time during the conception of or reduction to practice of any Company Owned Intellectual Property was any inventor of such Intellectual Property (i) subject to any employment agreement or invention assignment or nondisclosure agreement or
other obligation with any Third Party, (ii) operating under any grants from any Governmental Entity, university, college, other educational institution or private source, or (iii) performing research sponsored by any Governmental Entity,
university, college, other educational institution or private source. Except as set forth in
Section 3.17(e)
of the Company Disclosure Schedule, to the Companys Knowledge no facilities of any university, college, other educational
institution or research center were used in the development or reduction to practice of any Company Owned Intellectual Property.
(f) The Company has established and implemented commercially reasonable security measures and policies (i) to
protect all Personal Data collected by them or on their behalf from and against unauthorized access, use, modification and/or disclosure; (ii) to protect against any material anticipated threats or hazards to the security of Personal Data; and
A-27
(iii) for the disposal of Personal Data in compliance with the requirements of all applicable Information Privacy
and Security Laws. The Company is currently operating in compliance, in all material respects, with all applicable Information Privacy and Security Laws. There are no Proceedings pending against the Company asserting any violation by the
Company of any (i) Information Privacy and Security Law, (ii) agreement (or portion thereof) to which the Company is a party that relates to the protection of Personal Data, or (iii) of the Companys privacy and security policies
applicable to Personal Data. To the Knowledge of the Company, the Company has not made or suffered any unauthorized acquisition, access, use or disclosure of any Personal Data that would trigger a notification or reporting requirement under any
Information Privacy and Security Law.
(g) The Company has taken commercially reasonable actions to protect the
confidentiality, integrity and security of the IT Assets against unauthorized use, access, interruption, modification and corruption.
3.18
Regulatory Matters
.
(a) The Company has at all times during the past five (5) years operated in compliance, and currently is in
compliance, in all material respects with all health care laws applicable to the operation of its business as currently conducted, including, to the extent applicable to the operation of the Companys business, each of (i) the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. Section 301 et seq.) (the
FFDCA
) and the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder); (ii) federal, state, local and
foreign health care related fraud and abuse laws, including, without limitation, the federal Anti-Kickback Statute (42 U.S.C. Section
1320a-7b(b)),
the federal Civil False Claims Act (31 U.S.C.
Section 3729 et seq.), the exclusion laws (42 U.S.C. Section
1320a-7),
the Civil Monetary Penalties Law (42 U.S.C. Section
1320a-7a),
the federal criminal false
statements law (42 U.S.C. §
1320a-7b(a)),
the U.S. Physician Payments Sunshine Act (42 U.S.C. Section
1320a-7h),
all criminal laws relating to health care fraud and
abuse, including but not limited to 18 U.S.C. §§ 286 and 287, and the regulations promulgated pursuant to such statutes; (iii) the U.S. Health Insurance Portability and Accountability Act of 1996 (
HIPAA
), (42 U.S.C.
Section 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. Section 17921 et seq.), and the regulations promulgated thereunder and any state or
non-U.S.
counterpart thereof or other law or regulation the purpose of which is to protect the privacy of individuals or prescribers; (iv) the Medicare statute (Title XVIII of the Social Security Act);
(v) the Medicaid statute (Title XIX of the Social Security Act); (vi) TRICARE laws (10 U.S.C. § 1071, et seq.), and (vii) any other state or federal law, regulation, guidance document, manual provision, program memorandum, opinion letter
or other public issuance which regulates kickbacks, recordkeeping, claims process, documentation requirements, referrals, the hiring of employees or acquisition of services or supplies from those who have been debarred, suspended or excluded from
government health care programs, quality, safety, privacy, security, licensure or any other aspect of manufacturing and distributing drugs and biological products (collectively, the
Health Care Laws
). The Company has not
received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement audit, investigation, arbitration, or other action from the FDA, the Centers for Medicare and Medicaid Services, the U.S. Department of Justice, the
U.S. Department of Health and Human Services, or
A-28
other Governmental Entity alleging that any operation or activity of the Company is in material violation of any Health Care Laws. The Company has not engaged in activities which are, as
applicable, reasonably likely to be a cause for false claims liability, civil penalties, debarment, disqualification or mandatory or permissive exclusion from any U.S. state or federal healthcare program. Neither the Company, nor, to the
Knowledge of Company, any director, officer, employee or contractor of the Company, has made any voluntary or self-disclosure to any Governmental Entity regarding any potential
non-compliance
with any
applicable Health Care Law. To the Knowledge of Company, no act, omission, event or circumstance has occurred that would reasonably be expected to give rise to, or lead to, any Proceeding or material
non-compliance
with any applicable Health Care Laws.
(b) Section 3.18(b)
of the Company Disclosure Schedule sets forth a list of all current and pending Permits of the FDA and similar federal, state, local or foreign Governmental Entities (each a
Regulatory Authority
and collectively, the
Regulatory Authorities
) required for the conduct of the Companys business (collectively, the
Regulatory Permits
). The Company holds, and has been and currently is operating in material compliance with
the Regulatory Permits and all such Regulatory Permits are in full force and effect. The Company has fulfilled and performed all of its material obligations with respect to the Regulatory Permits, and the Knowledge of the Company, no event has
occurred which allows, or after notice or lapse of time would reasonable be expected to allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any Regulatory Permit.
(c) All applications, notifications, submissions, information, claims, reports and statistics, and other data and
conclusions derived therefrom (collectively, the
Submissions
), utilized as the basis for or submitted in connection with any and all requests for a Regulatory Permit from any Regulatory Authority relating to the Company or its
business and products, when submitted to the applicable Regulatory Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such
Submissions have been submitted to such Regulatory Authority.
(d) Except as set forth in
Section 3.18(d)
of the Company Disclosure Schedule, since January 1, 2014, the Company has not had any product or manufacturing site (whether Company-owned or that of a contract manufacturer for the products) subject to a Governmental Entity (including FDA or
other Regulatory Authority) shutdown, restriction, or import or export prohibition, nor received any FDA Form 483 or other Regulatory Authority notice of inspectional observations, warning letters, untitled letters or
requests or requirements to make changes to the products that if not complied with would reasonably be expected to have a material effect on the Company, or similar correspondence or notice from any Regulatory Authority alleging or asserting
noncompliance with any applicable Law, Regulatory Permit or such requests or requirements of a Regulatory Authority, and, to the Knowledge of the Company, no Regulatory Authority is considering such action.
(e)
Section 3.18(e)
of the Company Disclosure Schedule sets forth a list of (i) all recalls, safety alerts
or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of the Companys products (
Safety Notices
) since January 1, 2014;
A-29
(ii) the dates such Safety Notices, if any, were resolved or closed; and (iii) to the Companys Knowledge, any material complaints with respect to the products that are currently
unresolved. There are no outstanding orders or requests by any Regulatory Authority for a recall for any products, and no Safety Notices, or, to the Companys Knowledge, material product complaints with respect to the Companys
products, and to the Companys Knowledge, there are no facts that would reasonably be expected to result in (i) a recall or material Safety Notice with respect to the Companys products, (ii) a material change in labeling of any
the Companys products; or (iii) a termination or suspension of manufacturing, processing or testing of any of the Companys products.
(f) The clinical,
pre-clinical
and other studies and tests conducted by or on
behalf of or sponsored by the Company or in which the Company or its products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific
research procedures and all applicable Laws, including, but not limited to, the FFDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, and 312. Except to the extent disclosed on
Section 3.18(f)
of the
Company Disclosure Schedule, no investigational new drug application filed by or on behalf of the Company with the FDA has been disapproved, terminated or suspended by the FDA, and neither the FDA nor any other Regulatory Authority has commenced,
or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, or impose conditions of approval on any proposed or ongoing clinical investigation conducted or
proposed to be conducted by or on behalf of the Company.
(g) The Company is not the subject of any pending or, to
the Knowledge of the Company, threatened investigation in respect of the Company or its products, by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy set forth in 56 Fed.
Reg. 46191 (September 10, 1991) and any amendments thereto. Neither the Company, nor to the Knowledge of the Company any of its officers, directors, employees, agents, or contractors has been convicted of any crime or engaged in any conduct
that has resulted or would reasonably be expected to result in a material debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) other Health Care Law. As of the date hereof, no claims, actions, proceedings or investigations
that would reasonably be expected to result in such a material debarment, suspension or exclusion are pending or threatened against the Company or, to the Knowledge of the Company, any of its officers, directors, employees or agents.
(h) The Company is not a party to and does not have any ongoing reporting or disclosure obligations pursuant to or
under any corporate integrity agreements, monitoring agreements, deferred prosecution agreement, consent decrees, settlement orders, or similar agreements imposed by any Governmental Entity. Neither the Company, nor to the Knowledge of the Company
any of its officers, directors, employees, agents and contractors has been or is currently debarred, suspended or excluded from participation in any governmental health care program, or convicted of any crime or engaged in any conduct for which such
Person would reasonably be expected to be debarred, suspended or excluded from participating in any governmental health care program under Section 1128 of the Social Security Act of 1935 (42 U.S.C. §
1320a-7),
as amended, or any similar applicable Law or program.
A-30
3.19
Brokers Fees
. Except for the financial
advisors fees set forth in
Section
3.19
of the Company Disclosure Schedule, neither the Company nor any of its officers or directors on behalf of the Company has employed any financial advisor, broker or finder or
incurred any liability for any financial advisory, brokers fees, commissions or finders fees in connection with any of the Transactions.
3.20
Opinion of Financial Advisor
. Roth Capital Partners, LLC, the Companys financial advisor has
delivered to the Company Board its opinion in writing or orally, in which case, such opinion will be subsequently confirmed in writing, to the effect that, as of the date thereof and based upon and subject to the assumptions, limitations,
qualifications, and other matters set forth therein, the consideration to be received by the holders of Company Shares (other than Parent and its affiliates) pursuant to this Agreement is fair from a financial point of view to such holders.
3.21
Insurance
. Except as would not reasonably be expected to have a Company Material Adverse Effect,
(a) the Company maintains insurance of a scope and coverage as is sufficient to comply with applicable Law and in accordance with standard industry practices, (b) all insurance policies of the Company are in full force and effect, and all
premiums due and payable thereon have been paid and (c) the Company is not in breach of, or default under, any such insurance policy or has taken any action or failed to take any action which, with notice or lapse of time or both, would
constitute such a breach or default or permit termination or modification of any of the insurance policies. Since January 1, 2014, the Company has not received any written notice of cancellation, invalidation or termination or, as of the date
of this Agreement, denial of coverage, rejection of a material claim or material adjustment in the amount of the premiums payable under any material insurance policy currently maintained by the Company.
3.22
No Other Representations or Warranties
. Except for the representations and warranties expressly set
forth in this
Article 3
or the Company Disclosure Schedule, none of the Company, any of its affiliates or any other Person on behalf of the Company makes any express or implied representation or warranty (and there is and has been no reliance
by Parent, Merger Sub or any of their respective affiliates or Representatives on any such representation or warranty) with respect to the Company or its business or with respect to any other information provided, or made available, to Parent,
Merger Sub or their respective Representatives or affiliates in connection with the transactions contemplated hereby, including the accuracy or completeness thereof. Without limiting the foregoing, neither the Company nor any other Person will
have or be subject to any liability or other obligation to Parent, Merger Sub or their Representatives or affiliates or any other Person resulting from Parents, Merger Subs or their Representatives or affiliates use of any
information, documents, projections, forecasts or other material made available to Parent, Merger Sub or their Representatives or affiliates, including any information made available in the electronic data room maintained by the Company for purposes
of the transactions contemplated by this Agreement, teaser, marketing material, confidential information memorandum, management presentations, functional
break-out
discussions, responses to
questions submitted on behalf of Parent, Merger Sub or their respective
A-31
Representatives or in any other form in connection with the transactions contemplated by this Agreement, unless and to the extent any such information is expressly included in a representation or
warranty contained in this
Article 3
or the Company Disclosure Schedule.
ARTICLE 4
REPRESENTATIONS AND WARRANTIES OF PARENT AND MERGER SUB
Except as set forth in the disclosure schedule delivered by Parent and Merger Sub to the Company (the
Parent Disclosure
Schedule
) prior to the execution of this Agreement (with specific reference to the representations and warranties in this
Article 4
to which the information in such schedule relates;
provided
, that, disclosure in the Parent
Disclosure Schedule as to a specific representation or warranty shall qualify any other sections of this Agreement to the extent (notwithstanding the absence of a specific cross reference) it is reasonably apparent on its face that such disclosure
relates to such other sections), Parent and Merger Sub hereby represent and warrant to the Company as follows:
4.1
Corporate Organization
. Each of Parent and Merger Sub is a corporation or other entity duly organized,
validly existing and, to the extent applicable, in good standing under the laws of the jurisdiction of its organization and has the requisite corporate or other entity power and authority to own or lease all of its properties and assets and to carry
on its business as it is now being conducted. Each of Parent and Merger Sub is duly licensed or qualified to do business in each jurisdiction in which the nature of the business conducted by it or the character or location of the properties and
assets owned or leased by it makes such licensing or qualification necessary, except where the failure to be so licensed or qualified, has not had and would not reasonably be expected to have a Parent Material Adverse Effect.
4.2
Authority, Execution and Delivery; Enforceability
. Each of Parent and Merger Sub has all necessary power and
authority to execute and deliver this Agreement, to perform and comply with each of its obligations under this Agreement and to consummate the Transactions applicable to such party. The execution and delivery by each of Parent and Merger Sub of
this Agreement, the performance and compliance by Parent and Merger Sub with each of its obligations herein and the consummation by Parent and Merger Sub of the Transactions applicable to it have been duly authorized by all necessary corporate
action on the part of Parent and Merger Sub, and no other corporate proceedings on the part of Parent or Merger Sub and no stockholder votes are necessary to authorize this Agreement or the consummation by Parent and Merger Sub of the Transactions
to which it is a party. Each of Parent and Merger Sub has duly and validly executed and delivered this Agreement and, assuming the due authorization, execution and delivery by the Company of this Agreement, this Agreement constitutes
Parents and Merger Subs legal, valid and binding obligation, enforceable against each of Parent and Merger Sub in accordance with its terms, except as may be limited by Laws affecting the enforcement of creditors rights generally
or by general equitable principles (whether considered in a Proceeding at law or in equity).
4.3
No
Conflicts
.
(a) The execution and delivery of this Agreement by Parent and Merger Sub does not, and the
consummation by Parent and Merger Sub of the Transactions and
A-32
compliance by Parent and Merger Sub with any of the terms or provisions hereof will not, (i) conflict with or violate any provision of the certificate of incorporation, bylaws or similar
organizational documents of Parent or Merger Sub, (ii) assuming that all consents, approvals, authorizations and permits described in
Section 4.3(b)
have been obtained and all filings and notifications described in
Section 4.3(b)
have been made and any waiting periods thereunder have terminated or expired, conflict with or violate any Law applicable to Parent, Merger Sub or any other Subsidiary of Parent (each a
Parent Subsidiary
and, collectively, the
Parent Subsidiaries
), or by which any property or asset of Parent or any Parent Subsidiary is bound or affected or (iii) require any consent or approval under, result in any breach or violation of or any loss of any benefit
under, constitute a change of control or default (or an event which with notice or lapse of time or both would become a default) under or give to others any right of termination, vesting, amendment, acceleration or cancellation of, or result in the
creation of a Lien on any property or asset of Parent or any Parent Subsidiary, including Merger Sub, pursuant to, any Contract or Permit to which Parent or any Parent Subsidiary is a party, except, with respect to clauses (ii) and (iii), for
any such conflicts, violations, breaches, defaults or other occurrences which would not reasonably be expected to have a Parent Material Adverse Effect.
(b) Assuming the accuracy of the representations and warranties of the Company in
Section
3.4
, the execution and delivery of this Agreement by Parent and Merger Sub does not, and the consummation by Parent and Merger Sub of the Transactions and compliance by Parent and Merger Sub with any of the terms or
provisions hereof will not, require any consent, approval, authorization or permit of, or filing or registration with or notification to, any Governmental Entity, except (i) the filing with the SEC of (A) the Proxy Statement and
(B) the Form
S-4,
(ii) other filings required under, and compliance with other applicable requirements of under the Exchange Act and the rules and regulations of NYSE, (iii) the filing and
recordation of the Certificate of Merger as required by the DGCL and (iv) where failure to obtain such consents, approvals, authorizations or permits, or to make such filings, registrations or notifications would not reasonably be expected to
have a Parent Material Adverse Effect.
4.4
Litigation
. There is no Proceeding pending, or, to the
Knowledge of Parent, threatened that has had or would reasonably be expected to have a Parent Material Adverse Effect, and neither Parent nor Merger Sub is subject to any outstanding Order that has had or would reasonably be expected to have a
Parent Material Adverse Effect.
4.5
Capitalization
.
(a) The authorized capital stock of Parent consists of 200,000,000 shares of Parent Common Stock. As of
October 31, 2016, there were outstanding 118,575,964 shares of Parent Common Stock. All outstanding shares of capital stock of Parent have been duly authorized and validly issued, fully paid and nonassessable and free of preemptive rights.
(b) The shares of Parent Common Stock to be issued as part of the Merger Consideration have been duly authorized and,
when issued and delivered in accordance with the terms of this Agreement, will have been validly issued and will be fully paid and nonassessable and the issuance thereof is not subject to any preemptive or other similar right.
A-33
4.6
SEC Documents; Financial Statements; Undisclosed
Liabilities
.
(a) Parent has timely filed or furnished all reports, schedules, forms, statements, registration
statements, prospectuses and other documents required to be filed or furnished by Parent with the SEC under the Securities Act or the Exchange Act since January 1, 2014 (the
Parent SEC Documents
). None of the Parent
Subsidiaries is required to make any filings with the SEC.
(b) As of its respective filing date, and, if amended,
as of the date of the last amendment prior to the date of this Agreement, each Parent SEC Document complied in all material respects with the requirements of the Exchange Act, or the Securities Act or and the Sarbanes-Oxley Act, as the case may be,
and the rules and regulations of the SEC promulgated thereunder applicable to such Parent SEC Document and did not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary in order
to make the statements therein, in light of the circumstances under which they were made, not misleading. Parent has made available to the Company true and complete copies of all material correspondence between the SEC, on the one hand, and
Parent and any Parent Subsidiaries, on the other hand, occurring since January 1, 2014 and prior to the date hereof. As of the date hereof, there are no outstanding or unresolved comments in comment letters from the SEC staff with respect
to any of the Parent SEC Documents. To the Knowledge of Parent, as of the date hereof, none of the Parent SEC Documents is the subject of ongoing SEC review, outstanding SEC comment or outstanding SEC investigation.
(c) The consolidated financial statements of Parent included in the Parent SEC Documents (including, in each case, any
notes or schedules thereto) (the
Parent SEC Financial Statements
) fairly present, in all material respects, the financial condition and the results of operations, cash flows and changes in stockholders equity of Parent and
its Subsidiaries (on a consolidated basis) as of the respective dates of and for the periods referred to in the Parent SEC Financial Statements, and were prepared in accordance with GAAP applied on a consistent basis during the periods involved
(except as may be indicated in the notes thereto), subject, in the case of interim Parent SEC Financial Statements, to normal
year-end
adjustments and the absence of notes.
(d) Parent has established and maintains disclosure controls and procedures and internal control over financial
reporting (as such terms are defined in paragraphs (e) and (f), respectively, of
Rule 13a-15
and paragraph (e) of
Rule 15d-15
under the Exchange Act)
as required by
Rules 13a-15
and
15d-15
under the Exchange Act. Parents disclosure controls and procedures are designed to ensure that all information
(both financial and
non-financial)
required to be disclosed by Parent in the reports that it files or furnishes under the Exchange Act is recorded, processed, summarized and reported within the time periods
specified in the rules and forms of the SEC, and that all such information is accumulated and communicated to Parents management as appropriate to allow timely decisions regarding required disclosure and to make the certifications required
pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act. Parents management has completed an assessment of the effectiveness of Parents disclosure controls and procedures and, to the extent required by applicable Law, presented
in any applicable Parent SEC Document that is a report on Form
10-K
or Form
10-Q,
or any amendment thereto, its conclusions about the effectiveness of the disclosure
controls and procedures as of the end of the period covered by such report or amendment based on such
A-34
evaluation. Based on Parents managements most recently completed evaluation of Parents internal control over financial reporting, (i) Parent had no significant
deficiencies or material weaknesses in the design or operation of its internal control over financial reporting that would reasonably be expected to adversely affect Parents ability to record, process, summarize and report financial
information and (ii) Parent does not have Knowledge of any fraud, whether or not material, that involves management or other employees who have a significant role in Parents internal control over financial reporting. Since
January 1, 2014, Parents principal executive officer and its principal financial officer have disclosed to Parents auditors and the audit committee of the Board of Directors of Parent (the
Parent Board
) (i) all
significant deficiencies and material weaknesses in the design or operation of Parents internal control over financial reporting that would reasonably be expected to adversely affect Parents ability to record, process, summarize and
report financial information and (ii) any fraud, whether or not material, that involves management or other employees who have a significant role in Parents internal control over financing reporting, and Parent has made available to
Parent true and complete copies of any material written materials provided to Parents auditors or the audit committee of the Parent Board relating to each of the foregoing. Parent has not made any prohibited loans or extensions of
credit (within the meaning of Section 402 of the Sarbanes-Oxley Act) to any executive officer (as defined in Rule
3b-7
under the Exchange Act) or director of Parent.
(e) Parent and its Subsidiaries do not have any liabilities or obligations of any nature (whether absolute or
contingent, asserted or unasserted, known or unknown, primary or secondary, direct or indirect, and whether or not accrued), required by GAAP to be reflected or reserved on a consolidated balance sheet of Parent (or the notes thereto) except
(i) as reflected or reserved against in the most recent audited balance sheet included in the Parent SEC Financial Statements or the notes thereto, (ii) for liabilities and obligations incurred in the ordinary course of business since the
date of the most recent audited balance sheet included in the Parent SEC Financial Statements, (iii) for liabilities and obligations arising out of or in connection with this Agreement, the Merger or the Transactions and (iv) for
liabilities and obligations that have not had, and would not reasonably be expected to have, a Parent Material Adverse Effect.
4.7
Information Supplied
. None of the information supplied or to be supplied by Parent or Merger Sub for
inclusion or incorporation by reference in (a) the Proxy Statement will, at the date that the Proxy Statement or any amendment or supplement thereto is mailed to holders of Company Shares and at the time of the Company Meeting, contain any
untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in light of the circumstances in which they are made, not misleading and (b) the Form
S-4
will, at the time the Form
S-4
is filed with the SEC, and at any time it is amended or supplemented or at the time it becomes effective under the Securities Act, 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 are made, not misleading (except that no representation or warranty is made by Parent or
Merger Sub to such portions of the Proxy Statement or the Form
S-4,
as applicable, that relate expressly to the Company or to statements made therein based on information supplied by or on behalf of Company
for inclusion or incorporation by reference therein). The Form
S-4
will comply as to form in all material respects with the requirements of the Exchange Act and the Securities Act.
A-35
4.8
Ownership of Company Capital Stock
. None of Parent, Merger
Sub or any Parent Subsidiary beneficially owns any Company Shares as of the date hereof. Neither Parent nor Merger Sub is, nor at any time during the last three years has it been, an interested stockholder of the Company as defined
in Section 203 of the DGCL (other than as contemplated by this Agreement).
4.9
Available
Funds
. Parent and Merger Sub have or, at Closing, shall have, sufficient cash, available lines of credit or other sources of immediately available funds to permit Parent and Merger Sub to perform all of their obligations under this
Agreement and to consummate the Merger.
4.10
Ownership of Merger Sub
. All of the issued and
outstanding Equity Interests of Merger Sub are, and at the Effective Time will be, owned directly or indirectly by Parent. Merger Sub was formed solely for purposes of the Merger and, except for matters incident to formation and execution and
delivery of this Agreement and the performance of the transactions contemplated hereby, has not prior to the date hereof engaged in any business or other activities.
4.11
Brokers Fees
. Except for the financial advisors fees set forth in
Section
4.11
of the Parent Disclosure Schedule, neither Parent nor any Parent Subsidiary nor any of their respective officers or directors on behalf of Parent or such Parent Subsidiary has employed any financial advisor,
broker or finder or incurred any liability for any financial advisory, brokers fees, commissions or finders fees in connection with any of the Transactions.
4.12
No Other Representations and Warranties
. Except for the representations and warranties expressly set
forth in this
Article 4
, none of Parent, Merger Sub, any of their respective affiliates or any other Person on behalf of Parent or Merger Sub makes any express or implied representation or warranty (and there is and has been no reliance by
the Company or any of its affiliates or Representatives on any such representation or warranty) with respect to Parent, Merger Sub, any other Parent Subsidiary or their respective businesses or with respect to any other information provided, or made
available, to the Company or its Representatives or affiliates in connection with the transactions contemplated hereby, including the accuracy or completeness thereof. Without limiting the foregoing, none of Parent, Merger Sub or any other
Person will have or be subject to any liability or other obligation to the Company or its Representatives or affiliates or any other Person resulting from the Companys or its Representatives or affiliates use of any information,
documents, projections, forecasts or other material made available to the Company or its Representatives or affiliates, including any information made available in management presentations, functional
break-out
discussions, responses to questions submitted on behalf of the Company or its Representatives or in any other form in connection with the transactions contemplated by this Agreement,
unless and to the extent any such information is expressly included in a representation or warranty contained in this
Article 4
.
A-36
ARTICLE 5
COVENANTS
5.1
Conduct of Business by the Company Pending the Closing
. Between the date of this Agreement and the earlier
of the Effective Time and the termination of this Agreement in accordance with
Article 7
, except as set forth in
Section
5.1
of the Company Disclosure Schedule or as otherwise expressly required by any other
provision of this Agreement or by applicable Law, or with the prior written consent of Parent (not to be unreasonably withheld, conditioned or delayed), the Company will, (i) conduct its operations only in the ordinary course of business, and
(ii) use its commercially reasonable efforts to keep available the services of the current officers, employees and consultants of the Company and to preserve the goodwill and current relationships of the Company with customers, suppliers and
other Persons with which the Company has business relations. Without limiting the foregoing, except as set forth in
Section
5.1
of the Company Disclosure Schedule or as otherwise expressly required by any other
provision of this Agreement or by applicable Law, the Company shall not, between the date of this Agreement and the earlier of the Effective Time and the termination of this Agreement in accordance with
Article 7
, directly or indirectly, take
any of the following actions without the prior written consent of Parent (not to be unreasonably withheld, conditioned or delayed):
(a) amend its certificate of incorporation or bylaws or equivalent organizational documents;
(b) issue, sell, pledge, dispose of, grant, transfer or encumber any shares of capital stock of, or other Equity
Interests in, the Company of any class, or securities convertible into, or exchangeable or exercisable for, any shares of such capital stock or other Equity Interests, or any options, warrants or other rights of any kind to acquire any shares of
such capital stock or other Equity Interests or such convertible or exchangeable securities of the Company, other than the issuance of Company Shares upon the exercise of Company Options outstanding as of the date hereof in accordance with their
existing terms;
(c) sell, pledge, dispose of, transfer, lease, license, guarantee or encumber any property or
assets of the Company (other than Intellectual Property), except (i) pursuant to the express terms of any Company Material Contract in effect as of the date hereof, (ii) the sale or disposition of property or assets with a fair market
value not in excess of $10,000 individually or $25,000 in the aggregate, or (iii) the sale of inventory in the ordinary course of business;
(d) sell, assign, pledge, transfer, license, abandon, or otherwise dispose of any Intellectual Property of the
Company, except (A) the abandonment, in the ordinary course of business, of Company Owned Intellectual Property that in the Companys reasonable business judgment is no longer used or useful in the business of the Company and is no longer
commercially practicable to maintain, and (B) the
non-exclusive
licensing or sublicensing of Company Intellectual Property to affiliates, distributors, and customers in the ordinary course of business;
A-37
(e) declare, set aside, make or pay any dividend or other distribution
(whether payable in cash, stock, property or a combination thereof) with respect to any of its capital stock or other Equity Interests;
(f) reclassify, combine, split, subdivide or amend the terms of, or redeem, purchase or otherwise acquire, directly or
indirectly, any of its capital stock or other Equity Interests, except the acceptance of Company Shares as payment for the exercise price of Company Options or for withholding taxes incurred in connection with the exercise of Company Options in
accordance with past practice (or in accordance with
Section
2.4
of this Agreement) and the terms of the applicable Company Equity Plan and applicable award agreement(s);
(g) merge or consolidate the Company with any Person or adopt a plan of complete or partial liquidation or resolutions
providing for a complete or partial liquidation, dissolution, restructuring, recapitalization or other reorganization of the Company;
(h) acquire (including by merger, consolidation, or acquisition of stock or assets) any Person (or any business line
or division thereof) or assets, other than acquisitions of inventory, raw materials and other property in the ordinary course of business;
(i) incur any indebtedness for borrowed money or issue any debt securities or assume, guarantee or endorse, or
otherwise as an accommodation become responsible for (whether directly, contingently or otherwise), the obligations of any Person for borrowed money, except (i) in connection with refinancings of existing indebtedness on terms no less favorable
to the Company than (and in an aggregate principal amount not in excess of) such existing indebtedness, (ii) for borrowings under the Companys existing credit facilities or issuances of commercial paper for working capital and general
corporate purposes in the ordinary course of business, and (iii) other indebtedness not to exceed $10,000 in the aggregate;
(j) make any loans, advances or capital contributions to, or investments in, any other Person;
(k) terminate, cancel or renew, or agree to any material amendment to or waiver under, any Company Material Contract,
or enter into or amend any Contract that, if existing on the date hereof, would be a Company Material Contract, in each case other than in the ordinary course of business;
(l) make any capital expenditure in excess of the Companys capital expenditure budget as disclosed to Parent
prior to the date hereof, other than capital expenditures that are not, in the aggregate, in excess of $10,000;
(m) except to the extent required by (x) applicable Law, or (y) the existing terms of any Company Benefit
Plan disclosed in Section 3.11(a) of the Company Disclosure Schedule as in effect as of the date hereof: (A) materially increase the compensation or benefits payable or to become payable to any Service Provider, other than annual merit
increases in annual base salary or base rate of pay , in each case, in the ordinary course of business; (B) amend any Company Benefit Plan (other than any amendment that could not reasonably be expected result in a material additional cost to
the Company or its affiliates, or
A-38
obligate the Company or its affiliates to maintain such Company Benefit Plan beyond December 31, 2017), or establish, adopt, enter into any new arrangement that if in effect on the date
hereof would be a Company Benefit Plan (for the avoidance of doubt, including, any employment, severance, change in control, retention, bonus guarantee or similar agreement or arrangement); (C) take any action to amend or waive any performance or
vesting criteria or accelerate vesting, exercisability or funding under any Company Benefit Plan (including funding any grantor trust); (D) pay or award, or commit to pay or award, any bonuses or incentive compensation (other than annual bonuses
payable in the ordinary course of business during the first quarter of the Companys fiscal year); (E) grant any equity-based or equity-linked awards; (F) enter into any collective bargaining agreement, or any works council, labor union or
similar agreement or arrangement; (G) hire or terminate the employment (other than for cause due to the inability to provide services) of any officer; or (H) promote any officers or employees, except for new hires (in accordance with the
restrictions under the foregoing clause (G)) or for a promotion of any existing employee that is in the ordinary course of business and prior notice of which is provided to the Parent;
(n) make any change in accounting policies, practices, principles, methods or procedures, other than as required by
GAAP or by a Governmental Entity;
(o) compromise, settle or agree to settle any Proceeding other than
compromises, settlements or agreements of Proceedings (excluding Transaction Litigation) in the ordinary course of business that involve only the payment of monetary damages not in excess of $10,000 individually or $50,000 in the aggregate, in any
case without the imposition of equitable relief on, or the admission of wrongdoing by, the Company;
(p) (A) make,
change or revoke any material Tax election, (B) change any of its material methods of reporting income or deductions for Tax purposes (or file a request to make any such change), (C) settle or compromise any material Tax liability, claim, audit
or dispute, (D) surrender any right to claim a material Tax refund, (E) file any amended Tax Return with respect to any material Tax, (F) enter into any Tax allocation, sharing, indemnity or closing agreement, or (G) waive or
extend the statute of limitations with respect to any Tax other than pursuant to extensions of time to file Tax Returns obtained in the ordinary course of business;
(q) enter into any new line of business or materially alter any existing line of business, other than in the ordinary
course of business;
(r) voluntarily cancel, terminate or fail to renew (in a form and amount consistent with past
practice) any material insurance policies covering the Company or any of its business, assets or properties; or
(s) authorize or enter into any Contract or otherwise make any commitment to do any of the foregoing.
A-39
5.2
Access to Information; Confidentiality
.
(a) From the date of this Agreement to the earlier of the Effective Time and the termination of this Agreement in
accordance with
Article 7
, the Company shall: (i) provide to the Parent and Merger Sub and their respective Representatives reasonable access during normal business hours in such a manner as not to interfere unreasonably with the
business conducted by the Company, upon prior notice to the Company, to the officers, employees, properties, offices and other facilities of the Company and to the books and records thereof and (ii) promptly furnish during normal business hours
such information concerning the business, properties, Contracts, assets and liabilities of the Company as Parent or its Representatives may reasonably request;
provided
,
however
, that the Company shall not be required to afford such
access or furnish such information to the extent that the Company reasonably believes that doing so would: (A) result in the loss of attorney-client privilege (but the Company shall use its commercially reasonable efforts to allow for such
access or disclosure in a manner that does not result in a loss of attorney-client privilege), (B) result in the disclosure of any trade secrets of third parties or otherwise breach, contravene or violate any effective Contract existing on the date
hereof to which the Company is party, or (C) breach, contravene or violate any applicable Law.
(b) Each of
the Parent and Merger Sub agrees that it will not, and will cause its Representatives not to, prior to the Effective Time, use any information obtained pursuant to this
Section
5.2
for any competitive or other purpose
unrelated to the consummation of the Merger. The Mutual Confidentiality Agreement, dated August 14, 2015, by and between the Company and Parent, as amended by the Amendment to the Mutual Confidentiality Agreement, dated as of
August 14, 2016 (the
Confidentiality Agreement
), shall apply with respect to information furnished under this
Section
5.2
by the Company and its Representatives. Prior to the Closing, each of
Parent and Merger Sub shall not, and shall cause their respective Representatives not to, contract or otherwise communicate with employees (other than members of the Companys senior leadership team), customers, suppliers or distributors of the
Company and its Subsidiaries, or, except as required pursuant to
Section
5.5
, any Governmental Entity, regarding the business of the Company, this Agreement, or the Transactions, without the prior written consent of the
Chief Executive Officer of the Company (which consent shall not be unreasonably withheld, conditioned or delayed).
5.3
No Solicitation
.
(a) From and after the date hereof until the Effective Time, the Company shall, and shall cause its Representatives to,
(x) immediately cease and cause to be terminated any discussions or negotiations with any Third Party that may be ongoing as of the date hereof with respect to any Acquisition Proposal, and (y) deliver a written notice to any such Third
Party to the effect that the Company is terminating all discussions and negotiations with such Third Party with respect to any Acquisition Proposal, and requesting that such Third Party promptly return or destroy all confidential information
concerning the Company. Except as expressly permitted by this
Section
5.3
, from and after the date hereofuntil the Effective Time, or, if earlier, the termination of this Agreement in accordance with
Article 7
,
the Company shall and shall cause its Representatives not to on behalf of the Company, initiate, solicit, facilitate or knowingly encourage any Acquisition Proposal or the making or submission thereof, or engage in, continue or otherwise participate
in any discussions or negotiations with a Third Party regarding any Acquisition Proposal (other than to inform any Third Party of the existence of the provisions contained in this
Section
5.3
) or furnish or provide any
nonpublic information in
A-40
connection with any Acquisition Proposal. Except as expressly permitted by this
Section
5.3
, from and after the date hereof until the Effective Time, or, if
earlier, the termination of this Agreement in accordance with
Article 7
, neither the Company Board nor any committee thereof shall (i) adopt, approve or recommend, or publicly propose to adopt, approve or recommend, any Acquisition
Proposal, (ii) withdraw, change, qualify, withhold or modify, or publicly propose to withdraw, change, qualify, withhold or modify, in a manner adverse to Parent or Merger Sub, the Company Board Recommendation, (iii) fail to include the
Company Board Recommendation in the Proxy Statement, (iv) in the event a tender offer that constitutes an Acquisition Proposal subject to Regulation 14D under the Exchange Act is commenced, fail to recommend against such Acquisition Proposal in
any solicitation or recommendation statement made on Schedule
14D-9
within ten (10) Business Days of such commencement, (v) approve, authorize or cause or permit the Company to enter into any merger
agreement, acquisition agreement, letter of intent, memorandum of understanding or other similar agreement relating to any Acquisition Proposal (a
Company Acquisition Agreement
), or (vi) resolve or agree to do any of the
foregoing (any action set forth in the foregoing clauses (i) through (vi) of this sentence, a
Change of Board Recommendation
).
(b) Notwithstanding anything to the contrary contained in
Section 5.3(a)
, if at any time following the
date hereofand prior to the receipt of the Company Stockholder Approval (i) the Company has received a bona fide written Acquisition Proposal from a Third Party, (ii) the Company has not breached this
Section
5.3
(excluding immaterial, unintentional violations) and (iii) the Company Board (or a duly authorized committee thereof) determines in good faith, after consultation with its financial advisors and outside legal counsel, based on information then
available, that such Acquisition Proposal constitutes, or could reasonably be expected to result in, a Superior Proposal and that failure to take such actions would breach, or would reasonably be expected to breach, its fiduciary duties under
applicable Law, then the Company may (A) furnish information with respect to the Company to the Third Party making such Acquisition Proposal, its representatives and potential sources of financing pursuant to (but only pursuant to) one or more
Acceptable Confidentiality Agreements and (B) participate in discussions or negotiations with the Third Party making such Acquisition Proposal regarding such Acquisition Proposal;
provided
, however, that any
non-public
information concerning the Company provided or made available to any Third Party shall, to the extent not previously provided or made available to Parent or Merger Sub, be provided or made available to
Parent or Merger Sub as promptly as reasonably practicable (and in no event later than twenty-four hours) after it is provided or made available to such Third Party.
(c) The Company shall promptly (and in any event within 24 hours) notify Parent in writing of the receipt of any
Acquisition Proposal, which notice shall identify the Third Party making such Acquisition Proposal and include a copy of such Acquisition Proposal (or, where such Acquisition Proposal was not submitted in writing, a reasonably detailed written
description of such Acquisition Proposal including a summary of its material terms and conditions). Without limiting the foregoing, the Company shall keep Parent promptly informed (and in any event within 24 hours) in all material respects of
the status of, and any material communications relating to, such Acquisition Proposal (including any change in the price or other material terms thereof). The Company shall not terminate, amend, modify, waive or fail to enforce any provision of
any standstill or similar obligation of any Person unless the Company
A-41
Board (or a duly authorized committee thereof) determines in good faith, after consultation with its outside legal counsel, that the failure to take such action would breach, or would reasonably
be expected to breach, its fiduciary duties under applicable Law;
provided
, that the Company promptly (and in any event within 24 hours) advises Parent that it is taking such action.
(d) Notwithstanding anything to the contrary contained in
Section
5.3(a)
, if the Company has
received a bona fide written Acquisition Proposal from a Third Party (other than as a result of a breach of this
Section
5.3
) that the Company Board (or any duly authorized committee thereof) determines in good faith, after
consultation with its financial advisors and outside legal counsel, constitutes a Superior Proposal, the Company Board may at any time prior to the receipt of the Company Stockholder Approval, effect a Change of Board Recommendation with respect to
such Superior Proposal (and terminate this Agreement pursuant to
Section 7.1(g)
), subject to the requirements of this
Section 5.3(d)
. The Company shall not be entitled to effect a Change of Board Recommendation pursuant to this
Section 5.3(d)
(or terminate this Agreement pursuant to
Section 7.1(g)
) unless:
(i) the Company
Board shall have determined in good faith, after consultation with its outside legal counsel, that the failure to make such a Change of Board Recommendation in response to the receipt of such Superior Proposal would breach, or would reasonably be
expected to breach, its fiduciary duties under applicable Law;
(ii) the Company shall have provided to Parent at
least three (3) Business Days prior written notice (the
Notice Period
) of the Companys intention to take such actions, which notice shall specify the basis for such Change of Board Recommendation, the identity of
the Third Party making such Superior Proposal, the material terms and conditions of such Superior Proposal, and shall include a copy of the applicable Company Acquisition Agreement and any other material documents with respect thereto,
(iii) during the Notice Period, if requested by Parent, the Company shall have, and shall have caused its
Representatives to have, engaged in good faith negotiations with Parent and its Representatives regarding any amendments or modifications to this Agreement proposed in writing by Parent and intended to cause the relevant Acquisition Proposal to no
longer constitute a Superior Proposal; and
(iv) at the end of such Notice Period, the Company Board shall have
considered in good faith any proposed amendments or modifications to this Agreement (including a change to the price terms hereof) and the other agreements contemplated hereby that may be offered by Parent in writing (the
Proposed Changed
Terms
) no later than 11:59 a.m., New York City time, on the last day of the Notice Period and shall have determined in good faith, after consultation with its financial advisors and outside legal counsel, that the Superior Proposal would
continue to constitute a Superior Proposal if such Proposed Changed Terms were to be given effect and that failure to make a Change of Board Recommendation with respect to such Superior Proposal would reasonably be expected to breach its fiduciary
duties under applicable Law.
In the event of any change to the price terms or any other material revision or amendment to the terms of
such Superior Proposal, the Company shall be required to deliver a new written notice to Parent and to again comply with the requirements of this
Section 5.3(d)
(which shall apply
mutatis mutandis
) with respect to such new written
notice.
A-42
(e) Notwithstanding anything to the contrary contained in
Section
5.3(a)
, the Company Board (or a duly authorized committee thereof) may, at any time prior to the receipt of the Company Stockholder Approval, effect a Change of Board Recommendation if the Company Board (or a duly
authorized committee thereof) determines in good faith that an Intervening Event has occurred and is continuing, subject to the requirements of this
Section 5.3(e)
. The Company shall not be entitled to effect a Change of Board
Recommendation pursuant to this
Section 5.3(e)
unless:
(i) the Company Board (or a duly authorized
committee thereof) determines in good faith, after consultation with outside legal counsel, that the failure to effect a Change of Board Recommendation in response to such Intervening Event would breach, or would reasonably be expected to breach,
its fiduciary duties under applicable Law;
(ii) the Company shall have provided to Parent at least three
(3) Business Days prior written notice of the Companys intention to take such action, which notice shall specify the basis for such Change of Board Recommendation, including all available material information with respect to such
Intervening Event;
(iii) during such three (3) Business Day period, if requested by Parent, the Company
shall have, and shall have caused its Representatives to have, engaged in good faith negotiations with Parent and its Representatives regarding any amendments or modifications to this Agreement proposed in writing by Parent and intended to enable
the Company Board to proceed with the Company Board Recommendation;
(iv) at the end of such three
(3) Business Day period, the Company Board shall have considered in good faith any proposed amendments or modifications to this Agreement (including a change to the price terms hereof) and the other agreements contemplated hereby that may be
offered in writing by Parent no later than 11:59 a.m., New York City time, on the last day of such three (3) Business Day period, and shall have determined in good faith, after consultation with its outside legal counsel, that the failure to
effect a Change of Board Recommendation in response to such Intervening Event would reasonably be expected to breach its fiduciary duties under applicable Law.
(f) Nothing contained in this
Section
5.3
shall prohibit the Company Board from
(i) disclosing to the stockholders of the Company a position contemplated by Rule
14e-2(a),
Rule
14d-9
and Item 1012(a) of Regulation
M-A
promulgated under the Exchange Act; or (ii) making any disclosure to the stockholders of the Company if the Company Board (or any duly authorized committee thereof) determines in good faith, after
consultation with outside legal counsel, that the failure to make such disclosure would breach, or would reasonably be expected to breach, its fiduciary duties or violate Applicable Law. The issuance by the Company or the Company Board of a
stop, look and listen statement pending disclosure of its position, as contemplated by Rules
14d-9
and
14e-2(a)
promulgated under the Exchange Act, shall not
constitute a Change of Board Recommendation.
A-43
(g) The Company acknowledges and agrees that any violation of the
restrictions set forth in this
Section
5.3
by any of its Representatives shall be deemed to be a breach of this
Section
5.3
by the Company.
(h) For purposes of this Agreement:
(i)
Acquisition Proposal
means any inquiry, offer or proposal from a Third Party concerning
(A) a merger, consolidation, recapitalization, liquidation, dissolution or other business combination or similar transaction involving the Company, (B) a sale, lease or other disposition by merger, consolidation, business combination,
share exchange, joint venture or otherwise, of assets of the Company representing twenty percent (20%) or more of the assets of the Company, based on their fair market value as determined in good faith by the Company Board (or any duly authorized
committee thereof), (C) an issuance or acquisition (including by way of merger, consolidation, business combination or share exchange) of Equity Interests representing twenty (20%) or more of the voting power of the Company, or (D) any
combination of the foregoing (in each case, other than the Merger).
(ii)
Superior Proposal
means a bona fide written Acquisition Proposal (except the references therein to twenty percent (20%) shall be replaced by fifty percent (50%)) that is not solicited or received in violation, or resulting from any breach, of
this
Section
5.3
and that the Company Board (or a duly authorized committee thereof) determines in good faith, after consultation with its financial advisors and outside legal counsel, taking into account such factors as
the Company Board (or any duly authorized committee thereof) considers in good faith to be appropriate (including the conditionality, timing and likelihood of consummation of such proposals), is reasonably likely to be consummated in accordance with
its terms and, if consummated, would be more favorable from a financial point of view to the Companys stockholders than the Merger (taking in account any Proposed Changed Terms).
(iii)
Intervening Event
means any event, change, effect, development, state of facts, condition or
occurrence that is material to the Company that (A) was not known to or by the Company Board and could not reasonably be expected to have been known to or by the Company Board as of or prior to the date of this Agreement (or if known, the
magnitude or material consequences of which were not known and could not reasonably be expected to have been known to or by the Company Board as of or prior to the date of this Agreement), and (B) does not involve or relate to the receipt,
existence or terms of an Acquisition Proposal.
5.4
SEC Filings; Other Actions
.
(a) As promptly as reasonably practicable after the execution of this Agreement, (i) the Company shall prepare and
file the Proxy Statement with the SEC, which shall, subject to a Change of Board Recommendation having been effected in accordance with
Section
5.3
, include the Company Board Recommendation and (ii) Parent shall
prepare and file with the SEC the Form
S-4,
in which the Proxy Statement will be included as a prospectus, in connection with the registration under the Securities Act of the shares of Parent Common Stock to
be issued in the Merger. Each of Parent and the Company shall use its reasonable best efforts to cause the Form
S-4
to be declared effective as promptly as practicable after such filing
A-44
(including by responding to comments of the SEC) and, prior to the effective date of the Form
S-4,
each of Parent and the Company shall take all action
reasonably required to be taken by it under any applicable securities Laws in connection with the issuance of Parent Common Stock. Each of Parent and the Company shall furnish all information as may be reasonably requested by the other party in
connection with any such action and the preparation, filing and distribution of the Form
S-4
and the Proxy Statement. As promptly as reasonably practicable after the Form
S-4
shall have become effective, the Company shall cause the Proxy Statement to be mailed to its stockholders as of the record date established for the Company Meeting. No filing of, or amendment or
supplement to, the Form
S-4
will be made by Parent, and no filing of, or amendment or supplement to, the Proxy Statement will be made by the Company, in each case without providing the other party with a
reasonable opportunity to review and comment thereon, and each of Parent and the Company shall give reasonable and good faith consideration to any comments made by other party or its counsel. If at any time prior to the Effective Time any
information relating to the Company or Parent, or any of their respective affiliates, directors or officers, should be discovered by the Company or Parent which should be set forth in an amendment or supplement to either the Form
S-4
or the Proxy Statement, so that either such document would not include any misstatement of a material fact or omit to state any material fact necessary to make the statements therein, in light of the
circumstances under which they were made, not misleading, the party that discovers such information shall promptly notify the other party and an appropriate amendment or supplement describing such information shall be promptly filed with the SEC
and, to the extent required by applicable Law, disseminated to the stockholders of the Company. Each party shall notify the other party promptly of the time when the Form
S-4
has become effective, and of
the issuance of any stop order or suspension of the qualification of the shares of Parent Common Stock issuable in connection with the Merger for offering or sale in any jurisdiction, and each of Parent and the Company shall use its reasonable best
efforts to have any such stop order or suspension lifted, reversed or otherwise terminated. Parent and the Company shall also take any other action required to be taken under the Securities Act, the Exchange Act, any applicable foreign or state
securities or blue sky Laws and the rules and regulations thereunder, the DGCL, the rules of NASDAQ in connection with the filing and distribution of the Proxy Statement and the rules of NYSE in connection with the filing and
distribution of the Form
S-4,
and the solicitation of proxies from the Companys stockholders thereunder. In addition, each party agrees to provide the other party and their respective counsel with
copies of any written comments, and shall inform the other party of any oral comments, that such party or its counsel may receive from time to time from the SEC or its staff with respect to the Form
S-4
or the
Proxy Statement promptly after receipt of such comments, and any written or oral responses thereto. Each party and their respective counsel shall be given a reasonable opportunity to review and comment on any such written responses and each
party shall give reasonable and good faith consideration to any comments made by other party or its counsel.
(b) Subject to the other provisions of this Agreement, the Company shall (i) take all action necessary in
accordance with the DGCL, the Company Charter, and the Company Bylaws to duly call, give notice of, and, as soon as practicable following the effectiveness of the Form
S-4,
convene and hold a meeting of its
stockholders for the purpose of obtaining the Company Stockholder Approval (the
Company Meeting
), with the record date and meeting date of the Company Meeting to be selected after reasonable consultation with Parent, and
(ii) subject to a Change of Board Recommendation having been effected in
A-45
accordance with
Section
5.3
, shall include the Company Board Recommendation in the Proxy Statement and use its reasonable best efforts to solicit from its stockholders
proxies in favor of the adoption of this Agreement and the transactions contemplated hereby (including by postponing or adjourning the Company Meeting, after consultation with Parent, to allow additional solicitation of proxies in order to obtain
the Company Stockholder Approval if necessary). The Company may postpone or adjourn the Company Meeting from time to time (i) with the consent of Parent, (ii) if a quorum has not been established, (iii) to allow reasonable
additional time to solicit additional proxies if necessary in order to obtain the Company Stockholder Approval, (iv) after consultation with Parent, to allow reasonable additional time for the filing and mailing of any supplemental or amended
disclosure that the Company Board has determined in good faith after consultation with outside legal counsel is necessary under applicable Law and for such supplemental or amended disclosure to be disseminated and reviewed by the Companys
stockholders prior to the Company Meeting, or (v) if required by Law.
5.5
Appropriate Action; Consents;
Filings
.
(a) Upon the terms and subject to the conditions set forth in this Agreement, each of the parties
agrees to use its reasonable best efforts to take, or cause to be taken, all actions that are necessary, proper or advisable under this Agreement and applicable Law to consummate and make effective the Merger and the other Transactions contemplated
by this Agreement as promptly as practicable, including using reasonable best efforts to accomplish the following: (i) obtain all consents, approvals or waivers from, or participation in other discussions or negotiations with, third parties,
including under any Contract to which the Company or Parent is party or by which such Person or any of their respective properties or assets may be bound (provided, that the Company shall not be required to pay or agree to pay any material consent
fees or other material payments requested by any such third parties), (ii) obtain all necessary actions or nonactions, waivers, consents, approvals, orders and authorizations from Governmental Entities, make all necessary registrations,
declarations and filings with and take all steps as may be necessary to obtain an approval or waiver from, or to avoid any Proceeding by, any Governmental Entity, (iii) resist, contest or defend any Proceeding (including administrative or
judicial Proceedings) challenging the Merger or the completion of the Transactions, including seeking to have vacated, lifted, reversed or overturned any decree, judgment, injunction or other order (whether temporary, preliminary or permanent) that
is in effect and that could restrict, prevent or prohibit consummation of the Transactions, and (iv) execute and deliver any additional instruments necessary to consummate the Transactions and fully to carry out the purposes of this
Agreement. Each of the parties shall furnish to each other party such necessary information and reasonable assistance as such other party may reasonably request in connection with the foregoing. Subject to applicable Law relating to the
exchange of information, the Company and Parent shall have the right to review in advance, and to the extent practicable each shall consult with the other in connection with, all of the information relating to the Company or Parent, as the case may
be, that appears in any filing made with, or written materials submitted to, any third party and/or any Governmental Entity in connection with the Merger and the Transactions. In exercising the foregoing rights, each of the Company and Parent
shall act reasonably and as promptly as practicable. Subject to applicable Law and the instructions of any Governmental Entity, the Company and Parent shall keep each
A-46
other reasonably apprised of the status of matters relating to the completion of the Transactions, including promptly furnishing the other with copies of notices or other written substantive
communications received by the Company or Parent, as the case may be, from any Governmental Entity and/or third party with respect to such transactions, and, to the extent practicable under the circumstances, shall provide the other party and its
counsel with the opportunity to participate in any meeting with any Governmental Entity in respect of any substantive filing, investigation or other inquiry in connection with the transactions contemplated hereby.
(b) Nothing contained in this Agreement shall give Parent or Merger Sub, directly or indirectly, the right to control
or direct the operations of the Company prior to the consummation of the Merger.
5.6
Certain
Notices
. From and after the date of this Agreement until the earlier of the Effective Time or the termination of this Agreement in accordance with
Article 7
, unless prohibited by applicable Law, each party shall give prompt notice to
the other parties if any of the following occur: (a) receipt of any notice or other communication in writing from any Person alleging that the consent or approval of such Person is or may be required in connection with the Transactions;
(b) receipt of any notice or other communication from any Governmental Entity, NASDAQ or NYSE (or any other securities market) in connection with the Transactions; or (c) such party becoming aware of the occurrence of an event that could
prevent or delay beyond the Outside Date the consummation of the Transactions or that would reasonably be expected to result in any of the conditions to the Merger set forth in
Article 6
being incapable of satisfaction. Any such notice
pursuant to this
Section
5.6
shall not affect any representation, warranty, covenant or agreement contained in this Agreement and any failure to make such notice (in and of itself) shall not be taken into account in
determining whether the conditions set forth in
Article 6
have been satisfied or give rise to any right of termination set forth in
Article 7
.
5.7
Public Announcements
. So long as this Agreement is in effect, Parent and Merger Sub, on the one hand,
and the Company, on the other, shall not issue any press release or make any public statement with respect to the Merger or this Agreement without the prior written consent of the other party (which consent shall not be unreasonably withheld,
conditioned or delayed), except (a) as may be required by applicable Law or the rules or regulations of any applicable United States securities exchange or regulatory or governmental body to which the relevant party is subject, in which case
the party required to make the release or announcement shall use its commercially reasonable efforts to allow each other party reasonable time to comment on such release or announcement in advance of such issuance, or (b) with respect to any
press release or other public statement by the Company permitted by
Section
5.3
. The press release announcing the execution and delivery of this Agreement shall be a joint release of, and shall not be issued prior to
the approval of each of, the Company and Parent. The Company shall file a current report on Form
8-K
with the SEC attaching its press release and copy of this Agreement as exhibits.
5.8
Indemnification
.
(a) From and after the Effective Time, Parent shall, and shall cause the Surviving Corporation to, indemnify, defend
and hold harmless, and shall advance expenses as
A-47
incurred, to the extent provided in (i) the Company Charter or the Company Bylaws in effect as of the date of this Agreement and (ii) any indemnification Contract of the Company in
effect as of the date of this Agreement listed on
Section
5.8
of the Company Disclosure Schedule, each present and former director and officer of the Company and each of its employees who serves as a fiduciary of a Company
Benefit Plan (in each case, when acting in such capacity) (each, an
Indemnitee
and, collectively, the
Indemnitees
) against any costs or expenses (including reasonable attorneys fees), judgments,
settlements, fines, losses, claims, damages or liabilities incurred in connection with any Proceeding or investigation, whether civil, criminal, administrative or investigative, arising out of or pertaining to any action or omission by such
Indemnitee relating to their position with the Company occurring at or prior to the Effective Time, including in connection with this Agreement or the Transactions.
(b) Parent agrees that all rights to exculpation, indemnification or advancement of expenses arising from, relating
to, or otherwise in respect of, acts or omissions occurring prior to the Effective Time (including in connection with this Agreement or the Transactions) existing as of the Effective Time in favor of an Indemnitee as provided in (i) the Company
Charter or the Company Bylaws in effect as of the date of this Agreement and (ii) any indemnification Contract of the Company in effect as of the date of this Agreement listed on
Section
5.8
of the Company Disclosure
Schedule shall survive the Merger and shall continue in full force and effect in accordance with their terms. For a period of no less than six years from the Effective Time, Parent shall cause the Surviving Corporation to, and the Surviving
Corporation shall, maintain in effect the exculpation, indemnification and advancement of expenses provisions in favor of an Indemnitee as provided in (i) the Company Charter or the Company Bylaws in effect as of the date of this Agreement and
(ii) any indemnification Contract of the Company in effect as of the date of this Agreement listed on
Section
5.8
of the Company Disclosure Schedule, and shall not amend, repeal or otherwise modify any such provisions
in any manner that would adversely affect the rights thereunder of any individuals who immediately before the Effective Time were current or former directors, officers or employees of the Company;
provided
,
however
, that all rights to
exculpation, indemnification and advancement of expenses in respect of any Proceeding pending or asserted or any claim made within such period shall continue until the final disposition of such Proceeding.
(c) Prior to the Effective Time, the Company shall purchase a prepaid directors and officers liability
insurance and fiduciary liability insurance for the benefit of those persons that are directors and officers of the Company, as of the date of this Agreement and as of the Closing Date, that provides coverage for events occurring prior to the
Closing Date for an aggregate period of six years with respect to claims arising from facts or events that occurred on or before the Effective Time, including with respect to this Agreement or the Transactions, that is substantially equivalent to
and in any event not less favorable in the aggregate than the existing directors and officers liability insurance and fiduciary liability insurance policy of the Company, or, if substantially equivalent insurance coverage is unavailable,
the best available coverage then available
(d) In the event that either Parent or the Surviving Corporation or
any of its successors or assigns (i) consolidates with or merges into any other person and is not the continuing or surviving corporation or entity of such consolidation or merger or (ii) transfers or
A-48
conveys all or substantially all of its properties and assets to any person, then, and in each case, Parent shall, and shall cause the Surviving Corporation to, cause proper provision to be made
so that such successor or assign shall expressly assume the obligations set forth in this
Section
5.8
.
(e) The provisions of this
Section
5.8
are (i) intended to be for the benefit of, and
shall be enforceable by, each Indemnitee, his or her heirs and his or her representatives and (ii) in addition to, and not in substitution for, any other rights to indemnification, expense advancement or contribution that any such individual
may have under the Company Charter, the Company Bylaws or similar organization documents in effect as of the date of this Agreement or in any indemnification Contract of the Company in effect as of the date of this Agreement listed on
Section
5.8
of the Company Disclosure Schedule. From and after the Effective Time, the obligations of Parent under this
Section
5.8
shall not be terminated or modified in such a manner as to
adversely affect the rights of any Indemnitee to whom this
Section
5.8
applies unless (x) such termination or modification is required by applicable Law or (y) the affected Indemnitee shall have consented in
writing to such termination or modification (it being expressly agreed that the Indemnitees to whom this
Section
5.8
applies shall be third party beneficiaries of this
Section
5.8
).
(f) Nothing in this Agreement is intended to, shall be construed to or shall release, waive or impair any rights to
directors and officers insurance claims under any policy that is or has been in existence with respect to the Company for any of its directors, officers or employees, it being understood and agreed that the indemnification provided for
in this
Section
5.8
is not prior to or in substitution for any such claims under such policies.
5.9
Parent Agreements Concerning Merger Sub
. Parent shall take all actions necessary or advisable to cause
Merger Sub to perform its covenants, agreements and obligations under this Agreement in accordance with the terms hereof. Parent shall, promptly following execution of this Agreement, approve and adopt this Agreement in its capacity as sole
stockholder of Merger Sub and deliver to the Company evidence of its vote or action by written consent approving and adopting this Agreement in accordance with applicable Law and the certificate of incorporation and bylaws of Merger Sub.
5.10
Takeover Statutes
. If any state takeover Law or state Law that purports to limit or restrict business
combinations or the ability to acquire or vote Company Shares (including any control share acquisition, fair price, business combination or other similar takeover Law) becomes or is deemed to be applicable to the
Company, Parent or Merger Sub, the Merger or any other transaction contemplated by this Agreement, then the Company and the Company Board shall take all action reasonably available to it to render such Law inapplicable to the foregoing.
5.11
Section
16 Matters
. Prior to the Effective Time, the Company shall take all such
steps as may be required to cause the transactions contemplated by this Agreement and any other dispositions of Company Shares (including derivative securities with respect to Company Shares) resulting from the Transactions by each individual who is
subject to the reporting requirements of Section 16(a) of the Exchange Act with respect to the Company, to be exempt under
Rule 16b-3
promulgated under the Exchange Act.
A-49
5.12
Stockholder Litigation
. The Company shall give Parent
reasonable opportunity to participate in the defense or settlement of any stockholder litigation against the Company and/or its directors and officers relating to the transactions contemplated by this Agreement, including the Merger
(
Transaction Litigation
), and no such settlement of any Transaction Litigation shall be agreed to without the prior written consent of Parent (such consent not to be unreasonably withheld, conditioned or delayed). The Company
shall promptly notify Parent of any Transaction Litigation and shall keep Parent reasonably and promptly informed with respect to the status thereof.
5.13
Stock Exchange Delisting
. The Surviving Corporation shall cause the Companys securities to be
de-listed
from the NASDAQ Stock Market and
de-registered
under the Exchange Act as promptly as practicable following the Effective Time, and prior to the Effective Time the
Company shall reasonably cooperate with Parent with respect thereto.
5.14
Tax Matters
. None of the
parties shall (and each party shall cause its respective affiliates not to) take any action that would reasonably be expected to prevent or impede the Merger from qualifying as a reorganization within the meaning of Section 368 of the Code, and
the Treasury Regulations promulgated thereunder. Each of Parent, Merger Sub and the Company shall report the Merger as a reorganization within the meaning of Section 368 of the Code and shall not take any position inconsistent with
such treatment unless otherwise required pursuant to (i) a determination within the meaning of Section 1313(a) of the Code or (ii) a settlement on IRS Form
870-AD.
5.15
Employee Benefit Matters
. From and after the Closing Date, Parent shall, or shall cause one of its
affiliates to, specifically assume and honor in accordance with their terms any employment, severance and termination agreement or arrangement of or for a Continuing Employee set forth on Section 5.15(a) of the Company Disclosure
Schedule. Notwithstanding the foregoing, neither Parent nor any of its affiliates shall be obligated to continue to employ any Continuing Employee for any specific period of time following the Closing Date.
ARTICLE 6
CONDITIONS TO
CONSUMMATION OF THE MERGER
6.1
Conditions to Obligations of Each Party Under This Agreement
. The
respective obligations of each party to consummate the Merger shall be subject to the satisfaction (or waiver, if permissible under Law) at or prior to the Effective Time of each of the following conditions:
(a) The Company Stockholder Approval shall have been obtained.
(b) The consummation of the Merger shall not then be restrained, enjoined or prohibited by any Order (whether
temporary, preliminary or permanent) of any Governmental Entity and there shall not be in effect any Law enacted or promulgated by any Governmental Entity that prevents or makes illegal the consummation of the Merger.
A-50
(c) The shares of Parent Common Stock issuable to the stockholders of the
Company pursuant to this Agreement shall have been approved for listing on NYSE, subject to official notice of issuance.
(d) The Form
S-4
shall have been declared effective and no stop order
suspending the effectiveness of the Form
S-4
shall be in effect and no proceedings for such purpose shall be pending before the SEC.
(e) Holders representing no more than twenty percent (20%) of the Company Shares shall have exercised appraisal,
dissenters or similar rights under applicable Law with respect to their shares by virtue of the Merger.
6.2
Conditions to Obligations of the Company Under This Agreement
. The obligation of the Company to effect
the Merger is further subject to the fulfillment (or waiver by the Company) at or prior to the Effective Time of the following conditions:
(a) Each representation and warranty of Parent and Merger Sub (i) contained in
Section
4.5
(Capitalization) shall be true and correct in all respects (other than de minimis exceptions) as of the date of this Agreement and at and as of the Effective Time as though made at and as of the Effective Time,
except for representations and warranties that relate to a specific date or time (which need only be true and correct as of such date or time) and (ii) set forth in
Article 4
(other than the representations set forth in
Section
4.5
), without giving effect to any qualifications as to materiality or Parent Material Adverse Effect or other similar qualifications contained therein, shall be true and correct as of the date of this Agreement and
at and as of the Effective Time as though made at and as of the Effective Time, except for representations and warranties that relate to a specific date or time (which need only be true and correct as of such date or time), and except as has not had
and would not reasonably be expected to have, individually or in the aggregate with all other failures to be true or correct, a Parent Material Adverse Effect.
(b) Parent and Merger Sub shall have performed or complied with in all material respects all covenants and agreements
required to be performed or complied with by them under this Agreement at or prior to the Closing Date.
(c) Parent shall have delivered to the Company a certificate, dated the Closing Date and signed by a duly authorized
officer of Parent, certifying to the effect that the conditions set forth in
Sections 6.2(a)
and
6.2(b)
have been satisfied.
6.3
Conditions to Obligations of Parent and Merger Sub Under This Agreement
. The obligations of Parent and
Merger Sub to effect the Merger are further subject to the fulfillment (or waiver by Parent and Merger Sub) at or prior to the Effective Time of the following conditions:
(a) Each representation and warranty of the Company (i) contained in
Section 3.2(a)
(Capitalization) shall
be true and correct in all respects (other than de minimis exceptions) as of the date of this Agreement and at and as of the Effective Time as though made at and as of the Effective Time, except for representations and warranties that relate to a
specific
A-51
date or time (which need only be true and correct as of such date or time); (ii) contained in
Sections 3.1
(Corporate Organization),
3.3
(Authority; Execution and Delivery;
Enforceability) and
3.19
(Brokers Fees) shall be true and correct in all material respects as of the date of this Agreement and at and as of the Effective Time as though made at and as of the Effective Time, except for representations
and warranties that relate to a specific date or time (which need only be true and correct in all material respects as of such date or time); and (iii) set forth in
Article 3
(other than the representations and warranties referenced in
the immediately foregoing clauses (i) and (ii)), without giving effect to any qualifications as to materiality or Company Material Adverse Effect or other similar qualifications contained therein, shall be true and correct as of the date of
this Agreement and at and as of the Effective Time as though made at and as of the Effective Time, except for representations and warranties that expressly relate to a specific date or time (which need only be true and correct as of such date or
time), except as has not had and would not reasonably be expected to have, individually or in the aggregate with all other failures to be true or correct, a Company Material Adverse Effect.
(b) The Company shall have performed and complied with in all material respects all covenants and agreements required
to be performed or complied with by it under the Merger Agreement at or prior to the Closing Date.
(c) Since the
date of this Agreement, there has not been any change, event, development, condition, occurrence or effect that has had or would reasonably be expected to have a Company Material Adverse Effect.
(d) The Company shall have delivered to Parent a certificate, dated the Closing Date and signed by an executive
officer of the Company, certifying to the effect that the conditions set forth in
Sections 6.3(a)
and
6.3(b)
have been satisfied.
(e) The Company shall have delivered to Parent a statement satisfying the requirements of Treasury Regulations
Sections
1.897-2(h)
and
1.1445-2(c)(3)
certifying that interests in the Company are not United States real property interests within the meaning of Section
897(c) of the Code.
ARTICLE 7
TERMINATION, AMENDMENT AND WAIVER
7.1
Termination
. This Agreement may be terminated, and the Merger and the other transactions contemplated
hereby may be abandoned, by action taken or authorized by the board of directors of the terminating party or parties:
(a) By mutual written consent of Parent and the Company;
(b) By either the Company or Parent, if the Company Stockholder Approval shall not have been obtained upon a vote
taken at the Company Meeting duly convened therefor or any adjournment or postponement thereof;
(c) By either the
Company or Parent, if any Governmental Entity shall have issued an Order permanently restraining, enjoining or otherwise prohibiting, prior to the
A-52
Effective Time, the consummation of the Merger, and such Order shall have become final and
non-appealable,
or any Law enacted or promulgated by any
Governmental Entity is in effect that prevents or makes illegal the consummation of the Merger;
provided
, that the right to terminate this Agreement pursuant to this
Section
7.1(c)
shall not be available to a party
if the issuance of, or failure to resolve or have vacated or lifted, such Order was primarily due to a breach by such party of any of its covenants or agreements under this Agreement, including pursuant to
Section
5.5
;
(d) By either the Company or Parent if (i) the Effective Time shall not have occurred on or before July 24,
2017 (the
Outside Date
); provided that neither the Company nor Parent may terminate this Agreement pursuant to this
Section 7.1(d)
if it is in breach of this Agreement and such breach has primarily caused or resulted in the
failure of the Closing to have occurred prior to the Outside Date;
(e) By Parent, at any time prior to the
receipt of the Company Stockholder Approval, if the Company Board shall have effected a Change of Board Recommendation, whether or not in compliance with
Section
5.3
(it being understood and agreed that any written notice
of the Companys intention to make a Change of Board Recommendation prior to effecting such Change of Board Recommendation in accordance with
Section 5.3(e)
or
5.3(f)
shall not (in and of itself) result in Parent or Merger Sub
having any termination rights pursuant to this
Section 7.1(e)
);
provided
, that Parents right to terminate this Agreement pursuant to this
Section 7.1(e)
shall expire at 5:00 p.m. (New York City time) on the 5th calendar
day following the date on which such right to terminate first arose;
(f) By the Company, at any time prior to the
receipt of the Company Stockholder Approval, if the Company Board shall have effected a Change of Board Recommendation, or determined to effect a Change of Board Recommendation substantially concurrently with a termination pursuant to this
Section 7.1(f), with respect to a Superior Proposal, but only if the Company shall have complied with its obligations under
Section
5.3
with respect to such Superior Proposal and shall have approved, and substantially
concurrently with the termination hereunder, the Company shall have entered into, a Company Acquisition Agreement with respect to such Superior Proposal;
provided
,
however
, that such termination pursuant to this
Section 7.1(g)
shall not be effective and the Company shall not enter into any such Company Acquisition Agreement unless prior to or concurrently with such termination the Company has paid the Company Termination Fee to or for the account of Parent pursuant to
Section
7.3
;
(g) By Parent, at any time prior to the Effective Time, if: (i) there
has been a breach by the Company of its representations, warranties, covenants or agreements contained in this Agreement, in each case, such that any condition to the Merger contained in
Sections 6.3(a)
or
6.3(b)
is not reasonably
capable of being satisfied while such breach is continuing, (ii) Parent shall have delivered to the Company written notice of such breach and (iii) such breach is not capable of cure in a manner sufficient to allow satisfaction of the
conditions in
Sections 6.3(a)
and
6.3(b)
prior to the Outside Date or at least 30 days shall have elapsed since the date of delivery of such written notice to the Company and such breach shall not have been cured;
provided
,
however
, that Parent shall not be permitted to terminate this Agreement pursuant to this
Section
7.1(h)
if Parent or Merger Sub is then in material breachof its representations, warranties, covenants or agreements
contained in this Agreement; or
A-53
(h) By the Company, at any time prior to the Effective Time, if:
(i) there has been a breach by Parent or Merger Sub of any of its representations, warranties, covenants or agreements contained in this Agreement in each case, such that any condition to the Merger contained in
Sections 6.2(a)
or
6.2(b)
is not reasonably capable of being satisfied while such breach is continuing, (ii) the Company shall have delivered to Parentwritten notice of such breach and (iii) such breach is not capable of cure in a manner sufficient to
allow satisfaction of the conditions in
Sections 6.2(a)
and
6.2(b)
prior to the Outside Date or at least 30 days shall have elapsed since the date of delivery of such written notice to Parentand such breach shall not have been cured;
provided
,
however
, that the Company shall not be permitted to terminate this Agreement pursuant to this
Section
7.1(I)
if the Company is then in material breach of its representations, warranties, covenants or
agreements contained in this Agreement.
7.2
Effect of Termination
.
In the event of termination of this Agreement by either the Company or Parent as provided in
Section
7.1
, written
notice thereof shall be given to the other party or parties, specifying the provisions hereof pursuant to which such termination is made and the basis therefor described in reasonable detail, this Agreement shall forthwith become void and have no
further force and effect (other than the
Section
7.2
,
Section
7.3
, and
Article 8
, each of which shall survive termination of this Agreement), and, subject to the foregoing, there shall be no
liability or obligation on the part of Parent, Merger Sub or the Company or their respective Subsidiaries, officers, directors, Representatives or affiliates, whether arising before or after such termination, based on, arising out of or relating to
this Agreement or the negotiation, execution, performance or subject matter hereof;
provided
, that, subject to
Section
7.3
(including the limitations on liability contained therein), nothing herein shall relieve any
party from liabilities or damages incurred or suffered as a result of a willful and material breach of any representations, warranties, covenants or other agreements set forth in this Agreement prior to such termination.
7.3
Termination Fee
.
(a) The parties hereto agree that if this Agreement is terminated pursuant to
Section
7.1(e)
,
or
Section 7.1(f)
, then the Company shall pay to Parent prior to or concurrently with such termination, in the case of a termination by the Company, or within two (2) Business Days thereafter, in the case of a termination by Parent, the
Termination Fee. The
Termination Fee
means $550,000.
(b) The parties hereto agree that if
(x) this Agreement is terminated by the Company or Parent pursuant to
Section 7.1(d)
or by Parent pursuant to
Section 7.1(g)
based solely on a breach by the Company of a covenant or agreement contained in this Agreement,
(y) an Acquisition Proposal has been announced publicly or made to the Company after the date hereof (but prior to the termination of this Agreement) and such Acquisition Proposal has not been withdrawn prior to the termination of this
Agreement, and (z) the Company enters into a Company Acquisition Agreement or consummates an Acquisition
A-54
Proposal within twelve months after such termination, then the Company shall pay the Termination Fee to Parenton the earlier of the date of entry into such Company Acquisition Agreement or
consummation of such Acquisition Proposal. For purposes of this
Section
7.3(b)
, the term
Acquisition Proposal
shall have the meaning assigned to such term in
Section
5.3(h)(i)
,
except that the references to twenty percent (20%) shall be deemed to be references to fifty percent (50%).
(c) The parties hereto agree that if this Agreement is terminated pursuant to
Section 7.1(g)
based solely on a
breach by the Company of a covenant or agreement contained in this Agreement, and within six (6) months after the date of such termination the Company enters into a definitive agreement with a Third Party in respect of an Acquisition Proposal
(regardless of when the Company received such Acquisition Proposal), then the Company shall pay to Parent the reasonable costs, fees and expenses incurred by Parent, its affiliates and their Representatives in connection with the investigation, due
diligence, negotiation and documentation of this Agreement, such amount not to exceed $400,000 in the aggregate (the
Expense Reimbursement
), provided, however, that in addition to the Expense Reimbursement, if the Company had
willfully breached
Section
5.3
in any material respect, then in the circumstances in which an Expense Reimbursement shall be paid, the Company shall also pay an additional $200,000 (
Additional Expense
Amount
). In the event the Expense Reimbursement is paid to Parent and the Termination Fee thereafter becomes payable, the Termination Fee otherwise payable shall be reduced by the amount of such Expense Reimbursement and Additional
Expense Amount, if any.
(d) All payments under this
Section
7.3
shall be made by wire
transfer of immediately available funds to an account designated in writing by Parent, or in the absence of such designation, an account established for the sole benefit of Parent.
(e) Each of the parties acknowledges that (i) the agreements contained in this
Section
7.3
are an integral part of the transactions contemplated by this Agreement, and (ii) the damages resulting from termination of this Agreement under circumstances in which the Termination Fee or Expense
Reimbursement is payable pursuant to this
Section
7.3
are not a penalty but rather constitute liquidated damages in a reasonable amount that will compensate Parent and Merger Sub for the efforts and resources expended and
opportunities foregone while negotiating this Agreement in in reliance on this Agreement and on the expectation of the consummation of the transactions contemplated hereby, and (iii) without these agreements, Parent, Merger Suband the Company
would not enter into this Agreement. Accordingly, if the Company fails to pay the Termination Fee when due, and, in order to obtain such payment, Parent commences a Proceeding that results in a judgment against the Company for the Termination
Fee, the Company shall pay to Parent, together with the Termination Fee, (A) interest on the Termination Fee from the date of termination of this Agreement at a rate per annum equal to the Prime Rate and (B) Parents costs and
expenses (including reasonable attorneys fees) in connection with such Proceeding. For the avoidance of doubt, in no event shall the Company be required to pay the Termination Fee on more than one occasion
(f) In circumstances where the Termination Fee, Expense Reimbursement or Additional Expense Amount is payable pursuant
to this
Section
7.3
, Parents receipt of the Termination Fee, Expense Reimbursement or Additional Expense Amount (as applicable) from or on behalf of the Company shall be Parents and Merger Subs sole and
A-55
exclusive remedy (whether based in contract, tort or strict liability, by the enforcement of any assessment, by any legal or equitable proceeding, by virtue of any statute, regulation or
applicable Laws or otherwise) against the Company and any of its former, current or future direct or indirect equity holders, general or limited partners, controlling persons, stockholders, members, managers, directors, officers, employees, agents,
affiliates or assignees for all losses and damages suffered as a result of the failure of the Merger or the other transactions contemplated by this Agreement to be consummated and for any breach or failure to perform hereunder or otherwise, and upon
payment of such amount, no such Person shall have any further liability or obligation relating to or arising out of this Agreement or the transactions contemplated hereby.
7.4
Amendment
. This Agreement may be amended by each of the Company, Parent and Merger Sub by action taken
by or on behalf of their respective boards of directors at any time prior to the Effective Time;
provided
,
however
, that, after receipt of the Company Stockholder Approval, no amendment may be made which, by Law or in accordance with
the rules of any relevant stock exchange, requires further approval by the Companys stockholders without such approval. This Agreement may not be amended except by an instrument in writing signed by the parties hereto.
7.5
Waiver
. At any time prior to the Effective Time, Parent and Merger Sub, on the one hand, and the
Company, on the other hand, may (a) extend the time for the performance of any of the obligations or other acts of the other, (b) waive any breach of the representations and warranties of the other contained herein or in any document
delivered pursuant hereto or (c) waive compliance by the other with any of the agreements or covenants contained herein;
provided
,
however
, that after receipt of the Company Stockholder Approval, there may not be any extension or
waiver of this Agreement which decreases the Merger Consideration or which adversely affects the rights of the Companys stockholders hereunder without the approval of such stockholders. Any such extension or waiver shall be valid only if
set forth in an instrument in writing signed by the party or parties to be bound thereby, but such extension or waiver or failure to insist on strict compliance with an obligation, covenant, agreement or condition shall not operate as a waiver of,
or estoppel with respect to, any subsequent or other failure.
ARTICLE 8
GENERAL PROVISIONS
8.1
Non-Survival
of Representations and Warranties
. None of the
representations, warranties or covenants in this Agreement or in any instrument delivered pursuant to this Agreement shall survive the Effective Time except that this
Section
8.1
shall not limit any covenant or agreement of
the parties which by its terms contemplates performance after the Effective Time, which shall survive to the extent expressly provided for herein.
8.2
Fees and Expenses
. Subject to
Section
7.2
, all Expenses incurred by the
parties hereto shall be borne solely and entirely by the party which has incurred the same.
8.3
Notices
. Any notices or other communications to any party required or permitted under, or otherwise
given in connection with, this Agreement shall be in writing and
A-56
shall be deemed to have been duly given (a) when delivered or sent if delivered in Person or sent by facsimile transmission (provided confirmation of facsimile transmission is obtained), (b)
on the fifth Business Day after dispatch by registered or certified mail or (c) on the next Business Day if transmitted by nationally recognized overnight courier, in each case, as follows (or to such other Persons or addressees as may be
designated in writing by the party to receive such notice pursuant to a notice delivered in accordance with this
Section
8.3
):
If to Parent or Merger Sub, addressed to it at:
Intrexon Corporation
20374
Seneca Meadows Parkway
Germantown, MD 20876
Attention: Legal Department
Tel: (301)
556-9900
Fax: (301)
556-9902
Email:
DLehr@intrexon.com; CUlrich@intrexon.com
with a copy (which shall not constitute notice) to:
Thompson Hine LLP
Two
Alliance Center
3560 Lenox Road, Suite 1600
Atlanta, GA. 30326
Attention:
Peter W. Smith
Tel: (404) 407.3635
Fax: (404) 541.2905
Email:
Peter.Smith@thompsonhine.com
If to the Company, addressed to it at:
GenVec, Inc.
910 Clopper Road
Suite 220N
Gaithersburg,
Maryland 20878
Attention: Chief Executive Officer
Tel: (240)
632-0740
Fax: (301)
944-1902
Email: notices@genvec.com
with a copy (which shall not constitute notice) to:
Hogan Lovells US LLP
100
International Drive
Suite 2000
Baltimore, Maryland 21202
Attention: Asher Rubin and William Intner
Tel: (410)
659-2777
Fax: (410)
659-2701
Email:
asher.rubin@hoganlovells.com
;
william.intner@hoganlovells.com
A-57
8.4
Certain Definitions
. For purposes of this Agreement, the
term:
Acceptable Confidentiality Agreement
means a confidentiality agreement that contains provisions that are no less
favorable in the aggregate to the Company than those contained in the Confidentiality Agreement;
provided
, that any such confidentiality agreement need not prohibit the making of an Acquisition Proposal.
affiliate
means, as to any Person, any other Person that directly or indirectly, through one or more intermediaries,
controls, is controlled by, or is under common control with, the first-mentioned Person.
Anti-corruption Laws
means
Laws relating to anti-bribery or anti-corruption (governmental or commercial) which apply to the Company, including Laws that prohibit the corrupt payment, offer, promise or authorization of the payment or transfer of anything of value (including
gifts or entertainment), directly or indirectly, to any foreign Government Official, foreign government employee or commercial entity to obtain a business advantage, including the U.S. Foreign Corrupt Practices Act of 1977, the U.K. Bribery Act of
2010 and all national and international Laws enacted to implement the OECD Convention on Combating Bribery of Foreign Officials in International Business Transactions.
beneficial ownership
(and related terms such as beneficially owned or beneficial owner) has the
meaning set forth in Rule
13d-3
under the Exchange Act.
Business Day
means a
day other than Saturday, Sunday or any day on which banks located in New York, New York are authorized or obligated by applicable Law to close.
Code
means the United States Internal Revenue Code of 1986, as amended.
Company Material Adverse Effect
means any change, event, condition, occurrence, state of facts, development or effect (an
Effect
) that, individually or in the aggregate, (i) has a material adverse effect on the business, properties, assets, condition or results of operations of the Company, take as a whole;
provided
,
however
, that
adverse Effects arising out of, resulting from or attributable to the following shall not constitute or be deemed to contribute to a Company Material Adverse Effect, and shall not otherwise be taken into account in determining whether a Company
Material Adverse Effect has occurred or would reasonably be expected to occur, except that Effects with respect to clauses (a), (b) and (c) of the below shall be so considered to the extent such Effect disproportionately impacts the Company
relative to other companies operating in the same industries: (a) changes or proposed changes in applicable Laws, GAAP or the interpretation or enforcement thereof, (b) changes in general economic, business, labor or regulatory conditions,
or changes in securities, credit or other financial markets, including interests rates or exchange rates, in the United States or globally, or changes generally affecting the industries (including seasonal fluctuations) in which the Company operates
in the United States or globally, (c) changes in global or national political conditions (including the outbreak or escalation of war (whether or not declared), military action, sabotage
A-58
or acts of terrorism), changes due to natural disasters or changes in the weather or changes due to the outbreak or worsening of an epidemic, pandemic or other health crisis, (d) the public
announcement or pendency of this Agreement and the Transactions (
provided
, that the exception in this clause (d) shall not apply in the context of any representation or warranty set forth in
Section
3.4
or
Section
3.12
), (e) any Transaction Litigation, (f) changes in the trading price or trading volume of Company Shares or any suspension of trading, provided that the underlying facts or circumstances giving rise or
contributing to such changes may be taken into account in determining whether a Company Material Adverse Effect has occurred, (g) any failure by the Company to meet any revenue, earnings or other financial projections or forecasts, provided
that the underlying facts or circumstances giving rise or contributing to such changes may be taken into account in determining whether a Company Material Adverse Effect has occurred, (h) the performance of this Agreement and the transactions
contemplated hereby, including compliance with covenants set forth herein, or any action taken or omitted to be taken by the Company at the request or with the prior written consent of Parent or Merger Sub, or (i) any matter described on
Section 8.4(a)
of the Company Disclosure Schedule, or (ii) would prevent or materially impair or delay the consummation by the Company of the transactions contemplated by this Agreement.
Company Material Intellectual Property
means the Intellectual Property that is owned or licensed by the Company and that is
material to the business of the Company.
Company Owned Intellectual Property
means Intellectual Property that is owned
by the Company.
Continuing Employee
means any employee of the Company as of immediately prior to the Closing.
Contract
or
Contracts
means any of the agreements, arrangements, contracts, leases (whether for real or
personal property), powers of attorney, notes, bonds, mortgages, indentures, deeds of trust, loans, evidences of indebtedness, letters of credit, settlement agreements, franchise agreements, undertakings, covenants not to compete, employment
agreements, licenses, purchase and sale orders and other legal commitments to which in each case a Person is a party or to which any of the properties or assets of such Person or its Subsidiaries are subject.
control
(including the terms controlled by and under common control with) means the possession,
directly or indirectly, of the power to direct or cause the direction of the management or policies of a Person, whether through the ownership of capital stock or other Equity Interests, as trustee or executor, by Contract or credit arrangement or
otherwise.
Contingent Payment Rights Agreement
means the Contingent Payment Rights Agreement, by and between Parent
and a mutually agreed upon Person who shall act as rights agent, substantially in the form attached hereto as
Exhibit C
.
Environmental Claims
means any Proceeding and any written order, demand, allegation, accusation or notice by any Person or
entity alleging actual or potential violation of or liability arising out of or relating to any Environmental Laws, Environmental Permits or the presence in, or Release into, the environment of, or exposure to, any Hazardous Materials, but shall not
include any claims relating to products liability.
A-59
Environmental Laws
means any and all applicable, federal, state, provincial,
local or foreign Laws, and all rules or regulations promulgated thereunder, regulating or relating to Hazardous Materials, pollution, protection of the environment (including ambient air, surface water, ground water, land surface, subsurface strata,
wildlife, plants or other natural resources), and/or the protection of health and safety of persons from exposures to Hazardous Materials in the environment.
Environmental Permits
means any permit, certificate, registration, notice, approval, identification number, license or
other authorization required under any applicable Environmental Law.
Equity Interest
means any share, capital stock,
partnership, limited liability company, member or similar equity interest in any Person, and any option, warrant, right or security (including debt securities) convertible, exchangeable or exercisable into or for any such share, capital stock,
partnership, limited liability company, member or similar equity interest or other instrument or right the value of which is based on any of the foregoing.
ERISA
means the Employee Retirement Income Security Act of 1974, as amended, and the rules and regulations promulgated
thereunder.
ERISA Affiliate
means any Person (whether or not incorporated) that, together with another Person, is
considered under common control and treated as one employer under Section 414(b), (c), (m) or (o) of the Code.
Exchange
Act
means the Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
Expenses
includes all expenses (including all fees and expenses of counsel, accountants, investment bankers, financing
sources, experts and consultants to a party hereto and its affiliates) incurred by a party or on its behalf in connection with or related to the authorization, preparation, negotiation, execution and performance of this Agreement and the
transactions contemplated hereby, including the preparation, printing, filing and mailing of the Proxy Statement and all other matters related to the transactions contemplated by this Agreement.
FDA
means the United States Food and Drug Administration.
GAAP
means generally accepted accounting principles, as applied in the United States.
Governmental Entity
means any national, supranational, federal, state, county, provincial, municipal, local or foreign
government, or other political subdivision thereof, including commission or authority, and any entity exercising executive, legislative, judicial, regulatory, taxing, administrative or prosecutorial functions of or pertaining to government,
including any court of competent jurisdiction, any arbitral body or any administrative, regulatory (including any stock exchange) or other agency.
A-60
Hazardous Materials
means any pollutants, contaminants or any other toxic,
infectious, carcinogenic, reactive, corrosive, ignitable, flammable or otherwise hazardous substance, chemicals 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, PCBs, radon gas, toxic mold or microbes, crude oil or any fraction thereof, all forms of natural gas, petroleum products or
by-products
or derivatives.
Information Privacy and Security Laws
means all applicable Laws concerning the privacy and/or security of Personal Data,
and all regulations promulgated thereunder, including, without limitation, HIPAA, the Health Information Technology for Economic and Clinical Health Act (
HITECH
), the Gramm-Leach-Bliley Act, the Fair Credit Reporting Act, as
amended by the Fair and Accurate Credit Transaction Act, the Federal Trade Commission Act, the Privacy Act of 1974, the
CAN-SPAM
Act, the Telephone Consumer Protection Act, the Telemarketing and Consumer Fraud
and Abuse Prevention Act, social security number protection Laws and data security and security breach notification Laws.
Intellectual Property
means all intellectual property rights in any jurisdiction, including all: (a) patents, patent
applications, and patent disclosures, together with all provisionals, reissues, continuations,
continuations-in-part,
divisions, revisions, extensions, and
reexaminations thereof; (b) trademarks, service marks, trade dress, logos, slogans, brand names, trade names, Internet domain names and corporate names (whether or not registered), and other indicia of origin, and all applications,
registrations and renewals in connection therewith; (c) all copyrights (whether or not published), mask works, and industrial designs, and all applications, registrations and renewals in connection therewith; (d) intellectual property
rights in Software Programs; and (e) mask works and industrial designs, and all applications and registrations in connection therewith; and (f) trade secrets and other intellectual property rights in confidential and proprietary
information (including any intellectual property rights in inventions, ideas, research and development information,
know-how,
formulas, compositions, manufacturing and production processes and techniques,
technical data, designs, drawings, specifications, research records, test information, financial, marketing and business data, customer and supplier lists, algorithms and information, pricing and cost information, business and marketing plans and
proposals, and databases and compilations of data.
IRS
means the United States Internal Revenue Service.
IT Assets
means computers, Software Programs, servers, workstations, routers, hubs, switches, circuits, networks, data
communications lines and all other information technology equipment owned, used, or held for use by the Company.
Knowledge
means (a) when used with respect to the Company, the actual knowledge of the individuals listed in
Section
8.4(b)
of the Company Disclosure Schedule; and (b) when used with respect to Parent or Merger Sub, the actual knowledge of the individuals listed in
Section
8.4(b)
of the Parent
Disclosure Schedule.
A-61
Law
means any applicable national, provincial, state, municipal and local laws
(including common law), statutes, ordinances, codes, decrees, rules, regulations or Orders of any Governmental Entity, in each case, having the force of law.
Lien
means with respect to any property, equity interest or asset, any mortgage, deed of trust, hypothecation, lien,
encumbrance, pledge, charge, security interest, right of first refusal, right of first offer, adverse claim, conditional sales or other title retention agreement, easement, right of way or other title defect, restriction on transfer, covenant or
option in respect of such property, equity interest or asset.
NASDAQ
means the NASDAQ Capital Market.
NYSE
means the New York Stock Exchange.
Order
means any judgment, order, ruling, decision, writ, injunction, decree or arbitration award of any Governmental
Entity.
OSHA
means the Occupational Safety and Health Act of 1970, as amended, and the rules and regulations
promulgated thereunder.
Parent Material Adverse Effect
means any change, event, condition, occurrence, state of facts,
development or effect that, individually or in the aggregate, prevents or materially impairs or delays the consummation by Parent or Merger Sub of any the transactions contemplated this Agreement.
Permitted Liens
means (a) statutory Liens for Taxes not yet due and payable or for Taxes that are being contested in
good faith by appropriate Proceedings diligently conducted and for which appropriate reserves have been established in accordance with GAAP on the financial statements of the Company, (b) Liens in favor of landlords, vendors, carriers,
warehousemen, repairmen, mechanics, workmen, materialmen, construction or similar liens or encumbrances arising by operation of Law in the ordinary course of business for amounts not yet due and payable, (c) (i) applicable building, zoning and
land use regulations regulating the use or occupancy of Company Real Property or the activities conducted thereon which are imposed by any Governmental Entity having jurisdiction over such Company Real Property which are not violated by the current
use or occupancy of such Company Real Property or the operation of the business thereon, and (ii) other imperfections or irregularities in title, charges, restrictions and other encumbrances of record that do not materially detract from the use
of the Company Real Property to which they relate.
Person
means an individual, corporation, limited liability company,
partnership, association, trust, unincorporated organization, other entity or group (as defined in Section 13(d) of the Exchange Act), including a Governmental Entity.
Personal Data
means information, in any form, that identifies an individual or, in combination with any other information
or data in the possession of the Company, could be used to identify an individual.
A-62
Prime Rate
means the rate per annum published in
The Wall Street
Journal
from time to time as the prime lending rate prevailing during any relevant period.
Proceedings
means all
actions, suits, claims, investigations, audits, litigation or proceedings, in each case, by or before any Governmental Entity.
Release
means disposing, discharging, injecting, spilling, leaking, pumping, pouring, leaching, dumping, emitting, escaping
or emptying into or upon the indoor or outdoor environment, including any soil, sediment, subsurface strata, surface water, groundwater, ambient air, the atmosphere or any other media.
Representatives
means, with respect to a Person, such Persons directors, officers, employees, accountants,
consultants, legal counsel, investment bankers, advisors, agents and other representatives.
Rights Agreement
means the
Stockholder Rights Agreement, dated as of September 7, 2011, between American Stock Transfer & Trust Company, LLC, as rights agent, and the Company.
SEC
means the Securities and Exchange Commission.
Securities Act
means the Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
Software Programs
means computer programs (whether in source code, object code or other form), including any and all
software implementations of algorithms, models and methodologies, and all documentation, including user manuals and training materials, related to any of the foregoing.
Subsidiary
of Parent, the Company or any other Person means any corporation, partnership, limited liability company, joint
venture or other legal entity of which Parent, the Company or such other Person, as the case may be (either alone or through or together with any other Subsidiary), owns, directly or indirectly, a majority of the capital stock or other Equity
Interests the holders of which are generally entitled to vote for the election of the board of directors or other governing body of such corporation, limited liability company, partnership, joint venture or other legal entity, or otherwise owns,
directly or indirectly, such capital stock or other Equity Interests that would confer control of any such corporation, limited liability company, partnership, joint venture or other legal entity, or any Person that would otherwise be deemed a
subsidiary under Rule
12b-2
promulgated under the Exchange Act.
Tax
Authority
means any Governmental Entity having or purporting to exercise jurisdiction with respect to the determination, collection or imposition of any Tax.
Tax Return
means any report, return (including information return), claim for refund, election, estimated tax filing or
declaration required to be filed or actually filed with a Tax Authority, including any schedule or attachment thereto, and including any amendments thereof.
A-63
Taxes
means all federal, state, local or foreign taxes, fees, levies, duties,
tariffs, imposts, payments in lieu and other charges in the nature of a tax or any other similar fee, charge, assessment or payment, including, without limitation, income, franchise, windfall or other profits, gross receipts, branch profits, real
property, personal property, sales, use, goods and services, net worth, capital stock, license, occupation, premium, commercial activity, customs duties, alternative or
add-on
minimum, environmental, escheat
or unclaimed property, payroll, employment, social security, workers compensation, unemployment compensation, disability, excise, severance, estimated, withholding, ad valorem, stamp, transfer, registration, value-added, transactional and
gains tax, whether disputed or not, and any interest, penalty, fine or additional amounts imposed in respect of any of the foregoing.
Third Party
shall mean any Person other than Parent, Merger Sub and their respective affiliates.
Treasury Regulations
means regulations promulgated under the Code by the IRS.
8.5
Terms Defined Elsewhere
. The following terms are defined elsewhere in this Agreement, as indicated
below:
|
|
|
Acquisition Proposal
|
|
Section 5.3(h)(i)
|
|
|
Agreemen
t
|
|
Preamble
|
|
|
Book-Entry Company Shares
|
|
Section 2.2(b)(ii)
|
|
|
Certificate of Merger
|
|
Section 1.2
|
|
|
Certificates
|
|
Section 2.2(b)(i)
|
|
|
Change of Board Recommendation
|
|
Section 5.3(a)
|
|
|
Closing
|
|
Section 1.2
|
|
|
Closing Date
|
|
Section 1.2
|
|
|
Company
|
|
Preamble
|
|
|
Company Acquisition Agreement
|
|
Section 5.3(a)
|
|
|
Company Benefit Plan
|
|
Section 3.11(a)
|
|
|
Company Board
|
|
Recitals
|
|
|
Company Board Recommendation
|
|
Section 3.3(b)
|
|
|
Company Bylaws
|
|
Section 3.1
|
A-64
|
|
|
Company Charter
|
|
Section 3.1
|
|
|
Company Disclosure Schedule
|
|
Article 3
|
|
|
Company Equity Plan
|
|
Section 2.4(b)
|
|
|
Company Lease Agreements
|
|
Section 3.14(b)
|
|
|
Company Leased Real Property
|
|
Section 3.14(b)
|
|
|
Company Material Contracts
|
|
Section 3.16(b)
|
|
|
Company Meeting
|
|
Section 5.4(b)
|
|
|
Company Option
|
|
Section 2.4(a)
|
|
|
Company Owned Real Property
|
|
Section 3.14(a)
|
|
|
Company Real Property
|
|
Section 3.14(c)
|
|
|
Company Registered Intellectual Property
|
|
Section 3.17(a)
|
|
|
Company SEC Documents
|
|
Section 3.5(a)
|
|
|
Company SEC Financial Statements
|
|
Section 3.5(c)
|
|
|
Company Shares
|
|
Section 2.1(a)
|
|
|
Company Stockholder Approval
|
|
Section 3.3(c)
|
|
|
Confidentiality Agreement
|
|
Section 5.2(b)
|
|
|
Continuing Employee
|
|
Section 5.15
|
|
|
CPR
|
|
Section 2.1(a)
|
|
|
DGCL
|
|
Recitals
|
|
|
Dissenting Shares
|
|
Section 2.3
|
|
|
Effect
|
|
Section 8.4
|
|
|
Effective Time
|
|
Section 1.2
|
|
|
Exchange Agent
|
|
Section 2.2(a)
|
A-65
|
|
|
Exchange Fund
|
|
Section 2.2(a)
|
|
|
Exchange Ratio
|
|
Section 2.1(a)
|
|
|
Exercise Window
|
|
Section 2.4(a)
|
|
|
Expense Reimbursement
|
|
Section 7.3(c)
|
|
|
FFDCA
|
|
Section 3.18(a)
|
|
|
FLSA
|
|
Section 3.12(a)
|
|
|
Form
S-4
|
|
Section 3.4(b)
|
|
|
HIPAA
|
|
Section 3.18(a)
|
|
|
Health Care Laws
|
|
Section 3.18(a)
|
|
|
Indemnitee
|
|
Section 5.8(a)
|
|
|
Intervening Event
|
|
Section 5.3(h)(iii)
|
|
|
Merger
|
|
Recitals
|
|
|
Merger Consideration
|
|
Section 2.1(a)
|
|
|
Merger Sub
|
|
Preamble
|
|
|
Multiemployer Plan
|
|
Section 3.11(f)
|
|
|
Notice Period
|
|
Section 5.3(d)
|
|
|
OFAC
|
|
Section 3.9
|
|
|
Outside Date
|
|
Section 7.1(d)
|
|
|
Parent
|
|
Preamble
|
|
|
Parent Board
|
|
Section 4.6(d)
|
|
|
Parent Common Stock
|
|
Section 2.1(a)
|
|
|
Parent Disclosure Schedule
|
|
Article 4
|
|
|
Parent SEC Financial Statements
|
|
Section 4.6(c)
|
|
|
Parent Subsidiary
|
|
Section 4.3(a)
|
A-66
|
|
|
Permits
|
|
Section 3.10
|
|
|
Preferred Stock
|
|
Section 3.2(a)
|
|
|
Proposed Changed Terms
|
|
Section 5.3(d)(iv)
|
|
|
Proxy Statement
|
|
Section 3.4(b)
|
|
|
Regulatory Authority
|
|
Section 3.18(b)
|
|
|
Regulatory Permit
|
|
Section 3.18(b)
|
|
|
Safety Notices
|
|
Section 3.18(e)
|
|
|
Sarbanes-Oxley Act
|
|
Section 3.5(b)
|
|
|
Service Provider
|
|
Section 3.11(a)
|
|
|
Stock Consideration
|
|
Section 2.1(a)
|
|
|
Submissions
|
|
Section 3.18(c)
|
|
|
Superior Proposal
|
|
Section 5.3(h)(ii)
|
|
|
Surviving Corporation
|
|
Section 1.1(a)
|
|
|
Termination Fee
|
|
Section 7.3(a)
|
|
|
Title IV Plan
|
|
Section 3.11(f)
|
|
|
Transaction Litigation
|
|
Section 5.12
|
|
|
Transactions
|
|
Section 1.1(a)
|
8.6
Headings
. The headings and table of contents contained in this
Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.
8.7
Severability
. If any term or other provision of this Agreement is determined by a court of competent
jurisdiction to be invalid, illegal or incapable of being enforced by any rule of Law or public policy, all other terms, conditions and provisions of this Agreement 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. Upon such determination that any term or other provision is invalid, illegal or incapable of being enforced, the parties hereto
shall negotiate in good faith to modify this Agreement so as to effect the original intent of the parties as closely as possible to the fullest extent permitted by applicable Law and in an acceptable manner to the end that the transactions
contemplated hereby are fulfilled to the extent possible.
A-67
8.8
Entire Agreement
. This Agreement (together with the
Exhibits, Parent Disclosure Schedule and Company Disclosure Schedule and the other documents delivered pursuant hereto) and the Confidentiality Agreement constitute the entire agreement of the parties and supersede all prior agreements and
undertakings, both written and oral, among the parties, or any of them, with respect to the subject matter hereof and, except as otherwise expressly provided herein or therein, are not intended to confer upon any other Person any rights or remedies
hereunder or thereunder.
8.9
Assignment
. Neither this Agreement nor any of the rights, interests or
obligations hereunder shall be assigned by any of the parties hereto, in whole or in part (whether by operation of law or otherwise), without the prior written consent of each of the other parties, and any attempt to make any such assignment without
such 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 permitted assigns.
8.10
No Third Party Beneficiaries
. This Agreement shall be binding upon and inure solely to the benefit of
the parties and their respective successors and permitted assigns, and nothing in this Agreement, express or implied, other than pursuant to
Section
5.8
, is intended to or shall confer upon any other Person any right,
benefit or remedy of any nature whatsoever under or by reason of this Agreement.
8.11
Mutual Drafting;
Interpretation
. Each party has jointly participated in the drafting of this Agreement, which each party acknowledges is the result of extensive negotiations between the parties. If 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 by virtue of the authorship of any provision. For purposes of this Agreement,
whenever the context requires: the singular number shall include the plural, and vice versa; the masculine gender shall include the feminine and neuter genders; the feminine gender shall include the masculine and neuter genders; and the neuter
gender shall include masculine and feminine genders. As used in this Agreement, the words include and including, and variations thereof, shall not be deemed to be terms of limitation, but rather shall be deemed to be
followed by the words without limitation. As used in this Agreement, the words ordinary course of business shall be deemed to be followed by the words consistent with past practice. As used in this Agreement,
references to a party or the parties are intended to refer to a party to this Agreement or the parties to this Agreement. Except as otherwise indicated, all references in this Agreement to Sections,
Exhibits, Annexes and Schedules are intended to refer to Sections of this Agreement and Exhibits, Annexes and Schedules to this Agreement. All references in this Agreement to dollars $
are intended to refer to U.S. dollars. Unless otherwise specifically provided for herein, the term or shall not be deemed to be exclusive. As used in this Agreement, the words hereof, herein,
hereby, hereunder and words of similar import shall refer to this Agreement as a whole and not to any particular provision of this Agreement. Any Contract or Law defined or referred to herein means any such Contract or
Law as from time to time amended, modified or supplemented, unless otherwise specifically indicated.
A-68
8.12
Governing Law; Consent to Jurisdiction; Waiver of Trial by
Jury
.
(a) This Agreement and all claims and causes of action based upon, arising out of or in connection
herewith shall be governed by, and construed in accordance with, the Laws of the State of Delaware, without regard to Laws that may be applicable under conflicts of laws principles (whether of the State of Delaware or any other jurisdiction) that
would cause the application of the Laws of any jurisdiction other than the State of Delaware.
(b) Each of the
parties hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of the Court of Chancery of the State of Delaware or, if such Court does not have jurisdiction, any Delaware State court, or Federal
court of the United States of America, sitting in Delaware, and any appellate court from any thereof, in any Proceeding arising out of or relating to this Agreement or the transactions contemplated hereby or for recognition or enforcement of any
judgment relating thereto, and each of the parties hereby irrevocably and unconditionally (i) agrees not to commence any such Proceeding except in such courts, (ii) agrees that any claim in respect of any such Proceeding may be heard and
determined in such 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 Proceeding in any such court, and (iv) waives, to the
fullest extent permitted by Law, the defense of an inconvenient forum to the maintenance of such Proceeding in any such court. Each of the parties agrees that a final judgment in any such Proceeding shall be conclusive and may be enforced in
other jurisdictions by suit on the judgment or in any other manner provided by Law. Each party to this Agreement irrevocably consents to service of process in the manner provided for notices in
Section 8.3
. Nothing in this Agreement
will affect the right of any party to this Agreement to serve process in any other manner permitted by Law.
(c) 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 PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AGREEMENT AND ANY OF THE
AGREEMENTS DELIVERED IN CONNECTION HEREWITH OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY. EACH PARTY CERTIFIES AND ACKNOWLEDGES THAT (I) 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, (II) IT UNDERSTANDS AND HAS CONSIDERED THE IMPLICATIONS OF SUCH WAIVERS, (III) IT MAKES SUCH WAIVERS VOLUNTARILY AND (IV) IT HAS BEEN
INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS
SECTION
8.12(c)
.
8.13
Counterparts
. This Agreement may be signed in any number of counterparts, including by facsimile or
other electronic transmission each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. This Agreement shall become effective when each party hereto shall have received a
A-69
counterpart hereof signed by all of the other parties hereto. Until and unless each party has received a counterpart hereof signed by the other party hereto, this Agreement shall have no
effect and no party shall have any right or obligation hereunder (whether by virtue of any other oral or written agreement or other communication). The exchange of a fully executed Agreement (in counterparts or otherwise) by electronic transmission
in .PDF format or by facsimile shall be sufficient to bind the parties to the terms and conditions of this Agreement.
8.14
Specific Performance
. The parties hereto agree that if any of the provisions of this Agreement were
not performed in accordance with their specific terms or were otherwise breached, irreparable damage would occur, no adequate remedy at Law would exist and damages would be difficult to determine, and accordingly, (a) the parties shall be
entitled to an injunction or injunctions to prevent breaches of this Agreement and to specific performance of the terms hereof, in each case in the Court of Chancery of the State of Delaware or, if such court shall not have jurisdiction, any state
or Federal Court of the United States of America, or any state having jurisdiction, this being in addition to any other remedy to which they are entitled at Law or in equity, (b) the parties waive any requirement for the securing or posting of
any bond in connection with the obtaining of any specific performance or injunctive relief and (c) the parties will waive, in any action for specific performance, the defense of adequacy of a remedy at Law. The Companys or
Parents pursuit of specific performance at any time will not be deemed an election of remedies or waiver of the right to pursue any other right or remedy to which such party may be entitled.
[
Signature page follows
]
A-70
IN WITNESS WHEREOF, Parent, Merger Sub and the Company have caused this Agreement to be executed
as of the date first written above by their respective officersthereunto duly authorized.
|
|
|
|
|
PARENT:
|
|
INTREXON CORPORATION
|
|
|
By:
|
|
/s/ Donald P. Lehr
|
|
|
Name:
|
|
Donald P. Lehr
|
|
|
Title:
|
|
Chief Legal Officer
|
|
MERGER SUB:
|
|
INTREXON GV HOLDING, INC.
|
|
|
By:
|
|
/s/ Donald P. Lehr
|
|
|
Name:
|
|
Donald P. Lehr
|
|
|
Title:
|
|
Chief Legal Officer
|
|
COMPANY:
|
|
GENVEC, INC.
|
|
|
By:
|
|
/s/ Douglas J. Swirsky
|
|
|
Name:
|
|
Douglas J. Swirsky
|
|
|
Title:
|
|
President and Chief Executive Officer
|
[Signature Page to Agreement and Plan of Merger]
A-71
EXHIBIT A
FORM OF
CERTIFICATE OF
INCORPORATION
OF SURVIVING CORPORATION
SECOND AMENDED AND RESTATED
CERTIFICATE OF INCORPORATION
OF GENVEC, INC.
The
undersigned President and Treasurer of GenVec, Inc., a corporation organized and existing under the laws of the State of Delaware (the Corporation) does hereby certify as follows:
1. The Second Amended and Restated Certificate of Incorporation, the entirety of which is set forth below, has been duly adopted in
accordance with Sections 242 and 245 of the Delaware General Corporation Law and duly executed and acknowledged by the appropriate officer(s) of the Corporation in accordance with Section 103 of the Delaware General Corporation Law.
2. The Amended and Restated Certificate of Incorporation of the Corporation, as amended, is hereby amended and restated in its entirety
as follows:
First:
The name of this Corporation is GenVec, Inc.
Second:
The registered office of the Corporation in the State of Delaware is to be located at 1209 Orange Street, in the City of Wilmington, County of
New Castle, Zip Code 19801. The registered agent in charge thereof is The Corporation Trust Company.
Third:
The purpose of the corporation is
to engage in any lawful act or activity for which corporations may be organized under the General Corporation Law of Delaware.
Fourth:
The amount
of the total stock of this corporation is authorized to issue is 100 shares with a par value of $0.001 per share.
Fifth:
(1) Right to Indemnification.
Each person who was or is made a party or is threatened to be made a party to or is otherwise involved in any
action, suit or proceeding, whether civil, criminal, administrative or investigative (hereinafter a proceeding), by reason of the fact:
(a) that he or she is or was a director or officer of the Corporation, or
(b) that he or she, being at the time a director or officer of the Corporation, is or was serving at the request of the Corporation as a
director, trustee, officer, employee or agent of another corporation or of a partnership, joint venture, trust or other enterprise, including service with respect to an employee benefit plan (collectively, another enterprise or
other enterprise), whether either in case (a) or in case (b) the basis of such proceeding is alleged action or inaction (x) in an official capacity as a director or officer of the Corporation, or as a director, trustee,
officer, employee or agent of such other enterprise, or (y) in any other capacity related to the Corporation to the fullest extent not prohibited by Section 145 of the Delaware General Corporation Law (or any successor provision or
provisions) as the same exists or may
A-Exh. A-1
hereafter be amended (but, in the case of any such amendment, with respect to actions taken prior to such amendment, only to the extent that such amendment permits the Corporation to provide
broader indemnification rights than permitted prior thereto), against all expense, liability and loss (including, without limitation, attorneys fees, judgments, fines, ERISA excise taxes or penalties and amounts paid in settlement) incurred or
suffered by such person in connection therewith. The persons indemnified by this Article Fifth are hereinafter referred to as indemnitees. Such indemnification as to such alleged action or inaction shall continue as to an indemnitee
who has after such alleged action or inaction ceased to be a director or officer of the alleged action or inaction shall continue as to an indemnitee who has after such alleged action or inaction ceased to be a director or officer of the
Corporation, or director, officer, employee or agent of another enterprise; and shall inure to the benefit of the indemnitees heirs, executors, administrators, and personal or legal representatives, provided, however, that except for
proceedings to enforce rights to indemnification, the Corporation shall not be obligated to indemnify any director or officer (or his or her heirs, executors, administrators, or personal or legal representatives) in connection with a proceeding (or
part thereof) initiated by such person unless such proceeding (or part thereof) was authorized or consented to by the Board of Directors. The right to indemnification conferred in this Article Fifth: (i) shall be a contract right;
(ii) shall not be affected adversely as to any indemnitee by any amendment of this Second Amended and Restated Certificate of Incorporation with respect to any action or inaction occurring prior to such amendment; and (iii) shall, subject
to any requirements imposed by law, this Article Fifth, or the Bylaws, include the right to have paid by the Corporation the expenses incurred in defending any such proceeding in advance of its final disposition.
(2)
Agents and Employees
. The Corporation may, to the extent authorized from time to time by the Board of Directors, grant rights to
indemnification, and to the advancement of expenses, to any employee or agent of the Corporation (or any person serving at the Corporations request as a director, trustee, officer, employee or agent of another enterprise) or to persons who are
or were a director, officer, employee or agent of any of the Corporations affiliates, predecessor or subsidiary corporations or of a constituent corporation absorbed by the Corporation in a consolidation or merger or who is or was serving at
the request of such affiliate, predecessor or subsidiary corporation or of such constituent corporation as a director, officer, employee or agent of another enterprise, in each case as determined by the Board of Directors to the fullest extent of
the provisions of this Article Fifth in cases of the indemnification and advancement of expenses of directors and officers of the Corporation, or to any lesser extent (or greater extent, if permitted by law) determined by the Board of Directors.
(3)
Partial Indemnification
. If the indemnitee is entitled under any provision of this Article Fifth to indemnification by the
Corporation for some or a portion of the expenses, liabilities, losses, judgments, fines, penalties or ERISA excise taxes actually and reasonably incurred by him or her in the investigation, defense, appeal or settlement of any proceeding but not,
however, for the total amount thereof, the Corporation shall nevertheless indemnify the indemnitee for the portion of such expenses, liabilities, losses, judgments, fines, penalties or ERISA excise taxes to which the indemnitee is entitled.
(4)
Repeal or Modification by Stockholders
. Any repeal or modification of this Article Fifth by the stockholders of the Corporation shall not
adversely affect any rights to indemnification
A-Exh. A-2
and to the advancement of expenses or other protection of a director, officer, employee or agent of the Corporation existing at the time of such repeal or modification with respect to any acts or
omissions occurring prior to such repeal or modification.
(5)
Repeal or Modification of Law
. Any repeal or modification of the laws of the
State of Delaware, as now or hereafter in effect, shall not adversely affect any rights to indemnification and to the advancement of expenses or other protection of a director, officer, employee or agent of the Corporation existing at the time of
such repeal or modification with respect to any acts or omissions occurring prior to such repeal or modification.
(6)
Insurance
. The
Corporation may maintain insurance, at its expense, to protect itself and any director, trustee, officer, employee or agent of the Corporation or another enterprise against any expense, liability or loss, whether or not the Corporation would have
the power to indemnify such person against such expense, liability or loss under the Delaware General Corporation Law.
(7)
Binding Effect;
Successors and Assigns
. The indemnification and advance of expenses provided by or granted pursuant to this Article Fifth shall continue as to a person who has ceased to be a director or officer, and shall inure to the benefit of the heirs,
executors and administrators of such director or officer.
(8)
Severability
. In the event that any of the provisions of this Article Fifth
(including any provision within a single section, paragraph or sentence) is held by a court of competent jurisdiction to be invalid, void or otherwise unenforceable, the remaining provisions are severable and shall remain enforceable to the full
extent permitted by law.
(9)
Relationship to Other Rights and Provisions Concerning Indemnification
. The rights to indemnification and to
the advancement of expenses conferred in this Article Fifth shall not be exclusive of any other right which any person may have or hereafter acquire under any statute, this Second Amended and Restated Certificate of Incorporation, Bylaws, agreement,
vote of stockholders or disinterested directors or otherwise. The Bylaws may contain such other provisions concerning indemnification, including provisions specifying reasonable procedures relating to and conditions to the receipt by
indemnitees of indemnification, provided that such provisions are not inconsistent with the provisions of this Article Fifth.
I, The Undersigned
,
being the duly elected President and Treasurer of the Corporation, do on behalf of the Corporation make this Second Amended and Restated Certificate of Incorporation of the Corporation.
|
|
|
By:
|
|
|
Name:
|
|
|
Title:
|
|
President and Treasurer
|
A-Exh. A-3
EXHIBIT B
FORM OF BYLAWS
OF SURVIVING CORPORATION
GENVEC, INC.
* * * * *
AMENDED AND RESTATED BYLAWS
* * *
* *
ARTICLE I
OFFICES
Section 1. The registered office of the corporation shall be in the City of Wilmington, County of New Castle, State of Delaware.
Section 2. The corporation may also have offices at such other places both within and without the State of Delaware as the board of
directors may from time to time determine or the business of the corporation may require.
ARTICLE II
MEETINGS OF STOCKHOLDERS
Section
1. All meetings of the stockholders shall be held at such time and place, within or without the State of Delaware, as shall be stated in the notice of the meeting or in a duly executed waiver of notice thereof.
The board of directors may, in its sole discretion, determine that the meeting shall not be held at any place, but may instead be held solely
by means of remote communication as authorized by Section 211(a)(2) of the General Corporation Law of Delaware. If so authorized, and subject to such guidelines and procedures as the board of directors may adopt, stockholders and proxyholders
not physically present at a meeting of stockholders may, by means of remote communication, participate in a meeting of stockholders and be deemed present in person and vote at a meeting of stockholders whether such meeting is to be held at a
designated place or solely by means of remote communication, provided that (i) the corporation shall implement reasonable measures to verify that each person deemed present and permitted to vote at the meeting by means of remote communication
is a stockholder or proxyholder, (ii) the corporation shall implement reasonable measures to provide such stockholders and proxyholders a reasonable opportunity to participate in the meeting and to vote on matters submitted to the stockholders,
including an opportunity to read or hear the proceedings of the meeting substantially concurrently with such proceedings, and (iii) if any stockholder or proxyholder votes or takes other action at the meeting by means of remote communication, a
record of such vote or other action shall be maintained by the corporation.
Section 2. Annual meetings of stockholders shall be held
at such date and time as shall be designated from time to time by the board of directors and stated in the notice of the meeting, at which they shall elect by a plurality vote a board of directors, and transact such other business as may properly be
brought before the meeting.
A-Exh. B-1
Section 3. Written notice of the annual meeting stating the place if any, date and hour of
the meeting, the means of remote communication, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting, the record date for determining the stockholders entitled to vote at the meeting, if such
date is different from the record date for determining stockholders entitled to notice of the meeting, shall be given not less than ten nor more than sixty days before the date of the meeting, to each stockholder entitled to vote at such meeting as
of the record date for determining the stockholders entitled to notice of the meeting.
Section 4. The officer who has charge of the
stock ledger of the corporation shall prepare and make, at least ten days before every meeting of stockholders, a complete list of the stockholders entitled to vote at the meeting; provided, however, if the record date for determining the
stockholders entitled to vote is less than ten days before the meeting date, the list shall reflect the stockholders entitled to vote as of the tenth day before the meeting date, arranged in alphabetical order, and showing the address of each
stockholder and the number of shares registered in the name of each stockholder. Such list shall be open to the examination of any stockholder for any purpose germane to the meeting for a period of at least ten days prior to the meeting: (i) on
a reasonably accessible electronic network, provided that the information required to gain access to such list is provided with the notice of the meeting, or (ii) during ordinary business hours, at the principal place of business of the
corporation. In the event that the corporation determines to make the list available on an electronic network, the corporation may take reasonable steps to ensure that such information is available only to stockholders of the corporation. If the
meeting is to be held at a place, then a list of the stockholders entitled to vote at the meeting shall be produced and kept at the time and place of the meeting during the whole time thereof, and may be examined by any stockholder who is present.
If the meeting is to be held solely by means of remote communication, then such list shall also be open to the examination of any stockholder during the whole time of the meeting on a reasonably accessible electronic network, and the information
required to access such list shall be provided with the notice of the meeting.
Section 5. Special meetings of the stockholders, for
any purpose or purposes, unless otherwise prescribed by statute or by the certificate of incorporation, may be called by the president and shall be called by the president or secretary at the request in writing of a majority of the board of
directors, or at the request in writing of stockholders owning a majority in amount of the entire capital stock of the corporation issued and outstanding and entitled to vote. Such request shall state the purpose or purposes of the proposed meeting.
Section 6. Written notice of a special meeting stating the place if any, date and hour of the meeting, the means of remote
communication, if any, by which stockholders and proxyholders may be deemed to be present in person and vote at such meeting, the record date for determining the stockholders entitled to vote at the meeting, if such date is different from the record
date for determining stockholders entitled to notice of the
A-Exh. B-2
meeting, and the purpose or purposes for which the meeting is called, shall be given not less than ten nor more than sixty days before the date of the meeting, to each stockholder entitled to
vote at such meeting as of the record date for determining the stockholders entitled to notice of the meeting.
Section 7. The
holders of a majority of the stock issued and outstanding and entitled to vote thereat, present in person or represented by proxy, shall constitute a quorum at all meetings of the stockholders for the transaction of business except as otherwise
provided by statute or by the certificate of incorporation. If, however, such quorum shall not be present or represented at any meeting of the stockholders, the stockholders entitled to vote thereat, present in person or represented by proxy, shall
have power to adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present or represented. At such adjourned meeting at which a quorum shall be present or represented, any business may
be transacted which might have been transacted at the meeting as originally notified. If the adjournment is for more than thirty days a notice of the adjourned meeting shall be given to each stockholder of record entitled to vote at the meeting. If
after adjournment a new record date for stockholders entitled to vote is fixed for the adjourned meeting, the board of directors shall fix a new record date for notice of such adjourned meeting in accordance with Section 213(a) of the General
Corporation Law of Delaware, and shall give notice of the adjourned meeting to each stockholder of record entitled to vote at such adjourned meeting as of the record date fixed for notice of such adjourned meeting.
Section 8. When a quorum is present at any meeting, the vote of the holders of a majority of the stock having voting power present in
person or represented by proxy shall decide any question brought before such meeting, unless the question is one upon which by express provision of the statutes or of the certificate of incorporation, a different vote is required in which case such
express provision shall govern and control the decision of such question.
Section 9. Unless otherwise provided in the certificate of
incorporation, each stockholder shall at every meeting of the stockholders be entitled to one vote in person or by proxy for each share of the capital stock having voting power held by such stockholder, but no proxy shall be voted on after three
years from its date, unless the proxy provides for a longer period.
Section 10. Unless otherwise provided in the certificate of
incorporation, any action required to be taken, or which may be taken, at any annual or special meeting of stockholders of the corporation, may be taken without a meeting, without prior notice and without a vote, if a consent or consents in writing,
setting forth the action so taken, shall be signed by the holders of outstanding stock having not less than the minimum number of votes that would be necessary to authorize or take such action at a meeting at which all shares entitled to vote
thereon were present and voted. Prompt notice of the taking of the corporate action without a meeting by less than unanimous written consent shall be given to those stockholders who have not consented in writing and who, if the action had been taken
at a meeting, would have been entitled to notice of the meeting if the record date
A-Exh. B-3
for notice of such meeting had been the date that written consents signed by a sufficient number of holders to take the action were delivered to the corporation. Stockholders may, unless the
certificate of incorporation otherwise provides, act by written consent to elect directors; provided, however, that if such consent is less than unanimous, such action by written consent may be in lieu of holding an annual meeting only if all of the
directorships to which directors could be elected at an annual meeting held at the effective time of such action are vacant and are filled by such action.
A telegram, cablegram or other electronic transmission consenting to an action to be taken and transmitted by a stockholder or proxyholder, or
by a person or persons authorized to act for a stockholder or proxyholder, shall be deemed to be written, signed and dated for the purposes herein, provided that any such telegram, cablegram or other electronic transmission sets forth or is
delivered with information from which the corporation can determine (A) that the telegram, cablegram or other electronic transmission was transmitted by the stockholder or proxyholder or by a person or persons authorized to act for the
stockholder or proxyholder and (B) the date on which such stockholder or proxyholder or authorized persons or persons transmitted such telegram, cablegram or other electronic transmission. The date on which such telegram, cablegram or
electronic transmission is transmitted shall be deemed to be the date on which such consent was signed. No consent given by telegram, cablegram or electronic transmission shall be deemed to have been delivered until such consent is reproduced in
paper form and until such paper form shall be delivered in accordance with Section 228 of the General Corporation Law of Delaware, to the corporation by delivery to its registered office in Delaware, its principal place of business or an
officer or agent of the corporation having custody of the book in which proceedings of meetings of stockholders are recorded. Any copy, facsimile or other reliable reproduction of a consent in writing may be substituted or used in lieu of the
original writing for any and all such purposes for which the original writing could be used, provided that such copy, facsimile or other reproduction shall be a complete reproduction of the entire original writing.
ARTICLE III
DIRECTORS
Section 1. Until changed in accordance with the provisions of this section, there shall be two (2) directors of the
corporation. The number of directors may be fixed (i) at any meeting of stockholders called for the purpose of electing directors, at which a quorum is present, by the affirmative vote of the holders of a majority of the stock having
voting power present in person or by proxy at the meeting, or (ii) at any meeting of the directors at which a quorum is present, by the affirmative vote of a majority of the directors present. No reduction in the number of directors shall
of itself have the effect of shortening the term of any incumbent director. Each director elected shall hold office until his or her successor is elected and qualified.
Section 2. Vacancies and newly created directorships resulting from any increase in the authorized number of directors may be filled by a
majority of the directors then in office, though less than a quorum, or by a sole remaining director, and the directors so chosen shall hold office until the next annual election and until their successors are duly elected and shall qualify, unless
sooner displaced.
A-Exh. B-4
Section 3. The business of the corporation shall be managed by or under the direction of its
board of directors which may exercise all such powers of the corporation and do all such lawful acts and things as are not by statute or by the certificate of incorporation or by these bylaws directed or required to be exercised or done by the
stockholders.
Section 4. The board of directors of the corporation may hold meetings, both regular and special, either within or
without the State of Delaware.
Section 5. The first meeting of each newly elected board of directors shall be held at such time and
place as shall be fixed by the vote of the stockholders at the annual meeting and no notice of such meeting shall be necessary to the newly elected directors in order legally to constitute the meeting, provided a quorum shall be present. In the
event of the failure of the stockholders to fix the time or place of such first meeting of the newly elected board of directors, or in the event such meeting is not held at the time and place so fixed by the stockholders, the meeting may be held at
such time and place as shall be specified in a notice given as hereinafter provided for special meetings of the board of directors, or as shall be specified in a written waiver signed by all of the directors.
Section 6. Regular meetings of the board of directors may be held without notice at such time and at such place as shall from time to
time be determined by the board.
Section 7. Special meetings of the board may be called by the president on two days notice to
each director, either personally or by mail or by facsimile communication; special meetings shall be called by the president or secretary in like manner and on like notice on the written request of two directors unless the board consists of only one
director; in which case special meetings shall be called by the president or secretary in like manner and on like notice on the written request of the sole director.
Section 8. At all meetings of the board, a majority of directors shall constitute a quorum for the transaction of business and the act of
a majority of the directors present at any meeting at which there is a quorum shall be the act of the board of directors, except as may be otherwise specifically provided by statute or by the certificate of incorporation. If a quorum shall not be
present at any meeting of the board of directors, the directors present thereat may adjourn the meeting from time to time, without notice other than announcement at the meeting, until a quorum shall be present.
Section 9. Unless otherwise restricted by the certificate of incorporation or these bylaws, any action required or permitted to be taken
at any meeting of the board of directors or of any committee thereof may be taken without a meeting, if all members of the board or committee, as the case may be, consent thereto in writing or electronic
A-Exh. B-5
transmission, and the writing or writings or electronic transmission or transmissions are filed with the minutes of proceedings of the board or committee. Such filing shall be in paper form if
the minutes are maintained in paper form and shall be in electronic form if the minutes are maintained in electronic form.
Section
10. Unless otherwise restricted by the certificate of incorporation, members of the board of directors, or any committee designated by the board of directors, may participate in a meeting of the board of directors, or any committee, by means of
conference telephone or other communications equipment by means of which all persons participating in the meeting can hear each other, and such participation in a meeting shall constitute presence in person at the meeting.
Section 11. The board of directors may designate one or more committees, each committee to consist of one or more of the directors of the
corporation. The board may designate one or more directors as alternate members of any committee, who may replace any absent or disqualified member at any meeting of the committee.
In the absence or disqualification of a member of a committee, the member or members thereof present at any meeting and not disqualified from
voting, whether or not the member or members constitute a quorum, may unanimously appoint another member of the board of directors to act at the meeting in the place of any such absent or disqualified member.
Any such committee, to the extent provided in the resolution of the board of directors, shall have and may exercise all the powers and
authority of the board of directors in the management of the business and affairs of the corporation except as otherwise restricted by statute, and may authorize the seal of the corporation to be affixed to all papers which may require it.
Section 12. Each committee shall keep regular minutes of its meetings and report the same to the board of directors when required.
Section 13. Unless otherwise provided in the certificate of incorporation, the bylaws or the resolution of the board of directors
designating the committee, a committee may create one or more subcommittees, each subcommittee to consist of one or more members of the committee, and delegate to a subcommittee any or all of the powers and authority of the committee.
Section 14. Unless otherwise restricted by the certificate of incorporation or these bylaws, the board of directors shall have the
authority to fix the compensation of directors. The directors may be paid their expenses, if any, of attendance at each meeting of the board of directors and may be paid a fixed sum for attendance at each meeting of the board of directors or a
stated salary as director. No such payment shall preclude any director from serving the corporation in any other capacity and receiving compensation therefor. Members of special or standing committees may be allowed like compensation for attending
committee meetings.
A-Exh. B-6
Section 15. Any director or the entire board of directors may be removed, with or without
cause, by the holders of a majority of shares entitled to vote at an election of directors except as otherwise provided by statute.
ARTICLE IV
NOTICES
Section 1. Whenever, under the provisions of the statutes or of the certificate of incorporation or of these bylaws, notice is required
to be given to any director or stockholder, it shall not be construed to mean personal notice, but such notice may be given in writing, by mail, addressed to such director or stockholder, at his address as it appears on the records of the
corporation, with postage thereon prepaid, and such notice shall be deemed to be given at the time when the same shall be deposited in the United States mail. Notice may also be given to stockholders by a form of electronic transmission in
accordance with and subject to the provisions of Section 232 of the General Corporation Law of Delaware.
Section 2. Whenever
any notice is required to be given under the provisions of the statutes or of the certificate of incorporation or of these bylaws, a waiver thereof in writing, signed by the person or persons entitled to notice or a waiver by electronic transmission
by the person entitled to notice, whether before or after the time stated therein, shall be deemed equivalent thereto.
ARTICLE V
OFFICERS
Section 1. The
officers of the corporation shall be chosen by the board of directors and shall be a president, a secretary and a treasurer. The board of directors may also choose one or more vice presidents, assistant secretaries and assistant treasurers. Any
number of offices may be held by the same person, unless the certificate of incorporation otherwise provides.
Section 2. The board
of directors at its first meeting after each annual meeting of stockholders shall choose a president, a secretary and a treasurer.
Section 3. The board of directors may appoint such other officers and agents as it shall deem necessary who shall hold their offices for
such terms and shall exercise such powers and perform such duties as shall be determined from time to time by the board.
Section
4. The salaries of all officers and agents of the corporation shall be fixed by the board of directors.
A-Exh. B-7
Section 5. The officers of the corporation shall hold office until their successors are
chosen and qualify. Any officer elected or appointed by the board of directors may be removed at any time by the affirmative vote of a majority of the board of directors. Any vacancy occurring in any office of the corporation shall be filled by the
board of directors.
THE PRESIDENT
Section 6. The president shall be the chief executive officer of the corporation, shall preside at all meetings of the stockholders and
the board of directors, shall have general and active management of the business of the corporation and shall see that all orders and resolutions of the board of directors are carried into effect.
Section 7. He or she shall execute bonds, mortgages and other contracts requiring a seal, under the seal of the corporation, except where
required or permitted by statute to be otherwise signed and executed and except where the signing and execution thereof shall be expressly delegated by the board of directors to some other officer or agent of the corporation.
THE VICE-PRESIDENTS
Section
8. In the absence of the president or in the event of his or her inability or refusal to act, the vice-president (or in the event there be more than one vice-president, the vice-presidents in the order designated by the directors, or in the
absence of any designation, then in the order of their election) shall perform the duties of the president, and when so acting, shall have all the powers of and be subject to all the restrictions upon the president. The vice-presidents shall perform
such other duties and have such other powers as the board of directors may from time to time prescribe.
THE SECRETARY AND ASSISTANT
SECRETARY
Section 9. The secretary shall attend all meetings of the board of directors and all meetings of the stockholders and
record all the proceedings of the meetings of the corporation and of the board of directors in a book to be kept for that purpose and shall perform like duties for the standing committees when required. He or she shall give, or cause to be given,
notice of all meetings of the stockholders and special meetings of the board of directors, and shall perform such other duties as may be prescribed by the board of directors or president, under whose supervision he or she shall be. He or she shall
have custody of the corporate seal of the corporation and he or she, or an assistant secretary, shall have authority to affix the same to any instrument requiring it and when so affixed, it may be attested by his or her signature or by the signature
of such assistant secretary. The board of directors may give general authority to any other officer to affix the seal of the corporation and to attest the affixing by his or her signature.
Section 10. The assistant secretary, or if there be more than one, the assistant secretaries in the order determined by the board of
directors (or if there be no such determination, then in the order of their election) shall, in the absence of the secretary or in the event of his or her inability or refusal to act, perform the duties and exercise the powers of the secretary and
shall perform such other duties and have such other powers as the board of directors may from time to time prescribe.
A-Exh. B-8
THE TREASURER AND ASSISTANT TREASURERS
Section 11. The treasurer shall have the custody of the corporate funds and securities and shall keep full and accurate accounts of
receipts and disbursements in books belonging to the corporation and shall deposit all moneys and other valuable effects in the name and to the credit of the corporation in such depositories as may be designated by the board of directors.
Section 12. He or she shall disburse the funds of the corporation as may be ordered by the board of directors, taking proper vouchers for
such disbursements, and shall render to the president and the board of directors, at its regular meetings, or when the board of directors so requires, an account of all his or her transactions as treasurer and of the financial condition of the
corporation.
Section 13. If required by the board of directors, he or she shall give the corporation a bond in such sum and with
such surety or sureties as shall be satisfactory to the board of directors for the faithful performance of the duties of his or her office and for the restoration to the corporation, in case of his or her death, resignation, retirement or removal
from office, of all books, papers, vouchers, money and other property of whatever kind in his or her possession or under his or her control belonging to the corporation.
Section 14. The assistant treasurer, or if there shall be more than one, the assistant treasurers in the order determined by the board of
directors (or if there be no such determination, then in the order of their election) shall, in the absence of the treasurer or in the event of his or her inability or refusal to act, perform the duties and exercise the powers of the treasurer and
shall perform such other duties and have such other powers as the board of directors may from time to time prescribe.
ARTICLE VI
CERTIFICATES FOR SHARES
Section
1. The shares of the corporation shall be uncertificated.
FIXING RECORD DATE
Section 2. In order that the corporation may determine the stockholders entitled to notice of any meeting of stockholders or any
adjournment thereof, the board of directors may fix a record date, which shall not precede the date upon which the resolution fixing the record date is adopted by the board of directors and which record date shall not be more than sixty nor less
than ten days before the date of such meeting. If
A-Exh. B-9
the board of directors so fixes a date, such date shall also be the record date for determining the stockholders entitled to vote at such meeting unless the board of directors determines, at the
time it fixes such record date, that a later date on or before the date of the meeting shall be the date for making such determination. A determination of stockholders of record entitled to notice of or to vote at a meeting of stockholders shall
apply to any adjournment of the meeting; provided, however, that the board of directors may fix a new record date for determination of stockholders entitled to vote at the adjourned meeting and in such case shall also fix as the record date for
stockholders entitled to notice of such adjourned meeting the same or an earlier date as that fixed for determination of stockholders entitled to vote in accordance with Section 213(a) of the General Corporation Law of Delaware at the adjourned
meeting.
In order that the corporation may determine the stockholders entitled to express consent to corporate action in writing without
a meeting, or entitled to receive payment of any dividendor other distribution or allotment of any rights, or entitled to exercise any rights in respect of any change, conversion or exchange of stock or for the purpose of any other lawful action,
the board of directors may fix a record date, which, with respect to determining stockholders entitled to consent to corporate action in writing without a meeting, shall not be more than ten days after the date upon which the resolution fixing the
record date is adopted by the board of directors, or sixty days prior to any other action. No record date fixed as described above shall precede the date upon which the resolution fixing the record date is adopted by the board of directors.
REGISTERED STOCKHOLDERS
Section
4. The corporation shall be entitled to recognize the exclusive right of a person registered on its books as the owner of shares to receive dividends, and to vote as such owner, and to hold liable for calls and assessments a person registered
on its books as the owner of shares, and shall not be bound to recognize any equitable or other claim to or interest in such share or shares on the part of any other person, whether or not it shall have express or other notice thereof, except as
otherwise provided by the laws of Delaware.
ARTICLE VII
GENERAL PROVISIONS