UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section
13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) |
January 6, 2016 |
NAVIDEA BIOPHARMACEUTICALS, INC. |
(Exact name of registrant as specified in its charter) |
Delaware |
001-35076 |
31-1080091 |
(State or other jurisdiction |
(Commission |
(IRS Employer |
of incorporation) |
File Number) |
Identification No.) |
5600 Blazer Parkway, Suite 200, Dublin, Ohio |
43017 |
(Address of principal executive offices) |
(Zip Code) |
Registrant's telephone number, including area code |
(614) 793-7500 |
(Former name or former address, if changed
since last report.)
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Item 1.01 |
Entry Into a Material Definitive Agreement. |
On January 6, 2016, and effective December
23, 2015, Navidea Biopharmaceuticals, Inc. (the “Company”) entered into an amendment (the “Amendment”)
to its May 11, 2015 Term Loan Agreement (the “Loan Agreement”), with Capital Royalty Partners II L.P. in its capacity
as a lender and as control agent for other affiliated lenders party to the Loan Agreement. The principal change made by the Amendment
to the terms of the Loan Agreement was to amend the covenant contained in Section 10.02(a) of the Loan Agreement to reduce the
required minimum net revenue of the Company during the twelve month period beginning January 1, 2015 to $10,000,000. The foregoing
description of the terms of the Amendment is qualified in its entirety by reference to the text of the Amendment, a copy of which
is attached hereto as Exhibit 10.1 and incorporated herein by reference.
On January 11, 2016, the Company issued
two press releases entitled “Navidea Biopharmaceuticals Appoints Anton Gueth Chairman of the Board” and “Navidea
Meets Guidance With 2015 Unaudited Lymphoseek® Sales of $10.2 Million,” respectively. Copies of the Company’s January
11, 2016, press releases are attached hereto as Exhibits 99.1 and 99.2 to this Current Report on Form 8-K and are incorporated
herein by reference.
The information contained in Item 8.01 of this Current Report
on Form 8-K, including Exhibits 99.1, 99.2, and 99.3 attached hereto, shall not be treated as “filed” for purposes
of the Securities Exchange Act of 1934, as amended.
Exhibit |
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Number |
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Exhibit Description |
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10.1 |
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Amendment 1 to Term Loan Agreement, dated as of December 23, 2015. |
99.1 |
|
Press
Release, dated January 11, 2015, entitled “Navidea Biopharmaceuticals Appoints Anton Gueth Chairman of the Board.” |
99.2 |
|
Press
Release, dated January 11, 2015, entitled “Navidea Meets Guidance With 2015 Unaudited Lymphoseek® Sales of $10.2
Million.” |
Statements contained or incorporated by
reference in this Current Report on Form 8-K which relate to other than strictly historical facts, such as statements about the
Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies,
and markets for the Company’s products, are forward-looking statements. The words “believe,” “expect,”
“anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements
that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could
cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited
to, the Company’s continuing operating losses, uncertainty of market acceptance, reliance on third party manufacturers, accumulated
deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition,
limited marketing and manufacturing experience, and other risks detailed in the Company’s most recent Annual Report on Form
10-K and other filings with the United States Securities and Exchange Commission. The Company undertakes no obligation to publicly
update or revise any forward-looking statements.
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned
hereunto duly authorized.
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Navidea Biopharmaceuticals, Inc. |
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Date: January 11, 2016 |
By: |
/s/
Brent L. Larson |
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Brent L. Larson, Executive Vice President and Chief Financial Officer |
Exhibit 10.1
AMENDMENT
1 TO TERM LOAN AGREEMENT
THIS
AMENDMENT 1, dated as of December 23, 2015 (this “Amendment”) is made among Navidea Biopharmaceuticals,
Inc., a Delaware corporation (“Borrower”), and the lenders listed on the signature pages hereof under
the heading “LENDERS” (each a “Lender” and, collectively, the “Lenders”),
with respect to the Loan Agreement referred to below.
RECITALS
WHEREAS,
the Borrower and the Lenders are parties to a Term Loan Agreement, dated as of May 8, 2015 (the “Loan Agreement”),
with the Subsidiary Guarantors from time to time party thereto.
WHEREAS,
the parties hereto desire to amend the Loan Agreement on the terms and subject to the conditions set forth herein.
NOW,
THEREFORE, in consideration of the mutual agreements, provisions and covenants contained herein, the parties agree as follows:
SECTION 1. Definitions;
Interpretation.
(a) Terms
Defined in Loan Agreement. All capitalized terms used in this Amendment (including in the recitals hereof) and not otherwise
defined herein shall have the meanings assigned to them in the Loan Agreement.
(b) Interpretation.
The rules of interpretation set forth in Section 1.03 of the Loan Agreement shall be applicable to this Amendment and are
incorporated herein by this reference.
SECTION 2. Amendment.
Subject to Section 3, the Loan Agreement is hereby amended as follows:
(a) Section
10.02(a) of the Loan Agreement is amended and restated in its entirety as follows:
“(a)
during the twelve month period beginning on January 1, 2015, of at least $10,000,000;”
(b) Exhibit
E of the Loan Agreement is replaced in its entirety by the Exhibit E attached hereto.
(c) Schedule
7.05(b) to the Loan Agreement is replaced in its entirety by the Schedule 7.05(b) attached hereto.
(d) Schedule
7.05(c) to the Loan Agreement is replaced in its entirety by the Schedule 7.05(c) attached hereto.
SECTION 3. Conditions
of Effectiveness. The effectiveness of Section 2 shall be subject to the following conditions precedent:
(a) Borrower
and all of the Lenders shall have duly executed and delivered this Amendment pursuant to Section 12.04 of the Loan Agreement;
provided, however, that this Amendment shall have no binding force or effect unless all conditions set forth in this Section 3
have been satisfied;
(b) No
Default or Event of Default under the Loan Agreement shall have occurred and be continuing; and
(c) The
Borrower shall have paid or reimbursed Lenders for Lenders’ reasonable out of pocket costs and expenses incurred in connection
with this Amendment, including Lenders’ reasonable out of pocket legal fees and costs, pursuant to Section 12.03(a)(i)(z)
of the Loan Agreement.
SECTION 4. Representations
and Warranties; Reaffirmation.
(a) The
Borrower hereby represents and warrants to each Lender as follows:
(i) The
Borrower has full power, authority and legal right to make and perform this Amendment. This Amendment is within the Borrower’s
corporate powers and has been duly authorized by all necessary corporate and, if required, by all necessary shareholder action.
This Amendment has been duly executed and delivered by the Borrower and constitutes a legal, valid and binding obligation of the
Borrower, enforceable against the Borrower in accordance with its terms, except as such enforceability may be limited by (a) bankruptcy,
insolvency, reorganization, moratorium or similar laws of general applicability affecting the enforcement of creditors’
rights and (b) the application of general principles of equity (regardless of whether such enforceability is considered in a proceeding
in equity or at law). This Amendment (x) does not require any consent or approval of, registration or filing with, or any other
action by, any Governmental Authority or any third party, except for such as have been obtained or made and are in full force
and effect, (y) will not violate any applicable law or regulation or the charter, bylaws or other organizational documents of
the Borrower and its Subsidiaries or any order of any Governmental Authority, other than any such violations that, individually
or in the aggregate, could not reasonably be expected to have a Material Adverse Effect, (z) will not violate or result in an
event of default under any material indenture, agreement or other instrument binding upon the Borrower and its Subsidiaries or
assets, or give rise to a right thereunder to require any payment to be made by any such Person.
(ii) No
Default has occurred or is continuing or will result after giving effect to this Amendment.
(iii) The
representations and warranties made by or with respect to the Borrower in Section 7 of the Loan Agreement are (A) in the
case of representations qualified by “materiality,” “Material Adverse Effect” or similar language, true
and correct in all respects and (B) in the case of all other representations and warranties, true and correct in all material
respects (except that the representation regarding representations and warranties that refer to a specific earlier date are true
and correct on the basis set forth above as of such earlier date), in each case taking into account any changes made to schedules
updated in accordance with Section 7.21 of the Loan Agreement or attached hereto.
(iv) There
has been no Material Adverse Effect since the date of the Loan Agreement.
(b) The
Borrower hereby ratifies, confirms, reaffirms, and acknowledges its obligations under the Loan Documents to which it is a party
and agrees that the Loan Documents remain in full force and effect, undiminished by this Amendment, except as expressly provided
herein. By executing this Amendment, the Borrower acknowledges that it has read, consulted with its attorneys regarding, and understands,
this Amendment.
SECTION 5. Governing
Law; Submission to Jurisdiction; Waiver of Jury Trial.
(a) Governing
Law. This Amendment and the rights and obligations of the parties hereunder shall be governed by, and construed in accordance
with, the law of the State of New York, without regard to principles of conflicts of laws that would result in the application
of the laws of any other jurisdiction; provided that Section 5-1401 of the New York General Obligations Law shall apply.
(b) Submission
to Jurisdiction. The Borrower agrees that any suit, action or proceeding with respect to this Amendment or any other Loan
Document to which it is a party or any judgment entered by any court in respect thereof may be brought initially in the federal
or state courts in Houston, Texas or in the courts of its own corporate domicile and irrevocably submits to the non-exclusive
jurisdiction of each such court for the purpose of any such suit, action, proceeding or judgment. This Section 5 is for
the benefit of the Lenders only and, as a result, no Lender shall be prevented from taking proceedings in any other courts with
jurisdiction. To the extent allowed by applicable Laws, the Lenders may take concurrent proceedings in any number of jurisdictions.
(c) Waiver
of Jury Trial. The Borrower and each Lender hereby irrevocably waives, to the fullest
extent permitted by applicable law, any and all right to trial by jury in any suit, action or proceeding arising out of or relating
to this Amendment, the other Loan Documents or the transactions contemplated hereby or thereby.
SECTION 6. Miscellaneous.
(a) No
Waiver. Nothing contained herein shall be deemed to constitute a waiver of compliance with any term or condition contained
in the Loan Agreement or any of the other Loan Documents or constitute a course of conduct or dealing among the parties. Except
as expressly stated herein, the Lenders reserve all rights, privileges and remedies under the Loan Documents. Except as amended
hereby, the Loan Agreement and other Loan Documents remain unmodified and in full force and effect. All references in the Loan
Documents to the Loan Agreement shall be deemed to be references to the Loan Agreement as amended hereby.
(b) Severability.
In case any provision of or obligation under this Amendment shall be invalid, illegal or unenforceable in any jurisdiction, the
validity, legality and enforceability of the remaining provisions or obligations, or of such provision or obligation in any other
jurisdiction, shall not in any way be affected or impaired thereby.
(c) Headings.
Headings and captions used in this Amendment (including the Exhibits, Schedules and Annexes hereto, if any) are included for convenience
of reference only and shall not be given any substantive effect.
(d) Integration.
This Amendment constitutes a Loan Document and, together with the other Loan Documents, incorporates all negotiations of the parties
hereto with respect to the subject matter hereof and is the final expression and agreement of the parties hereto with respect
to the subject matter hereof.
(e) Counterparts.
This Amendment may be executed in any number of counterparts, all of which taken together shall constitute one and the same instrument
and any of the parties hereto may execute this Amendment by signing any such counterpart.
(f) Controlling
Provisions. In the event of any inconsistencies between the provisions of this Amendment and the provisions of any other Loan
Document, the provisions of this Amendment shall govern and prevail. Except as expressly modified by this Amendment, the Loan
Documents shall not be modified and shall remain in full force and effect.
[Remainder
of page intentionally left blank]
IN
WITNESS WHEREOF, the parties hereto have duly executed this Amendment, as of the date first above written.
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BORROWER: |
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NAVIDEA BIOPHARMACEUTICALS, INC. |
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By: |
/s/ Brent L. Larson |
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Name: Brent L. Larson |
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Title: EVP & CFO |
Signature Page
to Amendment 1 to Term Loan Agreement
LENDERS: |
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CAPITAL ROYALTY PARTNERS II L.P. |
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By CAPITAL ROYALTY PARTNERS II GP L.P., its General Partner |
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By CAPITAL ROYALTY PARTNERS II GP LLC, its General Partner |
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By |
/s/ Nathan Hukill |
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Name: Nathan Hukill |
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Title: Authorized Signatory |
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CAPITAL ROYALTY PARTNERS II – PARALLEL FUND “A” L.P. |
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By CAPITAL ROYALTY PARTNERS II – PARALLEL FUND “A” GP L.P., its
General Partner |
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By CAPITAL ROYALTY PARTNERS II – PARALLEL FUND “A” GP LLC, its
General Partner |
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By |
/s/ Nathan Hukill |
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Name: Nathan Hukill |
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Title: Authorized Signatory |
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PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II L.P. |
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By PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II GP L.P., its General Partner |
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By PARALLEL INVESTMENT OPPORTUNITIES PARTNERS II GP LLC, its General Partner |
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By |
/s/ Nathan Hukill |
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Name: Nathan Hukill |
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Title: Authorized Signatory |
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Signature Page
to Amendment 1 to Term Loan Agreement
Exhibit E
See attached.
Exhibit
E
to Term Loan Agreement
FORM
OF COMPLIANCE CERTIFICATE
[DATE]
This
certificate is delivered pursuant to Section 8.01(d) of, and in connection with the consummation of the transactions contemplated
in, the Term Loan Agreement, dated as of May 8, 2015 (as the same may be amended, restated, supplemented or otherwise modified
from time to time, the “Loan Agreement”), among Navidea Biopharmaceuticals, Inc., a Delaware corporation
(“Borrower”), Capital Royalty Partners II L.P., Capital Royalty Partners II – Parallel
Fund “A” L.P. and Parallel Investment Opportunities Partners II L.P., and other parties from time to time party thereto
as lenders (“Lenders”), and the subsidiary guarantors from time to time party thereto. Capitalized terms
used herein and not otherwise defined herein are used herein as defined in the Loan Agreement.
The
undersigned, a duly authorized Responsible Officer of Borrower having the name and title set forth below under his signature,
hereby certifies, on behalf of Borrower for the benefit of the Secured Parties and pursuant to Section 8.01(d) of the Loan
Agreement that such Responsible Officer of Borrower is familiar with the Loan Agreement and that, in accordance with each of the
following sections of the Loan Agreement, each of the following is true on the date hereof, both before and after giving effect
to any Loan to be made on or before the date hereof:
In
accordance with Section 8.01[(a)/(b)] of the Loan Agreement, attached hereto as Annex A are the financial
statements for the [fiscal quarter/fiscal year] ended [__________] required to be delivered pursuant to Section 8.01[(a)/(b)]
of the Loan Agreement. Such financial statements fairly present in all material respects the consolidated financial position,
results of operations and cash flow of Borrower and its Subsidiaries as at the dates indicated therein and for the periods indicated
therein in accordance with GAAP [(subject to the absence of footnote disclosure and normal year-end audit adjustments)]1
[without qualification as to the scope of the audit or as to going concern and without any other similar qualification together
with the certificate from Borrower’s independent auditors with respect to such financial statements required to be delivered
pursuant to Section 8.01(c) of the Loan Agreement. The examination by such auditors in connection with such financial
statements has been made in accordance with the standards of the United States’ Public Company accounting Oversight Board
(or any successor entity).]2
Attached
hereto as Annex B are the calculations used to determine compliance with each financial covenant contained in Section
10 of the Loan Agreement.
No
Default or Event of Default is continuing as of the date hereof[, except as provided for on Annex C attached hereto, with
respect to each of which Borrower proposes to take the actions set forth on Annex C].
1 Insert language in
brackets only for quarterly certifications.
2 Insert language in
brackets only for annual certifications.
IN
WITNESS WHEREOF, the undersigned has executed this certificate on the date first written above.
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NAVIDEA BIOPHARMACEUTICALS, INC. |
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By |
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Name: |
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Title: |
Annex
A to Compliance Certificate
Financial
Statements
[see attached]
Annex B
to Compliance Certificate
Calculations of Financial Covenant
Compliance
I. |
Section 10.01: Minimum
Liquidity |
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A. |
Amount of unencumbered cash
and Permitted Cash Equivalent Investments (which for greater certainty shall not include any undrawn credit lines), in each
case, to the extent held in an account over which the Lenders have a first priority perfected security interest: |
$__________ |
B. |
The greater of: |
$__________ |
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(1) $5,000,000
and |
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(2) to
the extent Borrower has incurred Permitted Priority Debt, the minimum cash balance required of Borrower by Borrower’s
Permitted Priority Debt creditors |
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Is Line IA equal to or
greater than Line IB?: |
Yes: In compliance; No: Not
in compliance |
II. |
Section 10.02(a)-(e): Minimum
Revenue or Minimum EBITDA —Subsequent Periods |
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A. |
Revenues during the twelve
month period beginning on January 1, 2015 |
$__________ |
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[Is line II.A equal to
or greater than $10,000,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]3 |
B. |
Revenues during the twelve
month period beginning on January 1, 2016 |
$__________ |
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[Is line II.B equal to
or greater than $22,500,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]4 |
C. |
Revenues during the twelve
month period beginning on January 1, 2017 |
$__________ |
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[Is line II.C equal to
or greater than $30,000,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]5 |
3 Include bracketed
entry only on the Compliance Certificate to be delivered within 90 days of the end of 2015 pursuant to Section 8.01(b) of the
Loan Agreement.
4
Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2016 pursuant to Section
8.01(b) of the Loan Agreement.
5
Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2017 pursuant to Section
8.01(b) of the Loan Agreement.
D. |
Revenues during the twelve
month period beginning on January 1, 2018 |
$__________ |
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[Is line II.D equal to
or greater than $35,000,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]6 |
E. |
Revenues during the twelve
month period beginning on January 1, 2019 |
$__________ |
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[Is line II.E equal to
or greater than $40,000,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]7 |
F. |
Revenues during the twelve
month period beginning on January 1, 2020 |
$__________ |
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[Is line II.E equal to
or greater than $45,000,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]8 |
G. |
Revenues during the twelve
month period beginning on January 1, 2021 |
$__________ |
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[Is line II.E equal to
or greater than $45,000,000 or is annual EBITDA at least $5,000,000? |
Yes: In compliance; No: Not
in compliance]9 |
6
Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2018 pursuant to Section
8.01(b) of the Loan Agreement.
7
Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2019 pursuant to Section
8.01(b) of the Loan Agreement.
8
Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2020 pursuant to Section
8.01(b) of the Loan Agreement.
9
Include bracketed entry only on the Compliance Certificate to be delivered within 90 days of the end of 2021 pursuant to Section
8.01(b) of the Loan Agreement.
Schedule 7.05(b)
See attached.
Amended Schedule 7.05(b)
to Term Loan Agreement
Certain
Intellectual Property
Patents
Owner |
Patent Description/Title |
Jurisdiction |
Patent
Number (if
issued)/Application
Number (if applied
for only) |
Issuance Date
(if
issued)/Filing
Date (if applied
for only) |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
US |
8,545,808 |
10/1/2013 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
US |
14/039,648 (Pending)
|
9/27/2013 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
EP |
EP10736135.4 (Pending) |
1/28/2010 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
AU |
2010208624 (Pending) |
1/28/2010 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
CA |
2,750,230 (Pending)
|
1/28/2010 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
JP |
2011-547973 (Pending)
|
1/28/2010 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
KR |
2011-7020202 (Pending) |
1/28/2010 |
Navidea/OSU |
"Compositions, Methods and Kits for Diagnosing and Treating
CD206 Expressing Cell-Related Disorders"
(Lymphoseek – New Field/Composition) |
US |
14/338,332 |
7/22/2014 |
Navidea/OSU |
"Compositions, Methods and Kits for Diagnosing and Treating
CD206 Expressing Cell-Related Disorders"
(Lymphoseek – New Field/Composition) |
PCT |
PCT/US14/47708 |
7/22/2014 |
Schedule 7.05(b)
Navidea |
"Compositions and Methods for Diagnosing and Treating Macrophage
Related Disorders Using Carbohydrate Based Macromolecular Carrier"
(Lymphoseek – New Field/Composition) |
US |
62/031,348 |
7/31/2014 |
Navidea/OSU |
"Compounds and Compositions for Targeting Macrophages and
Other CD206 High Expressing Cells and Methods of Treating and Diagnosing Using Same"
(Lymphoseek – New Field/Composition) |
US |
62/106,194 |
1/21/2015 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
US |
8,163,928 |
4/24/2012 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
US |
8,957,215 |
2/17/2015 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
EP |
7709290.6
(pending) |
1/25/2007 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
AR |
70100305
(pending) |
1/24/2007 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
AU |
2007207904
|
1/25/2007 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
BR |
PI0707283
(pending) |
1/25/2007 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
JP |
5289061 |
1/25/2007 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
CN |
101410393 |
1/25/2012 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
IN |
6133/DELNP/2008
(pending) |
1/25/2007 |
Schedule 7.05(b)
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
KR |
10-1406248 |
6/19/2014 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
RU |
2008130695 |
1/25/2007 |
Navidea |
“Heteroaryl Substituted Benzothiazoles”
(AZD2184) |
MX |
2008/009396 |
1/25/2007 |
Navidea |
“Heteroaryl substituted benzoxazoles”
(AZD2995) |
US |
7,670,591 |
3/2/2010 |
Navidea |
“Heteroaryl substituted benzoxazoles”
(AZD2995) |
EP |
7748254.5
(pending) |
6/18/2007 |
Navidea |
“Heteroaryl substituted benzoxazoles”
(AZD2995) |
CN |
200780030807.8 |
6/18/2007 |
Navidea |
“Heteroaryl substituted benzoxazoles”
(AZD2995) |
IN |
10035/DELNP/2008
(pending) |
6/18/2007 |
Navidea |
“Heteroaryl substituted benzoxazoles”
(AZD2995) |
JP |
5548842 |
6/18/2007 |
Schedule 7.05(b)
Trademarks
Owner |
Trademark |
Jurisdiction |
Registration
Number (if
registered)/Serial
Number (if
applied for only) |
Registration
Date (if
registered)/Filing
Date (if applied
for only) |
Navidea |
“LYMPHOSEEK"
(Standard Characters) |
US |
3,163,525 |
10/24/2006 |
Navidea |
“LYMPHOSEEK"
(Standard Characters) |
CA |
1647184 |
10/9/2013 |
Navidea |
“LYMPHOSEEK"
(Standard Characters) |
EP |
12,204,202 |
3/5/2014 |
Navidea |
“LYMPHOSEEK"
(Standard Characters) |
JP |
5,649,575 |
2/14/2014 |
Navidea |
“LYMPHOSEEK"
(Standard Characters) |
CN |
13988394 |
1/27/2014 |
Navidea |
"LYMPHOSEEK"
(Logo) |
US |
86/055,675 |
9/4/2013 |
Navidea |
"NAVIDEA"
(Standard Characters) |
US |
4,514,173 |
4/15/2014 |
Navidea |
"NAVIDEA"
(Standard Characters) |
CA |
1647179 |
10/9/2013 |
Navidea |
"NAVIDEA"
(Standard Characters) |
EP |
122,041,786 |
3/6/2014 |
Navidea |
"NAVIDEA"
(Standard Characters) |
JP |
5,652,414 |
2/28/2014 |
Navidea |
"NAVIDEA"
(Standard Characters) |
CN |
14109341 |
3/4/2013 |
Navidea |
"NAVIDEA BIOPHARMACEUTICALS"
(Logo) |
US |
4,207,633 |
9/11/2012 |
Navidea |
"MANOCEPT"
(Standard Characters – Class 5) |
US |
86/287,230 |
5/21/2014 |
Navidea |
"MANOCEPT"
(Standard Characters – Class 42) |
US |
86/287231 |
5/21/2014 |
Schedule 7.05(b)
Copyrights
Owner |
Identifier |
Registration
Number |
Registration
Date |
Navidea |
“Neoprobe Corporation OneMedPlace Finance Forum San Francisco, CA January 2010.” |
TX0007391587
|
7/1/2011 |
Navidea |
“Neoprobe Corporation Product Pipeline — Oncology Diagnostic Drugs." |
TX0007400138 |
7/5/2011 |
Schedule 7.05(b)
Schedule 7.05(c)
See attached.
Amended Schedule 7.05(c)
to Term Loan Agreement
Material
Intellectual Property
Patents
Owner |
Patent Description/Title |
Jurisdiction |
Patent Number (if
issued)/
Application
Number (if applied
for only) |
Issuance
Date (if
issued)/
Filing Date
(if applied
for only) |
Regents of Univ. of California
(licensed) |
“Macromolecular Carrier for Drug and Diagnostic Agent
Delivery”
(Lymphoseek - Composition) |
US |
6,409,990 |
6/25/2002 |
Regents of Univ. of California
(licensed) |
“Macromolecular Carrier for Drug and Diagnostic Agent
Delivery”
(Lymphoseek - Composition) |
Europe
|
EP1178838B1 |
9/29/04 |
Regents of Univ. of California
(licensed) |
“Macromolecular Carrier for Drug and Diagnostic Agent
Delivery”
(Lymphoseek - Composition) |
JP |
4056701 |
3/5/2008 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
US |
8,545,808
|
10/1/2013 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
US |
14/039,648 (Pending)
|
9/27/2013 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
EP |
EP10736135.4 (Pending) |
1/28/2010 |
Navidea |
“Compositions for radiolabeling DTPA dextran”
(Lymphoseek - Formulation) |
JP |
2011-547973 (Pending)
|
1/28/2010 |
Navidea/OSU |
"Compositions, Methods and Kits for Diagnosing and Treating
CD206 Expressing Cell-Related Disorders"
(Lymphoseek – New Field/Composition) |
US |
14/338,332 |
7/22/2014 |
Navidea/OSU |
"Compositions, Methods and Kits for Diagnosing and Treating
CD206 Expressing Cell-Related Disorders"
(Lymphoseek – New Field/Composition) |
PCT |
PCT/US14/47708 |
7/22/2014 |
Navidea |
"Compositions and Methods for Diagnosing and Treating Macrophage
Related Disorders Using Carbohydrate Based Macromolecular Carrier"
(Lymphoseek – New Field/Composition) |
US |
62/031,348 |
7/31/2014 |
Navidea/OSU |
"Compounds and Compositions for Targeting Macrophages and
Other CD206 High Expressing Cells and Methods of Treating and Diagnosing Using Same"
(Lymphoseek – New Field/Composition) |
US |
62/106,194 |
1/21/2015 |
AstraZeneca
(licensed) |
“2-Heteroaryl Substituted Benzothiophenes and Benzofuranes”
(NAV4694 – Drug Substance) |
US |
7,772,256 |
8/10/2010 |
AstraZeneca
(licensed) |
“2-Heteroaryl Substituted Benzothiophenes and Benzofuranes”
(NAV4694 – Drug Substance) |
EP |
08724190.7 (pending) |
3/5/2008 |
AstraZeneca
(licensed) |
“2-Heteroaryl Substituted Benzothiophenes and Benzofuranes”
(NAV4694 – Drug Substance) |
JP |
552641/2009 (pending) |
3/5/2008 |
AstraZeneca
(licensed) |
“Compounds Suitable as Precursors to Compounds that are
Useful for Imaging Amyloid Deposits”
(NAV4694 – Precursor Substance) |
US |
8,193,363 |
6/5/2012 |
AstraZeneca
(licensed) |
“Compounds Suitable as Precursors to Compounds that are
Useful for Imaging Amyloid Deposits”
(NAV4694 – Precursor Substance) |
US |
8,653,274 |
2/18/2014 |
AstraZeneca
(licensed) |
“Compounds Suitable as Precursors to Compounds that are
Useful for Imaging Amyloid Deposits”
(NAV4694 – Precursor Substance) |
US |
14/149,563
(pending) |
1/7/2014 |
Schedule 7.05(C)
AstraZeneca
(licensed) |
“Compounds Suitable as Precursors to Compounds that are
Useful for Imaging Amyloid Deposits”
(NAV4694 – Precursor Substance) |
EP |
09810319.5
(pending) |
8/28/2009 |
AstraZeneca
(licensed) |
“Compounds Suitable as Precursors to Compounds that are
Useful for Imaging Amyloid Deposits”
(NAV4694 – Precursor Substance) |
JP |
5613669
(pending) |
10/29/2014 |
Schedule 7.05(C)
Trademarks
Owner |
Trademark |
Jurisdiction |
Registration
Number (if
registered)/ Serial
Number (if applied
for only) |
Registration Date
(if registered)/
Filing Date (if
applied for only) |
Navidea |
“LYMPHOSEEK" (Standard Characters)
|
US |
3,163,525 |
10/24/2006 |
Navidea |
“LYMPHOSEEK" (Standard Characters) |
EP |
12,204,202 |
3/5/2014 |
Navidea |
“LYMPHOSEEK" (Standard Characters) |
JP |
5,649,575 |
2/14/2014 |
Schedule 7.05(C)
Exhibit 99.1
|
FOR IMMEDIATE RELEASE |
Navidea Appoints
Anton Gueth Chairman of the Board
DUBLIN OHIO January 11, 2016 — Navidea
Biopharmaceuticals, Inc. (NYSE MKT: NAVB), announced that its Board of Directors has appointed board member Anton Gueth to the
position of Chairman. Mr. Gueth succeeds Gordon Troup who joined Navidea's Board of Directors in July
2008 and was named as Chairman of the Board in August 2011. Although Mr. Troup has stepped down as Chairman, he continues
to serve as a director on the Board.
“For some time now, I have felt that
as we progressed our strategy to unlock the full potential of our Manocept™ technology platform, the time would come for
a new and highly qualified industry leader to assume the role of Navidea’s Chairman,” said Mr. Troup. “We believe
Anton will provide a strong commercial presence on the Board and help strengthen our ability to transform Navidea into a leader
in the development and commercialization of both immunodiagnostic and immunotherapeutic products.”
Mr. Gueth brings
over 30 years of global finance and operating experience in the pharmaceutical and healthcare industries. He is currently Managing
Director of EVOLUTION Life Science Partners. He is also the founder and Managing Partner of Gueth Consulting LLC, a consulting
firm focusing on pharmaceutical and biotechnology clients in the areas of licensing, early stage financing and alliance management
and was previously a Managing Director of Burrill Securities. His career includes nearly 19 years with Eli Lilly and Company ("Lilly"),
most recently as director of Alliance Management. He also served as General Manager of Lilly's African and Middle Eastern
operations; Vice President of Financial Planning and Treasury of PCS Health Systems; as well as other sales, marketing, operations
and financial positions. Mr. Gueth earned a Masters Degree in agricultural economics from the Justus Liebig University in
Giessen, Germany, as well as a Masters Degree in public affairs from Indiana University. He is currently a member of the Board
of Directors of Antares Pharma.
“I am excited to take on this expanded
role and look forward to partnering with Rick and the rest of the Board to advance our immunotherapeutic program and extend our
commercial success to unlock the full potential of the Manocept platform. I share Rick’s commitment to improving our corporate
governance and shareholder engagement in 2016 as we believe good corporate governance yields improved value for shareholders,"
said Mr. Gueth.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE
MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents
and immunotherapeutics. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making,
targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s
first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s
pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.
- more -
NAVIDEA BIOPHARMACEUTICALS
Page | 2
The
Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on
behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements
about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies,
anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within
the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,”
“project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors
are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical
or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty
of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty
of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing
experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent
Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly
update or revise any forward-looking statements.
Source: Navidea Biopharmaceuticals, Inc.
Navidea Biopharmaceuticals
Investors
Tom Baker, 617-532-0624
tbaker@navidea.com
or
Media
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications
or
David Shull or Chris Hippolyte, 858-717-2310
david.schull@russopartnersllc.com
Chris.hippolyte@russopartnersllc.com
###
- end -
Exhibit 99.2
|
FOR IMMEDIATE RELEASE |
Navidea
Meets Guidance With 2015 Unaudited Lymphoseek® Sales of $10.2 Million
- Provides Corporate
Update in Shareholder Letter Reviewing 2015 and Previewing 2016 -
DUBLIN, OH, January 11, 2016 – Navidea
Biopharmaceuticals, Inc. (NYSE MKT: NAVB), today reports 2015 preliminary unaudited Lymphoseek® (technetium
Tc 99m tilmanocept) injection sales of $10.2 million, achieving 2015 guidance. Total revenue, which will include license
and grant revenue, will be provided when the Company reports full-year end results in early March.
The letter to shareholders is now
available and may be accessed at the following link, 2016 Shareholder Letter.
As a reminder,
Rick Gonzalez, President and Chief Executive Officer, will present at Biotech Showcase 2016, taking place in San Francisco,
CA, on Tuesday, January 12th at 2:30 PM PT (5:30 PM ET). The live presentation will be available by webcast
at the following link: http://edge.media-server.com/m/p/6j593adk. An archived version of the webcast will be available
two hours following the presentation and can be accessed within the Investors' section of the Navidea website at www.navidea.com.
About Navidea
Navidea Biopharmaceuticals, Inc. (NYSE
MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision immunodiagnostic agents
and immunotherapeutics. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and
NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making,
targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s
first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. Navidea’s
strategy is to deliver superior growth and shareholder return by bringing to market novel products and advancing the Company’s
pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.
The Private Securities Litigation Reform
Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in
this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and
strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and
regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act.
The words “believe,” “expect,” “anticipate,” “estimate,” “project,”
and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that
such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated
results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market
acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital
funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience,
risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report
on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise
any forward-looking statements.
NAVIDEA BIOPHARMACEUTICALS
Page | 2
Navidea Biopharmaceuticals
Investors
Tom Baker, 617-532-0624
tbaker@navidea.com
or
Media
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications
or
David Shull or Chris Hippolyte, 858-717-2310
###
- end -
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