EXHIBIT 10.5
RESEARCH, DEVELOPMENT AND
COLLABORATION AGREEMENT
WARNER-LAMBERT COMPANY
AND
GENVEC, INC.
JULY 21, 1997
[*] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY
WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH
RESPECT TO THE OMITTED PORTIONS.
TABLE OF CONTENTS
PAGE
---- 1. DEFINITIONS.............................................................. 2
1.1 "Affiliate"......................................................... 2
1.2 "Agency"............................................................ 2
1.3 "Background Technology"............................................. 2
1.4 "Bulk Product"...................................................... 2
1.5 "Collaboration Product"............................................. 2
1.6 "Collaboration Technology".......................................... 2
1.7 "Control"........................................................... 2
1.8 "Co-Promotion Country".............................................. 2
1.9 "Core U.S. Dossier"................................................. 3
1.10 [*]................................................................. 3
1.11 [*]................................................................. 3
1.12 [*]................................................................. 3
1.13 "Development"....................................................... 3
1.14 "Development Candidate"............................................. 3
1.15 [*]................................................................. 3
1.16 "Development Plan".................................................. 4
1.17 "Drug Development Committee"........................................ 4
1.18 "Effective Date".................................................... 4
1.19 "Executive Committee"............................................... 4
1.20 "Field"............................................................. 4
1.21 "Finished Product".................................................. 4
1.22 "GAAP".............................................................. 4
1.23 "Gene Therapy"...................................................... 4
1.24 "IND"............................................................... 4
1.25 "Invention(s)"...................................................... 4
1.26 "Know-How".......................................................... 4
1.27 [*]................................................................. 4
1.28 "Party"............................................................. 5
1.29 "Patent Rights"..................................................... 5
1.30 "Phase I", "Phase II", and "Phase III".............................. 5
1.31 "Pivotal"........................................................... 6
1.32 "Pre-Clinical Activities"........................................... 6
1.33 "Pre-Clinical Development Criteria"................................. 6
1.34 [*]................................................................. 6
1.35 "Product License Application" or "PLA".............................. 6
1.36 "Project Team Leader"............................................... 6
1.37 "Regulatory Approval"............................................... 6
1.38 "Research Management Committee"..................................... 6
1.39 "Research Plan"..................................................... 6
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
1.40 "Research Program"............................................... 6
1.41 "Scientific FTE"................................................. 6
1.42 "Scios Agreement"................................................ 6
1.43 "Second Source".................................................. 7
1.44 "Stock Purchase Agreement"....................................... 7
1.45 "Sublicensee".................................................... 7
1.46 "Term of the Agreement".......................................... 7
1.47 "Term of the Research Program"................................... 7
1.48 "Territory"...................................................... 7
1.49 "Third Party".................................................... 7
1.50 "VEGF"........................................................... 7
1.51 "Valid Claim".................................................... 7
2. RESEARCH PROGRAM....................................................... 7
2.1 Collaborative Research............................................ 7
2.2 Research Program Expenses......................................... 8
2.3 Records; Reports.................................................. 10
2.4 Term and Termination of Research Program.......................... 11
2.5 Field Restriction................................................. 12
2.6 Gene Therapy Products Outside the Field........................... 14
3. COMMITTEES............................................................. 14
3.1 Executive Committee............................................... 14
3.2 Research Management Committee..................................... 15
3.3 Drug Development Committee........................................ 16
3.4 Meetings.......................................................... 17
3.5 Dispute Resolution................................................ 17
4. DEVELOPMENT............................................................ 17
4.1 Selection of Development Candidates and Collaboration Products.... 17
4.2 Collaborative Development......................................... 18
4.3 Pre-Clinical Activities........................................... 18
4.4 Development Plan.................................................. 18
4.5 [*]............................................................... 19
4.6 [*]............................................................... 19
4.7 [*]............................................................... 19
4.8 Suspension or Termination of Collaborative Development............ 20
5. LICENSE GRANTS......................................................... 21
5.1 Grant by GenVec................................................... 21
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
5.2 Grant by Warner...................................................... 22
5.3 Licenses to Affiliates............................................... 22
5.4 Sublicenses.......................................................... 22
5.5 Cross-Licenses....................................................... 22
5.6 Retained Rights...................................................... 22
5.7 Covenant Not to Sue.................................................. 23
5.8 No Unauthorized Use.................................................. 23
5.9 No Implied Licenses.................................................. 23
6. CONSIDERATION 23
[*]
6.2 Purchase of GenVec Stock............................................. 23
6.3 Research Program and Development Funding............................. 23
6.4 Milestone Payments................................................... 24
6.5 Royalties............................................................ 25
6.6 Third Party Royalties................................................ 26
6.7 Withholding Taxes.................................................... 27
6.8 Guaranty............................................................. 27
7. BOOKS AND RECORDS......................................................... 27
7.1 [*].................................................................. 27
7.2 Payment Method; Late Payments........................................ 28
7.3 Currency Conversion.................................................. 28
7.4 Restrictions on Payments............................................. 28
7.5 Records; Inspection.................................................. 28
8. COMMERCIALIZATION IN THE TERRITORY........................................ 29
8.1 Collaboration Product Development.................................... 29
8.2 Due Diligence........................................................ 29
8.3 Commercialization Outside the Territory and Co-Promotion Countries... 31
9. CO-PROMOTION OPTION....................................................... 31
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
10. TRADEMARKS..................................................................... 32
10.1 Warner Trademarks........................................................ 32
10.2 GenVec Trademarks........................................................ 32
10.3 Use of Trademarks........................................................ 32
11. SUPPLY OF COLLABORATION PRODUCTS............................................... 33
11.1 Manufacture of Bulk Product by GenVec.................................... 33
11.2 Manufacture of Finished Product by Warner................................ 33
11.3 Warner's Right to Identify and Qualify Second Source for Bulk Product.... 34
11.4 Use of Second Source for Bulk Product.................................... 34
11.5 Terms of Manufacture and Supply.......................................... 34
11.6 [*]...................................................................... 35
12. REGULATORY AFFAIRS............................................................. 35
12.1 Side Effects............................................................. 35
12.2 Regulatory and Other Inquiries........................................... 36
12.3 [*]...................................................................... 36
12.4 Access to Regulatory Filings............................................. 36
12.5 [*]...................................................................... 36
13. DEVICE DELIVERY................................................................ 37
13.1 Device Plan.............................................................. 37
13.2 Device Agreement......................................................... 37
14. INTELLECTUAL PROPERTY.......................................................... 37
14.1 Ownership of Technology.................................................. 37
14.2 Solely-Owned Patent Rights............................................... 38
14.3 Jointly Owned Inventions................................................. 38
14.4 Enforcement.............................................................. 39
14.5 [*]...................................................................... 40
14.6 Independent Inventions................................................... 41
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
15. OTHER ACTIVITIES................................................. 41
15.1 Product Configurations..................................... 41
15.2 [*]........................................................ 41
15.3 [*]........................................................ 42
16. REPRESENTATIONS AND WARRANTIES................................... 42
16.1 Legal Authority............................................ 42
16.2 No Conflicts............................................... 42
16.3 Others Bound............................................... 42
16.4 Disclaimer................................................. 42
16.5 Disclaimer of Warranties................................... 42
17. CONFIDENTIALITY.................................................. 43
17.1 Confidential Information................................... 43
17.2 Permitted Disclosures...................................... 43
17.3 Publicity.................................................. 44
17.4 Publication................................................ 44
18. INDEMNIFICATION.................................................. 45
18.1 Warner..................................................... 45
18.2 GenVec..................................................... 45
18.3 Procedure.................................................. 45
18.4 Insurance.................................................. 46
19. TERM AND TERMINATION............................................. 46
19.1 Term....................................................... 46
19.2 Termination for Cause...................................... 46
19.3 Effect of Bankruptcy....................................... 46
19.4 Termination Relating to Competing Products................. 46
19.5 Termination of Research Program............................ 47
19.6 Effect of Termination...................................... 47
19.7 Survival................................................... 48
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
20. DISPUTE RESOLUTION.................................................... 48
20.1 Mediation...................................................... 48
20.2 Venue.......................................................... 48
21. MISCELLANEOUS......................................................... 49
21.1 Governing Law.................................................. 49
21.2 Waiver......................................................... 49
21.3 [*]............................................................ 49
21.4 Notices........................................................ 49
21.5 Performance Warranty........................................... 50
21.6 Force Majeure.................................................. 50
21.7 Independent Contractors........................................ 50
21.8 Advice of Counsel.............................................. 50
21.9 Severability................................................... 50
21.10 Patent Marking................................................. 50
21.11 Further Assurances............................................. 51
21.12 Compliance with Laws........................................... 51
21.13 No Implied Licenses or Warranties.............................. 51
21.14 Entire Agreement............................................... 51
21.15 Headings....................................................... 51
21.16 Counterparts................................................... 51
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO
THE OMITTED PORTIONS.
RESEARCH, DEVELOPMENT AND COLLABORATION AGREEMENT
This RESEARCH, DEVELOPMENT AND COLLABORATION AGREEMENT (the "Agreement"), effective as of July 21, 1997, is made by and between Warner-Lambert Company, a Delaware corporation, with a principal place of business at 201 Tabor Road, Morris Plains, New Jersey 07950 ("Warner"), and GenVec, Inc., a Delaware corporation, with a principal place of business at 12111 Parklawn Drive, Rockville, Maryland 20852 ("GenVec").
BACKGROUND
A. GenVec has expertise in the field of gene therapy and is developing novel, proprietary materials and methods for use in the Field.
B. Warner is in the business of and has expertise in developing, manufacturing and commercializing pharmaceuticals.
C. Warner and GenVec wish to enter into a collaborative effort to share such expertise, to conduct research and development with respect to potential Collaboration Products for use in the Field and, if successful, Warner shall market certain Collaboration Products for use in the Field in the Territory, and the Parties may co-promote certain of such Collaboration Products for use in the Field in the Co-Promotion Countries (the "Collaboration").
D. Warner and GenVec wish to establish a framework for such Collaboration consisting of (i) the Research Program, (ii) the Pre-Clinical Activities, (iii) the Development and (iv) the commercialization, and possible co-promotion of Collaboration Products, each as defined and described further below.
E. Of even date herewith, GenVec and Warner have entered into a Stock Purchase Agreement, pursuant to which GenVec may offer to Warner, and in such event Warner shall purchase shares of GenVec preferred and/or common stock.
F. Warner will enter into a Guaranty pursuant to which Warner will guarantee a line of credit on behalf of GenVec, and in connection therewith GenVec and Warner will enter into a Security Agreement and any other agreements as provided for therein.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, contained herein, GenVec and Warner agree as follows:
1. DEFINITIONS
The following capitalized terms shall have the meanings indicated for purposes of this Agreement:
1.1 "Affiliate" shall mean any corporation, association or other entity
--------- which directly or indirectly controls, is controlled by or is under common control with the party in question. As used in this definition of "Affiliate," the term "control" shall mean direct or indirect beneficial ownership of more than fifty percent (50%) of the voting or income interest in such corporation or other business entity.
1.2 "Agency" shall mean the Food and Drug Administration of the United
------ States or any successor entity (the "FDA"), and agencies of other governments of other countries having similar jurisdiction over the development, manufacturing, and marketing of pharmaceuticals.
1.3 "Background Technology" shall mean all technology that a Party owns or
--------------------- Controls on the Effective Date and has the right to contribute to the Collaboration which is necessary for the design, development, testing, use, manufacture or sale of Product Configurations, Development Candidates and Collaboration Products for use in the Field, including all such United States and foreign patents and patent applications (including, without limitation, all reissues, extensions, substitutions, confirmations, registrations, revalidations, additions, continuations, continuations-in-part, and divisions thereof) and other proprietary information, data and know-how existing on the Effective Date.
1.4 "Bulk Product" shall mean the purified active ingredient of any
------------ Collaboration Product, in bulk form.
1.5 "Collaboration Product" shall mean a Product Configuration in
--------------------- Development pursuant to this Agreement through and including commercial sales.
1.6 "Collaboration Technology" shall mean all Know-How and Patent Rights
------------------------ that a Party owns or Controls, which is conceived, reduced to practice or otherwise developed by GenVec (or its agents) or Warner (or its agents) or jointly by GenVec and Warner (or their respective agents) during the Term of the Research Program and in connection with the Collaboration, including, without limitation, improvements on the Background Technology.
1.7 "Control" shall mean possession of the ability to grant the licenses
------- or sublicenses as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.
1.8 "Co-Promotion Country" shall mean each of the United States of America
-------------------- (including its fifty (50) states, and its territories and possessions, including the District of Columbia, the Commonwealth of Puerto Rico) and Canada.
1.9 "Core U.S. Dossier" shall have the meaning set forth in Section 4.4.
-----------------
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[*]
1.13 "Development" shall mean the development of any Product Configuration
----------- from and after the filing of an IND, through and including product registration as described in Article 4.
1.14 "Development Candidate" shall mean a Product Configuration which meets
--------------------- the Pre-Clinical Development Criteria, and which the Executive Committee agrees should undergo further development pursuant to Section 4.1.2.
[*]
1.16 "Development Plan" shall have the meaning set forth in Section 4.4.
----------------
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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1.17 "Drug Development Committee" shall have the meaning set forth in
-------------------------- Section 3.3.
1.18 "Effective Date" shall mean the date of this Agreement first written
-------------- above.
1.19 "Executive Committee" shall have the meaning set forth in Section 3.1.
-------------------
1.20 "Field" shall mean the research, drug discovery and development
----- collaboration aimed at therapeutic agents useful for Gene Therapy-based induction of angiogenesis and for the first two years of the Research Program shall include all clinical indications; provided, thereafter the Field shall be limited to the treatment of coronary artery disease ("CAD") and/or peripheral vascular disease ("PVD") and/or those other specific clinical indications selected by Warner pursuant to Section 2.5 below.
1.21 "Finished Product" shall mean the finished pharmaceutical form, in any
---------------- formulation, of a Collaboration Product packaged for sale to a Third Party.
1.22 "GAAP" shall mean generally accepted accounting principles applied in
---- the United States.
1.23 "Gene Therapy" shall mean the introduction of a gene into a person for
------------ therapeutic purposes by (i) in vivo introduction for incorporation into cells of
-- ---- such person, or (ii) by ex vivo introduction into cells for transfer into a
-- ---- person.
1.24 "IND" shall mean an Investigational New Drug application, as defined
--- in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding foreign application, registration or certification.
1.25 "Invention(s)" shall have the meaning set forth in Section 14.2.1.
------------
1.26 "Know-How" shall mean all ideas, inventions, data, instructions,
-------- processes, formulas, expert opinions and information, including, without limitation, biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, manufacturing and quality control data and information, in each case, which are developed as a result of the Collaboration and are necessary or useful for the development, testing, use, manufacture or sale of Collaboration Products. Know-How does not include any inventions included in the Patent Rights.
[*]
[*] CERTAIN INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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[*]
1.28 "Party" shall mean Warner or GenVec, and the "Parties" shall mean
----- ------- Warner and GenVec.
1.29 "Patent Rights" shall mean all United States and foreign patents
------------- (including all reissues, extensions, substitutions, confirmations, re- registrations, re-examinations, revalidations and patents of addition) and patent applications (including, without limitation, all continuations, continuations-in-part and divisions thereof) in each case, claiming an invention which is necessary or useful for the design, development, testing, use, manufacture or sale of Collaboration Products.
1.30 "Phase I", "Phase II", and "Phase III" shall mean Phase I (or Phase
------- -------- --------- I/II), Phase II, and Phase III (or Pivotal) clinical trials, respectively, in each case as prescribed by the applicable A ...
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