EX-10.76 5 a05-1830_1ex10d76.htm EX-10.76

Exhibit 10.76

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

 

COLLABORATION AGREEMENT

 

 

by and among

 

 

GILEAD SCIENCES, INC.,

 

GILEAD HOLDINGS, LLC,

 

 

BRISTOL-MYERS SQUIBB COMPANY,

 

E.R. SQUIBB & SONS, L.L.C.,

 

and

 

BRISTOL-MYERS SQUIBB & GILEAD SCIENCES, LLC

 

 

Dated as of December 17, 2004

 



 

TABLE OF CONTENTS

 

SECTION 1.

DEFINITIONS

 

SECTION 2.

COLLABORATION MANAGEMENT

 

2.1

General

 

2.2

Role of the Joint Executive Committee

 

2.3

Joint Development Committee

 

2.4

Joint Commercialization Committee

 

2.5

Joint Finance Committee

 

2.6

Procedural Rules of the Operating Committees

 

2.7

Alliance Managers

 

2.8

Dispute Resolution

 

2.9

Collaboration Principles

 

2.10

Commercialization Budget/Plan Deadlocks

 

2.11

Expenses

 

SECTION 3.

DEVELOPMENT ACTIVITIES

 

3.1

General

 

3.2

Clinical Development

 

3.3

Formulation and CMC Data

 

3.4

Regulatory Matters

 

3.5

Performance; Subcontracting

 

3.6

Records

 

3.7

Updates to Development Plan and Development Budget

 

3.8

Development Expenses

 

3.9

Reports

 

3.10

New Products

 

3.11

Publication

 

3.12

Certain Inspections

 

3.13

Medical Affairs and Medical Communications

 

SECTION 4.

MANUFACTURING AND SUPPLY

 

4.1

Clinical Supply

 

4.2

Commercial Supply

 

SECTION 5.

COMMERCIALIZATION ACTIVITIES

 

5.1

Co-Promotion Obligations

 

5.2

Distribution Obligations

 

5.3

Pricing of Combination Product

 

5.4

National Accounts

 

5.5

Performance; Subcontracting

 

5.6

Conflict Avoidance

 

5.7

Marketing Materials

 

5.8

Development and Use of Trademarks

 

5.9

Insurance

 

5.10

Records

 

5.11

Commercialization Plan and Budget

 

5.12

Commercialization Expenses

 

 

i



 

5.13

Reports

SECTION 6.

LICENSE GRANTS

6.1

Technology Licenses by Member Parties to the JV

6.2

Licenses and Sublicenses by the JV to Member Parties

6.3

Licenses and Rights of Reference Between Member Parties

6.4

Rights of Reference to and from the JV and Related Matters

6.5

Other Sublicenses

6.6

Trademark Licenses by Member Parties to the JV

6.7

Trademark License by the JV to Gilead

6.8

Retained Rights

6.9

Combination Product Sales for Outside the Territory, Canada and Europe

6.10

Combination Product Sales for Europe

6.11

EFV License Agreement

6.12

JV Obligations as Sublicensee

SECTION 7.

PAYMENTS AND THIRD PARTY ROYALTIES

7.1

Payments to Member Parties

7.2

Royalty Payments to Third Parties

7.3

Authorized Other Expenses; Mode and Timing of Payment

7.4

Taxes

SECTION 8.

FINANCIAL RECORDS

8.1

Financial Records

8.2

Audit of Records

8.3

Certain Reports

SECTION 9.

ADVERSE EVENT AND OTHER INFORMATION EXCHANGE

9.1

Pharmacovigilance

9.2

Material Communications

SECTION 10.

PRODUCT RECALL

10.1

Notification and Recall

10.2

Recall Expenses

SECTION 11.

INTELLECTUAL PROPERTY RIGHTS

11.1

Ownership of Intellectual Property

11.2

Prosecution of Patents

11.3

Enforcement of Patents

11.4

Infringement of Third Party Rights

11.5

Trademarks

SECTION 12.

CONFIDENTIALITY

12.1

Treatment of Confidential Information

12.2

Permitted Disclosure

12.3

Confidential Information.

12.4

Use of Name

12.5

Publicity; Terms of Agreement

12.6

Notification

12.7

Permitted Uses

12.8

Remedies

SECTION 13.

WARRANTIES; INDEMNITIES

13.1

Representations, Warranties and Covenants

 

ii



 

13.2

Additional Representations, Warranties and Covenants of BMS

 

13.3

Additional Representations, Warranties and Covenants of Gilead

 

13.4

Disclaimer

 

13.5

Indemnification by the JV

 

13.6

Indemnification by the Member Parties in General

 

13.7

Indemnification for Certain Product Liability Related Matters

 

13.8

Indemnification Procedure

 

13.9

Limitation on Damages

 

13.10

Ancillary Agreements

 

13.11

Employees

 

SECTION 14.

TERM AND TERMINATION

 

14.1

Term

 

14.2

Certain Litigation

 

14.3

Termination for NDA Filing Delay

 

14.4

Material Default

 

14.5

Termination Upon Generic Launch

 

14.6

Consequences of Termination

 

14.7

Rights in Bankruptcy

 

14.8

Accrued Rights; Surviving Obligations

 

SECTION 15.

GENERAL PROVISIONS

 

15.1

Force Majeure

 

15.2

Notice

 

15.3

Further Assurances

 

15.4

Successors and Assigns

 

15.5

Governing Law

 

15.6

Arbitration

 

15.7

Waiver

 

15.8

Severability

 

15.9

Counterparts

 

15.10

Construction

 

15.11

Status of the Parties

 

15.12

Standstill

 

15.13

Nonsolicitation of Employees

 

15.14

Entire Agreement

 

15.15

Consent to Jurisdiction

 

15.16

Third Parties

 

 

iii



 

Annexes:

 

Annex A – Initial Committee Members and Alliance Managers

 

Annex B – Development Plan and Development Budget as of Effective Date

 

Annex C – Commercialization Plan and Commercialization Budget as of Effective Date

 

Annex D – BMS Patents

 

Annex E – Gilead Patents

 

Annex F – Gilead Licensed Trademarks

 

Annex G – BMS Licensed Trademarks

 

Annex H – Quarterly Detail Report

 

Annex I – Manner of Calculation of Net Selling Price

 

Annex J – Calculation of Cost of Goods

 

Annex K – Calculation of Transfer Price

 

Annex L – Joint Press Release

 

Annex M – Certain Financial Data

 

Annex N – Data to be Provided to Independent Accounting Expert Pursuant to Section 7.1

 

Annex O – JV Obligations as Sublicensee

 

Annex P – Key Terms of Services Agreement

 

Annex Q – Pricing [*]

 

Annex R – List of Countries Comprising the Developing World

 

iv



 

THIS COLLABORATION AGREEMENT (this “Agreement”) is made as of December 17, 2004 (the “Effective Date”), by and among Gilead Sciences, Inc., a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404 (“Gilead Parent”), Gilead Holdings, LLC, a Delaware limited liability company and wholly-owned subsidiary of Gilead Parent (“Gilead Sub” and, collectively with Gilead Parent, “Gilead”), Bristol-Myers Squibb Company, a corporation organized and existing under the laws of the State of Delaware and having its principal place of business at 345 Park Avenue, New York, NY 10154 (“BMS Parent”), E.R. Squibb & Sons, L.L.C., a Delaware limited liability company and wholly-owned subsidiary of BMS Parent (“BMS Sub” and, collectively with BMS Parent, “BMS”), and Bristol-Myers Squibb & Gilead Sciences, LLC, a limited liability company organized and existing under the laws of the State of Delaware  and having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404 (the “JV”) (Gilead, BMS and the JV, collectively, the “Parties” and each a “Party”).

 

RECITALS

 

WHEREAS, Gilead has developed and is marketing a proprietary nucleotide reverse transcriptase inhibitor, Viread® (known under the generic name of tenofovir disoproxil fumarate (“TDF”)), a proprietary nucleoside reverse transcriptase inhibitor, Emtriva® (known under the generic name of emtricitabine (“FTC”)), and a fixed-dose co-formulated product containing TDF and FTC as its only active pharmaceutical ingredients, Truvada®, for the treatment of HIV infection in adults;

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