AMENDED AND RESTATED COLLABORATION AGREEMENT

Collaboration Agreement

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Bristol-Myers Squibb & Gilead Sciences, LLC | BRISTOL-MYERS SQUIBB COMPANY | ER SQUIBB & SONS, LLC | Gilead Holdings, LLC | Gilead Sciences, Inc | Member Party?s Alliance

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Title: AMENDED AND RESTATED COLLABORATION AGREEMENT
Governing Law: Delaware Date: 11/6/2006
Industry: Biotechnology and Drugs Law Firm: Hughes Hubbard;Covington Burling Sector: Healthcare

AMENDED AND RESTATED COLLABORATION AGREEMENT, Parties: bristol-myers squibb & gilead sciences llc , bristol-myers squibb company , er squibb & sons llc , gilead holdings llc , gilead sciences inc , member party?s alliance

[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

E XHIBIT 10.2

AMENDED AND RESTATED

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 September 28, 2006

TABLE OF CONTENTS


SECTION 1.	DEFINITIONS	2
SECTION 2.	COLLABORATION MANAGEMENT	23
2.1	General	23
2.2	Role of the Joint Executive Committee	24
2.3	Joint Development Committee	25
2.4	Joint Commercialization Committee	26
2.5	Joint Canadian Operating Committee	27
2.6	Joint Finance Committee	29
2.7	Procedural Rules of the Operating Committees	30
2.8	Alliance Managers	32
2.9	Dispute Resolution	32
2.10	Collaboration Principles	34
2.11	Commercialization Budget/Plan Deadlocks	35
2.12	Expenses	36
SECTION 3.	DEVELOPMENT ACTIVITIES	36
3.1	General	36
3.2	Clinical Development	36
3.3	Formulation and CMC Data	38
3.4	Regulatory Matters	38
3.5	Performance; Subcontracting	40
3.6	Records	40
3.7	Updates to Development Plan and Development Budget	41
3.8	Development Expenses	41
3.9	Reports	42
3.10	New Products	42
3.11	Publication	43
3.12	Certain Inspections	44
3.13	Medical Affairs and Medical Communications	44
SECTION 4.	MANUFACTURING AND SUPPLY	45
4.1	Clinical Supply	45
4.2	Commercial Supply	45
SECTION 5.	COMMERCIALIZATION ACTIVITIES	46
5.1	Co-Promotion Obligations	46
5.2	Distribution Obligations	48
5.3	Pricing of Combination Product	50
5.4	National Accounts in the United States	54
5.5	Performance; Subcontracting	55
5.6	Conflict Avoidance	55
5.7	Marketing Materials	55
5.8	Development and Use of Trademarks	57
5.9	Insurance	57
5.10	Records	57
5.11	Commercialization Plans and Budgets	58

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5.12	Commercialization Expenses	59
5.13	Reports	60
SECTION 6.	LICENSE GRANTS	61
6.1	Technology Licenses by Member Parties to the JV	61
6.2	Licenses and Sublicenses by the JV to Member Parties	61
6.3	Licenses and Rights of Reference Between Member Parties	64
6.4	Rights of Reference to and from the JV and Related Matters	65
6.5	Other Sublicenses	66
6.6	Trademark Licenses by Member Parties to the JV	66
6.7	Trademark License by the JV to Gilead	67
6.8	Retained Rights	68
6.9	Combination Product Sales for Outside the United States, Canada and Europe	68
6.10	Combination Product Sales for Europe	68
6.11	EFV License Agreement	68
6.12	JV Obligations as Sublicensee	69
SECTION 7.	PAYMENTS AND THIRD PARTY ROYALTIES	69
7.1	Payments to Member Parties	69
7.2	Royalty Payments to Third Parties	73
7.3	Authorized Expenses; Mode and Timing of Payment	73
7.4	Taxes	74
7.5	Restructuring	74
SECTION 8.	FINANCIAL RECORDS	74
8.1	Financial Records	74
8.2	Audit of Records	75
8.3	Certain Reports	75
SECTION 9.	ADVERSE EVENT AND OTHER INFORMATION EXCHANGE	75
9.1	Pharmacovigilance	75
9.2	Material Communications	76
SECTION 10.	PRODUCT RECALL	76
10.1	Notification and Recall	77
10.2	Recall Expenses	77
SECTION 11.	INTELLECTUAL PROPERTY RIGHTS	77
11.1	Ownership of Intellectual Property	77
11.2	Prosecution of Patents	78
11.3	Enforcement of Patents	79
11.4	Infringement of Third Party Rights	80
11.5	Trademarks	81
SECTION 12.	CONFIDENTIALITY	82
12.1	Treatment of Confidential Information	82
12.2	Permitted Disclosure	82
12.3	Confidential Information.	84
12.4	Use of Name	85
12.5	Publicity; Terms of Agreement	85
12.6	Notification	85
12.7	Permitted Uses	86
12.8	Remedies	86

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SECTION 13.	WARRANTIES; INDEMNITIES	86
13.1	Representations, Warranties and Covenants	86
13.2	Additional Representations, Warranties and Covenants of BMS	87
13.3	Additional Representations, Warranties and Covenants of Gilead	89
13.4	Disclaimer	90
13.5	Indemnification by the JV	90
13.6	Indemnification by the Member Parties in General	91
13.7	Indemnification for Certain Product Liability Related Matters	92
13.8	Indemnification Procedure	93
13.9	Limitation on Damages	94
13.10	Ancillary Agreements	94
13.11	Employees	95
SECTION 14.	TERM AND TERMINATION	95
14.1	Term	95
14.2	Certain Litigation	95
14.3	Termination with respect to Canada	95
14.4	Material Default	95
14.5	Termination Upon Generic Launch in the United States	97
14.6	Consequences of Termination	97
14.7	Rights in Bankruptcy	100
14.8	Accrued Rights; Surviving Obligations	100
SECTION 15.	GENERAL PROVISIONS	101
15.1	Force Majeure	101
15.2	Notice	101
15.3	Further Assurances	102
15.4	Successors and Assigns	102
15.5	Governing Law	103
15.6	Arbitration	103
15.7	Waiver	105
15.8	Severability	105
15.9	Counterparts	105
15.10	Construction	105
15.11	Status of the Parties	106
15.12	Standstill	106
15.13	Nonsolicitation of Employees	107
15.14	Entire Agreement	107
15.15	Consent to Jurisdiction	108
15.16	Third Parties	108

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Annexes:

Annex A – Initial Committee Members and Alliance Managers

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

Annex C – U.S. Commercialization Plan and U.S. Commercialization Budget as of Effective Date

Annex D – BMS Patents in the U.S.

Annex E – Gilead Patents in the U.S.

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 Following Effective Date

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 P1 – Key Terms of Services Agreement

Annex P2 – Key Terms of Canada Distribution and Supply Agreement; Structure Schematic

Annex Q1 – [ * ] Pricing [ * ]

Annex Q2 – [ * ] Pricing [ * ]

Annex R – List of Countries Comprising the Developing World

Annex S – BMS Patents in Canada

Annex T – Gilead Patents in Canada

Annex U – Canadian Commercialization Plan and Canadian Commercialization Budget as of Amended Effective Date

Annex V – Development Plan and Development Budget for Canada

Annex W – Joint Press Release Following Amended Effective Date

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THIS AMENDED AND RESTATED COLLABORATION AGREEMENT is made as of September 28, 2006 (the "Amended 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;

WHEREAS, BMS has developed and is marketing a proprietary non-nucleoside reverse transcriptase inhibitor, Sustiva ^® (known under the generic name of efavirenz ("EFV")) for the treatment of HIV infection in adults;

WHEREAS, Gilead and BMS, in order to develop and commercialize in the United States, through a joint venture entity, a fixed-dose, co-formulated combination product containing TDF, FTC and EFV as its only active pharmaceutical ingredients, entered into a Collaboration Agreement dated as of December 17, 2004 (the "Collaboration Agreement");

WHEREAS, for that purpose, Gilead and BMS formed such a joint venture pursuant to that certain Operating Agreement entered into as of the Effective Date by and between Gilead Sub and BMS Sub (the "Operating Agreement");

WHEREAS, the Parties allocated among themselves certain rights and duties relating to the development and commercialization of such a combination product, upon the terms and conditions of the Collaboration Agreement, the Operating Agreement and the Ancillary Agreements (as defined below); and

WHEREAS, pursuant to the BMS Guarantee Agreement and the Gilead Guarantee Agreement (as such terms are defined below), each dated as of the Effective Date, BMS Parent and Gilead Parent have guaranteed, and will continue to guarantee, the performance of all of the obligations of BMS Sub and Gilead Sub, respectively, under this Agreement, the Operating Agreement and all Ancillary Agreements to which the applicable Affiliate (as defined below) is or becomes a party;

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[ * ] = C ERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT , MARKED BY BRACKETS , HAS BEEN OMITTED AND FILED SEPARATELY WITH THE S ECURITIES AND E XCHANGE C OMMISSION PURSUANT TO R ULE 24B-2 OF THE S ECURITIES E XCHANGE A CT OF 1934, AS AMENDED .

WHEREAS, pursuant to the Collaboration Agreement, the JV has launched such a combination product in the United States; and

WHEREAS, the Parties now wish to amend and restate the Collaboration Agreement, as set forth herein, in order to provide for the development and commercialization of such a combination product in Canada as well;

NOW, THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:

SECTION 1.

DEFINITIONS

1.1 "Actual BMS Percentage" shall mean, for each Calendar Year, the percentage applicable to BMS for such Calendar Year based on historical data and determined pursuant to Section 7.1(b).

1.2 "Actual Gilead Percentage" shall mean, for each Calendar Year, the percentage applicable to Gilead for such Calendar Year based on historical data and determined pursuant to Section 7.1(b).

1.3 "Actual Percentage" shall mean, with respect to BMS, the Actual BMS Percentage and, with respect to Gilead, the Actual Gilead Percentage.

1.4 "Actual Yield" shall have the meaning set forth in Annex K.

1.5 "Affiliate" of a Person shall mean any other Person that, directly or indirectly, through one or more intermediaries, controls, is controlled by, or is under common control with such Person. For purposes of this definition only, "control" and, with correlative meanings, the terms "controlled by" and "under common control with" shall mean (a) the possession, directly or indirectly, of the power to direct the management or policies of a Person, whether through the ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) the ownership, directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a Person; provided , however , that if local law restricts foreign ownership, control shall be established by direct or indirect ownership of the maximum ownership percentage that may, under such local law, be owned by foreign interests. For purposes of this Agreement, the Operating Agreement and the Ancillary Agreements, the JV shall not be deemed to be an Affiliate of either Gilead or BMS.

1.6 "Agreement" shall mean the Collaboration Agreement, as amended and restated as of the Amended Effective Date.

1.7 "Alliance Manager" shall have the meaning set forth in Section 2.7(a).

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1.8 "Allocated Costs" shall have the meaning set forth in Section 5.12.

1.9 "Amended Effective Date" shall have the meaning set forth in the first paragraph above.

1.10 "AMP" shall have the meaning set forth in Annex Q.

1.11 "Ancillary Agreements" shall mean, collectively, the BMS Supply Agreement, the Gilead Supply Agreement, the Services Agreement and the SDEA.

1.12 [ * ] shall have the meaning set forth in Section 5.1(f).

1.13 "Applicable EFV Territory" shall mean (a) with respect to any BMS Technology licensed to BMS by the EFV Licensor or licensed to the EFV Licensor by BMS, in each case under the EFV License Agreement, the EFV License Agreement Territory, and (b) with respect to all other BMS Technology, worldwide.

1.14 "Applicable Law" shall mean the applicable laws, rules, and regulations, including, without limitation, any rules, regulations, guidelines or other requirements of the Regulatory Authorities, that may be in effect from time to time in the Territory.

1.15 "Approvals" shall mean, collectively, the approvals granted by the Regulatory Authorities for the Manufacture, Marketing, sale and/or use of the Combination Product in the Field in the Territory, including, without limitation, pricing and reimbursement approvals (if any).

1.16 "Approved Marketing Materials" shall have the meaning set forth in Section 5.7(a).

1.17 [ * ]

1.18 [ * ] Representative" shall have the meaning set forth in Section 5.3A(b).

1.19 "Authorized Commercialization Expenses" shall have the meaning set forth in Section 5.12.

1.20 "Authorized Development Expenses" shall have the meaning set forth in Section 3.8.

1.21 "Authorized Expenses" shall mean, collectively, the Authorized Commercialization Expenses, Authorized Development Expenses and Authorized Other Expenses.

1.22 "Authorized Other Expenses" shall mean all JV Expenses expressly stated in this Agreement or the Operating Agreement or any Ancillary Agreement to be Authorized Other Expenses or agreed by the JEC to be Authorized Other Expenses.

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1.23 "AWP" shall have the meaning set forth in Annex Q.

1.24 "BMS" shall have the meaning set forth in the first paragraph of this Agreement.

1.25 "BMS Core Improvement" shall mean any Improvement pertaining specifically to BMS Core Technology, which Improvement is conceived, discovered, developed, or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, solely or jointly, by or on behalf of Gilead or its Affiliates or the JV in the course of, as a result of, or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials; provided , however , that BMS Core Improvements shall not include any Dual Improvements.

1.26 "BMS Core Technology" shall mean all BMS proprietary technologies relating specifically to the Exploitation of EFV.

1.27 "BMS Guarantee Agreement" shall mean the guarantee agreement executed by BMS Parent in favor of Gilead and the JV, dated as of the Effective Date, as such agreement may be amended from time to time.

1.28 "BMS Indemnified Party" shall mean BMS Sub, BMS Parent and any of their Affiliates, officers, directors and employees.

1.29 "BMS Inventions" shall mean any Information and Inventions (whether or not patentable; and Improvements thereto, including Gilead Core Improvements to the extent owned by BMS) conceived, discovered, developed or otherwise made, as necessary to establish authorship or inventorship under United States or Canadian copyright or patent law, as the case may be, solely (or, in the case of Gilead Core Improvements, solely or jointly) by or on behalf of BMS or its Affiliates, in the course of, as a result of or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials, but excluding any Joint Inventions.

1.30 "BMS Know-How" shall mean any and all Information and Inventions under the Control of BMS or its Affiliates as of the Effective Date or at any time during the term of this Agreement that are necessary or reasonably useful for the Exploitation of the Combination Product and are not generally known, but excluding any and all (a) such Information and Inventions to the extent claimed by the BMS Patents and (b) Joint Know-How.

1.31 "BMS Licensed Trademarks" shall have the meaning set forth in Section 6.6(b).

1.32 "BMS Parent" shall have the meaning set forth in the first paragraph of this Agreement.

1.33 "BMS Patents" shall mean all of the Patents that BMS or its Affiliates Control as of the Effective Date or at any time during the term of this Agreement that would, in

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the absence of the license granted by BMS in Section 6.1(b) and assuming that the EFV active pharmaceutical ingredient therein was not purchased from BMS, be infringed by the Exploitation of the Combination Product by the JV in any country in the world. A list of the BMS Patents in the United States as of the Effective Date is attached hereto as Annex D, and a list of the BMS Patents in Canada as of the Amended Effective Date is attached hereto as Annex S.

1.34 "BMS Regulatory Documentation" shall mean all Regulatory Documentation applicable to Sustiva (or EFV) but not Sustiva (or EFV) in co-formulation with Viread (or TDF), Emtriva (or FTC), or Truvada (or TDF and FTC), that is or was developed by or on behalf of BMS or any of its Affiliates or sublicensees prior to the Effective Date or during the term of this Agreement.

1.35 "BMS Sub" shall have the meaning set forth in the first paragraph of this Agreement.

1.36 "BMS Supply Agreement" shall mean the supply agreement entered into between BMS Sub and the JV as of the Effective Date, as such agreement may be amended from time to time.

1.37 "BMS Technology" shall mean, collectively, the BMS Know-How and the BMS Patents.

1.38 "BMS Transfer Price" shall have the meaning set forth in Section 7.1(a).

1.39 "Breaching Member Party" shall have the meaning set forth in Section 14.4(a).

1.40 "Business Day" shall mean a day that is not a Saturday, Sunday or day on which banking institutions in New York, New York or San Francisco, California are required by law to remain closed.

1.41 [ * ] Representative" shall have the meaning set forth in Section 5.3A(b).

1.42 "Calendar Quarter" shall mean a period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.

1.43 "Calendar Year" shall mean a period of twelve (12) consecutive calendar months commencing on January 1 and ending on December 31.

1.44 "Canada" shall mean Canada, its provinces and territories.

1.45 "Canada Distribution and Supply Agreement" shall have the meaning set forth in Section 5.2.

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1.46 "Canadian Act" shall mean the Food and Drugs Act (Canada), as amended.

1.47 "Canadian Commercialization Budget" shall have the meaning set forth in Section 5.11(b). The initial Canadian Commercialization Budget is attached hereto as Annex U.

1.48 "Canadian Commercialization Plan" shall mean the plan for Marketing and otherwise commercializing the Combination Product in Canada as described in Section 5.11(b), as updated from time to time pursuant to Section 5.11(c). The initial Canadian Commercialization Plan is attached hereto as Annex U.

1.49 "Canadian Pricing Information" shall have the meaning set forth in Section 5.3B(f).

1.50 [ * ]

1.51 "Change of Control" shall mean, with respect to a Person, any of the following transactions with a Third Party (a "Third Party Acquirer"): (a) a merger or consolidation of such Person with the Third Party Acquirer which results in the holders of the voting securities of such Person outstanding immediately prior thereto (other than the Third Party Acquirer, its "affiliates" and "associates" (as such terms are used in the Exchange Act)) ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity (or, if applicable, its parent company) immediately after such merger or consolidation; (b) the sale to the Third Party Acquirer of all or substantially all of the business of such Person to which this Agreement relates (whether by merger, consolidation, sale of stock, sale of assets or other similar transaction); or (c) the Third Party Acquirer (which shall not be any trustee or other fiduciary holding securities under an employee benefit plan of such Person, or any corporation owned directly or indirectly by the stockholders of such Person, in substantially the same proportion as their ownership of stock of such Person), together with any of the Third Party Acquirer’s "affiliates" or "associates", as such terms are used in the Exchange Act, becoming the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Person or by contract or otherwise having the right to control the Board of Directors or equivalent governing body of such Person or the ability to cause the direction of management of such Person.

1.52 "Clinical Data" shall mean any and all data (together with the results of analysis thereof) derived or generated from any clinical trial of a pharmaceutical product or from testing or analysis of subjects or samples from such a clinical trial (e.g. in vitro testing of tissue samples from subjects enrolled in such a clinical trial), in each case where such clinical trial involves either or both of (i) any Single Agent Product or Double Agent Product, whether alone or in combination with any other product, and (ii) the Combination Product, whether alone or in combination with any other product.

1.53 "Clinical Trial Registry" shall have the meaning set forth in Section 3.11(b).

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1.54 "Clinical Trial Results Database" shall have the meaning set forth in Section 3.11(b).

1.55 "CMC Data" shall mean any and all information contained in, as well as data supporting, the "Chemistry, Manufacturing and Control" and facilities sections (or sections corresponding thereto) of an NDA or NDS, including, without limitation, any drug master files referenced in the NDA or NDS.

1.56 "Co-Funded Clinical Trial" shall have the meaning set forth in Section 3.2(b).

1.57 "Collaboration Agreement" shall have the meaning set forth in the recitals to this Agreement.

1.58 "Collaboration Principles" shall have the meaning set forth in Section 2.10.

1.59 "Combination Product" shall mean the fixed-dose co-formulated product developed pursuant to this Agreement containing, as its only active pharmaceutical ingredients per single daily dose, 300 mg TDF, 200 mg FTC and 600 mg EFV.

1.60 "Combination Product Regulatory Documentation" shall mean all Regulatory Documentation applicable to the Combination Product that is developed by or on behalf of any Party pursuant to, and during the term of, this Agreement, but excluding all BMS Regulatory Documentation and all Gilead Regulatory Documentation.

1.61 "Combination Product Trademarks" shall mean the trademark or trademarks selected by the JCC for the Combination Product, all packaging designs and other trade dress used in connection with the Combination Product, other Trademarks relating thereto and any registrations thereof or any pending applications relating thereto. For the avoidance of doubt, the following shall not be considered Combination Product Trademarks: (a) BMS Licensed Trademarks, (b) Gilead Licensed Trademarks and (c) the names, logos and other Trademarks of the Member Parties.

1.62 "Commercialization Activities" shall mean, with respect to Canada, Marketing and other activities for the commercialization of the Combination Product including those set forth in the Canadian Commercialization Plan and any other of the following conducted for the Combination Product in Canada: execution of product positioning, preparation of promotional and marketing materials, market research and advertising activities, Promotion, advocacy, government and other public relations activities, [ * ] and with respect to the United States, Marketing and other activities for the commercialization of the Combination Product including those set forth in the U.S. Commercialization Plan and any other of the following conducted for the Combination Product in the United States: execution of product positioning, preparation of promotional and marketing materials, market research and advertising activities, Promotion, advocacy, national accounts, government relations activities, pricing, reimbursement and patient assistance programs.

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1.63 "Commercialization Budgets" shall mean the Canadian Commercialization Budget and the U.S. Commercialization Budget.

1.64 "Commercialization Budget Deadlock" shall have the meaning set forth in Section 2.11(d).

1.65 "Commercialization Committee" shall mean the JCC or JCOC, as applicable.

1.66 "Commercialization Plans" shall mean the Canadian Commercialization Plan and the U.S. Commercialization Plan.

1.67 "Commercialization Plan Deadlock" shall have the meaning set forth in Section 2.11(d).

1.68 "Commercially Reasonable Efforts" shall mean, with respect to (a) the Development Activities that a Member Party is required to perform with respect to the Combination Product pursuant to the Development Plan, or (b) the Commercialization Activities that a Member Party is required to perform with respect to the Combination Product pursuant to a Commercialization Plan, as the case may be, the level of effort that would generally be used by a Member Party to conduct such development or commercialization activities in a manner consistent with the minimum level of expenditure contemplated for such activities by the Development Budget or a Commercialization Budget, as the case may be, for a product or compound owned by it or to which it has rights, which is of comparable market potential, profit potential or strategic value to such Member Party and is at a similar stage in its development or product life, taking into account, without limitation, issues of safety and efficacy, product profile, the proprietary position, the then-current competitive environment for such product or compound (and any individual agent comprising part of such product or compound), the likely timing of the product’s or compound’s (and any such individual agent’s) entry into the market, the then-current market penetration, the return on investment potential of such product (and any individual agent comprising part of such product), the regulatory environment and status of the product (and any individual agent comprising part of such product), and other relevant scientific, technical and commercial factors, in each case as measured by the facts and circumstances at the time such efforts are due. Such determination shall be made on a country-by-country basis.

1.69 "Commercial Record Request" shall have the meaning set forth in Section 5.10(b).

1.70 "Competing Product" shall mean (a) in the case of Gilead as the assigning Member Party, a [ * ] and (b) in the case of BMS as the assigning Member Party, a [ * ]

1.71 "Confidential Information" shall have the meaning set forth in Section 12.3(a).

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1.72 "Continuing Member Party" shall mean a Member Party as so designated pursuant to Section 14.5.

1.73 "Control" or "Controlled" shall mean, with respect to any item of Information and Inventions, Patents or other intellectual property rights, the right, whether by ownership, license or otherwise, to grant a license, sublicense or other right to or under such item, Patent or right as provided for in this Agreement without violating the terms of any agreement or other binding arrangement with any Third Party. For purposes of this Section 1.73, the consent referred to in Section 6.12 shall be deemed to have been obtained as of the Effective Date.

1.74 "Core Technology" shall mean the BMS Core Technology or the Gilead Core Technology, as the case may be.

1.75 "Cost Allocation Proposal" shall have the meaning set forth in Section 5.12.

1.76 "Cost of Goods" shall have the meaning set forth in Annex J hereto.

1.77 "CTA" shall mean a Clinical Trial Application to be filed in Canada with the HPFB in accordance with Applicable Law.

1.78 "Court" shall have the meaning set forth in Section 15.15.

1.79 "Detail" shall mean an in-person presentation to a health care provider specializing in treatment of HIV infection or AIDS, and who has prescribing authority, by a sales representative who is fully equipped with knowledge of, and (subject to Section 5.7) Approved Marketing Materials and product labels and inserts with respect to, the Combination Product, in which the characteristics of the Combination Product are described by such sales representative in a fair and balanced manner consistent with the requirements of Applicable Law and of this Agreement, and in a manner that is customary in the industry for the purpose of promoting a prescription pharmaceutical product, but without regard to the position of the presentation within a call to the health care provider. For the avoidance of doubt, a promotional material drop or product reminder shall not constitute a Detail. When used as a verb, to "Detail" shall mean to engage in a Detail.

1.80 "Detail Equivalent Amount" shall mean, for the 2005 Calendar Year and the 2006 Calendar Year, [ * ], and for each successive Calendar Year thereafter, such amount as adjusted by the [ * ] for each such Calendar Year.

1.81 "Developing World" shall mean the territory comprising the countries listed in Annex R and any additional countries outside the Territory and Europe that Gilead includes in its Gilead Access Program, as indicated at the website for the program, www.gileadaccess.org .

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1.82 "Development Activities" shall mean the activities set forth in the Development Plan, as updated from time to time pursuant to Section 3.7 and, only with respect to periods prior to the Effective Date, activities pursuant to the MTTA.

1.83 "Development Budget" shall mean the budget with respect to any expenses relating to Development Activities for the Combination Product that are chargeable to the JV, as updated from time to time pursuant to Section 3.7. The Development Budget as of the Effective Date is attached hereto as Annex B, and as of the Amended Effective Date shall include, with respect to Canada, the budget attached hereto as Annex V.

1.84 "Development Plan" shall mean the plan for the regulatory, clinical, formulation, Manufacturing Process and CMC Data development activities to be conducted for the Combination Product, including any Phase IV clinical studies and medical information and medical education programs, as updated from time to time pursuant to Section 3.7. The Development Plan as of the Effective Date is attached hereto as Annex B, and as of the Amended Effective Date shall include, with respect to Canada, the plan attached hereto as Annex V.

1.85 "Development Record Request" shall have the meaning set forth in Section 3.6(b).

1.86 "Disclosing Party" shall have the meaning set forth in Section 12.1.

1.87 [ * ] shall have the meaning set forth in Annex Q1.

1.88 "Double Agent Product" shall mean Truvada, the co-formulated product developed by Gilead containing, as its only active pharmaceutical ingredients, TDF and FTC.

1.89 "Dual Improvement" shall mean an Improvement that constitutes both an Improvement pertaining specifically to the Gilead Core Technology and an Improvement pertaining specifically to the BMS Core Technology, which Improvement is conceived, discovered, developed, or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, solely or jointly, by or on behalf of BMS or its Affiliates, Gilead or its Affiliates, the JV or jointly any combination of them, in the course of, as a result of, or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials. Any Dual Improvement shall constitute a Joint Invention.

1.90 "Effective Date" shall mean the effective date of the Collaboration Agreement, which is December 17, 2004.

1.91 "EFV" shall have the meaning set forth in the recitals to this Agreement.

1.92 "EFV License Agreement" shall mean that certain license agreement, dated as of September 1, 1994, as amended, between the EFV Licensor and E.R. Squibb & Sons, L.L.C., as successor in interest to DuPont Pharmaceuticals Company (formerly named The DuPont Merck Pharmaceutical Company).

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1.93 "EFV License Agreement Territory" shall mean BMS’ territory under the EFV License Agreement, which, as of the Effective Date, consists of the United States (including its territories and possessions), Canada, France (continental area), Germany, Italy, Spain, United Kingdom and the Republic of Ireland, provided , however , that (a) should the EFV License Agreement be amended to expand BMS’ territory, then EFV License Agreement Territory shall forthwith mean BMS’ territory as so expanded; and (b) should the EFV License Agreement be terminated as a result of BMS’ acquisition of all the rights of the EFV Licensor thereunder, then EFV License Agreement Territory shall forthwith mean all countries in the world.

1.94 "EFV Licensor" shall mean, collectively, Merck & Co., Inc., a New Jersey corporation, and Merck and Company Incorporated, a Delaware corporation, and their respective successors in interest.

1.95 "Estimated Net Selling Price" shall have the meaning set forth in Section 7.1(c)(ii).

1.96 "Europe" shall mean all countries comprising the European Union as it may be constituted from time to time.

1.97 "Exchange Act" shall have the meaning set forth in Section 15.12(b).

1.98 "Exploitation" shall mean the making, having made, importation, use, sale, offering for sale or disposition of a product or process, including, without limitation, the research, development, registration, modification, enhancement, Improvement, Manufacturing, storage, formulation, optimization, import, export, transport, distribution, promotion or Marketing of a product or process. When used as a verb, "Exploit" shall mean to engage in any of the foregoing activities.

1.99 "FDA" shall mean the United States Food and Drug Administration and any successor agency thereto.

1.100 "Field" shall mean the treatment of HIV infection in adult humans.

1.101 "Field Force" shall mean sales representatives, and regional or other subnational managers of the foregoing.

1.102 "Final Invoice Date" shall have the meaning set forth in Section 7.3(a).

1.103 "Finished Product Manufacturing Data" shall mean any and all data and information necessary or useful for the Manufacture of a finished product, packaged and labeled, from the active pharmaceutical ingredients thereof, in tablet, capsule or other form (but expressly excluding the Manufacture of such active pharmaceutical ingredients), that is not included in any CMC Data for such finished product.

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1.104 [ * ] Customers" shall have the meaning set forth in Annex Q1.

1.105 [ * ] shall have the meaning set forth in Annex Q2.

1.106 "FTC" shall have the meaning set forth in the recitals to this Agreement.

1.107 "GAAP" shall mean United States generally accepted accounting principles as in effect from time to time, as consistently applied.

1.108 "Generic Version" shall mean, with respect to the Combination Product or a Single Agent Product or Double Agent Product, a product containing the same active pharmaceutical ingredients as the Combination Product or the Single Agent Product or Double Agent Product, as the case may be, with those being the only active pharmaceutical ingredients in such product, and which product is approved in the United States under an Abbreviated New Drug Application (i.e., an ANDA), or in Canada under an Abbreviated New Drug Submission (i.e. an ANDS).

1.109 "Generic Version Launch" shall have the meaning set forth in Section 14.5.

1.110 "Gilead" shall have the meaning set forth in the first paragraph of this Agreement.

1.111 "Gilead Core Improvement" shall mean any Improvement pertaining specifically to Gilead Core Technology, which Improvement is conceived, discovered, developed, or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, solely or jointly, by or on behalf of BMS or its Affiliates or the JV in the course of, as a result of, or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials; provided , however , that Gilead Core Improvements shall not include any Dual Improvements.

1.112 "Gilead Core Technology" shall mean all Gilead proprietary technologies relating specifically to the Exploitation of FTC, TDF, or any combination of FTC and TDF (including, without limitation, the Double Agent Product, but excluding the Combination Product).

1.113 "Gilead Guarantee Agreement" shall mean the guarantee agreement executed by Gilead Parent in favor of BMS and the JV, dated as of the Effective Date, as such agreement may be amended from time to time.

1.114 "Gilead Indemnified Party" shall mean Gilead Sub, Gilead Parent and any of their Affiliates, officers, directors and employees.

1.115 "Gilead Inventions" shall mean any Information and Inventions (whether or not patentable; and Improvements thereto, including BMS Core Improvements to the extent owned by Gilead) conceived, discovered, developed or otherwise made, as necessary to

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establish authorship or inventorship under United States copyright or patent law, as the case may be, solely (or, in the case of BMS Core Improvements, solely or jointly) by or on behalf of Gilead or its Affiliates, in the course of, as a result of or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials, but excluding any Joint Inventions.

1.116 "Gilead Know-How" shall mean any and all Information and Inventions under the Control of Gilead or its Affiliates as of the Effective Date or at any time during the term of this Agreement that are necessary or reasonably useful for the Exploitation of the Combination Product and are not generally known, but excluding any and all (a) such Information and Inventions to the extent claimed by the Gilead Patents and (b) Joint Know-How.

1.117 "Gilead Licensed Trademarks" shall have the meaning set forth in Section 6.6(a).

1.118 "Gilead Parent" shall have the meaning set forth in the first paragraph of this Agreement.

1.119 "Gilead Patents" shall mean all of the Patents that Gilead or its Affiliates Control as of the Effective Date or at any time during the term of this Agreement that would, in the absence of the license granted by Gilead in Section 6.1(a) and assuming that the TDF and FTC active pharmaceutical ingredients therein were not purchased from Gilead, be infringed by the Exploitation of the Combination Product by the JV in any country in the world. A list of the Gilead Patents in the United States as of the Effective Date is attached hereto as Annex E, and a list of the Gilead Patents in Canada as of the Amended Effective Date is attached hereto as Annex T.

1.120 "Gilead Regulatory Documentation" shall mean all Regulatory Documentation applicable to Viread (or TDF), Emtriva (or FTC), or Truvada (or TDF in co-formulation with FTC) but not Viread (or TDF), Emtriva (or FTC) or Truvada (or TDF and FTC) in co-formulation with Sustiva (or EFV), that is or was developed by or on behalf of Gilead or any of its Affiliates or sublicensees prior to the Effective Date or during the term of this Agreement.

1.121 "Gilead Sub" shall have the meaning set forth in the first paragraph of this Agreement.

1.122 "Gilead Supply Agreement" shall mean the supply agreement entered into between Gilead Parent and the JV as of the Effective Date, as such agreement may be amended from time to time.

1.123 "Gilead Technology" shall mean, collectively, the Gilead Know-How and the Gilead Patents.

1.124 "Gilead Transfer Price" shall have the meaning set forth in Section 7.1(a).

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1.125 [ * ] shall have the meaning set forth in Section 5.3A(d).

1.126 "Good Clinical Practice" or "GCP" shall mean the then-current standards for clinical trials for pharmaceutical products, as set forth in the U.S. Act or the Canadian Act, as the case may be, and applicable regulations promulgated thereunder or other Applicable Law, as the same may be amended from time to time.

1.127 "Good Laboratory Practice" or "GLP" shall mean the then-current standards for laboratory activities for pharmaceutical products, as set forth in the U.S. Act or the Canadian Act, as the case may be, and applicable regulations promulgated thereunder or other Applicable Law, as the same may be amended from time to time.

1.128 "Good Manufacturing Practice" or "GMP" shall mean the regulatory requirements under Applicable Law for current good manufacturing practices for pharmaceutical products, including those set forth in U.S. Act and 21 C.F.R. (parts 210, 211, 600 and 610) or set forth in Division 2 of Part C of the Food and Drug Regulations (Canada) and associated guidelines, as the case may be, in each case as amended from time to time.

1.129 "HPFB" shall mean the Canadian Health Products and Food Branch and any successor agency thereto.

1.130 "Improvement" shall mean any modification to a compound, composition, product or technology or to any discovery, device, process or formulation related to such compound, composition, product or technology, whether or not patented or patentable, including, without limitation, any enhancement in the efficiency, operation, Manufacture, ingredients, preparation, presentation, formulation, means of delivery, packaging or dosage of a compound, composition, product or technology, or of any discovery, device, process or formulation related thereto; any discovery or development of any new or expanded indications or applications for a compound, composition, product or technology; any discovery or development that improves the stability, safety or efficacy of a compound, composition, product or technology; or any discovery or development of a new dosage regimen for a product or method of use or administration for a compound, composition, product or technology.

1.131 "IND" shall mean an Investigational New Drug Application to be filed with the FDA in accordance with Applicable Law.

1.132 "Indemnified Party" shall mean a Person seeking indemnification for Losses pursuant to Section 13.8.

1.133 "Indemnifying Member Party" shall have the meaning set forth in Section 13.6.

1.134 "Indemnifying Party" shall mean a Party from which indemnification is sought pursuant to Section 13.8.

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1.135 "Independent Accounting Expert" shall have the meaning set forth in Section 7.1(d).

1.136 "Information and Inventions" shall mean all technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, practices, formulas, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including, without limitation, pre-clinical and clinical trial results, Manufacturing procedures, test procedures, and purification and isolation techniques, (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form now known or hereafter developed, and all Improvements, whether to the foregoing or otherwise, and all other discoveries, developments, inventions (whether or not confidential, proprietary, patented or patentable), and tangible embodiments of any of the foregoing.

1.137 "Infringement" shall have the meaning set forth in Section 11.3(a).

1.138 "Infringing Combination Product" shall have the meaning set forth in Section 11.3(a).

1.139 "Initial Launch Period" shall mean, with respect to a country in the Territory, the first [ * ] commencing with the Launch of the Combination Product in such country.

1.140 "Initiating Member" shall have the meaning set forth in Section 7.1(e).

1.141 "Interim BMS Unit Transfer Price" shall have the meaning set forth in Section 7.1(a).

1.142 "Interim Gilead Unit Transfer Price" shall have the meaning set forth in Section 7.1(a).

1.143 "Interim Unit Transfer Price" shall mean, for each Calendar Year, with respect to BMS, the Interim BMS Unit Transfer Price and with respect to Gilead, the Interim Gilead Unit Transfer Price.

1.144 "Joint Commercialization Committee" or "JCC" shall have the meaning set forth in Section 2.4(a).

1.145 "Joint Canadian Operating Committee" or "JCOC" shall have the meaning set forth in Section 2.5(a).

1.146 "Joint Development Committee" or "JDC" shall have the meaning set forth in Section 2.3(a).

1.147 "Joint Executive Committee" or "JEC" shall have the meaning set forth in Section 6.1 of the Operating Agreement.

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1.148 "Joint Finance Committee" or "JFC" shall have the meaning set forth in Section 2.6(a).

1.149 "Joint Inventions" shall mean (a) any and all Information and Inventions pertaining specifically to the Combination Product (whether or not patentable; and Improvements thereto) conceived, discovered, developed or otherwise made, as necessary to establish authorship or inventorship under United States copyright or patent law, as the case may be, by or on behalf of BMS or its Affiliates, Gilead or its Affiliates, the JV, or jointly any combination of them, in the course of, as a result of or in connection with the Project Activities conducted pursuant to the Development Plan or in connection with Co-Funded Clinical Trials; and (b) any Dual Improvement.

1.150 "Joint Know-How" means all Information and Inventions included in the Joint Inventions that are not generally known, but excluding any Information and Inventions to the extent claimed by the Joint Patents. For the avoidance of doubt, "Joint Know-How" shall include all Clinical Data from the proposed bioequivalence study contemplated by the Development Plan.

1.151 "Joint Patents" shall mean any Patents to the extent that such Patents claim Joint Inventions.

1.152 "Joint Technology" shall mean, collectively, the Joint Know-How and the Joint Patents.

1.153 "Jurisdiction" shall mean a province or a territory of Canada.

1.154 "JV" shall have the meaning set forth in the first paragraph of this Agreement.

1.155 "JV Expenses" shall mean all direct, out-of-pocket expenses that Gilead or BMS may incur (or cause their Affiliates to incur) in performing the Project Activities on behalf of the JV. For the avoidance of doubt, with respect to any JV Expenses incurred by a Member Party (or its Affiliates), such expenses are chargeable to the JV by such Member Party only if such expenses constitute Authorized Expenses.

1.156 "Key Regulatory Submissions" shall have the meaning set forth in Section 3.4(a).

1.157 "Launch" shall mean, with respect to a country in the Territory, either (a) the date on which the Combination Product is first shipped by or on behalf of the JV for commercial sale to Third Parties in such country or (b) for any Generic Version product referred to in Section 14.5, the date on which it is first available for commercial sale and purchase in such country, as the case may be.

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1.158 "Losses" shall mean judgments, fines, amounts paid in settlement, and out-of-pocket expenses (including reasonable attorneys’ fees) reasonably incurred by a Party (or other indemnitee as provided in Section 13) in a Proceeding.

1.159 [ * ]

1.160 [ * ] shall have the meaning set forth in Annex Q1.

1.161 "Manufacture" or "Manufacturing" means, with respect to a product or compound, the manufacturing, processing, formulating, packaging, labeling, holding, and quality control testing of such product or compound.

1.162 "Manufacturing Process" shall mean any process or step thereof that is necessary or useful for Manufacturing the Combination Product from bulk active pharmaceutical ingredients, any Improvements thereto or any intermediate of the foregoing.

1.163 "Market" or "Marketing" shall mean all programs and activities relating to the Promotion and sale and other commercialization of the Combination Product in the Territory, including, without limitation, Detailing and advertising, as well as selling, contracting for sale of, and distributing the Combination Product.

1.164 "Material Default" shall have the meaning set forth in Section 14.4(a).

1.165 "Member Parties" shall mean, collectively, Gilead and BMS.

1.166 "Members" shall mean, collectively, Gilead Sub and BMS Sub.

1.167 "Member Vote" shall have the meaning set forth in Section 2.6(f).

1.168 [ * ] shall have the meaning set forth in Section 5.1(f).

1.169 [ * ] shall have the meaning set forth in Section 5.1(f).

1.170 "MTTA" shall have the meaning set forth in Section 15.14.

1.171 "NDA" shall mean a New Drug Application to be filed with the FDA in accordance with Applicable Law for the purpose of obtaining marketing approval for a pharmaceutical product in the U.S.

1.172 "NDS" shall mean a New Drug Submission to be filed with the HPFB in accordance with Applicable Law for the purpose of obtaining marketing approval for a pharmaceutical product in Canada.

1.173 [ * ] shall have the meaning set forth in Annex Q1.

1.174 "Net Sales" shall mean, with respect to a product for any period, the gross amount invoiced for commercial sales of that product in such period by or on behalf of the

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selling Party to Third Parties (provided that amounts invoiced for product sold or provided for use in the Developing World, if any, shall not be included), less deductions for: (a) normal and customary quantity and/or cash discounts and sales returns and allowances, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, rebates, administrative or other fees or reimbursements or similar payments to wholesalers or other distributors (including without limitation pursuant to inventory management agreements), buying groups, AIDS Drug Assistance Programs, pharmacy benefit management organizations, health care insurance carriers or other institutions, allowances, rebates, fees paid to distributors and chargebacks actually allowed or given; (b) freight, postage, shipping and insurance expenses (if separately identified in such invoice); (c) customs or excise duties or other duties related to the sales making up the gross invoice amount (if separately identified in such invoice); (d) any rebates or similar payments accrued with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the foregoing in this clause (d), United States Federal or state Medicaid, Medicare or similar state program or any government imposed retroactive price reduction; and (e) sales and other taxes and duties directly related to the sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale). Any of the deductions listed above that involves a payment by such Party shall not be taken as a deduction prior to the date accrued in accordance with GAAP as consistently applied in such Party’s audited financial statements. For purposes of determining Net Sales pursuant to Section 14.6(b)(ii), the Combination Product shall be deemed to be sold when invoiced.

For purposes of calculating Net Sales, sales between or among a Party and/or Affiliates shall be excluded from the computation of Net Sales, but sales by such Party and its Affiliates to Third Parties shall be included in the computation of Net Sales.

1.175 "Net Selling Price" shall mean, with respect to each country in the Territory, the price of a pharmaceutical product as calculated in accordance with Annex I hereto and expressed in the currency of such country, and with respect to the Territory, the weighted average of the Net Selling Prices in each country in the Territory, expressed in U.S. dollars, using the currency conversion rules established pursuant to Section 7.1(f).

1.176 "Non-Breaching Member Party" shall have the meaning set forth in Section 14.4(a).

1.177 "Operating Agreement" shall have the meaning set forth in the recitals to this Agreement.

1.178 "Operating Committees" shall mean, collectively, the JCC, the JCOC, the JDC and the JFC.

1.179 "Optional Update" shall have the meaning set forth in Section 5.7(d).

1.180 "Paragraph (iv) Certification" shall have the meaning set forth in Section 11.3(a).

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1.181 "Party" and "Parties" shall have the meanings set forth in the first paragraph of this Agreement.

1.182 "Patents" shall mean (a) all patents and patent applications (including, without limitation, provisional applications), (b) any substitutions, divisions, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like, and (c) any foreign or international equivalents of any of the foregoing.

1.183 "PCT" shall mean the Patent Cooperation Treaty, opened for signature June 19, 1970, 58 U.S.T. 7645.

1.184 "PMPRB" shall mean the Patented Medicine Prices Review Board of Canada.

1.185 "Permitted Assignee" shall have the meaning set forth in Section 15.4(a).

1.186 "Person" shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including, without limitation, a government or political subdivision, department or agency of a government.

1.187 "Prescription Drug Marketing Act" or "PDMA" shall have the meaning set forth in Section 5.1(d).

1.188 "Pricing Liaison" shall have the meaning set forth in Section 5.3B(c).

1.189 "Private Institutional Payor" shall mean a third party payor (such as an insurance company, pharmacy benefit management firm or hospital) of health care expenses incurred by a patient in Canada, which payor is not a provincial, federal or territorial government.

1.190 "Proceeding" shall mean a civil, criminal, administrative or investigative proceeding brought by or a demand made by a Third Party.

1.191 "Product Detail Period" shall have the meaning set forth in Section 5.1(e).

1.192 "Product EFV Yield" shall have the meaning set forth in Annex K.

1.193 "Product FTC Yield" shall have the meaning set forth in Annex K.

1.194 "Product TDF Yield" shall have the meaning set forth in Annex K.

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1.195 "Project Activities" shall mean any and all activities undertaken or performed by or on behalf of any of the Parties, pursuant to this Agreement or the MTTA, in the course of, as a result of or in connection with the research, development, Marketing, sale or use of the Combination Product, including, without limitation, the Development Activities and the Commercialization Activities; provided , however , that Project Activities shall not include any activities undertaken or performed by or on behalf of either Member Party or its Affiliates or sublicensees to the extent that they arise in the course of, as a result of or in connection with the Exploitation of the Combination Product for use outside the Territory (including, without limitation, any activities undertaken or performed by Gilead in the exercise of its rights under the license granted in Section 6.2(d)).

1.196 "Promotion" shall mean the conduct of activities normally undertaken by a pharmaceutical company’s Field Force to implement plans and strategies for marketing and other commercialization aimed at encouraging the approved use of a pharmaceutical product, including but not limited to Detailing. When used as a verb, "Promote" shall mean to engage in any of the foregoing activities.

1.197 "PSUR" means a periodic safety update report required to be submitted to an applicable Regulatory Authority in the Territory.

1.198 "Publication Standards" shall have the meaning set forth in Section 3.11(a).

1.199 [ * ] shall have the meaning set forth in Section 5.1(f).

1.200 "Recalculated Transfer Price" shall have the meaning set forth in Section 7.1(c)(iii).

1.201 "Receiving Party" shall have the meaning set forth in Section 12.1.

1.202 "Regulatory Authorities" shall mean any applicable supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities, including, without limitation, the FDA and the HPFB, or other entity exercising regulatory authority with respect to the Exploitation of the Combination Product in the Territory.

1.203 "Regulatory Documentation" shall mean all submissions to Regulatory Authorities in the Territory, including, without limitation, all INDs, NDAs, sNDAs, CTAs, NDSs, SNDSs, CMC Data, drug master files, filings with PMPRB, filings for listing with Canadian provincial drug plans, correspondence with regulatory agencies (registrations and licenses, regulatory drug lists, advertising and promotion documents), PSURs, adverse event files, complaint files and manufacturing records.

1.204 "Relevant Experience Information" shall mean adverse experience reports, reports based on marketing data and other documentation of relevant drug experience.

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1.205 [ * ] shall have the meaning in Section 5.3B(e).

1.206 "Required Update" shall have the meaning set forth in Section 5.7(b).

1.207 "Respective Percentage" shall mean, with respect to Gilead, the Actual Gilead Percentage, and with respect to BMS, the Actual BMS Percentage; provided , however , that whenever this Agreement provides that an amount shall be allocated between the Member Parties based on their Respective Percentages, such allocation shall first be made on the basis of the Member Parties’ respective Working Percentages at the time of the relevant event, which allocation shall then be adjusted, if applicable, after the determination of the Member Parties’ respective Actual Percentages for the Calendar Year in which the relevant event occurs, which adjustments shall occur no later than April 1 of the next Calendar Year unless otherwise provided in this Agreement or the Operating Agreement, or otherwise agreed in writing by the Member Parties.

1.208 "Right of Reference" shall have the meaning set forth in 21 C.F.R. § 314.3(b) or equivalents thereto under Applicable Law in Canada or jurisdictions outside the Territory. For the avoidance of doubt, as used in this Agreement "Right of Reference" shall refer to the right of Regulatory Authorities to rely upon and otherwise use the applicable information, but shall not confer on the Member Party to which such Right of Reference is granted any right to receive or access such information.

1.209 "SDEA" or "Safety Data Exchange Agreement" shall have the meaning set forth in Section 9.1.

1.210 "Selected Product Liability Claim" shall have the meaning set forth in Section 13.7(c).

1.211 "Services Agreement" shall mean the distribution services agreement to be entered into between Gilead Parent and the JV after the Effective Date, the key terms of which are outlined in Annex P1 hereto, as such agreement may be amended from time to time.

1.212 "Single Agent Product" shall mean each of Viread, Emtriva, and Sustiva.

1.213 "SNDS" shall mean a supplemental NDS.

1.214 "Study 934" shall mean the clinical study initiated by Gilead prior to the Effective Date under Gilead’s clinical study protocol entitled "A Phase 3, Randomized, Open-Label, Multicenter Study of the Treatment of Antiretroviral-Naïve, HIV-1-Infected Subjects comparing Tenofovir Disoproxil Fumarate and Emtricitabine in Combination with Efavirenz Versus Combivir ^® (lamivudine/zidovudine) and Efavirenz" (as such protocol may be revised and such study may be extended or expanded from time to time, in each case by Gilead). For the avoidance of doubt, the conduct of Study 934 shall not be deemed a Development Activity or Project Activity for purposes of this Agreement, and Clinical Data derived or generated from Study 934 or from testing or analysis of subjects or samples from Study 934 shall be Gilead Know-How, not Joint Know-How.

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1.215 "Subsequent Launch Period" shall mean, with respect to a country in the Territory, [ * ] after the Launch of the Combination Product in such country.

1.216 "Supplier" shall mean each Person selected as a commercial supplier of the Combination Product pursuant to Section 4.2(a).

1.217 "Supply Agreements" shall mean, collectively, the BMS Supply Agreement and the Gilead Supply Agreement.

1.218 "Supply Party" shall mean, with respect to any Supplier, (a) if a Member Party is the Supplier, such Member Party, or (b) if a Third Party is the Supplier, the Member Party that is designated pursuant to Section 4.2(a) to manage the relationship with such Supplier.

1.219 "TDF" shall have the meaning set forth in the recitals to this Agreement.

1.220 "Technology" shall mean the BMS Technology or the Gilead Technology, as the case may be.

1.221 "Terminated Member Party" shall mean a Member Party as so designated pursuant to Section 14.5.

1.222 "Territory" shall mean Canada and the United States.

1.223 "Third Party" shall mean any Person other than Gilead, BMS, the JV and their respective Affiliates.

1.224 "Third Party Acquirer" shall have the meaning set forth in Section 1.43.

1.225 "Trademark" shall include any word, name, symbol, color, designation or device or any combination thereof, including, without limitation, any trademark, trade dress, service mark, service name, brand mark, trade name, brand name, logo or business symbol.

1.226 "Transfer Price" shall mean the BMS Transfer Price or the Gilead Transfer Price, as the case may be.

1.227 "Transferring Member Party" shall have the meaning set forth in Section 15.4(b).

1.228 [ * ] shall have the meaning set forth in Section 5.3A(d).

1.229 "United States" or "U.S." shall mean the United States, the Commonwealth of Puerto Rico and any other territories and possessions of the United States

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1.230 "U.S. Act" shall mean the United States Food, Drug and Cosmetic Act, as amended.

1.231 "U.S. Commercialization Budget" shall have the meaning set forth in Section 5.11(b). The U.S. Commercialization Budget as of the Effective Date is attached hereto as Annex C.

1.232 "U.S. Commercialization Plan" shall mean the plan for Marketing and otherwise commercializing the Combination Product in the United States as described in Section 5.11(b), as updated from time to time pursuant to Section 5.11(c). The U.S. Commercialization Plan as of the Effective Date is attached hereto as Annex C.

1.233 [ * ] shall have the meaning set forth in Section 5.3A(d).

1.234 "US Pricing Committee" shall have the meaning set forth in Section 5.3A(b).

1.235 "US Pricing Information" shall have the meaning set forth in Section 5.3A(h).

1.236 [ * ] shall have the meaning set forth in Section 5.3A(a).

1.237 "WAC" shall have the meaning set forth in Annex Q1.

1.238 "Working BMS Percentage" shall mean, for each Calendar Year, the preliminary percentage applicable to BMS for such Calendar Year determined pursuant to Section 7.1(c)(i).

1.239 "Working Gilead Percentage" shall mean, for each Calendar Year, the preliminary percentage applicable to Gilead for such Calendar Year determined pursuant to Section 7.1(c)(i).

1.240 "Working Percentage" shall mean, with respect to BMS, the Working BMS Percentage and, with respect to Gilead, the Working Gilead Percentage.

SECTION 2.

COLLABORATION MANAGEMENT

2.1 General . As set forth in this Agreement and in the Operating Agreement, the Member Parties desire to establish a Joint Executive Committee which shall oversee the Member Parties’ collaboration under this Agreement and facilitate communications between the Member Parties with respect to the development, Approval, Manufacturing and commercialization of the Combination Product in the Territory. Subject to the foregoing, the Member Parties also desire to establish specialized committees to focus more closely on the Parties’ Development Activities, Commercialization Activities and finance activities hereunder. Each such committee shall have only the responsibilities and authority delegated to or vested in such committee in this Section 2 or elsewhere in this Agreement and the Operating Agreement.

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2.2 Role of the Joint Executive Committee . The establishment, composition, governance, powers and limitations on powers of the Joint Executive Committee (or "JEC") are governed by Section 6 of the Operating Agreement and by this Section 2.2. The initial JEC members are identified in Annex A hereto. The JEC shall have overall authority and responsibility with respect to the Development Activities and Commercialization Activities for the Combination Product (except for those matters reserved to the Member Parties pursuant to this Agreement or the Operating Agreement). Without limitation of the foregoing, the JEC shall have the following powers and duties:

(i) to oversee the work of the Operating Committees and, if possible, resolve disputes referred to it by the Alliance Managers pursuant to Section 2.8;

(ii) to oversee the activities of Gilead in keeping the JV’s books and records pursuant to Section 8.1;

(iii) to adopt guidelines for compliance by the Parties with antitrust laws in connection with the JV activities;

(iv) to approve the initial Capital Contributions (as defined in the Operating Agreement) of the Members, to approve each Capital Contribution planning schedule, and to issue certain requests for additional Capital Contributions, in each case pursuant to Section 4.1 of the Operating Agreement;

(v) to approve (x) each annual update of the Development Plan and the Development Budget and (y) any interim update of the Development Plan or Development Budget, as the case may be, as to which the JDC is unable to reach agreement;

(vi) to approve (x) each annual update of the Commercialization Plans and the Commercialization Budgets and (y) any interim update of the Commercialization Plans or Commercialization Budgets, as the case may be, as to which the JCC or JCOC is unable to reach agreement;

(vii) to approve unit volume forecasts as to which the JCC or JCOC is unable to reach agreement for use in preparation of Commercialization Plans and Commercialization Budgets and (regardless of whether there is a Commercialization Plan or Commercialization Budget) for use in planning for Manufacture of the Combination Product, planning for Commercialization Activities and for the Member Parties’ own financial planning purposes;

(viii) to approve Cost Allocation Proposals;

(ix) to approve the JFC’s reports on financial matters that the JEC determines to be reasonably necessary or appropriate for the implementation of the financial aspects of the JV;

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(x) to review recommendations of the JFC with respect to, and approve, one or more means of reconciling, one to the other, the internal reporting and accounting standards of each of the Member Parties where reasonably necessary, and methods of charging costs and expenses of each of the Member Parties;

(xi) to review and, if applicable, recommend to the Member Parties changes to the [ * ] pursuant to Section 5.3A(i);

(xii) to resolve disputes within the JDC with respect to (A) any required approval of publications or presentations pursuant to Section 3.11(a), and (B) a Member Party’s obligation under Section 3.6(b), if any, to provide the other Member Party with access to certain of such Member Party’s records, documentation and data;

(xiii) to resolve disputes within the JCC or JCOC with respect to (A) the initially proposed marketing materials for the Combination Product for the applicable country in the Territory, and thereafter, updates of any Approved Marketing Materials, (B) a Member Party’s obligation, if any, pursuant to Section 5.10 to provide the other Member Party with access to certain of such Member Party’s records, documentation and data, (C) issues relating to the patient assistance programs arising under Section 2.4(b)(vii) and (D) issues relating to Suppliers and alternate suppliers arising under Section 2.4(b)(ix);

(xiv) to decide major strategic issues and any other matters relating to the JV that are not (i) within the purview of the Operating Committees or (ii) reserved to the Member Parties pursuant to this Agreement or the Operating Agreement;

(xv) to determine whether Launch of the Combination Product in Canada should occur and, if so, the timing thereof; and

(xvi) to take such other actions as are reserved to the JEC in this Agreement or the Operating Agreement or as the Parties may mutually agree in writing, except that the JEC may not amend or take any action that would conflict with any provision of this Agreement, the Operating Agreement or any Ancillary Agreement and may not resolve any issue regarding termination of this Agreement for a potential or actual Material Default.

2.3 Joint Development Committee .

(a) Each Member shall appoint four (4) members of a joint development oversight and management committee (the "Joint Development Committee" or "JDC"). Gilead Sub shall appoint one (1) of the members designated by Gilead Sub, to serve as chairperson of the JDC through the first anniversary of the Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JDC members and the chairperson are identified in Annex A hereto.

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(b) Subject to the oversight of the JEC, the JDC shall have the following powers and duties:

- - - to (x) review and propose to the JEC for its approval each annual update of the Development Plan and Development Budget and (y) review and approve each interim update of the Development Plan and Development Budget, in each case proposed pursuant to Section 3.7;
      
      to oversee and coordinate the Parties’ activities under the Development Plan;
      
      to oversee and manage matters relating to clinical supply of the Combination Product, including, without limitation, Manufacturing requirements, inventory projections and inventory control;
      
      with the Alliance Managers, (x) to assist in coordinating scientific interactions between the Parties during the course of implementing the Development Plan and (y) to facilitate the exchange among the Parties of data, information, materials and results relating to clinical manufacturing, clinical trials, and communications and filings with Regulatory Authorities for the Combination Product (in each case solely to the extent that such data, information and materials are required to be exchanged among the Parties, or with respect to which one Member Party has the right to gain access from the other Member Party or the JV, pursuant to this Agreement or the Operating Agreement);
      
      to oversee regulatory matters for the JV, including, without limitation, approving all Combination Product Regulatory Documentation to the extent required pursuant to Section 3.4, overseeing Gilead’s activities as the JV’s liaison with Regulatory Authorities in the Territory, and overseeing the activities conducted pursuant to the SDEA and other pharmacovigilance and safety reporting;
      
      to oversee the Member Parties’ activities pursuant to their respective Supply Agreements and to oversee and coordinate with the JCC with respect to matters relating to the monitoring of Manufacturing capacity, forecasts and orders for the active pharmaceutical ingredients of the Combination Product;
      
      to resolve disputes between the Member Parties with respect to (A) any required approval of publications or presentations pursuant to Section 3.11(a), and (B) a Member Party’s obligation under Section 3.6(b), if any, to provide the other Member Party with access to certain of such Member Party’s records, documentation and data;
      
      to oversee medical affairs and medical communications activities;
      
      to review and approve or reject proposals for Phase IV clinical studies of the Combination Product;
      
      to provide updates on the JDC’s activities and achievements to the JEC each Calendar Quarter; and
      
      to perform such other functions as the Member Parties may mutually agree in writing from time to time.

2.4 Joint Commercialization Committee .

(a) Each Member shall appoint four (4) members of a joint commercialization oversight and management committee (the "Joint Commercialization Committee" or "JCC"). BMS Sub shall appoint one (1) of the members designated by BMS Sub, to serve as chairperson of the JCC through the first anniversary of the Effective Date. Thereafter a member designated by Gilead Sub and then a member designated by BMS Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JCC members and the chairperson are identified in Annex A hereto.

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(b) Subject to the oversight of the JEC, the JCC shall have the following powers and duties:

- - - to oversee and coordinate the Parties’ activities under the U.S. Commercialization Plan;
      
      to (x) review and propose to the JEC for its approval each annual update of the U.S. Commercialization Plan and U.S. Commercialization Budget and (y) review and approve each interim update of the U.S. Commercialization Plan and U.S. Commercialization Budget, in each case proposed pursuant to Section 5.11(c);
      
      to oversee Gilead’s activities pursuant to the Services Agreement with respect to the distribution of the Combination Product in the United States;
      
      to develop and approve (x) initial marketing materials for the Combination Product in the United States, and (y) updates to such materials from time to time as may be reasonably necessary or appropriate, all in accordance with Section 5.7;
      
      to develop and approve unit volume forecasts for use in preparation of the U.S. Commercialization Plans and U.S. Commercialization Budgets and (regardless of whether there is a U.S. Commercialization Plan or U.S. Commercialization Budget) for use in planning for Manufacture of the Combination Product, planning for Commercialization Activities in the United States and for the Member Parties’ own financial planning purposes;
      
      to (x) determine how the JV will respond to requests in the United States from health care providers or from individual patients who have or may obtain prescriptions for the Combination Product but are unable to afford it, and (y) to establish the appropriate procedures and response times that shall apply in responding to such requests in the United States, in each case ((x) and (y)) in accordance with Section 5.2(a);
      
      to make recommendations to the JEC with respect to Cost Allocation Proposals relating to costs in the United States;
      
      to maintain one Supplier and one or more alternate suppliers pursuant to Section 4.2(a) for Manufacture of commercial supplies of the Combination Product;
      
      oversee and coordinate with the JDC with respect to matters relating to the Manufacturing and labeling of the Combination Product for commercial supply in the United States, including, in the case of Manufacturing, with respect to quality control matters, and the monitoring of Manufacturing capacity, forecasts and orders for the Combination Product to ensure adequate commercial supply to meet the demand therefor in the United States as projected by the JCC and approved by the JEC;
      
      to resolve disputes between the Member Parties with respect to a Member Party’s obligation, if any, pursuant to Section 5.10 to provide the other Member Party with access to certain of such Member Party’s records, documentation and data relating to Commercialization Activities in the United States;
      
      to provide updates on the JCC’s activities and achievements to the JEC each Calendar Quarter; and
      
      to perform such other functions as the Member Parties may mutually agree in writing from time to time.

2.5 Joint Canadian Operating Committee .

(a) Each Member shall appoint three (3) members of a joint oversight and management committee for commercialization in Canada (the "Joint Canadian Operating

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Committee" or "JCOC"). BMS Sub shall appoint one (1) of the members designated by BMS Sub, to serve as chairperson of the JCOC through the first anniversary of the Amended Effective Date. Thereafter a member designated by Gilead Sub and then a member designated by BMS Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Amended Effective Date. The initial JCOC members and the chairperson shall be designated by the applicable Party promptly after the Amended Effective Date.

(b) Subject to the oversight of the JEC, the JCOC shall have the following powers and duties:

- - - to oversee and coordinate the Parties’ activities under the Canadian Commercialization Plan;
      
      to (x) review and propose to the JEC for its approval each annual update of the Canadian Commercialization Plan and Canadian Commercialization Budget and (y) review and propose to the JEC for its approval each interim update of the Canadian Commercialization Plan and Canadian Commercialization Budget, in each case proposed pursuant to Section 5.11(c);
      
      to oversee Gilead’s activities pursuant to the Canada Distribution and Supply Agreement with respect to the distribution of the Combination Product in Canada;
      
      to develop and approve (x) initial marketing materials for the Combination Product for Canada, and (y) updates to such materials from time to time as may be reasonably necessary or appropriate, all in accordance with Section 5.7;
      
      to develop and approve unit volume forecasts for use in preparation of the Canadian Commercialization Plans and the Canadian Commercialization Budgets and (regardless of whether there is a Canadian. Commercialization Plan or Canadian Commercialization Budget) for use in planning for Manufacture of the Combination Product, planning for the Commercialization Activities in Canada and for the Member Parties’ own financial planning purposes;
      
      to (x) determine how the JV will respond to requests from Canadian health care providers or from individual patients who have or may obtain prescriptions for the Combination Product in Canada but are unable to afford it, and (y) appropriate procedures and response times that shall apply in responding to such requests in Canada, in each case ((x) and (y)) in accordance with Section 5.2(a);
      
      to make recommendations to the JEC with respect to Cost Allocation Proposals relating to costs in Canada;
      
      coordinate with the JDC with respect to matters relating to the Manufacturing and labeling of the Combination Product for commercial supply in Canada, including, in the case of Manufacturing, with respect to quality control matters, and the monitoring of Manufacturing capacity, forecasts and orders for the Combination Product to ensure adequate commercial supply to meet the demand therefor in Canada as projected by the JCOC and approved by the JEC;
      
      to resolve disputes between the Member Parties with respect to a Member Party’s obligation, if any, pursuant to Section 5.10 to provide the other Member Party with access to certain of such Member Party’s records, documentation and data relating to Commercialization Activities in Canada;
      
      to provide updates on the JCOC’s activities and achievements to the JEC each Calendar Quarter; and

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- - - to perform such other functions as the Member Parties may mutually agree in writing from time to time.

2.6 Joint Finance Committee .

(a) Each Member shall appoint two (2) members of a joint finance committee to support the JEC, the JDC, the JCC and the JCOC (the "Joint Finance Committee" or "JFC"). Gilead Sub shall appoint one (1) of the members designated by Gilead Sub, to serve as chairperson of the JFC through the first anniversary of the Effective Date. Thereafter a member designated by BMS Sub and then a member designated by Gilead Sub shall serve alternately as chairperson, on a rotating annual basis from each anniversary of the Effective Date. The initial JFC members and the chairperson are identified in Annex A hereto.

(b) Subject to the oversight of the JEC, the JFC shall have the following powers and duties:

- - - to work with the JEC and the other Operating Committees to assist in financial, budgeting and planning matters as required, including assisting in the preparation of budgets and annual and long-term plans;
      
      to recommend, for approval by the JEC, procedures, formats and timelines consistent with this Agreement for reporting financial data as well as additional or alternative reporting procedures concerning financial aspects of the JV;
      
      to prepare such reports on financial matters as are approved by the JEC for the implementation of the financial aspects of the JV;
      
      to coordinate audits of financial data where appropriate and required or allowed by this Agreement;
      
      to address issues of implementation relating to the financial mechanics and calculations under this Agreement and the Operating Agreement;
      
      to recommend, for approval by the JEC, a means of reconciling, one to the other, the internal reporting and accounting standards of each of the Member Parties where necessary and methods of charging costs and expenses of each of the Member Parties;
      
      to review the appropriate allocation of costs and expenses with respect to Authorized Expenses ;
      
      to calculate or cause to be calculated, as the case may be, those matters expressly required to be calculated (or caused to be calculated) by the JFC pursuant to this Agreement, including Sections 7.1(c) and 7.1(d), and pursuant to the Operating Agreement, and to address issues of implementation relating to the cash netting procedures set forth in Section 4.1(c) of the Operating Agreement;
      
      to develop and recommend to the JEC for approval the initial Capital Contributions (as defined in the Operating Agreement) of the Members and each Capital Contribution planning schedule, and to recommend to the JEC certain requests for additional Capital Contributions, in each case pursuant to Section 4.1 of the Operating Agreement;
      
      to provide updates on the JFC’s activities and achievements to the JEC each Calendar Quarter; and
      
      to perform such other functions as the Member Parties may mutually agree in writing from time to time.

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2.7 Procedural Rules of the Operating Committees .

(a) Each of BMS Sub and Gilead Sub shall designate representatives with appropriate expertise to serve as members of each Operating Committee, and each representative may serve on more than one (1) Operating Committee (and/or the JEC) as appropriate in view of the individual’s expertise. The Members shall endeavor to match their respective representation on each Operating Committee, in terms of functional areas and management level.

(b) A member of an Operating Committee may be removed or replaced at any time, with or without cause, by the Member that appointed such committee member. Such action shall be accomplished by written notice to the other Member. Each member of an Operating Committee shall serve until a successor is named by the Member that appointed such committee member (or until his or her earlier resignation or removal).

(c) The JFC shall meet at least one (1) time per Calendar Quarter during the term of this Agreement. The JDC shall meet at least one (1) time per Calendar Quarter until the first anniversary of the later to occur of the Launch of the Combination Product in the United States and the Launch thereof in Canada (or termination of this Agreement with respect to Canada pursuant to Section 14.3), and thereafter at least semiannually (or on such other schedule as may be determined by the JDC). The JCC shall meet at least one (1) time per Calendar Quarter until the second anniversary of the Launch of the Combination Product and thereafter at least semiannually (or on such other schedule as may be determined by the JCC). The JCOC shall meet at least one (1) time per Calendar Quarter until the second anniversary of the Launch of the Combination Product in Canada. Each Operating Committee other than the JCOC shall meet at times and places in the United States mutually agreed by BMS Sub and Gilead Sub. The JCOC shall meet at times and places mutually agreed by BMS Sub and Gilead Sub. The respective Operating Committees shall meet to discuss the overall progress of the Development Activities in the Development Plan or Commercialization Activities in the Commercialization Plans, or the financial aspects of the JV, as the case may be, and any problems arising in the course of such activities; the status of the Development Plan and Development Budget, the Commercialization Plans and Commercialization Budgets, or other financial aspects of the JV, as the case may be; and any other matter that a member of such Operating Committee may reasonably request. Each Operating Committee shall keep accurate and complete minutes of its meetings to record all proposals, recommendations and actions taken. All such minutes and other records of each Operating Committee shall be available to each Member Party.

(d) The chairperson shall organize committee meetings, prepare the meeting agenda based on items submitted by committee members, take or cause to be taken accurate minutes of meetings, circulate draft minutes within seven (7) days after the meeting for approval by the other Member’s committee members, and circulate final minutes to the committee members promptly following such approval. Notice of, and the agenda for, each meeting (and any accompanying materials) shall be circulated to the members of the applicable Operating Committee sufficiently in advance so that in the normal course such materials will be received at least five (5) Business Days in advance of such meeting; provided , however , that under reasonable circumstances such materials may be circulated within a lesser period of time in advance of the meeting, so long as each Member agrees to the inclusion on such agenda of any

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items proposed for consideration by the other Member. Any member of an Operating Committee may waive notice of a meeting thereof, and shall be deemed to waive such notice (but not, if applicable, his or her right to object to the inclusion of a particular agenda item or items as set forth in the proviso to the previous sentence) if he or she attends the meeting and does not object to the meeting because of a lack of notice prior to its commencement.

(e) At least two (2) members appointed by Gilead Sub and two (2) members appointed by BMS Sub must be in attendance at a meeting of an Operating Committee to establish a quorum for the conduct of business. Committee members may attend meetings in person or, as long as each attendee is able to hear the others, by telephone or by video conference equipment; provided , however , that at least two (2) meetings per Calendar Year of each Operating Committee shall be held in person until the Launch of the Combination Product in the United States, and thereafter at least one (1) meeting per Calendar Year of each Operating Committee shall be held in person. Each Operating Committee may also act by unanimous written consent of its members without a meeting.

(f) At each meeting of an Operating Committee, each Member’s designees on such Operating Committee shall, collectively, have one (1) vote on all matters to be acted upon (the "Member Vote"). Each Operating Committee shall take action by unanimous Member Vote. If an Operating Committee is unable to reach agreement on a matter properly presented to such Operating Committee for its consideration, the matter shall be resolved by the procedure set forth in Section 2.9 (except as otherwise provided therein).

(g) Each Operating Committee may, as it deems appropriate, delegate its decision-making authority for specific matters or types of matters (other than, as applicable in the case of the JDC and JCC, approval of updates of the Development Plan, any Commercialization Plans, Development Budget or any Commercialization Budget for which that Operating Committee is responsible, or as provided in Section 3.4) to subcommittees or specific groups, each with representatives from both Members, which shall make such decisions by consensus. If such subcommittees or groups do not reach consensus on a matter, either Member may refer such matters back to such Operating Committee for resolution.

(h) Notwithstanding the enumerated authority of the JEC in this Agreement and the Operating Agreement and the express reservation to the decision-making authority of the Member Parties of certain matters herein and therein: in the event that the JEC, acting (i) by unanimous affirmative Member Votes (as defined in the Operating Agreement) pursuant to Section 6.5(d) of the Operating Agreement, or (ii) by unanimous written consent pursuant to Section 6.5(c) of the Operating Agreement, takes action on a matter relating to the Exploitation of the Combination Product, but with respect to which matter authority and responsibility have not been delegated to or vested in the JEC, the Member Parties shall be deemed to waive any objection to the effect that the JEC acted beyond the scope of its authority or responsibility, and the resolution of such matter shall be binding on the Member Parties for purposes of this Agreement and the Operating Agreement.

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2.8 Alliance Managers .

(a) Gilead and BMS shall each designate within their respective organizations an alliance manager (an "Alliance Manager") with responsibility for facilitating the interaction and cooperation between Gilead and BMS with respect to the JV and the Exploitation of the Combination Product in the Territory. The initial Alliance Managers are identified in Annex A hereto. Each Member Party may change its Alliance Manager from time to time upon written notice to the other Member Party.

(b) The Alliance Managers shall attend all meetings of the JEC and each Operating Committee (other than the JFC and JCOC) and support the chairpersons of the JEC and each Operating Committee in the discharge of their responsibilities. The Alliance Managers shall be nonvoting participants in such meetings, unless they are also appointed members of the applicable committee(s). Each Alliance Manager shall endeavor to create and maintain a collaborative work environment within and among the JEC and the Operating Committees. In addition, each Alliance Manager: (i) shall be the point of first referral in certain matters subject to dispute resolution as provided in Section 2.9; (ii) shall coordinate the relevant functional representatives of the Member Parties; (iii) shall provide a single point of communication for seeking consensus both internally within the respective Member Parties’ organizations and between the Member Parties; (iv) shall identify and bring disputes to the attention of the JEC or an Operating Committee as appropriate in a timely manner; (v) shall plan and coordinate cooperative efforts and internal and external communications; and (vi) shall take responsibility for ensuring that governance activities, such as the conduct of required JEC and Operating Committee meetings and production of meeting minutes, occur as set forth in this Agreement and in the Operating Agreement and that relevant action items agreed upon at such meetings are appropriately carried out or otherwise addressed.

(c) Notices given by a Member Party to the other Member Party with respect to Development Activities, Combination Product or EFV, TDF or FTC bulk active pharmaceutical ingredient Manufacturing and Commercialization Activities shall be made to the other Member Party’s Alliance Manager and to such other Operating Committee or JEC member of such other Member Party as is most directly involved in or informed of the relevant activity, except that if Gilead or BMS is selected as the Supplier pursuant to Section 4.2(a), it shall not be required to provide such notice to the other Member Party’s Alliance Manager with respect to its toll manufacturing activities.

2.9 Dispute Resolution .

(a) Disputes may be referred to the JEC for resolution, as follows: (i) if an Operating Committee is unable to reach agreement on a matter properly presented to such Operating Committee for its decision, the Operating Committee shall refer the matter to the Alliance Managers for Gilead and BMS, and if the Alliance Managers are unable to resolve the dispute within [ * ] after such referral, then the matter shall be referred to the JEC; and (ii) either Member Party may refer to the JEC any issue arising under this Agreement or the Operating Agreement and not otherwise covered by clause (i).

(b) If the JEC is unable to resolve a dispute referred to it by the Alliance Managers or by a Member Party pursuant to Section 2.8(a) within [ * ] after such

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referral, or in the event that the JEC is unable to resolve a dispute arising within the JEC, then the dispute shall be referred for resolution to the Chief Executive Officer of Gilead Parent and, for BMS, the Chief Executive Officer of BMS Parent or any direct report designated by the Chief Executive Officer of BMS Parent (who shall not be a member of the JEC or any Operating Committee).

(c) If the Chief Executive Officer of Gilead Parent and Chief Executive Officer (or designee, as applicable) of BMS Parent are unable to reach agreement on a disputed matter referred to them pursuant to Section 2.9(b) within [ * ] after such referral, then either Gilead or BMS may refer the disputed matter to binding arbitration pursuant to Section 15.6 if and only if, and to the extent that (A) the disputed matter relates to or arises out of the validity, interpretation or construction of, or the compliance with or breach of, this Agreement, the Operating Agreement, any Ancillary Agreement, or any other agreement contemplated by this Agreement to which a Member Party (or its Affiliates) and the JV and/or the other Member Party (or its Affiliates) are parties; (B) the disputed matter came before the JEC pursuant to Section [ * ], or Section [ * ] (provided that any dispute relating to the [ * ] may be submitted to arbitration only with respect to the issue of whether specific [ * ] are [ * ], any dispute relating to [ * ] pursuant to [ * ] may be submitted to arbitration only with respect to the issue of [ * ], any dispute relating to [ * ] may be submitted to arbitration only with respect to matters arising pursuant to [ * ] may be submitted to arbitration only with respect to matters arising pursuant to [ * ]; or (C) there is a dispute as to whether the [ * ] are satisfied with respect to a matter.

(d) For the avoidance of doubt, the dispute resolution procedures set forth in Sections 2.9(a), 2.9(b) and 2.9(c) shall not apply to any deadlock within the JEC or any Operating Committee resulting from a proposal by one Member’s committee members to reverse or modify a decision of the JEC or such Operating Committee with respect to a matter previously presented to it for decision and approved by unanimous Member Vote or unanimous written consent of its members, unless all of the following conditions are satisfied: (i) such proposal is [ * ] the applicable JEC or Operating Committee decision; (ii) the deadlock involves [ * ]; and (iii) the applicable JEC or Operating Committee decision, if not reversed or modified, would [ * ] pursuant to this Agreement (it being understood that if only certain aspects of the applicable JEC or Operating Committee decision produce these results, only they shall be subject to the dispute resolution procedures set forth in Sections 2.9(a), 2.9(b) and 2.9(c), and the balance of such decision shall remain in effect); provided , however , that this Section 2.9(d) shall not apply to the deliberations and decisions of the JCC pursuant to Sections [ * ], and deliberations and decisions of the JEC with respect to any disputes that arise within the JCC with respect thereto; and provided , further , that the JCC’s and the JEC’s reconsideration of prior decisions with respect to the matters covered by the preceding proviso shall be governed by [ * ], respectively, and in the event of any such reconsideration (and any dispute resolution and arbitration in connection therewith), the prior decision in force at the time of reconsideration shall remain in force and continue to apply until such time, if any, as a modified position may be agreed by the JCC or the JEC, or adopted by the arbitrator(s), as the case may be.

(e) Nothing in this Section 2.9 shall affect the right of a Member Party to exercise its rights under Section 14.4 with respect to a Material Default by the other Member Party, concurrently with the exercise of its rights under this Section 2.9. In the event that, at any

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time prior to completion of the dispute resolution procedures set forth in this Section 2.9, the Non-Breaching Member Party delivers a notice of Material Default to the Breaching Member Party, the sixty (60) day cure period referred to in Section 14.4(a) shall begin to run upon the receipt of such notice and shall run concurrently with the procedures set forth in this Section 2.9.

2.10 Collaboration Principles . The Parties agree to abide by the following principles ("Collaboration Principles") in their conduct of the Development Activities and the Commercialization Activities, and to cause their representatives on the JEC and the Operating Committees to observe these principles in connection with their committee-related activities:

(a) Subject to Sections 2.10(b) and (c), the purposes of the JV are (i) to develop, manufacture, and commercialize the Combination Product for use within the Territory, and (ii) to optimize the commercial potential of the Combination Product within the Commercialization Plans, subject to the applicable Commercialization Budget. For the avoidance of doubt, nothing in this Agreement or in the Operating Agreement shall be deemed to restrict or prohibit either Member Party or any of its Affiliates from (x) commercializing its Single Agent Product(s) and/or Double Agent Product as applicable, (y) subject to Sections 3.10 and 5.6, developing, manufacturing and commercializing combination products (other than the Combination Product) for the treatment of HIV infection or otherwise, including, without limitation, any product containing such Party’s Single Agent Product(s) and/or Double Agent Product or (z) conducting clinical studies involving one or more of EFV, FTC and TDF, or any combination thereof (including the Combination Product).

(b) Subject to Section 5.7, each Party’s Promotion of the Combination Product in the Territory shall be in accordance with the Approved Marketing Materials, and the label and the package insert for the Combination Product approved by the applicable Regulatory Authority; provided , however , that subject to the foregoing, each Party shall have a right to position the Combination Product within its HIV product portfolio in its sole discretion.

(c) Except as expressly provided otherwise in this Agreement (or in the Operating Agreement or any Ancillary Agreement) and notwithstanding the powers and authority delegated to a Party, the JEC or an Operating Committee, neither Party shall have any obligation (i) to conduct activities in support or furtherance of the Exploitation of the Combination Product, unless mutually agreed in writing by the Parties or expressly set forth in this Agreement, any Commercialization Plan or the Development Plan, or (ii) to make payments or incur expenses or liabilities in support or furtherance of the Exploitation of the Combination Product unless mutually agreed in writing by the Parties or expressly set forth in the Commercialization Budgets or the Development Budget.

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2.11 Commercialization Budget/Plan Deadlocks . In the event of a Commercialization Budget Deadlock or a Commercialization Plan Deadlock (as such terms are defined below) with respect to any portion of the period from the Effective Date through the end of the Subsequent Launch Period in the United States or Canada, as applicable, then in lieu of any other dispute resolution procedures set forth in this Agreement or in the Operating Agreement, the Parties agree that the dispute shall be conclusively resolved as follows:

(a) If a Commercialization Budget Deadlock relates to any Calendar Year (or part thereof) during the period from the Effective Date through the end of the Initial Launch Period in a Commercialization Budget, the level of aggregate expenditure for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (i) in the case of disputes on annual updates, the level for the Calendar Year in dispute provided for in the initial version of such Commercialization Budget included in Annex C or Annex U hereto (as most recently updated, if applicable), or (ii) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year.

(b) If a Commercialization Budget Deadlock relates to any Calendar Year (or part thereof) during the Subsequent Launch Period in a Commercialization Budget, (i) the level of aggregate expenditure for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (A) in the case of disputes on annual updates, [ * ] of the level (as most recently updated) budgeted for the Calendar Year immediately preceding the Calendar Year in dispute unless both Members, through their respective representatives on the JEC have proposed levels of aggregate expenditure both of which are lower than the aforesaid [ * ] level, in which case the level of aggregate expenditure for the Calendar Year in dispute shall instead be fixed at the [ * ] of the [ * ] by the Members through their respective representatives on the JEC, or (B) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year, and (ii) if there is a dispute regarding the level of aggregate expenditure provided for in a subsequent annual update to such Commercialization Budget covered by the foregoing clause (A), such level shall be fixed, upon notice given by a Member Party to the other Member Party, at the amount [ * ] which is the [ * ] of the [ * ] by the Members through their respective representatives on the JEC.

(c) If a Commercialization Plan Deadlock relates to any Calendar Year (or part thereof) during the Initial Launch Period in a Commercialization Plan, the [ * ] for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (i) in the case of disputes on annual updates, the level for the Calendar Year in dispute provided for in the initial version of such Commercialization Plan included in Annex C or Annex U hereto (as most recently updated, if applicable), or (ii) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year.

(d) If a Commercialization Plan Deadlock relates to any Calendar Year (or part thereof) during the Subsequent Launch Period in a Commercialization Plan, (i) the [ * ] for the Calendar Year (or part thereof) in dispute shall be fixed, upon notice given by a Member Party to the other Member Party, at (A) in the case of disputes on annual updates, [ * ] of the level (as most recently updated) in effect for the Calendar Year immediately preceding the Calendar Year in dispute, unless both Members, through their respective representatives on the JEC, have proposed [ * ] both of which are lower than the aforesaid [ * ] level, in which case the [ * ] for the Product Year in dispute shall instead be fixed at the [ * ] of the [ * ] by the Members through their respective representatives on the JEC, or (B) in the case of disputes on interim updates, the level then in effect for the relevant part of the current Calendar Year, and (ii) if there

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is a dispute regarding the [ * ] provided for in a subsequent annual update to such Commercialization Plan covered by the foregoing clause (A), such level shall be fixed, upon notice given by a Member Party to the other Member Party, at the amount (which [ * ] is the [ * ] of the [ * ] by the Members through their respective representatives on the JEC.

For Calendar Years (or any part thereof) commencing after the Subsequent Launch Period, any aggregate expenditures in the Commercialization Budget for a country in the Territory, and any [ * ] in the Commercialization Plan for such country, shall be decided by the mutual agreement in writing of the Member Parties; failure to reach agreement thereon shall not be subject to dispute resolution hereunder. As used in this Agreement, (x) a "Commercialization Budget Deadlock" shall mean that the JEC is unable to reach agreement, by unanimous Member Vote (as defined in the Operating Agreement) or unanimous written consent of the members of the JEC, on the level of aggregate expenditure in any annual or (in the case of clause (y) of Section 2.2(vi)) interim update to any Commercialization Budget covering all or any portion of the period from the Effective Date through the end of the Initial Launch Period for such country or all or any portion of the Subsequent Launch Period for such country, and (y) a "Commercialization Plan Deadlock" shall mean that the JEC is unable to reach agreement, by unanimous Member Vote or unanimous written consent of the members of the JEC, on the [ * ] to be conducted in any annual or (in the case of clause (y) of Section 2.2(vi)) interim update to a Commercialization Plan covering all or any portion of the Initial Launch Period or the Subsequent Launch Period for such country.

2.12 Expenses . Gilead and BMS shall each bear their own expenses related to the management of the JV, including without limitation all expenses relating to the meetings of the JEC and the Operating Committees, the participation of the Members’ representatives in such meetings, communications with the other Member in connection with such meetings or matters within the authority of the committees, and travel to and from such meetings, and such expenses shall not be deemed JV Expenses or Authorized Other Expenses.

SECTION 3.

DEVELOPMENT ACTIVITIES

3.1 General . Under the oversight of the JDC, Gilead and BMS shall each perform, or cause its Affiliates to perform, on behalf of and in the name of the JV, the Development Activities designated for such Member Party in the Development Plan, in each case in accordance with the timeline set forth in the Development Plan. For the avoidance of doubt, Gilead, on its own behalf and in its own name, shall have the sole right to [ * ] in its sole discretion and without oversight by the JDC or the JEC, but shall [ * ] with respect to [ * ] of such [ * ].

3.2 Clinical Development .

(a) Without limitation of Section 3.1, Gilead, under the oversight of the JDC, shall have primary responsibility for the development of the Combination Product and the conduct of any clinical trials and bioequivalence studies required for obtaining approval of (i) an NDA for the Combination Product in the United States in the Field, and (ii) an NDS for the

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Combination Product in Canada in the Field, in each case only as set forth in the Development Plan or otherwise mutually agreed upon by the Member Parties.

(b) In the event that either Member Party desires (i) to conduct or sponsor, or cause to be conducted or sponsored, jointly with the other Member Party, or in the name of the JV, a clinical trial of the Combination Product (whether such clinical trial would involve the Combination Product alone, or with one or more other products) other than any clinical trial contemplated by the Development Plan, including, without limitation, an expanded access program or Phase IIIb/IV study, or (ii) to support jointly with the other Member Party (either on their own behalf or in the name of the JV) any such clinical trial sponsored by an investigator, such Member Party shall so notify the other Member Party. The Member Parties shall then discuss the particulars of the proposed clinical trial. In the event that the Member Parties, each in its sole discretion, agree to conduct jointly or sponsor jointly such clinical trial (either on their own behalf or in the name of the JV), the JDC representatives shall prepare and agree upon a trial protocol and designate a Member Party to take the lead in conducting or supervising such clinical trial and negotiating any necessary clinical trial agreements, as the case may be, and the external, out-of-pocket costs of the Member Parties, if any, without any markup, relating to such clinical trial shall be treated as Authorized Development Expenses. In the event that the Member Parties, each in its sole discretion, agree to support jointly (either on their own behalf or in the name of the JV) any investigator-sponsored clinical trial, the Member Parties shall coordinate with the investigator seeking to conduct such clinical trial and agree upon an appropriate grant of support (including, without limitation, support in the form of funding or the contribution of drug product), and the external, out-of-pocket costs of the Member Parties, if any, without any mark up, with respect to such clinical trial shall be treated as Authorized Development Expenses. Each clinical trial that the Member Parties shall determine to conduct, sponsor or support jointly pursuant to the preceding two sentences shall be referred to as a "Co-Funded Clinical Trial." The Clinical Data with respect to any Co-Funded Clinical Trial shall be deemed to be Joint Know-How; provided , however , that, in the case of any investigator-sponsored clinical trial, the Clinical Data resulting from any such Co-Funded Clinical Trial shall be deemed to be Joint Know-How only if and to the extent that the JV or either or both Member Parties obtains any right, title and interest in and to such Clinical Data.

For the avoidance of doubt, nothing contained in this Section 3.2 is intended, or shall be construed, to restrict or prohibit either Member Party from conducting independently or together with one or more Third Parties, any clinical trial of the Combination Product (whether such clinical trial would involve the Combination Product alone, or with one or more other products). Prior to a Member Party’s commencing any such clinical trial sponsored by such Member Party, whether independently or together with one or more Third Parties, the applicable Member Party shall provide a brief summary of the protocols to the other Member Party’s representatives on the JDC (it being understood that neither such representatives nor the JDC shall have any approval rights with respect to such study or protocols), provided that (A) each such summary shall constitute Confidential Information of the disclosing Member Party to the extent that the information provided in such summary satisfies the criteria set forth in Section 12.3, (B) the receiving Member Party’s representatives shall not use such summary for any purpose other than providing comments thereon to the disclosing Member Party (which

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comments may be accepted or rejected by the disclosing Member Party in its sole discretion), and (C) the receiving Member Party’s representatives shall not disclose such summary to any Persons other than employees of such Member Party who have an obligation (x) not to further disclose such summary and (y) to use such summary solely in order to assist such Member Party’s representatives in providing comments thereon. For the avoidance of doubt, a Member Party’s providing such summary with respect to any such clinical trial pursuant to this Agreement shall not be construed to have the effect of causing the activities with respect to such clinical trial to be deemed to be Project Activities for purposes of this Agreement.

(c) In the event that the Member Parties determine to conduct additional Development Activities for an alternative formulation or presentation of the Combination Product, and conduct or cause to be conducted such additional activities, the external, out-of-pocket costs of the Member Parties, if any, without any markup, with respect to such activities shall be treated as Authorized Development Expenses.

3.3 Formulation and CMC Data . Without limitation of Section 3.1, Gilead, under the oversight of the JDC, shall have primary responsibility for formulation and Manufacturing Process development for, and preparation of the CMC Data relating to, the Combination Product as contemplated by the Development Plan. Formulation development shall include, without limitation, conducting the formulation screening, optimization, scale-up and technology transfer for the Combination Product in the Field.

3.4 Regulatory Matters .

(a) Without limitation of Section 3.1, Gilead, under the oversight of the JDC and with the participation of BMS as described in this Section 3.4, shall have primary responsibility for preparing and filing all necessary Regulatory Documentation and for acting as liaison on behalf of the JV for all communications with the Regulatory Authorities in the Territory relating to the obtaining of approval of the Combination Product in the Field, in the case of the United States, under an NDA separate from the respective NDAs for Sustiva, Viread, Emtriva and Truvada, and in the case of Canada, under an NDS separate from the respective NDSs for Sustiva, Viread, Emtriva and Truvada. Gilead shall prepare and file all Combination Product Regulatory Documentation with Regulatory Authorities in the Territory in the name of the JV. All submissions of Combination Product Regulatory Documentation consisting of any INDs, NDAs, sNDAs, CTAs, NDSs, SNDSs, CMC Data, drug master files and PSURs (collectively, the "Key Regulatory Submissions") shall be approved in advance by the JDC (which shall not delegate such approval to any subcommittees or groups referred to in Section 2.6(g)). If permitted by Applicable Law, the label for the Combination Product shall list the agents in the following order: [ * ]. For the avoidance of doubt, this Section 3.4(a) shall not apply with respect to obtaining and maintaining the [ * ].

(b) Gilead shall notify BMS as early as reasonably practicable in advance of all meetings (whether face to face or by teleconference) and communications with representatives of the Regulatory Authorities in the Territory concerning the Combination Product and in order to provide BMS with an opportunity to be present at such meetings and to review and comment on such communications; provided , however , that in no event shall Gilead,

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after using reasonable efforts to provide BMS with an opportunity to be present at any such meeting or to review and comment on such communications, be required to postpone any such meeting to ensure that BMS attends such meeting or to postpone any such communication in order to ensure that BMS’ comments are received by Gilead in advance of its submission to Regulatory Authorities, as the case may be. In order to enhance the efficiency of the Member Parties’ coordination on regulatory matters concerning the Combination Product, and increase the likelihood that BMS will have a meaningful opportunity to participate in such activities, during the term of this Agreement, BMS will cause one of its employees with the necessary regulatory expertise and decision-making authority to be dedicated on a full-time basis to serving as a conduit for BMS’ participation in such activities. Gilead shall promptly forward to BMS in advance of any such meeting copies of all documents and other relevant information relating to such meeting. Notwithstanding anything contained in this Agreement to the contrary, (i) at any such meeting with, or any such communication to, the Regulatory Authorities in the Territory concerning the Combination Product, at which BMS and Gilead are present or in which both Member Parties participate, each Member Party shall take the lead on matters relating to its respective Single Agent Product(s) or Double Agent Product and (ii) at any such meeting with, or any such communication to, such Regulatory Authorities concerning the Combination Product, at which only one Member Party meets or in which communication only one Member Party participates (without the other Member Party’s presence or participation), such Member Party shall not engage in any substantive discussions pertaining to the other Member Party’s Single Agent Product(s) or Double Agent Product, as the case may be, including, without limitation, with respect to API consisting of EFV, TDF or FTC, as the case may be, as it relates to the Combination Product. Notwithstanding anything in this Section 3.4(b) to the contrary, this Section 3.4(b) shall not apply with respect to obtaining and maintaining the [ * ].

(c) Each Member Party shall promptly forward to the other Member Party any written communications received from representatives of the Regulatory Authorities relating to the Combination Product. BMS shall provide Gilead with full access to and copies (including electronic copies if requested) of the BMS Regulatory Documentation, including without limitation the NDA and NDS for Sustiva, as Gilead may reasonably request in connection with (and solely for the purpose of) the performance of its duties under this Section 3.4. Notwithstanding anything in this Section 3.4(c) to the contrary, this Section 3.4(c) shall not apply with respect to obtaining and maintaining the [ * ].

(d) Nothing in this Section 3.4 shall prohibit or restrict either Member Party from communicating with the Regulatory Authorities on matters relating to the Exploitation of any of its respective Single Agent Product(s), Double Agent Product or other pharmaceutical products. Each Member Party shall promptly notify the other Member Party of any label change for the first Member Party’s respective Single Agent Product(s) or Double Agent Product that may result in a label change for the Combination Product. If any communications from Regulatory Authorities regarding potential label changes for the Combination Product are reasonably expected to lead to a label change for a Member Party’s Single Agent Product or Double Agent Product, then, notwithstanding anything in this Agreement to the contrary, the affected Member Party shall take the lead in dealing with the Regulatory Authorities on such matter.

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3.5 Performance; Subcontracting . Gilead and BMS each shall perform its respective Development Activities in material compliance with GCP, GLP, and GMP, in each case to the extent applicable, and the requirements of Applicable Law, and so long as there is a Development Plan in effect, shall use Commercially Reasonable Efforts to perform its Development Activities under the Development Plan efficiently and expeditiously, subject to the Development Budget. Either Member Party may subcontract the performance of its respective Development Activities; provided , however , that the subcontracting Member Party shall oversee the performance by its subcontractors of the subcontracted Development Activities in a manner that would be reasonably expected to result in their timely and successful completion and shall remain responsible for the performance of such Development Activities in accordance with this Agreement and the Development Plan.

3.6 Records .

(a) Maintenance of Records . Gilead and BMS each shall severally (in accordance with their respective allocations of responsibilities with respect to Project Activities) maintain, or cause to be maintained, all Combination Product Regulatory Documentation and final supporting records and documentation therefor (but not draft records or documentation therefor except as otherwise required by Applicable Law), in sufficient detail and in material compliance with GCP, GLP, and GMP, in each case to the extent applicable. Such records shall be complete and accurate and shall fully and properly reflect all work done and results achieved in the performance of its respective Development Activities in a manner appropriate for any regulatory purpose and, when applicable, for use in connection with Patent filings, prosecution and maintenance. Such documentation and records shall be retained for at least (i) three (3) years or (ii) such longer period as may be required by Applicable Law.

(b) Access to Records . Each Member Party shall have the right, during normal business hours and upon reasonable notice, to inspect and copy any Combination Product Regulatory Documentation and final supporting records and documentation therefor generated or maintained by the other Member Party, for use by the receiving Member Party solely in connection with the performance of its Development Activities in a manner consistent with the Development Plan. Subject to the terms and conditions of this Section 3.6(b), each Member Party shall also have the right, during normal business hours and upon reasonable notice, to obtain from the other Member Party access to or copies of scientific, regulatory and technical records, documentation and data solely to the extent relating to the Combination Product or such other Member Party’s Single Agent Product(s) and/or Double Agent Product, as the case may be, and solely to the extent (i) necessary in order for the receiving Member Party to perform its obligations with respect to Development Activities in a manner consistent with the Development Plan, (ii) necessary for the receiving Member Party to confirm compliance with and/or to comply with GLP, GCP and GMP (to the extent applicable), and other Applicable Law, as it relates to Project Activities, and/or (iii) necessary to enable the receiving Member Party to conduct reasonable diligence on matters potentially giving rise to liability on the part of the JV and/or such receiving Member Party, or to conduct a defense of itself and/or the JV with respect to any such liability, if and to the extent that a fact, circumstance or event has arisen that gives the receiving Member Party a reasonable basis to believe that it or the JV has or may incur such liability, in each case for use by the receiving Member Party for the purpose set forth in clause

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(i), (ii) or (iii) above, as the case may be. Clause (iii) of the immediately preceding sentence shall not require any Party to provide such data, documentation or records in the event that the Parties’ interests in such matter are or may be [ * ], in which case [ * ], shall apply. Each such request shall be made in writing and shall state the reason(s) therefor (each a "Development Record Request"). The Member Party from which such records, documentation or data are requested shall have the right to raise reasonable objections in writing in response to such Development Record Request, including, without limitation, based on such Member Party’s interests in protecting from disclosure to the requesting Member Party trade secrets or other competitive business information. Upon any such objection being asserted, the Member Parties shall promptly confer in an attempt to address each Member Party’s concerns and reach a resolution with respect to the matter, and in the event that the Member Parties are unable to agree upon a mutually agreeable resolution, either Member Party shall have the right to refer the matter to the JDC. In the event that any such dispute is ultimately [ * ] determine as a threshold matter whether and to what extent one or more criteria set forth in clauses (i), (ii) and/or (iii) above have been satisfied by the requesting Member Party, and, if so, shall make a determination with respect to whether and to what extent the disclosure of such information shall be required by [ * ]. In making such determination, [ * ] to the facts and arguments set forth in the Development Record Request and the other Member Party’s written response thereto, and (y) shall have the right to require the receiving Member Party to abide by terms and conditions for the handling, use and non-disclosure (either within such Member Party’s organization and/or to Third Parties) of such information as may be reasonable under the circumstances. Except as provided in this Section 3.6, a Member Party shall not have the right to obtain from the other Member Party access to or copies of the other Member Party’s records, documentation and data described above, unless otherwise expressly permitted pursuant to this Agreement or the other Member Party gives its consent in its sole discretion.

3.7 Updates to Development Plan and Development Budget . Gilead shall prepare and submit to each of the JDC and JFC (i) not less than [ * ] prior to the start of each Calendar Year, a proposed update to the Development Plan and the Development Budget for such Calendar Year and (ii) not less than [ * ] prior to the start of each Calendar Year, a preliminary update to such Development Budget (which may address budget issues at a general level, may be incomplete and is subject to change). In addition, either Member Party, directly or through its representatives on the JDC, may propose updates to the Development Plan and the Development Budget to the JDC from time to time as appropriate in light of changed circumstances. Such changes and updates shall be subject to approval by the JDC as set forth in Section 2.7(f), with annual updates to be approved at least [ * ] prior to the start of such Calendar Year. If an annual or interim update to the Development Plan or the Development Budget is not approved by the JDC, then, subject to Sections 2.2(v) and 2.9 as applicable, the Development Plan or Development Budget, as the case may be, shall continue in effect as approved and most recently updated pursuant to this Section 3.7. Updated Development Plans shall not cover items other than those included in the initial Development Plan unless mutually agreed by the Member Parties.

3.8 Development Expenses . [ * ] shall be [ * ] responsible for all costs that it incurs (a) in its sole discretion, in connection with the [ * ] or (b) in the performance of [ * ]

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Development Activities as set out in the Development Plan attached hereto as Annex B, [ * ] attached hereto as Annex V. The Parties agree that the JV shall bear all JV Expenses incurred by Gilead or BMS in connection with the performance of its respective Development Activities to the extent meeting all of the following criteria ("Authorized Development Expenses"): (i) such Development Activities are conducted pursuant to the Development Plan and are within an area of responsibility for the relevant Member Party listed in the Development Budget as being chargeable to the JV; (ii) the total expenses for that area of responsibility for that Member Party for the relevant period to the extent that they do not exceed the corresponding budgeted amount for that area in that period by more than [ * ] unless approved by the JDC; (iii) the expenses are external, out-of-pocket costs of Gilead or BMS, without any markup; and (iv) the expenses are not [ * ] costs of [ * ] referred to in the [ * ].

3.9 Reports . Gilead and BMS shall each present to the other, at a meeting of the JDC at least once per Calendar Quarter until the first anniversary of the Launch of the Combination Product in the United States, and, thereafter, at a meeting of the JDC, at least semiannually, a report (oral and written, which written report shall not be required to contain more detail than that typically included in an executive summary) describing (i) the Development Activities it has performed, or caused to be performed, since the preceding meeting at which such a report was presented (or, in the case of the first meeting of the JDC, prior to such meeting) and on a Calendar Year-to date basis, evaluating the work performed in relation to the goals and timeline of the Development Plan, (ii) its Development Activities in process and the future activities it expects to initiate during the then-current Calendar Year, as compared to the Development Plan, and (iii) in the case of the written report the Authorized Development Expenses incurred, and expected to be incurred, by such Member Party for the then-current Calendar Year, as compared to the Development Budget. In addition, Gilead and BMS shall report promptly to the JDC through their respective committee members any material developments with respect to Development Activities that they are responsible for performing under the Development Plan. Notwithstanding anything contained in this Section 3.9 to the contrary, each Member Party’s reporting obligations under this Section 3.9 shall automatically be deemed to terminate with respect to any period in which there is not then in effect a Development Plan and Development Budget.

3.10 New Products . During the period from the Effective Date through the [ * ] anniversary of the Effective Date, the Member Parties agree to use commercially reasonable efforts to evaluate and pursue an arrangement with each other for the co-development and co-commercialization of a [ * ] product comprising [ * ]; provided , however , that the Member Parties may terminate such efforts by mutual written agreement if they determine that the proposed product is not commercially or technically feasible, with such agreement to terminate not to be unreasonably withheld. In furtherance of the foregoing, notwithstanding anything in this Agreement to the contrary, during the period from the Effective Date through the [ * ] anniversary of the Effective Date (a) Gilead shall not (and shall cause its Affiliates not to) [ * ] an [ * ] with any [ * ] for [ * ] within the Territory of any [ * ] that contains [ * ] with a [ * ] that is (i) [ * ] to that Third Party and (ii) [ * ] in the Territory as of [ * ], and (b) BMS shall not (and shall cause its Affiliates not to) [ * ] an [ * ] with any [ * ] for [ * ] within the Territory of any [ * ] that contains [ * ] in combination with [ * ] that are (i) proprietary to that Third Party and (ii) [ * ] in the Territory as of [ * ].

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3.11 Publication .

(a) Either Member Party shall have the right to publish or present data and findings resulting from Project Activities, including, without limitation, Co-Funded Clinical Trials, subject to the right of objection or demand for modification by the other Member Party in the interest of (i) protecting the Confidential Information of such other Member Party, (ii) preserving the intellectual property rights of such other Member Party or the JV, and/or (iii) assuring that the publication or presentation presents such data and findings in a fair, accurate and balanced manner in accordance with ethical, medical and/or scientific standards. During the term of this Agreement, each Member Party shall provide to the other Member Party’s representatives on the JDC for review copies of all academic, scientific and medical publications and presentations specifically relating to the Combination Product (or otherwise relating to the combined use of EFV, FTC and TDF) that the Member Party proposes to submit for publication or presentation and that result from Project Activities; provided , however , that notwithstanding anything contained in this Section 3.11 to the contrary, the terms and conditions of this Section 3.11 shall not apply to any publications and presentations resulting directly or indirectly from Study 934. Review of such publications and presentations shall be conducted only for purposes of considering compliance with the standards set forth in clauses (i), (ii) and (iii) above (the "Publication Standards") and shall consider whether any portion of any such publication or presentation should be modified or deleted in order to conform to the Publication Standards. In addition, in the case of any such publication or presentation resulting from a Co-Funded Clinical Trial, the Member Party that proposes to submit such publication or presentation shall have the right to do so only if the other Member Party agrees that such publication or presentation, as may be modified, conforms to the Publication Standards, which agreement shall not be unreasonably withheld or delayed. Such Member Party shall consider in good faith any comments provided to it by such other Member Party with respect to such publication or presentation, including, without limitation, any comments of a scientific or medical nature. In the case of any such publication or presentation resulting from other Project Activities, the other Member Party shall have a right to comment on such publication or presentation, provided that the Member Party proposing such publication or presentation shall be under no obligation to accept such comments (except to the extent necessary to preserve the intellectual property rights of such other Member Party or the JV) and shall be free to publish or present, as the case may be. Written copies of each proposed publication or presentation required to be provided for review shall be provided to the other Member Party’s representatives on the JDC no later than [ * ] before submission for publication or presentation, except that (A) in the case of an abstract, a copy of the abstract shall be provided as soon as reasonably practicable in advance of the submission of such abstract to a Third Party (which period may be less than [ * ] and (B) if the deadline for submission of such publication or presentation is less than [ * ] from the date of completion of that publication or presentation, copies will be provided as soon as reasonably practicable in advance of such submission deadline. In the case of any proposed publication or presentation of a Member Party that is required to be reviewed by the other Member Party, in the event that the Member Parties fail to reach agreement, if applicable, on such publication or presentation by the conclusion of

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the applicable review period, and as a result there is a dispute between the Member Parties with respect to such publication or presentation, such dispute may be referred by either Member Party to the JDC. The Member Parties shall comply in any publications made pursuant to this Section 3.11 with standard academic practice regarding authorship of scientific publications and recognition of contribution of parties. For the avoidance of doubt, nothing contained in this Section 3.11 shall alter or affect a Member Party’s confidentiality obligations pursuant to Section 12.

(b) Subject to compliance with Section 3.11(a), nothing in this Agreement shall restrict either Member Party from providing information on Co-Funded Clinical Trials conducted by the other Member Party to any Clinical Trials Registry or Clinical Trials Results Database, in accordance with Applicable Law and industry practice. For purposes of this Section 3.11(b), (i) "Clinical Trial Registry" means any listing of Clinical Trials which have been initiated, whether maintained by the U.S. federal government ( e.g., www.clinicaltrials.org ), or an independent organization (e.g., PhRMA or Rx&D) and (ii) "Clinical Trials Results Database" means any database which provides access to Clinical Trial results to physicians, patients and the general public, whether maintained by any government, Regulatory Authority or independent organization (e.g., PhRMA or Rx&D).

3.12 Certain Inspections . Each Member Party shall involve the other Member Party, to the extent feasible, in its GCP, GLP and GMP audit process for any facilities used in the performance of Development Activities for the Combination Product (including the facilities of any subcontractors to the extent permitted pursuant to the terms of the applicable subcontract or otherwise permitted by the applicable subcontractor) and shall consider in good faith any issues concerning such compliance or any safety and efficacy issues with respect to the Combination Product or the active pharmaceutical ingredient(s) of the other Member Party’s Single Agent Product(s) or Double Agent Product, as applicable, that are raised by the other Member Party on a reasonable basis as a result of such audits. Each Member Party shall also have the right, during normal business hours and upon reasonable notice, to inspect the other Member Party’s facilities (or the facilities of any subcontractor to the extent permitted pursuant to the terms of the applicable subcontract or otherwise permitted by the applicable subcontractor), used in the performance of Development Activities for the Combination Product, if the Member Party desiring such inspection has a reasonable basis on which to raise in good faith any such compliance, safety or efficacy issues apart from the aforementioned audit inspections. Any audit referred to in this Section 3.12 shall be subject to reasonable restrictions on access to confidential information and trade secrets by the inspecting Member Party to the extent such confidential information and trade secrets are not expressly required to be disclosed by such Member Party to the other Member Party pursuant to this Agreement.

3.13 Medical Affairs and Medical Communications .

(a) Gilead and BMS shall determine independently how to utilize and deploy their respective medical science liaisons for activities relating to the Combination Product. The JDC shall develop and approve presentation materials for use by each Member Party’s medical science liaisons when engaging in activities to support the Combination Product, and the medical science liaisons shall use only such approved presentation materials in such

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activities. The JDC shall develop, and the Member Parties shall implement, procedures to coordinate the training of each Member Party’s medical science liaisons on any approved presentation materials.

(b) The JDC shall develop guidelines and procedures for determining and providing appropriate responses to medical inquiries about the Combination Product, including assigning responsibilities for medical communications. The Parties shall develop a set of standard response documents for the Member Parties to use in responding to medical inquiries about the Combination Product, as follows: (i) each Member Party shall develop standard response documents relating to their respective Single Agent Product(s) and Double Agent Product as incorporated in the Combination Product, and (ii) Gilead shall develop draft standard response documents relating to the Combination Product as a whole (substantially incorporating that developed by each Member Party for its Single Agent Product(s) and/or Double Agent Product), for review, comment and approval by the JDC.

SECTION 4.

MANUFACTURING AND SUPPLY

4.1 Clinical Supply . Gilead shall Manufacture or have Manufactured through a subcontractor, on behalf of the JV, clinical supplies of the Combination Product in such quantities as may be needed for the clinical trials and studies required to obtain Approvals of the Combination Product in each country in the Territory. In connection with such Manufacture, Gilead and BMS each shall donate to the JV quantities of FTC and TDF, in the case of Gilead, and EFV, in the case of BMS. Each Member Party’s Cost of Goods of such supply, as well as Gilead’s Cost of Goods for Manufacture of the clinical supplies of the Combination Product, shall not be chargeable to the JV.

4.2 Commercial Supply .

(a) The initial Development Plan designates the initial commercial Supplier of the Combination Product, which Supplier shall be the source of Combination Product supply for purposes of the NDA filing and Launch in the United States. Within [ * ] after the Effective Date, the JCC shall determine the most cost-efficient manner in which to source the commercial supply of the Combination Product, including, without limitation, one or more alternate suppliers. Thereafter, during the term of this Agreement, the JCC shall review annually the appropriate source(s) of commercial supply of the Combination Product after Launch in the United States and agree upon appropriate changes. Each Member Party may propose interim changes with respect thereto from time to time between such reviews, which changes the JCC shall adopt if failure to do so would be likely to have a material adverse effect on the Combination Product business. If Gilead or BMS desires to be considered as a possible Supplier of the Combination Product, it shall submit a confidential written proposal to the JV for consideration by the JCC alongside written proposals submitted by recognized, reliable and sufficiently capitalized Third Parties and/or the supply terms pertaining to the initial Supplier. Any proposal submitted by a possible Supplier shall include an offer to perform any required tableting, blistering, packaging, labeling, analytical testing and storage activities with respect to commercial supplies of the Combination Product. The JCC shall select a Person to supply the

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JV with commercial supplies of the Combination Product on the basis of price, quality, reliability, GMP compliance, security of supply and other relevant commercial considerations. If a Third Party is selected as a Supplier, the JCC shall designate a Member Party to manage the relationship with that Supplier. Any supply contract between the JV and Gilead or BMS as Supplier shall be negotiated on an arm’s-length basis and shall contain such terms and conditions as are customary in the pharmaceutical industry, modified as appropriate for the Combination Product. The Parties anticipate that, following the Amended Effective Date, the JV and Gilead will negotiate an amendment to that certain Product Supply Services Agreement entered into by the JV and Gilead as of May 24, 2006, as well as the related Quality Agreement, for the purpose of establishing commercial supply arrangements with respect to the Combination Product for Canada.

(b) The JCC, directly or through a designated Member Party, and in coordination with the JDC, shall monitor Manufacturing capacity of, and forecasts and orders for, the Combination Product submitted to the relevant Supplier(s) to ensure that adequate commercial supplies of the Combination Product will be available to meet the demand therefor as projected by the JCC in commercial unit volume forecasts. The JCC shall prepare [ * ] rolling unit volume forecasts at least [ * ] before the commencement of each forecast period, and shall update such unit volume forecasts on a [ * ] basis, or as the JCC deems necessary and appropriate.

(c) In connection with the Manufacture by the Supplier of the commercial supply of the Combination Product for the JV, Gilead and BMS each shall supply to the JV quantities of FTC and TDF, in the case of Gilead, and EFV, in the case of BMS, and in each case in the form of bulk active pharmaceutical ingredient, pursuant to and in accordance with their respective Supply Agreements. In consideration of such supply, the JV shall pay to Gilead and BMS, respectively, the Gilead Transfer Price and the BMS Transfer Price. The JDC shall monitor orders under the respective Supply Agreements to assure consistency in the quantities of FTC, TDF and EFV ordered by the JV thereunder.

SECTION 5.

COMMERCIALIZATION ACTIVITIES

5.1 Co-Promotion Obligations .

(a) Gilead and BMS each shall use Commercially Reasonable Efforts to perform in each country in the Territory the Commercialization Activities that such Member Party is required to perform under the applicable Commercialization Plan in accordance with the applicable Commercialization Budget, for so long as there is a Commercialization Plan in effect. Each Member Party shall be required, during the Initial Launch Period under each such plan and (to the extent there is a [ * ] applicable thereto) the applicable Subsequent Launch Period, to [ * ] per Calendar Quarter, and take the other actions, applicable to it as specified in the relevant Commercialization Plan. Subject to Section [2.11, no minimum Detail requirements] shall apply (i) during a Subsequent Launch Period unless approved by the JEC or the applicable Commercialization Committee, as part of an update to a Commercialization Plan pursuant to Section 5.11(c), and (ii) after a Subsequent Launch Period unless approved by the Member

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Parties. Each Member Party shall be free to engage in [ * ], and to engage in [ * ] when there is no longer a Commercialization Plan in effect, in each case in its sole discretion.

(b) Gilead and BMS shall select independently the target prescribers to which each shall Promote the Combination Product.

(c) In accordance with Section 2.10(b), Gilead and BMS shall each cause its Field Force to use only the product labels and inserts approved by the applicable Regulatory Authority and, subject to Section 5.7, the Approved Marketing Materials in Promoting the Combination Product, and to make only such statements and claims regarding the Combination Product as are consistent with Applicable Law and product labels and inserts approved by the applicable Regulatory Authority. Gilead and BMS shall not provide or give access to samples of the Combination Product to health care practitioners or patients in connection with Promotion of the Combination Product.

(d) Gilead and BMS shall each Detail the Combination Product and perform its other Promotional activities under this Agreement in the Territory in strict adherence to regulatory and professional requirements, and to all Applicable Law, including, to the extent applicable, the Canadian Act and the U.S. Act and applicable regulations promulgated thereunder; the rules on promotion set out in Health Canada guidelines and policies; the Code of Advertising Acceptance of the Pharmaceutical Advertising Advisory Board (PAAB); the Rx&D Code of Conduct for Canada’s research-based pharmaceutical companies; the Canadian Medical Association Policy on Physicians and the Pharmaceutical Industry; the FDA Guidance for Industry-Supported Scientific and Educational Activities; the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals; the Office of Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers; the American Medical Association Guidelines on Gifts to Physicians from Industry; the Pharmaceutical Marketing Research Group Guidelines on market research activities; the Prescription Drug Marketing Act of 1987, as amended ("PDMA"); and all federal, state and local "fraud and abuse," consumer protection and false claims statutes and regulations, including but not limited to the Medicare and State Health Programs Anti-Fraud and Abuse Amendments of the Social Security Act, the "Safe Harbor Regulations" found at 42 C.F.R. §1001.952 et seq. As among the Parties, each Member Party shall treat its sales representatives engaged in Detailing the Combination Product as its (or its Affiliate’s) own employees for all purposes, including, without limitation, federal, state, provincial and local tax and employment laws.

(e) Within [ * ] after the end of each Calendar Quarter (or part thereof) falling within (i) the Initial Launch Period for a country in the Territory, (ii) (to the extent there is a [ * ] applicable thereto) the Subsequent Launch Period in such country, or (iii) any period commencing after such Subsequent Launch Period if mutually agreed by the Member Parties pursuant to Section 2.11 (clauses (i), (ii) and (iii) being referred to herein collectively as the "Product Detail Period"), Gilead and BMS shall each furnish the other Parties with a written report, in the form set forth in Annex H attached hereto, setting out the number of Details that it has conducted during such Calendar Quarter (or part thereof) in such country. The number so reported shall be determined in accordance with applicable self-reporting procedures for details

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customarily employed by such Member Party in the Territory for other similarly detailed and similarly reported HIV products to the target health care audience, consistently applied.

(f) In each Calendar Year (or part thereof) falling within the Product Detail Period, subject to the terms of this Section 5.1(f), each Member Party shall [ * ] to conduct in each country in the Territory (x) the [ * ] for each Calendar Quarter (or part thereof) specified in the Commercialization Plan for such country (the [ * ]) and (y) the [ * ] for such Calendar Year (or part thereof) specified in such Commercialization Plan ( i.e ., the [ * ]) (the [ * ]). To the extent that the applicable Product Detail Period includes part but not all of a Calendar Quarter, then the [ * ] for such Calendar Quarter shall be [ * ]. If, in any Calendar Quarter during the applicable Calendar Year, the [ * ] of Details conducted by a Member Party [ * ] for such country for such Calendar Quarter (such [ * ] being a [ * ]), such Member Party may [ * ] of Details it conducts [ * ], if any, during the [ * ], and in [ * ], in each case in order to [ * ] some or all of the [ * ]. Subject to Section 5.1(g), if, in any Calendar Year, the [ * ] of Details conducted by a Member Party [ * ] for such Calendar Year (such [ * ] being [ * ]), then notwithstanding anything in this Agreement to the contrary, (i) the other Member Party shall [ * ], and (ii) any failure by a Member to comply with this Section 5.1(f) which results in such [ * ] shall not be subject to the [ * ] For clarity, no [ * ]

(g) If, during any Calendar Quarter, a Member Party expects that it will experience a [ * ] with respect to a country in the Territory for the succeeding Calendar Quarter (or part thereof), it shall inform the other Member Party of the anticipated [ * ] by written notice as promptly as practicable but no later than the due date of the report referred to in Section 5.1(e). The other Member Party shall have the right to [ * ] in such country in such succeeding Calendar Quarter (or part thereof) by up to the anticipated [ * ] for such succeeding Calendar Quarter (or part thereof) by giving notice to the first Member Party of its intent to do so within [ * ] of receiving the notice. For the avoidance of doubt, if the other Member Party gives such notice and so [ * ], the first Member Party shall [ * ] to the other Member Party an amount equal to the product of [ * ] multiplied by the [ * ] multiplied by the [ * ] In any such case, the [ * ] of the [ * ], if any, with respect to such country under [ * ] shall be [ * ]

5.2 Distribution Obligations .

(a) Gilead shall have the sole responsibility and right to fill orders with respect to the Combination Product on behalf of the JV; provided, however, in the case of Combination Product to be distributed in Canada, Gilead shall [ * ] the Combination Product as set forth in that certain distribution and supply agreement ("Canada Distribution and Supply Agreement") to be entered into by the Parties within [ * ] the Amended Effective Date substantially on the terms outlined in Annex P2. Annex P2 also sets forth, solely for illustrative purposes, a schematic outlining the contemplated manufacturing/commercial structure in Canada. The Parties expressly agree that on all Combination Product label, packaging and promotional materials in Canada the [ * ]

(b) If for any reason BMS receives sales orders for the Combination Product, it shall promptly forward such order to Gilead. An order for the Combination Product may be rejected by Gilead only if such rejection is commercially reasonable under the

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circumstances. For each country in the Territory, the Commercialization Committee for such country shall determine how the JV shall respond to requests from individual patients who have or may obtain prescriptions for the Combination Product in such country but may be unable to afford it, and from health care providers on behalf of such patients, including, without limitation, establishing appropriate procedures and response times that shall apply in responding to such requests; provided , however , that the applicable Commercialization Committee shall structure the applicable program in a manner that will make evident to such health care providers and patients the participation of the JV (and, as appropriate, each of its Member Parties) in such program and shall ensure that the procedures and response times are no less favorable to patients than the most favorable of either Member Party’s patient assistance programs for its Single Agent Product(s) and/or Double Agent Product as of the Effective Date. The applicable Commercialization Committee shall review the arrangements for the patient assistance program annually and agree upon appropriate changes. Each Member Party may propose interim changes with respect thereto from time to time between such reviews, which changes the Commercialization Committee shall adopt if failure to do so would be likely to have a material adverse effect on the Combination Product business.

(c) Without limitation of the foregoing, Gilead shall perform all the functions of a distributor with respect to sales of the Combination Product on behalf of the JV, including, without limitation, inventory management and control, warehousing and distribution, invoicing, collection of sales proceeds, preparation of sales records and reports, customer relations and services, and handling of returns, in accordance with customary practice in the biopharmaceutical industry, pursuant to (i) in the case of the United States, a separate Services Agreement to be entered into by the Parties within [ * ] of the Effective Date substantially on the terms outlined in Annex P1, or (ii) in the case of Canada, pursuant to the Canada Distribution and Supply Agreement.

(d) Gilead’s relationships with wholesale distributors for the Combination Product shall be governed by inventory management agreements to reduce inventory fluctuations to the extent commercially feasible, and if such agreements do not also cover Gilead’s other products in the Field, they shall be commercially reasonable and [ * ] For any [ * ] the Combination Product or services or activities relating thereto, Gilead shall ensure either that (i) such [ * ] are [ * ] for [ * ] on a [ * ] as for [ * ] or (ii) if such [ * ] Gilead shall use Commercially Reasonable Efforts to keep inventory levels of the Combination Product at wholesale distributors at [ * ] subject to fluctuations expected during the Launch period for the Combination Product in each country in the Territory.

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5.3 Pricing of Combination Product .

A. In the United States .

The provisions of this Section 5.3A shall govern, and accordingly shall be construed to apply to, only matters relating to the pricing of the Combination Product in the United States, and not Canada.

(a) Gilead shall have sole responsibility to act as agent for selling the Combination Product on behalf of the JV at prices that [ * ] with the [ * ] (as defined below) made pursuant to the provisions of this Section 5.3A and the [ * ] set forth on Annex Q1 (the [ * ]).

(b) Gilead and BMS shall each appoint two (2) members of a pricing committee for the JV (the "US Pricing Committee"). One (1) representative from each Member Party (the "[ * ] Representative") shall be an employee of that Member Party who is not at the time of his or her appointment, or at any time during his or her service on the US Pricing Committee, otherwise involved, directly or indirectly, in the [ * ] of such Member Party’s (or any of its Affiliates’) [ * ] (provided, that for purposes of this Section 5.3A, duties solely with respect to accounts receivable analysis, bookkeeping and accounting shall not, without more, be deemed involvement in [ * ]). Such representatives shall have skills reasonably appropriate to their responsibilities and functions as members of the US Pricing Committee. The other representative from each Member Party (the "[ * ] Representative") shall be [ * ] for that Member Party. Furthermore, each Member Party covenants that, for [ * ] immediately after an individual’s service on the US Pricing Committee (or for such shorter period as he or she is employed by such Member Party or its Affiliate), he or she will not be assigned to a function or position that involves, directly or indirectly, the pricing of such Member Party’s (or any of its Affiliates’) [ * ] products. Each Member Party shall have the right to approve the other Member Party’s proposed [ * ] Representative and [ * ] Representative on the US Pricing Committee (or any replacement therefor), which approval shall not be unreasonably withheld. Subject to the preceding sentence, each Member Party shall have the right to replace its [ * ] Representative and/or [ * ] Representative from time to time during the term of this Agreement, provided that the composition of the US Pricing Committee as so changed meets the requirements set forth above in this Section 5.3A(b). For the avoidance of doubt, the US Pricing Committee is not an Operating Committee of the JV and, accordingly, references in this Agreement, the Operating Agreement and, if applicable, any Ancillary Agreement to an Operating Committee shall not apply to the US Pricing Committee. The US Pricing Committee may determine in its sole discretion to retain independent legal counsel, in which case the expenses of such counsel shall be deemed to be Authorized Other Expenses.

(c) Gilead and BMS shall each be responsible for the performance of its representatives on the US Pricing Committee and their compliance with the terms of this Section 5.3A and the [ * ] Any issue regarding the [ * ] of the US Pricing Committee shall be reviewed [ * ] Gilead and BMS shall each bear their own expenses related to the US Pricing Committee, including without limitation all expenses relating to the meetings of the US Pricing Committee, the participation of the Member Parties’ representatives in such meetings,

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communications with the other Member Party in connection with such meetings or matters within the authority of the US Pricing Committee, and travel to and from such meetings, and such expenses shall not be deemed JV Expenses or Authorized Other Expenses.

(d) The US Pricing Committee shall be responsible, on an ongoing basis, for [ * ] Gilead, as agent of the JV [ * ] (i) the [ * ] in accordance with this Section 5.3A and the [ * ] (the [ * ]) and (ii) any [ * ] as [ * ] according to the [ * ] with respect to [ * ] (as defined in the [ * ]) from the JV. The US Pricing Committee shall meet at least quarterly (which meeting may be conducted by telephone or videoconference equipment, so long as each attendee is able to hear the others), and as otherwise required from time to time, to [ * ] The [ * ] will serve as [ * ], as applicable, in [ * ] Gilead, as agent of the JV, and [ * ] Gilead, as agent of the JV, shall have no authority to [ * ], as the case may be, for [ * ]

(e) Should interpretation of the [ * ] become necessary, the [ * ] Representatives on the US Pricing Committee shall discuss the matter with the [ * ] Representatives and attempt to resolve the matter by consensus. In the event that a consensus cannot be reached, no [ * ] with respect to [ * ] and Gilead, as agent of the JV, shall not [ * ]

(f) The functional role of each representative on the US Pricing Committee shall be limited to:

- - - coordinating with Gilead, as agent of the JV, to ascertain [ * ]
      
      on an as-needed basis, providing the US Pricing Committee the [ * ] as the case may be;
      
      only on an as-needed basis, and as specifically requested with respect to [ * ] providing the US Pricing Committee such other specifically limited [ * ] pertinent to [ * ] as the [ * ] Representatives shall agree is necessary and appropriate;
      
      applying the [ * ] with respect to [ * ] and
      
      ensuring that the [ * ] for the Combination Product, as [ * ] as the case may be, for [ * ]

(g) Either Member Party (the "Requesting Member") may, upon written notice to the other Member Party, cause the Independent Accounting Expert (selected pursuant to Section 7.1(d)) to confirm the accuracy, with respect to any [ * ] of (i) any [ * ] and/or (ii) any [ * ] to the US Pricing Committee, including, without limitation, the [ * ] as the case may be. In such case, each Member Party and the US Pricing Committee shall cooperate with the Independent Accounting Expert and (upon the Independent Accounting Expert’s entry into an appropriate confidentiality agreement) provide him or her with the data necessary to make the requisite calculations. Further, upon the written request of either Member Party, the calculations of the Independent Accounting Expert shall be audited by a second Third Party mutually agreed by the Member Parties. The Independent Accounting Expert and the Third Party auditor, if any, shall notify the JEC of their respective determinations, which notifications shall not contain any information provided to such Independent Accounting Expert (and/or such Third Party auditor) by either Member Party. The calculations made by the Independent Accounting Expert pursuant to this Section 5.3A(g) shall be binding upon the US Pricing Committee and the Parties; provided , however , that in the event that a Third Party auditor identifies a discrepancy in the Independent Accounting Expert’s calculations, the Member Parties shall cause the Independent Accounting Expert and such Third Party auditor to confer and agree upon the final calculations and advise the Member Parties in writing of same,

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whereupon such final agreed calculations shall be binding on the Parties. The Requesting Member shall bear the fees and costs of the Independent Accounting Expert in connection with its confirmation of the accuracy of such determination and/or information, unless the Independent Accounting Expert finds a discrepancy equal to or greater than [ * ] therein, in which case the JV (in the case of a discrepancy in a [ * ] or the other Member Party (in the case of a discrepancy in [ * ] shall bear such fees and costs. Nothing in this Section 5.3A(g) shall be deemed to limit any remedy available to either Member Party in the event of a breach of any of the provisions of this Section 5.3A or the [ * ] by the other Member Party. Notwithstanding anything in this Agreement to the contrary, such breach shall not be subject to the cure provisions set forth in Section 14.4.

(h) All information provided to the US Pricing Committee ("US Pricing Information") shall be considered Confidential Information of the disclosing Member Party and shall be used solely for the purpose of [ * ] and for no other purpose. For the avoidance of doubt, the exceptions to confidentiality set forth in Section 12.2 (other than in Sections 12.2(a) and (b)) shall not apply to US Pricing Information. Except as expressly permitted by the [ * ] US Pricing Information shall not be disclosed by the US Pricing Committee representatives except to counsel, the Independent Accounting Expert, or any Third Party auditor selected pursuant to Section 5.3A(g). All US Pricing Information shall be [ * ] maintained by the US Pricing Committee, which [ * ] shall not be accessible by Persons other than the members of the US Pricing Committee. Without limiting the foregoing, each of BMS and Gilead shall:

- - - cause its representatives on the US Pricing Committee not to disclose to any other Person [ * ] and
      
      not reference or use, directly or indirectly, any information from the US Pricing Committee [ * ]

(i) Prior to the Launch of the Combination Product in the United States and thereafter annually, the JEC shall review the [ * ] (as most recently modified pursuant to this Section 5.3A(i), if applicable) in light of the then-prevailing market conditions and JV marketing and sales strategies. If appropriate, the JEC shall recommend to the Member Parties changes to the [ * ] The JEC’s action or inaction under this Section 5.3A(i) shall not be subject to arbitration. If (and only if) Gilead and BMS mutually agree on any such changes proposed by the JEC, then the [ * ] as so changed shall be deemed to be the [ * ] hereunder.

(j) Gilead and BMS shall each retain sole discretion with respect to price-setting and discounts for its respective Single Agent Products and Double Agent Product, if any. Notwithstanding the foregoing, each Member Party covenants that it shall [ * ] and shall not directly or indirectly [ * ] solely or primarily for the purpose of [ * ]

B. In Canada .

The provisions of this Section 5.3B shall govern, and accordingly shall be construed to apply to, only matters relating to the pricing of the Combination Product in Canada, and not the United States.

(a) Gilead shall have sole responsibility to act as distributor for selling the Combination Product on behalf of the JV in Canada in all circumstances (whether such sales are private and cash sales or sales that are reimbursed by a public formulary) at prices that [ * ] with the [ * ]

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(b) [ * ] after the Amended Effective Date, the Member Parties shall, upon mutual agreement, designate [ * ] to be responsible on behalf of the JV, in each Jurisdiction and for [ * ] for [ * ] for the Combination Product and otherwise for obtaining and maintaining the [ * ]

(c) Gilead and BMS shall each appoint one (1) representative (a "Pricing Liaison"), who shall be an employee of that Member Party who is not at the time of his or her appointment, or at any time during his or her service as the Pricing Liaison, otherwise [ * ] (provided, that for purposes of this Section 5.3B, duties solely with respect to accounts receivable analysis, bookkeeping and accounting shall not, without more, be deemed involvement in pricing). Each such representative shall have skills reasonably appropriate to his or her [ * ] as Pricing Liaison. Furthermore, each Member Party covenants that, for [ * ] immediately after an individual’s service as Pricing Liaison (or for such shorter period as he or she is employed by such Member Party or its Affiliate), he or she will [ * ] Each Member Party shall have the right to approve the other Member Party’s proposed Pricing Liaison (or any replacement therefor), which approval shall not be unreasonably withheld. Subject to the preceding sentence, each Member Party shall have the right to replace its Pricing Liaison from time to time during the term of this Agreement, provided that the ea

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