Collaboration Agreement

Collaboration Agreement

CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2



AMENDED & RESTATED
(Complera and the R/F/TAF Product)
by and among
and
JANSSEN R&D IRELAND
Dated as of December 23, 2014


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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


TABLE OF CONTENTS
Page
1
DEFINITIONS    2
2
GOVERNANCE    39
2.1
Alliance Managers.    39
2.2
Procedural Rules of the Alliance Managers.    39
2.3
Financial Reporting Committee.    40
2.4
Ad Hoc Operating Committees.    42
2.5
Expenses.    42
3
DEVELOPMENT ACTIVITIES    42
3.1
Development of Edurant.    42
3.2
Development of Combination Products.    43
3.3
Performance; Subcontracting.    48
3.4
Records.    48
3.5
Reports.    49
3.6
Publication of Results.    49
3.7
Third Party Uses of Combination Product Clinical Data.    52
3.8
Limitations on Disclosure of Non-Oral Formulation Data.    52
4
REGULATORY MATTERS    52
4.1
General.    52
4.2
Registration Plan.    53
4.3
Regulatory Documentation to be Provided by the Parties.    54
4.4
Regulatory Filings and Communication.    56
4.5
Activities in Japan.    58
4.6
Records.    58
4.7
Regulatory Costs and Expenses.    58
4.8
Regulatory Dependencies.    59
5
MEDICAL AFFAIRS; CONFERENCES    59
5.1
Product Information; Medical Affairs and Medical Communications.    59
5.2
Responses to Medical Inquiries.    59
5.3
Conferences and Symposia.    60
5.4
Compliance.    60
6
COMMERCIALIZATION ACTIVITIES    61
6.1
Distribution in Region B and Region C.    61
6.2
Commercialization Activities.    61
6.3
Co-Detailing; Responses to Unsolicited Questions.    64
6.4
[Reserved].    66
6.5
Third Party Distributors.    66
6.6
Distribution and Related Matters.    66
6.7
Marketing Materials.    67
6.8
Selection and Use of Trademarks.    69
6.9
Restricted Export.    70
6.10
Patient Assistance Program; Product Donations.    70

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


6.11
Commercialization Costs and Expenses.    71
6.12
[Reserved].    71
6.13
[Reserved].    71
6.14
[Reserved].    71
6.15
Pricing for Commercial Sale.    71
6.16
Janssen Distributor Agreement.    71
7
[RESERVED]    71
8
MANUFACTURING AND SUPPLY    71
8.1
RPV Supply.    71
8.2
Territory Combination Product Supply.    73
8.3
Supplies of Territory Combination Product for use in Clinical Trials.    75
8.4
Additional Requirements.    76
9
LICENSE GRANTS AND RELATED COVENANTS    76
9.1
Licenses and Related Rights.    76
9.2
Rights of Reference and Related Rights.    78
9.3
Sublicenses.    80
9.4
Trademark Licenses.    82
9.5
Sublicensed Rights.    83
9.6
Retained Rights.    84
10
PAYMENTS    85
10.1
Payments.    85
10.2
Post-Conversion and Additional Supply Price Reductions.    85
10.3
Monthly Payment Term.    85
10.4
Mode of Payment.    85
10.5
Reports & Payments.    86
10.6
Financial Records.    87
10.7
Currency Conversion.    87
10.8
Audits.    87
10.9
Interest Due.    90
10.10
Tax Withholding.    90
10.11
Manufacturing Fees.    91
10.12
Branded Prescription Pharmaceutical Manufacturers Fee.    91
10.13
Research and Development Reimbursement Payments.    91
11
FINANCIAL CALCULATIONS AND ADJUSTMENTS    91
11.1
Calculations.    91
11.2
Working Percentages.    91
11.3
Actual Percentages.    91
11.4
Establishment of Standard Costs of Manufacturing.    91
11.5
[Reserved].    91
11.6
Post-Generic FTC/TDF Combination.    91
11.7
[Reserved].    91
11.8
[Reserved].    92
11.9
[Reserved].    92
11.10
Application of Original Agreement.    92
12
[RESERVED]    92

ii

CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


13
SAFETY DATA EXCHANGE AGREEMENT; PRODUCT RECALL AND
WITHDRAWAL    92
13.1
Generally.    92
13.2
Notification and Recall.    92
13.3
Recall Expenses.    95
13.4.
Recall Records.    95
13.5.
Communication with Regulatory Authorities Regarding Recalls.    95
13.6.
Public Statements Regarding Recalls.    96
14
INTELLECTUAL PROPERTY RIGHTS    96
14.1
Ownership of Intellectual Property.    96
14.2
Prosecution of Patents.    97
14.3
Liability for Prosecution and Maintenance.    100
14.4
Enforcement of Patents.    100
14.5
Defense of Patents.    104
14.6
Trademarks.    105
15
CONFIDENTIALITY    106
15.1
Treatment of Confidential Information.    106
15.2
Permitted Disclosure.    107
15.3
Confidential Information.    108
15.4
Notification.    109
15.5
Data Privacy.    109
15.6
Remedies.    110
16
PRESS RELEASES, PUBLICATIONS AND PUBLIC RELATIONS MATTERS    110
16.1
Initial Statements.    110
16.2
Other Public Disclosures.    110
16.3
Use of Names.    111
17
REPRESENTATIONS, WARRANTIES AND COVENANTS; DISCLAIMER    112
17.1
Mutual Representations, Warranties and Covenants.    112
17.2
Additional Representations, Warranties and Covenants of Janssen.    114
17.3
Additional Representations, Warranties and Covenants of Gilead.    116
17.4
Disclaimer.    118
18
INDEMNIFICATION AND INSURANCE    119
18.1
General Indemnification.    119
18.2
Indemnification for Certain Product Liability-Related Matters.    120
18.3
Selected Product Liability Losses.    121
18.4
Third Party Infringement Losses.    121
18.5
Enforcement and Defense of Patents.    122
18.6
Other Shared Combination Product-Related Losses.    122
18.7
Indemnification Procedure.    123
18.8
Limitation on Damages.    125
18.9
Insurance.    125
19
TERM AND TERMINATION    126
19.1
Term.    126

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


19.2
Challenge by Governmental Authority.    126
19.3
Territory Combination Product Withdrawal.    126
19.4
Material Breach.    126
19.5
Voluntary Termination.    127
19.6
Consequences of Termination.    129
19.7
Accrued Liabilities; Survival.    132
20
GENERAL PROVISIONS    139
20.1
Force Majeure.    139
20.2
Notice.    139
20.3
Further Assurances.    140
20.4
Successors and Assigns.    141
20.5
Governing Law.    141
20.6
Dispute Resolution.    141
20.7
Arbitration.    143
20.8
Consent to Jurisdiction.    145
20.9
Waiver.    146
20.10
Severability.    146
20.11
Counterparts.    146
20.12
Construction.    146
20.13
Status of the Parties.    147
20.14
Entire Agreement.    147
20.15
Third Parties.    148
20.16
Guarantee.    148
20.17
Prior Diligence.    148


iv

CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Annexes
Annex list included in attached Annexes.



v

CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


AMENDED & RESTATED COLLABORATION AGREEMENT
THIS AMENDED & RESTATED COLLABORATION AGREEMENT (as the same may be amended, modified or supplemented from time to time, this “Agreement”) is made as of December 23, 2014 (the “Restatement 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, California 94404 (“Gilead Parent”), Gilead Sciences Ireland UC (formerly known as Gilead Sciences Limited), an unlimited liability company existing under the laws of Ireland and wholly-owned subsidiary of Gilead Parent having its principal place of business at IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland (“Gilead Sub” and, collectively with Gilead Parent, “Gilead”) and Janssen R&D Ireland, a company organized and existing under the laws of Ireland, having its principal place of business at Eastgate Village, Eastgate, Little Island, County Cork, Ireland (“Janssen,” formerly known as Tibotec Pharmaceuticals, “Tibotec”). Each of Gilead and Janssen is sometimes referred to individually herein as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, Gilead has developed and is marketing a proprietary reverse transcriptase inhibitor, Viread® (containing TDF (particularly 300 mg Tenofovir Disoproxil Fumarate and lower pediatric doses) as its only active pharmaceutical ingredient) (“Viread”), a proprietary nucleoside reverse transcriptase inhibitor, Emtriva® (containing FTC (particularly 200 mg Emtricitabine) as its only active pharmaceutical ingredient) (“Emtriva”), and a fixed-dose co-formulated product containing TDF (particularly 300 mg Tenofovir Disoproxil Fumarate) and FTC (particularly 200 mg Emtricitabine) as its only active pharmaceutical ingredients, Truvada® (“Truvada”), for the treatment of HIV infection in adults;
WHEREAS, Janssen or one or more of its Affiliates (as defined below) have developed and are marketing a proprietary non-nucleoside reverse transcriptase inhibitor, Edurant® (containing RPV (particularly 27.5 mg rilpivirine hydrochloride equivalent to 25 mg Rilpivirine) as its only active pharmaceutical ingredient) (“Edurant”), for the treatment of HIV infection in adults;
WHEREAS, Gilead or one or more of its Affiliates own or otherwise control certain intellectual property and other rights in and to a proprietary reverse transcriptase inhibitor containing TAF (particularly GS-7340) as its only active pharmaceutical ingredient, which inhibitor is being developed for the treatment of HIV infection in adults;
WHEREAS, pursuant to the License and Collaboration Agreement between the Parties dated July 16, 2009 (the “Original Effective Date”), as amended prior to the date hereof (the “Original Agreement”), the Parties have developed and are marketing Complera (as defined below);
WHEREAS, Gilead desires to develop a fixed-dose co-formulated product containing TAF, FTC and RPV as its only active pharmaceutical ingredients, and the Parties wish

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


to allocate among themselves certain rights and duties relating to the development and commercialization of the R/F/TAF Product (as defined below) in the Territory (as defined below);
WHEREAS, Janssen was the Selling Party for Complera in certain countries under the Original Agreement as of the Restatement Effective Date and will continue to be the Selling Party for Complera in those countries under this Agreement pursuant to the Janssen Distributor Agreement (as defined below), subject to the terms and conditions hereof;
WHEREAS, the Parties believe that Complera is and the R/F/TAF Product will become an important treatment for the HIV community, and that in addition to the therapeutic benefit, Complera does and the R/F/TAF Product will improve health by driving compliance with treatment regimens;
WHEREAS, the Parties desire to amend and restate the Original Agreement to make certain modifications to their rights and obligations with respect to Complera and to set forth their rights and obligations with respect to the R/F/TAF Product; and
WHEREAS, both Complera and the R/F/TAF Product are, in part, the result of the cooperative effort of the Parties as set forth in this Agreement.
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:
1
DEFINITIONS
Unless otherwise specifically provided herein, the following terms shall have the following meanings:
1.1    3TC” shall mean the compound set forth in Annex GG-5, known as lamivudine.
1.2    Accounting Standards” shall mean United States Generally Accepted Accounting Principles (GAAP) or International Financial Reporting Standards (IFRS) if required in lieu of GAAP for a public company filing financial reports with the U.S. Securities and Exchange Commission, in each case as then current at the relevant time, and as consistently applied by the applicable Party and its Affiliates.
1.3    Act” shall mean the United States Food, Drug and Cosmetic Act, as amended.
1.4    ACTG” shall mean the AIDS Clinical Trials Group.
1.5    Actual Percentages” shall mean (a) with respect to Territory Complera, the Complera Actual Percentage, and (b) with respect to the Territory R/F/TAF Product, the R/F/TAF Product Actual Percentage.
1.6    Additional Personnel” shall have the meaning set forth in Section 1.250.

2

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.7    Additional Requirement” shall have the meaning set forth in Section 8.4.
1.8    Additional Supply Price” shall have the meaning set forth in Annex M-1.
1.9    Ad Hoc Operating Committee” shall have the meaning set forth in Section 2.3.
1.10    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 to fifty percent (50%) or less of such securities or such interest, 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 and the Ancillary Agreements, Bristol-Myers Squibb & Gilead Sciences, LLC shall constitute an Affiliate of Gilead solely when and to the extent that Gilead has voting control with respect to such entity.
1.11    [*].
1.12    Agreement” shall have the meaning set forth in the preamble hereto.
1.13    Alliance Manager” shall have the meaning set forth in Section 2.1.
1.14    Amended D/C/F/TAF Agreement” shall mean that certain Amended and Restated Collaboration Agreement between the Parties, relating to darunavir, cobicistat, FTC and TAF, dated as of even date herewith, as such agreement is amended from time to time.
1.15    Ancillary Agreements” shall mean, collectively, (a) the Janssen Distributor Agreement, (b) the PVA, (c) the Quality Agreement(s), (d) the RPV Supply Agreement, (e) the Co-Detailing LOA’s, (f) the Data Sharing LOA, (g) the Master Clinical Trial Material Agreement, and the quality agreement(s) related thereto (as may be amended from time to time), in each case (under this clause (g)) solely as relating to the following supplement(s) to the Master Clinical Trial Material Agreement: that certain Clinical Trial Material Agreement Supplement by and between Janssen R&D Ireland, Janssen Services, LLC, Janssen Infectious Diseases - Diagnostics BVBA, Gilead Sciences, Inc. and Gilead Sciences Ireland UC, dated as of October 23, 2014, as may be amended from time to time, and any other supplements entered into in the future that are designated by the Parties (or their Affiliates that are parties to such supplements) as an Ancillary Agreement hereunder, as may be amended from time to time, and (h) any other agreement that is now or in the future designated in writing to be an Ancillary Agreement by the Parties (or their Affiliates that are parties to such agreements), as may be amended from time to time.

3

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.16    Annual Manufacturing Fee” shall have the meaning set forth in Annex M-4.
1.17    Annual Yield Rate shall have the meaning set forth in Annex M-1.
1.18    API” shall mean active pharmaceutical ingredient.
1.19    API Conversion Amount shall have the meaning set forth in Annex M-1.
1.20    Applicable Law” shall mean all applicable laws, rules, regulations, guidelines or other requirements of governmental authorities, including those that may be in effect from time to time in the Territory with respect to the validity or enforceability of this Agreement or activities under this Agreement, as may be applicable.
1.21    Approved Price” shall have the meaning set forth Annex M-2.
1.22    Arbitration Matter” shall mean any Dispute other than a Patent Matter or Expert Dispute, to the extent such Dispute (a) requires a determination as to the validity (including any claim of inducement of this Agreement by fraud or otherwise), application, interpretation or construction of, the compliance with, termination of, or breach of, this Agreement or any Ancillary Agreement or (b) is designated as an Arbitration Matter hereunder or under any Ancillary Agreement, provided that, in each case ((a) and (b)), such Dispute has been referred to, but not resolved by mutual agreement of, the Executives pursuant to Section 20.6 or, in the case of an Arbitration Matter related to the determination of an Estimated Yield Rate, the Manufacturing Executives pursuant to Annex M-1. For clarity, nothing in this Section 1.22 is intended to impair or nullify either Party’s final decision-making authority or right to consent with respect to any matter for which such Party is expressly stated to have final decision-making authority or right to consent under this Agreement.
1.23    Atripla” shall mean that certain fixed-dose, co-formulated combination product containing as its only active pharmaceutical ingredients per single daily dose, TDF (particularly 300 mg Tenofovir Disoproxil Fumarate), FTC (particularly 200 mg Emtricitabine) and 600 mg efavirenz.
1.24    Attorney Representative” shall have the meaning set forth in Section 2.3.1.
1.25    Audit” shall have the meaning set forth in Section 10.8.1.1.
1.26    Audited Party” shall have the meaning set forth in Section 10.8.1.1.
1.27    Auditing Party” shall have the meaning set forth in Section 10.8.1.1.
1.28    Average Respective Percentage” shall mean (a) with respect to Territory Complera, the Complera Average Respective Percentage, and (b) with respect to the Territory R/F/TAF Product, the R/F/TAF Product Average Respective Percentage.
1.29    Biannual Month” shall have the meaning set forth in Annex M-1.

4

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.30    [*].
1.31    Branded Region B/C Complera” shall mean any Territory Complera that is Manufactured by or on behalf of Gilead or its Affiliates in accordance with the applicable Territory Complera Specifications (as such term is defined in the Janssen Distributor Agreement) (including the tablet color and shape set forth therein), which Territory Complera Specifications describe a product intended by the Parties to be sold or otherwise Distributed (or Manufactured for sale or other Distribution) exclusively in Region B and Region C.
1.32    Branded Region B/C R/F/TAF Product” shall mean any Territory R/F/TAF Product that is Manufactured by or on behalf of Gilead or its Affiliates in accordance with the applicable Territory R/F/TAF Product Specifications (as such term is defined in the Janssen Distributor Agreement) (including the tablet color and shape set forth therein), which Territory R/F/TAF Product Specifications describe a product intended by the Parties to be sold or otherwise Distributed (or Manufactured for sale or other Distribution) exclusively in Region B and Region C.
1.33    Breaching Party” shall have the meaning set forth in Section 19.4.1.
1.34    Business Day” shall mean a day that is not a Saturday, Sunday, a day on which banking institutions in New York, New York or San Francisco, California are required by law to remain closed, or December 26 through December 31.
1.35    Calculation Period” shall have the meaning set forth in Annex M-1.
1.36    Calendar Quarter” shall mean a period of three (3) consecutive calendar months ending on March 31, June 30, September 30 or December 31.
1.37    Calendar Year” shall mean a period of twelve (12) consecutive calendar months commencing on January 1 and ending on December 31, or a portion thereof in the case of a first or last Calendar Year.
1.38    Canada Co-Detailing LOA” shall mean that certain Letter Agreement, dated as of November 30, 2011, by and between Gilead Sciences Canada, Inc. and Janssen Inc., setting forth principles for Detailing by Janssen, Inc. in Canada, as such agreement is amended from time to time.
1.39    CDA” shall mean that certain amended and restated mutual confidential disclosure agreement between Gilead Parent and Janssen entered into as of August 9, 2007.
1.40    Cessation” shall have the meaning set forth in Section 11.6.
1.41    Clinical Data” shall mean, with respect to a Clinical Trial, any and all final clinical study reports, top line results reports and the tables, figures and listings as specified in the statistical analysis plan for such Clinical Trial, to the extent that such reports, tables, figures and listings are Controlled by a Party or any of its Affiliates. For the sake of clarity, Clinical Data shall not include any raw data.

5

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.42    Clinical Trial” shall mean (a) any Combination Product Clinical Trial; (b) any clinical trial in humans of any Single Agent Product in the Field; or (c) any clinical trial in humans of any Double Agent Product in the Field.
1.43    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 a Drug Approval Application, including information contained in, or data supporting, any drug master files referenced therein.
1.44    CMO” shall have the meaning set forth in Annex M-4.
1.45    Co-Detailing LOA’s” shall mean, collectively, the Canada Co-Detailing LOA, the International Co-Detailing LOA and the U.S. Co-Detailing LOA.
1.46    Collaboration Inventions” shall mean any and all Information and Inventions 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) in the course of, as a result of, or in connection with, (a) the Combination Product Development Activities or (b) the activities relevant to a Combination Product conducted under the MTA or TPA. “Collaboration Inventions” shall include inventions arising from Clinical Data derived or generated from Combination Product Development Activities and shall exclude any Information and Inventions made (x) by Janssen specifically with respect to any RPV Product or the APIs contained therein, and (y) by Gilead specifically with respect to any Gilead Compound Product or the APIs contained therein.
1.47    Combination Product” shall mean each of Complera and the R/F/TAF Product.
1.48    Combination Product Clinical Trial” shall mean any Complera Clinical Trial or any R/F/TAF Product Clinical Trial, as applicable.
1.49    [*].
1.50    Combination Product Development Activities” shall mean any Development Activities with respect to a Territory Combination Product (including any Combination Product Clinical Trials) that are necessary or reasonably expected to be necessary to obtain or maintain Regulatory Approval(s) for such Territory Combination Product in the Field in any or all countries in the Territory, except the term “Combination Product Development Activities” shall exclude (a) any Combination Product Clinical Trials conducted by or on behalf of Janssen or its Affiliates or any Combination Product Clinical Trials conducted by or on behalf of Gilead, its Affiliates or its Sublicensees, in each case other than those necessary or reasonably expected to be necessary to obtain or maintain Regulatory Approval(s) for such Territory Combination Product in the Field in any or all countries in the Territory, (b) any Development Activities relating specifically to RPV (or one or more of the RPV Products) and (c) any Development Activities relating specifically to TDF, TAF or FTC (or one or more of the Gilead Compound Products).

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.51    Combination Product Regulatory Activities” shall mean all regulatory activities conducted for the applicable Territory Combination Product (and not with respect to any other product) that are necessary or reasonably expected to be necessary to obtain or maintain Regulatory Approval(s) of a Territory Combination Product in the Field in any or all countries in the Territory, but excluding any Development Activities other than regulatory affairs activities with respect to such Territory Combination Product.
1.52    Combination Product Regulatory Documentation” shall mean all Regulatory Documentation that is (a) specifically applicable to a Combination Product or the Combination Product Development Activities and (b) developed by or on behalf of a Party, or any of its Affiliates, Third Party distributors or Sublicensees, pursuant to, and during the term of, this Agreement or any Ancillary Agreement, but excluding (i) any Regulatory Documentation developed, owned, or generated by any Generic Licensee, (ii) any Regulatory Documentation resulting from Development Activities relating specifically to RPV (or any RPV Product), including the Edurant Development Activities, (iii) any Regulatory Documentation resulting from Development Activities relating specifically to one or more of TDF, TAF or FTC (or one or more of the Gilead Compound Products), and (iv) any INDs that a Party that is not the MA Holder with respect to a given country is permitted to hold pursuant to Section 4.4.2.
1.53    Combination Product Trademarks” shall mean the Product Trademark(s) selected by Gilead for use in connection with the Exploitation of a Territory Combination Product in the Field in the Territory in accordance with this Agreement, including (with respect to Territory Complera) COMPLERA® and EVIPLERA®, and other Trademarks relating thereto, including any registrations of any of the foregoing or any pending applications relating to any of the foregoing. Notwithstanding the foregoing, the following shall not constitute Combination Product Trademarks: (a) Gilead Licensed Trademarks, (b) Janssen Licensed Trademarks and (c) the names, logos and other Trademarks of the Parties and their respective Affiliates (whether or not included in (a) or (b)).
1.54    Commence” shall mean to administer the first dosing of a subject in the applicable Clinical Trial. “Commencement” shall have a corresponding meaning.
1.55    Commercial Target Breach” shall mean Gilead’s failure to substantially achieve each or any of the Specific Targets under Section 6.2.2.
1.56    Commercialization Activities” shall mean the marketing, promotion, including Detailing, Distribution, selling and other activities for the commercialization of a Territory Combination Product in the Field (including obtaining and maintaining any pricing approvals under Applicable Law and securing local or national drug plan reimbursement).
1.57    Commercially Reasonable Efforts” shall mean, with respect to a given activity and a Party for a product or compound under this Agreement, the level of effort that would generally be used by such Party to conduct such activity 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 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

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


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; provided, however, that the R/F/TAF Product shall not be taken into account when determining whether Gilead is using Commercially Reasonable Efforts with respect to a given activity for Complera in a given country until the filing of a Drug Approval Application for the R/F/TAF Product in such country. To the extent that the performance of a Party’s obligations hereunder is adversely affected by the other Party’s failure to perform its obligations hereunder, the impact of such performance failure will be taken into account in determining whether such Party has used Commercially Reasonable Efforts to perform such affected obligations.
1.58    Company Sponsored Trial” shall mean a clinical trial sponsored by or on behalf of a Party or any of its Affiliates or (sub)licensees, but excluding any (a) investigator initiated studies or (b) ACTG studies, in each case ((a) and (b)), unless the applicable study is used by Janssen or its Affiliates in a Drug Approval Application for any Single Agent Product of Janssen or its Affiliates, or by the Selling Party in a Drug Approval Application for a Territory Combination Product.
1.59    Complera” shall mean the fixed-dose co-formulated product in oral dosage form containing, as its only APIs per single daily dose, TDF, FTC and RPV, which product is either (a) a solid form that contains a dosage form of TDF equivalent to three hundred (300) milligrams Tenofovir Disoproxil Fumarate, FTC equivalent to two hundred (200) milligrams Emtricitabine and RPV equivalent to twenty-five (25) milligrams Rilpivirine; or (b) an age-appropriate pediatric formulation and dosage consistent with the Pediatric Investigation/Study Plan for a product that corresponds to the product described in clause (a) above, which plan is developed by Gilead and approved by Janssen in accordance with this Agreement.
1.60    Complera Actual Percentage” shall have the meaning set forth on Annex I.
1.61    Complera Average Respective Percentage” shall mean, with respect to a given Party and with respect to given Losses, (a) the weighted average of such Party’s Complera Actual Percentage for each Calendar Year during the period commencing on the Original Effective Date and ending with the earlier of (i) the last Calendar Year during the Term and (ii) the Calendar Year immediately prior to the Calendar Year in which such Losses are incurred, with the weighting based on the Net Sales of Territory Complera in the Territory during each such Calendar Year or (b) in the case of any Losses incurred in or prior to the Calendar Year in which the First Commercial Sale of Territory Complera in the Territory first occurs, such Party’s Complera Working Percentage for the Calendar Year in which such Losses are incurred.
1.62    Complera Clinical Trial” shall mean: (a) any clinical trial in humans of Complera; or (b) any clinical trial in humans of a treatment regimen administered via multiple products that contain, in aggregate, all of RPV, FTC and TDF as its only three (3) APIs, in each

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


case ((a) and (b)), conducted in accordance with this Agreement. For clarity, a clinical trial involving a comparison of subjects treated with Complera (or the multiple products described in clause (b) above) to subjects treated with a different combination product or other treatment regimen shall be considered a Complera Clinical Trial. Any clinical trial that only qualifies as a Complera Clinical Trial because of the inclusion of an unspecified background regimen shall not be considered a Complera Clinical Trial.
1.63    Complera Key Selling Messages” shall have the meaning set forth in Section 6.7.1.
1.64    Complera Launch Period” shall have the meaning set forth in Section 6.2.2.1.
1.65    Complera PVA” shall mean that certain Amended Safety Data Exchange Agreement between the Parties dated September 19, 2013, as such agreement is amended from time to time.
1.66    Complera Third Party Trial” shall have the meaning set forth in Section 3.2.2.2a.iii.
1.67    Complera Working Percentage” shall have the meaning set forth on Annex H.
1.68    Completed Territory Combination Product” shall have the meaning set forth in Annex M-1.
1.69    Completion shall have the meaning set forth in Annex M-1.
1.70    Confidential Information” shall have the meaning set forth in Section 15.3.1.
1.71    Control” shall mean, with respect to a grant of any license, sublicense, access, or other right by a Party to the other hereunder relating to any Information and Inventions, Regulatory Documentation, Patents, know-how or other intellectual property rights, the right of such Party, whether by ownership, license or otherwise, to grant a license, sublicense, access, or other right to or under such item, Patent or right as provided for in this Agreement without violating Applicable Law or the terms of any agreement or other binding arrangement with any Third Party (before taking into account the effect of any licenses granted under this Agreement, but after taking into account the effect of Section 14.1).
1.72    Corresponding Ratio” shall have the meaning set forth in Annex M-1.
1.73    Country Monthly Payment” shall have the meaning set forth in Annex M-1.
1.74    Country Ratio” shall have the meaning set forth in Annex M-1.
1.75    Court” shall have the meaning set forth in Section 20.8.1.
1.76    Cover”, “Covered” or “Covering shall mean, with respect to a specified subject matter (such as a composition of matter, a method of use or activity), that, in the absence

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


of a license granted, the Exploitation of such subject matter would or is reasonably likely to infringe the applicable Patent or Valid Claim.
1.77    CTD” shall mean, with respect to each Combination Product, the portion of Gilead’s NDA for such Combination Product filed in accordance with the Common Technical Document requirements, as defined by the International Conference on Harmonization.
1.78    Cure Period” shall have the meaning set forth in Section 19.4.1.
1.79    Data Sharing LOA” shall mean, collectively, (a) that certain Letter Agreement, dated as of March 21, 2011, by and between Janssen, Gilead Sciences, Inc., and Gilead Sciences Limited, and (b) that certain Letter Agreement, dated as of November 21, 2011, by and between Janssen, Gilead Sciences, Inc., and Gilead Sciences Limited, both (a) and (b), setting forth the obligations of the Parties with regards to [*], as such agreement is amended from time to time.
1.80    Defending Party” shall have the meaning set forth in Section 18.7.2.
1.81    Detail” shall mean an in-person presentation to a health care provider who has prescribing authority by a sales representative who is fully equipped with knowledge of, and local promotional materials and the Product Label with respect to, a Combination Product, in which presentation the characteristics of such Combination Product are described by such sales representative in a fair and balanced manner consistent with the requirements of Applicable Law and 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.
1.82    Detailing Year” shall have the meaning set forth in Section 6.2.2.3.
1.83    Development Activities shall mean pre-clinical or clinical activities relating to any pharmaceutical product, including: pre-clinical testing, toxicology studies, formulation work, clinical studies (including bioequivalence studies), regulatory affairs activities with regard to clinical studies and clinical supplies, process development (including validation and scale-up), CMC Data development activities, pre-clinical and clinical manufacturing, validation, stability testing, and quality assurance technical support activities, test method development, statistical analysis, preparation of documentation and report writing.
1.84    Development Record Access Notice” shall have the meaning set forth in Section 3.4.2.
1.85    Disclosing Party” shall have the meaning set forth in Section 15.1.
1.86    Disclosure Statement” shall mean a separate statement exchanged by the Parties that is identified on its face as the “Disclosure Statement” to this Agreement, is signed by the

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Parties and contains disclosures relating to any representation, warranty or covenant made by a Party under Article 17 as of the Restatement Effective Date.
1.87    Dispute” shall have the meaning set forth in Section 20.6.1.
1.88    Distribute” or “Distribution” shall mean, with respect to each country in the Territory, importing, selling, distributing, exporting, transporting and other activities associated with the foregoing listed activities with respect to the distribution of a product, including inventory management and control, warehousing and distribution, invoicing, collection of sales proceeds, preparation of sales records and reports, customer relations and services, and the handling of returns.
1.89    Distribution Activities” shall have the meaning set forth in Section 6.6.
1.90    Distribution Subcontractor shall mean any Third Party subcontractor that (a) performs storage, warehousing or shipping, or coordination of any of the foregoing or (b) performs any of the Distribution Activities, in each case ((a) and (b)), with respect to a Territory Combination Product on behalf of a Selling Party (or its Affiliates) under this Agreement, other than Third Party Distributors.
1.91    Double Agent Product” shall mean each of the F/TDF Product and the F/TAF Product.
1.92    Drug Approval Application” shall mean, with respect to a product in a particular country, an application to the applicable Regulatory Authority for permission to market and/or sell such product in such country, including an NDA or MAA.
1.93    Edurant” shall have the meaning set forth in the recitals hereto and shall mean such product as of the Restatement Effective Date.
1.94    Edurant Development Activities” shall mean Development Activities with respect to Edurant.
1.95    Edurant Regulatory Activities” shall mean the regulatory activities to be conducted for Edurant as required in order to obtain or maintain Regulatory Approvals of Edurant in the Field in the Territory, but excluding any Edurant Development Activities.
1.96    Edurant Study” shall mean any Company Sponsored Trial that involves Edurant but does not include any other pharmaceutical product except (i) the F/TDF Product, (ii) the F/TAF Product, (iii) TDF and FTC (whether co-administered or co-formulated) or (iv) TAF and FTC (whether co-administered or co-formulated). Notwithstanding the foregoing, any clinical trial that would only qualify as an Edurant Study because of the inclusion of any of the items described in clauses (i) through (iv) in an unspecified background regimen shall not be considered an Edurant Study.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.97    EMA” shall mean the European Medicines Agency or any successor entity thereto having review authority over applications for centralized Regulatory Approvals in the European Union.
1.98    Emtricitabine” shall mean the compound set forth in Annex GG-3, known as emtricitabine.
1.99    Emtriva” shall have the meaning set forth in the recitals hereto and shall mean such product as of the Original Effective Date.
1.100    Estimated Yield Rate” shall have the meaning set forth in Annex M-1.
1.101    European Commission” shall mean the governing body of the European Union, or such other entity(ies) responsible for proposing legislation, implementing decisions, upholding treaties and the general operation of the European Union, including issuance of Regulatory Approvals in the European Union.
1.102    European Union” or “EU” shall mean all countries that are member states of the European Union as constituted from time to time.
1.103    Executive(s)” shall mean (a) in the case of Gilead, the President and Chief Operating Officer of Gilead Parent, and (b) in the case of Janssen, a Worldwide Chairman of Janssen Parent’s pharmaceutical group.
1.104    Executives Review Period” shall have the meaning set forth in Section 20.6.2.
1.105    Existing Gilead Licenses” shall mean any of those license agreements on Annex Y.
1.106    Existing RPV Licenses” shall mean any of those license agreements on Annex W.
1.107    Expert” shall have the meaning set forth in Section 20.6.3.
1.108    Expert Dispute” shall mean a matter that is subject to resolution by an Expert in accordance with Section 20.6.2.3.
1.109    Exploitation” or “Exploit” shall mean the making, having made, importation, exportation, use, sale, offering for sale, having sold, disposition, research, development, registration, modification, enhancement, Manufacturing, storage, formulation, optimization, 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.
1.110    FDA” shall mean the United States Food and Drug Administration and any successor entity thereto having authority over Regulatory Approvals in the United States.

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.111    Field” shall mean all human use in the prophylaxis and treatment of HIV infection.
1.112    Finance Representative” shall have the meaning set forth in Section 2.3.1.
1.113    Financial Records” shall have the meaning set forth in Section 10.6.
1.114    Financial Reporting Committee” shall have the meaning set forth in Section 2.3.
1.115    Finished Product” shall have the meaning set forth in Section 9.3.3.
1.116    First Calendar Year” shall have the meaning set forth in Annex M-1.
1.117    First Commercial Sale” shall mean, with respect to the applicable product in a country, the first sale in an arm’s length transaction and shipment of such product to a Third Party by a Party or any of its Affiliates or (sub)licensees in the Field in such country following Marketing Approval of such product in such country. For the avoidance of doubt, a first sale for compassionate use or named patient program sales shall not constitute a First Commercial Sale for purposes of this Agreement.
1.118    Force Majeure Event” shall have the meaning set forth in Section 20.1.
1.119    F/TAF Market” shall mean, [*].
1.120    F/TAF NSP shall have the meaning set forth in Annex M-1.
1.121    F/TAF Product” shall mean any fixed-dose co-formulated FTC Product in oral dosage form containing, as its only two (2) APIs, FTC and TAF.
1.122    F/TDF NSP shall have the meaning set forth in Annex M-1.
1.123    F/TDF Product” shall mean any fixed-dose co-formulated FTC Product in oral dosage form containing, as its only two (2) APIs, FTC and TDF, including Truvada.
1.124    FTC” shall mean Emtricitabine or any or all of the following:  [*].
1.125    FTC Product” shall mean any pharmaceutical product containing FTC, which product is under development or is being sold at any time by Gilead or an Affiliate, subcontractor, (sub)licensee, or Third Party distributor of Gilead or its Affiliates, including any FTC Single Agent Product, F/TDF Product or F/TAF Product; provided, however, that the term “FTC Product” shall not include any Combination Product or any STR (as defined in the Amended D/C/F/TAF Agreement).
1.126    FTC Single Agent Product” shall mean any FTC Product that contains FTC as its only API, including Emtriva.

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.127    Generic Basis shall mean, with regard to commercialization of a product, the commercialization of a generic oral version of such product that is approved for marketing by a Third Party in the Field either: (i) pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)) or a foreign equivalent thereof by reference to a Marketing Approval of such product, or (ii) pursuant to any other law or regulation where such approval is based on a demonstration of bio-equivalence or biosimilarity to such product. Under no circumstances shall a product be considered commercialized on a Generic Basis if a Party or its Affiliates or its (sub)licensees (a) transferred a Marketing Approval of such product to such Third Party, (b) transferred an application for Marketing Approval of such product to such Third Party, or (c) provided a Right of Reference to such Third Party in order to enable such Third Party to commercialize such product, except for a right of reference limited to qualifying the generic version for a government and/or nonprofit entity’s program for providing medicines at no or low cost to countries in Region C (such as the President’s Emergency Plan for AIDS Relief).
1.128    Generic Combination Product” shall mean (a) with respect to Complera, Generic Complera, and (b) with respect to the R/F/TAF Product, Generic R/F/TAF Product.
1.129    Generic Competition Period” shall mean, [*].
1.130    Generic Complera” shall mean an oral product owned or otherwise controlled by a Third Party that (a) contains all three (3) of RPV, FTC and TDF as its only APIs and (b) is approved (or sought to be approved) in the Field either: (i) pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)) or a foreign equivalent thereof by reference to a Marketing Approval of Territory Complera or any RPV Product, FTC Product or TDF Product, or (ii) pursuant to any other law or regulation where such approval is based on a demonstration of bio-equivalence or biosimilarity to any of the foregoing products.
1.131    Generic Equivalent” shall have the meaning set forth in [*].
1.132    Generic Exception” shall have the meaning set forth in Section 17.3.1.
1.133    Generic F/TAF Combination” shall mean a product owned or controlled by a Third Party that (a) is in oral dosage form, (b) contains as its only APIs per single daily dose, TAF equivalent to 25 mg GS-7340 and FTC equivalent to 200 mg Emtricitabine, and (c) is approved (or sought to be approved) in the Field either: (i) pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)) or a foreign equivalent thereof by reference to a Marketing Approval of F/TAF Product or any FTC Product or TAF Product, or (ii) pursuant to any other law or regulation where such approval is based on a demonstration of bio-equivalence or biosimilarity to any of the foregoing products.
1.134    Generic F/TAF Combination Threshold” shall mean, [*].
1.135    Generic FTC/TDF Combination” shall mean a product owned or controlled by a Third Party that (a) is in oral dosage form, (b) contains as its only APIs per single daily dose, TDF equivalent to 300 mg Tenofovir Disoproxil Fumarate and FTC equivalent to 200 mg Emtricitabine, and (c) is approved (or sought to be approved) in the Field either: (i) pursuant to

14

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Section 505(j) of the Act (21 U.S.C. 355(j)) or a foreign equivalent thereof by reference to a Marketing Approval of Truvada or any FTC Product or TDF Product, or (ii) pursuant to any other law or regulation where such approval is based on a demonstration of bio-equivalence or biosimilarity to any of the foregoing products.
1.136    Generic FTC/TDF Combination Threshold” shall mean, [*].
1.137    Generic Licensee” shall mean a Third Party that is authorized by a Party or a Party’s Affiliate to: (a) manufacture a generic version of such Party’s Single Agent Product(s) (or with respect to Gilead, its Double Agent Products) or other combination products containing one or more of such API(s), as applicable, on a Generic Basis or the API(s) therein, in order to sell such generic products or to sell such API(s) for use in such generic products; or (b) sell a generic version of any such products on a Generic Basis. With regard to Gilead, the term “Generic Licensee” shall also include MPP or any MPP Licensee(s).
1.138    Generic R/F/TAF Product” shall mean an oral product owned or otherwise controlled by a Third Party that (a) contains all three (3) of RPV, FTC and TAF as its only APIs and (b) is approved (or sought to be approved) in the Field either: (i) pursuant to Section 505(j) of the Act (21 U.S.C. 355(j)) or a foreign equivalent thereof by reference to a Marketing Approval of the Territory R/F/TAF Product or any RPV Product, FTC Product or TAF Product, or (ii) pursuant to any other law or regulation where such approval is based on a demonstration of bio-equivalence or biosimilarity to any of the foregoing products.
1.139    Generic Sales” shall have the meaning set forth in [*].
1.140    Generic Threshold” shall have the meaning set forth in Annex M-2.
1.141    Gilead” shall have the meaning set forth in the preamble hereto.
1.142    Gilead Clinical Data” shall have the meaning set forth in Section 3.2.4.4.
1.143    Gilead Component Characteristics” shall have the meaning set forth in Section 18.2.1.
1.144    Gilead Compound Data Exclusivity” shall have the meaning set forth in Section 9.2.3.1.
1.145    Gilead Compound Infringement” shall mean an infringement or misappropriation of any Patent or other intellectual property, including trade secrets, of a Third Party resulting from:
(a)
the importation of a Territory Combination Product by or on behalf of Janssen or its Affiliates, which infringement or misappropriation directly results from the incorporation into such Territory Combination Product of TAF, TDF or FTC, but [*], or

15

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


(b)
the importation of a Territory Combination Product by or on behalf of Janssen or its Affiliates, which infringement or misappropriation directly results from the manufacture of any TAF, TDF or FTC that is incorporated into such Territory Combination Product, but [*],
in each case ((a) and (b)) without reference to the combination of the applicable Gilead Compound Product with RPV. For purposes of the definition of Gilead Compound Infringement, (x) “incorporation” or “incorporated” shall mean the presence of TAF, TDF or FTC, as applicable, in a Territory Combination Product, and not the process of incorporating TAF, TDF or FTC, as applicable, into a Territory Combination Product, and (y) Gilead Compound Infringement shall include only misappropriation by Gilead (or its Affiliates or contract manufacturers) and not by Janssen or any of its Indemnified Persons.
1.146    Gilead Compound Product” shall mean any TDF Product, TAF Product or FTC Product. For the sake of clarity, “Gilead Compound Product” shall include any F/TAF Product or F/TDF Product, but shall exclude any Combination Product and the Duo Combination Product (as defined in the Amended D/C/F/TAF Agreement).
1.147    Gilead-Controlled Combination Product Joint Patents” shall have the meaning set forth in Section 14.2.3.1a.
1.148    Gilead Core Technology” shall mean all Information and Inventions Controlled by Gilead relating specifically to the Exploitation of FTC, TDF or TAF, or any combination of any of FTC, TDF and TAF, or any Gilead Compound Product (including the Double Agent Products and Atripla, but excluding, for clarity, any Combination Product).
1.149    Gilead Countries” shall mean, at any time, any country other than the Janssen Countries (for clarity, including any Gilead Take-Over Countries and excluding any Janssen Take-Over Countries).
1.150    Gilead In-License Requirements” shall have the meaning set forth in Section 9.5.1.
1.151    Gilead Know-How” shall mean any and all Information and Inventions under the Control of Gilead or any of its Affiliates at any time during the period beginning on the Original Effective Date and ending on the last day of the Term (other than pursuant to Section 9.1) that are necessary or reasonably expected to be necessary for the Exploitation of a Territory Combination Product or are disclosed to Janssen or its Affiliates by Gilead or its Affiliates in the course of the performance of this Agreement or under the PVA (or other safety-data exchange provisions contained in any other Ancillary Agreement) and are not generally known to Third Parties, including any such Information and Inventions included in the Gilead-Owned Collaboration Inventions, but excluding any and all (a) such Information and Inventions to the extent disclosed by published Gilead Patents, (b) Joint Know-How and (c) any (i) business information, medical education materials, promotional materials and marketing and strategic studies, or (ii) information relating to the validity or enforceability of any Patents or any freedom to operate analysis. For clarity, Gilead Know-How shall not (x) include any Gilead Regulatory

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Documentation, but shall include Clinical Data Controlled by Gilead or its Affiliates or (y) include any Information and Inventions with respect to any compound other than TDF, TAF, FTC or RPV.
1.152    Gilead Licensed Trademarks” shall mean any Trademarks used by Gilead or its Affiliates in connection with the Exploitation of Viread, Emtriva, Truvada or the F/TAF Product. A list of certain Gilead Licensed Trademarks existing as of the Restatement Effective Date is attached hereto as Annex A-1, which list Gilead shall update as reasonably requested by Janssen in writing.
1.153    Gilead Marketing Approval” shall have the meaning set forth in Section 4.8.
1.154    Gilead-Owned Collaboration Invention” shall mean any Collaboration Invention pertaining specifically and solely to Gilead Core Technology.
1.155    Gilead Parent” shall have the meaning set forth in the preamble hereto.
1.156    Gilead Patents” shall mean all of the Patents under the Control of Gilead or any of its Affiliates (other than pursuant to Section 9.1) at any time during the period beginning on the Original Effective Date and ending on the last day of the Term that would be infringed by the Exploitation of any Combination Product by a Person Distributing such Combination Product if such Combination Product were not purchased from Gilead. A list of certain Gilead Patents in the Janssen Countries, existing as of the Restatement Effective Date, is attached hereto as Annex B-1, which list Gilead shall update as reasonably requested by Janssen in writing. The Gilead Patents do not include the Joint Patents. For clarity, the Gilead Patents include Patents Covering the Gilead-Owned Collaboration Inventions.
1.157    Gilead Payment Term” shall have the meaning set forth in Annex M-5.
1.158    Gilead Permitted Use” shall mean (a) obtaining and maintaining Regulatory Approvals (including the initial Product Label and updates thereto) of any Territory Combination Product in the Gilead Countries, any Single Agent Product of Gilead or any Double Agent Product of Gilead in the Territory (such product(s) alone or in combination with RPV or an RPV Single Agent Product but not in combination with other compounds or products), (b) the performance of Gilead’s obligations and exercise of Gilead’s rights under this Agreement and (c) compliance with Applicable Law.
1.159    Gilead Redactable Information” shall mean:
[*].
1.160    Gilead Regulatory Documentation” shall mean all Regulatory Documentation that (a) is with respect to (i) TDF, TAF, FTC or a Gilead Compound Product, in each case in the Field, or (ii) a Combination Product and (b) is Controlled by Gilead or its Affiliates at any time during the period beginning on the Original Effective Date and ending on the last day of the Term.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.161    Gilead Results” shall have the meaning set forth in Section 3.6.1.
1.162    Gilead Specified Rights” shall have the meaning set forth in Section 19.3.
1.163    Gilead Sub” shall have the meaning set forth in the preamble hereto.
1.164    Gilead Take-Over Country” shall mean, at any time, any country (a) that was a Janssen Country as of the Restatement Effective Date, (b) with respect to which the Janssen Distributor Agreement has terminated and (c) with respect to which Gilead has elected to convert such country to a Gilead Country pursuant to [*].
1.165    Gilead Technology” shall mean, collectively, the Gilead Know-How and the Gilead Patents.
1.166    Good Clinical Practice” or “GCP” shall mean the then-current standards for clinical trials for pharmaceutical products, as set forth in Applicable Law, as amended from time to time.
1.167    Good Distribution Practice” or “GDP” shall mean the then-current standards for Distribution activities as set forth by the World Health Organization and Applicable Law, as amended from time to time.
1.168    Good Laboratory Practice” or “GLP” shall mean the then-current standards for laboratory activities for pharmaceutical products, as set forth in Applicable Law, as amended from time to time.
1.169    Good Manufacturing Practice” or “GMP” shall mean applicable current good manufacturing practices for pharmaceutical products (and components thereof) as described in regulations promulgated by the applicable Regulatory Authority, as amended from time to time.
1.170    GS-7340” shall mean the compound set forth in Annex GG-1, known as GS-7340.
1.171    [*] shall have the meaning set forth in [*].
1.172    Hold Criteria” shall have the meaning set forth in Section 4.8.
1.173    IND” shall mean (a) an Investigational New Drug Application as defined in the Act and regulations promulgated thereunder or any successor application or procedure required to initiate clinical testing of a drug in humans in the United States; (b) a counterpart of such an Investigational New Drug Application that is required in any other country in the Territory before beginning clinical testing of a drug in humans in such country; and (c) all supplements and amendments to any of the foregoing.
1.174    Indemnified Party” shall mean a Party that is seeking, or has an Indemnified Person that is seeking, indemnification (or other reimbursement) for Losses pursuant to Article 18.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.175    Indemnified Persons” shall mean, with respect to a Party, such Party, its Affiliates and their respective agents, officers, directors and employees.
1.176    Indemnifying Party” shall mean the Party responsible for indemnifying the Indemnified Party and its Indemnified Persons under Article 18.
1.177    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, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, apparatuses, specifications, data, results and other material, including Manufacturing procedures, test procedures, and purification and isolation techniques (whether or not confidential, proprietary, patented or patentable) in written, electronic or any other form, and all other discoveries, developments, inventions (whether or not confidential, proprietary, patented or patentable), and tangible embodiments of any of the foregoing. Information and Inventions shall be deemed to exclude Regulatory Documentation, but, for clarity, shall include Clinical Data. Notwithstanding the foregoing, in no event shall Information and Inventions include any (a) promotional or sales materials, or (b) information relating to the validity or enforceability of any Patents or any freedom to operate analysis.
1.178    Infringement” shall have the meaning set forth in Section 14.4.4.
1.179    Infringing Combination Product” shall have the meaning set forth in Section 14.4.4.
1.180    Initial Specific Target Breach” shall mean, with respect to each applicable Major Market Country and each Specific Target, the first failure by Gilead to substantially achieve such Specific Target in such country.
1.181    In-License Agreement” shall mean any Existing RPV License, any Existing Gilead License or any agreement deemed to be an In-License Agreement pursuant to Section 9.5.4.
1.182    In-License Requirements” shall mean the Janssen In-License Requirements or the Gilead In-License Requirements, as applicable.
1.183    Input Supplied RPV” shall have the meaning set forth in Annex M-1.
1.184    International Co-Detailing LOA” shall mean that certain Amended and Restated Letter Agreement, dated as of November 4, 2013, by and between Janssen R&D Ireland and Gilead Sciences, Inc., which sets forth Detailing principles for the Co-Detailing Territory (defined therein), as such agreement is amended from time to time.
1.185    International Public Organization” shall mean any of the organizations listed on 8 C.F.R. § 316.20, as amended from time to time.
1.186    JAMS” shall have the meaning set forth in Section 20.7.1.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.187    Janssen” shall have the meaning set forth in the preamble hereto.
1.188    Janssen Blended Ratio” shall have the meaning set forth in Annex M-3.
1.189    Janssen Clinical Data” shall have the meaning set forth in Section 3.1.2.
1.190    Janssen-Controlled Combination Product Joint Patents” shall have the meaning set forth in Section 14.2.3.1b.
1.191    Janssen Core Technology” shall mean all Information and Inventions Controlled by Janssen and relating specifically to the Exploitation of RPV or any RPV Product, but excluding for clarity the Combination Products.
1.192    Janssen Countries” shall mean, at any time, each of the countries set forth on Annex AA-2, but excluding any Gilead Take-Over Countries and including any Janssen Take-Over Countries.
1.193    [*].
1.194    Janssen Distributor Agreement” shall mean the agreement entered into on even date hereof between the Parties in the form set forth in Annex Z, which agreement amends and restates the Janssen Distributor Agreement (as defined in the Original Agreement), and pursuant to which Janssen will act as Gilead’s exclusive distributor of Territory Combination Products within the Janssen Countries, as such agreement is amended from time to time.
1.195    Janssen In-License Requirements” shall have the meaning set forth in Section 9.5.1.
1.196    Janssen Know-How” shall mean any and all Information and Inventions under the Control of Janssen or any of its Affiliates at any time during the period beginning on the Original Effective Date and ending on the last day of the Term that are necessary or reasonably expected to be necessary for the Exploitation of a Combination Product or are disclosed to Gilead or its Affiliates by Janssen or its Affiliates in the course of the performance of this Agreement or under the PVA (or other safety-data exchange provisions contained in any other Ancillary Agreement) and are not generally known to Third Parties, including any such Information and Inventions included in the Janssen-Owned Collaboration Inventions, but excluding any and all (a) such Information and Inventions to the extent disclosed by published Janssen Patents, (b) Joint Know-How and (c) (i) business information, medical education materials, promotional materials and marketing and strategic studies, or (ii) information relating to the validity or enforceability of any Patents or any freedom to operate analysis. For clarity, Janssen Know-How shall not include (x) any Janssen Regulatory Documentation, but shall include Clinical Data Controlled by Janssen or its Affiliates or (y) any Information and Inventions with respect to any compound other than RPV, TAF, TDF or FTC.
1.197    Janssen Licensed Trademarks” shall mean any Trademarks used by Janssen or its Affiliates in connection with the Exploitation of the RPV Single Agent Product, including

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Edurant. A list of certain Janssen Licensed Trademarks existing as of the Restatement Effective Date is attached hereto as Annex A-2, which list Janssen shall update as reasonably requested by Gilead in writing.
1.198    Janssen-Owned Collaboration Invention” shall mean any Collaboration Invention pertaining specifically and solely to Janssen Core Technology.
1.199    Janssen Parent” shall mean Johnson & Johnson, a New Jersey corporation.
1.200    Janssen Patents” shall mean all of the Patents under the Control of Janssen or any of its Affiliates at any time during the period beginning on the Original Effective Date and ending on the last day of the Term that Cover any or all of the following: the composition of matter, method of use, formulation, Manufacture, import or sale of RPV or any Combination Product. A list of certain Janssen Patents existing as of the Restatement Effective Date is attached hereto as Annex B-2, which list Janssen shall update as reasonably requested by Gilead in writing. The Janssen Patents do not include the Joint Patents. For clarity, the Janssen Patents do include Patents Covering the Janssen-Owned Collaboration Inventions.
1.201    Janssen Payment Term” shall have the meaning set forth in the Janssen Distributor Agreement.
1.202    Janssen Percentage” shall have the meaning set forth in Annex M-1.
1.203    Janssen Permitted Use” shall mean solely (a) obtaining and maintaining Regulatory Approvals (including the initial Product Label and updates thereto) of any Territory Combination Product in the Janssen Countries or any Single Agent Product of Janssen in the Territory (such Single Agent Product alone or in combination with FTC, TDF or TAF or Truvada, the F/TAF Product, the FTC Single Agent Product, the TDF Single Agent Product or the TAF Single Agent Product, but not in combination with other compounds or products), (b) performing Janssen’s obligations or exercising Janssen’s rights under this Agreement and (c) compliance with Applicable Law.
1.204    Janssen Portion” shall have the meaning set forth in Annex M-4.
1.205    Janssen Ratio” shall have the meaning set forth in Annex M-3.
1.206    Janssen Redactable Information” shall mean:
[*].
1.207    Janssen Regulatory Documentation” shall mean all Regulatory Documentation (a) with respect to any RPV Single Agent Product and (b) that is Controlled by Janssen or any of its Affiliates at any time during the period beginning on the Original Effective Date and ending on the last day of the Term.
1.208    Janssen Reliant Country” shall have the meaning set forth in Section 4.8.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.209    Janssen Results” shall have the meaning set forth in Section 3.6.2.
1.210    Janssen Share” shall have the meaning set forth in Annex M-1.
1.211    Janssen Specified Rights” shall have the meaning set forth in Section 19.3.
1.212    Janssen Take-Over Country” shall mean, at any time, any country that was a Gilead Country as of the Restatement Effective Date, with respect to which Janssen has elected to convert such country to a Janssen Country pursuant to any applicable provision of this Agreement.
1.213    Janssen Technology” shall mean, collectively, the Janssen Know-How and the Janssen Patents.
1.214    Joint Collaboration Inventions” shall mean all Collaboration Inventions, but excluding any Janssen-Owned Collaboration Inventions and Gilead-Owned Collaboration Inventions.
1.215    Joint Know-How” shall mean any and all Information and Inventions included in the Joint Collaboration Inventions that are not generally known, but excluding any Information and Inventions to the extent (a) disclosed by published Joint Patents, or (b) published pursuant to Section 3.6.
1.216    Joint Patents” shall mean any Patents to the extent that such Patents Cover Joint Collaboration Inventions.
1.217    Joint Technology” shall mean, collectively, the Joint Know-How and the Joint Patents.
1.218    Key Selling Messages” shall have the meaning set forth in Section 6.7.1.
1.219    Key Territory” shall mean the following countries: the countries comprising the European Union, [*] and the United States.
1.220    Label Characteristics” shall have the meaning set forth in Section 18.2.2.
1.221    Launch Period” shall mean, in the case of Territory Complera, the Complera Launch Period and, in the case of Territory R/F/TAF Product, the R/F/TAF Launch Period.
1.222    Lead Patent Party” shall have the meaning set forth in Section 14.2.3.2.
1.223    Licensor Patent” shall mean any Janssen Patent that Covers any or all of the following: the composition of matter, method of use, formulation, Manufacture, import or sale of RPV or Supplied RPV or a Combination Product.
1.224    Local Promotional Materials” shall have the meaning set forth in Section 6.7.2.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.225    Losses” shall mean judgments, fines, amounts paid in settlement, and reasonable, direct, out-of-pocket costs and expenses (including reasonable attorneys’ fees) incurred by a Party (or other indemnitee as provided in Article 18) in a Proceeding. For clarity, Recall Expenses shall not constitute Losses.
1.226    Lost Supplied RPV shall have the meaning set forth in Annex M-1.
1.227    MAA” shall mean (a) a marketing authorization application filed with (i) the EMA under the centralized EMA filing procedure or (ii) a Regulatory Authority in any country in the European Union if the centralized EMA filing procedure is not used to obtain Marketing Approval; or (b) any other equivalent or related regulatory submission to gain Marketing Approval in any country in the European Union.
1.228    MA Holder” shall mean the entity that holds the Marketing Approval for a product in a given country.
1.229    Major Market Countries” shall mean the United States, [*], France, Germany, Italy, Spain, the United Kingdom [*].
1.230    Mandatory Price Reduction” shall have the meaning set forth in Annex M-2.
1.231    Manufacture” or “Manufacturing” shall mean, with respect to a product or API, the manufacturing, processing, formulating, packaging, labeling, holding (including storage), and quality control testing (including release) of such product or API.
1.232    Manufacturing Completion” shall have the meaning set forth in Annex M-1.
1.233    Manufacturing Executives” shall have the meaning set forth in Annex M-1.
1.234    Manufacturing Fee” shall have the meaning set forth in Annex M-4.
1.235    Manufacturing Fee Percentage” shall have the meaning set forth in Annex M-3.
1.236    Manufacturing Process” shall mean any process or step thereof that is necessary or useful for Manufacturing a Territory Combination Product from (a) the Supplied RPV, (b) TDF or TAF, as applicable, and (c) FTC, in each case ((a), (b) and (c)) whether in bulk granulation form or any other form. Manufacturing Process shall not include making RPV in any form.
1.237    Marketing Approval” shall mean, with respect to a given product and a given country or jurisdiction, an approval by the applicable Regulatory Authority of a Drug Approval Application for such product in such country or jurisdiction, including all post-approval commitments, supplements and amendments to such an application, but excluding any pricing and reimbursement approvals or, except in countries where the import license provides a right to market and sell the product, import licenses.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.238    Master Clinical Trial Material Agreement” shall mean the Master Clinical Trial Material Agreement, effective as of November 17, 2005, entered into by Janssen and Gilead Parent, as amended by Janssen, Gilead Parent, and Tibotec Therapeutics Clinical Affairs, Division of Ortho Biotech Clinical Affairs LLC (as used in this Section 1.238, “Tibotec Therapeutics”) in Amendment #1 to Master Clinical Trial Material Agreement, last dated October 2, 2006, and as amended by Janssen, Gilead Parent, Tibotec Therapeutics, and Tibotec BVBA in Amendment # 2 to the Master Clinical Trial Material Agreement, effective as of November 5, 2010 and as thereafter amended from time to time.
1.239    Material” shall mean RPV, TDF, TAF or FTC, as applicable.
1.240    Material Breach” shall mean (a) with respect to Territory Complera, (i) in the case of Gilead, a Commercial Target Breach, or (ii) in the case of either Party, a breach of this Agreement that goes to the root of this Agreement with respect to Territory Complera and that is so substantial that it defeats the object of the aggrieved Party in making this Agreement with respect to Territory Complera, and (b) with respect to the Territory R/F/TAF Product, in the case of either Party, a breach of this Agreement that goes to the root of this Agreement with respect to the Territory R/F/TAF Product and that is so substantial that it defeats the object of the aggrieved Party in making this Agreement with respect to the Territory R/F/TAF Product. In determining whether a breach is a Material Breach, the arbitrator shall take into particular consideration the special purpose of this Agreement with respect to the applicable Territory Combination Product and the extent to which the injured Party will be deprived of the benefit which it reasonably expected in entering into this Agreement with respect to the applicable Territory Combination Product.
1.241    Material Supplier” shall mean, in the case of RPV, Janssen, or, in the case of TDF, TAF or FTC or Territory Combination Product, Gilead.
1.242    Monthly Payment shall have the meaning set forth in Annex M-1.
1.243    Monthly Payment Term” for a given Territory Combination Product and country of the Territory (including the Janssen Countries), shall mean the period that commences as of the date of First Commercial Sale of such applicable Territory Combination Product in such country and expires at the later of: (a) [*] after the date of First Commercial Sale of Territory Complera or the Territory R/F/TAF Product, as applicable, in such country; and (b) expiration or invalidation (as described in the definition of Valid Claim) of the last of the Valid Claims of the Licensor Patent(s) that Covers Exploitation of such applicable Territory Combination Product in such country by Gilead or its Affiliates, Sublicensees or Third Party Distributors.
1.244    Monthly Quantity” shall have the meaning set forth in Annex M-1.
1.245    MPP” shall mean the Medicines Patent Pool, a non-profit foundation registered under the laws of Switzerland, and having a principal place of business at 150 route de Ferney, P.O. Box 2100, CH-1211 Geneva 2, Switzerland, or any successor thereof.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.246    MPP License” shall mean each of (a) the license granted by Gilead to MPP pursuant to that certain license agreement between the MPP and Gilead Parent effective as of July 11, 2011, as amended from time to time (provided that any such amendment may not have the effect of removing any existing requirements (or substantially similar requirements) as set forth in clauses (a) through (c) of Section 1.310 with respect to MPP or its sublicensees as Generic Licensees) and (b) the license granted by Gilead to MPP pursuant to that certain license agreement between the MPP and Gilead Parent effective as of July 22, 2014, as amended from time to time (provided that any such amendment may not have the effect of removing any existing requirements (or substantially similar requirements) as set forth in clauses (a) through (c) of Section 1.310 with respect to MPP or its sublicensees as Generic Licensees).
1.247    MPP Licensee(s)” shall mean any Third Party that enters into a sublicense with MPP under either of the MPP Licenses.
1.248    MTA” shall mean that certain Materials Transfer Agreement by and between Gilead Parent and Janssen dated February 1, 2009, as such agreement is amended from time to time, including Addendum #1 dated April 2, 2014, Addendum #2 dated June 12, 2014, Addendum #3 dated September 15, 2014 and Addendum #4 dated October 30, 2014.
1.249    NDA shall mean a New Drug Application as defined in the Act and regulations promulgated thereunder or any successor application or procedure required to market or sell a drug in the United States or to export a pharmaceutical product from the United States.
1.250    Necessary Personnel” means, with respect to each Party [*] (such Persons, the “Additional Personnel”).
1.251    Negotiation Period” shall have the meaning set forth in Section 6.5.
1.252    Net Sales” shall mean, with respect to a product for any period for a country, expressed in local currency in such country, the gross amount invoiced for commercial sales of such product in such period by the applicable selling Party or any of its Affiliates or Sublicensees (in the case of Territory Combination Product where Gilead is the Selling Party) or (sub)licensees (in the case of any other product) to Third Parties, less charges, if any, to the applicable Third Party for freight, postage, shipping and insurance expenses (if separately identified in such invoice) and less deductions for: (a) normal and customary quantity or cash discounts and sales returns and allowances, including those granted on account of prompt payment, price adjustments, billing errors, permitted customer rejections or returns (including due to a recall or product withdrawal) for a given quantity of the applicable product, administrative fees or reimbursements or similar payments to wholesalers or other distributors, buying groups, pharmacy benefit management organizations, health care insurance carriers or other institutions, and allowances, rebates, fees paid to distributors and chargebacks allowed or given; (b) customs or excise duties or other duties related to the sales making up the gross invoice amount (if separately identified in such invoice); (c) any rebates or similar payments accrued with respect to sales paid for by any governmental or regulatory authority; (d) sales and other taxes and duties directly related to the sale, to the extent that such items are included in the gross invoice amount (but not including taxes assessed against the income derived from such sale); and (e) any other

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


item taken as a deduction to determine net sales under the Accounting Standards. 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 the Accounting Standards. Further, for purposes of determining Net Sales with respect to a product, the product shall be deemed to be sold when the revenue obtained in connection with the transfer of such product to a Third Party is recognized in accordance with the Accounting Standards. Net Sales with respect to a product for any period for the Territory as a whole (or the Gilead Countries as a whole or the Janssen Countries as a whole, as the case may be) shall be expressed in U.S. Dollars and, in the case of a Territory Combination Product, shall be equal to the sum of Net Sales of such Territory Combination Product (as converted into U.S. Dollars as provided under Section 10.7) in each country in the Territory (or the Gilead Countries or the Janssen Countries, as applicable) for such period.
For purposes of calculating the F/TAF NSP, F/TDF NSP, and RPV NSP or making the analogous calculation pursuant to Section 19.6.3, if (i) the applicable product is sold by a Third Party distributor of a Party, (ii) the applicable agreement between such Party and such Third Party distributor includes the record-keeping and audit provisions required to be included in such agreement under Section 10.8.2.3 and such Third Party distributor has not previously refused to allow an audit, which refusal has prevented such audit of its records under such provisions (or the Parties otherwise agree), and (iii) at the time the calculations in Section F of Annex M-1 or Section E of Exhibit B-1 of the Janssen Distributor Agreement, as applicable, are to be performed, the in-market Net Sales made by such Third Party distributor (calculated mutatis mutandis) are available, then such in-market Net Sales may be used in lieu of the Net Sales calculation based on the sale of such product to the Third Party distributor as set forth in this definition.
1.253    Net Selling Price” shall have the meaning set forth in Annex M-1.
1.254    [*] shall have the meaning set forth in Annex M-1.
1.255    [*] shall have the meaning set forth in Annex M-1.
1.256    Non-Breaching Party” shall have the meaning set forth in Section 19.4.1.
1.257    [*] shall have the meaning set forth in [*].
1.258    Notice of Allegation” shall mean (a) with respect to Canada, the filing of a notice of allegation under the Patented Medicines (Notice of Compliance) Regulations (Canada) and (b) with respect to any other country, the filing of a certification that is analogous to a Paragraph (iv) Certification or the filing of a notice that is analogous to a Notice of Allegation described in clause (a).
1.259    Notice of Claim” shall have the meaning set forth in Section 18.7.1.
1.260    NSP” shall have the meaning set forth in Annex M-2.
1.261    Officials” shall have the meaning set forth in Section 17.1.11.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.262    Ongoing Edurant Studies” shall have the meaning set forth in Section 3.1.2.
1.263    Original Agreement” shall have the meaning set forth in the recitals hereto.
1.264    Original Effective Date” shall have the meaning set forth in the recitals hereto.
1.265    Other Combination Product” shall mean [*].
1.266    Other Generic Licensee” shall mean [*].
1.267    Other Infringement” shall have the meaning set forth in Section 14.4.4.
1.268    Other Infringing Product” shall have the meaning set forth in Section 14.4.4.
1.269    Other RPV Product” shall mean an RPV Product containing RPV as its sole API at a dose which is the therapeutic equivalent of 25 mg Rilpivirine.
1.270    Paragraph (iv) Certification” shall have the meaning set forth in Section 14.4.4.
1.271    Party” and “Parties” shall have the meanings set forth in the preamble hereto.
1.272    Party Product” shall have the meaning set forth in Annex M-2.
1.273    Party-Specific Recall/Withdrawal” shall mean, with respect to a Party, any recall or withdrawal that (a) is caused by one or more of the following: (i) such Party’s (or its Affiliate’s or subcontractors’) negligence, gross negligence or willful misconduct or omission, (ii) safety issues with respect to such Party’s APIs, (iii) breach by such Party (or its Affiliate or subcontractor) of this Agreement or any Ancillary Agreement, (iv) any event occurring while the applicable Territory Combination Product is under the control of such Party (or its Affiliate) hereunder, including under the Janssen Distributor Agreement, or (v) such Party’s determination to withdraw a Territory Combination Product from the market in one or more countries in the Territory pursuant to Section 13.2.3; and (b) is not caused by any of the following: (i) the other Party’s (or its Affiliate’s or subcontractor’s) negligence, gross negligence or willful misconduct or omission, (ii) safety issues with respect to the other Party’s APIs, (iii) the breach by the other Party (or its Affiliate or subcontractor) of this Agreement or any Ancillary Agreement, or (iv) any event occurring while such Territory Combination Product is under the control of the other Party (or its Affiliate) hereunder, including under the Janssen Distributor Agreement.
1.274    Patent Cooperation Treaty” or “PCT” shall mean the Patent Cooperation Treaty, opened for signature June 19, 1970, 58 U.S.T. 7645.
1.275    Patent Matter” shall mean any Dispute between the Parties that relates to the inventorship, infringement, enforceability or validity of any Joint Patent or any Patent that is licensed hereunder by one Party to the other Party, which Dispute is not resolved by the Executives pursuant to Section 20.6.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.276    Patents” shall mean, with respect to a particular inventive subject matter, (a) all applications for certificates of invention, provisional or priority-establishing patent applications and non-provisional or utility patent applications, including patent applications under the Patent Cooperation Treaty and the European Patent Right Convention, claiming such inventive subject matter and all patents and certificates of invention issuing therefrom; together with (b) any renewal, division, continuation (in whole or in part), or request for continued examination of any of such patents, and any reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, registrations, revalidations, revisions, and additions of or to any of the foregoing, and any foreign counterparts of any of the foregoing and any other patents and patent applications claiming priority back to any of the foregoing.
1.277    Payment” shall have the meaning set forth in Section 17.1.11.
1.278    Pediatric Investigation/Study Plan” shall mean any requirement for consideration of pediatric investigations required or requested by a Regulatory Authority in connection with obtaining or maintaining a first Marketing Approval, including the EMA requirements for pediatric investigation plan and FDA requirements for pediatric assessment in the Field.
1.279    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 a government or political subdivision, department or agency of a government.
1.280    Pharmacovigilance Agreement” or “PVA” shall have the meaning set forth in Section 13.1.
1.281    Post-Approval Commitment Studies” shall mean any studies that are required by the applicable Regulatory Authority to maintain a first Marketing Approval for a product in any of the United States, [*] or by the European Commission.
1.282    Post-Conversion Invoice” shall have the meaning set forth in Annex M-5.
1.283    Post-Conversion Supply Price or “PCSP” shall have the meaning set forth in Annex M-1.
1.284    Post-Conversion Supply Price Country(ies)” shall mean any Gilead Countries in the Territory for which a Monthly Payment Term is in effect.
1.285    Post-Launch NSP Information” shall have the meaning set forth in Annex N.
1.286    Pre-Conversion Invoice shall mean an invoice for the Pre-Conversion Supply Price for Supplied RPV provided by Janssen to Gilead under the RPV Supply Agreement.
1.287    Pre-Conversion Supply Price” shall mean [*].

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.288     [*] shall have the meaning set forth in [*].
1.289    Premarket Launch Activities” shall mean marketing activities preceding the First Commercial Sale of the applicable Territory Combination Product, including market research, key opinion leader education and product positioning.
1.290    Proceeding” shall mean a civil, criminal, administrative or investigative suit or proceeding initiated or brought by, or a demand made by, a Third Party.
1.291    Product Label” shall mean, with respect to a product, the full prescribing information for such product, as approved by an applicable Regulatory Authority, including any required summary of product characteristics and patient information, and a package insert for such product.
1.292    Product Label and Package” shall mean, with respect to a product, (a) the Product Label for such product and (b) all other labels and other written, printed or graphic matter upon any container or wrapper for such product.
1.293    Product Trademark” shall mean any Trademark specifically selected for a product, but not including any Person’s company name, logo or similar Trademark.
1.294    Prosecution and Maintenance” shall have the meaning set forth in Section 14.3.
1.295    Publication” shall have the meaning set forth in Section 3.6.1.
1.296    Quality Agreement” shall have the meaning set forth in the RPV Supply Agreement.
1.297    Recalled Product” shall have the meaning set forth in Section 13.3.
1.298    Recall Expenses” shall mean the reasonable, direct, out-of-pocket costs and expenses incurred by either Party or any of its Affiliates in connection with any recall or withdrawal of a Territory Combination Product in the Territory, including (a) any reasonable, direct, out-of-pocket costs and expenses of notification and destruction or return of the recalled Territory Combination Product, and (b) any direct, out-of-pocket costs and expenses reasonably incurred by a Party (or its Affiliate) in connection with causing a Third Party Distributor to take any action that is required to be taken by such Third Party Distributor pursuant to Article 13.
1.299    Recall/Withdrawal Criteria” shall have the meaning set forth in Section 13.2.2.
1.300    Receiving Party” shall have the meaning set forth in Section 15.1.
1.301    [*] shall have the meaning set forth in [*].
1.302    [*] shall have the meaning set forth in [*].

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.303    [*] shall have the meaning set forth in [*].
1.304    [*] shall have the meaning set forth in [*].
1.305    Region” shall mean, as applicable, the Specified Percentage Countries, Region A2, Region B or Region C, or any combination of the foregoing, defined subdivision of the foregoing or defined grouping of subdivisions of the foregoing, as the case may be.
1.306    Region A” shall mean the Specified Percentage Countries and Region A2.
1.307    Region A2” shall mean those countries specified as Region A2 on Annex AA-1.
1.308    Region B” shall mean those countries specified as Region B on Annex AA-1.
1.309    Region C” shall mean those countries specified as Region C on Annex AA-1.
1.310    Region C Generic Conditions” shall mean, with respect to a Party or its Affiliates’ granting of a license or other rights permitted by such Party’s Generic Exception to a Region C Generic Licensee, the following requirements (or substantially similar requirements):
(a)    Such Generic Licensee shall agree in writing to comply with the following requirements (or substantially similar or more restrictive requirements), which shall be imposed by way of a covenant or a condition on or limitation in the scope of the rights or licenses granted:
(i)    Such Generic Licensee shall not sell (or assist any Third Party in selling) and shall prohibit its Affiliates, distributors and their respective wholesalers and distributors from selling any (A) Generic Combination Product or (B) Other Combination Product (which, in the case of (B), is within the scope of a license that such Generic Licensee has been granted by such Party or its Affiliates) outside of Region C or from assisting any Third Party in doing so, except that the granting Party may, if it desires, include any of the following exceptions to such restrictions as follows:
(A) [*];

(B) [*]; or

(C) [*].
(ii)    The Generic Licensee shall agree not to pursue or obtain any regulatory exclusivity for any (A) Generic Combination Product or (B) Other Combination Product (which, in the case of (B), is within the scope of a license that such Generic Licensee has been granted by such Party or its Affiliates) or (C) other product licensed under such agreement with such Party or its Affiliates that contains any of TDF, TAF, FTC or RPV (in each case, other than for pediatric formulations thereof).

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


(b)    The agreement between the applicable Party (or its Affiliate) and the Generic Licensee shall include essentially the following language (or language substantially similar or more restrictive):
(i)     in the case of Generic Licensees of Janssen and its Affiliates, “Licensee shall only be allowed to manufacture, sell or otherwise exploit RPV in combination with other active pharmaceutical ingredient(s) in a country in its territory if Licensee has the legal right to manufacture, sell and otherwise exploit such other active ingredient(s) in such country.”
(ii)    in the case of Generic Licensees of Gilead and its Affiliates, “Licensee     shall only be allowed to manufacture, sell or otherwise exploit TDF, TAF or FTC in     combination with other active pharmaceutical ingredient(s) in a country in its territory if     Licensee has the legal right to manufacture, sell and otherwise exploit such other active     ingredient(s) in such country.”
(c)    Each Party, upon request of the other Party, (i) shall provide the other Party a written list of its Region C Generic Licensees (excluding any Generic Licensees that are not licensed under their applicable agreement(s) with such Party or its Affiliates to make, use, sell, have sold, offer for sale, or import any fixed-dose combination product containing all of (x) TDF or TAF, as applicable, (y) FTC and (z) RPV) and (ii) from time to time, as requested by the other Party, shall provide a true and correct copy of the language included in its form generic license agreements for Region C Generic Licensees which agreements cover RPV (in the case of Janssen) or any of TDF, TAF or FTC (in the case of Gilead), excluding, in each case ((i) and (ii)), any license agreement executed with a Generic Licensee prior to the Original Effective Date, which language is sufficient to demonstrate compliance with this Agreement.
Notwithstanding the foregoing, nothing in this Section 1.310 shall require a Party to impose a restriction or other obligation on a Generic Licensee, the imposition of which would violate Applicable Law.
1.311    Region C Generic Licensee” shall mean a Generic Licensee granted a license or other rights by a Party or its Affiliate to engage in any or all of the Region C Generic Rights.
1.312    Region C Generic Rights” shall mean any or all of the following activities: to make, use, sell, have sold, offer for sale or import within Region C, [*] solely for purposes of exporting to Region C solely for use or sale in Region C, any product containing (a) in the case of a Generic Licensee of Janssen or its Affiliates, RPV in combination with any other APIs or (b) in the case of a Generic Licensee of Gilead or its Affiliates, one or more of TDF, TAF or FTC in combination with any other APIs.
1.313    Registration Plan” shall have the meaning set forth in Section 4.2.1.
1.314    Regulatory Approval” shall mean, with respect to a given product and given country, any and all approvals, licenses, registrations or authorizations of any Regulatory

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Authority necessary to develop or commercialize such product in such country, including, where applicable, pre- and post-marketing authorizations (including Marketing Approvals), labeling approvals and technical, medical and scientific licenses, but excluding pricing and reimbursement approvals.
1.315    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 exercising regulatory authority with respect to the Exploitation of a pharmaceutical product in the Territory, including the FDA and EMA.
1.316    Regulatory Documentation” shall mean, with respect to a product, all submissions to Regulatory Authorities in connection with obtaining and maintaining Regulatory Approvals for the Exploitation of such product, including all Drug Approval Applications, INDs, sNDAs, drug master files, summary product characterizations, product circulars, patient product information, packaging components, correspondence with regulatory agencies, registrations and licenses, regulatory drug lists, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents with respect to Clinical Data).
1.317    [*] shall have the meaning set forth in [*].
1.318    Responsible Party” shall have the meaning set forth in Section 13.3.
1.319    Restatement Effective Date” shall have the meaning set forth in the preamble hereto.
1.320    Results” shall have the meaning set forth in Section 3.6.2.
1.321    Revaluation Pre-Conversion Invoice” shall have the meaning set forth in Annex M-6.
1.322    Revaluation Supplied RPV Supply Price” shall have the meaning set forth in Annex M-6.
1.323    R/F/TAF Launch Period” shall mean [*].
1.324    R/F/TAF Product” shall mean the fixed-dose co-formulated product in oral dosage form containing, as its only APIs per single daily dose, TAF, FTC and RPV, which product is either (a) a solid form that contains a dosage form of TAF equivalent to twenty-five (25) milligrams GS-7340, FTC equivalent to two hundred (200) milligrams Emtricitabine and RPV equivalent to twenty-five (25) milligrams Rilpivirine or (b) an age-appropriate pediatric formulation and dosage consistent with the Pediatric Investigation/Study Plan for a product that corresponds to the product described in clause (a) above, which plan is developed by Gilead and approved by Janssen in accordance with this Agreement.
1.325    R/F/TAF Product Actual Percentage” shall have the meaning set forth on Annex I.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.326    R/F/TAF Product Average Respective Percentage” shall mean, with respect to a given Party and with respect to given Losses, (a) the weighted average of such Party’s R/F/TAF Product Actual Percentage for each Calendar Year during the period commencing on the Restatement Effective Date and ending with the earlier of (i) the last Calendar Year during the Term and (ii) the Calendar Year immediately prior to the Calendar Year in which such Losses are incurred, with the weighting based on the Net Sales of the Territory R/F/TAF Product in the Territory during each such Calendar Year or (b) in the case of any Losses incurred in or prior to the Calendar Year in which the First Commercial Sale of the Territory R/F/TAF Product in the Territory occurs, such Party’s R/F/TAF Product Working Percentage for the Calendar Year in which such Losses are incurred.
1.327    R/F/TAF Product Clinical Trial” shall mean: (a) any clinical trial in humans of a R/F/TAF Product; or (b) any clinical trial in humans of a treatment regimen administered via multiple products that contain, in aggregate, all of RPV, FTC and TAF as its only three (3) APIs, in each case ((a) and (b)), conducted in accordance with this Agreement. For clarity, a clinical trial involving a comparison of subjects treated with a R/F/TAF Product (or the multiple products described in clause (b) above) to subjects treated with a different combination product or other treatment regimen shall be considered a R/F/TAF Product Clinical Trial. Any clinical trial that only qualifies as a R/F/TAF Product Clinical Trial because of the inclusion of an unspecified background regimen shall not be considered a R/F/TAF Product Clinical Trial.
1.328    R/F/TAF Product Key Selling Messages” shall have the meaning set forth in Section 6.7.1.
1.329    R/F/TAF Product Third Party Trial” shall have the meaning set forth in Section 3.2.2.2b.i.
1.330    R/F/TAF Product Working Percentage” shall have the meaning set forth on Annex H.
1.331    Right of Reference” shall have the meaning set forth in 21 C.F.R. § 314.3(b) or equivalents thereto under Applicable Law in jurisdictions outside the United States. 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 Party to which such Right of Reference is granted any right to receive or access such information.
1.332    Rilpivirine” shall mean the compound set forth in Annex GG-4, known as rilpivirine.
1.333    ROFN Period” shall have the meaning set forth in Section 6.5.
1.334    ROFN Trigger Notice” shall have the meaning set forth in Section 6.5.
1.335    RPV” shall mean Rilpivirine or any or all of the following:  [*].

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.336    RPV Characteristics” shall have the meaning set forth in Section 18.2.2.
1.337    RPV Data Exclusivity” shall have the meaning set forth in Section 9.2.3.2.
1.338    RPV Generic Equivalent” shall mean [*].
1.339    RPV Infringement shall mean an infringement or misappropriation of any Patent or other intellectual property, including trade secrets, of a Third Party resulting from:
(a)
the manufacture or importation of any Supplied RPV by or on behalf of Janssen (including for supply to, or importation to or on behalf of, Gilead or its Affiliates or Sublicensees as Supplied RPV),
(b)
the importation of any Supplied RPV by or on behalf of Gilead or its Affiliates or Sublicensees, but only if such importation is into either a country within the Key Territory or a country in which Janssen or its Affiliate, (sub)licensee or Third Party distributor is manufacturing or selling (i) in the case of Janssen or its Affiliate or Third Party distributor, any RPV Product at the time of such importation, or (ii) in the case of Janssen’s (sub)licensee, any RPV Single Agent Product at the time of such importation,
(c)
the manufacture or importation of a Territory Combination Product by or on behalf of Gilead or its Affiliates or Sublicensees, which infringement or misappropriation directly results from the incorporation into such Territory Combination Product of any Supplied RPV, but [*] or
(d)
the manufacture or importation of a Territory Combination Product by or on behalf of Gilead or its Affiliates or Sublicensees, which infringement or misappropriation directly results from the manufacture of any Supplied RPV that is incorporated into such Territory Combination Product, but [*],
in each case ((a) through (d)) without reference to the combination of the applicable RPV Product with TAF, TDF or FTC. For purposes of the definition of RPV Infringement, (x) “incorporation” or “incorporated” shall mean the presence of Supplied RPV in a Territory Combination Product, and not the process of incorporating Supplied RPV into a Territory Combination Product, and (y) RPV Infringement shall include only misappropriation by Janssen (or its Affiliates or contract manufacturers) and not by Gilead or any of its Indemnified Persons.
1.340    RPV Invoice” shall mean, with respect to the RPV that is provided by Janssen to Gilead pursuant to the RPV Supply Agreement, either a Pre-Conversion Invoice or a Post-Conversion Invoice, as applicable, in each case provided by Janssen (or its Affiliate) to Gilead (or its Affiliate) pursuant to the RPV Supply Agreement.
1.341    RPV NSP shall have the meaning set forth in Annex M-1.
1.342    RPV Product” shall mean any pharmaceutical product containing RPV, which product is under development or is being sold at any time by Janssen or an Affiliate,

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


subcontractor, (sub)licensee, or Third Party distributor of Janssen or its Affiliates, including any RPV Single Agent Product; provided, however, that the term “RPV Product” shall not include any Combination Product.
1.343    RPV Single Agent Product” shall mean any RPV Product that contains RPV as its only API, including Edurant.
1.344    RPV Supply Agreement” shall have the meaning set forth in Section 8.1.1.
1.345    RPV Supply Agreement Quantities” shall have the meaning set forth in Section 8.1.2.
1.346    Safety Database Closing Date” shall mean, with respect to a Territory Combination Product, the day after the expiration of the period during which Gilead or its applicable Affiliate, is required to submit safety update reports pursuant to 21 C.F.R. §314.50(d)(5)(vi) for the first NDA for such Territory Combination Product submitted to the FDA by Gilead or any of its Affiliates (which period expires, per Applicable Law in effect as of the Restatement Effective Date, four (4) months after the initial submission of such NDA).
1.347    Selected Product Liability Losses” shall have the meaning set forth in Section 18.3.
1.348    Selected Product Liability Proceedings” shall have the meaning set forth in Section 18.3.
1.349    Selling Party” shall mean (a) Janssen, in the case of the Janssen Countries, and (b) Gilead, in the case of the Gilead Countries.
1.350    Semi-Annual Period” shall have the meaning set forth in Annex M-5.
1.351    Settlement Agreement” shall have the meaning set forth in Section 17.3.3.
1.352    Shared NSP Information” shall have the meaning set forth in Annex N.
1.353    Single Agent Product” shall mean (a) with respect to Gilead, any TDF Single Agent Product, any TAF Single Agent Product and any FTC Single Agent Product and (b) with respect to Janssen, any RPV Single Agent Product.
1.354    sNDA shall mean a Supplemental New Drug Application, as defined in the Act and applicable regulations promulgated thereunder, as amended or supplemented from time to time.
1.355    Specific Cure” shall have the meaning set forth in Section 6.2.2.5.
1.356    Specific Targets” shall have the meaning set forth in Section 6.2.2.4.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.357    Specified Percentage” shall mean (a) with respect to Territory Complera, (i) [*] subject to adjustment, on a country-by-country basis, pursuant to Section 11.6, and (ii) [*], and (b) with respect to the Territory R/F/TAF Product, (i) [*] subject to adjustment, on a country-by-country basis, pursuant to Section 11.6, and (ii) [*].
1.358    Specified Percentage Countries” shall mean the countries designated as Specified Percentage Countries on Annex AA-1.
1.359    Standard Cost of Manufacturing” shall mean, with respect to a given API or product, for a given Calendar Year, the sum (expressed in U.S. Dollars per kilogram) of (a) the direct labor costs incurred by the applicable Material Supplier or its Affiliates in the Manufacture of the applicable Material; (b) the direct material costs for materials used by the Material Supplier or its Affiliates in such Manufacture (including raw materials, intermediate compounds, active compounds, excipients, components and packaging materials, and including shipping and taxes therefor, to the extent borne by such Material Supplier or its Affiliates); (c) a reasonable allocation of overhead costs (including facilities expenses, depreciation over the expected life of the buildings and equipment, and costs for administration and for management of material procurement and other Manufacturing activities, including Quality Control (QC) and Quality Assurance (QA), performed directly in support of the Manufacture or acquisition of Material); (d) the cost of shipping of Material (including inter-plant and inter-location transportation expenses); (e) the cost of Manufacturing trial runs, Manufacturing development expenses, and start-up and new product introduction costs; (f) shut-down costs; (g) costs of unusual and excessive material scrapped; (h) lower of cost or market inventory adjustments, inventory write-downs and write-offs, and physical inventory adjustments; and (i) amounts paid (net of rebates or discounts, if any, and not including amounts paid as royalties or any other Third Party License Payments) to non-Affiliate contract manufacturers or service providers to acquire Material or in connection with the Manufacture of Material; provided, however, that no cost may be counted more than once in such calculation. For clarity, such methodology shall be applied on a standard cost basis for all of the applicable Material that is Manufactured by or on behalf of the Material Supplier across all of its products that contain such Material and such methodology shall be calculated in accordance with reasonable cost accounting methods that comply with the Accounting Standards in effect from time to time, consistently applied.
1.360    Sublicensee” shall mean a Third Party to which Gilead or its Affiliates grants a license or sublicense under its or its Affiliates’ rights to a Territory Combination Product, as permitted under this Agreement, but excludes any (i) Third Party Distributors, (ii) Distribution Subcontractors, and (iii) Generic Licensees. For clarity, there are no Sublicensees of Janssen.
1.361    (sub)licensee” shall mean any Third Party to which a Party or its Affiliate grants a license or sublicense, but in each case excluding any Generic Licensee of such Party.
1.362    Supplied RPV” shall mean any RPV supplied to Gilead by Janssen in the form supplied to Gilead by Janssen pursuant to the RPV Supply Agreement (or the Master Clinical Trial Material Agreement, to the extent that it is an Ancillary Agreement). Unless otherwise mutually agreed by the Parties, such RPV supplied shall be specific to Territory Complera or Territory R/F/TAF Product and only used for such product.

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.363    Supplied RPV Annual Revaluation” shall have the meaning set forth in Annex M-6.
1.364    Supplied RPV Ratio shall have the meaning set forth in Annex M-1.
1.365    TAF” shall mean GS-7340 or any or all of the following:  [*].
1.366    TAF Product” shall mean any pharmaceutical product containing TAF, which product is under development or is being sold at any time by Gilead or an Affiliate, subcontractor, (sub)licensee, or Third Party distributor of Gilead or its Affiliates, including any TAF Single Agent Product or F/TAF Product; provided, however, that the term “TAF Product” shall not include any Combination Product or any STR (as defined in the Amended D/C/F/TAF Agreement).
1.367    TAF Single Agent Product” shall mean any TAF Product that contains TAF as its only API.
1.368    TDF” shall mean Tenofovir Disoproxil Fumarate or any or all of the following: [*].
1.369    TDF Product” shall mean any pharmaceutical product containing TDF, which product is under development or is being sold at any time by Gilead or an Affiliate, subcontractor, (sub)licensee, or Third Party distributor of Gilead or its Affiliates, including any TDF Single Agent Product or F/TDF Product; provided, however, that the term “TDF Product” shall not include any Combination Product.
1.370    TDF Single Agent Product” shall mean any TDF Product that contains TDF as its only API, including Viread.
1.371    Tenofovir Disoproxil Fumarate” shall mean the compound set forth in Annex GG-2, known as tenofovir disoproxil fumarate.
1.372    Term” shall have the meaning set forth in Section 19.1.
1.373    Terminated Countries” shall have the meaning set forth in Section 19.6.1.
1.374    Territory” shall mean all countries of the world.
1.375    Territory Combination Product” shall mean (a) with respect to Complera, Territory Complera, and (b) with respect to the R/F/TAF Product, Territory R/F/TAF Product.
1.376    Territory Complera” shall mean any Complera that is: (a) manufactured by or on behalf of Gilead or any of its Affiliates or Sublicensees from Supplied RPV pursuant to this Agreement; (b) manufactured by or on behalf of Gilead or any of its Affiliates or Sublicensees from RPV that is (i) supplied by a Third Party or (ii) manufactured by Gilead or any of its Affiliates or Sublicensees, in either case ((i) or (ii)) pursuant to Section 19.6.3; or (c)

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


manufactured by Janssen or its Affiliate or Third Party supplier following the termination of Gilead’s supply obligations to Janssen under the JDA pursuant to Section 8.2.2.1.
1.377    Territory R/F/TAF Product” shall mean any R/F/TAF Product that is: (a) manufactured by or on behalf of Gilead or any of its Affiliates or Sublicensees from Supplied RPV pursuant to this Agreement; (b) manufactured by or on behalf of Gilead or any of its Affiliates or Sublicensees from RPV that is (i) supplied by a Third Party or (ii) manufactured by Gilead or any of its Affiliates or Sublicensees, in either case ((i) or (ii)) pursuant to Section 19.6.3; or (c) manufactured by Janssen or its Affiliate or Third Party supplier following the termination of Gilead’s supply obligations to Janssen under the JDA pursuant to Section 8.2.2.1.
1.378    Third Party” shall mean any Person other than Gilead, Janssen and their respective Affiliates.
1.379    Third Party Distributor” shall mean a Third Party distributor that purchases a Territory Combination Product from the Selling Party or any of its Affiliates or, in the case of Gilead, Sublicensees for Distribution in a country in the Territory. For clarity, Third Party Distributor does not include Janssen.
1.380    Third Party Distributor Agreement” shall mean any written agreement between the Selling Party or its Affiliates or, in the case of Gilead, Sublicensees, and a Third Party Distributor pursuant to which the Selling Party (or its Affiliates or, in the case of Gilead, Sublicensees) sells a Territory Combination Product to such Third Party Distributor for Distribution in a country in the Territory, to the extent that such agreement relates to such Territory Combination Product.
1.381    Third Party License Payments” shall have the meaning set forth in Section 9.5.1.
1.382    Tibotec” shall have the meaning set forth in the preamble hereto.
1.383    TMC278 Supply Agreement” shall mean that certain TMC278 Supply Agreement by and between Janssen and Gilead Sub dated June 1, 2010, as amended as of the Restatement Effective Date.
1.384    TPA” shall mean that certain Three Party Confidential Disclosure Agreement by and among [*] Gilead Parent and Janssen dated March 24, 2009, as such agreement is amended from time to time.
1.385    Trademark” shall mean any word, name, symbol, color, designation, slogan, catch phrase or device or any combination thereof used or intended to be used in commerce and indicating the source for a product or service, including any domain name, trademark, trade dress, brand mark, trade name, brand name, logo or business symbol, any registrations of any of the foregoing or any pending applications therefor.
1.386    Triangle” shall have the meaning set forth in Section 17.3.3.

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UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


1.387    Triggering Sale shall have the meaning set forth in Annex M-1.
1.388    Truvada” shall have the meaning set forth in the recitals hereto and shall mean such product as of the Original Effective Date.
1.389    Truvada Market” shall mean, with respect to a given period and a given country, the [*] during such period.
1.390    Unit” shall mean a thirty (30)-count bottle (or bottle equivalent) of the applicable product.
1.391    Universal Calendar Month” shall have the meaning set forth in Annex M-1.
1.392    Universal Calendar Quarter” shall have the meaning set forth in Annex M-1.
1.393    Universal Calendar Year” shall have the meaning set forth in Annex M-1.
1.394    U.S. Co-Detailing LOA” shall mean that certain Letter Agreement, dated as of November 24, 2014, by and between Gilead Sciences, Inc. and Janssen Products, LP, acting through its Janssen Therapeutics Division, setting forth Detailing responsibilities for Janssen Therapeutics Division in the United States, as such agreement is amended from time to time.
1.395    Valid Claim” shall mean a claim in any Licensor Patent, which claim has not expired or been held invalid or unenforceable by a non-appealed or unappealable decision by a court or other appropriate body of competent jurisdiction, and which is not admitted to be invalid through disclaimer or dedication to the public, including any claim in a Licensor Patent being prosecuted in a pending Patent application, provided that such claim is not pending for more than [*] after the earliest filing date of the Patent application.
1.396    Viread” shall have the meaning set forth in the recitals hereto and shall mean such product as of the Original Effective Date.
1.397    Working Percentages” shall mean (a) with respect to Territory Complera, the Complera Working Percentage, and (b) with respect to the Territory R/F/TAF Product, the R/F/TAF Product Working Percentage.
2
GOVERNANCE
2.1    Alliance Managers. Gilead and Janssen shall each designate within their respective organizations an alliance manager (an “Alliance Manager”) with responsibility for facilitating the interaction and cooperation between the Parties with respect to the activities conducted hereunder. The Alliance Managers as of the Restatement Effective Date shall be as set forth on Annex C.
2.2    Procedural Rules of the Alliance Managers.

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UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


2.2.1    Replacement. Each Party may change its Alliance Manager from time to time upon written notice to the other Party.
2.2.2    Meetings. The Alliance Managers shall meet at least once per Calendar Quarter (or on such other schedule as may be determined by the Alliance Managers) to discuss any issues and concerns relating to the Combination Product Development Activities and any other mutually agreed subject matter relating to the Combination Products. Alliance Managers may attend meetings in person or, as long as each is able to hear the other, by telephone or by video conference equipment.
2.2.3    Agreement on Decisions. The Alliance Managers shall seek to reach agreement on matters requiring decisions by the Parties and shall document any such agreements in written minutes to be approved and signed by each Alliance Manager. If the Alliance Managers are unable to reach agreement on a matter properly presented to them for their consideration, the matter shall be resolved by the procedure set forth in Section 20.6 (except as otherwise provided therein). Any written minutes referred to in this Section 2.2, signed by the Alliance Managers, shall not be deemed to be amendments to this Agreement or any Ancillary Agreement.
2.2.4    Authority. The Alliance Managers shall have the right to make only those determinations expressly enumerated in this Agreement; provided, however that the Alliance Managers shall also have the right to make determinations, consents and approvals on behalf of the Parties within the authority stipulated under this Agreement, provided that such determinations are documented in written minutes that are designated as final and mutually agreed by both Alliance Managers.
2.3    Financial Reporting Committee. In order for the Parties to exchange certain Net Selling Prices for the purposes of calculating revenues and performing other financial calculations described under this Agreement as set forth herein, the Parties shall establish a financial reporting committee (the “Financial Reporting Committee”). No non-public information on their respective pricing strategies shall be communicated between the Parties. The role of the Financial Reporting Committee shall be solely ministerial, i.e., to communicate product Net Selling Prices from one Party’s Financial Reporting Committee members to the other Party’s Financial Reporting Committee members, so that each Party’s Necessary Personnel may perform the financial calculations described under this Agreement or use the financial information provided herein for the purposes of financial reporting and auditing pursuant to the Accounting Standards, including pursuant to Articles 10 and 11 and Annex M-1, Annex M-2, Annex N and the Janssen Distributor Agreement, and pricing the Territory Combination Products (but no other products) in the countries where such Party is the Selling Party.
2.3.1    Composition of Financial Reporting Committee. The Financial Reporting Committee shall be comprised of the following from each Party: One (1) or more representatives from each Party (each, a “Finance Representative”) shall be an employee(s) having responsibility for finance matters of such Party (or any of its Affiliates). One (1) representative from each Party (the “Attorney Representative”) shall be an attorney for such Party. Neither the Finance Representative(s) nor the Attorney Representative of a Party shall, at

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


the time of his or her appointment to the Financial Reporting Committee or, or at any time during his or her service on the Financial Reporting Committee, be involved, directly or indirectly, in the pricing of such Party’s (or any of its Affiliates’) antiviral products (other than the Territory Combination Products) used to treat HIV infection, including any such products that are the subject of a collaboration with any Third Party (provided that, for purposes of this Section 2.3.1, duties solely with respect to accounts receivable, accounts payable, bookkeeping and accounting shall not, without more, be deemed involvement in pricing). Such representatives shall have skills reasonably appropriate to their responsibilities and functions as members of the Financial Reporting Committee. Furthermore, each Party covenants that, for twelve (12) months immediately after an individual’s service on the Financial Reporting Committee (or for such shorter period as he or she is employed by such 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 Party’s (or any of its Affiliates’) antiviral products used to treat HIV infection (other than the Territory Combination Products), including any such products that are the subject of a collaboration with any Third Party. Each Party shall have the right to approve the other Party’s proposed Finance Representative(s) and Attorney Representative on the Financial Reporting Committee (or any replacement therefor), which approval shall not be unreasonably withheld, conditioned or delayed. Subject to the preceding sentence, each Party shall have the right to replace its Finance Representative(s) or Attorney Representative from time to time during the Term, provided that the composition of the Financial Reporting Committee as so changed meets the requirements set forth above in this Section 2.3.1.
2.3.2    Restricted Access to Non-Public Pricing Information; Additional Restrictions.
2.3.2.1    Each Party shall be responsible for implementing internal procedures and security measures to restrict access to and use of non-public pricing information received from the other Party so as to comply with this Agreement and Applicable Law, including training its Financial Reporting Committee representatives and Necessary Personnel regarding such internal procedures and security measures.
2.3.2.2    A Party’s Necessary Personnel shall not be involved, directly or indirectly, in the pricing of such Party’s (or its Affiliates’) antiviral products used to treat HIV infection, including any such products that are the subject of a collaboration with any Third Party, except solely for the Territory Combination Products. This restriction shall apply at the time of his or her selection to perform activities that would qualify him or her as Necessary Personnel and at all times during which his or her job duties include the performance of activities that qualify him or her as Necessary Personnel.
2.3.2.3    Notwithstanding the foregoing, Additional Personnel of a Selling Party may be involved in the pricing of such Party’s (or its Affiliates’) antiviral products used to treat HIV infection for a country in addition to the Territory Combination Products to the extent that the Selling Party does not have sufficient personnel in its pricing group to reasonably allow for a Person to be involved in the pricing for that country of the Territory Combination Products and no other products.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


2.3.2.4    Additional Personnel shall only receive [*]. Unless and until the Parties mutually agree[*], the Selling Party shall ensure that none of the other Party’s Net Selling Price information is accessed by any Person involved in the pricing of such Party’s (or its Affiliates’) antiviral products used to treat HIV infection (other than the Territory Combination Products) [*].
2.3.3    Necessary Personnel and Financial Reporting Committee Member Oversight. Each Party shall be responsible for the performance of its Necessary Personnel and its representatives on the Financial Reporting Committee and their compliance with the terms of this Section 2.3. Any issue regarding the activities of the Necessary Personnel or the functioning of the Financial Reporting Committee shall be reviewed jointly by the Parties’ respective Attorney Representatives.
2.3.4    Meetings. The Financial Reporting Committee shall meet periodically (which meetings may be conducted by telephone or videoconference, so long as each attendee is able to hear the other attendees) as may be determined by members of the Financial Reporting Committee to determine such matters as are within the jurisdiction of the Financial Reporting Committee as set forth in this Section 2.3.
2.3.5    Authority. The Financial Reporting Committee shall perform only such functions as are assigned to the Financial Reporting Committee hereunder.
2.3.6    Decision-Making. The Financial Reporting Committee shall have no decision-making authority.
2.3.7    Retention of Counsel. The Financial Reporting Committee may determine, by consensus and in its sole discretion, to retain independent legal counsel, in which case the costs and expenses of such counsel shall be shared equally by the Parties.
2.4    Ad Hoc Operating Committees. The Parties may, from time to time, create such ad hoc committees (each, an “Ad Hoc Operating Committee”) with such responsibilities and such authority as the Parties may mutually agree in writing. Any Disputes arising in any such Ad Hoc Operating Committee shall be subject to Section 20.6.
2.5    Expenses. Gilead and Janssen shall each bear its own costs and expenses related to the management of its activities under this Article 2, including all costs and expenses relating to the meetings of the Alliance Managers, the Financial Reporting Committee or any Ad Hoc Operating Committee, the participation of its representatives in such meetings, communications with the other Party in connection with such meetings or matters within the authority of the Alliance Managers, the Financial Reporting Committee or any Ad Hoc Operating Committee and travel to and from such meetings.
3
DEVELOPMENT ACTIVITIES
3.1    Development of Edurant.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


3.1.5    Edurant Development Activities. The Parties acknowledge and agree that Janssen obtained a first Marketing Approval of Edurant in the Field in the United States, [*], and by the European Commission prior to the Restatement Effective Date. Janssen shall have no obligation to conduct any further Edurant Development Activities unless otherwise expressly required under this Section 3.1.
3.1.6    Clinical Data. As of the Restatement Effective Date, Janssen is conducting the Edurant Studies in the Field listed in Annex HH (such trial(s), the “Ongoing Edurant Studies”). With respect to each such Ongoing Edurant Study, Janssen shall provide to Gilead the Clinical Data from such Ongoing Edurant Study as follows: (A) the tables, figures and listings specified in the statistical analysis plan for the applicable Ongoing Edurant Study, no later than forty-five (45) days after database lock with respect to such study, (B) the top line results report and (C) the final clinical study report, in the case of (B) and (C), promptly following the completion of such report and in any event no later than thirty (30) days following completion, and in all cases ((A)-(C)), which shall be provided in electronic form, provided that Gilead (and its Affiliates) shall be permitted to use such Clinical Data only for the Gilead Permitted Use and Janssen may redact the Janssen Redactable Information from such Clinical Data. Without limitation of the foregoing, in the event that Janssen becomes aware of any clinical data that is reasonably likely to affect the Product Label for Edurant (which data has not previously been disclosed to Gilead), Janssen shall promptly provide to Gilead such clinical data (which clinical data shall be limited to tables, figures and listings specified in the applicable statistical analysis plans, top line results reports and final clinical study reports) and copies of any regulatory submissions made with respect thereto as are in Janssen’s or its Affiliates’ Control, provided that Gilead (and its Affiliates) shall be permitted to use such clinical data and regulatory submissions only for the Gilead Permitted Use and Janssen may redact any Janssen Redactable Information from such clinical data and regulatory submissions. In the event that Gilead believes that Janssen has failed to provide to Gilead any clinical data (including Clinical Data) or regulatory submissions required to be provided by Janssen to Gilead under this Section 3.1.2, or that Janssen has redacted from any clinical data or regulatory submissions provided by Janssen to Gilead under this Section 3.1.2 any information that is not Janssen Redactable Information, either Party may refer such matter to the Alliance Managers for resolution. If the Alliance Managers do not reach consensus with respect to such matter within the time period set forth in Section 20.6.1, such matter may be escalated by either Party to the Executives pursuant to Section 20.6.1 and, in the event that the Executives do not reach agreement on such matter within the Executives Review Period, such matter shall be an Expert Dispute. All clinical data (including Clinical Data) and regulatory submissions provided by Janssen to Gilead pursuant to this Section 3.1.2 and Section 4.3 shall comprise the “Janssen Clinical Data.” The Janssen Clinical Data shall constitute Confidential Information of Janssen to the extent that such information satisfies the criteria set forth in Section 15.3. The Janssen Clinical Data with respect to any Edurant Study shall be deemed to be Janssen Know-How.
3.1.7    Edurant Studies. In the event that Janssen or its Affiliates intend to conduct, sponsor or support, independently or together with one or more Third Parties, any Edurant Studies that would reasonably be expected to affect the Product Label for a Territory Combination Product in the Field, then prior to the commencement of any such Edurant Study,

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Janssen shall provide a high-level summary of the protocol(s) for such Edurant Study to Gilead (it being understood that Gilead shall not have any approval rights with respect to such Edurant Study or protocol(s)); provided, however, that each such summary shall constitute Confidential Information of Janssen to the extent that the information provided in such summary satisfies the criteria set forth in Section 15.3.
3.2    Development of Combination Products.
3.2.8    Formulation and Manufacturing Process Development for Territory Combination Products. Gilead shall use Commercially Reasonable Efforts to perform, at its expense, the formulation and Manufacturing Process development for, and to prepare the CMC Data relating to, the Territory R/F/TAF Product. Janssen shall, at its expense, provide to Gilead, in a timely manner, such technical support relating to RPV as is reasonably required by Gilead in connection with performing the formulation and Manufacturing Process development for, and to prepare the CMC Data relating to, each Territory Combination Product. Such support may include documents, procedures, know-how, and in-person technical assistance. Formulation development shall include conducting the formulation screening, optimization and scale-up for a Territory Combination Product in the Field.
3.2.9    Clinical Development.
3.2.9.1    Diligence.
a.    The Parties acknowledge and agree that Gilead obtained a first Marketing Approval of Territory Complera in each of the United States, [*] and by the European Commission prior to the Restatement Effective Date.
b.    Gilead shall use Commercially Reasonable Efforts to perform, at its expense, all studies necessary (including bioequivalence studies and Post-Approval Commitment Studies but excluding other human clinical trials) to obtain and maintain a first Marketing Approval of the Territory R/F/TAF Product in the Field in each of the United States, [*] and by the European Commission, in each case, with respect to the RPV portion of the Territory R/F/TAF Product, based on Clinical Data made available to Gilead by Janssen. For the sake of clarity, Gilead shall, subject to the terms and conditions of this Agreement, have the right to perform any Development Activities with respect to the Territory R/F/TAF Product and Territory Complera, regardless of whether such Development Activities are required to obtain a first Marketing Approval of the Territory R/F/TAF Product or Territory Complera, as applicable, in the Field in the United States, [*] or by the European Commission.
3.2.9.2    Combination Product Clinical Trials.
a.    Complera Clinical Trials.
i.    On and after the Restatement Effective Date and subject to the other terms and conditions of this Agreement (including Section 3.2.3), either Party (and its Affiliates and (sub)licensees) may Commence (and thereafter conduct) any

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Complera Clinical Trial, either independently or together with one or more Third Parties. Prior to the Commencement of any Complera Clinical Trial (but excluding any Complera Third Party Trial), the Party (or its Affiliate or (sub)licensee) conducting such Complera Clinical Trial shall provide a high-level summary of the protocol therefor to the other Party and such other Party shall have the right to review and provide comments on such summary to the conducting Party. The conducting Party (or its Affiliate or (sub)licensee) shall reasonably consider such comments, but shall have no obligation to incorporate or respond to such comments; provided, however, that upon the request of the other Party, the Parties shall discuss any reasonable concerns of the other Party that the proposed clinical trial is not designed in accordance with GCP and GLP or could result in the occurrence of a safety or tolerability finding that would raise material concerns regarding the clinical benefit of the Territory Combination Product.
ii.    Any protocols or summaries provided by one Party (or its Affiliate or (sub)licensee) to the other Party pursuant to this Section 3.2.2.2.a shall constitute Confidential Information of the providing Party to the extent that such information satisfies the criteria set forth in Section 15.3.
iii.    On and after the Restatement Effective Date, either Party may provide (1) Gilead Compound Products, in the case of Gilead, (2) RPV Products, in the case of Janssen, (3) Complera or (4) funding, in each case ((1) through (4)) in support of any Complera Clinical Trial sponsored by a Third Party (e.g., an investigator initiated trial or ACTG clinical trials) (such supported Complera Clinical Trials, “Complera Third Party Trials”).
b.    R/F/TAF Product Clinical Trials.
i.    Prior to Safety Database Closing Date. Prior to the Safety Database Closing Date for the R/F/TAF Product, except for the trials set forth on Annex EE: (x) [*] Gilead, its Affiliates and Sublicensees may conduct any R/F/TAF Product Clinical Trials that are necessary or reasonably expected to be necessary to obtain a first Marketing Approval(s) for the Territory R/F/TAF Product in the Field in any or all countries in the Territory ([*]); (y) [*].
ii.    On and After Safety Database Closing Date. On and after the Safety Database Closing Date for the R/F/TAF Product and subject to the other terms and conditions of this Agreement (including Section 3.2.3), either Party (and its Affiliates and (sub)licensees) [*].
iii.    Prior to the Commencement of any R/F/TAF Product Clinical Trial (excluding any R/F/TAF Product Third Party Trial), the Party (or its Affiliate or (sub)licensee) conducting such R/F/TAF Product Clinical Trial shall provide a high-level summary of the protocol therefor to the other Party and such other Party shall have the right to review and provide comments on such summary to the conducting Party. Such conducting Party (or its Affiliate or (sub)licensee) shall reasonably consider such comments, but shall have no obligation to incorporate or respond to such comments; provided, however, that upon the request of the other Party, the Parties shall discuss any reasonable concerns of the other Party

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


that the proposed clinical trial is not designed in accordance with GCP and GLP or could result in the occurrence of a safety or tolerability finding that would raise material concerns regarding the clinical benefit of the Territory Combination Product. Any protocols or summaries provided by one Party (or its Affiliate or (sub)licensee) to the other Party pursuant to this Section 3.2.2.2.b shall constitute Confidential Information of the providing Party to the extent that such information satisfies the criteria set forth in Section 15.3.
3.2.9.3    Rights to Conduct Other Clinical Trials. For clarity, nothing in this Section 3.2.2 is intended to (a) restrict Gilead or any of its Affiliates, (sub)licensees or Generic Licensees from conducting, independently or together with one or more Third Parties, any clinical trial in humans of any of the Gilead Compound Products that is not a R/F/TAF Product Clinical Trial or Complera Clinical Trial, (b) restrict Janssen or any of its Affiliates, (sub)licensees or Generic Licensees from conducting, independently or together with one or more Third Parties, any clinical trial in humans of any RPV Product that is not a R/F/TAF Product Clinical Trial or Complera Clinical Trial or (c) prevent either Party from exercising its rights under such Party’s Generic Exception.
3.2.9.4    Confidentiality. Each summary provided pursuant to Section 3.2.2 shall constitute Confidential Information of the disclosing Party to the extent that the information provided in such summary satisfies the criteria set forth in Section 15.3.
3.2.10    Pediatric Formulation. Gilead shall have the sole right, but not the obligation, to develop a pediatric formulation of each Combination Product. Prior to Gilead’s or any of its Affiliates’ conducting any Combination Product Development Activities relating to a pediatric dosage form or submitting any Pediatric Investigation/Study Plan for a Combination Product to any Regulatory Authority, Gilead shall consult with Janssen and obtain Janssen’s written approval, not to be unreasonably withheld, conditioned or delayed, of (a) such Combination Product Development Activities, including the quantity of RPV contained therein, and (b) any related Pediatric Investigation/Study Plan; provided, however, that the Pediatric Investigation/Study Plan for Complera developed by Gilead as of the Restatement Effective Date and any Combination Product Development Activities described therein, relating to a pediatric dosage form of Complera described therein shall be deemed approved by Janssen. Upon Gilead’s request, Janssen shall provide Gilead with clinical supplies of RPV for use in Combination Product Development Activities relating to a pediatric dosage form of a Territory Combination Product, which RPV shall be supplied [*] pursuant to the RPV Supply Agreement (or Gilead may use quantities of RPV in its possession, in which case Section 8.1.3.2 shall apply).
3.2.11    Data from Combination Product Clinical Trials Conducted by Gilead.
3.2.11.1    Data from Combination Product Clinical Trials.
a.    Prior to the Safety Database Closing Date. With respect to each Combination Product Clinical Trial conducted by Gilead in accordance with this Agreement that is Commenced prior to the Safety Database Closing Date or is a pediatric Combination Product Clinical Trial, Gilead shall provide to Janssen the Clinical Data from such

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Combination Product Clinical Trial as follows: (i) the top line results report (if generated) and final clinical study report for such Combination Product Clinical Trial, which shall be provided promptly following the completion of the applicable report and in any event no later than thirty (30) days following completion; and (ii) the tables, figures and listings as specified in the statistical analysis plan for such Combination Product Clinical Trial, which shall be provided no later than forty-five (45) days after database lock, in each case ((i) and (ii)), which shall be provided in electronic form, provided that Janssen (and its Affiliates) shall be permitted to use such Clinical Data only for the Janssen Permitted Use or to conduct its activities hereunder with respect to the Territory Combination Products in the Janssen Countries and Gilead may redact the Gilead Redactable Information from such Clinical Data. Janssen may submit a written request to Gilead for additional clinical data generated from a Combination Product Clinical Trial conducted by Gilead in accordance with this Agreement that is Commenced prior to the Safety Database Closing Date or is a pediatric Combination Product Trial, which shall be provided by Gilead if such additional data is necessary for Janssen to exercise its rights and perform its obligations under this Agreement, as determined by Gilead in Gilead’s sole discretion, provided that Janssen (and its Affiliates) shall be permitted to use such clinical data only for the Janssen Permitted Use and Gilead may redact the Gilead Redactable Information from such clinical data.
b.    On or After the Safety Database Closing Date. With respect to each Combination Product Clinical Trial (other than a pediatric Combination Product Clinical Trial) conducted by Gilead in accordance with this Agreement that is Commenced on or after the Safety Database Closing Date, Gilead shall provide to Janssen the Clinical Data from such Combination Product Clinical Trial solely to the extent that such Clinical Data is required by a Regulatory Authority (i) to obtain or maintain Regulatory Approvals with respect to the Territory Combination Products in the Janssen Countries or (ii) for the Janssen Permitted Use, which Janssen shall be permitted to use, in each case, solely for such purpose, provided that Gilead may redact the Gilead Redactable Information from such Clinical Data. Any such Clinical Data from a Combination Product Clinical Trial to be provided by Gilead to Janssen pursuant to this Section 3.2.4.1 shall be provided as follows: (i) the top line results report (if generated) and final clinical study report for such Combination Product Clinical Trial shall be provided promptly following the completion of the applicable report and in any event no later than thirty (30) days following completion; and (ii) the tables, figures and listings as specified in the statistical analysis plan for such Combination Product Clinical Trial shall be provided no later than forty-five (45) days after database lock, in each case ((x) and (y)), in electronic form.
3.2.11.2    Right of Reference. Notwithstanding the foregoing, Gilead shall not be required to provide any clinical data (including Clinical Data) to Janssen pursuant to this Section 3.2.4 if Gilead grants Janssen a Right of Reference to such clinical data (and maintains such clinical data in a manner) that is sufficient for Janssen to use such clinical data for the Janssen Permitted Use, or to exercise its rights and perform its obligations under this Agreement, as applicable.
3.2.11.3    Disputes Regarding Clinical Data. In the event that Gilead does not agree that any clinical data (including Clinical Data) requested by Janssen under Section

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


3.2.4.1 is necessary for Janssen to exercise its rights and perform its obligations under this Agreement, or Janssen believes that Gilead has redacted information from clinical data to be provided by Gilead under Section 3.2.4.1 that is not Gilead Redactable Information, either Party may refer such matter to the Alliance Managers for resolution. If the Alliance Managers do not reach consensus on such matter within the time period set forth in Section 20.6.1, such matter may be escalated by either Party to the Executives pursuant to Section 20.6.1, and in the event that the Executives do not reach agreement on such matter within the Executives Review Period, then such matter shall be an Expert Dispute.
3.2.11.4    Definition of Gilead Clinical Data. All clinical data (including Clinical Data) provided by Gilead to Janssen pursuant to this Section 3.2.4 and Section 4.3 shall comprise the “Gilead Clinical Data.” The Gilead Clinical Data shall constitute Confidential Information of Gilead to the extent that such information satisfies the criteria set forth in Section 15.3.
3.2.11.5    Electronic Format for Data. Any raw data sets provided by either Party to the other Party hereunder shall be in the form of SAS output data sets unless otherwise agreed by the Parties.
3.2.12    Combination Product Clinical Data. In the event that either Party becomes aware of any clinical data that is reasonably likely to affect the Product Label for (A) a Territory Combination Product or (B) Edurant, which clinical data is not covered by another provision of Article 3 or Article 4, then such Party shall promptly provide to the other Party such clinical data as are in such Party’s or its Affiliates’ Control, provided that the receiving Party (and its Affiliates) shall be permitted to use such clinical data only to update the Product Label of the Territory Combination Products or any RPV Product, as applicable, and the providing Party may redact any Gilead Redactable Information (if such providing Party is Gilead) or any Janssen Redactable Information (if such providing Party is Janssen) from such clinical data. The clinical data to be provided under this Section 3.2.5 shall be limited to the final clinical study reports and the tables, figures and listings as specified in the applicable statistical analysis plan.
3.2.13    [*].
3.3    Performance; Subcontracting. In performing the Combination Product Development Activities and Edurant Development Activities, Gilead and Janssen shall perform their respective activities in material compliance with GCP, GLP, and GMP, to the extent applicable, and the requirements of Applicable Law. Either Party may subcontract the performance of its respective development activities under this Article 3; provided, however, that the subcontracting 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.
3.4    Records.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


3.4.1    Maintenance of Records. Janssen shall maintain, or cause to be maintained, records of (a) any Edurant Development Activities conducted by, or on behalf of, Janssen or its Affiliates, provided that this obligation applies solely to the extent such activities relate to the use of Edurant in combination with the F/TDF Product or F/TAF Product in the Field or are relevant to a Territory Combination Product, and (b) any other activities conducted by, or on behalf of, Janssen or its Affiliates, if relevant to a Territory Combination Product, that result in data disclosed to Gilead under this Agreement. Gilead shall maintain, or cause to be maintained, records of the Combination Product Development Activities and any activities that result in data disclosed to Janssen under this Agreement. The applicable Party shall maintain or cause to be maintained such records 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 such activities in a manner appropriate for any regulatory purpose and, when applicable and permitted under this Agreement, for use in connection with Patent filings, prosecution and maintenance. Such records shall be retained for at least (i) three (3) years following creation or (ii) such longer period as may be required by the In-License Requirements or Applicable Law.
3.4.2    Access to Records. Subject to the terms and conditions of this Section 3.4.2, each Party shall have the right, during normal business hours and upon reasonable prior written notice, to access and copy the development records maintained by the other Party pursuant to Section 3.4.1, subject to each Party’s right to redact therefrom any Gilead Redactable Information (if Janssen is the accessing Party) or Janssen Redactable Information (if Gilead is the accessing Party), such access and copying to be solely (a) to the extent necessary or reasonably expected to be necessary to enable the accessing Party to (1) conduct reasonable diligence on matters potentially giving rise to liability on the part of the accessing Party or (2) defend itself with respect to any liability on the part of the accessing Party, in each case ((1) and (2)), if and to the extent that a fact, circumstance or event has arisen that gives the accessing Party a reasonable basis to believe that it has or may incur such liability, and (b) for use by the accessing Party for such purpose. The immediately preceding sentence shall not require any Party to provide access to any records in the event that the Parties’ interests in the matter potentially giving rise to liability are or may be adverse in any material respect, in which case Applicable Law, including discovery rules and procedures, shall apply. Each notice delivered under this Section 3.4.2 shall state the reason(s) therefor (each a “Development Record Access Notice”). The Party receiving a Development Record Access Notice shall have the right to raise reasonable objections in writing in response to such Development Record Access Notice within five (5) Business Days, including based on such Party’s interests in protecting from disclosure trade secrets or other competitive business information. Upon any such objection being asserted, the Parties shall promptly confer in an attempt to address each Party’s concerns and reach a resolution with respect to the matter, and in the event that the Parties are unable to agree upon a mutually agreeable resolution within five (5) Business Days of such objection being asserted, either Party shall have the right to refer the matter for resolution pursuant to Section 20.6. In the event that any such Dispute is ultimately referred by a Party to arbitration pursuant to Section 20.6, the arbitrator(s) shall determine as a threshold matter whether and to what extent one or more criteria set forth above have been satisfied by the requesting Party, and, if so, shall make a determination with respect to whether and to what extent the disclosure of such information shall

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


be required by balancing, on the one hand, the requesting Party’s need to obtain such records, and on the other hand, the objecting Party’s interests in protecting such records from disclosure. In making such determination, the arbitrator(s): (x) shall confine their consideration to the facts and arguments set forth in the Development Record Access Notice and the other Party’s written response thereto, and (y) shall have the right to require the accessing Party to abide by terms and conditions for the handling, use and non-disclosure (either within such Party’s organization or to Third Parties) of such information as may be reasonable under the circumstances.
3.5    Reports. Gilead and Janssen shall each keep the other reasonably informed through their respective Alliance Managers regarding any material developments with respect to the Combination Product Development Activities or Edurant Development Activities, as the case may be, for which it is responsible under Sections 3.1 or 3.2.
3.6    Publication of Results.
3.6.1    By Gilead. Gilead or its Affiliates shall have the right to publish or make a first public presentation, abstract or presentation at a scientific conference (each a “Publication”) of the data and findings resulting from its Combination Product Development Activities or any Combination Product Clinical Trials conducted by, or on behalf of, Gilead or its Affiliates (any of the aforesaid data and findings of Gilead described in this Section 3.6.1, “Gilead Results”), in each case subject to the remainder of this Section 3.6. The Parties acknowledge and agree that, as of the Restatement Effective Date, certain Publications with respect to data and findings resulting from Complera Clinical Trials completed prior to the Restatement Effective Date have been approved by the Parties and submitted for publication, and are not subject to further review or comment under this Section 3.6.
3.6.2    By Janssen. Janssen or its Affiliates shall have the right to make a Publication of the data and findings resulting from (a) any Edurant Development Activities, to the extent such data and findings relate specifically to one or more Territory Combination Products, TDF, TAF, FTC or one or more Gilead Compound Products, (b) any Combination Product Development Activities or (c) any Combination Product Clinical Trials, in each case ((a) – (c)) conducted by, or on behalf of, Janssen or its Affiliates, in each case subject to the remainder of this Section 3.6 (any of the aforesaid data and findings, collectively, “Janssen Results” and, together with Gilead Results, the “Results”). For clarity, Development Activities relating to any RPV Product conducted by, or on behalf of, Janssen or its Affiliates, other than Edurant Development Activities that relate specifically to one or more Territory Combination Products, TDF, TAF, FTC or one or more Gilead Compound Products, shall not be subject to this Section 3.6.
3.6.3    Copies. Each Party shall provide to the other Party’s Alliance Manager for review copies of any proposed Publication with respect to Results covered by (i) in the case of Janssen, Section 3.6.1 or (ii) in the case of Gilead, Section 3.6.2 that such Party proposes to submit for Publication during the Term (and thereafter to the extent set forth in Section 19.7).
3.6.4    Gilead Right to Comment. Regarding any Publication proposed by Janssen covered by this Section 3.6, Gilead shall have a right to comment on such Publication.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Written copies of each such proposed Publication required to be provided for review shall be provided to Gilead’s Alliance Manager no later than fifteen (15) Business Days before submission for Publication, except that in the case of an abstract and/or presentation, a copy of such abstract and/or presentation shall be provided as soon as reasonably practicable in advance of the submission or presentation thereof to a Third Party (which period may be less than fifteen (15) Business Days). Gilead shall provide its comments, if any, no later than seven (7) Business Days after receipt of such Publication, or in the case of an abstract and/or presentation, no later than four (4) Business Days after receipt. If Janssen does not accept such comments, it shall so notify Gilead and either Party shall have the right to request a meeting of the Alliance Managers to agree upon revisions to such Publication, provided that such request is made within three (3) Business Days after Janssen notifies Gilead that it will not accept Gilead’s comments. If so requested, the Parties shall convene such meeting within five (5) Business Days of such request. If the Alliance Managers do not reach consensus upon revisions to such Publication within the time period set forth in Section 20.6.1, such matter may be escalated by either Party to the Executives pursuant to Section 20.6.1 and, in the event that the Executives do not reach agreement on such matter within the Executives Review Period, Janssen shall have final decision-making authority with respect to such matter. During the time in which Gilead, the Alliance Managers or the Executives are reviewing a Publication pursuant to this Section 3.6.4, Janssen shall not make such Publication. If requested by Gilead, Janssen shall provide to Gilead the Clinical Data supporting a Publication by Janssen within three (3) Business Days of the later of such request and Gilead’s receipt of the proposed Publication, provided that Janssen may redact any Janssen Redactable Information from such Clinical Data.
3.6.5    Janssen Right to Comment. Regarding any Publications proposed by Gilead covered by this Section 3.6, Janssen shall have a right to comment on such Publication. Written copies of each such proposed Publication required to be provided for review shall be provided to Janssen’s Alliance Manager no later than fifteen (15) Business Days before submission for Publication, except that in the case of an abstract and/or presentation, a copy of such abstract and/or presentation shall be provided as soon as reasonably practicable in advance of the submission or presentation thereof to a Third Party (which period may be less than fifteen (15) Business Days). Janssen shall provide its comments, if any, no later than seven (7) Business Days after receipt of such Publication, or in the case of an abstract and/or presentation, no later than four (4) Business Days after receipt. If Gilead does not accept such comments, it shall so notify Janssen and either Party shall have the right to request a meeting of the Alliance Managers to agree upon revisions to such Publication, provided that such request is made within three (3) Business Days after Gilead notifies Janssen that it will not accept Janssen’s comments. If so requested, the Parties shall convene such meeting within five (5) Business Days of such request. If the Alliance Managers do not reach consensus upon revisions to such Publication within the time period set forth in Section 20.6.1, then such matter may be escalated by either Party to the Executives pursuant to Section 20.6.1 and, in the event that the Executives do not reach agreement on such matter within the Executives Review Period, Gilead shall have final decision-making authority with respect to such matter. During the time in which Janssen, the Alliance Managers or the Executives are reviewing the Publication pursuant to this Section 3.6.5, Gilead shall not make such Publication. If requested by Janssen, Gilead shall provide to Janssen the Clinical Data supporting a Publication by Gilead within three (3) Business Days of the later of

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


such request and Janssen’s receipt of the proposed Publication, provided that Gilead may redact any Gilead Redactable Information from such Clinical Data.
3.6.6    Authorship. The Parties shall comply, in any Publication made pursuant to this Section 3.6, 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 3.6 shall alter or affect a Party’s confidentiality obligations pursuant to Article 15.
3.6.7    Limitation. In no event shall either Party be obligated under this Section 3.6 to provide to the other Party any results other than the Results (but without limitation of any other disclosure obligations explicitly set forth in this Agreement). In addition, for clarity, this Section 3.6 does not govern the publication of the results of any Complera Third Party Trial or any R/F/TAF Product Third Party Trial.
3.6.8    Press Releases. Notwithstanding anything to the contrary in this Section 3.6, public announcements (such as press releases) that relate to the Exploitation of any Territory Combination Product in the Territory, other than with respect to Results, are governed by Article 16 and not this Section 3.6.
3.7    Third Party Uses of Combination Product Clinical Data. In the event a Party intends the patient-level data from any Combination Product Clinical Trials, or in the case of Janssen, Edurant Studies, conducted by or on behalf of such Party under this Agreement be made publicly available to the scientific community for further research through one or more industry organizations, the Alliance Managers shall agree upon the timing of release of such data from each such Combination Product Clinical Trial and Edurant Study to such industry organization(s). The proposing Party (or its Affiliate) shall have the right to release such data in an anonymized form to such industry organization(s) of such Party’s choosing in a manner that complies with any Regulatory Authority requirements and Applicable Law; provided, however, that if the Alliance Managers do not reach agreement upon the timing of releasing patient-level data from such Combination Product Clinical Trial(s) and Edurant Study(ies) to such industry organization(s) within the time period set forth in Section 20.6.1, the matter shall be referred to the Executives for resolution pursuant to Section 20.6.1 and if the Executives do not resolve the matter within the Executives Review Period, the data in question shall not be released by the proposing Party to such industry organization(s) until the Alliance Managers or Executives later agree on such release or, if earlier, [*] after the end of the Executives Review Period.
3.8    Limitations on Disclosure of [*]. Notwithstanding anything to the contrary herein, if a Party is required to provide data regarding any of its Single Agent Product(s) or Double Agent Product(s) pursuant to this Agreement, such Party shall [*].
4
REGULATORY MATTERS
4.1    General.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


4.1.14    Diligence. For clarity, without limiting a Party’s obligations under Article 3, this Section 4.1.1 shall not be construed to require a Party to use any efforts to perform any studies or other development activities (other than regulatory activities).
4.1.14.1    Gilead shall use Commercially Reasonable Efforts to obtain and maintain a first Marketing Approval for each of the Territory Combination Products in the Field from each of the FDA and the European Commission, and the applicable Regulatory Authorities in [*]; provided, however, that such obligation to obtain and maintain with respect to Territory Complera shall [*].
4.1.14.2    Janssen shall use Commercially Reasonable Efforts to obtain and maintain a first Marketing Approval (a) for Edurant in the Field from each of the FDA and the European Commission, and the applicable Regulatory Authorities in [*] and (b) for each of the Territory Combination Products in the Field from the applicable Regulatory Authorities in each Janssen Diligence Country; provided, however, that the obligation in clause (b) of this Section 4.1.1.2 with respect to Territory Complera shall [*]. In the event that Gilead believes that Janssen is in breach of its obligations under clause (b) of this Section 4.1.1.2 with respect to a given Territory Combination Product, Gilead shall have the right to give Janssen written notice specifying the nature of such breach. Janssen shall have a period of [*] after receipt of such written notice to cure such breach. If Janssen does not cure such breach within such [*] period, [*].
4.1.15    Performance; Subcontracting. The Selling Party, in the case of each Territory Combination Product, and Janssen, in the case of Edurant, shall perform, or cause its Affiliates or permitted subcontractors, as applicable, to perform, any activities with respect to obtaining or maintaining Regulatory Approvals for the Territory Combination Products and Edurant, respectively, in the Field in material compliance with the requirements of Applicable Law. The Selling Party, in the case of the Combination Product Regulatory Activities, and Janssen, in the case of Edurant Regulatory Activities, may subcontract the performance of their respective regulatory activities; provided, however, that the subcontracting Party shall oversee the performance by its subcontractors of the subcontracted 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 activities in accordance with this Agreement.
4.1.16    Limitations. Except as otherwise provided in this Section 4.1, neither Party shall have any obligation under this Agreement to obtain or maintain Regulatory Approvals for the other Party’s Single Agent Product(s) or Double Agent Products, as applicable, in any country in the Territory. Gilead shall be relieved of its diligence obligation under the first sentence of Section 4.1.1.1 in any applicable country to the extent that (i) Janssen fails to obtain and maintain a first Marketing Approval for Edurant in the Field in the applicable country or (ii) pursuant to Section 4.3.3, Janssen withholds from the relevant Regulatory Authority any information relating to Edurant that is reasonably requested by Gilead to be provided to such Regulatory Authority in order for Gilead to obtain or maintain a Marketing Approval for a Territory Combination Product in the Field in such country.
4.2    Registration Plan.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


4.2.1    Creation. An initial plan of activities for obtaining and maintaining a first Marketing Approval for the Territory R/F/TAF Product in the Field in each of the Major Market Countries is attached hereto as Annex JJ (such plan, together with the plan existing as of the Restatement Effective Date for obtaining and maintaining first Marketing Approvals for Territory Complera in the Field in each of certain countries in the Territory, the “Registration Plan”).
4.2.2    Updates. From time to time during the Term, each Party shall submit any updates it may have to the Registration Plan to the other Party’s Alliance Manager.
4.2.3    Purpose. The Registration Plan shall be established and updated solely for the purpose of coordinating logistics regarding filing for Marketing Approvals for the Territory Combination Products in the Field in the Territory. It is not intended to impose any binding obligation on either Party to perform the activities set forth therein.
4.3    Regulatory Documentation to be Provided by the Parties.
4.3.3    Regulatory Documentation for Use by Gilead. Subject to Section 4.3.3, Janssen shall provide Gilead with full access to and copies (in electronic form) of (i) the Janssen Regulatory Documentation and (ii) any other information related to a Territory Combination Product in the possession and Control of Janssen or its Affiliates, in each case, as Gilead may request, solely for the purpose of, and in the case of clause (ii) solely as necessary or reasonably expected to be necessary for the Gilead Permitted Use, provided that Janssen may redact any Janssen Redactable Information from such Janssen Regulatory Documentation or other information. In the event that Janssen does not agree that any information described in clause (ii) above requested by Gilead is necessary or reasonably expected to be necessary for the Gilead Permitted Use, or Gilead believes that Janssen has redacted information from Janssen Regulatory Documentation or other information requested by Gilead under this Section 4.3.1 that is not Janssen Redactable Information, either Party may refer such matter to the Alliance Managers for resolution. If the Alliance Managers do not reach consensus with respect to such matter within the time period set forth in Section 20.6.1, such matter may be escalated by either Party to the Executives pursuant to Section 20.6.1 and, in the event that the Executives do not reach agreement on such matter within the Executives Review Period, such matter shall be an Expert Dispute.
4.3.4    Regulatory Documentation for use by Janssen. The Parties acknowledge and agree that Gilead has previously provided Janssen the CTD for Territory Complera, and Gilead shall hereafter reasonably promptly provide Janssen with any updates by Gilead to the CTD for Territory Complera. Reasonably promptly following the later of the filing of the NDA or the authorization for Marketing Approval with the European Commission for the Territory R/F/TAF Product, Gilead shall provide Janssen the CTD for the Territory R/F/TAF Product for use by Janssen in connection with obtaining and maintaining Regulatory Approvals for the Territory R/F/TAF Product in the Field in the Janssen Countries, and shall thereafter reasonably promptly provide Janssen with any updates by Gilead to the CTD for the Territory R/F/TAF Product. The CTDs for Territory Complera and the Territory R/F/TAF Product, and updates thereto, shall be used by Janssen solely to obtain and maintain Regulatory Approvals for Territory Complera and

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


the Territory R/F/TAF Product, as applicable, in the Field in the Janssen Countries. Janssen shall include the applicable CTD (as updated by any updates provided by Gilead pursuant to this Section 4.3.2) in each Drug Approval Application (to the extent required to comply with the requirements for such Drug Approval Application) filed to obtain and maintain a first Marketing Approval in the Field for each Territory Combination Product in any Janssen Country. Janssen’s regulatory filings with the Regulatory Authorities, including Drug Approval Applications, with respect to each Territory Combination Product in the Janssen Countries shall be consistent with the applicable CTD and updates thereto. Janssen shall, to the extent required by Applicable Law or otherwise reasonably requested by Gilead, exercise Commercially Reasonable Efforts to update any such filings promptly to reflect any updates to the CTDs as are provided by Gilead to Janssen pursuant to this Section 4.3.2 from time to time after such filings are made. Gilead shall provide electronic versions of the CTDs (including any updates thereto) to Janssen in a mutually agreed-upon format for the purpose of expediting Janssen’s activities in preparing and filing Regulatory Documentation for the Janssen Countries.
4.3.5    Additional Regulatory Documentation Provided by Either Party Following Marketing Approval.
4.3.5.1    Once Gilead or any of its Affiliates, Sublicensees or Third Party Distributors has obtained a first Marketing Approval for a Territory Combination Product in the Field in a country, Janssen may not withhold Regulatory Documentation or other information related to such Territory Combination Product or Janssen’s Single Agent Product in Janssen’s or its Affiliates’ Control that Gilead reasonably requires to comply with Applicable Law with regards to such Territory Combination Product in such country. Except as otherwise expressly authorized by Janssen, Gilead (and its Affiliates) shall have the right to use any additional information related to a Territory Combination Product or Janssen’s Single Agent Product provided or made available pursuant to the foregoing sentence (and not pursuant to any other provision hereunder) solely to the extent necessary to comply with Applicable Law (solely for regulatory purposes contemplated by this Agreement or any Ancillary Agreement). The provisions of this Section 4.3.3.1 shall survive expiration of this Agreement. Without limitation of the foregoing, if any Regulatory Authority requires, in order for Gilead (or its Affiliate, Sublicensee or Third Party Distributor) to obtain or maintain Regulatory Approval for a Territory Combination Product in any Gilead Country, any Regulatory Documentation or other information (including any analyses of any data relating to RPV and results thereof), and Gilead would have the obligation under the Amended D/C/F/TAF Agreement to provide analogous Regulatory Documentation or information (including analyses and results thereof) to Janssen, then Section 4.3.1.3 or other applicable Section of the Amended D/C/F/TAF Agreement, as applicable, and any defined terms used therein shall apply mutatis mutandis with respect to such information or analyses (e.g., references to Gilead shall be changed to Janssen, references to “COBI, FTC or TAF” shall be changed to “RPV (as defined in the Complera Agreement),” references to “DRV” shall be changed to “FTC, TAF or TDF (as defined in the Complera Agreement)”, references to “STR Clinical Trial” shall be changed to “Combination Product Clinical Trial” and references to “the Licensed STR” shall be changed to “a Territory Combination Product (as defined in the Complera Agreement)”), except that references to “Gilead Redactable Information” in Section 4.3.1.3 or any other Section of the Amended D/C/F/

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


TAF Agreement shall be deemed to be replaced with the term “Janssen Redactable Information” as defined in this Agreement and references to “Regulatory Leads” in Section 4.3.1.1 or any other Section of the Amended D/C/F/TAF Agreement shall be deemed to be replaced with “Alliance Managers (or their designees).”
4.3.5.2    Once Janssen or any of its Affiliates or Third Party Distributors has obtained a first Marketing Approval for a Territory Combination Product in the Field in a country, Gilead may not withhold Regulatory Documentation or other information related to such Territory Combination Product or Gilead’s Single Agent Products or Double Agent Products in Gilead’s or its Affiliates’ Control that Janssen reasonably requires to comply with Applicable Law with regards to such Territory Combination Product in such country. Except as otherwise expressly authorized by Gilead, Janssen (and its Affiliates) shall have the right to use any additional information related to a Territory Combination Product or Gilead’s Single Agent Products or Double Agent Products provided or made available pursuant to the foregoing sentence (and not pursuant to any other provision hereunder) solely to the extent necessary to comply with Applicable Law (solely for regulatory purposes contemplated by this Agreement or any Ancillary Agreement). The provisions of this Section 4.3.3.2 shall survive expiration of this Agreement.
4.3.5.3    Limitations. Notwithstanding anything herein to the contrary (other than Section 4.3.3.1 or Section 4.3.3.2), except in the case of the FDA, EMA, the European Commission or any Regulatory Authority in [*], a Party shall have no obligation hereunder to provide to the other Party or any Regulatory Authority, in connection with any filings to obtain Regulatory Approvals of a Territory Combination Product in the Field in the Territory, any information relating to its API or any of its other products (including its Single Agent Product(s) or Double Agent Products), as the case may be, the disclosure of which such first Party reasonably believes may harm its or its Affiliates’ business interests with respect to its API or any of its other products (including its Single Agent Product(s) or Double Agent Products).
4.4    Regulatory Filings and Communication.
4.4.1    MA Holder. With respect to each country in the Territory, unless otherwise agreed to in writing by the Parties or prohibited by Applicable Law, the Selling Party, or its designated Affiliate, Sublicensee or (subject to Section 9.3.3 and, in the case of a Janssen Country, the Janssen Distributor Agreement) Third Party Distributor, shall hold any Drug Approval Application or Marketing Approval with respect to a Territory Combination Product with respect to such country. To the extent permitted by Applicable Law, Gilead hereby transfers, and shall cause its Affiliates, Sublicensees or Third Party Distributors to transfer, to Janssen all of its and their right, title and interest in the Marketing Approvals for Territory Complera for Russia and China to Janssen and, following the Restatement Effective Date, the Parties shall coordinate to transfer, subject to the terms of this Agreement and the Ancillary Agreements, such Marketing Approvals to Janssen as promptly as practicable after the Restatement Effective Date. To the extent such transfer is prohibited by Applicable Law, Gilead shall hold the Marketing Authorization(s) for the benefit of Janssen subject to the terms of this

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Agreement and the Ancillary Agreements. For clarity, such transfer of such Marketing Authorization(s) does not convey any ownership interest in the data contained therein. For clarity, Gilead will hold the Import Drug License for China.
4.4.2    Responsibilities With Respect to Combination Product Regulatory Filings. Subject to Section 4.3 and the remainder of this Section 4.4, with respect to each country in the Territory, the Selling Party, on behalf of the applicable entity designated to be the MA Holder with respect to such country, with the cooperation of the non-Selling Party as reasonably required, shall have primary responsibility for preparing and filing all necessary Regulatory Documentation and for acting as liaison for all communications with the Regulatory Authorities in such country for the purpose of obtaining and maintaining Regulatory Approval for the applicable Territory Combination Product in the Field in such country, including, subject to Section 4.4.2.2 below, with respect to any changes to the Product Label for such Territory Combination Product; provided, however, that for each of Russia and China, during any period in which such country is a Janssen Country and Gilead (or its Affiliate) is the MA Holder with respect to a Territory Combination Product with respect to such country, Janssen shall not file any Regulatory Documentation or otherwise communicate with a Regulatory Authority with respect to such Territory Combination Product in such country unless such filing or the substance of such communication has been approved by Gilead in writing, such approval not to be unreasonably withheld, conditioned or delayed. The Parties shall agree in writing on reasonable timeframes and processes to facilitate the foregoing approval process. Notwithstanding anything to the contrary in this Agreement, each Party shall be responsible for preparing and submitting any Regulatory Documentation or other materials with respect to any clinical trial that it or its Affiliate conducts (either solely or with one or more Third Parties) pursuant to this Agreement and the Party that is not the MA Holder for a given country may obtain and maintain INDs for such country in support of Combination Product Clinical Trials that such Party is permitted to conduct under Article 3.
4.4.2.1    Discussion of Single Agent Products or Double Agent Product. Notwithstanding anything contained in this Agreement to the contrary, at any meeting with, or any communication to, Regulatory Authorities in the Territory concerning a Territory Combination Product, the Selling Party shall not engage in any substantive discussions pertaining to the other Party’s Single Agent Product(s) or Double Agent Product(s) or the API contained therein, without such other Party’s prior written consent.
4.4.2.2    Label Change for Single Agent Products or Double Agent Product. If any communications from Regulatory Authorities in the Territory regarding potential changes to any Product Label for a Territory Combination Product in the Territory are reasonably expected to lead to a change in the Product Label for a Party’s Single Agent Product(s) or Double Agent Products, as the case may be, and are not reasonably expected to lead to a change in the Product Label for the other Party’s Single Agent Product(s) or Double Agent Products, as the case may be, then, notwithstanding anything in this Agreement to the contrary, the affected Party shall take the lead (in coordination with the Selling Party, if such Party is not the Selling Party) in dealing with such Regulatory Authorities on such matter.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


4.4.2.3    PVA. Notwithstanding the foregoing, the Party which has responsibility for communications with Regulatory Authorities in a country relating to routine safety-related submissions (e.g., individual case reports) pursuant to the PVA, shall have the right to communicate (or to cause one or more of its Affiliates or Third Party distributors to communicate) with Regulatory Authorities in such country in the Territory concerning such submissions in accordance with the terms of the PVA in a manner consistent with any determinations with respect to such communications made pursuant to the PVA.
4.4.3    Price Regulatory Approvals. Notwithstanding anything in this Section 4.4 to the contrary, this Section 4.4 shall not govern the obtaining and maintaining of pricing and reimbursement approvals in the Field in the Territory with respect to the Territory Combination Products, or any communications with any Regulatory Authorities with respect to the foregoing matters. For clarity, such approvals and communications shall be governed by Article 6.
4.4.4    Regulatory Matters Concerning Single/Double Agent Products. Nothing contained in this Section 4.4 shall prohibit or restrict either Party from communicating with the Regulatory Authorities on matters relating to the Exploitation of any of its respective Single Agent Product(s), Double Agent Products or pharmaceutical products other than the Territory Combination Products. Each Party shall promptly notify the other Party of any change proposed by the notifying Party to any Product Label for any of its Single Agent Product(s) or Double Agent Products in the Field in the Territory that is substantive in nature, where such proposed change is reasonably expected to have an impact on any Product Label for a Territory Combination Product, reasonably in advance of the anticipated filing date of such proposed change, by furnishing the other Party with the text of the proposed change and a summary description of the data supporting or basis for such proposed change, and, if requested by the notified Party, existing written summaries of any cumulative review done by or on behalf of the notifying Party, provided that the notifying Party may redact any Gilead Redactable Information (in the case of Gilead as the notifying Party) or Janssen Redactable Information (in the case of Janssen as the notifying Party), as applicable. In addition, promptly after the filing of such proposed change with the applicable Regulatory Authorities in the Territory, the Party that has provided such notice shall furnish the other Party with the text of the proposed change as filed. Any resulting filing with respect to the Product Label for a Territory Combination Product shall be governed by Section 4.4.2 and any documentation required in connection with such filing shall be exchanged to the extent and in the manner set forth in Section 4.3.
4.4.5    Regulatory Matters Concerning a Party’s Compliance with Applicable Law. Notwithstanding anything herein to the contrary, as between the Parties, regardless of which Party is the Selling Party, each Party shall have sole responsibility for any submissions to, or communications with, any Regulatory Authority in the Territory with respect to any matter relating to such Party’s or any of its Affiliates’, subcontractors’ or Third Party Distributor’s compliance with Applicable Law in connection with its performance of such Party’s Commercialization Activities, unless such submissions or communications are made in connection with obtaining or maintaining the applicable Drug Approval Application (in which case the applicable provisions of this Section 4.4 shall control).

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


4.4.6    Activities in the EU. This Section 4.4 shall apply to the preparing and filing of all necessary Regulatory Documentation and communications with the Regulatory Authorities of the European Union, including the EMA, as if the European Union were a “country” for purposes of this Section 4.4.
4.5    Activities in Japan. Notwithstanding the foregoing or anything else to the contrary in this Agreement, in the case of Japan, Gilead’s rights and obligations under this Agreement may, at Gilead’s option, be exercised or performed, as applicable, by its (sub)licensee for Japan; provided, however, that Gilead shall remain fully responsible for the performance of such (sub)licensee.
4.6    Records. Each Party shall maintain, or cause to be maintained, records with respect to its activities pursuant to this Article 4 in material compliance with Applicable Law. Such records shall be retained for at least (a) ten (10) years following creation or (b) such longer period as may be required by the In-License Requirements or Applicable Law.
4.7    Regulatory Costs and Expenses. With respect to each country in the Territory, each Party shall bear its own costs and expenses relating to the Combination Product Regulatory Activities and regulatory filings for the Territory Combination Products in such country. Janssen or its applicable Affiliate shall bear all costs and expenses relating to Edurant Regulatory Activities and any regulatory filings relating to Edurant, and Gilead or its applicable Affiliate shall bear all costs and expenses relating to regulatory activities and filings relating to of Gilead’s Single Agent Products or Double Agent Products.
4.8    Regulatory Dependencies. Annex AA-2 sets forth those Janssen Countries in which a Marketing Approval for a Territory Combination Product relies upon or references a Marketing Approval for such Territory Combination Product for the European Union or any Gilead Country (each such Janssen Country, a “Janssen Reliant Country”). Gilead shall provide Janssen [*] notice of any voluntary withdrawal or abandonment of a Marketing Approval in any country that is specified in Annex AA-2 as a country that is referenced or relied upon by any Janssen Reliant Country (a “Gilead Marketing Approval”). [*]. Notwithstanding the foregoing, this Section 4.8 shall not apply to preclude Gilead from engaging in any withdrawal of a Gilead Marketing Approval due to safety, efficacy or public health reasons or as required or requested by a Regulatory Authority.
5
MEDICAL AFFAIRS; CONFERENCES
5.1    Product Information; Medical Affairs and Medical Communications. Subject to this Article 5 and Section 6.3.2, each Party shall, with respect to the countries in which it is the Selling Party, determine independently how and if to utilize and deploy its medical science liaisons for activities relating to a Territory Combination Product in such countries.
5.2    Responses to Medical Inquiries.
5.2.6    Gilead Countries. Gilead shall apply its standard guidelines and procedures for determining and providing appropriate responses to medical inquiries about each

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Combination Product in the Gilead Countries. Gilead shall ensure that any such response procedures and standard response documents comply with Applicable Law.
5.2.7    Janssen Countries. Gilead shall make available to Janssen a core set of standard response documents for responding to medical inquiries about each Combination Product (“Core SRDs”), and Janssen shall use only such Core SRDs or adaptations thereof in responding to medical inquiries about the applicable Combination Product in the Janssen Countries, subject to Janssen’s ensuring that such Core SRDs and adaptations comply with Applicable Law. With respect to any Janssen Country for which Gilead (or its Affiliate, Sublicensee or Third Party Distributor) is the MA Holder for a Territory Combination Product, Janssen shall not use any adaptation of the Core SRDs (regardless of whether or not such adaptation reflects a change in the content of the Core SRDs) in responding to medical inquiries about such Territory Combination Product in such Janssen Country unless and until Gilead has approved such adaptation in writing. With respect to any Janssen Country for which Janssen (or its Affiliate or Third Party Distributor) is the MA Holder for a Territory Combination Product, Janssen shall not use any adaptation of the Core SRDs that reflects a change in the content of the Core SRDs in responding to medical inquiries about such Territory Combination Product in such Janssen Country unless and until Gilead has approved such adaptation in writing. Subject to the foregoing, Janssen shall apply its standard guidelines and procedures for determining and providing appropriate responses to medical inquiries about each Combination Product in the Janssen Countries, and Janssen shall ensure that any such response procedures comply with Applicable Law. In the event that Gilead does not provide any Core SRDs to Janssen with respect to a Territory Combination Product, Janssen may respond to any medical inquiries based on the approved Product Label for such Territory Combination Product.
5.2.8    Referrals. With respect to each country, the non-Selling Party shall refer any medical inquiries that it receives about a Territory Combination Product in such country (unless it relates specifically to RPV (if the non-Selling Party is Janssen) or to TAF, TDF or FTC (if the non-Selling Party is Gilead)) to the Selling Party or to such person(s) as the Selling Party shall designate. Each Party shall refer any medical inquiries that it receives about the other Party’s Single Agent Products or Double Agent Products to the other Party or to such person(s) as the other Party shall designate.
5.2.9    Procedures. Without limiting the foregoing or anything in the Janssen Distributor Agreement, the Alliance Managers shall ensure that appropriate procedures are in place for the Parties to respond to medical inquiries about a Territory Combination Product that go beyond the information contained in the Product Label for such Territory Combination Product. If at any time a Party has concerns about the other Party’s procedures for responding to medical inquiries about a Territory Combination Product or standard response documents for use in responding to medical inquiries about a Territory Combination Product, the concerned Party may refer the matter to the Alliance Managers and the Alliance Managers shall facilitate discussion and resolution of such concerns.
5.3    Conferences and Symposia. Janssen shall not (and shall cause its Affiliates not to) participate in or sponsor any formal presentation or panel or medical booths with respect to a

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Combination Product at any conference or symposia or provide any information with respect to a Combination Product at any conference or symposia without the prior written consent of Gilead; provided, however, that Janssen may participate in or sponsor such presentations or panels or medical booths or provide such information at conferences or symposia (other than international meetings) in the Janssen Countries. Gilead shall not (and shall cause its Affiliates not to) participate in or sponsor any formal presentation or panel or medical booths with respect to any RPV Product at any conference or symposia anywhere in the Territory or with respect to any Combination Product at any conference or symposia (other than international meetings) in the Janssen Countries, or provide any information with respect to any RPV Product at any conference or symposia anywhere in the Territory or with respect to any Combination Product at any conference or symposia (other than international meetings) in the Janssen Countries, without the prior written consent of Janssen.
5.4    Compliance. Each Party shall cause its Affiliates, Sublicensees and Third Party Distributors to comply with the terms of this Article 5 as if such Affiliate, Sublicensee or Third Party Distributor were a Party.


6
COMMERCIALIZATION ACTIVITIES
6.1    Distribution in Region B and Region C. Neither Party nor any of its Affiliates, Sublicensees or Third Party Distributors shall Distribute any Combination Product in Region C other than Branded Region B/C Complera or Branded Region B/C R/F/TAF Product.
6.2    Commercialization Activities.
6.2.7    Diligence. Subject to the terms and conditions of this Agreement, the Selling Party (or its Affiliate, Sublicensee or Third Party Distributor) shall have the sole right to perform Commercialization Activities for a Territory Combination Product with respect to the countries for which it is the Selling Party.
6.2.7.1    Gilead shall use Commercially Reasonable Efforts to perform Commercialization Activities (including through its Affiliates, Sublicensees or Third Party Distributors), including Premarket Launch Activities, for each Territory Combination Product in each of the Major Market Countries; provided, however, that such obligation with respect to Territory Complera shall terminate with respect to each Major Market Country, [*].
6.2.7.2    Janssen shall use Commercially Reasonable Efforts to perform Commercialization Activities (including through its Affiliates or Third Party Distributors), including Premarket Launch Activities, for each Territory Combination Product in each of the Janssen Diligence Countries; provided, however, that such obligation with respect to Territory Complera shall terminate with respect to each Janssen Diligence Country [*]. In the event that Gilead believes that Janssen is in breach of its obligations under this Section 6.2.1.2

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


with respect to a given Territory Combination Product in a Janssen Diligence Country, Gilead shall have the right to give Janssen written notice specifying the nature of such breach. Janssen shall have a period of [*] after receipt of such written notice to cure such breach. If Janssen does not cure such breach within such [*] period, [*].
6.2.8    Specific Commercialization Obligations. Without limitation of Section 6.2.1, Gilead agrees to the following solely with respect to each of the Major Market Countries other than [*]:
6.2.8.6    With respect to each Major Market Country other than [*], as of the later of the first Marketing Approval or First Commercial Sale of Territory Complera in the applicable country until the earlier of (x) [*] or (y) [*] (such period, a “Complera Launch Period”), Gilead shall ensure (and certify in writing each Calendar Quarter) that the incentive compensation provided by Gilead each Calendar Quarter with respect to Territory Complera to each of the sales representatives of Gilead who are responsible for Detailing Complera in such Major Market Country satisfies the following criteria: the incentive compensation payable to each such sales representative if such sales representative achieves his or her target sales for such Calendar Quarter with respect to Territory Complera shall equal or exceed twenty five percent (25%) of the total incentive compensation such sales representative is eligible to receive if he or she achieves his or her target sales for such Calendar Quarter for all of the products for which such sales representative is responsible for Detailing.
6.2.8.7    [Reserved]
6.2.8.8    For each Detailing Year (as defined below), through the Calendar Quarter that includes the last day of the applicable Launch Period, Gilead shall perform the number of Details of each Territory Combination Product in the specific Major Market Countries set forth in Section 1(a) or 1(b) of Annex F, as applicable, in either the first or second product presentation during the call in which such Detail occurs. Gilead shall use Commercially Reasonable Efforts to ensure that the number of such Details for each such Major Market Country in each Calendar Quarter of each Detailing Year is no less than twenty percent (20%) of the number of Details required for such Major Market Country for such Detailing Year; provided, however, the Parties may by written mutual agreement modify such obligation on a country-by-country basis due to local extrinsic conditions (e.g., seasonality) that may impact the ability of Gilead to fulfill such obligation. Gilead shall certify in writing its compliance with this Section 6.2.2.3 on a quarterly basis. A “Detailing Year” for an applicable Major Market Country shall mean, in the case of Territory Complera, (A) in the case of the first Detailing Year, the period beginning on the first day of the first full Calendar Quarter after the later to occur of the First Commercial Sale or the first Marketing Approval of Territory Complera in such Major Market Country through the end of the Calendar Year in which such First Commercial Sale or the first Marketing Approval, as applicable, occurs (in which case, Gilead’s obligations under this paragraph with respect to such Detailing Year (but not with respect to any Calendar Quarter in such Detailing Year) shall be prorated accordingly), and (B) in the case of each other Detailing Year, the Calendar Year following the prior Detailing Year, until the end of the Calendar Quarter that includes the last day of the applicable Launch Period (and in the case of the last Detailing

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Year with respect to a Major Market Country, Gilead’s obligations under this paragraph with respect to such Detailing Year (but not with respect to any Calendar Quarter in such Detailing Year) shall be prorated accordingly). A “Detailing Year” for an applicable Major Market Country shall mean, in the case of Territory R/F/TAF Product, [*]. Notwithstanding anything contained herein to the contrary, the Parties may from time to time mutually agree in writing on adjustments to the number of Details set forth in Annex F.
6.2.8.9    Gilead acknowledges and agrees that Gilead’s achievement of each and all of the requirements in Sections 6.2.2.1 and 6.2.2.3 (the “Specific Targets”) with respect to each applicable Major Market Country goes to the root of this Agreement and is an essential element of this Agreement, and that Gilead’s failure to substantially achieve each or any of the Specific Targets with respect to an applicable Major Market Country is a Material Breach that entitles Janssen to terminate this Agreement with respect to the applicable Territory Combination Product pursuant to Section 19.4 if Gilead fails to cure such failure as provided in Section 19.4 or, with respect to each Initial Specific Target Breach, Section 6.2.2.5.
6.2.8.10    With respect to each Initial Specific Target Breach, Janssen agrees that Gilead shall be deemed to have cured such failure if Gilead complies with the following (each a “Specific Cure”) with respect to the applicable failure:
a.    in the case of a breach of Section 6.2.2.1 with respect to an applicable Major Market Country, for a number of consecutive Calendar Quarters equal to the number that Gilead was so in breach, starting with the Calendar Quarter immediately following the Calendar Quarter in which Gilead received written notice of such breach, Gilead complies (and on a quarterly basis certifies its compliance in writing) with the requirements of Section 6.2.2.1 in all respects, except that the incentive compensation with respect to Territory Complera for such period shall be thirty percent (30%) instead of twenty-five percent (25%); and
b.    in the case of a breach of Section 6.2.2.3 with respect to an applicable Major Market Country for a given Detailing Year (or a given Calendar Quarter within a Detailing Year), no later than ninety (90) days following Gilead’s receipt of notice of such breach, Gilead conducts in such country a number of Details of the applicable Territory Combination Product, in either the first or second product presentation during the call in which such Detail occurs, equal to the number of Details by which Gilead fell short of its obligations under Section 6.2.2.3 with respect to such country and such Detailing Year (or Calendar Quarter, as applicable), provided that the Details performed by Gilead in curing said breach shall not count toward Gilead’s fulfillment of its Detailing obligations under Section 6.2.2.3 for any Calendar Quarter or Detailing Year other than the Calendar Quarter and Detailing Year in which the breach occurred;
provided, however, that, with respect to each applicable Major Market Country, once Gilead successfully completes a Specific Cure for a given Territory Combination Product with respect to a breach of Sections 6.2.2.1 or 6.2.2.3, no further breach of the same section in such country shall automatically be deemed cured by a Specific Cure with respect to such Territory Combination Product, and the curing of any such further breach shall be governed by the general principles governing cure set forth in Section 19.4 and not by this Section 6.2.2.5.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


6.2.8.11    If there is a modification in Applicable Law or industry guidelines with respect to the compensation of, or activities performed by, pharmaceutical sales representatives, or if Detailing is prohibited at customer facilities, then, to the extent such modification or prohibition would render the achievement of the Specific Targets commercially impracticable or unethical, then the Parties shall negotiate in good faith substitute obligations, which obligations take account of such modification or prohibition.
For clarification, the satisfaction of the obligations of Sections 6.2.2.1 and 6.2.2.3 does not necessarily, in and of itself, constitute satisfaction of Gilead’s obligations under Section 6.2.1.
6.2.9    Performance; Subcontracting. Each Party shall comply, and shall cause its Affiliates and any of its permitted subcontractors to comply, with all Applicable Law and the requirements of all Regulatory Approvals for the Territory Combination Products in conducting their respective Commercialization Activities. Either Party may subcontract the performance of Commercialization Activities allocated to it hereunder, including to a contract sales organization or Distribution Subcontractor; provided, however, that (i) Gilead shall not use a contract sales organization in any of the Major Market Countries, (ii) Janssen shall not use a contract sales organization to conduct its Detailing activities with respect to a Territory Combination Product in any Gilead Country and (iii) the subcontracting Party shall oversee the performance by its subcontractors of such subcontracted Commercialization 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 Commercialization Activities in accordance with this Agreement.
6.2.10    Co-Detailing LOAs. The Parties acknowledge and agree that the Parties (or their Affiliates) currently have (or may in the future have) certain additional rights and obligations with respect to the Detailing of the Territory Combination Products in certain countries, as set forth in the Co-Detailing LOA’s for the applicable countries in each Co-Detailing LOA, or as may be set forth from time to time by other separate written agreements between the Parties. For each Co-Detailing LOA, unless and until such Co-Detailing LOA is amended to cover the Parties’ activities with respect to the Territory R/F/TAF Product (or unless otherwise agreed by the Parties in writing), the provisions of such Co-Detailing LOA shall be deemed to apply to the Territory R/F/TAF Product to the same extent as they apply to Territory Complera.
6.3    Co-Detailing; Responses to Unsolicited Questions.
6.3.9    Co-Detailing.
6.3.9.1    Territory Complera. The Parties acknowledge and agree that, as of the Restatement Effective Date, Janssen has made an election under the Original Agreement to commence, at its expense, Detailing of Territory Complera in each country listed in Annex FF, and, during the Term with respect to each such country, subject to the terms and conditions of this Agreement and any Ancillary Agreements, Janssen shall have the non-exclusive right to Detail Territory Complera in such country; provided, however, that such right shall terminate with respect to any country upon the First Commercial Sale of the Territory R/F/

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


TAF Product in such country; provided, however, that with respect to any country in which Janssen or its applicable Affiliate is Detailing Territory Complera as of the First Commercial Sale of the Territory R/F/TAF Product in such country, such termination shall be effective at the conclusion of a reasonable wind down period to be agreed by the Parties. For any country listed in Annex FF in which the First Commercial Sale of Territory Complera has not occurred as of the Restatement Effective Date, if Janssen or its applicable Affiliate decides not to commence Detailing Territory Complera in such country upon the First Commercial Sale of Territory Complera in such country, or to commence Detailing Territory Complera in such country at any time after the First Commercial Sale of Territory Complera in such country, Janssen shall notify Gilead of such decision promptly after such decision is made.
6.3.9.2    Territory R/F/TAF Product. During the Term, subject to the terms and conditions of this Agreement and any Ancillary Agreements, Janssen shall have the non-exclusive right to Detail, at its expense, the Territory R/F/TAF Product in each country listed in Annex FF. Subject to the preceding sentence, Detailing by Janssen or its applicable Affiliate under this Section 6.3.1.2 may commence upon or after the First Commercial Sale of the Territory R/F/TAF Product in the applicable country; provided, however, that if Janssen or its applicable Affiliate decides not to commence Detailing the Territory R/F/TAF Product in a country upon the First Commercial Sale of the Territory R/F/TAF Product in such country, or to commence Detailing the Territory R/F/TAF Product in a country at any time after the First Commercial Sale of the Territory R/F/TAF Product in such country, Janssen shall notify Gilead of such decision promptly after such decision is made.
6.3.10    Responses to Unsolicited Questions and Related Matters.
6.3.10.3    Each Party may, with respect to the countries in which it is the Selling Party, respond to unsolicited questions that it receives with respect to any Territory Combination Product in such countries.
6.3.10.4    For any country in Region A, the non-Selling Party with respect to such country (and its Affiliates) may respond to unsolicited questions that it receives with respect to any Territory Combination Product solely in accordance with Applicable Law and based solely upon the Product Label for the applicable Territory Combination Product in such country in Region A and any approved materials the Selling Party provides to the non-Selling Party for responding to such questions in such country, which approved materials may be withdrawn from use by the Selling Party at any time upon notice to the non-Selling Party.
6.3.10.5    For any country in Region B or Region C, the non-Selling Party with respect to such country and its Affiliates shall not respond to any unsolicited question that they receive with respect to any Territory Combination Product and shall use reasonable efforts to refer any such unsolicited questions to the Selling Party for such country.
6.3.10.6    Janssen may not market or promote (other than Detail in accordance with Section 6.3.1) any Territory Combination Product in any Gilead Country. Notwithstanding the foregoing or anything to the contrary in Section 6.3.2.2 or Section 6.3.2.3, Janssen may, in connection with its Detailing of the Territory Combination Products in

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


accordance with Section 6.3.1 or its activities relating to Edurant or RPV, respond to unsolicited questions that it receives with respect to the Territory Combination Products, provided that Janssen responds solely in accordance with any approved slide deck or other background materials provided by Gilead to Janssen for the purpose of responding to such questions. Such approved slide deck or other background materials shall comply with Applicable Law and shall be provided by Gilead to Janssen in accordance with procedures to be agreed upon by the Alliance Managers. In the event Gilead does not provide such slide deck or other materials, Janssen may respond to such questions that do not relate specifically to RPV based solely upon the Product Label for the applicable Territory Combination Product in such country. In connection with Gilead’s Detailing activities, Gilead shall refer any unsolicited questions with respect to Edurant or RPV to Janssen.
6.3.10.7    For clarity, this Section 6.3 is not intended to (a) apply to medical inquiries about Territory Combination Products, which are governed by Section 5.2, or (b) restrict the ability of Janssen to respond to any unsolicited questions with respect to Edurant or RPV or (c) restrict the ability of Gilead to respond to any unsolicited questions with respect to any Gilead Compound Product or FTC, TDF or TAF. Each Party shall cause its Affiliates, Sublicensees and Third Party Distributors to comply with the terms of this Section 6.3 as if such Affiliate, Sublicensee or Third Party Distributor were a Party.
6.4    [Reserved].    
6.5    Third Party Distributors. Gilead shall have the right, with respect to all countries in the Territory other than the Janssen Countries, to engage a Third Party Distributor to Distribute Territory Combination Products. In the event Gilead decides to engage a Third Party Distributor with respect to any Territory Combination Product with respect to any country in Region A (other than a Gilead Take-Over Country) for which Gilead has not previously engaged a Third Party distributor for any of its products and Gilead desires to engage a Third Party Distributor for such country which Third Party Distributor does not already serve as a distributor for any Gilead Products in any country, (a) Gilead shall so notify Janssen in writing (the “ROFN Trigger Notice”) and (b) if Janssen notifies Gilead, within [*] after receiving a ROFN Trigger Notice (the “ROFN Period”), that it desires to negotiate with Gilead with respect to becoming Gilead’s exclusive distributor of one or both Territory Combination Products in such country, the Parties shall negotiate in good faith for [*] (or such longer period as agreed by the Parties) (the “Negotiation Period”) an amendment to this Agreement (and, if applicable, the Janssen Distributor Agreement) pursuant to which such country would become a Janssen Country; provided, however, that neither Party will be obligated to enter into such an amendment. If, following receipt of a ROFN Trigger Notice with respect to a country, (i) Janssen notifies Gilead, prior to the expiration of the ROFN Period, that it does not desire to negotiate to become Gilead’s exclusive distributor in such country, (ii) the ROFN Period expires without Gilead’s receipt of a notification from Janssen that it desires to negotiate to become Gilead’s exclusive distributor for the Territory Combination Product in such country or (iii) Janssen notifies Gilead, prior to the expiration of the ROFN Period, that it desires to negotiate to become Gilead’s exclusive distributor for the Territory Combination Product in such country, but the Negotiation Period expires before the Parties execute an amendment to this Agreement (and, if applicable, the

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Janssen Distributor Agreement) pursuant to which such country would become a Janssen Country, then Gilead shall thereafter be free to engage a Third Party Distributor to Distribute Territory Combination Products in such Gilead Country.
6.6    Distribution and Related Matters.
6.6.1    Distribution Activities. Subject to the terms and conditions of this Agreement and the Janssen Distributor Agreement, the Parties hereby acknowledge and agree that Gilead (or its Affiliate or Sublicensee or Third Party Distributor) shall have the right to Distribute each Territory Combination Product in each country in the Territory (other than the Janssen Countries). Subject to the Janssen Distributor Agreement, Gilead (or such other Person) shall have the sole responsibility and right to fill orders with respect to such Territory Combination Product in such country and shall have the sole responsibility and right to distribute (or right to cause such other Person to distribute) such Territory Combination Product and to perform distribution activities with respect thereto, including inventory management and control, warehousing and storage, order filling, invoicing, collection of sales proceeds, determination and processing of charge-backs and rebates, preparation of sales records and reports, customer relations and services, and handling of returns (the “Distribution Activities”). Gilead shall not (i) grant rights to conduct any Distribution Activities with respect to a Territory Combination Product in any country to any Person other than its Affiliates, Sublicensees, Distribution Subcontractors or Third Party Distributors, (ii) sell or permit its Affiliates, Sublicensees or Third Party Distributors to sell any Territory Combination Product in a country outside of the European Union if Gilead (or such Affiliate, Sublicensee or Third Party Distributor) has reason to believe that such Territory Combination Product will be exported from such country to any Janssen Country, or (iii) export or have exported (other than pursuant to the Janssen Distributor Agreement), or permit its Affiliates, Sublicensees or Third Party Distributors to export, any Territory Combination Product from any country outside of the European Union if Gilead (or such Affiliate, Sublicensee or Third Party Distributor) has reason to believe that such Territory Combination Product will be Distributed (by Gilead or any other Person) in or to any Janssen Country without the written consent of Janssen, unless refusing to so export the Territory Combination Product would violate Applicable Law. Gilead shall perform (or cause to be performed) the Distribution Activities in the Territory consistent with Applicable Law. Janssen shall promptly forward (or cause its Affiliates to forward) to Gilead (or its designee) any order(s) for the purchase of a Territory Combination Product that are received by Janssen or any of its Affiliates (excluding any orders for the purchase of a Territory Combination Product in the Janssen Countries), provided that Janssen’s failure to forward any such order to Gilead (or its designee) shall not constitute a breach of this Agreement unless such failure constitutes willful misconduct.
6.6.2    First Expiration, First Out. The Selling Party shall Distribute (and shall cause its Affiliates and Distribution Subcontractors to Distribute) all Territory Combination Product on a first expiration, first out (FEFO) basis.
6.7    Marketing Materials.
6.7.1    Key Selling Messages.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


6.7.1.5    Territory Complera. The Parties acknowledge and agree that, as of the Restatement Effective Date, they have agreed on a set of core messages with respect to Territory Complera, which core messages shall serve as a basis for the promotion of Territory Complera to physicians (the “Complera Key Selling Messages”), and from time to time the Parties may develop and propose to each other any updates to the Complera Key Selling Messages, which updates shall be mutually agreed by the Parties. If the Parties cannot reach agreement with respect to a given update to the Complera Key Selling Messages, the Parties shall (on a country-by-country basis if and to the extent appropriate) refer any disputed issues to the Executives for resolution pursuant to Section 20.6. If the Executives are unable to reach agreement with respect thereto within the Executives Review Period, neither Party shall be obligated to use such updated Complera Key Selling Message, but each Party shall be permitted to use such updated Complera Key Selling Message (and include such updated Complera Key Selling Message in its Local Promotional Materials) if such updated Complera Key Selling Message is consistent with both (a) the Product Label for Territory Complera and (b) Applicable Law. This Section 6.7.1.1 shall be effective until the second anniversary of the first date on which the First Commercial Sale of the Territory R/F/TAF Product has occurred in all Major Market Countries.
6.7.1.6    Territory R/F/TAF Product. Before the First Commercial Sale of the Territory R/F/TAF Product in a Major Market Country, Gilead shall develop and propose to Janssen a set of core messages with respect to the Territory R/F/TAF Product, which core messages shall serve as a basis for the promotion of the Territory R/F/TAF Product in such countries to physicians (as updated from time to time, the “R/F/TAF Product Key Selling Messages” and, together with the Complera Key Selling Messages, the “Key Selling Messages”). From time to time, Gilead may develop and propose to Janssen updates to the R/F/TAF Product Key Selling Messages. All R/F/TAF Product Key Selling Messages, including updates thereto, shall be consistent with the Product Label for the Territory R/F/TAF Product and scientifically accurate. At Janssen’s request, the Parties shall discuss such proposed or updated R/F/TAF Product Key Selling Messages and Gilead shall consider Janssen’s comments. If the Parties cannot reach agreement with respect to any such R/F/TAF Product Key Selling Message or any updates thereto, the Parties may refer any disputed issues to the Executives for resolution pursuant to Section 20.6. If the Executives are unable to reach agreement with respect thereto within the Executives Review Period, Gilead shall have final decision-making authority with respect to such matter.
6.7.2    Local Promotional Materials. Except as otherwise provided in the Co-Detailing LOA’s, all advertising and promotional materials, if any, to be used in connection with the marketing and promotion, including Detailing, of a Territory Combination Product in a given country in the Territory (such advertising and promotional materials for each such country, the “Local Promotional Materials”) shall be developed by the Selling Party at its cost and expense. All Local Promotional Materials shall be (a) consistent with the most recent Key Selling Messages (if any) made effective under Section 6.7.1.1 or Section 6.7.1.2, as applicable, for the applicable Territory Combination Product; provided, however, that Janssen shall not be required to conform its Local Promotional Materials to any Key Selling Messages to the extent that Janssen reasonably believes that such Key Selling Messages are inconsistent with the Product

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Label for the applicable Territory Combination Product or that conforming its Local Promotional Materials to such Key Selling Messages would be inconsistent with Applicable Law (for clarity, with respect to Section 6.7.1.1, this clause (a) shall apply during the period Section 6.7.1.1 is effective (as described in the last sentence thereof) and after such period), (b) consistent with the Product Label for the applicable Territory Combination Product, (c) consistent with Applicable Law and (d) in the case of Janssen, consistent with the branding guidance provided by Gilead from time to time, with deviation solely to the extent required by Applicable Law; provided, however, that Janssen shall not be required to conform its Local Promotional Materials to any such branding guidance to the extent that Janssen reasonably believes that such branding guidance is inconsistent with the Product Label for the applicable Territory Combination Product or that conforming its Local Promotional Materials to such branding guidance would be inconsistent with Applicable Law. Any Local Promotional Materials for any Janssen Country in which Gilead (or its applicable Affiliate, Sublicensee or Third Party Distributor) is the MA Holder shall be approved by Gilead in writing prior to their use. In the event of any updates to the applicable Key Selling Messages, or if Gilead notifies Janssen in writing of a modification to Gilead’s applicable branding guidance, each Party shall promptly review and update its Local Promotional Materials, if any, to conform such materials thereto. Except as otherwise provided in this Section 6.7.2, each Party (and its Affiliates, Sublicensees and Third Party Distributors) shall use the applicable Local Promotional Materials (and only the Local Promotional Materials) for a given country (as developed in accordance with this Section 6.7), together with Product Label for the applicable Territory Combination Product in such country, in marketing and promoting, including Detailing, a Territory Combination Product in such country; provided, however, that subject to the foregoing, the Selling Party shall have the right to position the applicable Territory Combination Product within its HIV product portfolio in its sole discretion in the countries for which it is the Selling Party.
6.7.3    Regulatory Approval for Promotional Materials. For clarity, in any interactions with a Regulatory Authority with respect to the Local Promotional Materials, the allocation of the Parties’ rights and responsibilities shall be as set forth in Section 4.4, except as otherwise provided in the Co-Detailing LOA’s, or in any other written agreement between the Parties.
6.7.4    Compliance with Applicable Law. The Parties hereby agree and acknowledge that, notwithstanding the provisions of this Section 6.7, neither Party (nor its Affiliates, Sublicensees and Third Party Distributors) shall be required to market a Territory Combination Product utilizing Local Promotional Materials which such Party believes in good faith do not comply with Applicable Law.
6.7.5    Promotional Materials in Co-Detailing Countries. With respect to each country listed in Annex FF in which Janssen is engaged in Detailing a Territory Combination Product, Gilead shall provide Janssen with copies of promotional materials to be used for Detailing in the applicable country, which materials (and the timelines for providing them) are specified in the applicable Co-Detailing LOA. Gilead may redact from such materials any information relating to Gilead products other than the Territory Combination Products.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


6.8    Selection and Use of Trademarks. The Parties hereby agree and acknowledge that Gilead has selected COMPLERA® and EVIPLERA®, and other Trademarks relating thereto, for use in connection with the Exploitation of Territory Complera by the Parties. Gilead shall have the right to select any other Combination Product Trademarks, provided that any such Combination Product Trademark shall comply with Applicable Law. Gilead shall not, and shall not permit its Affiliates to, select or use, as a Combination Product Trademark, any Trademark that is identical to or likely to cause confusion with the Product Trademark for any prescription pharmaceutical product of Janssen or any of its Affiliates or that violates any Applicable Law. Janssen shall not, and shall not permit its Affiliates to, use, in connection with any RPV Product, any Trademark that is identical to or likely to cause confusion with any of the Combination Product Trademarks or the Product Trademarks for any prescription pharmaceutical product of Gilead or any of its Affiliates or that violates any Applicable Law; provided, however, that the foregoing shall not be construed to preclude Janssen or its Affiliates from (a) using any Trademark in connection with the Exploitation of any RPV Product to the extent that Applicable Law requires such Trademark to be so used or (b) using EDURANT®. Gilead shall refrain from, and shall cause its Affiliates, Sublicensees and Third Party Distributors to refrain from, using, directly or indirectly, any Product Trademarks other than the Combination Product Trademarks, the Gilead Licensed Trademarks and the Janssen Licensed Trademarks in connection with the Exploitation of Territory Combination Products for sale or distribution in the Territory; provided, however, that, the foregoing shall not be construed to preclude Gilead or its Affiliates or its Sublicensees or Third Party Distributors from using any Trademark in connection with the Exploitation of Territory Combination Products for sale or distribution in the Territory to the extent that Applicable Law requires such Trademark to be so used.
6.9     [*].
6.10    Patient Assistance Program; Product Donations.
6.10.1    Patient Assistance. For each country in the Territory, the applicable Selling Party shall have the right, but not the obligation, in accordance with its standard practice to respond to requests from individual patients who have or may obtain prescriptions for a Territory Combination Product in such country but may be unable to afford it, and from health care providers on behalf of such patients, including establishing appropriate procedures and response times that shall apply in responding to such requests. The non-Selling Party for any country in the Territory may not conduct any of the activities described in this Section 6.10.1, without the prior written consent of the Selling Party for such country.
6.10.2    Donations. For each country in the Territory, the applicable Selling Party shall have the sole right, but not the obligation, to donate any Territory Combination Product to any Third Party for use in such country; provided, however, that the non-Selling Party’s consent, not to be unreasonably withheld, delayed or conditioned, shall be required for any such donation in any country in Region A. Notwithstanding the foregoing, this Section 6.10.2 shall not apply to any Territory Combination Product to be used in any Clinical Trial (which use is addressed in Section 8.3).

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


6.10.3    Price of Territory Combination Product for Donation or Patient Assistance. In the event that either Party desires to use a Territory Combination Product in connection with any activities permitted pursuant to Section 6.10.1 or Section 6.10.2, such Party may provide written notice to the other Party of its desire to use such Territory Combination Product in connection with such activities, which notice shall specify the quantity of such Territory Combination Product desired. If Gilead is the requesting Selling Party, then notwithstanding anything to the contrary in this Agreement or the Ancillary Agreements, the compensation due to Janssen (or its Affiliate) from Gilead (or its Affiliate) under the RPV Supply Agreement shall be adjusted so that the quantity of the Supplied RPV corresponding to the applicable quantity of the applicable Territory Combination Product is supplied at the then-current Standard Cost of Manufacturing for RPV. If Janssen is the requesting Selling Party, Gilead shall use reasonable efforts to supply the applicable quantity of the applicable Territory Combination Product for such purpose to Janssen as promptly as practical, taking into account Gilead’s Manufacturing capacity and schedule and the availability of TDF or TAF, FTC and the Supplied RPV, at a price that compensates Gilead for the TDF or TAF and FTC contained therein at the then-current Standard Cost of Manufacturing for TDF, TAF and FTC, respectively; provided, however, that the compensation due to Janssen (or its Affiliate) from Gilead (or its Affiliate) under the RPV Supply Agreement shall be adjusted so that the quantity of the Supplied RPV corresponding to such quantity of Territory Complera is provided at the then-current Standard Cost of Manufacturing for such Supplied RPV.
6.11    Commercialization Costs and Expenses. Except as otherwise expressly provided hereunder, each Party or its applicable Affiliate or Third Party Distributor shall bear all of its costs and expenses relating to its Commercialization Activities.
6.12    [Reserved].    
6.13    [Reserved].    
6.14    [Reserved].     
6.15    Pricing for Commercial Sale. With respect to each country in the Territory, the Selling Party for such country and its Affiliates, Sublicensees and Third Party Distributors shall be solely responsible for pricing all Territory Combination Products in such country and obtaining and maintaining price approvals therefor, subject to the terms and conditions of this Agreement. Gilead and Janssen shall each retain sole discretion with respect to price-setting and discounts for its respective Single Agent Products and Double Agent Products. Notwithstanding the foregoing, each Party covenants that it shall, and shall cause its Affiliates to, (a) act in good faith in setting the price and discounts for such Party’s Single Agent Product(s) and (in the case of Gilead) Double Agent Products in the Field in the Territory and (b) not directly or indirectly manipulate pricing or discounting arrangements of such Party’s Single Agent Product(s) or (in the case of Gilead) Double Agent Products in the Field in the Territory solely or primarily for the purpose of increasing such Party’s portion of the revenue from the Territory Combination Products.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


6.16    Janssen Distributor Agreement. Each Party shall (and, notwithstanding anything to the contrary in this Agreement, each Party shall have the right to) exercise its rights and perform its obligations under the Janssen Distributor Agreement in accordance with the terms thereof.
7
[RESERVED]
8
MANUFACTURING AND SUPPLY
8.1    RPV Supply.
8.1.11    The Parties shall work in good faith to negotiate and execute (or cause to be executed) within sixty (60) days after the Restatement Effective Date a new supply agreement with respect to supply of RPV for the Territory Combination Products. The “RPV Supply Agreement” shall mean (a) with respect to Supplied RPV for Territory Complera and, if and only to the extent mutually agreed by the Parties in writing, the Territory R/F/TAF Product, unless and until the Parties execute such new supply agreement and such new agreement becomes effective, that certain TMC278 (Rilpivirine (RPV)) Commercial Supply Agreement, dated as of June 1, 2010 and amended as of June 18, 2014, and (b) thereafter such new agreement as amended from time to time. [*]. The Parties acknowledge and agree that, subject to Section 8.3, the Parties’ rights and obligations with respect to the supplies of the RPV (in API or other form) for use in the Territory Combination Products for commercial sale in the Territory and Clinical Trial use consistent with this Agreement shall be as set forth in the RPV Supply Agreement or any other applicable Ancillary Agreements.
8.1.12    Without limitation of either Party’s (or its Affiliates’) rights and obligations under the RPV Supply Agreement, Janssen shall supply quantities of RPV, in such form as supplied under the RPV Supply Agreement or any Ancillary Agreement, to Gilead as promptly as practicable following a reasonable request from Gilead for such RPV for use in any Development Activities with respect to Territory Combination Products that Gilead is permitted to perform under Article 3 and as required to supply Janssen with Territory Combination Product for Development purposes pursuant to Section 8.2. In lieu of such supply, Gilead may use existing quantities of RPV previously supplied under the RPV Supply Agreement for such activities (“RPV Supply Agreement Quantities”). Notwithstanding anything to the contrary in the RPV Supply Agreement, Gilead shall have the right to use such quantities of RPV in conducting such activities. If specifically supplied for such purposes, such RPV shall be supplied to Gilead (a) for use in Combination Product Clinical Trials that Commence prior to the Safety Database Closing Date with respect to the applicable Territory Combination Product, [*], and (b) for use in Combination Product Clinical Trials that Commence after the Safety Database Closing Date with respect to the applicable Territory Combination Product, at [*]. If, in the alternative, Gilead uses RPV Supply Agreement Quantities, then the applicable adjustment set forth in Section 8.1.3 shall apply. For clarity, the RPV Supply Agreement shall apply to the supply of RPV under this Section 8.1.2, except that in the case of a conflict with respect to the pricing of such RPV for such purposes, this Agreement shall control.
8.1.13    Adjustments.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


8.1.13.1    Gilead shall promptly notify Janssen in the event that any quantity of RPV (in API or other form) supplied [*] under the MTA or Section 8.1.2 that is incorporated into Territory Combination Product is designated for use in Combination Product Clinical Trials that Commence after the Safety Database Closing Date. Promptly following receipt of any such notice, Janssen shall invoice Gilead [*] for the quantity of RPV (in API or other form) identified in Gilead’s notice.
8.1.13.2    Gilead shall promptly notify Janssen in the event that any quantity of RPV (in API or other form) supplied at the Pre-Conversion Supply Price that is incorporated into Territory Combination Product is designated for use in Combination Product Clinical Trials that Commence prior to the Safety Database Closing Date or pursuant to Section 3.2.3. Promptly following receipt of any such notice, Janssen shall [*] for the quantity of RPV (in API or other form) identified in Gilead’s notice.
8.1.13.3    Gilead shall promptly notify Janssen in the event that any quantity of RPV (in API or other form) supplied at the Pre-Conversion Supply Price is incorporated into Territory Combination Product is designated for use in Combination Product Clinical Trials that Commence after the Safety Database Closing Date. Promptly following receipt of any such notice, Janssen shall invoice Gilead for an amount [*] for the quantity of RPV (in API or other form) identified in Gilead’s notice.
8.1.13.4    Gilead shall promptly notify Janssen in the event that any quantity of RPV (in API or other form) supplied [*] under the MTA or Section 8.1.2 that is incorporated into Territory Combination Product is designated for commercial sale in the Territory. Promptly following receipt of any such notice, Janssen shall invoice Gilead at the Pre-Conversion Supply Price in accordance with the terms of the RPV Supply Agreement for the quantity of RPV (in API or other form) identified in Gilead’s notice and such RPV (in API or other form) shall be treated for all purposes (including the invoicing and payment of the Post-Conversion Supply Price) hereunder and under any Ancillary Agreement as though it were supplied by Janssen under the RPV Supply Agreement for commercial sale.
8.1.13.5    Gilead shall promptly notify Janssen in the event that any quantity of RPV (in API or other form) supplied at [*] under Section 8.1.2 is incorporated into Territory Combination Product intended for commercial sale in the Territory. Promptly following receipt of any such notice, Janssen shall [*] for such quantity of RPV, and such RPV (in API or other form) shall be treated for all purposes (including the invoicing and payment of the Post-Conversion Supply Price) hereunder and under any Ancillary Agreement as though it were supplied by Janssen under the RPV Supply Agreement for commercial sale.
8.1.13.6    Invoices issued under this Section 8.1.3 shall be due forty-five (45) days follows receipt by Gilead.
8.2    Territory Combination Product Supply.
8.2.1    Except as otherwise expressly set forth herein, Gilead shall Manufacture (including package and label), or have Manufactured, Territory Combination Products, including

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


for clinical use and commercial sale. Except as otherwise set forth in Section 19.6.3, Gilead shall Manufacture (or have Manufactured) such Territory Combination Products (a) solely using Supplied RPV and (b) in accordance with the specifications for the Territory Combination Products, GMP, Applicable Law and the terms and conditions of this Agreement and the RPV Supply Agreement. Gilead covenants to Janssen that it shall not, and shall cause its Affiliates, Sublicensees and Third Party Distributors not to, make any use of the Supplied RPV other than (i) to Manufacture (or have Manufactured) Territory Combination Products as set forth herein and (ii) to conduct Development Activities with respect to a Territory Combination Product permitted under this Agreement (but not to Manufacture (or have Manufactured) any products other than Territory Combination Products).
8.2.2    Supply of Territory Combination Products to Janssen.
8.2.2.4    Gilead’s supply of each Territory Combination Product (including Branded Region B/C Complera and Branded Region B/C R/F/TAF Product) to Janssen for Distribution in the Janssen Countries and Janssen’s Distribution of Territory Combination Products shall be governed by the Janssen Distributor Agreement; provided, however, that Gilead shall have the right to terminate its supply obligations to Janssen (but, for clarity, not Janssen’s Distribution rights or payment obligations) under the Janssen Distributor Agreement (a) with respect to Territory Complera, upon [*] written notice to Janssen, which notice may not be provided until after the First Commercial Sale of the Territory R/F/TAF Product has occurred in each of the Janssen Diligence Countries, and (b) with respect to Territory R/F/TAF Product, upon [*] written notice to Janssen, if (i) Janssen provides Gilead written notice of termination of its supply obligations to Gilead under this Agreement and the RPV Supply Agreement with respect to Territory R/F/TAF Product pursuant to Section 19.5.1 (provided, however, that such termination by Gilead shall not be effective earlier than the effectiveness of such termination by Janssen), (ii) this Agreement expires or terminates with respect to Territory R/F/TAF Product in [*], or (iii) this Agreement expires or terminates with respect to Territory R/F/TAF Product in all of the Janssen Countries.
8.2.2.5    In the case of any termination of Gilead’s supply obligations with respect to a Territory Combination Product under Section 8.2.2.1, at the request of Janssen:
c.    the Parties shall enter into a supply agreement pursuant to which Gilead would supply such quantities of TAF, TDF or FTC, as applicable, to Janssen at [*] or such other amount as the Parties may agree in writing pursuant to Section 8.2.2.4;
d.    the Parties shall negotiate an amendment to this Agreement and the Janssen Distributor Agreement pursuant to which Gilead shall no longer have any obligation to supply such Territory Combination Product for the remainder of the Term, but according to which Janssen may continue to Distribute such Territory Combination Product in the Janssen Countries for the remainder of the Term and following expiration of this Agreement, to the extent otherwise permitted hereunder (other than, for clarity, in any countries with respect to which the Janssen Distributor Agreement has terminated with respect to such Territory

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Combination Product) using quantities of such Territory Combination Product supplied from Third Parties or manufactured by Janssen or an Affiliate of Janssen, which amendment(s) shall (i) grant Janssen such licenses or sublicenses as may be required in order for Janssen to obtain such Territory Combination Product from Third Parties or for Janssen or an Affiliate of Janssen to manufacture such Territory Combination Product from (x) TAF or TDF (as applicable), (y) FTC and (z) RPV (including any such licenses or sublicenses as may be required in the event of any transfer of any Information and Inventions under Section 8.2.2.2c), (ii) include such other commercially reasonable terms and conditions as may be required to reflect the fact that Gilead is no longer the supplier of such Territory Combination Product to Janssen and may be the supplier of Gilead Compounds to Janssen, (iii) subject Janssen to any requirements of any applicable in-license agreements of Gilead or its Affiliates and (iv) permit Janssen to continue to use any Third Party Distributor or Affiliate of Janssen (but excluding any Generic Licensee) as specified in this Agreement; and
e.    without limitation of any of the foregoing, at Janssen’s sole cost and expense, Gilead shall (i) provide reasonable assistance to Janssen or its Affiliate in sourcing such Territory Combination Product from an alternate Third Party supplier and/or (ii) transfer to Janssen (or an Affiliate thereof) or Janssen’s selected Third Party supplier all Information and Inventions Controlled by Gilead that are necessary or useful to enable the manufacture of such Territory Combination Product from its APIs by providing copies or samples of relevant documentation, materials and other embodiments of such Information and Inventions, and by making available Gilead’s qualified technical personnel on a reasonable basis to consult with, Janssen (or an Affiliate thereof) or such Third Party supplier, as applicable, with respect to such Information and Inventions and the manufacturing process for such Territory Combination Product. Janssen shall use Commercially Reasonable Efforts to complete any technology transfer required under this Section 8.2.2.2 with respect to Territory R/F/TAF Product within the notice period set forth in Section 8.2.2.1(b).
8.2.2.6    Following any termination of Gilead’s supply obligations with respect to a Territory Combination Product under Section 8.2.2.1, Gilead’s indemnity obligations hereunder with respect to any quantities of such Territory Combination Product supplied by a Third Party to Janssen or manufactured by Janssen or its Affiliate shall apply only to the extent that any Losses are not attributable to the fault of Janssen or its Affiliate or the Third Party that supplies such Territory Combination Product.
8.2.2.7    In the case of any termination of Gilead’s supply obligations with respect to a Territory Combination Product under Section 8.2.2.1, (a) the Parties shall coordinate in good faith to wind down matters relating to the supply of such Territory Combination Product under the Janssen Distributor Agreement and (b) Janssen shall pay to Gilead with respect to any Triggering Sales of such Territory Combination Product manufactured by Janssen or its Affiliate or Third Party supplier an amount of compensation analogous to the compensation that Janssen would have paid to Gilead if such Territory Combination Product had been supplied by Gilead hereunder, adjusted for the fact that Janssen is paying for all of the costs of Manufacturing Territory Combination Product from the APIs contained therein and that there was no corresponding Pre-Conversion Supply Invoice for the RPV contained therein.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


8.3    Supplies of Territory Combination Product for use in Clinical Trials. Gilead shall Manufacture (including package and label), or have Manufactured, Territory Combination Product, including for clinical use. As requested by Janssen for use by Janssen (or its Affiliates or (sub)licensees) solely in Combination Product Clinical Trials performed in accordance with the terms and conditions of this Agreement, for Clinical Trials Commencing after the Safety Database Closing Date for the applicable Territory Combination Product, Janssen shall have the right to order Territory Combination Product for such purpose from Gilead [*] and Gilead shall fill such orders, provided that, Gilead shall have no obligation to fill such orders unless (i) Janssen complies with the provisions of Section 3.2.2.2, (ii) the quantity of Territory Combination Product requested by Janssen is reasonable in light of the number of study subjects described in the protocol summaries for such Combination Product Clinical Trials and (iii) Gilead has sufficient manufacturing capacity to manufacture and supply such quantity. In the event Gilead does not have sufficient manufacturing capacity or available supply of the applicable Territory Combination Product to fill Janssen’s orders, Gilead shall allocate its manufacturing capacity or available supply, as between Gilead’s obligations under this Section 8.3 to Janssen and the other then-current needs of Gilead and its Affiliates (including contractual obligations to Third Parties) for Territory Combination Product to be used in clinical trials, on a pro-rata basis based on the quantity reasonably requested by Janssen and the good faith forecasted requirements of Gilead and/or its Affiliates (taking into consideration any contractual obligations to Third Parties) for use in clinical trials. Notwithstanding the foregoing, in the event of any such shortage, Gilead shall have no obligation to reallocate or otherwise divert any manufacturing capacity or supply of the Territory Combination Product from (A) the Combination Product Clinical Trials that are necessary or reasonably expected to be necessary to obtain or maintain Marketing Approval(s) of the Territory Combination Products (including any bioequivalence studies or Post-Approval Commitment Studies), (B) any clinical trial conducted by Gilead or its Affiliates or any Third Party with respect to the Territory Combination Product for which Gilead has already committed to supply quantities of the Territory Combination Products, provided that such clinical trial has already commenced at the time of Janssen’s request, or (C) the commercial supply of the Territory Combination Product. Janssen covenants to Gilead that it shall not, and shall cause its Affiliates and Third Party distributors not to, make any use of the Territory Combination Product provided by Gilead to Janssen under this Section 8.3 other than use by Janssen solely in the Combination Product Clinical Trials permitted under this Agreement. At the request of either Party, the Parties will discuss in good faith a supplement to the Master Clinical Trial Material Agreement to cover the supply of Territory Combination Product for Combination Product Clinical Trials by Gilead to Janssen hereunder.
8.4    Additional Requirements. In the event that Applicable Law or a Regulatory Authority in the Territory imposes, with respect to the Manufacture of a Territory Combination Product (or TDF, TAF, FTC or the Supplied RPV contained therein) for sale or distribution in one or more countries in the Territory, a requirement that is not imposed by any of the EMA, the European Commission and the FDA with respect to the Manufacture of such Territory Combination Product (or such component) for sale or distribution in the European Union or United States, as applicable (an “Additional Requirement”), the Selling Party for such country that imposes the Additional Requirement shall notify the non-Selling Party of such Additional Requirement. The Parties shall consider the relative costs and benefits of complying with such

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Additional Requirement and discuss whether, how and when to implement such Additional Requirement in order to obtain or maintain Regulatory Approvals for such Territory Combination Product in the Field in the applicable country(ies). In the event that the Parties determine to implement such Additional Requirement, the Parties shall establish an implementation plan for such Additional Requirement. Either Party’s obligation hereunder or under any Ancillary Agreement to comply with any Additional Requirement, and the allocation between the Parties of costs to be incurred pursuant to such obligations, shall be solely as agreed under such plan. In the event the Selling Party for a country fails to notify the non-Selling Party of any Additional Requirement imposed by such country pursuant to this Section 8.4, the non-Selling Party shall not be liable hereunder or under any Ancillary Agreement for any failure to comply with such Additional Requirement and such a failure shall not constitute a default hereunder or under any Ancillary Agreement.
9
LICENSE GRANTS AND RELATED COVENANTS
9.1    Licenses and Related Rights. Subject to the terms and conditions of this Agreement and any Ancillary Agreements:
9.1.3    Combination Product Development Activities and Commercialization Activities. Janssen hereby grants to Gilead:
a.    an exclusive (even as to Janssen and its Affiliates, except for the performance of Janssen’s obligations as provided hereunder), royalty-free (except as provided in this Section 9.1) license or sublicense (but without limitation of Gilead’s payment obligations under this Agreement), with the right to grant sublicenses to the extent permitted pursuant to Section 9.3, under the Janssen Technology and any and all rights, title and interest that Janssen and its Affiliates may have in and to any Joint Technology, solely to conduct Development Activities with respect to the Territory Combination Product in the Field in the Territory, other than those Development Activities with respect to the Territory Combination Product in the Field in the Territory that Janssen is permitted to conduct under Article 3, and to conduct Combination Product Regulatory Activities;
b.    a non-exclusive, royalty-free (except as provided in this Section 9.1) license or sublicense (but without limitation of Gilead’s payment obligations under this Agreement), with the right to grant sublicenses to the extent permitted pursuant to Section 9.3, under the Janssen Technology, solely to conduct any Development Activities with respect to the Territory Combination Product in the Field in the Territory that Janssen is also permitted to conduct under Article 3; and
c.    an exclusive (even as to Janssen and its Affiliates, except for the performance of Janssen’s obligations as provided hereunder), royalty-free (except as provided in this Section 9.1) license or sublicense (but without limitation of Gilead’s payment obligations under this Agreement), with the right to grant sublicenses to the extent permitted pursuant to Section 9.3, under the Janssen Technology and any and all rights, title and interest that Janssen and its Affiliates may have in and to any Joint Technology, solely to conduct Commercialization Activities with respect to a Territory Combination Product in the Field in the Territory;

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


but in each of (a), (b) and (c), not to Exploit RPV individually or in combination with any other API other than in a Territory Combination Product or as otherwise expressly permitted hereunder, pursuant to and in accordance with the terms of this Agreement (including Section 17.3.6) and any Ancillary Agreements, provided that such license shall not extend to any Exploitation that constitutes a violation of this Agreement, including Sections 17.3.1 or 17.3.6. For clarity, Gilead is not granted any rights to Manufacture RPV under this Agreement except to the limited extent provided in Section 19.6.3. The licenses and sublicenses granted under this Section 9.1.1 shall be paid-up, perpetual and non-exclusive upon the expiration of this Agreement with respect to the applicable country as provided in Section 19.1, but shall remain subject to any royalties or any other payments due under applicable In-License Agreements for sales of a Territory Combination Product after such expiration, which royalties and other payments shall be the responsibility of Gilead (provided that such payment obligations are disclosed to Gilead by Janssen).
9.1.4    Combination Product Manufacturing. Janssen hereby grants to Gilead an exclusive (even as to Janssen and its Affiliates, except for the performance of Janssen’s obligations as provided hereunder), royalty-free (except as provided in this Section 9.1) license or sublicense (but without limitation of Gilead’s payment obligations under this Agreement), with the right to grant sublicenses to the extent permitted pursuant to Section 9.3, under the Janssen Technology and any and all rights, title and interest that Janssen and its Affiliates may have in and to any Joint Technology, solely to Manufacture and have Manufactured: each Territory Combination Product in the Territory for use in (i) Development Activities with respect to a Combination Product in the Field in the Territory and (ii) Commercialization Activities with respect to a Territory Combination Product in the Field in the Territory but not to Manufacture or have Manufactured RPV individually or in combination with any other API other than in a Territory Combination Product, pursuant to and in accordance with the terms of this Agreement and any Ancillary Agreements, provided that such license shall not extend to any Exploitation that constitutes a violation of this Agreement, including Section 17.3.1 or 17.3.6. Such license or sublicense granted under this Section 9.1.2 shall be paid-up, perpetual and non-exclusive upon the expiration of this Agreement as provided in Section 19.1, but shall remain subject to any royalties or any other payments due under applicable In-License Agreements for sales of a Territory Combination Product after such expiration, which royalties and other payments shall be the responsibility of Gilead (provided that such payment obligations are disclosed to Gilead by Janssen).
9.1.5    To Janssen. Upon request, to the extent required by Applicable Law in connection with Janssen’s (or its Affiliates’ or Third Party Distributors’) Commercialization Activities with respect to a Territory Combination Product in the Janssen Countries, Gilead shall provide written documentation, in a form acceptable to the applicable Regulatory Authority, of Janssen’s (or its Affiliate’s or applicable Third Party Distributor’s) right to engage in Commercialization Activities with respect to such Territory Combination Product (but not to Exploit the TDF or FTC APIs individually or in combination other than in a Territory Combination Product) in the Field in the Janssen Countries pursuant to and in accordance with the terms of this Agreement and any Ancillary Agreements.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


9.2    Rights of Reference and Related Rights.
9.2.1    To Gilead. Subject to the terms and conditions of this Agreement and any Ancillary Agreements, with respect to any Gilead Country and any Janssen Country with respect to which Gilead (or its Affiliate, Sublicensee or Third Party Distributor) is the MA Holder for a Territory Combination Product, Janssen (including on behalf of its Affiliates) hereby grants, and shall cause its (sub)licensees and Third Party distributors for the RPV Single Agent Product to grant, to Gilead (and its Affiliates, Sublicensees, or Third Party Distributors, as applicable), in Janssen’s (or its Affiliate’s or (sub)licensee’s or Third Party Distributor’s, as applicable) capacity as the MA Holder of the RPV Single Agent Product, in the Field in such country, a non-exclusive Right of Reference, with the right to grant further Rights of Reference to the extent permitted pursuant to Section 9.3, with regard to the Janssen Regulatory Documentation for the RPV Single Agent Product in the Field in such country, as necessary or reasonably expected to be necessary to, and for the sole purpose of allowing Gilead (or its Affiliates, Third Party Distributors or Sublicensees, as applicable) to, obtain and maintain Regulatory Approvals for such Territory Combination Product in the Field in such country or to comply with Applicable Law. Within ten (10) Business Days following Gilead’s request, Janssen shall deliver to Gilead an executed Right of Reference letter with respect to any Right of Reference granted herein. For clarity, such Rights of Reference granted to Gilead under this Section 9.2.1 shall be to the entire item of Janssen Regulatory Documentation (not portions thereof) and shall include those listed as items 1 through 3 (in the case of Territory Complera) or 4 through 6 (in the case of the Territory R/F/TAF Product) in Annex II. Janssen agrees to provide any required signed statement to that effect in accordance with the applicable Regulatory Authority’s position on authorization to cross reference. Such Right of Reference granted under this Section 9.2.1 shall be paid-up, perpetual and non-exclusive upon the expiration of this Agreement with respect to the applicable country as provided in Section 19.1.
9.2.2    To Janssen. Subject to the terms and conditions of this Agreement and any Ancillary Agreements, with respect to any Janssen Country for which Janssen (or its Affiliate or Third Party Distributor) is the MA Holder with respect to a Territory Combination Product, Gilead (including on behalf of its Affiliates) hereby grants, and shall cause its (sub)licensees and Third Party distributors for its Single Agent Products and Double Agent Products, as applicable, to grant, to Janssen (and its Affiliates or Third Party Distributors, as applicable), in Gilead’s (or its Affiliate’s or (sub)licensee’s or Third Party distributor’s, as applicable) capacity as the MA Holder of any Single Agent Product or Double Agent Product of Gilead, in each case in the Field in such country, a non-exclusive Right of Reference, with the right to grant further Rights of Reference to the extent permitted pursuant to Section 9.3, with regard to the Gilead Regulatory Documentation for, (a) with respect to Territory Complera, Truvada, FTC Single Agent Product or TDF Single Agent Product and (b) with respect to Territory R/F/TAF Product, the F/TAF Product and, only if required by a Regulatory Authority in addition to or in lieu of such Right of Reference with regard to F/TAF Product, FTC Single Agent, in each case in the Field in such country, as necessary or reasonably expected to be necessary to, and for the sole purpose of allowing Janssen (or its Affiliates or Third Party Distributors, as applicable) to, obtain and maintain Regulatory Approvals for such Territory Combination Product in the Field in such country or to comply with Applicable Law. Within ten (10) Business Days following Janssen’s

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


request, Gilead shall deliver to Janssen an executed Right of Reference letter with respect to any Right of Reference granted herein. For clarity, such Rights of Reference granted to Janssen under this Section 9.2.2 shall be to the entire item of Gilead Regulatory Documentation (not portions thereof) and shall include those listed as items 7 through 9 (in the case of Territory Complera) or 10 through 12 (in the case of the Territory R/F/TAF Product) in Annex II. Gilead agrees to provide any required signed statement to that effect in accordance with the applicable Regulatory Authority’s position on authorization to cross reference. Such Right of Reference granted under this Section 9.2.2 shall be paid-up, perpetual and non-exclusive upon the expiration of this Agreement with respect to the applicable country as provided in Section 19.1.
9.2.3    Data Exclusivity.
9.2.3.7    Gilead Compound Data Exclusivity. In the event that (i) Janssen or an Affiliate of Janssen receives Marketing Approval for a Territory Combination Product in a jurisdiction in which any applicable Gilead Compound Products have not received Marketing Approval, and (ii) as a result of such Marketing Approval of such Territory Combination Product, Janssen (or its Affiliate) is the owner of Gilead Compound Data Exclusivity for any of TAF, TDF or FTC, then Janssen (or its Affiliate, as the case may be) shall, at Gilead’s request, provide a letter to the applicable Regulatory Authority permitting Gilead and/or Gilead’s designee (including any Generic Licensee of Gilead with respect to a Gilead Compound Product (provided that the scope of such letter is consistent with the rights permitted to be granted under the granting Party’s Generic Exception)) to file for Marketing Approval of the applicable Gilead Compound Product in that jurisdiction notwithstanding the Gilead Compound Data Exclusivity. For clarity, the foregoing shall not be construed as altering Janssen’s rights to control commercialization of each Territory Combination Product in the Janssen Countries or to control Marketing Approval (including Rights of Reference thereto) of each Territory Combination Product as provided for under this Agreement. Notwithstanding the foregoing, Janssen shall not be required to take any action that would result in a loss of the data exclusivity and marketing exclusivity associated with the grant of Marketing Approval for a Territory Combination Product in all other respects. “Gilead Compound Data Exclusivity” shall mean, with respect to any of TAF, TDF or FTC, a right or protection, obtained in a jurisdiction, as a result of the fact that a Territory Combination Product contains TAF, TDF or FTC, as applicable, as an active ingredient that has not previously been approved in such jurisdiction, which right or protection provides marketing exclusivity that prevents the Regulatory Authority in such jurisdiction from accepting a Drug Approval Application (whether new or abbreviated), submitted by a Person other than the MA Holder for such Territory Combination Product, of the applicable Gilead Compound Product. The rights afforded to Gilead under this Section 9.2.3.1 shall survive termination or the expiration of this Agreement.
9.2.3.8    RPV Data Exclusivity. In the event that (i) Gilead or an Affiliate or Sublicensee of Gilead receives Marketing Approval for a Territory Combination Product in a jurisdiction in which any applicable RPV Products have not received Marketing Approval, and (ii) as a result of such Marketing Approval of such Territory Combination Product, Gilead (or its Affiliate or Sublicensee) is the owner of RPV Data Exclusivity, then Gilead (or its Affiliate or Sublicensee, as the case may be) shall, at Janssen’s request, provide a

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


letter to the applicable Regulatory Authority permitting Janssen and/or Janssen’s designee (including any Generic Licensee of Janssen with respect to an RPV Product (provided that the scope of such letter is consistent with the rights permitted to be granted under the granting Party’s Generic Exception)) to file for Marketing Approval of the applicable RPV Product in that jurisdiction notwithstanding the RPV Data Exclusivity. For clarity, the foregoing shall not be construed as altering Gilead’s rights to control commercialization of each Territory Combination Product in the Gilead Countries or to control Marketing Approval (including Rights of Reference thereto) of each Territory Combination Product as provided for under this Agreement. Notwithstanding the foregoing, Gilead shall not be required to take any action that would result in a loss of the data exclusivity and marketing exclusivity associated with the grant of Marketing Approval for a Territory Combination Product in all other respects. “RPV Data Exclusivity” shall mean a right or protection, obtained in a jurisdiction, as a result of the fact that a Territory Combination Product contains RPV as an active ingredient that has not previously been approved in such jurisdiction, which right or protection provides marketing exclusivity that prevents the Regulatory Authority in such jurisdiction from accepting a Drug Approval Application (whether new or abbreviated), submitted by a Person other than the MA Holder for such Territory Combination Product, of the applicable RPV Product. The rights afforded to Janssen under this Section 9.2.3.2 shall survive termination or the expiration of this Agreement.
9.3    Sublicenses.
9.3.3    For Manufacturing. Subject to Gilead’s payment of amounts due to Janssen under this Agreement, Gilead (and its Affiliates) shall have the right to grant Third Party manufacturers (but excluding any Generic Licensee, [*]) a non-exclusive, royalty-free sublicense anywhere in the world, without the right to further sublicense, under the licenses granted to Gilead in Section 9.1.2, for the sole purpose of Manufacturing any Territory Combination Product (but not the RPV therein) for supply to Gilead or its Affiliates or Sublicensees, or Janssen or its Affiliates pursuant to the Janssen Distributor Agreement, for Exploitation of such Territory Combination Product in the Field (including sale by Gilead, its Affiliates or Sublicensees, or by Janssen or its Affiliates, to a Third Party Distributor) in accordance with this Agreement and the Ancillary Agreements, provided that Gilead shall provide to its Third Party manufacturers only such Janssen Confidential Information and Janssen Regulatory Documentation as is required in order for such Third Party manufacturer to Manufacture the applicable Territory Combination Product in accordance with GMP.
9.3.4    For Development or Commercialization Activities. Subject to Gilead’s payment of amounts due to Janssen under this Agreement, Gilead (and its Affiliates) shall have the right to grant any Third Party(ies) (other than a Generic Licensee of Gilead) a sublicense (which may, at the election of Gilead, be non-exclusive or exclusive, to the extent consistent with Gilead’s rights hereunder) in any country in the Territory, without the right to further sublicense, under the licenses granted to Gilead in Section 9.1.1 in the Field with respect to any Territory Combination Product in such country, provided that either (i) such Third Party has the same rights with respect to any of Gilead’s Single Agent Products or Double Agent Products or another pharmaceutical product of Gilead or its Affiliate, or (ii) Janssen provides its written consent to such sublicense, which consent shall not be unreasonably withheld, conditioned or delayed.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Gilead shall not have the right to grant any sublicense or further Right of Reference under this Agreement in order to enable any Third Party to sell a Combination Product (A) on a Generic Basis, or (B) in Region C under any Product Trademark other than a Product Trademark Controlled by Gilead or an Affiliate of Gilead.
9.3.5    Limitations on Third Party Distributors. Subject to the Janssen Distributor Agreement, either Party may engage a Third Party Distributor to sell in any country in which such Party is the Selling Party a Territory Combination Product under this Agreement, but in Region C this right shall be subject to each of the following: (i) such Third Party Distributor shall purchase such Territory Combination Product in the form of Finished Product from the applicable Party or its Affiliates, (ii) unless a Party obtains the other Party’s prior written approval, such Party or its Affiliate (or a Third Party agent that is not engaged in the business of distribution or manufacturing of pharmaceutical products) shall hold the Marketing Approval for the applicable Territory Combination Product in the applicable country under which such Third Party Distributor sells such Territory Combination Product, and (iii) for clarity, (x) Gilead shall not grant to a Third Party Distributor any access to any Confidential Information of Janssen or Janssen Regulatory Documentation or afford any Right of Reference provided by Janssen to such Third Party Distributor, in each case under this clause (iii)(x), except with Janssen’s prior written approval, and (y) Janssen shall not grant to a Third Party Distributor any access to any Confidential Information of Gilead or Gilead Regulatory Documentation or afford any Right of Reference provided by Gilead to such Third Party Distributor, in each case under this clause (iii)(y), except with Gilead’s prior written approval. The term “Finished Product” shall mean drug product in finished dosage forms.
9.3.6    To Affiliates. Either Party may grant sublicenses under any license granted to it pursuant to Section 9.1 to any of its Affiliates. Either Party may grant a further Right of Reference under any Right of Reference granted to it pursuant to Section 9.2 to any of its Affiliates.
9.4    Trademark Licenses.
9.4.6    Subject to the terms and conditions of this Agreement and any Ancillary Agreement, Gilead hereby grants to Janssen a non-exclusive, royalty-free, fully paid-up license, with the right to sublicense to its Affiliates, Third Party Distributors and permitted subcontractors, to use in the Janssen Countries and any country in which Janssen is Detailing a Territory Combination Product hereunder (i) the Gilead Licensed Trademarks for the sole purpose of exercising its rights under the Janssen Distributor Agreement and Detailing the applicable Territory Combination Product (but not to Exploit the APIs thereof individually or in combination other than in such Territory Combination Product) in the Field and (ii) Gilead’s name and company logo/identifiers, in each case ((i) and (ii)) solely for use on the approved Product Label and Package and the Local Promotional Materials for the applicable Territory Combination Product. In its use of any publicly disseminated packaging, labeling, advertising and promotional materials referencing the Gilead Licensed Trademarks, Janssen shall use the Gilead Licensed Trademarks as set forth in standards provided in writing by Gilead from time to time. Any deviation from those standards must be approved in writing by Gilead.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


9.4.7    Subject to the terms and conditions of this Agreement and any Ancillary Agreement, Janssen hereby grants to Gilead a non-exclusive, royalty-free, fully paid-up license, with the right to sublicense to its Affiliates, Third Party Distributors and permitted subcontractors, to use in the Gilead Countries (i) the Janssen Licensed Trademarks for the sole purpose of conducting Commercialization Activities with respect to any Territory Combination Product (but not to Exploit the APIs thereof individually or in combination other than in the Territory Combination Products) in the Field and (ii) Janssen’s name and company logo/identifiers, solely for use on the approved Product Label and Package and the Local Promotional Materials for any Territory Combination Product. In its use of any publicly disseminated packaging, labeling, advertising and promotional materials referencing the Janssen Licensed Trademarks, Gilead shall use the Janssen Licensed Trademarks as set forth in standards provided in writing by Janssen from time to time. Any deviation from those standards must be approved in writing by Janssen.
9.4.8    Subject to the terms and conditions of this Agreement and any Ancillary Agreement, Gilead hereby grants to Janssen a non-exclusive, royalty-free, fully paid-up license, with the right to sublicense to its Affiliates, Third Party Distributors and permitted subcontractors, to use in the Janssen Countries and any country in which Janssen is Detailing a Territory Combination Product hereunder the applicable Combination Product Trademarks for the sole purpose of exercising its rights under the Janssen Distributor Agreement and Detailing the applicable Territory Combination Product (but not to Exploit the APIs thereof individually or in combination other than in such Territory Combination Product) in the Field and solely for use on the approved Product Label and Package and the Local Promotional Materials for the applicable Territory Combination Product.
9.4.9    Gilead hereby recognizes Janssen’s right, title, and interest in and to the Janssen Licensed Trademarks. Gilead further recognizes that this Agreement, or use of the Janssen Licensed Trademarks in connection with this Agreement, in no way confers to Gilead any right, title, and interest in and to the Janssen Licensed Trademarks or any other Trademarks or intellectual property rights owned by Janssen, except as may otherwise be expressly provided in this Agreement. Janssen hereby recognizes Gilead’s right, title, and interest in and to the Gilead Licensed Trademarks and the Combination Product Trademarks. Janssen further recognizes that this Agreement, or use of the Gilead Licensed Trademarks or the Combination Product Trademarks in connection with this Agreement, in no way confers to Janssen any right, title, and interest in and to the Gilead Licensed Trademarks, the Combination Product Trademarks or any other trademarks or intellectual property rights owned by Gilead, except as may otherwise be expressly provided in this Agreement. Janssen agrees that the materials on which it uses the Gilead Licensed Trademarks shall be of similar standard as those materials on which Gilead uses the Gilead Licensed Trademarks and shall comply with Applicable Law. Gilead agrees that the materials on which it uses the Janssen Licensed Trademarks shall be of similar standard as those materials on which Janssen uses the Janssen Licensed Trademarks and shall comply with Applicable Law.
9.5    Sublicensed Rights.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


9.5.1    Third Party License Payments. [*].
9.5.2    Existing RPV License(s). Gilead acknowledges that it has received a sublicense under this Article 9 with regard to certain Patents or Information and Inventions that are subject to the terms and conditions of the Existing RPV Licenses as applicable to Janssen’s sublicensees thereunder and Gilead agrees to comply with such terms and conditions as specified by Janssen in the In-License Requirements established pursuant to this Section 9.5.
9.5.3    In-License Requirements. In order to ensure that Janssen is able to meet its obligations under the Existing RPV Licenses as they relate to the activities under this Agreement, and to ensure Gilead is clear with regard to the requirements on Janssen in order to ensure such compliance, the Parties have agreed upon those obligations, beyond those set forth herein, to which Gilead shall be required to adhere in order to ensure such compliance (such written terms, and any additional written terms the Parties agree upon in good faith under Section 9.5.4, referred to herein the “Janssen In-License Requirements”). The Janssen In-License Requirements effective as of the Restatement Effective Date are attached as Annex W. In order to ensure that Gilead is able to meet its obligations under any license agreements entered into by Gilead pursuant to Section 9.5.4, the Parties will agree in good faith upon written terms setting forth those obligations of such license agreements beyond those obligations set forth herein to which Janssen shall be required to adhere, and to ensure Janssen is clear with regard to such obligations (such written terms referred to herein the “Gilead In-License Requirements”). The Parties will set forth the Gilead In-License Requirements in a separate signed document.
9.5.4    Additional In-Licenses. In the event that a first Party determines that there is a Patent or other intellectual property that is licensed to such first Party or its Affiliates by a Third Party under a sublicensable license agreement, which Patent or intellectual property is sublicensed to the other Party hereunder (such as, in the case of Janssen as the first Party, the Existing RPV Licenses) or for which such first Party has obligations to such Third Party under such license agreement that would be, to the first Party’s good faith knowledge, triggered by any activities conducted hereunder by the other Party (such as, in the case of Gilead, the Existing Gilead Licenses), then such first Party shall promptly notify the other Party and the Parties shall promptly thereafter negotiate and agree on and set forth in writing, (a) either (i) in the case of such a license agreement of Janssen, an amendment to the Janssen In-License Requirements, or (ii) in the case of such a license agreement of Gilead, an amendment to the Gilead In-License Requirements; and (b) an amendment to this Agreement to the extent that a sublicense to the other Party is necessary. For clarity, upon entering into such amendment(s) under this Section 9.5.4, the at-issue Third Party license agreement shall be deemed an “In-License Agreement.” Each Party shall only be bound by any In-License Requirement on and after the date on which such In-License Requirement has been disclosed to such Party and only for so long as such Party is a sublicensee under the applicable In-License Agreement or conducting activities in accordance with this Agreement that trigger the other Party’s obligations under the applicable In-License Agreement and only for so long as the In-License Requirement is required by the applicable In-License Agreement. [*]. Upon the request of either Party, the other Party shall disclose to the requesting Party the applicable financial terms of any Existing Gilead License (in the case the requested Party is Gilead), any Existing RPV License (in the case the requested

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Party is Janssen) and any In-License Agreement of such requested Party entered into after the Restatement Effective Date that would require the requesting Party to pay a royalty or other monetary compensation after expiration of the Agreement with respect to such country; provided that such request by the requesting Party may be made no earlier [*].
9.5.5    Modifications or Amendments to any In-License Agreement. Modifications or amendments to any In-License Agreement, including the Existing RPV Licenses and the Existing Gilead Licenses, by a Party after the Restatement Effective Date that would materially increase a Party’s obligations under the In-License Requirements shall not apply to the obligated Party unless and until such first Party obtains the obligated Party’s prior written approval. If a Party modifies or amends any In-License Agreement in a manner that would require modification of the In-License Requirements, the Parties shall negotiate in good faith modifications to the In-License Requirements in order to reflect such modification or amendment, provided that such modification or amendment complies with the preceding sentence, in which case the other Party shall not unreasonably withhold its consent to such modifications or amendments to the In-License Requirements.
9.5.6    Payments. [*].
9.6    Retained Rights. All (sub)license rights not specifically granted in this Article 9 or elsewhere herein or in any Ancillary Agreements are expressly reserved by each licensing Party (or its Affiliates). Any (sub)license granted in this Article 9 which is not sublicensable, may be transferred or assigned by the licensee Party only in connection with a permitted assignment of this Agreement by such Party. Notwithstanding anything contained in this Article 9, none of the licenses granted under this Agreement apply to Generic Combination Product. For clarity, each Party and its Affiliates retains all rights under any intellectual property Controlled by such Party (other than Controlled as a result of the licenses granted in this Article 9) (a) to exercise any of its rights under such Party’s Generic Exception, including granting licenses to Generic Licensees permitted thereunder, or any of its rights to conduct clinical trials in accordance with this Agreement, and (b) to perform its obligations hereunder or under any Ancillary Agreement.
10
PAYMENTS
10.1    Payments.
10.1.4    Payment of Pre-Conversion Supply Price. Janssen shall submit an invoice to Gilead at the Pre-Conversion Supply Price for any Supplied RPV used or intended to be used for commercial purposes at the time of delivery to Gilead of such Supplied RPV or promptly thereafter. Payments with respect to each such invoice shall be payable and due in accordance with the terms of the RPV Supply Agreement and the terms of this Agreement, including Section 10.4 and Section 10.5.1. In the event of any inconsistency between the financial provisions of the RPV Supply Agreement and the financial provisions of this Agreement, such terms of this Agreement shall control. For clarity, for each Territory Combination Product, the Pre-Conversion Supply Price shall be invoiced collectively for Region A, Region B and Region C.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


10.1.5    Monthly Payments. Subject to Annex M-1, for each Territory Combination Product, Gilead shall make a Monthly Payment with respect to all Gilead Countries that are Post-Conversion Supply Price Countries in Region A, Region B and Region C (in a single amount for all such Post-Conversion Supply Price Countries), subject to any adjustments specified hereunder, which payment shall be payable and due in accordance with the terms of this Agreement, including Sections 10.4, 10.5.2 and 10.5.3.
10.2    Post-Conversion and Additional Supply Price Reductions. With respect to Supplied RPV, the Post-Conversion Supply Price or Additional Supply Price, as applicable, for each Territory Combination Product shall be adjusted as set forth in Annex M-2 (provided that, with respect to Section A of Annex M-2, such adjustments shall apply [*].
10.3    Monthly Payment Term. For each Territory Combination Product, the Monthly Payment shall be made for the Gilead Countries in Region A, Region B and Region C, until the expiration of the last to expire Monthly Payment Term in the Gilead Countries in Region A, Region B and Region C (and the calculations in Annex M-1 shall take account of the exclusion of countries for which the Monthly Payment Term has expired following the end of the applicable Monthly Payment Term).
10.4    Mode of Payment. All payments to Janssen hereunder and under the RPV Supply Agreement shall be made by wire transfer of U.S. Dollars in the requisite amount to the account designated by Janssen; provided, however, that any notice by Janssen of a change in such account shall not be effective until thirty (30) days after receipt thereof by Gilead.
10.5    Reports & Payments.
10.5.1    Pre-Conversion Supply Price Payments and Revaluation Pre-Conversion Payments. Pre-Conversion Invoices shall be due and payable by Gilead or its designated Affiliate in accordance with Annex M-5. Revaluation Pre-Conversion Invoices shall be due and payable by Gilead in accordance with Annex M-6.
10.5.2    Monthly Payments. For each Territory Combination Product, Gilead or its designated Affiliate shall make the Monthly Payments collectively for Region A, Region B and Region C, for each calendar month during the Term in accordance with Annex M-5, subject to prior receipt of an invoice from Janssen for such amount.
10.5.3    Monthly Payment Calculation. For each Territory Combination Product, the calculation of a Monthly Payment shall be based on the total number of Units of such Territory Combination Product sold by Gilead and its Affiliates and Sublicensees to Third Parties during such calendar month (adjusted on a pro rata basis in the event that the applicable Monthly Payment Term has expired during such calendar month) in Gilead Countries that are Post-Conversion Supply Price Countries where the Monthly Payment Term has not yet expired, as provided in Annex M-1.
10.5.4    Monthly Reports. Gilead shall provide to Janssen the reports described in Annex N on a product-by-product and country-by-country basis setting forth the Units of each

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Territory Combination Product sold and any adjustments to which either Party is entitled hereunder. Such reports shall be due no later than fifteen (15) Business Days after the end of each calendar month. Gilead shall be responsible for making the calculations set forth in Annex M-1. In addition to the aforementioned, each Party shall also provide such other information requested by the other Party and necessary for the other Party (or any of its Affiliates) to comply with such other Party’s royalty payment and financial reporting obligations under any In-License Agreement, as specified in the In-License Requirements.
10.5.5    Lost Supplied RPV. Gilead shall notify Janssen in writing on an annual basis of any Supplied RPV that becomes Lost Supplied RPV in such Calendar Year, which notice shall specify the quantity of such Lost Supplied RPV. Such notification shall occur in January of each Calendar Year with regards to Lost Supplied RPV from the prior Calendar Year. Notwithstanding anything to the contrary in this Agreement or the Ancillary Agreements, the compensation due to Janssen (or its Affiliate) from Gilead (or its Affiliate) under the RPV Supply Agreement with respect to any quantity of Lost Supplied RPV shall be adjusted so that it equals the Standard Cost of Manufacturing for such Supplied RPV. Gilead shall pay the then-current Standard Cost of Manufacturing with respect to any quantity of Lost Supplied RPV for a given Calendar Year forty-five (45) days following the receipt of an invoice from Janssen for such Lost Supplied RPV. At the same time, Janssen shall issue to Gilead a credit note for the Pre-Conversion Supply Price with respect to the quantity of Lost Supplied RPV (taking into account any Revaluation Pre-Conversion Invoices with respect to such Pre-Conversion Supply Price).
10.5.6    Other Payments. For all other payments due hereunder or under the RPV Supply Agreement, the invoicing Party shall submit an invoice to the paying Party and such invoices shall be due and payable within forty-five (45) days after receipt unless otherwise provided in this Agreement or the RPV Supply Agreement.
10.5.7    Communication of Non-Public Pricing Information. The Parties shall communicate all non-public Net Selling Price information necessary to perform the financial calculations required by this Agreement solely through their respective representatives on the Financial Reporting Committee or as otherwise approved by such committee.
10.5.8    Other Reports. Without limitation of the foregoing, each Party shall also provide such other financial-related reports as are set forth on Annex N and otherwise comply with the requirements of Annex N.
10.6    Financial Records. Each Party shall keep, and shall cause its Affiliates, (sub)licensees, Third Party distributors and Third Party contractors to keep, accurate records sufficient to support the calculation of the payments due under this Agreement and any Ancillary Agreement (collectively, “Financial Records”) in accordance with the Accounting Standards and in sufficient detail to enable the amounts due hereunder and thereunder to be determined and verified by the other Party’s auditor. Such records shall be retained for at least (i) three (3) years after creation thereof or (ii) such longer period as may be required under any In-License Agreement, as specified in the In-License Requirements, or Applicable Law. Financial Records shall be open for examination, in accordance with Section 10.8, during reasonable business hours for so long as they are required to be maintained under this Section 10.6.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


10.7    Currency Conversion. The Party responsible for making any currency conversions hereunder shall, in a manner consistent with Gilead’s then-current standard worldwide currency conversion methodology, convert the applicable amounts incurred or sold, as the case may be, into the applicable currency. Gilead’s standard worldwide currency conversion methodology on the Restatement Effective Date is based on a monthly rate that is within the day’s trading range during NYC trading hours in Bloomberg Professional service application on the third (3rd) to last Business Day of the prior month. Gilead shall inform Janssen of any changes to its standard worldwide currency conversion methodology prior to any such changes becoming effective. For clarity, all currency conversions required under this Section 10.7 shall use the exchange rate for the applicable month then used by Gilead in accordance with the foregoing.
10.8    Audits.
10.8.1    Audits.
10.8.1.8    Mutually Agreed Audits. Subject to Section 10.8.1.3, within three (3) years after the First Commercial Sale of a Territory Combination Product in the Territory and every three (3) years thereafter (provided that after completion of the initial Audit by each Party pursuant to this Section 10.8.1.1, the Parties may mutually agree to extend the period between subsequent Audits pursuant to this Section 10.8.1.1 to a period greater than three (3) years), each Party (the “Audited Party”) shall, and shall cause its Affiliates and Sublicensees (in the case of Gilead) and, to the extent relevant to the revenue share calculations hereunder, Third Party Distributors and other Third Party distributors, if applicable, to permit an independent public accounting firm of national prominence selected by such Party and the other Party (the “Auditing Party”) by mutual agreement to have access during normal business hours to those Financial Records of such Audited Party, its Affiliates, Sublicensees (in the case of Gilead), Third Party Distributors and other Third Party distributors as may be reasonably necessary for the sole purpose of verifying the accuracy of the financial reports and calculations hereunder and under any Ancillary Agreement (including all of the components and deductions relating to the payments under Section 10.1 and adjustments under Section 10.2 and analogous payments under the Janssen Distributor Agreement with respect to the Janssen Countries, the Manufacturing Fees and the [*]) and for verifying the accuracy of any information relating to payments due under this Agreement and any Ancillary Agreement (each, an “Audit”). For each Audit under this Section 10.8.1.1 with respect to reports and calculations for each Territory Combination Product, [*]. The Parties shall agree on the scope of any such Audit (e.g., whether the Audit shall be one (1), two (2), or three (3) Calendar Years).
10.8.1.9    Party Initiated Audits. Subject to Section 10.8.1.3, and without limitation of Section 10.8.1.1, upon the written request and expense of the Auditing Party, each Audited Party shall, and shall cause its Affiliates and Sublicensees (in the case of Gilead) and , to the extent relevant to the revenue share calculations hereunder, Third Party Distributors and other Third Party distributors, if applicable, to permit an independent public accounting firm of national prominence selected by the Auditing Party and acceptable to the Audited Party to have access during normal business hours to those Financial Records of such

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Audited Party, its Affiliates, Sublicensees (in the case of Gilead) and, to the extent relevant to the revenue share calculations hereunder, Third Party Distributors and other Third Party distributors, if applicable, as may be reasonably necessary for the sole purpose of conducting an Audit. An Auditing Party may not initiate an Audit of the Audited Party under this Section 10.8.1.2 more than once per Calendar Year.
10.8.1.10    Generally. Each Auditing Party may conduct an Audit of the Financial Records relating to a particular Calendar Year of the Audited Party no more than once and there shall be no Audit of the Financial Records relating to a particular Calendar Year of the Audited Party more than once under Section 10.8.1.1 and Section 10.8.1.2, collectively, provided that any Financial Records relating to a particular Calendar Year of a Party that have been Audited may be Audited a second time to the extent that such Financial Records were not included in the scope of the first Audit. Notwithstanding anything herein to the contrary, in no event may an Auditing Party conduct an Audit of the Financial Records of the Audited Party relating to any Calendar Year ending more than three (3) years prior to the date of such Audit. With respect to Third Party Distributors and other Third Party distributors, all Audits shall be conducted solely by the Party that is party to the applicable agreement with such Third Party Distributor or Third Party distributor and in accordance with terms and conditions of such agreement using the independent public accounting firm or other mutually acceptable certified or chartered accountant (in each case as permitted by the terms and conditions of such agreement) and the Auditing Party shall only have the right to review the results of such Audit generated by the contracting Party and such independent public accounting firm or accountant to the extent such Audit results may be revealed pursuant to the applicable agreement with such Third Party Distributor or Third Party distributor; and this Section 10.8 shall not confer rights to any Party that exceed those rights set forth in the applicable agreement with such Third Party Distributor or Third Party distributor. For clarity, any information relating to providing Janssen estimates of amounts to be paid hereunder or under the RPV Supply Agreement shall not be subject to an Audit.
10.8.2    Sublicenses, Distribution Agreements and other Third Party Agreements.
10.8.2.1    With respect to any sublicense agreement entered into after the Restatement Effective Date with respect to a Territory Combination Product, the Parties shall include a provision requiring, among others, the Sublicensee to keep and maintain adequate Financial Records pursuant to such sublicense agreement sufficient to make the calculations hereunder and to grant access to such Financial Records to the extent required under Section 10.6 and Section 10.8.1.
10.8.2.2    With respect to any (sub)license agreement entered into after the Restatement Effective Date with respect to any F/TDF Product, F/TAF Product, RPV Single Agent Product, TDF Single Agent Product or FTC Single Agent Product, to the extent that the sales information generated thereunder is required in order to calculate the F/TAF NSP, F/TDF NSP, FTC NSP or RPV NSP, as applicable, the Party that is a party to such agreement shall include a provision requiring the applicable (sub)licensee to keep and maintain adequate Financial Records pursuant to such sublicense agreement sufficient to make such calculations

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


and to grant access to such Financial Records to the extent required under Section 10.6 and Section 10.8.1. With respect to any existing (sub)license agreements, neither Party shall modify such agreements to reduce compliance with the foregoing and, in the event of a modification of such agreements, shall use reasonable efforts to include such provision described in this Section 10.8.2.2.
10.8.2.3    In the event with respect to a country, a Party [*] then the Party that is a party to such agreement shall include a provision requiring the applicable Third Party distributor to keep and maintain adequate Financial Records pursuant to such agreement sufficient to make such calculations and to grant access to such Financial Records to the extent required under Section 10.6 and Section 10.8.1.
10.8.3    Any report prepared by such independent public accounting firm or other accountant, a copy of which shall be sent or otherwise provided to the Auditing Party by such independent public accounting firm or other accountant at the same time as it is sent or otherwise provided to the other Party, shall contain the conclusions of such independent public accounting firm or other accountant regarding the Audit and will specify that the amounts paid by or to the Auditing Party pursuant thereto were correct or, if incorrect, the amount of any underpayment or overpayment.
10.8.4    If such independent public accounting firm’s or other accountant’s report shows any underpayment, the paying Party shall remit to the other Party within sixty (60) days after receipt of the Audit report, (i) the amount of such underpayment and (ii) if such underpayment exceeds [*] of the total amount owed for the Calendar Year then being audited, the reasonable and necessary fees and expenses of such independent public accounting firm or other accountant performing the Audit, subject to reasonable substantiation thereof. If such independent public accounting firm’s report shows any overpayment, the paying Party shall receive a credit equal to such overpayment against future amounts, if any, payable under this Agreement; if no further payments are due under this Agreement, reimbursement of the overpayment shall be due and paid no later than sixty (60) days after receipt of the Audit report (and no invoicing shall be required).
10.9    Interest Due. In case of any delay in payment by a Party to the other Party hereunder or under the RPV Supply Agreement, interest on the overdue payment shall accrue at an annual interest rate equal to the lower of (a) the sum of (i) the prime rate of interest in force on the date the payment is due as published in The Wall Street Journal (Eastern United States Edition) and (ii) [*] and (b) the maximum rate of interest permissible by Applicable Law. The foregoing interest shall be due from the paying Party without any special notice.
10.10    Tax Withholding.
10.10.1    A Party making payments to the other Party under this Agreement or the RPV Supply Agreement shall make such payments without deduction or withholding for taxes except to the extent that any such deduction or withholding is required by Applicable Law in effect at the time of payment.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


10.10.2    Any tax required to be withheld on amounts payable under this Agreement or the RPV Supply Agreement will promptly be paid by the applicable paying Party on behalf of the other Party to the appropriate governmental authority, and such paying Party will furnish the other Party with proof of payment of such tax within sixty (60) days. Any such tax required to be withheld shall be an expense of and borne by such other Party.
10.10.3    Janssen and Gilead shall cooperate with respect to all documentation required by any taxing authority or reasonably requested by Janssen or Gilead to secure a reduction in the rate of applicable withholding taxes.
10.10.4    If the applicable paying Party had a duty to withhold taxes in connection with any payment it made to the other Party under this Agreement or the RPV Supply Agreement but such paying Party failed to withhold, and such taxes were assessed against and paid by such paying Party, then the other Party shall indemnify and hold harmless such paying Party from and against such taxes (including interest, but not including any related penalties). If such paying Party makes a claim under this Section 10.10.4, it shall comply with the obligations imposed by Section 10.10.2 as if such paying Party had withheld taxes from a payment to the other Party.
10.10.5    If either Party assigns in whole or in part this Agreement or the RPV Supply Agreement to an Affiliate or Third Party or grants to an Affiliate or Third Party a sublicense hereunder, in each case in a manner that adversely impacts the other Party economically due to increased withholding taxes on amounts paid by such Party hereunder or under the RPV Supply Agreement, or additional VAT taxes on the transfer of inventory hereunder or thereunder, then such first Party shall pay to such other Party an amount equal to the difference between the amount such other Party owes to the relevant tax authority on payments received or paid hereunder or thereunder, or inventory sold hereunder or thereunder, and the amount such other Party would have owed to such tax authority had this Agreement or the RPV Supply Agreement not been assigned or sublicensed to such Affiliate or Third Party.
10.11    Manufacturing Fees. The Parties shall perform their respective obligations with respect to the Manufacturing Fee as set forth in Annex M-4.
10.12    Branded Prescription Pharmaceutical Manufacturers Fee. [*].
10.13    Research and Development Reimbursement Payments. The Parties acknowledge and agree that Gilead has paid to Janssen all amounts that are required to be paid by Gilead to Janssen under Section 10.1 of the Original Agreement, and accordingly Gilead shall have no further obligations with respect to the payment of such amounts.
11
FINANCIAL CALCULATIONS AND ADJUSTMENTS
11.1    Calculations. Any obligation of a Party hereunder to make any calculation or to provide the results of such calculation, which calculation requires any information that the other Party is obligated to provide hereunder, shall be subject to receipt of such information from such other Party. In the event that delivery of any such information to the Party performing such

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


calculation is delayed, the deadline for performing such calculation and providing the results of such calculation shall be extended for a period of time corresponding to such delay.
11.2    Working Percentages. The Working Percentages for each Calendar Year shall be determined as set forth in Annex H.
11.3    Actual Percentages. Gilead shall calculate the Actual Percentages with respect to each Calendar Year in accordance with Annex I. Gilead shall use reasonable efforts to provide such percentages to Janssen no later than January 31 after the end of such Calendar Year.
11.4    Establishment of Standard Costs of Manufacturing. [*].
11.5    [Reserved].
11.6    Post-Generic FTC/TDF and F/TAF Combination. For each Calendar Quarter following the occurrence of the Generic FTC/TDF Combination Threshold [*] with respect to a given Specified Percentage Country, this Section 11.6 shall apply with respect to such Specified Percentage Country as follows:
11.6.1    the Specified Percentage with respect to Territory Complera sold in such Specified Percentage Country shall be modified to equal [*] and [*].
11.7    [Reserved].
11.8    [Reserved].
11.9    [Reserved].
11.10    Application of Original Agreement. Notwithstanding anything to the contrary in this Agreement or any Ancillary Agreement, the provisions related to pricing, revenue sharing, payment, currency conversion, financial reporting and audit and committees related to the foregoing (including the Discount Committee (as defined in the Original Agreement) and the Launch Coordination Committee (as defined in the Original Agreement)) of the Original Agreement and not the provisions related to pricing, revenue sharing, payment, currency conversion, financial reporting, audit and committees of this Agreement, shall govern any applicable activities conducted by the Parties (including any Triggering Sales (as defined in the Original Agreement)) with respect to Territory Complera on or before December 31, 2014, as well as any audits hereunder with respect to such period.
12
[RESERVED]
13
SAFETY DATA EXCHANGE AGREEMENT; PRODUCT RECALL AND WITHDRAWAL
13.1    Generally.     Subject to the terms of this Agreement, within one hundred and twenty (120) days after the Restatement Effective Date, Janssen and Gilead (under the guidance of their respective pharmacovigilance departments, or equivalents thereof) shall cooperate in

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


good faith to discuss and develop mutually acceptable guidelines and procedures for the investigation, exchange, receipt, recordation and communication (as between the Parties and their Affiliates) of safety-related information with respect to the Territory R/F/TAF Product, and to set forth such guidelines and procedures in a written amendment to the Complera PVA or a separate written agreement between the Parties (the Complera PVA as amended by such amendment, or such separate written agreement (as it may be amended from time to time) together with the Complera PVA, the “Pharmacovigilance Agreement” or “PVA”). In connection with entering into any Third Party Distributor Agreement, the Selling Party shall ensure that it and the applicable Third Party Distributor enter into an appropriate pharmacovigilance agreement consistent with the terms of the PVA. Gilead shall, at its expense, maintain the global safety database with respect to the Territory Combination Products.
13.2    Notification and Recall.
13.2.9    Notification. In the event that either Party becomes aware that any governmental agency or authority has issued or requested a recall or market withdrawal or taken similar action in connection with (a) a Combination Product anywhere in the world, (b) in the case of Janssen, the RPV Single Agent Product, if the reason for such field alert is reasonably likely to affect a Territory Combination Product and Janssen has the right to make such disclosure to Gilead or (c) in the case of Gilead, any of the Gilead Compound Products, if the reason for such field alert is reasonably likely to affect a Territory Combination Product and Gilead has the right to make such disclosure to Janssen, or in the event that either Party determines that such a recall or market withdrawal of a Territory Combination Product may be necessary or advisable, such Party shall notify the other Party thereof by telephone within twenty-four (24) hours after becoming aware of such request, action or determination. Each Party shall also notify the other (i) if such Party issues an FDA field alert or similar alert or foreign equivalent thereof (in which case the Party issuing such field alert shall notify the other Party within twenty-four (24) hours after the decision to issue such field alert, and prior to notification of the applicable governmental agency or authority) with respect to (x) a Territory Combination Product or (y) any of such Party’s Single Agent Product(s) (including, in the case of Janssen, any Other RPV Product) or Double Agent Products in the Field, if the reason for such field alert is reasonably likely to affect a Territory Combination Product and the disclosing Party has the right to make such disclosure to the other Party, and (ii) within twenty-four (24) hours after such Party’s receipt of any communication from any governmental agency or authority regarding a potential recall or market withdrawal of a Territory Combination Product or any of such Party’s aforementioned products anywhere in the world.
13.2.10    Decision to Recall or Withdraw. Within a period of time reasonable under the circumstances after the date of a notice given pursuant to the first sentence of Section 13.2.1 that relates to, or otherwise has implications for, the Exploitation of a Territory Combination Product in any country(ies) in the Territory, for each country in the Territory, the Selling Party with respect thereto shall recall or withdraw such Territory Combination Product in such country if the Recall/Withdrawal Criteria (described below) are met with respect to such country. In such a case, the Selling Party shall determine in its reasonable judgment (i) the extent to which to conduct such recall or withdrawal (where such determination shall be made by

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


the Selling Party, in its reasonable judgment, based on the circumstances (e.g., a discrete Manufacturing non-conformity would justify a recall with respect to the applicable quantities of the applicable Territory Combination Product, but not a market withdrawal of such Territory Combination Product from such country)), (ii) the breadth, extent and level of customer to which any such recall or withdrawal shall reach, (iii) the strategies and notifications to be used, and (iv) other related matters with respect to the conduct of such recall or withdrawal. The “Recall/Withdrawal Criteria” shall be deemed to have been met in any country in the Territory if (A) the recall or withdrawal is mandated by any Regulatory Authority, (B) the Selling Party reasonably determines to recall or withdraw a Territory Combination Product, or the non-Selling Party reasonably requests such recall or withdrawal in writing, and such determination by the Selling Party, or such request by the non-Selling Party, is made: (v) for failure of such Territory Combination Product to meet the specifications therefor, (w) with a reasonable basis to conclude that material harm to patients may occur in the absence of such recall or withdrawal, (x) in the event the Manufacture of such Territory Combination Product sold in such country does not comply with Applicable Law, (y) on account of safety issues with respect to (1) such Territory Combination Product or (2) any Single Agent Product(s) or Double Agent Product in the Field, including in the event of a withdrawal of any Single Agent Product(s) or Double Agent Product in the Field from markets in the European Union or the United States for safety concerns, or (z) on account of a Regulatory Authority mandating a withdrawal of any Single Agent Product(s) or Double Agent Product in the Field from markets in the European Union or the United States or (C) the applicable Territory Combination Product is recalled or withdrawn in the applicable country(ies) in accordance with Section 13.2.3.
13.2.11    Product Withdrawal.
13.2.11.1    Without limitation of Section 13.2.2, (a) subject to Section 4.8 and Section 13.2.3.2, at any time, Gilead may, for commercial reasons or otherwise determine in its sole discretion, withdraw any Territory Combination Product from the market in any Gilead Country that is not a Major Market Country (and recall such Territory Combination Product in connection therewith, if applicable), (b) at any time after the First Commercial Sale of the Territory R/F/TAF Product has occurred in a Janssen Country, Janssen may, for commercial reasons or otherwise, determine in its sole discretion to withdraw Territory Complera from the market in such Janssen Country (and to recall Territory Complera in connection therewith, if applicable), and (c) at any time after Gilead has withdrawn the Territory R/F/TAF Product in a Major Market Country pursuant to Section 13.2.2, Janssen may, for commercial reasons or otherwise, determine in its sole discretion to withdraw the Territory R/F/TAF Product from any Janssen Country (and to recall the Territory R/F/TAF Product in connection therewith, if applicable). If the reason for such market withdrawal is based on any of the Recall/Withdrawal Criteria (other than clause (C) thereof), such withdrawal shall be conducted in accordance with Section 13.2.2. In all other cases of market withdrawal, the Selling Party shall, upon receiving any necessary or appropriate approval from the applicable Regulatory Authority(ies), cease selling (and cause its subdistributors and Third Party Distributors, as applicable, to cease selling) the applicable Territory Combination Product in the applicable country, and the Selling Party shall determine whether, and if so how, to recall any of such Territory Combination Product already on the market in such country.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


13.2.11.2    If Gilead determines to withdraw the Territory R/F/TAF Product from the market in any Gilead Country that is not a Major Market Country pursuant to Section 13.2.2 or Section 13.2.3.1 for any reason other than a reason described in clause (A) or clause (B) of the Recall/Withdrawal Criteria, Gilead shall promptly notify Janssen in writing and the Parties shall discuss in good faith such Gilead determination to withdraw the Territory R/F/TAF Product. In the event that the Parties are unable to agree on whether Gilead may withdraw the Territory R/F/TAF Product from such country pursuant to Section 13.2.2 or Section 13.2.3.1, either Party shall have the right to refer such matter for resolution by the Alliance Managers pursuant to Section 20.6. If the Alliance Managers do not reach consensus with respect to such matter within the time period set forth in Section 20.6.1, such matter may be escalated by either Party to the Executives pursuant to Section 20.6.1 and, in the event that the Executives do not reach agreement on such matter within the Executives Review Period, Gilead shall have final decision-making authority with respect to such matter.
13.2.12    Conduct of Recall or Withdrawal. Subject to Section 13.3 and the Janssen Distributor Agreement, without limitation of Section 13.2.2, any withdrawal or recall with respect to a Territory Combination Product in any country in the Territory required or agreed upon by the Parties pursuant to this Section 13.2 shall be conducted by the Selling Party with respect to such country or its applicable Affiliate (or in the case of a country in which a Sublicensee or Third Party Distributor is the distributor in such country, the Selling Party shall cause the Sublicensee or Third Party Distributor to conduct such product recall or withdrawal) with reasonable cooperation from the other Party, regardless of whether the other Party requested such withdrawal or recall.
13.2.13    Regulatory Filings; Required Reporting. In the case of any recall or withdrawal of a Territory Combination Product in any country in the Territory, the Selling Party with respect to such country shall make (or cause to be made) such regulatory filings with Regulatory Authorities in such country as may be required to effect such recall or withdrawal.
13.2.14    Reporting and other Actions Required by Applicable Law. Nothing set forth in this Section 13.2 shall be construed as restricting the right of either Party (or its Affiliates, Sublicensees or Third Party Distributors) to make a timely report of any matter relating to an actual or potential recall or similar action to any government agency or take other action that it deems appropriate or required by Applicable Law.
13.3    Recall Expenses. Each Party (the “Responsible Party”) shall bear any and all Recall Expenses with respect to any Party-Specific Recall/Withdrawal of such Party. Any Recall Expenses that are not exclusively borne by one of the Parties pursuant to the preceding sentence shall be borne by the Parties in accordance with their applicable Average Respective Percentages with respect to the Territory. In addition, if any existing quantity of Territory Combination Product is rendered unusable as a result of a recall or withdrawal (either by way of a return resulting in unusable Territory Combination Product or an inability to make future sales of Territory Combination Product in inventory) (“Recalled Product”), the following shall apply with respect to the Recalled Product (and the quantity of APIs contained therein): (x) for any amounts invoiced by Janssen to Gilead for the Supplied RPV contained in such Recalled

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Product, Janssen shall issue a credit note to Gilead which shall be credited against the outstanding invoice for such Supplied RPV (if not yet due or paid, or otherwise against any other outstanding invoice), (y) solely with respect to Recalled Product supplied by Gilead pursuant to the Janssen Distributor Agreement, for any amounts invoiced by Gilead to Janssen for such Recalled Product, Gilead shall issue a credit note to Janssen which shall be credited against the outstanding invoice for such Recalled Product if not yet due or paid or otherwise against any other outstanding invoice), and (z) solely in the case of a Party-Specific Recall/Withdrawal, the Responsible Party shall pay to the non-Responsible Party (1) for each API of the non-Responsible Party in such Recalled Product, an amount equal to the quantity of such API corresponding to the quantity of such Recalled Product multiplied by the Standard Cost of Manufacturing for such API, and (2) an amount equal to the non-Responsible Party’s portion of the applicable Manufacturing Fees for such Recalled Product.
13.4    Recall Records. Each Party shall maintain records of all sales, in countries in which it is the Selling Party, of each Territory Combination Product to direct accounts sufficient to administer a recall until the date that is the latest of (a) three (3) years from the termination or expiration of this Agreement with respect to such Territory Combination Product, (b) three (3) years from the date of the last such sale of such Territory Combination Product in the Territory or (c) the last expiration date of such Territory Combination Product sold by, or on behalf of, such Party, or such longer period as may be required under any In-License Agreement, as specified in the In-License Requirements, or Applicable Law.
13.5    Communication with Regulatory Authorities Regarding Recalls.
13.5.5    Gilead shall make all contacts with any applicable Regulatory Authority in the Gilead Countries relating to the implementation of any recall of the Territory Combination Product, and shall be responsible for coordinating all of the necessary activities in connection with any such recall.
13.5.6    Janssen shall make all contacts with any applicable Regulatory Authority in the Janssen Countries relating to the implementation of any recall of the Territory Combination Product, and shall be responsible for coordinating all of the necessary activities in connection with any such recall.
13.6    Public Statements Regarding Recalls. Gilead shall make all public statements with regard to any recall of the Territory Combination Product in the Gilead Countries and Janssen shall make all public statements with regard to any recall of the Territory Combination Product in the Janssen Countries. Prior to the issue of any press release or making of any other public statement by a Party relating to, connected with or arising out of any recall of the Territory Combination Product that contains the name of or that could reasonably be construed to refer to the other Party or its Affiliate, the other Party’s Single Agent Product(s) or Double Agent Products or, in the event such other Party is Gilead, TDF, TAF or FTC, or, in the event such other Party is Janssen, RPV, such Party issuing such press release or making such other public statement shall provide the other Party with a copy of such press release or public statement and reasonably consider the comments of such other Party. Each Party shall make all public

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


statements with regard to any recall of its respective Single Agent Product(s) or Double Agent Product.
14
INTELLECTUAL PROPERTY RIGHTS
14.1    Ownership of Intellectual Property.
14.1.15    Gilead Intellectual Property. Janssen shall have no right, title, and interest in and to the Gilead Technology, the Gilead-Owned Collaboration Inventions (including any Patents Covering a Gilead-Owned Collaboration Invention) and the Gilead Regulatory Documentation, except such licenses and other rights as are granted to Janssen in this Agreement and the Ancillary Agreements.
14.1.16    Janssen Intellectual Property. Gilead shall have no right, title, and interest in and to the Janssen Technology, the Janssen-Owned Collaboration Inventions (including any Patents Covering a Janssen-Owned Collaboration Invention) and the Janssen Regulatory Documentation, except such licenses and other rights as are granted to Gilead in this Agreement and the Ancillary Agreements.
14.1.17    Clinical Data. Notwithstanding Sections 14.1.1, 14.1.2 and 14.1.4, subject to the license and other rights granted to the other Party in this Agreement and the Ancillary Agreements, as among the Parties and their Affiliates, each Party shall own all right, title and interest in and to any clinical data generated by or on behalf of such Party or its Affiliates.
14.1.18    Joint Intellectual Property. Subject to the licenses and other rights granted under this Agreement and the Ancillary Agreements, as among the Parties and their Affiliates, the Parties shall jointly own all right, title and interest in and to the Joint Technology and Joint Collaboration Inventions. Subject to the licenses and other rights granted under this Agreement and the Ancillary Agreements and the other terms of this Agreement (including the terms set forth in Section 17.2.1 and 17.3.1), each Party and its Affiliates may independently Exploit its rights in the Joint Technology and Joint Collaboration Inventions without the consent of, or duty of accounting to, the other Party, including the right to assign, license or transfer any of its right, title and ownership in and to any Joint Technology or Joint Collaboration Inventions to (a) any Affiliate, (b) any Third Party that is a permitted assignee of this Agreement, (c) (i) in the case of Gilead or its Affiliates, any of its Third Party (sub)licensees or Generic Licensees to Exploit any Gilead Compound Product or, in the case of a Generic Licensee, a generic version thereof or, in the Gilead Countries, a Territory Combination Product, subject to the terms of this Agreement, or (ii) in the case of Janssen or its Affiliates, any of its Third Party (sub)licensees or Generic Licensees to Exploit any RPV Product or, in the case of a Generic Licensee, a generic version thereof or, in the Janssen Countries, a Territory Combination Product, subject to the terms of this Agreement, or (d) any of its Third Party contract manufacturers, in each case ((a) through (d)), without the consent of the other Party, but any assignment, license or transfer of a Party’s (or its Affiliates’) right, title or interest in or to any Joint Technology or Joint Collaboration Inventions to any other Third Party shall require the prior written consent of the other Party.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


14.1.19    Disclosure and Assignment of Collaboration Inventions. Each Party shall disclose to the other Party promptly in writing any and all Collaboration Inventions, other than, in the case of Janssen as the disclosing Party, Janssen-Owned Collaboration Inventions and, in the case of Gilead as the disclosing Party, Gilead-Owned Collaboration Inventions, that are conceived, discovered, developed or otherwise made by or on behalf of the disclosing Party. Each Party hereby assigns, and agrees to cause its Affiliates and their respective employees and agents to assign, to the other Party, without payment of additional consideration, such Party’s (or its Affiliates’) rights, title and interest in and to all Collaboration Inventions to the extent necessary to effect the ownership thereof as set forth in this Section 14.1.
14.1.20    Combination Product Regulatory Documentation. Subject to the licenses and other rights granted by each Party to the other Party pursuant to this Agreement, as between the Parties, Gilead, or its designated Affiliate, Sublicensee, or Third Party Distributor, shall own all right, title and interest in and to the Combination Product Regulatory Documentation; provided, however, that Janssen or its applicable Affiliate shall retain ownership of any Information and Inventions, including Clinical Data, included in the Combination Product Regulatory Documentation developed by or on behalf of Janssen or its Affiliates. Janssen shall, and shall cause its Affiliates and their respective employees and agents to, reasonably cooperate, by the execution of documents and otherwise, to vest ownership of the Combination Product Regulatory Documentation in Gilead (subject to the proviso in the first sentence of this Section 14.1.6).
14.2    Prosecution of Patents.
14.2.4    Gilead Patents. Gilead, through patent attorneys or agents of its choice, shall have the sole right, at its sole cost and expense, to prepare, file, prosecute and maintain the Gilead Patents, including Patents Covering the Gilead-Owned Collaboration Inventions, anywhere in the world in the name of Gilead. Without limitation of Section 14.1.5, Janssen shall, and shall cause its Affiliates and their respective employees and agents to, reasonably cooperate, by the execution of documents and otherwise, to vest ownership of the Gilead-Owned Collaboration Inventions in Gilead.
14.2.5    Janssen Patents. Janssen, through patent attorneys or agents of its choice, shall have the sole right, at its sole cost and expense, to prepare, file, prosecute and maintain the Janssen Patents, including Patents Covering the Janssen-Owned Collaboration Inventions, anywhere in the world in the name of Janssen. Janssen shall use Commercially Reasonable Efforts to prepare, file, prosecute and maintain any Janssen Patent in the Territory that Covers RPV or a Combination Product. Without limitation of Section 14.1.5, Gilead shall, and shall cause its Affiliates and their respective employees and agents to, reasonably cooperate, by the execution of documents and otherwise, to vest ownership of the Janssen-Owned Collaboration Inventions in Janssen.
14.2.6    Joint Patents.
14.2.6.7    Relating to a Combination Product.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


a.    Gilead, through patent attorneys or agents of its choice, shall have the first right, but not the obligation, at its sole expense, to prepare, file, prosecute and maintain applications for Patents in the Territory claiming the Joint Know-How, to the extent that such Joint Know-How is (x) related to a Combination Product and (y) would have utility with regard to any Gilead Compound Product and would not have utility with regard to any RPV Product (“Gilead-Controlled Combination Product Joint Patents”) and to obtain, prosecute, and maintain such Gilead-Controlled Combination Product Joint Patents in the name of both Parties as assignees throughout the Territory. Gilead shall provide (or shall cause its foreign agents to provide) to Janssen copies of all written official communications correspondence between Gilead or any of its Affiliates or their respective patent counsel and the applicable patent office relating to the prosecution or maintenance of such Gilead-Controlled Combination Product Joint Patents, and Janssen shall have the right, but not the obligation, to provide substantive review and comment on any such correspondence. Without limitation of the foregoing, Janssen shall have the right to request that Gilead file, prosecute and maintain any Gilead-Controlled Combination Product Joint Patent in a particular country. If Gilead declines in writing to do so, or otherwise fails to initiate any such requested action with respect to such Gilead-Controlled Combination Product Joint Patent within sixty (60) days after receiving a request (or to thereafter diligently pursue such action), Janssen shall have the right, but not the obligation, at its sole cost and expense, through counsel of its choosing, to pursue such action with respect to such Gilead-Controlled Combination Product Joint Patent.
b.    Janssen, through patent attorneys or agents of its choice, shall have the first right, but not the obligation, at its sole expense, to prepare, file, prosecute and maintain applications for Patents in the Territory claiming the Joint Know-How, to the extent that such Joint Know-How is (x) related to a Combination Product and (y) would have utility with regard to any RPV Product and would not have utility with regard to any Gilead Compound Product (“Janssen-Controlled Combination Product Joint Patents”) and to obtain, prosecute, and maintain such Janssen-Controlled Combination Product Joint Patents in the name of both Parties as assignees throughout the Territory. Janssen shall provide (or shall cause its foreign agents to provide) to Gilead copies of all written official communications correspondence between Janssen or any of its Affiliates or their respective patent counsel and the applicable patent office relating to the prosecution or maintenance of such Janssen-Controlled Combination Product Joint Patents and Gilead shall have the right, but not the obligation, to provide substantive review and comment on any such correspondence. Without limitation of the foregoing, Gilead shall have the right to request that Janssen file, prosecute and maintain any Janssen-Controlled Combination Product Joint Patent in a particular country. If Janssen declines in writing to do so, or otherwise fails to initiate any such requested action with respect to such Janssen-Controlled Combination Product Joint Patent within sixty (60) days after receiving a request (or to thereafter diligently pursue such action), Gilead shall have the right, but not the obligation, at its sole cost and expense, through counsel of its choosing, to pursue such action with respect to such Janssen-Controlled Combination Product Joint Patent.
c.    Gilead and Janssen shall, and shall cause their respective Affiliates, as applicable, to assist and cooperate with one another in filing, prosecuting and maintaining the Joint Patents under this Section 14.2.3.1 and the reasonable costs and

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


expenses of such assistance and cooperation shall be allocated as costs and expenses are otherwise allocated under this Section 14.2.3.1.
14.2.6.8    Other Joint Patents. In the event that either Party desires to prepare and have filed any Patent application in the Territory claiming the Joint Know-How to the extent that such Joint Know-How is either (A) not related to a Combination Product or (B) not covered by Section 14.2.3.1a or Section 14.2.3.1b above, then in either case ((A) or (B)), such Party shall propose such filing to the other Party and the Parties shall discuss and agree in writing on which Party shall take responsibility for preparing and filing the Patent application and the allocation as between the Parties of costs and expenses related to such Joint Patent application. In the event that the Parties fail to reach agreement that such Patent application should be filed, neither Party may file or cause to be filed such Patent application. In the event that the Parties agree that a Patent application for a Joint Patent Covering such Joint Know-How should be filed, the Party designated to lead such application process (the “Lead Patent Party”) shall have the sole right and obligation, in consultation with the non-Lead Patent Party, to prepare, file, prosecute, maintain and take any other actions as directed by the Parties with respect to such Joint Patent in the name of both Parties as the assignees in such countries as the Parties shall direct, and the costs and expenses with respect thereto shall be shared by the Parties as agreed pursuant to this Section 14.2.3.2. The Lead Patent Party shall keep the other Party advised of the status of Joint Patent filings pursuant to this Section 14.2.3.2 and shall provide (or shall cause its foreign agents to provide) copies of all written official communications correspondence between such Lead Patent Party or any of its Affiliates or their respective patent counsel and the applicable patent office relating to the prosecution or maintenance of such Joint Patents. For the avoidance of doubt, the Lead Patent Party may elect to use outside patent counsel for the filing, prosecution and maintenance of the Joint Patents. The non-Lead Patent Party may engage outside patent counsel, at its expense, to review any filings to be made with respect to any Joint Patent pursuant to this Section 14.2.3.2. The non-Lead Patent Party shall, and shall cause its Affiliates to, assist and cooperate with the Lead Patent Party in filing, prosecuting and maintaining the Joint Patents pursuant to this Section 14.2.3.2. Costs and expenses with respect to such assistance shall be shared by the Parties as agreed pursuant to this Section 14.2.3.2.
14.2.6.9    Without limitation of Section 14.1.5, each Party shall, and shall cause its Affiliates and their respective employees and agents to, reasonably cooperate, by the execution of documents and otherwise, to vest co-ownership of the Joint Patents in one another.
14.2.7    Extensions. Gilead may file and prosecute to obtain extensions of the Gilead Patents and the Gilead-Controlled Combination Product Joint Patents. Janssen may file and prosecute to obtain extensions of the Janssen Patents and the Janssen-Controlled Combination Product Joint Patents. The Lead Patent Party with respect to any other Joint Patents may file and prosecute to obtain extensions of such Joint Patents. The foregoing rights shall apply in any country in which such extensions are available and each Party may exercise its rights in this Section 14.2.4 in its sole discretion. Each Party shall provide such assistance as may reasonably be required to obtain such extensions.

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


14.2.8    Orange Book. Gilead shall have sole discretion to determine which (i) Gilead Patents, including Patents Covering Gilead-Owned Collaboration Inventions, if any, (ii) Janssen Patents, including Patents Covering Janssen-Owned Collaboration Inventions, if any, and (iii) Joint Patents, if any, shall be listed in the “Orange Book” in the U.S., or any analogous or similar listing in the Territory, with respect to a Territory Combination Product in the Field; provided, however, that, in the case of the Janssen Patents and Joint Patents, Gilead shall consult with Janssen in advance, afford Janssen a reasonable opportunity to comment and consider in good faith any comments made by Janssen in good faith with regard to such determination.
14.3    Liability for Prosecution and Maintenance. Each Party acknowledges that the Party responsible for prosecution and maintenance of Patents licensed or co-owned under this Agreement or the Ancillary Agreements (the “Prosecution and Maintenance”) does not guarantee the issuance, validity, or enforceability of any such Patent or any claim resulting from its efforts hereunder. Neither Party shall have any liability to the other Party for any negligent acts or misconduct of outside counsel utilized in connection with the Prosecution and Maintenance. The foregoing provisions of this Section 14.3 are without prejudice to either Party’s potential liability for breach of its obligations under Section 14.1 or 14.2.
14.4    Enforcement of Patents. Each Party shall promptly notify the other Party in writing of any alleged or threatened Infringement (as defined in Section 14.4.4) of which it becomes aware.
14.4.7    Effect on In-License Agreements. In the event that any Gilead Patents (in the case of Gilead) or Janssen Patents (in the case of Janssen) are subject to an In-License Agreement and such In-License Agreement would restrict or impair the exercise of the other Party of its step-in rights set forth in this Section 14.4 or Section 14.5, then at the request of the step-in Party (which request may only be made if and when such step-in Party intends to exercise such step-in rights), Gilead (in the case of the Gilead Patents) or Janssen (in the case of the Janssen Patents) shall use good faith efforts (a) to reasonably enable such other Party to exercise its such step-in rights, or (b) to achieve an alternate resolution to the exercise of the other Party’s step-in rights, provided, however, that the Parties agree that such good faith efforts shall not require Gilead (in the case of the Gilead Patents) or Janssen (in the case of the Janssen Patents) to offer further compensation to a Third Party.
14.4.8    Janssen Patents. As between the Parties, Janssen shall have, with respect to the Major Market Countries, the first right and option, and with respect to the remaining countries in the Territory, the sole right and option, at its sole expense, in each case, to respond to any Infringement (as defined in Section 14.4.4) with respect to any Janssen Patent, including Patents Covering the Janssen-Owned Collaboration Inventions, by appropriate steps, including by filing an infringement suit or taking other similar action. With respect to the Major Market Countries, in the event that Janssen fails to, within forty (40) days following notice of such Infringement, or earlier notifies Gilead in writing of its intent not to, file an infringement suit or other similar action against the infringer with respect to at least one claim of one Janssen Patent, Gilead shall have the right, but not the obligation, to do so at Gilead’s sole cost and expense, the foregoing provided that: (i) Janssen has the legal right to allow Gilead to take such steps to

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


remove such Infringement, including considering any contractual obligations Janssen may have to Third Parties; (ii) any such steps to respond to such Infringement by Gilead shall only be with respect to claims of Janssen Patents that are directed to a composition-of-matter of RPV alone or in combination with TDF, TAF or FTC or the use in the Field of RPV alone or in combination with TDF, TAF or FTC; and (iii) to the extent that Gilead undertakes steps to remove such Infringement, Gilead shall indemnify Janssen and its Indemnified Persons as set forth in Section 18.5 (and Janssen shall have no obligations of indemnity under Article 18 arising from such enforcement). In the event that Gilead exercises such right, Gilead shall not settle any infringement suit or similar action without the prior written consent of Janssen, which consent shall not be unreasonably withheld; provided, however, that Janssen may in its sole discretion withhold its consent with respect to any settlement that involves an admission of invalidity or unenforceability of any Janssen Patent. The Party not bringing the suit or action shall provide, at such Party’s own expense, reasonable assistance to the Party bringing the suit or action, including providing access to relevant documents and other evidence in its possession and control (to the extent it is able to do so without violation of any Third Party agreement), making its employees available at reasonable business hours, and joining the action to the extent necessary to allow the Party bringing the suit or action to maintain the suit or action. In the event of a conflict between Janssen’s rights under its Generic Exception and this Section 14.4.2, such rights under Janssen’s Generic Exception shall control.
14.4.9    Gilead Patents. As between the Parties, Gilead shall have, with respect to Major Market Countries, the first right and option, and with respect to the remaining countries in the Territory, the sole right and option, at its sole expense, to respond to any Infringement (as defined in Section 14.4.4) with respect to any Gilead Patent, including Patents Covering the Gilead-Owned Collaboration Inventions, by appropriate steps, including by filing an infringement suit or taking other similar action. With respect to Major Market Countries, in the event that Gilead fails to, within forty (40) days following notice of such Infringement, or earlier notifies Janssen in writing of its intent not to, file an infringement suit or other similar action against the infringer with respect to at least one claim of one Gilead Patent, Janssen shall have the right, but not the obligation, to do so at Janssen’s sole cost and expense, the foregoing provided that: (i) Gilead has the legal right to allow Janssen to take such steps to remove such Infringement, including considering any contractual obligations Gilead may have to Third Parties; (ii) any such steps to respond to such Infringement by Janssen shall only be with respect to claims of Gilead Patents that are directed to a composition-of-matter of TDF, TAF or FTC alone or in combination with RPV or the use in the Field of TDF, TAF or FTC alone or in combination with RPV; and (iii) to the extent that Janssen undertakes steps to remove such Infringement, Janssen shall indemnify Gilead and its Indemnified Persons as set forth in Section 18.5 (and Gilead shall have no obligations of indemnity under Article 18 arising from such enforcement). In the event that Janssen exercises such right, Janssen shall not settle any infringement suit or similar action without the prior written consent of Gilead, which consent shall not be unreasonably withheld; provided, however, that Gilead may in its sole discretion withhold its consent with respect to any settlement that involves an admission of invalidity or unenforceability of any Gilead Patent. The Party not bringing the suit or action shall provide, at such Party’s own expense, reasonable assistance to the Party bringing the suit or action, including providing access to relevant documents and other evidence in its possession and

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


control (to the extent it is able to do so without violation of any Third Party agreement), making its employees available at reasonable business hours, and joining the action to the extent necessary to allow the Party bringing the suit or action to maintain such suit or action. In the event of a conflict between Gilead’s rights under its Generic Exception and this Section 14.4.3, such rights under Gilead’s Generic Exception shall control.
14.4.10    For purposes of this Section 14.4, (i) “Infringement” shall mean infringement or potential infringement of any Janssen Patent, Gilead Patent or Joint Patent by the actions of a Third Party in connection with an Combination Product or Other Combination Product (an “Infringing Combination Product”) where such infringement or potential infringement relates to the Exploitation of such Combination Product or Other Combination Product in the Territory, (ii) “Other Infringement” shall mean infringement or potential infringement of any Joint Patent by the actions of a Third Party in connection with any product that is not an Infringing Combination Product, (an “Other Infringing Product”) and (iii) “other similar action” shall include responses to paragraph (iv) certifications under the United States Drug Price Competition and Patent Term Restoration Act (also known as the Hatch-Waxman Act) (a “Paragraph (iv) Certification”) or a Notice of Allegation, which Paragraph (iv) Certification or Notice of Allegation relates to any Gilead Patent or Janssen Patent and results from an attempt to market (A) in the case of an Infringing Combination Product, a Generic Combination Product or (B) in the case of an Other Infringing Product, a generic version thereof. For the avoidance of doubt, the Parties acknowledge and agree that infringement of a Gilead Patent or a Janssen Patent, as the case may be, other than by an Infringing Combination Product, is outside the scope of this Agreement and shall not create any rights or impose any obligations on the Parties hereunder, including any right or obligation to take actions to respond to such infringement.
14.4.11    Joint Patents.
14.4.11.1    Right to Respond to Infringements. As between the Parties, Gilead, on behalf of and in the name of both Parties as joint owners, shall have the first right and option, at its sole expense, to respond to any Infringement with respect to any Joint Patent by appropriate steps, including filing an infringement suit or taking other similar action, provided that Gilead shall promptly notify Janssen of such Infringement, consult with Janssen, and consider Janssen’s recommended actions, regarding choice of outside counsel and development of litigation strategy regarding any such suit or other action. Gilead shall incur no liability to Janssen as a consequence of such litigation or any unfavorable decision resulting therefrom, including any decision holding such Joint Patent invalid or unenforceable. In the event that Gilead fails to file an infringement suit or other similar action with respect to any Infringement of any Joint Patent within forty (40) days following notice of such Infringement, or notifies Janssen that it will not take action with respect to such Infringement, then Janssen shall have the right, but not the obligation, to take action with respect to such Infringement at Janssen’s sole cost and expense. The Party not bringing the suit or action shall provide, at such Party’s own expense, reasonable assistance to the Party bringing the suit or action, including providing access to relevant documents and other evidence in its possession and control, to the extent it is able to do so without violation of any Third Party agreement, making its employees available at

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


reasonable business hours, and joining the action to the extent necessary to allow the Party to maintain such suit or action.
14.4.11.2    Right to Respond to Other Infringements Related to RPV Products Not Including TDF, TAF or FTC. Janssen, on behalf of and in the name of both Parties as joint owners, shall have the sole right and option, at its sole expense, to respond to any Other Infringement with respect to any Joint Patent to the extent that such Other Infringement relates to any RPV Product that does not contain TDF, TAF or FTC by appropriate steps, including filing an infringement suit or taking other similar action. Janssen shall incur no liability to Gilead as a consequence of such litigation or any unfavorable decision resulting therefrom, including any decision holding such Joint Patent invalid or unenforceable. Gilead, at Janssen’s expense, shall provide reasonable assistance to Janssen, including providing access to relevant documents and other evidence in its possession and control, to the extent it is able to do so without violation of any Third Party agreement, making its employees available at reasonable business hours, and joining the action to the extent necessary to allow Janssen to maintain such suit or action.
14.4.11.3    Right to Respond to Other Infringements Related to Gilead Compound Products Not Including RPV. Gilead, on behalf of and in the name of both Parties as joint owners, shall have the sole right and option, at its sole expense, to respond to any Other Infringement with respect to any Joint Patent to the extent that such Other Infringement relates to any of the Gilead Compound Products that does not contain RPV by appropriate steps, including filing an infringement suit or taking other similar action. Gilead shall incur no liability to Janssen as a consequence of such litigation or any unfavorable decision resulting therefrom, including any decision holding such Joint Patent invalid or unenforceable. Janssen, at Gilead’s expense, shall provide reasonable assistance to Gilead, including providing access to relevant documents and other evidence in its possession and control, to the extent it is able to do so without violation of any Third Party agreement, making its employees available at reasonable business hours, and joining the action to the extent necessary to allow Gilead to maintain such suit or action.
14.4.11.4    Right to Respond to Other Infringements. To the extent that the right to respond to an Other Infringement of a Joint Patent is not covered by Sections 14.4.5.1, 14.4.5.2 or 14.4.5.3, the Parties shall mutually agree on the rights, procedures and obligations of the Parties with respect to such Other Infringement.
14.4.12    Paragraph (iv) Certifications; Notices of Allegation. Each Party shall notify the other Party in writing within five (5) Business Days of receiving any Paragraph (iv) Certification or Notice of Allegation with respect to a Combination Product or any of its respective Single Agent Product(s) or Double Agent Products. In the event that a Party provides a notice pursuant to this Section 14.4.6 of a Paragraph (iv) Certification or a Notice of Allegation resulting from an attempt to market an Infringing Combination Product or, in the case of the Joint Patents, a generic version of an Other Infringing Product, then the rights and obligations in Sections 14.4.1, 14.4.3 and 14.4.5, if applicable, shall apply with respect to any responses to such Paragraph (iv) Certification or Notice of Allegation to the extent that it relates to any Gilead Patent, Janssen Patent or Joint Patent as if such Paragraph (iv) Certification or Notice of

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Allegation were an enforcement action under this Section 14.4 with respect to such Patents. For clarity, neither Party shall have any right to initiate infringement lawsuits or other similar actions to protect the other Party’s Patents or Joint Patents with respect to the other Party’s Single Agent Products or Double Agent Products.
14.4.13    Recoveries. As between the Parties, any amounts recovered by either Party pursuant to this Section 14.4 (other than pursuant to Section 14.4.5.2 or 14.4.5.3), whether by settlement or judgment, shall first be used to reimburse the applicable Party(ies) for their costs and expenses in making such recovery (which amounts shall be allocated first to reimburse the costs and expenses of the Party that prosecuted the infringement suit and second to reimburse the costs and expenses of the other Party). Any remaining recovery shall be allocated between the Parties based on the proportion of the Net Sales of the applicable Territory Combination Product to which each Party is entitled hereunder (at the time that the applicable infringement occurred) with regard to the applicable country; provided, however, that any portion of such remaining recovery that constitutes punitive or enhanced damages recovered by judgment (assuming that recoveries constituting punitive or enhanced damages are first applied to the foregoing costs and expenses) shall be retained by the Party that prosecuted the infringement suit. As between the Parties, any amounts recovered by the Party bringing an action under Section 14.4.5.2 or 14.4.5.3 shall be retained by such Party.
14.5    Defense of Patents.
14.5.1    In the event that a Third Party asserts as a counterclaim to an Infringement action or Other Infringement action brought pursuant to Section 14.4 that any Gilead Patent, Janssen Patent or Joint Patent is invalid or unenforceable, the Party controlling such infringement action shall have the right, but not the obligation, at its sole cost and expense, to defend against such assertion (and costs and recoveries shall be apportioned as described in Section 14.4).
14.5.2    In the event that a Third Party asserts, in a declaratory judgment action or similar action or claim filed by such Third Party (other than in an Infringement action brought pursuant to Section 14.4), that any Gilead Patent, Janssen Patent or Joint Patent relating to a Combination Product or Other Combination Product is invalid or unenforceable: (i) Gilead shall have (x) the sole right, but not the obligation, at its sole cost and expense, to defend such action or claim made against any Gilead Patent and (y) the first right, but not the obligation, at its sole cost and expense, to defend such action or claim made against any Joint Patent other than any Janssen-Controlled Combination Product Joint Patent, and (ii) Janssen shall have (x) the sole right, but not the obligation, at its sole cost and expense, to defend such action or claim made against any Janssen Patent and (y) the first right, but not the obligation, at its sole cost and expense, to defend such action or claim made against any Janssen-Controlled Combination Product Joint Patent, and in each case ((x) and (y)) Janssen shall use Commercially Reasonable Efforts to defend such Patents. In the event Janssen fails to take commercially appropriate steps to take action with respect to any declaratory judgment action or similar action or claim alleging that any Janssen-Controlled Combination Product Joint Patent Covering the Manufacture (including formulation), sale or approved use of a Combination Product or an Other Combination

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Product is invalid or unenforceable, to the extent relating to a Combination Product, within [*] following notice of such declaratory judgment action or similar action or claim, or notifies Gilead that it will not take action with respect to such declaratory judgment action or similar action or claim, then if Gilead is a party to such action or claim, Gilead shall have the right, but not the obligation, to take action with respect to such declaratory judgment action or similar action or claim at Gilead’s sole cost and expense, provided that such right shall not apply to any Janssen-Controlled Combination Product Joint Patent Covering RPV or its manufacture or sale. In the event Gilead fails to take commercially appropriate steps to take action with respect to any declaratory judgment action or similar action or claim alleging that any Joint Patent other than any Janssen-Controlled Combination Product Joint Patent is invalid or unenforceable, where such claim or action relates to a Combination Product, within [*] following notice of such declaratory judgment action or similar action or claim, or notifies Janssen that it will not take action with respect to such declaratory judgment action or similar action or claim, then Janssen shall have the right, but not the obligation, to take action with respect to such declaratory judgment action or similar action or claim at Janssen’s sole cost and expense.
14.6    Trademarks.
14.6.6    Gilead Licensed Trademarks. Gilead shall have the sole right, at its sole cost and expense, to search, clear, file, register, prosecute, maintain and enforce the Gilead Licensed Trademarks in the Territory. Gilead shall have the sole right and option, at its sole cost and expense, to respond to any infringement with respect to any Gilead Licensed Trademark in the Territory by appropriate steps, including by filing an infringement suit or taking other similar action. Gilead shall also have the sole right and option not to prosecute, maintain or enforce Gilead Licensed Trademarks in the Territory or take action to respond to any such infringement in the Territory.
14.6.7    Janssen Licensed Trademarks. Janssen shall have the sole right, at its sole cost and expense, to search, clear, file, register, prosecute, maintain and enforce the Janssen Licensed Trademarks in the Territory. Janssen shall have the sole right and option, at its sole cost and expense, to respond to any infringement with respect to any Janssen Licensed Trademark in the Territory by appropriate steps, including by filing an infringement suit or taking other similar action. Janssen shall also have the sole right and option not to prosecute, maintain or enforce Janssen Licensed Trademarks in the Territory or take action to respond to any such infringement in the Territory.
14.6.8    Combination Product Trademarks.
14.6.8.1    Registration. Subject to the licenses granted in Section 9.4.3, the Parties agree that, as among Gilead and Janssen and their respective Affiliates, Gilead (or its designee) shall own all right, title and interest in and to the Combination Product Trademarks. Gilead (or its designee) shall have the sole right, at its sole cost and expense, to search, clear, file, register, prosecute and maintain the Combination Product Trademarks anywhere in the world in the name of Gilead (or its designee).

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


14.6.8.2    Infringement. If Janssen has a reasonable basis to believe that a Third Party is engaging in commercially significant infringement of any Combination Product Trademark in any country in the Territory, Janssen shall use commercially reasonable efforts to notify Gilead in writing and provide it with any evidence of such infringement that is reasonably available. As between the Parties, Gilead shall have the sole right and option, at its sole expense, to respond to any infringement or potential infringement with respect to any Combination Product Trademark by appropriate steps, including filing an infringement suit or taking other similar action, and with respect to any infringement or potential infringement with respect to any Combination Product Trademark in the Janssen Countries, shall notify Janssen of, and consult with Janssen from time to time regarding, any such suit or other action. Janssen shall provide commercially reasonable assistance to Gilead or its designee, at Gilead’s expense for any out-of-pocket expenses, with respect to any enforcement activities with respect to the Combination Product Trademarks pursuant to this Section 14.6.3.2, including providing access to relevant documents and other evidence, making its employees available at reasonable business hours, and joining the action to the extent necessary to allow Gilead or its designee to maintain the action. Any amounts recovered pursuant to this Section 14.6.3.2, whether by settlement or judgment, shall first be used to reimburse the applicable Party(ies) for their costs and expenses in making such recovery. Any remaining recovery shall be allocated between the Parties based on the proportion of the Net Sales of the applicable Combination Product to which each Party is entitled hereunder (at the time at which the infringement occurred) with regard to the applicable country; provided, however, that any portion of such remaining recovery that constitutes punitive or enhanced damages recovered by judgment (assuming that recoveries constituting punitive or enhanced damages are first applied to the foregoing costs and expenses) shall be retained by Gilead.
15
CONFIDENTIALITY
15.1    Treatment of Confidential Information. Except as provided in this Article 15, during the Term and for five (5) years thereafter, each Party (the “Receiving Party”) (a) shall hold in confidence and shall not publish or otherwise disclose, directly or indirectly, to any Third Party any Confidential Information of the other Party (the “Disclosing Party”), (b) shall not directly or indirectly use Confidential Information of the Disclosing Party for any purpose other than performance of its obligations or the enforcement or exercise of its rights under this Agreement or any Ancillary Agreement, and (c) shall use the same level of effort to maintain the confidentiality of Confidential Information of the Disclosing Party as it uses for its own confidential or proprietary information, but in any event at least commercially reasonable efforts.
15.2    Permitted Disclosure. Each Party may disclose Confidential Information of the Disclosing Party to the extent that such disclosure is:
15.2.2    Made as required by Applicable Law; provided, however, that to the extent practicable, the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to seek any available limitations on, exemptions from or protections available with respect to such disclosure requirement and reasonably cooperate in any efforts by the Disclosing Party to obtain such protections or

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


assurances that confidential treatment will be afforded to any Confidential Information so disclosed;
15.2.3    Subject to Section 4.3, made by (i) Janssen or its Affiliates or (sub)licensees or Third Party distributors to Regulatory Authorities as is necessary or reasonably expected to be necessary for Janssen (or its Affiliates, (sub)licensees or Third Party distributors), (A) to engage in the Janssen Permitted Use, or (B) with respect to such Confidential Information disclosed under the PVA (or other safety-data exchange provisions contained in any Ancillary Agreement), and solely to the extent relating to the safety of RPV, (X) to obtain and maintain Regulatory Approvals for any RPV Product or (Y) to update the Product Label for any RPV Product; or (ii) Gilead or its Affiliates or (sub)licensees or Third Party distributors to Regulatory Authorities as is necessary or reasonably expected to be necessary for Gilead (or its Affiliates, (sub)licensees or Third Party distributors) (A) to engage in the Gilead Permitted Use, or (B) with respect to such Confidential Information disclosed under the PVA (or other safety-data exchange provisions contained in any Ancillary Agreement), and solely to the extent relating to the safety of TDF, TAF or FTC, (X) to obtain and maintain Regulatory Approvals for any Gilead Compound Product or (Y) to update the Product Label for any Gilead Compound Product; provided, however, that, in each case ((i) and (ii)), the Receiving Party shall take reasonable measures to assure confidential treatment of such information;
15.2.4    Made by the Receiving Party to its employees, Affiliates, independent contractors, legal counsel, consultants, auditors and advisors who (except in the case of legal counsel) are bound by confidentiality and non-use obligations no less protective than those in this Article 15 and who reasonably require such Confidential Information for the performance of such Party’s obligations or the enforcement or exercise of such Party’s rights under this Agreement or any Ancillary Agreement; provided, however, that the Receiving Party shall remain responsible for any failure by any such Person to treat such Confidential Information as required by this Article 15;
15.2.5    Made by the Receiving Party or its Affiliates to its licensors (i) listed on Annex W, as applicable, pursuant to contractual obligations to such licensors existing as of the Restatement Effective Date or (ii) otherwise approved in writing by the Disclosing Party such approval not to be unreasonably withheld, conditioned or delayed or (iii) pursuant to any In-License Requirements in accordance with Section 9.5.4, in the case of any In-License Agreement entered into after the Restatement Effective Date, under confidentiality and non-use obligations no less protective than those in this Article 15; provided, however, that the Receiving Party shall remain responsible for any failure by any such Person to treat such Confidential Information as required by this Article 15;
15.2.6    Made by the Receiving Party or its Affiliates as necessary for the filing of its tax returns or pursuant to any audit thereof; provided, however, that the Receiving Party shall take reasonable measures to assure confidential treatment of such information;
15.2.7    Made by the Receiving Party or its Affiliates to Third Party Distributors and its permitted (sub)licensees and subcontractors under confidentiality and non-use obligations no less protective than those in this Article 15; provided, however, that the Receiving Party shall

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


remain responsible for any failure by any such Person to treat such Confidential Information as required by this Article 15;
15.2.8    Made by the Receiving Party or its designee to prosecute or defend litigation consistent with this Agreement, or otherwise exercise rights or enforce obligations under this Agreement or any Ancillary Agreement; or
15.2.9    Made by the Receiving Party or its designee as reasonably necessary to file, prosecute or maintain Patents Covering the Collaboration Inventions, consistent with this Agreement; provided, however, that the Receiving Party shall obtain written approval from the Disclosing Party prior to filing any documents that contain the Disclosing Party’s Confidential Information in any pending patent application or patent office, which approval shall not be unreasonably withheld, conditioned or delayed.
15.3    Confidential Information.
15.3.14    Defined. “Confidential Information” of a Party shall mean the terms of this Agreement and each Ancillary Agreement and all information provided by or on behalf of such Party (or its Affiliates) to the other Party (or its Affiliates) either in connection with the discussions and negotiations pertaining to this Agreement or any Ancillary Agreement, the MTA or the CDA or in the course of performing this Agreement or any such other agreement, including data; knowledge; practices; processes; ideas; research plans; engineering designs and drawings; research data; manufacturing processes and techniques; scientific, manufacturing, marketing and business plans; and financial and personnel matters relating to the Disclosing Party or its Affiliates, or its or their respective present or future products, sales, suppliers, customers, employees, investors or business, including any of the foregoing included in any Annexes or Exhibits to this Agreement or any Ancillary Agreement. Regardless of which Party is the disclosing Party, the Janssen-Owned Collaboration Inventions shall constitute Confidential Information of Janssen, and not Gilead (and Janssen shall be considered the Disclosing Party), the Gilead-Owned Collaboration Inventions shall constitute Confidential Information of Gilead, and not Janssen (and Gilead shall be considered the Disclosing Party), and the Joint Collaboration Inventions shall constitute the Confidential Information of both Parties (and each Party shall be considered the Disclosing Party).
15.3.15    Exclusions. Notwithstanding the foregoing, any information of the Disclosing Party shall not be deemed Confidential Information with respect to the Receiving Party if it:
15.3.15.1    was already known to the Receiving Party or any of its Affiliates, other than to the extent and for so long as the Receiving Party (or its Affiliate) is under an obligation of confidentiality or non-use with respect to such information, at the time of disclosure to such Receiving Party or its Affiliate;
15.3.15.2    was generally available or known, or was otherwise part of the public domain, at the time of disclosure to such Receiving Party or its Affiliate;

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


15.3.15.3    became generally available or known, or otherwise became part of the public domain, through no fault of the Receiving Party or any of its Affiliates in violation of this Article 15 or the CDA, after its disclosure to such Receiving Party or its Affiliate;
15.3.15.4    was received by such Receiving Party or any of its Affiliates from a Third Party that, to the knowledge of the Receiving Party, had no obligation to the Disclosing Party (or its Affiliate) not to make such disclosure; or
15.3.15.5    was independently discovered or developed by such Receiving Party or any of its Affiliates, as evidenced by their written records, without the use of Confidential Information of the Disclosing Party.
Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of a Party or its Affiliate merely because the Confidential Information is embraced by more general information in the public domain or in the possession of such Party or its Affiliate. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of a Party or its Affiliate merely because individual elements of such Confidential Information are in the public domain or in the possession of such Party or its Affiliate unless the combination and its principles are in the public domain or in the possession of such Party or its Affiliate.
15.4    Notification. Each Party shall notify the other Party immediately, and cooperate with the other Party as the other Party may reasonably request, upon the first Party’s discovery of any loss or compromise of the other Party’s Confidential Information.
15.5    Data Privacy. Without limitation of its other obligations under this Article 15, each Party shall, and shall cause each of its Affiliates to, comply with Applicable Law, including the applicable national laws implementing the European Union Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data of 24 October 1995, with respect to the collection, use, transfer, storage, deletion, processing (both by computer and manually), combination or other use of subject or other personal data as contemplated by applicable data protection or privacy laws of all data relating to any Person about whom or which data may be collected, retained or exchanged pursuant to this Agreement or any Ancillary Agreement. Without limitation of the foregoing, each Party shall, and shall cause each of its Affiliates to, ensure that it takes any technical and organizational measures required by Applicable Law to protect any such data against accidental or unlawful destruction, loss, damage, alteration, disclosure, access or data processing and against all other unauthorized disclosure, access or forms of data processing.
15.6    Remedies. Each Party agrees that the unauthorized use or disclosure of any material Confidential Information by the Receiving Party in violation of this Agreement may cause severe and irreparable damage to the Disclosing Party, for which money damages may represent an insufficient remedy. In the event of any violation of this Article 15, notwithstanding anything in this Agreement to the contrary, the Disclosing Party shall be authorized and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or

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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


permanent, with respect to such violation as well as any other relief permitted by Applicable Law.
16
PRESS RELEASES, PUBLICATIONS AND PUBLIC RELATIONS MATTERS
16.1    Initial Statements. Each Party shall have the right to release publicly, upon or after the Restatement Effective Date, that certain press release of such Party attached hereto as Annex S.
16.2    Other Public Disclosures. As between the Parties, subject to Section 3.6 and this Section 16.2, Gilead shall have the primary responsibility for public communications regarding the Exploitation of the Territory Combination Products in the Territory. If either Party or its Affiliates desires to make a public announcement (such as a press release) that relates to the Exploitation of a Territory Combination Product, other than (i) with respect to Results, which are governed by Section 3.6, or (ii) subject to the following sentence, general business updates (even if they include information relating to a Territory Combination Product, so long as they are of the type of updates that are also generally made for such Party’s other similar pharmaceutical products generally), the announcing Party (or Affiliate) shall give reasonable advance notice of the proposed text of such announcement (translated into English, if not in English) to the other Party for its prior review. Other than with respect to Results, which are governed by Section 3.6, (a) in the case of Janssen as the announcing Party, any proposed public announcement that refers to the safety, efficacy or other characteristics of a Territory Combination Product or any Gilead Compound Product, shall be subject to prior written approval by Gilead, such approval not to be unreasonably withheld, conditioned or delayed and (b) in the case of Gilead as the announcing Party, any proposed public announcement that refers to the safety, efficacy or other characteristics of a Territory Combination Product or any RPV Product, shall be subject to prior written approval by Janssen, such approval not to be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, nothing shall preclude either Party from making any public announcement regarding its generics program that is not specific to the other Party (or its Affiliates) and no such announcement shall be subject to prior review by the other Party hereunder. Further, if any proposed public announcement by either Party that relates to the Exploitation of a Territory Combination Product uses any name or any Trademark of the other Party or its Affiliates (other than a Gilead Licensed Trademark or a Janssen Licensed Trademark used in connection with Territory Combination Product), such public announcement shall be subject to prior approval of such other Party, except to the extent such announcement is required by Applicable Law. If the non-announcing Party with respect to any public announcement provided by the announcing Party for review under this Section 16.2 desires to provide comments or, if applicable, indicate whether the applicable public announcement is approved, it shall do so as soon as reasonably practicable but in any event within three (3) Business Days after receiving the proposed announcement for review. Subject to Section 16.3, neither Party shall be required to have the other Party review or, if applicable, approve the public disclosure of any information that has already been publicly disclosed by either Party in accordance with Section 3.6, Section 15.2 or this Section 16.2. In the event of a legally required press release or other public announcement or disclosure, the Party (or its Affiliate) desiring to make such announcement shall provide the other Party with a copy of the proposed text with as much notice

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


as practicable (which shall, to the extent practicable under the circumstances, be no less than three (3) Business Days prior to the proposed disclosure), the other Party shall respond with its comments (if any) as promptly as practicable (but not less than one (1) Business Day prior to the proposed disclosure), and the proposing Party shall take into due consideration any and all reasonable comments that the other Party may provide in a timely manner; provided, however, that, notwithstanding the foregoing, if a Party determines that it or any of its Affiliates must make a legally required disclosure under Applicable Law, then it or its Affiliate, as applicable, shall have the right to make such disclosure at such time as is necessary to comply with Applicable Law, and shall provide the other Party as much notice and opportunity for review and comment as is practicable in the circumstances. Without limitation of any of the foregoing, each Party shall comply, and ensure that its Affiliates and Sublicensees comply with, any press release or other non-disclosure provisions as required by any In-License Agreement, as specified in the In-License Requirements.
16.3    Use of Names. Except as otherwise permitted expressly herein or in any Ancillary Agreement or other written agreement between the Parties (or their respective Affiliates), neither Party shall mention or otherwise use any Trademark, including any name, insignia, symbol, trade name or logotype of the other Party or its Affiliates or of any party to an In-License Agreement of the other Party or its Affiliates (or any abbreviation or adaptation thereof) in any publication, press release, promotional material or other form of publicity without the prior written approval of such other Party in each instance. The restrictions imposed by this Section 16.3 shall not prohibit a Party from making any (a) use of the brand name or brand mark of the other Party’s Single Agent Product(s) or Double Agent Product or (b) disclosure identifying the other Party (or such other Party’s predecessor) or such other Party’s Single Agent Product(s) or Double Agent Product(s), in each case ((a) and (b)), that is required by Applicable Law, nor shall it prohibit Janssen from using the brand name or brand mark for a Territory Combination Product or Combination Product Trademarks in informational materials, provided that any substantive inquiries relating to the Territory Combination Products that arise from such use are referred to the appropriate Party in accordance with Section 5.2 or Section 6.3.2, as applicable, and, further provided that such use shall not be accompanied by any claims regarding the safety or efficacy of such Territory Combination Product, or otherwise describe the characteristics of such Territory Combination Product, other than the identification of the RPV therein, in each case, without such approval.

17
REPRESENTATIONS, WARRANTIES AND COVENANTS; DISCLAIMER
17.1    Mutual Representations, Warranties and Covenants. Except as set forth in the applicable Disclosure Statement with respect to representations, warranties and covenants made as of the Restatement Effective Date, each Party hereby represents and warrants and covenants to the other Party, as of the Original Effective Date and the Restatement Effective Date, as follows:
17.1.16    Good Standing. In the case of Gilead Parent, it (a) is a corporation duly organized and in good standing under the laws of Delaware and (b) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


now being conducted and as it is contemplated to be conducted by this Agreement. In the case of Gilead Sub, it (i) is a company duly organized and in good standing under the laws of Ireland, and (ii) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement. In the case of Janssen, it (x) is a company duly organized and in good standing under the laws of Ireland, and (y) has full power and authority and the legal right to own and operate its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement.
17.1.17    Power and Authority. Such Party (or, in the case of Gilead, each of Gilead Parent and Gilead Sub) (i) has the power and authority and the legal right to enter into this Agreement and any Ancillary Agreements to which it is a party and to perform its obligations hereunder and thereunder, and (ii) has taken (or will take, in the case of the Ancillary Agreements not yet executed) all necessary action on its part required to authorize the execution and delivery of this Agreement and any Ancillary Agreements to which it is a party. This Agreement has been (and all Ancillary Agreements to which it is a party, when executed and delivered, will have been) duly executed and delivered on behalf of such Party (or, in the case of Gilead, each of Gilead Parent and Gilead Sub, as applicable) and constitutes (and all such Ancillary Agreements, when duly executed and delivered by all parties thereto, will constitute) a legal, valid and binding obligation of such Party and is (and in the case of all such Ancillary Agreements, when duly executed and delivered by all parties thereto, will be) enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered in a proceeding at law or equity.
17.1.18    Litigation. Such Party is not aware of any pending or threatened litigation (and has not received any communication) that alleges that such Party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated in this Agreement such Party would violate, any of the intellectual property rights of any other Person (after giving effect to the license grants in this Agreement). As of the Original Effective Date, to such Party’s knowledge as of such date, and the Restatement Effective Date, to such Party’s knowledge as of such date, there is no products liability litigation, with respect to such Party’s Single Agent Product(s) or Double Agent Products, as applicable, that is currently pending or that was pending at any time on or after January 1, 2001.
17.1.19    Consents. All necessary consents, approvals and authorizations of all regulatory and governmental authorities and other Persons (i) required to be obtained by such Party in connection with the execution and delivery of this Agreement and any Ancillary Agreements have been obtained (or will have been obtained prior to such execution and delivery) and (ii) required to be obtained by such Party in connection with the performance of its obligations under this Agreement and any Ancillary Agreements have been obtained or will be obtained prior to such performance.

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


17.1.20    No Conflicts. With respect to such Party, the execution and delivery of this Agreement and the Ancillary Agreements, and the performance of such Party’s obligations hereunder and thereunder (i) do not conflict with or violate in any material way any requirement of Applicable Law, (ii) do not conflict with or violate any provision of the articles of incorporation, bylaws, limited partnership agreement or any similar instrument of such Party or any of its Affiliates, and (iii) do not conflict with, violate, or breach or constitute a default under, any contractual obligation of such Party or any of its Affiliates, including in the case of Gilead, any obligation under any agreement relating to Atripla to which Gilead Parent or Gilead Sub or any of their Affiliates is a party, or any court or administrative order by which such Party (or, in the case of Gilead, either Gilead Parent or Gilead Sub) or any of its Affiliates is bound.
17.1.21    No Adverse Proceedings. There is not pending or, to the knowledge of such Party, threatened, against such Party, any claim, suit, action or governmental proceeding, that would, if adversely determined, materially impair the ability of such Party to perform its obligations under this Agreement or any Ancillary Agreement.
17.1.22    No Debarment. Neither such Party nor any of its Affiliates has been debarred or is subject to debarment, and neither such Party nor any of its Affiliates shall use in any capacity, in connection with the activities to be performed under this Agreement, any Person who has been debarred pursuant to Section 306 of the Act, or who is the subject of a conviction described in such section. Such Party agrees to inform the other Party in writing immediately if it or any Person who is performing activities on its behalf under this Agreement is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the knowledge of such first Party, is threatened, relating to the debarment or any such conviction of such Party or any Person performing activities on its behalf under this Agreement.
17.1.23    No Conflicting Grants; Absence of Encumbrance. Such Party has the right to grant the licenses granted by such Party to the other Party hereunder, and has not, prior to the Restatement Effective Date, made a grant to any Third Party of any right or license that would conflict with any grant of rights or licenses granted by such Party to the other Party hereunder. The Patents licensed by such Party hereunder are not subject to any encumbrance or lien by any Third Party (except for any such encumbrances or liens as would not, in the aggregate, have a material adverse effect on the license rights granted to the other Party under this Agreement). Such Party covenants and agrees that it shall not, from and after the Restatement Effective Date and throughout the Term, grant to any Third Party any right or license in respect of the Patents licensed hereunder, including by amending any existing agreement, that would conflict with any grant to the other Party hereunder.
17.1.24    Compliance with Applicable Law. Notwithstanding anything to the contrary in this Agreement, such Party shall, and shall cause its Affiliates, Sublicensees and Third Party Distributors to, comply with all Applicable Law of the country or other jurisdiction, or any court or agency thereof, applicable to the performance of its activities hereunder or any obligation or transaction hereunder, including those pertaining to the production and handling of drug products (which shall also be subject in the case of the Supplied RPV, to the RPV Supply

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


Agreement), such as those set forth by the Regulatory Authorities as applicable, and the applicable terms of this Agreement in the performance of its obligations hereunder.
17.1.25    Affiliates. To the extent the intellectual property or Regulatory Documentation licensed under Article 9 by a Party is Controlled by such Party’s Affiliates, such Party has the right to use, and has the right to grant sublicenses to the other Party to use, such intellectual property or Regulatory Documentation.
17.1.26    Ethical Business Practices. Neither such Party nor its Affiliates will make any payment, either directly or indirectly, of money or other assets, including the compensation such Party derives from this Agreement (collectively a “Payment”), to government or political party officials, officials of International Public Organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively “Officials”) or other individuals where such Payment would constitute violation of any law, including the Foreign Corrupt Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et seq, and the United Kingdom Bribery Act. In addition regardless of legality, neither such Party nor its Affiliates will make any Payment either directly or indirectly to Officials or other individuals if such Payment is for the purpose of improperly influencing decisions or actions to secure a business advantage, including with respect to the subject matter of this Agreement. Each Party shall have necessary procedures in place to prevent bribery and corrupt conduct by itself and each of its Affiliates and subcontractors. All activities will be conducted in compliance with the U.S. False Claims Act and the U.S. Anti-Kickback Statute. Each Party and each of its Affiliates and subcontractors shall conduct its activities hereunder in accordance with the provisions of Annex T attached hereto.
17.1.27    Cooperation with In-License Agreement Compliance. Each Party shall, at the reasonable request of the other Party, provide reasonable assistance and cooperation to the requesting Party to enable such requesting Party (or any of its Affiliates) to comply with its obligations under any In-License Agreement as specified in the In-License Requirements.
17.2    Additional Representations, Warranties and Covenants of Janssen. Except as set forth in the applicable Disclosure Statement with respect to representations, warranties and covenants made as of the Restatement Effective Date, Janssen hereby represents, warrants and covenants to Gilead as follows:
17.2.3    Without the prior written consent of Gilead: (i) Janssen shall not, and shall cause its Affiliates not to, make, have made, use, sell, have sold, offer for sale, or import, and (ii) Janssen shall not, and shall cause its Affiliates not to, grant any rights to any Third Party to make, have made, use, sell, have sold, offer for sale, or import, in each case ((i) and (ii)) in the Field in the Territory (A) a Combination Product other than pursuant to this Agreement or (B) any Other Combination Product in each case ((A) and (B)) for a period commencing as of the Restatement Effective Date and ending on [*] provided, however that in each case ((A) and (B)):
17.2.3.10    Janssen and its Affiliates shall not be precluded by the foregoing or otherwise under this Agreement from granting licenses or other rights, but, except in the case of the MPP, excluding the right to sublicense, under Janssen’s and its Affiliates’

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


intellectual property (but, for clarity, not including any of the Gilead Technology or Gilead Regulatory Documentation or Combination Product Regulatory Documentation and in the case of the Joint Technology, solely as permitted under Section 14.1.4), to allow as to any prohibition under this Agreement (a) any Other Generic Licensee to engage in any or all of the following: [*] or (b) any Region C Generic Licensee to engage in the Region C Generic Rights subject to the Region C Generic Conditions; and
17.2.3.11    nothing in this Section 17.2.1 shall preclude Janssen or its Affiliates from conducting any clinical trial that it is permitted to conduct under Article 3 or from granting rights in accordance with Article 3 to one or more Third Party(ies) to conduct any clinical trials as permitted under Article 3; and
17.2.3.12    nothing in this Section 17.2.1 shall require Janssen or its Affiliates to amend any license agreement executed with a Generic Licensee prior to the Restatement Effective Date, provided that nothing in this Section 17.2.1.3 shall excuse Janssen from a failure to comply with one or more of its obligations in the Original Amendment with respect to its Generic Licensees prior to the Restatement Effective Date.
17.2.4    There are no judgments or settlements against, or amounts with respect thereto owed by, Janssen relating to the Janssen Patents. To the knowledge of Janssen, except as was otherwise disclosed in writing by Janssen to Gilead on or before the Original Effective Date, Janssen has not received written notice of any Proceeding in which it is alleged that, with respect to the Territory (i) any of the Janssen Patents that are composition of matter Patents are invalid or unenforceable or (ii) the Exploitation of RPV (in API or other form), whether alone or in combination with either or both of TDF and FTC, infringes any Third Party Patent (other than any such infringement that would arise from the Exploitation of either or both of TDF and FTC in the absence of the RPV (in API or other form)). The representations in this Section 17.2.2 are made as of the Original Effective Date.
17.2.5    There are no judgments or settlements against, or amounts with respect thereto owed by, Janssen relating to the Janssen Patents that are composition of matter Patents. To the knowledge of Janssen, Janssen has not received written notice of any Proceeding in which it is alleged that, with respect to the Territory (i) any of the composition of matter claims in any Janssen Patents are invalid or unenforceable or (ii) the Exploitation in the Field of RPV (in API or other form), whether alone or in combination with TDF, TAF or FTC, or both TDF and FTC or TAF and FTC, infringes any Third Party Patent (other than any such infringement that would arise from the Exploitation of TDF, TAF or FTC, or both TDF and FTC or TAF and FTC, in the absence of the RPV (in API or other form)). Janssen represents and warrants that it shall remain in good standing with regard to any In-License Agreements of Janssen throughout the Term. The representations in this Section 17.2.3 are made as of the Restatement Effective Date.
17.2.6    To the knowledge of Janssen as of the Original Effective Date, the information contained in its INDs for Edurant represents, in all material respects, a complete and accurate reflection of the safety and efficacy profile of Edurant as of such date. As of the date of submission of the NDA for Edurant to the FDA, to the knowledge of Janssen as of such date, the information contained in such NDA as of such date represented, in all material respects, a

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


CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. §§ 200.80(b)(4) AND 240.24B-2


complete and accurate reflection of the safety and efficacy profile of Edurant as of such date. It is understood and agreed that Janssen makes the representation, warranty and covenant to Gilead set forth in this Section 17.2.4 solely for purposes of the Parties’ collaboration pursuant to this Agreement, and for no other purpose. The representation in the first sentence of this Section 17.2.4 is made as of the Original Effective Date.