Third Amendment to License Agreement




			
	Execution Copy	 	Exhibit 10.85

 THIRD AMENDMENT TO LICENSE AGREEMENT 

THIS THIRD AMENDMENT (this “Amendment”) is made and entered into as of July 5, 2011 by and between JAPAN TOBACCO INC.,
a Japanese corporation having its principal place of business at JT Building, 2-1 Toranomon, 2-chome, Minato-ku, Tokyo 105-8422, Japan (“JT”), and GILEAD SCIENCES, INC., a Delaware corporation having its principal place of business
at 333 Lakeside Drive, Foster City, CA 94404, United States (“Gilead”). JT and Gilead are sometimes referred to herein individually as a “Party” and collectively as the “Parties.” 

RECITALS 
 WHEREAS, JT
and Gilead have previously entered into a License Agreement dated March 22, 2005 which was amended on May 19, 2005 and May 17, 2010 (such License Agreement, as amended previously and contemporaneously with this Amendment, the
“EVG Agreement”) relating to a compound designated as JTK-303, which is now known as Elvitegravir (“EVG”); and 

WHEREAS, Gilead desires to arrange for a product containing EVG as the sole active pharmaceutical ingredient and the Quad (as defined below)
to be made available in developing countries which cannot afford developed-world pricing for the products and JT desires to facilitate such Gilead efforts by agreeing to amend the EVG Agreement as set forth herein. 

NOW THEREFORE, based on the foregoing premises and the mutual covenants and obligations set forth below, the Parties agree as follows: 

ARTICLE 1 
 DEFINITIONS

 Unless otherwise specified, capitalized terms not defined in this Amendment shall have the definitions set forth therefor in the
EVG Agreement. The EVG Agreement is hereby amended by adding the following defined terms: 

1.1         “Access Countries” shall mean the Access Group A Countries, the Access Group B
Countries and the Access Group C Countries. 
 1.2         “Access Group A
Countries” shall mean the countries listed on Schedule 1.65 A attached to this Amendment which consists of (i) the countries of Sub-Saharan Africa defined by The World Bank on the date of this Amendment, (ii) countries classified
as low-income economies by The World Bank on the date of this Amendment, and (iii) countries listed by United Nations Conference On Trade and Development as least developed countries. If on the Launch Date or at any time thereafter a country
not on Schedule 1.65 A is classified as a low-income economy by The World Bank or a country listed by United Nations Conference On Trade and Development as least developed country, then Gilead may amend Schedule 1.65 A to add such country upon prior
written notice to JT and in accordance with any applicable requirements set forth in Section 2.8 of this Amendment. If such added country is listed on any other Schedule of this Amendment, then such Schedule shall be amended to delete such
country. 

  
 1 


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








 Exectuion Copy 
  

1.3         “Access Group B Countries” shall mean the countries listed on Schedule 1.65 B
attached to this Amendment. If on the Launch Date or at any time thereafter a country not on Schedule 1.65 B is classified as a lower-middle-income economy (or lower classification than lower-middle-income economy) by The World Bank, then Gilead may
amend Schedule 1.65 B to add such country upon prior written notice to JT and in accordance with any applicable requirements set forth in Section 2.8. If on the Launch Date or at any time thereafter a country not on Schedule 1.65 B is
classified in higher class than lower–middle-income economy by The World Bank, then Gilead may only amend Schedule 1.65 B to add such country upon prior written approval by JT and in accordance with any other requirements, if applicable, set
forth in Section 2.8 of this Amendment. If any such added country is listed on any other Schedule of this Amendment, then such Schedule shall be amended to delete such country. 

1.4         “Access Group C Countries” shall mean the countries listed on Schedule 1.65 C
attached to this Amendment. Gilead may only amend Schedule 1.65 C to add such country upon prior written approval by JT and in accordance with any applicable requirements set forth in Section 2.8 of this Amendment. 

1.5         “B/C Countries” shall mean all Access Group B Countries and the Access Group C
Countries. 
 1.6         “Branded Products” shall mean the Products sold by
Gilead or its Affiliates or Sublicensees other than Generic Versions. 
 1.7        
“Excluded Net Sales” shall mean Net Sales of Branded Products sold by Gilead or its Affiliates or Sublicensees for distribution solely within Access Group A Countries and Net Sales of Generic Versions under Generic Licenses in the
Generic Territory. 
 1.8         “Generic License” shall mean a sublicense by
Gilead or its Affiliate of its rights granted under Article 6 of the EVG Agreement to a Generic Licensee to (i) sell Generic Versions solely within the Generic Territory, (ii) make Generic Versions in India (Republic of India) solely for
the purpose of selling them in the Generic Territory, (iii) make Generic Versions in South Africa solely for sale in Sub-Saharan Africa, from EVG API made by a Generic Licensee in India (Republic of India) or made by a contract manufacturer
that makes EVG API for Gilead’s Branded Product, (iv) make Generic Versions in Thailand solely for sale in Thailand, from EVG API made by a Generic Licensee in India (Republic of India) or made by a contract manufacturer that makes EVG API
for Gilead’s Branded Product, and/or (v) make API of EVG in India (Republic of India) and sell such API of EVG to other Generic Licensees in India (Republic of India), Thailand or in South Africa, solely for the purpose of making Generic
Versions pursuant to 1.8(ii) or 1.8(iii) or 1.8(iv) set forth above. For clarity, unless otherwise expressly provided in this Amendment, both of the sublicense granted by Gilead to MPPF as well as MPPF License shall be deemed to be included in
Generic License. 
 1.9         “Generic Licensee” shall mean a Sublicensee of
Gilead or its Affiliate that has been granted a Generic License to make and/or sell API of EVG and/or Generic Versions and that has been granted no other rights to Products, except that a Generic Licensee may be granted the right to distribute
Branded Products solely within countries in the Generic Territory. For clarity, unless otherwise expressly provided in this Amendment, both of the MPPF and any 

  
 2 


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








 Exectuion Copy 
  


third party granted the sublicense from MPPF under Section 3.2 of this Amendment shall be deemed to be included in Generic Licensee. 

1.10         “Generic Net Sales” shall mean the net sales of EVG Generic Versions in the
Generic Territory as such net sales are defined in the applicable Generic License, and as reported by the applicable Generic Licensee. For products containing EVG and one or more other APIs, such net sales shall mean the portion of net sales
allocated to the EVG component as set forth in section 4.2 of the Generic License templates attached as Attachments A and B to this Amendment, or as set forth the corresponding provision in a Generic Sublicense to TGPO. If such allocations are not
reported by the Generic Licensee(s), then Gilead and JT shall agree on the allocation based on available data on net selling prices of applicable generic products in the Generic Territory. 

1.11         “Generic Territory” shall mean the Access Group A Countries and the Access
Group B Countries. 
 1.12         “Generic Versions” shall mean the Products
manufactured by Generic Licensees that are not sold under any Regulatory Approvals obtained by or for Gilead or its Affiliate, and which are marketed and promoted using different product trademarks than the Trademark. For clarity, it is expected
that Generic Versions will receive Regulatory Approvals based on reference to Regulatory Approvals obtained by or for Gilead for Branded Products. 
 1.13         “JT Patent Expenses” shall mean [*] expenses (including attorneys’ fees) actually incurred by JT to file, maintain, Prosecute or
enforce any patents or patent applications in or for the Access Group A Countries which are licensed by JT to Gilead under EVG Agreement. 

1.14         “Launch Date” shall mean the earliest date of Commercial Launch of a Branded
Product. 
 1.15         “MPPF” shall mean the Medicines Patent Pool Foundation,
at 150 route de Ferney, PO Box 2100, CH-1211 Geneva 2, Switzerland. The sublicense of the Generic License granted by Gilead to MPPF pursuant to Section 3.2 of this Amendment shall be referred to as the “MPPF License”.

 1.16         “Net Sales” shall mean Net Sales as defined in Section 1.65
of the EVG Agreement and not as defined in section 1.8 of the Second Amendment dated May 10, 2010 to the EVG Agreement. 

1.17         “Region” shall mean any one of Access Group A Countries, Access Group B
Countries or Access Group C Countries. 
 1.18         “TGPO” shall mean The
Government Pharmaceutical Organization, a state enterprise of the government of Thailand. 
 ARTICLE 2 

ACCESS COUNTRIES AND NET SALES 

  
 3 


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








 Exectuion Copy 
  

2.1         Net Sales in Access Countries. “Net Sales” shall [*] provided, however,
that annual net sales and unit sales volume of each of Branded Products and Generic Versions (including, but not limited to, Generic Version containing a combination of APIs that are different from any Product under development or being marketed by
Gilead, as set forth in Section 3.3 of this Amendment) in the Access Countries shall be reported by Gilead to JT in writing on a country-by-country and product-by-product basis, within ninety (90) days after the end of each calendar year,
to the extent such information is available to Gilead. 
 2.2         Amendment of Net Sales
Definition. Section 1.65 (“Net Sales”) of the EVG Agreement hereby is amended by deleting the following words and replacing them by the following words: 
 Deleted Words: “Distribution to Global Access Programs. To the extent Gilead or its Affiliates distribute Product through government agencies, not-for-profit non-governmental organizations,
physicians, pharmacies or patients in the countries listed in Schedule 1.65 at reduced rates (the “Gilead Global Access Program”), Net Sales for the purposes of determining royalties payable under this Agreement on Products distributed to
a Gilead Global Access Program will be calculated by reducing the gross amount invoiced to the Global Access Program for such Product by Gilead’s Manufacturing Costs, including, to the extent not included as Manufacturing Costs, reasonable
overhead and depreciated facilities expenses and administrative costs in direct support of the manufacturing of the Product and of Gilead’s Global Access Program in accordance with practices and procedures consistent with those of other
relevant products in the Gilead Global Access Program, for the Product less all credits or allowances granted on account of rejections, returns, billing errors or retroactive price reductions, and duties, taxes and other governmental charges,
provided that the total resulting amount shall not be reduced below zero after deduction of applicable credits and allowances.” 

Replacement Words: “Adjustment for Combination Products.” 
 Schedule 1.65 attached to the EVG Agreement is hereby deleted. 

2.3         Royalty Due to JT for Sales of Generic Versions. Gilead shall pay JT a royalty of
[*] of Generic Net Sales only in Access Group B Countries of the Generic Territory. The provisions of Sections 8.4, 8.5, 8.6, 8.7, 8.8 and 8.9 of the EVG Agreement shall apply to such royalty payments, except that Gilead’s payment shall
be due thirty (30) days after receipt of the royalty report from the Generic Licensee reporting such Generic Net Sales. 

2.4         [*] shall be reported in the quarterly royalty reports to JT under Section 8.4 of
the EVG Agreement. 
 2.5         Access Countries. Section 5.5 (“Global Access
Program”) of the EVG Agreement hereby is amended to read as follows: 
 “5.5     Access Countries. In
its program to provide Products in the Access Countries (either by itself or through Generic Licensees) Gilead shall undertake commercially reasonable efforts to seek to prevent adverse effects on Net Sales of Products in countries that are not in
the Access Countries, which efforts are consistent with those Gilead uses with its other HIV products. Gilead will discuss in good faith with JT any such preventative efforts and 

  
 4 


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








 Exectuion Copy 
  


shall keep JT reasonably informed of actions taken in furtherance of such efforts to prevent adverse effects on Net Sales of Product in countries that are not Access Countries. In any Gilead
press release announcing an expansion of the Gilead global access program with respect to the Product, Gilead shall comply with Section 13.3 of the EVG Agreement and also shall include a statement to the effect that JT has agreed to reduce or
waive its right to a royalty on sales of the Product in the Access Countries.” 
 2.6        
No Application of Certain Provisions to Access Countries. [*]. 
 2.7         JT Patent
Expenses. JT Patent Expenses will be billed to Gilead quarterly and shall be paid by Gilead to JT within thirty (30) days from receipt of invoice, such invoice and payments to be in United States Dollars (converted from other currencies
pursuant to JT’s central currency conversion system). The IP Subcommittee shall determine a reasonable strategy, including the [*] that would cause JT to incur JT Patent Expenses. If the IP Subcommittee agrees on the strategy for such
proceeding or action, then Gilead will reimburse JT for such JT Patent Expenses. If the IP Subcommittee does not agree on a strategy for such proceeding or action at any time, then (a) JT will be entitled to pursue its own strategy for such
proceeding or action, keeping Gilead reasonably informed, and (b) Gilead [*] for such proceeding or action. Any such failure by the IP Subcommittee to agree shall not be subject to further review under Section 9.2(c) or Article 15
of the EVG Agreement. For clarity, [*] even if Gilead does not agree on the strategy therefor. 

2.8         Changes to Schedules 1.65 A, 1.65 B or 1.65 C. Gilead may remove a country from any of
Schedules 1.65 A, 1.65 B or 1.65 C (the “ABC Schedules”) upon prior written notice to JT. If any country on an ABC Schedule (e.g., Sudan) is divided into two or more countries, then such countries automatically shall take the place, on
such ABC Schedule, of the country which was divided. If Gilead wishes to add a country to an ABC Schedule and this Amendment does not permit Gilead to do so upon prior written notice to JT, then Gilead shall request the addition of such country to
JT along with a justification for such addition, and such addition shall be subject to JT’s written consent. If the criteria (except routine adjustments to the threshold income levels) of categorization of a country’s economic situation by
The World Bank or United Nations Conference On Trade and Development is changed, upon JT’s request, Gilead and JT shall discuss in good faith to modify the criteria to amend Schedules 1.65 A, 1.65 B or 1.65 C set out in Sections 1.2, 1.3 and
1.4. 
 ARTICLE 3 

GENERIC LICENSES 

3.1         JT Consent. JT consents to Gilead entering into Generic Licenses with Generic Licensees
on the condition that: (i) the terms and conditions of Generic Licenses shall not be less favorable to JT than the agreement templates attached hereto as Attachment A for semi-exclusive license and Attachment B for non-exclusive license; and
(ii) Gilead shall use reasonable efforts to cause each Generic Licensee to substantially fulfill all its obligations under Generic License and Gilead’s obligations under the EVG Agreement. Gilead shall not grant to Generic Licensee or any
other entity the right to sublicense the Generic License to a third party. For clarity, Gilead may sell Branded Products in the Generic Territory. Any Generic License granted by Gilead to TGPO shall be subject to the prior written approval of JT and
shall be subject to subsection 3.1(ii) above. For clarity, any Generic License granted by Gilead to sell 

  
 5 


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








 Exectuion Copy 
  


EVG API to TGPO shall be subject to the prior written approval of JT and shall be subject to subsection 3.1(ii) above. 
 3.2         MPPF License. Notwithstanding Section 3.1 of this Amendment, Gilead may grant the right to MPPF to issue single tier sublicenses to Generic Licensees
under terms and conditions approved by JT in writing. 
 3.3         Generic Version of
Different Combination. If a Generic Licensee proposes to commercialize a Generic Version which contains a combination of APIs that are different (including different dosages, other than of EVG) from any Product under development or being
marketed by Gilead, then such commercialization shall be subject to prior review and approval by Gilead with regard to safety considerations. 
 3.4         Sharing of Generic License Agreement. Upon JT’s request, Gilead shall promptly provide to JT a list of the then-current Generic Licensees and a copy
of the Generic License agreement (including any amendment thereto) with each Generic Licensee, and a copy of the MPPF License. Gilead may redact information pertaining only to products which are not Products. 

3.5         Generic Licensee Know-How and Patents. JT understands that Gilead has obligations under
Section 6.5 of the EVG Agreement with respect to sublicense of Gilead Sublicensee Know-How and Gilead Sublicensee Patents, and that [*]. Gilead will keep JT apprised of any Gilead Sublicensee Know-How and Gilead Sublicensee Patents of
Generic Licensees that is provided or reported to Gilead by the Generic Licensees and sublicensable to JT, including [*]. For purposes of Section 9.3(c) (“Gilead Patents”) and 9.4(c) (“Infringement of Gilead Patents”)
of the EVG Agreement, “Gilead Patents” shall not include Patents of Generic Licensees. For clarity, any inconsistent or additional obligations of Gilead to obtain rights to Sublicensee Know-How and Sublicensee Patents of Generic Licensees
under the EVG Agreement are hereby superseded. 
 3.6         Generic Licensee Information and
Regulatory Filings. JT acknowledges that it shall have no access to or rights to obtain, use or reference any Regulatory Information, records, regulatory filings, correspondence with Regulatory Authorities, Marketing Authorization Applications,
INDs and post-approval Phase IIIB/IV data for Products or Regulatory Approvals of Generic Licensees with respect to Generic Versions, except as provided under Section 3.5 of this Amendment. Notwithstanding the foregoing, JT shall have the right
to obtain, use or reference the above-mentioned data, documents and information, if and to the extent Gilead has the right to obtain, use or reference the above-mentioned data, documents and information. 

3.7         Safety Data. JT agrees that Section 4.4 (“Adverse Event Reporting and Safety
Data Exchange”) of the EVG Agreement shall not apply to Generic Versions. Notwithstanding the foregoing, JT shall have the right to obtain, use or reference such data, documents and information with respect to safety or adverse events, if and
to the extent Gilead has the right to obtain, use or reference such data, documents and information with respect to safety or adverse events. 
 3.8         Promotional Materials. JT agrees that Section 5.3 (“Promotional Materials”) of the EVG Agreement shall not apply to Promotional Materials of
Generic Licensees. 

  
 6 


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








 Exectuion Copy 
  

3.9           Trademark. Gilead and JT agree that the Trademark shall not be used with
respect to the Generic Versions. The Generic Licenses shall prohibit the Generic Licensee from using the Trademark with respect to Generic Versions and shall require that the Generic Versions have a trade dress that is distinct from Branded
Products. 
 3.10         Responsibility for Generic Licensees. JT acknowledges that
enforcing legal rights in some or all of the Access Countries is more challenging than in countries that are not Access Countries. Therefore, JT agrees that if the actions or inactions of a Generic Licensee cause Gilead to be in breach of the EVG
Agreement (including situations where the Generic Licensee acts in a manner inconsistent with the EVG Agreement under Section 16.9), then so long as Gilead is acting in good faith to remedy such breaches (including, without limitation,
notifying JT of any material breach (e.g. (A) material quantity of leakage of (i) Generic Versions to the countries other than Access Group A Countries and Access Group B Countries or (ii) API to the countries other than India,
Thailand or South Africa or (B) substantial deviation from Good Manufacturing Practices) of the EVG Agreement by Generic Licensees promptly after it is known to Gilead and, upon reasonable request by JT, terminating the Generic License with
respect to Products in a timely manner in accordance with the relevant provisions of Generic License), then JT agrees that it will not terminate the EVG Agreement with respect to countries that are not Access Countries because of such breach. Gilead
shall indemnify the JT Indemnitees from any losses or damages arising from any breach of the EVG Agreement due to the acts or omissions of Generic Licensees pursuant to Sections 11.2 and 11.4 of the EVG Agreement. Except as specifically set forth in
this Section 3.10, nothing in this Amendment limits any rights or remedies of JT for any breach by Gilead of the EVG Agreement. 

3.11         Amendment to Gilead’s Indemnification. The first sentence of Section 11.2 of
the EVG Agreement is hereby amended to read as follows: 
 “Gilead hereby agrees to Indemnify JT and its Affiliates, agents,
directors, officers and employees (the “JT Indemnitees”) from and against any and all Losses resulting from Third Party Claims arising directly or indirectly out of (i) a breach of any obligations of Gilead under this Agreement,
including without limitation Gilead’s representation and warranties or covenants pursuant to Article 10; or (ii) the Development, manufacture (to the extent of any formulation work performed by Gilead pursuant to Article 7), storage,
distribution, promotion, labeling, handling, use, sale, offer for sale or importation of Compound and/or Products by Gilead, its Affiliates or its Generic Licensees in the Gilead Territory (subject to Section 11.3).” 

3.12         Audit of Generic Licensees. JT agrees that it shall not have the right to directly
audit Generic Licensees under Section 12.1 (“Records; Audits”) of the EVG Agreement. Gilead shall secure the right to audit Generic Licensee in each Generic License. When Gilead has audited Generic Licensee(s), Gilead shall provide
the portions of the audit result and report relevant to Products to JT within sixty (60) days from completion of each audit. If requested by JT, Gilead shall promptly audit a Generic Licensee in accordance with Gilead’s audit rights under
the applicable Generic License. For clarity, nothing in this Section 3.8 affects JT’s right to audit Gilead or its Affiliates. 

3.13         Alternate Dosage. Gilead shall obligate and require Generic Licensees not to
manufacture or sell any Generic Versions formulated at a single dose concentration other than 

  
 7 


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








 Exectuion Copy 
  


those dose concentrations approved by the FDA for such agents, without prior written consent of Gilead. 
 3.14         Generic Licensees’ Quarterly Reports. Gilead shall obligate and require Generic Licensees to provide Gilead with quarterly reports on manufacturing
and sales as set forth in section 4.3 in Attachment A and Attachment B (and any similar provision in the Generic License to TGPO). Upon JT’s request, Gilead shall provide JT with copies of such quarterly reports; provided that Gilead may redact
information which does not pertain to the Products. 
 3.15         Annual Reports on Different
Combination or Alternate Dosage. Gilead shall make commercially reasonable efforts to determine, by itself or through Generic Licensees, the regulatory status in each country of the Generic Version (i) with different combination of APIs and
(ii) with alternate dosage, for which Gilead give the approval or consent pursuant to Section 3.3 or 3.13 of this Amendment, respectively and shall annually report to JT thereon. 

3.16         Third Party’s Infringement. If Gilead learns of any alleged or threatened
infringement of the JT Patents in the Access Countries, Gilead shall promptly report same in writing to JT in accordance with Section 9.4(a)(i) of the EVG Agreement and shall cooperate and assist JT, by itself or through Generic Licensees, in
the investigation and enforcement pertaining to such infringement. 
 3.17         JT Mark.
Gilead shall obligate and require Generic Licensees not to use any JT’s trademark, trade name, logo or service mark (each, a “JT Mark”), or any word, logo or any expression that is similar to any JT Mark. 

3.18         Consultation before disclosure of the EVG Agreement. Notwithstanding
Section 13.3(c)(iv) of the EVG Agreement, if Gilead plans to disclose any or all of the contents of the EVG Agreement to any Generic Licensee that are not in public domain, Gilead shall give JT reasonable prior written notice thereof, in which
case Gilead and JT shall discuss the necessity and the manner of such disclosure and no disclosure shall be made in the absence of agreement by the parties thereon. 
 3.19         Termination of Generic Licenses. If the EVG Agreement is terminated, Gilead shall terminate the Generic Licenses with respect to the Products as set forth
in Section 10.3(b)(iv) in Attachment A, Attachment B (and any similar provision in the Generic License to TGPO) as well as shall terminate the MPPF License with respect to the Products. 

ARTICLE 4 
 MISCELLANEOUS

 4.1           Effect. Except as expressly amended by this Amendment, the
EVG Agreement remains in full force and effect. 
 4.2          Governing Law.
This Amendment shall be governed and construed in accordance with the substantive laws of the State of New York and the federal law of the United States of America without regard to its conflict of law rules that would require the application of the
laws of a foreign state or country. 

  
 8 


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








 Exectuion Copy 
  

4.3         Further Actions. Each Party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry out the purposes and intent of this Amendment. 
 4.4         Headings. The headings for each Article and Section in this Amendment have been inserted for convenience of reference only and are not intended to limit or
expand on the meaning of the language contained in the particular Article or Section. 

4.5         Translations. This Amendment is in the English language only, which language shall be
controlling in all respects, and all versions hereof in any other language shall be for accommodation only and shall not be binding upon the Parties. All communications and notices to be made or given pursuant to this Amendment, and any dispute
proceeding related to or arising hereunder, shall be in the English language. If there is a discrepancy between any Japanese translation of this Amendment and this Amendment, this Amendment shall prevail. 

4.6         Counterparts. This Amendment may be executed in two (2) or more counterparts, each
of which shall be deemed an original, but all of which together shall constitute one (1) and the same instrument. 
 IN WITNESS
WHEREOF the Parties have executed this Amendment in duplicate originals by their duly authorized officers as of the date first set forth above. 
  

									
	Gilead Sciences, Inc.	 		 	Japan Tobacco Inc.
					
		 		 		 		 	
	By:	 	/s/ John F. Millilgan	 		 	By:	 	/s/ Noriami Okubo
		 	Name: John F. Milligan, Ph.D.	 		 		 	Name: Noriaki Okubo
			
	Title: President & Chief Operating Officer	 		 	Title: President, Pharmaceutical Business

  

  
 9 


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








 Exectuion Copy 
  

SCHEDULE 1.65 A 
 List of Access A Countries set forth in Section 1.2. 
  

							
	1.	  	Afghanistan	 	 44.
	  	Nigeria
	2.	  	Angola	 	 45.
	  	Rwanda
	3.	  	Bangladesh	 	 46.
	  	Samoa
	4.	  	Benin	 	 47.
	  	São Tomé and Principe
	5.	  	Bhutan	 	 48.
	  	Senegal
	6.	  	Botswana	 	 49.
	  	Seychelles
	7.	  	Burkina Faso	 	 50.
	  	Sierra Leone
	8.	  	Burundi	 	 51.
	  	Solomon Islands
	9.	  	Cambodia	 	 52.
	  	Somalia
	10.	  	Cameroon	 	 53.
	  	South Africa
	11.	  	Cape Verde	 	 54.
	  	Sudan
	12.	  	Central African Republic	 	 55.
	  	Swaziland
	13.	  	Chad	 	 56.
	  	Tajikistan
	14.	  	Comoros	 	 57.
	  	Tanzania
	15.	  	Congo, Dem. Rep.	 	 58.
	  	Timor-Leste
	16.	  	Congo, Rep.	 	 59.
	  	Togo
	17.	  	Côte d’Ivoire	 	 60.
	  	Tuvalu
	18.	  	Djibouti	 	 61.
	  	Uganda
	19.	  	Equatorial Guinea	 	 62.
	  	Vanuatu
	20.	  	Eritrea	 	 63.
	  	Yemen, Rep.
	21.	  	Ethiopia	 	 64.
	  	Zambia
	22.	  	Gabon	 	 65.
	  	Zimbabwe
	23.	  	Gambia, The	 		  	
	24.	  	Ghana	 		  	
	25.	  	Guinea	 		  	
	26.	  	Guinea-Bissau	 		  	
	27.	  	Haiti	 		  	
	28.	  	Kenya	 		  	
	29.	  	Kiribati	 		  	
	30.	  	Kyrgyz Republic	 		  	
	31.	  	Lao PDR	 		  	
	32.	  	Lesotho	 		  	
	33.	  	Liberia	 		  	
	34.	  	Madagascar	 		  	
	35.	  	Malawi	 		  	
	36.	  	Mali	 		  	
	37.	  	Mauritania	 		  	
	38.	  	Mauritius	 		  	
	39.	  	Mozambique	 		  	
	40.	  	Myanmar	 		  	
	41.	  	Namibia	 		  	
	42.	  	Nepal	 		  	
	43.	  	Niger	 		  	


  
 10 



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








 Execution Copy 
 SCHEDULE 1.65 B 
 List of Access B Countries set forth in Section 1.3. 

 

									
	 	1.	  	  	Anguilla (UK)	  		  	
	 	2.	  	  	Antigua and Barbuda	  		  	
	 	3.	  	  	Armenia	  		  	
	 	4.	  	  	Bahamas, The	  		  	
	 	5.	  	  	Barbados	  		  	
	 	6.	  	  	Belize	  		  	
	 	7.	  	  	Bolivia	  		  	
	 	8.	  	  	British Virgin Islands	  		  	
	 	9.	  	  	Cuba	  		  	
	 	10.	  	  	Dominica	  		  	
	 	11.	  	  	Ecuador	  		  	
	 	12.	  	  	El Salvador	  		  	
	 	13.	  	  	Fiji	  		  	
	 	14.	  	  	Georgia	  		  	
	 	15.	  	  	Grenada	  		  	
	 	16.	  	  	Guatemala	  		  	
	 	17.	  	  	Guyana	  		  	
	 	18.	  	  	Honduras	  		  	
	 	19.	  	  	India	  		  	
	 	20.	  	  	Indonesia	  		  	
	 	21.	  	  	Jamaica	  		  	
	 	22.	  	  	Kazakhstan	  		  	
	 	23.	  	  	Maldives	  		  	
	 	24.	  	  	Moldova	  		  	
	 	25.	  	  	Mongolia	  		  	
	 	26.	  	  	Nauru, Rep (UK)	  		  	
	 	27.	  	  	Nicaragua	  		  	
	 	28.	  	  	Pakistan	  		  	
	 	29.	  	  	Palau	  		  	
	 	30.	  	  	Papua New Guinea	  		  	
	 	31.	  	  	Sri Lanka	  		  	
	 	32.	  	  	St. Kitts and Nevis	  		  	
	 	33.	  	  	St. Lucia	  		  	
	 	34.	  	  	St. Vincent and the Grenadines	  		  	
	 	35.	  	  	Suriname	  		  	
	 	36.	  	  	Syrian Arab Republic	  		  	
	 	37.	  	  	Thailand	  		  	
	 	38.	  	  	Tonga	  		  	
	 	39.	  	  	Trinidad and Tobago	  		  	
	 	40.	  	  	Turkmenistan	  		  	
	 	41.	  	  	Turks and Caicos Islands	  		  	
	 	42.	  	  	Uzbekistan	  		  	
	 	43.	  	  	Vietnam	  		  	


  
 11 

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







 SCHEDULE 1.65 C 
 List of Access C Countries set forth in Section 1.4. 
  

			
	  	  	1.      Algeria
		  	 2.      Dominican Republic

		  	 3.      Egypt, Arab Rep.

		  	 4.      Morocco

		  	 5.      Tunisia



  
 1 

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







 ATTACHMENT A 

AMENDED AND RESTATED LICENSE AGREEMENT
(TEMPLATE) 
 This AMENDED AND RESTATED
LICENSE AGREEMENT (the “Agreement”) is made as of July         , 2011 (the “Effective Date”) by and between Gilead Sciences, Inc. a
Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), and
                                         a
company registered under the laws of India, and having a registered office at
                                         
                                         
      , India (“Licensee”), and amends and restates in its entirety the License Agreement dated
                                    between Gilead and
Licensee, as previously amended (the “TDF License Agreement”). 
 R E C
I T A L S 
 WHEREAS,
Gilead wishes to facilitate access to its antiviral agents to patients in the developing world to help satisfy unmet medical needs; 
 WHEREAS, to accomplish this goal, Gilead granted Licensee a non-exclusive license to manufacture Gilead’s proprietary agent TDF in India and sell such agent in India and
elsewhere in the developing world pursuant to the TDF License Agreement; 
 WHEREAS, Gilead wishes to expand the
scope of the TDF License Agreement to expand the licensed Territory and grant Licensee non-exclusive rights to Gilead’s proprietary agents elvitegravir and cobicistat, and including rights in Gilead’s proprietary fixed-dose single-tablet
regimen referred to as the “Quad”, as specifically provided herein; and 
 WHEREAS, Licensee
wishes to manufacture TDF, elvitegravir and cobicistat in India and sell products containing such agents in the Territory to help achieve the goal set forth above; 
 NOW, THEREFORE, in consideration of the mutual covenants set forth herein and other good and valuable considerations, the receipt of which is hereby acknowledged, the
parties hereto mutually agree to amend and restate the TDF License Agreement in its entirety, as follows: 
 1.    
          Definitions 
 “Active Pharmaceutical
Ingredient” or “API” shall mean one or more of the following active pharmaceutical ingredients: tenofovir disoproxil fumarate (“TDF”); elvitegravir (“EVG”), and cobicistat
(“COBI”). 
 “Alternate Dosage” shall have the meaning set forth in Section 6.2(d).


  
 2 

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







 “COBI Combination Product” shall mean a formulated and finished
pharmaceutical product containing COBI in combination with any other active pharmaceutical ingredient other than EVG, including combinations containing COBI together with TDF provided such combination does not also contain EVG (in each case subject
to the restrictions set forth in Section 2.4(c)(ii)), including any co-formulation, co-packaged product, bundled product, or other type of combination product. For clarity, the Quad is not a COBI Combination Product. 

“COBI Product” shall mean a formulated and finished pharmaceutical product containing COBI as its sole active
pharmaceutical ingredient. 
 “COBI Territory” shall mean those countries listed on Appendix 5. 

“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products, and the
Quad. 
 “Confidential Information” shall have the meaning set forth in Section 11.1. 

“Distributor” shall mean a third party wholesaler or distributor that is not a Gilead Distributor and that is operating
under an agreement with Licensee for the distribution and sale of Product in the Territory. 
 “Emtricitabine
Patents” shall have the meaning set forth in Section 7.6. 
 “EVG Combination Product” shall mean
a formulated and finished pharmaceutical product containing EVG in combination with any other active pharmaceutical ingredient (in each case subject to the restrictions set forth in Section 2.4(c)(iii)), including any co-formulation,
co-packaged product, bundled product, or other type of combination product, but not including the Quad. 
 “EVG
Product” shall mean a formulated and finished pharmaceutical product containing EVG as its sole active pharmaceutical ingredient. 
 “EVG-Quad Territory” shall mean those countries listed on Appendix 6. 
 “FDA” shall mean the United States Food and Drug Administration, and any successor agency thereto. 
 “Field” shall mean the treatment and prophylaxis of HIV infection, provided, however, that (a) for Product containing TDF as its sole active pharmaceutical ingredient, the
Field shall include the treatment and prophylaxis of Hepatitis B Virus infection, and (b) for Product containing EVG or COBI, the Field shall include any use that is consistent with the label approved by the FDA or applicable foreign regulatory
authority for the use of such Product containing EVG or COBI. 
 “Gilead Distributor” shall mean any third
party distributor that is operating under an agreement with Gilead for the distribution and sale of Gilead’s branded product in the Territory. Gilead will provide Licensee with a list, which may be updated by Gilead from time to time, of the
identity of the Gilead Distributors and their licensed territories. 

  
 3 

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







 “Gilead Mark” shall have the meaning set forth in Section 2.5(b).

 “Gilead Supplier” shall mean PharmaChem Technologies (Grand Bahama), Ltd. 

“Improvements” shall have the meaning set forth in Section 2.3. 

“Japan Tobacco” shall mean Japan Tobacco Inc., a Japanese corporation, and its affiliates. 

“Japan Tobacco Agreement” shall mean the License Agreement between Gilead and Japan Tobacco dated March 22, 2005,
as amended from time to time. 
 “JT Mark” shall have the meaning set forth in Section 2.5(b). 

“Licensed API” shall mean API that is either (a) made by Licensee pursuant to the license grant in
Section 2.1; or (b) acquired by Licensee from a Gilead Supplier or from a Licensed API Supplier on the terms and conditions set forth in Section 3. 
 “Licensed API Supplier” shall mean an entity (other than Licensee) that is licensed by Gilead to manufacture and sell API to third parties in the Field in India. 

“Licensed Know-How” shall have the meaning set forth in Section 5.5. 

“Licensed Product Supplier” shall mean an entity (other than Licensee) located in India that is licensed by Gilead to
make, use, sell, have sold, offer for sale and export Product in the Field in the Territory. 
 “Licensed
Technology” shall mean the Patents and the Licensed Know-How. 
 “Minimum Quality Standards” shall
have the meaning set forth in Section 6.2(a). 
 “NCE Exclusivity” shall mean five years of marketing
exclusivity granted by FDA pursuant to its authority under 21 U.S.C. §§ 355(c)(3)(E)(ii) and 355(j)(5)(F)(ii). 

“Net Sales” shall mean, with respect to a given calendar quarter, the total amount invoiced by Licensee for sales of
Product in the Territory, less landed cost (including freight, insurance, packing, shipping and custom duty) of imported components, VAT/Indian excise tax, sales tax, packing for shipment and shipping costs actually incurred, to the extent
consistent with Generally Accepted Accounting Principles as consistently applied across all products of Licensee. In no event shall the total deductions allowed exceed ten percent (10%) of the total amount invoiced by Licensee without Licensee
providing Gilead with supporting documentation justifying such excess and obtaining Gilead’s written consent, not to be unreasonably withheld. Net Sales on Combination Products shall be calculated based on the portion of product Net Sales
attributable to Licensed API, as set forth in Section 4.2. 

  
 4 

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







 “Patents” shall mean the patents described in Appendix 2 hereto and any
other patents and patent applications (and resulting patents therefrom) (a) owned by Gilead during the term of this Agreement, or (b) exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement, in each case
solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof, and solely to the extent the claims in such patents and patent applications cover the manufacture, use or sale of API. 

“Pediatric Formulation” shall have the meaning set forth in Section 6.2(e). 

“Product” shall mean COBI Product, EVG Product, TDF Product, COBI Combination Product, EVG Combination Product, TDF
Combination Product, and the Quad. 
 “Quad” or “the Quad” shall mean the finished
pharmaceutical product containing TDF (300 mg), emtricitabine (200 mg), EVG and COBI (each at their dose concentration approved by the FDA or applicable regulatory authority) as its only active pharmaceutical ingredients, and that is manufactured
and sold as a fixed-dose single-tablet regimen and not as a bundled or co-packaged product. 
 “Quarterly
Report” shall have the meaning set forth in Section 4.3. 
 “Royalty Term” shall have the meaning
set forth in Section 4.9. 
 “Semi-Exclusive Territory” shall mean those countries listed on
Appendix 7. 
 “TDF Combination Product” shall mean a formulated and finished pharmaceutical
product containing TDF in combination with any other active pharmaceutical ingredient other than EVG or COBI (in each case subject to the restrictions set forth in Section 2.4(c)(i)), including any co-formulation, co-packaged product, bundled
product, or other type of combination product. For clarity, the Quad is not a TDF Combination Product.  
 “TDF
Product” shall mean a formulated and finished pharmaceutical product containing TDF as its sole active pharmaceutical ingredient. 
 “TDF Territory” shall mean those countries listed on Appendix 1. 
 “Territory” shall mean the TDF Territory, the COBI Territory, the EVG-Quad Territory, and the Semi-Exclusive Territory. 

“Third-Party Resellers” shall mean Licensed Product Suppliers, Distributors and Gilead Distributors. 

2.       License Grants 
 2.1         API License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Licensee a royalty-free, non-exclusive,
non-sublicensable, non-transferable license under the Licensed Technology to make, use, offer to sell and sell 

  
 5 

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







 
API in the Field and in India, solely for the purpose of offering to sell and selling API to Licensed Product Suppliers, or for Licensee’s own internal use. For clarity, the license granted
in this Section 2.1 does not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TDF, EVG
and COBI. 
 2.2         Product License. Subject to the terms and conditions of
this Agreement, Gilead hereby grants to Licensee the following licenses: 
 (a)        
a royalty-bearing, non-exclusive, non-sublicensable (except as set forth in Section 2.4(b)), non-transferable license under the Licensed Technology solely to make, use, sell, have sold, offer for sale, export from India and import (i) TDF
Product and TDF Combination Products in the Field in the TDF Territory, (ii) COBI Product and COBI Combination Products in the Field in the COBI Territory, and (iii) EVG Product, EVG Combination Products and Quad in the Field in the
EVG-Quad Territory; provided that in each case such Products shall be made only from Licensed API; and 

(b)         a royalty-bearing, semi-exclusive (as set forth in Section 2.6),
non-sublicensable (except as set forth in Section 2.4(b)), non-transferable license under the Licensed Technology solely to make, use, sell, have sold, offer for sale, export from India and import COBI Product, COBI Combination Products, EVG
Product, EVG Combination Products and Quad in the Field in the Semi-Exclusive Territory; provided that in each case such Products shall be made only from Licensed API. 
 For clarity, (a) the licenses granted in this Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute
any product containing active pharmaceutical ingredients owned or controlled by Gilead other than Products containing TDF, EVG and COBI, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to
any active pharmaceutical ingredient included within a Product other than TDF, EVG and COBI. 

2.3         License Grant to Gilead. Licensee hereby grants to Gilead a nonexclusive,
royalty-free, worldwide, sublicensable license to all improvements, methods, modifications and other know-how developed by or on behalf of Licensee and relating to API or a Product (“Improvements”), subject to the restrictions on
further transfer of Licensee’s technology by Gilead as set forth in Section 5.3. 

2.4         Licensee Right to Sell Through Third Party Resellers. 

(a) Licensed Product Suppliers. Licensee agrees that it will not sell or offer to sell API to any entity other than to Licensed
Product Suppliers in India that have been approved by Gilead in accordance with Section 2.4(e). 
 (b) Product
Sales. Licensee agrees that it will not sell, offer for sale, or assist third parties in selling Product except for the sale and offer for sale of (A) TDF Product 

  
 6 

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







 and TDF Combination Product for use in the Field and in the countries of the TDF Territory,
(B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory and the Semi-Exclusive Territory, and (C) EVG Product, EVG Combination Product and Quad for use in the Field and in the countries
of the EVG-Quad Territory and the Semi-Exclusive Territory. 
 (i) Licensee agrees that it will prohibit its Distributors from
selling Product (A) to any other wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. 

(ii) Licensee agrees that it will not administer the Quad to humans, or sell the Quad until Gilead has obtained marketing approval for
the Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for EVG from the FDA. Licensee agrees that it will not administer COBI to humans, or sell
Products containing COBI until Gilead has obtained marketing approval for COBI from the FDA. If Gilead obtains marketing approval from the FDA for the Quad prior to obtaining marketing approval for a product containing EVG or COBI as a single agent,
then Licensee will be allowed to administer the Quad to humans, and sell the Quad, but will not (A) administer to humans or sell Combination Products containing EVG other than the Quad until Gilead has obtained marketing approval from the FDA
for EVG, or (B) administer to humans or sell Combination Products containing COBI other than the Quad until Gilead has obtained marketing approval from the FDA for COBI. 
 (c)     Limitations on Product Combinations. 
 (i)
Licensee will be allowed to manufacture and sell TDF in combination with other active pharmaceutical ingredients in the TDF Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active
pharmaceutical ingredients in the applicable country in the TDF Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein. 
 (ii) Licensee will be allowed to manufacture and sell COBI in combination with other active pharmaceutical ingredients in the COBI Territory and the Semi-Exclusive Territory, provided in each case
(A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the COBI Territory or Semi-Exclusive Territory, and (B) such manufacture and sale is in accordance with the
licenses granted herein. 
 (iii) Licensee will be allowed to manufacture and sell EVG in combination with other active
pharmaceutical ingredients in the EVG-Quad Territory and the Semi-Exclusive Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the
EVG-Quad Territory or Semi-Exclusive Territory, (B) such manufacture and sale is in accordance with the licenses granted herein, and (C) Licensee has obtained Gilead’s prior written consent for the manufacture or sale of such product
containing EVG, such consent not to be unreasonably withheld. For clarity, the requirement for Gilead’s prior consent set forth in the preceding clause (C) shall not apply to the Quad. 

  
 7 

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







 (d)     Terms of Agreements with Third Party Resellers.

 (i) Gilead Distributors. Licensee may elect to sell finished Product in the Territory to any Gilead Distributor,
provided, however, that (A) Licensee may only sell and offer for sale TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF Territory, and may not sell or offer for sale TDF Product or TDF Combination Product outside
the TDF Territory, (B) Licensee may only sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors in the COBI Territory and the Semi-Exclusive Territory, and may not sell or offer for sale COBI Product or COBI
Combination Product outside the COBI Territory or the Semi-Exclusive Territory, and (C) Licensee may only sell and offer for sale EVG Product, EVG Combination Product and Quad to Gilead Distributors in the EVG-Quad Territory and the
Semi-Exclusive Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or Quad outside the EVG-Quad Territory or the Semi-Exclusive Territory, and (D) Licensee shall only sell to such Gilead Distributor those Products
that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory. Licensee shall only allow such Gilead Distributor to sell such Product in the countries within
the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a Product containing TDF, FTC and efavirenz, unless Gilead
has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the Territory, or (Y) a Product containing both TDF and 3TC. 

(ii) Other Third Party Resellers. Licensee shall require any such Third Party Reseller to agree, in a written agreement with
Licensee, (i) to comply with the applicable terms of this Agreement; and (ii) to report to Licensee such information, and allow Licensee to provide Gilead with the information described in Section 4.3 (and also to provide Japan
Tobacco with such information to the extent it relates to EVG, EVG Product, EVG Combination Product or Quad). Gilead has the right to audit, on no less than thirty (30) days’ advance notice to Licensee, such records of Licensee solely to
the extent necessary to verify such compliance. Gilead will bear the full cost of any such audit, and shall have the right to share the outcome of any such audit with Japan Tobacco to the extent such outcome relates to EVG, EVG Product, EVG
Combination Product, or Quad. 
 (e)     Gilead Approval of Third Party Reseller Agreements. Licensee
shall not enter into any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any Third Party Reseller, then Licensee shall
notify Gilead in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies of all agreements executed between
Licensee and Third Party Resellers. Gilead shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement. In the event that any inconsistency is found which had not been specifically
discussed and agreed with Gilead, then Gilead shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad, Gilead shall also have the right to
share such agreements with Japan Tobacco. 

  
 8 

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







 (f)         Termination of Third Party
Agreements by Licensee. Licensee shall immediately terminate its agreement(s) with a Third-Party Reseller in the event that such Third Party Reseller engages in material activities that Licensee is prohibited from performing under this
Agreement, or that are inconsistent with Licensee’s covenants under this Agreement, including without limitation the unauthorized use, sale or diversion by such Third Party Reseller of API or Product outside the Field or the applicable
Territory, or upon Licensee first reasonably believing that such Third-Party Reseller has engaged in such activities. 

(g)         Termination of Third Party Agreements by Gilead. Gilead may terminate the
right of Licensee to sell Product to any Third-Party Reseller pursuant to this Section 2.4, if in Gilead’s reasonable belief the Third-Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this
Agreement, or if Licensee does not terminate Licensee’s agreement with such Third-Party Reseller under the circumstances described in Section 2.4(e) or Section 2.4(f). 

2.5         License Limitations. 

(a)         Gilead Retained Rights. Licensee hereby acknowledges that Gilead retains all
rights in API and Products except as otherwise provided in this Agreement, and that Gilead may license or otherwise convey to third parties its rights in API and Products as it wishes without obligation or other accounting to Licensee. 

(b)         Gilead Marks. The licenses granted hereunder do not include any license or
other right to use any Gilead trademark, trade name, logo or service mark (each, a “Gilead Mark”) or any word, logo or any expression that is similar to or alludes to any Gilead Mark, except as provided in Section 6.5. Licensee
agrees not to use any Japan Tobacco trademark, trade name, logo or service mark (each, a “JT Mark”), or any word, logo or any expression that is similar to any JT Mark. 

(c)         Sublicensed Technology. The licenses relating to EVG, EVG Product, EVG
Combination Product and Quad granted to Licensee under this Agreement include sublicenses of intellectual property rights from Japan Tobacco, and remain subject to the terms and conditions of the Japan Tobacco Agreement. Gilead and Licensee shall
not permit any action to be taken or event to occur, in each case to the extent within such party’s reasonable control, that would give Japan Tobacco the right to terminate the Japan Tobacco Agreement. If either party is notified or otherwise
becomes aware that Licensee’s activities may constitute a material breach of the Japan Tobacco Agreement, it shall promptly notify the other party. The parties shall confer regarding an appropriate manner for curing any such alleged breach.
Licensee shall cure such alleged breach as promptly as possible, and in any case within the time allotted under the Japan Tobacco Agreement. Gilead shall remain responsible for EVG Product, EVG Combination Product, and Quad royalties owed to Japan
Tobacco pursuant to the Japan Tobacco Agreement. 

  
 9 

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







 (d)         No Other Licenses. 

(i)     Licensee agrees that it shall not use any contract manufacturers without obtaining Gilead’s prior
written consent, or grant any sublicenses hereunder. 
 (ii)     Except as expressly set forth in this
Agreement, Gilead does not grant any license under any of its intellectual property rights (including, without limitation, Patents or rights to any proprietary compounds or drug substances other than API) to Licensee. 

2.6         Licensee Rights in the Semi-Exclusive Territory. 

(a)         Licensee shall have the right to market and sell EVG Product, EVG Combination
Product, COBI Product, COBI Combination Product, and Quad in the Semi-Exclusive Territory on a semi-exclusive basis in accordance with the terms and conditions of this Agreement. As such, during the Semi-Exclusive Term, Gilead agrees not to grant
any third party the right to sell (i) any generic pharmaceutical product containing EVG, whether as a single agent or in combination with other active pharmaceutical ingredients (including generic versions of the Quad) in the Semi-Exclusive
Territory, and (ii) any generic pharmaceutical product containing COBI, whether as a single agent or in combination with other active pharmaceutical ingredients (including generic versions of the Quad) in the Semi-Exclusive Territory, provided
Licensee remains compliant with the terms and conditions of this Agreement. Gilead retains the right to sell branded versions of the Quad and other branded products containing EVG and COBI by itself or through use of its own distributors and
licensees in the Semi-Exclusive Territory. 
 (b)         [*] 

(c)         Licensee’s semi-exclusive rights in the Semi-Exclusive Territory shall have a
term of 5 years commencing on the date Licensee first launches its first COBI Product, COBI Combination Product, EVG Product, EVG Combination Product, or Quad in the Semi-Exclusive Territory (the “Semi-Exclusive Term”). The
Semi-Exclusive Term may be extended due to Licensee’s development of a Pediatric Formulation pursuant to Section 6.2(e). Once the Semi-Exclusive Term expires, or if Gilead terminates Licensee’s rights in the Semi-Exclusive Territory
due to Licensee’s non-compliance with this Agreement, then the semi-exclusive license granted in Section 2.2(b) shall terminate, and Gilead in its sole discretion may authorize other Licensed Product Suppliers to register and sell COBI
Product, COBI Combination Product, EVG Product, EVG Combination Product, and/or Quad in such territory. 

3.       Sourcing of API 
 3.1         Sourcing of API from API Suppliers. Licensee agrees that it shall not make, use or sell any Product that contains API other than API that is
Licensed API. If Licensee wishes to manufacture Product using API made by either a Gilead Supplier or a Licensed API Supplier, then Licensee shall notify Gilead in writing, and shall certify that 

  
 10 

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







 
its arrangement with such Gilead Supplier or Licensed API Supplier, as applicable, is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies
of all agreements between Licensee and such Gilead Supplier or Licensed API Supplier upon execution. To the extent any such agreements relate to EVG, Gilead shall have the right to share such agreements with Japan Tobacco. In the event that any
inconsistency is found which had not been specifically discussed and agreed with Gilead, Gilead shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier. 

3.2         Gilead Assistance with Gilead Suppliers. Upon receipt of a notice described in
Section 3.1 of Licensee’s intention to obtain Licensed API from a Gilead Supplier, Gilead shall use commercially reasonable efforts to assist Licensee in procuring supply of API from such Gilead Supplier. Gilead shall not be obligated to
assist Licensee in procuring any supply of API from a Licensed API Supplier. 

3.3         Conditions of Supply from Gilead Suppliers. Gilead shall be a party to any
agreement between Licensee and a Gilead Supplier that provides for the supply of API to Licensee from such Gilead Supplier. Any such agreement between Gilead, Licensee and a Gilead Supplier shall include and be subject to the following conditions:

 (a)         Gilead Supply Needs. Licensee shall not obtain API from the
Gilead Supplier until Gilead has received confirmation in writing from the Gilead Supplier of its ability to continue to supply Gilead with Gilead’s forecasted requirements of API, as reflected in Gilead’s then-current twelve
(12) month forecast for API provided to the Gilead Supplier. 
 (b)        
Consistency with Agreement. The Gilead Supplier shall be permitted to supply API to Licensee only to the extent that any such supply does not (A) adversely affect its ability to meet Gilead’s forecasted requirements or
(B) adversely affect the Gilead Supplier’s ability to supply Gilead’s requirements, whether or not such requirements are consistent with Gilead’s twelve (12) month forecast. Gilead shall have the right to terminate any such
agreement if such supply adversely affects Gilead as set forth in this Section 3.3(b). 

3.4         No Other Arrangements. Licensee agrees that it shall not enter into any
agreements, nor amend any existing agreements, for the supply of intermediates or API the terms of which would be inconsistent with this Agreement without Gilead’s prior written approval as provided for in this Section 3. 

3.5         Supply of other components. The obligations set forth in Sections 3.1, 3.2 and
3.3 with respect to Licensee’s supply of API shall not apply to active pharmaceutical ingredients other than API that Licensee may incorporate into Combination Products. 

  
 11 

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







 4.       Consideration/Payment Terms/Audit 

4.1         Royalty. As consideration for the licenses granted in Section 2, Licensee
shall pay Gilead the following royalties on Net Sales of Product in the Territory for the duration of the Royalty Term: 

(a)     5% of TDF Product Net Sales in the TDF Territory. 

(b)     5% of the portion of TDF Combination Product Net Sales attributable to the TDF component of such TDF
Combination Product in the TDF Territory as determined in accordance with Section 4.2. 
 (c)     5%
of the portion of Quad Net Sales attributable to the TDF, EVG and COBI components of the Quad in the EVG-Quad Territory as determined in accordance with Section 4.2. 
 (d)     5% of EVG Product Net Sales in the EVG-Quad Territory. 
 (e)     5% of COBI Product Net Sales in the COBI Territory. 

(f)     5% of the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the EVG
component of such EVG Combination Product in the EVG-Quad Territory as determined in accordance with Section 4.2. In addition, (i) to the extent any such EVG Combination Product also contains TDF, Licensee will also pay Gilead 5% of the
portion of EVG Combination Product (other than the Quad) Net Sales attributable to the TDF component of such EVG Combination Product in the EVG-Quad Territory as determined in accordance with Section 4.2. and (ii) to the extent any such
EVG Combination Product also contains COBI, Licensee will also pay Gilead 5% of the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the COBI component of such EVG Combination Product in the EVG-Quad Territory as
determined in accordance with Section 4.2. 
 (g)     5% of the portion of COBI Combination Product
(other than the Quad) Net Sales attributable to the COBI component of such COBI Combination Product in the COBI Territory, as determined in accordance with Section 4.2. In addition, to the extent any such COBI Combination Product also contains
TDF, Licensee will also pay Gilead 5% of the portion of COBI Combination Product (other than the Quad) Net Sales attributable to the TDF component of such COBI Combination Product in the COBI Territory, as determined in accordance with
Section 4.2. 
 (h)     10% of the portion of Quad Net Sales attributable to the TDF, EVG and COBI
components of the Quad in the Semi-Exclusive Territory as determined in accordance with Section 4.2. 

(i)     15% of EVG Product Net Sales in the Semi-Exclusive Territory. 

(j)     15% of COBI Product Net Sales in the Semi-Exclusive Territory. 

  
 12 

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







 (k)     15% of the portion of EVG Combination Product (other than the
Quad) Net Sales attributable to the EVG component of such EVG Combination Product in the Semi-Exclusive Territory as determined in accordance with Section 4.2. In addition, (i) to the extent any such EVG Combination Product also contains
TDF, Licensee will also pay Gilead 15% of the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the TDF component of such EVG Combination Product in the Semi-Exclusive Territory as determined in accordance with
Section 4.2., and (ii) to the extent any such EVG Combination Product also contains COBI, Licensee will also pay Gilead 15% of the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the COBI component of
such EVG Combination Product in the Semi-Exclusive Territory as determined in accordance with Section 4.2. 

(l)     15% of the portion of COBI Combination Product (other than the Quad) Net Sales attributable to the COBI
component of such COBI Combination Product in the Semi-Exclusive Territory as determined in accordance with Section 4.2. In addition, to the extent any such COBI Combination Product also contains TDF, Licensee will also pay Gilead 15% of the
portion of COBI Combination Product (other than the Quad) Net Sales attributable to the TDF component of such COBI Combination Product in the Semi-Exclusive Territory as determined in accordance with Section 4.2. 

(m)     No royalties will be owed on Pediatric Formulations developed and sold by Licensee in accordance with
Section 6.2(e). 
 (n)     No royalties will be owed on the emtricitabine component of any Combination
Product. 
 (o)     No royalties will be owed on Licensee’s sale of API to other Licensed Product
Suppliers, provided such Licensed Product Supplier has executed an agreement with Gilead requiring such Licensed Product Supplier to pay Gilead royalties on finished Product containing such API. 

(p)     Royalties on sales of Product to Gilead Distributors will be based on Licensee’s invoice price to such
Gilead Distributor. 
 (q)     Royalties will only be owed once on each royalty-bearing API of a
Combination Product. By means of example, if Licensee pays royalties on the Quad pursuant to Section 4.1(c) or 4.1(h), then Licensee will not also have to pay additional royalties on the TDF component for the sale of the Quad pursuant to
Section 4.1(a) or (b), the EVG component pursuant to Section 4.1(d), (f), (i) or (k), or the COBI component pursuant to Section 4.1(e), (g), (j) or (l). 

4.2         Adjustment for Combination Products. Solely for the purpose of calculating Net
Sales of Combination Products, if Licensee sells Product in the form of a Combination Product containing any Licensed API and one or more other active pharmaceutical ingredients in a particular country, Net Sales of such Combination Product in such
country for the purpose of determining the royalty due to Gilead pursuant to Section 4.1 will be calculated by multiplying actual Net Sales of such Combination 

  
 13 

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







 
Product in such country by the fraction A/(A+B), where A is the invoice price of such Product if sold separately in such country, and B is the total invoice price of the other active
pharmaceutical ingredient(s) in the combination if sold separately in such country. If, on a country-by-country basis, such other active pharmaceutical ingredient or ingredients in the Combination Product are not sold separately in such country, but
the Product component of the Combination Product is sold separately in such country, Net Sales for the purpose of determining royalties due to Gilead for the Combination Product will be calculated by multiplying actual Net Sales of such Combination
Product by the fraction A/C, where A is the invoice price of such Product component if sold separately, and C is the invoice price of the Combination Product. If, on a country-by-country basis, such Product component is not sold separately in such
country, Net Sales for the purposes of determining royalties due to Gilead for the Combination Product will be D/(D+E), where D is the fair market value of the portion of the Combination Products that contains the Product, and E is the fair market
value of the portion of the Combination Products containing the other active pharmaceutical ingredient(s) or delivery device included in such Combination Product, as such fair market values are determined by mutual agreement of the Parties, which
shall not be unreasonably withheld. 
 4.3         Reports. Within sixty
(60) days after the end of each calendar quarter, Licensee shall (a) provide Gilead with a detailed report of amounts of API and Product produced, API and Product on stock, total invoiced sales, Net Sales, the deductions used to determine
Net Sales, number of units of Product sold, each of which shall be reported on a Product-by-Product and country-by-country basis, adjustments for combination products (pursuant to Section 4.2) including calculations showing the Net Sales of the
EVG component of any EVG Combination Product, total royalties owed for the calendar quarter, the countries to which the Product has been sent and in what quantities, the Third Party Resellers, if any, to which Licensee has provided Product and in
what quantities, and Net Sales by each Third-Party Reseller, and, in the case of the sale of any API to third-party manufacturers of Product, the identity of such third parties and quantities of API sold to each such third party (the
“Quarterly Report”); (b) provide Gilead with a written certification of the accuracy of the contents of the Quarterly Report, signed by an appropriate Licensee senior officer; and (c) pay royalties due to Gilead for the
calendar quarter on a Product-by-Product and country-by-country basis. Additionally, together with each Quarterly Report, Licensee shall provide Gilead with a Regulatory Report as set forth in Section 6.3. Licensee shall provide Quarterly
Reports and Regulatory Reports to Gilead at the address listed below. Licensee shall pay royalties to Gilead by wire transfer to the bank account indicated by Gilead from time to time. To the extent such Quarterly Reports relate to EVG, EVG Product,
EVG Combination Product, or Quad, Gilead will have the right to share such Quarterly Reports with Japan Tobacco. 

4.4         Payment Terms. Licensee shall make all payments to Gilead in US Dollars. With
regard to sales in currencies other than US Dollars, conversion from local currency into US Dollars shall be at the rate of exchange of the local currency to the US Dollar on the day of payment as reported by the Reserve Bank of India. 

  
 14 

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







 4.5         Records. Licensee shall keep
complete and accurate records of API and Product produced and sold in sufficient detail to enable Licensee to determine the amount of royalties due, the parties to whom Product or API was sold, and the countries in which sales occurred. 

4.6         Audit. Gilead has the right to engage an independent public accountant to
perform, on no less than thirty (30) days’ advance notice to Licensee, an audit, conducted in accordance with generally accepted auditing standards, of such books and records of Licensee that are deemed necessary by such public accountant
to report amounts of API and Product produced, gross sales, Net Sales for the periods requested and accrued royalties. Gilead will bear the full cost of any such audit unless such audit discloses a difference of more than five percent (5%) from
the amount of royalties due. In such case, Licensee shall promptly pay Gilead any underpayment and shall bear the full cost of such audit. To the extent relevant to EVG, EVG Product, EVG Combination Product, or Quad, Gilead will have the right to
disclose such audit results to Japan Tobacco. 
 4.7         Interest. Any amount
payable hereunder by Licensee, which is not paid on a timely basis, shall bear a pro rata monthly interest rate of one percent (1%) subject to any necessary approvals that may be required. 

4.8         Taxes 

(a)         Withholding Taxes. Licensee shall promptly pay the withholding tax for and on
behalf of Gilead to the proper governmental authority and shall promptly furnish Gilead with the tax withholding certificate furnished by the Licensee. Licensee shall be entitled to deduct the withholding tax actually paid from such payment due
Gilead. Each party agrees to assist the other party in claiming exemption from such withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.

 (b)         Other Taxes. Except as provided in this Section 4.8, all
taxes or duties in connection with payments made by Licensee shall be borne by Licensee. 

4.9         Royalty Term. Royalty payments shall be paid to Gilead by Licensee on a
Product-by-Product and country-by-country basis starting on the date of the first commercial sale of a Product in a country and continuing until the last to occur of the following: 

(a)         the expiration of the last-to-expire Patent containing a valid claim covering the
manufacture, use, import, offer for sale or sale of API or the Product in such country; or 

(b)         the date of expiration of the last-to-expire Patent containing a valid claim
covering the manufacture, use, import, offer for sale or sale of API or the Product in India (the “Royalty Term”). 

  
 15 

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







 5.     Intellectual Property 

5.1         Maintenance of Patents. Gilead shall use commercially reasonable efforts to
maintain and enforce the Patents in India and in the Semi-Exclusive Territory (including with respect to the exercise of back-up rights to maintain and enforce Patents relating to EVG, EVG Product, EVG Combination Product or Quad in India and the
Semi-Exclusive Territory that are subject to the Japan Tobacco Agreement), but shall not be obligated to maintain or enforce the Patents in the remainder of the Territory. 
 5.2         Cooperation. If either party becomes aware of a suspected infringement of any Patent, such party will notify the other party promptly, and
following such notification, the parties will confer. Gilead (except in the case of Patents relating to EVG, EVG Product, EVG Combination Product or Quad that are subject to the Japan Tobacco Agreement and controlled by Japan Tobacco) will have the
right, but not the obligation, to bring an infringement action at its own expense, in its own name, and entirely under its own direction and control. Licensee will reasonably assist Gilead (or, where applicable, Japan Tobacco) in such actions or
proceedings if so requested, and will lend its name to such actions or proceedings if required by law in order for Gilead (or Japan Tobacco) to bring such action. 
 5.3         Reporting of Improvements. Licensee shall provide Gilead with an annual report, in writing and in reasonable detail that sets forth any
Improvements, including any patent applications claiming Improvements. Licensee shall transfer to Gilead, upon request by Gilead and at Gilead’s expense, any know-how owned or controlled by Licensee relating to such Improvements. Any failure to
report any such Improvements to Gilead in accordance with the terms of this Agreement shall constitute a breach of this Agreement and shall provide Gilead with the right to terminate this Agreement pursuant to Section 10.3(b). Gilead shall not
transfer any Improvements obtained from Licensee to any third party, provided, however, that (a) Gilead may transfer Improvements to Gilead’s own affiliates and suppliers, provided such affiliates and suppliers utilize such Improvements
solely for the benefit of Gilead and/or Japan Tobacco, and (b) Gilead may transfer Improvements relating to EVG, EVG Product, EVG Combination Product, or Quad to Japan Tobacco in accordance with the Japan Tobacco Agreement for use solely for
the benefit of Japan Tobacco, including the transfer and use of such Improvements to Japan Tobacco’s suppliers for the benefit of Japan Tobacco. 
 5.4         Trademarks 
 (a)
    Any Product offered for sale or sold shall have a different trade dress, including a distinct color, shape and trade name, than the comparable product sold by Gilead and, where applicable, the comparable product sold by Japan
Tobacco. For clarity, Licensee’s non-performance of the obligations set forth in this Section 5.4(a) shall constitute a material breach of Licensee’s material obligation under this Agreement. 

  
 16 

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







 (b)     Licensee shall provide to Gilead, prior to any regulatory
submissions for any Product, or selling or offering for sale any Product, samples of the Product and any packaging, labeling information or marketing materials (including, but not limited to, advertisement and promotional materials) to be used with
the Product to permit Gilead to review and approve the Product and packaging as consistent with the requirements of Section 5.4(a). If Gilead reasonably objects to the trade dress or other aspects of the Product or product packaging based on
the requirements of Section 5.4(a), the parties shall discuss in good faith the changes to be made to the Product or packaging to address Gilead’s concerns. 
 5.5         Technology Transfer. Licensee acknowledges that following execution of the TDF License Agreement Gilead provided to Licensee, and Licensee
received, a one-time technology transfer of know-how relating to TDF and TDF Product. Promptly following Gilead’s receipt of marketing approval from the FDA (and on a Product-by-Product basis), Gilead shall make a one-time technology transfer
of know-how (a) owned or controlled by Gilead as of the Effective Date, or (b) exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement, relating to the manufacture of EVG, COBI and the Quad to the extent
and in the manner specified in Appendix 3 hereto (such TDF, EVG, COBI and Quad know-how, the “Licensed Know-How”). Such Licensed Know-How shall be sufficient to enable Licensee to manufacture TDF and TDF Product, EVG and COBI,
EVG Product, COBI Product and Quad, at commercial-scale quantities. Gilead shall have no further obligation to transfer any other know-how to Licensee. 
 6.       Manufacturing and Commercialization of Product 
 6.1         Promotion of Sales in the Territory. The parties hereto agree that an important purpose of this Agreement is to increase patient access to the
Products licensed under this Agreement in the Territory. Except as otherwise provided in this Agreement, Licensee shall have the sole discretion to manage its own commercial strategy to promote and sell the Product in the Territory, provided,
however, that Licensee shall not engage in activities that are inconsistent with the first sentence of this Section 6.1. By means of example and without limitation, Licensee agrees that Licensee shall not accept patient orders that Licensee
does not have the capacity to fill, and shall not obtain API or Product without having the means, either directly or through the use of permitted third parties, to manufacture such API into Product and/or distribute such Product to patients within
the Territory. 
 6.2         Manufacturing Requirements 

  
 17 

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







 (a)         Minimum Standards. Licensee
agrees that it shall manufacture API and Product in a manner consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the
European Medicines Agency (“EMA”), or United States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any
applicable national, regional or local standards as may be required by the specific country where Product is sold. Licensee shall apply for WHO pre-qualification or FDA conditional approval for (1) at least one TDF Product or TDF Combination
Product no later than the first anniversary of the Effective Date, (2) at least one COBI Product or COBI Combination Product no later than the first anniversary of the FDA approval date for COBI (if COBI is approved), (3) at least one EVG
Product or EVG Combination Product no later than the first anniversary of the FDA approval date for EVG (if EVG is approved), and (4) the Quad no later than the first anniversary of the FDA approval date for the Quad (if the Quad is approved).

 (b)         Audit Right. Licensee hereby agrees to allow Gilead reasonable
access to Licensee’s books and records, facilities and employees solely for the purpose and to the extent required for Gilead to audit Licensee’s compliance with the requirements of this Section 6.2. Gilead agrees to provide at least
thirty (30) days prior notice of the proposed audit, and agrees that such audits shall not be conducted more than once a year unless circumstances outside the ordinary course of business warrant such an audit (such as an investigation or other
government action). To the extent any such audit relates to EVG, EVG Product, EVG Combination Product, or Quad, Gilead will have the right to share reports from any such audit with Japan Tobacco. 

(c)         Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality
Standards or has not received either WHO pre-qualification or FDA conditional approval, as applicable, by the second anniversary of the Effective Date, Gilead may elect, in its sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to
suspend the effectiveness of the licenses granted hereunder until such time Gilead has determined that Licensee has corrected any such failure to Gilead’s reasonable satisfaction. During any such suspension, Gilead and Licensee shall coordinate
with each other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension. 
 (d)         Dose Requirements. All TDF Product and TDF Combination Product manufactured, used or sold by Licensee shall consist of a single dose
concentration of 300 milligrams of TDF per dose. All EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, and Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of EVG and/or COBI that
are the same as the dose concentration for such agent that has been approved by the FDA. Licensee agrees that it shall not manufacture or sell Products (including Combination Products) formulated at a single dose concentration other than those dose


  
 18 

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







 
concentrations approved by the FDA for such agents (each an “Alternate Dosage”), without prior written consent from Gilead, provided, however, that in the case of TDF and COBI,
Licensee may manufacture or sell TDF Product, TDF Combination Product, COBI Product, or COBI Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory
authority having jurisdiction over such Product. By means of example, dosage concentrations of TDF lower than 300 milligrams in tablet form will be allowed for pediatric administrations only if such lower dosage has been approved by the FDA or the
appropriate foreign regulatory authority for such administration. 
 (e)        
Pediatric Formulations. Licensee agrees to use reasonable efforts to develop a TDF Product, TDF Combination Product, EVG Product, EVG Combination Product, COBI Product or COBI Combination Product as either a liquid or dispersible tablet
formulation for use in pediatric patients less than 12 years of age (each, a “Pediatric Formulation”), provided, however, that with respect to EVG Product and EVG Combination Product, Licensee agrees not to develop any such
Pediatric Formulation without Gilead’s prior written consent, not to be unreasonably withheld. Licensee may seek regulatory approval for Pediatric Formulations anywhere in the Territory. 

(i)         If Licensee has used reasonable efforts to develop a Pediatric Formulation, then the
Semi-Exclusive Term in the Semi-Exclusive Territory will be extended for an additional 5 years. The determination of whether Licensee has used reasonable efforts with respect to such Pediatric Formulation will be at Gilead’s sole
discretion, however, if Licensee either (A) commences a human clinical trial of a Pediatric Formulation under an approved US investigational new drug application, or (B) commercializes a Pediatric Formulation in the Territory under
an approved US Abbreviated New Drug Application, then Licensee will be deemed to have satisfied the reasonable efforts requirement set forth in this Section 6.2(e)(i) and the Semi-Exclusive Term in the Semi-Exclusive Territory will be extended
for an additional 5 years. 
 (ii)         If Licensee is granted regulatory approval to
market such Pediatric Formulation, then Licensee will use reasonable efforts to make such Pediatric Formulation available (A) if such Pediatric Formulation is a TDF Product or a TDF Combination Product, throughout the TDF Territory, (B) if
such Pediatric Formulation is a COBI Product or a COBI Combination Product, throughout the COBI Territory and the Semi-Exclusive Territory, or (C) if such Pediatric Formulation is an EVG Product or EVG Combination Product, throughout the
EVG-Quad Territory and the Semi-Exclusive Territory (for purposes of this Section 6.2(e), “Licensee’s Applicable Territory”), unless the Semi-Exclusive Term is expired or terminated and Licensee no longer has rights in the
Semi-Exclusive Territory. Gilead would agree to waive any royalty Gilead otherwise would be entitled to receive for sale of such Pediatric Formulation pursuant to Section 4.1, provided such Pediatric Formulation is sold for use in pediatric
populations under age 12 and not in adult populations. 
 (iii)         Licensee will
further agree either to license such Pediatric Formulation to Gilead or to other Licensed Product Suppliers, or to manufacture and supply such Pediatric Formulation to one or more Gilead Distributors, for sale (a) in territories that either are
outside the scope of Licensee’s Applicable Territory but within the scope of the licensed territory 

  
 19 

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







 
of such designated Licensed Product Supplier or Gilead Distributor, or (b) in territories that are within Licensee’s Applicable Territory but in which Licensee is not able to make such
Pediatric Formulation available. Licensee will be entitled to receive compensation for any such license or sale of such Pediatric Formulation to Gilead, a Licensed Product Supplier or Gilead Distributor that would be commensurate with (and not in
excess of) the compensation Licensee would receive if Licensee itself sold such Pediatric Formulation in Licensee’s Applicable Territory. 
 (iv)         If Gilead, in its sole discretion, is interested in pursuing the regulatory approval or marketing of such Pediatric Formulation in countries outside
Licensee’s Applicable Territory, or in facilitating access to such Pediatric Formulation to countries within Licensee’s Applicable Territory where Licensee has not made such Pediatric Formulation available, then Gilead and Licensee will
negotiate a separate agreement relating to such Pediatric Formulation, with such agreement including appropriate compensation for Licensee for such Pediatric Formulation. Gilead shall have the right to sublicense such Pediatric Formulation to Japan
Tobacco for use in Japan in accordance with the Japan Tobacco Agreement. 
 6.3        
Regulatory Filings and Inspections. Except as provided otherwise herein, Licensee shall be responsible for obtaining and maintaining all applicable regulatory or other approvals or authorizations to carry out its activities under this
Agreement and shall provide Gilead with a quarterly written report setting forth (a) a list of countries within the Territory for which such regulatory approvals or authorization have been obtained for any Product and (b) a description of
activities performed by Licensee, its designee or, to its knowledge any other third party, with respect to the filing, obtaining or maintaining of such regulatory approvals or authorizations within the Territory for any Product (each such report, a
“Regulatory Report”). Gilead may, in its discretion, elect to file for regulatory or other approval or authorization to make and sell API and Product anywhere in the Territory. Upon either party’s request, the other party shall
provide non-proprietary data that the other party perceives is reasonably necessary to obtain any such approvals, authorizations, permits or licenses. Licensee shall obtain, have and maintain all required registrations for its manufacturing
facilities. Licensee shall allow appropriate regulatory authorities to inspect such facilities to the extent required by applicable law, rule or regulation. Gilead agrees to provide Licensee with NCE Exclusivity or other regulatory exclusivity
waivers as may be required by the applicable regulatory authorities in order to manufacture or sell Product in the Territory, provided such manufacture and sale by Licensee is compliant with the terms and conditions of this Agreement. Licensee
agrees not to pursue or obtain regulatory exclusivity on any Product in any country within the Territory. 

6.4         Marketing Materials. Any marketing materials (including, but not limited to,
advertisement and promotional materials) used by Licensee and its Third-Party Resellers shall not contain any misstatements of fact, shall be fully compliant with the applicable laws, rules and regulations, and shall be distinct from, and not cause
any confusion with, any marketing materials or Products used or sold by Gilead, or any marketing materials or products sold by Japan Tobacco. Any statements made in such marketing materials regarding Gilead, including without limitation statements
made in reference to Licensee’s collaboration with Gilead, require Gilead’s prior written approval. 

  
 20 

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







 6.5         Product Labeling. The labeling of
all Products sold or offered for sale under this Agreement shall expressly state that the Product is manufactured under a license from Gilead. 

7.      Representations, Warranties and Covenants 

7.1         Ability to Perform. Gilead and Licensee each represent and warrant that

 (a)         they are duly organized, validly existing and in good standing under the
laws of the jurisdiction of their incorporation and have full corporate power and authority to enter into this Agreement and to carry out the provisions hereof; 
 (b)         this Agreement has been duly executed and delivered, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the
terms hereof; and 
 (c)         the execution, delivery and performance of this
Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having
jurisdiction over such Party 
 7.2         Diversion of Product and Technology.
Licensee covenants and agrees that it shall not: (i) divert or allow the diversion of API, or any intermediates or other chemical entities generated during the process of manufacturing API, outside of India, (ii) divert or allow the
diversion of TDF Product or TDF Combination Product outside the TDF Territory, (iii) divert or allow the diversion of COBI Product or COBI Combination Product outside the COBI Territory or the Semi-Exclusive Territory, (iv) divert or allow
the diversion of EVG Product, EVG Combination Product or Quad outside the EVG-Quad Territory or the Semi-Exclusive Territory, (v) divert or allow the diversion of Licensed Technology to any third party, except as expressly permitted under this
Agreement, or (vi) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i)—(v). 
 7.3         Access Promotion. Licensee covenants and agrees that it shall not engage in activities that are contrary to the goal of promoting patient access
to Product to satisfy unmet medical needs within the Territory. 
 7.4         Law
Compliance 
 (a)         General. Licensee covenants and agrees that it
shall perform all activities under this Agreement in accordance with all applicable laws and regulations, including, without limitation, with respect to recalls, safety and reporting requirements and shall obtain, have and maintain all necessary
regulatory approvals (including in 

  
 21 

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







 
India), marketing authorizations, permits and licenses, at Licensee’s expense for the manufacture and sale of the API and/or Product and any other Licensee activities contemplated hereby.

 (b)         FCPA and UK Bribery Act. Licensee covenants and agrees that it
shall provide to Gilead on the Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the United States Foreign Corrupt Practices
Act of 1977 and with the UK Bribery Act of 2010. 
 (c)         Conflicts.
Neither party shall be required to take any action or perform any obligation under this Agreement to the extent that such action or obligation is in direct conflict with any applicable law, rule or regulation, provided, however, that both Licensee
and Gilead are in agreement regarding (i) the requirements of such law, rule or regulation, and (ii) the affect that such law, rule or regulation has on such action or obligation required under this Agreement. 

7.5         Patent Infringement. Licensee covenants and agrees that it shall not infringe
the Patents outside the scope of the licenses granted to it pursuant to Section 2, and shall not infringe the Emtricitabine Patents outside the scope of the covenant not to sue set forth in Section 7.6. 

7.6         Covenant Concerning Certain Gilead Patents. Gilead covenants and agrees that
it shall not, at any time during the term of this Agreement, bring any claim or proceeding of any kind or nature against Licensee in relation to any of the pending and issued patents identified in Appendix 4 hereto (the “Emtricitabine
Patents”) to the extent that Licensee decides to make, use, sell, have sold and export any Product in the Territory that may infringe any claims covering the manufacture, use and sale of emtricitabine contained in such Emtricitabine
Patents. 
 7.7         EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, GILEAD
DOES NOT GIVE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT IN THE TERRITORY. Gilead also does not give any warranty, express or implied, with regard to the safety or efficacy of
API or the Product and it shall be the sole responsibility of the Licensee to ensure such safety or efficacy. 

8.      Liability and Indemnity 
 (a)         Licensee Indemnity. Licensee shall jointly and severally indemnify, hold harmless and defend Gilead, and its subsidiaries, licensors, directors,
officers, employees and agents (together the “Gilead Indemnitees”), from and against any and all losses, damages, expenses, cost of defense (including, without limitation, attorneys’ fees, witness fees, damages, judgments,
fines and amounts paid in settlement) and any amounts a Gilead Indemnitee 

  
 22 

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







 
becomes legally obligated to pay because of any claim against it (i) arising out of any breach by Licensee of the terms and conditions of this Agreement, or (ii) for any product
liability, liability for death, illness, personal injury or improper business practice, or any other statutory liability or any other liability under any law or regulation, to the extent that such claim or claims are due to reasons caused by or on
behalf of Licensee related to API or Product (including, without limitation, their manufacture, use or sale). The indemnification obligations of Licensee stated in this Section 8(a) shall apply only in the event that Gilead provides Licensee
with prompt written notice of such claims, grants Licensee the right to control the defense or negotiation of settlement, and makes available all reasonable assistance in defending the claims. Licensee shall not agree to any final settlement or
compromise with respect to any such claim that adversely affects Gilead without obtaining Gilead’s consent. 

(b)         Product Liability. Licensee shall be solely responsible in respect of any
product liability or any other statutory liability under any regulation, in respect of API or the Product. 

(c)         Gilead Liability. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS
AGREEMENT, IN NO EVENT SHALL GILEAD BE LIABLE TO LICENSEE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING BUT NOT LIMITED TO LOSS OF BUSINESS OR PROFITS) RELATED TO THIS AGREEMENT, AND SHALL NOT HAVE
ANY RESPONSIBILITIES OR LIABILITIES WHATSOEVER WITH RESPECT TO API OR PRODUCT, EVEN IF, IN ANY SUCH CASE, ADVISED OF THE POSSIBILITY OF SUCH CLAIMS OR DEMANDS, REGARDLESS OF THE FORM OF ACTION OR LEGAL THEORY WHETHER UNDER CONTRACT LAW, TORT LAW
(INCLUDING WITHOUT LIMITATION NEGLIGENCE), STRICT LIABILITY, STATUTE, WARRANTY OR OTHERWISE. 

9.      Insurance 
 Within thirty (30) days prior to the first commercial launch by Licensee of a Product, and each year thereafter for so long as this Agreement is in effect, Licensee shall provide to Gilead
certificates of insurance by insurers acceptable to Gilead evidencing comprehensive general liability coverage, including products liability, with a combined limit of no less than one million dollars ($1,000,000.00) for bodily injury, including
personal injury, and property damage. Gilead shall have the right to provide any such certificate to Japan Tobacco. Licensee shall not cancel any such policy without at least sixty (60) days prior written notice to Gilead, and agrees that such
policy shall be maintained (or have an extended reporting period) of at least seven (7) years after the termination of this Agreement. 

10.    Term and Termination 
 10.1         Term. This Agreement shall enter into force upon the Effective Date and, unless earlier terminated as provided herein, shall continue until the
expiration of the Royalty Term. Upon expiration of the Royalty Term, and with respect to a particular Product in a 

  
 23 

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







 
particular country in the Territory, subject to the terms and conditions herein with respect to such Product and such country, the license and sublicense granted in Article 2 to Licensee shall
become a perpetual, irrevocable, fully paid-up, royalty free license under the Licensed Know-How to develop, make, have made, use, sell, have sold, offer for sale, import and distribute such Product in the Field in such country. 

10.2         Termination for Breach. A party (“non-breaching party”) shall have
the right to terminate this Agreement in the event the other party (“breaching party”) is in material breach of any of its material obligations under this Agreement. The non-breaching party shall provide written notice to the breaching
party. The breaching party shall have a period of thirty (30) days after such written notice is provided to cure such breach. If such breach is not cured within the thirty day period, this Agreement shall effectively terminate. 

10.3         Gilead Right to Terminate 

(a)         Gilead shall have the right to terminate this Agreement and/or one or both of the
licenses granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), immediately if in the reasonable opinion of Gilead, control (through ownership or
otherwise) of Licensee changes. 
 (b)         Gilead shall have the right to terminate
this Agreement and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 or the covenant contained in Section 7.6 (whether or not such event constitutes a right of termination pursuant to Section 10.2),
if: 
 (i)     Gilead reasonably determines that a material quantity of API or Product made and/or sold by
Licensee has been diverted to countries outside the Territory, whether or not by any fault or action or inaction of Licensee; 

(ii)     Gilead reasonably determines that, due to material deficiencies in Licensee’s compliance, or repeated
failure to comply, with the Minimum Quality Standards, Licensee is unable to reliably and consistently manufacture API or Product in accordance with the Minimum Quality Standards; 

(iii)     Gilead reasonably determines that Licensee has obtained material quantities of API from sources outside the
Territory, or in ways that are inconsistent with the terms and conditions of Section 3; or 
 (iv)    
Gilead’s rights to EVG terminate due to the termination of the Japan Tobacco Agreement, provided, however, that in such event, such termination would only apply on a Product-by-Product basis and with respect to Products containing EVG that are
subject to the sublicense granted by Gilead under the Japan Tobacco Agreement. 

  
 24 

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







 Gilead shall give Licensee written notice of any such event and provide Licensee with a
period of thirty (30) days after such notice to demonstrate that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be
terminated effective upon the thirtieth (30th) day
following such notice. 
 10.4         Insolvency. In the event that Licensee
becomes insolvent, makes an assignment to the benefit of creditors, or has a petition in bankruptcy filed for or against it, Gilead shall have the right to treat such event as a material breach. 

10.5         Waiver. The waiver by either party of any breach of any term or condition of
this Agreement shall not be deemed a waiver as to any subsequent or similar breach. 

10.6         Survival. Sections 2.3, 2.5(b), 4.5, 5.3, 5.4(a), 6.2(e)(iii), 7.7, 8, 9,
10.1, 10.6, 11 and 12 shall survive termination or expiry of this Agreement. 
 11.     Confidentiality and
Publications 
 11.1         Confidential Information. All technology and
know-how disclosed by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) hereunder (“Confidential Information”) shall be used solely and exclusively by Receiving Party in
a manner consistent with the licenses granted hereunder and the purposes of this Agreement as stated in the preamble and recitals hereto; maintained in confidence by the Receiving Party; and shall not be disclosed to any non-party or used for any
purpose except to exercise its rights and perform its obligations under this Agreement without the prior written consent of the Disclosing Party, except to the extent that the Receiving Party can demonstrate by competent written evidence that such
information: (a) is known by the Receiving Party at the time of its receipt and, not through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s business records; (b) is in the public domain other than
as a result of any breach of this Agreement by the Receiving Party; (c) is subsequently disclosed to the Receiving Party on a non-confidential basis by a third party who may lawfully do so; or (d) is independently discovered or developed
by the Receiving Party without the use of Confidential Information provided by the Disclosing Party, as documented by the Receiving Party’s business records. Within thirty (30) days after any expiration or termination of this Agreement,
Receiving Party shall destroy (and certify to the Disclosing Party such destruction) or return all Confidential Information provided by the Disclosing Party except as otherwise set forth in this Agreement. One (1) copy of the Confidential
Information may be retained in the Receiving Party’s files solely for archival purposes as a means of determining any continuing or surviving obligations under this Agreement. The confidential obligations under this Agreement shall survive this
Agreement for a period of five (5) years. To the extent Gilead receives any Confidential Information from Licensee relating to EVG, EVG Product, EVG Combination Product or Quad, Gilead will have the right to disclose such Confidential
Information to Japan Tobacco, provided such disclosure remains 

  
 25 

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







 
subject to the obligations of confidentiality and non-disclosure set forth in the Japan Tobacco Agreement. 
 11.2         Press Release. Each party may disclose to third parties or make public statements, by press release or otherwise, regarding the existence of
this Agreement, the identity of the parties, the terms, conditions and subject matter of this Agreement, or otherwise in reference to this Agreement, provided such disclosures or statements are accurate and complete with respect to the subject
matter thereof and the information disclosed therein. 
 11.3         Use of
Name. Except as provided for under Section 11.2, neither party shall use the other party’s name, logo or trademarks for any purpose including without limitation publicity or advertising, except with the prior written consent of the
other party. Licensee agrees not to use Japan Tobacco’s name, logo or trademarks for any purpose except with the prior written consent of Japan Tobacco. 
 12.      Miscellaneous 

12.1         Agency. Neither party is, nor will be deemed to be, an employee, agent or
representative of the other party for any purpose. Each party is an independent contractor, not an employee or partner of the other party. Neither party shall have the authority to speak for, represent or obligate the other party in any way without
prior written authority from the other party. 
 12.2         Entire
Understanding. This Agreement embodies the entire understanding of the parties with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written,
between the parties relating to the subject matter hereof. Gilead and Licensee hereby expressly agree that this Agreement amends and restates in its entirety the TDF License Agreement as of the Effective Date. 

12.3         Severability. The parties hereby expressly state that it is not their
intention to violate any applicable rule, law or regulation. If any of the provisions of this Agreement are held to be void or unenforceable with regard to any particular country by a court of competent jurisdiction, then, to the extent possible,
such void or unenforceable provision shall be replaced by a valid and enforceable provision which will achieve as far as possible the economic business intentions of the Parties. The provisions held to be void or unenforceable shall remain, however,
in full force and effect with regard to all other countries. All other provisions of this Agreement shall remain in full force and effect. 
 12.4         Notices 

(a)         Any notice or other communication to be given under this Agreement, unless otherwise
specified, shall be in writing and shall be deemed to have been provided when delivered to the addressee at the address listed below (i) on the date of delivery if delivered in person or (ii) three days after mailing by registered or
certified mail, postage paid: 

  
 26 

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







 In the case of Gilead: 

Gilead Sciences, Inc. 
 333 Lakeside Drive 
 Foster City, CA 94404 

Attention: General Counsel 
 Facsimile: (650) 522-5537 
     In the case of Licensee:

 [Insert Address] 
 Attention: 
 Facsimile: 

(b)         Either party may change its address for communications by a notice in writing to the
other party in accordance with this Section 12.4. 
 12.5         Governing
Law. This Agreement is made in accordance with and shall be governed and construed under the laws of England, without regard to its choice of law principles. 
 12.6         Arbitration 

(a)         All disputes arising out of or in connection with the present Agreement shall be
finally settled under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators. 

(b)         Each party shall nominate one arbitrator. Should the claimant fail to appoint an
arbitrator in the Request for Arbitration within thirty (30) days of being requested to do so, or if the respondent should fail to appoint an arbitrator in its Answer to the Request for Arbitration within thirty (30) days of being
requested to do so, the other party shall request the ICC Court to make such appointment. 

(c)         The arbitrators nominated by the parties shall, within thirty (30) days from the
appointment of the arbitrator nominated in the Answer to the Request for Arbitration, and after consultation with the parties, agree and appoint a third arbitrator, who will act as a chairman of the Arbitral Tribunal. Should such procedure not
result in an appointment within the thirty (30) day time limit, either party shall be free to request the ICC Court to appoint the third arbitrator. 
 (d)         London, England shall be the seat of the arbitration. 
 (e)         The language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted
together with an English translation. 

  
 27 

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







 (f)         This arbitration agreement does not
preclude either party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either party’s domicile. Conservatory or interim measures sought
by either party in any one or more jurisdictions shall not preclude the Arbitral Tribunal granting conservatory or interim measures. Conservatory or interim measures sought by either party before the Arbitral Tribunal shall not preclude any court of
competent jurisdiction granting conservatory or interim measures. 
 (g)         In the
event that any issue shall arise which is not clearly provided for in this arbitration agreement the matter shall be resolved in accordance with the ICC Arbitration Rules. 
 12.7         Assignment. Gilead is entitled to transfer and assign this Agreement and the rights and obligations under this Agreement on prior notice to
Licensee. Licensee is not entitled to transfer or assign this Agreement or the rights and obligations under this Agreement. 

12.8         Amendment. No amendment or modification hereof shall be valid or binding upon
the parties unless made in writing and signed by both parties. 
 [signatures appear on following page] 

  
 28 

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







 IN WITNESS WHEREOF, the parties hereto have
executed this Amended and Restated License Agreement as of the Effective Date. 
 GILEAD:

  

			
	Gilead Sciences, Inc.
		
	By	 	 
	Name:	 	
	Title:	 	


 LICENSEE: 

 

			
	[Licensee]
		
	By	 	 
	Name:	 	
	Title:	 	



  

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







 Appendix 1 
 Countries in the TDF Territory 

 

 1.   Afghanistan 
 2.   Angola 
 3.   Anguilla 

4.   Antigua and Barbuda 
 5.
  Armenia 
 6.   Aruba 
 7.   Bahamas 
 8.   Bangladesh 

9.   Barbados 
 10. Belize 

11. Benin 
 12. Bhutan 

13. Bolivia 
 14. Botswana 

15. British Virgin Islands 
 16. Burkina Faso

 17. Burundi 
 18. Cambodia

 19. Cameroon 
 20. Cape Verde

 21. Central African Republic 
 22. Chad 
 23. Comoros 
 24. Congo, Rep 
 25. Congo, Dem. Rep. of the 

26. Côte d’Ivoire 
 27. Cuba

 28. Djibouti 
 29. Dominica

 30. Dominican Republic 
 31. Ecuador

 32. El Salvador 
 33. Equatorial
Guinea 
 34. Eritrea 
 35. Ethiopia

 36. Fiji Islands 
 37. Gabon

 38. Gambia



 39. Georgia 
 40. Ghana 
 41. Grenada 
 42. Guatemala 
 43. Guinea 
 44. Guinea-Bissau 
 45. Guyana 
 46. Haiti 
 47. Honduras 
 48. India 
 49. Indonesia 
 50. Jamaica 
 51. Kazakhstan 
 52. Kenya 
 53. Kiribati 
 54. Kyrgyzstan 
 55. Lao, People’s Dem. Rep. 

56. Lesotho 
 57. Liberia 

58. Madagascar 
 59. Malawi 

60. Maldives 
 61. Mali 

62. Mauritania 
 63. Mauritius 

64. Moldova, Rep. of 
 65. Mongolia 

66. Montserrat 
 67. Mozambique 

68. Myanmar 
 69. Namibia 

70. Nauru 
 71. Nepal 

72. Nicaragua 
 73. Niger 

74. Nigeria 
 75. Pakistan 

76. Palau 
 77. Papua NewGuinea



 78.   Rwanda 
 79.   Saint Kitts and Nevis 
 80.   Saint Lucia 

81.   Saint Vincent & the   Grenadines 

82.   Samoa 
 83.   São Tomé and Príncipe 
 84.   Senegal 

85.   Seychelles 
 86.
  Sierra Leone 
 87.   Solomon Islands 
 88.   Somalia 
 89.   South Africa 

90.   Sri Lanka 
 91.   Sudan

 92.   Surinam 
 93.
  Swaziland 
 94.   Syrian Arab Republic 

95.   Tajikistan 
 96.
  Tanzania, U. Rep. of 
 97.   Thailand 
 98.   Timor-Leste 
 99.   Togo 

100. Tonga 
 101. Trinidad and Tobago 

102. Turkmenistan 
 103. Turks and Caicos

 104. Tuvalu 
 105. Uganda 

106. Uzbekistan 
 107. Vanuatu 

108. Vietnam 
 109. Yemen 

110. Zambia 
 111. Zimbabwe


 


  
 30 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 Appendix 2 
 1. TDF Patents 
 Gilead either owns or has exclusive rights to the TDF Patents. 

2. EVG Patents 
 TITLE: 4-OXOQUINOLINE COMPOUNDS
AND UTILIZATION THEREOF AS HIV INTEGRASE 
 INHIBITORS 

									
	 Country
	  	Filing Date	  	Serial Number	  	Patent Number	  	Grant Date
	 Bolivia
	  	18-Nov-2003	  	SP-230265	  	 	  	 
	 India
	  	20-Nov-2003	  	01316/CHENP/2004	  	245833	  	3-Feb-2011
	 Indonesia
	  	20-Nov-2003	  	W00/200401542	  	P0023507	  	1-Jun-2009
	 Nigeria
	  	19-Nov-2003	  	424/2003	  	RP.15779	  	20-Oct-2004
	 South Africa
	  	20-Nov-2003	  	2004/4537	  	2004/4537	  	31-Aug-2005
	 Thailand
	  	20-Nov-2003	  	086853	  	 	  	 
	 Viet Nam
	  	20-Nov-2003	  	1-2004-00605	  	 	  	 

 TITLE: STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND 

									
	 Country
	  	Filing Date	  	Serial Number	  	Patent Number	  	Grant Date
	 Bolivia
	  	19-May-2005	  	SP-250121	  	 	  	 
	 India
	  	19-May-2005	  	357/CHENP/2010	  	 	  	 
	 South Africa
	  	19-May-2005	  	2006/10647	  	2006/10647	  	25-Jun-2008
	 Thailand
	  	19-May-2005	  	100718	  	 	  	 

 TITLE: METHOD FOR PRODUCING 4-OXOQUINOLINE COMPOUND 

									
	 Country
	  	Filing Date	  	Serial Number	  	Patent Number	  	Grant Date
	 African Regional

Industrial Property

Organization

(ARIPO)
	  	6-Mar-2007	  	AP/P/2008/004621	  	 	  	 
	 Eurasian Patent

Organization

(EAPO)
	  	6-Mar-2007	  	200870321	  	 	  	 
	 India
	  	6-Mar-2007	  	5341/CHENP/2008	  	 	  	 
	 African Union

Territories (OAPI)
	  	6-Mar-2007	  	1200800317	  	14280	  	31-Mar-2009
	 South Africa
	  	6-Mar-2007	  	2008/07547	  	2008/07547	  	25-Nov-2009
	 Viet Nam
	  	6-Mar-2007	  	1-2008-02431	  	 	  	 

 TITLE: PROCESS FOR PROUDCTION OF 4-OXOQUINOLINE COMPOUND 

									
	 Country
	  	Filing Date	  	Serial Number	  	Patent Number	  	Grant Date
	 India
	  	6-Mar-2007	  	5344/CHENP/2008	  	 	  	 


  
 31 


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







 TITLE: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS (I) 

									
	 Country
	  	Filing Date	  	Serial Number	  	Patent Number	  	Grant Date
	 African Regional

Industrial Property

Organization

(ARIPO)
	  	11-Sep-2007	  	AP/P/2009/004831	  	 	  	 
	 Eurasian Patent

Organization

(EAPO)
	  	11-Sep-2007	  	200900441	  	 	  	 
	 India
	  	11-Sep-2007	  	1808/DELNP/2009	  	 	  	 
	 Indonesia
	  	11-Sep-2007	  	W00/200900634	  	 	  	 
	 African Union

Territories (OAPI)
	  	11-Sep-2007	  	1200900070	  	 	  	 
	 Thailand
	  	11-Sep-2007	  	0701004583	  	 	  	 
	 Viet Nam
	  	11-Sep-2007	  	1-2009-00636	  	 	  	 
	 South Africa
	  	11-Sep-2007	  	2009/01576	  	 	  	 

 TITLE: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS (II) 

									
	 Country
	  	Filing Date	  	Serial Number	  	Patent Number	  	Grant Date
	 African Regional

Industrial Property

Organization

(ARIPO)
	  	11-Sep-2008	  	AP/P/2010/005187	  	 	  	 
	 Eurasian Patent

Organization

(EAPO)
	  	11-Sep-2008	  	201070256	  	 	  	 
	 India
	  	11-Sep-2008	  	1615/DELNP/2010	  	 	  	 
	 Indonesia
	  	11-Sep-2008	  	W00/201000759	  	 	  	 
	 African Union

Territories (OAPI)
	  	11-Sep-2008	  	1201000093	  	 	  	 
	 Thailand
	  	11-Sep-2008	  	0801004676	  	 	  	 
	 Viet Nam
	  	11-Sep-2008	  	1-2009-00636	  	 	  	 
	 South Africa
	  	11-Sep-2008	  	1-2010-00483	  	 	  	 

 For purposes of this Appendix 2, references to “OAPI,” “EAPO” and “ARIPO” shall not be construed or
interpreted to grant rights to Licensee in any country other than those countries expressly included within the licenses granted to Licensee in Sections 2.1 and 2.2 of this Agreement. 
 [Gilead may only delete some of the patents in the above list if necessary.] 
 3. COBI
Patents 

  
 32 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 Gilead either owns or has exclusive rights to the COBI Patents. 

Appendix 3 

Terms for Technology Transfer 
 Gilead shall provide Licensee with the following information to fully enable Licensee to manufacture TDF, EVG, COBI, TDF Product, EVG Product, COBI Product and Quad at commercial-scale quantities and in
compliance with Gilead’s required quality specifications: 
  

	 	1.	Manufacturing process descriptions, specifications and methods; 

  

	 	2.	Stability data; 

  

	 	3.	Analytical method validation; and 

  

	 	4.	Discussion of impurities. 


  
 33 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 Confidential 

Appendix 4 

Emtricitabine Patents 

Gilead either owns or has exclusive rights to the Emtricitabine Patents. 

  
 35 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 Confidential 

Appendix 5 

Countries in the COBI Territory 

 

 1.     Afghanistan 
 2.     Angola 
 3.     Anguilla 

4.     Antigua and Barbuda 

5.     Armenia 
 6.
    Aruba 
 7.     Bahamas 
 8.     Bangladesh 
 9.     Barbados 

	10.	Belize 


	11.	Benin 


	12.	Bhutan 


	13.	Bolivia 


	14.	British Virgin Islands 


	15.	Burkina Faso 


	16.	Burundi 


	17.	Cambodia 


	18.	Cameroon 


	19.	Cape Verde 


	20.	Central African Republic 


	21.	Chad 


	22.	Comoros 


	23.	Congo, Rep 


	24.	Congo, Dem. Rep. of the 


	25.	Côte d’Ivoire 


	26.	Cuba 


	27.	Djibouti 


	28.	Dominica 


	29.	Dominican Republic 


	30.	Equatorial Guinea 


	31.	Eritrea





	32.	Ethiopia 


	33.	Fiji Islands, Rep. of the 


	34.	Gabon 


	35.	Gambia 


	36.	Georgia 


	37.	Ghana 


	38.	Grenada 


	39.	Guatemala 


	40.	Guinea 


	41.	Guinea-Bissau 


	42.	Guyana 


	43.	Haiti 


	44.	Honduras 


	45.	India 


	46.	Jamaica 


	47.	Kenya 


	48.	Kiribati 


	49.	Kyrgyzstan 


	50.	Lao People’s Dem. Rep. 


	51.	Lesotho 


	52.	Liberia 


	53.	Madagascar 


	54.	Malawi 


	55.	Maldives 


	56.	Mali 


	57.	Mauritania 


	58.	Mauritius 


	59.	Moldova, Rep. of 


	60.	Mongolia 


	61.	Montserrat 


	62.	Mozambique 


	63.	Myanmar 


	64.	Nauru 


	65.	Nepal 


	66.	Nicaragua





	67.	Niger 


	68.	Nigeria 


	69.	Pakistan 


	70.	Palau 


	71.	Papua New Guinea 


	72.	Rwanda 


	73.	Saint Kitts and Nevis 


	74.	Saint Lucia 


	75.	Saint Vincent & the     Grenadines 


	76.	Samoa 


	77.	São Tomé and Príncipe 


	78.	Senegal 


	79.	Seychelles 


	80.	Sierra Leone 


	81.	Solomon Islands 


	82.	Somalia 


	83.	South Africa 


	84.	Sudan 


	85.	Suriname 


	86.	Swaziland 


	87.	Syrian Arab Republic 


	88.	Tajikistan 


	89.	Tanzania, U. Rep. of 


	90.	Timor-Leste 


	91.	Togo 


	92.	Tonga 


	93.	Trinidad and Tobago 


	94.	Turks and Caicos 


	95.	Tuvalu 


	96.	Uganda 


	97.	Uzbekistan 


	98.	Vanuatu 


	99.	Vietnam 


	100.	Yemen 


	101.	Zambia 


	102.	Zimbabwe 


 


  
 35 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 Confidential 

Appendix 6 

Countries in the EVG-Quad Territory 

 

 1.     Afghanistan 
 2.     Angola 
 3.     Anguilla 

4.     Antigua and Barbuda 

5.     Armenia 
 6.
    Bahamas 
 7.     Bangladesh 
 8.     Barbados 
 9.     Belize 

	10.	Benin 


	11.	Bhutan 


	12.	Bolivia 


	13.	British Virgin Islands 


	14.	Burkina Faso 


	15.	Burundi 


	16.	Cambodia 


	17.	Cameroon 


	18.	Cape Verde 


	19.	Central African Republic 


	20.	Chad 


	21.	Comoros 


	22.	Congo, Rep 


	23.	Congo, Dem. Rep. of the 


	24.	Côte d’Ivoire 


	25.	Cuba 


	26.	Djibouti 


	27.	Dominica 


	28.	Equatorial Guinea 


	29.	Eritrea 


	30.	Ethiopia 


	31.	Fiji Islands, Rep. of the 


	32.	Gabon 


	33.	Gambia 


	34.	Georgia 


	35.	Ghana





	36.	Grenada 


	37.	Guatemala 


	38.	Guinea 


	39.	Guinea-Bissau 


	40.	Guyana 


	41.	Haiti 


	42.	Honduras 


	43.	India 


	44.	Jamaica 


	45.	Kenya 


	46.	Kiribati 


	47.	Kyrgyzstan 


	48.	Lao People’s Dem. Rep. 


	49.	Lesotho 


	50.	Liberia 


	51.	Madagascar 


	52.	Malawi 


	53.	Maldives 


	54.	Mali 


	55.	Mauritania 


	56.	Mauritius 


	57.	Moldova, Rep. of 


	58.	Mongolia 


	59.	Mozambique 


	60.	Myanmar 


	61.	Nauru 


	62.	Nepal 


	63.	Nicaragua 


	64.	Niger 


	65.	Nigeria 


	66.	Pakistan 


	67.	Palau 


	68.	Papua New Guinea 


	69.	Rwanda 


	70.	Saint Kitts and Nevis 


	71.	Saint Lucia 


	72.	Saint Vincent & the     Grenadines 


	73.	Samoa





	74.	São Tomé and Príncipe 


	75.	Senegal 


	76.	Seychelles 


	77.	Sierra Leone 


	78.	Solomon Islands 


	79.	Somalia 


	80.	South Africa 


	81.	Sudan 


	82.	Suriname 


	83.	Swaziland 


	84.	Syrian Arab Republic 


	85.	Tajikistan 


	86.	Tanzania, U. Rep. of 


	87.	Timor-Leste 


	88.	Togo 


	89.	Tonga 


	90.	Trinidad and Tobago 


	91.	Turks and Caicos 


	92.	Tuvalu 


	93.	Uganda 


	94.	Uzbekistan 


	95.	Vanuatu 


	96.	Vietnam 


	97.	Yemen 


	98.	Zambia 


	99.	Zimbabwe 


 


  
 36 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 Appendix 7 
 Countries in the Semi-Exclusive Territory 
 1. Sri Lanka 

2. Thailand 
 3. Botswana

 4. Namibia 
 5. El
Salvador 
 6. Ecuador 

7. Indonesia 
 8. Kazakhstan

 9. Turkmenistan 

  
 1 

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







 ATTACHMENT B 

AMENDED AND RESTATED NON-EXCLUSIVE LICENSE
AGREEMENT (TEMPLATE) 
 This AMENDED AND RESTATED
NON-EXCLUSIVE LICENSE AGREEMENT (the “Agreement”) is made as of July __, 2011 (the “Effective Date”) by and between Gilead Sciences, Inc. a Delaware
corporation having its principal place of business at 333 Lakeside Drive, Foster City, California 94404, USA (“Gilead”), and ________________________ a company registered under the laws of India, and having a registered
office at _______________________________________________________, India (“Licensee”), and amends and restates in its entirety the License Agreement dated _________________ between Gilead and Licensee, as previously amended (the
“TDF License Agreement”). 
 R E C I T
A L S 
 WHEREAS, Gilead wishes to facilitate access to
its antiviral agents to patients in the developing world to help satisfy unmet medical needs; 
 WHEREAS,
to accomplish this goal, Gilead granted Licensee a non-exclusive license to manufacture Gilead’s proprietary agent TDF in India and sell such agent in India and elsewhere in the developing world pursuant to the TDF License Agreement;

 WHEREAS, Gilead wishes to expand the scope of the TDF License Agreement to expand the licensed Territory and
grant Licensee non-exclusive rights to Gilead’s proprietary agents elvitegravir and cobicistat, and including rights in Gilead’s proprietary fixed-dose single-tablet regimen referred to as the “Quad”, as specifically provided
herein; and 
 WHEREAS, Licensee wishes to manufacture TDF, elvitegravir and cobicistat in India and sell
products containing such agents in the Territory to help achieve the goal set forth above; 
 NOW,
THEREFORE, in consideration of the mutual covenants set forth herein and other good and valuable considerations, the receipt of which is hereby acknowledged, the parties hereto mutually agree to amend and restate the TDF
License Agreement in its entirety, as follows: 
  

	1.	Definitions 


“Active Pharmaceutical Ingredient” or “API” shall mean one or more of the following active
pharmaceutical ingredients: tenofovir disoproxil fumarate (“TDF”); elvitegravir (“EVG”), and cobicistat (“COBI”). 

  
 2 

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







 “Alternate Dosage” shall have the meaning set forth in Section 6.2(d).

 “COBI Combination Product” shall mean a formulated and finished pharmaceutical product containing COBI in
combination with any other active pharmaceutical ingredient other than EVG, including combinations containing COBI together with TDF provided such combination does not also contain EVG (in each case subject to the restrictions set forth in
Section 2.4(c)(ii)), including any co-formulation, co-packaged product, bundled product, or other type of combination product. For clarity, the Quad is not a COBI Combination Product. 

“COBI Product” shall mean a formulated and finished pharmaceutical product containing COBI as its sole active
pharmaceutical ingredient. 
 “COBI Territory” shall mean those countries listed on Appendix 5. 

“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products and the
Quad. 
 “Confidential Information” shall have the meaning set forth in Section 11.1. 

“Distributor” shall mean a third party wholesaler or distributor that is not a Gilead Distributor and that is operating
under an agreement with Licensee for the distribution and sale of Product in the Territory. 
 “Emtricitabine
Patents” shall have the meaning set forth in Section 7.6. 
 “EVG Combination Product” shall mean
a formulated and finished pharmaceutical product containing EVG in combination with any other active pharmaceutical ingredient (in each case subject to the restrictions set forth in Section 2.4(c)(iii)), including any co-formulation,
co-packaged product, bundled product, or other type of combination product, but not including the Quad. 
 “EVG
Product” shall mean a formulated and finished pharmaceutical product containing EVG as its sole active pharmaceutical ingredient. 
 “EVG-Quad Territory” shall mean those countries listed on Appendix 6. 
 “FDA” shall mean the United States Food and Drug Administration, and any successor agency thereto. 
 “Field” shall mean the treatment and prophylaxis of HIV infection, provided, however, that (a) for Product containing TDF as its sole active pharmaceutical ingredient, the
Field shall include the treatment and prophylaxis of Hepatitis B Virus infection, and 

  
 3 

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







 
(b) for Product containing EVG or COBI, the Field shall include any use that is consistent with the label approved by the FDA or applicable foreign regulatory authority for the use of such
Product containing EVG or COBI. 
 “Gilead Distributor” shall mean any third party distributor that is
operating under an agreement with Gilead for the distribution and sale of Gilead’s branded product in the Territory. Gilead will provide Licensee with a list, which may be updated by Gilead from time to time, of the identity of the Gilead
Distributors and their licensed territories. 
 “Gilead Mark” shall have the meaning set forth in
Section 2.5(b). 
 “Gilead Supplier” shall mean PharmaChem Technologies (Grand Bahama), Ltd. 

“Improvements” shall have the meaning set forth in Section 2.3. 

“Japan Tobacco” shall mean Japan Tobacco Inc., a Japanese corporation, and its affiliates. 

“Japan Tobacco Agreement” shall mean the License Agreement between Gilead and Japan Tobacco dated March 22, 2005,
as amended from time to time. 
 “JT Mark” shall have the meaning set forth in Section 2.5(b). 

“Licensed API” shall mean API that is either (a) made by Licensee pursuant to the license grant in
Section 2.1; or (b) acquired by Licensee from a Gilead Supplier or from a Licensed API Supplier on the terms and conditions set forth in Section 3. 
 “Licensed API Supplier” shall mean an entity (other than Licensee) that is licensed by Gilead to manufacture and sell API to third parties in the Field in India. 

“Licensed Know-How” shall have the meaning set forth in Section 5.4. 

“Licensed Product Supplier” shall mean an entity (other than Licensee) located in India that is licensed by Gilead to
make, use, sell, have sold, offer for sale and export Product in the Field in the Territory. 
 “Licensed
Technology” shall mean the Patents and the Licensed Know-How. 
 “Minimum Quality Standards” shall
have the meaning set forth in Section 6.2(a). 
 “NCE Exclusivity” shall mean five years of marketing
exclusivity granted by FDA pursuant to its authority under 21 U.S.C. §§ 355(c)(3)(E)(ii) and 355(j)(5)(F)(ii). 

  
 4 

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







 “Net Sales” shall mean, with respect to a given calendar quarter, the total
amount invoiced by Licensee for sales of Product in the Territory, less landed cost (including freight, insurance, packing, shipping and custom duty) of imported components, VAT/Indian excise tax, sales tax, packing for shipment and shipping costs
actually incurred, to the extent consistent with Generally Accepted Accounting Principles as consistently applied across all products of Licensee. In no event shall the total deductions allowed exceed ten percent (10%) of the total amount
invoiced by Licensee without Licensee providing Gilead with supporting documentation justifying such excess and obtaining Gilead’s written consent, not to be unreasonably withheld. Net Sales on Combination Products shall be calculated based on
the portion of product Net Sales attributable to Licensed API, as set forth in Section 4.2. 
 “Patents”
shall mean the patents described in Appendix 2 hereto and any other patents and patent applications (and resulting patents therefrom) (a) owned by Gilead during the term of this Agreement, or (b) exclusively licensed by Gilead from Japan
Tobacco pursuant to the Japan Tobacco Agreement, in each case solely to the extent necessary for Licensee to practice the licenses granted in Section 2 hereof, and solely to the extent the claims in such patents and patent applications cover
the manufacture, use or sale of API. 
 “Pediatric Formulation” shall have the meaning set forth in
Section 6.2(e). 
 “Product” shall mean COBI Product, EVG Product, TDF Product, COBI Combination Product,
EVG Combination Product, TDF Combination Product, and the Quad. 
 “Quad” or “the Quad” shall
mean the finished pharmaceutical product containing TDF (300 mg), emtricitabine (200 mg), EVG and COBI (each at their dose concentration approved by the FDA or applicable regulatory authority) as its only active pharmaceutical ingredients, and that
is manufactured and sold as a fixed-dose single-tablet regimen and not as a bundled or co-packaged product. 

“Quarterly Report” shall have the meaning set forth in Section 4.3. 

“Royalty Term” shall have the meaning set forth in Section 4.9. 

“TDF Combination Product” shall mean a formulated and finished pharmaceutical product containing TDF in
combination with any other active pharmaceutical ingredient other than EVG or COBI (in each case subject to the restrictions set forth in Section 2.4(c)(i)), including any co-formulation, co-packaged product, bundled product, or other type of
combination product. For clarity, the Quad is not a TDF Combination Product.  
 “TDF Product” shall
mean a formulated and finished pharmaceutical product containing TDF as its sole active pharmaceutical ingredient. 

  
 5 

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







 “TDF Territory” shall mean those countries listed on Appendix 1.

 “Territory” shall mean the TDF Territory, the COBI Territory and the EVG-Quad Territory. 

“Third-Party Resellers” shall mean Licensed Product Suppliers, Distributors and Gilead Distributors. 

 

	2.	License Grants 


2.1        API License. Subject to the terms and conditions of this Agreement, Gilead
hereby grants to Licensee a royalty-free, non-exclusive, non-sublicensable, non-transferable license under the Licensed Technology to make, use, offer to sell and sell API in the Field and in India, solely for the purpose of offering to sell and
selling API to Licensed Product Suppliers, or for Licensee’s own internal use. For clarity, the license granted in this Section 2.1 does not include, expressly or by implication, a license under any Gilead intellectual property right to
manufacture, sell or distribute any active pharmaceutical ingredient owned or controlled by Gilead other than TDF, EVG and COBI. 
 2.2        Product License. Subject to the terms and conditions of this Agreement, Gilead hereby grants to Licensee a royalty-bearing, non-exclusive,
non-sublicensable (except as set forth in Section 2.4(b)), non-transferable license under the Licensed Technology solely to make, use, sell, have sold, offer for sale, export from India and import (i) TDF Product and TDF Combination
Products in the Field in the TDF Territory, (ii) EVG Product, EVG Combination Products and the Quad in the Field in the EVG-Quad Territory, and (iii) COBI Products and COBI Combination Products in the Field and in the countries of the COBI
Territory; provided that in each case such Products shall be made only from Licensed API. 
 For clarity, (a) the licenses granted in this
Section 2.2 do not include, expressly or by implication, a license under any Gilead intellectual property right to manufacture, sell or distribute any product containing active pharmaceutical ingredients owned or controlled by Gilead other than
Products containing TDF, EVG and COBI, and (b) notwithstanding the foregoing, the licenses granted under this Section 2.2 shall not extend to any active pharmaceutical ingredient included within a Product other than TDF, EVG and COBI.

 2.3        License Grant to Gilead. Licensee hereby grants to Gilead a
nonexclusive, royalty-free, worldwide, sublicensable license to all improvements, methods, modifications and other know-how developed by or on behalf of Licensee and relating to API or a Product (“Improvements”), subject to the
restrictions on further transfer of Licensee’s technology by Gilead as set forth in Section 5.2. 

  
 6 

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







 2.4      Licensee Right to Sell Through Third Party
Resellers. 
 (a)      Licensed Product Suppliers. Licensee agrees that it will not
sell or offer to sell API to any entity other than to Licensed Product Suppliers in India that have been approved by Gilead in accordance with Section 2.4(e). 
 (b)      Product Sales. Licensee agrees that it will not sell, offer for sale, or assist third parties in selling Product except for the sale and offer for sale
of (A) TDF Product and TDF Combination Product for use in the Field and in the countries of the TDF Territory, (B) COBI Product and COBI Combination Product for use in the Field and in the countries of the COBI Territory, and (C) EVG
Product, EVG Combination Product and Quad for use in the Field and in the countries of the EVG-Quad Territory. 

(i)      Licensee agrees that it will prohibit its Distributors from selling Product (A) to any other
wholesaler or distributor, (B) outside the Territory for which Licensee is licensed for sale of such Product pursuant to Section 2.2, or (C) for any purpose outside the Field. 

(ii)      Licensee agrees that it will not administer the Quad to humans, or sell the Quad until Gilead
has obtained marketing approval for the Quad from the FDA. Licensee agrees that it will not administer EVG to humans, or sell Products containing EVG until Gilead has obtained marketing approval for EVG from the FDA. Licensee agrees that it will not
administer COBI to humans, or sell Products containing COBI until Gilead has obtained marketing approval for COBI from the FDA. If Gilead obtains marketing approval from the FDA for the Quad prior to obtaining marketing approval for a product
containing EVG or COBI as a single agent, then Licensee will be allowed to administer the Quad to humans, and sell the Quad, but will not (A) administer to humans or sell Combination Products containing EVG other than the Quad until Gilead has
obtained marketing approval from the FDA for EVG, or (B) administer to humans or sell Combination Products containing COBI other than the Quad until Gilead has obtained marketing approval from the FDA for COBI. 

(c)      Limitations on Product Combinations. 

(i)      Licensee will be allowed to manufacture and sell TDF in combination with other active
pharmaceutical ingredients in the TDF Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the TDF Territory, and (B) such
manufacture and sale is in accordance with the licenses granted herein. 
 (ii)       Licensee
will be allowed to manufacture and sell COBI in combination with other active pharmaceutical ingredients in the COBI Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other 

  
 7 

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







 
active pharmaceutical ingredients in the applicable country in the COBI Territory, and (B) such manufacture and sale is in accordance with the licenses granted herein. 

(iii)      Licensee will be allowed to manufacture and sell EVG in combination with other active
pharmaceutical ingredients in the EVG-Quad Territory, provided in each case (A) Licensee has the legal right to manufacture and sell such other active pharmaceutical ingredients in the applicable country in the EVG-Quad Territory, (B) such
manufacture and sale is in accordance with the licenses granted herein, and (C) Licensee has obtained Gilead’s prior written consent for the manufacture or sale of such product containing EVG, such consent not to be unreasonably withheld.
For clarity, the requirement for Gilead’s prior consent set forth in the preceding clause (C) shall not apply to the Quad. 
 (d)      Terms of Agreements with Third Party Resellers. 
 (i)      Gilead Distributors. Licensee may elect to sell finished Product in the Territory to any Gilead Distributor, provided, however, that (A) Licensee may
only sell and offer for sale TDF Product and TDF Combination Product to Gilead Distributors to sell in the TDF Territory, and may not sell or offer for sale TDF Product or TDF Combination Product outside the TDF Territory, (B) Licensee may only
sell and offer for sale COBI Product and COBI Combination Product to Gilead Distributors in the COBI Territory, and may not sell or offer for sale COBI Product or COBI Combination Product outside the COBI Territory, (C) Licensee may only sell
and offer for sale EVG Product, EVG Combination Product and Quad to Gilead Distributors in the EVG-Quad Territory, and may not sell or offer for sale EVG Product, EVG Combination Product or Quad outside the EVG-Quad Territory, and (D) Licensee
shall only sell to such Gilead Distributor those Products that are bioequivalent to the branded products Gilead has granted such Gilead Distributor the right to sell in such country of the applicable Territory. Licensee shall only allow such Gilead
Distributor to sell such Product in the countries within the country of the applicable Territory for which such Gilead Distributor has the right to sell branded Gilead product. For example, Licensee shall not sell to a Gilead Distributor (X) a
Product containing TDF, FTC and efavirenz, unless Gilead has granted such distributor the right to sell a branded product containing TDF, FTC and efavirenz in such country in the Territory, or (Y) a Product containing both TDF and 3TC.

 (ii)      Other Third Party Resellers. Licensee shall require any such Third Party
Reseller to agree, in a written agreement with Licensee, (i) to comply with the applicable terms of this Agreement; and (ii) to report to Licensee such information and allow Licensee to provide Gilead with the information described in
Section 4.3 (and also to provide Japan Tobacco with such information to the extent it relates to EVG, EVG Product, EVG Combination Product or Quad). Gilead has the right to audit, on no less than thirty (30) days’ advance notice to
Licensee, such records of Licensee solely to the extent necessary to verify such compliance. Gilead will bear the 

  
 8 

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







 
full cost of any such audit, and shall have the right to share the outcome of any such audit with Japan Tobacco to the extent such outcome relates to EVG, EVG Product, EVG Combination Product or
Quad. 
 (e)      Gilead Approval of Third Party Reseller Agreements. Licensee shall not
enter into any agreements with Third Party Resellers on terms inconsistent with this Agreement without obtaining Gilead’s prior written approval. If Licensee enters into an agreement with any Third Party Reseller, then Licensee shall notify
Gilead in writing, and shall certify that its arrangement with such Third Party Reseller is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies of all agreements executed between Licensee and
Third Party Resellers. Gilead shall have the right to review all such agreements to verify consistency with the terms and conditions of this Agreement. In the event that any inconsistency is found which had not been specifically discussed and agreed
with Gilead, then Gilead shall have the right to require Licensee to terminate such agreement. To the extent any such agreements relate to EVG, EVG Product, EVG Combination Product, or Quad, Gilead shall also have the right to share such agreements
with Japan Tobacco. 
 (f)      Termination of Third Party Agreements by Licensee.
Licensee shall immediately terminate its agreement(s) with a Third-Party Reseller in the event that such Third Party Reseller engages in material activities that Licensee is prohibited from performing under this Agreement, or that are inconsistent
with Licensee’s covenants under this Agreement, including without limitation the unauthorized use, sale or diversion by such Third Party Reseller of API or Product outside the Field or the applicable Territory, or upon Licensee first reasonably
believing that such Third-Party Reseller has engaged in such activities. 

(g)      Termination of Third Party Agreements by Gilead. Gilead may terminate the right of
Licensee to sell Product to any Third-Party Reseller pursuant to this Section 2.4, if in Gilead’s reasonable belief the Third-Party Reseller is not acting in a way that is consistent with Licensee’s covenants under this Agreement, or
if Licensee does not terminate Licensee’s agreement with such Third-Party Reseller under the circumstances described in Section 2.4(e) or Section2.4(f). 
 2.5      License Limitations. 

(a)      Gilead Retained Rights. Licensee hereby acknowledges that Gilead retains all rights in API
and Products except as otherwise provided in this Agreement, and that Gilead may license or otherwise convey to third parties its rights in API and Products as it wishes without obligation or other accounting to Licensee. 

(b)      Gilead Marks. The licenses granted hereunder do not include any license or other right to
use any Gilead trademark, trade name, logo or service mark (each, a “Gilead Mark”) or any word, logo or any expression that is similar to or 

  
 9 

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







 
alludes to any Gilead Mark, except as provided in Section 6.5. Licensee agrees not to use any Japan Tobacco trademark, trade name, logo or service mark (each, a “JT Mark”),
or any word, logo or any expression that is similar to any JT Mark. 
 (c)      Sublicensed
Technology. The licenses relating to EVG, EVG Product, EVG Combination Product and Quad granted to Licensee under this Agreement include sublicenses of intellectual property rights from Japan Tobacco, and remain subject to the terms and
conditions of the Japan Tobacco Agreement. Gilead and Licensee shall not permit any action to be taken or event to occur, in each case to the extent within such party’s reasonable control, that would give Japan Tobacco the right to terminate
the Japan Tobacco Agreement. If either party is notified or otherwise becomes aware that Licensee’s activities may constitute a material breach of the Japan Tobacco Agreement, it shall promptly notify the other party. The parties shall confer
regarding an appropriate manner for curing any such alleged breach. Licensee shall cure such alleged breach as promptly as possible, and in any case within the time allotted under the Japan Tobacco Agreement. Gilead shall remain responsible for EVG
Product, EVG Combination Product, and Quad royalties owed to Japan Tobacco pursuant to the Japan Tobacco Agreement. 

(d)      No Other Licenses. 

(i)      Licensee agrees that it shall not use any contract manufacturers without obtaining Gilead’s
prior written consent, or grant any sublicenses hereunder. 
 (ii)      Except as expressly set
forth in this Agreement, Gilead does not grant any license under any of its intellectual property rights (including, without limitation, Patents or rights to any proprietary compounds or drug substances other than API) to Licensee. 

 

	3.	Sourcing of API 


3.1      Sourcing of API from API Suppliers. Licensee agrees that it shall not make, use or sell any
Product that contains API other than API that is Licensed API. If Licensee wishes to manufacture Product using API made by either a Gilead Supplier or a Licensed API Supplier, then Licensee shall notify Gilead in writing, and shall certify that its
arrangement with such Gilead Supplier or Licensed API Supplier, as applicable, is consistent with the terms and conditions of this Agreement. Licensee shall provide Gilead with written copies of all agreements between Licensee and such Gilead
Supplier or Licensed API Supplier upon execution. To the extent any such agreements relate to EVG, Gilead shall have the right to share such agreements with Japan Tobacco. In the event that any inconsistency is found which had not been specifically
discussed and agreed with Gilead, Gilead shall have the right to require Licensee to terminate such agreement with such Gilead Supplier or Licensed API Supplier. 

  
 10 


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







 3.2      Gilead Assistance with Gilead Suppliers. Upon
receipt of a notice described in Section 3.1 of Licensee’s intention to obtain Licensed API from a Gilead Supplier, Gilead shall use commercially reasonable efforts to assist Licensee in procuring supply of API from such Gilead Supplier.
Gilead shall not be obligated to assist Licensee in procuring any supply of API from a Licensed API Supplier. 

3.3      Conditions of Supply from Gilead Suppliers. Gilead shall be a party to any agreement
between Licensee and a Gilead Supplier that provides for the supply of API to Licensee from such Gilead Supplier. Any such agreement between Gilead, Licensee and a Gilead Supplier shall include and be subject to the following conditions: 

(a)      Gilead Supply Needs. Licensee shall not obtain API from the Gilead Supplier until Gilead
has received confirmation in writing from the Gilead Supplier of its ability to continue to supply Gilead with Gilead’s forecasted requirements of API, as reflected in Gilead’s then-current twelve (12) month forecast for API provided
to the Gilead Supplier. 
 (b)      Consistency with Agreement. The Gilead Supplier shall
be permitted to supply API to Licensee only to the extent that any such supply does not (A) adversely affect its ability to meet Gilead’s forecasted requirements or (B) adversely affect the Gilead Supplier’s ability to supply
Gilead’s requirements, whether or not such requirements are consistent with Gilead’s twelve (12) month forecast. Gilead shall have the right to terminate any such agreement if such supply adversely affects Gilead as set forth in this
Section 3.3(b). 
 3.4      No Other Arrangements. Licensee agrees that it shall not
enter into any agreements, nor amend any existing agreements, for the supply of intermediates or API the terms of which would be inconsistent with this Agreement without Gilead’s prior written approval as provided for in this Section 3.

 3.5      Supply of other components. The obligations set forth in Sections 3.1, 3.2 and
3.3 with respect to Licensee’s supply of API shall not apply to active pharmaceutical ingredients other than API that Licensee may incorporate into Combination Products. 
 4.      Consideration/Payment Terms/Audit 

4.1      Royalty. As consideration for the licenses granted in Section 2, Licensee shall pay
Gilead the following royalties on Net Sales of Product in the Territory for the duration of the Royalty Term: 

(a)      5% of TDF Product Net Sales in the TDF Territory. 

  
 11 


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







 (b)      5% of the portion of TDF Combination Product Net
Sales attributable to the TDF component of such TDF Combination Product in the TDF Territory as determined in accordance with Section 4.2. 
 (c)      5% of the portion of Quad Net Sales attributable to the TDF, EVG and COBI components of the Quad in the EVG-Quad Territory as determined in accordance with
Section 4.2. 
 (d)      5% of EVG Product Net Sales in the EVG-Quad Territory. 

(e)      5% of the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the
EVG component of such EVG Combination Product in the EVG-Quad Territory as determined in accordance with Section 4.2. In addition, (i) to the extent any such EVG Combination Product also contains TDF, Licensee will also pay Gilead 5% of
the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the TDF component of such EVG Combination Product in the EVG-Quad Territory as determined in accordance with Section 4.2, and (ii) to the extent any
such EVG Combination Product also contains COBI, Licensee will also pay Gilead 5% of the portion of EVG Combination Product (other than the Quad) Net Sales attributable to the COBI component of such EVG Combination Product in the EVG-Quad Territory
as determined in accordance with Section 4.2. 
 (f)      5% of COBI Product Net Sales in
the COBI Territory. 
 (g)      5% of the portion of COBI Combination Product (other than the
Quad) Net Sales attributable to the COBI component of such COBI Combination Product in the COBI Territory, as determined in accordance with Section 4.2. In addition, to the extent any such COBI Combination Product also contains TDF, Licensee
will also pay Gilead 5% of the portion of COBI Combination Product (other than the Quad) Net Sales attributable to the TDF component of such COBI Combination Product in the COBI Territory, as determined in accordance with Section 4.2.

 (h)      No royalties will be owed on Pediatric Formulations developed and sold by Licensee in
accordance with Section 6.2(e). 
 (i)      No royalties will be owed on the emtricitabine
component of any Combination Product. 
 (j)      No royalties will be owed on Licensee’s
sale of API to other Licensed Product Suppliers, provided such Licensed Product Supplier has executed an agreement with Gilead requiring such Licensed Product Supplier to pay Gilead royalties on finished Product containing such API. 

(k)      Royalties on sales of Product to Gilead Distributors will be based on Licensee’s invoice
price to such Gilead Distributor. 

  
 12 


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







 (l)      Royalties will only be owed once on each
royalty-bearing API of a Combination Product. By means of example, if Licensee pays royalties on the Quad pursuant to Section 4.1(c), then Licensee will not also have to pay additional royalties on the TDF component for the sale of the Quad
pursuant to Section 4.1(a) or 4.1(b), the EVG component pursuant to Section 4.1(d) or 4.1(e), or the COBI component pursuant to Section 4.1(f) or 4.1(g). 
 4.2      Adjustment for Combination Products. Solely for the purpose of calculating Net Sales of Combination Products, if Licensee sells Product in the form of a
Combination Product containing any Licensed API and one or more other active pharmaceutical ingredients in a particular country, Net Sales of such Combination Product in such country for the purpose of determining the royalty due to Gilead pursuant
to Section 4.1 will be calculated by multiplying actual Net Sales of such Combination Product in such country by the fraction A/(A+B), where A is the invoice price of such Product if sold separately in such country, and B is the total invoice
price of the other active pharmaceutical ingredient(s) in the combination if sold separately in such country. If, on a country-by-country basis, such other active pharmaceutical ingredient or ingredients in the Combination Product are not sold
separately in such country, but the Product component of the Combination Product is sold separately in such country, Net Sales for the purpose of determining royalties due to Gilead for the Combination Product will be calculated by multiplying
actual Net Sales of such Combination Product by the fraction A/C, where A is the invoice price of such Product component if sold separately, and C is the invoice price of the Combination Product. If, on a country-by-country basis, such Product
component is not sold separately in such country, Net Sales for the purposes of determining royalties due to Gilead for the Combination Product will be D/(D+E), where D is the fair market value of the portion of the Combination Products that
contains the Product, and E is the fair market value of the portion of the Combination Products containing the other active pharmaceutical ingredient(s) or delivery device included in such Combination Product, as such fair market values are
determined by mutual agreement of the Parties, which shall not be unreasonably withheld. 

4.3      Reports. Within sixty (60) days after the end of each calendar quarter, Licensee shall
(a) provide Gilead with a detailed report of amounts of API and Product produced, API and Product on stock, total invoiced sales, Net Sales, the deductions used to determine Net Sales, number of units of Product sold, each of which shall be
reported on a Product-by-Product and country-by-country basis, adjustments for combination products (pursuant to Section 4.2) including calculations showing the Net Sales of the EVG component of any EVG Combination Product, total royalties owed
for the calendar quarter, the countries to which the Product has been sent and in what quantities, the Third Party Resellers, if any, to which Licensee has provided Product and in what quantities, and Net Sales by each Third-Party Reseller, and, in
the case of the sale of any API to third-party manufacturers of Product, the identity of such third parties and quantities of API sold to each such third party (the “Quarterly Report”); (b) provide Gilead with a written
certification of the accuracy of the contents of the Quarterly Report, signed by an 

  
 13 


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







 
appropriate Licensee senior officer; and (c) pay royalties due to Gilead for the calendar quarter on a Product-by-Product and country-by-country basis. Licensee shall provide Quarterly
Reports and Regulatory Reports to Gilead at the address listed below. Additionally, together with each Quarterly Report, Licensee shall provide Gilead with a Regulatory Report as set forth in Section 6.3. Licensee shall pay royalties to Gilead
by wire transfer to the bank account indicated by Gilead from time to time. To the extent such Quarterly Reports relate to EVG, EVG Product, EVG Combination Product, or Quad, Gilead will have the right to share such Quarterly Reports with Japan
Tobacco. 
 4.4      Payment Terms. Licensee shall make all payments to Gilead in US
Dollars. With regard to sales in currencies other than US Dollars, conversion from local currency into US Dollars shall be at the rate of exchange of the local currency to the US Dollar on the day of payment as reported by the Reserve Bank of India.

 4.5      Records. Licensee shall keep complete and accurate records of API and Product
produced and sold in sufficient detail to enable Licensee to determine the amount of royalties due, the parties to whom Product or API was sold, and the countries in which sales occurred. 

4.6      Audit. Gilead has the right to engage an independent public accountant to perform, on no
less than thirty (30) days’ advance notice to Licensee, an audit, conducted in accordance with generally accepted auditing standards, of such books and records of Licensee that are deemed necessary by such public accountant to report
amounts of API and Product produced, gross sales, Net Sales for the periods requested and accrued royalties. Gilead will bear the full cost of any such audit unless such audit discloses a difference of more than five percent (5%) from the
amount of royalties due. In such case, Licensee shall promptly pay Gilead any underpayment and shall bear the full cost of such audit. To the extent relevant to EVG, EVG Product, EVG Combination Product, or Quad, Gilead will have the right to
disclose such audit results to Japan Tobacco. 
 4.7      Interest. Any amount payable
hereunder by Licensee, which is not paid on a timely basis, shall bear a pro rata monthly interest rate of one percent (1%) subject to any necessary approvals that may be required. 

4.8      Taxes 
 (a)      Withholding Taxes. Licensee shall promptly pay the withholding tax for and on behalf of Gilead to the proper governmental authority and shall promptly furnish
Gilead with the tax withholding certificate furnished by the Licensee. Licensee shall be entitled to deduct the withholding tax actually paid from such payment due Gilead. Each party agrees to assist the other party in claiming exemption from such
withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted. 

  
 14 


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







 (b)      Other Taxes. Except as provided in this
Section 4.8, all taxes or duties in connection with payments made by Licensee shall be borne by Licensee. 

4.9      Royalty Term. Royalty payments shall be paid to Gilead by Licensee on a Product-by-Product
and country-by-country basis starting on the date of the first commercial sale of a Product in a country and continuing until the last to occur of the following: 
 (a)      the expiration of the last-to-expire Patent containing a valid claim covering the manufacture, use, import, offer for sale or sale of API or the Product in such
country; or 
 (b)      the date of expiration of the last-to-expire Patent containing a valid
claim covering the manufacture, use, import, offer for sale or sale of API or the Product in India (the “Royalty Term”). 
  

	5.	Intellectual Property 


5.1      Maintenance of Patents. Gilead (or, where applicable, Japan Tobacco) shall not be obliged
to maintain or enforce the Patents. 
 5.2      Reporting of Improvements. Licensee shall
provide Gilead with an annual report, in writing and in reasonable detail that sets forth any Improvements, including any patent applications claiming Improvements. Licensee shall transfer to Gilead, upon request by Gilead and at Gilead’s
expense, any know-how owned or controlled by Licensee relating to such Improvements. Any failure to report any such Improvements to Gilead in accordance with the terms of this Agreement shall constitute a breach of this Agreement and shall provide
Gilead with the right to terminate this Agreement pursuant to Section 10.2. Gilead shall not transfer any Improvements obtained from Licensee to any third party, provided, however, that (a) Gilead may transfer Improvements to Gilead’s
own affiliates and suppliers, provided such affiliates and suppliers utilize such Improvements solely for the benefit of Gilead and/or Japan Tobacco, and (b) Gilead may transfer Improvements relating to EVG, EVG Product, EVG Combination
Product, or Quad to Japan Tobacco in accordance with the Japan Tobacco Agreement for use solely for the benefit of Japan Tobacco, including the transfer and use of such Improvements to Japan Tobacco’s suppliers for the benefit of Japan Tobacco.

 5.3      Trademarks 
 (a)      Any Product offered for sale or sold shall have a different trade dress, including a distinct color, shape and trade name, than the comparable product sold by Gilead
and, where applicable, the comparable product sold by Japan Tobacco. For clarity, Licensee’s non-performance of the obligations set forth in this Section 

  
 15 


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







 
5.3(a) shall constitute a material breach of Licensee’s material obligation under this Agreement. 
 (b)      Licensee shall provide to Gilead, prior to any regulatory submissions for any Product, or selling or offering for sale any Product, samples of the Product and any
packaging, labeling information, or marketing materials (including, but not limited to, advertisement and promotional materials) to be used with the Product to permit Gilead to review and approve the Product and packaging as consistent with the
requirements of Section 5.3(a). If Gilead reasonably objects to the trade dress or other aspects of the Product or product packaging based on the requirements of Section 5.3(a), the parties shall discuss in good faith the changes to be
made to the Product or packaging to address Gilead’s concerns. 
 . 

5.4      Technology Transfer. Licensee acknowledges that following execution of the TDF License
Agreement Gilead provided to Licensee, and Licensee received, a one-time technology transfer of know-how relating to TDF and TDF Product. Promptly following Gilead’s receipt of marketing approval from the FDA (and on a Product-by-Product
basis), Gilead shall make a one-time technology transfer of know-how (a) owned or controlled by Gilead as of the Effective Date, or (b) exclusively licensed by Gilead from Japan Tobacco pursuant to the Japan Tobacco Agreement, relating to
the manufacture of EVG, COBI and the Quad to the extent and in the manner specified in Appendix 3 hereto (such TDF, EVG, COBI and Quad know-how, the “Licensed Know-How”). Such Licensed Know-How shall be sufficient to enable
Licensee to manufacture TDF and TDF Product, EVG and COBI, EVG Product, COBI Product and Quad, at commercial-scale quantities. Gilead shall have no further obligation to transfer any other know-how to Licensee. 

  
 16 


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








	6.	  Manufacturing and Commercialization of Product 

 6.1      Promotion of Sales in the Territory. The parties hereto agree that an important purpose of this Agreement is to increase patient access to the Products
licensed under this Agreement in the Territory. Except as otherwise provided in this Agreement, Licensee shall have the sole discretion to manage its own commercial strategy to promote and sell the Product in the Territory, provided, however,
that Licensee shall not engage in activities that are inconsistent with the first sentence of this Section 6.1. By means of example and without limitation, Licensee agrees that Licensee shall not accept patient orders that Licensee does not
have the capacity to fill, and shall not obtain API or Product without having the means, either directly or through the use of permitted third parties, to manufacture such API into Product and/or distribute such Product to patients within the
Territory. 
 6.2      Manufacturing Requirements 

(a)      Minimum Standards. Licensee agrees that it shall manufacture API and Product in a manner
consistent with (i) the applicable Indian manufacturing standards; (ii) either World Health Organization (“WHO”) pre-qualification standards, standards of the European Medicines Agency (“EMA”), or United
States Food and Drug Administration (“FDA”) tentative approval standards (“Minimum Quality Standards”); and (iii) on a country-by-country basis, any applicable national, regional or local standards as may be
required by the specific country where Product is sold. Licensee shall apply for WHO pre-qualification or FDA conditional approval for (1) at least one TDF Product or TDF Combination Product no later than the first anniversary of the Effective
Date, (2) at least one COBI Product or COBI Combination Product no later than the first anniversary of the FDA approval date for COBI (if COBI is approved), (3) at least one EVG Product or EVG Combination Product no later than the first
anniversary of the FDA approval date for EVG (if EVG is approved), or (4) the Quad no later than the first anniversary of the FDA approval date for the Quad (if the Quad is approved). 

(b)      Audit Right. Licensee hereby agrees to allow Gilead reasonable access to Licensee’s
books and records, facilities and employees solely for the purpose and to the extent required for Gilead to audit Licensee’s compliance with the requirements of this Section 6.2. Gilead agrees to provide at least thirty (30) days
prior notice of the proposed audit, and agrees that such audits shall not be conducted more than once a year unless circumstances outside the ordinary course of business warrant such an audit (such as an investigation or other government action). To
the extent any such audit relates to EVG, EVG Product, EVG Combination Product, or Quad, Gilead will have the right to share reports from any such audit with Japan Tobacco. 
 (c)      Remedy for Failure. If Licensee fails at any time to meet the Minimum Quality Standards or has not received either WHO pre-qualification or FDA 

  
 17 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 
conditional approval, as applicable, by the second anniversary of the Effective Date, Gilead may elect, in its sole discretion and notwithstanding Section 10.2 or 10.3 hereof, to suspend the
effectiveness of the licenses granted hereunder until such time Gilead has determined that Licensee has corrected any such failure to Gilead’s reasonable satisfaction. During any such suspension, Gilead and Licensee shall coordinate with each
other to provide for the supply of API or Product, as appropriate, to ensure that end-user patient requirements are not disrupted as a result of such suspension. 
 (d)      Dose Requirements. All TDF Product and TDF Combination Product manufactured, used or sold by Licensee shall consist of a single dose concentration of 300
milligrams of TDF per dose. All EVG Product, COBI Product, EVG Combination Product, COBI Combination Product, and Quad manufactured, used or sold by Licensee shall consist of single dose concentrations of EVG and/or COBI that are the same as the
dose concentration for such agent that has been approved by the FDA. Licensee agrees that it shall not manufacture or sell Products (including Combination Products) formulated at a single dose concentration other than those dose concentrations
approved by the FDA for such agents (each an “Alternate Dosage”), without prior written consent from Gilead, provided, however, that in the case of TDF and COBI, Licensee may manufacture or sell TDF Product, TDF Combination Product,
COBI Product, or COBI Combination Product consisting of an Alternate Dosage if such Alternate Dosage has been approved for use in the Field by the appropriate regulatory authority having jurisdiction over such Product. By means of example, dosage
concentrations of TDF lower than 300 milligrams in tablet form will be allowed for pediatric administrations only if such lower dosage has been approved by the FDA or the appropriate foreign regulatory authority for such administration. 

(e)      Pediatric Formulations. Licensee will have the right to develop a TDF Product, TDF
Combination Product, EVG Product, EVG Combination Product, COBI Product or COBI Combination Product as either a liquid or dispersible tablet formulation for use in pediatric patients less than 12 years of age (each, a “Pediatric
Formulation”), provided, however, that with respect to EVG Product and EVG Combination Product, Licensee agrees not to develop any such Pediatric Formulation without Gilead’s prior written consent, not to be unreasonably withheld.
Licensee may seek regulatory approval for Pediatric Formulations anywhere in the Territory. 

(i)      If Licensee is granted regulatory approval to market such Pediatric Formulation, then Licensee
will use reasonable efforts to make such Pediatric Formulation available (A) if such Pediatric Formulation is a TDF Product or a TDF Combination Product, throughout the TDF Territory, (B) if such Pediatric Formulation is a COBI Product or
a COBI Combination Product, throughout the COBI Territory, or (C) if such Pediatric Formulation is an EVG Product or EVG Combination Product, throughout the EVG-Quad Territory (for purposes of this Section 6.2(e), “Licensee’s
Applicable Territory”). Gilead would agree to waive any royalty Gilead otherwise would be entitled to receive for sale of such Pediatric Formulation pursuant to Section 

  
 18 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 
4.1, provided such Pediatric Formulation is sold for use in pediatric populations under age 12 and not in adult populations. 

(ii)      Licensee will further agree either to license such Pediatric Formulation to Gilead or to other
Licensed Product Suppliers or to manufacture and supply such Pediatric Formulation to one or more Gilead Distributors for sale (a) in territories that either are outside the scope of Licensee’s Applicable Territory but within the scope of
the licensed territory of such designated Licensed Product Supplier or Gilead Distributor, or (b) in territories that are within Licensee’s Applicable Territory but in which Licensee is not able to make such Pediatric Formulation
available. Licensee will be entitled to receive compensation for any such license or sale of such Pediatric Formulation to Gilead, a Licensed Product Supplier or Gilead Distributor that would be commensurate with (and not in excess of) the
compensation Licensee would receive if Licensee itself sold such Pediatric Formulation in Licensee’s Applicable Territory. 
 (iii)      If Gilead, in its sole discretion, is interested in pursuing the regulatory approval or marketing of such Pediatric Formulation in countries outside
Licensee’s Applicable Territory, or in facilitating access to such Pediatric Formulation to countries within Licensee’s Applicable Territory where Licensee has not made such Pediatric Formulation available, then Gilead and Licensee will
negotiate a separate agreement relating to such Pediatric Formulation, with such agreement including appropriate compensation for Licensee for such Pediatric Formulation. Gilead shall have the right to sublicense such Pediatric Formulation to Japan
Tobacco for use in Japan in accordance with the Japan Tobacco Agreement. 
 6.3      Regulatory
Filings and Inspections. Except as provided otherwise herein, Licensee shall be responsible for obtaining and maintaining all applicable regulatory or other approvals or authorizations to carry out its activities under this Agreement and shall
provide Gilead with a quarterly written report setting forth (a) a list of countries within the Territory for which such regulatory approvals or authorization have been obtained for any Product and (b) a description of activities performed
by Licensee, its designee or, to its knowledge any other third party, with respect to the filing, obtaining or maintaining of such regulatory approvals or authorizations within the Territory for any Product (each such report, a “Regulatory
Report”). Gilead may, in its discretion, elect to file for regulatory or other approval or authorization to make and sell API and Product anywhere in the Territory. Upon either party’s request, the other party shall provide
non-proprietary data that the other party perceives is reasonably necessary to obtain any such approvals, authorizations, permits or licenses. Licensee shall obtain, have and maintain all required registrations for its manufacturing facilities.
Licensee shall allow appropriate regulatory authorities to inspect such facilities to the extent required by applicable law, rule or regulation. Gilead agrees to provide Licensee with NCE Exclusivity or other regulatory exclusivity waivers as may be
required by the applicable regulatory authorities in order to manufacture or sell Product in the Territory, provided such manufacture and sale by Licensee is compliant with the terms and conditions of this Agreement. Licensee 

  
 19 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 
agrees not to pursue or obtain regulatory exclusivity on any Product in any country within the Territory. 
 6.4      Marketing Materials. Any marketing materials (including, but not limited to, advertisement and promotional materials) used by Licensee and its Third-Party
Resellers shall not contain any misstatements of fact, shall be fully compliant with the applicable laws, rules and regulations, and shall be distinct from, and not cause any confusion with, any marketing materials or Products used or sold by
Gilead, or any marketing materials or products sold by Japan Tobacco. Any statements made in such marketing materials regarding Gilead, including without limitation statements made in reference to Licensee’s collaboration with Gilead, require
Gilead’s prior written approval. 
 6.5      Product Labeling. The labeling of all
Products sold or offered for sale under this Agreement shall expressly state that the Product is manufactured under a license from Gilead. 
  

	7.	  Representations, Warranties and Covenants 

 7.1      Ability to Perform. Licensee and Gilead each represent and warrant that 
 (a)      they are duly organized, validly existing and in good standing under the laws of the jurisdiction of their incorporation and have full corporate power and authority
to enter into this Agreement and to carry out the provisions hereof; 
 (b)      this Agreement
has been duly executed and delivered, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with the terms hereof; and 
 (c)      the execution, delivery and performance of this Agreement does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party
or by which it is bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party 
 7.2      Diversion of Product and Technology. Licensee covenants and agrees that it shall not: (i) divert or allow the diversion of API, or any intermediates or
other chemical entities generated during the process of manufacturing API, outside of India, (ii) divert or allow the diversion of TDF Product or TDF Combination Product outside the TDF Territory, (iii) divert or allow the diversion of
COBI Product or COBI Combination Product outside the COBI Territory, (iv) divert or allow the diversion of EVG Product, EVG Combination Product or Quad outside the EVG-Quad Territory, (v) divert or allow the diversion of Licensed
Technology to any third party, except as expressly permitted 

  
 20 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 
under this Agreement, or (vi) assist or support, directly or indirectly, any third party in the conduct of the activities described in clauses (i) - (v). 

7.3      Access Promotion. Licensee covenants and agrees that it shall not engage in activities that
are contrary to the goal of promoting patient access to Product to satisfy unmet medical needs within the Territory. 

7.4      Law Compliance 
 (a)      General. Licensee covenants and agrees that it shall perform all activities under this Agreement in accordance with all applicable laws and regulations,
including, without limitation, with respect to recalls, safety and reporting requirements and shall obtain, have and maintain all necessary regulatory approvals (including in India), marketing authorizations, permits and licenses, at Licensee’s
expense for the manufacture and sale of the API and/or Product and any other Licensee activities contemplated hereby. 

(b)      FCPA and UK Bribery Act. Licensee covenants and agrees that it shall provide to Gilead on
the Effective Date and within thirty (30) days after the beginning of each calendar year thereafter, certification in writing by Licensee of Licensee’s compliance with the United States Foreign Corrupt Practices Act of 1977 and with the UK
Bribery Act of 2010. 
 (c)      Conflicts. Neither party shall be required to take any
action or perform any obligation under this Agreement to the extent that such action or obligation is in direct conflict with any applicable law, rule or regulation, provided, however, that both Licensee and Gilead are in agreement regarding
(i) the requirements of such law, rule or regulation, and (ii) the affect that such law, rule or regulation has on such action or obligation required under this Agreement. 

7.5      Patent Infringement. Licensee covenants and agrees that it shall not infringe the Patents
outside the scope of the licenses granted to it pursuant to Section 2, and shall not infringe the Emtricitabine Patents outside the scope of the covenant not to sue set forth in Section 7.6. 

7.6      Covenant Concerning Certain Gilead Patents. Gilead covenants and agrees that it shall not,
at any time during the term of this Agreement, bring any claim or proceeding of any kind or nature against Licensee in relation to any of the pending and issued patents identified in Appendix 4 hereto (the “Emtricitabine Patents”)
to the extent that Licensee decides to make, use, sell, have sold and export any Product in the Territory that may infringe any claims covering the manufacture, use and sale of emtricitabine contained in such Emtricitabine Patents. 

  
 21 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the
Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 7.7      EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, GILEAD DOES NOT GIVE ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF NON-INFRINGEMENT IN THE TERRITORY. Gilead also does not give any warranty, express or implied, with regard to the
safety or efficacy of API or the Product and it shall be the sole responsibility of the Licensee to ensure such safety or efficacy. 
  

	8.	    Liability and Indemnity 

 (a)      Licensee Indemnity. Licensee shall jointly and severally indemnify, hold harmless and defend Gilead, and its subsidiaries, licensors, directors, officers,
employees and agents (together, the “Gilead Indemnitees”), from and against any and all losses, damages, expenses, cost of defense (including, without limitation, attorneys’ fees, witness fees, damages, judgments, fines and
amounts paid in settlement) and any amounts a Gilead Indemnitee becomes legally obligated to pay because of any claim against it (i) arising out of any breach by Licensee of the terms and conditions of this Agreement, or (ii) for any
product liability, liability for death, illness, personal injury or improper business practice, or any other statutory liability or any other liability under any law or regulation, to the extent that such claim or claims are due to reasons caused by
or on behalf of Licensee related to API or Product (including, without limitation, their manufacture, use or sale). The indemnification obligations of Licensee stated in this Section 8(a) shall apply only in the event that Gilead provides
Licensee with prompt written notice of such claims, grants Licensee the right to control the defense or negotiation of settlement, and makes available all reasonable assistance in defending the claims. Licensee shall not agree to any final
settlement or compromise with respect to any such claim that adversely affects Gilead without obtaining Gilead’s consent. 

(b)      Product Liability. Licensee shall be solely responsible in respect of any product
liability or any other statutory liability under any regulation, in respect of API or the Product. 

(c)      Gilead Liability. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT, IN
NO EVENT SHALL GILEAD BE LIABLE TO LICENSEE FOR ANY INDIRECT, SPECIAL, CONSEQUENTIAL, PUNITIVE, EXEMPLARY OR INCIDENTAL DAMAGES (INCLUDING BUT NOT LIMITED TO LOSS OF BUSINESS OR PROFITS) RELATED TO THIS AGREEMENT, AND SHALL NOT HAVE ANY
RESPONSIBILITIES OR LIABILITIES WHATSOEVER WITH RESPECT TO API OR PRODUCT, EVEN IF, IN ANY SUCH CASE, ADVISED OF THE POSSIBILITY OF SUCH CLAIMS OR DEMANDS, REGARDLESS OF THE FORM OF ACTION OR LEGAL THEORY WHETHER UNDER CONTRACT LAW, TORT LAW


  
 22 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 
(INCLUDING WITHOUT LIMITATION NEGLIGENCE), STRICT LIABILITY, STATUTE, WARRANTY OR OTHERWISE. 
  

	9.	Insurance 

 Within thirty
(30) days prior to the first commercial launch by Licensee of a Product, and each year thereafter for so long as this Agreement is in effect, Licensee shall provide to Gilead certificates of insurance by insurers acceptable to Gilead evidencing
comprehensive general liability coverage, including products liability, with a combined limit of no less than one million dollars ($1,000,000.00) for bodily injury, including personal injury, and property damage. Gilead shall have the right to
provide any such certificate to Japan Tobacco. Licensee shall not cancel any such policy without at least sixty (60) days prior written notice to Gilead, and agrees that such policy shall be maintained (or have an extended reporting period) of
at least seven (7) years after the termination of this Agreement. 
  

	10.	Term and Termination 


10.1      Term. This Agreement shall enter into force upon the Effective Date and, unless earlier
terminated as provided herein, shall continue until the expiration of the Royalty Term. Upon expiration of the Royalty Term (but not the earlier termination therof), and with respect to a particular Product in a particular country in the Territory,
subject to the terms and conditions herein with respect to such Product and such country, the license and sublicense granted in Article 2 to Licensee shall become a perpetual, irrevocable, fully paid-up, royalty free license under the Licensed
Know-How to develop, make, have made, use, sell, have sold, offer for sale, import and distribute such Product in the Field in such country. 
 10.2      Termination for Breach. A party (“non-breaching party”) shall have the right to terminate this Agreement in the event the other party
(“breaching party”) is in material breach of any of its material obligations under this Agreement. The non-breaching party shall provide written notice to the breaching party. The breaching party shall have a period of thirty
(30) days after such written notice is provided to cure such breach. If such breach is not cured within the thirty day period, this Agreement shall effectively terminate. 
 10.3      Gilead Right to Terminate 

(a)      Gilead shall have the right to terminate this Agreement and/or one or both of the licenses
granted pursuant to Section 2.1 or Section 2.2 (whether or not such event constitutes a right of termination pursuant to Section 10.2), immediately if in the reasonable opinion of Gilead, control (through ownership or otherwise) of
Licensee changes. 

  
 23 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 (b)      Gilead shall have the right to terminate this
Agreement and/or one or both of the licenses granted pursuant to Section 2.1 or Section 2.2 or the covenant contained in Section 7.6 (whether or not such event constitutes a right of termination pursuant to Section 10.2), if:

 (i)      Gilead reasonably determines that a material quantity of API or Product made and/or
sold by Licensee has been diverted to countries outside the Territory, whether or not by any fault or action or inaction of Licensee; 
 (ii)      Gilead reasonably determines that, due to material deficiencies in Licensee’s compliance, or repeated failure to comply, with the Minimum Quality Standards,
Licensee is unable to reliably and consistently manufacture API or Product in accordance with the Minimum Quality Standards; 

(iii)      Gilead reasonably determines that Licensee has obtained material quantities of API from sources
outside the Territory, or in ways that are inconsistent with the terms and conditions of Section 3; or 

(iv)      Gilead’s rights to EVG terminate due to the termination of the Japan Tobacco Agreement,
provided, however, that in such event, such termination would only apply on a Product-by-Product basis and with respect to Products containing EVG that are subject to the sublicense granted by Gilead under the Japan Tobacco Agreement. 

Gilead shall give Licensee written notice of any such event and provide Licensee with a period of thirty (30) days after such notice to demonstrate
that the conditions giving rise to Gilead’s determination no longer exist to Gilead’s reasonable satisfaction. If Licensee is unable to do so, this Agreement shall be terminated effective upon the thirtieth (30th) day following such notice. 

10.4      Licensee Right to Terminate Agreement. Licensee shall have the right to terminate this
Agreement in its entirety upon thirty (30) days prior written notice to Gilead. 

10.5      Licensee Right to Terminate License on an API Basis. Licensee shall have the right at its
sole discretion, to terminate the licenses granted under Article 2 with respect to any particular API at any time by notifying Gilead in writing. Any such written notice shall expressly identify the API or APIs for which Licensee desires to
terminate its license from Gilead (each, a “Terminated API”). Any such termination shall become effective immediately upon receipt of such written notice by Gilead (the “API Termination Date”). In the event of any
such termination, and with respect to any such Terminated API, and in each case subject to Section 10.8, the following terms shall apply as of the API Termination Date. 

  
 24 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 (a)      All licenses granted by Gilead under this Agreement
with respect to such Terminated API, and any other rights granted by Gilead with respect to such Terminated API, including without limitation Gilead’s obligation to conduct a technology transfer with respect to such API pursuant to
Section 5.4, shall terminate and all Sections of this Agreement shall be interpreted to exclude such Terminated API therefrom (including with respect to rights granted to Gilead pursuant to Sections 5.2 and 6.2(e)(iii)). 

(b)      All licenses granted by Gilead under this Agreement with respect to any product containing such
Terminated API (each, a “Terminated Product”), and any other rights granted by Gilead with respect to such Terminated Product, shall terminate and all Sections of this Agreement shall be interpreted to exclude such Terminated
Product therefrom (including with respect to rights granted to Gilead pursuant to Sections 5.2 and 6.2(e)(iii)). For the avoidance of doubt (i) any termination by Licensee of its license to TDF pursuant to this Section 10.5 shall in turn
terminate the license and rights granted to Licensee hereunder with respect to TDF Product and TDF Combination Product, and the Quad; (ii) any termination by Licensee of its license to COBI pursuant to this Section 10.5 shall in turn
terminate the license and rights granted to Licensee hereunder with respect to COBI Product, COBI Combination Product, and the Quad; and (iii) any termination by Licensee of its license to EVG pursuant to this Section 10.5 shall in turn
terminate the license and rights granted to Licensee hereunder with respect to EVG Product, EVG Combination Product, and the Quad. 
 (c)      For the avoidance of doubt, Licensee will have no obligation to pay Gilead any royalties on Net Sales generated from such Terminated Product after the API
Termination Date. 
 Termination of any license with respect to any API under this Section 10.5 shall not relieve Licensee
of any obligation accruing on or prior to the API Termination Date therefor, including the obligation to pay royalties pursuant to Article 4 on Net Sales of any Product sold prior to the API Termination Date. Upon termination of all API licensed to
Licensee under this Agreement, this Agreement shall be deemed terminated in its entirety pursuant to Section 10.4. Nothing set forth in this Section 10.5 shall be deemed a waiver by Gilead to enforce any Patent or any other intellectual
property right owned or controlled by Gilead against Licensee for any activities Licensee may undertake with respect to any Terminated API or Terminated Product after any such API Termination Date. 

10.6      Insolvency. In the event that Licensee becomes insolvent, makes an assignment to the
benefit of creditors, or has a petition in bankruptcy filed for or against it, Gilead shall have the right to treat such event as a material breach. 
 10.7      Waiver. The waiver by either party of any breach of any term or condition of this Agreement shall not be deemed a waiver as to any subsequent or similar
breach. 

  
 25 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 10.8      Survival. Sections 2.3, 2.5(b), 4.5, 5.2,
5.3(a), 6.2(e)(iii), 7.7, 8, 9, 10.1, 10.8, 11 and 12 shall survive (a) termination or expiry of this Agreement or (b) in the event Licensee terminates its license with respect to any API as provided in Section 10.5, the API
Termination Date with respect to such Terminated API and Terminated Product; provided, however, that in the event of such a termination pursuant to this clause 10.8(b), (i) Sections 5.2 and 6.2(e)(iii) shall not survive with respect to such
Terminated API or Terminated Product and (ii) Section 2.3 shall survive solely with respect to those Improvements relating to such Terminated API or Terminated Product first developed by Licensee prior to the API Termination Date therefor.

  

	11.	Confidentiality and Publications 

 11.1      Confidential Information. All technology and know-how disclosed by one party (the “Disclosing Party”) to the other party (the
“Receiving Party”) hereunder (“Confidential Information”) shall be used solely and exclusively by Receiving Party in a manner consistent with the licenses granted hereunder and the purposes of this Agreement as
stated in the preamble and recitals hereto; maintained in confidence by the Receiving Party; and shall not be disclosed to any non-party or used for any purpose except to exercise its rights and perform its obligations under this Agreement without
the prior written consent of the Disclosing Party, except to the extent that the Receiving Party can demonstrate by competent written evidence that such information: (a) is known by the Receiving Party at the time of its receipt and, not
through a prior disclosure by the Disclosing Party, as documented by the Receiving Party’s business records; (b) is in the public domain other than as a result of any breach of this Agreement by the Receiving Party; (c) is
subsequently disclosed to the Receiving Party on a non-confidential basis by a third party who may lawfully do so; or (d) is independently discovered or developed by the Receiving Party without the use of Confidential Information provided by
the Disclosing Party, as documented by the Receiving Party’s business records. Within thirty (30) days after any expiration or termination of this Agreement, Receiving Party shall destroy (and certify to the Disclosing Party such
destruction) or return all Confidential Information provided by the Disclosing Party except as otherwise set forth in this Agreement. One (1) copy of the Confidential Information may be retained in the Receiving Party’s files solely for
archival purposes as a means of determining any continuing or surviving obligations under this Agreement. The confidential obligations under this Agreement shall survive this Agreement for a period of five (5) years. To the extent Gilead
receives any Confidential Information from Licensee relating to EVG, EVG Product, EVG Combination Product or Quad, Gilead will have the right to disclose such Confidential Information to Japan Tobacco, provided such disclosure remains subject to the
obligations of confidentiality and non-disclosure set forth in the Japan Tobacco Agreement. 

11.2      Press Release. Each party may disclose to third parties or make public statements, by
press release or otherwise, regarding the existence of this Agreement, the 

  
 26 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 
identity of the parties, the terms, conditions and subject matter of this Agreement, or otherwise in reference to this Agreement, provided such disclosures or statements are accurate and complete
with respect to the subject matter thereof and the information disclosed therein. 

11.3      Use of Name. Except as provided for under Section 11.2, neither party shall use the
other party’s name, logo or trademarks for any purpose including without limitation publicity or advertising, except with the prior written consent of the other party. Licensee agrees not to use Japan Tobacco’s name, logo or trademarks for
any purpose except with the prior written consent of Japan Tobacco. 
  

	12.	Miscellaneous 


12.1      Agency. Neither party is, nor will be deemed to be, an employee, agent or representative
of the other party for any purpose. Each party is an independent contractor, not an employee or partner of the other party. Neither party shall have the authority to speak for, represent or obligate the other party in any way without prior written
authority from the other party. 
 12.2      Entire Understanding. This Agreement embodies
the entire understanding of the parties with respect to the subject matter hereof and supersedes all previous communications, representations or understandings, and agreements, whether oral or written, between the parties relating to the subject
matter hereof. Gilead and Licensee hereby expressly agree that this Agreement amends and restates in its entirety the TDF License Agreement as of the Effective Date. 
 12.3      Severability. The parties hereby expressly state that it is not their intention to violate any applicable rule, law or regulation. If any of the provisions
of this Agreement are held to be void or unenforceable with regard to any particular country by a court of competent jurisdiction, then, to the extent possible, such void or unenforceable provision shall be replaced by a valid and enforceable
provision which will achieve as far as possible the economic business intentions of the Parties. The provisions held to be void or unenforceable shall remain, however, in full force and effect with regard to all other countries. All other provisions
of this Agreement shall remain in full force and effect. 
 12.4      Notices 

(a)      Any notice or other communication to be given under this Agreement, unless otherwise specified,
shall be in writing and shall be deemed to have been provided when delivered to the addressee at the address listed below (i) on the date of delivery if delivered in person or (ii) three days after mailing by registered or certified mail,
postage paid: 

  
 27 


 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 In the case of Gilead: 

Gilead Sciences, Inc. 
 333 Lakeside Drive 
 Foster City, CA 94404 

Attention: General Counsel 
 Facsimile: (650) 522-5537 
 In the case of Licensee:

 [Insert Address] 
 Attention: 
 Facsimile: 

(b)      Either party may change its address for communications by a notice in writing to the other party
in accordance with this Section 12.4. 
 12.5      Governing Law. This Agreement is
made in accordance with and shall be governed and construed under the laws of England, without regard to its choice of law principles. 
 12.6      Arbitration 

(a)      All disputes arising out of or in connection with the present Agreement shall be finally settled
under the Rules of Arbitration of the International Chamber of Commerce by three arbitrators. 

(b)      Each party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in
the Request for Arbitration within thirty (30) days of being requested to do so, or if the respondent should fail to appoint an arbitrator in its Answer to the Request for Arbitration within thirty (30) days of being requested to do so,
the other party shall request the ICC Court to make such appointment. 
 (c)      The arbitrators
nominated by the parties shall, within thirty (30) days from the appointment of the arbitrator nominated in the Answer to the Request for Arbitration, and after consultation with the parties, agree and appoint a third arbitrator, who will act
as a chairman of the Arbitral Tribunal. Should such procedure not result in an appointment within the thirty (30) day time limit, either party shall be free to request the ICC Court to appoint the third arbitrator. 

(d)      London, England shall be the seat of the arbitration. 

(e)      The language of the arbitration shall be English. Documents submitted in the arbitration (the
originals of which are not in English) shall be submitted together with an English translation. 

  
 28 

 [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended 







 (f)      This arbitration agreement does not preclude either
party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either party’s domicile. Conservatory or interim measures sought by either party
in any one or more jurisdictions shall not preclude the Arbitral Tribunal granting conservatory or interim measures. Conservatory or interim measures sought by either party before the Arbitral Tribunal shall not preclude any court of competent
jurisdiction granting conservatory or interim measures. 
 (g)      In the event that any issue
shall arise which is not clearly provided for in this arbitration agreement the matter shall be resolved in accordance with the ICC Arbitration Rules. 
 12.7      Assignment. Gilead is entitled to transfer and assign this Agreement and the rights and obligations under this Agreement on prior notice to Licensee.
Licensee is not entitled to transfer or assign this Agreement or the rights and obligations under this Agreement. 

12.8      Amendment. No amendment or modification hereof shall be valid or binding upon the parties
unless made in writing and signed by both parties. 
 [signatures appear on following page] 

  
 29 


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







 IN WITNESS WHEREOF, the parties hereto have
executed this Amended and Restated Non-Exclusive License Agreement as of the Effective Date. 

GILEAD: 
  

							
		 		 	Gilead Sciences, Inc.
		 		 		 	
				
		 		 	By	 	 
		 		 	 Name:

Title:


 LICENSEE: 

 

							
		 		 	[Licensee]
		 		 		 	
				
		 		 	By	 	 
		 		 	 Name:

Title:



  

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







 Appendix 1 
 Countries in the TDF Territory 

 


	 	112.	Afghanistan 


	 	113.	Angola 


	 	114.	Anguilla 


	 	115.	Antigua and Barbuda 


	 	116.	Armenia 


	 	117.	Aruba 


	 	118.	Bahamas 


	 	119.	Bangladesh 


	 	120.	Barbados 


	 	121.	Belize 


	 	122.	Benin 


	 	123.	Bhutan 


	 	124.	Bolivia 


	 	125.	Botswana 


	 	126.	British Virgin Islands 


	 	127.	Burkina Faso 


	 	128.	Burundi 


	 	129.	Cambodia 


	 	130.	Cameroon 


	 	131.	Cape Verde 


	 	132.	Central African Republic 


	 	133.	Chad 


	 	134.	Comoros 


	 	135.	Congo, Rep 


	 	136.	Congo, Dem. Rep. of the 


	 	137.	Côte d’Ivoire 


	 	138.	Cuba 


	 	139.	Djibouti 


	 	140.	Dominica 


	 	141.	Dominican Republic 


	 	142.	Ecuador 


	 	143.	El Salvador 


	 	144.	Equatorial Guinea 


	 	145.	Eritrea 


	 	146.	Ethiopia 


	 	147.	Fiji Islands 


	 	148.	Gabon 


	 	149.	Gambia





	 	150.	Georgia 


	 	151.	Ghana 


	 	152.	Grenada 


	 	153.	Guatemala 


	 	154.	Guinea 


	 	155.	Guinea-Bissau 


	 	156.	Guyana 


	 	157.	Haiti 


	 	158.	Honduras 


	 	159.	India 


	 	160.	Indonesia 


	 	161.	Jamaica 


	 	162.	Kazakhstan 


	 	163.	Kenya 


	 	164.	Kiribati 


	 	165.	Kyrgyzstan 


	 	166.	Lao, People’s Dem. Rep. 


	 	167.	Lesotho 


	 	168.	Liberia 


	 	169.	Madagascar 


	 	170.	Malawi 


	 	171.	Maldives 


	 	172.	Mali 


	 	173.	Mauritania 


	 	174.	Mauritius 


	 	175.	Moldova, Rep. of 


	 	176.	Mongolia 


	 	177.	Montserrat 


	 	178.	Mozambique 


	 	179.	Myanmar 


	 	180.	Namibia 


	 	181.	Nauru 


	 	182.	Nepal 


	 	183.	Nicaragua 


	 	184.	Niger 


	 	185.	Nigeria 


	 	186.	Pakistan 


	 	187.	Palau





	 	188.	Papua NewGuinea 


	 	189.	Rwanda 


	 	190.	Saint Kitts and Nevis 


	 	191.	Saint Lucia 


	 	192.	Saint Vincent & the Grenadines 


	 	193.	Samoa 


	 	194.	São Tomé and Príncipe 


	 	195.	Senegal 


	 	196.	Seychelles 


	 	197.	Sierra Leone 


	 	198.	Solomon Islands 


	 	199.	Somalia 


	 	200.	South Africa 


	 	201.	Sri Lanka 


	 	202.	Sudan 


	 	203.	Surinam 


	 	204.	Swaziland 


	 	205.	Syrian Arab Republic 


	 	206.	Tajikistan 


	 	207.	Tanzania, U. Rep. of 


	 	208.	Thailand 


	 	209.	Timor-Leste 


	 	210.	Togo 


	 	211.	Tonga 


	 	212.	Trinidad and Tobago 


	 	213.	Turkmenistan 


	 	214.	Turks and Caicos 


	 	215.	Tuvalu 


	 	216.	Uganda 


	 	217.	Uzbekistan 


	 	218.	Vanuatu 


	 	219.	Vietnam 


	 	220.	Yemen 


	 	221.	Zambia 


	 	222.	Zimbabwe 


 


  
 31 


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







 Appendix 2 
 1. TDF Patents 
 Gilead either owns or has exclusive rights to the TDF Patents. 

2. EVG Patents 
 TITLE: 4-OXOQUINOLINE COMPOUNDS
AND UTILIZATION THEREOF AS HIV INTEGRASE INHIBITORS 

									
	 Country
	 	Filing Date	 	Serial Number	 	Patent Number	 	Grant Date
	 Bolivia
	 	18-Nov-2003	 	SP-230265	 	 	 	 
	 India
	 	20-Nov-2003	 	01316/CHENP/2004	 	245833	 	3-Feb-2011
	 Nigeria
	 	19-Nov-2003	 	424/2003	 	RP.15779	 	20-Oct-2004
	 South Africa
	 	20-Nov-2003	 	2004/4537	 	2004/4537	 	31-Aug-2005
	 Viet Nam
	 	20-Nov-2003	 	1-2004-00605	 	 	 	 

 TITLE: STABLE CRYSTAL OF 4-OXOQUINOLINE COMPOUND 

									
	 Country
	 	Filing Date	 	Serial Number	 	Patent Number	 	Grant Date
	 Bolivia
	 	19-May-2005	 	SP-250121	 	 	 	 
	 India
	 	19-May-2005	 	357/CHENP/2010	 	 	 	 
	 South Africa
	 	19-May-2005	 	2006/10647	 	2006/10647	 	25-Jun-2008

 TITLE: METHOD FOR PRODUCING 4-OXOQUINOLINE COMPOUND 

									
	Country	 	Filing Date	 	Serial Number	 	Patent Number	 	Grant Date
	African Regional Industrial Property Organization (ARIPO)	 	6-Mar-2007	 	AP/P/2008/004621	 	 	 	 
	Eurasian Patent Organization (EAPO)	 	6-Mar-2007	 	200870321	 	 	 	 
	India	 	6-Mar-2007	 	5341/CHENP/2008	 	 	 	 
	African Union Territories (OAPI)	 	6-Mar-2007	 	1200800317	 	14280	 	31-Mar-2009
	South Africa	 	6-Mar-2007	 	2008/07547	 	2008/07547	 	25-Nov-2009
	Viet Nam	 	6-Mar-2007	 	1-2008-02431	 	 	 	 

 TITLE: PROCESS FOR PROUDCTION OF 4-OXOQUINOLINE COMPOUND 

									
	 Country
	 	Filing Date	 	Serial Number	 	Patent Number	 	Grant Date
	 India
	 	6-Mar-2007	 	5344/CHENP/2008	 	 	 	 


  

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







 Confidential 
 TITLE: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS (I) 

									
	Country	 	Filing Date	 	Serial Number	  	Patent Number	  	Grant Date
	African Regional
Industrial Property
Organization
(ARIPO)	 	11-Sep-2007	 	AP/P/2009/004831	  	  	  	  
	Eurasian Patent
Organization
(EAPO)	 	11-Sep-2007	 	200900441	  	  	  	  
	India	 	11-Sep-2007	 	1808/DELNP/2009	  	  	  	  
	African Union
Territories (OAPI)	 	11-Sep-2007	 	1200900070	  	  	  	  
	Viet Nam	 	11-Sep-2007	 	1-2009-00636	  	  	  	  
	South Africa	 	11-Sep-2007	 	2009/01576	  	  	  	  

 TITLE: PROCESS AND INTERMEDIATES FOR PREPARING INTEGRASE INHIBITORS (II) 

									
	Country	 	Filing Date	 	Serial Number	  	Patent Number	  	Grant Date
	African Regional
Industrial Property
Organization
(ARIPO)	 	11-Sep-2008	 	AP/P/2010/005187	  	  	  	  
	Eurasian Patent
Organization
(EAPO)	 	11-Sep-2008	 	201070256	  	  	  	  
	India	 	11-Sep-2008	 	1615/DELNP/2010	  	  	  	  
	African Union
Territories (OAPI)	 	11-Sep-2008	 	1201000093	  	  	  	  
	Viet Nam	 	11-Sep-2008	 	1-2009-00636	  	  	  	  
	South Africa	 	11-Sep-2008	 	1-2010-00483	  	  	  	  

 For purposes of this Appendix 2, references to “OAPI,” “EAPO” and “ARIPO” shall not be construed or interpreted to grant rights to Licensee in any country other than those countries
expressly included within the licenses granted to Licensee in Sections 2.1 and 2.2 of this Agreement. 
 3. COBI Patents 

  
 33 


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







 Confidential 
 Gilead either owns or has exclusive rights to the COBI Patents. 

  
 34 


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







 Confidential 

Appendix 3 

Terms for Technology Transfer 
 Gilead shall provide Licensee with the following information to fully enable Licensee to manufacture TDF, EVG, COBI, TDF Product, EVG Product, COBI Product and Quad at commercial-scale quantities and in
compliance with Gilead’s required quality specifications: 
  

	 	5.	Manufacturing process descriptions, specifications and methods; 

  

	 	6.	Stability data; 

  

	 	7.	Analytical method validation; and 

  

	 	8.	Discussion of impurities. 


  
 35 


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







 Confidential 

Appendix 4 

Emtricitabine Patents 

Gilead either owns or has exclusive rights to the Emtricitabine Patents. 

  
 36 


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







 Confidential 

Appendix 5 

Countries in the COBI Territory 

 


	 	1.	Afghanistan 


	 	2.	Angola 


	 	3.	Anguilla 


	 	4.	Antigua and Barbuda 


	 	5.	Armenia 


	 	6.	Aruba 


	 	7.	Bahamas 


	 	8.	Bangladesh 


	 	9.	Barbados 


	 	10.	Belize 


	 	11.	Benin 


	 	12.	Bhutan 


	 	13.	Bolivia 


	 	14.	British Virgin Islands 


	 	15.	Burkina Faso 


	 	16.	Burundi 


	 	17.	Cambodia 


	 	18.	Cameroon 


	 	19.	Cape Verde 


	 	20.	Central African Republic 


	 	21.	Chad 


	 	22.	Comoros 


	 	23.	Congo, Rep 


	 	24.	Congo, Dem. Rep. of the 


	 	25.	Côte d’Ivoire 


	 	26.	Cuba 


	 	27.	Djibouti 


	 	28.	Dominica 


	 	29.	Dominican Republic 


	 	30.	Equatorial Guinea 


	 	31.	Eritrea 


	 	32.	Ethiopia 


	 	33.	Fiji Islands, Rep. of the 


	 	34.	Gabon 


	 	35.	Gambia





	 	36.	Georgia 


	 	37.	Ghana 


	 	38.	Grenada 


	 	39.	Guatemala 


	 	40.	Guinea 


	 	41.	Guinea-Bissau 


	 	42.	Guyana 


	 	43.	Haiti 


	 	44.	Honduras 


	 	45.	India 


	 	46.	Jamaica 


	 	47.	Kenya 


	 	48.	Kiribati 


	 	49.	Kyrgyzstan 


	 	50.	Lao People’s Dem. Rep. 


	 	51.	Lesotho 


	 	52.	Liberia 


	 	53.	Madagascar 


	 	54.	Malawi 


	 	55.	Maldives 


	 	56.	Mali 


	 	57.	Mauritania 


	 	58.	Mauritius 


	 	59.	Moldova, Rep. of 


	 	60.	Mongolia 


	 	61.	Montserrat 


	 	62.	Mozambique 


	 	63.	Myanmar 


	 	64.	Nauru 


	 	65.	Nepal 


	 	66.	Nicaragua 


	 	67.	Niger 


	 	68.	Nigeria 


	 	69.	Pakistan 


	 	70.	Palau





	 	71.	Papua New Guinea 


	 	72.	Rwanda 


	 	73.	Saint Kitts and Nevis 


	 	74.	Saint Lucia 


	 	75.	Saint Vincent & the Grenadines 


	 	76.	Samoa 


	 	77.	São Tomé and Príncipe 


	 	78.	Senegal 


	 	79.	Seychelles 


	 	80.	Sierra Leone 


	 	81.	Solomon Islands 


	 	82.	Somalia 


	 	83.	South Africa 


	 	84.	Sudan 


	 	85.	Suriname 


	 	86.	Swaziland 


	 	87.	Syrian Arab Republic 


	 	88.	Tajikistan 


	 	89.	Tanzania, U. Rep. of 


	 	90.	Timor-Leste 


	 	91.	Togo 


	 	92.	Tonga 


	 	93.	Trinidad and Tobago 


	 	94.	Turks and Caicos 


	 	95.	Tuvalu 


	 	96.	Uganda 


	 	97.	Uzbekistan 


	 	98.	Vanuatu 


	 	99.	Vietnam 


	 	100.	Yemen 


	 	101.	Zambia 


	 	102.	Zimbabwe 


 


  
 37 


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







 Confidential 

Appendix 6 

Countries in the EVG-Quad Territory 

 


	 	100.	Afghanistan 


	 	101.	Angola 


	 	102.	Anguilla 


	 	103.	Antigua and Barbuda 


	 	104.	Armenia 


	 	105.	Bahamas 


	 	106.	Bangladesh 


	 	107.	Barbados 


	 	108.	Belize 


	 	109.	Benin 


	 	110.	Bhutan 


	 	111.	Bolivia 


	 	112.	British Virgin Islands 


	 	113.	Burkina Faso 


	 	114.	Burundi 


	 	115.	Cambodia 


	 	116.	Cameroon 


	 	117.	Cape Verde 


	 	118.	Central African Republic 


	 	119.	Chad 


	 	120.	Comoros 


	 	121.	Congo, Rep 


	 	122.	Congo, Dem. Rep. of the 


	 	123.	Côte d’Ivoire 


	 	124.	Cuba 


	 	125.	Djibouti 


	 	126.	Dominica 


	 	127.	Equatorial Guinea 


	 	128.	Eritrea 


	 	129.	Ethiopia 


	 	130.	Fiji Islands, Rep. of the 


	 	131.	Gabon 


	 	132.	Gambia 


	 	133.	Georgia





	 	134.	Ghana 


	 	135.	Grenada 


	 	136.	Guatemala 


	 	137.	Guinea 


	 	138.	Guinea-Bissau 


	 	139.	Guyana 


	 	140.	Haiti 


	 	141.	Honduras 


	 	142.	India 


	 	143.	Jamaica 


	 	144.	Kenya 


	 	145.	Kiribati 


	 	146.	Kyrgyzstan 


	 	147.	Lao People’s Dem. Rep. 


	 	148.	Lesotho 


	 	149.	Liberia 


	 	150.	Madagascar 


	 	151.	Malawi 


	 	152.	Maldives 


	 	153.	Mali 


	 	154.	Mauritania 


	 	155.	Mauritius 


	 	156.	Moldova, Rep. of 


	 	157.	Mongolia 


	 	158.	Mozambique 


	 	159.	Myanmar 


	 	160.	Nauru 


	 	161.	Nepal 


	 	162.	Nicaragua 


	 	163.	Niger 


	 	164.	Nigeria 


	 	165.	Pakistan 


	 	166.	Palau 


	 	167.	Papua New Guinea





	 	168.	Rwanda 


	 	169.	Saint Kitts and Nevis 


	 	170.	Saint Lucia 


	 	171.	Saint Vincent & the Grenadines 


	 	172.	Samoa 


	 	173.	São Tomé and Príncipe 


	 	174.	Senegal 


	 	175.	Seychelles 


	 	176.	Sierra Leone 


	 	177.	Solomon Islands 


	 	178.	Somalia 


	 	179.	South Africa 


	 	180.	Sudan 


	 	181.	Suriname 


	 	182.	Swaziland 


	 	183.	Syrian Arab Republic 


	 	184.	Tajikistan 


	 	185.	Tanzania, U. Rep. of 


	 	186.	Timor-Leste 


	 	187.	Togo 


	 	188.	Tonga 


	 	189.	Trinidad and Tobago 


	 	190.	Turks and Caicos 


	 	191.	Tuvalu 


	 	192.	Uganda 


	 	193.	Uzbekistan 


	 	194.	Vanuatu 


	 	195.	Vietnam 


	 	196.	Yemen 


	 	197.	Zambia 


	 	198.	Zimbabwe 


 


  
 38 


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







 Execution Copy 

  
 39