Microsoft Word - Form Gilead Semi-Excl Generic License Agmt _redacted 061212

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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”).

E C I T A L S

HEREAS, Gilead wishes to facilitate access to its antiviral agents to patients in the

developing world to help satisfy unmet medical needs;

HEREAS, 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;

HEREAS, 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

HEREAS, 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;

OW, 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).

“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

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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.

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“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.

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“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.

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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 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.

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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 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.

(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

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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.

(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

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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 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.

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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.

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) [***].

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

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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 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

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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) 3% of TDF Product Net Sales in the TDF Territory.

(b) 3% 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.

component of the Quad in the EVG-Quad Territory as determined in accordance with

Section 4.2, and (ii) 5% of the portion of Quad Net Sales attributable to the 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 3% 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.

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(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 3% 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) (i) 3% of the portion of Quad Net Sales attributable to the TDF

component of the Quad in the Semi-Exclusive Territory as determined in accordance with

Section 4.2, and (ii) 10% of the portion of Quad Net Sales attributable to the 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.

(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

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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).

Notwithstanding the foregoing, (i) the royalty due on TDF Product Net Sales under Section

4.1(a) and (ii) the royalty due on the portion of Net Sales attributable to the TDF

component of a TDF Combination Product, the Quad, an EVG Combination Product or a

COBI Combination Product as set forth in Sections 4.1(b), (c)(i), (f)(i), (g) and (h)(i)

above, respectively, shall, in all cases, increase from 3% to 5% at such time when a Patent

covering the composition of matter of tenofovir disoproxil (“TD”) or TDF issues in India.

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.

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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.

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.

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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”).

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,

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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 10.4(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.

(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

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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

(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

Final Version

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.

. 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 10.4 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 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

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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 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

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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.

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

conflict with any agreement, instrument or understanding, oral or written, to which it is a

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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 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.

. 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.

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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 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.

. 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

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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 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.

Final Version

10.3 Licensee’s Right to Terminate Agreement for Convenience. Licensee shall

have the right to terminate this Agreement in its entirety by providing Gilead with thirty

(30) days prior written notice

10.4 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.

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 (30

) day

following such notice.

10.5 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.

Final Version

10.6 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.

10.7 Survival

. Sections 2.3, 2.5(b), 4.5, 5.3, 5.4(a), 6.2(e)(iii), 7.7, 8, 9, 10.1,

10.7, 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 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

Final Version

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:

In the case of Gilead:

Gilead Sciences, Inc.

333 Lakeside Drive

Foster City, CA 94404

Attention: General Counsel

Facsimile: (650) 522-5537

Final Version

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.

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.

(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

Final Version

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]

N WITNESS WHEREOF, the parties hereto have executed this Amended and Restated

License Agreement as of the Effective Date.

ILEAD:

Gilead Sciences, Inc.

Name:

Title:

ICENSEE:

[Licensee]

Name:

Title:

Final Version

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. South Sudan

91. Sri Lanka

92. Sudan

93. Surinam

94. Swaziland

95. Syrian Arab

Republic

96. Tajikistan

97. Tanzania, U. Rep. of

98. Thailand

99. Timor-Leste

100. Togo

101. Tonga

102. Trinidad and Tobago

103. Turkmenistan

104. Turks and Caicos

105. Tuvalu

106. Uganda

107. Uzbekistan

108. Vanuatu

109. Vietnam

110. Yemen

111. Zambia

112. Zimbabwe

Appendix 2

TDF Patents

TITLE: NUCLEOTIDE ANALOGS

Country Filing Date Serial Number Patent Number: Grant Date

India 25-Jul-1997 2076/DEL/1997

India 25-Jul-1997 602/DEL/2007

TITLE: NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS

METHOD

Country Filing Date Application Number Patent Number Grant Date

India 24-Jul-1998 2174/DEL/1998 190780 15-Mar-2004

India 24-Jul-1998 896/DEL/2002

India 24-Jul-1998 963/DEL/2002

India 24-Jul-1998 1362/DEL/2004

India 24-Jul-1998 2100/DEL/2007

India 24-Jul-1998 2256/DEL/2009

India 24-Jul-1998 1135/DEL/2007

Indonesia 23-Jul-1998 W-991548 0007658 11-Apr-2002

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

Final Version

TITLE: METHOD FOR PRODUCING 4-OXOQUINOLINE COMPOUND

Country Filing Date Serial Number Patent Number Grant Date

frican Regional

Industrial

Property

6-Mar-2007 AP/P/2008/004621

Eurasian Patent

Organization

(EAPO)

6-Mar-2007 200870321

India 6-Mar-2007 5341/CHENP/2008

frican 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

TITLE: PROCESS AND INTERMEDIATES FOR PREPARING

INTEGRASE INHIBITORS (I)

Country Filing Date Serial Number Patent Number Grant Date

frican Regional

Industrial Property

anization

11-Sep-2007 AP/P/2009/004831

Eurasian Patent

Organization

11-Sep-2007 200900441

India

11-Sep-2007 1808/DELNP/2009

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

Final Version

Country Filing Date Serial Number Patent Number Grant Date

frican 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

frican Regional

Industrial Property

Organization

(ARIPO)

11-Sep-2008 AP/P/2010/005187

Eurasian Patent

Organization

11-Sep-2008 201070256

India

11-Sep-2008 1615/DELNP/2010

frican Union

Territories (OAPI)

11-Sep-2008 1201000093

Viet Nam

11-Sep-2008 1-2009-00636

South Africa

11-Sep-2008 1-2010-00483

COBI Patents

TITLE: MODULATORS OF PHARMACOKINETIC PROPERTIES OF

THERAPEUTICS

Country Filing Date Serial Number Patent Number Grant Date

African Regional

Industrial

Property

Organization

(ARIPO) 06-Jul-2007 AP/P/2008/004720

Eurasian Patent

Organization

(EAPO) 06-Jul-2007 200900155

Final Version

India 06-Jul-2007 10487/DELNP/2008

African Union

Territories

(OAPI) 06-Jul-2007 1200800450 14409 30-Sep-2009

Viet Nam 06-Jul-2007 1-2009-00240

South Africa 06-Jul-2007 2008/10399

TITLE: MODULATORS OF PHARMACOKINETIC PROPERTIES OF

THERAPEUTICS

Country Filing Date Serial Number Patent Number Grant Date

African Regional

Industrial

Property

Organization

(ARIPO) 22-Feb-2008 AP/P/2009/004964

Eurasian Patent

Organization

(EAPO) 22-Feb-2008 200901155

India 22-Feb-2008 5324/DELNP/2009

African Union

Territories

(OAPI) 22-Feb-2008 1200900273

Viet Nam 22-Feb-2008 1-2009-01990

South Africa 22-Feb-2008 2009/05882

TITLE: THE USE OF SOLID CARRIER PARTICLES TO IMPROVE THE

PROCESSABILITY OF A PHARMACEUTICAL AGENT

Country Filing Date Serial Number Patent Number Grant Date

African Regional

Industrial

Property

Organization

(ARIPO) 01-May-2009 AP/P/2010/005429

Eurasian Patent

Organization

(EAPO) 01-May-2009 201071173

India 01-May-2009 7565/DELNP/2010

African Union

Territories

(OAPI) 01-May-2009

Viet Nam 01-May-2009 1-2010-02929

Final Version

South Africa 01-May-2009 2010/08007

TITLE: METHODS AND INTERMEDIATES FOR PREPARING

PHARMACEUTICAL AGENTS

Country Filing Date Serial Number Patent Number Grant Date

Bolivia 30-Mar-2010 SP-0082-2010

Patent

Cooperation

Treaty (PCT) 01-Apr-2010 PCT/US10/29633

Pakistan 31-Mar-2010 262/2010

TITLE: TABLETS FOR COMBINATION THERAPY

Country Filing Date Serial Number Patent Number Grant Date

Bolivia 05-Feb-2010 SP-00292010

Patent

Cooperation

Treaty (PCT) 04-Feb-2010 PCT/US10/023226

Pakistan 05-Feb-2010 94/2010

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.

Final Version

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.

Final Version

Appendix 4

Emtricitabine Patents

TITLE: METHOD AND COMPOSITIONS FOR THE SYNTHESIS OF

BCH-189 AND RELATED COMPOUNDS

Country Filing Date Serial Number Patent Number Grant Date

Malawi 31-Jan-1991 MW49/92 MW49/92 12-Dec-1994

Sri Lanka 31-Jan-1991 10414 10414 03-Aug-1992

TITLE: ANTIVIRAL ACTIVITY AND RESOLUTION OF

2-HYDROXYMETHYL- 5-(5-FLUOROCYTOSIN-1-YL)-1,3-OXATHIOLANE

Countr

Filin

Date Serial Number Patent Numbe

Grant Date

Indonesia 22-Feb-1992 P-002339 ID0001489 17-Apr-1997

Nigeria 21-Feb-1992 RP48/92

Pakistan 25-Feb-1992 79/92 133092 28-Mar-1994

South Africa 20-Feb-1992 92/01251 92/01251 27-Oct-1993

Thailand 20-Feb-1992 015518 17659 16-Sep-2004

TITLE: THERAPEUTIC NUCLEOSIDES

Country Filing Date Serial Number Patent Number Grant Date

South Africa 05-Mar-1992 92/1658 92/1658 24-Nov-1993

Thailand 05-Mar-1992 015608 10939 06-Sep-2001

TITLE: 1,3-OXATHIOLANE NUCLEOSIDE ANALOGUES

Country Filing Date Serial Number Patent Number Grant Date

rmenia 24-Jul-1992 000446 749 01-Mar-2000

Benin 24-Jul-1992 PV60465 09883 15-Sep-1994

Botswana 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Botswana 27-Apr-1998

BW/A/1998/0016

BW/P/2002/0004

22-May-2003

Burkina Faso 24-Jul-1992 PV60465 09883 15-Sep-1994

Burundi 28-Jul-1992 92/5668 92/5668 28-Apr-1993

Final Version

Country Filing Date Serial Number Patent Number Grant Date

Cameroon 24-Jul-1992 PV60465 09883 15-Sep-1994

Central African

Republic

24-Jul-1992 PV60465 09883 15-Sep-1994

Chad 24-Jul-1992 PV60465 09883 15-Sep-1994

Congo, Republic

24-Jul-1992 PV60465 09883 15-Sep-1994

Congo, Republic

28-Jan-2000 NP/04/EXT/2000 2000/3587 22-Jun-2003

Cote d’Ivoire

(Ivory Coast)

24-Jul-1992 PV60465 09883 15-Sep-1994

Dominican

Republic

10-Jul-1997 1793970004607 370 23-Jul-2001

Gabon 24-Jul-1992 PV60465 09883 15-Sep-1994

Gambia 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Georgia 24-Jul-1992 001988 2094 10-Feb-2000

Ghana 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Guinea 24-Jul-1992 PV60465 09883 15-Sep-1994

Guinea-Bissau 24-Jul-1992 PV60465 09883 15-Sep-1994

Honduras 18-Aug-1997 PICA97118 3775 25-Apr-2000

Indonesia 01-Aug-1992 P-004494 ID0002829 22-Jun-1998

Jamaica 08-Jul-1997 18/1/3809 3615 25-May-2005

Kenya 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Kyrgyz Republic 10-Nov-1994 940226.1 310 29-Sep-2000

Lesotho 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Madagascar 24-Jul-1992 26/94 28 03-Jun-1996

Malawi 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Mali 24-Jul-1992 PV60465 09883 15-Sep-1994

Mauritania 24-Jul-1992 PV60465 09883 15-Sep-1994

Moldova 24-Jul-1992 95-0114 1434 31-Mar-2000

Nicaragua 05-Dec-1997 97.0096 1134RPI 17-May-1999

Final Version

Country Filing Date Serial Number Patent Number Grant Date

Niger 24-Jul-1992 PV60465 09883 15-Sep-1994

Nigeria 28-Jul-1992 171/92 RP11323 24-Mar-1993

Pakistan 30-Jul-1992 352/92 133305 22-Sep-1994

Rwanda 28-Jul-1992 92/5668 50 19-Apr-2000

Senegal 24-Jul-1992 PV60465 09883 15-Sep-1994

South Africa 28-Jul-1992 92/5668 92/5668 28-Apr-1993

Sri Lanka 24-Jul-1992 10609 10609 07-Apr-1995

Sudan 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Swaziland 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Tajikistan 24-Jul-1992 94000128/22 TJ244 12-Aug-1999

Togo 24-Jul-1992 PV60465 09883 15-Sep-1994

Uganda 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Uzbekistan 24-Jul-1992 IHAP9400856.2 IAP02360 10-Sep-2003

Zambia 31-Jul-1992 APP9200414 AP321 28-Feb-1994

Zimbabwe 31-Jul-1992 APP9200414 AP321 28-Feb-1994

TITLE: NON-HOMOGENEOUS SYSTEMS FOR THE RESOLUTION OF

ENANTIOMERIC MIXTURES

Country Filing Date Serial Number Patent Number Grant Date

India 08-Oct-1999

IN/PCT/2001/00368/D

197625 02-Mar-2007

India 08-Oct-1999 3639/DELNP/2004 247136 29-Mar-2011

TITLE: METHOD OF MANUFACTURE OF 1,3-OXATHIOLANE

NUCLEOSIDES

Countr

Filin

Date Serial Number Patent Numbe

Grant Date

India

12-Aug-1999

IN/PCT/2001/00191/D

220526 29-May-2008

India 12-Aug-1999

IN/PCT/04834/DELNP

/2005

243267 30-Sep-2010

Final Version

Countr

Filin

Date Serial Number Patent Numbe

Grant Date

India 12-Aug-1999

IN/PCT/04835/DELNP

/2006

239028 03-Mar-2010

TITLE: PROCESS FOR THE SYNTHESIS OF NUCLEOSIDE ANALOGS

Countr

Filin

Date Serial Number Patent Numbe

Grant Date

Pakistan 26-Mar-1996 172.96 N/A N/A

TITLE: SUBSTITUTED 1,3-OXATHIOLANE ANALOGUES WITH

ANTIVIRAL

PROPERTIES

Countr

Filin

Date Serial Number Patent Numbe

Grant Date

frican Regional

Industrial Property

Organization (ARIPO)

8-Feb-1990 AP/P/90/00163 AP136 5-Aug-1991

rmenia 28-Apr-1995 000316 455 15-May-1998

Botswana 21-Apr-1998 BW/A/98/00042

Georgia 9-Jan-1994 245/01 1599 29-Apr-1999

Jamaica 12-Jan-1997 18-1-3799

Kazakhstan 23-Nov-1993 932441.1 6138 15-Apr-1998

Kyrgyzstan 31-Oct-1994 940208.1 219 31-Oct-1994

Moldova 14-Jul-1994 94-0408 1007 31-Aug-1998

eria 7-Feb-1990 31/90 RP10849 30-Dec-1999

frican Union Territories

(OAPI)

8-Feb-1990 59735 9193 30-Jan-1992

Pakistan 8-Feb-1990 57/90 132128 23-May-1992

South Africa 8-Feb-1990 90/0943 90/0943 31-Oct-1990

Tajikistan 2-May-1994 94000018 TJ135 2-May-1994

Turkmenistan 24-Aug-1995 195 306 17-Sep-1997

Uzbekistan 29-Sep-1994 IHAP9400855.2 4707 3-Nov-1997

TITLE: PROCESSES FOR THE DIASTEREOSELECTIVE SYNTHESIS

NUCLEOSIDES

Country Filing Date Serial Number Patent Number Grant Date

Final Version

Country Filing Date Serial Number Patent Number Grant Date

rmenia 20-May-1992 000553 529 15-Mar-1999

Botswana 24-Apr-1998 BW/A/98/00109

BW/P/2002/0003

2-Oct-2002

Botswana 27-Apr-1998 BW/A/98/00187

BW/P/1999/0002

2-Dec-1999

Georgia 20-May-1992 001732 2030 10-Jan-2000

Guatemala 3-Mar-2000 P1-980047

Kyrgyzstan 10-Nov-1994 940225.1 323 29-Dec-2000

Moldova 20-May-1992 950172 1155 28-Feb-1999

frican Union Territories

(OAPI)

20-May-1992 PV60438 10349 29-Dec-1997

Pakistan 21-May-1992 246/92 133215 31-Jul-1994

Paraguay 21-May-1992 26/97 3.685 7-Apr-1997

Sri Lanka 21-May-1992 10587 10587 25-Mar-1994

South Africa 13-May-1992 92/3477 92/3477 27-Jan-1993

South Africa 19-May-1992 92/3640 92/3640 24-Feb-1993

Tajikistan 20-May-1992 94000017/22 267 18-Apr-2000

Uzbekistan 30-Sep-1994 IHAP9400869.2 5442 20-Oct-1998

Final Version

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. South Sudan

85. Sudan

86. Suriname

87. Swaziland

88. Syrian Arab Republic

89. Tajikistan

90. Tanzania, U. Rep. of

91. Timor-Leste

92. Togo

93. Tonga

94. Trinidad and Tobago

95. Turks and Caicos

96.

Tuvalu

97. Uganda

98. Uzbekistan

99. Vanuatu

100. Vietnam

101. Yemen

102. Zambia

103. Zimbabwe

Final Version

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. South Sudan

82. Sudan

83. Suriname

84. Swaziland

85. Syrian Arab Republic

86. Tajikistan

87. Tanzania, U. Rep. of

88. Timor-Leste

89. Togo

90. Tonga

91. Trinidad and Tobago

92. Turks and Caicos

93. Tuvalu

94. Uganda

95. Uzbekistan

96. Vanuatu

97. Vietnam

98. Yemen

99. Zambia

100. Zimbabwe

Final Version

Appendix 7

Countries in the Semi-Exclusive Territory

The Semi-Exclusive Territory for Matrix Laboratories Ltd:

1. Sri Lanka

2. Thailand

The Semi-Exclusive Territory for Ranbaxy Laboratories Ltd:

1. Botswana

2. Namibia

The Semi-Exclusive Territory for Strides Arcolab Ltd:

1. El Salvador

2. Ecuador

3. Indonesia

4. Kazakhstan

5. Turkmenistan