Exhibit 10.1

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

LICENSE AGREEMENT

This License Agreement (the “Agreement”) is made and entered into as of March 22, 2005 (the “Execution Date”) by and between Japan Tobacco Inc., a Japanese corporation having its principal place of business at JT Building, 2-1 Toranomon, 2-chome, Minato-ku, Tokyo 105-8422, Japan (“JT”), and Gilead Sciences, Inc., a Delaware corporation having its principal place of business at 333 Lakeside Drive, Foster City, CA 94404, United States (“Gilead”). JT and Gilead are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

Recitals

Whereas, JT has developed a proprietary anti-viral compound designated as JTK-303, to be used in a product or products for the treatment of HIV; and

Whereas, Gilead possesses extensive capabilities in the development, promotion and marketing of pharmaceutical products to treat human diseases and conditions, and desires to further develop, seek regulatory approval for and market formulations and dosages of JTK-303; and

Whereas, Gilead desires to obtain the exclusive right to develop and commercialize, for itself and its Affiliates such formulations and dosages of JTK-303 outside of Japan, and JT desires to grant Gilead such rights, all as set forth below;

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

ARTICLE 1

DEFINITIONS

The following terms shall have the following meanings as used in this Agreement:

1.1 “Affiliate” shall mean, except as provided below, an entity that, directly or indirectly, through one (1) or more intermediaries, controls, is controlled by or is under common control with JT or Gilead. The term “control” as used in this definition means ownership of more than fifty percent (50%) of the voting interest in the entity in question or having otherwise

the power to govern the financial and the operating policies or to appoint the management of an organization. Notwithstanding the foregoing, neither the government of Japan, nor any entity controlled by the government of Japan, shall be deemed to be an Affiliate of JT.

1.2 “Alliance Manager” shall have the meaning given such term in Section 2.3(a)

1.3 “API” shall mean active pharmaceutical ingredients.

1.4 “Calendar Quarter” shall mean the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.5 “Change in Control” shall mean any sale of voting securities, any sale or purchase of assets, or any merger, consolidation or similar transaction that, directly or indirectly: (i) results in the transfer of substantially all of a Party’s assets that relate to or are engaged in the Commercialization of any Products to any Third Party; or (ii) results in any Third Party becoming an Affiliate of a Party.

1.6 “Combination Product” shall mean any Product in the form of a combination product that contains Compound in addition to one or more active pharmaceutical ingredients.

1.7 “Commercial Launch” shall mean, with respect to a Product, the first commercial sale of such Product to a Third Party occurring after Regulatory Approval for such Product.

1.8 “Commercialize” shall mean to promote, market, distribute, sell or provide product support for a Product (other than in connection with clinical trials of such Product), and “Commercializing” and “Commercialization” shall be interpreted accordingly.

1.9 “Compound” shall mean (i) the compound known as JTK-303, the chemical structure of which is shown in Schedule 1.9A, (ii) the salts, esters, hydrates, isomers, and metabolites of that compound; (iii) any other compounds claimed in or covered by a Valid Claim in the Patent(s) described on Schedule 1.9B; and (iv) crystalline forms of (i) through (iii).

1.10 “Condition Precedent” shall have the meaning set forth in Article 17.

1.11 “Confidential Disclosure Agreements” shall mean (i) the Confidential Disclosure Agreement between the Parties dated September 16, 2004, as amended by the Amendment to Confidential Disclosure Agreement dated October 29, 2004 and the Second Amendment to Confidential Disclosure Agreement dated February 1, 2005; (ii) the Confidential Disclosure Agreement between the Parties dated February 1, 2005 (JT as recipient); and (iii) the Confidential Disclosure Agreement between the Parties dated February 1, 2005 (Gilead as recipient).

1.12 “Confidential Information” shall mean (i) all information and materials, received by either Party from the other Party pursuant to this Agreement and (ii) all information and materials disclosed pursuant to the Confidential Disclosure Agreements and/or the Material Transfer Agreements, in each case other than that portion of such information or materials that:

(a) is publicly disclosed by the disclosing Party, either before or after it becomes known to the receiving Party;

(b) was known to the receiving Party, without obligation to keep it confidential, prior to when it was received from the disclosing Party, as evidenced by competent written proof;

(c) is subsequently disclosed to the receiving Party by a Third Party lawfully in possession thereof without obligation to keep it confidential;

(d) has been publicly disclosed other than by the disclosing Party and without breach of an obligation of confidentiality with respect thereto; or

(e) has been independently developed by the receiving Party without the aid, application or use of Confidential Information, as evidenced by competent written proof.

1.13 “Control”, “Controls” and “Controlled” shall mean, with respect to a particular item of information or intellectual property right, that the applicable Party owns or has a license to such item or right and has the ability to grant to the other Party access to and a license or sublicense (as applicable) under such item or rights as provided for herein without violating the terms of any agreement or other arrangement with any Third Party, and without incurring material additional costs to procure such Third Party rights beyond those already incurred.

1.14 “Develop” shall mean the conduct of any pre-clinical, clinical or other studies or activities with respect to, or required for obtaining Regulatory Approval of, a Product (including without limitation quality assurance and quality control activities) or for Commercialization of a Product, along with any other clinical studies that may be conducted in each case as set forth in the Gilead Development Plan and the Gilead Update and in accordance with this Agreement. The terms “Developing” and “Development” shall be interpreted accordingly.

1.15 “Diligent Efforts” shall mean, with respect to a Party’s obligation under this Agreement to Develop or Commercialize a Product, the level of efforts required to carry out such obligation in a sustained manner consistent with the efforts a similarly situated pharmaceutical company devotes to a product of similar market potential, risk, profit potential and strategic value resulting from its own research efforts, based on conditions then prevailing. Diligent Efforts requires, with respect to such an obligation, that: (i) a Party promptly assign responsibility for such obligation to qualified employee(s) who are held accountable for progress and monitor such progress on an on-going basis; (ii) a Party set and consistently seek to achieve specific, meaningful and measurable objectives for carrying out such obligation; and (iii) a Party consistently make and implement decisions and allocate resources designed to advance progress with respect to such objectives.

1.16 “Dispute” shall have the meaning set forth in Section 15.1.

1.17 “Dollar” shall mean a United States dollar, and “$” shall be interpreted accordingly.

1.18 “Effective Date” shall mean the date on which the Condition Precedent has been satisfied.

1.19 “EMEA” shall mean the European Medicines Evaluation Agency, or any successor thereto, which coordinates the scientific review of human pharmaceutical products under the centralized licensing procedures of the EU.

1.20 “Emtriva” shall mean an enantiomeric mixture of emtricitabine (which is the (-) enantiomer of the chemical [*], in which the ratio of such (-) enantiomer to its (+) enantiomer is equal to or greater than [*], including without limitation the ratio of such enantiomers being [*].

1.21 “EU” shall mean the European Union.

1.22 “Execution Date” shall have the meaning set forth in the Preamble of this Agreement.

1.23 “FDA” shall mean the United States Food and Drug Administration, or a successor thereto.

1.24 “GAAP” shall mean generally accepted accounting principles in the United States as consistently applied.

1.25 “Generic Product” shall mean a Product that is sold by an unlicensed Third Party (i) in any country where there are no JT Patents or Gilead Patents; (ii) in a country where there are no Valid Claims in the JT Patents or Gilead Patents; (iii) in a country where the laws do not provide for the effective enforcement of Patent rights; or (iv) in any other country where the Parties both determine that it is not commercially reasonable to pursue Third Party infringers. A Generic Product is also a Product that is sold pursuant to a compulsory license for the Licensed Indication (which compulsory license is for sales at a Net Selling Price that is less than or equal to what would be the Net Selling Price of a Product sold by an unlicensed Third Party in a comparable non-patent country).

1.26 “Gilead Commercialization Plan” shall have the meaning set forth in Section 5.2(a).

1.27 “Gilead Development Plan” shall have the meaning set forth in Section 3.2(a).

1.28 “Gilead Indemnitees” shall have the meaning set forth in Section 11.1.

1.29 “Gilead Know-How” shall mean: (a) Know-How Controlled by Gilead or a Gilead Affiliate that is necessary for, or that has been otherwise actually used during the Term in, the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds or Products; and (b) Gilead Sublicensee Know-How.

1.30 “Gilead Patent” shall mean: (a) any Patent Controlled by Gilead or a Gilead Affiliate that is necessary for, or that has otherwise actually been used during the Term in, the research, Development, manufacture, use, sale, offer for sale, or importation of a Compound or a

Product, including without limitation Gilead’s interest in Joint Patents; and (b) any Gilead Sublicensee Patent.

1.31 “Gilead Sublicensee Know-How” shall mean Sublicensee Know-How necessary for or actually used during the Term in connection with a sublicense of Article 6 rights from Gilead.

1.32 “Gilead Sublicensee Patent” shall mean a Sublicensee Patent necessary for or actually used during the Term in connection with a sublicense of Article 6 rights from Gilead.

1.33 “Gilead Technology” shall mean all Gilead Patents and Gilead Know-How.

1.34 “Gilead Territory” shall mean all countries of the world except for the JT Territory.

1.35 “Gilead Update” shall have the meaning set forth in Section 3.2(a)(ii).

1.36 “HIV” shall mean the human immunodeficiency virus.

1.37 “IND” shall mean (i) an Investigational New Drug Application as defined in the United States Food, Drug and Cosmetic Act and applicable regulations promulgated thereunder by the FDA, or (ii) an equivalent application to the equivalent agency in any other country or group of countries, the filing of which is necessary to commence clinical testing of a pharmaceutical product in humans in a particular jurisdiction.

1.38 “Indemnify” shall have the meaning set forth in Section 11.1.

1.39 “Infringement” shall have the meaning set forth in Section 9.4(a)(i). “Infringe” shall mean the carrying out of an Infringement.

1.40 “IP Subcommittee” shall have the meaning set forth in Section 9.2(a).

1.41 “Joint Committee” shall mean the committee described in Section 2.1(a).

1.42 “Joint Invention” shall have the meaning set forth in Section 9.1(a).

1.43 “Joint Patent” shall have the meaning set forth in Section 9.3(d).

1.44 “JT Commercialization Plan” shall have the meaning set forth in Section 5.2(b).

1.45 “JT Development Plan” shall have the meaning set forth in Section 3.2(b)(i).

1.46 “JT Indemnitees” shall have the meaning set forth in Section 11.2.

1.47 “JT Know-How” shall mean: (a) Know-How that is Controlled by JT or a JT Affiliate that is necessary for, or that has been otherwise actually used during the Term in, the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds or Products; and (b) JT Sublicensee Know-How.

1.48 “JT Patent” shall mean: (a) any Patent Controlled by JT or a JT Affiliate that is necessary for, or that has been otherwise actually used during the Term in, the research, Development, manufacture, use, sale, offer for sale, or importation of Compounds or Products, including without limitation JT’s interest in any Joint Patents; and (b) any JT Sublicensee Patent. As of the Execution Date, the JT Patents include those Patents listed on Schedule 1.48, and it shall include those added to such Schedule pursuant to Section 9.1(c).

1.49 “JT Sublicensee Know-How” shall mean Sublicensee Know-How necessary for or actually used during the Term in connection with a sublicense of Article 6 rights from JT.

1.50 “JT Sublicensee Patent” shall mean a Sublicensee Patent necessary for or actually used during the Term in connection with a sublicense of Article 6 rights from JT.

1.51 “JT Technology” shall mean all JT Patents and JT Know-How.

1.52 “JT Territory” shall mean Japan and its possessions and territories thereof.

1.53 “JT Update” shall have the meaning set forth in Section 3.2(b)(ii).

1.54 “ [*]” shall have the meaning set forth in Section 6.8(a)(i).

1.55 “Key JT Personnel” shall mean the JT employees described on Schedule 1.55 hereto.

1.56 “Know-How” shall mean (i) all information, know-how, techniques and data specifically relating to development, manufacture, use or sale of a Compound or a Product, including but not limited to, inventions, practices, methods, knowledge, know-how, skill, experience, test data (including without limitation pharmacological, toxicological, clinical, analytical and quality control data, regulatory submissions, correspondence and communications, and marketing, pricing, distribution, cost, sales, manufacturing, patent and legal data or descriptions); (ii) Regulatory Information containing know-how; and (iii) compositions of matter, assays and biological materials specifically relating to development, manufacture, use or sale of a Compound or a Product. Solely for purposes of this definition of Know-How, Product shall not include a Combination Product.

1.57 “Licensed Indication” shall mean all possible therapeutic and prophylactic uses (including without limitation, mono-and combination uses in the treatment of HIV infection).

1.58 “Losses” shall have the meaning assigned such term in Section 11.1.

1.59 “Major EU Countries” shall mean France, Germany, Italy, Spain and the United Kingdom, and “Major EU Country” shall mean any one of the foregoing.

1.60 “Major Market” shall mean any of the United States and the Major EU Countries.

1.61 “Manufacturing Cost” shall mean an amount equal to Gilead’s cost to produce Product consisting of the amounts described in clauses (a), (b) or (c) below, as appropriate:

(a) Internal Costs.

(i) Material Costs, which means the prices paid to Third Parties for raw materials including intermediates and active compounds, excipients, components, packaging and labeling materials to the extent used in the manufacture and transportation of Product and purchased finished goods which are purchased from outside vendors as well as any freight and duty where applicable. Material Costs includes the quantity of the components included in the bill of material multiplied by the purchase price and the waste factor (i.e., scrap percentage) included in the bill of materials. It also includes the normal quality assurance sample quantity which is included in the bill of materials; and

(ii) Direct Labor Costs, which means the standard labor hours required for an operation according to the standard operating procedures multiplied by the direct labor rate (i.e., the employment costs per man-hour including, without limitation, salary and employee benefits) for work centers within the relevant manufacturing operating unit; and

(iii) Overhead Costs, which means a reasonable allocation of overhead calculated by Gilead in accordance with reasonable cost accounting methods that comply with GAAP and consistent with the way Gilead allocates such costs to products it supplies to other of its customers pursuant to contract manufacturing relationships, specifically excluding products supplied pursuant to corporate partnering and/or other co-development relationships. Overhead Costs shall include administrative costs directly in support of Gilead’s manufacturing operation and expenses associated with quality assurance, manufacturing and engineering associated with the operating unit(s) manufacturing a Product and shall include depreciation and property taxes associated with the plant(s) manufacturing a Product. These costs shall be allocated to each product line in such operating unit(s) or plant(s), whichever is applicable, based on specific criteria consistent with the standard operating procedures for each product and work center overhead rates of the party performing the work determined and allocated in a manner consistently applied within and across operating unit(s); and

(iv) Third-Party royalties and costs of manufacturing to the extent not already paid or credited under this Agreement and not including royalties Gilead is obligated to pay under Section 8.3(a) of this Agreement.

(b) Contract Manufacturing Costs. Gilead’s costs to acquire a Product from suppliers (which amount will be net of rebates, if any, from suppliers).

(c) Combined Costs. For a Product that has costs arising under both Section 1.61(a) and Section 1.61(b), “Manufacturing Costs” shall consist of the sum of the costs described in each such subsection.

1.62 “Marketing Authorization Application” or “MAA” shall mean an application for Regulatory Approval (but excluding Price Approvals) required for marketing of pharmaceutical product. Solely as used in Section 8.2, “MAA” shall mean the application for Regulatory Approval (but excluding Price Approvals) required for marketing of the first Product in the EU.

1.63 “Material Transfer Agreements” shall mean the Material Transfer Agreement between the Parties dated October 6, 2004, and the Clinical Trial Material Transfer Agreement between the Parties dated as of March 17, 2005.

1.64 “NDA” shall mean a New Drug Application filed with the FDA to seek Regulatory Approval for a pharmaceutical product in the United States.

1.65 “Net Sales” means, with respect to a given period of time, the total amount invoiced by Gilead or its Affiliates and Sublicensees for sales of Products to a Third Party (whether an end-user, wholesaler or otherwise) in the Gilead Territory, less the following deductions with respect to such sale, to the extent applicable to the Product and to the extent consistent with Gilead’s accounting practices used with respect to sales of Viread: (a) trade, cash and quantity credits, discounts, distributor fees, wholesaler fees for inventory management or similar purposes (provided the fees charged by the wholesaler are consistent across Gilead’s product lines), credits, and refunds, (b) allowances or credits for returns or rejected Product and a reasonable allowance for bad debt expense consistent with GAAP; (c) prepaid freight and insurance; (d) sales taxes and other governmental charges (including value added and similar taxes, but solely to the extent not otherwise creditable or reimbursed and excluding any income tax) actually paid by Gilead or its Affiliates and Sublicensees in connection with the sale; and (e) customary rebates (including, for this purpose, discounts provided by means of chargebacks or rebates) granted to managed health care organizations, federal, state, or local governments (or their agencies) (including without limitation Medicaid rebates), all to the extent in accordance with GAAP as consistently applied across all products of Gilead.

Gilead and its Affiliates and Sublicensees will use commercially reasonable efforts to collect any amount designated as a credit or as an allowance that was previously deducted pursuant to clause (b) of the preceding paragraph. If Gilead or its Affiliate or Sublicensee collects any amount designated as a credit or as an allowance that was previously deducted pursuant to clause (b) of the preceding paragraph, then, to the extent the amount collected exceeds or is less than the corresponding credit or allowance taken, Net Sales for the period in which such amount is determined shall be increased or decreased by such amount.

Sales to Distributors; Not-for-Profit and Charitable Distributions. For clarification, sale of a Product by Gilead or its Affiliates and Sublicensees to Gilead or its Affiliates and Sublicensees for resale by such entity to an unaffiliated Third Party shall not be deemed a sale for purposes of “Net Sales” hereunder, but the sale of such Product by such entity to an unaffiliated Third Party (whether an end-user, wholesaler, distributor (including Gilead’s exclusive distributors covering countries, territories or regions) or otherwise) shall be deemed to be a sale by Gilead of a Product to a Third Party for purposes of calculating Net Sales hereunder and royalties owed by Gilead under Section 8.3. Further, transfers or dispositions of Products in commercially reasonable quantities (consistent with Gilead’s usual practice as applied to other compounds and products of a similar nature) and without receipt of compensation, or if sold for at or less than Manufacturing Cost for charitable or promotional purposes or for pre-clinical or clinical Development, manufacturing scale-up or regulatory purposes prior to receiving Regulatory Approval shall not be deemed “sales” for purposes of “Net Sales” hereunder.

Distribution to Global Access Programs. To the extent Gilead or its Affiliates distribute Product through government agencies, not-for-profit non-governmental organizations, physicians, pharmacies or patients in the countries listed in Schedule 1.65 at reduced rates (the “Gilead Global Access Program”), Net Sales for the purposes of determining royalties payable under this Agreement on Products distributed to a Gilead Global Access Program will be calculated by reducing the gross amount invoiced to the Global Access Program for such Product by Gilead’s Manufacturing Costs, including, to the extent not included as Manufacturing Costs, reasonable overhead and depreciated facilities expenses and administrative costs in direct support of the manufacturing of the Product and of Gilead’s Global Access Program in accordance with practices and procedures consistent with those of other relevant products in the Gilead Global Access Program, for the Product less all credits or allowances granted on account of rejections, returns, billing errors or retroactive price reductions, and duties, taxes and other governmental charges, provided that the total resulting amount shall not be reduced below zero after deduction of applicable credits and allowances. Where Product is sold in the form of a Combination Product containing one or more API in addition to a Compound, the Net Sales for such Combination Product for purposes of determining royalties payable under this Agreement will be calculated by multiplying the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) by the fraction A/(A+B) where A is the Net Selling Price for the stock keeping unit most comparable to the component of the Product containing that Compound as the sole API, if sold separately, in such country during the relevant fiscal quarter, and B is the Net Selling Price for the stock keeping unit, most comparable to the component containing other API, if sold separately, in such country during the relevant fiscal quarter. For clarity, if there are three or more API (including the Compound), additional B terms calculated in the same manner, shall be included in the denominator so that such fraction shall be A/(A+B1+ B2+…).

If, on a country-by-country basis, one or more of the other API in the Combination Product are not sold separately in said country, the Net Sales for the purpose of determining royalties payable under this Agreement for the Combination Product shall be calculated by multiplying the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) by the fraction A/C where A is the Net Selling Price for the stock keeping unit most comparable to the component of the Product containing the relevant Compound as the sole API, if sold separately, in such country during the relevant fiscal quarter and C is the Net Selling Price for the Combination Product in such country during the relevant fiscal quarter.

If, on a country-by-country basis, the Product containing a Compound as the sole API is not sold separately in said country during the relevant fiscal quarter but one or more of the other API in the Combination Product are sold separately in said country during the relevant fiscal quarter, the Net Sales for the Combination Product shall be calculated by multiplying the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) by the fraction (1-(D/C)) where D is the Net Selling Price for the stock keeping unit most comparable to the product containing the other API as the sole API and C is the Net Selling Price for the Combination Product in such country during the relevant fiscal quarter. For clarity, if there are two or more other product API, additional D terms calculated in the same manner shall be included in the numerator so that the fraction shall be
(1-(D1+D2+. . .)/C).

If, on a country-by-country basis, the Product containing a Compound as the sole API is not sold separately in a country and one or more of the other API in the Combination Product are not sold separately in such country, the Net Sales of the Combination Product shall be deemed to be the Net Sales of such Combination Product (without regard to the adjustment established by this paragraph) multiplied by the fraction A/C where A is the Net Selling Price on an average worldwide basis for the stock keeping unit most comparable to the Product containing the relevant Compound as the sole API, and C is the Net Selling Price for the Combination Product on an average worldwide basis.

1.66 Net Selling Price” means the Net Sales (as defined in the first and second paragraphs of the definition of “Net Sales”, without giving effect to the subsequent paragraphs of such definition) of a Product divided by the number of units of Product sold.

1.67 “Non-breaching Party” shall have the meaning set forth in Section 14.3(a).

1.68 “Offsetting Patents” shall mean Patents controlled by a Third Party and that are required for the research, Development, manufacture, use, sale, offer for sale or importation of JTK-303 based on the formulation furnished by JT to Gilead, as used for treatment and/or prophylaxis of HIV infection and to the extent based on the manufacturing process provided by JT to Gilead.

1.69 “Other Indication” shall mean therapeutic and prophylactic uses other than in the treatment and prophylaxis of HIV infection.

1.70 “Patent” shall mean (a) all patents, certificates of invention, applications for certificates of invention, and patent applications, including without limitation patent applications under the Patent Cooperation Treaty and the European Patent Convention, and abandoned patent applications throughout the world, together with (b) any renewal, divisional, continuation (in whole or in part), or continued prosecution applications of any of such patents, certificates of invention and patent applications, and any all patents or certificates of invention issuing thereon, and any and all reissues, reexaminations, extensions, divisions, renewals, substitutions, confirmations, supplemental protection certificates, registrations, revalidations, revisions, and additions of or to any of the foregoing, and any counterparts in any other country of any of the foregoing and any other patents and patent applications claiming priority back to any of the foregoing.

1.71 “Payment Term” shall have the meaning set forth in Section 8.3(d).

1.72 “Phase II Study” shall mean initial clinical trials of a Product on a limited number of patients for the purposes of determining dose and evaluating safety and efficacy of the proposed therapeutic indication as more fully defined in 21 C.F.R. §312.21(b) (or the equivalent process in other countries or groups of countries in the Gilead Territory).

1.73 “Phase III Study” shall mean expanded clinical trials of a Product on a large number of patients for the purposes of evaluation of the overall benefit-risk relationship and long-term safety of the proposed therapeutic indication as more fully defined in 21 C.F.R. §312.21(c) (or the equivalent process in other countries or groups of countries in the Gilead Territory).

1.74 “Phase IIIB/IV Study” shall mean any clinical trials of a drug that are not required for receipt of Regulatory Approval, but that may be useful in providing additional Product Profile data for such drug, supporting label expansion for such drug, or satisfying any conditions imposed by a Regulatory Authority upon the granting of Regulatory Approval for such drug.

1.75 “Price Approval” shall mean the receipt of approval (to the extent that such approval is required) by the applicable governmental authority with respect to the price at which a pharmaceutical product is sold and can be reimbursed by healthcare insurers, non-profits, government programs, and the like.

1.76 “Product” shall mean (i) any pharmaceutical product that contains Compound as the sole active pharmaceutical ingredient, or (ii) a Combination Product.

1.77 “Product Labeling” shall mean (i) the full prescribing information for any Product, as approved by the relevant Regulatory Authority and (ii) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for any Product that complies with the Regulatory Approval for such product.

1.78 “Product Profile” shall mean the recommendations for and limitations upon use of a pharmaceutical product that must be included in product labeling and packaging pursuant to any Regulatory Approval for such product.

1.79 “Promotional Materials” shall mean written, printed, graphic, electronic, audio or video matter, including but not limited to journal advertisements, sales visual aids, leave items, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings, broadcast advertisements and sales reminder aids (for example, note pads, pens and other such items) intended for use or used by Gilead or its Affiliate or Sublicensees in connection with the promotion of a Product, but excluding Product Labeling.

1.80 “Prosecution” shall have the meaning set forth in Section 9.3(a).

1.81 “Regulatory Approval” shall mean all approvals (including without limitation supplements, amendments, and Price Approvals), licenses, registrations or authorizations of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the manufacture, distribution, use or sale of a Product in a given regulatory jurisdiction.

1.82 “Regulatory Authority” shall mean the FDA or a counterpart of the FDA outside the United States.

1.83 “Regulatory Information” shall mean know-how, trade secrets, procedures, information, technology, experimental data, pre-clinical, non-clinical and clinical data, clinical safety, post-market safety, efficacy or comparative data, including without limitation raw or patient data, and any and all material information or reports relating to the development, registration, manufacture and commercialization of a Product that is reasonably necessary or required for Regulatory Approval of a Product. For illustration, Regulatory Information includes, but is not limited to, draft and final copies of all NDAs and INDs that are to be

submitted or have been submitted by JT and Gilead or their respective Affiliates to the regulatory authorities, including, without limitation, the FDA or EMEA, and that are included in other NDAs and INDs for a Product filed by either Party or its Affiliates, together with all material subsequent correspondence and data submissions relating to the foregoing, and all improvements or inventions made or obtained by either Party or its Affiliates, which are reasonably necessary or required to the formulation of a Product or the manufacture, development and registration of a Product.

1.84 “Remaining Competitive Recovery” shall have the meaning set forth in Section 9.4(f)(i).

1.85 “Reverted Country” shall mean a country in the Gilead Territory as to which Gilead’s rights under this Agreement are terminated in part by JT pursuant to Section 14.3(c).

1.86 “Sole Invention” shall have the meaning set forth in Section 9.1(a).

1.87 “Sublicensee” shall mean a Third Party that is a sublicensee of a Party’s rights granted under Article 6.

1.88 “Sublicensee Know-How” shall mean Know-How owned, assigned to, developed by, or in-licensed by a Sublicensee that is necessary for, or actually used during the Term in, the Sublicensee’s Development or Commercialization of a Product.

1.89 “Sublicensee Patent” shall mean any Patent owned, assigned to, or in-licensed by a Sublicensee that is necessary for, or actually used during the Term in, the Sublicensee’s Development or Commercialization of a Product.

1.90 “Supply Agreement” shall mean an agreement entered into by the Parties after the Execution Date governing the commercial supply of Products.

1.91 “Term” shall have the meaning set forth in Section 14.1.

1.92 “Third Party” shall mean any entity other than JT or Gilead or an Affiliate of either Party.

1.93 “Third Party Claim” shall have the meaning set forth in Section 11.1.

1.94 “Third Party Royalties” shall mean up-front, milestone, royalty and any other similar payments paid by Gilead to any Third Party for Offsetting Patents for the Development, manufacture, use sale, offer for sale, or importation of Compound or Product.

1.95 “Trademark” shall have the meaning set forth in Section 9.7(a).

1.96 “Truvada” shall mean the fixed dose combination of Emtriva and Viread.

1.97 “Valid Claim” shall mean a claim of an issued and unexpired Patent, which has not been revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, and which is not appealable or has not been appealed within

the time allowed for appeal, and which has not been disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination, disclaimer or otherwise.

1.98 “Viread” shall mean shall mean the pro-drug of Tenofovir known as tenofovir disoproxil fumarate, having the chemical formula (9-[(R)-2-[[bis [[isopropoxycarbonyl)oxy] methoxy] phosphinyl] methoxy] propyl] adenine fumarate).

1.99 “Viread Supply Agreement” shall mean the Supply Agreement between the Parties dated December 25, 2003 with respect to Viread, and as amended thereunder.

ARTICLE 2

MANAGEMENT

2.1 Joint Committee.

(a) Formation and Role. The Parties wish to establish a Joint Committee (the “Joint Committee”) to provide a forum for the Parties to share and discuss their respective plans relating to the Development and Commercialization of Compound(s) and Products and to coordinate activities to be taken by the Parties with respect to the Development and Commercialization of such Compound(s) and Products. The Joint Committee shall operate by the procedures set forth in this Section 2.1 and in Section 2.2 and shall have only the powers described in this Article 2 and elsewhere in this Agreement. The role of the Joint Committee will be to:

(i) review and discuss the Parties’ respective strategies for seeking Regulatory Approval of Products for treatment of HIV infection, and such Other Indications for which a Party wishes to seek Regulatory Approval, within the Parties’ Territories (for clarification, the Parties may meet with Regulatory Authorities in their respective Territory with respect to Products for the Licensed Indication without the approval of the Joint Committee), subject to their obligations under this Agreement;

(ii) facilitate the exchange of information between the Parties with respect to Gilead’s activities hereunder for the Gilead Territory and JT’s activities hereunder for the JT Territory;

(iii) review and discuss the Gilead Development Plan, the Gilead Commercialization Plan and updates thereof;

(iv) review and discuss the JT Development Plan, the JT Commercialization Plan and updates thereof;

(v) review, discuss and facilitate resolution of matters discussed in the Joint Committee, including other agenda items submitted in accordance with Section 3.4 and Section 5.4;