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The agreement amends and restates a prior TDF License Agreement, expanding the Territory and granting non-exclusive rights to manufacture and sell Gilead antiviral agents, including TDF, elvitegravir, cobicistat, and the fixed-dose regimen known as the “Quad.” It defines key terms such as APIs, products, fields of use, confidential information, and distributor roles.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":41,"@type":70,"position":76},"https://docshare.wps.com/template/letters/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/amended-and-restated-license-agreement-july-2011/281902/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/amended-and-restated-license-agreement-july-2011/281902.png","ImageObject",442,249,{"name":88,"@type":89},"Liam","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-27","2026-09-16",true,{"@type":98,"interactionType":99,"userInteractionCount":15},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What agreement is this and when is it effective?","Question",{"text":108,"@type":109},"It is an Amended and Restated License Agreement effective as of July __, 2011, between Gilead Sciences, Inc. and the Licensee.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How does the agreement expand the prior TDF license?",{"text":113,"@type":109},"It amends and restates the TDF License Agreement to expand the licensed Territory and grant non-exclusive rights covering additional Gilead agents and the “Quad” regimen.",{"name":115,"@type":106,"acceptedAnswer":116},"What are the defined products and active ingredients covered?",{"text":117,"@type":109},"The agreement defines Active Pharmaceutical Ingredients (including TDF, EVG, and COBI) and related formulated products such as the Quad and various combination products, along with their treatment and prophylaxis Field of use.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},281902,1789568881,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":40,"category_name":41,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":15,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":135,"language":136,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":61,"update_tm":125,"read_time":25},8796095461564,"https://ap-avatar.wpscdn.com/davatar_155a257f0dc6eb9ab79c44ca47cae57d","Final Version  \nAMENDED ANDRESTATED LICENSE AGREEMENT (TEMPLATE)  \nThis 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 andrestates in its entirety the License Agreement dated   between Gilead and Licensee, as previously amended (the “TDF License Agreement”) .  \nR E C I T A L S  \nWHEREAS, Gilead wishes to facilitate access to its antiviral agents to patients in the developing world to help satisfy unmet medical needs;  \nWHEREAS, 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;  \nWHEREAS, Gilead wishes to expand the scope ofthe 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  \nWHEREAS, 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;  \nNOW, 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:  \n1. Definitions  \n“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”) .  \n“Alternate Dosage” shall have the meaning set forth in Section 6.2(d) .  \n“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  \nFinal Version  \ntogether 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.  \n“COBI Product” shall mean a formulated and finished pharmaceutical product containing COBI as its sole active pharmaceutical ingredient.  \n“COBI Territory” shall mean those countries listed on Appendix 5.  \n“Combination Products” shall mean COBI Combination Products, EVG Combination Products, TDF Combination Products, and the Quad.  \n“Confidential Information” shall have the meaning set forth in Section 11.1.  \n“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.  \n“Emtricitabine Patents” shall have the meaning set forth in Section 7.6.  \n“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.  \n“EVG Product” shall mean a formulated and finished pharmaceutical product containing EVG as its sole active pharmaceutical ingredient.  \n“EVG-Quad Territory” shall mean those countries listed on Appendix 6.  \n“FDA” shall mean the United States","cbCaieaQA12cljzX","https://ap.wps.com/l/cbCaieaQA12cljzX","pdf",228685,44,"English","# Definitions\n## Licensed APIs and Products\n## Territory and Field of Use\n## Confidential Information and Distributors","[{\"question\":\"What agreement is this and when is it effective?\",\"answer\":\"It is an Amended and Restated License Agreement effective as of July __, 2011, between Gilead Sciences, Inc. and the Licensee.\"},{\"question\":\"How does the agreement expand the prior TDF license?\",\"answer\":\"It amends and restates the TDF License Agreement to expand the licensed Territory and grant non-exclusive rights covering additional Gilead agents and the “Quad” regimen.\"},{\"question\":\"What are the defined products and active ingredients covered?\",\"answer\":\"The agreement defines Active Pharmaceutical Ingredients (including TDF, EVG, and COBI) and related formulated products such as the Quad and various combination products, along with their treatment and prophylaxis Field of use.\"}]","AMENDED AND RESTATED LICENSE AGREEMENT - July 2011 | PDF"]