Master Alliance Provisions Guide (MAPGuide)

MPP – Gilead, TDF License Agreement

  • Intellectual Property | Use of background IP

2. License Grants

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

[“Field” means 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.]

[See agreement appendices for the list of countries included in the TDF, EVG-Quad and COBI territories.]