Master Alliance Provisions Guide (MAPGuide)

AbbVie – MPP, HIV Antiretroviral License Agreement

  • Intellectual Property | License Grants

Definitions

AbbVie Patents” shall mean Territory Patents and Non-Territory Patents.

Non-Territory Eligible Purchasers” shall mean: (a) the following organizations to the extent that they are not–for–profit organizations: () NGOs including without limitation those recognized by the applicable local government ministry: (i) UN–related organizations working for or within the Territory, including but not limited to UNDP and UNICEF; (ii) Not-for-profit organizations including without limitation, Médecins Sans Frontières, Save the Children, OXFAM and the International Committee of the Red Cross (ICRC); and (iv) Funding mechanisms and programs funded by such mechanisms, including without limitation, UNITAID, PEPFAR, USAID, Global Fund, etc.; and agencies based outside the Territory to the extent that they are supporting implementation locally within the Territory, and (b) nominally for-profit procurement organizations but only to the extent that such procurements are supporting not-for-profit treatment programs as described in (a) of this provision.

Non–Territory Patents” shall mean those patents and patent applications listed in Exhibit B, and any continuation, continuation-in-part, divisional applications, and foreign equivalents thereof.

Territory” shall mean all countries in the continent of Africa.

Territory Patents” shall mean those patents and patent applications listed in Exhibit A, and any continuation, continuation-in-part, divisional applications, and foreign equivalents thereof.

2. License Grants

2.1 Subject to other terms and conditions of this Agreement, AbbVie hereby grants to MPP:

(a) a non–exclusive, non–transferable license to grant sublicenses in accordance with Section 3 under the Territory Patents to Exploit the Licensed Products in the Field and in the Territory.

(b) a non–exclusive, non–transferable license to grant sublicenses in accordance with Section 3 under the AbbVie Patents to Manufacture and Develop the Licensed Compounds and Licensed Products solely for the purpose of Commercialization of the Licensed Products in the Field and in the Territory

(c) a non–exclusive, non–transferable license to grant sublicenses in accordance with Section 3 under the AbbVie Patents to sell, offer to sell, or otherwise distribute Licensed Products to Non–Territory Eligible Purchasers solely for the purpose of Commercialization of the Licensed Products in the Field and in the Territory; and

(d) a non–exclusive, non–transferable license to grant sublicenses in accordance with Section 3 under the AbbVie Patents to sell, offer to sell, or otherwise distribute Licensed Compounds solely for the purpose of Commercialization of the Licensed Products in the Field and in the Territory.

2.2 MPP agrees that it will not itself Exploit the AbbVie Patents in any manner. The licenses granted hereunder do not include any license or other right to use and AbbVie trademark, trade name, logo or service mark (each, an “AbbVie Mark“😉 or any word, logo or any expression that is similar to or alludes to an AbbVie Mark.

2.3 Nothing in this Agreement shall be construed to prevent Sublicensees from engaging in any activities where such activities would not infringe and AbbVie Patent granted and in force included, without limitation, where a country has issued a compulsory license on AbbVie Patent(s).

2.4 AbbVie shall provide , upon MPP’s request, a Sublicensee with NCE Exclusivity or other regulatory exclusivity waivers to the extent required by the applicable regulatory authorities in order to manufacture or sell Licensed Product(s) in the Territory in accordance with the terms of the Sublicense.

2.5 Except as expressly set forth in this Agreement, AbbVie does not grant any license to MPP under any of its intellectual property rights (including, without limitation, AbbVie Patents or rights to any proprietary compounds or drug substances other than the Licensed Compounds). Nothing in this agreement obligates AbbVie to provide to MPP or any Sublicensee any information related to the composition or formulation of, or the method of making or using, the Licensed Compounds or Licensed Products.

2.6 Notwithstanding anything to the contrary herein, MPP acknowledges and agrees that the license granted under this Section 2 is granted solely under and with respect to AbbVie Patents for the purposes of supplying Licensed Compounds and Licensed Products for ultimate use in Licensed Products used in the Field and in the Territory. Nothing in this Agreement will be construed as granting MPP or a Sublicensee any rights under any patents, know–how, or otherwise to use or sell the Licensed Product for ultimate use outside of the Field or outside of the Territory.

3. Sublicense

3.1 Form of Sublicense. MPP shall not grant sublicenses other than in the form of the Sublicense.

3.2 Sublicensee Identification. The parties intend that MPP will identify potential manufacturers of pharmaceutical products with a view to enter into Sublicenses. Upon identification of such a manufacturer, in each case, MPP shall provide notice to AbbVie of the identity of the manufacturer (including the name, address, principal place of business, list of affiliated entities) and any additional information that may be at the time reasonably requested by AbbVie.

3.3 Sublicensee Certification. MPP shall only enter into sublicenses with entities that have produced reasonable evidence demonstrating (i) their intent and capability to comply with applicable laws relating to corruption (including anti–bribery laws and the U.S. Foreign Corrupt Practices Act and the U.K. Bribery Act 2010) and (ii) where such licensee obtains the right to manufacture Licensed Compounds or Licensed Products, their capability to engage in such manufacture in a manner consistent with (a) World Health Organization pre–qualification standards; or (ii) the standards of any applicable regulatory authority which are members, observers or associates of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.