Provision Language
Definitions
“New Formulation” shall mean any Licensed Product that has not been approved for pediatric use as of the Effective Date.
“New Lopinavir/Ritonavir Formulation” shall mean those New Formulations containing only lopinavir and ritonavir, individually or in combination.
“Non-Territory Eligible Purchasers” shall mean: (a) the following organizations to the extent that they are not–for–profit organizations: (i) NGOs including without limitation those recognized by the applicable local government ministry; (ii) UN-related organizations working for or within the Territory, including but not limited to UNDP and UNICEF; (iii) 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.
“Sole License” shall mean a non–exclusive license granted solely to AbbVie and to no other third party.
AbbVie – MPP Agreement
2. License Grants
2.1 Subject to the 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 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 Licensed Products in the Field and in the Territory;
(d) and 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 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 any 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 any AbbVie Mark.
2.3 Nothing in this Agreement or in the Sublicense shall be construed to prevent Sublicensees from engaging in any activities where such activities would not infringe an AbbVie Patent granted and in force, including, 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 Licensed Compounds).
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. Sublicenses
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, principle place of business, list of affiliated entities) and provide AbbVie with (i) the information contemplated by Section 3.3, (ii) the complete development, manufacturing and commercialization plans proposed by the manufacturer, including without limitation the proposed supply chain of the Licensed Compounds and Licensed Products; and (iii) any additional information that may be at the time reasonably requested by AbbVie to enable AbbVie to evaluate a proposed Sublicensee.
3.3 Sublicensee Certification. MPP shall only enter into Sublicenses with entities that have produced reasonable evidence demonstrating their intent and capability to:
(a) comply with applicable laws relating to corruption (including anti bribery laws and the U.S. Foreign Corrupt Practices Act and the UK Bribery Act 2010), where certification to this effect, absent other contrary evidence, shall constitute reasonable evidence under this Section 3.3; and
(b) manufacture Licensed Products in compliance with the obligations set forth in the Sublicense.
3.4 AbbVie Consent of Proposed Sublicensee.
(a) MPP shall not enter into a Sublicense with a party without AbbVie’s prior written consent with respect to that party. AbbVie’s consent shall not be withheld, except as reasonably based upon the Sublicensee requirements set forth in Section 3.3. AbbVie’s consent shall be understood as granted unless otherwise notified by AbbVie in writing within thirty (30) days of MPP’s initial written notice of pursuant to Section 3.2.
(b) AbbVie’s consent to a Sublicense pursuant to this Section 3.3 shall not waive or derogate from any other obligation of MPP under this Agreement.
3.5 Insurance. MPP shall cause the Sublicensees to purchase and maintain appropriate product liability insurance as per the terms of the Sublicense.
5. AbbVie Commercialization Rights
5.1 New Lopinavir/Ritonavir Formulations. MPP will require that the Sublicensees grant to AbbVie an option to and right of first refusal for:
(a) (1) the sole right to purchase New Lopinavir/Ritonavir Formulations from the Sublicensee developing such formulation for sale in the United States and the European Union under terms to be agreed upon by the Sublicensee and AbbVie; or (2) a Sole License to any patents and know-how necessary or useful in exploiting such New Lopinavir/Ritonavir Formulations in the United States and the European Union under terms to be agreed upon by Sublicensee and AbbVie; provided, in the event that AbbVie chooses option (2), the term of such Sole License shall last until the termination or expiration of this Agreement, whereupon such Sole License will be converted into a license under royalty and terms to be agreed upon by Sublicensee and AbbVie, and AbbVie will pay Sublicensee a royalty of 4% of the Net Sales of the New Lopinavir/Ritonavir Formulation, payable at the end of each Agreement Quarter for such Sole License; and
(b) a non-exclusive right to commercialize and otherwise exploit the New Lopinavir/Ritonavir Formulations outside the United States and the European Union and outside the Territory through purchase or royalty-free non-exclusive license.
AbbVie will have ninety (90) days from the date of notification to AbbVie of a New Lopinavir/Ritonavir Formulation in which it may provide notice of its intent to exercise the option provided in this section, failing which the option(s) will have been deemed to be declined.
5.2 New Formulations Containing Other Compounds. MPP will require that Sublicensee grant to AbbVie a right of first negotiation to obtain the sole rights to commercialize any New Formulation which is not a New Lopinavir/Ritonavir Formulation under the two options described in Section 5.1(a). In the event that such New Formulation contains compounds also under license to MPP from a third party that contains non-exclusive grant-back obligations, the parties will confer regarding commercialization rights outside the Territory. Financial terms for the agreement(s) contemplated by this paragraph will be on terms to be negotiated among the parties. AbbVie will have ninety (90) days from the date of notification to AbbVie of a New Formulation containing other compounds in which it may provide notice of its intent to exercise the option provided in this section, failing which the option(s) will have been deemed to be declined.
Form of Sublicense
2. License Grants
2.1 Subject to the other terms and conditions of this Agreement and the AbbVieMPP Agreement, Licensor hereby grants to Licensee:
(a) a non–exclusive, non–transferable license under the Territory Patents to Exploit the Licensed Products in the Field and in the Territory;
(b) a non–exclusive, non–transferable license under the AbbVie Patents to Manufacture and Develop the Licensed Compounds and Licensed Products solely for the purpose of Commercialization of Licensed Products in the Field and in the Territory;
(c) a non–exclusive, non–transferable license 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 Licensed Products in the Field and in the Territory; and
(d) a non–exclusive, non–transferable license under the AbbVie Patents to sell, offer to sell, or otherwise distribute Licensed Compounds solely for the purpose of Commercialization of Licensed Products in the Field and in the Territory.
2.2 The licenses granted hereunder do not include any license or other right to use any 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 any AbbVie Mark.
2.3 Nothing in this Agreement shall be construed to prevent Licensee from engaging in any activities where such activities would not infringe AbbVie Patents granted and in force, including, without limitation, where a country has issued a compulsory license on AbbVie Patent(s).
2.4 Except as expressly set forth in this Agreement, (i) Licensor does not grant any license to Licensee under any of AbbVie intellectual property rights (including, without limitation, AbbVie Patents or rights to any AbbVie proprietary compounds or drug substances other than Licensed Compounds) and (ii) Licensee shall not further sublicense any of the rights set forth in this Agreement.
2.5 Notwithstanding anything to the contrary herein, Licensee acknowledges and agrees that the license granted under this Section 2 is granted solely under and with respect to AbbVie Patents Rights 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 Licensee 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.
5. AbbVie Commercialization Rights
5.1 New Lopinavir/Ritonavir Formulations. Licensee hereby grants to AbbVie an option and right of first refusal for:
(a) (1) the sole right to purchase New Lopinavir/Ritonavir Formulations from Licensee for sale in the United States and the European Union under terms to be agreed upon by Licensee and AbbVie; or (2) a Sole License to any patents and know–how necessary or useful in exploiting such New Lopinavir/Ritonavir Formulations in the United States and the European Union under terms to be agreed upon by Sublicensee and AbbVie; provided, in the event that AbbVie chooses option (2), the term of such Sole License shall last until the termination or expiration of this Agreement, whereupon such Sole License will be converted into a license under royalty and terms to be agreed upon by Sublicensee and AbbVie, and AbbVie will pay Licensee a royalty of 4% of the Net Sales of the New Lopinavir/Ritonavir Formulation, payable at the end of each Agreement Quarter for such Sole License; and
(b) a non–exclusive right to commercialize and otherwise exploit the New Lopinavir/Ritonavir Formulations outside the United States and the European Union and outside the Territory through purchase or non–exclusive, royalty–free license.
(c) AbbVie will have ninety (90) days from the date of notification to AbbVie of a New Lopinavir/Ritonavir Formulation in which it may provide notice of its intent to exercise the option provided in this section, failing which the option(s) will have been deemed to be declined.
5.2 New Formulations Containing Other Compounds. Licensee hereby grants to AbbVie a right of first negotiation to obtain the sole rights to commercialize any New Formulation which is not a New Lopinavir/Ritonavir Formulation under the two options described in Section 5.1(a). In the event that such New Formulation contains compounds also under license to Licensee from a third party that contains non-exclusive grant-back obligations, the parties will confer regarding commercialization rights outside the Territory. Financial terms for the agreement(s) contemplated by this section will be on terms to be negotiated between Licensee and AbbVie. AbbVie will have ninety (90) days from the date of notification to AbbVie of a New Formulation containing other compounds in which it may provide notice of its intent to exercise the option provided in this section, failing which the option(s) will have been deemed to be declined.
Exhibit A
