Provision Language
Definitions
“Territory” shall mean worldwide.
“Know-How” shall mean the Confidential Information described in Exhibit B and provided to MPP by Pfizer through Pfizer’s secure data transfer within thirty (30) days of the Effective Date.
“Licensed IP” shall mean the Know-How and the Patent Rights.
“Patent Right” shall mean the patents and patent applications as set forth in Exhibit A.
2. LICENSE GRANT
2.1. Upon the terms and subject to the conditions set out in this Agreement, Pfizer hereby grants to the MPP, and the MPP hereby accepts, a non-exclusive, sublicensable, royalty-free, fully-paid license under the Licensed IP to develop, make, have made, use, file for regulatory approval, sell, have sold, offer to sell, import and export Products in the Field in the Territory.
3. SUBLICENSES
3.1. Sublicensees. It is understood and agreed that MPP will not itself further develop and commercialize Compound or Products or exploit the Licensed IP, but it will do so through its Sublicensees without receiving compensation in exchange for such rights. MPP may grant Sublicenses, under the terms and conditions of this Agreement, to any entity which in the reasonable opinion of the MPP, based on reasonable diligence of MPP, has demonstrated willingness, capability, and capacity to develop and/or commercialize the Product(s) in the Field in a manner consistent with the goals of Accessibility as described in Section 3.3 herein. Each Sublicense will contain all the benefits to Pfizer stated herein including, inter alia, the disclaimers contained within Sections 6.3, 6.4, and 6.5 herein, the confidentiality requirements included in Article 5 herein, and shall require the Sublicensee to carry indemnification and insurance requirements as described in Article 7 herein. MPP shall provide Pfizer with a copy of all Sublicenses granted under this Agreement within 30 days of execution of each Sublicense and shall (a) refer to this Agreement and be subject to and subordinate to this Agreement; (b) the sublicense rights granted to each Sublicensee will be non- sublicensable and non-transferable; and (c) the Sublicense will not be royalty-bearing.
3.2. Development timelines. MPP will require any Sublicensee that intends to further develop the Compound into one or more Product(s) to agree upon reasonable diligence requirements and development milestones. MPP will require any Sublicensee that intends to commercialize the Product(s) to agree upon reasonable registration and commercialization timelines.
3.3. Accessibility. MPP will require that for any Sublicensee(s) that commercializes Product(s), the Sublicensee(s) do so in a manner that facilitates its widespread availability, which commercially reasonable efforts shall include adequate manufacturing capacity, adequate supply of product meeting specifications, registration of Product(s) with applicable local and global health authorities, participation in local tenders and making available to local policy makers information regarding the Product(s). MPP will require that such Sublicensee(s) use commercially reasonable efforts to ensure that the Product(s) be made available at Affordable Pricing as quickly as possible in sufficient quantities to meet the needs of TB patients throughout the world. “Affordable Pricing” as used herein shall mean the lowest sustainable, competitive price for the Product(s) which covers the cost of raw materials, manufacturing, distribution and operational overheads, and includes a reasonable margin to help ensure the economic sustainability of the production and distribution of the Product(s).
3.4. Quality. MPP will require that for any Sublicensee(s) that commercialize the Product(s), it will do so in a manner consistent with: (i) World Health Organization (“WHO”) pre-qualification standards; or (ii) the standards of any Stringent Regulatory Authority, as defined by the WHO. Where such approvals are not yet available, the Sublicensee(s) may obtain temporary approval through a WHO Expert Review Panel.
3.5. Limited License. The Parties acknowledge and agree that the scope of the license is limited to the Licensed IP and that Pfizer is not granting a right or license, express or implied, to MPP or to Sublicensee to any other patent right, copyright, trademark, trade name, trade dress, service mark or any other intellectual property right owned or controlled by Pfizer or any of its Affiliates.
3.6. No Technical Assistance. Pfizer will provide MPP with one copy of the Know-How. MPP acknowledges and agrees that Pfizer is not under any obligation to provide MPP or any Sublicensee with any technical assistance or documentation (other than the documents specifically identified as Know-How).
4. Obligations of MPP
4.1. Monitoring of Compliance. MPP agrees to monitor compliance by each Sublicensee, including but not limited by:
(a) reviewing with all reasonable skill and care any reports provided to MPP by the Sublicensee under the Sublicense; and
(b) assessing in relation to each applicable Sublicensee whether its progress in the development of Product(s) is in line with the milestones agreed pursuant to Section 3.2 of this Agreement;