Provision Language
Whereas, MICHIGAN, which has as a goal to maximize the positive societal impact of research discoveries from its laboratories and to collaborate with industry partners to bring these discoveries to broad public adoption, in which MICHIGAN has allowed the LICENSEE the flexibility to develop its own plans for technical and commercial development of MICHIGAN’s PATENT RIGHTS, in accordance with the terms set forth.
ARTICLE 4 – REPORTS
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4.7 LICENSEE shall provide to MICHIGAN an Affordable Access Plan of the scope set forth in this Section 4.7 within three (3) months after the first marketing approval of a LICENSED PRODUCT received by LICENSEE or a SUBLICENSEE from the U.S. Food and Drug Administration or the European Medicines Agency. LICENSEE agrees to use reasonable efforts to make progress toward completing the plans stated in the Affordable Access Plan, as it may be amended from time-to-time.
(a) “Affordable Access Plan” means a written statement setting forth: (a) the specific LMICs in which neither LICENSEE nor any SUBLICENSEE intends to commercialize the LICENSED PRODUCTS (the “Non-Commercialized Territories”); (b) actions to be taken by LICENSEE and, if applicable, SUBLICENSEE(s) that reasonably intended to support affordable access in the Non-Commercialized Territories by patients to products that would constitute LICENSED PRODUCTS if covered by one or more of the PATENT RIGHTS; and (c) actions to be taken by LICENSEE and, if applicable, SUBLICENSEE(s) that are reasonably intended to support affordable access for the vulnerable, underserved and special needs populations in the U.S. Such actions, as referred to above, shall at a minimum include strategies, such as licensing or partnerships (which may include, for example, partnerships with non-profit organizations), and timelines therefor. As used herein, “LMICs” means Low and Middle Income Countries as the term is defined and/or used by the World Bank Group, its primary recognized member organizations, and/or successor of any of the foregoing. Upon LICENSEE’s request, MICHIGAN agrees to meet with LICENSEE to assist in the drafting of the Affordable Access
Plan.
(b) Notwithstanding the foregoing, in lieu of providing an Affordable Access Plan, LICENSEE may instead submit a reasonably detailed written explanation as to why LICENSEE believes that an Affordable Access Plan is unreasonable or infeasible (the “Infeasibility Statement”), which is due on the same date that the Affordable Access Plan would have been due. After LICENSEE submits an Infeasibility Statement to MICHIGAN, LICENSEE agrees to promptly (but in no event less than two months thereafter) meet with MICHIGAN in person or by video conference to discuss the Infeasibility Statement (the “Initial Discussion”). If, following such meeting, MICHIGAN concludes that the Affordable Access Plan requirements of this Agreement are reasonable and desirable, LICENSEE shall nevertheless provide an Affordable Access Plan to MICHIGAN within three (3) months after MICHIGAN’S written request following the Initial Discussion (and, for clarity, the remaining provisions relating to the Affordable Access Plan shall apply).
(c) If LICENSEE fails to follow any plan, take any action, or meet any milestone by a deadline that is specifically or generally stated in the Affordable Access Plan, it shall promptly and in good faith negotiate an amended Affordable Access Plan with MICHIGAN. In addition, within thirty (30) days after a request by MICHIGAN (but not to be requested any more than once in any calendar year), LICENSEE agrees to confer with MICHIGAN in good faith to review LICENSEE’s progress, and to consider in good faith any reasonable modifications suggested by MICHIGAN concerning LICENSEE’s Affordable Access Plan (“Progress Discussion”). MICHIGAN may invite a designated entity to join either the Initial Discussion or Progress Discussion, provided that such discussions shall at all times be made subject to the confidentiality obligations of this Agreement (or another mutually agreed-upon nondisclosure agreement).