Provision Language
4. SUBLICENSES
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4.9 Affordable Access Plan. Within three (3) months of receiving FDA (or its foreign equivalent’s) approval of a LICENSED PRODUCT, LICENSEE will provide the REGENTS with either (a) an Affordable Access Plan (defined below), or (b) a written explanation as to why such an Affordable Access Plan is not needed or infeasible. In the case of (b), LICENSEE agrees to discuss such reasoning with the REGENTS in good faith within one (1) month thereafter (“Initial Discussion”) and, if following such Initial Discussion the REGENTS concludes an Affordable Access Plan is reasonable and desired, to provide an Affordable Access Plan to the REGENTS within three (3) months of such Initial Discussion. The “Affordable Access Plan” means LICENSEE’S and/or its SUBLICENSEES’ plans (including strategies and timelines) reasonably intended to support affordable access in a) Low and Middle Income Countries as defined by the World Bank Group (“LMICs”), and b) vulnerable, underserved, and special needs populations in the U.S., as defined by the Department of Health and Human Services, such as through licensing or partnerships including with non-profit organizations. To the extent such Affordable Access Plan includes Proprietary Information, LICENSEE will also provide a non-confidential version or statement of such Plan that the REGENTS can make available to third parties:
(a) A specified set of LMICs in which the LICENSEE does not intend to commercialize the LICENSED PRODUCTS (the “Non-Commercialized Territory”);
(b) LICENSEE’S and/or its SUBLICENSEES’ plans (including strategies and timelines) reasonably intended to support affordable access in LMICs and Non-Commercialized Territories, such as through licensing or partnerships including with non-profit organizations; and
(c) LICENSEE’S and/or its SUBLICENSEE’ plans (including strategies and timelines) reasonably intended to support affordable access for the vulnerable, underserved and special needs populations in the U.S.
Within thirty (30) days of the REGENTS’ request (but no more often than once annually), LICENSEE agrees to confer with the REGENTS to review LICENSEE’S progress, and to consider in good faith any modifications suggested by the REGENTS, with respect to its Affordable Access Plan (“Progress Discussions”). For clarity, while the REGENTS may invite a designated entity to join either the Initial and/or Progress Discussions under this Paragraph 4.9, such discussions will at all times be made subject to the confidentiality obligations set forth in Article 25 (Confidentiality).