The intellectual property standards that the ICOC develops shall include:
(a) A requirement that each grantee or the exclusive licensee of the grantee submit a plan to CIRM to afford access to any drug that is, in whole or in part, the result of research funded by CIRM to Californians who have no other means to purchase the drug. The access plan must be consistent with industry standards at the time of commercialization in California, accounting for the size of the market for the drug, and the resources of the grantee or exclusive licensee.
(b) A requirement that the grantee or exclusive licensee either submit the plan required by subdivision (a), seek an extension from CIRM, or notify CIRM of its intention to seek a waiver, within 10 business days following final approval of the drug by the federal Food and Drug Administration. If the grantee seeks an extension, the plan must be submitted within 30 business days following final approval of the drug by the federal Food and Drug Administration. The plan shall be subject to the approval of CIRM, after a public hearing and opportunity for public comment.
(c) A process by which the ICOC may waive the requirement in subdivision (a) if the ICOC determines, after a public hearing, that in the absence of the waiver, development and broad delivery of the drug will be unreasonably hindered or that the waiver will provide significant benefits that equal or exceed the benefits that would otherwise flow to the state pursuant to subdivision (a). The process shall include the requirement that a request for a waiver shall be posted on CIRM’s Internet Web site for a minimum of 10 business days in advance of the public hearing and that CIRM shall notify the Legislature if the ICOC grants a waiver request, including the reasons that justified the waiver request.
(d) Procedures to protect from public disclosure proprietary information submitted by grantees and exclusive licensees to CIRM pursuant to this section.
(Added by Stats. 2010, Ch. 637, Sec. 8. (SB 1064) Effective January 1, 2011.)
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