California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 4 - Intellectual Property and Revenue Sharing Requirements for for-Profit Organizations › Section 100406 - Licensing CIRM-Funded Patented Inventions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A Grantee bears responsibility for
				Licensing Activities including identification of potential licensees,
				negotiation of license agreements, and documentation of the progress and
				execution of development under a License Agreement of a CIRM-funded Patented
				Invention. A Grantee must submit an annual report of these Licensing Activities
				as described in Title 17, California Code of Regulations, section
				100402.
(b) If a Grantee elects not to develop a
				CIRM-funded Patented Invention itself, then it shall make commercially
				reasonable efforts to negotiate non-exclusive licenses for third party
				development of such inventions, unless doing so would put the Grantee at a
				competitive disadvantage with a competitor.
(c) A Grantee may negotiate an Exclusive
				License if exclusivity is reasonably believed by Grantee to be an economic
				incentive necessary to achieve commercial development and availability of the
				invention.
(1) A Grantee must document the
				development and commercialization capabilities of any intended exclusive
				licensee prior to entering into an Exclusive License.
(2) A Grantee must include in any Exclusive
				License terms addressing all reasonably anticipated therapeutic and diagnostic
				uses for the invention.
(3) A
				Grantee must include in any Exclusive License terms including:
(A) a commercial development plan to bring
				the invention to practical application, including milestones and benchmarks, so
				that the progress of development can be assessed and monitored;
(B) explicit remedies for failure to develop,
				including modification or termination of an Exclusive License in the event that
				a licensee is unable to fully develop the rights granted; and
(C) explicit grounds for modification or
				termination, such as failure to use commercially reasonable efforts to meet
				agreed-upon milestones or benchmarks, failure to negotiate in good faith
				alternative milestones or benchmarks, and failure to provide access as provided
				in subdivision (c)(5).
(4) A Grantee may negotiate an Exclusive
				License for a CIRM-funded Patented Invention that is required for
				commercialization of a Drug, as defined in Title 17, California Code of
				Regulations, section
				100401, subdivision (e), only if
				the licensee agrees to abide by the provisions of Title 17, California Code of
				Regulations, section
				100407.
(5) A Grantee must monitor and annually
				report to CIRM the performance of an exclusive licensee to ensure that the
				licensee develops the invention according to the milestones and benchmarks of
				the commercial development plan.
(6) A Grantee must take commercially
				reasonable action to enforce the terms of an Exclusive License and must
				promptly report any material breach of an Exclusive License to the CIRM
				scientific program officer.