California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100306 - Licensing CIRM-Funded Patented Inventions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A Grantee Organization shall assume
				responsibility for licensing activities including identification of potential
				licensees, negotiation of license agreements and documentation of development
				progress for licenses relating to CIRM-funded patented inventions. In licensing
				CIRM-funded patented inventions, a Grantee Organizations agrees that it shall
				retain the right to practice the use of its CIRM-funded patented inventions for
				its non-commercial purposes. A Grantee Organization agrees to make its
				CIRM-funded patented inventions readily accessible on reasonable terms,
				directly or through a licensee or licensees, to other Grantee Organizations for
				non-commercial purposes, upon request from a Grantee Organization. Grantee
				organizations are required to submit an Invention Utilization Report relevant
				to CIRM-funded patented inventions on an annual basis.
(b) Grantee organizations shall negotiate
				non-exclusive licenses of CIRM-funded inventions whenever possible.
				Nevertheless, grantee organizations may negotiate and award exclusive licenses
				for CIRM-funded inventions if such licenses are necessary to provide economic
				incentives required to enable commercial development and availability of the
				inventions. In due diligence relating to such exclusive licenses, grantee
				organizations shall document development and commercialization capabilities of
				the intended licensee, and include terms in the license agreement addressing
				all relevant therapeutic and diagnostic uses for which the invention is
				applicable and the licensee agrees to diligently develop.
(c) In exclusive license agreements, grantee
				organizations shall include terms for commercial development plans to bring the
				invention to practical application. Such provisions shall include commercial
				development milestones and benchmarks so that development can be assessed and
				monitored.
(d) Grantee
				organizations shall grant exclusive licenses involving CIRM-funded patented
				inventions relevant to therapies and diagnostics only to persons that agree to
				have a plan in place at the time of commercialization to provide access to
				resultant therapies and diagnostics for uninsured California patients. In
				addition, such licensees will agree to provide drugs at prices negotiated
				pursuant to the California Discount Prescription Drug Program (commencing with
				California Health and Safety Code section
				130500,
				et seq.) to eligible Californians under that program. This regulation is not
				intended, and this regulation shall not be construed, to preempt any other
				requirement under state or federal law or regulation that would otherwise
				require provision of drugs at a lower price than provided hereunder. The CIRM
				may make access plans available for review by the ICOC on an annual
				basis.
(e) Grantee organizations
				shall monitor the performance of exclusive licensees of CIRM-funded patented
				inventions to ensure that the licensed invention is developed in a timely
				fashion. Remedies for failure to develop may include modification or
				termination of a license by the grantee in the event that a licensee is unable
				to fully develop the rights granted.
(f) Grantee organizations shall negotiate
				relevant and specific grounds for modification or termination of the license.
				Examples would include failure to meet agreed-upon commercialization
				benchmarks, failure to keep the licensed invention reasonably accessible to the
				public for research purposes, and failure to reasonably meet the agreed-upon
				plan for access to resultant therapies as described in subdivision (d) of this
				regulation.
(g) Grantee
				organizations shall monitor the commercial development activities of the
				licensees to determine compliance with the terms of the license agreement and
				include reports of monitoring activities annually to the CIRM.
(h) Grantee organizations shall take
				administrative action to modify or terminate license rights where necessary and
				report such action to the CIRM.
1. New section
				  filed 6-14-2007; operative 7-14-2007 (Register 2007, No.
				  24).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Section
					 125290.30,
					 Health and Safety Code.