California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 6 - Intellectual Property and Revenue Sharing Requirements for Non-Profit and for-Profit Grantees › Section 100602 - Invention and Licensing Reporting Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Prior to an NGA and continuing 12 months
				after the close of a Grant, a Grantee must have written agreements with Grantee
				Personnel and Collaborators requiring prompt disclosure to the Grantee of any
				CIRM-Funded Invention.
(b) Within
				60 calendar days after a CIRM-Funded Invention has been disclosed to a Grantee,
				the Grantee must notify CIRM of the CIRM-Funded Invention through the use of
				the CIRM Invention Disclosure Form, which will be received in confidence by
				CIRM. The Invention Disclosure Form shall identify the Grant under which the
				CIRM-Funded Invention was made, the Inventor(s) and the Principle Investigator.
				The Disclosure shall be sufficiently complete in technical detail to convey a
				clear understanding, to the extent known at the time of the disclosure, of the
				nature, purpose, operation, and physical, chemical, biological or electrical
				characteristics of the CIRM-Funded Invention. If the CIRM-Funded Invention has
				been submitted for publication or presentation, then the Disclosure shall
				identify the publication, the date of the abstract or manuscript or
				presentation, the submission date and if relevant any publication dates,
				including publication via the internet.
(c) Within 90 calendar days after a Grantee
				executes a License Agreement (exclusive or non-exclusive) conveying rights in
				CIRM-Funded Inventions or CIRM-Funded Technology, a Grantee shall notify CIRM
				of the execution of such agreement(s) and submit to CIRM a copy of those parts
				of the agreement that address license revenue, including but not limited to
				upfront and milestone payments, royalties, income and equity. The notification
				and disclosures made pursuant to this subdivision by a Grantee may be made
				without identifying the licensee, and shall be marked "Confidential" in
				accordance with Health and Safety Code section
				125290.30,
				subdivision (g)(2)(B). In lieu of the disclosure process described in this
				subdivision, CIRM and a Grantee may agree to an alternative method of conveying
				the information described in this subdivision.
(d) A Grantee must submit annually to CIRM
				during, and for 15 years after, the Project Period of the Grant, an Invention
				Utilization Report containing the following information:
(1) Grantees must report all patent
				applications filed which claim, or cite to publications concerning, CIRM-Funded
				Inventions, including the countries in which application(s) were filed,
				application serial number(s), status and detailed description(s) of the
				CIRM-Funded Invention(s); and
(2)
				Grantees must report the issuance or abandonment of any patent applied for that
				claims, or cites to publications concerning, CIRM-Funded Invention, including
				the patent number and date of issuance or abandonment and the countries in
				which the applications have issued or have been abandoned; and
(3) Grantees must report the total funding
				from all sources that directly contributed to a CIRM-Funded Invention disclosed
				or claimed in the patent application, including each co-funder's identity, the
				dollar amounts each contributed and the dates of contribution. CIRM may audit
				all such co-funding reports; and
(4) A Grantee must report to CIRM the
				execution of all Material Transfer Agreements or Collaborative Agreements
				conveying rights in CIRM-Funded Inventions or CIRM-Funded Technology;
				and
(5) In the event that a
				CIRM-Funded Invention or CIRM-Funded Technology generates revenue or other
				consideration (whether from a License Agreement or otherwise), a Grantee must
				report such revenue or consideration received during the preceding 12 month
				period or since the last report, whichever is longer.
(6) A Grantee must report the following key
				progress toward commercialization of a CIRM-Funded Invention or CIRM-Funded
				Technology including the following:
(A)
				Initiation of clinical testing;
(B)
				Initiation of pivotal studies; and
(C) Application for marketing
				approval.
(7) Grantee
				shall have written agreements with its Grantee Personnel, Collaborators,
				licensees and transferees requiring such third parties to report to the Grantee
				information described in this subdivision (c).