California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100301 - Intellectual Property Regulations - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) "Authorized Organizational Official." The
				individual, named by the applicant organization, who is authorized to execute
				agreements that legally bind the applicant institution to assume the
				obligations imposed by the laws, regulations, requirements, and conditions that
				apply to grant applications or grant awards.
(b) "Award." The provision of funds by CIRM,
				based on an approved application and budget or progress report, to an
				organizational entity or an individual to carry out a project or
				activity.
(c) "Bayh-Dole Act."
				Section 6(a) of the
				federal Patent and Trademark Law Amendments Act as amended (35 U.S.C. §§
										200-212).
(d) "Biomedical Materials." Entities of
				biomedical relevance first produced as a consequence of CIRM-funded scientific
				research including but not limited to unique research resources such as
				synthetic compounds, organisms, cell lines, viruses, cell products, cloned DNA,
				as well as DNA sequences, mapping information, crystallographic coordinates,
				and spectroscopic data. Specific examples include specialized and/or
				genetically defined cells, including normal and diseased human cells,
				monoclonal antibodies, hybridoma cell lines, microbial cells and products,
				viruses and viral products, recombinant nucleic acid molecules, DNA probes,
				nucleic acid and protein sequences, certain types of animals including
				transgenic mice and other property such as computer programs.
(e) "Data." The recorded factual material
				commonly accepted in the scientific community as necessary to validate research
				findings, but not any of the following: preliminary analyses, drafts of
				scientific papers, plans for future research, peer reviews, or communications
				with colleagues. This "recorded" material excludes physical objects (e.g.,
				laboratory samples).
(f) "Exclusive
				License." Any License Agreement for a CIRM-funded patented invention that
				permits the licensee to exclusively exercise any commercial right within the
				state of California or the United States, or within any field of use, or for
				any licensed product or licensed purpose.
(g) "Grantee/Grantee Organization." The
				non-profit organization awarded a grant by CIRM that is legally responsible and
				accountable for the use of the funds provided and for the performance of the
				grant-supported project or activity. The grantee is the entire legal entity
				even if a particular component is designated in the Notice of Grant Award
				("NGA"). All University of California grantee campuses shall be considered as
				separate and individual Grantee Organizations.
(h) "Grantee Organization's Share." The
				revenues received by a Grantee Organization under a commercial license of a
				CIRM-funded patented invention remaining after deducting the direct costs
				associated with patents and patent applications claiming inventions made under
				CIRM funding and the inventor's share of those revenues.
(i) "Invention." A discovery that is or may
				be patentable (novel, useful and non-obvious) or otherwise protectable under
				Title 35 of the United States Code.
(j) "Invention Disclosure." A description of
				an invention that, if made public, would trigger a patent bar under U.S. Patent
				Law.
(k) "Invention Disclosure
				Form." A written notification to CIRM that a CIRM-funded patentable invention
				has been made.
(l) "Invention
				Utilization Report." Applicable to Grantee Organizations that have previously
				filed an Invention Disclosure Form, this annual report is a written description
				of efforts made by authorized organizational officials to commercialize
				CIRM-funded patentable inventions. This report will include information about
				the status of development, date of first commercial sale or use and any
				licensing fees and/or gross royalties received by the Grantee Organization
				relating to CIRM-funded patented inventions.
(m) "Inventor." A person who thinks of,
				finds, discovers, or creates an invention during the project period of a CIRM
				grant and using CIRM funds as determined under U.S. Patent Law.
(n) "License Agreement." An agreement by
				which a patent owner allows another party to make, use, sell, offer to sell,
				and/or import an invention protected by a patent.
(o) "Licensing Activities." Actions taken by
				authorized organizational officials, the desired outcome of which is a
				contractual agreement under which the Grantee Organization grants permission to
				another party to use intellectual property under specific conditions.
(p) "Licensing Fee." A one-time cost payable
				by a licensee to the patent owner typically associated with execution of a
				license agreement.
(q) "Materials
				Transfer Agreement." A document ("MTA") which governs the exchange of a
				substance, element or item (material) to another party for the purposes of
				research. It limits the commercial exploitation of the material without the
				permission of the provider party.
(r) "No-Cost License." An agreement to
				practice an invention protected by a patent where no licensing fee, royalty or
				any other payment is required of the licensee.
(s) "Non-Profit Organization." A (1)
				university or other institution of higher education or another organization of
				the type described in 501(c)(3) of the Internal Revenue Code of 1986, as
				amended (26 U.S.C.
				501(c)(3)) and is exempt
				from taxation under 501(a) of the Internal Revenue Code (26 U.S.C.
				501(a)), or (2) any other
				non-profit scientific or educational organization qualified under a state
				non-profit organization statute whose organizational charter provides that (A)
				the organization is not organized or operated for the private gain of any
				person, (B) no part of the organization's net income or assets shall inure to
				the benefit of any person, and (C) the organization's net assets upon
				dissolution shall be distributed to a non-profit fund, foundation or
				corporation which is organized and operated exclusively for charitable
				purposes.
(t) "Notice of Grant
				Award." ("NGA") The document that notifies the grantee and others that an award
				has been made, contains or references all terms and conditions of the award,
				and documents the obligation of CIRM funds.
(u) "Patentable Invention." A novel, useful
				and non-obvious invention that advances science and enables new useful
				applications including therapeutics or diagnostic tools, as determined under
				relevant patent law.
(v) "Person."
				A "person" means an individual, proprietorship, firm, partnership, joint
				venture, syndicate, business trust, company, corporation, limited liability
				company, association, or any other organization or group of persons acting in
				concert.
(w) "Principal
				Investigator/Program Director." The principal investigator ("PI") or program
				director ("PD") is an individual designated by the grantee to direct the
				project or activity being supported by the grant. He or she is responsible and
				accountable to the grantee and CIRM for the proper conduct of the project or
				activity. For training programs or similarly structured programs, the PD is the
				same as the PI.
(x) "Project
				period." The total amount of time for which CIRM promises to fund a grant and
				authorizes a grantee to conduct the approved work of the project described in
				the application.
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.