reglab/statecodes huggingface dataset:
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100144 - hES Cell Research That is Prohibited. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100145 - Obligations of Investigators and Institutions. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100146 - Establishment of an Institutional Embryonic Stem Cell Research Oversight Committee. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100147 - Procurement of Gametes, Blastocysts or Cells for hES Generation. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100148 - Derivation of hES Cell Lines. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100149 - Banking and Distribution of hES Cell Lines. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100150 - Research Use of hES Cell Lines. [Repealed]

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
1. New section
				  filed 7-24-2006 as an emergency; operative 7-24-2006 (Register 2006, No. 30). A
				  Certificate of Compliance must be transmitted to OAL by 11-21-2006 or emergency
				  language will be repealed by operation of law on the following
				  day.
2. Repealed by operation of Government Code section
				  11346.1(g)
				  (Register 2006, No. 47).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.35(b)(1)
					 and
					 125290.55,
					 Health and Safety Code.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100300 - Intellectual Property Requirements for Non-Profit Organizations - Scope

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The regulations of this chapter apply to all CIRM grant
				  awards issued on or after the effective date of these regulations. By accepting
				  a CIRM grant award, the grantee agrees to comply with the provisions of these
				  regulations. Any new or amended regulations adopted by the Independent
				  Citizen's Oversight Committee ("ICOC") will be applied to currently active
				  grants on the start date of the next non-competitive renewal period after the
				  effective date of the regulations. A currently active grant is a grant that is
				  still in the Project Period or a grant for which CIRM funds are still being
				  expended. New or amended regulations under this chapter adopted after the
				  expiration of the Project Period of a grant and after all CIRM funds for the
				  grant have been expended will apply on January 1 following the effective date
				  of the new or amended regulation, unless specified otherwise in the regulation.
				  Principal investigators, program directors and organizational officials with
				  active CIRM grants will receive notification of revised grant terms and
				  conditions or revised editions of the CIRM Grants Administration Policy as they
				  are released. In addition, all revisions to these regulations will be posted on
				  the CIRM website at
www.cirm.ca.gov
.
				  Failure by a principal investigator or other person affiliated with the grantee
				  to have notification of new or amended regulations, revised grant terms and
				  conditions, or revised editions of the Grants Administration Policy, shall not
				  excuse non-compliance as long as the CIRM has notified the
				  grantee.
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100302 - Invention Reporting Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) Grantee organizations are required to
				have written agreements with researchers requiring prompt disclosure of
				inventions made in the performance of CIRM-funded research.
(b) Within 60 days after an inventor
				discloses a CIRM-funded invention to a grantee organization, the grantee
				organization must notify CIRM of the 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 invention
				was made and the inventor(s). It 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 invention. The disclosure shall
				also identify whether a manuscript describing the invention has been submitted
				for publication. If so, the disclosure shall identify the publication to which
				the manuscript has been submitted and the submission date.
(c) Grantee organizations must notify CIRM on
				an annual basis regarding the filing of patent applications that claim
				inventions made in the performance of CIRM-funded research.
(d) Grantee organization must notify CIRM on
				an annual basis regarding execution of any licensing agreements of inventions
				made in the performance of CIRM-funded research.
(e) Grantee organizations must submit
				annually an Invention Utilization Report that lists all CIRM-funded inventions,
				patents claiming such inventions and a statement of efforts made to utilize
				CIRM-funded inventions. Such reports shall include information about the status
				of development, date of first commercial sale or use and all licensing fees
				and/or gross royalties received by the grantee organization under licenses of
				CIRM-funded patented inventions.
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100304 - Biomedical Materials

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
Grantees shall share biomedical materials first created under
				  CIRM funding and described in published scientific articles for research
				  purposes in California within 60 days of receipt of a request and without bias
				  as to the affiliation of the requestor unless legally precluded. Under special
				  circumstances, exceptions to the above are possible with approval by CIRM.
				  Alternatively, authors may provide requestors with information on how to
				  reconstruct or obtain the material. Such materials are to be shared without
				  cost or at the actual cost of providing the material without an allocation of
				  costs for overhead, research, discovery or other non-direct costs of providing
				  the material.
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100305 - Patent Applications

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				Grantee organizations shall bear responsibility for costs associated with
				patents and patent applications claiming their CIRM-funded inventions. This
				requirement shall not restrict the rights of Grantee Organizations to recover
				these costs through license fees or otherwise.
(b) Grantee organizations shall report
				pursuant to Code of California Regulations, Title 17, section
				100302, on an annual basis filings
				of such patent applications that claim inventions made in the performance of
				CIRM-funded research.
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100308 - Revenue Sharing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				Grantee organizations shall share a fraction of any net revenues with the
				inventor(s) in accordance with their established policies. Net revenues are
				defined as gross revenues minus the direct costs incurred in the generation and
				protection of the patents from which the revenues are received.
(b) The grantee organization may retain a
				threshold amount of its share (after payments to inventors) of any net revenues
				received under a license agreement or agreements of any CIRM-funded patented
				invention(s). Thereafter, the grantee organization shall pay 25% of its share
				after payments to inventors of such net revenues to the State of California for
				deposit into the State's General Fund unless such action violates any federal
				law. The threshold amount is $500,000 (in the aggregate) multiplied by a
				fraction, the denominator of which is the Consumer Price Index, All Urban
				Consumers, All Items (San Francisco-Oakland-San Jose; 1982-84=100) as prepared
				by the Bureau of Labor Statistics of the United States Department of Labor and
				published for the month of February, 2006, and the numerator of which is such
				Index published for the month in which the grant award is accepted by the
				grantee.
(c) If funding sources in
				addition to CIRM were used in the creation of a CIRM-funded patented invention,
				the return to the State of California of any resultant revenues shall be
				proportionate to the support provided by CIRM for the discovery of the
				invention.
(d) Grantees shall apply
				the grantee organization's share of any revenues earned as a result of
				CIRM-funded patented inventions to the support of scientific research or
				education.
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100309 - Press Release Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
CIRM grantees must notify CIRM prior to any press releases
				  that refer to research findings, collaborations, inventions, patents or
				  licensing activities that arise as a consequence of CIRM funding by contacting
				  the CIRM Communications Officer and the Scientific Program Officer. In the
				  event that the CIRM wishes to participate in a joint press release, the grantee
				  will coordinate with the CIRM Communications Officer.
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.
California Code of Regulations › Title 17 - Public Health › Division 4 - California Institute for Regenerative Medicine › Chapter 2 - Scientific and Medical Accountability Standards › Section 100310 - March-In Rights

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				With regard to CIRM-funded patented inventions, CIRM shall have the right to
				require the grantee organization, or exclusive licensee of a CIRM-funded
				invention, to grant a nonexclusive, partially exclusive, or exclusive license
				in any field of use to a responsible applicant or applicants, upon terms that
				are reasonable under the circumstances, and if the grantee organization, or
				exclusive licensee refuses such request, to grant such a license itself, if the
				CIRM determines that such an action is required:
(1) Because the grantee organization or the
				licensee has not made responsible efforts in a reasonable time to achieve
				practical application of a CIRM-funded patented invention;
(2) Because the licensee has failed to adhere
				to the agreed-upon plan for access to resultant therapies as described in
				subdivision (d) of Code of California Regulations, Title 17, section
				100306;
(3) To meet requirements for public use and
				the requirements have not been satisfied by the grantee organization or its
				licensee;
(4) To alleviate public
				health and safety needs which are not reasonably satisfied by the grantee
				organization or its licensee and which needs constitute a public health
				emergency.
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 100400 - Intellectual Property and Revenue Sharing Requirements for For-Profit Organizations - Scope

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The regulations of this chapter apply to all California
				  Institute for Regenerative Medicine ("CIRM") Grants issued to For-Profit
				  Organizations on or after the effective date of these regulations. By accepting
				  a CIRM Grant, the Grantee agrees to comply with these regulations. Any new or
				  amended regulations subsequently adopted by the Independent Citizens Oversight
				  Committee ("ICOC") will apply to Currently Active Grants on the start date of
				  the next noncompetitive renewal period after the effective date of the
				  regulations, except amendments to Title 17, California Code of Regulations,
				  sections 100406,
				  100407 and
				  100408, which shall only apply to
				  grants awarded after adoption of the new or amended regulations. CIRM will
				  notify a Grantee's Principal Investigator and Authorized Organizational
				  Official of the adoption of new or amended regulations. In addition, all
				  revisions to CIRM regulations will be posted on the CIRM website at
www.cirm.ca.gov
. Failure of actual notice
				  to a Grantee's Principal Investigator or Authorized Organizational Official
				  shall not excuse non-compliance with any regulation if CIRM has notified the
				  Grantee of the changes.
1. New chapter
				  4 (sections
				  100400-100410) and section filed
				  3-4-2008; operative 4-3-2008 (Register 2008, No.
				  10).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Section
					 125290.30,
					 Health and Safety Code.
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 100401 - Intellectual Property Regulations - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The following definitions apply to the regulations in this
				  chapter:
(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) CIRM-funded Patented Invention. An
				invention that has been patented under Title 35 of the United States Code, and
				that resulted wholly or in part from CIRM-funded Research, except in the event
				the patent has expired, been abandoned or found to be invalid or otherwise
				unenforceable (unless noted otherwise in these regulations).
(c) CIRM-funded Research. Research that has
				been funded in whole or in part by a CIRM Grant.
(d) Currently Active Grant. A Grant that is
				still in the Project Period, or that is outside the Project Period but CIRM
				funds are still being spent on the project, or the repayment of CIRM grant
				funds remains unsatisfied.
(e)
				Drug.
(1) An article recognized in the
				official United States Pharmacopoeia, Homoeopathic Pharmacopoeia of the United
				States, or National Formulary, or any supplement to any of them;
(2) an article intended for use in the
				diagnosis, cure, mitigation, treatment, or prevention of disease in man or
				other animals; or,
(3) an article
				intended for use as a component of any article specified in subdivision (1) or
				(2). This term includes therapeutic products such as blood, blood products,
				cells, and cell therapies.
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 100402 - Invention and Licensing Reporting Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A Grantee must annually report to CIRM all patenting and
				  Licensing Activities relating to CIRM-funded Research during and for 15 years
				  after the Project Period of the Grant as follows:
(a) A Grantee must report all patent
				applications filed with respect to any inventions arising out of CIRM-funded
				Research, including the application serial number(s), and detailed
				description(s) of the invention(s). These reports shall be marked confidential
				in accordance with Health and Safety Code section
				125290.30,
				subdivision (e)(2)(B).
(b) A
				Grantee must report the issuance or nonissuance of any patent applied for with
				respect to inventions arising out of CIRM-funded Research, including the patent
				number and date of issuance.
(c) At
				the time of filing of a patent application, a Grantee must report the
				percentage of support provided by CIRM and by all other sources of funding that
				contributed in whole or in part to the discovery of the CIRM-funded invention.
				CIRM may audit all such co-funding reports. This information shall be marked
				confidential in accordance with Health and Safety Code section
				125290.30,
				subdivision (e)(2)(B).
(d) A
				Grantee must report to CIRM the execution of any Licensing Agreement pertaining
				to CIRM-funded Patented Inventions. This information shall be marked
				confidential in accordance with Health and Safety Code section
				125290.30,
				subdivision (e)(2)(B).
(e) In the
				event that a CIRM-funded Patented Invention generates revenue (whether from a
				License Agreement or otherwise), a Grantee must report such revenue received
				during the preceding 12 month period or since the last report, whichever is
				longer. This information shall be marked confidential in accordance with Health
				and Safety Code 125290.30, subdivision (e)(2)(B).
(f) CIRM reserves the right to itself and its
				agents to conduct an audit of the Grantee to ensure compliance with this
				section and the Grantee agrees to maintain and provide such documentation as
				necessary to establish compliance.
1. New section
				  filed 3-4-2008; operative 4-3-2008 (Register 2008, No.
				  10).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Section
					 125290.30,
					 Health and Safety Code.
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 100404 - Publication-Related Biomedical Materials Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A Grantee shall share Publication-related
				Biomedical Material that results from CIRM-funded Research, for bona fide
				purposes of research in California. Such materials are to be shared without
				cost to the requestor or at the actual cost of providing the materials without
				an allocation of costs for overhead, research, discovery or other non-direct
				costs of providing the materials.
(b) A Grantee must share such materials
				within 60 days of receipt of a written request, without bias as to the
				affiliation of the requestor, unless otherwise prohibited by law.
(c) CIRM may approve alternatives to this
				sharing requirement on a showing that:
(1)
				the number of sharing requests has become financially onerous for the
				Grantee;
(2) a sharing request is
				in direct conflict with the business of the Grantee;
(3) the material or its transfer could pose a
				public health risk; or
(4) the
				request is otherwise inappropriate, as determined by CIRM.
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 100405 - Patents

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A Grantee shall bear the costs associated with any patent
				  application claiming any one or more inventions arising out of CIRM-funded
				  Research, any patent itself, and all costs of protecting such
				  patents.
1. New section
				  filed 3-4-2008; operative 4-3-2008 (Register 2008, No.
				  10).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Section
					 125290.30,
					 Health and Safety Code.
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 100407 - Access Requirements for Products Developed by For-Profit Grantees

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A Grantee (or,
				by terms of an Exclusive License, its exclusive licensee) must submit a plan to
				afford uninsured Californians access to a Drug, as defined in Title 17,
				California Code of Regulations, section
				100401, subdivision (e), the
				development of which was in whole or in part the result of CIRM-funded
				Research.
(1) A Grantee must submit this
				access plan to CIRM no fewer than 90 days prior to the time the Drug is
				commercialized in California, unless the agency agrees to shortened
				time.
(2) The access plan must be
				consistent with industry standards at the time of commercialization, accounting
				for the size of the market for the Drug and the resources of the Grantee or its
				exclusive licensee.
(3) The plan
				shall be subject to the approval of CIRM after a public hearing conducted by
				CIRM that provides for receipt of public comment.
(4) The Grantee or its exclusive licensee is
				responsible only for providing the Drug itself, not any costs of administering
				the Drug or other attendant care.
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 100408 - Revenue Sharing

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) A
				Grantee must share with the State of California a fraction of any Net Licensing
				Revenue it receives under a License Agreement for a CIRM-funded Patented
				Invention as follows:
(1) Subject to
				subdivision (a)(2) of this regulation, a Grantee must pay 25 percent of Net
				Licensing Revenue in excess of $500,000 to the State of California for deposit
				into the State's General Fund. The threshold amount of $500,000 (in the
				aggregate) shall be adjusted annually by a multiple of a fraction, the
				denominator of which is the Consumer Price Index, All Urban Consumers, All
				Items (San Francisco-Oakland-San Jose; 1982-84=100) as prepared by the Bureau
				of Labor Statistics of the United States Department of Labor and published for
				the month of December 2007, and the numerator of which is such Index published
				for the month in which the Grantee accepts the Grant.
(2) If funding sources other than CIRM
				(including those of the Grantee) contributed to the development of a
				CIRM-funded Patented Invention, then the return to the State of California on
				Net Licensing Revenue in excess of the threshold amount described in
				subdivision (a)(1) of this regulation shall be proportionate to the support
				provided by CIRM, as follows: The amount of CIRM funding of the patented
				invention shall be divided by the total of funding provided by all sources, and
				that fraction shall be multiplied by 25. That numeral is the percentage due to
				the State of California of Net Licensing Revenue.
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 100409 - Press Release Requirements

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
A Grantee must notify CIRM's communications officer at least
				  one day in advance of issuing any press release that refers to CIRM-funded
				  Research.
1. New section
				  filed 3-4-2008; operative 4-3-2008 (Register 2008, No.
				  10).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Section
					 125290.30,
					 Health and Safety Code.
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 100410 - March-In Rights

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a)
				CIRM may request that a Grantee or its exclusive licensee to enter into a
				nonexclusive, partially exclusive, or exclusive License Agreement with respect
				to a CIRM-funded Patented Invention and/or data generated in CIRM-funded
				Research, in any field of use with a responsible applicant or applicants, upon
				terms that are reasonable under the circumstances.
(b) If a Grantee or its exclusive licensee
				refuses CIRM's request to enter into a License Agreement to a CIRM-funded
				Patented Invention as provided by this regulation, CIRM shall have the right to
				enter into such a license with an applicant on behalf of the Grantee or its
				exclusive licensee (march in) if:
(1) the
				Grantee or its exclusive licensee has not made commercially reasonable efforts
				to achieve practical application of a CIRM-funded Patented Invention and/or
				CIRM-funded Research data, as applicable;
(2) the Grantee or its exclusive licensee has
				failed to provide or comply with a plan for access to a Drug in accordance with
				Title 17, California Code of Regulations, section
				100407;
(3) the Grantee or its exclusive licensee has
				failed to satisfy requirements for public use, including broad availability in
				California (for reasons other than price) in accordance with Title 17,
				California Code of Regulations, section
				100407;
(4) the Grantee or its exclusive licensee has
				unreasonably failed to use a CIRM-funded Patented Invention or CIRM-funded
				Research data to alleviate public health and safety needs that constitute a
				public health emergency as declared by the Governor.
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 100500 - Grants Administration Policy for Academic and Non-Profit Institutions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All recipients
				of a grant, loan or guarantee from the California Institute for Regenerative
				Medicine ("CIRM") who are academic or non-profit institutions agree to be bound
				by the terms and conditions of the CIRM Grants Administration Policy for
				Academic and Non-Profit Institutions (Rev. November, 2014) and incorporated
				herein by reference as identified below.
(b) The CIRM Grants Administration Policy for
				Academic and Non-Profit Institutions is incorporated by reference herein in its
				entirety as to Sections "II" through and including "VI" and Appendix. As to
				Section "I," only parts "I.B.," ("Abbreviations"), "I.C.," ("Glossary"), and
				"I.E.2." ("Roles and Responsibilities, Grantee Organization Staff") are
				incorporated by reference.
(c)
				Amendments to this regulation and the policy incorporated herein will be
				applied to already active grants on the start date of the next budget period
				after the effective date of this regulation's amendment.
(d) The CIRM's right to enforce the
				provisions of the policy incorporated herein shall survive the end of the term
				of the grant and, should CIRM no longer exist, those rights may be enforced by
				the State of California.
1. New section
				  filed 2-28-2007; operative 3-30-2007 (Register 2007, No. 9).
2.
				  Amendment of subsections (a) and (b) and amendment of the CIRM Grants
				  Administration Policy for Academic and Non-Profit Institutions (incorporated by
				  reference) filed 9-18-2009; operative 10-18-2009 (Register 2009, No.
				  38).
3. Amendment of subsection (a) filed 11-2-2012; operative
				  11-2-2012 pursuant to Government Code section
				  11343.4
				  (Register 2012, No. 44).
4. Amendment of subsection (a) filed
				  6-5-2015; operative 6-5-2015 pursuant to Government Code section
				  11343.4(b)(3)
				  (Register 2015, No. 23).
Note: Authority cited: California Constitution, article
					 XXXV; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.30(i),
					 125290.40,
					 125290.60
					 and
					 125292.10,
					 Health and Safety Code.
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 100501 - Grants Administration Policy for For-Profit Organizations

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) In addition to
				the provisions of Title 17, California Code of Regulations section
				100500, all for-profit recipients
				of a grant from the California Institute for Regenerative Medicine ("CIRM")
				agree to be bound by the terms and conditions of the CIRM Grant Administration
				Policy for For-Profit Organizations, as adopted by the Independent Citizens
				Oversight Committee and incorporated herein by reference as identified
				below.
(b) The CIRM Grant
				Administration Policy for For-Profit Organizations, dated November 3, 2008, is
				incorporated by reference herein in its entirety except for its
				"Preface."
(c) Amendments to this
				regulation (and the policy incorporated) herein will be applied to already
				active grants on the anniversary date of the Notice of Grant Award following
				the effective date of the regulation's amendment unless specified otherwise in
				the regulation or policy amendment.
(d) The CIRM's right to enforce the
				provisions of the policy incorporated herein shall survive the end of the term
				of the grant and, should CIRM no longer exist, those rights may be enforced by
				the State of California.
1. New section
				  filed 12-26-2008; operative 1-25-2009 (Register 2008, No.
				  52).
Note: Authority cited: California Constitution, article
					 XXXV; Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.30(i),
					 125290.40,
					 125290.60,
					 125290.70
					 and
					 125292.10,
					 Health and Safety Code.
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 100502 - Definition of "California Supplier"

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) As used in section
				125290.30(i) and
				in CIRM policies and regulations, "California supplier" means:
(1) any sole proprietorship, partnership,
				joint venture, corporation, or other business entity whose permanent, principal
				office or place of business from which the supplier's trade is directed or
				managed is located in California and which produces, builds, researches,
				develops or manufactures a product or service in California that is used for
				life science research, training, or facilities; or
(2) any sole proprietorship, partnership,
				joint venture, corporation, or other business entity that:
(A) employs at least one-third of its total
				employees in California; or
(B)
				includes a business unit, division or subsidiary whose permanent principal
				office or place of business from which the unit, division or subsidiary's trade
				is directed or managed is located in California, for the specific product or
				products that are sold by the unit, division or subsidiary to CIRM grantees;
				or
(C) sells, produces, builds, or
				manufactures a product or products in California for the specific product or
				products that are sold to CIRM grantees, so long as the supplier certifies that
				at least 50% of the cost of the product is attributable to activity undertaken
				in California; or
(3) any
				sole proprietorship, partnership, joint venture, corporation, affiliate or
				other business entity, including those owned by, or under common control with,
				a corporation, that either individually or as an aggregated group under common
				control:
(A) employs at least 800 California
				residents engaged in functions relating to or supporting products or services
				used for life science research, training, or facilities regardless of where its
				principal office or place of business is located; or
(B) employs 5,000 or more California
				residents.
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 100503 - Grants Administration Policy for Clinical Stage Projects

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All recipients
				of a grant, loan or guarantee from the California Institute for Regenerative
				Medicine ("CIRM") for Clinical Stage Projects (pursuant to Program
				Announcements PA 15-01, PA 15-02, and PA 15-03, incorporated by reference
				herein in their entirety, effective January 6, 2016) agree to be bound by the
				terms and conditions of the CIRM Grants Administration Policy for Clinical
				Stage Projects incorporated herein by reference as identified below.
(b) The CIRM Grants Administration Policy for
				Clinical Stage Projects (effective January 6, 2016) is incorporated by
				reference herein in its entirety as to Sections "II" through and including
				"VI". As to Section "I," only parts "I.B.," ("Abbreviations"), "I.C.,"
				("Defined Terms"), "I.D" ("Types of Support") and "I.E." ("Roles and
				Responsibilities") are incorporated by reference.
(c) Amendments to this regulation and the
				policy incorporated herein will be applied to already active grants on the
				start date of the next budget period after the effective date of this
				regulation's amendment.
(d) The
				CIRM's right to enforce the provisions of the policy incorporated herein shall
				survive the end of the term of the grant and, should CIRM no longer exist,
				those rights may be enforced by the State of California.
1. New section
				  filed 1-6-2016; operative 1-6-2016 pursuant to Government Code section
				  11343.4(b)(3)
				  (Register 2016, No. 2).
Note: Authority cited: California Constitution, article
					 XXXV; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.30,
					 125290.40,
					 125290.60
					 and
					 125292.10,
					 Health and Safety Code.
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 100504 - Grants Administration Policy for Discovery, Translation and Education Projects

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
(a) All
				recipients of a grant, loan or guarantee from the California Institute for
				Regenerative Medicine ("CIRM") for Discovery, Translation and Education
				Projects agree to be bound by the terms and conditions of the CIRM Grants
				Administration Policy for Discovery, Translation and Education Projects,
				adopted September 2016, incorporated herein by reference as identified
				below.
(b) The CIRM Grants
				Administration Policy for Discovery, Translation and Education Projects is
				incorporated by reference herein in its entirety as to Sections "II" through
				and including "VI". As to Section "I," only parts "I.B.," ("Abbreviations"),
				"I.C.," ("Defined Terms"), "I.D" ("Types of Support") and "I.E." ("Roles and
				Responsibilities") are incorporated by reference.
(c) Amendments to this regulation and the
				policy incorporated herein will be applied to already active grants on the
				start date of the next budget period after the effective date of this
				regulation's amendment.
(d) The
				CIRM's right to enforce the provisions of the policy incorporated herein shall
				survive the end of the term of the grant and, should CIRM no longer exist,
				those rights may be enforced by the State of California.
1. New section
				  filed 12-5-2016; operative 12-5-2016 pursuant to Government Code section
				  11343.4(b)(3)
				  (Register 2016, No. 50).
Note: Authority cited: California Constitution, article
					 XXXV; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Sections
					 125290.30,
					 125290.40,
					 125290.60
					 and
					 125292.10,
					 Health and Safety Code.
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 100600 - Intellectual Property and Revenue Sharing Requirements for Non-Profit and For-Profit Grantees - Scope

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The regulations of this chapter apply to all California
				  Institute for Regenerative Medicine ("CIRM") Grants awarded to Non-Profit and
				  For-Profit Grantees on or after the effective date of these regulations. By
				  accepting a CIRM Grant, the Grantee agrees to comply with these regulations.
				  Any new or amended regulations of this Chapter subsequently adopted by the
				  Independent Citizens Oversight Committee ("ICOC") will apply to CIRM-Funded
				  Project(s) or Activities on the start date of the next Budget Period after the
				  effective date of the regulations. Notwithstanding the foregoing sentence,
				  amendments to Title 17, California Code of Regulations, sections
				  100606,
				  100607 and
				  100608, shall only apply to Grants
				  awarded after adoption of the new or amended regulations unless the parties
				  agree the amendments shall apply to existing Grants. All revisions to CIRM
				  regulations will be posted on the CIRM website at
www.cirm.ca.gov
, which shall serve as notice to
				  the Grantee or Authorized Organization Official of such
				  revisions.
1. New chapter
				  6 (sections
				  100600-100611) and section filed
				  12-17-2009; operative 12-17-2009 pursuant to Government Code section
				  11343.4
				  (Register 2009, No. 51). For prior history, see Register 2007, No.
				  26.
2. Amendment filed 1-27-2014; operative 1-27-2014 pursuant to
				  Government Code section
				  11343.4(b)(3)
				  (Register 2014, No. 5).
Note: Authority cited: Article XXXV, California
					 Constitution; and Section
					 125290.40(j),
					 Health and Safety Code. Reference: Section
					 125290.30,
					 Health and Safety Code.
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 100601 - Intellectual Property Regulations - Definitions

Current through Register 2024 Notice Reg. No. 28, July 12, 2024
The following definitions apply to the regulations in this
				  chapter:
(a) Authorized Organizational
				Official. The individual, named by the applicant organization, who is
				authorized to act for the applicant organization and to assume the obligations
				imposed by the laws, regulations, requirements, and conditions that apply to
				applications and awards.
(b) Budget
				Period. The intervals of time (usually 12 months) into which a Project Period
				is divided for budgetary funding and reporting purposes as specified in the
				relevant NGA.
(c) CIRM-Funded
				Invention. An Invention, whether patentable or not, which arises from
				CIRM-Funded Research and is either:
(1)
				reduced to practice by a Grantee, Grantee Personnel and/or its Collaborator(s)
				during a CIRM-Funded Project or Activity; or
(2) conceived during a CIRM-Funded Project or
				Activity and reduced to practice by a Grantee, Grantee Personnel and/or its
				Collaborator(s) during a CIRM-Funded Project or Activity or within 12 months of
				the close of the Grant.