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. 12, March 22, 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.
(b) A Grantee (or its exclusive licensee) must provide a Drug, the development of which was in whole or in part the result of CIRM-funded Research, at a price as provided in the California Discount Prescription Drug Program (commencing with California Health and Safety Code section 130500) (or a successor statewide prescription drug discount program) to eligible Californians under this program.
(c) A Grantee or its exclusive licensee must sell a Drug, the development of which is in whole or in part the result of CIRM-funded Research, and which is purchased in California with Public Funds (as defined in Title 17, California Code of Regulations, section 100401, subdivision (q)) at any benchmark price described in the California Discount Prescription Drug Program or a successor statewide prescription drug discount program.
(d) This regulation is not intended, and this regulation shall not be construed, to preempt or prevent any other requirement under state or federal law or regulation, or agreement or contract, that would result in selling a Drug at a lower price than provided hereunder.
1. New section
filed 3-4-2008; operative 4-3-2008 (Register 2008, No. 10).
2.
Amendment of subsections (a)(1)-(3) filed 10-30-2008; operative 11-29-2008
(Register 2008, No. 44).
Note: Authority cited: Article XXXV, California Constitution; and Section 125290.40(j), Health and Safety Code. Reference: Section 125290.30, Health and Safety Code.