RESPONSIBILITY
Nuvation Bio’s Statement Regarding Compliance with California Health & Safety Codes §§ 119400-119402
California Health & Safety Code, Sections 119400–119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code.
Nuvation Bio (“Nuvation”) has established a Compliance Program in accordance with the OIG Compliance Guidance and has policies in place to foster compliance with the PhRMA Code. Nuvation has updated its policies and procedures to comply with the most recent PhRMA Code revisions, effective January 1, 2022. For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Nuvation has established a specific annual aggregate dollar limit of $2,000 on gifts, promotional materials, and items or activities to give or provide to an individual healthcare professional in California on an annual basis from January 1st to December 31st.
Such items or activities may include medical textbooks and other items that principally entail a patient benefit or are related to the healthcare professional’s practice; modest meals associated with a substantive discussion of a Company product or a disease state; and other items or activities permitted under the PhRMA Code. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for healthcare professionals to assist in making clinical or other medical judgments.
This limit may be revised from time to time, in which case the revised limit will be published on the Company website. This limit represents a spending cap, not a goal or average. In many cases, the amount spent per physician may be substantially less than the dollar cap. The Company has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and as part of Nuvation’s Compliance Program aimed at continuous improvement. Our monitoring processes and other elements of the Compliance Program are updated as appropriate.
The annual limits do not include the following:
- Drug samples given to physicians and healthcare professionals
- Financial support for continuing medical education forums
- Financial support for health educational scholarships
- Payments for legitimate professional services, and any meals or expenses associated with the provision of such services
Annual Declaration for 2025
Nuvation’s Compliance Program was developed with consideration given both to the goals of sections 119400-119402 of the California Health and Safety Code and to the operations, size, and organization of the Company. Based upon our good faith understanding of these statutory requirements, we believe we are in compliance in all material respects with our Compliance Program and the requirements of the California Health and Safety Code. For a written copy of the Compliance Program description or this declaration, please call 1-332-208-6102.