Halozyme Therapeutics, Inc. Annual Declaration pursuant to the California Health and Safety Code§§ 119400 -119402 (CA Senate Bill 1765)
Sections 119400-119402 of the California Health & Safety Code (“California Compliance Law”) requires a pharmaceutical company to adopt a Comprehensive Compliance Program that is in accordance with the U.S. Department of Health and Human Services, Office of Inspector General’s (“OIG”) “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”), and the PhRMA Code on Interactions with Healthcare Providers and any updates or revisions thereto (“PhRMA Code”). Further, the California Compliance Law requires that the Comprehensive Compliance Program include an annual limit for certain gifts or incentives given to healthcare professionals covered by the California Compliance Law. Finally, the California Compliance Law requires that each manufacturer make its Comprehensive Compliance Program and an annual declaration of compliance publicly available.
Halozyme Therapeutics, Inc. (“Halozyme”) has invested significant time and resources to the development of its policies, procedures and processes that make up its Comprehensive Compliance Program (the “Program”). In addition, the Program is intended to address the elements of an effective compliance program in accordance with the OIG Compliance Guidance and include policies for complying with the PhRMA Code. For purposes of compliance with the requirements of the California Compliance Law, the Program also includes an annual spend limit of $2,000 for gifts or incentives provided to healthcare professionals in California. The annual limit incudes the value of educational items, promotional materials and meals provided to healthcare professional in connection with business and educational discussions. The annual limits do not include the following: (a) drug samples given to physicians and healthcare professionals intended for free distribution to patients, financial support for continuing medical education forums, and financial support for health educational scholarships, provided that the support is provided in a manner that conforms to the OIG Compliance Guidance and the PhRMA Code, and (b) fair market value payments made for legitimate professional services provided by a health care or medical professional, including, but not limited to, consulting, provided that those payments are provided in a manner that conforms to the OIG Compliance Guidance and the PhRMA Code. This annual limit represents a spending cap and not a goal or average.
As stated in its Program description above, Halozyme is committed to conducting its business ethically and in compliance with all applicable laws. To the best of Halozyme’s knowledge, Halozyme believes it is in substantial compliance with its Compliance Program and in its good faith understanding of the requirements of the California law. Halozyme will update this declaration on an annual basis, as necessary.
Anyone wishing to obtain a copy of Halozyme’s Corporate Compliance Program Overview, the Code of Conduct or a copy of this Declaration can call 858.794.8889 or email firstname.lastname@example.org.