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. Revisions to the July 1, 2009 PhRMA Code were effective January 2022.
Neurelis, Inc. is committed to conducting its business ethically and in accordance with all applicable laws. For purposes of compliance with the requirements of the California Compliance Law and as part of the Compliance Program, Neurelis, Inc. has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that Neurelis, Inc. may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis from January 1st to December 31st. Such items or activities primarily 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, and/or the OIG Compliance Guidance. 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 in this section of 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 cap amount.
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
- Items of nominal value with a retail value of less than $10 (e.g., visual aids, reprints of medical journal articles)
- Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition
ANNUAL DECLARATION OF COMPLIANCE (2022)
Based on a good faith understanding of the requirements of Section 119402 of the California Health & Safety Code, Neurelis, Inc. hereby declares that, to the best of its knowledge, its Comprehensive Compliance and Ethics Program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and PhRMA Code and limits on gifts and incentives to health professionals. Subject to the above, Neurelis, Inc. also hereby declares that it is, in all material respects, in compliance with its Comprehensive Compliance Program as of October 10, 2019.
The Office of the Inspector General has recognized in its Compliance Program Guidance for Pharmaceutical Manufacturers, that the implementation of an effective compliance program cannot ensure the elimination of improper conduct from a pharmaceutical manufacturer. By making this declaration, Neurelis, Inc. is not declaring that in all circumstances it can prevent individual employees from conduct that deviates from its policies. To the extent that any deviations are identified, we are committed to taking necessary and appropriate corrective action.
Copies of this Declaration and the Comprehensive Corporate Compliance and Ethics Program may be obtained by contacting the Chief Compliance Officer at firstname.lastname@example.org.
Version: January 1, 2022