NOTICE: This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and also to provide annual written declaration of their adherence to the requirements of the Compliance Program.
California Health & Safety Code, Section 119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a “Comprehensive Compliance Program” in accordance with the requirements set forth in the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”) published by the United States Department of Health and Human Services Office of Inspector General (“OIG”). Further, the California Compliance Law requires manufacturers to include in their Comprehensive Compliance Program policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”). The California Compliance Law further states that companies shall institute limits on gifts and incentives to health care professionals and also requires that companies declare annually, in writing, their compliance with their Comprehensive Compliance Program as well as the requirements of the California Compliance Code. Companies are also required to make available to the public both their annual declaration and the provisions of their Comprehensive Compliance Program via their website and a toll-free telephone number.
Pharmacosmos Therapeutics Inc. (“PTI” or the “Company”) has established a Comprehensive Compliance Program in accordance with the OIG Guidance and also has put in place policies to foster compliance with the requirements of the PhRMA Code. As part of its Comprehensive Compliance Program, PTI does not permit the provision of gifts to medical or healthcare professionals. In addition, PTI has established a specific annual aggregate dollar limit of [$2,000] on promotional materials, items, or activities that PTI may provide to an individual medical or healthcare professional in California. This amount does not include the value of pharmaceutical drug samples, grants for medical education, medical scholarships, professional service or consulting fees, patient education materials, and approved scientific reprints. This limit may be revised by PTI from time to time. The foregoing limit does not represent a usual, customary, average or typical amount for medical or health care professionals. This annual aggregate limit is based on an estimate of the maximum value of promotional materials and other items or activities as defined herein that a California medical or health care professional may receive in one year.
Annual Declaration (June 2021)
As stated in its Compliance Program, the Company is committed to conducting its business ethically and in compliance with applicable laws. To the best of its knowledge and based on a good faith understanding of the applicable statutory requirements, PTI has established a Comprehensive Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402. The Company’s Comprehensive Compliance Program is tailored to the size, organizational structure and resources of the Company and has been developed to meet the issues addressed by the above-referenced California Law. By making this declaration, PTI is not asserting that it can prevent individual employees from improper conduct and/or otherwise violating the standards set forth in its Comprehensive Compliance Program. PTI has established procedures to identify potential violations and will discipline employees as necessary. As of the date of this declaration, such procedures are in place and will be reassessed periodically and no less frequently than on an annual basis. Thus, subject to the limitations described above, the Company declares that, based upon its current tracking and monitoring systems, the Company is, in all material respects, in compliance with the Compliance Program and with the established annual spending limits.
As recognized by the OIG Compliance Program Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employee engages in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that the Company has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program. In such situations, the Company takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.
