California Health and Safety Code

NOTICE: This information is provided pursuant to the requirements of California Health and Safety Code, Sections 119400-119402 (“California Compliance Law”).

The California Compliance Law requires pharmaceutical companies doing business in California to adopt a “Comprehensive Compliance Program” in accordance with 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 pharmaceutical companies 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”). A pharmaceutical company must also make conforming changes to its Comprehensive Compliance Program within six months of any update or revision of the OIG Guidance or PhRMA Code. The California Compliance Law further mandates that pharmaceutical companies institute a specific annual dollar limit on gifts, promotional materials, and items or activities that pharmaceutical companies may give or otherwise provide to an individual medical or health care professional as defined under the law and declare annually, in writing, their compliance with their Comprehensive Compliance Program as well as the requirements of the California Compliance Law. Pharmaceutical 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”) has established a Comprehensive Compliance Program in accordance with the OIG Guidance that includes policies for compliance with the requirements of the PhRMA Code as amended. The Comprehensive Compliance Program includes: (1) policies and procedures designed to detect, prevent, identify, and correct unlawful, non-compliant, and/or unethical behavior; (2) a designated compliance officer and committee; (3) effective training and education for applicable PTI employees and third parties; (4) effective lines of communication; (5) internal monitoring, oversight, and auditing; (6) enforcing standards through well-publicized disciplinary guidelines; and (7) responding promptly to detected and/or reported problems and taking corrective action.

As part of its Comprehensive Compliance Program, PTI does not permit the provision of gifts to medical or health care 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 health care professional in California. This amount does not include the value of pharmaceutical drug samples, grants for medical education, medical scholarships, fair market value professional service or consulting fees and any meals or other expenses related to the provision of such services, patient education materials, and approved scientific reprints. This limit may be revised by PTI from time to time in its sole discretion. These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for medical or health care professionals to assist in making clinical or other medical judgments. The foregoing limit is a cap and does not represent a goal or usual, customary, average or typical amount for medical or health care professionals.

As stated in its Comprehensive Compliance Program, PTI is committed to conducting its business ethically and in compliance with applicable laws. As of July 1, 2025, to the best of its knowledge and based on a good faith understanding of the applicable statutory requirements, PTI is in substantial compliance with its Comprehensive Compliance Program and the requirements set forth in the California Compliance Law. PTI’s Comprehensive Compliance Program is tailored to the size, organizational structure and resources of PTI and has been developed to meet the requirements of the California Compliance Law.  PTI has established an internal monitoring system designed to help ensure compliance with the annual spending limits in California and is working to establish additional monitoring processes. PTI’s Comprehensive Compliance Program will be reassessed periodically, and no less frequently than on an annual basis, and this declaration is based on PTI’s most recent evaluation. Thus, subject to the limitations described above, PTI declares that, based upon its current tracking and monitoring systems, PTI is, in all material respects, in compliance with the Comprehensive Compliance Program and with the established annual spending limits.

As recognized by the OIG Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper. Accordingly, this declaration is not intended and should not be construed to imply that PTI has not identified any individual instances in which an employee has or may have violated one or more provisions of its Comprehensive Compliance Program. In such situations, PTI takes reasonable and appropriate remedial or corrective action in a manner consistent with its Comprehensive Compliance Program.

For a written copy of the Comprehensive Compliance Program description or this declaration, contact compliance@pharmacosmos.us.