California Compliance Program Declaration
California Compliance Program Declaration
Effective Date: February 1, 2026
Milestone Pharmaceuticals USA, Inc. (the “Company”) has adopted and maintains a Comprehensive Compliance Program (“CCP”) in accordance with California Health & Safety Code §§ 119400–119402, the U.S. Department of Health and Human Services Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, and the PhRMA Code on Interactions with Health Care Professionals.
The CCP is designed to prevent, detect, and address potential violations of applicable federal and California laws and to promote ethical, transparent, and compliant business conduct.
Oversight of the CCP is the responsibility of the Company’s Compliance Officer, who has direct access to senior management and, as appropriate, the Board of Directors. The Compliance Officer is supported by a cross-functional compliance governance structure to ensure that compliance responsibilities are integrated throughout the organization and that the CCP is periodically reviewed and updated.
The CCP includes written policies and procedures governing interactions with health care professionals, government officials, patients, and third parties; mandatory compliance training; and mechanisms for the confidential reporting of compliance concerns without fear of retaliation.
As required by California law, the Company has established an annual aggregate dollar limit on expenditures for California-licensed health care professionals, excluding categories of activity expressly permitted by law, including the provision of drug samples, financial support for continuing medical education, scholarships, and payments for bona fide professional services provided at fair market value.
The CCP incorporates monitoring, auditing, and risk assessment processes proportionate to the size, scope, and nature of the Company’s operations.
Based on a good-faith assessment and to the best of the Company’s knowledge, the Company declares that it is in compliance with its Comprehensive Compliance Program and California Health & Safety Code § 119402 as of the Effective Date stated above.
Annual Review and Availability
This California Compliance Program Declaration is reviewed and updated at least annually, or more frequently as required by applicable California law.
Additional information regarding the Company’s compliance program may be obtained by contacting the Company’s Ethics & Compliance function.
