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US Compliance Notices

California Annual Declaration of Compliance

Mayne Pharma (“Mayne”) has adopted a Comprehensive Compliance Program in accordance with California Health and Safety Code, § 119402. Mayne Pharma’s Comprehensive Compliance Program was developed in accordance with the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” drafted by the United States Department of Health and Human Services Office of Inspector General (OIG) and incorporates policies that comply with the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals,” as last revised in October 2019.

Mayne Pharma is committed to ensuring compliance with its company policies and with all applicable laws and regulations. The Comprehensive Compliance Program represents Mayne Pharma’s commitment to the highest standards of corporate conduct. The OIG Guidance acknowledges that the implementation of a compliance program, such as the Comprehensive Compliance Program, cannot ensure that improper employee conduct will never occur. Nonetheless, Mayne Pharma expects and requires its employees to abide by its Business Code of Conduct and all other company policies and procedures described in its Comprehensive Compliance Program.

Mayne Pharma declares, to the best of its knowledge and based on its good faith understanding of the statutory requirements, that it is in compliance with the company’s Comprehensive Compliance Program and Chapter 8, Part 15, Division 104 of the California Health and Safety Code.

Mayne Pharma has set the annual aggregate limit on covered promotional expenditures at $2,000 per covered medical or healthcare professional for annual periods commencing on July 1, 2019. This limit is reviewed annually and may be revised from time to time. The foregoing limit does not represent any usual, customary, average, or typical amount for medical or health care professionals.

This iteration of Mayne Pharma’s Comprehensive Compliance Program became effective as of July 1, 2019.

Mayne Pharma will assess its Comprehensive Compliance Program at least annually.

A copy of the Comprehensive Compliance Program may be obtained by calling (in the U.S.) +1 984 242 1335 or by downloading the file Comprehensive Compliance Program.