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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’s Comprehensive Compliance Program is in accordance with the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” developed 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 revised from time to time.

Mayne is committed to ensuring compliance with its company policies and with applicable laws and regulations. The Comprehensive Compliance Program represents Mayne’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 expects and requires its employees to abide by Mayne’s Business Code of Conduct and the other policies described in its Comprehensive Compliance Program.

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

Mayne has set the annual aggregate limit on covered promotional expenditures at $1,500 per covered medical or healthcare professional for annual periods commencing on July 1, 2015. This limit may be revised by Mayne from time to time. The foregoing limit does not represent any usual, customary, average, or typical amount for medical or health care professionals.

This program became effective as of July 1, 2015.

Mayne 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 1397 or by downloading the file Comprehensive Compliance Program.