California Declaration of Compliance
Salix Pharmaceuticals, Inc. ("Salix") has adopted a Comprehensive Compliance Program in accordance with California Health and Safety Code, Section §119402. Salix's Comprehensive Compliance Program is in accordance with the "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 Health Care Professionals."
Salix is committed to ensuring compliance with its company policies and with applicable laws and regulations. The Comprehensive Compliance Program represents Salix'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, Salix expects and requires its employees to abide by Salix's Code of Conduct and the other policies described in its Comprehensive Compliance Program.
Salix declares, to the best of its knowledge and based on its good faith understanding of the statutory requirements that Salix is in compliance with its Comprehensive Compliance Program and Chapter 8, Part 15, Division 104 of the California Health and Safety Code.
Salix has set the annual aggregate limit on covered promotional expenditures at $3,000 per covered medical or health care professional for annual periods commencing on July 1, 2007. This limit may be revised by Salix from time to time. The foregoing limit does not represent any usual, customary, average, or typical amount for medical or health care professionals.
Salix exempts certain expenditures from this limit based upon a good faith understanding of California Health & Safety Code §§ 119400-119402 and the PhRMA Code. Such exemptions include:
- Drug samples given to physicians and healthcare professionals intended for free distribution to patients;
- Financial support for continuing medical education forums;
- Financial support for health educational scholarships;
- Payments made for legitimate professional services provided by a healthcare or medical professional that are provided at the fair market value for the services rendered;
- Items of de minimis value and primarily associated with a healthcare or medical professional’s practice or that primarily benefit patients; and
- Documents, informational or educational brochures, and other items that inform medical or healthcare professionals about Salix products, provide scientific and educational data, support medical research and education, or enhance a patient’s understanding or management of a disease state or disorder.
This Declaration is effective as of July 1, 2005. Salix will assess its Comprehensive Compliance Program at least annually.
A copy of the Comprehensive Compliance Program and this Declaration may be obtained by:
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