Kadmon Pharmaceuticals, LLC (“KPL”) is committed to the highest standards of corporate citizenship and ethical conduct and complying with all applicable laws and regulations in its marketing, promotional, educational and research activities. Accordingly, for purposes of complying with the State of California’s requirement that pharmaceutical companies implement and maintain a Comprehensive Compliance Program regarding the sales and marketing of its products, KPL has established a Comprehensive Compliance Program that is consistent with the “Compliance Program Guidance for Pharmaceutical Manufacturers” published in April 2003 by the Office of Inspector General of the United States Department of Health and Human Services (the “OIG Guidance”) and the updated “Code on Interactions with Healthcare Professionals” effective January 2009 adopted by the Pharmaceutical Research and Manufacturers of America.
KPL’s Comprehensive Compliance Program includes the following:
As required by California Health & Safety Code sections 119400-119402, with specific reference to the provision of “gifts, promotional material, or items or activities” that a pharmaceutical company may provide to an individual medical or healthcare professional, KPL has established an aggregate, annual dollar limit of $2,500 on promotional items and/or meals directed to an individual medical or healthcare professional who resides or practices in the State of California. The limit represents a maximum amount and is not necessarily a usual, customary, average or typical amount for medical or healthcare professional and may be revised in the future as appropriate.
KPL declares that, to the best of its knowledge, and based on its good faith understanding of the statutory requirements, it has developed a Comprehensive Compliance Program that is consistent with California Health & Safety Code sections 119400-119402. Accordingly, to the best of its knowledge, KPL declares that it is in compliance with its Comprehensive Compliance Program and California Health & Safety Code sections 119400-119402.
As recommended in the OIG Guidance, KPL has developed a Compliance Program tailored to the size, organizational structure and resources of its company. While the OIG Guidance recognizes that even an effective compliance program may not completely eliminate all misconduct by individuals, KPL’s Comprehensive Compliance Program is reasonably designed to prevent and detect violations. The expectation of KPL is that all directors, officers and employees will adhere to its Comprehensive Compliance Program. KPL’s Comprehensive Compliance Program is dynamic, and in order to address evolving compliance needs, KPL will assess its Comprehensive Compliance Program at least annually and as part of this assessment, KPL may modify aspects of its Program to enhance the Program’s effectiveness.
Copies of this summary of the Comprehensive Compliance Program and declaration are available on KPL’s website at www.kadmon.com or by calling the following toll-free number 1-800-405-8506.
This Comprehensive Compliance Program, as well as the underlying policies and procedures, are intended to satisfy certain legal and reporting requirements, including, but not limited to, Nev. Rev. Stat. § 639 (Marketing Code of Conduct) and Cal. Code, Health & Safety § 119400 et seq (Comprehensive Compliance Program).