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Apligraf®

Commitment to Ethics and Compliance

Organogenesis, Inc. is committed to the highest standards of ethical conduct and regulatory compliance. We have established a Comprehensive Compliance Program that is reasonably designed to prevent and detect violations of our Standards of Conduct and applicable healthcare laws and regulations. Our Comprehensive Compliance Program is tailored to the size, organizational structure, operational activities and resources of Organogenesis to meet compliance goals consistent with our corporate ethics and with the statutory requirements of California Health and Safety Code §§119400-119402.

The Comprehensive Compliance Program recognizes that compliance with healthcare laws is dynamic. Accordingly, we may revise it to reflect changes in company operations, the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General for the U.S. Department of Health and Human Services, the PhRMA & AdvaMed Codes on Interactions with Health Professionals, and applicable laws.

The current version of the Comprehensive Compliance Program may be viewed by clicking on the link below:

Comprehensive Compliance Program (PDF, 61 Kb)

To the best of our knowledge, we are in material compliance with the Comprehensive Compliance Program and accordingly, have established the elements outlined and have set up procedures to implement the program's requirements. This declaration is made as of February 1, 2006.

Please feel free to contact us at 1-888-432-5232 to obtain a written copy of this declaration or our Comprehensive Compliance Program.
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© 2007 Organogenesis. All rights reserved. | California Compliance Law Declaration

References:

3. Falanga V, Sabolinski ML. A bilayered living skin construct (Apligraf®) accelerates complete closure of hard-to-heal venous ulcers. Wound Repair Regen. 1999;7:201-207.

4. Veves A, Falanga V, et al. Graftskin, a human skin equivalent, is effective in management of non-infected neuropathic diabetic foot ulcers. Diabetes Care. 2001;24:290-295