NOTICE:  This information is provided pursuant to the requirements of California Health & Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.

California Health & Safety Code, Sections 119400 – 119402, (“California Compliance Law”) requires pharmaceutical companies to adopt a compliance program in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Compliance Guidance”) developed by the United States Department of Health and Human Services Office of Inspector General (“OIG”) and policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) “Code on Interactions with Health Care Professionals” (“PhRMA Code”) within six months of any update or revision of the PhRMA Code.  Revisions to the July 1, 2002 PhRMA Code were effective January 2009.

Sanofi-aventis U.S. has established a Compliance Program in accordance with the OIG Compliance Guidance and has policies in place to foster compliance with the PhRMA Code.  For purposes of compliance with the requirements of the California Compliance Law and as part of its Compliance Program, sanofi-aventis U.S. has established a specific annual aggregate dollar limit of $2000 on gifts, promotional materials, or items or activities that sanofi-aventis U.S. may give or otherwise provide to an individual medical or health care professional in California.  Such items or activities primarily include: medical textbooks and other items that principally entail a patient benefit or are related to the health care professional’s practice; modest meals associated with a substantive discussion of a sanofi-aventis product or a disease state; and other items or activities permitted under the PhRMA Code and OIG Compliance Guidance.  These items and activities are primarily directed to the dissemination or communication of medical and scientific information as a resource for health care professionals to assist in making clinical or other medical judgments.  This limit may be revised from time to time, in which case the revised limit will be published in this section of the sanofi-aventis website.  This limit represents a spending cap, not a goal or average; in many cases, the amount spent per physician may be substantially less than the cap amount.  Sanofi-aventis has established an internal monitoring system designed to help ensure compliance with the annual spending limit in California and is working to establish additional monitoring processes.

The annual limit does not include the following:

• Drug samples given to physicians and health care professionals 
• Financial support for continuing medical education forums 
• Financial support for health educational scholarships 
• Payments for legitimate professionals services, and any meals or expenses associated with the provision of such services 
• Items of nominal value with a retail value of less than $10 (e.g., pens, pads, visual aids, reprints of medical journal articles) 
• Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition   

As stated in its Compliance Program, sanofi-aventis U.S. is committed to conducting its business ethically and in compliance with all applicable laws.  To the best of its knowledge and based on a good faith understanding of the statutory requirements, sanofi-aventis U.S. has established a Compliance Program that meets the requirements set forth in California Health & Safety Code, Sections 119400-119402.  Sanofi-aventis U.S. has tailored its Compliance Program to meet the specific needs of the company and continuously assesses the effectiveness of the Compliance Program.  Sanofi-aventis has established an internal monitoring system designed to help ensure compliance with the annual spending limit in California and is working to establish additional corporate tracking and monitoring processes.  Thus, subject to the limitations described above, sanofi-aventis declares that, based upon current tracking and monitoring systems, the company is, in all material respects, in compliance with the Compliance Program and with the established annual spending limit for reporting period of July 1, 2008 through June 30, 2009.

As recognized by the OIG Compliance Guidance, even an effective compliance program cannot eliminate the possibility that one or more individual employees engage in conduct that would be considered improper.  Accordingly, this declaration is not intended and should not be construed to imply that sanofi-aventis U.S. has not identified any individual instances in which an employee has or may have violated one or more provisions of its Compliance Program.  In such situations, sanofi-aventis U.S. takes reasonable and appropriate remedial or corrective action in a manner consistent with its Compliance Program.

For a written copy of the sanofi-aventis Compliance Program description
or this declaration, call 1-800-648-1297.