Compliance

 
Renovis Surgical is a member of the Advanced Medical Technology Association (“AdvaMed”), the leading medical device industry organization dedicated to the advancement of medical science and the improvement of patient care, and the contribution that high-quality, cost-effective healthcare technology can make toward achieving those goals.

In addition, to Renovis’s own Code of Conduct and core values, Renovis has voluntarily adopted AdvaMed’s Code of Ethics on Interactions with Health Care Professionals, which is intended to help the medical technology industry facilitate ethical interactions with Health Care Professionals.


California Health Care Compliance Information

The following information is provided pursuant to the California Health & Safety Code § 119402 (S.B. 1765), which requires pharmaceutical and medical device companies doing business in California to make available their program for compliance with applicable federal and state laws and industry standards regulating the marketing and promotion of their products. To request a copy of the Renovis Compliance Program, please call 1-800-RENOVIS, extension 409.

Compliance Program Overview

Introduction
Renovis Surgical Technologies, Inc. (“Renovis”) has established a Corporate Compliance Program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General of the United States Department of Health and Human Services, (“OIG Guide”). The OIG Guide advises that an effective compliance program is comprised of seven elements. Renovis has used these seven elements as the basis for its Compliance Program regarding the marketing and promotion of its products.

Written Policies and Procedures:
Renovis has written policies and procedures and has adopted the AdvaMed Code of Ethics on Interactions with Healthcare Professionals as the Company’s primary statement of policies for assuring compliance with applicable laws, regulations and standards governing the marketing and promotion of Renovis’s products.

Compliance Officer and Committee
Renovis has appointed a Compliance Officer who has been empowered to exercise independent judgment and is responsible for developing, monitoring and otherwise administering our compliance program.

Renovis has appointed a Compliance Committee comprised of the Compliance Officer and members of the Company’s senior management to assist the Compliance Officer with review, revision and implementation of the Compliance Program to meet legal and regulatory requirements applicable to the Company.

Training
Renovis has an annual compliance training process for appropriate employees on their legal and ethical obligations and the Company’s policies regarding the promotion and marketing of our products. The Compliance Officer will work with the Compliance Committee to update the training process as needed and keep records of all training activity.

Communication
Renovis encourages open communication between employees and management regarding the compliance program. Employees are encouraged to report any concerns or suspected violations to the Compliance Officer, any member of Compliance Committee or anonymously in a written report to our corporate address.

Auditing and Monitoring
Renovis monitors and periodically audits compliance with its policies and procedures. The Compliance Officer will document and maintain records of such audits.

Enforcement and Appropriate Disciplinary Action
The Compliance Officer will promptly investigate all possible violations of the compliance program and policies. With oversight from Compliance Committee, the Compliance Officer will determine the appropriate disciplinary action for any violation of policies.

Responding to Detected Problems and Corrective Action
Renovis requires a prompt and diligent response to potential violations of the compliance program. Actions in response to detected problems may include improving policies, procedures, training, communication and monitoring or may require disciplinary action to prevent future violations.


AdvaMed Code of Ethics on Interactions with Health Care Professionals (2009)