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Statement on Compliance with California Law
Integra LifeSciences Corporation’s (“Integra”) Policy on Interactions with Health Care Professionals complies with California law (Cal. Health & Safety Code §§ 119400-119402). This Statement on Compliance with California Law is applicable to any Integra employee who interacts with any of the following California healthcare professionals: physicians (including podiatrists), medical students, certified nurse practitioners, and licensed physicians assistants. In addition to the requirements of Integra’s Policy on Interactions with Health Care Professionals, which are in accordance with the revised AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”), effective July 1, 2009, Integra has established annual spending limits for certain promotional activities directed toward these healthcare professionals practicing in California (“Annual Spending Limit”).
The Annual Spending Limit is set at $1,000 per year for each applicable California healthcare professional. The Annual Spending Limit includes: the value of gifts, promotional materials, and items or activities, including meals and receptions, that are provided to these healthcare professionals for the promotion of Integra’s products.
The exceptions to the Annual Spending Limit include: 1) the value of samples; 2) financial support for continuing medical education conferences or health education scholarships if provided in accordance with Company policy; 3) fair market value payments, meals, and expenditures made in connection with approved consulting relationships or for healthcare professionals who speak on behalf of the company; 4) food and beverages incidental to programs offered through hospitals and other institutions designed to train healthcare professionals on the use of Integra’s products; 5) Training programs necessary for the safe and effective use of Integra products, consistent with the AdvaMed Code or 6) pens, pads, and other giveaways with the company logo that have a value of less than $10.00. The Annual Spending Limit is cumulative across all sales divisions and employees of Integra and applies to interactions with the applicable California-based healthcare professionals taking place both inside and outside California.
This Statement and the subject matter hereof, supplements Integra’s Code of Conduct and Corporate Compliance Program, which Integra believes is in accordance with the guidelines for compliance programs provided in Cal. Health & Safety Code §§ 119400-119402.
To obtain a copy of Integra’s Statement on Compliance with California Law or Code of Conduct and Compliance Program, please call toll-free 1-866-377-0579.
ANNUAL DECLARATION FOR COMPLIANCE WITH CALIFORNIA LAW
As stated in its Code of Conduct, Integra is committed to ethical and legal conduct that is compliant with all relevant laws and regulations and to correcting wrongdoing wherever it may occur in the organization. As part of its continued efforts in the area of compliance, Integra has developed a Comprehensive Compliance Program that is reasonably designed to prevent and detect violations.
Consistent with the Department of Health and Human Services Office of the Inspector General Compliance Program Guidance for Pharmaceutical Manufacturers (“HHS-OIG Guidance”), Integra has tailored its Compliance Program to the nature of its business as a medical device manufacturer. While Cal. Health and Safety Code §§ 119400-119402 makes reference to compliance with the Pharmaceutical Research and Manufacturers of America’s Code on Interactions with Healthcare Professionals (“PhRMA Code”), Integra manufactures medical devices rather than pharmaceutical products. Therefore, Integra determined that it was more appropriate for the company instead to adopt policies and procedures consistent with The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”) which, although substantially similar to the PhRMA Code, recognizes significant differences applicable to the medical device industry.
To the best of its knowledge, information, and belief, and based upon a good faith understanding of the statutory requirements, Integra hereby declares that it has established and is, in all material respects, operating in compliance with a Comprehensive Compliance Program (“CCP”) that satisfies the requirements of Cal. Health and Safety Code §§ 119400-119402 (2004). Integra has developed a CCP tailored to the size, organizational structure, and resources of the company, and implemented it to meet the compliance goals set forth by the State of California.
Compliance is a dynamic concept that must be adapted to the characteristics of a particular company; thus, it is impossible for Integra’s CCP to completely reflect at any given moment in time all current, collective efforts of the company toward compliance. In an effort, however, to keep its CCP updated, Integra periodically reassesses the CCP and enhances it. Government guidance on compliance programs, including the U.S. Sentencing Guidelines and the HHS-OIG Guidance, recognize that no program can completely prevent individual employees from improper conduct. Therefore, Integra cannot completely eliminate the possibility of that an employee will violate these standards; however, Integra has established procedures to both prevent and identify potential violations and discipline employees as necessary.
This declaration is made as of July 31, 2014, and, as noted above, it is possible Integra will further modify and update its CCP subsequent to this declaration.