I. COOPERCOMPANIES – 2024 DECLARATION OF COMPLIANCE WITH COMPREHENSIVE COMPLIANCE PROGRAM

The CooperCompanies, Inc., including CooperVision, Inc. and CooperSurgical, Inc. (collectively referred to as “Cooper”) has developed and implemented a Comprehensive Compliance Program (CCP) that is designed to comply with applicable federal and state laws including California Health & Safety Code, Sections 119400-119402. To the best of its knowledge and based on a good faith understanding of the requirements of the California Code, as of January 31, 2024, Cooper declares that is in material compliance with its CCP and the California Code.

II. COMPREHENSIVE COMPLIANCE PROGRAM

Cooper has established a CCP consistent with the Department of Health and Human Services Office of the Inspector General Compliance Program Guidance to help ensure: (1) ethical interactions with health care providers; and (2) promotion and marketing practices that are in compliance in material respects with applicable federal and state laws and industry standards for medical device manufacturers.

The CCP includes the following:

  • A dedicated Compliance Officer supported by a Compliance Committee
  • Documented compliance policies and procedures
  • Regular compliance training and education
  • Open lines of communication, including a toll-free hotline for reporting
  • Enforcement standards
  • Monitoring and auditing activities to continually evaluate and assess compliance with the Cooper Compliance Program
  • Procedures for responding to identified offenses and implementing corrective actions

III. ANNUAL SPENDING LIMIT

The California Code also requires pharmaceutical and medical device companies to adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the company may give or otherwise provide to an individual medical or healthcare professional (HCP) in accordance with the OIG Guidance. Cooper policies address the giving of gifts to HCPs, including items for the personal benefit of HCPs or their family members, cash gifts or cash equivalents, and non-educational items.

IV. CONCLUSION

Cooper is committed to an ongoing assessment of ethical conduct and compliance with applicable laws. This CCP is designed, implemented, and enforced with the goal of preventing and detecting unlawful and unethical behavior. The OIG recognized in its Compliance Program Guidance that the implementation of a CCP does not ensure the elimination of improper conduct. Likewise, by making this declaration, Cooper is not declaring that it can prevent all deviations from its policy. However, Cooper is committed to taking appropriate corrective actions when deviations are identified.

To request a copy of the CooperCompanies Declaration and CCP description, please call +1-925-460-3600.