OUR U.S. HEALTHCARE COMPLIANCE PROGRAM

Guerbet LLC is committed to conducting business honestly, ethically, and in compliance with laws and regulations. We strive to make the right, principled decisions when interacting with healthcare professionals and healthcare institutions. Our goal is to conduct business and promote our products in an informed, compliant manner.

Our U.S. compliance program is integral to our overall commitment to operating ethically. Our program is based on recommendations and principles set forth in the U.S. Health and Human Services Office of Inspector General (“HHS-OIG”) Compliance Program Guidance for Pharmaceutical Manufacturers, U.S. Federal Sentencing Guidelines, Pharmaceutical Research and Manufacturers of America Code on Interactions the with Healthcare Professionals (the “PhRMA Code”), the Advanced Medical Technology Association Code of Ethics (the “AdvaMed Code”), as well as other relevant industry guidance and laws.

PAYMENTS TO U.S. HEALTHCARE PROFESSIONALS & ORGANIZATIONS

Guerbet LLC collects and submits data on transfers of values such as research, meals, travel, gifts, or speaking fees to the Centers for Medicare and Medicaid Services (“CMS”) Open Payments program (often referred to as the “Sunshine Act”) each year. Open Payments is a national disclosure program that promotes a more transparent and accountable health care system by making the financial relationships between applicable manufacturers and group purchasing organizations and healthcare providers (physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists & anesthesiologist assistants, certified nurse-midwives and teaching hospitals; collectively referred to as “Covered Recipients”) available to the public.

Through the CMS Open Payments website, you can view information about Sun Pharma’s financial relationships with Covered Recipients, as well as the relationships that Covered Recipients maintain with other companies. You can read more about the Open Payments program by going to https://www.cms.gov/priorities/key-initiatives/open-payments.  

Guerbet LLC’s past disclosures of payments or other transfers of value provided to Covered Recipients can be viewed by going to the CMS Open Payments Data Search Tool website: https://openpaymentsdata.cms.gov/company/100000010729.

CALIFORNIA COMPLIANCE & DECLARATION

California Health & Safety Code, Sections 119400-119402, (the “California Compliance Law”) requires pharmaceutical companies to adopt a “Comprehensive Compliance Program” in accordance with the requirements set forth in the April 2003 “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the HHS-OIG. Further, the California Compliance Law requires manufacturers to include in their Comprehensive Compliance Program policies for compliance with the PhRMA Code. The California Compliance Law further states that companies shall institute limits on gifts and incentives to healthcare professionals and also requires that companies declare annually, in writing, their compliance with their Comprehensive Compliance Program as well as the requirements of the California Compliance Law. Companies are also required to make available to the public both their annual declaration and the provisions of their Comprehensive Compliance Program via their website and a toll-free telephone number.

Guerbet LLC has established a Comprehensive Compliance Program in accordance with the California Compliance Law. In addition, Guerbet LLC has established a specific annual aggregate dollar limit of $2,000 on promotional materials, items, or activities that Guerbet LLC may provide to an individual medical or health professionals in California. This amount does not include the value of pharmaceutical drug samples, grants for medical education, medical scholarships, professional service or consulting fees, patient education materials, and approved scientific reprints. This limit may be revised by Guerbet LLC from time to time. The foregoing limit does not represent a usual, customary, average or typical amount for medical or health professionals. This annual aggregate limit is based on an estimate of the maximum value of promotional materials and other items, or activities as defined herein that a California medical or health professionals may receive in one year.

To the best of our knowledge, as of the date of this declaration, Guerbet LLC declares that it is, in all material respects, in compliance with the California Compliance Law.

For a copy of this declaration, please contact compliance.US@guerbet.com or (877) 729-6679.

Updated: June 1, 2024.