Annual Certification of Compliance with the Corporate Comprehensive Compliance Program for California:
As part of our continuing efforts in the area of compliance, BioPorto Diagnostics, Inc. (“BioPorto”) has established and is operating under a Comprehensive Compliance Program (“CCP”), tailored to its business as an in vitro medical device manufacturer. Where applicable, our CCP is in accordance with The AdvaMed Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed”).
While the California law makes reference to compliance with the PhRMA Code on Interactions with Healthcare Professionals, BioPorto manufactures in vitro diagnostic devices, rather than pharmaceutical products, and has therefore adopted the AdvaMed Code. While AdvaMed is substantially similar to the PhRMA Code, it recognizes significant differences applicable to the medical device industry. We believe that adherence to the AdvaMed Code also constitutes compliance with the PhRMA Code for purposes of satisfying the requirement of the California law.
To the best of our knowledge and belief, and based on our good faith understanding of the statutory requirements, we have established a CCP that in all material respects is compliant with the requirements of California Health and Safety Code §§119400-119402, to the extent they apply to BioPorto.
Suppliers doing business with the Company and its affiliates must fully comply with and abide by the California Transparency in Supply Chain Act of 2010 and the United Kingdom Modern Slavery Act of 2015. Supplier also represents that it will comply with verification, audit and certification processes to attest to full compliance with the aforementioned laws and statutes.