Zerigo Health, Inc. (“Zerigo Health” or the “Company”) has adopted a Comprehensive Compliance Program (“Compliance Program”) consistent with guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”). Zerigo Health’s Compliance Program is intended to provide guidance for Company interactions with healthcare professionals, promote the prevention and resolution of actual or apparent conflicts of interest, ensure compliance with applicable laws and regulations, and provide process for reporting of violations of the Company’s policies relating to the sale and marketing of the Company’s products. All Zerigo Health employees, officers, directors, and agents (“Team Members”) must comply with Company policies and procedures as well as all laws, rules and regulations of the U.S. and the states, counties, cities and other jurisdictions applicable to the Company’s sale or marketing of its products.
COMPREHENSIVE COMPLIANCE PROGRAM SUMMARY
The OIG advises that an effective compliance program is comprised of seven elements. Zerigo Health has used these seven elements as a basis for its Compliance Program. Fundamental elements of our Compliance Program are summarized below.
REPORTING OF VIOLATIONS; NO RETALIATION
Any Team Member who suspects a violation of the Company Code of Conduct, financial fraud, or other violations of Company policy should promptly contact the Compliance Officer or Company management. Any Team Member wishing to make an anonymous report regarding suspected illegal behavior or financial fraud of any type may do so by calling one of the Company’s Integrity Hotline, 1-833-833-1319. The Company will investigate and treat confidentially (to the extent possible) all reported potential violations. All Team Members are expected to cooperate in any internal or external investigations of possible violations of Company policy. The Company will not permit retaliation of any kind by, or on behalf of, the Company or its Team Members against good faith reports or complaints of potential policy violations.
DECLARATION OF COMPLIANCE WITH CALIFORNIA LAW
California Health & Safety Code § 119402 requires certain medical device manufacturers to develop a Comprehensive Compliance Program for interactions with healthcare professionals. Zerigo Health has tailored its Compliance Program to the nature of its business as a medical device company. While § 119402 references the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”), Zerigo Health has adopted policies and procedures for compliance which are based on the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, adopted by the Advanced Medical Technology Association (the “AdvaMed Code”), which is similar to the PhRMA Code but is written for medical device companies. To the best of its knowledge, as of the date of this declaration, Zerigo Health is in compliance with California Health & Safety Code §§ 119402 and the Company’s Compliance Program. Anyone may obtain a copy of this document by calling the Company’s toll-free number at 1-877-520- 5697.
Reviewed and Updated 09/01/2021