Clarify Medical is now Zerigo Health.

WEBSITE CORPORATE COMPLIANCE OVERVIEW

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.

  1. Written Policies and Procedures: Zerigo Health has ratified a Code of Ethical Conduct and has adopted the AdvaMed Code of Ethics on Interactions with Healthcare Professionals as the Company’s primary statement of policies for assuring compliance with applicable laws, regulations and standards governing the marketing and promotion of Zerigo Health’s products. To the best of its ability and consistent with the OIG’s guidance regarding tailoring compliance programs to the nature of Zerigo Health’s business as a medical device company, the Company also has incorporated into its policies and procedures additional requirements of federal and/or state laws.
  2. Compliance Leadership: Zerigo Health has designated a Compliance Officer (the “Compliance Officer”). The Compliance Officer is empowered to exercise independent judgment and is responsible for developing, monitoring and otherwise administrating the Compliance Program. The Company also has appointed a Compliance Committee comprised of the Compliance Officer and members of the Company’s senior management to assist the Compliance Officer with review, revision and implementation of the Compliance Program to meet legal and regulatory requirements applicable to the Company.
  3. Education and Training: The Company trains Team Members on the Code of Conduct, on the legal and ethical obligations for Zerigo Health Team Members, and Company policies and procedures concerning the Company’s products.
  4. Communication: Zerigo Health has adopted open-door, confidentiality (to the extent possible) and non-retaliation policies in the event a Team Member is concerned about a potential violation of the Company’s Code of Conduct. Team Members may also use the Company’s anonymous Integrity Hotline at 1-833-833-1319 to report suspected violations of Company policies or the Code of Conduct.
  5. Auditing and Monitoring: The Compliance Officer is responsible for auditing and monitoring compliance with Company policies and procedures.
  6. Enforcement and Appropriate Disciplinary Action: All reported potential violations shall be reported to the Integrity Hotline or forwarded to the Compliance Officer.
  7. Corrective Action Procedures: As needed and on an ongoing basis, the Compliance Officer will assess the need to revise policies, procedures, training, communication or other elements of Zerigo Health’s Compliance Program.

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