Compliance Program

Statement regarding compliance with California Health & Safety Code § 119402

NOTICE: This information is provided in accordance with the requirements established by California Health & Safety Code Section 119402, which requires medical device companies that conduct business in California to publish on their website their comprehensive compliance program and a written declaration of compliance with such program.

Introduction

Contego Medical, Inc. (“Contego” or the “Company”) is committed to the highest ethical standards and to compliance with all applicable laws, regulations, and guidelines that govern the healthcare industry. As part of that commitment, Contego has established and maintains a comprehensive compliance program (the “Compliance Program”) in accordance with the compliance program guidance published by the U.S. Department of Health and Human Services, Office of Inspector General (“OIG Guidance”) and California Health and Safety Code Sections 119400-119402.

As described below, Contego has structured its Compliance Program around the seven elements of an effective compliance program identified by the OIG Guidance. However, the below description of the Compliance Program does not necessarily capture the entirety of the program, which is composed of multiple policies, procedures, and practices.

Overview of Compliance Program

  1. Written Policies and Procedures Contego has developed a Code of Conduct and written policies and procedures to address key compliance risk areas and to guide the conduct of Company personnel in their day-to-day operations. These policies and procedures are regularly reviewed and updated on an as-needed basis in response to legal and regulatory developments and changes in Company activities.The topics covered by the Code of Conduct and policies and procedures include, among others: interactions with healthcare professionals; discounts, rebates, and other price concessions; compliance with U.S. Food and Drug Administration laws and rules; anti-bribery; and data privacy and security. Moreover, the policies establish a limit on gifts, promotional materials, items, activities, and incentives that may be provided to medical or healthcare professionals.
  1. Chief Compliance Officer & Compliance Committee Contego’s Board of Directors has appointed Nathalie Greene, the Company’s Chief Financial Officer, to concurrently serve as its Chief Compliance Officer. The Chief Compliance Officer has direct access to the Company’s Chief Executive Officer, Board of Directors, and senior management and is charged with developing, operating, and monitoring the Compliance Program.Contego has also formed a Compliance Committee to advise and support the Chief Compliance Officer and assist in the implementation and maintenance of the Compliance Program. The Compliance Committee currently consists of the Chief Compliance Officer, the Vice President of Medical Affairs, the Vice President of Regulatory Affairs, and the Chief Commercial Officer.
  1. Training and Education The education and training of officers, directors, and employees on their legal and ethical obligations under all applicable laws, regulations, guidelines, and Company policies is a key element of the Compliance Program. The Company provides all personnel with general compliance training after hire and annually thereafter. Additionally, the Company provides targeted compliance training as appropriate.
  1. Effective Lines of Communication Contego is committed to fostering open lines of communication between Company personnel and management regarding any compliance concerns. Company personnel are encouraged to report their concerns to their manager, the Chief Compliance Officer/Compliance Committee, or Company leadership. To that end, the Company has adopted open-door, confidentiality, and non-retaliation policies. In addition, the Company has established an anonymous compliance hotline where Company personnel can report compliance concerns 24 hours a day, seven days a week.
  1. Auditing and Monitoring The Compliance Program also includes efforts to conduct ongoing monitoring and auditing of business practices to assess whether Company personnel are in compliance with compliance policies, protocols, and practices, as well as applicable laws and regulations. The nature of oversight and frequency of compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations, in accordance with OIG Guidance.
  1. Well-Publicized Disciplinary Guidelines The Company maintains clear disciplinary policies that detail the consequences of violating Compliance Program policies or applicable laws and regulations. Company personnel who are found to have violated a Compliance Program requirement are disciplined appropriately. The severity of the disciplinary action is situation-dependent and informed by all relevant factors.
  1. Responding to Compliance Issues All Company personnel are obligated to report any issue or practice that may constitute a violation of, or potential non-compliance with, applicable law, the Contego Code of Conduct, or a Compliance Program requirement. Reports of potential violations or instances of non-compliance are reviewed and investigated as appropriate, with the exact nature and level of thoroughness of the investigation varying according to the circumstances. Moreover, the Chief Compliance Officer and the Compliance Committee continuously evaluate reports of potential violations and instances of non-compliance to determine whether the violation is in part due to gaps in the Compliance Program. When such gaps are identified, the Chief Compliance Officer and the Compliance Committee work to revise the Compliance Program to prevent future non-compliance.

Contego’s 2023 Declaration of Compliance

As part of Contego’s ongoing compliance efforts, the Company has developed a Compliance Program that is designed to comply with applicable federal and state laws and prevent and detect potential compliance violations. The Compliance Program has been tailored to fit the unique risks faced by Contego and has been informed by the AdvaMed Code of Ethics on Interactions with Health Care Professionals, which provides industry guidance to medical device manufacturers.

The Company believes that its Compliance Program meets the compliance goals set forth by California Health & Safety Code Sections 119400-119402. Further, to the best of its knowledge as of the date of this declaration, the Company certifies that it is, in all material respects, in compliance with its Compliance Program and all applicable law. We will continue to evaluate and update our Compliance Program as necessary and appropriate.

A copy of this document may be obtained by calling 919-459-7250.

Dated: December 2022