California Comprehensive Compliance Program

Introduction

Doing business in a compliant way is a key corporate value at BioWound Solutions (“BWS”) that influences how we do our work every day.  BWS has adopted a comprehensive compliance program designed to advance our corporate values and prevent and detect violations of our business standards, which complies with California Health and Safety Code § 119402 (S.B. 1765).

The BWS compliance program is in accordance with the Compliance Program Guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services.  BWS’s primary business is the sale of medical devices.  The BWS compliance program reflects our adoption of policies and procedures appropriate to our company, including compliance with the AdvaMed Code of Ethics in Interactions with Healthcare Professionals.  Substantially similar to the PhRMA Code referenced in the California Health and Safety Code § 119402, the AdvaMed Code addresses potential risk areas that apply to the unique environment of the medical device industry.  Therefore, consistent with the OIG Guidance, the BWS compliance program includes policies and training for compliance with the AdvaMed Code. 

Compliance Program Components

Code of Business Conduct, Policies and Procedures

BWS has developed and implemented a Code of Business Conduct (“Code”) that effectively sets forth BWS’s compliance obligations, including compliance with all applicable laws and regulations.  In addition, BWS has developed and will continue to develop, policies and procedures that reflect BWS’s commitment to compliance, effectively address BWS’s compliance obligations, provide clarity in terms of how to conduct a given activity in a compliant manner, and account for specific areas of risk relevant to medical device companies.  Every team member must comply with the Code and all applicable policies and procedures.  BWS has established an annual limit of $1,500 for meals and educational items as the aggregate value of the items or activities that may be provided to California health care professionals pursuant to the requirements of Cal. Health and Safety Code § 119402 (S.B. 1765), which excludes the value of travel expenses for attendance at company medical education and product training meetings; patient education materials; and fair market value payments for bona fide healthcare services provided by the healthcare professional.

            Leadership and Structure

BWS has appointed a Chief Compliance Officer to design, implement and oversee the compliance program.  The Chief Compliance Officer reports to the Chief Executive Officer and has been empowered with appropriate authority to exercise independent judgment.  The Chief Compliance Officer regularly meets with the Chief Executive Officer and informs the Chief Executive Officer of any significant compliance risks, concerns, issues, or violations that may come to the attention of the Chief Compliance Officer.  The Chief Executive Officer and other members of executive management assist the Chief Compliance Officer in the implementation and effective operation of the compliance program.

            Communication

Every team member is encouraged to report any potential compliance violations in a timely fashion.  If a team member needs guidance on a legal or ethical question or has knowledge of a potentially illegal or unethical activity, he or she should seek counsel from a supervisor, senior management, BWS legal counsel, the Human Resources Department, and/or the Chief Compliance Officer.

Compliance questions and reports of potential violations may also be directed to BWS’s helpline, via toll free number or online.  The helpline number and online access address are included in the Code of Business Conduct and publicized via posters and other means.  Team members may choose to remain anonymous when reporting a potential violation on the helpline.  As with all questions and inquiries, the information given on the helpline is treated as confidential to the extent possible.  It is a violation of BWS policy for any team member to be retaliated against in any way for asking questions or voicing concerns in good faith.

            Education and Training

BWS has developed and delivered, and will continue to develop and deliver, regular and effective compliance education and training programs for all team members.  Each team member is recertified annually on the Code of Business Conduct.  BWS regularly reviews and updates its training programs and deploys additional training on an ad hoc basis.

            Auditing and Monitoring

BWS monitors and periodically audits its compliance with its policies and procedures.

            Investigations and Corrective Action

All reports of alleged violations are investigated by BWS.  If the results of an investigation indicate that corrective action is required, the company will decide the appropriate steps to take, including team member discipline, dismissal, and possible legal action.  In addition, BWS will implement preventive measures to help ensure there is not a repeat of the issue.  If appropriate, at its discretion, BWS may turn over an investigation to applicable outside authorities, and outside investigators may assist in the inquiry.

Response and Discipline for Compliance Violations

Each team member is responsible and accountable for adhering to all applicable laws and regulations as well as BWS’s Code of Conduct, policies, and procedures. Team members who fail to meet these responsibilities are subject to appropriate disciplinary action by BWS, which may include termination.

            Declaration

As of the date of this declaration, to the best of our knowledge, BWS is in compliance with this compliance program and the provisions of the California Health and Safety Code § 119402 in all material respects, as of September 24, 2024.  Copies of this California Comprehensive Compliance Program are available by calling us at 800-989-4155 or emailing us at contact@biowound.com.