COMPLIANCE

Journey Medical Corporation Comprehensive Compliance Program Summary

I. INTRODUCTION:

Journey Medical Corporation (“Journey”) is committed to conducting business with a high degree of ethics and integrity and in compliance with all applicable legal and regulatory requirements, including but not limited to all federal and state health care program requirements.

The purpose of our Comprehensive Compliance Program (“Compliance Program”) is to promote compliance with the laws, regulations and guidance that govern our interactions with healthcare professionals and healthcare institutions as well as communications about our products. The compliance program has been developed in accordance with the principles set forth in the US Department of Health and Human Services Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers dated May 5, 2003 (the “OIG Compliance Guidance”) and the standards set forth in the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the “PhRMA Code”), as well as other relevant industry guidance.

Journey through its Office of Compliance will review and update its Compliance Program from time to time to promote an organizational culture of integrity, ethical conduct, principled decision-making, openness and trust. It is every colleague at Journey’s responsibility for understanding and meeting our compliance requirement and Journey strives every day to foster an environment where Journey personnel operate in compliance with all applicable laws, regulations, and guidance.

II. Leadership and Structure

Journey has appointed a Chief Compliance Officer (“Compliance Officer”) who is responsible for the operation and oversight of Journey’s Compliance Program. The Compliance Officer may appoint other delegates as necessary to implement the Compliance Program. The Compliance Officer’s responsibilities include, among other things, promoting an atmosphere of responsible and ethical conduct, developing policies and procedures, training employees on the Compliance Program, ensuring all Journey personnel including independent contractors and agents are aware of Compliance Program requirements, addressing allegations of non-compliance, and implementing appropriate remedial measures where applicable. As appropriate, the Compliance Officer will report compliance-related issues directly to the Chief Executive Officer and/or the Board of Directors.

III. Written Standards

Journey has adopted a Compliance Program in an effort to ensure that it and its personnel operate in full compliance with applicable laws including but not limited to all federal and state health care program requirements. The Compliance Program includes a Code of Conduct with core values that include: Respecting Others; Integrity and Honesty, Obeying the Law, Maintaining Confidentiality, Avoiding Conflicts of Interest, and Respecting Property.

Journey’s Compliance Program includes a system of compliance manuals that set forth Journey’s standards and rules to ensure compliance with applicable healthcare laws and regulations and to support ethical business practices. These compliance manuals that set forth the Company’s standards and rules to ensure compliance with applicable healthcare laws and regulations and to support ethical business practices by Journey. These compliance manuals clearly set out the consequences for violations of the law or company policy. Although each situation is considered on a case-by-case basis, Journey will consistently undertake appropriate disciplinary action to address inappropriate conduct and deter future violations.

IV. Education and Training

A key aspect of Journey’s Compliance Program is educating and training its employees on their legal and ethical obligations under applicable laws, regulations, and Journey policies and procedures. Journey provides training on its Compliance Program, policies, how to report suspected violations, applicable laws, regulations and industry codes.

V. Open Lines of Internal Communication

Journey’s policies provide for open and effective lines of communication including:

Having an open-door policy for the discussion and reporting of compliance issues. Journey employees and agents are encouraged to ask when there are compliance related questions;
Development and promotion of several independent reporting paths for employees to report fraud or other potential misconduct;
The reporting paths include a method to protect the anonymity of complainants;
A written non-intimidation and non-retaliation policy are in place to encourage the reporting of potential compliance incidents, as well as prohibit the intimidation or retaliation against an individual for the good faith participation in Journey’s Compliance Program.

VI. Auditing and Monitoring

Journey’s Compliance Program includes:

The incorporation of thorough monitoring of Journey’s Compliance Policies and their implementation and an ongoing evaluation process;
Documentation of the ongoing monitoring and evaluation of Journey’s Compliance Policies by its Compliance Office. The assessments derived from compliance audits will be provided to Journey’s senior management and Board of Directors;
Focus on areas that have substantive involvement with or impact on federal health care programs and on risk areas identified by the OIG and monitoring compliance with applicable government fraud alerts and other governmental guidance.
Compliance audits will specifically evaluate whether:
- a. Journey’s policies cover identified risks areas;
- b. Whether such policies were implemented and communicated;
- c. Whether such policies were followed.

VII. Procedures for Reporting Violations

Journey’s Compliance Program implements a duty and responsibility of Journey employees and any other individuals covered by its compliance program to report any actual or suspected violations of Journey’s policies and procedures, including its Compliance Program, in addition to applicable federal, state or local law. Journey employees must also report any other compliance-related issues, including but not limited to conflicts of interest or misconduct of any type relating to Journey’s operations. Journey employees are trained on and provided information on all ways it can report suspected violations.

VIII. Investigations, Corrective Actions and Sanctions

In the event that Journey becomes aware of any violations of the policies and procedures of its Compliance Program, or any applicable federal, state, or local laws, it will fully investigate the circumstances surrounding the suspected infraction to determine whether a violation has occurred. If a violation is found, Journey will take appropriate corrective action, which may include disciplinary action up to and including termination of employment or contracts.