Elements of an Effective Compliance Program

Endo’s Corporate Compliance Program is led by our Chief Compliance Officer, who reports directly to our CEO and keeps the Board of Directors apprised of substantive compliance matters. This direct line of communication supports the Program’s autonomy.

In addition to oversight by the Board of Directors, Endo has a Global Compliance Committee that is comprised of senior leaders from across the organization. This Global Compliance Committee oversees our Corporate Compliance Program and supports Endo’s strategic approach to compliance across all of our business segments.

Having a robust process to manage compliance risks is one of the main ways the Company can anticipate and mitigate possible risks to the business. The process is co-owned by Corporate Compliance and senior leaders. The Corporate Compliance team partners directly with the business to identify compliance risks through a formal assessment process. The teams then work together to create a risk mitigation plan that tracks all mitigation activities to completion. The periodic review of our risk assessment enables the Company to evolve and revise its risk profile due to changes in our business, compliance and/or legal environments. This feeds into a broader enterprise risk management process that is overseen by our leaders, Senior Executive Team and Board of Directors.

Additional components of the Program are in keeping with the seven fundamental elements of an effective compliance program established by the Office of Inspector General, and other available guidance. For more information on the specific components of Endo’s Corporate Compliance Program, please see the following:

Policies, procedures and standards of conduct The Corporate Compliance Team maintains relevant policies and procedures to provide guidance and direction to employees as well as third parties conducting business on our behalf. These policies set out the overarching compliance framework that applies to the interactions and activities for individuals who engage in or support commercial activities, medical activities, or product development, including those who interact with healthcare professionals or government officials. Additionally, the Company maintains a Code of Conduct that that is based on our Company values. The Code of Conduct provides guidance to employees and contractors for how to conduct themselves in a lawful and ethical manner during their daily activities and interactions.
Training & Education The Company promotes and supports ongoing education and training of team members on legal and regulatory requirements as well as Company policies and procedures. Throughout the year, our employees are required to complete trainings that are relevant for their specific role.
Internal monitoring and auditing Monitoring and auditing activities that are focused on the risks identified during the risk assessment process help us detect and prevent violations of policies, procedures, laws, or regulations. They also allow us to identify trends and learn key lessons that assist us in improving our business practices as well as implementing enhancements to Company policies and procedures. Monitoring and auditing results are reported to respective management for awareness, and remediation when required. Reportable investigative matters are also reported to the Board of Directors for awareness and consideration.
Enforcement of standards through disciplinary guidelines Our policies and trainings provide education to all employees about the importance of adhering to the expectations set forth in Endo policies and procedures. Employees are informed that failure to operate in alignment with Company policies and conduct standards may result in disciplinary consequences, up to and including termination. If disciplinary action is required, it will be issued in a fair and impartial manner, regardless of the position or title of the person who engaged in such conduct. Our policies and procedures also provide that all disciplinary actions will be taken without regard to an individual’s race, color, national origin, religion, age, sex, gender (including gender identity), or any other protected status.
Effective Communication Endo provides multiple channels for asking questions and raising concerns. We foster an open door environment through anti-retaliation and confidentiality policies which encourage and protect employees who raise a valid concern.
Responding to offenses and taking corrective action Corporate Compliance promptly responds to matters that have been raised through one of the many channels of communication available to Endo employees. Compliance concerns are carefully considered and investigated in a thorough, timely and fair manner. Based on the outcome of the investigative process, reports or concerns are concluded with a proper resolution.
Designated Compliance Officer and Compliance Committee Our Chief Compliance Officer reports directly to our Chief Executive Officer and reports significant compliance matters directly to the Board of Directors. Oversight is provided by our Board of Directors through a Compliance Committee that receives at least quarterly updates on Endo’s Corporate Compliance Program.