Commitment to Corporate Compliance

Tanabe Pharma America, Inc. (TPA) is committed to conducting its affairs in compliance with all applicable law and industry practices. TPA’s comprehensive Compliance Program aims to ensure that TPA operates at the highest ethical standard. To that end, TPA has equipped its Compliance Program with the resources and authority necessary.

TPA’s Compliance Program has been designed in accordance with recommendations provided by the U.S. Department of Health and Human Services (HSS) Office of the Inspector General (OIG) and the Pharmaceutical Research and Manufacturers of America (PhRMA). The Compliance Program aims to prevent violations of law and company policy, and to detect and resolve potential violations. Regular updating to the program helps ensure that the Compliance Program remains viable and effective.

Compliance is the culture of TPA and is the responsibility of every person at TPA. TPA encourages open lines of communication, fosters an open-door environment, offers an anonymous compliance hotline (1-888-209-5640) and has a clear anti-retaliation policy.

Written Policies and Procedures:

TPA’s Code of Conduct reflects the principles of corporate responsibility and integrity that all TPA personnel must strive to embody. All TPA personnel certify that she or he has read and agrees to abide by the Code and TPA’s written policies and procedures.

TPA’s written policies and procedures cover its business activities across a wide array of legal, regulatory, business and governance perspectives. These policies and procedures are certified by TPA personnel and applied to those suppliers and service providers who contract with TPA.

Compliance Personnel:

TPA’s Head of Compliance is responsible for overseeing and administering TPA’s Compliance Program. In that regard, the Head of Compliance owns the authority to exercise appropriate professional judgment regarding the Compliance Program. The Head of Compliance reports directly to the General Counsel for the Americas region.

The Legal and Compliance Department and the Head of Compliance work closely with TPA’s President and senior leadership to implement TPA’s Compliance Program, including issuing policies and procedures, providing training and education, promoting open lines of communication, monitoring and auditing, and performing other duties as directed by the TPA Board of Directors.

Effective Training and Education:

TPA provides online and live training and compliance education to TPA personnel. This includes comprehensive new-hire training, annual updated training, and online compliance training and targeted live training based on risk-assessments and the advice of the Legal and Compliance Department.

Effective Lines of Communication:

TPA has an open door policy that encourages TPA personnel to be forthright in discussing any concerns, problems, suggestions or other issues with supervisors, managers, human resources personnel, Officers of the corporation, Board Members of the corporation, the Legal and Compliance Department members or via the anonymous reporting hotline, under a policy prohibiting retaliation.

TPA personnel are encouraged to direct compliance-related questions or concerns to their supervisor, Human Resources, the Legal and Compliance Department, Officers of the corporation, or Board Members of the corporation. Moreover, TPA offers an anonymous compliance hotline (1-888-209-5640) that allows anyone to raise concerns anonymously and in a confidential manner.

Internal Monitoring and Auditing:

Internal auditing and monitoring are a part of TPA’s Compliance Program to discover and address risks to its business activities.

Enforcement:

TPA’s corporate policies and procedures, including TPA’s Code of Conduct, make it clear that there are consequences for failure to adhere to TPA’s compliance mission—including disciplinary action. TPA’s corporate policies and procedures are published and provided to all TPA personnel.

Prompt Response & Corrective Actions:

TPA’s Compliance Program is designed so that compliance deviations or issues will be reviewed and investigated in a timely and appropriate manner. If necessary after completion of an investigation, on the recommendation of the Head of Compliance and the advice of legal counsel, TPA will take all appropriate corrective actions.