Indivior PLC Corporate Compliance Program

Introduction

Indivior PLC, (the “Company”) has established a program, in accordance with the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals (PhRMA Code) and the Compliance Program Guidance for Pharmaceutical Manufacturers published by the U.S. Department of Health and Human Services Office of Inspector General in April 2003 (OIG Guidance), designed to materially comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products.

Overview of Compliance Program

  1. Written Policies and Procedures

The Company has written policies to assure substantial compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. The Company has established written policies that govern activities involving interactions with our customers regarding the appropriate use of our products including appropriate instruction, education, training, and technical support required for the safe and effective use of our products. The Company also has policies governing activities involving the advancement of scientific and educational activities supporting medical research and education.

It is our policy not to provide entertainment such as sporting events or golf outings to customers. The Company has established an annual limit of $3,500.00 for meals and educational items as the aggregate value of the items or activities that may be provided to California healthcare professionals.

  1. Assigned Compliance Officer

The Company has appointed a Vice President, Corporate Compliance, who has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.

In addition, a Corporate Compliance Committee has been formed. This committee is chaired by the Company’s VP, Corporate Compliance and members of the company’s North America Management Team.

  1. Training

The Company has an annual Corporate Compliance Training process that is mandated for all employees. New associates received training at the time of hire and annually thereafter. The training covers applicable guidelines governing our compliance program.

  1. Communication

The Company encourages open and candid discussion between management and employees regarding any compliance concerns. The Company personnel are encouraged to report their concerns to their manager, to the Human Resources Department, or to the Company’s Legal Department or Corporate Compliance Department. The Company personnel also have the option to report potential violations by calling the Company’s EthicsLine at 1-855-881-7196.

  1. Auditing and Monitoring

The Company self-assesses and audits its compliance programs and reviews policies and procedures periodically. Audit observations are tracked to ensure timely closure of any identified items.

  1. Enforcement and Disciplinary Guidelines

The Company will take disciplinary actions in response to violation of the company’s compliance policies or procedures. An investigation of any matter that is brought to the company’s attention will occur and will be brought to closure in a timely manner.

  1. Responses to Detected Problems and Actions to Correct Issues

The Company responds promptly to any potential violations of the Company’s compliance program. Reponses may include additional training, enhanced communications, refinement of policies, or possible disciplinary actions.

 

Last update: June 30, 2016