HEALTHCARE COMPLIANCE PROGRAM OVERVIEW

Ono Pharma USA is committed to doing business in an ethical manner and in compliance with all applicable laws, regulations and industry standards.

We have implemented a healthcare compliance program based on the fundamental elements outlined in the Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers. The program is designed to foster compliance with the laws, regulations and guidelines that apply to our business, to train our employees on these matters, and to prevent, detect and correct instances of non-compliance. We assess our compliance program periodically to meet our evolving compliance needs and to ensure consistency with additional laws and guidance.

The program includes a Code of Business Ethics and Standards of Conduct that helps to guide our daily operations and is supplemented by more detailed compliance policies and guidelines that address risk areas relevant to pharmaceutical manufacturers and are consistent with the Pharmaceutical Research and Manufacturers of America Code on Interactions with Health Care Professionals (PhRMA Code).

Our Compliance Officer has overall responsibility for oversight of our compliance program. In this role, our Compliance Officer has direct access to our President/CEO and Board of Directors concerning operation of our compliance program. We have also appointed a compliance committee to advise and assist our Compliance Officer in the implementation and monitoring of our compliance program.

We are committed to effectively and timely training employees on the policies and guidelines relevant to their job function and responsibilities.   We regularly review and update our training programs to ensure that they meet our educational needs.

We encourage open communication. We encourage our employees to ask questions about any activity that may present risk and to seek advice about interpretation and best application of our policies and other elements of our compliance program. Our employees, officers and directors are also expected to promptly report potential, suspected, planned or actual violations of our policies and guidelines or applicable laws that govern our activities. Reports of potential instances of inappropriate activity can be made to an employee’s manager, Human Resources, Legal or directly to our Compliance Officer. 

Acts of retaliation or retribution against any person who in good faith reports a potential, suspected, planned or actual violation of our policies and guidelines and/or applicable laws is strictly prohibited by our Code of Business Ethics and Standards of Conduct.

Our Compliance Officer promptly reviews all reports of possible violations to assess the need for an investigation. As appropriate, an investigation into potentially non-compliant activity will be conducted to determine whether a violation of our compliance program has occurred. We take corrective actions when it has been determined that a violation has occurred. Such corrective actions will be appropriate for the severity of the violation. Corrective actions may include appropriate disciplinary measures, up to and including termination, new or revised policies and procedures, new or revised monitoring and auditing protocols, additional training and other internal controls and information systems to prevent future non-compliance.