Sumitomo Pharma America, Inc. Compliance Program

Effective: July 1, 2023


Sumitomo Pharma America, Inc. (SMPA) is committed to establishing and maintaining a comprehensive and effective compliance program (“Compliance Program”) in accordance with the “Compliance Program Guidelines for Pharmaceutical Manufacturers” published by the Office of Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”) and California SB 1765 (California Health and Safety Code §§ 119400 and 119402). SMPA’s Compliance Program reflects its unwavering commitment to the highest standards of corporate conduct and integrity.

The SMPA Compliance Program, as described in further detail below, addresses risk areas identified by the OIG Guidance and the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals” (the “PhRMA Code”). SMPA’s Compliance Program is scalable to address the size, organizational structure, and operations of our company. As recommended by the OIG Guidance, the SMPA Compliance Program is regularly reviewed and evaluated to ensure that it continues to meet changing legal requirements and the evolving needs of our company.

Compliance Program Overview

  1. Governance

    Compliance Officer: The Chief Compliance Officer is responsible for developing, operating, and monitoring this Compliance Program. The Chief Compliance Officer has direct access to the SMPA Board of Directors and senior management and provides regular reports on the status of the Compliance Program.

    Compliance Committee: SMPA has established an internal Compliance Committee to support the Chief Compliance Officer in the implementation of this Compliance Program. The internal Compliance Committee’s membership includes senior leaders across various functions within the Company.

  2. Written Standards

    SMPA has established written policies and procedures to ensure compliance with the OIG Guidance and PhRMA Code, including the Code of Business Conduct and Ethics, Healthcare Compliance Manual, and other policies that detail the company’s commitment to compliance and corporate responsibility. SMPA regularly evaluates its policies to ensure continued compliance with these rules. The standards set forth in the policies and procedures apply to all SMPA personnel and adherence to them is a condition of employment.

    SMPA does not permit gifts, promotional materials, items, or activities prohibited by the PhRMA Code, OIG Guidance, or FDA regulations. In addition, as required by the state of California , SMPA has established an annual, aggregate dollar limit of $2,500 on applicable items of value provided to each healthcare provider or other medical/health professional who is licensed or practicing in the state. The limit includes the value of legitimate educational items and meals provided in connection with business and educational discussions/presentations. In accordance with California law, this limit does not include the value of drug samples that are intended for free distribution to patients or payments associated with legitimate consulting and/or advisory services performed by such healthcare professionals. We track and monitor compliance with this annual spending limit and update our internal processes as appropriate.

  3. Internal Lines of Communication

    Ensuring dialogue between management and employees is a key component of our Compliance Program. Our goal is to foster a “speak up” culture where employees may ask questions or report potential instances of inappropriate activity without fear of retribution. Such reports may be communicated anonymously and confidentially through the SMPA Compliance Hotline, which is operated by an independent, third-party and always available by phone and on the internet. The phone number and web address can be found on the “Contact Us” page of the Company’s website.

  4. Auditing and Monitoring

    SMPA recognizes that auditing and monitoring are critical to maintaining the effectiveness of a Compliance Program. The subject of our auditing and monitoring assessments, as well as the extent and frequency of our reviews, may vary according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations, and are scaled to address the size, organizational structure and operations of our company. As appropriate, auditing and monitoring results will be reported to senior management to help guide and inform the SMPA risk assessment process.

  5. Responding to Potential Violations

    The purpose of our Compliance Program is to prevent and detect violations of law or company policy. As the OIG Guidance recognizes, however, the implementation of such a program cannot guarantee that improper employee conduct will be eliminated. Nonetheless, it is SMPA’s expectation that SMPA personnel will comply with the Compliance Program and the policies established in support of such program. If SMPA becomes aware of violations of law or company policy, we will promptly investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to address potential policy or internal controls gaps and prevent future violations.

  6. Corrective Action Procedures

    A key element of the Compliance Program is to provide clear disciplinary policies that set out the consequences of violating the law or company policy. After investigation of a reported or detected issue, the company will assess whether disciplinary action is appropriate, and whether a violation is in part due to gaps in our policies, training, or internal controls, and act to prevent future violations.