California Comprehensive Compliance Program
Exelixis, Inc. is committed to establishing and maintaining a comprehensive and effective compliance program in accordance with California SB 1765 (California Business & Professions Code 119400, 119402), and the Office of Inspector General, U.S. Department of Health and Human Services, "Compliance Program Guidance for Pharmaceutical Manufacturers" (OIG Guidance).
Our Compliance Program reflects our unwavering commitment to the highest standards of corporate conduct and integrity.
COMPREHENSIVE COMPLIANCE PROGRAM DESCRIPTION
The Exelixis Compliance Program, described in further detail below, contains policies, procedures and processes to address risk areas identified in the OIG Guidance and the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals” (the “PhRMA Code”). We believe that our Compliance Program is scalable to address the size, organizational structure and operations of our company. As recommended by the OIG Guidance, the Exelixis Compliance Program is regularly reviewed and evaluated to help ensure it continues to meet the evolving needs of our company.
COMPLIANCE PROGRAM OVERVIEW
1. Leadership and Structure
Chief Compliance Officer. Exelixis has appointed a Chief Compliance Officer, who is charged with establishing, operating and monitoring the Compliance Program, including oversight of healthcare compliance. The Chief Compliance Officer has direct access to the Exelixis Board of Directors and senior management, and provides regular reports on the status of the Compliance Program.
Healthcare Compliance Committee. Exelixis has formed a Healthcare Compliance Committee to advise and assist the Chief Compliance Officer in the implementation of the Compliance Program. The Healthcare Compliance Committee is comprised of leadership from relevant functional units across the company. It meets on a regular basis to assess operational risks and potential compliance concerns facing the company and to identify areas of enhancement for the Compliance Program. The Healthcare Compliance Committee also has a direct line of communication into the Ethics Committee, which is the senior management governance body that supports the Board of Directors (“Board”) in overseeing company activities in the areas of corporate responsibility and business ethics, risk management, quality, and compliance.
2. Written standards
Exelixis has established written policies and procedures to ensure compliance with the OIG Guidance and PhRMA Code, including the Code of Conduct and Business Conduct Manual, and other complimentary policies that outline the company’s commitment to compliance and corporate responsibility. The standards set forth in the policies apply to all Exelixis employees and adherence to company policies is a condition of employment.
Exelixis does not permit gifts, promotional materials, items, or activities prohibited by the PhRMA Code, OIG Guidance, or FDA regulations. For items and activities that are not prohibited, Exelixis has set a cumulative annual spending limit of $2,500 per healthcare professional, outside of the context of legitimate investigative and consultative arrangements. We track and monitor compliance with this promotional spending limit to the best of our ability and will modify our internal processes as necessary.
3. Education and Training
All employees are required to receive compliance training applicable to their job function and responsibilities, which includes training on the Compliance Program and Exelixis policies. In addition, further specialized training may be provided where a need for additional training has been identified. Annual healthcare compliance training is required of all employees, contractors and agents who engage in, or support, commercial activities. Exelixis regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees.
4. Internal Lines of Communication
Exelixis is committed to open dialogue between management and employees. 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. We have established a confidential and anonymous Exelixis Hotline number that is available 24 hours a day, seven days a week for reporting known or suspected violations of Exelixis policies.
5. Auditing and Monitoring
Exelixis recognizes that a comprehensive auditing and monitoring plan is 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. As appropriate, auditing and monitoring results will be reported to the Legal department and senior management in order to help guide the Exelixis risk-assessment process.
6. 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 entirely eliminated. Nonetheless, it is Exelixis' expectation that employees will comply with the Compliance Program, and the policies established in support of such program. In the event that Exelixis 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 gaps and prevent future violations.
7. 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, practices, training or internal controls, and take action to prevent future violations.
8. Exelixis Declaration of Compliance
Exelixis, Inc. declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California Health and Safety Code § 119400 and 119402, as of July 17, 2015, Exelixis, Inc. believes that it is maintaining a comprehensive Compliance Program in compliance with the requirements of California SB 1765.
For a copy of this Comprehensive Compliance Program Policy, please call 650-837-7000 or email email@example.com.