PaxVax Social Community Guidelines
PaxVax California Comprehensive Compliance Program and Declaration of Compliance
PaxVax, Inc. is committed to establishing and maintaining a comprehensive compliance program in accordance with California SB 1765 (California Business & Professions Code 119400, 119402), and the Office of Inspector General, US Department of Health and Human Services, “Compliance Program Guidance for Pharmaceutical Manufacturers” (the “OIG Guidance”).
Our Comprehensive Compliance Program reflects our unwavering commitment to the highest standards of corporate conduct and integrity.
PaxVax Comprehensive Compliance Program Description
The PaxVax Comprehensive 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 Comprehensive Professionals” (the “PhRMA Code”). We believe that our Comprehensive Compliance Program is scalable to address the size, organizational structure and operations of our company. Furthermore, the PaxVax Comprehensive Compliance Program is regularly reviewed and evaluated to help ensure it continues to meet the evolving needs of our company.
PaxVax Comprehensive Compliance Program Overview
Leadership and Structure
PaxVax has appointed a Compliance Officer, who is charged with establishing, operating and monitoring the PaxVax Comprehensive Compliance Program. PaxVax has also established a Compliance Committee (the “Compliance Committee”) to advise and assist the PaxVax Compliance Officer in the implementation of the Comprehensive Compliance Program. The Compliance Committee is comprised of senior management from functional units across PaxVax. It meets on a regular basis to assess the PaxVax Comprehensive Compliance Program, evaluate its effectiveness and identify areas for enhancement.
The PaxVax Compliance Officer has direct access to the Compliance Committee and other members of senior management and to the PaxVax Audit Committee (the “Audit Committee”). The PaxVax Compliance Officer provides periodic reports on the status of the PaxVax Comprehensive Compliance Program to the Compliance Committee and Audit Committee.
PaxVax has established written policies and procedures to ensure compliance with the OIG Guidance and PhRMA Code, including our Code of Business Conduct, our Policy on Interactions with Healthcare Professionals and other complimentary policies and procedures that outline our commitment to compliance and corporate accountability. The standards set forth in these policies apply to all PaxVax employees, and adherence to company policies is a condition of employment.
PaxVax does not permit gifts, promotional materials, items or activities prohibited by the PhRMA Code or the OIG Guidance. For items and activities that are not prohibited, PaxVax has set a cumulative annual spending limit of $2,500 per healthcare professional.
Education and Training
Each PaxVax employee is required to receive compliance training applicable to their job function and responsibilities, including training on the PaxVax Comprehensive Compliance Program and applicable PaxVax policies. In addition, further specialized training may be provided where a need for additional training has been identified. Annual compliance training is required of all employees who engage in, or support, commercial activities. PaxVax regularly reviews and updates its training programs to help ensure it continues to meet the educational needs of its employees.
Internal Lines of Communication
PaxVax 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 noncompliance without fear of retribution. We have established a confidential and anonymous Hotline that is available for reporting known or suspected violations of the law or PaxVax policies.
Auditing and Monitoring
PaxVax recognizes that a comprehensive auditing and monitoring plan is critical to maintain the effectiveness of the PaxVax Comprehensive 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. Auditing and monitoring results are reported to the PaxVax Legal department, the Compliance Committee and senior management in order to help guide PaxVax’s compliance risk-assessment process.
Responding to Potential Violations
The purpose of the PaxVax Comprehensive Compliance Program is to prevent and detect violations of law or regulation or PaxVax 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 our expectation that all employees will comply with the PaxVax Comprehensive Compliance Program and the policies established in support of such program. In the event that we become aware of violations of law or regulation or PaxVax policy, we will promptly investigate the matter and, where appropriate, take action and implement corrective measures to address potential policy gaps and prevent future violations.
Corrective Action Procedures
A key element of the PaxVax Comprehensive Compliance Program is to provide clear disciplinary policies that set out the consequences of violating law or regulation or PaxVax policy. After investigation of a reported or detected issue, PaxVax 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 further violations.
PaxVax Declaration of Compliance
PaxVax declares, in good faith, that as of July 1, 2016 it is in substantial compliance with its Comprehensive Compliance Program and the requirements of California SB 1765. Our declaration is based upon an analysis of information available as of such date.