2016 Annual Declaration of Compliance
Based on our good faith understanding of the statutory requirements, Zogenix Inc. believes that its Corporate Compliance Program meets the requirements of Chapter 8, Part 15, Division 104 of the California Health and Safety Code (§§ 119400-119402). Zogenix also believes that it complies with its Corporate Compliance Program in all material respects.
Zogenix's Compliance Policies and Procedures are available upon request at any time. If you would like to receive a printed version of this Annual Declaration of Compliance or Zogenix's Compliance Policies and Procedures, please call 1-866-ZOGENIX (1-866-964-3649) and request a printed copy of Zogenix's Annual Declaration of Compliance and/or the Compliance Policies and Procedures.
The Office of the Inspector General has recognized in its Compliance Program Guidance for Pharmaceutical Manufacturers, that the implementation of an effective compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer. By making this declaration, Zogenix is not asserting that in all circumstances it can prevent individual employees from conduct that deviates from its policies. Zogenix expects employees to comply with its Comprehensive Compliance Policies and has made a good faith effort to enforce its Compliance Policies, prevent violations, and address any inappropriate conduct that may occur.
Dated: July 31, 2016
Zogenix is committed to operating with integrity, honesty and in accordance with the law. As a publicly-traded, pharmaceutical company we are subject to various federal, state and local laws and regulations. The Company Compliance Program is adopted to assist in directing compliance with these various laws and regulations and maintaining high ethical standards. The Compliance Program applies to our officers, directors, employees and, in certain situations, our agents and independent contractors. It is our expectation that all company representatives will comply with this Compliance Program as well as the policies and procedures covered by it, including our Compliance Policy Guide and our Code of Business Ethics. We conduct training of our company representatives on the Compliance Policy Guide and have established processes for identifying potential violations. In the event that we become aware of violations of law or company policies or procedures, we will investigate and if appropriate, implement corrective measures to prevent future violations.
We regularly monitor and reassess the Company Compliance Program as well as the policies and procedures covered by it in order to improve its content and coverage. The Board of Directors may amend or supplement this Compliance Program at any time. Zogenix prescribes to the below fundamental seven elements discussed in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of the Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”).
1. DESIGNATION OF A COMPLIANCE OFFICER AND COMPLIANCE COMMITTEE
Zogenix has appointed a Compliance Officer, who is charged with developing, operating and monitoring the Compliance Program and chairing the Company Compliance Committee. The Compliance Officer reports directly to the President and has direct access to other members of senior management and the Zogenix Board of Directors providing necessary compliance updates and input when needed. A Compliance Committee has been established to advise the Compliance Officer and assist in compliance investigations and recommendations in regards to the Compliance Program. The Compliance Committee consists of members from functional units across the company.
2. WRITTEN COMPLIANCE POLICIES AND PROCEDURES
Zogenix has established written policies and procedures to ensure compliance with various laws and regulations, including the Code, the Policy Guide and numerous other policies and procedures that outline our commitment to compliance and corporate accountability. The standards set forth in the policies and procedures apply to all employees according to their job function and responsibilities, and adherence to the applicable company’s policies and procedures is a condition of employment. Zogenix expects all officers and managers to ensure that their employees are trained on the pertinent policies and procedures and that their employees adhere to these policies and procedures, applicable laws, guidance and regulations.
We have policies and procedures that address risk areas identified in the OIG Guidance and comply with the Pharmaceutical Research and Manufacturers of America voluntary “Code on Interactions with Healthcare Professionals.”
Zogenix in accordance with California Health and Safety Code Sections 119400-119402 has established spending limits of $2,500 on meals or promotional educational items directed toward individual California healthcare professionals.
3. EFFECTIVE EDUCATION AND TRAINING
All company representatives receive general compliance training on the Company Compliance Program, the Compliance Policy Guide and the Code as well as training on policies and procedures applicable to their job function and responsibilities. Specialized training occurs in specific departments where a need for additional training has been identified. Company representatives are trained on how to report compliance concerns through appropriate channels, including anonymously either online or via telephone.
4. ESTABLISHED EFFECTIVE LINES OF COMMUNICATION
A variety of internal communications tools exist for communicating compliance issues and concerns including meetings and emails. Company representatives are required to report known or suspected violations of laws, or the company’s policies or procedures, to their supervisor or the Compliance Officer. Any reported information shall remain confidential to the extent possible consistent with the law and our need to investigate the potential violation. We will not retaliate or take adverse action against any company representative who, in good faith, seeks help or who reports known or suspected violations. If an individual who reports a violation is directly involved in the violation, the fact that he or she reported the violation will be given appropriate consideration in any resulting disciplinary action.
Employees are encouraged to first speak with their supervisor or the Compliance Officer and have the option to anonymously raise concerns about potential illegal behavior or violations of our policies or procedures through the Company hotline at 1-877-775-6750. Reports will be forwarded to the Compliance Officer for response or investigation.
Copies of the Company Compliance Policy Guide and the company’s annual declaration of compliance required by California Health and Safety Code Sections 119400-119402, are available to the public upon request.
5. INTERNAL AUDITING AND MONITORING
Zogenix will conduct auditing and monitoring activities designed to assess compliance with the Company Compliance Program and our various policies and procedures as well as the need for future policies and procedures. Results are reported to the Compliance Committee and to appropriate managers.
6. PROMPT RESPONSE TO POTENTIAL VIOLATIONS THROUGH CORRECTIVE ACTION
When Zogenix believes that an employee has violated a law or company policy, we investigate the matter quickly and take appropriate disciplinary action in order to address the violation and prevent future violations.
7. ENFORCING OF DISCIPLINARY STANDARDS
Zogenix enforces discipline for violations of its compliance policies through its well publicized standards and guidelines.