Novocure is a global oncology business with subsidiaries in the U.S., Europe, and Asia. Novocure’s mission is to improve the lives of cancer patients through the development and commercialization of Tumor Treating Fields as a fourth modality in cancer care. Novocure and its employees are committed to adopting the highest ethical standards in all of its dealings. A key component of this commitment is establishing and maintaining an effective compliance program. Our corporate plan to promote these values is detailed in our Comprehensive Compliance Program (“CCP”). Novocure’s CCP is designed to promote Novocure’s culture of compliance, support Novocure’s compliance with regulations and industry guidance, and prevent and detect violations of law and/or Novocure policy.
Novocure has appointed a Chief Compliance Officer (“CCO”), who is charged with overseeing the CCP and team of compliance professionals. The CCO reports to and has direct access to the CEO. The CCO is charged with developing and enforcing the standards of conduct issued as part of the CCP, implementing a compliance training program, directing and conducting auditing and monitoring activities, investigating allegations of misconduct, and implementing corrective measures, as necessary.
Comprehensive Compliance Plan
The goal of Novocure’s CCP is to prevent, detect, and correct practices or incidents that do not comply with the law or with Novocure’s policies. The United States Office of Inspector General’s (“OIG”) voluntary Guidance for Pharmaceutical Manufacturers (the “OIG Guidance”) and other related laws and regulation serve as the basis of Novocure’s CCP on an ongoing basis. In accordance with the voluntary standards established by the OIG Guidance and as explicitly recognized in the OIG Guidance, Novocure’s CCP has been tailored to fit the size of the Company and the unique environment of the Company’s business as a medical device manufacturer. The CCP is designed to address areas of potential problems or high risk, as determined by the CCO.
Novocure has created a corporate Code of Conduct that all employees have read, acknowledged understanding, and certified to. The Code of Conduct has been adopted by Novocure’s Board of Directors and applies to all Novocure employees, including officers and directors. Novocure’s Code of Conduct has incorporated the Advanced Medical Technologies Code of Ethics on Interactions with Healthcare Professionals (the “AdvaMed Code”) as well as the MedTech Europe Code of Ethical Business Practice. Novocure and its CCO have developed and implemented written policies based on relevant laws, regulations and the OIG Guidance, as appropriate. All of Novocure’s personnel are expected to comply with the Code of Conduct, local codes, and all compliance policies, as applicable to their specific activities.
Novocure is committed to developing and providing effective compliance training for all of its employees, not only on the elements of the CCP, but also on the pertinent federal and state standards. Novocure will periodically conduct internal auditing and monitoring to evaluate compliance with company policies.
Novocure has established internal lines of communications, and requires all employees to promptly report any concerns that they may have regarding violations of the Code of Conduct or the CCP. Concerns may be reported anonymously through the Compliance Hotline at +1 855-379-1486, or online at reportlineweb.com/novocure directly to the CCO, any manager, the HR Department, a member of Senior Management, or the General Counsel.
Novocure will evaluate and investigate all reports, as appropriate. When appropriate, corrective disciplinary action will be imposed.
Novocure may revise and amend the CCP at any time.
SB 1765 Declaration
California law SB 1765, codified at California Business and Professions Code, Sections 119400 to 119402 (the “California law”), requires all pharmaceutical and medical device companies to adopt a comprehensive compliance plan based upon the OIG Guidance and the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the “PhRMA Code”). Consistent with the OIG Guidance, Novocure has tailored its CCP to the nature of our business as a medical device manufacturer. The medical device industry has established, and Novocure’s CCP is designed in accordance with, the AdvaMed Code. The AdvaMed Code is substantially equivalent to the PhRMA Code, but reflects the unique interactions between medical technology companies and healthcare professionals. Novocure believes that our CCP meets the compliance goals set forth in the California Law.
Under the California law, a pharmaceutical or medical device company must also annually declare that it is in compliance with its own comprehensive compliance plan and the requirements of the Sections 119400 to 119402. A pharmaceutical or medical device company must make its comprehensive compliance plan and its annual declaration of compliance available to the public on its website and through a toll-free number. Novocure understands the California statute only imposes obligations for activities directed to California.
Novocure declares that to the best of its knowledge, and based on a good faith understanding of the California statute, as of this date, Novocure is in material compliance with the Comprehensive Compliance Program described above. Ensuring ethical and legal conduct is an ongoing company commitment and as a result, the Comprehensive Compliance Program is intended to be dynamic to meet the Company’s evolving compliance needs and expectations. Therefore, Novocure will continue to develop and refine its Comprehensive Compliance Program.
Annual Spending Limit
The California law requires pharmaceutical and medical device companies to adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the company and its employees and representatives may give or otherwise provide to an individual medical or healthcare professional in California. The limit does not include amounts attributable to samples, financial support for continuing medical education, or payment for legitimate professional services. Novocure has adopted an annual spending limit.
Novocure’s annual spending limit shall be $2500. This limit is neither an average spending limit, nor a targeted spending limit, and Novocure believes that its actual spending will fall short of this limit. The annual limit may be revised from time to time.
A copy of Novocure’s Comprehensive Compliance Plan and this declaration may be obtained by calling +1-603-436-2809.