Introduction

Stallergenes Greer is committed to maintaining the highest ethical standards in conducting its business and adhering to all applicable laws, regulations, and guidelines. In furtherance of that commitment, Stallergenes Greer continues to develop and implement a comprehensive compliance program (“CCP”) for its U.S. operations which is based on guidance from the U.S. Department of Health & Human Services Office of Inspector General, and the PhRMA Code on Interactions with Healthcare Professionals. To our knowledge, as of the date of this declaration, Stallergenes Greer is in compliance with our CCP and the requirements of the California Health and Safety Code §§ 119400–119402. Stallergenes Greer regularly reassesses, modifies, and enhances its CCP on an ongoing basis. The central elements of the CCP are described below.

Written Policies and Procedures

Stallergenes Greer’s CCP is designed to help ensure ethical interactions with healthcare professionals and promotional/marketing practices in compliance with applicable federal and state laws and industry codes, as well as policies and procedures that provide direction to company employees on ethical and compliant behavior. Stallergenes Greer expects its employees to comply with these standards, policies and procedures, and all applicable laws, regulations, and guidelines. Employees must annually acknowledge their responsibility and commitment to conduct Stallergenes Greer’s business consistent with these standards.

In accordance with California Health and Safety Code §§ 119400–119402, Stallergenes Greer has established an annual aggregate spending limit of $2,000 for various educational items and promotional activities which are not prohibited by the PhRMA Code or HHS-OIG Guidance or related federal/state laws or regulations and may be provided to or directed at an individual California medical or health professional.

Compliance Committee

Stallergenes Greer has designated its Head of Legal, Americas to be responsible for overseeing the administration, implementation, and monitoring of the CCP, and the authority to make compliance-related decisions and changes within the company. The Head of Legal, Americas reports directly to the Stallergenes Greer Chief Executive Officer. Further, Stallergenes Greer has established a Compliance Committee that is responsible for assisting in the oversight of the CCP and providing guidance and support to the Head of Legal, Americas. The Compliance Committee reports to the Board of Directors regarding the status of the CCP.

Training and Education

Stallergenes Greer has developed and is continually enhancing/reviewing its training program for employees regarding obligations and responsibilities under the CCP.

Lines of Communication

Stallergenes Greer promotes an environment of open communication, including questions or concerns regarding the CCP. Employees must report any activity or individual that is suspect or in violation of the CCP to their manager, the Compliance Officer, or through use of the Compliance Hotline by calling (844) 990-0002, or emailing reports@lighthouse-services.com. The Compliance Hotline is available 24 hours a day, 7 days a week and allows for confidential, anonymous reporting. Stallergenes Greer does not tolerate retaliation against employees who make reports in good faith.

Auditing and Monitoring Stallergenes Greer’s CCP includes activities designed to audit and monitor compliance with Stallergenes Greer’s policies and procedures. The Compliance Officer oversees monitoring and auditing through use of an audit plan, which includes internal and external auditing activities. The Compliance Officer works with relevant resources to review audit reports regarding the execution of appropriate responses.

Investigations, Corrective Actions, and Disciplinary Policies

Stallergenes Greer promptly and thoroughly investigates any reports of suspect or noncompliant conduct made in good faith. The CCP includes disciplinary actions to be implemented as appropriate upon determination that noncompliant conduct has occurred. Each situation is evaluated and handled on a case-by-case basis, and based on the severity of the circumstances, the disciplinary and corrective actions may vary. If disciplinary action is warranted, subject to local law, it may range anywhere from a warning to termination of employment. Stallergenes Greer also implements corrective and preventive actions, as appropriate. Corrective and preventive actions may include, but are not limited to, editing compliance policies and procedures, increasing auditing and monitoring, and revising the training program.

This Compliance Declaration was updated as of August 1, 2020.

Please call (828) 754-5327 for a copy of this declaration of compliance and a description of Stallergenes Greer’s CCP.