OptiNose US, Inc. and its parent, affiliate, and subsidiary companies (collectively, “Optinose”) are committed to conducting business in compliance with all applicable federal and state laws and regulations. To that end, Optinose has established and maintains an effective Compliance Program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”). Our Compliance Program is a key component in fostering a culture of compliance and represents our commitment to transparent and ethical business practices.
The primary purpose of our Compliance Program is to help prevent, detect, and remediate violations of law, regulations, and Company policies. As the OIG Guidance recognizes, the implementation of such a program cannot guarantee that improper conduct will be entirely eliminated. Nonetheless, it is Optinose’s expectation that employees will comply with the policies and procedures established in support of our Compliance Program. In the event that Optinose becomes aware of violations of law or Company policy, we will investigate the matter and, where appropriate, take appropriate disciplinary action and implement corrective measures to prevent future violations.
Following is a brief summary of the components to our Compliance Program. To request a copy of the Optinose Compliance Program overview, please email firstname.lastname@example.org.
Optinose has implemented a Code of Conduct, which captures our fundamental values and outlines the policies and legal requirements that apply to our business. The Code is further supported by a comprehensive set of healthcare compliance policies governing our general business operations as well as those activities specifically related to the marketing and sale of our products and interactions with healthcare professionals.
Raegan McClain serves as Optinose’s Chief Compliance Officer and head of the Compliance Department. Optinose is committed to ensuring that the Compliance Department is afforded appropriate resources to maintain an effective Compliance Program and effect change within the organization as necessary.
Training and Education
Critical to the success of the Compliance Program is each individual’s understanding of the policies established as part of that Program. Optinose is focused on communicating Company policies and procedures to its employees and other personnel to ensure a thorough understanding of and appreciation for how to conduct business practices appropriately. The Company also will regularly review and update its training efforts to ensure effectiveness and identify additional areas of training.
Lines of Communication
Optinose promotes open dialogue between management and employees in seeking guidance and reporting concerns about non-compliance. All employees have a responsibility to report suspected misconduct and are encouraged to discuss matters with their supervisor, other members of the management team, or the Compliance Department. Matters may also be reported to the Optinose Compliance Hotline. Optinose further prohibits retaliation against any individual who reports a concern in good faith.
Auditing and Monitoring
Optinose utilizes auditing and monitoring to verify that the business practices engaged in by its employees follow the policies and procedures that are in place to ensure compliance with the laws and regulations applicable to the Company. The Compliance Department identifies areas of potential risk on which to focus its auditing and monitoring, and the extent and frequency of these activities varies according to a number of factors, including new regulatory requirements and changes in business practices.
Failure to comply with our Compliance Program will be treated as a breach of Company policy and will result in appropriate disciplinary action, up to and including termination. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address matters of non-compliance and deter future violations.
Investigations and Corrective Actions
Optinose will investigate suspected non-compliance with its policies and procedures as well as all applicable laws and regulations in a manner designed to promptly and accurately ascertain the facts and to determine the underlying cause or causes of any substantiated, non-compliant conduct. The Legal and Compliance Departments will direct investigations of suspected non-compliance, document the nature and results of such investigations, and collaborate with others as needed to ensure appropriate corrective action is taken to prevent future violations.
State Compliance Declarations
California Annual Declaration of Compliance
July 1, 2017
This information is provided pursuant to the requirements of California Health and Safety Code, Sections 119400 – 119402, which requires pharmaceutical companies doing business in California to make available their Compliance Program and annual written declaration of compliance with the Compliance Program.
Optinose has adopted a Comprehensive Compliance Program in accordance with California Health and Safety Code, Sections 119400 – 119402. This Program is tailored to its current size and business operations and continues to develop as compliance and operational needs evolve. To the best of its knowledge and based on its good faith understanding of the statutory requirements, Optinose declares that it is in compliance with this Program and the statutory requirements in all material respects, as of the above date.
California Transparency in Supply Chains Act Disclosure
Optinose is committed to ensuring that our supply chain reflects the Company’s values and respect for human rights and the environment. Optinose’s relationships with suppliers are based on lawful, efficient, and fair practices. We expect our suppliers to obey the laws that require them to treat workers fairly, provide a safe and healthy work environment, and protect environmental quality. In furtherance of this expectation, Optinose obligates its suppliers by contract to comply with all applicable laws and regulations, including those relating to slavery and human trafficking of the country or countries in which they are doing business.
Optinose Compliance Hotline
Every Optinose employee has a responsibility to report suspected violations of Company policy, law, regulation, or ethical principles applicable to Optinose. Such reports may be made without fear of retaliation, if done in good faith. In most cases, employees should discuss a matter of suspected non-compliance with their immediate supervisor and/or Optinose’s Compliance Department. However, if an employee is not comfortable raising a concern in this manner, they may also make a report via the Optinose Compliance Hotline. The Compliance Hotline is managed by an outside, independent service provider and all calls will be treated (to the extent possible) confidentially and, if requested, anonymously. Identity may have to be disclosed to conduct a thorough investigation and to comply with legal requirements.
Optinose Compliance Hotline
Written communications may also be received by the Optinose Chief Compliance Officer at the below address.Optinose Chief Compliance Officer
1020 Stony Hill Road, Suite 300
Yardley, PA 19067
Commitment to Transparency
At Optinose, we are focused on delivering safe and effective treatments to patients and healthcare professionals. To help ensure the availability of new treatment options, we may work and innovate with other individuals and organizations including physicians and teaching hospitals. We are fully committed to the financial transparency of these relationships and to preventing any real or perceived conflict of interest.
Under federal law and implementing “Sunshine” regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS), any payment or other transfer of value from the manufacturer of a commercial pharmaceutical drug or medical device product made to a physician or teaching hospital is subject to tracking and potential public reporting. Certain states have also enacted similar compliance laws relating to transparency of interactions with healthcare professionals which often cover additional categories of healthcare professionals and are separate from, and in addition to, the federal reporting requirements.
Adverse Event Reports and Product Complaints
Optinose has implemented procedures which allow adverse event information and product complaints to be reported to the Company. This may include information regarding an adverse event experienced by a patient who is currently using, or who recently used, an Optinose product. The procedures in place allow product complaints and adverse event reports to be documented and handled in accordance with applicable laws and regulations. Company personnel who become aware of an adverse event or product complaint must report it by calling 833-678-6673 within 24 hours of becoming aware of the potential adverse event or product complaint.