Ethics and Compliance

We’re committed to the ethical standards outlined below, and to conducting
our work with professionalism.

Ethics & Compliance Program

Axogen has established and maintains an effective compliance program in accordance with federal, state, and industry regulations and guidelines 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 (The “HHS-OIG Guidance”). We are committed to the highest standards of business conduct, and this Compliance Program is a key component of our efforts to ensure these standards are met.

The aim of our Compliance Program is to help prevent, detect, and remediate violations of law, regulations, or Company Policies with respect to the marketing of our products. The HHS-OIG Guidance recognizes that the implementation of such a program cannot guarantee the complete elimination of improper employee conduct. It is Axogen’s expectation that employees will comply with our Code of Business Conduct and Ethics, Code on Interactions with Health Care Professionals (“Health Care Code”), and our policies established in support of such Codes. In the event that we become aware of violations of law, regulations, or our Company Policies, we will investigate the matter and, where appropriate, take disciplinary action and implement corrective measures to prevent future violations.

Speaking Up

Critical to the success of any compliance program is maintaining and fostering a culture where employees and others feel comfortable to speak up by asking questions, raising concerns or offering ideas, without fear of retaliation.

Axogen employees are encouraged to have open communications with their manager(s), HR partners, and the Compliance Department directly.

Axogen maintains an anonymous and confidential 24-hour Ethics & Compliance hotline that provides individuals, whether employed by Axogen or not, the means to raise concerns over any Axogen activity that may be inconsistent with any law, regulation, company policy or our Codes.

Individuals who wish to remain anonymous may report to our Ethics & Compliance Hotline by using our online reporting tool available at axogeninc.ethicspoint.com or calling (844) 989-2990.

Transparency

Axogen collaborates with Health Care Professionals (“HCPs”) and Teaching Hospitals to pursue its mission. We are committed to transparency in these relationships.

In the United States, the Sunshine Act and various State healthcare transparency disclosure laws require that medical device and pharmaceutical manufacturers publicly report payments or transfers of value made to U.S. licensed HCPs or Teaching Hospitals on an annual basis. The Sunshine Act is administered by the Center for Medicare & Medicaid Services (“CMS”). Axogen’s data regarding payments or transfers of value made to HCP’s and Teaching Hospitals is publicly available and can be found on the CMS Open Payment Database.

Further information regarding the Sunshine Act/Open Payments Program can be found in the following links:

Contact us with your questions:

Questions?

Contact us at Compliance@axogeninc.com

Code of Business Conduct and Ethics

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Anti-fraud policy

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Anti-human trafficking policy

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CA Comprehensive Compliance Program and Declaration of Compliance

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Axogen code on interactions with HCPs (“Health Care Code”)

View code

Whistleblower policy

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Business partners code of conduct

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MAT-US-CORP-0189 V1.0