Company: OFIX
Filing Date: 2025-02-25
Form Type: 10-K
Source: 0000950170-25-026066
Chunk: 98

Company: Orthofix Medical Inc.
Filing Date: 2025-02-25
Form: 10-K
Item: Item 1
Chunk 98
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 rights under such assignments or licenses in exchange for lump-sum payments or arrangements under which we pay a percentage of sales to the licensor. However, while assignments or licenses to us generally are irrevocable, no assurance can be given that these arrangements will continue to be made available to us on terms that are acceptable to us, or at all. The terms of our license and assignment agreements vary in length from a specified number of years, to the life of the patents, or for the economic life of the product. These agreements generally provide for royalty payments and termination rights in the event of a material breach. 

Compliance and Ethics Program 

It is our fundamental policy to conduct business in accordance with the highest ethical and legal standards. We have a comprehensive compliance and ethics program, which is overseen by a Chief Compliance and Risk Officer, who reports directly to our Chief Executive Officer and the Compliance and Ethics Committee of the Board of Directors. The program is intended to promote lawful and ethical business practices throughout our domestic and international businesses. It is designed to prevent and detect violations of applicable federal, state, and local laws in accordance with the standards set forth in guidance issued by the U.S. Department of Justice ("U.S. DOJ") ("Evaluation of Corporate Compliance Programs" (updated March 2023)), the Office of 

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Inspector General (HCCA-OIG "General Compliance Program Guidance" (November 2023)), and the U.S. Sentencing Commission ("Effective Compliance and Ethics Programs" (November 2014)). Key elements of the program include: 

•Organizational oversight by senior-level personnel responsible for the compliance function within the Company; 

•Written standards and procedures, including a Corporate Code of Conduct; 

•Methods for communicating compliance concerns, including anonymous reporting mechanisms; 

•Investigation and remediation measures to ensure a prompt response to reported matters and timely corrective action; 

•Compliance education and training for employees and contracted business associates; 

•Auditing and monitoring controls to promote compliance with applicable laws and to assess program effectiveness; 

•Disciplinary guidelines to enforce compliance and address violations; 

•Due diligence reviews of high-risk intermediaries and exclusion lists screening of employees and contracted business associates; and

•Risk assessments to identify areas of compliance risk. 

Government Regulation

Classification and Approval of Products by the FDA and other Regulatory Authorities

Our research, development, clinical programs, and our manufacturing and marketing operations, are subject to extensive regulation in the U.S. and other countries. Most notably, all of our products sold