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Compliance
Compliance at Aesculap Implant Systems, LLC
As a B. Braun of America Inc. company, we believe that compliance is what gives us the right to do business.
We are committed to the highest ethical standards and to conducting all our business activities in compliance with all applicable laws and regulations. To put our commitment into action, and as called for under the B. Braun Group Code of Conduct, we have adopted the B. Braun of America Inc. Code of Business Conduct and implemented an Ethics and Compliance Program. This Program is designed, managed and updated in accordance with compliance guidance issued by the U.S. Department of Justice and the U.S. Department of Health & Human Services, Office of Inspector General, as well as other federal and state government agencies, including, but not limited to, the U.S. Food and Drug Administration and Centers for Medicare & Medicaid Services.
Our Ethics and Compliance Program is overseen by the Board of Directors of B. Braun of America Inc. through its Risk Management Committee, by the B. Braun Chief Ethics and Compliance Officer (“Compliance Officer”) and by the B. Braun Corporate Ethics and Compliance Committee. These parties work together to design, implement, uphold and oversee our Ethics and Compliance Program.
With regard to interactions with healthcare professionals, our Ethics and Compliance Program reflects and reinforces industrywide best practices and standards outlined in the AdvaMed Code of Ethics on Interactions with Health Care Professionals, adopted by the Advanced Medical Technology Association (the “AdvaMed Code”) and the PhRMA Code on Interactions with Healthcare Professionals, adopted by the Pharmaceutical Research and Manufacturers of America (the “PhRMA Code”).
In addition to our Ethics and Compliance Program, our Quality Department has implemented and maintains a Quality Management System to address laws and regulations related to the manufacture, sale and distribution of medical and pharmaceutical products in the U.S. and Canada.
For information about our commitment to a transparent supply chain, click here.
Empowered to Speak Up
Speaking up at B. Braun is a virtue and an expectation. We speak up for what we stand for and to follow through on our commitments. By speaking up, we preserve our ethical culture and help protect the health and safety of our colleagues, customers and the patients treated with our products.
There are no wrong ways to Speak Up about a question or concern, and all B. Braun representatives who report in good faith are protected from retaliation.
When a concern is raised, it is treated confidentially to the fullest extent allowed by law and addressed with urgency, impartiality, and expertise to ensure investigations are conducted fairly. Each review begins with the understanding that no violation has occurred unless the facts confirm otherwise.
Anyone can report a concern using our Speak Up Line regardless of their relationship with us.
Our Speak Up Line is an accessible and secure reporting service. It is available 24 hours a day, seven days a week. It allows people to report concerns anonymously if desired and does not track IP addresses. We use an independent company to receive all reported concerns and transfer the information to our Ethics and Compliance Department.
Speak Up Line Contact Information:
U.S. and Canada toll-free at: +1-833-629-3390 (Company Access Pin: 1025)
Dominican Republic: +1-829-946-6153 (Company Access Pin: 1025)
Report Online at: https://bbraun.integrityline.app.
In addition to our Speak Up Line, you may also contact our Ethics and Compliance Department directly at CorporateCompliance@bbraunusa.com.
California Compliance Law Statement
As stated in the description of our Ethics and Compliance Program (“Program”), our Company is committed to conducting its business ethically and in compliance with all applicable laws. Our Program has been implemented in accordance with the Compliance Program Guidance published by the Office of Inspector General (“OIG”), U.S. Department of Health & Human Services that, to the best of our knowledge, meets all the requirements of California Health and Safety Code §§ 119400-119402 (“California Law”).
Recognizing that compliance is a dynamic concept that must be adapted to the characteristics of a particular company, we regularly assess and modify our Program for improvements. Consistent with OIG Guidance, we tailored our Program to the nature of our business. Our Program reflects the unique interactions between medical technology companies and healthcare professionals.
To the best of our knowledge, our company is in material compliance with its Program and California Law. As recognized by the OIG, a company’s implementation of a compliance program may not entirely eliminate improper conduct by employees. Our company expects all of its employees to fully comply with our Program, and takes reasonably necessary steps to detect, prevent, investigate and properly address violations.
To obtain supporting documentation of our Program and this written declaration of compliance, please email CorporateCompliance@bbraunusa.com.
This annual declaration is made as of July 1, 2026.