Applied Medical is dedicated to upholding the highest ethical, quality and compliance standards as we fulfill our customers’ demand for surgical products that satisfy clinical and economic needs. Instead of aiming to merely meet minimum requirements, we have always been committed to exceeding the expectations set forth by applicable policies, standards and laws.
Our organization is guided by the belief that we can have a significant and sustainable impact on global healthcare by maintaining an unwavering commitment to transparent business practices. To this end, we conduct business in an open and honest manner and reject business practices that unnecessarily increase the cost of healthcare, compromise patient safety, or stifle innovation.
Applied Medical (“Applied” or the “Company”) has adopted a Comprehensive Compliance Program (“Compliance Program”), summarized below and consistent with guidance published by the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”). Applied’s Compliance Program is intended to promote the prevention and resolution of actual or apparent conflicts of interest, appropriate disclosure in Company reports and public communications, compliance with applicable laws and regulations, accountability and prompt reporting of violations of Company policy relating to the sale and marketing of Applied’s products. It is Applied’s expectation that all Team Members, officers, directors, agents, representatives, consultants, and distributors shall comply with Company policies and procedures as well as all of the laws, rules and regulations of the U.S. and other countries, and the states, counties, cities and other jurisdictions, applicable to the Company’s sale or marketing of its products.
The OIG advises that an effective compliance program is comprised of seven elements. Applied has used these seven elements as a basis for its Compliance Program. Fundamental elements of our Compliance Program are summarized below.
Any Team Member who suspects a violation of the Company policy, financial fraud, accounting irregularities, or auditing issues should promptly contact the Compliance Officer, the Legal Department or the Personnel Department. Any Team Member wishing to make an anonymous report regarding suspected illegal behavior or financial fraud of any type may do so by calling one of the Company’s anonymous hotlines. From the United States, Team Members may call the following toll-free number: 1-877-571-9750. From countries outside the United States, except for those countries such as France which do not permit use of collect calls for hotline purposes, Team Members may call the following number collect: 1-770-776-5686. The anonymous hotlines are intended only for reporting potential financial fraud, concerns regarding accounting controls or irregularities, auditing issues or illegal or unethical behavior in violation of Applied’s policies. For other workplace issues, Team Members should contact their manager or the Personnel Department. The Company will investigate and treat confidentially (to the extent possible) all reported potential violations. All Team Members are expected to cooperate in any internal or external investigations of possible violations of Company policy. The Company will not permit retaliation of any kind by, or on behalf of, the Company or its Team Members against good faith reports or complaints of potential violations involving financial irregularities, violations of Company policy or other illegal or unethical behavior.
California Health & Safety Code § 119402 requires certain medical device manufacturers to develop a Comprehensive Compliance Program for interactions with healthcare professionals. Consistent with the OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers, Applied has tailored its Compliance Program to the nature of Applied’s business as a medical device company. While § 119402 references the PhRMA Code on Interactions with Healthcare Professionals (“PhRMA Code”), Applied has adopted policies and procedures for compliance which are substantially similar to the PhRMA Code given Applied is a medical device company and not a pharmaceutical company. To the best of our knowledge, as of the date of this declaration, Applied is in compliance with California Health & Safety Code §§ 119402 and the Company’s Compliance Program. Anyone may obtain a copy of this document by calling the toll-free number 1-800-840-1870 and asking for extension 8450.
Adopted: July 1, 2005
Last revised: January 1, 2023