COMPREHENSIVE COMPLIANCE PROGRAM

Darby Dental Supply, LLC (“DDS” or the “Company”) is committed to high standards of ethical conduct and corporate compliance. To that end, we have established a Comprehensive Compliance Program designed to incorporate key elements set-out in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the U.S. Department of Health and Human Services Office of Inspector General (OIG). Although Darby Dental Supply, LLC is a distributor of dental products, the OIG’s Compliance Program Guidance represents relevant government guidance for health products company compliance programs.

The purpose of DDS Comprehensive Compliance Program is to prevent and detect violations of Company standards and applicable law. We describe below the fundamental elements of the Company’s Comprehensive Compliance Program, which has been tailored to fit DDS size and resources, as well as the unique interactions that the Company has as a distributor of dental products. As envisioned by OIG’s Compliance Program Guidance, the Company endeavors to continually improve its Comprehensive Compliance Program in response to ever-evolving business activities, applicable laws, and associated compliance risks.



Written Policies and Procedures

We have adopted written policies and procedures, guidelines, directives and other communications that provide guidance to our Darby Dental Supply, LLC employees in their dealings with health care professionals, customers, suppliers, government entities, society at large, other employees, and other third parties. They also address the methods and means by which the Comprehensive Compliance Program is administered and enforced.

The cornerstone of our written standards is Darby Dental Supply, LLC Business Standards, which is supplemented by policies and procedures, guidelines, directives and other communications that address applicable federal and state laws and industry standards relating to the marketing, promotion, distribution and sale of the Company’s products and services. Among other issue specific policies underlying our Business Standards, DDS has adopted a Marketing Code of Conduct Policy.

Training and Education

DDS is committed to effectively communicating our standards and procedures to Company personnel. Our training activities include a combination of in-person presentations, online web modules, & printed materials. DDS periodically reviews and updates its training programs, and identifies additional areas of training on an “as needed” basis.

Communication and Helpline Reporting

DDS encourages open and candid discussion between management and Darby team members regarding any compliance concerns. Our goal is that all Darby team members, when seeking answers to questions or reporting potential instances of misconduct, should know to whom to turn for a meaningful response and should be able to do so without fear of retaliation. Darby team members are encouraged to report their concerns to their manager, the Human Resources Department, and through the Company’s Compliance Helpline. DDS maintains a toll-free number to receive communications from Darby team members and others in connection with alleged violations of our standards or applicable laws by any Darby team member, contractor, subcontractor, supplier, customer, or other person. The Compliance Helpline is maintained on a dedicated line that allows calls to be made anonymously, if desired.

Auditing and Monitoring

DDS conducts compliance audits periodically to evaluate adherence to the Company’s standards. The Company also seeks to identify new and emerging risk areas on an ongoing basis. The nature of our reviews, as well as the extent and frequency of our compliance monitoring and auditing, varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.

Enforcement and Disciplinary Measures

We conduct fair and diligent investigations of compliance matters that are brought to the Company’s attention. DDS takes disciplinary actions, where appropriate, in response to confirmed violations of the Company’s compliance standards, and strives to ensure consistent application of the Company’s standards.

Responses to Detected Problems and Corrective Actions

An effective compliance program increases the likelihood of preventing and detecting unlawful and unethical behavior. However, even an effective compliance program may not prevent all violations. Accordingly, the Company’s Comprehensive Compliance Program requires a prompt response to potential violations of law or Company policy. Actions in response to detected problems, and to prevent future violations, may include improving policies or procedures, training, communication and monitoring or disciplinary action.

CALIFORNIA HEALTH AND SAFETY CODE §§119400-119402

Darby Dental Supply, LLC has adopted a Comprehensive Compliance Program guided by OIG’s Compliance Program Guidance for Pharmaceutical Manufacturers and industry standards. We tailored our Comprehensive Compliance Program to the nature of our business as a distributor of dental products. The California law makes reference to compliance with the PhRMA Code on Interactions with Healthcare Professionals (PhRMA Code), which is an industry standard that applies to pharmaceutical manufacturers and does not reflect the unique nature of distributor activities. We have, accordingly, not adopted the PhRMA Code, but instead have adopted a marketing code of conduct intended to help ensure our compliance with applicable laws and regulations and consistent with industry standards for distributors. We believe that DDS has developed a Comprehensive Compliance Program that meets the compliance goals set forth by California Health and Safety Code sections 119400 through 119402. To our knowledge, we are, in all material respects, in compliance with our Comprehensive Compliance Program and the requirements of California Health and Safety Code sections 119400 through 119402, as we interpret and apply the requirements to the nature of our business. Although we are not making a representation that every employee and agent will always fully comply with our standards and rules, our Comprehensive Compliance Program is reasonably designed to prevent and detect violations. We are committed to monitoring our conduct and taking appropriate action to discipline Company personnel who violate our standards. Copies of this declaration and the above description of our Comprehensive Compliance Program may be obtained by calling DDS Compliance Helpline: 1-(800) 645-2310.
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