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COMPREHENSIVE COMPLIANCE PROGRAM AND DECLARATION
INTRODUCTION
Darby Dental Supply LLC ("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 we are a distributor of Dental products, the OIG's Compliance Program Guidance represents relevant government guidance for health products company compliance programs.
The purpose of our Company's 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 our Company's size and resources,
as well as the unique interactions that the Company has as a distributor of dental supplies. 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.
COMPREHENSIVE COMPLIANCE PROGRAM
Written Policies and Procedures
We have adopted written policies and procedures, guidelines, directives and other communications that provide guidance to our employees in their dealings with health care professionals, customers, suppliers, government entities, and other third parties.
The cornerstone of our written standards is our Company's Marketing Code of Conduct policy. In addition, in accordance with California law, our Company has set an annual dollar limit on promotional materials,
and items of value that the Company provides to each individual California health professional.
Leadership and Oversight
The Company's management team has overall responsibility for managing and overseeing the Compliance Program.
Training and Education
Our Company is committed to effectively communicating our standards and procedures to Company personnel. Our Company periodically reviews and updates its training programs and identifies additional areas of training on an "as needed" basis.
Communication and Helpline Reporting
Our Company encourages open and candid discussion between management and employees regarding any compliance concerns. Our goal is that all employees, 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.
Auditing and Monitoring
Our Company may conduct audits periodically to evaluate adherence to the Company's standards. The nature of our reviews, as well as the extent and frequency of our 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 into compliance matters that are brought to the Company's attention. Our Company 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 SECTIONS 119400-119402
Our Company 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 and medical products.
California law refers 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 ensure our compliance with applicable laws and regulations and consistent with industry standards for distributors.
We believe that our Company 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.
Dated: June 30, 2025