Comprehensive Compliance Program
Braeburn Pharmaceuticals, Inc. (“Braeburn”) is committed to conducting its business in full compliance with applicable laws. Braeburn has developed and implemented this Comprehensive Compliance Program (“CCP”) to help us meet this commitment.
At its heart, the CCP is a set of internal standards and controls intended to promote the prevention, detection, and correction of conduct that is illegal or that does not conform to the Braeburn Corporate Code of Conduct and Ethics. The CCP applies to all officers, directors, and employees of Braeburn. It is intended to be an integral and routine part of Braeburn’s operations and to demonstrate Braeburn’s commitment to the highest standards of ethics and compliance. The CCP is reviewed and revised when necessary to ensure that it continues to meet the applicable legal and ethical requirements of Braeburn’s business operations as they evolve.
The CCP applies to all officers, directors, and employees of Braeburn, as well as to applicable independent contractors who act on Braeburn’s behalf in providing services to Braeburn.
The CCP consists of seven key elements, as described below.
1. COMMITMENT OF BRAEBURN’S LEADERSHIP
The effectiveness of Braeburn’s Compliance Program begins with the support and public commitment of Braeburn leadership. The members of the Braeburn Board of Directors, the Chief Executive Officer, and the Chief Financial Officer are committed to governing and growing Braeburn through ethical and compliant business strategies. Overall responsibility for oversight and operation of the CCP is given to Braeburn’s Compliance Officer. The Compliance Officer reports directly to the Chief Executive Officer and makes reports to the Board of Directors concerning the operation of the CCP. While each member of the Braeburn leadership has a role in promoting effective compliance, the Board of Directors ultimately is responsible for ensuring that Braeburn conducts its operations in accordance with applicable laws and regulations.
2. POLICIES AND PROCEDURES
The Braeburn Corporate Code of Conduct and Ethics and accompanying Policies and Procedures are the foundation of the CCP. They are intended to lay out the legal and ethical standards that govern Braeburn day-to-day activities and operations, in a manner that can be easily understood and applied by Braeburn personnel. The Policies and Procedures are designed to address key activities and relationships with physicians and other health care professionals, health care institutions, patients, third-party payers, independent contractors, vendors, and consultants, as well as internal Braeburn operations.
3. EDUCATION AND TRAINING
All of Braeburn’s employees receive education and training on Braeburn’s Corporate Code of Conduct and Ethics and the applicable Policies and Procedures sufficient to enable them to perform their functions in full compliance with the applicable laws and regulations. At a minimum, this education and training shall consist of distribution of this Compliance Program Overview and the applicable policies and procedures to each employee, officer, director and where applicable independent contractor acting on Braeburn’s behalf. In addition, where appropriate, more targeted training and education of employees, officers, directors, and independent contractors will be conducted on laws, regulations, and compliance matters of relevance to their work. The Compliance Officer shall consult with counsel, as necessary, to determine the need and scope for such additional education and training.
4. REPORTING AND INVESTIGATING MISCONDUCT
It is the responsibility of all Braeburn personnel to be attentive to possible violations of applicable laws, regulations, Code of Conduct and Ethics, Company policies and procedures, and to communicate possible violations directly to their managers, the Compliance Officer, any member of the leadership team or anonymously through the following channels:
Braeburn commits to fully investigating and responding to all reported compliance concerns, although we recognize that submission of anonymous reports limits the ability to obtain additional information that may necessary or helpful to the investigation of a reported matter. The ability to discuss ethical and legal issues without fear of retribution is vital to the effectiveness of the CCP. Braeburn makes every effort to maintain, within the limits of the law, the confidentiality of any individual who reports possible misconduct. Moreover, Braeburn will not tolerate retaliation against any employee, director, or officer who, in good faith, reports an ethical or legal concern.
5. RESPONDING TO VIOLATIONS
Where an internal investigation substantiates a reported violation, a member of the Braeburn review team will initiate timely and appropriate corrective action. Such action may include, as appropriate and without limitation, imposing disciplinary action, terminating contracts, notifying government agencies, or implementing training or systemic changes to prevent similar violations from recurring.
6. MONITORING OF COMPLIANCE
Braeburn is committed to making compliance with ethical and legal standards an integral part of its daily operations. As noted above, the Board of Directors is ultimately responsible for ensuring that Braeburn is conducting appropriate monitoring of its compliance with laws, regulations, policies and procedures. The Board of Directors shall regularly evaluate, as part of its oversight function and in consultation with Braeburn officers, whether the Compliance Officer has adequate time and resources to effectively monitor compliance or whether additional resources, including for example a compliance audit performed by a third party, may be necessary.
7. FUTURE DEVELOPMENT AND REFINEMENT OF COMPLIANCE PROGRAM
Braeburn is a small but growing pharmaceutical company. Accordingly, we fully expect that the CCP will be updated as necessary to reflect the evolving complexity of our operations and address any new areas of risk for Braeburn. To that end, Braeburn’s officers shall periodically reevaluate the CCP and implement appropriate measures to enhance the CCP’s effectiveness. We are committed to ensuring that Braeburn, and all its personnel, remain equipped to promote full compliance as Braeburn grows.
Questions concerning the CCP should be directed to Reed Brady at firstname.lastname@example.org.
Click here to view our 2018 Declaration of Compliance
Code of Conduct
Braeburn is committed to conducting all Company business with integrity and according to the highest ethical standards. The Code reflects our core principles of business conduct and ethics and is intended to be a guide to all Braeburn employees on these principles and what is expected of them.
Click here to view our Code of Conduct.
Reporting a Concern
Braeburn has established the below methods of communication that our employees, vendors and other third parties may use to report suspected violations of laws, regulations, our Code of Conduct and Company policies.