Comprehensive Compliance Program
Defender Pharmaceuticals (“Defender” or “Company”) is committed to creating an environment where we do our best work while maintaining the highest standards of business integrity and ethics. It is the responsibility of every director, officer, and employee (collectively, “personnel”) to conduct themselves in the most appropriate and compliant manner when acting on behalf of the Company.
Defender has implemented a comprehensive Compliance Program that conforms to the U.S. Department of Health and Human Services Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers” (the “OIG Guidance”) and relevant industry guidance.
Defender is dedicating significant time and resources to establish a compliance program consistent with the OIG Guidance and tailor it to fit the Company’s unique environment. We regularly review and enhance our Compliance Program to meet our evolving compliance needs.
1. Written Standards
Defender’s Code of Conduct outlines the Company’s fundamental guiding principles and values for action within the organization. Defender has also adopted compliance policies and procedures to govern its activities.
2. Leadership and Structure
Defender has appointed a Compliance Officer who is responsible for the operation and oversight of the Company’s Compliance Program. The Compliance Officer and Defender’s Compliance Committee are responsible for promoting an atmosphere of responsible and ethical conduct. As appropriate, the Compliance Officer reports compliance-related issues directly to the Chief Executive Officer and/or the Board of Directors.
3. Education and Training
A central aspect of the Company’s Compliance Program is educating and training employees on their legal and ethical obligations under applicable laws, regulations, and Company policies. All new personnel must complete initial compliance training as part of new hire orientation, and additional compliance training as new developments in applicable laws, regulations, or policies and procedures arise. Personnel who have been newly hired, transferred, or promoted into a new role will have appropriate compliance training assigned to them. Defender’s compliance training program includes appropriate requirements for its contractors, consultants, and agents.
4. Internal Lines of Communication
Defender personnel are responsible for ensuring that the requirements outlined within the Company’s compliance policies and procedures are met. Compliance guidance is available to personnel when they require additional information or assistance to address an ethical situation or specific conduct. Defender’s policies provide for confidential reporting of allegations of misconduct and protections against retaliation for such reporting.
5. Auditing and Monitoring
Defender’s Compliance Program includes efforts to audit, monitor, and evaluate activities for compliance with the Company’s compliance policies and procedures. The nature, extent, and frequency of compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
6. Disciplinary Standards
Adherence to the Company’s Code of Conduct and policies and procedures is a condition of employment with Defender. The Company investigates potential violations of law or Company policy and, where appropriate, implements corrective measures to prevent, detect and deter future violations. Any violation of these requirements by directors, officers, or Defender personnel is subject to disciplinary action up to and including termination of employment.
7. Responding to Potential Violations
A Compliance Program designed in accordance with the OIG Guidance is intended to increase the likelihood of preventing, or at least detecting, unlawful and unethical behavior. Even an effective Compliance Program, however, may not prevent all violations. As such, Defender investigates potential violations of law or Company policy, and appropriate action will be taken as determined necessary to deter any future compliance violations.
February 22, 2023