Ethics & Compliance

The fundamental elements of our Ethics & Compliance program are described below.

II. Overview of Ethics & Compliance Program

1. Leadership and Structure.
   • Margaret K. Feltz is our Vice President, Chief Compliance Officer (“CCO”), and serves as the primary contact for compliance activities. The Company seeks to ensure the CCO has sufficient authority, independence, resources, and access to information to exercise independent judgment and effectuate change as needed. The CCO is responsible for developing, operating, and monitoring the Ethics & Compliance Program, including opioid/controlled substances compliance and the SOM program. The CCO reports to the Company’s Chief Executive Officer, is a member of the Company’s Executive Committee, and has direct, unfiltered access to the Chief Executive Officer and the Audit Committee of the Board of Directors, including for escalation of significant compliance issues, diversion risk concerns, or potential CSA/DEA reporting matters.
   • We have established a Compliance Committee & Risk Management Council (Council) to advise the CCO and assist in the implementation of the Ethics & Compliance Program. The Council includes cross-functional leadership (e.g., Legal, Regulatory, Quality, Commercial, Supply Chain, IT, and Human Resources) and oversees risk assessments, controls, and remediation.
2. Written Standards.
   • The Company’s Code of Ethics is our statement of ethical and compliance principles guiding our daily operations. The Code establishes our expectation that management, employees, and certain agents of the Company act in accordance with all laws, regulations, and Company policies. The Code describes our fundamental principles and values, providing a framework for action within our organization.  
   • We have published Healthcare Law Compliance Policies and supporting procedures to address industry compliance risks and to train our employees to act in accordance with these policies. For opioid and other controlled substance activities, we maintain additional policies and procedures addressing CSA/DEA obligations, anti-diversion expectations, distributor and third-party oversight, data integrity, and Suspicious Order Monitoring (including order review, investigation, blocking, and reporting decision protocols).
   • We have established annual spending limits for certain promotional activities directed toward healthcare professionals (HCPs) who prescribe or may influence prescribing in California and elsewhere. At the present time our annual spending limit is $1,000.00 per HCP. Examples of items that fall within this spending limit are infrequent, modest, in-service meals for HCPs and their staff; infrequent, modest meals in connection with product specific and non-product educational programs; and items of use to HCPs in their practice or to their patients. This amount does not include cash payments or honoraria paid to HCPs pursuant to contracts for bona fide consulting or other services. Our Company does not and will not provide any item of value to any HCP with the intent of influencing prescribing habits.
3. Education and Training. A critical element of our Ethics & Compliance Program is the education and training of employees on their legal and ethical obligations under applicable state and federal requirements. We provide general compliance training and supplemental role-based training tailored to job functions and risk (e.g., Commercial, Medical, Supply Chain, Customer Service, Finance, and leadership). For opioid and other controlled substance activities, training includes CSA/DEA obligations, diversion red flags, SOM processes, escalation and reporting expectations, and documentation requirements.
4. Internal Lines of Communication. Our Company actively fosters dialogue among management and employees. Our goal is that all employees know who to turn to when seeking answers or reporting possible Code violations and are able to do so without fear of retaliation. We maintain open-door policies, confidentiality protections, and a non-retaliation policy. We also maintain a confidential, toll-free Integrity Helpline (1-877-787-3831) through which employees and external parties may report concerns or suspected violations of law, regulation, Company policies, or our Injunction, including potential diversion concerns, suspicious orders, or CSA/DEA-related issues.
5. Auditing and Monitoring. Our Ethics & Compliance Program includes monitoring, auditing, and evaluating adherence to compliance policies and procedures. The nature, extent, and frequency of monitoring and auditing may vary according to regulatory requirements, changes in business practices, and risk. For opioid and other controlled substance activities, monitoring and auditing may include SOM governance and effectiveness testing; establishment of thresholds and rules; investigation timeliness; documentation of order block/ship/report decisions; data integrity controls; and periodic reviews of distributor/third-party compliance obligations.
6. Responding to Potential Violations.  Our Company sets forth clear disciplinary consequences for violating laws, the Injunction, or Company policies. We consider each situation on a case-by-case basis and apply discipline consistently to address inappropriate conduct and deter future violations. Where potential controlled substances issues are identified (including suspicious order concerns or potential diversion), we follow documented escalation, investigation, and—where applicable—reporting protocols and implement timely corrective actions.
7. Corrective Action Procedures. A compliance program increases the likelihood of identifying and preventing unlawful and unethical behavior. As HHS-OIG recognizes, even an effective program may not prevent all violations. Our Ethics & Compliance Program requires prompt response to potential violations of law, regulation, the Injunction, or Company policies, including controlled substances concerns. We assess whether issues are due to gaps in policies, practices, training, systems, or internal controls; conduct root cause analyses; implement corrective and preventive actions (CAPA); and test for sustained effectiveness to prevent recurrence.