Aurinia Compliance Program
Introduction
Aurinia Pharmaceuticals Inc. is committed to conducting its business in accordance with the highest ethical and compliance standards. A key component of this commitment is the establishment of our comprehensive Compliance Program in accordance with all applicable laws, regulations and Codes of the countries within which it operates.
The purpose of our Compliance Program is to prevent and detect violations of law or Aurinia policies and standards. We expect our employees to comply with our Compliance Program and we investigate and appropriately resolve potential violations of the Compliance Program, applicable laws, and Aurinia policies and standards. Where appropriate, we take disciplinary action, up to and including termination, and implement corrective measures to prevent future violations.
Our Compliance Program is an evolving and flexible program that is designed to account for Aurinia’s growth and other changes, as well as changes in our legal, regulatory or industry obligations. Aurinia reevaluates the Compliance Program on a regular basis for opportunities to further enhance its reach and effectiveness. The fundamental elements of the Compliance Program are detailed below.
ELEMENT 1: Written Policies and Procedures
Aurinia has established its commitment to compliance through written policies and standards, including the Aurinia Code of Conduct and Ethics. Aurinia expects all employees to adhere to these policies and standards as a condition of employment. These policies and standards are reviewed regularly to ensure relevancy to Aurinia’s business and the evolving regulatory environment.
Aurinia has also established an aggregate annual dollar limit of $1,000 for certain spending on California Healthcare Professionals in accordance with Cal. Health & Safety Code §§ 119400-402. This annual limit may be revised by the Company from time to time.
ELEMENT 2: Compliance Officer and Compliance Committee
Compliance Officer. The Chief Compliance Officer is responsible for overseeing the administration and implementation of the Compliance Program. This individual reports directly to the CEO and reports on the Compliance Program to the Board of Directors on at least an annual basis and provides regular updates to senior management.
Compliance Committee. Aurinia has established a Compliance Committee to advise the Chief Compliance Officer and to assist in the implementation of the Compliance Program. The Compliance Committee is comprised of senior members of functional units across Aurinia. The Committee meets on a regular basis to monitor Aurinia activities and compliance developments.
ELEMENT 3: Effective education and Training
A critical element of the Compliance Program is the education and training of relevant personnel on their legal and ethical obligations. Aurinia is committed to effectively communicating these obligations to all affected personnel. This includes training specific to the Code of Conduct and Ethics, Aurinia policies and standards, and applicable laws, regulations and industry codes. Aurinia regularly reviews and updates its training programs, including additional areas of training on an “as needed” basis.
ELEMENT 4: Effective Lines of Communication.
Aurinia employs a variety of internal communication tools to communicate with employees about compliance issues and concerns, including an internal Compliance SharePoint site. In addition, we routinely respond to compliance questions from individual employees, regularly respond to compliance inquiries and address compliance issues through regular compliance communications. Employees are instructed on their obligation to report actual or potential compliance violations, and have access to various resources including an independent, third party operated Compliance Hotline by which employees can anonymously report compliance questions, concerns or violations. Aurinia does not tolerate any retaliation against employees who make a good faith report of suspected misconduct or improper behavior.
ELEMENT 5: Internal Auditing and Monitoring.
The Compliance Program includes activities designed to monitor and audit compliance with Aurinia policies and standards and applicable law. The Chief Compliance Officer oversees all monitoring and auditing activities. Any issues identified as part of the monitoring and auditing are addressed, and education, training and corrective action are taken when necessary.
ELEMENT 6: Enforcing standards through well-publicized disciplinary guidelines
The Compliance Program aims to instill confidence in Aurinia employees to make the right decisions and practice good judgement. Aurinia recognizes those employees who carry out business activities in accordance with Aurinia policies and standards. Aurinia maintains processes for addressing potential compliance issues. Using this approach, Aurinia ensures that relevant facts and circumstances are understood and considered in connection with all remediation activities. In addition, these policies are intended to make sure that appropriate and consistent action is employed to avoid any future violations.
ELEMENT 7: Corrective Action and Discipline
If it is determined, after investigation, that non-compliant conduct occurred, the matter is forwarded to the appropriate parties for corrective and/or disciplinary actions. Such response and disciplinary action take place in a timely fashion and may include (but is not limited to) termination or otherwise disciplining the employee(s) involved; disciplining supervisors in accordance with the facts for failure to supervise adequately and control the behavior of the employee(s); revising guidelines, policies and standards or any function of the Compliance Program to prevent the recurrence of misconduct in the area; or increasing auditing and monitoring.
CALIFORNIA DECLARATION OF COMPLIANCE
To the best of our knowledge, Aurinia is in material compliance with our Compliance Program and the requirements of the California Health and Safety Code §§ 119400-119402. Aurinia makes this declaration, in good faith and reflects our consideration of the OIG Guidance, which gives broad discretion to manufacturers in the development, design and definition of the scope of compliance programs.
A written copy of this declaration may be obtained by contacting our Compliance Department at legal@auriniapharma.com or calling Aurinia’s toll free number at 1-844-744- 2487.
Please state that you are requesting a printed copy of Aurinia’s Annual Declaration of Compliance and provide your contact information, including your first name and last name, your email address or home address, and your phone number.
