Summary and Declarations
A2 Biotherapeutics (“A2 Bio”) and its affiliates are committed to complying with all applicable laws, regulations, and industry standards. A2 Bio has developed a comprehensive compliance program in accordance with the Compliance Program Guidance for Pharmaceutical Manufacturers developed by the U.S. Department of Health and Human Services Office of the Inspector General (the “OIG Guidance”) and California Health and Safety Code §§119400 – 119402, including policies consistent with AdvaMed’s Code Of Ethics On Interactions With Healthcare Professionals (“AdvaMed Code”). A2 Bio holds its representatives and vendors to the same standards of applicable laws and regulations.
A2 Bio’s written policies govern activities involving communicating with healthcare professionals about the appropriate use of our products including instruction, education, and training required for the safe and effective use of our products. A2 Bio also has policies governing activities involving the advancement of scientific and educational activities supporting research and education. Every A2 Bio employee must understand and comply with these obligations.
California Spend Limit
A2 Bio’s relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Informational presentations and discussions by A2 Bio representatives and others speaking on behalf of A2 Bio provide valuable scientific and educational benefits. In connection with such presentations or discussions, A2 Bio may offer occasional meals and healthcare practice-related items in accordance with the AdvaMed Code.
Pursuance to the requirements of California Health & Safety Code §§119400-119402, A2 Bio has established a specific annual aggregate limit of $2,000 for meals and educational items that may be provided to California healthcare professionals.
In accordance with California law, certain items and payments are excluded in determining whether the annual limit has been met. The annual spending limit does not include the value of:
- Drug samples provided to individual healthcare professionals;
- Financial support of independent education, including continuing medical education programs and the value of travel expenses for attendance;
- Financial support for health education scholarships; and
- Payments for legitimate professional services, including professional speaking, advising, consulting, product training or market research services, that are based on the fair market value of the services provided.
Annual Declaration for Purposes of Health & Safety Code, §§119400-119402
To the best of our knowledge, as of the date of this declaration, A2 Bio’s comprehensive compliance program addresses the California statutory requirements for inclusion of policies addressing the OIG Guidance and Advanced Code and limits on gifts and incentives to healthcare professionals. Subject to the above, A2 Bio declares that it is, in all material respects, in compliance with California Health & Safety Code §§119400-119402.
Please contact the Compliance Officer at A2 Bio for a copy of this summary and declaration document or if you are aware of any activity that violates this policy and would like to discuss that activity anonymously.
Updated: September 23, 2021