Twenty Twenty Therapeutics Compliance Program

California Comprehensive Compliance Program

Twenty/Twenty Therapeutics, LLC (“Twenty/Twenty”) is committed to establishing and maintaining an effective compliance program in accordance with the Compliance Program Guidance published by the U.S. Department of Health and Human Services, Office of Inspector General[1](the “OIG Guidance”). Further, the medical device industry has established and Twenty/Twenty’s Comprehensive Compliance Program (Compliance Program) is designed in accordance with the AdvaMed Code of Ethics on Interactions with Health Care Professionals (AdvaMed Code)[2]. Twenty/Twenty has established a Compliance Program to address the relevant risk areas and business activities of our company. We regularly review our Compliance Program to meet the evolving industry guidance and our company’s compliance needs.

Our Compliance Program was established by our Board of Directors in conjunction with Twenty/Twenty’s management team.  Our Compliance Program is designed to prevent and detect violations of law and Twenty/Twenty’s policies.  However, as recognized by the OIG Guidance, the implementation of a Compliance Program cannot guarantee that improper conduct will be entirely eliminated.  It is our expectation that our employees and our representatives will comply with our Compliance Program including our HCP Interactions Policy. In the event that Twenty/Twenty becomes aware of potential violations of law or company policy, Twenty/Twenty will investigate the matter and take relevant disciplinary action and implement corrective measures to prevent future violations.

 

As required by the California Health & Safety Code §119402(d) Twenty/Twenty has implemented an annual promotional spending limit for educational items, promotional items or activities that Twenty/Twenty may provide to licensed California healthcare professionals.  These promotional items and activities are also subject to restrictions set forth in our HCP Interactions Policy (consistent with the AdvaMed Code) and other Compliance Program policies and procedures.

 

Twenty/Twenty 2022 Declaration of Compliance

Twenty/twenty declares that to the best of its present knowledge and belief, it is in compliance with its Comprehensive Compliance Program and the relevant requirements of California Health & Safety Code §§119400-119402.

Contact Information

For a copy of this Declaration or for more information regarding our Compliance Program, please contact our Chief Compliance Officer at 901.712.3181 or by sending an e-mail to mshields@ebglaw.com

[1] Compliance Program Guidance for Pharmaceutical Manufacturers.

[2] The AdvaMed Code is aligned with the PhRMA Code.