California Declaration of Comprehensive Compliance Program
Viridian’s Commitment to Ethical Conduct
Viridian Therapeutics, Inc. (“Viridian”) is committed to conducting its business with integrity, transparency, and respect for healthcare professionals (“HCPs”) and the patient community. This commitment is at the heart of what we do and is woven into every part of Viridian’s Comprehensive Compliance Program (“Compliance Program”).
Viridian’s Compliance Program incorporates guidance published by the Office of Inspector General (“OIG”) of the United States Department of Health and Human Services, including its elements of an effective compliance program from the April 2003 publication Compliance Program Guidance for Pharmaceutical Manufacturers. It furthermore integrates Pharmaceutical Research and Manufacturers of America’s (PhRMA) Code on Interactions with Healthcare Professionals in our policies and practices.
Overview of the fundamental elements of our Compliance Program:
Leadership and Oversight
Viridian’s Compliance and Ethics program is led by our Chief Compliance Officer, who oversees program implementation and effectiveness, providing regular updates to Viridian’s Compliance Committee and Board of Directors. The Compliance Committee, composed of senior leaders from across the organization, provide strategic oversight, identify compliance risks, and support program enhancements.
Written Standards
Viridian’s Code of Business Conduct and Ethics, available on our website, along with supporting policies and procedures, sets clear expectations for how the company conducts business with integrity and in line with its internal standards. These materials, aligned with applicable laws, regulations, and industry standards, provide guidance on interactions with healthcare professionals, healthcare organizations, and government officials. We routinely review and update our written standards to address changes in the regulatory landscape, our business, and emerging risk areas.
Education and Training
Viridian provides regular training for all employees, including but not limited to our:
- The Code of Business Conduct and Ethics
- Applicable policies and procedures
- Federal and state healthcare laws and transparency requirements
New employees receive Compliance Program training as part of onboarding, with ongoing education provided throughout employment.
Speaking Up and Reporting Concerns
Viridian encourages open communication and provides multiple avenues for individuals to ask questions, raise concerns, or report potential violations to management, Compliance, Legal, and Human Resources. We have also implemented the Viridian Hotline which facilitates anonymous reporting for individuals (both internal and external to the company), as permitted by local law. Viridian makes all efforts to maintain confidentiality and non‑retaliation protections for individuals who raise concerns in good faith.
Auditing and Monitoring
To assess the effectiveness of the Compliance Program and support our risk mitigation practices, Viridian conducts routine risk-based monitoring and audits. The type, scope, location, and frequency of these activities vary based on factors as identified through our risk assessment processes. Findings help identify and prioritize potential compliance risks, which are then addressed through various corrective actions, updates to written standards, and targeted training.
Enforcement of Standards
Violations of Viridian’s Code of Business Conduct and Ethics and other written standards can be subject to disciplinary actions, up to and including termination. While circumstances may vary, we aim to apply disciplinary actions consistently and appropriately.
Investigations and Corrective Actions
Viridian’s Compliance and Ethics Department oversees internal investigations into potential violations to ensure timely, complete, and objective investigations are conducted. Upon conclusion of an investigation, corrective action and preventative measures are assessed and implemented as appropriate. Aggregated, anonymized investigation outcomes are reported to the Compliance Committee and the Audit Committee of the Board of Directors.
Annual California Declaration of Compliance (California Health & Safety Code §§ 119400–119402)
Viridian acknowledges, in line with OIG guidance, that no Compliance Program can eliminate every instance of individual misconduct. That said, Viridian has established processes to identify, investigate, and appropriately address potential violations of its Code of Business Conduct and Ethics, internal policies, and applicable laws and regulations. The company regularly reviews and strengthens its compliance program to support accountability and drive ongoing improvement.
Viridian has established an annual spending limit of $3,000 per individual California licensed HCP for certain permissible interactions, including educational items and meals associated with bona-fide business or scientific discussions. The dollar limit is a maximum only and does not necessarily represent a typical, average, usual, or customary amount.
To the best of our knowledge and based on a good faith understanding of the statutory requirements, Viridian maintains a Compliance Program that complies with California Health & Safety Code §§ 119400–119402.
A copy of Viridian’s Comprehensive Compliance Program and declaration of compliance may be obtained by contacting us via email at compliance@nullviridiantherapeutics.com or by telephone at +1-617-272-4600 or the Viridian Hotline at +1-833-596-6699