Calyxo Inc. California Compliance Disclosure
March 15, 2024
This California Compliance Disclosure (“Compliance Disclosure”) is provided pursuant to the requirements of CAL. HEALTH & SAFETY CODE §§ 119400 – 119402 (the “California Code”), which requires that medical device companies adopt and make public Comprehensive Compliance Programs (“Compliance Programs”) that govern such companies’ marketing and promotional activities.
Calyxo, Inc. (“Calyxo”) is a medical device manufacturer headquartered in Pleasanton, California. As of the date of this Compliance Disclosure, Calyxo believes that its operations follow its Compliance Program and the provisions of the California Code.
The policies and procedures of Calyxo’s Compliance Program are modeled on guidance set forth in the AdvaMed Code of Ethics on Interactions with Healthcare Professionals, the Anti-Kickback Statute, the Sunshine Act, and various other statutory provisions and regulatory codes applicable to where Calyxo does business. The scope and scale of the Compliance Program is appropriate to Calyxo’s current commercial and clinical operations.
Calyxo investigates and resolves all reported compliance concerns in a timely manner and Calyxo employees and contractors are made aware that non-compliance with the Compliance Program obligations may result in disciplinary action up to and including termination of employment or contract. The Compliance Program is reasonably designed to prevent and detect violations and discipline employees as necessary. The Compliance Program will be assessed on an annual basis.
The Calyxo Compliance Program includes the following: (i) a dedicated compliance officer; (ii) oversight by executive leadership; (iii) documented compliance policies and procedures; (iv) regular and effective compliance education and training; (v) open lines of communication, (vi) monitoring and auditing activities to continually evaluate and reassess compliance; and (vii) procedures for responding to identified problems and implementing corrective action.
This Compliance Disclosure is made solely for the purpose of complying with the California Code. To obtain a copy of our Compliance Program documents, please call our headquarters at (925) 526-5900.
MA00048.B