Compliance
Declaration of Compliance with California Health and Safety Code
SPR® Therapeutics, Inc. (“SPR” or the “Company”) has established a Comprehensive Compliance Program that is designed to comply with applicable federal and state laws and industry standards relating to the marketing and promotion of our products. To our knowledge as of the date of this declaration, SPR is in compliance with our Comprehensive Compliance Program, as described herein, and with California Health & Safety Code, Division 104, Part 15, Chapter 8, Sections 119400-119402 (the “Statute”). This declaration is based on our good faith understanding of the requirements of the Statute as it may apply to medical device manufacturers. Through monitoring, audits, or reports, SPR may identify potential or actual violations of the Compliance Program, including the Statute. If this occurs, SPR shall investigate and address any such violations consistent with the investigation policy within SPR’s Compliance Manual.
In accordance with the Statue, SPR has established an annual limit of $2500 per California medical or health professional on items, and activities. As provided for by law, this limit does not include (i) payments made for legitimate professional services, including consulting services within fair market value, (ii) demonstration units, (iii) training and support on the safe and effective use of SPR’s products, or (iv) receptions at third-party educational or professional meetings.
A print copy of this document can be obtained by calling us at (844) 378-9108 or emailing us at support@sprpainrelief.com.
Last updated: April 17, 2024
Comprehensive Compliance Program
SPR has developed and maintains a Comprehensive Compliance Program that is based on company values, laws, and regulations. It is informed by the Compliance Program Guidance for Pharmaceutical Manufacturers, published by the Office of Inspector General of the U.S. Department of Health and Human Services (the “OIG Guidance”). The OIG Guidance advises that effective compliance programs are comprised of seven elements, which are outlined below. As described below, these elements form the basis of SPR’s program for compliance with the laws and standards regulating the marketing and promotion of our products.
(1) Written Policies and Procedures
SPR Therapeutics has written policies and procedures to assure substantial compliance with the applicable laws, regulations and standards governing the marketing and promotion of our products. SPR follows the AdvaMed Code of Ethics on Interactions with Health Care Professionals (“AdvaMed Code”) last updated in June 2023. SPR has established written policies and procedures that govern activities involving communicating with health care professionals about the appropriate use of our products, including appropriate instruction and education required for the safe and effective use of our products. SPR also has policies and procedures governing activities involving the advancement of scientific and educational activities supporting medical research and education.
(2) Compliance Officer
SPR Therapeutics has a Compliance Officer who is empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to the President & CEO. SPR also has a Compliance Committee that is comprised of the Compliance Officer, the President & CEO, and employees from multiple functions within the business.
(3) Training
All SPR employees are trained to the Compliance Manual, which details the operation of the Program, describes SPR’s guiding values, and references specific procedures within the Program. SPR employees are trained on subordinate procedures as appropriate for their job functions. This training is conducted at the time of hire and as the Manual and any procedures are revised over time.
(4) Communication
SPR Therapeutics encourages open and candid discussion between management and employees regarding any compliance concern. Employees are encouraged to report their concerns to their manager or to the Compliance Officer. Employees also have the option to report potential violations anonymously using the SPR Compliance Hotline.
(5) Monitoring
SPR Therapeutics regularly monitors our compliance with our policies and procedures to measure compliance, identify problem areas, and address identified problems.
(6) Enforcement and Disciplinary Guidelines
SPR Therapeutics may take disciplinary action, up to and including discharge/termination, in response to violation of the Company’s compliance policies or procedures. SPR Therapeutics may conduct an investigation of matters that are brought to the Company’s attention in order to ensure the consistent application of the Company’s standards by its employees and representatives.
(7) Investigation of Noncompliance or Misconduct
SPR Therapeutics requires a prompt and diligent response to potential violations of the Company’s Compliance Program. Actions in response to detected problems may include improving procedures, training, communication and monitoring or may require disciplinary action to prevent future violations. SPR shall report violations to relevant authorities in appropriate circumstances.