Tenpoint Therapeutics California Declaration of Comprehensive Compliance Program

Declaration of Compliance

Tenpoint Therapeutics as of May 1, 2026, affirms its compliance with the Comprehensive Compliance Program (CCP) and California Health and Safety Code §§ 119400-119402. The CCP, further detailed below, incorporates the essential elements of an effective compliance program as outlined in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the Office of the Inspector General, U.S. Department of Health and Human Services (HHS-OIG Guidance). Additionally, Tenpoint Therapeutics has adopted the “Code on Interactions with Healthcare Professionals” from The Pharmaceutical Research and Manufacturers of America (PhRMA Code), and has developed policies, procedures, and processes to ensure adherence to the PhRMA Code.

Comprehensive Compliance Program Description

I. Introduction

Tenpoint Therapeutics is dedicated to conducting business in line with the highest ethical and compliance standards. Central to this commitment is the establishment and ongoing maintenance of a CCP consistent with HHS-OIG Guidance. Employees are expected to comply with the CCP, and any potential violations of the CCP, applicable laws, regulations, industry codes, or company policies are thoroughly investigated and resolved. When appropriate, disciplinary measures—including termination—are taken, and corrective actions are implemented to prevent future violations.

The CCP is designed to be adaptable, evolving with the company’s growth and changes in legal, regulatory, or industry obligations. Regular reevaluation ensures continued improvement and effectiveness. The fundamental components of the CCP are outlined below.

II. Compliance Program Overview

A. Leadership and Structure

  • Compliance Officer: The Vice President, Head of Compliance is responsible for developing, operating, and monitoring the CCP. This officer reports directly to the Chief Executive Officer, interacts regularly with senior management, provides CCP updates to the Board of Directors at least annually, and delivers frequent reports to senior management.
  • Compliance Committee: Tenpoint Therapeutics has formed a Compliance Committee to advise the Vice President, Compliance and assist with CCP implementation. The Committee consists of C-Suite members representing various departments, including sales, marketing, clinical, medical affairs, legal, regulatory, finance, and human resources. Regular meetings are held to review company activities and compliance trends.

B. Written Standards

  • Tenpoint Therapeutics demonstrates its commitment to compliance through multiple company policies, including Tenpoint’s Code of Conduct. These standards apply to all employees, and compliance is a condition of employment. Senior leadership and managers are tasked with reviewing relevant policies—including those supporting the CCP—with employees and ensuring adherence to company policies, laws, regulations, and industry codes.
  • The company has established restrictions on items of value provided to healthcare providers (HCPs) that align with the PhRMA Code.
  • Tenpoint Therapeutics has also set an annual dollar limit for items of value (including meals) that may be provided to California HCPs in compliance with California Health and Safety Code §§ 119400-119402. The annual aggregate limit per California HCP is set at $2500 subject to revision. This limit does not apply to drug samples intended for free patient distribution or payments for legitimate professional services rendered by HCPs.

C. Education and Training

Compliance training is routinely provided to all Tenpoint Therapeutics employees, including during new hire orientation. Training covers the CCP, company policies, and all relevant laws, regulations, and industry codes.

D. Internal Lines of Communication

The company uses various internal communication tools to address compliance topics with employees. These include an intranet site for the Compliance Department and a regularly distributed newsletter. Tenpoint Therapeutics responds to individual compliance questions, addresses issues at company meetings, and maintains ongoing compliance communications. Employees are instructed to report actual or potential compliance violations and are provided resources, such as an independent, third-party operated Compliance Hotline, to anonymously report compliance matters if desired.

E. Auditing and Monitoring

Annual compliance risk assessments, routine monitoring, and audits are conducted by Tenpoint Therapeutics. Reports from these activities are shared with the Vice President, Head of Compliance, the Compliance Committee, and senior management. Identified issues and opportunities for improvement are addressed, with education, training, and corrective actions implemented as needed.

F. Responding to Potential Violations

The CCP mandates prompt responses to potential violations of law, regulation, industry codes, or company policies. Each potential violation is investigated and evaluated individually. When appropriate, disciplinary action—including termination—is taken.

G. Corrective Action Procedures

Upon investigation of reported or detected compliance issues, the company assesses whether additional corrective actions are warranted. This assessment includes determining whether any gaps exist in policies, training, or internal controls. If a gap is identified, corrective action is taken to address it.

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