Kite Pharma, Inc. has declared its commitment to support and maintain an effective compliance program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers” published in May 2003 by the Office of Inspector General, US Department of Health and Human Services (The “HHS-OIG Guidance”). As a company, Kite is committed to the highest standards of business conduct, and this Compliance Program is a key part of our efforts to ensure these standards are met.
The goal of the Compliance Program is to help prevent and detect violations of law or company policy with respect to the marketing of our products. The HHS-OIG Guidance recognizes that the implementation of such a program cannot guarantee the complete elimination of improper employee conduct. Kite’s expectation, however, is that employees will comply with our Compliance program and our policies established in support of such program. Kite will investigate any violation of law or company policy and where appropriate take disciplinary action and institute measures to avoid future violations.
The fundamental elements of this Compliance Program are described below. In accordance with the HHS-OIG Guidance, Kite’s Compliance Program is designed specifically for our company. This Compliance Program is subject to fundamental quality standards. On an ongoing basis, we review and enhance our Compliance Program to meet changing legal requirements and our evolving compliance needs.
Kite’s Compliance Program includes clear disciplinary policies that outline the consequences of violating the law or company policy. Each situation must be considered on a case-by-case basis. Appropriate disciplinary action, up to and including termination, will be taken against any employee or agent who violates Kite’s policies or applicable laws and regulations. Disciplinary action will also be taken against any manager who intentionally or negligently permits or condones violations of these policies or applicable laws and regulations.
As part of Kite Pharma, Inc.’s continuing activities in the area of corporate compliance, we implemented our Kite Healthcare Product Compliance Program effective July 1, 2018. We developed the Compliance Program with consideration given both to the goals of sections 119400-119402 of the California Health and Safety Code and to the operations, size, and organization of our company. Based upon our good faith understanding of these statutory requirements, we have initiated this Compliance Program and modified existing procedures accordingly.
No Compliance Program can guarantee that no violations will take place. The goal is to deter violations and identify them as promptly as possible and then facilitate appropriate corrective actions. Since compliance is a dynamic process, we will be evaluating and assessing our Compliance Program on an ongoing basis to adjust to new circumstances and to maintain and improve the strength of the Compliance Program.
This Declaration and the Kite Pharma Healthcare Product Compliance Program may be printed from this website. If you would like to receive printed versions of these documents by mail, you may do so by emailing your request to [email protected] or by calling our toll-free number at 1-855-650-5483.
As of December 31, 2019, to the best of our knowledge, and based on a good faith belief, Kite Pharma, Inc. is in substantial compliance with its Compliance Program and the requirements of sections 119400-119402.