Compliance Program

Contact

Tel: + 1 973 324 0200
Fax: + 1 973 324 0795

US Compliance Program 

Exeltis USA, Inc. (“Exeltis” or “Company”) is committed to conducting business in compliance with applicable laws, regulations, guidelines and policies. To that end, Exeltis has established and maintains an effective Compliance Program which is designed following the framework laid out in the  “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, U.S. Department of Health and Human Services (“OIG Guidance”) and the Pharmaceutical Research and Manufacturers of America “Code on Interactions with Healthcare Professionals” (“PhRMA Code”). Our Compliance Program is a key component in fostering a culture of compliance and represents our commitment to transparent and ethical business practices. 

Leadership and Structure  

Exeltis has designated a Compliance Director to implement and oversee its US Compliance Program. Exeltis has also established a US Healthcare Compliance Committee that meets as frequently as necessary to meet the Company’s compliance needs, but in any event, no less than quarterly each year.    

Written Standards 

Exeltis is part of the Spanish multinational Insud Pharma, which has implemented a Code of Ethics applicable to its business operations in 50 countries, including the US, and which captures the fundamental values of our Company. The Code is further supported by a set of US healthcare compliance policies governing our general business operations as well as those activities specifically related to the marketing and sale of our products and interactions with healthcare professionals. 

Training and Education 

Everyone’s understanding of the policies established as part of the Exeltis US Compliance Program is critical to the success of the Compliance Program. Exeltis is focused on communicating Company policies and procedures to its employees and other personnel to ensure a thorough understanding of and appreciation for how to conduct business practices appropriately. New US employees receive healthcare compliance training as part of their initial training.  Also, all US employees whose job functions involve interactions with healthcare professionals receive on-going healthcare compliance training on a routine and periodic basis. 

Lines of Communication 

Exeltis promotes open dialogue between management and employees in seeking guidance and reporting concerns about non-compliance. All employees have a responsibility to report suspected misconduct and are encouraged to discuss matters with their supervisor, members of the management team, HR or Compliance. Matters may also be reported anonymously through a global hotline, DirectLine, assured to reach the Insud Pharma Compliance and Audit Committee.  The Company expressly prohibits retaliation or retribution against any employee who reports or makes a good faith report of suspected misconduct of improper behavior. 

Auditing and Monitoring 

Exeltis utilizes auditing and monitoring to verify that the business practices engaged in by its employees follow the policies and procedures that are in place to ensure compliance with the laws and regulations applicable to the Company.  Compliance identifies areas of potential risk on which to focus its auditing and monitoring, and the extent and frequency of these activities varies according to several factors, including new regulatory requirements and changes in business practices.  In addition, Compliance will work with relevant internal and external experts and management as necessary to evaluate auditing and monitoring findings and ensure the implementation of any corrective action deemed necessary because of audits or routine monitoring activities. 

Disciplinary Measures 

Failure to comply with our Compliance Program will be treated as a violation of Company policy and may result in disciplinary action, up to and including termination of employment or contracting services. Although each situation is considered on a case-by-case basis, we will consistently undertake appropriate disciplinary action to address matters of non-compliance and deter future violations. 

Investigations and Corrective Actions 

Exeltis will investigate suspected non-compliance with its policies and procedures as well as applicable laws and regulations in a manner designed to promptly and accurately ascertain the facts and to determine the underlying cause or causes of any substantiated, non-compliant conduct. Compliance will direct investigations of suspected non-compliance, document the nature and results of such investigations, and collaborate with others as needed to ensure appropriate corrective action is taken to prevent future violations.  

California Annual Declaration of Compliance 

November 4, 2025 

This information is provided pursuant to the requirements of California Health and Safety Code, Section 119402, which requires pharmaceutical companies doing business in California to make a description of their Compliance Program available and to provide an annual written declaration of compliance with their Compliance Program. 

Exeltis has adopted a Comprehensive Compliance Program in accordance with California Health and Safety Code, Sections 119400 – 119402. This Program is tailored to fit the current size and business operations of the Company; it continues to develop as compliance and operational needs evolve. For purposes of compliance with the requirements of the California Compliance Law and as part of the US Compliance Program, Exeltis has established an annual aggregate dollar limit of $2,000 on gifts, promotional materials, or items or activities that Exeltis may give or otherwise provide to an individual medical or healthcare professional in California on an annual basis. This limit represents a spending cap; it is not a goal, an average, customary or a typical amount. 

To the best of its knowledge and based on its good faith understanding of the statutory requirements, Exeltis declares that it is, in all material respects, in compliance with the Compliance Program and with the respective established annual spending limits for reporting period of January 1, 2024 through December 31, 2024. 

For a written copy of the Compliance Program description or this declaration, please call: 973-324-0200 

Written communications may also be received by the Exeltis US Compliance Director:  

Exeltis US Compliance Director
180 Park Avenue, Suite 101 

Florham Park, NJ 07932 

compliance.usa@exeltis.com 

Commitment to Transparency 

At Exeltis, we are focused on delivering safe and effective treatments to patients and healthcare professionals. To help ensure the availability of new treatment options, we may work and innovate with other individuals and organizations including healthcare professionals and teaching hospitals. We are fully committed to the financial transparency of these relationships and to preventing any real or perceived conflict of interest. 

Under federal law and implementing “Sunshine” regulations (now referred to as “Open Payments”), issued by the Centers for Medicare and Medicaid Services (CMS), any payment or other transfer of value from the manufacturer of a commercial pharmaceutical drug or medical device product made to a relevant covered recipient is subject to tracking and potential public reporting. Certain states have also enacted similar compliance laws relating to transparency of interactions with certain healthcare professionals, which are separate from, and in addition to, the federal reporting requirements.