GUERBET LLC

COMPREHENSIVE U.S. COMPLIANCE PROGRAM

A. General

Guerbet LLC (“Guerbet”) is committed to the highest possible standards of ethical, moral and legal business conduct. This Comprehensive Compliance Program (“CCP”) is a summary of Guerbet’s compliance program and does not summarize all laws and regulations applicable to Guerbet and its employees, officers, directors and vendors. The standards enumerated below are embodied in Guerbet’s Code of Ethics.

B. Interactions with Healthcare Professionals

Guerbet’s CCP was established in accordance with the Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers (“OIG CPG”), the Pharmaceutical Research Manufacturers of America’s Code on Interactions with Healthcare Professionals as revised and effective January 1, 2022 (“PhRMA Code”), and the Advanced Medical Technology Association Code of Ethics as revised and effective June 1, 2023 (“AdvaMed Code”). Guerbet employees, officers, directors and vendors are expected to interact with healthcare providers in compliance with this CCP (including the OIG CPG, PhRMA Code and AdvaMed Code), Guerbet’s Code of Ethics and compliance policies and procedures, and such other applicable laws, regulations and guidelines.

Guerbet’s CCP provides Guerbet representatives with guidance regarding interactions with healthcare providers and healthcare entities including, but not limited to, advisory boards, speaker programs, gifts, educational items, grants, informational lunches, physician consulting and advisory arrangements, and Guerbet promotional materials. Members of the commercial operations department each receive Guerbet’s Code of Ethics, which includes additional compliance guidance.

C. Compliance Officer; Compliance Committee

Guerbet has a Corporate Compliance Officer who reports directly to Guerbet’s Global Head of Legal and Compliance. The Corporate Compliance Officer’s primary responsibilities, in conjunction with Guerbet’s Corporate Compliance Committee as applicable, include, but are not limited to: (i) oversight of CCP day-to-day operations; (ii) developing and implementing policies, procedures and practices to implement and administer the CCP; (iii) assessing, developing and implementing Guerbet’s compliance training activities, including dissemination of guidelines and policies; (iv) monitoring Guerbet’s Compliance Ethics Alert Line and responding as appropriate; (v) investigating compliance matters, including recommendations and oversight of any required disciplinary or other corrective actions; and (vi) establishing and executing adequate auditing and monitoring processes to assure adherence with the CCP. 

D. Training and Education

Guerbet’s Code of Ethics and relevant job-specific materials are distributed to newly hired employees engaged in sales and commercial operations. Each new hire must agree in writing to comply with Guerbet’s Code of Ethics. All Guerbet employees are formally trained in an introductory CCP training and must sign a verification of participation in this session. Follow-up training is provided at least annually to all employees who have sales and marketing responsibilities via employee meetings, videoconference or email. Follow-up training includes periodic updates to the Code of Ethics and supplemental compliance materials.  Such training is documented by the signing of an acknowledgement form.

E. Lines of Communication

Guerbet employees are encouraged to openly communicate compliance issues and concerns in a prompt manner. Employees are instructed that any actual or perceived communication problem should be reported to their supervisors, the HR Department, the Corporate Compliance Officer or the Legal Department. No retaliation will be taken against any employee for raising concerns or issues of legal, regulatory or policy compliance. The taking of any such retaliation by any employee, officer or director is grounds for disciplinary action.

Guerbet operates an anonymous Compliance Ethics Alert Line administered by a third-party vendor to help ensure compliance violations are properly reported and thoroughly investigated. The Ethics Alert Line promotes a culture of adherence to ethical business practices related to the sales, marketing and contracting of Guerbet promoted products and to provide the tools with which to do so. Communications to the Compliance Ethics Alert Line are answered by trained personnel and monitored daily. Communications may be made on an anonymous and confidential basis. Information from each communication will be forwarded to the appropriate Guerbet office for follow-up, depending on the nature of the issue or concern raised. All communications are otherwise kept confidential to the extent permitted by law. All reports of improper conduct will be reviewed and investigated and action will be taken as appropriate.

• https://report.whistleb.com/en/GuerbetEthicsAlertLine

F. Auditing and Monitoring

The Corporate Compliance Officer periodically monitors and audits Guerbet’s activities to ensure CCP compliance. Actions include periodic reviews of financial and other records related to interactions with healthcare professionals, and reporting and monitoring employee training participation. Audit results and corrective actions are periodically reported to executive management.

G. Disciplinary Guidelines; Investigation; Corrective Action

The Corporate Compliance Officer, in conjunction with Guerbet’s HR Department as applicable, oversees investigations of compliance-related issues. Guerbet is committed to responding promptly to non-compliance with CCP or Guerbet policy and taking appropriate corrective action. Disciplinary actions, ranging from verbal reprimand, written warning, suspension and termination are determined on a case-by-case basis and are set forth in the Code of Ethics and employee handbooks.

H. Annual Spending Limit - California

California law requires pharmaceutical companies to voluntarily adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company and its employees and representatives may give or otherwise provide to an individual medical or health care professional in California. The limit does not include amounts attributable to drug samples, financial support for continuing medical education, or payment for legitimate professional services.  

Guerbet has adopted an annual spending limit of $2,000 for gifts, promotional materials, or items or activities provided to an individual California health care professional pursuant to the California Health and Safety Code. This limit represents a spending cap and Guerbet anticipates that amounts provided will be substantially less than this maximum amount. The annual limit may be revised from time to time.

I. Annual California Declaration of Compliance; Availability of Program

As part of its continuing commitment to maintain the highest standards of business ethics and conduct, Guerbet has posted a Comprehensive Compliance Program (“CCP”), as required by California Law.

Guerbet declares, as required by section 119402(e) of the California Health and Safety Code, that to the best of its knowledge it is, in all material respects, in substantial compliance with its CCP and the requirements of the California Health and Safety Code sections §§119400-119402. In accordance with Section 119402(e) of the California Health & Safety Code, Guerbet will post an Annual Declaration of Compliance on its website each calendar year. 

Copies of this declaration and the CCP can be downloaded from the Guerbet website at https://www.guerbet.com/en-us/footer/compliance, and is made available to any interested person. Requests for copies can also be obtained via email at compliance.US@guerbet.com or toll-free at (877) 729-6679.

Updated July 2025