Ethics and Compliance
At UroGen, our mission is to build novel solutions to treat urothelial and specialty cancers because patients deserve better options. As important as our mission is how we conduct ourselves every day striving to achieve that mission on behalf of the patients that we collectively serve. That is why we at UroGen are committed to conducting all aspects of our business consistent with the highest ethical standards and applicable laws and regulations that govern our industry.
As part of this commitment, UroGen has adopted a Comprehensive Compliance Program (“CCP”) that is designed to prevent, detect, and resolve potential compliance issues. Our CCP is designed to effectuate the principles and framework set forth in the “Compliance Program Guidance for Pharmaceutical Manufacturers” published by the by the U.S. Department of Health and Human Services Office of Inspector General in 2003 and the Pharmaceutical Research Manufacturers of America’s “Code on Interactions with Healthcare Professionals.”
Governance and Oversight
The Chief Compliance Officer at UroGen oversees all compliance activities. The Chief Compliance Officer is responsible for developing, operating, and monitoring our CCP. The Chief Compliance Officer reports directly to the President and Chief Executive Officer and has the authority to report to the Board of Directors. UroGen has established a Compliance & Business Integrity Committee, which consists of senior leaders across various business functions. The Chief Compliance Officer also provides quarterly reports to the Compliance Committee of the UroGen Board of Directors.
Documented Standards of Conduct
UroGen has established written standards of conduct. These policies and procedures are designed to ensure compliance with the requirements associated with federal healthcare programs and that our activities are appropriate, ethical, and consistent with applicable laws and regulations.
California Annual Spending Limit
Consistent with the requirements with California Health and Safety Code §§ 119400-119402, UroGen has established a specific annual aggregate dollar limit of $2,500 on the following items of value that UroGen may provide to healthcare professionals licensed in California: (a) meals provided in connection with informational presentations or scientific exchange; (b) educational items intended to enhance patient care (excluding items of minimal monetary value and/or of no independent value (i.e., printed advertising, reimbursement fact sheets, etc.); and (c) items provided for the benefit of (and distribution to) patients or caregivers.
The annual limit does not include the following:
- Drug samples given to physicians and healthcare professionals;
- Financial support for continuing medical education programs or health educational scholarships;
- Payments for bona fide services, and any meals or expenses associated with the provision of such services;
- Materials that inform healthcare professionals about UroGen’s approved medicine or otherwise contain scientific and educational data
- Select medical devices that accompany sales of our prescription medicine that have no substantial independent value to healthcare professionals; and
- Patient educational materials provided to patients by their physician with the purpose of educating the patient or enhancing the patient’s understanding or management of the condition.
Education and Training
UroGen provides its employees with periodic training and education to assist them in meeting the responsibility of conducting our business in an ethical manner and consistent with applicable laws and regulations. New employees will receive such instruction as part of their initial training and existing employees are expected to receive certain training on an annual basis.
Open Lines of Communication
UroGen is committed to fostering an environment where open communication regarding our policies, procedures, and business activities is encouraged. This includes the airing of concerns and reporting potential inappropriate activities. Any employee who has concerns about a particular activity is required to report such concerns. Employees may either report their concerns to their supervisors, senior leaders, or to any member of the compliance and legal team. UroGen also maintains a “Compliance Hotline” where employees may anonymously (where allowed by law) report potential inappropriate conduct or violations of our policies. Reports can be made to the UroGen Compliance Hotline by email at firstname.lastname@example.org
or toll-free by telephone at 1‑844‑421‑1607.
The Compliance department (or its designee) will make a good-faith inquiry into any reported violation. UroGen expressly prohibits retaliation or retribution against any employee who reports or makes a good-faith effort to report suspected misconduct or inappropriate behavior.
Auditing and Monitoring
UroGen conducts auditing and monitoring activities to assess and evaluate compliance with the company’s policies and procedures as well as identify training policy or procedure needs. The Compliance Department will work with relevant internal and external experts and management as necessary to evaluate auditing and monitoring findings and ensure the implementation of any corrected action deemed necessary.
Corrective and Disciplinary Action
Compliance program violations result in corrective and/or disciplinary action. The corrective and/or disciplinary action may include (but is not limited to) termination or other discipline of the colleague(s) involved; retraining; or revisions to policies, procedures, training or any other aspect of the CCP to prevent reoccurrence of violations in the area.
UroGen Declaration of Compliance: California Health and Safety Code §§ 119400-119402
UroGen Pharma Inc. and UroGen Pharma Ltd. (collectively, “UroGen Pharma”) declares that, to the best of its knowledge and based on a good faith understanding of Health & Safety Code §§ 119400-119402, it has developed a Comprehensive Compliance Program (“CCP”) consistent with the requirements of California law. UroGen has tailored its CCP to the size, organization structure, and business operations of UroGen. UroGen will continually evaluate and update its CCP as necessary and appropriate as compliance and operational needs evolve. To the best of our knowledge and on a good-faith belief, UroGen is in substantial compliance with its Comprehensive Compliance Program and the requirements of California Health and Safety Code sections 119400-119402. A description of our Comprehensive Compliance Program and a copy of this annual declaration are publicly available on our website and can be requested by emailing us at email@example.com
or calling 609.467.4971.
Dated: January 2024