Compliance

UroNova’s dedicated, patient-focused company culture sets high standards for corporate responsibility and compliance. Our vision, values and mission to improve the lives of patients around the world guide UroNova’s commitment to compliance in all areas of our business. UroNova makes a proactive effort to ensure our employees and contractors adhere to our standard of conduct. UroNova, has established a Compliance Program designed to meet the requirements of all applicable laws. We place a significant importance on integrity, and to that end we strive to foster a culture that represents our dedication to ethics. The UroNova Pharmaceuticals, Inc., Compliance Program aids in preventing and detecting violations of such laws and our company policies.

UroNova, maintains a compliance program consistent with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” published by the Office of Inspector General, US Department of Health and Human Services (hereinafter, “OIG Guidance”); and the “Code on Interactions with Healthcare Professionals,” published by the Pharmaceutical Research and Manufacturers of America in 2008 (hereinafter, “PhRMA Code”).

While UroNova has established policies that require proper conduct of all its employees and contractors, we cannot guarantee that all of our employees and agents will always adhere. In the event UroNova becomes aware of any violations of law or policy, we are committed to investigating the matter fully. Through our investigation, we will determine whether or not corrective or disciplinary action is appropriate in order to prevent such future occurrences. The UroNova Compliance Program is designed to meet the spirit and requirements identified in the OIG Guidance and PhRMA Code of 2008, however, UroNova reserves the right to continually assess the program objectives and may continually modify this program without notice.

 

1. Compliance Leadership

UroNova has identified a Compliance person within its organization who is responsible for the overall compliance of the organization, including but not limited to adherence to this Compliance Program. This Compliance person has the ability to make decisions for the company with regard to its compliance and is responsible for developing, monitoring and implementing the Compliance Program.

2. Documented Policies and Procedures

UroNova has documented policies and procedures that address the company’s expectations and management of its employees with regard to adherence to all applicable laws and the policies set forth in the UroNova Compliance Policy Book. The information contained in the Compliance Policy Book addresses the specific risk areas identified in the OIG Guidance as well as other practice areas specific to UroNova’s business practices.

The OIG Guidance risk areas include (a) data integrity, (b) kickbacks, (c) compliance with drug sampling laws. The PhRMA Code addresses the inappropriate uses of meals, entertainment and recreation when interacting with healthcare professionals; as well as the appropriate use of speaker programs, educational programs, consulting arrangements, training and other issues related to interactions with healthcare personnel. In addition, there are various state laws that maintain their own restrictions, disclosures and other requirements with regard to compliance and codes of conduct. UroNova has adopted policies and procedures designed to meet these requirements and laws.

Pursuant to California Health and Safety Code section 119402(d)(1), UroNova has established an annual limit on the amount it may spend on promotional activities directed at healthcare professionals. This amount is $2,500 per provider. This stated limit is not a goal, but a maximum that the company sets for itself as a limitation. In most cases, the amounts actually spent are significantly less than the maximum amount set by this limitation. This limitation is also subject to ongoing review and may be changed from time to time at the discretion of the company.

3. Training

UroNova is dedicated to an ongoing training and education program for its employees with regard to their legal and ethical obligations. UroNova has specific documented training programs in identified areas of education and employees are required to complete certain programs in accordance with their expected job obligations. These training programs are subject to review, modification and addition from time to time, as deemed appropriate by the company. It is the policy of UroNova, Pharmaceuticals, Inc., to train all of its employees on the Compliance Program and Compliance Policy Book.

4. Communication

UroNova encourages free flow of information, ideas and concerns with regard to its business activities. To that end, all employees should have a communication channel to express concerns or other information about the company and its practices, especially concerns regarding compliance with the company Compliance Program or Code of Conduct. Retaliation against an employee for expressing a concern or other good faith report of a potential violation of any law or company policy is prohibited. UroNova, also has established a toll free hotline, where employees may express their concerns in an anonymous manner. UroNova employees are also encouraged to report their concerns to their direct supervisors, Human Resources or the Compliance Department.

5. Auditing & Monitoring

UroNova has established an audit and monitoring program with regard to its internal review of business activity of UroNova relating to its Compliance Policies. This program includes a random and for-cause element; and is subject to change from time to time. Tolmar is always assessing its risk of non-compliance and will focus its audits and monitoring in those areas consistent with OIG Guidance, the PhRMA Code and its own internal assessments.

6. Corrective Action

UroNova has established disciplinary policies for those employees who violate the law or company policy. Based upon the nature of each violation, the company will investigate the matter and consider disciplinary action in accordance with company policy. In addition, based upon the nature of any transgression or violation, and after proper investigation, the company would consider implementation of preventative or corrective action where necessary.

Annual Declaration (May 7, 2025)

In ensuring compliance coverage through policies, procedures and processes, UroNova reviewed the OIG Guidance and the PhRMA Code, and believes that its Compliance Program is consistent with a reasonable interpretation of those guidelines and is in compliance with other applicable laws and regulations, including California Health & Safety Code, Sections 119400-119402, as of the date of this declaration. Based upon UroNova’s good faith understanding of applicable laws and regulations, and to the best of its knowledge, UroNova is in substantial compliance with its Compliance Program and California law.

While UroNova seeks to comply with the spirit and intent of the laws and rules mentioned above, there is no guarantee that its interpretation will be consistently agreed upon by other enforcing agencies.

Please visit our Compliance Portal if you have a question at Speak Up