Compliance

TOLMAR is dedicated to conducting its business in a manner consistent with all applicable laws. To that end, TOLMAR is committed to establishing and maintaining 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”).

The TOLMAR Compliance Program is designed to meet the requirements set forth in applicable laws and to prevent and detect violations of such laws and company policy. While TOLMAR makes efforts to create policies that require proper conduct of all its employees and contractors, TOLMAR cannot guarantee that all of its employees and agents will always adhere to same. Therefore, in the event TOLMAR becomes aware of any violations of law or policy, it is committed to investigating the matter to determine whether disciplinary action or other corrective action is appropriate in order to prevent such occurrence from happening again in the future. While this Compliance Program is designed to meet the spirit and requirements identified in the OIG Guidance and PhRMA Code of 2008, TOLMAR reserves the right to continually assess its program objectives and to continually modify its program without notice.

1. Compliance Leadership
TOLMAR has identified a person within its organization who is responsible for the overall commercial compliance of the organization, including but not limited to adherence to this Compliance Program. This 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. This person reports to the President/CEO of TOLMAR and has direct access to the Board of Directors, with regard to all compliance concerns.

2. Documented Policies and Procedures
TOLMAR 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 TOLMAR 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 TOLMAR’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. TOLMAR has adopted policies and procedures designed to meet these requirements and laws.

Pursuant to California Health and Safety Code section 119402(d)(1), TOLMAR has established an annual limit on the amount it may spend on promotional activities directed at healthcare professionals. This amount is $2,500. 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
TOLMAR is dedicated to an ongoing training and education program for its employees with regard to their legal and ethical obligations. TOLMAR 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 TOLMAR to train all of its employees on the Compliance Program and Commercial Compliance Policy Book.

4. Communication
TOLMAR 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. TOLMAR also has established a toll free hotline, where employees may express their concerns in an anonymous manner. TOLMAR employees are also encouraged to report their concerns to their direct supervisors, Human Resources or the Compliance Department.

5. Auditing & Monitoring
TOLMAR has established an audit and monitoring program with regard to its internal review of business activity of TOLMAR relating to its Commercial 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
TOLMAR 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 (November 8, 2017)
In ensuring compliance coverage through policies, procedures and processes, TOLMAR 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 TOLMAR’s good faith understanding of applicable laws and regulations, and to the best of its knowledge, TOLMAR is in substantial compliance with its Compliance Program and California law.

While TOLMAR 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.