Comprehensive Compliance Program

Validus Pharmaceuticals LLC (“Validus”) is committed to complying with all applicable law and to operating our business in accordance with the highest ethical standards.  To this end, Validus has established a comprehensive compliance program (“CCP”) to help ensure that our employees and contractors perform their responsibilities for Validus in a legal and ethical manner.

The key elements of Validus’s CCP include the following internal policies and/or training requirements: Code of Conduct, Healthcare Compliance Handbook, Policy Regarding Promotion (Detailing) to HCPs, Samples Management, Impact of Fraud and Abuse Laws on Pharmaceutical Promotion, and Drug Detailing Legal Considerations.  Consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers published by the Office of Inspector General (OIG) of the United States Department of Health and Human Services (HHS), our CCP seeks to prevent and detect violations of applicable law and our internal policies by our employees and contractors.

Our Policy Regarding Promotion (Detailing) to HCPs and our Drug Detailing Legal Considerations training reflect the Code on Interactions with Healthcare Professionals (PhRMA Code) published by the Pharmaceutical Research and Manufacturers of America and sets forth limits on gifts, promotional materials, and items or activities that our employees and contractors may give or provide to a medical or health professional. All employees and contractors who interact directly or indirectly with healthcare professionals receive a copy of this policy and this training. Training records are maintained in accordance with our internal policies.

Additional ethics and compliance education and training programs are provided to our personnel and contractors on an ongoing basis as required by an individual’s job responsibilities, by current Good Manufacturing Practices (19 C.F.R. §§ 210 and 211), and by changes in applicable law and our internal policies. Training records are maintained in accordance with our internal policies and current Good Manufacturing Practices.

Validus hereby declares that, to the best of its knowledge, information, and belief, and based upon its good-faith understanding of statutory and regulatory requirements, it has established a Comprehensive Compliance Program that is in material compliance with the requirements of California Health and Safety Code §§ 119400 and 119402. This declaration is made solely for the purpose of complying with the California law cited above and should not be read in isolation from current or future Validus internal policies.

Anyone who would like to obtain a copy of Validus’s CCP and/or the above California declaration may contact the General Counsel at (973) 265-2777 or [email protected]