Ironshore Pharmaceuticals Inc. Annual Declaration of Compliance for Purposes of California Health & Safety Code §§ 119400-119402


Ironshore Pharmaceuticals Inc. (“Ironshore”) has a Comprehensive Compliance Program (CCP) in accordance with the requirements of California Health & Safety Code §§ 119400-119402. Ironshore has designed its CCP in accordance with the April 2003 publication “Compliance Program Guidance for Pharmaceutical Manufacturers,” which was developed by the United States Department of Health and Human Services Office of Inspector General. In addition, Ironshore has policies, procedures and processes designed to help ensure compliance with the "Code on Interactions with Healthcare Professionals" published by The Pharmaceutical Research and Manufacturers of America (the "PhRMA Code").


As part of its ongoing commitment to operate in an ethical and compliant manner, Ironshore continually (at least annually) assesses its CCP and makes changes as necessary to improve it. As of July 1, 2023, Ironshore hereby declares, to the best of its knowledge that it is in compliance with its CCP and the requirements of California Health & Safety Code §§ 119400-119402. In making this declaration of compliance, Ironshore is asserting that its CCP consists of a Compliance Officer, policies, training, open lines of communication, auditing and monitoring and has processes in place to prevent and identify any potential violations of the CCP and provides for any appropriate disciplinary and corrective actions. To obtain a copy of this declaration of compliance please send an email to: compliance@ironshorepharma.com.

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