Declaration of Compliance Pursuant to California Health and Safety Code
Pursuant to the State of California Health and Safety Codes sections 119400 – 119402, Defender Pharmaceuticals (“Defender” or the “Company”) has established a Comprehensive Compliance Program (the “Compliance Program”) that is in accordance with the U.S. Department of Health and Human Services Office of Inspector General’s “Compliance Program Guidance for Pharmaceutical Manufacturers” (“OIG Guidance”)”, includes policies for compliance with the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code on Interactions with Healthcare Professionals (the “PhRMA Code”) and otherwise adheres to relevant industry guidance.
Our Compliance Program is intended to prevent, detect, and correct violations of law and company policies and to encourage a culture of compliance that guides our interactions with healthcare providers, patients, government officials, and customers. We regularly review and enhance our Compliance Program to meet our evolving compliance needs.
Defender hereby declares, to the best of its knowledge, and based on its good faith understanding of the statutory requirements, that it is in compliance with its Compliance Program and the statutory requirements set forth in California Health and Safety Code sections 119400-119402.
Defender has tailored its Compliance Program to meet the needs of the organizational structure of the Company and continuously assesses and refines its Compliance Program, demonstrating its commitment to fulfill the statutory requirements of the State of California.
Defender recognizes that even an effective Compliance Program cannot completely eliminate improper conduct by individual employees and thus does not claim that its Compliance Program eliminates all employee conduct that would be considered improper.
For purposes of complying with the California Health and Safety Code Sections 119400 to 119402, and as part of Defender’s CCP, the Company has set an annual dollar limit of $3,000 for spending on promotional materials, educational items, incidental meals, and other items or activities that it may provide to a healthcare professional in California, as defined in the statute.
This annual aggregate limit is intended to establish an upper spending limit on items covered under the California statute and does not represent an annual spending goal. The limit may be revised at any time based on a variety of factors.
Consistent with California law, this annual spending limit does not include the value of: (1) drug samples given to healthcare professionals intended for free distribution to patients; (2) financial support of independent education including continuing medical education; (3) financial support for health education scholarships; and (4) payments made for legitimate professional services provided by a healthcare professional so long as the amount paid is based up the fair market value of the services provided and in compliance with OIG Guidance and policies established by Defender to comply with the PhRMA Code and relevant industry guidance.
A copy (or copies) of this Annual Written Declaration of Compliance and Defender’s Comprehensive Compliance Program may be obtained by calling the toll-free telephone number 314-697-1330 or sending an email to [email protected]. Defender’s corporate governance documents, including this Annual Written Declaration of Compliance and Comprehensive Compliance Program, may be found at www.defenderpharma.com.
This declaration is made on February 22, 2023.