(As required by the California Health & Safety Code Sections 119400 - 119402)

Secura Bio, Inc.® (“SECURA BIO”), is a pharmaceutical company that develops and commercializes innovative medicines and life changing products for patients that need them most. We are committed to meeting this goal while maintaining high standards of integrity and ethical behavior as we conduct our business.

SECURA BIO has established a Comprehensive Compliance Program (CCP) that is overseen by the Compliance Officer and the Compliance Committee to ensure adherence to U.S. laws, regulations and industry standards. It is based on the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and in accordance with the PhRMA Code.

The CCP applies to all SECURA BIO personnel, including its Governing Board, administration, physicians and other practitioners, employees, volunteers, and other entities providing services on behalf of SECURA BIO (collectively “SECURA BIO personnel”). The CCP includes the following elements:

  1. Written standards, policies and procedures which promote SECURA BIO’s commitment to compliance with applicable laws and regulations and set forth the guiding principles applicable to all employees.
  2. The designation of a Compliance Officer and Compliance Committee charged with the responsibility of implementing and overseeing the CCP.
  3. Regular, effective education and training programs for all SECURA BIO personnel as appropriate to their functions and pursuant to applicable healthcare laws and guidance such as the False Claims Act (FCA), Anti-Kickback Statute (AKS) and Federal and State transparency and disclosure requirements.
  4. An open line of communication through which employees are encouraged to speak up when they have questions or concerns or are seeking to report potential violations of the law, our Code or company policies. SECURA BIO makes every effort to protect a reporter’s confidentiality and prohibits any retaliation or harassment in response to a report made in good faith. Internal auditing and monitoring to help detect and prevent violations of SECURA BIO’s Code of Conduct and all applicable U.S. laws, regulations and guidance.
  5. The Compliance function is responsible for responding to reports of improper activities, investigating the situation and suggesting appropriate disciplinary action against SECURA BIO personnel who have violated SECURA BIO policies, laws, regulations, or health care program requirements.

As required by the California Health & Safety Code Section 119402, SECURA BIO has established an aggregate dollar limit of $2,000 per calendar year on educational items, promotional materials and meals for each medical or healthcare professional who holds a license in the State of California.

Request for copies of Secura Bio®’s CCP can be made by calling (858) 251-1420.