Compliance Systems. The Grantee shall implement and use the required compliance systems, as well as adhere to the policies, procedures, and requirements relating to COMETS. Grantee shall use COMETS to respond to any citation of non-compliance.
Compliance Systems. The Grantee shall implement and use the required compliance systems as well as adhere to the policies, procedures and requirements relating to the following formalized or automated systems designed to track and enforce administrative law:
Compliance Systems. With respect to the researching, developing, manufacturing, making, using, selling, offering for sale, importing, exporting or other exploitation of the Products, to the extent applicable to Prophylix and the Products, Prophylix has complied and continue to comply, in all material respects, with, and maintains systems and programs to ensure compliance, in all material respects, with, applicable requirements of the FDCA, the Prescription Drug Marketing Act (the “PDMA”) and the rules and regulations issued under the FDCA, the PDMA, and similar or related foreign Legal Requirements pertaining to programs or systems regarding product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest including requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and Adverse Drug Reaction Reporting requirements.
