definiens: means the actualknowledge of the officers and employees listed on Schedule III ), all human clinical trials conducted by a third party on behalfof the Company or any of the Company Subsidiaries, have been and are being conducted in material compliance with allapplicable requirements of, and, to the knowledge of the Company,, as those terms are defined by FDA and in all applicable Drug Laws relating to clinical trials orthe protection of human subjects, including those contained in the International Conference on Harmonization 6 : GoodClinical Practices Consolidated Guideline, and in 21 C.F.R. Parts 50, 54, 56, and 312, and the provisions governing theprivacy of patient medical records under the Health Insurance Portability and Accountability Act of 1996 and theimplementing regulations of the United States Department of Health and Human Services, and all comparable foreign DrugLaws . Neither the Company nor any Company Subsidiary, nor to the knowledge of the Company, anyone acting on behalf ofthe Company or any Company Subsidiary, has received any written notice ( or to the knowledge of the Company any oralnotice ) that the FDA or any other Governmental Authority or institutional review board has initiated, or threatened to initiate, any clinical hold or other action to suspend any clinical trial or suspend or terminate any IND ( or foreign equivalent thereto)sponsored by the Company or any Company Subsidiary, or otherwise restrict the preclinical research on or clinical study ofany Company product candidate . Notwithstanding the foregoing, any representation is made only to the knowledge of theCompany with respect to activities by third parties to which the Company has transferred its regulatory obligations under theprovisions of 21 C.F.R. Section 312.52 or any comparable foreign Drug Law