(aa) The Company and its subsidiaries, and to the Companys knowledge, its respective directors, officers, employees, agents, affiliates and representatives, are, and at all times have been, in compliance in all material respects with all health care laws applicable to the Company or its subsidiaries, respectively, or any of their respective products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the civil False Claims Act (31 U.S.C. §§3729 et seq.), the administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), the Public Health Service Act (42 U.S.C. § 201 et seq.), the Physician Payments Sunshine Act (42 USC § 1320a-7h), any similar local, state or federal laws and the regulations promulgated pursuant to such laws (collectively, the Health Care Laws), and have not engaged in activities which are, as applicable, prohibited or cause for civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any other state health care program or federal health care program. The Company and its subsidiaries have not received any notification, correspondence or any other written or oral communication, including, without limitation, notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, from any governmental authority of potential or actual non-compliance by, or liability of, the Company or its subsidiaries under any Health Care Laws.
(bb) The Company and its subsidiaries possess, and are in compliance in all material respects with the terms of, all certificates, approvals, clearances, registrations, exemptions, franchises, licenses, permits and other authorizations necessary to conduct their respective businesses (collectively, Licenses), including, without limitation, all Licenses required by the FDA and/or by any other U.S., state, local or foreign government or drug regulatory agency (collectively, the Regulatory Agencies). All Licenses are in full force and effect and the Company and its subsidiaries are not in violation of any term of any License in any material respect. The Company and its subsidiaries have fulfilled and performed all of their obligations in all material respects with respect to the Licenses and, to the Companys knowledge, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other material impairment of the rights of the holder of any License. Neither the Company nor any of its subsidiaries have received any notice of proceedings relating to the revocation or modification of any Licenses that, if determined adversely to the Company or its subsidiaries, would reasonably be expected to have a material impact on the Company. To the Companys knowledge, no Regulatory Agency has taken any action to limit, suspend or revoke any License possessed by the Company or its subsidiaries.
(cc) The preclinical tests and clinical trials that are described in, or the results of which are referred to in, the Time of Sale Prospectus were and, if still pending, are, being conducted in all material respects in accordance with the protocols established for each such preclinical test or clinical trial and all Health Care Laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58 and 312, and, where applicable, the EU Clinical Trials Directive (Directive 2001/20/EC) as implemented; each description of such tests and trials, and the results thereof, contained in the Time of Sale Prospectus is accurate