presents the data derived from such Studies, and the Company, after due inquiry, has no knowledge of any other Studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus in any material respect, except as described therein; no investigational device exemption application filed by or on behalf of the Company with the U.S. Food and Drug Administration (“FDA”) has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing Studies conducted or proposed to be conducted by or on behalf of the Company.
(xxxix) Compliance with Health Care Laws. The Company has operated and has been in material compliance with all applicable health care laws, rules and regulations, including, (i) the Federal Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.); (ii) applicable federal, state, local and applicable foreign healthcare related fraud and abuse laws, including, the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. §§ 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), criminal laws relating to health care fraud and abuse, including 18 U.S.C. §§ 286 and 287, the health care fraud criminal provisions under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) (42 U.S.C. §§ 1320d et seq.), the exclusion law (42 U.S.C. § 1320a-7), and the civil monetary penalties law (42 U.S.C. § 1320a-7a) and the U.S. Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h); (iii) Medicare (Title XVIII of the Social Security Act); (iv) Medicaid (Title XIX of the Social Security Act); (v) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (42 U.S.C. §§ 17921 et seq.); (vi) the regulations promulgated pursuant to such laws; and (viii) other similar local, state, federal, or foreign laws (collectively, the “Health Care Laws”); neither the Company nor any of its officers, directors, or to the Company’s knowledge, its employees or agents, have engaged in activities which are, as applicable, cause for false claims liability, civil penalties, or mandatory or permissive exclusion from Medicare, Medicaid, or any other state or federal healthcare program (collectively, the “Programs”); the Company has not received notice or other correspondence of any material claim, action, suit, audit, survey, proceeding, hearing, enforcement, investigation, arbitration or other action (“Action”) from any Government Authority or third party alleging that any product operation or activity is in material violation of any Health Care Laws, and, to the Company’s knowledge, no such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action is threatened; the Company is not a party to, and does not have any ongoing reporting obligations pursuant to any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any Government Authority; additionally, neither the Company nor any of its officers or directors nor, to the Company’s knowledge, any of its employees or agents have been excluded, suspended or debarred from participation in the Programs or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to result in debarment, suspension, or exclusion from the Programs.
-17-