FDA and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). Except as would not be reasonably expected to
result in a Material Adverse Effect, the Company has not failed to file with the FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA, any filing, declaration,
listing, registration, report or submission that is required to be so filed. All such filings were in material compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority (including,
without limitation, the FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) with respect to any such filings, declarations, listings, registrations, reports or
submissions.
(B) The Company and, to the Companys knowledge, its directors, officers, employees, and agents are, and
at all times have been, in material compliance with, all health care laws applicable to the Company or any of its products or activities, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C.
§ 1320a-7b(b)), the Beneficiary 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 Stark Law (42 U.S.C. § 1395nn), 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 federal healthcare exclusion laws (42 U.S.C.
§ 1320a-7), the Federal Food Drug and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the Controlled Substances Act (21 U.S.C. §§ 801 et seq.), Medicare (Title XVIII of the Social
Security Act), Medicaid (Title XIX of the Social Security Act), the regulations promulgated pursuant to such laws, and any other state, federal or foreign law, including the Medical Devices Directive (93/42/EEC), accreditation standards, regulation,
memorandum, opinion letter, or other issuance which imposes requirements on the manufacturing, development, testing, labeling, marketing or distribution of pharmaceutical products, kickbacks, patient or program charges, recordkeeping, claims
process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services or supplies from those who have been excluded from government health care programs, quality, safety, privacy, security, licensure,
accreditation or any other aspect of providing health care or pharmaceutical services (collectively, Health Care Laws). The Company has not received any written notification, correspondence or any other written communication, including
notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental authority, including, without limitation, the FDA, the Drug Enforcement Agency
(DEA), the Centers for Medicare & Medicaid Services, the U.S. Department of Health and Human Services Office of Inspector General, or foreign governmental or regulatory authority performing similar functions, of potential or actual non-compliance by, or liability of, the Company under any Health Care Laws. Except as would not be reasonably expected to result in a Material Adverse Effect, to the Companys knowledge, there
are no facts or circumstances that would reasonably be expected to give rise to liability of the Company under any Health Care Laws.
(C) The Company holds, and is operating in material compliance with, all material permits, licenses, franchises, registrations,
exemptions, approvals, authorizations and clearances of the FDA, its foreign equivalents and other governmental authorities that are required for the conduct of its business as currently conducted (collectively, the Permits), and all
such Permits are in full force and effect. The Company has fulfilled and performed all of its material obligations with respect to the Permits, 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 would result in any other material impairment of the rights of the holder of any Permit. To the Companys knowledge, all applications, submissions, information, and data utilized as the
basis for any and all requests for a Permit from the FDA or other governmental authority relating to the Company, its business and the products of the Company, when submitted to the FDA or other governmental authority, were true, complete and
correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification to such applications, submissions, information and data have been submitted to the FDA or other governmental
authority. To the Companys knowledge, the claims approved or allowed by the FDA and other governmental authorities for the products of the Company are valid, and, to the Companys knowledge, there are no circumstances that would
reasonably be expected to materially impair the validity of such claims.
(D) The manufacture of Company products by or on
behalf of the Company is being conducted in compliance in all material respects with all applicable Health Care Laws, including, without limitation, the FDAs current good manufacturing practice regulations at 21 C.F.R. Part 820 for
products sold in the United States, and the respective counterparts thereof promulgated by governmental authorities in countries outside the United States.
9