(rr) Except as would not reasonably be expected to have a material adverse effect on the Company and its subsidiaries, taken as a whole, the Company and each of its subsidiaries possess all certificates, authorizations and permits issued by the appropriate federal, state or foreign regulatory authorities necessary to conduct their respective businesses as currently conducted, and neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of any such certificate, authorization or permit which, singly or in the aggregate, if the subject of an unfavorable decision, ruling or finding, would reasonably be expected to have a material adverse effect on the Company and its subsidiaries, taken as a whole, except as described in the Time of Sale Information.
(ss) The preclinical tests and clinical trials conducted by or on behalf of the Company, or in which the Company’s product candidates have participated, including those that are described in, or the results of which are referred to in, the Registration Statement, the Prospectus, the Time of Sale Information and any preliminary prospectus, were and, if still pending, are being and have been conducted in all material respects in accordance with all applicable laws, rules, and regulations of the Regulatory Agencies, including without limitation 21 C.F.R. Parts 50, 54, 56, 58, and 312; each description of such tests and trials, and the results thereof, contained in the Registration Statement, the Prospectus, the Time of Sale Information and any preliminary prospectus is accurate and complete in all material respects and fairly presents the data about and derived from such tests and trials, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement, the Prospectus, the Time of Sale Information and any preliminary prospectus; and the Company has not received any notices or other correspondence from any Regulatory Agency requiring the termination, suspension or material adverse modification of any preclinical tests or clinical trials that are, or whose results of which are, described or referred to in the Registration Statement, the Prospectus, the Time of Sale Information and any preliminary prospectus.
(tt) The Company and their directors, officers, employees and, to the knowledge of the Company, agents, are, in compliance in all material respects with all applicable Health Care Laws (as defined below), and have not 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, provincial, or federal health care program. “Health Care Laws” means the laws and regulations of the Regulatory Agencies, including, without limitation, the Public Health Service Act (42 U.S.C. § 201 et. seq.), the Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.), the regulations promulgated pursuant to such laws, and any other similar local, state, provincial, or federal law. The Company has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration or any other Regulatory Agency alleging or asserting noncompliance with any Health Care Laws applicable to the Company or its subsidiaries. Additionally, the Company is not a party to nor has any ongoing reporting obligations pursuant to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Regulatory Agency. None of the Company nor any of its respective employees, officers or directors, or, to the
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