(rr) FDA Compliance. The Company and its subsidiaries possess all licenses, exemptions, certificates, approvals, clearances, authorizations (including emergency use authorizations), registrations, permits, and supplements or amendments issued by the appropriate federal, state or foreign regulatory authorities, including the U.S. Food and Drug Administration (FDA), the U.S. Department of Health and Human Services, the Drug Enforcement Administration, and comparable state and foreign governmental or regulatory agencies (collectively, Regulatory Authorities), necessary to conduct their respective businesses or required by any applicable law, statute, rule or regulation, and neither the Company nor any of its subsidiaries has received any written notice relating to the revocation, suspension or modification of any such license, exemption, certificate, approval, clearance, authorization, registration or permit, and has no knowledge that any Regulatory Authorities are taking or considering such action. Except as would not reasonably be expected to result in a Material Adverse Effect, the Company and its subsidiaries (i) are, and at all times have been in compliance with all laws, statutes, rules, and regulations of the Regulatory Authorities and the laws, statutes, rules, and regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labelling, promotion, sale, offer for sale, storage, import, export or disposal of any product developed, manufactured, processed, distributed, marketed, labeled, promoted, sold, offered for sale, imported, exported or disposed by the Company and its subsidiaries (Applicable Regulatory Laws); and (ii) have not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter, letter of admonition or other correspondence or written notice from any court or arbitrator or governmental authority or Regulatory Authorities alleging or asserting non-compliance with (x) any Applicable Regulatory Laws or (y) any licenses, exemptions, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Applicable Regulatory Laws, except in each case any of the same that have been closed.
(ss) Regulatory Filings. Except as would not reasonably be expected to result in a Material Adverse Effect, (i) the Company and its subsidiaries have not failed to file with the Regulatory Authorities or any other governmental authorities any required filing, declaration, listing, registration, report or submission as required by any applicable laws, statutes, rules, and regulations; (ii) all such filings, declarations, listings, registrations, reports or submissions were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission) and were in compliance with applicable laws when filed; and (iii) no deficiencies regarding compliance with applicable laws, statutes, rules or regulations have been asserted by any Regulatory Authorities or any other governmental authorities with respect to any such filings, declarations, listings, registrations, reports or submissions.
(tt) Tests, Studies, and Preclinical and Clinical Trials. (i) The studies, tests, research and preclinical and clinical trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, were, and if still ongoing are, being conducted in all material respects in accordance with all Applicable Regulatory Laws, current Good Clinical Practices, current Good Laboratory Practices, standard medical and scientific research standards and procedures, each as applicable, and any applicable laws, statutes, rules, and regulations