(aa) The Company has operated and currently is in compliance in all material respects with all applicable laws, statutes, rules and regulations of the jurisdictions in which they are conducting business. The Company (i) is and at all times has been in material compliance with all laws, statutes, rules or regulations applicable to the ownership, research, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product candidate of the Company, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C.§ 301 et seq.), the Public Health Service Act (42 U.S.C. § 262 et. seq.) the federal Anti-kickback Statute (42 U.S.C. §1320a-7b(b)), the regulations promulgated pursuant to such laws, and any successor government programs, and comparable state laws, and all other local, state, federal, and foreign laws, rules, regulations, manual provisions, policies and administrative guidance relating to the regulation of the Company (“Regulatory Laws”); (ii) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Regulatory Laws or any licenses, exemptions, certificates, approvals, consents, clearances, authorizations, registrations, permits and supplements or amendments thereto required by any Regulatory Laws to conduct the Company’s business as described in Time of Sale Prospectus (“Authorizations”); (iii) possesses all material Authorizations and such Authorizations are valid and in full force and effect, (iv) is in compliance with and is not in violation of, or in default under, any such Authorization, and to the knowledge of the Company, no event has occurred which allows, or after notice or lapse of time would allow, revocation, termination or modification of any Authorization or result in any other material impairment of the rights of the holder of any Authorization, and the Company does not have any reason to believe that any Authorization will not be renewed in the ordinary course; (v) has not received notice of any pending or completed claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any other federal, state, local or foreign governmental or regulatory authority or third party allegingnon-compliance with any Regulatory Laws or Authorizations and, to the knowledge of the Company, neither the FDA nor any other federal, state, local or foreign governmental or regulatory authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (vi) has not received notice that the FDA or any other federal, state, local or foreign governmental or regulatory authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any material Authorizations and, to the knowledge of the Company, neither the FDA nor any other federal, state, local or foreign governmental or regulatory authority is considering such action; (vii) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Regulatory Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were materially complete and correct on the date filed (or were corrected or supplemented by a subsequent submission), (viii) is not a party to any corporate integrity agreements,
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