the aggregate, have a Material Adverse Effect, the Company has filed, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or
amendments as required by any applicable Health Care Laws, and all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material
respects (or were corrected or supplemented by a subsequent submission). 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 governmental authority. Since July 1, 2020, the Company has not received any written notification or correspondence or any other written
communication from the FDA or any similar regulatory authority alleging material noncompliance with any applicable Health Care laws, including, without limitation, any FDA Form 483, notice of adverse finding, warning letter, untitled letter, or any
written notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, from any arbitrator or regulatory or governmental authority or third party alleging potential or actual non-compliance by, or liability of, the Company under any Health Care Laws in any material respect;
(ee) Since July 1, 2020, and except as would not, individually or in the aggregate, have a Material Adverse
Effect, the Company has possessed and currently possesses all certificates, approvals, clearances, registrations, exemptions, franchises, licenses, permits, consents and other authorizations issued by governmental authorities, including, without
limitation, those required by the FDA, or any component thereof, and/or by any other U.S., state, local or foreign government or drug regulatory agency (collectively, the Regulatory Agencies) necessary to conduct its business as
currently conducted (collectively, Licenses). All such Licenses are in full force and effect and the Company is not in violation of any term or conditions of any License, except for such violations that would not, individually or
in the aggregate, have a Material Adverse Effect. Since July 1, 2020 and except for such noncompliance that would not, individually or in the aggregate, have a Material Adverse Effect: (1) the Company has fulfilled and performed all of its
obligations with respect to such Licenses 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 results in any other impairment of the rights of
the holder of any License; and (2) the Company has not received any written notice of proceedings relating to the revocation or modification of any such Licenses and no Regulatory Agency has taken any action to limit, suspend or revoke any such
License possessed by the Company;
(ff) The pre-clinical studies and
clinical trials conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with all applicable Health Care Laws, except as would not, individually or in the aggregate, reasonably
be expected to have a Material Adverse Effect; the descriptions of the pre-clinical studies and clinical trials conducted by or, to the Companys knowledge, on behalf of the Company, and the results
thereof, contained in the Registration Statement and the Prospectus are accurate in all material respects and fairly present the data derived from such pre-clinical studies and clinical trials, if any; the
Company is not aware of any other pre-clinical studies or clinical trials, the results of which reasonably call into question the results described in the Registration Statement and the Prospectus when viewed
in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review
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