Company nor any of the Companys employees, officers, directors, contractors or, to the Companys knowledge, any of its agents, is or has been excluded, suspended or debarred from
participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is subject to a governmental inquiry, investigation, proceeding, or other similar action that could reasonably be expected to
result in debarment, suspension, or exclusion, or engaged in any conduct that would reasonably be expected to result in debarment, suspension, or exclusion. Except as not reasonably be expected to, individually or in the aggregate, result in a
material adverse effect on the Company, the Company has filed, obtained, 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 timely, complete, accurate and not misleading on the date filed in all respects (or were corrected or
supplemented by a subsequent submission). Except in each case as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company (A) possesses and is in compliance with all licenses,
certificates, approvals, clearances, exemptions, authorizations, permits and supplements or amendments thereto required by any applicable Health Care Laws, (B) has fulfilled and performed all of its obligations with respect to all such
licenses, sublicenses, certificates, permits and other authorizations, and (C) 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.
(ss) The Company: (A) is and at all relevant times has been in
material compliance with all applicable Health Care Laws enforced by the FDA and other comparable governmental entities (Applicable Laws) except where such non-compliance would not
reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company; (B) has not received any FDA Form 483, written notice of adverse finding, warning letter, untitled letter or other written
correspondence or written notice from the FDA or any governmental entity alleging or asserting material noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, exemptions, authorizations, permits and supplements
or amendments thereto required by any such Applicable Laws (Authorizations); (C) possesses all Authorizations, such Authorizations are valid and in full force and effect and the Company is not in violation of any term of any such
Authorizations except as would not reasonably be expected to, individually or in the aggregate, result in a material adverse effect on the Company; (D) has not received written notice of any claim, action, suit, proceeding, hearing,
enforcement, investigation, arbitration or other action from the FDA or any governmental entity or third party alleging that any product operation or activity is in material violation of any Applicable Laws or Authorizations and has no knowledge
that the FDA or any comparable governmental entity or third party has threatened any such claim, litigation, arbitration, action, suit, investigation or proceeding, which in each case, if
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