(iii) The Entity represents and covenants that, except as detailed in
the Registration Statement and the Prospectus, for the past 5 years, it has not engaged in, is not now engaging in, and will not engage in, any dealings or transactions with any Person, or in any country or territory, that at the time of the dealing
or transaction is or was the subject of Sanctions or is or was a Sanctioned Country.
(ww) Stock Transfer Taxes. On each Settlement
Date, all stock or share transfer or other taxes (other than income taxes) which are required to be paid in connection with the sale and transfer of the Placement Shares to be sold hereunder will be, or will have been, fully paid or provided for by
the Company and all laws imposing such taxes will be or will have been fully complied with.
(xx) Compliance with Laws. Each of the
Company and its Subsidiaries: (A) is and at all times has been in compliance with all statutes, rules, or regulations applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling,
promotion, sale, offer for sale, storage, import, export or disposal of any product manufactured or distributed by the Company or its Subsidiaries (such statutes, rules or regulations, excluding the Privacy Laws, Applicable
Laws), except as could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect; (B) has not received any FDA Form 483, notice of adverse finding, warning letter, untitled letter or
other correspondence or notice from the FDA or any other Governmental Authority alleging or asserting noncompliance with any Applicable Laws or any licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments
thereto required by any such Applicable Laws (Authorizations); (C) possesses all material Authorizations and such Authorizations are valid and in full force and effect and are not in material violation of any term of any
such Authorizations; (D) has not received notice of any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any Governmental Authority or third party alleging that any product operation or
activity is in violation of any Applicable Laws or Authorizations and has no knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding;
(E) has not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations and has no knowledge that any such Governmental Authority is considering such
action; (F) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all
such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); and (G) has not,
either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, dear healthcare provider letter, or other
notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Companys knowledge, no third party has initiated, conducted or intends to initiate any such notice or
action, except, in the case of any of clauses (A)-(G) above, as disclosed in the Registration Statement and the Prospectus, or as would not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect.
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