(n) Regulatory Permits. (1) The Company possesses all
certificates, licenses, authorizations, approvals, clearances, consents, registration and permits issued by the appropriate federal, state, local or foreign regulatory authorities including, without limitation, those administered by the U.S. Food
and Drug Administration (FDA) of the U.S. Department of Health and Human Services, the Federal Trade Commission (the FTC), or by any foreign, federal, state or local governmental or regulatory authority
performing functions similar to those performed by the FDA and the FTC, or reasonably necessary to conduct its business as described in the Registration Statement or the Prospectus, except where the failure to possess such permits would not
reasonably be expected to result in a Material Adverse Effect (each, an Authorization), and the Company has not received any written notice of proceedings relating to the revocation or modification of any Authorization or the
noncompliance with any ordinance, law, rule or regulation applicable to the Company. The disclosures in the Registration Statement, if any concerning the effects of federal, state, local and all foreign regulation on the Companys business as
currently contemplated are correct in all material respects. The Company is and has been in material compliance with any term of any such Authorizations, except for any violations which would not reasonably be expected to have a Material Adverse
Effect. The Company has not failed to file with the applicable regulatory authorities (including the FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) any
filing, declaration, listing, registration, report or submission that is required to be so filed for the Companys business operation as currently conducted, except for any failure to file which would not reasonably be expected to have a
Material Adverse Effect. All such filings were in material compliance with applicable laws when filed and no deficiencies have been asserted in writing by any applicable regulatory authority (including, without limitation, the FDA or any foreign,
federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) with respect to any such filings, declarations, listings, registrations, reports or submissions.
(2) The Company: (i) is and at all times has been in substantial compliance with all statutes, rules, or regulations
applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, advertising, sale, offer for sale, storage, import, export or disposal of any product manufactured or
distributed by the Company, including but not limited to the U.S. Food, Drug and Cosmetic Act (the FDCA) (21 U.S.C. § 301 et seq.), the Federal Trade Commission Act (15 U.S.C.
§ 41-58) and the rules and regulations of the Consumer Product Safety Commission (Applicable Laws), except as could not, individually or in the aggregate, reasonably be
expected to have a Material Adverse Effect; (ii) has not received any warning letter, untitled letter or other correspondence or notice from any other governmental authority alleging or asserting noncompliance with any Applicable Laws or any
Authorizations; (iii) 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; (iv) 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; (v) 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 and the FDA has not sent any warning letters; imposed any fines, penalties
or injunctions; or required or requested termination of any distribution of the Companys products; requested or required any recalls or seizures of products; or withdrawals or suspensions of clearances or approvals, resulting in prohibitions
on sales of our products; (vi) 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 (vii) to the Companys knowledge, 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, 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.
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