|AVEXIS, INC. filed this Form S-1/A on 02/01/2016|
reasonable for the conduct of its business; and neither the Company nor any of its subsidiaries has (i) received notice from any insurer or agent of such insurer that capital improvements or other expenditures are required or necessary to be made in order to continue such insurance or (ii) any reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage at reasonable cost from similar insurers as may be necessary to continue its business;
(ee) The Companys board of directors meets the independence requirements of, and has established an audit committee and a compensation committee, in each case, that meets the independence requirements of, the rules and regulations of the Commission and the Exchange;
(ff) The Company and its subsidiaries and its and their respective directors, officers and employees, and to the Companys knowledge, its and their respective agents, affiliates and representatives, are, and at all times have been, in material compliance with the following laws applicable to the Company and its subsidiaries or any of its respective products or activities: the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 301 et seq.), the Public Health Service Act (42 U.S.C. § 201 et seq.), any similar local, state or federal laws, and the regulations promulgated pursuant to such laws (collectively, the Health Care Laws). Neither the Company nor any of its subsidiaries is a party to or has 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. Neither the Company nor any of its subsidiaries has received any notification, correspondence or any other written or oral communication, including, without limitation, any FDA Form 483, notice of adverse finding, warning letter, untitled letter or other correspondence or notice from the U.S. Food and Drug Administration (FDA) or any similar regulatory authority, or any notification of any pending or threatened claim, suit, proceeding, hearing, enforcement, investigation, arbitration or other action, from any governmental authority of potential or actual non-compliance by, or liability of, the Company or its subsidiaries under any Health Care Laws, which would reasonably expected to have a Material Adverse Effect;
(gg) Each of the Company and its subsidiaries possesses, and is in material compliance with the terms of, all applications, certificates, approvals, clearances, registrations, exemptions, franchises, licenses, permits and other authorizations necessary to conduct their current respective businesses (collectively, Licenses), including, without limitation, all Licenses required by the FDA, the National Institutes of Health (NIH) and/or by any other U.S., state, local or foreign government or drug regulatory agency (collectively, the Regulatory Agencies). All Licenses are in full force and effect and neither the Company nor any of its subsidiaries is in violation of any term of any License in any material respect. Each of the Company and its subsidiaries has fulfilled and performed all
of its respective obligations with respect to the Licenses in all material respects 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. Neither the Company nor any of its subsidiaries has received any notice of proceedings relating to the revocation or modification of any Licenses. To the Companys knowledge, no Regulatory Agency has taken any action to limit, suspend or revoke any License possessed by the Company;
(hh) The pre-clinical studies and clinical trials conducted by or, to the Companys knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Prospectus and the Prospectus were and, if still pending, are being, conducted in all material respects in accordance with the protocols submitted to the U.S. Food and Drug Administration (the FDA) or any foreign governmental body exercising comparable authority, procedures and controls pursuant to, where applicable, accepted professional and scientific standards, and all applicable laws and regulations; 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, the Pricing Prospectus and the Prospectus are accurate and complete in all material respects; 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, the Pricing Prospectus and the Prospectus; and the Company has not received any notices or correspondence from the FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board requiring the termination, suspension, material modification or clinical hold of any pre-clinical studies or clinical trials conducted by or on behalf of the Company:
(ii) Neither the Company nor its subsidiaries nor any of its or their respective officers, employees or directors, nor, to the Companys knowledge, any of its or their respective agents or clinical investigators, has been suspended, debarred, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. § 335a.
(jj) The Company owns or has valid, binding and enforceable licenses or other rights to practice and use all patents and patent applications, copyrights, trademarks, trademark registrations, service marks, service mark registrations, trade names, service names and know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential information, systems or procedures) and all other technology and intellectual property rights necessary for, or used in the conduct, or the proposed conduct, of the business of the Company in the manner described in the Pricing Prospectus (collectively, the Company Intellectual Property), and, to the Companys knowledge, the conduct of its and its subsidiaries respective business (including the development and commercialization of the product candidates described in the Pricing Prospectus)
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