SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 01/18/2018
Entire Document
 

 

(ii)       The nonclinical studies and clinical trials conducted by or, to the Company’s 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 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 nonclinical studies and clinical trials conducted by or, to the Company’s 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 nonclinical 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 nonclinical studies or clinical trials conducted by or on behalf of the Company;

 

(jj)       Neither the Company nor its subsidiaries nor any of its or their respective officers, employees or directors, nor, to the Company’s 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;

 

(kk)     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 Company’s knowledge, other than as disclosed in the Pricing Prospectus, the the conduct of its and its subsidiaries’ respective business (including the development and commercialization of the product candidates described in the Pricing Prospectus) has not and will not infringe or misappropriate any intellectual property rights of others where such infringement or misappropriation would reasonably be expected to have a Material Adverse Effect; the intellectual property owned by the Company is free and clear of all material liens or encumbrances; to the knowledge of the Company, the patents, trademarks and copyrights held or licensed by the Company included within the Company Intellectual Property are valid, enforceable and subsisting; other than as disclosed in the Pricing Prospectus, (i) neither the Company nor its subsidiaries is obligated to grant a license, or provide other material consideration to any third party in

 

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