SEC Filings

S-1
AVEXIS, INC. filed this Form S-1 on 01/15/2016
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each sublicensee’s compliance with the sublicense agreement as if such entity was performing as Licensee under the terms and conditions of this Agreement, and at Children’s request, Licensee shall audit sublicensee(s) in accordance with the terms of the applicable sublicense agreement to determine compliance.

 

2.1.5                     IND License. An Investigational New Drug application for the scAAV9-SMN gene therapy product for the treatment of spinal muscular atrophy type 1 (the “IND”) will be initially filed and sponsored by Children’s. Within **** days of the Effective Date, Children’s shall provide Licensee with continual, read-only access to the IND. Children’s shall store and maintain pre-clinical study records, specimens, samples, and data related to the IND, in accordance with FDA regulations 21CFR 58.195(b), which in summary states data, specimens, and records will be stored for **** after FDA marketing approval or **** after submission to FDA for marketing approval. On October 14th 2015, Licensee shall have the right (the “IND Option”) to become the sponsor of the IND. Within **** of exercise of the IND Option, Children’s shall complete the transfer of the IND and associated regulatory filings from Children’s to Licensee. Thereafter, Licensee shall have exclusive access to all information owned by Children’s with respect to satisfying Licensee’s obligations as the sponsor of the IND. Furthermore, in the event that Licensee exercises the IND Option, Children’s shall thereafter have the right to file for a change in the sponsorship of the IND to remove Licensee and redesignate Children’s if (i) any act or omission of Licensee constituting negligence or willful misconduct with respect to Licensee’s control of the IND has or could reasonably be expected to have a material adverse effect on the clinical trials conducted under the IND, (ii) Licensee has not cured such act or omission within **** (or such longer period as the parties may agree upon in accordance with Section 11.2.2) of its receipt of written notice and demand from Children’s. If delays in curing such act or omission occur without fault by Licensee while Licensee is in the process of curing such act or omission, the time to cure such act or omission shall be extended, upon written approval of Children’s, which approval shall not be unreasonably withheld.

 

2.2                               Reservation of Rights.

 

2.2.1                     Children’s and OSU reserve on behalf of themselves and their affiliates and subsidiaries: (a) all rights, titles and interests not expressly granted in Sections 2.1.1 and 2.1.2; (b) the right to practice, have practiced and transfer the Licensed Technology for research and development purposes, including education, research, teaching, clinical trials, publication and public service;  and (c) the right to practice and license the Licensed Technology in connection with its use in Children’s GMP manufacturing facility for research and development purposes, including education, research, teaching, clinical trials, publications and public service. Notwithstanding the foregoing, in no event shall Children’s or OSU’s use or practice, or permit others to use or practice, the Licensed Technology in the Field of Use for any commercial for profit purpose For purposes of clarification nothing in this Agreement is intended to or shall be construed to restrict ability of Children’s or OSU to

 


****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.

 

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