AVEXIS,INC. (NASDAQ:AVXS) Files An 8-K Entry into a Material Definitive Agreement

AVEXIS,INC. (NASDAQ:AVXS) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement.

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Amendment to License Agreement with REGENXBIO

On January8, 2018, AveXis,Inc. (the “Company”) entered into a First Amendment (the “Amendment”) to the License Agreement dated March21, 2014 (the “License Agreement”) between the Company and REGENXBIO Inc. (“REGENXBIO”). Under the Amendment, REGENXBIO granted the Company an exclusive, worldwide commercial license, with rights to sublicense, to any recombinant adeno-associated virus (AAV) vector in REGENXBIO’s intellectual property portfolio during the term of the License Agreement for the treatment of spinal muscular atrophy (“SMA”) in humans by in vivo gene therapy. Under the original License Agreement, REGENXBIO had granted the Company a license relating only to the AAV9 vector.

Additionally, the Amendment modifies the terms and conditions of the License Agreement relating to assignment. Under the amended assignment provision, the Company is permitted to transfer the License Agreement without REGENXBIO’s consent in connection with a change of control of the Company, subject to the transferee or successor agreeing in writing to be bound by the terms of the License Agreement and the payment to REGENXBIO of certain fees due upon such change of control, as described below. Under the original License Agreement, any assignment by the Company without REGENXBIO’s prior written consent had been prohibited. The Amendment also provides that, solely upon the written request of the Company, REGENXBIO may, in its sole discretion after receipt of such request, provide certain collaboration services to the Company regarding the development and commercialization of gene therapy product candidates for the treatment of SMA.

to the Amendment, in consideration for the additional rights granted thereunder, the Company paid to REGENXBIO a fee of $80.0million upon entry into the Amendment. In addition, the Company will pay to REGENXBIO (i)$30.0million on the first anniversary of the effective date of the Amendment, (ii)$30.0million on the second anniversary of the effective date of the Amendment and (iii)potential commercial milestone payments of up to $120 million. In the event of a change of control of the Company, to the extent that any fee described in (i)or (ii)above, or the first $40 million of milestone payments described in (iii)above, has not yet been paid to REGENXBIO, the Company will be obliged to pay any such unpaid fee to REGENXBIO upon the change of control. Additionally, for any product developed for the treatment of SMA using an AAV vector, other than AAV9, REGENXBIO will receive a low double-digit royalty on net sales.

A copy of the Amendment will be filed as an exhibit to the Company’s Annual Report on Form10-K for the year ended December31, 2017. The Company intends to seek confidential treatment for certain portions of the Amendment.

Item 7.01. Regulation FD Disclosure.

On January8, 2018, the Company and REGENXBIO issued a press release announcing their entry into the Amendment. A copy of the press release is furnished herewith as Exhibit99.1 and is incorporated herein by reference.

The information in Item 7.01 of this Current Report on Form8-K and Exhibit99.1 attached hereto shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

AveXis, Inc. Exhibit
EX-99.1 2 a18-2531_1ex99d1.htm EX-99.1 Exhibit 99.1 PRESS RELEASE REGENXBIO and AveXis Announce Expansion of Relationship through Amended License Agreement for the Development and Commercialization of Treatments for Spinal Muscular Atrophy AveXis acquires exclusive rights to entire NAV Technology Platform for the development of treatments for SMA Amended agreement permits assignment by AveXis upon a change of control without REGENXBIO’s consent REGENXBIO could receive up to $260 million,…
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AveXis, Inc., formerly Biolife Cell Bank, Inc., is a clinical-stage gene therapy company. The Company operates through developing and commercializing gene therapy treatments for patients suffering from neurological genetic diseases segment. The Company’s product candidate, AVXS-101, is its gene therapy product candidate that is in a Phase I clinical trial for the treatment of spinal muscular atrophy (SMA) Type 1, which is a genetic disorder characterized by motor neuron loss and associated muscle deterioration. The survival motor neuron (SMN) is a protein for normal motor neuron signaling and function. Patients with SMA Type 1 either carry a mutation in their SMN1 gene or their SMN1 genes have been deleted. AVXS-101 is designed to deliver a functional human SMN gene into the nuclei of motor neurons that then generates an increase in SMN protein levels. It also focuses to develop AVXS-101 to treat additional SMA types and other treatments for rare neurological genetic diseases.

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