REGENXBIO INC. (NASDAQ:RGNX) Files An 8-K Entry into a Material Definitive Agreement
Item 1.01. Entry into a Material Definitive Agreement.

Amendment to License Agreement with AveXis

On January8, 2018, REGENXBIO Inc. (the “Company”) entered into a First Amendment (the “Amendment”) to the License Agreement dated March21, 2014 (the “License Agreement”) between the Company and AveXis, Inc. (“AveXis”). Under the Amendment, the Company granted AveXis an exclusive, worldwide commercial license, with rights to sublicense, to any recombinant adeno-associated virus (AAV) vector in the Company’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, the Company had granted AveXis 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, AveXis is permitted to transfer the License Agreement without the Company’s consent in connection with a change of control of AveXis, subject to the transferee or successor agreeing in writing to be bound by the terms of the License Agreement and the payment to the Company of certain fees due upon such change of control, as described below. Under the original License Agreement, any assignment by AveXis without the Company’s prior written consent had been prohibited. The Amendment also provides that, solely upon the written request of AveXis, the Company may, in its sole discretion after receipt of such request, provide certain collaboration services to AveXis 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, AveXis paid to the Company a fee of $80.0million upon entry into the Amendment. In addition, AveXis will pay to the Company (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 $120million. In the event of a change of control of AveXis, to the extent that any fee described in (i)or (ii) above, or the first $40million of milestone payments described in (iii)above, has not yet been paid to the Company, AveXis will be obliged to pay any such unpaid fee to the Company 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 Form 10-K for the year ended December31, 2017. The Company intends to seek confidential treatment for certain portions of the Amendment.

On January8, 2018, the Company and AveXis issued a press release announcing their entry into the Amendment. A copy of the press release is furnished herewith as Exhibit 99.1 and is incorporated herein by reference.

The information in Item 1.01 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.

(d) Exhibits

REGENXBIO Inc. Exhibit
EX-99.1 2 d509281dex991.htm EX-99.1 EX-99.1 Exhibit 99.1                  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,…
To view the full exhibit click here

About REGENXBIO INC. (NASDAQ:RGNX)

REGENXBIO Inc. is a biotechnology company. The Company is focused on the development, commercialization and licensing of recombinant adeno-associated virus (AAV) gene therapy. Its AAV gene delivery platform (its NAV Technology Platform) consists of rights to over 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10 (NAV Vectors). Its NAV Technology Platform is applied in the development of approximately 30 product candidates for a range of diseases, including over five internally developed product candidates and approximately 20 partnered product candidates developed by its NAV Technology Licensees. Its therapeutic programs include RGX-501 for Homozygous familial hypercholesterolemia (HoFH); RGX-111 for Mucopolysaccharidosis Type I (MPS I); RGX-121 for Mucopolysaccharidosis Type II (MPS II); RGX-314 for Wet age related macular degeneration (wet AMD), and RGX-321 for X-linked retinitis pigmentosa (XLRP).