Item 1.01. Entry into a Material Definitive Agreement.
Amendment to License Agreement with REGENXBIO
On January 8, 2018, AveXis, Inc. (the Company) entered into a First Amendment (the Amendment) to the License Agreement dated March 21, 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 REGENXBIOs 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 REGENXBIOs 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 REGENXBIOs 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.
Pursuant to the Amendment, in consideration for the additional rights granted thereunder, the Company paid to REGENXBIO a fee of $80.0 million upon entry into the Amendment. In addition, the Company will pay to REGENXBIO (i) $30.0 million on the first anniversary of the effective date of the Amendment, (ii) $30.0 million 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 Companys Annual Report on Form 10-K for the year ended December 31, 2017. The Company intends to seek confidential treatment for certain portions of the Amendment.
Item 7.01. Regulation FD Disclosure.
On January 8, 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 Exhibit 99.1 and is incorporated herein by reference.
The information in Item 7.01 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall not be deemed filed for purposes of Section 18 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.