EXHIBIT 10.18

 

 

[*]

Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange
Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as
amended.

 

 

FIRST AMENDMENT TO License Agreement

This FIRST AMENDMENT TO LICENSE AGREEMENT (“First Amendment”) is entered into as
of November 3, 2017 (“First Amendment Effective Date”) by and between REGENXBIO
Inc., a corporation organized under the laws of the State of Delaware, with
offices at 9600 Blackwell Road, Suite 210, Rockville, MD 20850 (“Licensor”), and
Audentes Therapeutics, Inc., a corporation organized under the laws of the State
of Delaware, with offices at 600 California Street, 17th Floor, San Francisco,
California, 94108 (“Licensee”).  Licensor and Licensee are hereinafter referred
to individually as a “Party” and collectively as the “Parties.”

WHEREAS, Licensor and Licensee entered into that certain License Agreement dated
November 3, 2015 (the “Original Agreement”); and

WHEREAS, the Parties desire to make certain amendments to the Original
Agreement;

NOW, THEREFORE, in consideration of the promises and covenants contained in this
Amendment, and intending to be legally bound, the Parties hereby agree as
follows:

1.

Definitions.  Capitalized terms not defined in this First Amendment have the
meanings given such terms in the Original Agreement.

2.

Amendments.

 

a.

Section 4.1 of the Agreement is hereby amended and restated in its entirety to
read as follows:

4.1Diligence Obligations.  

4.1.1Licensed Product Diligence Obligations.  Licensee will use commercially
reasonable efforts to develop, commercialize, market, promote, and sell Licensed
Products in the CPVT Field unless Licensee elects a Substitution Indication
Option for the CPVT Field.  Furthermore, if Licensee exercises the Substitution
Indication Option and/or Additional Indication Option granted to Licensee under
Sections 2.2 and 2.3, respectively, Licensee will use commercially reasonable
efforts to develop, commercialize, market, promote, and sell Licensed Products
for the Disease Indication(s) subject to such option in the Commercial
Field.  Commercially reasonable efforts means efforts equivalent to those
utilized by [*].  Without limiting the foregoing, Licensee will meet the
following:

* CONFIDENTIAL TREATMENT REQUESTED

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(a)

(i)acceptance by the FDA of an Investigational New Drug application, or
acceptance by the European Medicines Agency (or any successor entity thereto) of
an equivalent application, for a Licensed Product in the CPVT Field by no later
than [*] after the Effective Date; or

(ii)if Licensee exercises the Substitution Indication Option granted to Licensee
under Section 2.2, acceptance by the FDA of an Investigational New Drug
application, or acceptance by the European Medicines Agency (or any successor
entity thereto) of an equivalent application, for a Licensed Product for an
Additional Disease Indication selected in the exercise of such Substitution
Indication Option by no later than [*] after the Substitution Grant Date; and

(b)if Licensee exercises the Additional Indication Option granted to Licensee
under Section 2.3, acceptance by the FDA of an Investigational New Drug
application, or acceptance by the European Medicines Agency (or any successor
entity thereto) of an equivalent application, for a Licensed Product for an
Additional Disease Indication selected in the exercise of such Additional
Indication Option by no later than [*] after the Grant Date;

provided, however, that, if Licensee expects not to achieve the milestone set
forth in clause (a)(i) on or before the specified deadline, Licensee may pay
Licensor an extension fee of [*] for an extension of the deadline in clause
(a)(i) until [*].  Licensee is only entitled to a single extension for the
milestone in clause (a)(i).  Licensee will provide Licensor written notice
within [*] of achieving each milestone set forth in clause (a) and (b).  

3.

Incorporation.  Article 10 of the Original Agreement is hereby incorporated
mutatis mutandis into this First Amendment.

4.

Effect on Original Agreement.  Except as specifically amended by this First
Amendment, the Original Agreement will remain in full force and effect and is
hereby ratified and confirmed.  Each future reference to the Original Agreement
will refer to the Original Agreement as amended by this First Amendment.  To the
extent a conflict arises between the terms of the Original Agreement and this
Amendment, the terms of this Amendment shall prevail but only to the extent
necessary to accomplish their intended purpose.

 

* CONFIDENTIAL TREATMENT REQUESTED

 

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IN WITNESS WHEREOF, the Parties, intending to be legally bound, have caused this
First Amendment to License Agreement to be executed by their duly authorized
representatives.

REGENXBIO INC.

AUDENTES THERAPEUTICS, INC..

By:  /s/ Kenneth T. Mills

By:  /s/ Natalie Holles

Name:  Kenneth T. Mills

Name:  Natalie Holles

Title:  President & CEO

Title: COO

 

* CONFIDENTIAL TREATMENT REQUESTED