SEC Filings

10-K
AVEXIS, INC. filed this Form 10-K on 02/28/2018
Entire Document
 

REGENXBIO, Inc.

In March 2014, we entered into an exclusive license agreement or the REGENXBIO SMA License, with ReGenX Biosciences, LLC, or ReGenX, predecessor to REGENXBIO, under certain patents and patent applications owned by the Trustees of the University of Pennsylvania and licensed to ReGenX, for the development and commercialization of products to treat SMA using AAV9. In January 2018, we entered into an amendment to the REGENXBIO SMA License, pursuant to which REGENXBIO granted us an exclusive, worldwide commercial license, with rights to sublicense, to any recombinant AAV vector in REGENXBIO’s intellectual property portfolio during the term of the license agreement for the treatment of SMA in humans by in vivo gene therapy. Under the REGENXBIO SMA License, REGENXBIO granted us an exclusive, worldwide license under the licensed patent rights to make, have made, use, import, sell and offer for sale any products covered by the REGENXBIO SMA License, or REGENXBIO SMA licensed products, in the field of the treatment of spinal muscular atrophy in humans by in vivo gene therapy using such AAV vectors subject to certain rights reserved by REGENXBIO and its licensors. The patent rights exclusively in‑licensed include an issued United States patent, which expires September 2024, not including 473 days of patent term adjustment (as well as issued patents in Europe, Japan, Australia, Canada, New Zealand and China, which expire in 2024). These issued patents claim AAV9 vectors and viruses having an AAV9 capsid, as well as methods of use. In addition, the in‑licensed patent rights include pending patent applications in the United States, Canada, China, Europe and Japan, that if issued as patents, will expire in 2024. These pending applications claim AAV9 vectors and viruses having an AAV9 capsid, as well as its use in treatment. We have the right to sublicense the licensed technology to third parties subject to certain conditions as specified in the REGENXBIO SMA License. Under the REGENXBIO SMA License we grant a non‑exclusive, worldwide, royalty‑free, transferable, sublicenseable, irrevocable, perpetual license back to REGENXBIO to (a) use any patentable modifications and improvements to the licensed technology that we or our affiliates or sublicensees develop, or licensed back improvements, and (b) to practice the licensed back improvements in connection with AAV9 outside of our field of use.

Under the terms of the REGENXBIO SMA License, we paid or are required to pay:

·

an initial fee of $2.0 million;

·

additional fees of (i) $80.0 million upon entry into the amendment to the REGENXBIO SMA License; (ii) $30.0 million on the first anniversary of the effective date of the amendment; and (iii) $30.0 million on the second anniversary of the effective date of the amendment;

·

an annual maintenance fee;

·

up to $120.0 million in sales-based milestone fees for all REGENXBIO SMA Licensed Products;

·

mid‑single digit to low double-digit royalty percentages on net sales of REGENXBIO SMA Licensed Products using AAV9, subject to reduction in specified circumstances;

·

a low-double digit royalty percentage on net sales of REGENXBIO SMA Licensed Products using an AAV vector other than AAV9, subject to reduction in specified circumstances; and

·

lower mid‑double digit percentages of any sublicense fees we receive from sublicensees for the licensed intellectual property rights.

As of December 31, 2017, we have paid $3.4 million under the REGENXBIO SMA License, which includes $1.3 million in aggregate milestone payments.

The REGENXBIO SMA License requires us to use commercially reasonable efforts to develop, commercialize, market, promote and sell products utilizing the licensed patent rights in our field of use. We are obligated to achieve certain development milestones with respect to the licensed disease indication. We do not have the right to control

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