SEC Filings

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

The Company paid REGENXBIO $80 million upon entering the amendment on January 8, 2018. See Note 15 – Subsequent Events. 

The REGENXBIO SMA License term continues until the last valid patent claim expires or lapses in all countries of the world. Additionally, the Company may terminate the REGENXBIO SMA License at any time upon a specified notice period and REGENXBIO SMA may terminate upon the breach or insolvency of the Company, if we are greater than a specified number of days late (after notice and cure periods) in paying money due under the REGENXBIO SMA License or if the Company, its affiliates, or sublicensees challenges the REGENXBIO SMA patents subject to the REGENXBIO SMA License. Either party may terminate the REGENXBIO SMA License for material breach if such breach is not cured within a specified number of days.

Asklepios Biopharmaceutical, Inc. License

On May 29, 2015, the Company and Asklepios Biopharmaceutical, Inc. (“AskBio”) entered into a Non‑Exclusive License Agreement (the “AskBio License”). Under the terms of the AskBio License, AskBio granted the Company a non‑exclusive, non‑transferable, worldwide license to certain patents and know-how held by AskBio.

As consideration for the AskBio License, the Company paid an up-front fee of $1.0 million and agreed to make potential future milestone payments of up to $9.6 million in the aggregate, and a tiered royalty on net sales, if any, of the Company’s Product Candidate, on a country‑by‑country basis, starting at percentages in the low‑single digits and increasing to mid‑single digits. These royalty rates are subject to potential reduction in specified circumstances, including, in the event the Company exercises its option to make a specified one‑time royalty option fee payment to AskBio. The Company must also pay AskBio a low double-digit percentage of all consideration the Company receives from any sublicense of the licensed technology.

The rights granted to the Company under the AskBio License represent distinct components that need to be combined with other licensed intellectual property and know‑how in order to complete the clinical development of AVXS‑101. Additionally, the Company did not acquire any employees or manufacturing capabilities in connection with the AskBio License. As a result, the Company accounted for the AskBio License as an asset acquisition.

The AskBio up‑front payment of $1.0 million is included in the research and development expense for the year ended December 31, 2015.

The AskBio License term continues until the last valid patent claim expires or lapses in all countries of the world. Additionally, the Company may terminate the AskBio License at any time upon six months’ notice and AskBio may terminate upon the breach (after notice and cure periods) or insolvency of the Company.

Additionally, AskBio may terminate the AskBio License in the event the Company (i) researches, develops or commercializes any AAV-based treatment for hemophilia or (ii) undergoes a change in control or is otherwise acquired by a third party that researches, develops or commercializes any AAV-based treatment for hemophilia, in each case, until April 1, 2019, unless such change in control is first approved by AskBio, such approval not to be unreasonably withheld if the party in control following such a change of control event agrees to additional restrictive measures as reasonably proposed by AskBio in its sole discretion prior to such change of control respecting the use of the AskBio licensed technology.

The Company has entered into the following license agreements related to its planned new programs in Rett syndrome and a genetic form of amyotrophic lateral sclerosis (“ALS”) caused by mutations in the superoxide dismutase 1 gene (“genetic ALS”).

REGENXBIO Inc.

 

Effective June 7, 2017, the Company entered into an exclusive license agreement with REGENXBIO under certain patents and patent applications owned by the Trustees of the University of Pennsylvania and licensed to REGENXBIO, for the development and commercialization of products to treat Rett syndrome and genetic ALS using the

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