SEC Filings

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

AAV 9 vector (the “REGENXBIO Rett and ALS License.”) Under the REGENXBIO Rett and ALS License, REGENXBIO granted the Company 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 Rett and ALS License, or the REGENXBIO Rett and ALS licensed products, in the field of the treatment of (i) Rett syndrome in humans by in vivo gene therapy using AAV9 delivering the gene encoding for methyl CpG binding protein 2, and (ii) ALS caused by SOD1 mutation in humans by in vivo gene therapy using AAV9 delivering the gene encoding for SOD1, subject to certain rights reserved by REGENXBIO and its licensors.

As consideration for the REGENXBIO Rett and ALS License, the Company agreed to make an up-front payment of $6 million, which was recorded within research and development expenses for the year ended December 31, 2017.  Additionally, the Company agreed to pay up to $36 million in total milestone fees for products made under the REGENXBIO Rett and ALS License (“REGENXBIO Rett and ALS licensed products”), a low-double digit royalty percentage on net sales of products made under the REGENXBIO Rett and ALS licensed products, subject to reduction in specified circumstances, and a lower mid-double digit percentage of any sublicense fees the Company receives from sublicenses of the licensed intellectual property rights.

The REGENXBIO Rett and ALS License will expire upon the later of (i) the expiration, lapse, abandonment or invalidation of the last valid claim of the licensed intellectual property to expire, lapse or become abandoned or unenforceable in all the countries of the world or (ii) seven years from the first commercial sale of each REGENXBIO Rett and ALS licensed product. Upon expiration of the REGENXBIO Rett and ALS License, the license granted to us becomes irrevocable, perpetual, royalty-free and fully paid-up. The Company has the right to terminate the REGENXBIO Rett and ALS License upon a specified period of prior written notice.

Nationwide Children’s Hospital

 

In September 2016, the Company entered into exclusive license agreements with NCH, pursuant to which NCH granted the Company exclusive, worldwide licenses under certain patent rights to make, have made, use, sell, offer for sale and import any products covered by each license, or NCH licensed products, and a non-exclusive, worldwide license under certain technical information to develop and manufacture the NCH licensed products, in the field of therapies and treatments of Rett syndrome and ALS in human use, respectively (each, an “NCH License” and together, the “NCH Licenses”).

As consideration for the NCH Licenses, the Company paid an aggregate up-front fee of $0.3 million, which was recorded within research and development expenses during the year ended December 31, 2016. Following the first commercial sale of a licensed product under an applicable NCH License, the Company must begin paying NCH an aggregate low-single digit royalty on net sales of such licensed products.  With certain exceptions, the Company is required to make certain development milestone-based payments to NCH under each NCH License and must also pay NCH a portion of sublicensing revenue received from the Company’s sublicense of the rights to licensed technology at a mid-single digit percentage.

Unless terminated earlier, each NCH License will expire on a NCH licensed product-by-NCH licensed product and country-by-country basis upon the expiration of the royalty term for such NCH licensed product in such country. The royalty term will expire on the later of (i) the date on which the last relevant patent underlying the relevant NCH licensed product expires or (ii) the expiration of any orphan drug-based exclusive marketing rights conferred by any regulatory authority with respect to a NCH licensed product in a licensed territory. Each NCH License may be terminated prior to its expiration:

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By the Company at any time after the second anniversary of the effective date of the applicable NCH License by providing six months' prior written notice to NCH;

·

By either party upon the other party's material breach of the applicable NCH License that is not cured within 90 days after receiving written notice of such breach, except in certain cases in which we may request a longer cure period;

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