Table of Contents
property" for a more comprehensive description of risks related to our intellectual property.
have licensed certain patents and patent applications and we have licensed or otherwise possess substantial know-how and trade secrets relating to AVXS-101, our product candidate
that uses the AAV9 capsid. We believe that the patents and patent applications we have in-licensed include claims that, if issued, would cover AVXS-101 and that the latest to expire of such currently
in-licensed patent rights is a patent application owned by NCH and pending only in the United States that, if issued, would expire in 2029. Our proprietary, in-licensed intellectual property,
including patent and non-patent intellectual property, generally is directed to AAV9 vectors, methods of treatment of clinical indications important for our development programs and processes to
manufacture and purify AVXS-101. We are heavily dependent on the patented or proprietary technologies that we license from third parties. We anticipate that we will require additional licenses to
third party intellectual property rights relating to our development programs in the future, including from NCH, which may not be available on commercially reasonable terms, if at all.
Licensed patents and patent applications
We license patents and patent applications from NCH, ReGenX and AskBio as described below. We also anticipate that additional patent
or other intellectual property licenses, which we do not hold today, will likely be required for our commercial use of AVXS-101, including use by intravenous and/or intrathecal injection, and our
manufacturing processes. Moreover, additional licenses which we do not hold today will be required to the extent we seek to develop additional product candidates in the future.
In addition to patents and licenses, we rely on trade secrets and know-how to develop and maintain our competitive position. However,
trade secrets can be difficult to protect. We seek to protect our proprietary technology and processes, and obtain and maintain ownership of certain technologies, in part, through confidentiality
agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and commercial partners. We also seek to preserve the integrity and confidentiality of
our data, trade secrets and know-how, as well as that of our licensees, including by implementing measures intended to maintain the physical security of research facilities and the physical and
electronic security of our information technology systems.
Our Collaboration and License Agreements
Strategic Collaborators and Relationships
An important factor to our success is our strategic partnerships and relationships. Our key research collaborators are NCH and The
Ohio State University College of Medicine.
Nationwide Children's Hospital
In October 2013, we entered into an exclusive license agreement with NCH, which we amended and restated in its entirety in
January 2016, or the NCH License. Pursuant to the NCH License, NCH granted us an exclusive, worldwide license under certain patent rights to make, have made, use, sell, offer for sale and
import any products covered by the NCH 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 SMA. The patent rights exclusively in-licensed from NCH and relevant to our contemplated SMA product are a currently pending patent application
being pursued only in the United States. The