SEC Filings

AVEXIS, INC. filed this Form 10-K on 02/28/2018
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and enforce licensed patent rights, and, if sought and obtained in the future, any patent rights we may own; preserve the confidentiality of our trade secrets; and operate without infringing the valid enforceable patents and proprietary rights of third parties. Our ability to stop third parties from making, using, selling, offering to sell or importing our current product candidate and any future product candidates may depend on the extent to which we have rights under valid and enforceable patents or trade secrets that cover these activities. With respect to our licensed intellectual property, we cannot be sure that patents will issue with respect to any of the pending patent applications to which we license rights. With respect to any patent applications that we or our licensors may file in the future, if any, we cannot be sure that any such applications will issue or, if issued, that such applications will be commercially useful in protecting our product candidate and methods of manufacturing the same, or otherwise provide any competitive advantage. Even with respect to issued patents that we currently license, we cannot be certain that any such patents will provide any competitive advantage. See “Risk factors—Risks related to our intellectual property” for a more comprehensive description of risks related to our intellectual property.

We 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 have also licensed certain patents and patent applications relating to our planned new programs in Rett syndrome and genetic ALS. 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, 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, REGENXBIO and AskBio as described below relating to AVXS-101 and NCH and REGENXBIO relating to our planned new programs in Rett syndrome and ALS. 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.

Trade Secrets

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 collaborator is NCH.



To date, we have entered into three license agreements relating to the development of AVXS-101.



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