RISK FACTORS 4 We may not be aware of all third-party intellectual property rights sufficient protection to exclude others from commercializing potential ly relating to our product candidates and our future product candidates similar or identical to ours. candidates. Because patent applications in the United States and most other countries are confidential for a period of time after Our intellectual property licenses with third parties may be subject filing, and some remain so until issued, and because publication of to disagreements over contract interpretation, which could narrow discoveries in the scientific or patent literature often lags behind the scope of our rights to the relevant intellectual property or actual discoveries and filings of patent applications, we cannot be technology or increase our financial or other obligations to our certain of the priority of inventions covered by any pending patent licensors. applications. We currently depend, and will continue to depend, on our license Accordingly, with respect to our current patent applications agreements, including our agreements with Inserm Transfert, and any patent applications that we may file in the future in the Adverum Biotechnologies and Massachusetts Institute of European Union or the United States, we may not be the first to Technology, whereby we obtain rights in certain patents and file patent applications covering such subject matter, meaning that patent applications owned by them. Further, development and we may be unable to protect or exploit the invention(s) concerned. commercialization of our current product candidates may, and development of any future product candidates will, require us Furthermore, for U.S. patent applications in which al l claims to enter into additional licenses or col laboration agreements. are entitled to a priority date before March 16, 2013, we may The agreements under which we currently license intel lectual become subject to interference proceedings or derivation property or technology from third parties are complex, and certain proceedings before the United States Patent and Trademark provisions in such agreements may be susceptible to multiple Office, or the USPTO, to determine priority of invention. For interpretations. The resolution of any contract interpretation U.S. patent applications containing a claim not entitled to priority disagreement that may arise could narrow what we believe to before March 16, 2013, there is a greater level of uncertainty in be the scope of our rights to the relevant intellectual property the U.S. patent laws in view of the passage of the Leahy-Smith or technology, or increase what we believe to be our financial or America Invents Act, or the Leahy-Smith Act, signed into law other obligations under the relevant agreement, either of which on September 16, 2011, which brought into effect significant could have a material adverse effect on our business, financial changes to these laws, including new procedures for challenging condition, results of operations and prospects. pending patent applications and issued patents. We may fail to comply with our obligations under the agreements Even if the patent applications that we own or license from third under which we in-license intellectual property and could thereby parties or may own in the future do issue as patents, they may not lose license rights that are important to our business. issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with We are a party to a number of intel lectual property license us or otherwise provide us with any competitive advantage. Our agreements, including agreements with Inserm Transfert S.A., competitors or other third parties may be able to design around or Adverum and M.I.T. that are important to our business, and we otherwise circumvent our or our licensors’ patents by developing expect to enter into additional license agreements in the future. similar or alternative technologies or products in a non-infringing Our existing license agreements impose, and we expect that manner. any future license agreements wil l impose, various diligence, development and commercialization timelines, milestone The issuance of a patent is not conclusive as to its inventorship, payments, royalties and other obligations on us. See Section 11.5 scope, validity or enforceability, and our licensors’ patents, or any “Intellectual Property” and Section 22.2 “In-License Agreements” patents that we may independently seek may be challenged in the of this Registration Document for a description of our license courts or patent offices in the United States, the European Union agreements. If we fail to comply with our obligations under these or elsewhere. Such challenges may result in loss of exclusivity or in agreements, or we are subject to a bankruptcy or certain other patent claims being narrowed, invalidated or held unenforceable, specified events, the licensor may have the right to terminate which could limit our ability to stop others from using or the license, in which event we would not be able to market commercializing similar or identical technology and products, products covered by the license. Further, in certain of our license or limit the duration of the patent protection of our technology agreements, we have the first right to bring actions against any and product candidates. Given the amount of time required for third party for infringing the patents licensed to us. Certain of the development, testing and regulatory review of new product our license agreements also require us to meet development candidates, patents protecting such candidates might expire thresholds to maintain the license, including establishing a set before or shortly after such candidates are commercialized. As timeline for developing and commercializing product candidates a result, our intellectual property rights may not provide us with and minimum yearly diligence obligations in developing and 46 – GENSIGHT BIOLOGICS – 2017 Registration Document