RISK FACTORS 4 commercializing the product. Disputes may arise regarding or sale of such products, or, with respect to our sales, an obligation intellectual property subject to a licensing agreement, including: on our part to pay royalties and/or other forms of compensation • the scope of rights granted under the license agreement and to third parties. The in-licensing or acquisition of third-party other interpretation-related issues; intel lectual property rights is a competitive area, and several more established companies may pursue strategies to in-license • the extent to which our technology and processes infringe any or acquire third-party intellectual property rights that we may intellectual property of the licensor that is not subject to the consider attractive. These established companies may have a licensing agreement; competitive advantage over us due to their size, capital resources • the sublicensing of intellectual property and other rights under and greater clinical development and commercialization our collaborative development, manufacturing and other third- capabilities. In addition, companies that perceive us to be a party relationships; competitor may be unwilling to assign or license rights to us. We • our diligence obligations under the license agreement and what may be unable to in-license or acquire third-party intel lectual activities satisfy those diligence obligations; property rights on terms acceptable to us or at all. • the inventorship or ownership intellectual property resulting For example, we sometimes col laborate with non-profit or from the joint creation or use of intellectual property by our academic institutions to further our preclinical research or licensors, consultants, contractors, collaborators or partners development activities under written agreements with these and us; and institutions. Typically, these institutions may provide us with an • the priority of invention of patented technology. option to negotiate a license to, or co-ownership of, any of the institution’s rights in technology resulting from the collaboration. If disputes over intel lectual property that we have in-licensed Regardless of such option, we may be unable to negotiate a license prevent or impair our ability to maintain our current licensing or ownership rights within the specified timeframe or under arrangements on acceptable terms, we may be unable to terms that are acceptable to us or at all. If we are unable to do so, successful ly develop and commercialize the affected product the institution may offer the intellectual property rights to other candidates. parties, potentially blocking our ability to pursue our program. We may not be successful in obtaining or maintaining necessary If we are unable to successfully obtain rights to required third- rights to gene therapy components and processes for our party intel lectual property rights or maintain the existing development pipeline. intel lectual property rights we have, we may have to abandon We currently have certain rights to intellectual property, through development of the relevant program or product candidate licenses from third parties, to develop our product candidates. and our business, financial condition, results of operations and Because our product candidate development pipeline may prospects could be adversely affected. require the use of additional proprietary rights held by these or Our patent protection could be reduced or eliminated for non- other third parties, the growth of our business likely will depend, compliance with various procedural, document submission, fee in part, on our ability to acquire, in-license or use proprietary payment and other requirements imposed by government patent rights from third parties in the future. We may be unable to agencies. acquire or in-license compositions, methods of use, processes or other intellectual property rights from third parties necessary to Periodic maintenance fees, renewal fees, annuity fees and various advance our research or allow commercialization of our product other government fees on patents and/or applications wil l be candidates at a reasonable cost or on reasonable terms, or that due to the USPTO, the European Patent Office, or the EPO, and we may otherwise identify as necessary or desirable for our to various government patent agencies outside of the United product candidates. In that event, we may be required to expend States and the European Union, over the lifetime of our patent significant time and resources to redesign our product candidates applications or in-licensed patents or applications and any patent or the methods for manufacturing them or to develop or license rights we may own in the future. For the patent applications that from third parties replacement technology, some or all of which we own, we employ reputable outside counsel to help us timely may not be feasible on a technical or commercial basis. If we are pay these fees due to the USPTO, the EPO and other government unable to do so, we may be unable to develop or commercialize patent agencies and, for our in-licensed patents, we rely on our the affected product candidates, which could harm our business licensing partners to timely pay these fees. The USPTO and various significantly. We cannot provide any assurances that third-party other government patent agencies, including the EPO, require patents do not exist that might be enforced against our product compliance with several procedural, documentary, fee payment candidates or future products or methods for manufacturing the and other similar provisions during the patent application process. same, resulting in either an injunction prohibiting our manufacture We are dependent on our licensors to take the necessary actions GENSIGHT BIOLOGICS – 2017 Registration Document– 47