RISK FACTORS 4 conducted in accordance with the applicable legal, regulatory, delay our ability to obtain regulatory approval, delay or prevent ethical and scientific standards, and our reliance on the third party starting or completion of clinical trials and delay or prevent does not relieve us of our regulatory responsibilities. commercialization of our product candidates. In the event of a We and our CROs are required to comply with the FDA’s, the default, bankruptcy or shutdown of, or a dispute with, a third EMA’s and other regulatory authorities’ GCP, cGMP, Good party, we may be unable to enter into a new agreement with Laboratory Practice, or GLP, and other applicable requirements another third party on commercially acceptable terms. In addition, for conducting, recording and reporting the results of our our third-party agreements usually contain a clause limiting such preclinical studies and clinical trials to assure that the data and third party’s liability, such that we may not be able to obtain full reported results are credible and accurate and that the rights, compensation for any losses we may incur in connection with the integrity and confidentiality of clinical trial participants are third party’s performance failures. While we believe that there protected. Regulatory authorities around the world, including the are numerous alternative sources to provide these services, in the FDA and the EMA, enforce these requirements through periodic event that we seek such alternative sources, we may not be able inspections of study sponsors, CROs, principal investigators and to enter into replacement arrangements without incurring delays clinical trial sites. If we, our CROs, our investigators or trial sites or additional costs. fail to comply with applicable GCP, GLP and cGMP requirements, We have entered, and may in the future enter, into collaborations the clinical data generated in our future clinical trials may be with third parties for the development and commercialization deemed unreliable and the FDA, the EMA or other regulatory of our product candidates. If we are unable to enter into such authorities around the world may require us to perform additional collaborations on acceptable terms, or if these collaborations are clinical trials before issuing any marketing authorizations for not successful, our business could be adversely affected. our product candidates. Upon inspection, the FDA or EMA may determine that our clinical trials did not comply with GCP and We have limited capabilities for product development and cGMP requirements, which may render the data generated in may seek to enter into col laborations in the future with third those trials unreliable or unusable for the purpose of supporting parties, such as pharmaceutical and biotechnology companies, the marketing authorization applications for our products. In for the development and potential commercialization of our addition, our future clinical trials will require a sufficient number of product candidates, whether in specific geographic regions or study subjects to evaluate the safety and efficacy of our product worldwide, due to substantial capital costs required to develop candidates. Accordingly, if, for example, our CROs fail to comply the product candidates or manufacturing constraints. We with these regulations or if trial sites fail to recruit a sufficient may not be successful in our efforts to establish such strategic number of patients, we may be required to repeat such clinical partnerships or other alternative arrangements for our product trials or incur delays in the performance of such trials, which candidates because our research and development pipeline may would delay the regulatory approval process. be insufficient, our product candidates may be deemed to be at Therefore, the timing of the initiation and completion of trials is too early of a stage of development for collaborative effort or largely controlled by such third parties and may occur at times third parties may not view our product candidates as having the substantial ly different from our estimates. Our development requisite potential to demonstrate safety and efficacy. In addition, activities, including preclinical studies and clinical trials conducted we may be restricted under existing collaboration agreements in reliance on third parties, may be delayed, suspended or from entering into future agreements with potential collaborators. terminated if: If we are unable to reach agreements with suitable collaborators • we are unable to negotiate agreements with third parties under on a timely basis, on acceptable terms or at all, we may have to reasonable terms; curtail the development of a product candidate, reduce or delay • termination or nonrenewal of agreements with third parties its development program, delay its potential commercialization, occurs in a manner or at a time that is costly or damaging to us; reduce the scope of any sales or marketing activities or • the third parties do not successfully carry out their contractual increase our expenditures and undertake development or duties or fail to meet regulatory obligations or expected commercialization activities at our own expense. If we elect to deadlines; or fund development or commercialization activities on our own, • the quality or accuracy of the data obtained by third parties is we may need to obtain additional expertise and additional capital, compromised due to their failure to adhere to clinical protocols, which may not be available to us on acceptable terms or at all. regulatory or ethical requirements, or for other reasons. If we fail to enter into collaborations and do not have sufficient funds or expertise to undertake the necessary development Third party performance failures in connection with our and commercialization activities, we may not be able to further preclinical studies and clinical trials may increase our costs, develop our product candidates. 30 – GENSIGHT BIOLOGICS – 2017 Registration Document