RISK FACTORS 4 develop. Competitors also may obtain FDA or other regulatory product candidate must be approved for reimbursement before approval for their products more rapidly or earlier than we may it can be approved for sale in that country. In some cases, the obtain approval for ours, which could result in our competitors price that we intend to charge for our products, if approved, is establishing a strong market position before we are able to enter also subject to approval. We also intend to submit a marketing the market. authorization application to the EMA for approval of our product candidates in the European Union, but obtaining such approval Furthermore, members of our management team may be from the European Commission following the opinion of the EMA affected by conflicts of interest to the extent that they serve in is a lengthy and expensive process. Even if a product candidate management or directorship capacities at our competitors. For is approved, the FDA or the EMA may limit the indications for example, Bernard Gilly is currently non-executive Chairman of which the product may be marketed, require extensive warnings the Board of Directors of Pixium Vision, a company working on a on the product labeling or require expensive and time-consuming retinal implant technology that targets end stage, non-syndromic additional clinical trials or reporting as conditions of approval. patients with no photoreceptors, whereas gene therapy targets Regulatory authorities in countries outside of the United States patients earlier in the disease with some residual vision and and the European Union also have requirements for approval of photoreceptors. See Section 14.1.2, “Biographical Information product candidates with which we must comply prior to marketing About the Members of the Board of Directors and Officers of in those countries. Obtaining such regulatory approvals and the Company” and Section 6.6, “Our Second Product Candidate: compliance with such other regulatory requirements could result GS030 for the Treatment of RP—No Existing Therapies for the in significant delays, difficulties and costs for us and could delay Treatment of RP” of this Registration Document. or prevent the introduction of our product candidates in certain In addition, as a result of the expiration or successful challenge of countries. the patent rights that we license from third parties, we could face Further, clinical trials conducted in one country may not be more litigation with respect to the validity or scope of patents. The accepted by regulatory authorities in other countries. Also, availability of our competitors’ products could limit the demand regulatory approval for any of our product candidates may be and the price we are able to charge for any product candidate that withdrawn. If we fail to comply with the regulatory requirements, we may develop and commercialize. our target market will be reduced and our ability to realize the If we are not able to compete effectively against our current and full market potential of our product candidates will be harmed future competitors, our business will not grow and our financial and our business, financial condition, results of operations and condition and operations will suffer. prospects will be adversely affected. Even if we obtain and maintain approval for our product candidates from the FDA or the EMA, such approval does not ensure approval 4.3 from other regulatory authorities, and we still may never obtain approval for our product candidates in other countries or RISKS RELATED TO THIRD PARTIES jurisdictions outside of the United States or the European Union. We rely on third parties to conduct, supervise and monitor our Approval of a product candidate in the United States by the preclinical studies and clinical trials. If these third parties do not FDA or in the European Union by the EMA does not ensure meet our deadlines or otherwise conduct the studies and trials as approval of such product candidate by regulatory authorities in required, our clinical development programs could be delayed or other countries or jurisdictions, and approval by one regulatory unsuccessful and we may not be able to obtain regulatory approval authority does not ensure approval by the FDA, the EMA or for or commercialize our product candidates when expected or at all. regulatory authorities in other countries. Sales of our product We do not have the ability to conduct all aspects of our preclinical candidates outside of the United States and the European Union studies or clinical trials ourselves. We rely, and expect to will be subject to different regulatory requirements governing continue to rely, on medical institutions, clinical investigators, clinical trials and marketing approval. Even if the FDA or the EMA CROs, contract laboratories and col laborators to carry out grants marketing approval for a product candidate, comparable our preclinical studies and clinical trials and to perform data regulatory authorities of other countries also must approve the collection and analysis. Such third parties play a significant role manufacturing and marketing of the product candidates in those in the conduct of these studies and trials and the subsequent countries. Approval procedures vary among jurisdictions and col lection and analysis of data. While we have agreements can involve requirements and administrative review periods governing their activities, we have limited influence over their different from, and more onerous than, those in the United States actual performance and will control only certain aspects of such and the European Union, including additional preclinical studies third parties’ activities. Nevertheless, we are responsible for or clinical trials. In many countries outside the United States, a ensuring that each of our preclinical studies and clinical trials is GENSIGHT BIOLOGICS – 2017 Registration Document– 29