36 • costs to defend the related litigation; • a diversion of management’s time and our resources; • subs u tantial monetary awards to trial participants or patients; • product recalls, withdrawals or labe a ling, marketing or promotional restrictions; • loss of revenue; • exhaustion of any availabl a e insurance and our capital resources; • the inability to commercialize any product candidate; and • a decline in our share price. Our inability to obtain sufficient product liability insurance at an acceptabl a e cost to protect against potential product liabi a lity claims could prevent or inhibit the commercialization of products we develop, alone or with collaborators. Our insurance policies may have various exclusions, and we may be subj u ect to a product liabi a lity claim for which we have no coverage. We may have to pay any amounts awarded by a court or negotiated in a settlement that exceed our coverage limitations or that are not covered by our insurance, and we may not have, or be able to obtain, sufficient capital to pay such amounts. Even if our agreements with any future corporate collabor a ators entitle us to indemnific f ation against losses, such indemnific f ation may not be availabl a e or adequate should any claim arise. Risks Related to Regulatory Approval and Other Legal Compliance Matters The regu e latory approval processes of the FDA, D EMA M and comparablel foreign g regu e latory authorities are lengthy, h time i consuming, and inherently t unpr n edic d table. l If we are ultima l tely unablel to obtai t n i regu e latory approval for our product candid d at d es t ,s we will i be unable to generate product revenue and our busine i ss will i be substantia t llyl harmed.d The time required to obtain approval by the FDA, EMA and comparable foreign regulatory r authorities is unpredictabl a e, typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, approval policies, regulations or the type and amount of clinical data necessary r to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory r authorities have subs u tantial discretion in the approval process and may refuse to accept any application or may decide that our data are insufficient for approval and require additional preclinical, clinical or other studi t es. We have not subm u itted for or obtained regulatory approval for any product candidate, and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory r approval. Applications for our product candidates could fail to receive regulatory r approval for many reasons, including but not limited to the following: • the FDA, EMA or comparable foreign regulatory r authorities may disagree with the design, implementation or results of our clinical trials or the portfol f io of clinical trials planned for subm u ission in our BLA; • the FDA, EMA or comparable foreign regulatory r authorities may determine that our product candidates are not safe and effe f ctive, only moderately effe f ctive or have undesirabl a e or unintended side effe f cts, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use of our products; • the population studi t ed in the clinical program may not be suffic f iently broad or representative to assure effi f cacy and safety in the full population for which we seek approval; • we may be unabl a e to demonstrate to the FDA, EMA or comparable foreign regulatory r authorities that a product candidate’s risk-benefit f ratio for its proposed indication(s), when compared to the standard of care, is acceptabl a e; • the FDA, EMA or comparable foreign regulatory r authorities may disagree with our interpretation of data from preclinical studi t es or clinical trials; • the data collected from clinical trials of our product candidates may not be sufficient to suppor u t the subm u ission of a BLA or other subm u ission or to obtain regulatory r approval in the United States or elsewhere; • study t data may not be positive in all clinical trials demonstrating a mix of positive and negative clinical trial results; • the FDA, EMA or comparable foreign regulatory r authorities may fail to approve the chemistry, r manufactur t ing and controls processes, test procedur d es and specifications, or facilities or third-party manufact f ur t ers with which we contract for clinical and commercial suppl u ies; and