45 Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair our research, product development and manufact f ur t ing effo f rts. In addition, we cannot entirely eliminate the risk of accidental inju n ry or contamination from these materials or wastes. Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to inju n ries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabi a lities. We do not carry specific biological or hazardous waste insurance coverage, and our property, casualty, and general liabi a lity insurance policies specifically exclude coverage for damages and fines arising from biological or hazardous waste exposure or contamination. Accordingly, in the event of contamination or inju n ry, we could be held liabl a e for damages or be penalized with fines in an amount exceeding our resources, and our clinical trials or regulatory r approvals could be suspended, which could have a material adverse effe f ct on our business, financial condition, results of operations, and prospects. Our busine i ss activities may a be subject to the Foreign g Corrupt u Practices Act, or FCPA, P and simila i r anti-bribery r and anti- corrupt u io t n laws. Our business activities may be subj u ect to the FCPA and similar anti-bribery r or anti-corrupt u ion laws, regulations or rules of other countries in which we operate or may operate in the future, including the UK Bribery r Act. The FCPA generally prohibits offe f ring, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government offi f cial in order to influence offi f cial action, or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. Our business is heavily regulated and therefor f e involves significant interaction with public offi f cials, including offi f cials of non-U.S. governments. Additionally, in many other countries, the health care providers who prescribe pharmaceuticals are employed by their government, and the purchasers of pharmaceuticals are government entities; therefor f e, our dealings with these prescribers and purchasers are subj u ect to regulation under the FCPA. Recently the SEC and Department of Justice have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies. There can be no assurance that all of our employees, agents, contractors or collabor a ators, or those of our affi f liates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against us, our offi f cers, or our employees, the closing down of our facilities, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs and prohibitions on the conduct of our business. Any such violations could include prohibitions on our ability to offe f r our products in one or more countries and could materially damage our reputation, our brand, our ability to attract and retain employees, and our business, prospects, operating results, and financial condition. Risks Related to Our Reliance on Third Parties We expe x ct to rely on third parties to conduct many aspe s ctst of our clin l ical trials and some aspe s ctst of our research and preclin l ical testin t g, and those third parties may a not perfor f m r satisf i ac f torily i ,y includin d g failin l g to meet deadlin l es for the completion of such trials,s research or testin t g. We currently rely and expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institut t ions and clinical investigators, to conduct some aspects of our research, preclinical testing and clinical trials. Any of these third parties may terminate their engagements with us or be unabl a e to fulfill f their contractua t l obligations. If we need to enter into alternative arrangements, it would delay our product development activities. Our reliance on these third parties for research and development activities reduces our control over these activities, but does not relieve us of our responsibilities. For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA requires us to comply with GCPs for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible, reproducible and accurate and that the rights, integrity and confid f entiality of trial participants are protected. We are also required to register on-going clinical trials and to post the results of completed clinical trials on a government- sponsored databa a se within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. If these third parties do not successfully carry out their contractua t l duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we will not be able to obtain, or may be delayed in obtaining, marketing approvals for any product candidates we may develop and will not be able to, or may be delayed in our effo f rts to, successful f ly commercialize our medicines. We also expect to rely on other third parties to store and distribute drug r suppl u ies for our clinical trials. Any performance failure on the part of our distributors could delay clinical development or marketing approval of any product candidates we may develop or commercialization of our medicines, producing additional losses and depriving us of potential product revenue.