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
manufacturing efforts. In addition, we cannot entirely eliminate
the risk of accidental injury 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 injuries to
our employees resulting from the use of hazardous materials, this
insurance may not provide adequate coverage against potential
liabilities. We do not carry specific biological or hazardous waste
insurance coverage, and our property, casualty, and general
liability 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 injury, we could be held liable for damages or be
penalized with fines in an amount exceeding our resources, and our
clinical trials or regulatory approvals could be suspended, which
could have a material adverse effect on our business, financial
condition, results of operations, and prospects.
Our business activities may be subject to the FCPA and
similar anti-bribery and anti-corruption laws.
Our business activities may be subject to the Foreign Corrupt
Practices Act (“FCPA”) and similar anti-bribery or anti-corruption
laws, regulations, or rules of other countries in which we operate,
including the U.K. Bribery Act. The FCPA generally prohibits
offering, promising, giving, or authorizing others to give anything
of value, either directly or indirectly, to a non-U.S. government official in order
to influence official 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 therefore involves significant interaction
with public officials, including officials of non-U.S. governments. Additionally, in
many other countries, the researchers with whom we conduct clinical
trials, and the healthcare providers who prescribe pharmaceuticals,
are employed by their government, and the purchasers of
pharmaceuticals are government entities. As a result, our dealings
with these researchers, prescribers, and purchasers are subject to
regulation under the FCPA. Recently the Securities and Exchange
Commission (“SEC”) and Department of Justice have increased their
FCPA enforcement activities with respect to biotechnology and
pharmaceutical companies. There is no certainty that all of our
employees, agents, contractors or collaborators, or those of our
affiliates, 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 officers 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 offer our products in one or more
countries and could materially damage our reputation, our brand,
our international expansion efforts, our ability to attract and
retain employees, and our business, prospects, operating results
and financial condition.
Failure to comply with privacy and data protection laws,
regulations, or contractual obligations could lead to government
enforcement actions (which could include civil or criminal
penalties), private disputes and litigation, and/or adverse
publicity and could negatively affect our operating results and
business.
We receive, generate, and store significant and increasing volumes
of sensitive information, such as employee, personal, patient and
collaborator data. In addition, we actively seek access to medical
information, including patient data, through research and
development partnerships and collaborations or otherwise. We have
legal and contractual obligations regarding the protection of
confidentiality and appropriate use of personal data. We and our
partners may be subject to federal, state, and foreign data
protection laws and regulations (i.e., laws and regulations that
address privacy and data security). These data protection laws and
regulations continue to evolve and may result in ever-increasing
public scrutiny and escalating levels of enforcement and sanctions
and increased costs of compliance.
In the United States, numerous federal and state laws and
regulations, including state data breach notification laws, state
health information privacy laws, and federal and state consumer
protection laws (e.g., Section 5 of the Federal Trade
Commission Act), that govern the collection, use, disclosure and
protection of health-related and
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