We are required to comply with certain export control laws which may limit our ability to sell our
products to
non-U.S.
persons and may subject us to regulatory requirements that may delay or limit our ability to develop and commercialize our products.
Our product candidates are subject to the Export Administration Regulations (EAR), administered by the U.S. Department of Commerce
and are, in certain instances subject to the International Traffic in Arms Regulations (ITAR), administered by the U.S. Department of State. EAR restricts the export of
dual-use
products and
technical data to certain countries, while ITAR restricts the export of defense products, technical data and defense services. In addition, EAR and ITAR may also regulate the disclosure to certain foreign nationals in the United States, such as
research staff, of technical data about controlled commodities. The U.S. government agencies responsible for administering EAR and ITAR have significant discretion in the interpretation and enforcement of these regulations. Failure to comply with
these regulations can result in criminal and civil penalties and may harm our ability to enter into contracts with the U.S. government. It is also possible that these regulations could adversely affect our ability to sell our products to
non-U.S.
customers.
Our product candidates may also be subject to export control laws within the United
Kingdom and European Union resulting in the need for authorization from customs authorities before they can leave the United Kingdom or European Union customs territories and restrictions on export from these territories to certain countries. Again,
such laws could adversely affect our ability to sell to customers in certain countries and
non-compliance
can result in civil and criminal penalties. Such restrictions exist across the European Union and
within its member states individually and may vary between member states.
We must comply with environmental laws and regulations, and failure to
comply with these laws and regulations could expose us to significant liabilities.
We use hazardous chemicals and biological
materials in certain aspects of our business and are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of these materials. We
cannot eliminate the risk of accidental injury or contamination from the use, manufacture, distribution, storage, handling, treatment or disposal of hazardous materials. In the event of contamination or injury, or failure to comply with
environmental, occupational health and safety and export control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources. In addition, we may be required to pay damages or
civil judgments related to third-party claims, for which we are uninsured, including those relating to personal injury (including exposure to hazardous chemicals and biological materials), product quality issues, property damage or contribution to
remedial obligations.
If we use biological and hazardous materials in a manner that causes contamination or injury or violates laws, we may be
liable for damages.
Our research and development activities and clinical trials involve the use of potentially harmful biological
materials, including anthrax, as well as hazardous materials and chemicals. We cannot completely eliminate the risk of accidental contamination or injury from the distribution, use, storage, handling or disposal of these materials. In the event of
contamination or injury, we could be held liable for damages that result, and any liability could exceed our available financial resources. The Company, our collaborative partners, the third parties that conduct clinical trials on our behalf, and
our third-party manufacturers are subject to federal, state, local or foreign laws and regulations governing the use, storage, handling and disposal of these materials and waste products. The cost of compliance with these laws and regulations could
be significant. The failure to comply with any of these laws and regulations could result in significant fines and work stoppages.
Risks Related to
our Securities
Future sales and issuances of our common stock or rights to purchase common stock could result in substantial dilution to the
percentage ownership of our stockholders.
We expect that significant additional capital will be needed in the future to continue
our planned operations. To raise capital, we may sell common stock or other securities convertible into or exchanged for our common stock in one or more transactions, and in a manner we determine from time to time and at prices that may not be the
same as the price per share paid by other investors, and dilution to our stockholders could result. The price per share at which we sell additional shares of our common stock, or securities convertible or exchangeable into common stock, in future
transactions may be higher or lower than the price per share paid by other investors. New investors could also receive rights, preferences and privileges senior to those of existing holders of our common stock. In addition, in the event of stock
dividends, stock splits, reorganizations or similar events affecting our common stock, we may be required to proportionally adjust the conversion price, exercise price or number of shares issuable upon exercise of our outstanding warrants.
If we do not meet the continued listing standards of The Nasdaq Global Market our common stock could be delisted from trading, which could limit
investors ability to make transactions in our common stock and subject us to additional trading restrictions.
Our common
stock is listed on The Nasdaq Global Market, a national securities exchange, which imposes continued listing requirements with respect to listed shares. If we fail to satisfy the continued listing standards, including with respect to the maintenance
of a minimum share price, or if NASDAQ in its discretion, determines that a condition exists that makes further dealings of our Company on the exchange unwarranted, NASDAQ may issue
a non-compliance letter
or initiate delisting proceedings.
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