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related topics |
{financial, litigation, operation} |
{product, liability, claim} |
{regulation, change, law} |
{product, candidate, development} |
{operation, international, foreign} |
{control, financial, internal} |
{acquisition, growth, future} |
{regulation, government, change} |
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If retigabine and other product candidates in development do not become approved and commercially successful products, our ability to generate future growth in revenue and earnings will be adversely affected.
Obtaining necessary government approvals is time consuming and not assured.
If we, our partners or licensees cannot successfully develop and/or commercialize our products, our growth rate would be negatively impacted.
Due to the large portion of our business conducted outside the United States, we have significant foreign currency risk.
We may be unable to identify, acquire and integrate acquisition targets successfully.
If we or our third-party manufacturers are unable to manufacture our products or the manufacturing process is interrupted due to failure to comply with regulations or for other reasons, the manufacture of our products could be interrupted.
Adverse U.S. and international economic and market conditions may adversely affect our product sales and business.
If our products cause, or are alleged to cause, serious or widespread personal injury, we may have to withdraw those products from the market and/or incur significant costs, including payment of substantial sums in damages.
Legislative or regulatory reform of the healthcare system may affect our ability to sell our products profitably.
Products representing a significant amount of our revenue are not protected by patent or data exclusivity rights.
Many of our key processes, opportunities and expenses are a function of existing national and/or local government regulation. Significant changes in regulations could have a material adverse impact on our business.
We are involved in various legal proceedings that could adversely affect us.
We are subject to fraud and abuse and similar laws and regulations, and a failure to comply with such regulations or prevail in any litigation related to noncompliance could harm our business.
We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery laws.
We may be involved in infringement actions which are uncertain, costly and time-consuming and could have a material adverse effect on our business, results of operations, financial condition and cash flows.
Existing and future audits by, or other disputes with, taxing authorities may not be resolved in our favor.
We are subject to a consent order with the SEC.
The current SEC investigation could adversely affect our business and the trading price of our securities.
The matters relating to the Special Committee s review of our historical stock option granting practices and the restatement of our consolidated financial statements have resulted in increased litigation and regulatory proceedings against us and could have a material adverse effect on us.
If we identify a material weakness in our internal control over financial reporting in future periods, our stock price could be adversely affected and our ability to prepare complete and accurate financial statements in a timely manner could be adversely affected.
Full 10-K form ▸
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