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related topics |
{product, candidate, development} |
{property, intellectual, protect} |
{cost, regulation, environmental} |
{regulation, government, change} |
{product, liability, claim} |
{operation, international, foreign} |
{customer, product, revenue} |
{loan, real, estate} |
{personnel, key, retain} |
{acquisition, growth, future} |
{tax, income, asset} |
{debt, indebtedness, cash} |
{provision, law, control} |
{competitive, industry, competition} |
{financial, litigation, operation} |
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Adverse safety events can negatively affect our assets, product sales, operations and products in development
If we fail to compete effectively, our business and market position would suffer
We depend on collaborators for both product and royalty revenue and the clinical development of future collaboration products, which are outside of our full control
We depend, to a significant extent, on reimbursement from third party payors and a reduction in the extent of reimbursement could negatively affect our product sales and revenue
If we do not successfully execute our strategy of growth through the acquisition, partnering and in-licensing of products, technologies or companies, our future performance could be adversely affected
Our business is subject to extensive governmental regulation and oversight and changes in laws could adversely affect our revenues and profitability
If we fail to comply with the extensive legal and regulatory requirements affecting the healthcare industry, we could face increased costs, penalties and a loss of business
Problems with manufacturing or with inventory planning could result in our inability to deliver products, inventory shortages or surpluses, product recalls and increased costs
We rely on third parties to provide services in connection with the manufacture of our products and, in some instances, the manufacture of the product itself
If we fail to meet the stringent requirements of governmental regulation in the manufacture of our products, we could incur substantial remedial costs and a reduction in sales
We have made a significant investment in constructing a manufacturing facility the success of which depends upon the completion and licensing of the facility and continued demand for our products
If we are unable to attract and retain qualified personnel and key relationships, the growth of our business could be harmed
Our sales and operations are subject to the risks of doing business internationally
Our operating results are subject to significant fluctuations
If we are unable to adequately protect and enforce our intellectual property rights, our competitors may take advantage of our development efforts or our acquired technology
If our products infringe the intellectual property rights of others, we may incur damages and be required to incur the expense of obtaining a license
Uncertainty over intellectual property in the biotechnology industry has been the source of litigation, which is inherently costly and unpredictable
Pending and future product liability claims may adversely affect our business and our reputation
We have recently incurred substantial indebtedness that could adversely affect our business and limit our ability to plan for or respond to changes in our business
Our business involves environmental risks, which include the cost of compliance and the risk of contamination or injury
Our investments in marketable securities are significant and are subject to market, interest and credit risk that may reduce their value
We may incur liabilities to tax authorities in excess of amounts that have been accrued
Several aspects of our corporate governance and our collaboration agreements may discourage a third party from attempting to acquire us
Full 10-K form ▸
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