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| related topics |
| {product, liability, claim} |
| {product, candidate, development} |
| {property, intellectual, protect} |
| {acquisition, growth, future} |
| {regulation, change, law} |
| {product, market, service} |
| {competitive, industry, competition} |
|
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We are engaged in litigation, including patent litigation, and a court could determine that our products could infringe the intellectual property rights of others and may require us to pay substantial damages or prohibit us from selling our products.
It is possible that we may be forced to pay damages to CytoLogix which exceed the amounts we have reserved.
Our future growth depends on our ability to develop and successfully introduce new products, product extensions and improvements to existing products to address unmet patient and market needs.
We face significant competition and may not be able to compete effectively.
If our customers do not receive adequate third-party reimbursement, our products may not be accepted in the market.
If we make acquisitions or divestitures, we could encounter difficulties that harm our business.
We are subject to a complex system of domestic and foreign taxation and unanticipated changes in our tax rates or exposure to additional tax liabilities could affect our profitability.
If we fail to comply with the FDA s Quality System regulations, our manufacturing operations could be delayed, and our product sales and profitability could suffer.
Clinical Laboratory Improvement Act (CLIA) regulations or FDA regulation of clinical laboratories could harm our business by limiting the potential market for our products.
If we have problems with key suppliers, our product development and commercialization efforts could be delayed or stopped.
Complying with international regulatory requirements is an expensive, time-consuming process, and approval is never certain.
We could bring litigation to enforce our intellectual property rights, which might result in substantial expense.
We cannot assure you that we will be able to fund our future capital requirements through internal sources or from other sources.
Full 10-K form ▸
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