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related topics |
{product, liability, claim} |
{customer, product, revenue} |
{acquisition, growth, future} |
{product, market, service} |
{property, intellectual, protect} |
{stock, price, operating} |
{tax, income, asset} |
{investment, property, distribution} |
{interest, director, officer} |
{provision, law, control} |
{personnel, key, retain} |
{cost, operation, labor} |
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If we fail to develop or market new products and enhance existing products, we could lose market share to our competitors and our results of operations could suffer.
Competition may decrease our market share and cause our revenues to decline.
We may be exposed to risks associated with acquisitions, including integration risks and risks associated with methods of financing and the impact of accounting treatment. Accordingly, completed acquisitions may not enhance our business.
If we fail to adequately protect our intellectual property rights, our business may suffer.
If third parties claim that our products infringe their intellectual property rights, we may be forced to expend significant financial resources and management time defending against such actions and our results of operations could suffer.
We are dependent on single and limited source suppliers, which puts us at risk for supplier business interruptions.
If we do not maintain our relationships with interventional physicians, our growth will be limited and our business could be harmed.
Our business could be harmed if we lose the services of our key personnel.
Undetected defects may increase our costs and impair the market acceptance of our products.
If a product liability claim is brought against us or our product liability insurance coverage is inadequate, our business could be harmed.
Healthcare reform could cause a decrease in demand for our interventional products.
Inadequate levels of reimbursement from governmental or other third-party payors for procedures using our products may cause our revenues to decline.
If we cannot obtain and maintain marketing clearance or approval from governmental agencies, we will not be able to sell our products.
Modifications to our current products may require new marketing clearances or approvals or require us to cease marketing or recall the modified products until such clearances or approvals are obtained.
If we or some of our suppliers fail to comply with the FDA s Quality System Regulation, or QSR, and other applicable postmarket requirements, our manufacturing operations could be disrupted, our product sales and profitability could suffer, and we may be subject to a wide variety of FDA enforcement actions.
Even after receiving regulatory clearance or approval, our products may be subject to product recalls, which may harm our reputation and divert managerial and financial resources.
Failure to attract additional capital which we may require to expand our business could curtail our growth.
Any disaster at our manufacturing facilities could disrupt our ability to manufacture our products for a substantial amount of time, which could cause our revenues to decrease.
One stockholder may influence our affairs due to the ownership of a significant amount of our stock.
Risks Related to our Relationship with and Separation from E-Z-EM
We have limited ability to engage in acquisitions and other strategic transactions using our equity, or to obtain equity financing, because of the Federal income tax requirements for a tax-free distribution of our stock by E-Z-EM.
Our obligation to indemnify E-Z-EM if we cause the distribution to not be tax-free could discourage or divert a third party from acquiring us and could result in substantial liability.
Some of our directors may have conflicts of interest because they are also directors or officers of E-Z-EM and also own E-Z-EM stock or options to purchase E-Z-EM stock.
We face risks associated with being a member of E-Z-EM s consolidated group for Federal income tax purposes.
Provisions in our charter documents, our rights plan, Delaware law and tax considerations related to the distribution by E-Z-EM may delay or prevent a change in control.
Full 10-K form ▸
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