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related topics |
{financial, litigation, operation} |
{product, liability, claim} |
{control, financial, internal} |
{regulation, government, change} |
{regulation, change, law} |
{cost, regulation, environmental} |
{operation, natural, condition} |
{loss, insurance, financial} |
{property, intellectual, protect} |
{debt, indebtedness, cash} |
{product, market, service} |
{condition, economic, financial} |
{cost, contract, operation} |
{stock, price, share} |
{customer, product, revenue} |
{product, candidate, development} |
{interest, director, officer} |
{operation, international, foreign} |
{gas, price, oil} |
{system, service, information} |
{personnel, key, retain} |
{tax, income, asset} |
{stock, price, operating} |
{acquisition, growth, future} |
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(a) Risks Related to Our Business and Industry
The markets for our eye care products are intensely competitive and new medical and technological developments may reduce the need for our products.
Resources devoted to research and development may not yield new products that achieve commercial success
Market acceptance of our products requires, in many cases, that users of our products obtain adequate reimbursement from third-party payers.
Federal, state and non-U.S. laws pertaining to healthcare fraud and abuse could materially adversely affect our business and results of operations.
Healthcare initiatives and other cost-containment pressures could cause us to sell our products at lower prices, resulting in less revenue to us.
Economic conditions and price competition may cause sales of our products used in elective surgical procedures to decline and reduce our profitability.
If we fail to maintain our relationships with healthcare providers, including ophthalmologists, optometrists, opticians, hospitals, ambulatory surgical centers, corporate optometry chains and group purchasing organizations, customers may not buy our products and our revenue and profitability may decline.
The majority of our business is conducted outside the United States, subjecting us to additional business risks, including increased costs, market and currency fluctuations, business interruption and changing demands, all of which may result in fluctuations and declines in our sales and profits.
If we were to experience an interruption of our manufacturing operations, our business, financial condition and operating results would be materially harmed.
We rely on independent suppliers for raw materials and we could experience inventory shortages if we were required to use an alternative supplier on short notice.
If we fail to attract, hire and retain qualified personnel, we may not be able to design, develop, market or sell our products or successfully manage our business.
(b) Risks Related to Our Financial Condition
Our indebtedness could adversely affect our financial health.
We are vulnerable to interest rate risk with respect to our debt.
The market price of our Common stock has been volatile and may continue to be volatile, and the value of any investment may decline.
We incur substantial costs with respect to pension benefits and providing healthcare for our employees.
Changes in accounting may affect our reported earnings and operating income.
Catastrophic events may disrupt our business.
Acquisitions and joint ventures may have an adverse effect on our business.
We are in the process of upgrading certain of our management information systems and we cannot ensure that there will not be associated excessive costs or disruption of our business.
The spending to address the
recall, our investigations and consent solicitations and bank waiver matters could negatively affect our financial performance.
We have made certain assumptions and could experience other risks concerning our financial performance.
(c) Risks Related to Litigation, Actions, Claims, Investigations, Internal Control Deficiencies, the Restatement of Our Financial Statements, the Delay in Filing Our Periodic Reports and Intellectual Property
Unfavorable results in pending and future claims and litigation matters as well as the outcome of pending or future investigations could have an adverse impact on us.
We may not have sufficient insurance to cover our liability in our pending litigation claims and future claims either due to coverage limits or as a result of insurance carriers seeking to deny coverage of such claims, which in either case could have a material adverse effect on our business and financial condition.
Our potential indemnification obligations and limitations of our director and officer liability insurance could have a material adverse effect on our business, results of operations and financial condition.
Our potential liability relating to a Notice of Final Partnership Administrative Adjustment from the Internal Revenue Service
could have a material adverse effect on our financial results
Management has identified a number of material weaknesses in our internal control over financial reporting.
We may face risks related to the recent restatement of our financial statements.
We expect to continue to incur significant expenses related to our internal control over financial reporting and the preparation of our financial statements.
We have postponed the filing of this Annual Report and of our Quarterly Reports on Form 10-Q for the quarters ended September 24, 2005, April 1, 2006, July 1, 2006 and September 30, 2006. As a result, we do not have current financial information available and will be limited in our ability to register our securities for offer and sale until we are deemed a current filer with the SEC.
As a result of the delays in filing our periodic reports, we required certain waivers in connection with the delivery of financial statements and related matters under financing arrangements for our public and bank debt. We may require additional waivers in the future, and failure to obtain the necessary waivers could have a material adverse effect on our business, liquidity and financial condition.
The delay in filing this Annual Report on Form 10-K with the SEC and any failure to satisfy other NYSE listing requirements could cause the NYSE to commence suspension or delisting procedures with respect to our common stock.
We depend on proprietary technologies, and may not be able to protect our intellectual property rights adequately.
Our products could be subject to claims of infringement.
(d) Risks Related to Regulatory Matters
We are subject to extensive government regulation that increases our costs and could prevent us from selling our products
We have undertaken, and may in the future implement, a product recall or voluntary market withdrawal, or could be required by a governmental authority to do so, and could be exposed to significant product liability claims; we may have to pay significant amounts to those harmed and may suffer from adverse publicity as a result.
Our worldwide voluntary withdrawal of our
product has had an adverse effect on our business, which could continue longer than previously estimated, even permanently
Our activities involve hazardous materials and emissions and may subject us to environmental liability
We may incur increased costs or suffer competitive disadvantage as a result of recently enacted and proposed changes in laws and regulations.
Full 10-K form ▸
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