1428156--3/10/2010--Celera

related topics

{product, candidate, development}

{regulation, government, change}

{interest, director, officer}

{property, intellectual, protect}

{product, liability, claim}

{stock, price, share}

{financial, litigation, operation}

{product, market, service}

{acquisition, growth, future}

{tax, income, asset}

{competitive, industry, competition}

{personnel, key, retain}

{system, service, information}

{provision, law, control}

{condition, economic, financial}

{cost, operation, labor}

{cost, regulation, environmental}

Our net revenues will be negatively affected if third-party payors decide that our products or services are not approved for reimbursement or if healthcare providers do not accept our diagnostic products as clinically useful. Efforts by third-party payors, including Medicare, to reduce utilization and reimbursement rates could decrease our net revenues and profitability. Payment practices by third-party payors where we are out-of-network can harm our operating results and financial condition. We may need to accept lower prices for some of our testing services in exchange for participating in provider networks. Our business is affected by macroeconomic conditions, and adverse changes in U.S. and global economic conditions have had and may continue to have an adverse effect on our business. Medicare contracting reforms could change Medicare s reimbursement policies or rates for our laboratory testing services. Our business could be adversely impacted if healthcare reform focuses on reducing healthcare costs and/or does not recognize the value and importance of diagnostic testing. The competition in the biotechnology and healthcare industries is intense and evolving. Failure to collect receivables, or to timely or accurately bill for our services, could have a material adverse effect on our business. Our competitive position depends on maintaining our intellectual property protection. Following the split-off from Life Technologies, Life Technologies may compete with us in our diagnostics business directly or enable others to compete with us by providing them access to its intellectual property, reagents, and technologies. Life Technologies is subject to a class action lawsuit relating to its offering of shares of Celera Group tracking stock in 2000 that may result in liabilities for which we have agreed to indemnify Life Technologies. The allocation of intellectual property rights between Life Technologies and us in connection with the split-off may harm our business. We may be subject to restrictions to preserve the tax-free treatment of the split-off and may not be able to engage in desirable acquisitions and other strategic transactions following the split-off. The negotiation of the split-off agreements between us and Life Technologies were effected through discussions among Life Technologies employees, some of whom, following the split-off, became our employees but some of whom did not and may have remained as employees of Life Technologies, and without involvement in, or review of, the agreements by independent outside advisors to us or an independent Board of Directors of Celera. We may be required to record additional impairment of our long-lived assets, including goodwill and other intangible assets, and these impairment charges would adversely affect our operating results. We may be unable to operate profitably as a stand-alone company. We may become involved in expensive intellectual property legal proceedings. We have a dispute with Life Technologies concerning the tax matters agreement entered into in connection with our separation from Life Technologies. We rely on independent healthcare providers, laboratories, and others to collect and process patient specimens. Some of our diagnostic research and product development programs require access to human tissue and/or blood samples, other biological materials, and related information, which may be in limited supply. If the split-off is determined to be taxable for U.S. federal income tax purposes, we and our stockholders could incur significant income tax liabilities, and we could be required to indemnify Life Technologies for taxes. We conduct our clinical laboratory testing business in a heavily regulated industry and changes in regulations or violations of regulations could, directly or indirectly, harm our operating results and financial condition. Our clinical laboratory testing services are subject to federal and state anti-kickback and anti-referral laws and regulations. Our clinical laboratory testing service business is subject to HIPAA and other laws and regulations pertaining to privacy, security and identity theft. Certain of our specialized diagnostic tests take advantage of the laboratory developed test exception from FDA review and any changes to the FDA s policies with respect to this exception could adversely affect our operating results and financial condition. There is a high demand for, and short supply of, key personnel needed for our clinical laboratory testing services. A portion of our workforce has unionized, and our operations may be adversely affected by increased labor costs, work stoppages or strikes. We rely on single suppliers or a limited number of suppliers of instruments, key components of our products and a test kit used in our clinical laboratory testing services. We expect BHL s lawsuit against Health Diagnostic Laboratory, Inc. and certain former employees of BHL to divert management s attention and involve significant costs, and the actions of these defendants have adversely affected and may continue to adversely affect BHL s business. Our success will depend on our ability to retain our key employees. Ethical, legal, and social issues may decrease demand for our diagnostic products and clinical laboratory testing business. Our scientific discoveries may not be replicated in some studies by other investigators, which may negatively impact the acceptance of our diagnostic products and testing services. The FDA has issued draft guidance on IVDMIAs, which may prevent others from using our diagnostic products. Our clinical laboratory testing service business could be adversely impacted by CMS adoption of the new coding set for diagnoses. We need to maintain federal and state operating licenses and similar clearances to conduct our clinical laboratory testing. We no longer have early access to Life Technologies instrumentation, reagents, and technologies for use in our diagnostic products and services. The historical financial information of Celera prior to our split-off from Life Technologies may not be representative of our results as an independent entity, and, therefore, may not be reliable as an indicator of our historical or future results as an independent entity. We could encounter difficulties if we were to expand our diagnostic product manufacturing and clinical laboratory testing services. Our business may be harmed by any disruption to our computer hardware, software, and internet applications. We have changed our sales and marketing strategy for our clinical laboratory testing services, and our new strategy could harm our revenues. Our rights under the split-off agreements we have with Life Technologies may be less favorable to us than if we had remained a business segment of Life Technologies and the terms of our master purchase agreement we have with Life Technologies may be less favorable to us than if it had been negotiated with an unaffiliated third party. Our separation agreement with Life Technologies requires us to indemnify Life Technologies for specified liabilities, including liabilities relating to the Celera business, specified litigation and one-half of any liabilities resulting from the split-off. Our clinical laboratory testing services depend primarily on a single courier for the delivery of our clinical specimens. Commercialization of our diagnostic products is dependent on our agreement with Abbott Molecular, Inc. Our successful development of diagnostic products may depend on entering into other collaborations, alliances, and partnership arrangements with other companies. Our development and commercialization of diagnostic products could be harmed if collaborators or licensees fail to perform under their agreements with us or if they terminate those agreements. Our licensing and royalty revenues depend on our licensees and partners maintenance of their agreements with us and their sales of their products. Our diagnostic product candidates may never result in a commercialized product. Development and commercialization of diagnostic product candidates depends on the satisfaction of regulatory requirements. Commercialization of our products depends on satisfaction of ongoing regulatory requirements. Clinical trials of diagnostic product candidates may not be successful. We could be harmed by disruptions to our critical manufacturing, clinical laboratory, or other facilities. We may pursue acquisitions, investments, or other strategic relationships or alliances, which may consume significant resources, may be unsuccessful, may require us to obtain financing on a stand-alone basis, and could dilute the holders of our common stock. The market price and trading volume of our common stock has been volatile and may face negative pressure. Future sales of our stock could adversely affect our stock s market price and our ability to raise capital in the future. We do not expect to pay dividends on our common stock. Anti-takeover provisions could deter takeover attempts of Celera Corporation and limit appreciation of the market price for shares of our common stock. Our collaborations with outside experts may be subject to restriction and change. We may be exposed to product liability or other legal claims relating to our products and services. Our operations are subject to potential exposure to environmental liabilities.

Full 10-K form ▸

1428156--3/10/2010--Celera_CORP