1203957--3/13/2008--BIONOVO

related topics

{product, candidate, development}

{product, liability, claim}

{property, intellectual, protect}

{stock, price, operating}

{provision, law, control}

{personnel, key, retain}

{cost, regulation, environmental}

{acquisition, growth, future}

Our drug development programs will require substantial additional future funding which could hurt our operational and financial condition. Our potential products face significant regulatory hurdles prior to marketing which could delay or prevent sales. Failure to obtain regulatory approvals in foreign jurisdictions would prevent us from marketing our products internationally. Our products, if and when any of them are approved, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements, or if such products exhibit unacceptable problems. If our competitors develop and market products that are more effective than our existing product candidates or any products that we may develop, or if they obtain marketing approval for their products before we do, our commercial opportunity will be reduced or eliminated. We will face uncertainty in any commercialization of our product candidates relating to coverage, pricing and reimbursement due to health care reform and heightened scrutiny from third-party payers, which may make it difficult or impossible to sell our product candidates on commercially reasonable terms. We expect to rely heavily on collaborative relationships and termination of any of these programs could reduce the financial resources available to us, including research funding and milestone payments. Failure to secure patents and other proprietary rights or challenges to those patents and rights may significantly hurt our business. If third parties successfully assert that we have infringed their patents and proprietary rights or challenge the validity of our patents and proprietary rights, we may become involved in intellectual property disputes and litigation that would be costly, time consuming, and delay or prevent the development of our product candidates. If we are unable to protect our trade secrets, we may be unable to protect our interests in proprietary know-how that is not patentable or for which we have elected not to seek patent protection. There is a substantial risk of product liability claims in our business. If we are unable to obtain sufficient insurance, a product liability claim against us could adversely affect our business. Our product candidates may have difficulties with market acceptance even after FDA approval. Claims relating to any improper handling, storage or disposal of biological and hazardous materials by us could be time-consuming and costly. Because we have limited manufacturing experience, we depend on third-party manufacturers to manufacture product candidates for us. If we cannot rely on third-party manufacturers, we will be required to incur significant costs and devote significant efforts to establish our own manufacturing facilities and capabilities. If we lose the services of our co-founders who serve as directors and officers of our company, our operations could be disrupted and our business could be harmed. Risks Related to Our Common Stock Volatility of our stock price could adversely affect stockholders. Our principal stockholders have significant voting power and may take actions that may not be in the best interest of other stockholders. Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable.

Full 10-K form ▸

1203957--3/13/2008--BIONOVO_INC