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related topics |
{product, candidate, development} |
{product, liability, claim} |
{product, market, service} |
{cost, operation, labor} |
{property, intellectual, protect} |
{customer, product, revenue} |
{personnel, key, retain} |
{provision, law, control} |
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We do not have sufficient capital resources to fully develop, commercialize and market our products in development and will require partnerships or additional financing to do so.
Our inability to enter into or successfully manage strategic relationships to develop, manufacture, commercialize and market our products in development will have a material adverse effect on our future business, financial condition and results of operations.
Our strategic alternatives process may not be successful.
Our product candidates are in or will undergo clinical trials and the results from these trials may not be favorable.
To be successful, we must attract, retain and motivate key employees, and the inability to do so could seriously harm our operations.
We may not collect any further milestone or royalty payments under the PhosLo Agreement.
We depend upon third parties to manufacture our products in development.
Under the Biologics strategic business unit asset purchase agreement, we will have continuing obligations to indemnify Biotest, and may be subject to other liabilities.
Our patents and proprietary rights may not provide sufficient protection, and patents of other companies could prevent us from developing and marketing our products.
We compete with larger, better-financed and more mature pharmaceutical and biotechnology companies that are capable of developing and marketing products more effectively than we are able to do.
The market may not be receptive to our products upon their introduction
If we fail to comply with extensive regulations enforced by the FDA and foreign regulatory agencies, the sale of our future products could be prevented or delayed
We may be subject to costly and damaging product liability and other claims in connection with the development and commercialization of our product candidates
We may not be able to maintain sufficient insurance, including products liability and directors and officers insurance, to cover claims against us.
There are potential limitations on third-party reimbursement, complex regulations for reimbursement of products and other pricing-related matters that could adversely affect our ability to successfully commercialize our products in development and impair our ability to generate sufficient revenues from future product sales.
Anti-takeover provisions in our charter documents, under Delaware law and under our stockholder rights plan, could make an acquisition of us more difficult.
Full 10-K form ▸
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