- the achievement of desired clinical trial results related to the
Company's pipeline products;
- timely regulatory approval of the Company's products;
- the ability to comply with regulatory requirements applicable to the
manufacture and marketing of the Company's products;
- the Company's ability to obtain and enforce effective patents;
- the non-infringement of third party patents or proprietary rights by
the Company and its products;
- factors beyond our control that could cause interruptions in our
operations in our single manufacturing facility (including, without
limitation, material equipment breakdowns);
- reimbursement policies related to health care;
- the establishment and maintenance of strategic collaborative and
commercial relationships;
- the Company's dependence on a small number of key customers;
- the disclosure of confidential information by our collaborators,
employees or consultants;
- the preservation of healthy working relationships with the Company's
union and employees;
- the Company's ability to grow the business;
- the fluctuation of our financial results and exchange and interest
rate fluctuations;
- the adaptation to changing technologies;
- the loss of key personnel;
- the avoidance of product liability claims;
- the loss incurred if current lawsuits against us s
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