Such factors include (but are not limited to) the following: (1)
changes in the current and future business environment, including interest
rates and capital and consumer spending; (2) the difficulty of predicting
FDA approvals, including timing, and that any period of exclusivity may not
be realized; (3) acceptance and demand for new pharmaceutical products; (4)
the impact of competitive products and pricing, including as a result of
so-called authorized-generic drugs; (5) new product development and launch,
including the possibility that any product launch may be delayed or that
product acceptance may be less than anticipated; (6) reliance on key
strategic alliances; (7) the availability of raw materials and/or products
manufactured for the Company under contract manufacturing arrangements with
third parties; (8) the regulatory environment, including regulatory agency
and judicial actions and changes in applicable law or regulations; (9)
fluctuations in revenues; (10) the difficulty of predicting international
regulatory approval, including timing; (11) the difficulty of predicting
the pattern of inventory movements by the Company's customers; (12) the
impact of competitive response to the Company's sales, marketing and
strategic efforts; (13) risks that the Company may not ultimately prevail
in litigation, including challenges to our patents; (14) actions by the
Securities and Exchange Commission and the Internal Revenue Service with
respect to the Company's stock option grants and accounting practices; (15)
actions by the NYSE Regulation, Inc. with re
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