Date:8/7/2009

d judicial actions and changes in applicable law or regulations; (11) fluctuations in revenues; (12) the difficulty of predicting international regulatory approvals, including timing; (13) the difficulty of predicting the pattern of inventory movements by the Company's customers; (14) the impact of competitive response to the Company's sales, marketing and strategic efforts, including the introduction or potential introduction of generic or competing products against products sold by the Company and its subsidiaries; (15) risks that the Company may not ultimately prevail in litigation, including challenges to the Company's intellectual property rights by actual or potential competitors or to the Company's ability to market generic products due to brand company patents and challenges to other companies' introduction or potential introduction of generic or competing products by third parties against products sold by the Company or its subsidiaries, including without limitation the litigation and claims referred to in Note 16 of the Notes to the Consolidated Financial Statements in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2008 and under the heading "Certain Other Matters" in the Company's Form 8-K filed with the SEC on April 30, 2009; (16) the possibility that the Company's current estimates of the financial effect of certain announced product recalls could prove to be incorrect; (17) whether any product recalls or product introductions result in litigation, agency action or material damages; (18) the possibility that the findings of the Audit Committee inquiry referenced in the Company's Form 10-Q for the quarter ended June 30, 2008, Form 12b-25 filed with the SEC on November 13, 2008, Form 12b-25 filed with the SEC on February 2, 2009, Form 12b-25 filed with the SEC on June 6, 2009, as well as certain other of the Company's SEC filings, could have a material impact on the Company's financial results; (19) the satisfaction or waiver o
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