These risks and uncertainties include: the risk that additional lots of Daytrana(R) may be recalled by Shire due to product failing to meet the release liner specification or otherwise; the risk that Noven may not be successful in identifying or implementing a solution to resolve the release liner issue; uncertainties related to the financial impact of the recall; the risk that Noven's response to the FDA's January 2008 warning letter, which remains under FDA review, may not be acceptable to the FDA or adequately address the FDA's concerns, and in such case, the risk that the FDA may take regulatory action against Noven, which may include fines, product seizures or recalls, injunctions, suspension of production and/or the withdrawal of product approval; and the risk that any adverse effect to the market for Daytrana(R) due to the foregoing or other factors could adversely affect Noven's reputation, results of operations and/or its financial position.