Date:3/1/2011

n ("FDA") and the Company's suspension of the production and shipment of all of the products that it manufactures (other than the Potassium Chloride ER Capsule products that are the subject of the FDA letter received September 8, 2010 allowing the return of those products to the marketplace) and the related nationwide recall affecting all of the other products that it manufactures, as well as the related material adverse effect on its revenue, assets and liquidity and capital resources, as more fully described in Item 1-"Business-(b) Significant Recent Developments-Discontinuation of Manufacturing and Distribution; Product Recalls; and the FDA Consent Decree" in the Form 10-K;

the two agreements between the Company and the Office of Inspector General of the U.S. Department of Health and Human Services ("HHS OIG") pertaining to the exclusion of our former chief executive officer from participation in federal healthcare programs and pertaining to the dissolution of our ETHEX subsidiary, in order to resolve the risk of potential exclusion of our company, as more fully described in Note 15-"Commitments and Contingencies-Litigation and Governmental Inquiries" of the Notes to the Consolidated Financial Statements included in the Form 10-K;

the plea agreement between the Company and the U.S. Department of Justice and the Company's obligations therewith, as well as the related material adverse effect, if any, on its revenue, assets and liquidity and capital resources, as more fully described in Item 1-"Business-(b) Significant Recent Developments-Plea Agreement with the U.S. Department of Justice" in the Form 10-K;

changes in the current and future business environment, including interest rates and capital and consumer spending;

the availability of raw materials and/or products, including Makena™, manufactured for the Company under contract manufacturing agreements with third parties;

the regulatory environment, including regula
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