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K-V Pharmaceutical Comments on ACOG and SMFM Information Update Regarding Hydroxyprogesterone Caproate - FDA-Approved Makena™ and Compounded 17P
Date:10/13/2011

ary, in order to resolve the risk of potential exclusion of our Company, as more fully described in Note 1—"Description of Business—Changes in Management" in the Notes to the Consolidated Financial Statements included in Part I of this Report;
  • 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 Note 1—"Description of Business—Plea Agreement with the U.S. Department of Justice" in the Notes to the Consolidated Financial Statements included in Part I of this Report;
  • 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™ and Evamist ® , manufactured for the Company under contract manufacturing agreements with third parties;
  • the regulatory environment, including legislative, government or regulatory agency and judicial actions and changes in applicable laws or regulations, including the risk of obtaining necessary state licenses in a timely manner;
  • fluctuations in revenues;
  • the difficulty of predicting the pattern of inventory movements by the Company's customers;
  • risks that the Company may not ultimately prevail in litigation, including product liability lawsuits and challenges to its intellectual property rights by actual or potential competitors or to its 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—"Commitments and Contingencies" of the Notes to the Consolidated Financ
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