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Published on 12/9/2005 in the Prospect News Biotech Daily.

Cephalon settles patent infringement suit with Teva

By Ted A. Knutson

Washington, Dec. 9 - Cephalon, Inc. announced Friday it has entered into an agreement with Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA, Inc. to settle its pending patent infringement disputes in the United States and the United Kingdom related to Provigil (modafinil) tablets [C-IV]. Financial terms were not disclosed.

In connection with the settlement, Cephalon will grant Teva a non-exclusive royalty-bearing right to market and sell a generic version of Provigil. Teva's license in the United States will become effective in October 2011 absent a pediatric extension for Provigil, which would delay the entry date by six months to April 2012.

Outside the United States, the parties agreed to comparable terms for the license effective date, which generally allow for entry in October 2012. An earlier entry by Teva in any of the territories may occur based upon the entry of another generic version of Provigil.

The companies also agreed to a series of business arrangements related to modafinil. Specifically, Teva has agreed to grant to Cephalon a non-exclusive license, effective immediately, to its worldwide intellectual property rights related to the manufacture, development and formulation of modafinil in exchange for royalty payments. Cephalon has also agreed to enter into certain arrangements with Teva related to Teva's manufacture and supply of the active pharmaceutical ingredient modafinil.

The terms of the agreement are confidential and are subject to review by the U.S. Federal Trade Commission.

Cephalon is a Fraser, Pa.-based biotechnology company.

Teva is a Jerusalem, Israel-based pharmaceutical company.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.


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