Teva Announces Agreement with Cephalon Regarding Settlement of Provigil® Patent Litigation

Parties Also Agree to Business Arrangements Related to Modafinil Jerusalem, Israel, December 9, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and Teva Pharmaceuticals USA, Inc. announced today that they have entered into an agreement with Cephalon, Inc. (Nasdaq: CEPH) to settle their pending patent infringement disputes in the United States and the United Kingdom related to PROVIGIL® (modafinil) Tablets [C-IV]. 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. Financial terms were not disclosed. The parties will promptly file dismissals with prejudice with the United States District Court for the District of New Jersey and United Kingdom High Court of Justice, Chancery Division, which will conclude all pending litigations between the parties regarding PROVIGIL. Cephalon's U.S. Patent No. RE37,516 expires in October 6, 2014 and may be extended by six months (to April 6, 2015) upon submission of pediatric study data that is acceptable to the U.S. Food and Drug Administration. Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients. Close to 90% of Teva's sales are in North America and Europe. Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause Teva's future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include whether and when the proposed acquisition of IVAX Corporation will be consummated and the terms of any conditions imposed in connection with such closing, the terms and conditions of the financing utilized by Teva for the IVAX acquisition, Teva's ability to rapidly integrate IVAX's operations and achieve expected synergies, Teva's ability to successfully develop and commercialize additional pharmaceutical products, the introduction of competitive generic products, the impact of competition from brand-name companies that sell or license their own generic products under generic trade dress and at generic prices (so called "authorized generics") or seek to delay the introduction of generic products, regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to a final court decision, including that relating to the generic versions of Neurontin® and Allegra®, the effects of competition on Copaxone® sales, the impact of pharmaceutical industry regulation and pending legislation that could affect the pharmaceutical industry, the difficulty of predicting U.S. Food and Drug Administration, European Medicines Association and other regulatory authority approvals, the regulatory environment and changes in the health policies and structure of various countries, Teva's ability to successfully identify, consummate and integrate acquisitions, exposure to product liability claims, dependence on patent and other protections for innovative products, significant operations outside the United States that may be adversely affected by terrorism or major hostilities, fluctuations in currency, exchange and interest rates, operating results and other factors that are discussed in Teva's Annual Report on Form 20-F and its other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and the Company undertakes no obligation to update publicly or revise any forward-looking statement, whether as a result of new information, future developments or otherwise. View All News Quick links Quarterly Results Events and Presentations Shareholder Meetings ESG Debt Securities SEC Filings Investor FAQ Email alerts To opt-in for investor email alerts, please enter your email address in the field below and select at least one alert option. After submitting your request, you will receive an activation email to the requested email address. You must click the activation link in order to complete your subscription. You can sign up for additional alert options at any time. At Teva Pharmaceutical Industries Ltd., we promise to treat your data with respect and will not share your information with any third party. You can unsubscribe to any of the investor alerts you are subscribed to by visiting the ‘unsubscribe’ section below. If you experience any issues with this process, please contact us for further assistance. By providing your email address below, you are providing consent to Teva Pharmaceutical Industries Ltd. to send you the requested Investor Email Alert updates. * Required Email Address * Mailing Lists * Press Releases Events SEC Filings Financial Reports Enter the code shown above. * Email Alert Sign Up Confirmation IR Inquiries IR Contacts Interactive Financial Reports At Teva, we strive to deliver quality medicines to patients around the world with integrity and ethical business practices. What we do is important, but how we do it is just as important. Learn more: Teva Code of Conduct Teva Code of Conduct Supplier Code of Conduct Supplier Code of Conduct Social Impact Positions and Policies Social Impact Positions and Policies All Corporate Governance & Policy Documents All Corporate Governance & Policy Documents Contact Us Terms of Use Data Privacy PhV privacy Notice Cookie Settings Teva api Social Media Guidelines Follow us Facebook Linkedin © - Teva Pharmaceutical Industries Ltd Powered By Q4 Inc. 5.184.0.5 (opens in new window)

The release as fetched from its publisher. tevapharm.com ↗