Free Redacted Document - District Court of Delaware - Delaware

Case 1:04-cv-00939-GMS

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE MERCK & CO., INC., Plaintiff, v. TEVA PHARMACEUTICALS USA, INC., Defendants. ) ) ) ) ) ) ) ) ) )

C.A. No. 04-939-GMS REDACTED VERSION

APPENDIX OF EXHIBITS TO REPLY BRIEF IN SUPPORT OF MOTION OF MERCK & CO., INC. TO REOPEN FACT AND EXPERT DISCOVERY AND OTHERWISE STAY THIS ACTION MORRIS, NICHOLS, ARSHT & TUNNELL LLP Mary B. Graham (# 2256) James W. Parrett, Jr. (#4292) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 302.658.9200 Attorneys for Plaintiff Merck & Co., Inc.

OF COUNSEL: John F. Lynch HOWREY, LLP 750 Bering Drive Houston, TX 77057-2198 713.787.1400 Nicolas G. Barzoukas Suzy S. Harbison Jason C. Abair WEIL, GOTSHAL & MANGES 700 Louisiana, Suite 1600 Houston, TX 77002 713.546.5000 Paul D. Matukaitis MERCK & CO., INC. One Merck Drive Whitehouse Station, NJ 08889-0100 908.423.1000 Edward W. Murray Gerard M. Devlin MERCK & CO., INC. 126 E. Lincoln Avenue RY28-320 Rahway, NJ 07065-0907 732.594.4000 Originally Filed: June 21, 2006 Redaction Filed: June 22, 2006

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TABLE OF EXHIBITS EXHIBIT W X Y United States Patent Application Publication US 2005/0026871 A1 Teva Press Release, August 12, 2005 Teva Documents (Stamped Highly Confidential)

525894

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EXHIBIT W

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EXHIBIT X

Teva News and PR

http://www.tevapharm.com/pr/2005/pr_540.asp

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Search

Press Release
Teva Announces Tentative Approval of Risedronate Sodium Tablets

Jerusalem, Israel, August 12, 2005 - Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that
the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Risedronate Sodium Tablets, 5 mg, 30 mg and 35 mg. Final approval is expected upon the resolution of pending patent litigation. Teva's Risedronate Sodium Tablets are the AB-rated generic equivalent of Procter and Gamble's Actonel® Tablets, a product indicated for treatment and prevention of postmenopausal and glucocorticoid-induced osteoporosis, and treatment of Paget's disease. The brand product has annual sales of approximately $942 million. 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 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 (so called "authorized generics") or successfully extend the exclusivity period of their branded products, the effects of competition on Copaxone® sales, including potential competition from the expected launch of Tysabri®/Antegren®, Teva's ability to rapidly integrate the operations of acquired businesses, including its acquisition of Sicor Inc., regulatory changes that may prevent Teva from exploiting exclusivity periods, potential liability for sales of generic products prior to completion of appellate litigation, including that relating to Neurontin, 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.

Company Contacts:
Dan Suesskind Chief Financial Officer Teva Pharmaceutical Industries Ltd. (011) 972-2-589-2840 George Barrett

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President and CEO Teva North America (215) 591-3030 Dorit Meltzer Director, Investor Relations Teva Pharmaceutical Industries Ltd. (011) 972-3-926-7554

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Legal Note | Site Map

Copyright © 1999 - 2006 Teva. All rights reserved

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EXHIBIT Y

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CONFIDENTIAL EXHIBIT

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CERTIFICATE OF SERVICE I hereby certify that on June 22, 2006, I caused the foregoing to be electronically filed with the Clerk of the Court using CM/ECF which will send electronic notification of such filing to the following: Josy Ingersoll, Esquire YOUNG CONAWAY STARGATT & TAYLOR, LLP The Brandywine Building 1000 West Street, 17th Floor Wilmington, DE 19801

Additionally, I hereby certify that true and correct copies of the foregoing were caused to be served on June 22, 2006 upon the following individuals in the manner indicated: BY E-MAIL AND HAND DELIVERY Josy Ingersoll, Esquire YOUNG CONAWAY STARGATT & TAYLOR, LLP The Brandywine Building 1000 West Street, 17th Floor Wilmington, DE 19801 BY E-MAIL James Galbraith, Esquire KENYON & KENYON One Broadway New York, NY 10004

/s/ James W. Parrett, Jr.
James W. Parrett, Jr. (#4292)