Free Redacted Document - District Court of Delaware - Delaware


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Case 1:08-cv-00021-GMS-LPS

Document 109

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE FOREST LABORATORIES, INC., et al., Plaintiffs, v. COBALT LABORATORIES INC., et al., Defendants. ) ) ) ) ) ) ) ) )

C.A. No. 08-021 (GMS) (LPS) CONSOLIDATED REDACTED VERSION

FOREST LABORATORIES, INC., et al., Plaintiffs, v. BARR LABORATORIES, INC., et al., Defendants.

) ) ) ) ) ) ) ) )

C.A. No. 08-022 (GMS) (LPS)

FOREST LABORATORIES, INC., et al., Plaintiffs, v. DR. REDDY'S LABORATORIES, INC., et al., Defendants.

) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) )

C.A. No. 08-052 (GMS) (LPS)

FOREST LABORATORIES, INC., et al., Plaintiffs, v. ORGENUS PHARMA INC., Defendant.

C.A. No. 08-291 (GMS) (LPS)

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FOREST LABORATORIES, INC., et al., Plaintiffs, v. APOTEX INC., et al., Defendants.

) ) ) ) ) ) ) ) ) )

C.A. No. 08-336 (GMS) (LPS)

APPENDIX (VOLUME II OF II) TO PLAINTIFFS' ANSWERING BRIEF IN OPPOSITION TO DEFENDANT ORCHID INDIA'S MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION AND OPENING BRIEF IN SUPPORT OF THEIR CONTINGENT CROSS-MOTION TO TRANSFER MORRIS, NICHOLS, ARSHT & TUNNELL LLP Jack B. Blumenfeld (#1014) Maryellen Noreika (#3208) 1201 North Market Street P.O. Box 1347 Wilmington, DE 19899-1347 (302) 658-9200 [email protected] [email protected] Attorneys for Plaintiffs

Of Counsel: John Desmarais Gerald J. Flattmann, Jr. Melanie R. Rupert KIRKLAND & ELLIS LLP Citigroup Center 153 East 53rd Street New York, NY 10022 (212) 446-4800 F. Dominic Cerrito Daniel L. Malone Eric C. Stops JONES DAY 222 East 41st Street New York, NY 10017 (212) 326-3939 Original Filing Date: June 27, 2008 Redacted Filing Date: July 3, 2008

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TABLE OF CONTENTS Description ANDA No. 90-044 Module 1 Excerpts from the Deposition of Dr. C. Bhaktavatsala Rao, Dated June 13, 2008 Orchid India 2006-2007 Annual Report Orchid Pharmaceuticals, Inc. Certificate of Incorporation Orchid India 2005-2006 Annual Report Orchid India 2004-2005 Annual Report ANDA 90-044 Telephone Amendment, Dated November 20, 2007 Development, Supply and Distribution Agreement between Stada Pharmaceuticals, Inc. and Orchid India Contract Manufacturing Agreement between Northstar Healthcare Ltd. and Orchid India Master Development, Manufacturing, Supply and Marketing Agreement Between Purepac Pharmaceutical Co. and Orchid India Development, Manufacturing, Supply and Commercialization Agreement Between Apotex Corp. and Orchid India Orchid Sales Summary (OCP00005431-33) First Amendment to the Master Development, Manufacturing, Supply and Marketing Agreement with Actavis Supply and Distribution Agreement between Karalex Pharma. LLC and Orchid India Supply and Distribution Agreement between Ranbaxy Pharmaceuticals Inc. and Orchid India Services Agreement Between Orchid India and Orgenus Top Pharmaceutical Company Signs World Safety Declaration, Dated January 18, 2008 Exhibit 1 2 3 4 5 6 7

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Description Safety Service Agreement between DuPont and Orchid India Chevron Phillips Chemical Company Certificate of Incorporation Rexam Closures and Containers Certificate of Incorporation Selig Holding Corporation Certificate of Incorporation AAIPharma Inc. Certificate of Incorporation Orchid Healthcare's ANDA No. 90-044 Module 2.3 ANDA 90-044 Telephone Amendment, Dated November 15, 2007 Orchid Healthcare's ANDA No. 90-044 Module 5 ANDA No. 90-044 Fasted Bioequivalence Study ANDA No. 90-044 Fed Bioequivalence Study Orchid India's Paragraph IV Notice for U.S. Pat. 5,061,703 Orchid Pharmaceuticals, Inc. 2006 Delaware Franchise Tax Report Orchid Pharmaceuticals, Inc. 2004 Delaware Franchise Tax Report Orchid Pharmaceuticals, Inc. 2005 Delaware Franchise Tax Report

Exhibit 18 19 20 21 22 23 24 25 26 27 28 29 30 31

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CERTIFICATE OF SERVICE I hereby certify that on July 3, 2008 I electronically filed the foregoing with the Clerk of the Court using CM/ECF, which will send notification of such filing to:. Mary B. Matterer, Esquire MORRIS JAMES LLP Frederick L. Cottrell, III, Esquire Anne Shea Gaza, Esquire Kelly E. Farnan, Esquire RICHARDS, LAYTON & FINGER, P.A. Richard L. Horwitz, Esquire David E. Moore, Esquire POTTER ANDERSON & CORROON LLP Richard D. Kirk, Esquire Ashley B. Stitzer, Esquire BAYARD, P.A. Joseph Grey, Esquire Thomas G. Whalen, Jr., Esquire STEVENS & LEE, P.C. John M. Seaman, Esquire Kevin G. Abrams, Esquire ABRAMS & LASTER LLP I further certify that I caused to be served copies of the foregoing document on July 3, 2008 upon the following in the manner indicated: Mary B. Matterer, Esquire MORRIS JAMES LLP 500 Delaware Avenue Suite 1500 Wilmington, DE 19801 Counsel for Cobalt Laboratories Inc. VIA ELECTRONIC MAIL

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William A. Rakoczy, Esquire Paul J. Molino, Esquire Deanne M. Mazzochi, Esquire Neil A. Benchell, Esquire John Polivick, Esquire RAKOCZY MOLINO MAZZOCHI SIWIK LLP 6 West Hubbard Street Suite 500 Chicago, IL 60610 Counsel for Cobalt Laboratories Inc. Kelly E. Farnan, Esquire RICHARDS, LAYTON & FINGER, P.A. One Rodney Square 920 North King Street Wilmington, DE 19801 Counsel for Wockhardt USA Inc. and Wockhardt Limited Michael Dzwonczyk, Esquire Mark Boland, Esquire Chid Iyer, Esquire SUGHRUE MION, PLLC 2100 Pennsylvania Avenue, N.W. Washington, DC 23307 Counsel for Wockhardt USA Inc. and Wockhardt Limited Frederick L. Cottrell, III, Esquire Anne Shea Gaza, Esquire RICHARDS, LAYTON & FINGER, P.A. One Rodney Square 920 North King Street Wilmington, DE 19801 Counsel for Upsher-Smith Laboratories Inc. David E. Marder, Esquire Jake M. Holdreith, Esquire Yixin H. Tang, Esquire ROBINS, KAPLAN, MILLER & CIRESI L.L.P. Prudential Tower, 25th Floor 800 Boylston Street Boston, MA 02199 Counsel for Upsher-Smith Laboratories Inc.

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Richard L. Horwitz, Esquire David E. Moore, Esquire POTTER ANDERSON & CORROON LLP 1313 North Market Street ­ 6th Floor Wilmington, DE 19801 Counsel for Orchid Pharmaceuticals Inc., Orchid Chemicals & Pharmaceuticals Ltd (d/b/a Orchid Healthcare), PLIVA d.d., PLIVA-Hrvatska d.o.o., Barr Laboratories, Inc., Barr Pharmaceuticals, Inc., Interpharm Holdings, Inc., Interpharm, Inc., Dr. Reddy's Laboratories, Inc., Dr. Reddy's Laboratories Limited, Orgenus Pharma Inc., Genpharm Inc., Genpharm, L.P., Mylan Pharmaceuticals Inc., Apotex Inc. and Apotex Corp Kenneth G. Schuler, Esquire LATHAM & WATKINS LLP Sears Tower ­ Suite 5800 233 South Wacker Drive Chicago, IL 60606 Counsel for Orchid Pharmaceuticals Inc., Orchid Chemicals & Pharmaceuticals Ltd (d/b/a Orchid Healthcare) and Orgenus Pharma Inc. Terrence J. Connolly, Esquire LATHAM & WATKINS LLP 885 Third Avenue ­ Suite 1000 New York, NY 10022-4834 Counsel for Orchid Pharmaceuticals Inc., Orchid Chemicals & Pharmaceuticals Ltd (d/b/a Orchid Healthcare) and Orgenus Pharma Inc. Darryl H. Steensma, Esquire LATHAM & WATKINS LLP 12636 High Bluff Drive ­ Suite 300 San Diego, CA 92130 Counsel for Orchid Pharmaceuticals Inc., Orchid Chemicals & Pharmaceuticals Ltd (d/b/a Orchid Healthcare) and Orgenus Pharma Inc.

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Richard D. Kirk, Esquire Ashley B. Stitzer, Esquire BAYARD, P.A. 222 Delaware Avenue Suite 900 Wilmington, DE 19801 Counsel for Lupin Pharmaceuticals USA, Inc. and Lupin, Ltd. Douglass C. Hochstetler, Esquire D. Christopher Ohly, Esquire Sailesh K. Patel, Esquire SCHIFF HARDIN LLP 6600 Sears Tower Chicago, IL 60606 Counsel for Lupin Pharmaceuticals USA, Inc. and Lupin, Ltd. Joseph Grey, Esquire Thomas G. Whalen, Jr., Esquire STEVENS & LEE, P.C. 1105 North Market Street 7th Floor Wilmington, DE 19801 Counsel for Teva Pharmaceuticals USA, Inc. Steven J. Lee, Esquire Sheila Mortazavi, Esquire KENYON & KENYON LLP One Broadway New York, NY 10004 Counsel for Teva Pharmaceuticals USA, Inc. Thomas J. Meloro, Esquire Eugene L. Chang, Esquire Coleman B. Ragan, Esquire WILLKIE FARR & GALLAGHER LLP 787 Seventh Avenue New York, NY 10019-6099 Counsel for PLIVA d.d., PLIVA-Hrvatska d.o.o., Barr Laboratories, Inc. and Barr Pharmaceuticals, Inc.

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Louis H. Weinstein, Esquire Bruce D. Radin, Esquire BUDD LARNER, P.C. 150 John F. Kennedy Parkway Short Hills, NJ 07078-2703 Attorney for Interpharm Holdings, Inc., Interpharm, Inc., Dr. Reddy's Laboratories, Inc. and Dr. Reddy's Laboratories Limited John M. Seaman, Esquire Kevin G. Abrams, Esquire ABRAMS & LASTER LLP 20 Montchanin Road, Suite 200 Wilmington, DE 19807 Attorneys for Sun India Pharmaceutical Industries Limited (a/k/a Sun Pharmaceutical Industries Limited) James F. Hurst, Esquire Charles B. Klein, Esquire Jay L. Levine, Esquire WINSTON & STRAWN LLP 35 West Wacker Drive Chicago, IL 60601 Attorneys for Sun India Pharmaceutical Industries Limited (a/k/a Sun Pharmaceutical Industries Limited) Ron E. Shulman, Esquire Terry Kearney, Esquire Roger J. Chin, Esquire WILSON SONSINI GOODRICH & ROSATI 650 Page Mill Road Palo Alto, CA 94304 Attorneys Genpharm Inc., Genpharm, L.P. and Mylan Pharmaceuticals Inc.

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Robert B. Breisblatt, Esquire Stephen P. Benson, Esquire Craig M. Kuchii, Esquire Brain J. Sodikoff, Esquire Jeremy C. Daniel, Esquire Joanna R. Stevason KATTEN MUCHIN ROSENMAN LLP 525 W. Monroe Street Chicago, IL 60661 Attorneys for Apotex Inc. and Apotex Corp

VIA ELECTRONIC MAIL

/s/ Jack B. Blumenfeld
Jack B. Blumenfeld (#1014)

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EXHIBIT 23
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EXHIBIT 24
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EXHIBIT 25
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EXHIBIT 26
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EXHIBIT 27
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EXHIBIT 29

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EXHIBIT 30

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EXHIBIT 31

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Document 109-3

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