Free Proposed Pretrial Order - District Court of Delaware - Delaware


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Case 1:06-cv-00033-SLR

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EXHIBIT 6

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IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE TAKEDA PHARMACEUTICAL COMPANY LTD. AND TAP PHARMACEUTICAL PRODUCTS INC. V. TEVA PHARMACEUTICALS USA, INC. AND TEVA PHARMACEUTICAL INDUSTRIES LTD. CIVIL ACTION NO. 1:06-CV-0033-SLR

____________________________________________________________________________________________________________ TEVA PHARMACEUTICALS USA, INC. AND TEVA PHARMACEUTICAL INDUSTRIES LTD.

TRIAL EXHIBIT LIST
DEF EX. NO. DTX1 DTX2 DTX3 DTX4 DTX5 DTX6 DTX7 DTX8 DTX9 DTX10 DTX11 DTX12 DTX13 DTX14 DTX15 DTX16 DTX17 DTX18 DTX19 DTX20 OFFERED ADMT WITNESS EX. DESCRIPTION U.S. Patent 4,628,098 U.S. Patent 4,628,098 File History U.S. Patent 5,045,321 U.S. Patent 5,045,321 File History U.S. Patent 4,255,431 U.S. Patent 4,255,431 File History U.S. Patent 4,472,409 U.S. Patent 4,472,409 File History U.S. Patent 4,555,518 U.S. Patent 4,555,518 File History U.S. Patent 4,045,563 U.S. Patent 4,045,564 Publication Entitled "Pump Blockers & Ulcer Disease," New England Journal of Medicine, by Sachs NDA No. 20-406 ­ CD ANDA #77-255 ­ CD U.S. Patent 4,686,230 U.S. Patent 4,686,230 File History Japanese Patent Application No. 19715/85 U.S. Patent 4,666,919 U.S. Patent 5,026,560 DATE 12/09/86 12/09/86 09/03/91 02/15/87 03/10/81 04/05/79 09/18/84 06/21/84 11/26/85 05/01/84 08/30/77 08/30/77 03/22/84 00/00/00 00/00/00 08/11/87 03/00/89 01/31/85 05/19/87 06/25/91 BATES NO. TVL 010937-10943 TVL 010937-10943 TVL 010962-010972 TAKEDA 739426-739858 TVL 011020-11029 TAKEDA 389629-389829 TVL 011030-11039 TVL 069908-70042 TVL 059822-59837 TVL 070043-70192 TVL 010912-10925 TVL 064006-64012 TVL 063219-63221 TAP 000664-194332 TVL 000001-7850 TVL 011082-11106 TVL 070193-70335 TAKEDA 681581-681598 TVL 011076-11081 TVL 010956-10961

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DEF EX. NO. DTX21 DTX22 DTX23 DTX24 DTX25 DTX26 DTX27 DTX28 DTX29 DTX30 DTX31 DTX32 DTX33

OFFERED

ADMT

WITNESS

EX. DESCRIPTION U.S. Patent 5,026,560 File History U.S. Patent 5,093,132 U.S. Patent 5,093,132 File History U.S. Patent 5,433,959 U.S. Patent 5,433,959 File History First Expert Report of W. Chambliss Data & Information Considered in Support of First Chambliss Report Second Expert Report of W. Chambliss Rebuttal Expert Report of W. Chambliss Curriculum Vitae of W. Chambliss Data & Information Considered in Support of Second Chambliss Report Chart: Particle Size Conversion Publication Entitled "Omeprazole, A Study of Its Inhibition of Gastric pH & Oral Pharmacokinetics after Morning or Evening Dosage," by Prichard, et al. Publication Entitled "Kinetic Analysis of Penicillin Degradation of Acidic Media," Journal of Pharmaceutical Sciences by Blaha, et al. Publication Entitled "Digoxin Degradation in Acidic Dissolution Medium," by Sonobe Publication Entitled "The Forgotten Dosage Form: EntericCoated Tablets," Pharmaceutical Technology, by Chambliss Publication Entitled "Evidence for Acid-induced Transformation of Omeprazole into an Active Inhibitor by (H+ + K+)-ATPase Within the Parietal Cell," by Wallmark, et al. Publication Entitled "Hydrogen Peroxide Solution (3 per cent)," British Pharmecopeia Composite with Amidon Expert Report & CV, Westlaw Document - Tabeta, et al., Publication Entitled "Chemical Stability of Pharmaceuticals," by Connors, et al., & Handbook of Pharmaceutical Excipients from Chambliss U.S. Patent Application No. 07/014,303 ­ Declaration Under Rule 132

DATE 01/14/88 03/03/92 08/31/90 07/18/95 07/18/95 06/26/07 06/26/07 08/08/07 08/13/07 00/00/00 08/08/07 08/08/07 00/00/85

BATES NO. TVL 008854-9046 TVL 010973-10986 TVL 009449-9587 TVL 010987- 11002 TVL 009588-9787 CHAMBLISS 06/26/07 REP. EX. B CHAMBLISS DEP. EX. 7 CHAMBLISS 08/08/07 REP. EX. B CHAMBLISS DEP. EX. 11 TVL 065992-65997

DTX34 DTX35 DTX36 DTX37 DTX38

08/00/76 04/04/80 09/00/83 08/15/84 12/01/98

TVL 065978-65984 TVL 063845-63848 TVL 065972-65977 TVL 063980-63989 CHAMBLISS DEP. EX. 28 CHAMBLISS DEP. EX. 29 TAKEDA 739677-739680

DTX39

00/00/00

DTX40

02/13/87

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DEF EX. NO. DTX41 DTX42 DTX43 DTX44 DTX45 DTX45.1 DTX46 DTX 46.1 DTX47 DTX48 DTX49

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "The Theory & Practice of Industrial Pharmacy,"3rd Edition by Lachman, Lieberman, & Kanig Publication Entitled "Development of an Oral Formulation of Omeprazole," Gastroenterology, by Pilbrant & Cederberg ANDA #77-255 ­ Section VII ­ Components & Composition Statements Publication Entitled "The U.S. Pharmacopoeia, 21st Revision, The National Formulary" 16th Edition Publication Entitled "Remington's Pharmaceutical Science: Powders," 15th Edition Publication Entitled "Remington's Pharmaceutical Science: Stability of Pharmaceutical Products," 15th Edition Publication Entitled "Pharmaceutical Pelletization Technology," edited by Ghebre-Sellassie Publication Entitled "Pellets: A General Overview," edited by Ghebre-Sellassie Data & Information Considered by W. Chambliss Prior Deposition or Trial Testimony in Last Five Years of Chambliss Publication Entitled "The Theory & Practice of Industrial Pharmacy: Kinetic Principles & Stability Testing," 2nd Edition, by Lachman, Lieberman, & Kanig Publication Entitled "The Theory & Practice of Industrial Pharmac: Mixing," 2nd Edition, by Lachman, Lieberman, & Kanig Publication Entitled "Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists" by Connors, Amidon & Kennon Excerpt from `321 Patent File History ­ Amendment Publication Entitled "Handbook of Pharmaceutical Excipients," 5th Edition, by Rowe, et al. U.S. Patent 2,991,226 Publication Entitled "Modern Pharmaceutics," 3rd Edition, by Banker & Rhodes Publication Entitled "The United States. Pharmacopoeia, 21st Revision"

DATE 00/00/86 00/00/00 07/00/04 01/01/85 00/00/75 00/00/75 00/00/89 00/00/89 00/00/00 00/00/00 00/00/78

BATES NO. TVL 069283-69285 TVL 059548-59557 TVL 006613-6822 TVL 059558-59564 TVL 063869-63871 TVL 063886-63888 TVL 063839-63841 TVL 069308-69310 CHAMBLISS REBUTTAL RPT. EX. A CHAMBLISS EXPERT RPT. EX. C TVL 065988-65991

DTX49.1 DTX50 DTX51 DTX52 DTX53 DTX54 DTX55

00/00/78 00/00/79 03/10/81 00/00/00 07/04/61 00/00/96 01/01/85

TVL 069297-69300 TVL 063880-63885 TAKEDA 739684 TVL 069301-69307 TVL 069286-69291 TVL 069292-69296 TVL 059558-59564

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DEF EX. NO. DTX56 DTX57 DTX58 DTX59 DTX60 DTX61 DTX62

OFFERED

ADMT

WITNESS

EX. DESCRIPTION ANDA #77-255 - Section XI.2 ­ Manufacturing & Processing Instructions Commercial Batch Records Expert Report of A. Hirt Curriculum Vitae of A. Hirt Data & Documentation in Support of Hirt Report, with Referenced CD Prior Deposition or Trial Testimony in Last Five Years of A. Hirt E-mail from L. Fritts to D. Kim & J. Blake Letter from D. Cole to A. Hirt Publication Entitled "Report MRL3862: Analytical Study of Lansoprazole Granules using Diamond Knife Microtomy, Timeof Flight Secondary Ion Mass Spectroscopy, Laser Raman Spectroscopy, Scanning Electron Microscopy & EnergyDispersive X-ray Spectroscopy" Raman Spectroscopy: Sample Analysis Form Expert Report of G. Meyer Curriculum Vitae of G. Meyer Data & Information Considered by G. Meyer Prior Deposition or Trial Testimony in Last Five Years of Meyer Publication Entitled "Validation of Analytical Procedures: Text & Methodology Q2(R1)" Publication Entitled "Infrared & Raman Characteristic Group Frequencies," by Socrates Expert Report of G. Lenz Second Expert Report of G. Lenz Curriculum Vitae of G. Lenz List of Articles Reviewed or Relied upon by G. Lenz Publication Entitled "Dissociation Constants of Organic Bases in Aqueous Solution," by Perrin

DATE 07/15/04 08/06/07 00/00/00 00/00/00 00/00/00 08/27/07 07/12/07

BATES NO. TVL 006849-6907 KITAO DEP. EX. 1 HIRT EXPERT RPT. EX. B HIRT EXPERT RPT. EX. C HIRT EXPERT RPT. EX. D HIRT DEP. EX. 3 HIRT 0071-74

DTX63

08/06/07

HIRT 0001-47

DTX64 DTX65 DTX66 DTX67 DTX68 DTX69 DTX70 DTX71 DTX72 DTX73 DTX74 DTX75

00/00/00 08/08/07 00/00/00 00/00/00 00/00/00 11/00/05 00/00/01 06/27/07 08/13/07 00/00/00 00/00/00 00/00/65

HIRT 0048-70 MEYER DEP. EX. 1 MEYER EXPERT RPT. EX. B MEYER EXPERT RPT. EX. C MEYER EXPERT RPT. EX. D MEYER EXPERT RPT. EX. E MEYER EXPERT RPT. EX. F LENZ DEP. EX. 4 LENZ DEP. EX. 17 LENZ 1ST EXPERT RPT. EX. A LENZ 1ST EXPERT RPT. EX. B TVL 065643-65712

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DEF EX. NO. DTX76

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Histamine & 5-Hydroxytryptamine (Serotonin) & Their Antagonists," The Pharmacological Basis of Therapeutics, 6th Edition, by Douglas Publication Entitled "Structure & Basicity. Part III: The Basicity of Homogeneously Substituted Cyclotriphospazatrienes & Cyclotetraphosphazatetraenes," by Feakins, et al. Publication Entitled "Substituted Benzimidazoles Inhibit Gastric Acid Secretion by Blocking (H++K+) ATPase," Nature, by Fellenius, et al. Publication Entitled "Atropine, Scopolamine, & Related Antimuscarinic Drugs," The Pharmacological Basis of Therapeutics, 6th Edition, by Weiner Publication Entitled "Steric Effects in Displacement Reactions III: The Base Strengths of Pyridine, 2,6-Lutidine & the Monoalkylpyridines" Publication Entitled "Thermodynamics of Protonation of Substituted Pyridines in Aqueous Solutions" Publication Entitled "Synthesis of 2-[(4-Fluoroalkoxy-2pyridyl)methyl]sulfinyl]-1H-benzimidaxoles as Antiulcer Agents," by Kubo, Oda, Kaneko, Satoh, & Nohara Certified Translation of Central Research Division Monthly Report, June 1984 Publication Entitled "Structure & Reactivity in the Pyridine Series. Part I: Acid Dissociation Constants of Pyridinium Ions," by Hoshini Publication Entitled "Gastric Antacids & Digestants," by Harvey Certified Translation of Central Research Division Monthly Report, July 1984 Publication Entitled "Consultant Comment," New Ethicals, by Scobia Publication Entitled "Effects of a Proton Pump Inhibitor, Omeprazole, on Gastric Secretion & Gastric & Duodenal Ulcers or Erosions in Rats" Glaxo Wellcome: Knowledge Acquisition & Learning Publication Entitled "The Pharmacology of Antiulcer Drugs"

DATE 00/00/80

BATES NO. TVL 063935-63943

DTX77

03/00/65

TVL 059746-59755

DTX78

03/12/81

TAKEDA 362159-362161

DTX79

00/00/80

TVL 063915-63934

DTX80 DTX81 DTX82 DTX83 DTX84 DTX85 DTX86 DTX87 DTX88 DTX89 DTX90

04/05/55 00/00/00 10/00/90 06/01/84 00/00/64 00/00/80 07/01/84 02/00/91 01/94 00/00/05 10/00/89

TVL 063303-63306 TVL 063307-63311 TAKEDA 015682-15687 TAKEDA 040929-935 TVL 065625-65630 TVL 063899-63914 TAKEDA 040936-942 TAKEDA 683409-683412 TVL 069356-69364 TVL 069353-69355 TVL 069365-69373

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DEF EX. NO. DTX91 DTX92 DTX93 DTX94 DTX95 DTX96 DTX97 DTX98 DTX99 DTX100 DTX101 DTX102 DTX103 DTX104 DTX105 DTX106

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Data & Information Considered of Lenz Affidavit of Direct Testimony of Professor Hopfinger ­ Eisai v. Teva, Case No. 03-CV-9053 Publication Entitled "Medicinal Chemical Properties of Successful Central Nervous System Drugs," by Pajouhesh & Lenz ChemSpider Beta Data: Search Results for Pantoprazole ChemSpider Beta Data: Search Results for Pantoprazole ChemSpider Beta Data: Search Results for Rabeprazole ChemSpider Beta Data: Search Results for Omeprazole Publication Entitled "Patent & Trademark Copyright Laws Editied," June 2007 Edition, by Samuels U.S. Patent 4,500,708 Publication Entitled "Omeprazole: The First Proton Pump Inhibitor," by Lindberg Publication Entitled "A Survey of Hammett Substituent Constants & Resonance & Field Parameters," by Hansch Expert Report of E. Dajani Curriculum Vitae of E. Dajani References & Documents Reviewed & Relied upon by E. Dajani Prior Deposition or Trial Testimony in Last Five Years Publication Entitled "1',1' -Dimethylheptyl-8tetrahydrocannabinol-11-oic Acid: A Novel, Orally Effective Cannabinoid with Analgesic & Anti-inflammatory Properties," Publication Entitled "Ulcer Disease: Investigation & Basis for Therapy ­ Chapter 22: Pharmaceutical Industry Perspectives on Human Investigation & Development of Anti-Ulcer Drugs," by Swabb & Szabo Publication Entitled Textbook of Organic Medicinal & Pharmaceutical Chemistry," by Wilson & Gisvold Publication Entitled Textbook of Organic Medicinal & Pharmaceutical Chemistry," 3rd Edition, Wilson & Gisvold

DATE 00/00/00 02/28/07 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 06/00/07 02/19/85 00/00/90 12/07/90 06/27/07 00/00/00 00/00/00 00/00/00 03/02/99

BATES NO. LENZ 2ND EXPERT RPT. EX. A DAJANI DEP. EX. 3 LENZ DEP. EX. 11 LENZ DEP. EX. 12 LENZ DEP. EX. 13 LENZ DEP. EX. 14 LENZ DEP. EX. 15 LENZ DEP. EX. 18 LENZ DEP. EX. 2 TAKEDA 360478-360531 TVL 063319-63349 DAJANI DEP. EX. 20 DAJANI DEP. EX. 1 DAJANI DEP. EX. 22 DAJANI EXPERT RPT. EX. C DAJANI DEP. EX. 10

DTX107

00/00/91

DAJANI DEP. EX. 2

DTX108 DTX109

00/00/00 00/00/00

TVL 069797-69828 TVL 069797-69828

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DEF EX. NO. DTX110 DTX111 DTX112 DTX113 DTX114 DTX115 DTX116 DTX117 DTX118 DTX119 DTX120 DTX121 DTX122 DTX123 DTX124 DTX125 DTX126 DTX 126.1 DTX127 DTX128

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Drugs for Treatment of Peptic Ulcers," Journal of the Assoc. for Academic Minority Physicians, by Dajani & Trotman Evaluation of Test Agent Inhibitors Against Indomethacin Induced Gastric Mucosal Irritation: Rats ­ Table 1 & 2 Transcript of H. Jacoby Deposition First Declaration of G. Fuller ­ Eisai v. Teva, Case No. 03-CV9053 European Patent Application No. 0 174 726 U.S. Patent 3,950,537 U.S. Patent 5,679,375 Publication Entitled Synergistic Actions of Propantheline Bromide with Cimetidine and Thiopropazate Hydrochloride in the Prevention of Stress Ulcer Formation in Rats," by Dajani, Bianchi & Calhoun U.S. Patent Application Publication No. US 2005/0020638 A1 European Patent EP-B-174,726 Appeal Brief Central Research Division AG-1749 (H++K+) ­ ATPase Inhibitor ­ Sept. 1986 PSL - O-5361 (Compound D) & Safety Data Sheet Pre-Clinical & Clinical References Comparing Lansoprazole & Omeprazole PSL - Comparison of Properties of Fluorinated & Nonfluorinated Drugs Sigma-Aldrich: I8280 Indomethacin Meets USP Testing Specifications Curricula Vitae of G. Dong, Jacoby & Boulet Publication Entitled Fluorinated Compounds of Medicinal Interest" by Filler Publication Entitled Fluorinated Compounds of Medicinal Interest" by Filler Certified Translation of Central Research Division Monthly Report September 1984 Expert Report of M. Solny

DATE 07/00/92 12/11/06 08/14/07 03/01/07 07/31/85 04/13/76 10/21/97 05/07/79 01/27/05 12/00/93 09/00/86 11/29/06 00/00/00 00/00/00 00/00/00 00/00/00 01/00/74

BATES NO. DAJANI DEP. EX. 25 PSL 0462-465 DAJANI DEP. EX. 27 DAJANI DEP. EX. 4 DAJANI DEP. EX. 5 DAJANI DEP. EX. 7 DAJANI DEP. EX. 8 DAJANI DEP. EX. 9 DAJANI DEP. EX. 19 TAKEDA 358545 TAKEDA 571236-571279 DAJANI EXPERT RPT., EX. M TAKEDA 642702-441658 PSL 0001-36 TVL 066065-66066 DAJANI EXPERT RPT. EX. L TVL 066324-66690 TVL 065998-66004

09/01/84 06/26/07

TAKEDA 040951-957 SOLNY DEP. EX. 3

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DEF EX. NO. DTX129 DTX130 DTX131 DTX132 DTX133 DTX134

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Curriculum Vitae of M. Solny Data & Information Considered by M. Solny List of Court Testimony of M. Solny Publication Entitled "Lansoprazole vs. Omeprazole in Shortterm Treatment of Reflux Oesophagitis," Scandinavian Journal of Gastroenterology Publication Entitled "Efficacy & Safety of Lansoprazole in the Treatment of Erosive Reflux Esophagitis," by Castell, et al. Publication Entitled "Low-Dose lansoprazole provides Greater relief of heartburn & Epigastric pain than low-dose Omeprazole in patients with Acid-related dyspepsia," by Jones, et al. Publication Entitled "Rapid Symptom Relief in Reflux Oesophagitis: A Comparison of Lansoprazole & Omeprazole," by Mee, et al. Publication Entitled "Best Buy Drugs, Proton Pump Inhibitors," Consumer Reports Publication Entitled "Gastroesophageal Reflux Disease," by Richter Publication Entitled "Lansoprazole vs. Omeprazole: Influence on Meal-Stimulated Gastric Acid Secretion," by Dammann, et al. Prilosec Product Description Sheet Prevacid Product Description Sheet Drug Class Review on Proton Pumo Inhibitors ­ Final Report Publication Entitled "Lessons Learned from Intragastric pH Monitoring " Publication Entitled "Drugs to Treat Heartburn, Ulcers, & Stomach Acid Reflux: The Proton Pump Inhibitors" Publication Entitled "Lansoprazole Provided More & Faster Relief for Heartburn than did Omeprazole in Erosive Esophagitis" Publication Entitled "Management of Gastroesophageal Reflux Disease"

DATE 09/27/05 00/00/00 00/00/00 09/28/92 05/13/96 10/24/98

BATES NO. SOLNY EXPERT RPT. EX. A SOLNY DEP. EX. 2 SOLNY DEP. EX. 1 SOLNY DE P. EX. 10 FENNERTY 0306-314 FENNERTY 0357-363

DTX135 DTX136 DTX137 DTX138 DTX139 DTX140 DTX141 DTX142 DTX143 DTX144 DTX145

05/28/96 01/00/07 00/00/07 12/18/96 00/00/00 00/00/00 07/00/06 00/00/01 00/00/00 06/00/02 11/00/03

FENNERTY 0412-418 TVL 64522-64535 SOLNY DEP. EX. 16 FENNERTY 0315-320 SOLNY DEP. EX. 7 SOLNY DEP. EX. 8 TVL 063419-63514 TVL 063402-63408 TVL 063992-64005 TVL 064522-64535 TVL 063990-63391 TVL 063409-63418

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DEF EX. NO. DTX146

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Treating Reflux Esophagitis: Symptom Relief in Patients with Reflux Esophagitis: Comparative Study of Omeprazole, Lansoprazole, & Rabeprazole," by Adachi, et al. Publication Entitled "Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, & Stress-Related Erosive Syndrome," by Wolfe & Sachs Expert Report of W. Vandaele Curriculum Vitae of W. Vandaele Data & Information Considered of W. Vandaele Chart: Leading 20 Products by U.S. Sales, MAT 11/01 ­ 11/06 Chart: TRx Trends by Specialty for Total Prevacid TOP 10 U.S. Products by Sale / Chart: PPI Market TRx Volume / Chart: PPI Market NRx Volume / PPI Market Sales Dollars Publication Entitled "Do Pharmaceutical Sales Respond to Scientific Evidence," Journal of Economics & Management Strategy, by Azoulay 98 Stat. 1585, Public Law Section 98-417 ­ Drug Price Competition & Patent Term Restoration Act of 1984 Brochure: Pharmaceutical Overview, Executive's Guide Brochure: Prescription Drug Trends: A Chartbook Update, by Kaiser Family Foundation Brochure: Santarus Presentation Chart: Comparison of Dosage Strengths/Formulations of Brand Name PPIs Chart: Prevacid 1995-2006 Annual Sales Revenue Chart: Prevacid 1995-2006 Historical Units/Gross Sales/Net Sales Chart: Prevacid 2004-2006 Product Line P&L

DATE

BATES NO.

01/00/03

TVL 064021-64027

DTX147

00/00/02

TVL 063350-63372 VANDAELE DEP. EX. Ex. 1 VANDAELE EXPERT RPT. EX. 1 VANDAELE EXPERT RPT. EX. 2 VANDAELE DEP. EX. 5 VANDAELE DEP. EX. 6 VANDAELE EXPERT RPT. EX. 32 VANDAELE DEP. EX. 8 TVL 064970-64991 TVL 065419-65423 TVL 065287-65358 TVL 064881-64905 VANDAELE EXPERT RPT. EX. 4 VANDAELE EXPERT RPT. EX. 3 VANDAELE EXPERT RPT. EX. 30 VANDAELE EXPERT RPT. EX. 31

DTX148 DTX149 DTX150 DTX151 DTX152 DTX153 DTX154 DTX155 DTX156 DTX157 DTX158 DTX159 DTX160 DTX161 DTX162

08/13/07 00/00/00 08/13/07 06/00/07 00/00/00 2001 ­ 2007 00/00/02 09/24/84 00/00/04 11/00/01 09/27/06 19892006 19952006 19952006 20042006

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DEF EX. NO. DTX163 DTX164 DTX165 DTX166 DTX167 DTX168 DTX169 DTX170

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Chart: Prevacid Promotional Expenses Chart: Top 10 products by U.S. Sales Internet Record Search: Orange Book Data Press Release "Prilosec OTC Launch Off & Running: Strongest Start of Any New P&G Brand Ever" Proton Pump Inhibitors Preauthorization Criteria, BlueCross BlueShield of Nebraska Publication Entitled "The $800 Million Pill, the Truth Behind the Cost of New Drugs" Publication Entitled "A Homerun for American Home," by Seiden Publication Entitled "Abbreviated Drug Class Review: Proton Pump Inhibitors, Pharmacy Benefits Management Strategic Healthcare Group," by Goodman Publication Entitled "Advertising & Competition in the Ethical Pharmaceutical Industry: The Case of Antihypertensive Drugs," The Journal of Law & Economics, by Rizzo Publication Entitled "CIGNA Healthcare Coverage Position re: Proton Pump Inhibitor Therapy" Publication Entitled "Colitis Due to Clostridium Difficile Toxins: Underdiagnosed, Highly Virulent, & Nosocomial," by Fordtran Publication Entitled "Commercial & Pipeline Perspectives: Upper GI Disorders," by Datamonitor Publication Entitled "Demand Effects of Recent Changes in Prescription Drug Promotion," by Kaiser Family Foundation Publication Entitled "Direct to Consumer Advertising & Prescription Choice," by Iizuka & Jin Publication Entitled "Drug Digest: Proton Pump Inhibitors" Publication Entitled "Drug Digest: Antacids" Publication Entitled "Drug Firms, Stymied in the Lab, Become Marketing Machines," by Harris

DATE 19952006 03/00/07 06/15/07 09/22/03 04/20/07 06/18/07 00/00/00 07/00/01

BATES NO. VANDAELE EXPERT RPT. EX. 53 VANDAELE EXPERT RPT. EX. 32 TVL 064810-64845 TVL 064852 TVL 069311- 69316 TVL 064785-64809 TVL 065619- 65624 TVL 069325-69336

DTX171 DTX172 DTX173 DTX174 DTX175 DTX176 DTX177 DTX178 DTX179

04/00/99 06/15/06 00/00/06 10/00/04 06/00/03 04/04/05 00/00/00 00/00/00 07/06/00

TVL 065198-65212 TVL 064941-64950 TVL 065505- 65514 TVL 065614- 65618 TVL 064679-64714 TVL 065457- 65476 TVL 064536-64537 TVL 064538-64539 TVL 065359-65365

AO 1769495.1

10

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Document 146-3

Filed 10/08/2007

Page 35 of 118

DEF EX. NO. DTX180 DTX181 DTX182 DTX183 DTX184 DTX185

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Entry Order as a Consideration for Innovation Strategies," Nature Reviews Drug Discovery, by Cohen Publication Entitled "Esomeprazole (Nexium): A New Proton Pump Inhibitor," by Leonard Publication Entitled "Federal Panel Backs Prilosec for Overthe-Counter Sales," by Caroll Publication Entitled "Generic Pharmaceutical Industry Review," by Fletcher Publication Entitled "Heading Off Heartburn" Publication Entitled "Higher Prices from Entry: Pricing of Brand-Name Drugs, Dept of Agricultural & Resource Economics, UCB," by Perloff, Suslow & Seguin Publication Entitled "How Increased Competition from Generic Drugs Has Affected Prices & Returns in the Pharmaceutical Industry" by Congressional Budget Office Publication Entitled "Industrial Market Structure & Economic Performance," 3rd Edition, by Scherer & Ross Publication Entitled "Industry Structure, Strategy, & Public Policy," Chapter 9, by Scherer Publication Entitled "Information, Marketing, & Prices in the U.S. Antiulcer Drug Market, American Economic Review," by Berndt, Bui, Reily, & Urban Publication Entitled "Just What the Patient Ordered? Direct-toConsumer Advertising & the Demand for Pharmaceutical Products," by Wosinksa, Harvard Business School Marketing Research Papers Publication Entitled "Medical Treatment of GERD" Publication Entitled "Network Effects & Diffusion in Pharmaceutical Markets: Antiulcer Drugs," by Berndt, Pindyck & Azoulay Publication Entitled "Now Available Without a Prescription," by Nordenberg Publication Entitled "Persistence in Prescriptions of Branded Drugs," by Rich & Horn

DATE 03/10/06 08/00/01 06/22/02 07/15/04 06/13/07 00/00/96

BATES NO. TVL 065539- 65547 TVL 069317-69319 TVL 064676-64678 TVL 065135-65190 TVL 064620-64623 TVL 065213-65253

DTX186 DTX187 DTX188 DTX189

07/00/98 00/00/90 00/00/96 05/0//95

TVL 064992-65077 TVL 065548- 65562 TVL 065078-65134 TVL 065191-65197

DTX190 DTX191 DTX192 DTX193 DTX194

10/00/02 06/13/07 03/00/99 06/13/07 10/02/03

TVL 064715-64760 TVL 064617-64619 TVL 065563- 65595 TVL 064604-64609 TVL 065596-65613

AO 1769495.1

11

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Page 36 of 118

DEF EX. NO. DTX195 DTX196 DTX197 DTX198 DTX199 DTX200 DTX201 DTX202 DTX203 DTX204 DTX205 DTX206 DTX207 DTX208

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Pharmaceutical Economics & Policy," by Schweitzer Publication Entitled "Prices, Profits, & Innovation: Examining Criticisms of New Psychotropic Drugs' Value," by Huskamp Publication Entitled "Prilosec OTC ­ How Does It Compare to Zantac 75, Pepcid AC, & Other Over-the-Counter Heartburn Remedies?" Publication Entitled "Prilosec's Maker Switches to Nexium, Thwarting Generics," by Harris Publication Entitled "Proton Pump Inhibitors," by McDonagh & Carson Publication Entitled "Returns on Research & Development for 1990's New Drug Introductions," by Grabowski, Vernon, & DiMasi Publication Entitled "Santarus Reports First Quarter 2007 Financial Results" Publication Entitled "Takeda Abbott Pharmaceuticals (TAP) in 2002," by Duke School of Business Publication Entitled "The Big Squeeze," by Hisey Publication Entitled "The Effect of Prescription Drug Advertising on Doctor Visits," by Iizuka & Jin Publication Entitled "The Long Shadow of Patent Expiration: Generic Entry & RX to OTC Switches," by Berndt, Kyle, & Ling Publication Entitled "The Pink Sheet," pg. 23 Publication Entitled "The Prescription Generic Omeprazole DTC Launch," by McLinden, et al. Publication Entitled "The United States' Experience with Direct-to-Consumer Advertising of Prescription Drugs: What Have We Learned?" by Berndt Publication Entitled "Top 10 Selling Drugs in America... How the Drug Companies Deceive You: The Inside Story of Nexium," by Swidey Publication Entitled "WebMD: Gastroesophageal Reflux Diseases in Infants & Children"

DATE 00/00/97 00/00/06 06/14/07 06/06/07 07/00/06 00/00/02 05/01/07 11/00/03 10/01/04 00/00/05 01/17/02 11/22/04 06/14/07 00/00/00

BATES NO. TVL 065366-65369 TVL 064930-64940 TVL 064668-64675 TVL 064610-64616 TVL 064258-64353 TVL 064951-64969 TVL 064906-64908 TVL 069337-69352 TVL 064778-64784 TVL 065477-65504 TVL 065370-65418 TVL 065286 TVL 064846-64851 TVL 065424- 65456

DTX209 DTX210

11/17/02 00/00/03

TVL 064540-64551 TVL 064601-64603

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Filed 10/08/2007

Page 37 of 118

DEF EX. NO. DTX211 DTX212 DTX213 DTX214 DTX215 DTX216 DTX217 DTX218 DTX219 DTX220 DTX221 DTX222 DTX223 DTX224 DTX225 DTX226 DTX227

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "What Explains the Use of Direct-toConsumer Advertising of Prescription Drugs?" The Journal of Industrial Economics," by Iizuka Publication Entitled "Marketing, Product Differentiation, & Competition in the Market for Antiulcer Drugs," by King Publication Entitled "Prescription Drugs & Mass Media Advertising, 2000," by Findlay, et al. Publication Entitled "Proton Pump Inhibitor (PPI) Quarterly Sales Revenue by Product 2Q01-1Q07" Publication Entitled "Steady But Not Stellar," IMS Business Health Watch, by Kumart & Zaugg Study: CME Enterprise Research Project Brochure Zegerid Presentation Brochure Expert Report of R. Hirsch Curriculum Vitae of R. Hirsch Citations Used in Expert Report of Hirsch PSL Report: Evaluation of Compounds A & B Inhibition of Indomethacin Induced Gastric Mucosal Lesions in Rats PSL Report: Effect of Compound Against Indomethacin Induced Gastric Mucosal Lesions in Rats PSL Report: Effect of Compound D Against Indomethacin Induced Gastric Mucosal Lesions in Rats PSL Data cited in expert report of R. Hirsch Takeda Data cited in expert report of R. Hirsch Publication Entitled "Form Biostatistical Analysis," by Zar Publication Entitled "Dynamics of Protozoan Population Density, Plasma Glutamic Oxalacetic Transaminase & Plasma Bilirubin Concentrations During Histomoniasis in Turkeys," by Hirsch Publication Entitled "Studying a Study & Testing a Test," by Riegelman & Hirsch

DATE 09/00/04 09/16/02 11/00/01 00/00/0100/00/07 05/00/03 00/00/00 05/23/07 06/26/07 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/84 03/22/78

BATES NO. TVL 065254-65285 TVL 064552-64600 TVL 064761-64777 VANDAELE EXPERT RPT. EX. 4 TVL 069320-69324 TVL 065515- 65538 TVL 064853-64880 HIRSCH DEP. EX. 5 HIRSCH EXPERT RPT. EX. A HIRSCH EXPERT RPT. EX. B PSL 0001-21 PSL 0022-27 PSL 0028-36 HIRSCH EXPERT RPT. EX. D HIRSCH EXPERT RPT. EX. E HIRSCH DEP. EX. 1 HIRSCH DEP. EX. 12

DTX228

00/00/96

HIRSCH DEP. EX. 13

AO 1769495.1

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Filed 10/08/2007

Page 38 of 118

DEF EX. NO. DTX229 DTX230 DTX231 DTX232 DTX233 DTX234 DTX235 DTX236 DTX237

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Using Confidence Intervals Around Individual Means to Assess Statistical Significance Between Two Means," by Julious PSL - SOP Deviation Transcript of Dr. Hirsch's Videotaped Deposition Publication Entitled "Statistical First Aid Interpretation of Health Research Data," Chapter 7, by Hirsch & Riegelman PSL - Table 1, Effect of Compound C Against Indomethacin Induced Gastric Antral Lesions & Attached Documents Publication Entitled "Introduction to Biostatistics, Part 6, Correlation & Regression," by Gaddis & Gaddis Publication Entitled "Applied Regression Analysis & Other Multivariable Methods," Chapter 5 & 6, by Kleinbaum, Kupper, & Muller Publication Entitled "Statistics Review 7, Correlation & Regression," by Bewick, Cheek, & Ball Publication Entitled "Analyzing Data with GraphPad Prism," by Motulsky

DATE 00/00/04 01/03/07 08/18/05 00/00/92 00/00/00 12/12/90 00/00/00 11/05/03 00/00/99

BATES NO. HIRSCH DEP. EX. 14 PSL 0087-89 TVL 069153-69278 HIRSCH DEP. EX. 3 PSL 0462-465 HIRSCH DEP. EX. 6 TVL 066071-66081 HIRSCH DEP. EX. 8 HIRSCH DEP. EX. 9 TAKEDA 639117; TAKEDA 642666-667; TAKEDA 642702-706; TAKEDA 642708; TAKEDA 642781; TAKEDA 642785; TAKEDA 642789; TAKEDA 649115-116; TAKEDA 649123-124; TAKEDA 638780-781; TAKEDA 638808-809; TAKEDA 639115; TAKEDA 642672-673; TAKEDA 649135-136 TVL 066082-66091 TVL 066093-66096

DTX238

Excerpts from Lab Notebook

00/00/00

DTX239 DTX240

Publication Entitled "Mathematical Statistics with Applications," by Mendenhall, et al. Publication Entitled "Probabilities of the Type I Errors of the Welch Tests for the Behrens-Fisher Problem," by Wang

00/00/90 09/00/71

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Page 39 of 118

DEF EX. NO. DTX241 DTX242 DTX243 DTX244 DTX245 DTX246 DTX247 DTX248 DTX249 DTX250 DTX251 DTX252 DTX253 DTX254 DTX255 DTX256 DTX257 DTX258 DTX259 DTX260 DTX261 DTX262 DTX263 DTX264 DTX265 DTX266 DTX267 DTX268

OFFERED

ADMT

WITNESS

EX. DESCRIPTION PSL - Evaluation of Test Agent Inhibition Against Indomethacin Induced Gastric Mucosal Irritation: Rats PSL - Study 20637: Indomethacin Induced Gastric Lesions PSL - Study Notes PSL - Raw Data Gastric Lesions PSL - Bodyweight & Dosing Sheet PSL - Raw Data Gastric Lesions PSL ­ Bodyweight & Dosing Sheet PSL - Study 21149: Dosing, Feed, & Obs PSL - Study 21149: Dosing, Feed, & Obs PSL - Study 21149: Dosing, Feed, & Obs PSL - Bodyweight & Dosing Sheet PSL - Bodyweight & Dosing Sheet PSL - Bodyweight & Dosing Sheet PSL - Study 21411: Dosing, Feed, & Obs PSL - Study 21411: Dosing, Feed, & Obs PSL - Bodyweight & Dosing Sheet PSL - Individual Animal Data Sheet PSL - Raw Data Gastric Lesions Evaluation of Details from Study 20637 Indomethacin Induced Gastric Lesions Safety Data Sheets from Organix Publication Entitled "Pharmacological Profile of the Thyroid Hormone Receptor Antagonist NH3 in Rats," by Grover, et al. PSL - Raw Data Gastric Lesions Publication Entitled "Gastroenterology: Indomethacin Produces Gastric Antral Ulcers in Refed Rats" by Satoh PSL - Protocol Amendment to Study 20637 PSL - Protocol Deviation to Study 20637 U.S. Patent 4,265,900 Publication Entitled "The Mechanism of Action of the Gastric Acid Secretion Inhibitor Omeprazole," Journal of Medicinal Chemistry, by Lindberg Inhibition of Indomethacin Induced Antral Ulcers

DATE 00/00/00 00/00/00 12/15/06 12/06/06 12/08/06 01/24/07 01/24/07 12/08/06 12/07/06 12/06/06 12/07/06 12/06/06 01/24/07 01/2/407 01/25/07 10/13/06 10/13/06 10/13/06 00/00/00 11/29/06 04/13/07 09/16/06 09/19/06 12/00/81 10/13/06 12/20/06 05/05/81 08/00/86 00/00/00

BATES NO. PSL 0043-49 PSL 0058 PSL 0094-95 PSL 0466-561 PSL 0443-444 PSL 0606-661 PSL 0587-588 PSL 0445-447 PSL 0458-460 PSL 0454-456 PSL 0440-441 PSL 0434-438 PSL 0592-593 PSL 0589-591 PSL 0594-596 PSL 0166-171 PSL 0172-308 PSL 0335-399 PSL 0050-57 ORG 0001-74 DONG DEP. EX. 14 PSL 0310-333 PSL 0112-119 PSL 0059-81 PSL 0082-86 JACOBY DEP. EX. 2 LIPINISKI 0815-817 PSL 0401-411

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Page 40 of 118

DEF EX. NO. DTX269 DTX270 DTX271 DTX272 DTX273 DTX274 DTX275 DTX276 DTX277 DTX278 DTX279 DTX280 DTX281 DTX282 DTX283 DTX284 DTX285 DTX286 DTX287 DTX288 DTX289 DTX290 DTX291 DTX292 DTX293 DTX294

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Study 21149 Excerpts: Evaluation of Test Agent Inhibition Against Indomethacin Induced Gastric Mucosal Irritation: Rats PSL - Raw Data Gastric Lesions PSL - Raw Data Gastric Lesions Organizational Structure - Generic R&D 30(b)(6) Notice of Deposition of Takeda to Teva E-mail from S. DiCapua to B. Iozefzon & K. Cohen ANDA #77-255 - Section XV.2 ­ Analytical Methods: Drug Product U.S. Patent Application Publication No. US 2005/0214371 A1 U.S. Patent Application Publication No. US 2005/0214372 A1 30(b)(6) Notice of Deposition of Takeda to Teva ANDA #77-255 ­ Lansoprazole ­ Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use ANDA #77-255 ­ Section VI ­ Bioavailability / Bioequivalence ANDA #77-255 ­ Lansoprazole ­ Pre-Approval Correspondence Letter from P. Erickson to FDA ANDA #77-255 ­ Bioequivalency Amendment Letter from P. Erickson to FDA Teva Pharmaceuticals & Teva Pharmaceutical Industries Supplemental Responses & Objections to TAP's Interrogatory No. 3 E-mail from P. Fackler to G. DeRosa Teva Memorandum from B. Iosefzon to J. Hrakovsky Series of Emails from N. Shterman to M. Boutin, et al. ANDA #77-255 ­ Summary of Stability Studies 30(b)(6) Notice of Deposition of Takeda to Teva Lab Notebook No. BPG-07-012 Analysis of Samples Report from Materials Research Laboratories Raman Analysis Sheets Expert Report of Amidon

DATE 12/08/06 12/07/06 12/08/06 00/00/00 11/17/06 09/07/02 07/04/04 09/29/05 09/29/05 11/17/06 00/00/00 07/01/04 12/05/05 12/14/06 02/06/06 01/17/07 12/12/06 07/28/03 07/04/01 11/25/04 00/00/00 11/17/06 00/00/00 00/00/00 00/00/00 07/30/07

BATES NO. PSL 0462-465 PSL 0502-537 PSL 0538-561 DICAPUA DEP. EX. 1 DICAPUA DEP. EX. 2 TVL 052763 TVL 007573-7594 DICAPUA DEP. EX. 7 DICAPUA DEP. EX. 8 ERICKSON DEP. EX. 1 TVL 000001-21 TVL 000223-261 TVL 008271-8293 TVL 062439-62508 TVL 028155-28156 ERICKSON DEP. EX. 7 FACKLER DEP. EX.. 11 TVL 046731-733 TVL 028941-953 TVL 034143-54 TVL 007716-17 FACKLER DEP. EX.. 9 TVL 069861-69863 HIRT 0048-68 HIRT 0051-63; HIRT 0069 AMIDON DEP. EX. 1

AO 1769495.1

16

Case 1:06-cv-00033-SLR

Document 146-3

Filed 10/08/2007

Page 41 of 118

DEF EX. NO. DTX295

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists," 2nd Edition, by Connors, Amidon & Kennon Publication Entitled "Stabilization of a New Antiulcer Drug Lansoprazole in the Solid Dosage Forms," by Tabata, Makino, Kashihara, Hirai, Tiamori & Taguchi Publication Extract Entitled "Handbook of Pharmaceutical Excipients," 1st Edition Curriculum Vitae of Amidon In re Omeprazole Patent Litigation Expert Report of D. Bugay Supplemental Expert Report of D. Bugay Color-coded Charts from Bugay Expert Report ANDA #77-255 ­ Ingredient List Collected Spectra from Position Three Charts: Collection of 13 Comparison Graphs re: Teva 30mg Lansoprazole Granules & Magnesium Carbonate Chart: Comparison Graph of the Spatial Positions in Which Lansoprazole & Magnesium Carbonate are Located on Teva's 30mg Lansoprazole Confocal Raman-Spectroscopy: Analytical Approach to Solid Dispersions & Mapping of Drugs Correlates the Spatial Position to the Spectrum for the Other Fourteen Raman Maps that were Collected on Various Granules Designation of Raman Map Filenames that are Associated with Each Spatial Region EDX Map Detecting a Band of Fluorine EDX Map of Lansoprazole with that of Magnesium Obtained from the Subtraction Procedure. EDX Map of the 1st Granule in Which any Spatial Positions of Silicon have been Subtracted from Spatial Positions Indicative of Magnesium. EDX Maps Collected for the 1st Granule EDX Maps Collected for the 2nd Granule EDX Maps Collected for the 3rd Granule Granule 4, 6:00 Position, Map 222145-1

DATE 00/00/86

BATES NO. AMIDON 0237-269

DTX296 DTX297 DTX298 DTX299 DTX300 DTX301 DTX302 DTX303 DTX304 DTX305 DTX306 DTX307 DTX308 DTX309 DTX310 DTX311 DTX312 DTX313 DTX314 DTX315 DTX316

00/00/92 00/00/86 00/00/00 00/00/00 06/27/07 07/17/07 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 04/12/99 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00

BYRN 0318-328 AMIDON 0270-280 AMIDON 0001-80 AMIDON 0101-225 BUGAY DEP. EX. 1 BUGAY DEP. EX. 2 BUGAY 196.001-196.050 BUGAY 0131 BUGAY 0034 BUGAY 0063-75 BUGAY 0062 BUGAY 0124-128 BUGAY 0030-33 BUGAY 0028 BUGAY 0090 BUGAY 0094 BUGAY 0093 BUGAY 0077-85 BUGAY 0086-87 BUGAY 0088-89 BUGAY 0057

AO 1769495.1

17

Case 1:06-cv-00033-SLR

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Filed 10/08/2007

Page 42 of 118

DEF EX. NO. DTX317 DTX318 DTX319 DTX320 DTX321 DTX322 DTX323 DTX324 DTX325 DTX326 DTX327

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Optical Image of a Granule Surface Optical Image of One of Teva's 30mg Lansoprazole Granules that has been Prepared for Raman Spectroscopic Mapping Analysis Output of Profile Fitting Procedure Overlay of the 36 Spectra that were Collected for Granule #4, 6:00 Position Overlay of the Raman Spectra of Each Granule Component on an Absolute Intensity Scale Overlay Plot of the Six Pharmaceutical Components Photograph of Scanning Electron Microscope Equipped with an X-ray Detector Photograph of 5th Raman Map Collected from First Granule Photograph of 5th Raman Map Collected from First Granule with Labels Photograph Showing Magnesium Present in the Intermediate Layer Publication Entitled "Applications of Vibrational Spectroscopy in Pharmaceutical Research & Development," by Pivonka, et al. Publication Entitled "Raman & EDXRF Chemical Imaging for Formulation Process Development & Quality Control," by Clark, Whitley, Mamedov, Adar, Lewis & Lee Raman Spectrometer with a Microscope Raman Spectrum Acquired for the Lansoprazole API Raman Spectrum for Hypromellose Raman Spectrum for Magnesium Carbonate Raman Spectrum for Sugar Raman Spectrum for Talc Raman Spectrum for Titanium Dioxide Raw Data ­ CD Representation of Detectable Lansoprazole as a Function of Spatial Position SEM Image for Each Granule Spatial Position vs. Concentration Graph for Lansoprazole

DATE 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/07

BATES NO. BUGAY 0026 BUGAY 0027 BUGAY 0035 BUGAY 0029 BUGAY 0025 BUGAY 0024 BUGAY 0017 BUGAY 0058 BUGAY 0059 BUGAY 0092 BUGAY 0096-123

DTX328 DTX329 DTX330 DTX331 DTX332 DTX333 DTX334 DTX335 DTX336 DTX337 DTX338 DTX339

06/00/05 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00

BYRN 0252-253 BUGAY 0016 BUGAY 0018 BUGAY 0021 BUGAY 0019 BUGAY 0023 BUGAY 0022 BUGAY 0020 BUGAY 0132 BUGAY 0036 BUGAY 0076 BUGAY 0060

AO 1769495.1

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Page 43 of 118

DEF EX. NO. DTX340 DTX341 DTX342 DTX343 DTX344 DTX345 DTX346 DTX347 DTX348 DTX349 DTX350 DTX351 DTX352 DTX353 DTX354 DTX355 DTX356 DTX357 DTX358 DTX359 DTX360 DTX361

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Spatial Position vs. Concentration Graph for Magnesium Carbonate Spatial Positions Upon the Surface of the First Granule in Which Magnesium is Present Zoomed in View of the Granule Map of Magnesium Carbonate & Lansoprazole Photograph of Opened Bottles of Lansoprazole DR USP 15mg & 30mg Curriculum Vitae of D. Bugay Analogous Graph with Indications as to the Spatial Position of Magnesium Carbonate in Teva's Granule #4 Map 222145-1 Photograph of Unopened Bottles of Lansoprazole DR USP 15mg & 30mg Brostrom Lab Notebook 2726 Complete EDX Results ­ CD Composite Map for Each of the Four 15mg Granule & One 30mg Granule EDX Map of the 15mg Granules & 30mg Granule in Which any Spatial Positions of Silicon have been Subtracted from Spatial Positions Indicative of Magnesium. EDX Maps of 4 Granules from Teva's 15mg Capsules & One Granule from Teva's 30mg Capsules Experimental Details for Each Line Map on the 15mg Granules & the 30mg Granules Fluorine & Magnesium EDX Images from the Four 15mg Granules & the One 30mg Granule Representations of Detectable Lansoprazole & Magnesium Carbonate as a Function of Spatial Position Representative, Color Optical Image of a 15mg Granule Surface Results of 30mg Granules Analysis The Three Lines of Spectral Acquisition Expert Report of S. Byrn Supplemental Expert Report of S. Byrn Declaration of S. Byrn Curriculum Vitae of S. Byrn

DATE 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 06/27/07 07/17/07 09/11/07 00/00/00

BATES NO. BUGAY 0061 BUGAY 0091 BUGAY 0095 BUGAY 0015 BUGAY 0001-13 BUGAY 0056 BUGAY 0014 BUGAY 0166-194 BUGAY 0037-55 BUGAY 00195 BUGAY 0161 BUGAY 0164-165 BUGAY 000160 BUGAY 0148-149 BUGAY 0162-163 BUGAY 0151-159 BUGAY 0133-136 BUGAY 0137-147 BUGAY 0150 AMIDON DEP. EX. 3 BYRN DEP. EX. 2 BYRN DEP. EX. 3 BYRN 0001-31

AO 1769495.1

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Page 44 of 118

DEF EX. NO. DTX362 DTX363 DTX364 DTX365 DTX366 DTX367 DTX368

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Solid-State Chemistry of Drugs," by Byrn Photographs - EDX Spectra from Bugay Exp. Report Prevacid Drug Information Sheet ANDA #77-255 ­ Section VII ­ Components & Composition Statements Chart: Lansoprazole DR 30mg Capsules Batch Summary Excerpts from S. DiCapua Deposition from Byrn Report Charts: Intermixing of Lansoprazole & Magnesium Carbonate Shown in Line Maps from Bugay Report Publication Entitled "Drug-Excipient Incompatibility Studies of the Dipeptide Angiotensin-Converting Enzyme Inhibitor, Moexipril Hydrochloride: Dry Powder vs. Wet Granulation," by Gu, Strickley, Chi & Chowhan Publication Entitled "Effect of Salt Form on Chemical Stability of an Ester Prodrug of a Glycoprotein IIb/IIIa Receptor Antagonist in Solid Dosage Forms," by Badawy ANDA #77-255 ­ Section XII ­ In-Process Controls ANDA #77-255 ­ Section VI.3 ­ Dissolution ANDA #77-255 ­ Lansoprazole 15mg Strength Expert Report of B. Fennerty Curriculum Vitae of B. Fennerty Data & Information Considered by B. Fennerty Publication Entitled "Drug Class Review on Proton Pump Inhibitor" Systematic Review: Direct Comparative Trials at the Efficacy of Proton Pump Inhibitors in the Management of Gastrooesophageal Reflux Disease & Peptic Ulcer Disease Publication Entitled "Gastrooesophageal Reflux Disease" Publication Entitled "Early Heartburn Relief with Proton Pump Inhibitors: A Systematic Review & Meta-analysis of Clinical Trials" Publication Entitled "Med-Psych Drug-Drug Interactions Update: Gastrointestinal Medications," by Wynn, et al. Publication Entitled "Pharmacokinetics of Proton Pump Inhibitors in Children," by Litalien, et al.

DATE 00/00/82 00/00/00 09/00/06 07/01/04 00/00/00 02/07/07 00/00/00

BATES NO. BYRN DECLARATION EX. I BYRN 0254-258 BYRN 0282-317 BYRN 0032-191 TVL 035179-184 BYRN 0243-251 BYRN 0259-269

DTX369

10/23/89

BYRN 0270-274

DTX370 DTX371 DTX372 DTX373 DTX374 DTX375 DTX376 DTX377 DTX378 DTX379 DTX380 DTX381 DTX382

04/18/01 08/00/04 02/27/04 07/00/04 07/30/07 09/00/06 00/00/00 7/00/06 07/11/03 00/00/00 00/00/05 02/00/07 00/00/05

BYRN 0275-281 BYRN 0329-607 BYRN 0608-626 BYRN 0057-180 FENNERTY DEP. EX. 11 FENNERTY DEP. EX. 4 TVL 063419-63514 FENNERTY 0445-454 FENNERTY DEP. EX. 9 FENNERTY 0401-411 FENNERTY 0455-461 FENNERTY 0375-400

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DEF EX. NO. DTX383 DTX384 DTX385 DTX386

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Prevacid Drug Information Prevacid Marketing/Advertisements Prilosec Drug Information Sheet Publication Entitled "Comparing Lansoprazole & Omeprazole in Onset of Heartburn Relief: Results of a Randomized, Controlled Trial in Erosive Esophagitis Patients," by Richter, et al. Publication Entitled "Fast Acid Control & Rapid Symptom Relief for Patients with Gastro-esophageal Reflux Disease ­ the Evidence from Proton Pump Inhibitor Studies" by Bytzer Publication Entitled "Gastroenterology: Lansoprazole vs. Omeprazole in Short-Term Treatment of Reflux Pesophagitis" Publication Entitled "Management of Heartburn in a Large, Randomized, Community-Based Study: Comparison of Four Therapeutic Strategies" Publication Entitled "pH, Healing Rate, & Symptom Relief in Patients with GERD," Yale Journal of Biology & Medicine Publication Entitled "Systematic Review: Is There Excessive Use of Proton Pump Inhibitors in Gastro-oesophageal Reflux Disease?" by Lee, et al. Top 200 Brand Name Drugs by Retail Dollars in 2006 Publication Entitled "What are the Alternative Approaches to the Long-Term Management of GERD?" by Fennerty Publication Entitled "Acid Inhibition on the First Day of Dosing: Comparison of Four Proton Pump Inhibitors," by Pantoflickova Publication from American Journal of Health-System Pharmacy U.S. Patent Application No. 07/014,303 ­ Declaration Under Rule 132 U.S. Patent Application No. 07/014,303 ­ Amendment Submitted Under 37 CFR 1.115 U.S. Patent Application No. 07/014,303 ­ Reply Brief - USPTO Board of Appeals Byrn Expert Certificate of Experimental Results

DATE 06/00/07 00/00/00 00/00/00 00/00/01

BATES NO. FENNERTY 0486-521 TAP 273505-524; TAP 273655-669; TAP 273643-646 FENNERTY 0462-485 TVL 063687-63696

DTX387 DTX388 DTX389 DTX390 DTX391 DTX392 DTX393 DTX394 DTX395 DTX396 DTX397 DTX398 DTX399

04/26/06 09/28/92 00/00/01 06/00/99 09/24/04 00/00/06 00/00/05 12/30/02 12/01/99 02/13/87 02/13/87 08/13/90 06/16/91

FENNERTY 0293-305 FENNERTY 0327-333 FENNERTY 0334-340 FENNERTY 0341-356 FENNERTY 0364-374 FENNERTY 0522 FENNERTY 0321-326 FENNERTY 0419-426 FENNERTY 0427-434 HAM 3522-25 HAM 3515-3521 HIRAI DEP. EX. 34 TAKEDA 380476-88

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DEF EX. NO. DTX400 DTX401 DTX402 DTX403 DTX404 DTX405 DTX406 DTX407 DTX408 DTX409 DTX410 DTX411 DTX412 DTX413 DTX414 DTX415 DTX416 DTX417 DTX418 DTX419 DTX420 DTX421 DTX422 DTX423 DTX424 DTX425 DTX426 DTX427 DTX428 DTX429 DTX430 DTX431 DTX432

OFFERED

ADMT

WITNESS Kaneko Drawing Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook Kaneko Lab Notebook

EX. DESCRIPTION

DATE 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 08/01/07 00/00/00 00/00/00 11/17/06 00/00/00 00/00/00 02/16/07 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 00/00/00 07/29/07 06/18/07 00/00/00

BATES NO. KANEKO DEP. EX. 41 TAKEDA 445983-446084 TAKEDA 446085-446188 TAKEDA 446189-446291 TAKEDA 446292-446396 TAKEDA 446397-446501 TAKEDA 446502-446605 TAKEDA 446606-446709 TAKEDA 446710-446813 TAKEDA 446814-446916 TAKEDA 446917-447024 KAUNITZ DEP. EX. 3 KAUNITZ DEP. EX. 4 KAUNITZ DEP. EX. 2 KITAO DEP. EX. 1 KITAO DEP. EX. 5 TAKEDA 638687-638797 KITAO DEP. EX. 61 TAKEDA 638798-638966 TAKEDA 649039-649161 TAKEDA 639072-639163 TAKEDA 039372-39476 TAKEDA 039477-39581 TAKEDA 039582-39685 TAKEDA 039686-39789 TAKEDA 039790-39893 TAKEDA 039894-40000 TAKEDA 040001-40114 TAKEDA 051182-51184 LENZ DEP. EX. 10 LIPINSKI 0001-27 LIPINSKI 2714-2717

Expert Report of J. Kaunitz Color Version of J. Kaunitz Report Curriculum Vitae of J. Kaunitz 30(b)(6) Notice of Deposition of Teva to Takeda List of People Contacted by T. Kitao for Document Search Kitao Lab Notebook 1753 E-mail from J. Blake to P. Riesen, et al. Kitao Lab Notebook Kitao Lab Notebook Kitao Lab Notebook Kubo Lab Notebook Kubo Lab Notebook Kubo Lab Notebook Kubo Lab Notebook Kubo Lab Notebook Kubo Lab Notebook Kubo Lab Notebook Lab Notebook 2352 Expert Report of C. Lipinski Second Expert Report of C. Lipinski Curriculum Vitae of C. Lipinski Materials Reviewed by C. Lipinski

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DEF EX. NO. DTX433 DTX434 DTX435 DTX436 DTX437 DTX438 DTX439 DTX440 DTX441 DTX442 DTX443 DTX444 DTX445 DTX446 DTX447

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Teva's Responses to Takeda's 1 Set of Requests for Admission (Nos 1-3) ANDA #77-255 ­ Section V ­ Labeling U.S. Patent Certification Notice for the `098, 321, 560, 132 & 959 Patents U. S. Patent Application to Market a New Drug: Lansoprazole ANDA #77-255 ­ Section IV ­ Comparison: Generic Drug vs. Reference Listed Drug ANDA #77-255 ­ Labeling Amendment Byk Compound Reported in the `098 Patent in or about July 1984 Comparative Stability Study for Lansoprazole & Omeprazole in Solid State Compounds Incorporating the Trifluoroethoxy Group with Pharmaceutical Activity ­ Compounds Before 1985 Compounds Incorporating the Trifluoroethoxy Group with Pharmaceutical Activity ­ Compounds After 1985 Compounds Incorporating Trifluoroethoxy at the 4-Position of the Pyridine Ring Publication Entitled "Effect of Substituted Benzimidazoles on Acid Secretion in Isolated & Enriched Guinea Pig Parietal Cells," by Sewing, et al. Publication Entitled "Effects of Substituted Benzimidazole (H 149/94) on Gastric Acid Secretion in Humans," by Olbe, et al. Lab Notebook ­ AG Screening Data Publication Entitled "Omeprazole, a Specific Inhibitor of Gastric (H-K)-ATPase, is a H-activated Oxidizing Agent of Sulfhydryl Groups," by Eim, et al. Publication Entitled "Pharmaceutical Innovation by the Seven UK-owned Pharmaceutical Companies (1964-1985)," by Prentis, et al. Publication Entitled "Pharmacology & Toxicology of Omeprazole ­ with Special Reference to the Effects on the Gastric Mucosa," Carlsson, et al.
st

DATE 01/18/07 00/00/00 12/05/05 08/27/04 00/00/00 01/17/07 07/00/84 05/00/90 06/14/07 06/14/07 05/17/05 00/00/83 00/00/82 00/00/00 04/25/86

BATES NO. LIPINSKI 0142-146 LIPINSKI 0151-180 LIPINSKI 0218-229 LIPINSKI 0147 LIPINSKI 0148-150 LIPINSKI 0181-217 LIPINSKI 1974-2186 LIPINSKI 2678-2682 LIPINSKI 1331-1352 LIPINSKI 1353-1389 LIPINSKI 1321-1330 LIPINSKI 0956-959 LIPINSKI 0846-851 LIPINSKI 2187-2400 LIPINSKI 0755-762

DTX448

10/23/87

LIPINSKI 0867-876

DTX449

00/00/00

LIPINSKI 0623-630

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DEF EX. NO. DTX450 DTX451 DTX452 DTX453

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "2-[[(4-Amino-2-pyridyl) methyl] sulfinyl] benzimidazole H+/K+-ATPase Inhibitors: The Relationship Between Pyridine Basicity, Stability, & Activity," by Ife, et al. Publication Entitled "Drugs & People: Molecular Modification of Prototype Drugs" Publication Entitled "Is There An Optimal Degree of Acid Suppression for Healing of Duodenal Ulcers?" Publication Entitled "Structure of 5-Methoxy-{[4-Methoxy-3,5dimethyl-2-pyridinyl)methyl]sulfinyl}-1H-benzimidazole (Omeprazole)," by Ohishi, et al. Publication Entitled "Structure-Activity Relationships of Omeprazole Analogues & Their Mechanism of Action," Linberg, et al. Publication Entitled "Synthesis of 2-[[(4-Fluoroalkoxy-2pyridyl] sulfinyl]-1H-benzimidazoles as Antiulcer Agents," by Kubo, et al. Publication Entitled "Tetrahedron Report No. 31: Introduction of Fluorine Into Organic Molecules: Why & How," by Schlosser Publication Entitled "The Pharmacology of the Gastric Pump: The H+,K+ ATPase 1,2," by Sachs, et al. Publication Entitled "The Protective Role of Gastric Acid," by Hunt Publication Entitled "The Treatment of Gastric Ulcer with Antisecretory Drugs: Relationship of Pharmacological Effect to Healing Rates," by Howden, et al. Publication Entitled "Toxicological Studies on Omeprazole," by Ekman, et al. Lab Notebook ­ AG Compounds Table Certified Translation of TAKEDA 040730 Certified Translation of TAKEDA 040780 Certified Translation of TAKEDA 040832-833 Certified Translation of TAKEDA 040834 Certified Translation of TAKEDA 040843 Certified Translation of TAKEDA 040859-860 Certified Translation of TAKEDA 040852

DATE 12/12/88 00/00/00 08/00/90 04/10/89

BATES NO. LIPINSKI 0748-754 LIPINSKI 0687-690 LIPINSKI 0691-697 LIPINSKI 0843-845

DTX454

10/00/87

LIPINSKI 0818-821

DTX455

10/00/90

LIPINSKI 0564-570

DTX456 DTX457 DTX458 DTX459 DTX460 DTX461 DTX462 DTX463 DTX464 DTX465 DTX466 DTX467 DTX468

03/09/77 00/00/95 00/00/88 05/00/88 00/00/85 00/00/00 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07

TVL 062414-62429 LIPINSKI 2683-2713 LIPINSKI 0742-747 LIPINSKI 0720-725 LIPINSKI 0698-704 TAKEDA 050988-51252 LIPINSKI 1171-1173 LIPINSKI 1174-1176 LIPINSKI 1177-1181 LIPINSKI 1182-1184 LIPINSKI 1185-1187 LIPINSKI 1188-1192 LIPINSKI 1222-1224

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DEF EX. NO. DTX469 DTX470 DTX471 DTX472 DTX473 DTX474 DTX475 DTX476 DTX477 DTX478 DTX479 DTX480 DTX481 DTX482 DTX483 DTX484 DTX485

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Certified Translation of TAKEDA 040861 Certified Translation of TAKEDA 040869 Certified Translation of TAKEDA 040875-876 Certified Translation of TAKEDA 436710-733 Certified Translation of TAKEDA 040893 Certified Translation of TAKEDA 040901 Certified Translation of TAKEDA 040909 Certified Translation of TAKEDA 040924 Certified Translation of TAKEDA 040931 Certified Translation of TAKEDA 040938 Certified Translation of TAKEDA 040944 Certified Translation of TAKEDA 040951-952 Certified Translation of TAKEDA 040953 Certified Translation of TAKEDA 040877 Certified Translation of TAKEDA 040886 Certified Translation of TAKEDA 040945 Lab Notebook in Japanese Publication Entitled "Simultaneous High Performance Liquid Chromatographic Analysis of Omeprazole & its Sulphone & Sulphide Metabolites in Human Plasma & Urine," by Milaly, et al. Publication Entitled "Acid Activation of (H+-K+)_ATPase Inhibiting 2-(2-Pyridylmethyl-sulphinyl)benzimidazoles: Isolation & Characterization of the Thiophilic `Active Principle' & its Reactions," by Figala Publication Entitled "Sites of Reaction of the Gastric H,KATPase with Extracytoplasmic Thiol Reagents," by Beasocon Publication Entitled "(H+K+)-ATPase Inhibiting 2-[(2Pyridylmethyl) sulfinyl]benzimidazoles: A Novel Series of Dimethoxypyridyl-Substituted Inhibitors with Enhanced Selectivity. The Selection of Pantoprazole as a Clinical Candidate," by Kohl, et al. Publication Entitled "2-((2-Pyridylmethyl) Sulfinyl) Benzimidazoles: Acid Sensitive Suicide Inhibitors of the Proton Transport System in the Parietal Cell," by Rackur, et al.

DATE 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 07/03/07 19831984 07/13/83

BATES NO. LIPINSKI 1225-1227 LIPINSKI 1228-1230 LIPINSKI 1231-1235 LIPINSKI 1272-1320 LIPINSKI 1193-1195 LIPINSKI 1196-1198 LIPINSKI 1199-1201 LIPINSKI 1202-1204 LIPINSKI 1205-1207 LIPINSKI 1208-1210 LIPINSKI 1211-1213 LIPINSKI 1214-1218 LIPINSKI 1219-1221 LIPINSKI 1236-1238 LIPINSKI 1239-1241 LIPINSKI 1242-1244 LIPINSKI 1768-1973

DTX486

LIPINSKI 0829-837

DTX487

09/02/85

LIPINSKI 0705-707

DTX488

05/29/97

LIPINSKI 0631-639

DTX489

00/00/92

LIPINSKI 0763-771

DTX490

04/16/85

LIPINSKI 0877-884

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DEF EX. NO. DTX491

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Cimetidine: A Review of its Pharmacological Properties & Therapeutic Efficacy in Peptic Ulcer Disease," by Brogden, et al. Publication Entitled "Analogue-based Drug Discovery: The Development of a New Proton-Pump Inhibitor: The Case History of Pantoprazole," by Fischer & Ganellin Publication Entitled "Aromatic Substituent Constants for Structure ­ Activity Correlations" by Hansch, et al. Publication Entitled "The Chemically Elegant Proton Pump Inhibitors," by Roche Publication Entitled "Biotransformation & Elimination of 14CFlecainide Acetate in Humans," by McQuinn, et al. Publication Entitled "Analogue-based Drug Discovery: Esomeprazole in the Framework of Proton-Pump Inhibitor Development," by Fischer & Ganellin Certified Translation of Takeda 436694-709 Publication Entitled "Proton Pump Inhibitors," by Olbe Publication Entitled "Dissociation Constants of Organic Bases in Aqueous Solution, Supplement 1972," by Perrin Publication Entitled "Proton Pump Inhibitors," by Olbe Publication Entitled "Chemistry of Covalent Inhibition of the Gastric (H+, K+)-ATPase by Proton Pump Inhibitors," by Shin, et al. Publication Entitled "A Proton-Pump Inhibitor Expedition: The Case Histories of Omeprazole & Esomeprazole," by Olbe, et al. Publication Entitled "The Continuing Development of Proton Pump Inhibitor's with Particular Reference to Pantoprazole" by Huber, et al. Publication Entitled "Structure Activity Relationships of Substituted Benzimidazoles," by Brandstrom, et al. Publication Entitled "Molecular Modeling of SCH28080 Binding to the Gastric H,K-ATPase & MgATP Interactions with SERCA- & Na,K-ATPases," by Munson, et al. Publication Entitled "Inhibition of Gastric Acid Secretion by Omeprazole in the Dog & Rat," by Larsson, et al.

DATE 00/00/78

BATES NO. LIPINSKI 0648-686

DTX492 DTX493 DTX494 DTX495 DTX496 DTX497 DTX498 DTX499 DTX500 DTX501 DTX502 DTX503 DTX504 DTX505 DTX506

00/00/06 06/18/73 10/15/06 03/08/84 00/00/06 07/11/07 00/00/99 00/00/72 00/00/99 06/04/04 02/00/03 02/21/95 00/00/85 00/00/03 10/00/83

LIPINSKI 0921-944 LIPINSKI 0714-719.004 LIPINSKI 0893-903 LIPINSKI 0822-828 LIPINSKI 0780-814 LIPINSKI 1245-1271 LIPINSKI 0972-997 TVL 065713-65839 LIPINSKI 0998-1017 LIPINSKI 0960-971 LIPINSKI 0852-859 LIPINSKI 0726-741 TVL 059671-59679 LIPINSKI 0838-842 LIPINSKI 0772-779

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DEF EX. NO. DTX507 DTX508 DTX509 DTX510 DTX511 DTX512 DTX513 DTX514 DTX515 DTX516 DTX517 DTX518 DTX519 DTX520 DTX521 DTX522 DTX523 DTX524 DTX525 DTX526 DTX527 DTX528 DTX529 DTX530 DTX531 DTX532 DTX533 DTX534

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Safety Profile of the Proton-Pump Inhibitors," American Journal of Health System Pharmacy, by Reilly Certified Translation of Monthly Report December 1984 Certified Translation of Central Research Division Monthly Report October 1983 Certified Translation of Central Research Division Monthly Report November 1983 Certified Translation of Central Research Division Monthly Report August 1984 Certified Translation of Takeda 047495 Certified Translation of Takeda 422781 Certified Translation of Takeda 422831 Japanese Patent Application No. 61-29567 Japanese Patent Application No. 61-38059 Prevacid: Power Plus Versatility TAP Memorandum from J. Wargel to Distribution Abbott Memorandum from J. Ackerman to Distribution Prevacid Advertisement TAP R&D Committee Meeting Minutes History on Formulation & Manufacturing Procedure for AG1749 Capsules Certified Translation of Monthly Report June 1985 Certified Translation of Monthly Report July 1985 Certified Translation of Monthly Report December 1985 Certified Translation of Monthly Report December 1985 Certified Translation of Monthly Report August 1986 Tetsuro Tabata Deposition from Astra v. Takeda Expert Report of Whittle Curriculum Vitae of B. Whittle Materials Considered by B. Whittle Pharmacological Profile of AG-1749, a (H-K) ­ ATPase Translation of Takeda Notebook - September 1984 Monthly Report Chart: Inhibition of IMAU Graph by AG-1749

DATE 12/06/99 12/01/84 10/01/83 11/01/83 08/01/84 00/00/00 00/00/00 00/00/00 02/13/86 02/21/86 00/00/00 10/10/94 11/07/94 00/00/00 04/16/91 06/00/92 06/01/85 07/01/85 12/01/85 12/01/85 08/01/86 03/15/94 07/26/07 00/00/00 00/00/00 00/00/00 09/00/84 00/00/00

BATES NO. LIPINSKI 0885-892 TAKEDA 040986-992 TAKEDA 040866-873 TAKEDA 040874-882 TAKEDA 040943-950 TAKEDA 047495 TAKEDA 422781 TAKEDA 422831 MAKINO DEP. EX.27 MAKINO DEP. EX.28 TAP 273713-273720 TAP 000314-315 TAP 000552 TAP 273581-273602 TAKEDA 493766-493772 TAKEDA 601019-601042 TAKEDA 610685 TAKEDA 610684 TAKEDA 047455-456 TAKEDA 610681 TAKEDA 047535-536 TABATA DEP. EX. 9 WHITTLE DEP. EX. 1 WHITTLE 0001-80 WHITTLE 2013-2016 TAKEDA 100743 WHITTLE 0254-256 WHITTLE 0547-562

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DEF EX. NO. DTX535 DTX536 DTX537 DTX538 DTX539 DTX540 DTX541 DTX542 DTX543 DTX544 DTX545 DTX546

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Chart: Dose Response Curves Plotted by H. Satoh for the IMAU Experiments Publication Entitled "Cytoprotection by Prostaglandins," by Robert Publication Entitled "Drug Intelligence & Clinical Pharmacy" Publication Entitled "Effects of 2-(E-2-Decenoylamino)ethyl 2(Cyclohexylethyl) Sulfide on Various Ulcer Models in Rats," by Kohda Publication Entitled "Experimental Gastric Mucosal Injury," by Glarin & Szabo Publication Entitled "Experimental Models of Gastric Ulceration & Injury," by Silen Publication Entitled "Further Evidences on Gastric Cytoprotection Exerted by Pirenzepine," by Varin, et al. IMAU 1749 Publication Entitled "Indomethacin Produces Gastric Antral Ulcers in the Refed Rat" by Satoh, et al. Publication Entitled "Microcirculatory Disturbance in Indomethacin-Induced Intestinal Ulcer," by Miura, et al. Publication Entitled "Nonsteriodal Anti-Inflammatory Drugs & Peptic Ulcer Disease," by Soll, et al. Publication Entitled "Non-Steroidal Anti-Inflammatory DrugInduced Gastric Damage in Experimental Animals: Underlying Pathological Mechanisms," by Trevethick, et al. Publication Entitled "Possible Involvement of Hyperinsulinemia & Adrenergic Activation in the Pathogenesis of IndomethacinInduced Antral Ulcers in Nonfasted Hamsters & Refed Rats," by Kuratani, et al. Publication Entitled "Prevention & Healing of Experimental Indomethacin-induced Gastric Lesions: Effects of Ebrotidine, Omeprazole & Ranitidine," by Arroup, et al. Publication Entitled "Principles & Practice of Gastroenterology & Hepatology" by Kauff, Mari & Whittle PSL - Bodyweight & Dosing Sheet PSL - Bodyweight & Dosing Sheet

DATE 00/00/00 04/10/79 06/00/88 07/00/91 02/00/92 00/00/88 00/00/84 00/00/00 00/00/81 00/00/91 02/15/91 00/00/95

BATES NO. TAKEDA 649161 WHITTLE 0857-863 WHITTLE 0699-706 WHITTLE 0707-710 WHITTLE 0623-629 WHITTLE 0917-924 WHITTLE 0977-989 WHITTLE 0223 WHITTLE 0871-877 WHITTLE 0801-807 WHITTLE 0925-937 WHITTLE 0964-968

DTX547

07/24/92

WHITTLE 0731-735

DTX548 DTX549 DTX550 DTX551

12/00/93 00/00/88 01/24/07 01/25/07

WHITTLE 0570-576 WHITTLE 1027-1038 WHITTLE 1658-1659 WHITTLE 1663-1664

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DEF EX. NO. DTX552

OFFERED

ADMT

WITNESS

EX. DESCRIPTION Publication Entitled "Close-Arterial Administration of the Thromboxane Mim