Free Proposed Pretrial Order - District Court of Delaware - Delaware


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Case 1:04-cv-00939-GMS

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EXHIBIT 3B

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EXHIBIT 3B DEFENDANT'S TRIAL EXHIBIT LIST AND PLAINTIFF'S OBJECTIONS THERETO C.A. NO. 04-939 (GMS) ADMISSION RESOLUTION

DTX # 1 2

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DDX 1

No Obj N N

Obj Basis Comment Admitted Date s

11/30/99 U.S. Patent 5,994,329 01/00 Bone, et al., Weekly Administration of Alendronate: Rationale and Plan for Clinical Assessment, Clinical Therapeutics, Jan. 2000 Gertz, et al., Clinical Pharmacology of Alendronate Sodium, Osteoporosis International, 1993 MK 02231140223128

DDX 2

3

1993

DDX 3

N

1

"DDX _" refers to defendant's deposition exhibits, marked in CV-01-048 (JJF); "DX _" refers to defendant's deposition exhibits marked in the instant lawsuit.

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ADMISSION

RESOLUTION

DTX # 4

Date of Doc. 1997

Description

Bates Range

Depo. Ex. No.1 DDX 4

No Obj N

Obj Basis Comment Admitted Date s

Daifotis & Karpf, Summary of MK 0229494Safety Profile and Future 0229497 Research with Alendronate, British Journal of Rheumatology, 1997

5

10/03/96 DeGroen, et al., Esophagitis MR 0047366Associated With the Use of 0047376 Alendronate; Liberman and Hirsch, Esophagitis and Alendronate, Letter to the Editor 10/03/96 DeGroen, et al., Esophagitis Associated With the Use of Alendronate, N.E.J.M., October 1996 10/03/96 Liberman and Hirsch, Esophagitis and Alendronate, N.E.J.M., Letter to the Editor, October 1996 10/03/96 Castell, Pill Esophagitis - The Case of Alendronate, N.E.J.M., October 1996

DDX 5

N

6

N

7

N

8

N

-2-

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ADMISSION

RESOLUTION

DTX # 9

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DDX 7

No Obj N

Obj Basis Comment Admitted Date s

02/01/01 Periodic Safety Update Report MK 0215615for: Alendronate Tablets Report 0215648 #15 , July 16, 2000 - January 15, 2001 06/24/97 06/24/97 email from Daifotis to Rodan re: Weekly Dosing 10/96 Reid, et al., Biochemical and Radiologic Improvement in Paget's Disease of Bone Treated with Alendronate: A Randomized, PlaceboControlled Trial MK 0217454

10 11

DDX 9

N N

12 13

11/30/99 U.S. Utility Patent Application for 5,994,329- FW 09/134,214 2000 Schnitzer, et al., Therapeutic Equivalence of Alendronate 70mg Once-Weekly and Alendronate 10mg Daily in the Treatment of Osteoporosis, Aging Clin. Exp. Res, 2000

DDX 14 DDX 16

N N

-3-

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ADMISSION

RESOLUTION

DTX # 14

Date of Doc.

Description

Bates Range MK 03158830315886

Depo. Ex. No.1 DDX 20

No Obj N

Obj Basis Comment Admitted Date s

04/04/01 Manuscript Review: Emkey, R., Two-Year Gastrointestinal Safety and Tolerability of Alendronate 70mg Once Weekly, for presentation at October 2001 ASBMR Annual Meeting 12/29/97 Memo from Dicesare to Fosamax Commercialization Team re: Highlights of the 12/11/97 Fosamax Commercialization Team Meeting 04/99 Watts, et al., The Clinical Tolerability Profile of Alendronate, LICP Supp., April 1999

15

MR 00786460078652

DDX 21

N

16

MK 02847220284732

DDX 29

N

17

03/15/96 March 15, 1996 "Dear Doctor" MK 0156420letter from Sherwood re: 0156421 Fosamax Dosing and Avoidance of Esophageal Side Effects

DDX 31

N

-4-

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ADMISSION

RESOLUTION

DTX # 18

Date of Doc.

Description Draft of March "Dear Doctor" letter from Sherwood re: Fosamax: Proper Dosing and Avoidance of Esophageal Side Effects

Bates Range MK 03073140307317

Depo. Ex. No.1 DDX 32

No Obj N

Obj Basis Comment Admitted Date s

19 20 21

09/03/96 Memo from Pyron to Roberts re: Lunar News 03/13/97 Letter from Anstice to Mazess re: Response to 02/07/97 letter 04/01/97 Letter from Anstice to Mazess re: Merck representatives meeting with Lunar in Madison 05/21/97 Agenda for May 21, 1997, Merck/Lunar management Meeting

MK 02721830272195 MK 0307359 MK 03341660334186 MK 0272082

DDX 34A DDX 37 DDX 38 N

H

H, C

22

DDX 40

H

23 24

08/29/97 Letter from Mazess to Sherwood MK 0307347enclosing Lunar News 0307349 03/18/99 Letter from Yates to Mazess re: MK 0286269 review of draft Lunar News

DDX 42 DDX 45 N

H

-5-

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ADMISSION

RESOLUTION

DTX # 25

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DDX 46

No Obj N

Obj Basis Comment Admitted Date s

Lunar Newsletter (excerpts from MK 0272059December 1996, July 1996, 0272060 April 1996 and April 1997 editions) 12/01/00 Letter from Sherwood to Pyle responding to 11/20/00 letter from Pyle to Sherwood 12/10/00 Letter from Pyle to Sherwood re: Sherwood's 12/01/00 letter MK 03072480307250 MK 0307247

26

DDX 51

N

27 28

DDX 52 DDX 56

N PRIV

08/11/99 Memo from Sabatelli to Daifotis MK 0230459 et al. re: Notice of Allowance for 09/134,215 06/30/99 Letter from Mazess to Yates re: MK 0286265Update Bisphosphonates report 0286266 with handwritten marginalia 1991 Seedor, et al. The Bisphosphonate Alendronate (MK-217) Inhibits Bone Loss Due To Ovariectomy in Rats, Bone & Min. Res., 1991

29

DDX 68

H

30

H

-6-

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ADMISSION

RESOLUTION

DTX # 31

Date of Doc. 12/93

Description Balena, et al., The Effects of 2Year Treatment with the Aminobisphosphonate Alendronate on Bone Metabolism, Bone Histomorphometry, and Bone Strength in Overlectomized Nonhuman Primates, The Amer. Soc. For Clin. Invest. , 1993 Thompson, et al., The Bisphosphonate, Alendronate, Prevents Bone Loss in Ovariectomized Baboons, Bone & Min. Res., 1992

Bates Range

Depo. Ex. No.1 DDX 78

No Obj

Obj Basis Comment Admitted Date s H

32

1992

DDX 79

H

33

02/27/98 Memo From DiCesare to Distribution re: Worldwide Statement of Interest: Fosamax (MK-217) Weekly Dosing 04/24/95 PCT WO 95/30421 - Goodship

MR 01225800122595

DDX 80

N

34

DDX 81

N

-7-

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ADMISSION

RESOLUTION

DTX # 35

Date of Doc.

Description

Bates Range MK 02908890290895

Depo. Ex. No.1 DDX 82

No Obj N

Obj Basis Comment Admitted Date s

02/02/98 Memo from DiCesare to Fosamax Commercialization Team re: Highlights of the 01/23/98 Fosamax Commercialization Team Meeting 12/30/98 Memo From DiCesare to Fosamax Commercialization Team re: 2/10/98 Fosamax Commercialization Team meeting

36

MK 01682670168271

DDX 85

N

37

04/22/96 Memo From DiCesare to MR 75889-75900 Meeting Attendees re: Summary of 04/01/96 Fosamax Alternative Formulation Development meeting 06/17/96 Memo from Katdare to Distribution List re: Alternative Dosage Forms for Alendronate Sodium MK 26741626718

DDX 88

N

38

DDX 93

N

-8-

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ADMISSION

RESOLUTION

DTX # 39

Date of Doc.

Description

Bates Range MK 175200175203

Depo. Ex. No.1 DDX 94

No Obj N

Obj Basis Comment Admitted Date s

06/17/96 Memo from Katdare to Luby, et al. re: Product Profile for Iontophoretic Delivery of Alendronate Sodium 07/01/96 Fosamax / Onclast Project Team Meeting Minutes

40 41

MR 61310.9661310.105

DDX 96 DDX 97

N N

07/07/96 Email from Katdare to DiCesare MK 175247 re: Agenda Items for Alendronate Alternative Formulation Task Force 07/19/96 Memo from DiCesare to Distribution re: Fosamax Alternative Formulation Development Task Force MK 175808175812

42

DDX 98

N

43

11/27/96 Memo from Katdare to DiCesare MK 282658re: Alternative Formulation 282659 Development

DDX 99

N

-9-

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ADMISSION

RESOLUTION

DTX # 44

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DDX 100

No Obj N

Obj Basis Comment Admitted Date s

02/07/97 Memo From DiCesare to MK 175642Meeting Attendees re: Summary 175644 of 01/13/97 Fosamax Alternative Formulation Development Task Force Meeting 02/06/97 Memo from Senich to DPC Members re: New Perspective on Competitive Threat: Formulations and Dosing for Fosamax 02/07/97 Email from Katadare to DiCesare re: New Competitive Intelligence - Formulation Strategies 02/18/97 Memo From DiCesare to Fosamax Commercialization Team re: Highlights of 02/07/97 Fosamax Commercialization Team Meeting MK 174600

45

DDX 101

N

46

MK 174629

DDX 102

N

47

MK 174595174599

DDX 104

N

- 10 -

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ADMISSION

RESOLUTION

DTX # 48

Date of Doc.

Description

Bates Range MK 158554158558

Depo. Ex. No.1 DDX 105

No Obj N

Obj Basis Comment Admitted Date s

02/28/97 Memo From DiCesare to Fosamax Commercialization Team re: Highlights of 02/24/97 Fosamax Commercialization Team Meeting

49

03/12/97 Fosamax Alternative Formulation Development Task Force Meeting Agenda 05/14/97 Email from Katdare to Distribution re: Draft #5 & 6 of the Fosamax PDP 05/97 Product Profile for Alternative Formulations/Regimens

MK 175611175612 MK 158237; 158234 MK 291242291243 MK 159883159888

DDX 106

N

50

DDX 108

N

51 52

DDX 109 DDX 111

N N

02/18/98 Memo From DiCesare to Fosamax Commercialization Team re: Highlights of 02/05/98 Fosamax Commercialization Team Meeting

- 11 -

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ADMISSION

RESOLUTION

DTX # 53

Date of Doc.

Description

Bates Range MK 355787355790

Depo. Ex. No.1 DDX 113

No Obj N

Obj Basis Comment Admitted Date s

07/10/96 Memo From DiCesare to Fosamax Commercialization Team re: Highlights of 07/01/96 Fosamax Commercialization Team Meeting

54

09/30/98 Memo From DiCesare to Fosamax Commercialization Team re: Summary of 09/03/98 Fosamax Commercialization Team Meeting

MK 181817181821

DDX 114

N

55

09/29/97 Email from Harning to Distribution re: Clinical Development Strategy (Draft) CDS

MK 01967790196799

DDX 116

N

56

01/25/96 Memo from DiCesare to MK 0193104Fosamax/Onclast Project Team 0193107 re: 02/01/96 Project Team Meeting

DDX 117

N

- 12 -

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ADMISSION

RESOLUTION

DTX # 57 58 59

Date of Doc.

Description

Bates Range MK 01753900175391

Depo. Ex. No.1 DDX 118 DDX 122 DDX 125

No Obj N N N

Obj Basis Comment Admitted Date s

02/13/96 Email from Hirsch to DiCesare re: alternative formulations

07/01/96 Fosamax/Onclast Project Team MK 0155292meeting Minutes 0155300 11/05/96 Memo from DiCesare to Distribution re: Fosamax Alternative Formulation Development Task Force MK 01756850175687

60

03/25/97 Fosamax Product Development MK 0158533Plan and Technical Review 0158535 Schedule 01/13/97 Fosamax Alternative Formulation Development Task Force Meeting MK 0175655

DDX 128

N

61

DDX 129

N

62

02/07/97 Memo from DiCesare to Meeting MK 0175633Attendees re: Summary of 0175635 01/13/97 Fosamax Alternative Formulation Development Task Force Meeting

DDX 131

N

- 13 -

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ADMISSION

RESOLUTION

DTX # 63

Date of Doc.

Description

Bates Range MK 01756300175632

Depo. Ex. No.1 DDX 132

No Obj N

Obj Basis Comment Admitted Date s

02/10/97 Memo from DiCesare to Distribution re: Fosamax Alternative Formulation Development Task Force 02/13/97 Email from Katdare to Mundt et al. re: Market Research Study for Fosamax 04/08/97 Memo from DiCesare to Distribution re: Fosamax Alternative Formulations Development Task Force 08/19/96 Tactical PAC Review 05/07/97 Email from Santora to Peter re: Preclinical Study to Support 40mg Fosamax 05/20/97 Tactical PAC Review 05/20/97 Tactical PAC Review

64

MK 0175645

DDX 134

N

65

MK 01755260175528

DDX 138

N

66 67

MK 01675970167649 MK 0175545

DDX 140 DDX 142

N N

68 69

MK 01583080158328 MK 01582420158287

DDX 145 DDX 146

N N

- 14 -

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ADMISSION

RESOLUTION

DTX # 70

Date of Doc.

Description

Bates Range MK 0175446

Depo. Ex. No.1 DDX 151

No Obj N

Obj Basis Comment Admitted Date s

06/12/97 Email from Santora to Holland re: Bioavailability Studies for Fosamax 09/12/97 Memo from DiCesare to Fosamax Commercialization Team re: Highlights of the 08/11/97 Fosamax Team Meeting 08/21/98 Memo from Wolfe to Miller re: Once Weekly Pricing Considerations 11/13/96 Fosamax Reunion a l'Agence du Medicament 04/02/96 Memo from Peter to van Zwieten re: Fosamax Esophageal Irritation Potential 05/22/97 Memo from Peter to van Zwieten re: Bisphosphonates Comparative GI Irritation Potential in Animals

71

MK 01748540174857

DDX 152

N

72

MR 03434900343491 MK 02828980282923 MK 0283646

DDX 156

N

73 74

DDX 214 DDX 217

N N

75

MK 0267360

DDX 228

N

- 15 -

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ADMISSION

RESOLUTION

DTX # 76

Date of Doc.

Description

Bates Range MR 00666730066711

Depo. Ex. No.1 DDX 231

No Obj N

Obj Basis Comment Admitted Date s

03/05/98 Memo/Letter from Kloss to Sobel-Distribution re: NDA 20560 Fosamax (Alendronate Sodium Tablets) Meeting Request and Background Package 03/19/96 NDA 20-560 Fosamax 10/22/02 (Alendronate Sodium) Meeting Background Package on 03/19/96 07/22/97 Patent Application Serial No. 60/053351, July 23, 1997 07/23/97 Patent Application Serial No. 60/053535, July 22, 1997

77

MK 02495420249569

DDX 236

N

78 79 80 81 82

DDX 240 DDX 241 DDX 245 DDX 248 DDX 249

N N N N N

11/06/98 Manuscript Review 98-ms-2926 MR 0029565(Yates) 0029567 01/19/00 Publications Coordination 99ms-3316 (Schnitzer) 01/19/00 Publications Coordination 99ms-3316 (Schnitzer)(redacted) MR 0041423 MK 03426670342683

- 16 -

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ADMISSION

RESOLUTION

DTX # 83 84 85

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DDX 250 DDX 251 DDX 256

No Obj

Obj Basis Comment Admitted Date s R R

08/22/97 Request for grant of a patent 04/25/00 Correspondence from the Patent Office 07/28/97 Memo from R. Harning to List MK 0339462re: Once Weekly Formulation 0339463 CDP Development Meeting, July 25, 1997; Minutes 03/95 Reddy, et al., Alendronate Treatment of Naturally Occurring Periodontitis in Beagle Dogs, J. Periodontol., 1995

N

86

H

87

08/05/96 Memo from DiCesare to MK 0384680Fosamax Commercialization 0384681 Team re: Highlights of 08/01/96 Team Meeting 09/17/96 Memo from DiCesare to MK 0160066Fosamax Commercialization 0160068 Team re: Highlights of 08/21/96 Team Meeting

DDX 280 Santora

N

88

DDX 281 Santora

N

- 17 -

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ADMISSION

RESOLUTION

DTX # 89

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DDX 282 Santora

No Obj N

Obj Basis Comment Admitted Date s

09/30/96 Memo from DiCesare to MK 0160041Fosamax Commercialization 0160044 Team re: Highlights of 09/20/96 Team Meeting 10/11/96 Memo from DiCesare to MK 0160037Fosamax Commercialization 060040 Team re: Highlights of 10/02/96 Team Meeting 10/30/96 Memo from DiCesare to MK 0159981Fosamax Commercialization 0159983 Team re: Highlights of 10/28/96 Team Meeting 12/06/96 Tactical PAC Review MK 01676500167681

90

DDX 283 Santora

N

91

DDX 284 Santora

N

92 93 94

DDX 285 Santora DDX 287 DDX 325

N N N

04/10/97 Email from Santora to Senich re: MK 0175602Updated Tables 0175603 08/13/97 Memo from Browne to MK 0174460Alternative Formulation Task 0174878 Force, Commercialization Team WHHM Osteoporosis Team re: Market Research

- 18 -

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ADMISSION

RESOLUTION

DTX # 95

Date of Doc.

Description

Bates Range MK 01813330181343

Depo. Ex. No.1 DDX 326

No Obj N

Obj Basis Comment Admitted Date s

01/15/98 Memo from WHHM Worldwide Statement of Interest re: Alendronate Once Weekly Dosing

96

02/28/02 Memo From A. Miller to MK 0269594Osteoporosis re: The Launch of 0269597 Fosamax Once Weekly in the US Market 02/12/01 Marketing/Public Affairs Cross - MK 0332706Functional Team Exercise 0332707 1996 Siris, et al., Comparative Study of Alendronate Versus Etidronate for the Treatment of Paget's Disease of Bone, J. Clin. Endo. Meta., 1996 Emkey, et al., Tolerability of MR 0047664Alendronate: Similar Experience 0047676 in Clinical Practice and in Clinical Trials

DDX 336

N

97 98

DDX 339

N N

99

DDX 354

N

- 19 -

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ADMISSION

RESOLUTION

DTX # 100

Date of Doc. 03/99

Description

Bates Range

Depo. Ex. No.1 DDX 355

No Obj N

Obj Basis Comment Admitted Date s

Letter to the Editor from A. John MK 0232109Yates, The American Journal of 232111 Managed Care, 1999

101

03/26/99 Email from Freedholm to Yates, MK 0232108 et al. re: Ettinger response to Letter to the editor 11/30/95 Liberman, et al., Effect of Oral Alendronate on Bone Mineral Density and the Incidence of Fractures in Postmenopausal Osteoporosis, The New England Journal of Medicine, 1995 09/27/02 Letter to Palmese from Rodriquez with attached page from Merck's Privilege Log (page 221) 10/16/98 Letter from Orloff to All Flex Study Coordinators re: Publication of Ettinger Surveys MR 00386630038674

DDX 356

N

102

N

103

DDX 362

R

104

DDX 387

N

- 20 -

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ADMISSION

RESOLUTION

DTX # 105 106

Date of Doc.

Description History of the Development of Fosamax

Bates Range MK 01640030164022 MR 0114135

Depo. Ex. No.1 DDX 396 DDX 397

No Obj N N

Obj Basis Comment Admitted Date s

03/18/96 Memo from Freedholm to RIRD re: Alendronate/Consultant Agreement/ Dr. Piet DeGroen 03/12/96 Memo from Grosser to Distribution re: Clinical Development Oversight Committee

107

MK 01683470168352

DDX 399

N

108

04/08/94 Mazess et al., Bone Density of MK 0122213the Radius, Spine, and Proximal 0122218 Femur in Osteoporosis, J. Bone Min. Res., 1988 Press Release: Outcome Data Presented About Ulcer Incidence in Patients w/ Osteoporosis MK 02920450292047

DDX 403

H, Q

109

DDX 422

N

- 21 -

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ADMISSION

RESOLUTION

DTX # 110

Date of Doc.

Description Harris, et al., The Effect of Short Term Treatment with Alendronate on Vertebral Density and Biochemical Markers of Bone Remodeling in Early Postmenopausal Women, J. Clin. Endo. & Met.., 1993 Black, et al., Randomized Trial of Effect of Alendronate on Risk of Fracture in Women with Existing Vertebral Fractures, The Lancet, Dec. 1996 Khan, et al. Alendronate in the Treatment of Paget's Disease of Bone, Bone, 1997

Bates Range

Depo. Ex. No.1

No Obj N

Obj Basis Comment Admitted Date s

111

N

112

N

113 114 115

Fosamax Promotional Spending MK 03916641995 3Q 2002 0391669 Fosamax Catalog Gross Sales 09/09/99 Profit Plan 2000 Fosamax MK 03916620391663 MK 03776050377645

DDX 441 DDX 443 DDX 447

N N N

- 22 -

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ADMISSION

RESOLUTION

DTX # 116 117 118 119 120 121

Date of Doc.

Description Business Plan for USHH Osteoporosis FBG 2002-2006

Bates Range MK 02751810275229 MK 03773290377344

Depo. Ex. No.1 DDX 452 DDX 455 DDX 459 DDX 472 DDX 474 DDX 477

No Obj N N N N N N

Obj Basis Comment Admitted Date s

08/30/01 2001 Profit Plan Fosamax

09/09/02 2003 Profit Plan Presentation for MK 0384995Fosamax 0385156 12/95 Osteoporosis FBG YTD Actual Performance Fosamax Discounts / Rebates 1995 - 3Q 2002 07/11/01 Memo from Davies/Lewis to Jordan re: USHH Perspectives on Fosamax and the Osteoporosis Market Environment: 2001 MK 03916520391658 MK 03916700391674 MK 02704070270413

122

09/03/96 Memo from Pyron to Roberts re: MK 0272253 Lunar News with handwritten annotations

N

- 23 -

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ADMISSION

RESOLUTION

DTX # 123

Date of Doc.

Description

Bates Range

Depo. Ex. No.1

No Obj N

Obj Basis Comment Admitted Date s

04/02/97 Memo from Anstice to Allen and MK 0307357Sherwood forwarding 04/01/97 0307358 letter to Mazess from Anstice re: BMI 03/13/97 Letter from Anstice to Mazess re: BMI Merck & Co., Inc.'s Response to Defendant's First Set of Interrogatories Merck & Co., Inc.'s Supplemental Response to Defendant's Interrogatory No. 5 Merck & Co., Inc.'s Second Supplemental Response to Defendant's Interrogatory No. 5 1996 (Supplement A) Fosamax PDR entry Fosamax prescribing information MK 0307359

124 125

N N

126

N

127

N

128 129

N N

- 24 -

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ADMISSION

RESOLUTION

DTX # 130 131

Date of Doc.

Description October 30, 1996 Meeting Background Package Thompson et. al., Aminohydroxybutane Bisphosphonate Inhibits Bone Loss Due to Immobilization in Rats, J. Bone Min. Res., 1990 Balena et al., The Aminobisphosphonate Alendronate Inhibits Bone Loss Induced By Thyroid Hormone in the Rat Comparison Between Effects on Tibiae and Vertebrae, Bone, 1993 Passeri, et al., Intermittent Treatment With Intravenous 4amino-1-hydroxybutylidene-1,1bisphosphonate (AHBuBP) In The Therapy Of Postmenopausal Osteoporosis, Bone and Mineral, 1991

Bates Range MK 250129250220

Depo. Ex. No.1

No Obj N N

Obj Basis Comment Admitted Date s

132

N

133

H

- 25 -

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ADMISSION

RESOLUTION

DTX # 134

Date of Doc.

Description Devogelaer, et al., Oral Alendronate Induces Progressive Increases in Bone Mass of the Spine, Hip, and Total Body Over 3 Years in Postmenopausal Women With Osteoporosis, Bone, 1996

Bates Range

Depo. Ex. No.1

No Obj N

Obj Basis Comment Admitted Date s

135

01/21/03 Decision In the High Court of Justice Chancery Division Patents Court: Teva Pharmaceutical Industries, Ltd., et al., v. Merck & Co, Inc. 04/04/95 Letter from Mazess to J. Bevan re: Licensing for Vitamin D Products 04/96 07/96 Lunar News - April `96 Lunar News - July `96 MK 0272082 GE 0007 PDX 21 N

H, R, U

136

137 138 139

PDX 22 PDX 23 PDX 32

N N N

05/15/97 Agenda for Lunar Meeting 05/21/97

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ADMISSION

RESOLUTION

DTX # 140

Date of Doc.

Description 01/02/03 memo from George Korenko to File re: IMS New Prescription Data National Osteoporosis Foundation, "NOF Applauds USPSTF Recommendations on BMD Tests," http://www.nof.org/news/pressre leases/uspstf_02.html Vijay Mahajan, Eitan Muller, Frank M. Bass, "New Product Diffusion Models in Marketing: A Review and Directions for Research," Journal of Marketing, January 1990, Volume 54, pp. 1-26 National Osteoporosis Foundation, "America's Bone Health: The State of Osteoporosis and Low Bone Mass," http://www.nof.org/advocacy/pre valence/index.htm

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, A, R

141

H, A, R, I

142

H, A, R, I

143

H, A, R, I

- 27 -

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Document 70-5

Filed 06/28/2006

Page 29 of 59

ADMISSION

RESOLUTION

DTX # 144

Date of Doc.

Description Frank Maier, "Substitution among Successive Product Generations­An Almost Neglected Problem in Innovation Diffusion Models," presented at Industrieseminar der Universitat Mannheim. System Dynamics Konferenz, 1996 Herman Simon, "Marketing Science's Pilgrimage to the Ivory Tower," Chapter 2 in Gilles Laurent, Gary L. Lilien and Bernard Pras, Research Traditions in Marketing, (Norwell, MA Kluwer Academic Publishers), 1994, p. 34 Jagdish N. Sheth, Rajendra S. Sisodia, "Revisiting Marketing's Lawlike Generalizations," Marketing in the 21st Century, Journal of the Academy of Marketing Science, Volume 27, No. 1, pp. 75-77

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, A, R, I

145

H, A, R, I

146

H, A, R, I

- 28 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 30 of 59

ADMISSION

RESOLUTION

DTX # 147

Date of Doc.

Description Malcolm Wright, Clinton Upritchard, Tony Lewis, "A Validation of the Bass New Product Diffusion Model in New Zealand," Marketing Bulletin, 1997, Volume 8, http://marketingbulletin.massey.ac.nz/article8/ar ticle2b.asp Declining Incidence of Esophagitis in Alendronate Postmarketing Surveillance

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, A, R, I

148

MK 0235069

N

149 150

Slide Presentation: - 2001 DTC MK 0290000Market Map 0290032 Slide Presentation - Overview of MK 0334077Initiatives to Drive New Patients 0334124 Into the Market and Share for Fosamax 04/12/00 Fosamax Product Workshop April 12, 2000 MK 03775090377542

N N

151

N

- 29 -

Case 1:04-cv-00939-GMS

Document 70-5

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ADMISSION

RESOLUTION

DTX # 152 153

Date of Doc. 05/00

Description Market Plan May 2000

Bates Range MK 03781950378231

Depo. Ex. No.1

No Obj N

Obj Basis Comment Admitted Date s

10/03/97 Document entitled "Fosamax Once-Weekly / Twice ­ Weekly Dosing Program" Undated memo re: Rationale 04/16/98 Document entitled "Alendronate Once and Twice Weekly Dosing" Presentation to FDA 04/16/98 A. John Yates MD Number and Length (mm) of Macroscopic Antral Lesions (Hand written Curve Papapoulos, S., Bisphonates, The Aging Skeleton, Chap. 44, pps. 541-549 (1999) Fleisch, H, Paget's Disease, Bisphosphates In Bone Disease From Laboratory to the Patient, pps. 68-85 (1995)

H, A, I

154 155

H, A, I H, A, I

156

M

157

H, A, I, R

158

H, A, I, R

- 30 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 159 160

Date of Doc.

Description

Bates Range MK 01659680165972

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, A, I, R

10/09/98 Press Release ­ Statement on Publication of Ettinger Surveys 10/25/05 Subpoena to Procter & Gamble Company in Merck v. Teva Litigation 08/13/02 US Patent No. 6,432,932 10/15/02 US Patent No. 6,465,443 04/01/02 Letter from Julie Seawall to Karen Clark Re: Confidential Disclosure Agreement dated March 27th 05/10/02 Letter from Paul Matukaitis to Karen Clark Re: Bisphosphonate Patent Licenses 05/17/02 License Agreement Amng Merck &Co., Inc., Merck and Company, Incorporated and Procter & Gamble Company

DX 1

H

161 162 163

DX 3 DX 4 PG 0067341 DX 5

N N H

164

PG 0067394

DX 6

H

165

PG 00579390057956

DX 7

N

- 31 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 166 167

Date of Doc.

Description Royalty payments to Merck for OAW

Bates Range PG 944110094412

Depo. Ex. No.1 DX 8 DX 9

No Obj N N

Obj Basis Comment Admitted Date s

05/17/02 License Agreement Merck &Co., PG 0057966Inc., Merck and Company, 0057979 Incorporated and Procter & Gamble Company 12/26/00 US Patent No. 6,165,513

168

DTX 228, DX 10 C.A. #01048JJF

N

169 170

Powerpoint Presentation with handwritten notes 03/13/98 Email dated 3/13/98 from B. Senich to several re P&G abstract with attachment Toolan, et al., "Effects of 41992 Amino- 1Hydroxybutylidene Bisphosphonate on Bone Biomechanics in Rats," J. Bine Min. Res., 05/13/99 Email dated 5/13/99 from A. Daifotis to several re P&G's risedronate rechallenge

MK 04388520438857 MK 04291740429175

DX 11 DX 12

H, U N

171

H, R

172

MK 0637418

DX 14

H, I, R

- 32 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 173

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DX 19

No Obj

Obj Basis Comment Admitted Date s H, R

174

175

03/11/94 Seminars in Arthritis and Rheumatism by Roy D. Eltman: Jacques P. Brown et al. "Risedronate in Paget's Disease-Preliminary Results of a Multicenter Study" Valentin-Opran, "Risedronate: 8/28/90 Preliminary Results of a Pharmacologic Study in Pagetic Patients", Journal of Bone and Mineral Research 1990 Program & Abstracts 01/12/96 Agenda- Friday, January MK 016850812,1996: Bisphosphonate 0168522 Therapies For Osteoporosis Pirow J. Bekker, "Clinical Experience with Risedronate (Including Paget's Disease and Postmenopausal Osteoporosis) Micheal R. McClung, The Risedronate Phase III Program

DX 21

N

DX 22

H

176

10/08/97 Arthritis & Rheumatism Abstract Supplement 1997 National Scientific Meeting (Singh)

DX 23

H, R

- 33 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 177

Date of Doc.

Description

Bates Range

Depo. Ex. No.1 DX 24

No Obj

Obj Basis Comment Admitted Date s H, U, R

178

179

180

181

182

09/11/97 P&G Product News Releases: Study Results Highlight the Promise of Risedronate in Treating Postmenopausal Women with Low Bone Mass 9/11/97 08/05/97 Journal of Bone and Mineral Research 1997 Program & Abstracts (ASBMR 19th Annual Meeting) Lene Mortensen, et al. 03/07/05 "Risedronate Increases Bone Mass in an Early Postmenopausal Population: Two Years of Treatment Plus one Year of Follow-up" D. J. Hosking, et al. "Paget's 01/00/98 Disease of Bone: Reduction of Disease Activity with Oral Risedronate" B. Clemmesen, et al., "A 2-Year 1997 Phase II Study with 1-Year of Follow-up of Risedronate (NE58095) in Postmenopausal Osteoporosis" 02/09/99 US Patent 5,869,471

DX 25

H, U, R

DX 26

H, U, R

DX 27

H, U, R

DX 28

H, U

DX 33

H, U, R

- 34 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 36 of 59

ADMISSION

RESOLUTION

DTX # 183

Date of Doc. 05/00/95

Description

Bates Range

Depo. Ex. No.1 DX 34

No Obj N

Obj Basis Comment Admitted Date s

184

185

186 187

Johnston et al., "Risedronate Prevention of Bone Loss in Early Post-Menopausal Women" Eastell et al., "Risedronate 07/22/97 Therapy Prevents Bone Loss in Glucocorticoid-Treated Rheumatoid Arthritis patients: A Three-Year Study" Delmas et al., "Bisphosphonate 03/00/97 Risedronate Prevents Bone Loss in Women With Artificial Menopause Due to Chemotherapy of Breast Cancer: A Double Blind, Placebo-Controlled Study" 04/00/99 April 1997 Lunar News 11/23/93 European Patent Application 0 600 834 A1 to Goodship, entitled, "Use of methanebisphosphonic acid derivatives for the manufacture of a medicament for fracture healing"

DX 35

H, U

DX 36

H

H N

- 35 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

Page 37 of 59

ADMISSION

RESOLUTION

DTX # 188

Date of Doc.

Description

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H

189

190

191

03/26/82 Delmas PD, Chapuy MC, Vignon E, Charhon S, Briancon D, Alexandre C, Edouard C, and Meunier PJ. "Long term effects of dichloromethylene diphosphonate in Paget's disease," Journal of Clinical Endocrinology and Metabolism 1982; 54(4):837-844 07/00/97 Lilley LL and Guanci R, "Avoiding alendronate-related esophageal irritation" American Journal of Nursing July 1997; 97(7): 12-14. Lanza F, Sahba B, Schwartz H, 2002 Winograd S, Torosis J, Quan H, Reyes R, Musliner T, Daifotis A, and Leung A. "The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once-weekly: a placebo-controlled endoscopy study," The American Journal of Gastroenterology 2002; 97(1): 58-64. MK 0170895-0170944

H

N

H, R, I

- 36 -

Case 1:04-cv-00939-GMS

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ADMISSION

RESOLUTION

DTX # 192 193 194 195 196 197 198

Date of Doc.

Description MK 0080527-0080585 MK 0384834-0384974 MK 0154684-0154694 MK 0382423-0382456 ACTONELŽ Package insert

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s C C C H, R, I M

3/20/96

March 20, 1996 Meeting Background Package

MK 249542-69 MR 0047664-76

N H, R

199 200

1998 2000

Tolerability of Alendronate: Similar Experience in Clinical Practice and in Clinical Trials Update on Safety & Tolerability of Bisphosphonates
Bauer et al., "Upper Gastrointestinal Tract Safety Profile of Alendronate", Arch Inter. Med., Vol. 160 (2000) Lowe et al., "Upper Gastrointestinal Toxicity of Alendronate", Am. J. Gastroenterology, Vol. 95, No. 3 (2000)

MK 0234350-82

N R, H

201

2000

H

- 37 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 202

Date of Doc. 1998

Description
Ferrari et al., "Esophageal Ulcer and Alendronate," Rev. Paul Med. (1998) Vol. 116, No. 6 Kaye, "Gastric Hemorrhage and Ulceration in Hiatal Hernia SAC Associated With Alendronate," Dig. Dis. & Sci., Vol. 44, No. 5 (1999) Ryan et al., "Alendronate-induced Esophagitis: Case Report of a Recently Recognized Form of Severe Esophagitis with Esophageal Stricture--Radiographic Features," Radiology, Vol. 206 (1998) Canadian Adverse Drug Reaction Newsletter, Alendronate-induced Esophagitis Gennari and Reginster, "Bisphosphonate and Osteoporosis Treatment in Italy," Aging Clin. Exp. Res., Vol. 10 (4) Lanza et al., "Effects of Alendronate on Gastric and Duodenal Mucosa," Am. J. Gastro., Vol. 93(5)

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, U

203

05/99

N

204

1998

N

205

04/98

N

206

1998

H

207

1998

N

- 38 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

Page 40 of 59

ADMISSION

RESOLUTION

DTX # 208

Date of Doc. 2000

Description
Lanza et al., "Endoscopic Comparison of Esophageal and Gastroduodenal Effects of Risedronate and Alendronate in Postmenopausal Women," Am. J. Gastro., Vol. 93 Lanza et al., "An Endoscopic Comparison of the Effects of Alendronate and Risedronate on Upper Gastrointestinal Mucosae," Am. J. Gastrol., Vol. 95 "Postmarketing Surveillance Indicates Need For Better Education of Patients Taking Alendronate," Am. J. HealthSyst. Pharm., Vol. 53 (1996) Ettinger et al., "Clinic Visits and Hospital Admissions for Care of AcidRelated Upper Gastrointestinal Disorders in women Using Alendronate for Osteoporosis," Am. J. Man. Care, Vol. 4 Suri et al., "Nitrogen-containing Bisphosphonate Induced Apoptosis of Caco-2 Cells in Vitro by Inhibiting the Mevalonate Pathway: A Model of Bisphosphonate-induced Gastrointestinal Toxicity," Bone, Vol. 29

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, R

209

2000

H

210

5/14/96

H

211

10/98

N

212

10/02

H, R

- 39 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

Page 41 of 59

ADMISSION

RESOLUTION

DTX # 213

Date of Doc.

Description
Reszka et al., "Nitrogen-

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, R

08/24/00 Bisphosphonate Block Retinoblastoma
Phosphorylation and Cell Growth by Inhibiting the Cholesterol Biosynthetic Pathway in a Kerotinocyte Model for Esophageal Irritation," Mol. Pharma., Vol. 59

214

1998

Siris et al., "Risedronate in the Treatment of Paget's Disease of Bone: An Open- Label, Multicenter Study," J: Bone & Min. Res., 13 :1032 (1998) Brown et al., "Risedronate, a Highly Effective, Short-Term Oral Treatment for Paget's Disease: A Dose-Response Study," Calcif Tissue Int., 64:9399 (1999) Singer et al., "A Safety Review of the Use of Risedronate in the Treatment of Paget's Disease of Bone," Arthritis Rheum., 40(9):S279 (1997)

N

H, R

215

04/02/99

H, R

216

10/08/97

H, R

- 40 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 217 218 219

Date of Doc.

Description

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, I H, I H, R

08/23/02 6,432,932 File Wrapper 10/15/02 6,465,443 File Wrapper 08/05/97 Bekker et al, "Risedronate Treatment Improves Pain Status in Patients with Paget's Disease of Bone," J. Bone & Min. Res., 12(1):S270 (1997)
Package insert of Risedronate Sodium Tablets 5, 30 and 35 mg from Teva's Abbreviated New Drug Application No. 77 ­ 132 The Opinion of the United States Court of Appeals for the Federal Circuit published as Merck & Co., Inc. v. Teva Pharmaceuticals, USA, 395 F.3d 1364 (Fed. Cir. 2005)

220

TEVA R 06314 ­ 06345

H

221

H, U

222

12/00/93 Intermittent Cyclic Etidronate

Harris et al., "Four-Year Study of Treatment of Postmenopausal Osteoporosis: Three Years of Blinded therapy Followed by One Year of Open Therapy," Am. J. Med., Vol. 95

N

- 41 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 223

Date of Doc. 1980

Description
Reitsma et al., "Kinetic Studies of Bone and Mineral Metabolism During Treatment with (3-Amino-1Hydroxypropylidene)-1, 1Bisphosphonate (APD) in Rats," Calcif. Tissue Int., 32: 145-57 (1990) Francis, "Oral Bisphosphonates in the Treatment of Osteoporosis: A Review," Curr. Thera. Res., Vol. 56( 9) Tang, L., et al., "Restoring and Maintaining Bone in Osteopenic Female Rat Skeleton: Change in Bone Mass and Structure," J. Bone Min. Res., 7(9): 1903 -104 (1992) Jee, S., et al., "Extra Cancellous Bone Induced by Combined Prostaglandin E2 and Risedronate Administration is Maintained after Their Withdrawal in Older Female Rats", J. Bone Min. Res. 10(6): 963-70 (1995) Ma, Y., et al., "Partial Maintenance of Extra Cancellous Bone mass by Antiresorptive Agents After Discontinuation of Human Parathyroid Hormone (1-38) in Right Hindlimb Immobilized Rats," J. Bone Min. Res. 10(6): 963-70 (1995)

Bates Range

Depo. Ex. No.1

No Obj N

Obj Basis Comment Admitted Date s

224

1995

H, R

225

1992

R, H

226

1995

N

H, R

227

1995

H, R

- 42 -

Case 1:04-cv-00939-GMS

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ADMISSION

RESOLUTION

DTX # 228 229 230 231 232 233 234 235 236 237

Date of Doc. 03/24/98 02/09/99 01/17/05 03/13/06

Description
U.S. Patent No. 5,730,715 U.S. Patent No. 5,869,471 2005 PDR Information for Actonel Actonel Prescribing Information http://www.fda.gov/cder/foi/label/2005/ 020560s038_021575s007lbl.pdf http://www.pg.com/annualreports/200 5/pdf/pg2005annualreport.pdf

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, R, A H, A, R M M M M H

08/15/05 http://www.actonel.compressrele asefda.jsp http://www.fda.govcderfoilabel20 0321455_boniva_lbl http://www.fda.govcderfoilabel20 0420835slr014_actionel_lbl 03/16/06 .htm
http://www.fda.govcderrdmtESCY05AP

N N N

238

03/16/06 tindexC0,2478,6599_1825,00.htm

http://www.imshealth.comimsportalfron

H

- 43 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 239 240 241 242 243 244

Date of Doc.

Description
Expert Report of Richard P. Rozek,

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, R, U, I, B M H, U M M H, R, U

01/10/03 January 10, 2003 08/25/04 2004

First Amended Complaint, August 25, Merck & Co. v. Teva Pharmaceuticals Merck & Co. v. Teva Pharmaceuticals

01/28/05 USA, Inc. , 395 F.3d 1364 (2005)

03/06/03 USA, Inc., CV 01-048, Trial Volume 03/07/03 06/00/00

245

09/11/02

246

10/23/02

Number 3, March 6, 2003 Merck & Co. v. Teva Pharmaceuticals USA, Inc., CV 01-048, Trial Volume Number 4, March 7, 2003 Campbell, Margaret C. and Amna Kirmani "Consumers' Use of Persuasion Knowledge: The Effects of Accessibility and Cognitive Capacity on Perceptions of an Influence Agent," Journal of Consumer Research , Vol. 27 (June 2000), No. 1., pp. 69­83. Degnan, Stephen and Corwin Horton, "A Survey of Licensed Royalties," les Nouvelles , Volume 22, Number 2, June 1997, pp. 91­96. Gross, Michael, "Actual Royalty Rates in Patent-, Know-how-, and Computer program-License Agreements," CASRIP Newsletter, Volume 413

H, A, I, R

H, A, I, R

- 44 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 247

Date of Doc.

Description
Khoury, Sam et. al., "Selection and

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, A, I, R

09/00/01 Application of Intellectual Property

248

07/00/03

249

1985

250

06/00/92

251

12/12/04

252

07/00/05

Valuation Methods In Portfolio Management and Value Extraction." Les Nouvelles, Volume 36, No. 3, September 2001, pp. 77­86 Lovallo, Dan and Daniel Kahneman, "Delusions of Success: How Optimism Undermines Executives' Decisions." Harvard Business Review, July, 2003, pp. 56­63. Mahajan, Vijay and Robert Peterson, "Models for Innovation Diffusion," Sage University Paper Series on Quantitative Applications in the Social Sciences, Series No. 48, 1985. McGavock, Daniel M., David Haas and Michael Patin, "Factors Affecting Royalty Rates", Les Nouvelles, Volume 27, Number 2, June 1992, pp. 107­ 116. Mizik, Natalie and Robert Jacobson, "Are Physicians `Easy Marks'? Quantifying the Effects of Detailing and Sampling on New Prescriptions (04105)," Marketing Science Institute Working Paper Series, Issue 1 (2004), No., 04-001, pp. 129 ­151. "Fast Facts on Osteoporosis," National Osteoporosis Foundation, July 2005

H, A, I, R

H, A, I, R

H, A, I, R

H, A, I, R

M

- 45 -

Case 1:04-cv-00939-GMS

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ADMISSION

RESOLUTION

DTX # 253 254 255 256 257

Date of Doc.

Description
Novavax Inc., Form 8-K, Exhibit 10.3, "Other News to Note" Bioworld Today, P&G 2006 Annual Report Results of RoyaltySourceŽ Intellectual "Pharmaceuticals: Bone Related." Seachrist, Lisa, "Ligand, Parke-Davis in Pact on Estrogen Receptor Drugs," BIOWORLD Today, Volume 10, Issue No. 170, September 3, 1999 Teva's Letter of Paragraph IV Certification, April 19, 2004 "Unigene in Chinese pharmaceutical 1995

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s M M M M M

01/08/03 January 8, 2001

01/08/03 Volume 14, Issue 5, January 8, 2003 2005

04/04/06 Property Database with Criteria 09/03/99

258 259 260

04/19/04

H, R, I M M

06/26/95 venture," Reuters News, June 26,

261 262 263

03/10/06 www.evista.com/include/print_p age.jsp?content=/content_files/u nderstanevista/chototake.jsp,ac cessed March 10, 2006. www.fda.gov/medwatch/SAFET Y/2005/MAY_PI/Actonel_PI.pdf
www.nof.org/advocacy/prevalence/ind ex.htm, accessed April 4, 2006 www.pharma.us.novartis.com/product/ pi/pdf/miacalcin_nasal.pdf.

M M M

- 46 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 264

Date of Doc.

Description

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s M

265

266 267 268 269 270

10/02/01 www.prnewswire.com/cgibin/micro_stories.pl?ACCT=103 068&TICK=PDII&STORY= 03/10/06 www.rxlist.com/cgi/generic3/fort eo_pi.htm, accessed March 10, 2006. 04/01/05 Merck's Initial Disclosure 07/06/05 Merck's response to Teva's first set of interrogatories 08/18/05 Subpoena to Custodian of Records, Procter & Gamble Co 10/25/05 Subpoena to the Procter & Gamble Company 10/26/05 Merck's Supplemental Response to Teva's first set of Interrogatories 11/15/05 Merck's Supplementalst Response to Teva's 1 Set of Interrogatories 12/07/05 Merck's Supplemental Responses to Defendant's 1st set of Interrogatories (Nos. 4, 5, 8, and 9). E-mail from Matukaitis, P. Re MK 0384760Bisphosphonate Agreements 0384762

M

N N N N N

271

N

272

N

273

278D

H

- 47 -

Case 1:04-cv-00939-GMS

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Filed 06/28/2006

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ADMISSION

RESOLUTION

DTX # 274 275 276 277 278 279 280 281

Date of Doc. 1/25/88 4/1/02 3/27/02 5/17/02

Description Know-How License Agreement b/w Merck & Gentili Letter from Seawall to Clark re: Confidential Agreement Confidential Disclosure Statement License Agreement w/ Merck & Procter & Gamble

Bates Range MR 00759220075942 MK 03848290384830 MK 0384828 MK03846940384707

Depo. Ex. No.1 279D 280D 281D 282D 283D

No Obj

Obj Basis Comment Admitted Date s R H

N N N N N H, A, R

12/26/00 U.S. patent 6,165,513, Dansereau et al. 5/17/02 License Agreement w/ Merck & Procter & Gamble

MK03847080384726

284D 285D

11/01/01 Fosamax Esophageal Studies MK0285294 from Dr. Srinavasa Prahalada Administration on Aging, "Aging of Older Americans:2001. The Older Population." http://www.aoa.dhhs.gov/aoa/st ats/profile/2001/1.html

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RESOLUTION

DTX # 282

Date of Doc.

Description "NPD Reports Treatment of Osteoporosis is on the Rise: Over-The-Counter Medications Gain Share of the Market, "http://www.ipsosnpd.com/about/news/o1_1127.h tml Curriculum Vitae of Sunil Wimalawansa Curriculum Vitae of David Markowitz Curriculum Vitae of Dr. Jesse David

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, A, R, I

283 284 285 286 287 288 289 05/12/99 03/24/99 08/20/99 08/30/02

H, R, I H, R, I H, R, I PG 01003200100322 PG 01005450100589 PG 00974090097451 PG 01006220100630 H, R H, R H, R H, R

- 49 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 51 of 59

ADMISSION

RESOLUTION

DTX # 290 291

Date of Doc. 12/10/99 08/20/99

Description

Bates Range PG 01550430155309 PG 01544710154694 MK 0384694 0384707 MK 038474 0384759 MK 09349870935030 MK 0935206 0935249 PG 00025960002607 PG 00032930003303 PG 00139820014148 PG 00148150015234 PG 00193200019327

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, R H, R

292 293 294 295 296 297 298 299 300

05/17/02 05/17/02

N M N C C C C C I, H, R

01/31/06 06/30/03 06/30/02

03/21/01

- 50 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 52 of 59

ADMISSION

RESOLUTION

DTX # 301 302 303 304 305 306 307 308 309 310 311 312 313

Date of Doc.

Description

Bates Range PG 00219650021976 PG 0037533

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s C I, R, H R, H, I R, H, I C I, H C I, H, R I, H, R C C C C

PG 00379100037918 PG 00704810070505 PG 00785650080800 PG 0094159- DX 65 0094161 PG 0094411DX 61 & 0094415 62 PG 00946980094705 PG 00950410096069 PG 01878760187889 PGK000000010000124 PGK000001750000336 PGK000024130002618

- 51 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 53 of 59

ADMISSION

RESOLUTION

DTX # 314 315 316 317 318 319 320 321 322 323 324 325 326

Date of Doc.

Description

Bates Range PGK00004117 PGK000041200004150 PGK000041910004191 PGK000041930004194 PGK00004209 PGK000090900009108 PGK000092400009341 PGK000093530009363 PGK000093710009382 PGK000093890009411 PGK000095550009556 PGK000095770009631 PGK00009814

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, I, R I, H, R I, H, R I, H, R I, H, R I, H, R I, H, R I, H, R I, H, R C I, H, R H, R I, H, R

- 52 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 54 of 59

ADMISSION

RESOLUTION

DTX # 327 328 329 330 331 332 333 334 335 336 337 338 339

Date of Doc.

Description

Bates Range PGK000100510010057 PGK000103100010357 PGK000104660010643 PGK00013225 PGK000132370013403 PGK000134530013605 PGK000136260013714 PGK000137280013772 PGK000137990013805 PGK00013808 PGK000138120013817 PGK000139090013952 PGK000139820014148

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s C C C I, H, R C C I, H C I, H H, I, R H, I H C

- 53 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 55 of 59

ADMISSION

RESOLUTION

DTX # 340 341 342 343 344 345 346 347 348 349 350 351 352

Date of Doc.

Description

Bates Range PGK00014152 PGK00014173 PGK00014175 PGK00014205 PGK000145450014712 PGK000147160015235 PGK00015307 PGK000154810015541 PGK00015644 PGK000156460015648 PGK000171890017638 PGK000181580018162 PGK000222860022321

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, I H, I H, I H, I H, I C H, I H, I

N H, I C H, I C

- 54 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 56 of 59

ADMISSION

RESOLUTION

DTX # 353 354 355 356 357 358 359 360 361 362 363 364 365

Date of Doc.

Description

Bates Range PGK000228430022940 PGK0002285800864 PGK0002286500868 PGK000229390022942 PGK000229440022947 PGK000230570023064 PGK000231630023168 PGK000231720023175 PGK000233170023322 PGK000233260023328 PGK000234220023424 PGK000234700023471 PGK000234880023496

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s C H, R, I H, R, I H, R, I H, R, I H, R, I H, R, I H, R, I H, I H, I H, I H, I H, I

- 55 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 57 of 59

ADMISSION

RESOLUTION

DTX # 366 367 368 369 370 371 372 373 374 375 376

Date of Doc.

Description

Bates Range PGK000235320023534 PGK00023537 PGK000236270023631 PGK00023999 PGK00024184 PGK00024548 PGK000245520024553 PGK000250400025069

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s H, I H, I H H H, I H, I H, I H, I H, R M M

Letter from Vinita Ferrera to A. Pfeffer, April 24, 2006 Demonstratives 3/04/03 Merck & Co. v. Teva Pharmaceuticals USA, Inc., CV 01-048, Trial Volume Number 1, March 4, 2003

- 56 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 58 of 59

ADMISSION

RESOLUTION

DTX # 377

Date of Doc. 3/05/03

Description

Bates Range

Depo. Ex. No.1

No Obj

Obj Basis Comment Admitted Date s M

378

379

380 381 382 383 384

Merck & Co. v. Teva Pharmaceuticals USA, Inc., CV 01-048, Trial Volume Number 2, March 5, 2003 McClung, et al., "Risedronate 08/1997 Increases BMD at the Hip, Spine, and Radius in Postmenopausal Women With Low Bone Mass," J. Bone & Min. Res. 12(1): S169 (1997) Pharmacokinetics: Regulatory, 1995 Industrial, and Academic Perspectives, Chapter 12 (Peter G. Welling & Francis L. S. Tse eds., 2nd ed. 1995) PCT/US98/14796 PG0100603PG0100805 PG0097402PG0097637 US Patent No. 5,583,122 2006 FDA Orange Book, 26th Ed., pp. 3-311

H, R

H, R

R H, R H, R H, R A, H, I

Key to Plaintiff Merck's above specific objections: - 57 -

Case 1:04-cv-00939-GMS

Document 70-5

Filed 06/28/2006

Page 59 of 59

A B C H I M N

= Authenticity (Fed. R. Evid. 901) = Best Evidence Rule (Fed. R. Evid. 1002-1004) = Improper compilation of separate documents. Merck reserves the right to further object to any specific document in the compilation Teva proposes to use. = Hearsay (Fed. R. Evid. 801, 802) = Incompleteness. The submitted exhibit appears to be an incomplete document and/or is missing pages. = A copy of the exhibit was not provided by Teva, or Teva failed to sufficiently describe the document. Merck reserves the right to object to the exhibit after obtaining a copy, reviewing a physical exhibit, or receiving a sufficient description from Teva. = No objection, provided that the exhibit is introduced and authenticated by the appropriate sponsoring witness.

Priv = Merck has requested the return of this privileged document which was inadvertently produced. Q R S U = Not qualified opinion, conclusion, or summary (Fed. R. Evid. 702, 703); lack of foundation for opinion, conclusion, or summary = Relevance (Fed. R. Evid. 401, 402) = Inadmissible as compromise and offers to compromise (Fed. R. Evid. 408) = Unfair prejudice, confusion, waste of time, cumulative (Fed. R. Evid. 403)

Withdrawn = Teva has withdrawn the exhibit.

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