throbber
Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 1 of 8 PageID #:3348
`Case: 1:16—cv—00651 Document #: 114-3 Filed: 06/25/18 Page 1 of 8 PageID #:3348
`
`SECTION III-A
`
`SECTION III-A
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 2 of 8 PageID #:3349
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Joint Exhibit List
`
`Any description of a document on this Exhibit List is provided for convenience only and shall not be used as an admission or otherwise as evidence regarding the listed document or any other listed document.
`
`The listing of an Exhibit does not constitute an admission as to the admissibility of the Exhibit (i.e., a waiver of any applicable objection). Each party reserves the right to object to the relevance or admissibility of any Exhibit
`offered by the other party, at the time such Exhibit is offered, in view of the specific context in which such Exhibit is offered, or for any other reason as set forth in the Federal Rules of Evidence or other applicable principles of
`law.
`Beg Bates
`
`JTX
`
`Document Date Description
`
`End Bates
`
`Hospira Objections
`
`FK Objections
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`
`14
`15
`16
`
`17
`
`18
`19
`
`20
`
`21
`
`22
`
`23
`24
`
`25
`
`26
`
`27
`28
`
`U.S. Patent No. 8,648,106
`U.S. Patent No. 9,616,049
`U.S. Patent No. 8,455,527
`U.S. Patent No. 9,320,712
`US Patent No. 8,242,158
`US Patent No. 8,338,470
`File History of U.S. Patent No. 8,648,106
`Prosecution History for US Patent 9,616,049
`File History of U.S. Patent No. 8,455,527
`Prosecution History for US Patent 9,320,712
`File History of U.S. Patent No. 8,242,158
`File History of U.S. Patent No. 8,338,470
`ANDA Section 1.12.12 Comparison Between Generic
`Drug and RLD
`NDA No. 21-038 review package
`NDA No. 21-038 Final Printed Labeling
`President’s Message, “Dexmedetomidine and Hextend: Their Role in
`Trauma Care,” International Traumacare, 17(1):4-5 (2007) (“Cain”)
`Palmgren, “Drug Adsorption in Plastic Containers and Retention of Drugs in Cultured
`Cells Under In Vitro Conditions,” 64 Eur. J. Pharm. and
`Biopharmaceutics 369, 369-378 (2006) (“Palmgren”)
`US Patent No. 6,716,867 (“Aantaa”)
`J. Fanikos, “Premixed Products Improve Safe Medication Practices,” Pharmacy Practice
`News (November 2011) (“Fanikos”)
`Remington: The Science and Practice of Pharmacy, 21st edition (published 2006)
`(“Remington”)
`Walter F. Stanaszek et al., Comparison of Drug Stability in Glass Versus Plastic
`Containers: Analysis of Prefilled Syringe Admixtures, PROC. OKLA. ACAD. SCI. 58:102-
`105 (1978) (“Stanaszek”)
`De Giorgi et al., “Risk and pharmacoeconomic analyses of the injectable medication
`process in the pediatric and neonatal intensive care units,” Int’l J. Quality in Health Care,
`Vol. 22, No. 3 (Apr. 9, 2010) (“De Giorgi”)
`Lavoisier Sodium Chloride 09% injectable solution
`Gregory A. Sacha, et al., Practical Fundamentals of Glass, Rubber, and Plastic Sterile
`Packaging Systems, PHARM. DEV. TECH. 15(1):6-34 (2010) (“Sacha”)
`
`4/22/2013
`
`11/15/2012
`
`1/4/2012
`7/3/2012
`
`12/17/1999
`
`4/6/2004
`November 2011
`
`1978
`
`4/9/2010
`
`11/25/2009
`
`Sharp T.R., Calculated Carbon-Hydrogen Bond Dissociation Enthalpies for Predicting
`Oxidative Susceptibility of Drug Substance Molecules. INT. J. PHARM. 418:304-317
`(2011) (“Sharp”)
`Email chain re FINAL signed docs NPA
`
`10/9/2013
`
`HOSPIRA_00001039
`HOSPIRA_02500339
`HOSPIRA_00000707
`HOSPIRA_02499862
`HOSPIRA_00000001
`HOSPIRA_00000317
`FK-DEXMED 0000050
`
`HOSPIRA_00001178
`HOSPIRA_02500921
`HOSPIRA_00001038
`HOSPIRA_02500338
`HOSPIRA_00000316
`HOSPIRA_00000706
`FK-DEXMED 0000051
`
`F, H, P
`F, H, P
`F, H, P, R
`F, H, P, R
`F, H, P, R
`F, H, P, R
`F, H, P, X, Y
`
`FK-DEXMED 0005774
`FK-DEXMED 0005820
`FK-DEXMED 0005834
`
`FK-DEXMED 0005819
`FK-DEXMED 0005833
`FK-DEXMED 0005835
`
`F, H, P, D
`F, H, P
`
`FK-DEXMED 0005841
`
`FK-DEXMED 0005850
`
`F, H, P
`
`R, F
`
`FK-DEXMED 0005898
`FK-DEXMED 0006017
`
`FK-DEXMED 0005908
`FK-DEXMED 0006018
`
`FK-DEXMED 0006019
`
`FK-DEXMED 0006032
`
`FK-DEXMED 0006033
`
`FK-DEXMED 0006036
`
`F, H, P
`F, H, P
`
`F, H, P
`
`F, H, P
`
`FK-DEXMED 0006090
`
`FK-DEXMED 0006098
`
`F, H, P
`
`FK-DEXMED 0006133
`FK-DEXMED 0195975
`
`FK-DEXMED 0006134
`FK-DEXMED 0196004
`
`F, H, P
`F, H, P
`
`FK-DEXMED 0197882
`
`FK-DEXMED 0197895
`
`F, H, P
`
`FK-DEXMED0088049
`
`FK-DEXMED0088060
`
`F, H
`
`4/12/2004
`8/8/2013
`
`Separation and Distribution Agreement - Abbott Laboratories and Hospira Inc
`Email re Cross-Functional NPA Meeting on Aug 08, 2013: Meeting minutes
`
`FK-DEXMED0196497
`FX-DEXMED0193120
`
`FK-DEXMED0196526
`FX-DEXMED0193126
`
`Au, F, H, P, X
`F, H, K
`
`1
`
`R, AU, F, Y (bates range includes
`attachment)
`
`P, R, Y (bates range includes
`attachment)
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 3 of 8 PageID #:3350
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Joint Exhibit List
`
`JTX
`
`Document Date Description
`
`Beg Bates
`
`End Bates
`
`Hospira Objections
`
`FK Objections
`
`29
`
`30
`31
`32
`33
`34
`35
`36
`
`37
`
`38
`39
`40
`
`41
`42
`43
`44
`45
`46
`47
`48
`
`49
`50
`51
`
`52
`53
`54
`55
`
`56
`57
`58
`
`59
`60
`61
`
`62
`
`63
`64
`65
`66
`
`5/28/2015
`
`Email re Dexmed RTU PHB
`
`FX-DEXMED0194719
`
`FX-DEXMED0194754
`
`11/30/1999
`10/12/2012
`12/14/1998
`12/18/1998
`12/14/1998
`3/17/1989
`2/28/1990
`
`3/19/1990
`
`10/10/1990
`February 1991
`5/10/2004
`
`3/6/2015
`
`6/5/2013
`4/2-3/2013
`7/2009
`
`1/24/2011
`8/22/2012
`
`6/2014
`
`2/2008
`
`2/11/2013
`
`FDA Memorandum by Cynthia G. McCormick, M.D.
`NDA 021038 Prior Approval Supplement re 50 ml and 100 ml premix
`NDA 21-038 Section 4.3 portions
`NDA 21-038 Section 4.3 portions (cntd.)
`NDA 21-038 re Phase I studies
`Farmos Group Ltd., Dexmedetomidine IND
`Letter and enclosures re Investigational New Drug Application 32,934: Dexmedetomidine
`hydrochloride injection
`Letter and enclosures re Investigational New Drug Application 32,934: Dexmedetomidine
`hydrochloride injection
`IND 32,934 Clinical Protocol CL-0690
`Stability data re Batch OK 029 L1
`Letter from K. Patterson to FDA re IND 32,934 - Precedex® (Dexmedetomidine
`Hydrochloride Injection)
`Precedex Overview Presentation Deck
`20 mL Precedex Premix Launch
`Staging Precedex Premix Conversions
`Strong Finish to 2014 Slide
`Precedex Premix Return to Market Deck
`Precedex Premix Launch Update Deck
`Precedex Premix Launch Deck
`Decision Development Inc., Precedex® Pre-Mix
`Research Presentation to Hospira, Inc. (July 2009)
`Launch of Premixed Precedex Market research findings report deck
`Precedex US Commercial Deep Dive Deck
`Development Report for Precedex Injection - Hospira Scientific Report (4-2-2010)
`
`Decision Development Inc. Presentation - 2014
`Premix Market Research Deck
`2013 Kickoff Deck
`Barr, et al., Clinical Practice Guidelines for the Management of Pain, Agitation, and
`Delirium in Adult Patients in the Intensive Care Unit, Critical Care Medicine, 41(1):263
`(2013)
`Precedex Premix Deck
`2014 Plan - Precedex Promo Budget excel
`Precedex Qualitative Market Research Deck - Decision Development Inc 2008
`
`Hospira Stability Data
`Letter to customer re Precedex Premix approval
`Development Report for Precedex Injection 4 mcg-mL initiated by Skora Rev 2.0
`
`HOSPIRA_00000394
`HOSPIRA_00001187
`HOSPIRA_00006525
`HOSPIRA_00006854
`HOSPIRA_00132543
`HOSPIRA_00308480
`HOSPIRA_00311242
`
`HOSPIRA_00000403
`HOSPIRA_00002305
`HOSPIRA_00006853
`HOSPIRA_00007185
`HOSPIRA_00132920
`HOSPIRA_00311241
`HOSPIRA_00311415
`
`HOSPIRA_00311416
`
`HOSPIRA_00312432
`
`HOSPIRA_00312433
`HOSPIRA_00312601
`HOSPIRA_00356713
`
`HOSPIRA_00500884
`HOSPIRA_00501917
`HOSPIRA_00502426
`HOSPIRA_00502505
`HOSPIRA_00503023
`HOSPIRA_00504215
`HOSPIRA_00504816
`HOSPIRA_00507545
`
`HOSPIRA_00507586
`HOSPIRA_00543429
`HOSPIRA_00545097
`
`HOSPIRA_00595931
`HOSPIRA_00606976
`HOSPIRA_00607301
`HOSPIRA_00610077
`
`HOSPIRA_00610467
`HOSPIRA_00658437
`HOSPIRA_00661235
`
`HOSPIRA_00737251
`HOSPIRA_00801235
`HOSPIRA_00856539
`
`HOSPIRA_00312522
`HOSPIRA_00312607
`HOSPIRA_00356721
`
`HOSPIRA_00500901
`HOSPIRA_00501944
`HOSPIRA_00502428
`HOSPIRA_00502505
`HOSPIRA_00503037
`HOSPIRA_00504230
`HOSPIRA_00504861
`HOSPIRA_00507585
`
`HOSPIRA_00507626
`HOSPIRA_00543457
`HOSPIRA_00545168
`
`HOSPIRA_00595994
`HOSPIRA_00606992
`HOSPIRA_00607327
`HOSPIRA_00610120
`
`HOSPIRA_00610501
`HOSPIRA_00658462
`HOSPIRA_00661272
`
`HOSPIRA_00737276
`HOSPIRA_00801269
`HOSPIRA_00856610
`
`Development Report for Precedex LE Injection Rev 1.0 authored by Roychowdhury
`
`HOSPIRA_00877283
`
`HOSPIRA_00877323
`
`8/11/2014
`3/12/2013
`6/2013
`12/17/1999
`
`Precedex 20 mL Premix launch discussion
`Precedex Premix Launch Readiness Review
`Precedex™ Label, updated June 2013
`Approval letter re NDA 21-038
`
`HOSPIRA_00879052
`HOSPIRA_00885114
`HOSPIRA_00901665
`HOSPIRA_00903128
`
`HOSPIRA_00879056
`HOSPIRA_00885125
`HOSPIRA_00901688
`HOSPIRA_00903145
`
`2
`
`F, H, K
`
`F, H, P
`V, X, Y
`Y, F, K
`F, K
`F, H, P
`V, AU
`AU, X
`
`AU, X
`
`F, P
`K, AU
`F, H, P
`
`F, H, K, S
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`K, H
`
`F, H, P, R, K
`V, F
`F, K
`
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`H, K
`
`F, H, P, R, K
`F, H, P, R, K
`H, K
`
`F, H, K
`F, H, K, R
`
`F, H, P
`
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R
`F, H, P
`
`P, R, Y (bates range includes
`attachment)
`H, R
`H, R
`H, R
`H, R
`H, R
`
`R
`
`R
`
`R, X
`
`H, R
`H, R
`H, R
`H, R
`H, R
`H, R
`H, R
`H, R
`
`H, R
`H, R
`H, R
`
`H, R
`H, R
`H, R
`H, R
`
`H, R
`H, R
`H, R
`
`H, R, Y
`H, R
`H, R
`
`H, R, F
`
`H
`H
`H, R
`H
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 4 of 8 PageID #:3351
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Joint Exhibit List
`
`JTX
`
`Document Date Description
`
`Beg Bates
`
`End Bates
`
`Hospira Objections
`
`FK Objections
`
`Development Report for Precedex LE Injection 4ug/mL, 20 mL, 50 mL and 100 mL
`
`HOSPIRA_01098606
`
`HOSPIRA_01098646
`
`F, H, P, R, K
`
`67
`
`68
`69
`70
`71
`72
`73
`
`74
`75
`76
`77
`
`78
`79
`80
`81
`82
`83
`84
`85
`86
`87
`88
`89
`90
`91
`92
`93
`94
`95
`96
`97
`98
`99
`100
`101
`
`102
`
`103
`
`104
`105
`106
`107
`108
`
`3/13/2013
`
`9/22/2006
`3/7/2008 &
`3/14/2008
`8/30/2007
`
`10/31/2006
`7/14/2004
`
`10/27/2006
`10/21/2008
`5/15/2003
`6/12/2009
`11/14/2007
`8/2015
`8/27/2015
`8/28/2013
`5/23/2013
`9/8/2014
`
`5/16/2013
`
`10/27/2016
`5/24/2016
`
`5/1999
`
`4/2004
`
`3/2016
`7/28/2004
`4/16/2004
`
`Precedex Injection March 13, 2013 A Day that will go Down in History
`Laboratory Notebook Excerpt - 00737
`Laboratory Notebook Excerpt - 00738
`Chart re Precedex Line Extension
`Hospira Product Development Concept Proposal
`Precedex Line Extension Meeting Minutes
`
`HOSPIRA_01124546
`HOSPIRA_01138634
`HOSPIRA_01138637
`HOSPIRA_01138677
`HOSPIRA_01140245
`HOSPIRA_01145154
`
`HOSPIRA_01146197
`Precedex Line Extension Meeting Minutes
`HOSPIRA_01146265
`Precedex Line Extension Meeting Minutes (2-2-2007)
`HOSPIRA_01150882
`Email re Precedex Line Extension Core Team Meeting Minutes for 10/27/06
`Letter enclosing Amendment to License and Supply Agreement dated September 9, 1994 HOSPIRA_01768591
`
`HOSPIRA_01846472
`HOSPIRA_01982846
`HOSPIRA_02013574
`HOSPIRA_02119137
`HOSPIRA_02156189
`HOSPIRA_02481930
`HOSPIRA_02482111
`HOSPIRA_02482796
`HOSPIRA_02482812
`HOSPIRA_02483045
`HOSPIRA_02484931
`HOSPIRA_02485552
`HOSPIRA_02485615
`HOSPIRA_02497376
`HOSPIRA_02497451
`HOSPIRA_02497608
`HOSPIRA_02497770
`HOSPIRA_02497937
`HOSPIRA_02498026
`HOSPIRA_02498190
`HOSPIRA_02498345
`HOSPIRA_02498510
`HOSPIRA_02498544
`HOSPIRA_02498545
`
`NDA 21-038 Supplement
`Decision Development Inc. script
`Fax enclosing Amendment to Orion License Agreement
`Market Research Supplier Agreement
`Letter re Decision Development Inc. engagement with Hospira, Inc.
`US Pharma August 2015 Financial Review
`Email re Precedex Plan V2.0
`Precedex Premix Return to Market Deck
`Precedex Premix Meeting Deck
`Email re ACCS LEADERSHIP NEWS: SEPTEMBER 8, 2014 EDITION
`Letter re production of Precedex Premix
`Release re HOSPIRA announces allocation for Precedex
`Talking Points - Precedex Premix Constrained Supply
`Sales data through Q2 2015
`Laboratory Notebook - 01123
`Laboratory Notebook - 01572
`Laboratory Notebook - 01729
`Laboratory Notebook - 01236
`Laboratory Notebook - 02282
`Laboratory Notebook - 02294
`Sales data through Q2 2016
`Precedex Premix Value Proposition Evaluation
`Precedex margin and price data
`FDA, Guidance for Industry: Container Closure Systems for Packaging Human Drugs and
`Biologics
`Webb, P. et al., "Ensure Safety, Efficacy of Ready-to-Use IV Drug Products," PFQ Vol.
`11, No. 6, Oct/Nov. 2009
`Dahlstrom et al., “Impact of polymer surface affinity of novel antifouling agents,” 86(1)
`BIOTECH. BIOENG. 1-8 (Apr. 2004)
`J. Anes, Use of Plastics for Parenteral Packaging
`Precedex Prescribing Information (rev. 5/2016)
`Prescribing Information Precedex
`Recordation Form Cover Sheet Patents Only, Reel 014921 / Frame 0536
`Tax Sharing Agreement between Abbott Laboratories and Hospira Inc.
`
`HOSPIRA_01124549
`HOSPIRA_01138636
`HOSPIRA_01138653
`HOSPIRA_01138679
`HOSPIRA_01140253
`HOSPIRA_01145156
`
`HOSPIRA_01146198
`HOSPIRA_001146268
`HOSPIRA_01150883
`HOSPIRA_01768600
`
`HOSPIRA_01846521
`HOSPIRA_01982855
`HOSPIRA_02013730
`HOSPIRA_02119141
`HOSPIRA_02156193
`HOSPIRA_02481958
`HOSPIRA_02482113
`HOSPIRA_02482810
`HOSPIRA_02482819
`HOSPIRA_02483047
`HOSPIRA_02484931
`HOSPIRA_02485552
`HOSPIRA_02485615
`HOSPIRA_02497376
`HOSPIRA_02497519
`HOSPIRA_02497769
`HOSPIRA_02497936
`HOSPIRA_02498025
`HOSPIRA_02498189
`HOSPIRA_02498344
`HOSPIRA_02498345
`HOSPIRA_02498543
`HOSPIRA_02498544
`HOSPIRA_02498600
`
`F, H, P, R
`F, K
`F, K
`F, K, H
`D, F, K, H
`F, K
`
`F, K
`F, K
`F, H, P, R
`F, H, P
`
`F, H, P
`F, H, P
`F, H, P
`F, H, P
`F, H, P
`F, H, P, R, K
`F, H, K, S
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`F, K
`F, K
`F, K
`F, K
`V, F
`V, F
`F, H, P, R, K
`F, H, P, R, K
`F, H, P, R, K
`F, H, P
`
`F, H, P
`
`F, H, P
`
`F, H, P
`F, P
`F, H, P, D
`K
`F, H, P
`
`HOSPIRA_02498601
`
`HOSPIRA_02498604
`
`HOSPIRA_02498605
`
`HOSPIRA_02498612
`
`HOSPIRA_02498613
`HOSPIRA_02498671
`HOSPIRA_02501013
`HOSPIRA_02501036
`HOSPIRA_02501064
`
`HOSPIRA_02498670
`HOSPIRA_02498693
`HOSPIRA_02501035
`HOSPIRA_02501063
`HOSPIRA_02501092
`
`3
`
`H
`
`H, F
`H
`H
`H
`H
`H
`
`H
`H
`H, F
`H
`
`H, F
`H, F
`H
`H, F
`H, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H
`H
`H
`H
`H
`H
`H
`H
`H, R, AU, F
`H, R, AU, F
`H
`
`H
`
`H
`
`H
`
`H, R, AU, F
`H, R, AU, F
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 5 of 8 PageID #:3352
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Joint Exhibit List
`
`JTX
`
`Document Date Description
`
`Beg Bates
`
`End Bates
`
`Hospira Objections
`
`FK Objections
`
`4/12/2004
`
`Separation and Distribution Agreement Abbott Laboratories and Hospira Inc
`Dexmedetomidine License and Supply Agreement Orion Corp and Abbott Laboratories
`
`HOSPIRA_02501093
`HOSPIRA_02501571
`
`HOSPIRA_02501570
`HOSPIRA_02501705
`
`HOSPIRA_02501706
`HOSPIRA_02501707
`HOSPIRA_02501708
`HOSPIRA_02501997
`
`HOSPIRA_02502069
`HOSPIRA_02502075
`HOSPIRA_02502082
`
`HOSPIRA_02501706
`HOSPIRA_02501707
`HOSPIRA_02501826
`HOSPIRA_02502068
`
`HOSPIRA_02502074
`HOSPIRA_02502081
`HOSPIRA_02502098
`
`HOSPIRA_02502099
`
`HOSPIRA_02502123
`
`HOSPIRA_02502144
`
`HOSPIRA_02502171
`
`F, H, P, D
`F, H, P
`
`F, H, P, R, K
`F, H, P, R, K
`F, H, P
`F, H, P
`
`F, H, P
`F, H, P
`F, H, P
`
`F, H, P
`
`H, F, K
`
`109
`110
`
`111
`112
`113
`114
`
`115
`116
`117
`
`118
`
`119
`
`120
`121
`122
`123
`
`124
`125
`
`126
`
`127
`
`128
`
`129
`130
`
`131
`132
`
`133
`
`134
`135
`136
`
`4/16/2004
`
`3/25/2010
`
`4/2017
`3/25/2011
`
`7/2008
`
`2009
`
`Chart re Net Sales
`Chart re Medication Sales by each Medication
`Letter to Shareholders and Information Statement
`Boyd, Donald B., The Power of Computational Chemistry to Leverage Stress Testing of
`Pharmaceuticals (Ch. 12) (2005)
`FDA.gov - Investigative New Drug (IND) Application
`Impurities in Drug Substances and Drug Products
`Guidance of Industry ANDAs: Stability Testing of Drug Substances and Products (May
`2014)
`Guidance for Industry Q1A(R2) Stability Testing of New Drug Substances and Products
`(November 2003)
`BIO, Clinical Development Success Rates 2006-2015
`(https://www.bio.org/sites/default/files/Clinical%20Development%20Success%20Rates%2
`02)
`006-2015%20-%20BIO,%20Biomedtracker,%20Amplion%202016.pdf
`Stability of dexmedetomidine in polypropylene syringes
`Ativan (lorazepam) Injection Label
`Bioalliance, WO 2010/031819 A1
`C.E. Blogg, M.A.E. Ramsay, and J.D. Jarvis, “Infection Hazard
`from Syringes,” Br. J. Anaesth., 46, pp. 260-262 (1974)
`Diprivan Label, Revised: April 2017
`FDA, Advisory to Drug Manufacturers: Formation of Glass Lamellae
`in Certain Injectable Drugs (Mar. 25, 2011)
`Anesthesiology Core Review: Chap. 55
`(http://accessanesthesiology.mhmedical.com/content.aspx?bookid=974&sectionid=615879
`29)
`FDA Orange Book listing re Precedex -
`https://www.accessdata.fda.gov/scripts/cder/ob/patent_info.cfm?Product_No=004&Appl_
`No=021038&A
`ppl_type=N
`FDA.gov, Information for Outsourcing Facilities
`(https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompo
`unding/ucm393571.htm)
`PharMEDium, About PharMEDium (https://www.pharmedium.com/company/)
`PharMEDium, Critical Care (https://www.pharmedium.com/compounded-services/critical-
`care/)
`Midazolam Label, Revised March 2017
`PhRMA, “The Facts About Pharmaceutical Marketing & Promotion,” July 2008,
`http://www.phrma.org/sites/default/files/pdf/marketing_and_promotion_facts_071108_fina
`l.pdf
`
`Rahul Guha, Jian Li, and Andrea L. Scott, “The Economics of Commercial Success in
`Pharmaceutical Patent Litigation,” Landslide 1.5 (2009)
`U.S. Patent No. 4,910,214
`US Patent 9,649,296
`US Patent 9,717,796
`
`H, R, AU, F
`H, R, AU, F
`
`H, R, AU, F
`H, R, AU, F
`
`H, R, AU, F
`
`H, R, AU, F
`
`H, R
`
`H, R
`H, AU, F
`
`H, R
`
`HOSPIRA_02502192
`HOSPIRA_02502195
`HOSPIRA_02502212
`HOSPIRA_02502278
`
`HOSPIRA_02502194
`HOSPIRA_02502211
`HOSPIRA_02502277
`HOSPIRA_02502280
`
`HOSPIRA_02502281
`HOSPIRA_02502335
`
`HOSPIRA_02502334
`HOSPIRA_02502337
`
`H, K
`Au, F, H, P, R
`F, H, P, R
`K, H
`
`Au, F, H, P, R
`F, H, K
`
`HOSPIRA_02502338
`
`HOSPIRA_02502340
`
`Au, F, H, P, R
`
`HOSPIRA_02502347
`
`HOSPIRA_02502348
`
`Au, F, H, P, R, X
`
`HOSPIRA_02502377
`
`HOSPIRA_02502379
`
`F, H, K
`
`H, R
`
`HOSPIRA_02502389
`HOSPIRA_02502397
`
`HOSPIRA_02502396
`HOSPIRA_02502404
`
`HOSPIRA_02502405
`HOSPIRA_02502457
`
`HOSPIRA_02502456
`HOSPIRA_02502480
`
`H, K
`F, H, P
`
`F, H, P, R
`F, H, P
`
`H, R, AU, F
`H, R, AU, F
`
`H, R
`H, R, AU, F
`
`HOSPIRA_02502481
`
`HOSPIRA_02502485
`
`Au, F, H, P, R
`
`H, R, AU, F
`
`HOSPIRA_02502487
`HOSPIRA_02502492
`HOSPIRA_02502498
`
`HOSPIRA_02502491
`HOSPIRA_02502497
`HOSPIRA_02502503
`
`F, H, P, R
`F, H, P
`F, H, P
`
`R
`R
`
`4
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 6 of 8 PageID #:3353
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Joint Exhibit List
`
`JTX
`
`Document Date Description
`
`Beg Bates
`
`End Bates
`
`Hospira Objections
`
`FK Objections
`
`137
`
`138
`139
`140
`141
`142
`143
`144
`145
`146
`147
`
`148
`
`149
`
`150
`
`151
`
`152
`
`153
`
`154
`
`155
`
`Westfall, Clinical Trials Simulation: A Statistical Approach, 18 Journal of
`Biopharmaceutical Statistics 611–630 (2008)
`Expert Report of Andrew W. Carter Exhibit 1 - CV
`Expert Report of Andrew W. Carter Exhibit 3 - Timeline of Events
`Expert Report of James J. White Exhibit A - CV
`Opening Expert Report of Michael Ramsay Exhibit A - CV
`Opening Expert Report of Robert Linhardt, PH.D Exhibit A - CV
`Rebuttal Expert Report of Christopher Seaton Exhibit A - CV
`Rebuttal Expert Report of Michael Ramsay Exhibit A - CV
`Rebuttal Expert Report of Stephan Ogenstad, PHD Exhibit A - CV
`Rebuttal Report of Eric Sheinin Exhibit A - CV
`Defendant Fresenius Kabi USA, LLC's Responses to Plaintiff Hospira, Inc.'s First Set of
`Requests for the Production of Documents and Things (Nos. 1-37)
`Fresenius Kabi USA, LLC's Response to Plaintiff's First Set of Interrogatories (Nos. 1-8)
`
`Hospira's Notice of Deposition of Defendant Fresenius Kabi USA, LLC Pursuant to Fed. R.
`Civ. P. 30(b)(6)
`Defendant Fresenius Kabi's Objections and Responses to Plaintiff Hospira's Notice of Rule
`30(b)(6) Deposition Topics
`Fresenius Kabi USA, LLC's Supplemental Objections and Responses to Plaintiff's
`Interrogatory Nos. 1, 4-8
`Fresenius Kabi USA, LLC's Responses to Plaintiff Hospira, Inc's First Set of Requests for
`Admissions (Nos. 1-50)
`Fresenius Kabi USA, LLC's Second Supplemental Objections and Responses to Plaintiff's
`Interrogatory Nos. 1, 5, 6, and 8
`Fresenius Kabi USA, LLC's Responses to Plaintiff Hospira, Inc's Second Set of
`Interrogatories (Nos. 9-12)
`Fresenius Kabi USA, LLC's Responses to Plaintiff Hospira, Inc's Second Set of Requests
`for Admission (Nos. 51-56)
`
`6/9/2016
`
`6/9/2016
`
`9/2/2016
`
`9/29/2016
`
`9/30/2016
`
`10/6/2016
`
`11/30/2016
`
`3/7/2018
`
`3/7/2018
`
`HOSPIRA_02502521
`
`HOSPIRA_02502540
`
`H, K
`
`H
`
`D
`
`F, P, R, H
`
`F, P, R
`
`R, H, LC
`
`F, P, R, H
`
`F, P, R, H
`
`F, P, R, H
`
`F, P, R, H
`
`F, P, R, H
`
`H, R
`
`H
`H, R, AU, F
`H
`H
`H
`H
`H
`H
`H
`R
`
`R, X (for responses later
`supplemented)
`R, B
`
`R, X (for responses later
`supplemented)
`
`5
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 7 of 8 PageID #:3354
`OBJECTIONS KEY
`
`
`
`Objection
`
`Argumentative
`
`Attorney objections not removed
`
`Authenticity or Identification (FRE 901)
`
`Violates Best Evidence Rule (FRE 1002-1004)
`
`Compound
`
`Duplicative/Cumulative
`
`Lack of Foundation (FRE 602)
`
`Hearsay/Improper Use of Deposition (FRE 801-802: FRCP 32)
`
`Improper/Incomplete Designation (FRE 106: FRCP 32(a)(6))
`
`Improper Counter-Designation (FRE 106: FRCP 32(a)(6))
`
`Improper Designation of a Witness To Be Called Live (FRCP 32)
`
`Improper Lay or Expert Opinion (FRE 701-703)
`
`Lack of Personal Knowledge/Incompetent (FRE 602)
`
`Improper Legal Conclusion (FRE 403)
`
`Misleading/Mischaracterizes Prior Testimony
`
` Mischaracterizes Underlying Document (FRE 401-403)
`
`Assumes Facts Not In Evidence (FRE 103)
`
`Nonresponsive
`
`Prejudice/Confusion/Delay/Waste of Time (FRE 403)
`
`Relevance (FRE 401/402)
`
`Calls for Speculation (FRE 602)
`
`Code
`
`A
`
`AT
`
`AU
`
`B
`
`C
`
`D
`
`F
`
`H
`
`I
`
`IC
`
`ID
`
`IO
`
`K
`
`LC
`
`M
`
`MD
`
`NE
`
`NR
`
`P
`
`R
`
`S
`
`SC
`
`Beyond the Scope of the Witness's Testimony as a Corporate Representative
`
`U
`
`V
`
`X
`
`Improper Use Against Other Parties or For Other Purposes (FRE 105)
`
`Vague/Ambiguous/Overbroad
`
`Incomplete Document (FRE 106)
`
`

`

`Case: 1:16-cv-00651 Document #: 114-3 Filed: 06/25/18 Page 8 of 8 PageID #:3355
`
`Wrong Document or Incorrectly Described
`
`Reserved Because Exhibit Has Not Been Provided, the Copy Provided is Illegible, and/or the Entry Includes
`Multiple Documents
`
`Y
`
`Z
`
`
`
`

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