Case: 1:16-cv-00651 Document #: 114-4 Filed: 06/25/18 Page 1 of 3 PageID #:3356
`Case: 1:16—cv—00651 Document #: 114-4 Filed: 06/25/18 Page 1 of 3 PageID #:3356
`
`SECTION III-B
`
`SECTION III-B
`
`

`

`Case: 1:16-cv-00651 Document #: 114-4 Filed: 06/25/18 Page 2 of 3 PageID #:3357
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Hospira's Exhibit List
`
`Hospira’s Exhibit List contains the Exhibits that it may present at trial other than for impeachment / cross-examination. Hospira reserves the right to supplement this list in good faith as the case
`progresses.
`
`Any description of a document on an 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). Hospira reserves the right to object to the relevance or
`admissibility of any Exhibit offered by Fresenius Kabi, 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
`
`PTX
`
`Document Date Description
`
`End Bates
`
`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
`29
`30
`
`9/2015
`
`Precedex label
`ANDA Sec. 2.3Quality Overall Summary in Quality-based Review (QbR) (Dexmedetomidine
`Hydrochloride in 0.9% Sodium Chloride Injection, 4ug/mL, Terminally Sterilized)
`
`FK-DEXMED 0000072
`FK-DEXMED 0000340
`
`FK-DEXMED 0000093
`FK-DEXMED 0000341
`
`R, F
`
`6/26/2014
`
`ANDA 3.2.P.2 Pharmaceutical Development
`ANDA 3.2.P.5.1 Specifications
`Fresenius Kabi ANDA PR-14-00252 Final Report
`Fresenius Kabi ANDA stability data
`
`7/18/2013
`9/5/2012
`10/12/2015
`1/22/2014
`11/4/2013
`11/4/2013
`6/30/2015
`7/24/2015
`9/24/2015
`11/19/2015
`4/2/2014
`7/19/2014
`
`11/2012
`
`10/2016
`1/4/2012
`8/16/2013
`4/2/2010
`
`3/13/2013
`11/15/2014
`
`4/23/2012
`
`Scenarios for Expedited Development
`Email re DexmedRTU
`Email re Assistance for bus reviews
`Email chain between c. Nguyen and J. Kao (with attachment)
`Email re Dexmedetomidine RTU NPA
`Attachment to Email re Dexmedetomidine RTU NPA
`Email re Impact of missing leachables data for Dexmed RTU submission
`Email re Dexmedetomidine RTU Stability Testing Meeting Discussion
`Email re Dexmed RTU Stage Gate - Please Review (with attachment)
`Email re dexmed RTU cleaning method
`Email chain between P. Torralba and C. Nguyen
`Dexmedetomidine RTU (US)
`Fresenius Kabi Minutes
`FK Project Review Presentation
`ANDA 1.11 Information Request - Quality
`Fresenius Kabi Proposed Dexmedetomidine Hydrochloride Label
`Patent Assignment record
`NDA 021038 Prior Approval Supplement re 20 ml premix
`Development Report for Precedex Injection 4 mcg-mL initiated by Skora Rev 1.0
`
`FDA Approval Letter for NDA 21-038 S-020
`Email re Precedex Supplements 19, 24, and 26 Approved
`Precedex sNDA Master Production Batch Records
`FDA Letter re NDA 021038 S-019, S-024, and S-026 approval
`Amended Clinical Study Report
`
`1
`
`FK-DEXMED 0000654
`FK-DEXMED 0001364
`FK-DEXMED 0001494
`FK-DEXMED 0194960
`
`FK-DEXMED 0000706
`FK-DEXMED 0001365
`FK-DEXMED 0001568
`FK-DEXMED 0195036
`
`FK-DEXMED0013437
`FK-DEXMED0013634
`FK-DEXMED0085334
`FK-DEXMED0085627
`FK-DEXMED0088903
`FK-DEXMED0088916
`FK-DEXMED0098996
`FK-DEXMED0099115
`FK-DEXMED0099225
`FK-DEXMED0099259
`FK-DEXMED0116399
`FK-DEXMED0147554
`FK-DEXMED0161128
`FK-DEXMED0161493
`FK-DEXMED0194885
`FK-DEXMED0195190
`HOSPIRA_00001179
`HOSPIRA_00002306
`HOSPIRA_00872188
`
`HOSPIRA_00876644
`HOSPIRA_00878588
`HOSPIRA_00920816
`HOSPIRA_00947428
`HOSPIRA_01069529
`
`FK-DEXMED0013442
`FK-DEXMED0013634
`FK-DEXMED0085336
`FK-DEXMED0085630
`FK-DEXMED0088903
`FK-DEXMED0088917
`FK-DEXMED0098997
`FK-DEXMED0099117
`FK-DEXMED0099227
`FK-DEXMED0099260
`FK-DEXMED0116400
`FK-DEXMED0147580
`FK-DEXMED0161134
`FK-DEXMED0161501
`FK-DEXMED0194903
`FK-DEXMED0195210
`HOSPIRA_00001186
`HOSPIRA_00003341
`HOSPIRA_00872259
`
`HOSPIRA_00876652
`HOSPIRA_00878589
`HOSPIRA_00920879
`HOSPIRA_00947464
`HOSPIRA_01073289
`
`R, F
`R, F
`R, F
`Y (bates range includes multiple
`docs)
`R, AU, F, H, S
`R, AU, F, H
`R, AU, F, P, S
`R, AU, F, P, S
`R, AU, F, P, S
`R, AU, F, P, S
`R, AU, F
`R, AU, F
`R, AU, F
`R, AU, F
`P, R
`P, R
`P, R
`P, R
`P, R
`P, R
`AU, H, R
`H, R
`H, R, AU, F
`
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`H, R, AU, F
`
`

`

`Case: 1:16-cv-00651 Document #: 114-4 Filed: 06/25/18 Page 3 of 3 PageID #:3358
`Hospira, Inc. v. Fresenius Kabi USA, LLC, C.A. Nos. 16-cv-00651, 17-cv-7903 (ND. Ill.)
`Hospira's Exhibit List
`
`PTX
`
`Document Date Description
`
`Beg Bates
`
`End Bates
`
`FK Objections
`
`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
`
`8/20/2007
`4/14/2008
`4/17/2009
`
`12/5/2007
`
`6/6/2008
`5/16/2008
`7/25/2008
`
`4/18/2008
`10/24/2008
`9/21/2007
`1/31/2007
`12/17/1999
`8/1/2016
`
`Laboratory Notebook Excerpt - 02418
`Email re Precedex update
`Email re ResourcePlan
`Email re Precedex assay specifications
`Report re Helvoet Omniflex stoppers
`Email re Precedex Filter Compatibility
`Scientific Report re Precedex RTU stability data
`Precedex Line Extension Meeting Minutes
`Precedex Line Extension Meeting Minutes
`Precedex Extension Meeting Minutes
`Precedex LE PTR Deck
`Precedex Line Extension Meeting Minutes
`Precedex Line Extension Meeting Minutes
`Precedex Line Extension Meeting Minutes
`Email re Precedex - Line Extension - Plastics discussion on 1/30/07
`FDA Approval Letter re Precedex Concentrate
`Stopper Impurity by Ion Trap LC-MS and LC-MS/MS
`Laboratory Notebook - 01539
`Laboratory Notebook - 02117
`W. Jenkins, PACKAGING DRUGS AND PHARMACEUTICALS (1993)
`
`HOSPIRA_01138654
`HOSPIRA_01142923
`HOSPIRA_01143119
`HOSPIRA_01144073
`HOSPIRA_01144225
`HOSPIRA_01144236
`HOSPIRA_01144356
`HOSPIRA_01144669
`HOSPIRA_01145430
`HOSPIRA_01145676
`HOSPIRA_01145686
`HOSPIRA_01146210
`HOSPIRA_01146233
`HOSPIRA_01147912
`HOSPIRA_01150810
`HOSPIRA_01971227
`HOSPIRA_02468291
`HOSPIRA_02497520
`HOSPIRA_02498346
`HOSPIRA_02501967
`
`HOSPIRA_01138655
`HOSPIRA_01142926
`HOSPIRA_01143119
`HOSPIRA_01144074
`HOSPIRA_01144230
`HOSPIRA_01144238
`HOSPIRA_01144380
`HOSPIRA_01144670
`HOSPIRA_01145432
`HOSPIRA_01145677
`HOSPIRA_01145700
`HOSPIRA_01146211
`HOSPIRA_01146234
`HOSPIRA_01147913
`HOSPIRA_01150810
`HOSPIRA_01971231
`HOSPIRA_02468308
`HOSPIRA_02497607
`HOSPIRA_02498509
`HOSPIRA_02501973
`
`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, 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, R, AU, F
`H
`H
`R
`
`Technical Report No. 5 Sterile Pharmaceutical Packaging: Compatibility and Stability
`
`HOSPIRA_02501974
`
`HOSPIRA_02501996
`
`R, F, AU
`
`LES, Licensing Executives Society (USA & Canada) Announces 2010 Deals of Distinction
`Awards (https://lesusacanada.site-ym.com/news/266230/Licensing-
`Executives-Society-USA--Canada-Announces-2010-Deals-of-Distinction-Awards.htm)
`
`HOSPIRA_02502341
`
`HOSPIRA_02502346
`
`H, R, AU, F
`
`Drugs.com, Benzodiazepenes: Overview and Use
`(https://www.drugs.com/article/benzodiazepines.html)
`FDA.gov, Drug Master Files
`(https://www.fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/Dru
`gMasterFilesDMFs/default.htm)
`FDA.gov, The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
`(https://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143534.htm)
`
`HOSPIRA_02502349
`
`HOSPIRA_02502361
`
`HOSPIRA_02502362
`
`HOSPIRA_02502376
`
`H, R
`
`H, R
`
`HOSPIRA_02502380
`
`HOSPIRA_02502383
`
`H, R
`
`FDA.gov, Step 3: Clinical Research
`(https://www.fda.gov/ForPatients/Approvals/Drugs/ucm405622.htm)
`Royal Society of Chemistry, Periodic Table,
`http://www.rsc.org/periodic-table/trends
`US Patent No. 8,436,033
`Decision Denying Institution of Inter Partes Review (US Patent 8,648,106) (Case IPR2016-
`01580)
`
`HOSPIRA_02502384
`
`HOSPIRA_02502388
`
`H, R
`
`HOSPIRA_02502486
`
`HOSPIRA_02502486
`
`HOSPIRA_02502504
`
`HOSPIRA_02502520
`
`R
`
`R
`R
`
`5/7/2013
`2/3/2017
`
`2
`
`