Case 1:15-cv-00697-RGA Document 104 Filed 09/28/17 Page 1 of 4 PageID #: 1483
`
`
`HOSPIRA, INC.
`
`
`
`
`
`AMNEAL PHARMACEUTICALS, LLC
`
`
`
`Plaintiff,
`
`Defendant.
`
`
`
`v.
`
`
`
`
`
`
`
`
`
`
`
`PRESIDING JUDGE
`The Honorable Judge
`Richard G. Andrews
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`
`
`
`
`
`
`
`C.A. No. 15-697-RGA
`
`
`JOINT ADMITTED TRIAL EXHIBIT LIST
`
`PLAINTIFF’S ATTORNEY
`Jenner & Block LLP
`Connolly Gallagher LLP
`
`DEFENDANT’S ATTORNEY
`Maddox Edwards PLLC
`Richards, Layton & Finger,
`P.A.
`
`
`COURT REPORTER
`Valerie Gunning
`
`TRIAL DATE(S)
`August 21 – August 24, 2017
`
`EX. NO.
`JTX 001
`JTX 002
`JTX 003
`JTX 004
`JTX 017
`JTX 022
`JTX 025
`JTX 026
`JTX 027
`JTX 049
`JTX 052
`
`JTX 056
`JTX 063
`JTX 064
`JTX 066
`JTX 068
`JTX 069
`JTX 071
`
`JTX 073
`
`
`
`DESCRIPTION OF EXHIBITS
`U.S. Patent No. 8,242,158
`U.S. Patent No. 8,338,470
`U.S. Patent No. 8,455,527
`U.S. Patent No. 8,648,106
`Precedex Pre-Mix Research Deck
`Letter to customer re Precedex Premix approval
`Precedex Qualitative Market Research Deck
`Hospira Product Development Concept Proposal
`Precedex Line Extension Meeting Minutes
`Ex. A of Opening Expert Report of Michael Ramsay - CV
`Ex. A of Opening Expert Report of Robert Linhardt, Ph.D. - CV
`Amneal ANDA 3.2.P.8.3 Stability Report for Accelerated and Long Term
`Conditions
`Sales data through Q2 2016
`Precedex Premix Value Proposition Evaluation
`Staging Precedex Premix Conversions
`Precedex margin and price data
`Precedex Premix Launch Readiness Review
`Precedex Premix Deck
`K. Kumar, Linear and non-linear regression analysis for the sorption kinetics of
`methylene blue onto activated carbon, JOURNAL OF HAZARDOUS
`MATERIALS pp. 1538-44 (Apr. 2006)
`
`

`

`Case 1:15-cv-00697-RGA Document 104 Filed 09/28/17 Page 2 of 4 PageID #: 1484
`
`
`EX. NO.
`
`JTX 074
`JTX 076
`
`JTX 083
`JTX 093
`JTX 095
`JTX 096
`PTX 005
`PTX 006
`PTX 007
`PTX 008
`PTX 031
`
`PTX 040
`PTX 063
`PTX 064
`PTX 065
`PTX 071
`
`PTX 092
`PTX 093
`PTX 095
`
`PTX 122
`PTX 143
`PTX 144
`PTX 146
`PTX 204
`
`PTX 214
`
`DTX 003
`DTX 023
`
`DTX 024
`
`DTX 043
`
`DTX 044
`
`DTX 046
`DTX 063
`
` 
`
`DESCRIPTION OF EXHIBITS
`R. Matthews, Photooxidative degradation of coloured organics in water using
`supported catalysts, 25(10) WATER RESEARCH 1169-76 (1991)
`Amneal ANDA Section 3.2.P.5.1 Finished Product Specification
`Defendant Amneal Pharmaceuticals LLC's Response to Plaintiff's First Requests
`for the Production of Documents and Things (Nos. 1-37)
`Laboratory Notebook - 02282
`Laboratory Notebook Excerpt - 00737
`Laboratory Notebook Excerpt - 00738
`File History of U.S. Patent No. 8,242,158
`File History of U.S. Patent No. 8,338,470
`File History of U.S. Patent No. 8,455,527
`File History of U.S. Patent No. 8,648,106
`Launch of Premixed Precedex Market research findings report Deck
`Development Report for Precedex LE Injection Rev 1.0 authored by
`Roychowdhury
`Amneal ANDA Section 2.3 Quality (CMC) Overall Summary
`Amneal ANDA Section 3.2.P.7 Container Closure System
`Amneal ANDA Section 3.2.P.2 Pharmaceutical Development
`FDA Memorandum by Cynthia G. McCormick, M.D.
`Amneal ANDA 3.2.P.8.3 Stability Report for Accelerated and Long Term
`Conditions
`Amneal ANDA Stability Protocol
`Y. Wang, Sterile Pharmaceutical Packaging: Compatibility and Stability
`Development Report for Precedex Injection 4 mcg-mL initiated by Skora Rev
`2.0
`Laboratory Notebook - 01123
`Laboratory Notebook - 01539
`Laboratory Notebook - 01729
`Precedex Marketing costs
`October 1, 2014, Declaration of Alpaslan Yaman, Ph.D. (IPR Pet. for Pat. No.
`7,659,291)
`Cain, J., Dexmedetomidine and Hextend: Their Role in Trauma Care,
`International TraumaCare, Vol 17, No. 1, 4-5 (2007)
`Precedex® Label (2010)
`Ramsay, M., et al., Dexmedetomidine as a total intravenous anesthetic agent,
`Anesthesiology, Vol. 101, No. 3, 787-790 (2004)
`Eichhorn, J., APSF Hosts Medication Safety Conference, APSF Newsletter, Vol.
`25, No. 1, 1-20 (2010)
`Fanikos, J., Premixed Products Improve Safe Medication Practices, Pharmacy
`Practice News, 56-57 (November 2011)
`Giorgi, I., et al., Risk and pharmacoeconomic analyses of the injectable
`medication process in the paediatric and neonatal intensive care units,
`International Journal for Quality in Health Care, Vol. 22, No. 3, 170-178 (2010)
`Palmgrén, J., et al., Drug adsorption to plastic containers and retention of drugs
`
`2
`
`

`

`Case 1:15-cv-00697-RGA Document 104 Filed 09/28/17 Page 3 of 4 PageID #: 1485
`
`
`EX. NO.
`
`DESCRIPTION OF EXHIBITS
`in cultured cells under in vitro conditions, European Journal of Pharmaceutics
`and Biopharmaceutics, Vol. 64, 369-378 (2006)
`U.S. Patent No. 4,910,214 (Karjalainen)
`Amneal's Module 3-2-P-8-3 – Stability Report
`Hospira's Module 3-2-P-2-2-1 – Drug Product, Formulation Development
`Anes, Use of Plastics for Parenteral Packaging
`Avis, K. (ed.), Pharmaceutical Dosage Forms: Parenteral Medications, Volume
`1, 2nd ed., 161
`FDA Memorandum from McCormick to Jenkins
`Linden, P., et al., Ready-to-use Injection Preparations versus Conventional
`Reconstituted Admixtures, Pharmacoeconomics, Vol. 20, No. 8, 529-536 (2002)
`Hospira Scientific Report – Precedex Stability Data to Support Qualifications of
`the Product in a 20 mL glass vial
`IND 32,934 - Letter to FDA from Azarnoff (5-23-94)
`Trissel, L., et al., Compatibility Screening of Precedex During Simulated Y-Site
`Administration with Other Drugs, International Journal of Pharmaceutical
`Compounding, Vol. 6, No. 3 (2002)
`Hospira, Inc.’s Responses to Amneal’s Second Set Of Interrogatories (Nos. 7-
`23)
`Abbott IND excerpt dexmedetomidine (3-17-1989)
`Akers, Sterile Drug Products: Formulation, Packaging, Manufacturing, and
`Quality, Ch. 7, “Sterile Products Packaging Chemistry” at 72-95 (2010)
`Avis, K. (ed.), Sterile Pharmaceutical Products: Process Engineering
`Applications, 297, 300, 380, and 389 (1995)
`Bauer, E., Pharmaceutical Packaging Handbook, ch. 6, Pharmaceutical
`Packaging Materials, 189-272 (2009)
`Development Report for Precedex Injection - Hospira Scientific Report (4-2-
`2010)
`Hospira Scientific Report - Precedex LE
`ICH Harmonised Tripartite Guideline, Stability Testing of New Drug Substances
`and Products - Q1A(R2) (February 6, 2003)
`DTX 207
`Linhardt Opening Expert Report
`DTX 208
`DTX 209 Morrison and Boyd, Organic Chemistry, 6th ed., 136-138 (1992)
`Nema, S., et al. (ed.), Pharmaceutical Dosage Forms: Parenteral Medications,
`3rd ed., Vol. 3: Regulations, Validation and the Future, (2010) (excerpts)
`Precedex Life Cycle Management Strategy Session (11-7-2006)
`Precedex Line Extension Meeting Minutes (2-2-2007)
`Precedex Line Extension Meeting Minutes (5-18-2007 and 5-25-2007)
`Sacha, G., et al., Practical fundamentals of glass, rubber, and plastic sterile
`packaging systems, Pharmaceutical Development and Technology, Vol. 15, No.
`1, 6-34 (2010)
`Email chain re Precedex Overview
`Hospira SEC Form 10-K (fiscal year ending 12-31-2012)
`Hospira SEC Form 10-K (fiscal year ending 12-31-2013)
`
`DTX 073
`DTX 086
`DTX 095
`DTX 102
`
`DTX 104
`DTX 108
`
`DTX 111
`
`DTX 113
`DTX 114
`
`DTX 120
`
`DTX 191
`DTX 199
`
`DTX 200
`
`DTX 201
`
`DTX 202
`
`DTX 203
`DTX 206
`
`DTX 210
`DTX 213
`DTX 214
`DTX 216
`
`DTX 219
`DTX 231
`DTX 246
`DTX 247
`
` 
`
`3
`
`

`

`Case 1:15-cv-00697-RGA Document 104 Filed 09/28/17 Page 4 of 4 PageID #: 1486
`
`
`EX. NO.
`DTX 248
`DTX 301
`DTX 315
`DTX 416
`DTX 426
`
`DTX 434
`DTX 458
`DTX 469
`DTX 472
`DTX 478
`DTX 486
`DTX 495
`DTX 516
`DTX 517
`DTX 518
`DTX 533
`DTX 534
`DTX 535
`DTX 537
`DTX 551
`
`DTX 553
`
`DESCRIPTION OF EXHIBITS
`Hospira SEC Form 10-K (fiscal year ending 12-31-2014)
`Hospira Presentation, "Precedex Business Overview with Orion Pharma"
`Hospira Presentation, "Precedex/Propofol Deal Strategy
`Orange Book - Patent and Exclusivity for NDA 021038
`Presentation - Precedex US Commercial Deep Dive (8-22-2012)
`Erkola, O., et al., Comparison of Intramuscular Dexmedetomidine and
`Midazolam Premedication for Elective Abdominal Hysterectomy, Anesth.
`Analg., Vol. 79, 646-653 (1994)
`Amneal's Notice of 30(b)(6) Deposition of Hospira
`Precedex Prescribing information (03-2008)
`NDA Module 3 - 3-2-P-8-3 – Stability Data
`Joint Appendix in Hospira v Fresenius - NDIL
`Linhardt Reply Expert Report
`S. Yoshioka, Stability of Drugs and Dosage Forms § 4.4 (2000)
`Bloch Curriculum Vitae (CV)
`Hofmann Curriculum Vitae (CV)
`Yaman Curriculum Vitae (CV)
`Physical Sample of Precedex Premix Vial
`Physical Sample of Precedex Concentrate Vial
`Trissel, L., Handbook on Injectable Drugs, 16th ed. (2011) (excerpts) [updated]
`Cain Curriculum Vitae (CV) (updated)
`Hospira Stability Data
`Akers, M., Parenteral Preparations, Remington’s Pharmaceutical Sciences 802-
`836 (2006, 21st ed.)
`
`
`
` 
`
`4
`
`