Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 1 of 9 PageID #: 15055
`
`UNITED STATES DISTRICT COURT
`EASTERN DISTRICT OF TEXAS
`MARSHALL DIVISION
`
` DEFENDANTS' EXHIBIT LIST
`
`Case No. 2:20-cv-00337-JRG
`
`PLAINTIFF'S ATTORNEYS: Michael
`A. Jacobs, Bryan Wilson, Matthew
`Chivvis, T. John Ward Jr., Jack Wesley
`Hill, Andrea Fair
`
`DEFENDANTS'
`ATTORNEYS: Deron R.
`Dacus, J. Mark Mann, G.
`Blake Thompson, Preston K.
`Ratliff II, Jeffrey A. Pade,
`Jennifer Parker Ainsworth,
`David I. Berl
`
`COURTROOM DEPUTY:
`Andrea Brunson, CP
`
` SEAGEN INC.
`v.
`DAIICHI SANKYO CO., LTD.
`
`PRESIDING JUDGE:
`The Hon. Rodney Gilstrap
`
`TRIAL DATES: April 4‐8, 2022
`
`COURT REPORTER: Shawn
`McRoberts, RMR, CRR
`
`PLF NO.
`DX‐0001
`DX‐0002
`DX‐0003
`DX‐0004
`DX‐0005
`DX‐0006
`DX‐0007
`DX‐0008
`DX‐0009
`DX‐0010
`DX‐0011
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`DX‐0012
`DX‐0013
`DX‐0014
`DX‐0015
`DX‐0016
`DX‐0040
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`DX‐0041
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`DEF. NO.
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`DATE
`OFFERED MARKED ADMITTED TRANSCRIPT
`4/4/2022
`4/5/2022
`4/5/2022
`4/6/2022
`4/6/2022
`4/7/2022
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`4/6/2022
`4/6/2022
`4/6/2022
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`4/6/2022
`4/6/2022
`4/6/2022
`4/6/2022
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`4/6/2022
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`4/6/2022
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`4/7/2022
`4/8/2022
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`4/8/2022
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`DX‐0043
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`4/7/2022
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`4/8/2022
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`DESCRIPTION OF EXHIBITS
`United States Patent No. 10,808,039
`United States Patent No. 7,498,298
`United States Patent No. 7,994,135
`United States Patent No. 8,703,714
`United States Patent No. 10,414,826
`File History of United States Patent No. 10,808,039
`File History of United States Patent No. 7,498,298
`File History of United States Patent No. 7,994,135
`File History of United States Patent No. 8,703,714
`File History of United States Patent No. 10,414,826
`File History of United States Patent Application No. 14/194,106
`File History of United States Patent Application No. 15/188,843
`United States Provisional Patent Application No. 60/518,534
`United States Provisional Patent Application No. 60/557,116
`United States Provisional Patent Application No. 60/598,899
`United States Provisional Patent Application No. 60/622,455
`Novel HER2-Targeted Therapies Pose Sequencing Challenges,
`ASCO Post
`S. Modi et al., Abstract PD3-06, Updated Results from DESTINY-
`breast01, a Phase 2 Trial of Trastuzumab Deruxtecan (T-DXd) in
`HER2 Positive Metastatic Breast Cancer, 2020 San Antonio Breast
`Cancer Symposium
`C. Seymour, Subgroup Analyses Support T-DXd as Second-Line
`Standard in HER2+ Metastatic Breast Cancer, ONCLIVE
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`

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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 2 of 9 PageID #: 15056
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`TRANSCRIPT
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`DEF. NO.
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`PLF NO.
`DX‐0057
`DX‐0058
`DX‐0059
`DX‐0060
`DX‐0061
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`
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`DATE
`OFFERED
`4/6/2022
`4/6/2022
`4/6/2022
`4/6/2022
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`4/6/2022
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`MARKED
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`ADMITTED
`4/7/2022
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`4/7/2022
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`4/7/2022
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`4/7/2022
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`4/7/2022
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`DX‐0062
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`4/6/2022
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`4/7/2022
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`DX‐0063
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`4/5/2022
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`4/6/2022
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`DX‐0064
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`4/6/2022
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`4/7/2022
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`DX‐0069
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`DX‐0070
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`4/6/2022
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`4/7/2022
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`4/6/2022
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`4/7/2022
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`DX‐0071
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`4/6/2022
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`4/7/2022
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`DX‐0074
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`4/6/2022
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`4/7/2022
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`DX‐0075
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`4/6/2022
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`4/7/2022
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`DX‐0077
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`4/6/2022
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`4/7/2022
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`DX‐0078
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`4/6/2022
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`4/7/2022
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`DX‐0079
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`4/6/2022
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`4/7/2022
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`DX‐0082
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`4/6/2022
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`4/7/2022
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`DX‐0083
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`DX‐0085
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`4/6/2022
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`4/7/2022
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`4/6/2022
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`4/7/2022
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`DESCRIPTION OF EXHIBITS
`ADCETRIS Product Label (Rev. 10/2019)
`ENHERTU Product Label (Rev. 01/2021)
`POLIVY Product Label (Rev. 06/2019)
`PADCEV Product Label (Rev. 12/2019)
`V. Carceller, AACR-NCI-EORTC - 27th International Symposium -
`Molecular Targets and Cancer Therapeutics (November 5-9, 2015
`- Boston, Massachusetts, USA) 51 Drugs of Today 669 (2015)
`Y. Ogitani et al., Abstract A145: DS-8201a, a Novel HER2-targeting
`ADC with a Novel DNA Topoisom Erase I Inhibitor, Demonstratesa
`Potent Anti-tumor Efficacy with Differentiation from T-DM 1 in
`Preclinical Studies, 14 (12 Suppl 2) Molecular Targets and Cancer
`Therapeutics (2015)
`B. Halford, A New Generation of Antibody-Drug Conjugates for
`Cancer Patients, 98(14) CHEM. & ENGINEERING NEWS (2020)
`
`T. Nakada et al., The Latest Research and Development into the
`Antibody-Drug Conjugate, [fam-] Trastuzumab Deruxtecan (DS-
`8201a), for HER2 Cancer Therapy, 67 Chem. Pharm. Bull. 173
`(2019)
`A. Tolcher, Antibody Drug Conjugates: Lessons from 20 Years of
`Clinical Experience, 27(12) Ann. Oncol. 2168 (2016)
`J. Lambert et al., Ado-trastuzumab Emtansine (T-DM1): An
`Antibody-Drug Conjugate (ADC) for HER2-Positive Breast Cancer,
`57 J. Med. Chem. 6949 (2014)
`Applicant Arguments/Remarks Made in an Amendment (October
`14, 2010) (Excerpt from File History of U.S. Application No.
`12/016,978)
`R. Singh et al., A New Triglycyl Peptide Linker for Antibody-Drug
`Conjugates (ADCs) with Improved Targeted Killing of Cancer Cells,
`15 Mol. Cancer Ther. 1311 (2016)
`E. Kraynov et al., Current Approaches for Absorption, Distribution,
`Metabolism, and Excretion Characterization of Antibody-Drug
`Conjugates: An Industry White Paper, 44 Drug Metab. Dispos. 617
`(2016)
`A. Beck et al., Strategies and Challenges for the Next Generation
`of Antibody-Drug Conjugates, 16 Nat. Rev. Drug Discov. 315
`(2017)
`J. Lambert et al., Antibody-Drug Conjugates (ADCs) for
`Personalized Treatment of Solid Tumors: A Review, 34 Adv. Ther.
`1015 (2017)
`V. Goldmacher et al., Immunotoxins and Antibody-Drug
`Conjugates for Cancer Treatment, Biomedical Aspects of Drug
`Targeting 291 (2002)
`J. McCombs et al., Antibody Drug Conjugates: Design and
`Selection of Linker, Payload and Conjugation Chemistry, 17 AAPS
`J. 339 (2015)
`D. Leung et al., Antibody Conjugates-Recent Advances and Future
`Innovations, 9 Antibodies 2 (2020)
`W. Widdison et al., Factors Involved in the Design of Cytotoxic
`Payloads for Antibody-Drug Conjugates, Antibody‐Drug
`Conjugates and Immunotoxins 93 (2013)
`‐ 2 ‐
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`

`

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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 3 of 9 PageID #: 15057
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`TRANSCRIPT
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`PLF NO.
`DX‐0086
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`DX‐0088
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`DX‐0089
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`DEF. NO.
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`MARKED
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`DATE
`OFFERED
`4/6/2022
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`ADMITTED
`4/7/2022
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`4/6/2022
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`4/7/2022
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`4/6/2022
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`4/7/2022
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`DX‐0092
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`4/6/2022
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`4/7/2022
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`DX‐0093
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`4/6/2022
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`4/7/2022
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`DX‐0096
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`4/6/2022
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`4/7/2022
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`DX‐0107
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`4/6/2022
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`4/7/2022
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`DX‐0108
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`4/6/2022
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`4/7/2022
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`DX‐0109
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`4/4/2022
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`4/5/2022
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`DX‐0110
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`4/6/2022
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`4/7/2022
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`DX‐0111
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`4/4/2022
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`4/5/2022
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`DX‐0112
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`4/6/2022
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`4/7/2022
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`DX‐0113
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`4/5/2022
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`4/6/2022
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`DX‐0114
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`4/6/2022
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`4/7/2022
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`DX‐0115
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`4/6/2022
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`4/7/2022
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`DX‐0118
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`4/6/2022
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`4/7/2022
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`DX‐0123
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`4/6/2022
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`4/7/2022
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`DESCRIPTION OF EXHIBITS
`R. Chari et al., Antibody-Drug Conjugates: An Emerging Concept in
`Cancer Therapy, 53 Angew. Chem. Int. Ed. 3796 (2014)
`J. Lambert, Design Factors Important for Antibody-Drug Conjugate
`(ADC) Payloads, 71 Drug Discoveries 31 (2019)
`H. Tang et al., The Analysis of Key Factors Related to ADCs
`Structural Design, 10(373) Frontiers Pharmacology Art. (2019)
`
`R. Chari, Expanding the Reach of Antibody-Drug Conjugates, 7 ACS
`Medicinal Chemistry Letters 974 (2016)
`
`M. Dorywalska et al., Molecular Basis of Valine-Citrulline-PABC
`Linker Instability in Site-Specific ADCs and Its Mitigation by Linker
`Design, 15 Molecular Cancer Therapeutics 958 (2016)
`S. Yan et al., Molecular Regulation of Human Cathepsin B:
`Implication in Pathologies, 384 Biol. Chem. 845 (2003)
`
`S.2.6.1 Manufacturing Process Development – Manufacturing
`Process Development History fam‐trastuzumab deruxtecan,
`Daiichi Sankyo Chemical Pharma Co., Ltd. (Onahama)
`S.3.1 Elucidation of Structure and Other Characteristics fam‐
`trastuzumab deruxtecan, Daiichi Sankyo Chemical Pharma Co.,
`Ltd. (Onahama)
`Y. Ogitani et al., DS-8201a, A Novel HER2-Targeting ADC with a
`Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising
`Antitumor Efficacy with Differentiation from T-DM1, 22 Clin.
`Cancer Res. 5097 (2016)
`Y. Ogitani et al., Bystander Killing Effect of DS-8201a, a Novel Anti-
`Human Epidermal Growth Factor Receptor 2 Antibody-Drug
`Conjugate, in Tumors with Human Epidermal Growth Factor
`Receptor 2 Heterogeneity, 107(7) Cancer Science 1039 (2016)
`Y. Abe et al., Development of New ADC Technology with
`Topoisomerase I Inhibitor, Antibody Engineering & Therapeutics
`(2015)
`Annual Meeting of The Antibody Society, Antibody Engineering &
`Therapeutics 2015 Event Guide
`
`Certified translation of presentation DSC_ENHERTU_00289894‐
`907
`
`Certified translation of laboratory notebook
`DSC_ENHERTU_00290036‐139
`
`The 76th Annual Meeting of the Japanese Cancer Association, DS‐
`8201a, a New ADC from bench to bed side
`
`Y. Ogitani et al., DS-8201a, A Novel HER2-Targeting ADC with a
`Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising
`Antitumor Potent Anti-Tumor Efficacy with Differentiation from T-
`DM1 in Preclinical Studies
`Press Release, Daiichi Sankyo Presents Late‐Breaking Phase 1 Data
`for Novel Investigational HER‐2Targeting Antibody Drug
`Conjugate DS‐8201a in T‐DM1 Pre‐Treated Breast Cancer at the
`ESMO 2016 Congress (2016)
`
`‐ 3 ‐
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`

`

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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 4 of 9 PageID #: 15058
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`PLF NO.
`DX‐0124
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`DEF. NO.
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`MARKED
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`DATE
`OFFERED
`4/6/2022
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`ADMITTED
`4/7/2022
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`DX‐0125
`DX‐0126
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`4/6/2022
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`4/6/2022
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`4/7/2022
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`4/7/2022
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`DX‐0127
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`4/6/2022
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`DX‐0128
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`4/6/2022
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`DX‐0129
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`DX‐0145
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`4/7/2022
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`DX‐0153
`DX‐0155
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`4/6/2022
`4/6/2022
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`4/7/2022
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`4/7/2022
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`DX‐0157
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`4/6/2022
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`4/7/2022
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`DX‐0158
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`4/6/2022
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`4/7/2022
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`DX‐0159
`DX‐0161
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`4/6/2022
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`4/6/2022
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`4/7/2022
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`4/7/2022
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`DX‐0163
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`4/6/2022
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`4/7/2022
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`DX‐0164
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`4/6/2022
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`4/7/2022
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`TRANSCRIPT
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`DESCRIPTION OF EXHIBITS
`Certified translation of document titled "Research Report," dated
`March 18, 2005
`
`Certified translation of document titled "Conjugation Protocol"
`Fact Witness Statement of Yuki Abe, Ph.D. (May 31, 2021), Seagen
`v. Daiichi Sankyo Co., Ltd., AAA No. 01‐19‐0004‐0115
`
`Fact Witness Statement of Yuji Kasuya, Ph.D., (May 31, 2021),
`Seagen v. Daiichi Sankyo Co., Ltd., AAA No. 01‐19‐0004‐0115
`
`P. Burke et al., Development of Novel Quarternary Ammonium
`Linkers for Antibody-Drug Conjugates, 15(5) Molecular Cancer
`Therapeutics 938 (2016)
`P. Senter et al., The Discovery and Development of Brentuximab
`Vedotin for Use in Relapsed Hodgkin Lymphoma and Systemic
`Anaplastic Large Cell Lymphoma, 30(7) Nature Biotechnology 631
`(2012)
`R. Chari, Targeted Delivery of Chemotherapeutics: Tumor-
`Activated Prodrug Therapy, 31 Advanced Drug Delivery Reviews
`89 (1998)
`A. Staudacher et al., Antibody Drug Conjugates and Bystander
`Killing: Is Antigen-Dependent Internalisation Required? 117 Brit. J.
`Cancer 1736 (2017)
`S. Jordans et al., Monitoring Compartment-Specific Substrate
`Cleavage by Cathepsins B, K, L, and S at Physiological pH and
`Redox Conditions, 10 BMC Biochemistry 23 (2009)
`M. Studer et al., Influence of a Peptide Linker on Biodistribution
`and Metabolism of Antibody-Conjugated Benzyl-EDTA.
`Comparison of Enzymatic Digestion in Vitro and in Vivo, 3
`Bioconjugate Chem. 424 (1992)
`T. Kaillunki et al., Cancer-Associated Lysosomal Changes: Friends
`or Foes?, 32 Oncogene 1995 (2013)
`
`U.S. Patent Application Publication No. 2017/0247412
`Y. Tai et al., Novel Anti-B-Cell Maturation Antigen Antibody-Drug
`Conjugate (GSK2857916) Selectively Induces Killing of Multiple
`Myeloma, 123 Blood 3128 (2014)
`B. Teicher et al., Nitrobenzyl Halides and Carbamates as Prototype
`Bioreductive Alkylating Agents, 23 J. Med. Chem. 955 (1980)
`
`V. Kostova et al., The Chemistry Behind ADCs, 14 Pharmaceuticals
`442 (2021)
`
`United States Patent No. 4,981,979 issued to Sivam
`Y. Kovtun et al., Antibody-Drug Conjugates Designed to Eradicate
`Tumors with Homogeneous and Heterogeneous Expression of the
`Target Antigen, 66 Cancer Res. 3214 (2006)
`B. Toki et al., Protease-Mediated Fragmentation of p-Amidobenzyl
`Ethers: A New Strategy for the Activation of Anticancer Prodrugs,
`67 J. Organic Chem. 1866 (2002)
`S. Doronina et al., Development of Potent Monoclonal Antibody
`Auristatin Conjugates for Cancer Therapy, 21 Nature
`Biotechnology 778 (2003)
`
`‐ 4 ‐
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`

`

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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 5 of 9 PageID #: 15059
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`PLF NO.
`DX‐0166
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`DEF. NO.
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`MARKED
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`DATE
`OFFERED
`4/6/2022
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`ADMITTED
`4/7/2022
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`DX‐0167
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`4/6/2022
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`4/7/2022
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`DX‐0168
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`4/6/2022
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`4/7/2022
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`DX‐0169
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`4/6/2022
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`DX‐0172
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`4/6/2022
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`4/6/2022
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`DX‐0176
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`4/6/2022
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`4/6/2022
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`4/6/2022
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`4/6/2022
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`4/6/2022
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`DX‐0183
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`4/6/2022
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`DX‐0185
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`4/6/2022
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`4/7/2022
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`DX‐0186
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`4/6/2022
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`4/7/2022
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`DX‐0190
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`4/6/2022
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`4/7/2022
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`DX‐0191
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`4/6/2022
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`4/7/2022
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`DX‐0195
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`4/6/2022
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`4/7/2022
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`TRANSCRIPT
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`DESCRIPTION OF EXHIBITS
`J. Tong et al., An Insight into FDA Approved Antibody-Drug
`Conjugates for Cancer Therapy, 26 Molecules 5847 (2021)
`
`J. Lambert et al., Antibody-Drug Conjugates for Cancer Treatment,
`69 Ann. Rev. Med. 191 (2018)
`
`S. Doronina et al., Enhanced Activity of Monomethylauristatin F
`Through Monoclonal Antibody Delivery: Effects of Linker
`Technology on Efficacy and Toxicity, 17 Bioconjugate Chem. 114
`(2006)
`J. Lambert, Drug‐Conjugated Antibodies for the Treatment of
`Cancer, 76(2) British J. Clinical Pharmacology 248 (2012)
`
`J. Lambert, Typical Antibody-Drug Conjugates, 13 Antibody‐Drug
`Conjugates 3 (2017)
`
`S. Doronina et al., Novel Peptide Linkers for Highly Potent
`Antibody-Auristatin Conjugate, 19 Bioconjugate Chem. 1960
`(2008)
`G. Phillips et al., Targeting HER2-Positive Breast Cancer with
`Trastuzumab-DM1, an Antibody-Cytotoxic Drug Conjugate, 68
`Cancer Res. 9280 (2008)
`R. Duncan et al., Anticancer agents coupled to N-(2-
`hydroxypropyl)methacrylamide copolymers. II. Evaluation of
`daunomycin conjugates in vivo against L1210 leukaemia, 57 Br. J.
`Cancer 147 (1988)
`C. Liu et al., Eradication of Large Colon Tumor Xenografts by
`Targeted Delivery of Maytansinoids, 93 Proc. Natl. Acad. Sci. 8618
`(1996)
`J. Bargh et al., Sulfatase-Cleavable Linkers for Antibody-Drug
`Conjugates, 11 Chem. Sci. 2375 (2020)
`
`H. Erickson et al., The Effect of Different Linkers on Target Cell
`Catabolism and Pharmacokinetics/Pharmacodynamics of
`Trastuzumab Maytansinoid Conjugates, 11 Molecular Cancer
`Therapy 1133 (2012)
`J. Masters et al., Clinical Toxicity of Antibody Drug Conjugates: A
`Meta-Analysis of Payloads, 36 Invest New Drugs 121 (2018)
`
`M. Barok et al., Trastuzumab Emtansine: Mechanisms of Action
`and Drug Resistance, 16 Breast Cancer Research 209 (2014)
`
`ADC Drugs with New Targets Clinical Pipeline Review, Biopharma
`PEG, https://www.biochempeg.com/article/202.html
`
`K. Poon et al., Preclinical Safety Profile of Trastuzumab Emtansine
`(T-DM1): Mechanism of Action of its Cytotoxic Component
`Retained with Improved Tolerability, 273 Toxicology & Applied
`Pharmacology 298 (2013)
`C. Fennelly et al., Lysosomal Biology in Cancer, 1594 Methods
`Mol. Biol. 293 (2017)
`
`J. Francisco et al., cAC10-vcMMAE, an Anti-CD30-Monomethyl
`Auristatin E Conjugate with Potent and Selective Antitumor
`Activity, 102(4) Blood 1458 (2003)
`
`‐ 5 ‐
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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 6 of 9 PageID #: 15060
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`PLF NO.
`DX‐0199
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`DEF. NO.
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`MARKED
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`DATE
`OFFERED
`4/6/2022
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`ADMITTED
`4/7/2022
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`DX‐0202
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`4/6/2022
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`4/7/2022
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`DX‐0205
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`4/6/2022
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`DX‐0208
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`4/6/2022
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`DX‐0210
`DX‐0213
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`4/4/2022
`4/6/2022
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`4/5/2022
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`4/7/2022
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`DX‐0214
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`4/6/2022
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`DX‐0220
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`4/6/2022
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`DX‐0221
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`4/6/2022
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`DX‐0223
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`4/6/2022
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`4/7/2022
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`DX‐0225
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`4/6/2022
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`DX‐0226
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`4/6/2022
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`4/7/2022
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`DX‐0233
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`4/6/2022
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`4/7/2022
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`TRANSCRIPT
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`DESCRIPTION OF EXHIBITS
`P. Carl et al., Communications to the Editor: A Novel Connector
`Linkage Applicable in Prodrug Design, 24 J. Med. Chem. 479
`(1981)
`J. Cassady et al., Recent Developments in the Maytansinoid
`Antitumor Agents, 52 Chem. Pharm. Bull. (2004)
`
`R. Chari et al., Immunoconjugates Containing Novel
`Maytansinoids: Promising Anticancer Drugs, 52 Cancer Research
`127 (1992)
`Applicant Amendment to the Claims (October 14, 2010) (Excerpt
`from File History of U.S. Application No. 12/016,978)
`
`Email from K. Shah to Y. Tomoko et al.
`G. Dubowchik et al., Cathepsin B-Sensitive Dipeptide Prodrugs. 2.
`Models of Anticancer Drugs Paclitaxel (Taxol®), Mitomycin C and
`Doxorubicin, 8 Bioorganic Medicinal Chemistry Letters 3347
`(1998)
`G. Dubowchik et al., Doxorubicin Immunoconjugates Containing
`Bivalent, Lysosomally-Cleavable Dipeptide Linkages, 12 Bioorganic
`Medicinal Chemistry Letters 1529 (2002)
`G. Dubowchik et al., Cathepsin B-Sensitive Dipeptide Prodrugs. 1.
`A Model Study of Structural Requirements for Efficient Release of
`Doxorubicin, 8 Bioorganic Medicinal Chemistry Letters 3341
`(1998)
`K. Hamblett et al., SLC46A3 Is Require to Transport Catabolites of
`Noncleavable Antibody Maytansine Conjugates from the
`Lysosome to the Cytoplasm, 75 Cancer Research 5329 (2015)
`J. Peterson & C. Meares, Enzymatic Cleavage of Peptide-Linked
`Radiolabels from Immunoconjugates, 10(4) Bioconjugate Chem.
`618 (1998)
`H. Nogusa et al., Structure-Activity Relationships of
`Carboxymethylpullulan-Peptide-Doxorubicin Conjugates—
`Systematic Modification of Peptide Spacers, 10 Bioorganic
`Medicinal Chemistry Letters 227 (2000)
`W. Widdison et al., Development of Anilino-Maytansinoid ADCs
`that Efficiently Release Cytotoxic Metabolites in Cancer Cells and
`Induce High Levels of Bystander Killing, 26 Bioconjugate Chemistry
`2261 (2015)
`R. Lyon et al., Reducing Hydrophobicity of Homogeneous
`Antibody-Drug Conjugates Improves Pharmacokinetics and
`Therapeutic Index, 33 Nature Biotechnology 733 (2015)
`S. Alley et al., Contribution of Linker Stability to the Activities of
`Anticancer Immunoconjugates, 19 Bioconjugate Chemistry 759
`(2008)
`M. Brinkley, A Brief Survey of Methods for Preparing Protein
`Conjugates with Dyes, Haptens, and Cross-Linking Reagents, 3
`BIOCONJUGATE CHEM. 2 (1992)
`K. Hamblett et al., Effects Of Drug Loading On The Antitumor
`Activity Of A Monoclonal Antibody Drug Conjugate, 10 CLIN.
`CANCER RES. 7063 (2004)
`G. Hermanson, Heterobifunctional Cross-Linkers, BIOCONJUGATE
`TECHNIQUES 228 (1996)
`
`Pierce Cross‐Linking Reagents Technical Handbook (2005)
`
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`‐ 6 ‐
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`

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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 7 of 9 PageID #: 15061
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`TRANSCRIPT
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`PLF NO.
`DX‐0235
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`DEF. NO.
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`DX‐0236
`DX‐0237
`DX‐0242
`DX‐0243
`DX‐0244
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`
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`DATE
`OFFERED
`4/6/2022
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`4/6/2022
`4/6/2022
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`4/6/2022
`4/6/2022
`4/6/2022
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`MARKED
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`ADMITTED
`4/7/2022
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`4/7/2022
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`4/7/2022
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`4/7/2022
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`4/7/2022
`4/7/2022
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`DX‐0246
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`4/6/2022
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`4/7/2022
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`DX‐0247
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`4/6/2022
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`4/7/2022
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`DX‐0250
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`4/6/2022
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`4/7/2022
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`DX‐0251
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`4/6/2022
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`4/7/2022
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`DX‐0252
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`4/6/2022
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`4/7/2022
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`DX‐0281
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`4/6/2022
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`4/7/2022
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`DX‐0286
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`4/5/2022
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`4/6/2022
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`DX‐0336
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`4/7/2022
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`4/8/2022
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`DX‐0340
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`4/7/2022
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`4/8/2022
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`DX‐0341
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`DX‐0342
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`DX‐0355
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`DX‐0363
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`DX‐0383
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`DX‐0440
`DX‐0445
`DX‐0461
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`4/7/2022
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`4/8/2022
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`4/7/2022
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`4/8/2022
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`4/7/2022
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`4/8/2022
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`4/7/2022
`4/6/2022
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`4/8/2022
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`4/8/2022
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`4/7/2022
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`DESCRIPTION OF EXHIBITS
`Our History, Seagen, https://www.seagen.com/who‐we‐
`are/history
`TIVDAK Product Label (Rev. 09/2021)
`United States Patent No. 4,867,973 issued to Goers et al.
`United States Patent No. 9,808,537 issued to Masuda et al.
`United States Patent No. 10,195,288 issued to Masuda et al.
`G. Dubowchik et al., Peptide Linkers for Selective Intralysosomal
`Release of Anticancer Drugs from Monoclonal Antibody
`Conjugates, PEPTIDES 1996 (1998)
`M. Sun et al., Reduction-Alkylation Strategies for the Modification
`of Specific Monoclonal Antibody Disulfides, 16 BIOCONJUGATE
`CHEM.1282 (2005)
`D. Willner et al., (6-Maleimidocaproyl)hydrazone of Doxorubicin-A
`New Derivative for the Preparation of Immunoconjugates of
`Doxorubicin, 4 Bioconjugate Chem. 521 (1993)
`I. Krop et al., Phase I Study of Trastuzumab-DM1, an HER2
`Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With
`HER2-Positive Metastatic Breast Cancer, 28(16) J. CLIN.
`ONCOLOGY 2698 (2010)
`T. Nitta et al., Bispecific F(ab’)2 Monomer Prepared With Anti-CD3
`and Anti-Tumor Monoclonal Antibodies Is Most Potent In
`Induction Of Cytosis Of Human T Cells, 19 EUR. J. IMMUNOL. 1437
`(1989)
`A. Younes et al., Brentuximab Vedotin (SGN-35) for Relapsed
`CD30-Positive Lymphomas, 363 N. ENGL J. MED. 1812 (2010)
`
`Fact Witness Statement of DS‐8201 Inventor Hiroyuki Naito, Ph.D,
`Seagen Inc. v. Daiichi Sankyo Co., Ltd., AAA No. 01‐19‐0004‐0115
`
`Daiichi Sankyo Press Release, ENHERTU® Approved in the U.S. for
`HER2 Positive Unresectable Metastatic Breast Cancer Following
`Two or More Prior Anti-HER2-Based Regimens
`Collaboration Agreement between Seattle Genetics, Inc. and
`Genentech Inc.
`
`Collaboration Agreement between Seattle Genetics, Inc. and
`Curagen Corporation
`
`Collaboration Agreement between Seattle Genetics, Inc. and
`MedImunne, Inc.
`Collaboration Agreement between Seattle Genetics, Inc. and
`PSMA Development Company LLC
`License and Collaboration Agreement by and between Seattle
`Genetics, Inc. and Genmab A/S
`Collaboration Agreement between Seattle Genetics, Inc. and
`Pfizer, Inc.
`Amended and Restated Collaboration Agreement between
`Seattle Genetics, Inc. and AbbVie Biotechnology Ltd.
`Email from P. Burke to P. Burke
`Email from P. Burke to C. Pugh et al.
`Email from S. Jeffrey to P. Burke
`
`‐ 7 ‐
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`

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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 8 of 9 PageID #: 15062
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`PLF NO.
`DX‐0466
`DX‐0475
`DX‐0490
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`DX‐0495
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`DX‐0533
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`DX‐0538
`DX‐0571
`DX‐0595
`DX‐0596
`DX‐0616
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`DX‐0636
`DX‐0654
`DX‐0675
`DX‐0676
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`DEF. NO.
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`DATE
`OFFERED
`4/7/2022
`4/7/2022
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`4/4/2022
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`4/6/2022
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`MARKED
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`ADMITTED
`4/8/2022
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`4/8/2022
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`4/5/2022
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`4/8/2022
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`DX‐0681
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`4/7/2022
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`4/8/2022
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`DX‐0691
`DX‐0692
`DX‐0693
`DX‐0694
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`4/6/2022
`4/6/2022
`4/6/2022
`4/5/2022
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`4/7/2022
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`4/6/2022
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`DX‐0716
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`4/7/2022
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`4/8/2022
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`DX‐0940
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`4/6/2022
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`4/7/2022
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`DX‐0941
`DX‐0961
`DX‐0990
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`4/6/2022
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`4/5/2022
`4/5/2022
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`4/7/2022
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`4/6/2022
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`4/6/2022
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`DX‐1142
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`4/5/2022
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`4/6/2022
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`DX‐1151
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`4/5/2022
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`4/6/2022
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`TRANSCRIPT
`
`DESCRIPTION OF EXHIBITS
`United States Provisional Patent Application No. 60/518,534
`Document titled "Auristatin derivatives 2003‐2005"
`Email from S. Jeffrey to P. Senter et al.
`
`Presentation titled "Thinking About Linking: Evolving the Way We
`Release Drugs"
`Presentation titled "Auristatin ADCs: From a Vague Idea to MC‐
`MMAF and Beyond"
`Document dated December 22, 2004
`Email from S. Jeffrey to P. Senter et al.
`C. Bertozzi Twitter Post
`United States Patent No. 6,214,345 issued to Firestone et al.
`Y. Ogitani et al., Bystander Killing Effect of DS-8201a, a Novel Anti-
`human Epiidermal Growth Factor Receptor 2 Antibody-drug
`Conjugate, in Tumors with Human Epidermal Growth Factor
`Receptor 2 Heterogeneity, 107 Cancer Sci. 1039 (2016)
`Document dated December 22, 2004
`Email from S. Jeffrey to P. Burke
`License Agreement between RemeGen Co., Ltd. and Seagen Inc.
`Collaboration Agreement between Seattle Genetics, Inc. and
`Genentech Inc.
`Collaboration and License Agreement between Seattle Genetics,
`Inc. and Bayer Pharmaceuticals Corporation
`
`United States Patent No. 9,808,537 issued to Masuda et al.
`United States Patent No. 10,195,288 issued to Masuda et al.
`United States Patent No. 10,155,821 issued to Naito et al.
`Y. Ogitani et al., DS-8201a, A Novel HER2-Targeting ADC with a
`Novel DNA Topoisomerase I Inhibitor, Demonstrates a Promising
`Antitumor Efficacy with Differentiation from T-DM1, 22 Clin
`Cancer Res 5097 (2016)
`Amendment to Collaboration Agreement for Expanded Antigens
`between Seattle Genetics, Inc. and Genentech, Inc.
`
`Presention titled "When the linkers were designed and
`synthesized, what did we think about and how did we think about
`it?"
`Lab Notebook No. 54847 and translation
`Email from T. Masuda to Y. Ogitani et al. and translation
`Certified translation of email from T. Masuda to Y. Ogitani et al.
`(Naito Exhibit 9)
`Daiichi Sankyo Press Release, ENHERTU Approved in the U.S. for
`the Treatment of Patients with Previously Treated HER2 Positive
`Advanced Gastric Cancer
`Letter to Julie Beaver, M.D., Director at FDA re Presubmission to
`Rolling Submission ‐ Part 1 of 2
`
`‐ 8 ‐
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`Case 2:20-cv-00337-JRG Document 383 Filed 04/13/22 Page 9 of 9 PageID #: 15063
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`PLF NO.
`DX‐1195
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`DEF. NO.
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`DATE
`OFFERED
`4/7/2022
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`MARKED
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`ADMITTED
`4/8/2022
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`TRANSCRIPT
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`DESCRIPTION OF EXHIBITS
`Exhibit B‐2 to Expert Report of Peter A. Kaufman, M.D., P.
`Tarantino et al., Third-line treatment of HER2-positive advanced
`breast cancer: From no standard to a Pandora's box, 1875 BBA
`Reviews on Cancer 188 (2021)
`
`‐ 9 ‐
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`