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`Stability of Lucentis in Pre-tilled
`Syringe: Ethylene Oxide Cycle
`Development
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`
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`Presenter:—
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`Lucentis PFS Design Review Freeze
`August 10, 2006
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.001
`Regeneronv. Novartis, IPR2021-00816
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`Criteria for EtO Treatment
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.002
`Regeneronv. Novartis, IPR2021-00816
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`EtO Sterilization for Molecular Biologists
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`DNA structure
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`Nucieotidens--consist of a sugar (ribose or deoxyribose), a phosphate, and ane
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`of live citragennue bam.
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`Guaniee (G)
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`Cytoxine (C}
`NHy
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`Thymine (1
`o
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`G
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`: bet
`or TL Yr
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`wong A Totes Mato ae
`hese
`.
`A
`K ;
`Phosphate
`Adenine“ Uracil a}
`group
`GH
`i
`é
`H
`Super(Deaxyribose} T yy
`Keo RH
`a Nt
`A
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`a
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`HO
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`Hi
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`#
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`:
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`:
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.003
`Regeneron v. Novartis, IPR2021-00816
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`Novartis Exhibit 2130.003
`Regeneron v. Novartis, IPR2021-00816
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`tt
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`¥
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`Ne sk ' \e i4
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`“ A a C1~ NH
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`EtO Sterilization for Molecular Biologists
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`N-7 on Adenine and Guanine are main alkylation targets
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`0
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`O
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`vial
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`Ke
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`fi a
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.004
`Regeneron v. Novartis, IPR2021-00816
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`Novartis Exhibit 2130.004
`Regeneron v. Novartis, IPR2021-00816
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`Protein Degradation
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`Reaction with Proteins
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`BON>
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`Amino termini
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`Cysteine
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`Histidine imidazole nitrogens
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`Carboxylic groups
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.005
`Regeneron v. Novartis, IPR2021-00816
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`Novartis Exhibit 2130.005
`Regeneron v. Novartis, IPR2021-00816
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`EtO Cycle Development: BD Syringes
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.006
`Regeneronv. Novartis, IPR2021-00816
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`EtO Treated Lucentis Syringes (BD)
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`Stored at 2-8°C for 2 Months
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.007
`Regeneronv. Novartis, IPR2021-00816
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`Degradation of Lucentis in EtO Treated
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`BD Syringes after 2 Months@2-8°C
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.008
`Regeneronv. Novartis, IPR2021-00816
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` lime, min
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.009
`Regeneronv. Novartis, IPR2021-00816
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`EtO Cycle Developmen iii!
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`Syringes
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0010
`Regeneronv. Novartis, IPR2021-00816
`
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`Stability (IEC) of Lucentis in EtO Treated
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`Pre-filled Syringes (3 Mos. @ 5, 30 & 40°C)
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0011
`Regeneronv. Novartis, IPR2021-00816
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0012
`Regeneronv. Novartis, IPR2021-00816
`
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0013
`Regeneronv. Novartis, IPR2021-00816
`
`
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`EtO Cycle Development
`
`Syringes
`
`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0014
`Regeneronv. Novartis, IPR2021-00816
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`Test Procedures to Assess Lucentis Drug
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`Product Stability Studies
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0015
`Regeneronv. Novartis, IPR2021-00816
`
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`Stability Data for rhuFab V2 Lot PT1977HOta (10 mg/mL)
`Product Code: G188EH
`Parent Bulk Drug Substance: Lot L77099
`Date of Manufacture:
`0.17 mL fill inoo Pre-filled Syringes
`
`March 2004
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`
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0016
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability Data for rhuFab V2 Lot PT1977H01a (10 mg/mL)
`Product Code; G188EH
`Parent Bulk Drug Substance: Lot L77099
`0.17 mLfill in 05-cia Pre-filled Syringes
`Date of Manufacture: 25 March 2004
`
`Date of EtO Treatmentat Itasca, IL (Cycle #6): 21 April, 2004
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0017
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability (IEC) of Lucentis in Pre-filled Syringe
`Lot PT1977H01a Stored at 5, 30 & 40°C
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`(Pre- and Post-EtO Treatment, Cycle 6)
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0018
`Regeneronv. Novartis, IPR2021-00816
`
`
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`EtO Cycle Development: Syringes
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0019
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability (IEC) of Lucentis in EtO Treated
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0020
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability Data for rhuFab V2 Lot PT1977H02a (10 mg/mL)
`Product Code: G188EH
`Parent Bulk Drug Substance: Lot L77099
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`0.18 mLfill in 05c Pre-filled Syringes
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0021
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability Data for rhuFab V2 Lot PT1977H02a (10 mg/mL)
`Product Code: G188EH
`Parent Bulk Drug Substance: Lot L77099
`0.18 mLfill in 0.5ccaa Syringes
`Date of Manufacture:
`July 2004
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`Date of EtO treatmentat Itasca, IL (Cycle #10); October 14, 2004
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0022
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability (IEC) of Lucentis in Pre-filled Syringe
`Lot PT1977H02a Stored at 5, 30 & 40°C
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`(Pre- and Post-EtO Treatment, Cycle 10)
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0023
`Regeneronv. Novartis, IPR2021-00816
`
`
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`EtO Cycle Selected for Lucentis Syringes
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`Based on Development Runs
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0024
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability Data for rhuFab VA Lot PT1977H03a (10 mg/mL)
`Product Code: G188EH
`Parent Bulk Drug Substance: Lot M30582 (Run 14)
`0.18 mL fill in 0.5cc Bunder Glas Pre-filled Syringes
`
`Date of Manufacture: 21 March 2005
`
`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0025
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability Data for rhuFab V2Lot PT1977HO3a (10 mg/mL)
`Product Code: G188EH
`Parent Bulk Drug Substance: Lot M80352 (Run 14)
`0.18 mLfill in 0.5cc Bunder Glas Pre-filled Syringes
`Date of Manufacture: 21 March 2005
`
`Date of EtO treatment at Salt Lake, Utah (Cycle #75): June 29, 2005
`
`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0026
`Regeneronv. Novartis, IPR2021-00816
`
`
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`Stability (IEC) of Lucentis in Pre-filled Syringe
`Lot PT1977H03a Stored at 5, 30 & 40°C
`
`(Pre- and Post-EtO Treatment, Commercial Chamber)
`
`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0027
`Regeneronv. Novartis, IPR2021-00816
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`NOVITC(CH)00169036
`Novartis Exhibit 2130.0028
`Regeneron v. Novartis, IPR2021-00816
`
`Novartis Exhibit 2130.0028
`Regeneron v. Novartis, IPR2021-00816
`
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`EtO Cycle Validation
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`Double Cycles Validation
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`NOVITC(CH)00169036
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`Novartis Exhibit 2130.0029
`Regeneronv. Novartis, IPR2021-00816
`
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