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`
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`Lucentis PreFilled Syringe
`Project update — ad-hoc GPT
`November 15, 2011
`
`{ ve
`és NOVARTIS
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.001
`Regeneron v. Novartis, IPR2021-00816
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`
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`Executive Summary
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.002
`Regeneron v. Novartis, IPR2021-00816
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`
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`PFS Development history
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.003
`Regeneron v. Novartis, IPR2021-00816
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`
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`Key issues and challenges for PFS development
`
`See back-up for 2008 Scientific Advice details
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.004
`Regeneron v. Novartis, IPR2021-00816
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`Product requirements...
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.005
`Regeneron v. Novartis, IPR2021-00816
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`
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`... drive selection of technical option
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.006
`Regeneron v. Novartis, IPR2021-00816
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`
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`PFS — Innovation and key developmentpartners
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.007
`Regeneron v. Novartis, IPR2021-00816
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`Design Verification Highlighted Key Risk
`| PFS strategy modified in May 2011
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`
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`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.008
`Regeneron v. Novartis, IPR2021-00816
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`
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`Status November 11, 2011 — Reg Stab batches
`
`New plunger rod, current stopper
`
`'
`| Lucentis Project Review a Confidential gis NOVARTIS
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`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.009
`Regeneron v. Novartis, IPR2021-00816
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`
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`Lucentis Processing — much more than EVEMeRuriuaiiiaja
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
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`Novartis Exhibit 2144.0010
`Regeneron v. Novartis, IPR2021-00816
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`
`
`Status November 11, 2011 — Validation Batches
`
`New plunger rod and new stopper(tbc)
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0011
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Status November 11, 2011 — Validation Batches
`
`New plunger rod and new stopper(tbc) '
`
`
`
`| Lucentis Project Review fl Confidential é NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0012
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Key development milestones
`Each milestone must pass successfully to support blue sky vision submission readiness;
`contingencyplans will result in delay of overall plan
`
`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0013
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Key challenges and progress
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0014
`Regeneron v. Novartis, IPR2021-00816
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`
`
`
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`Key risks 1/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0015
`Regeneron v. Novartis, IPR2021-00816
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`
`
`
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`Key risks 2/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0016
`Regeneron v. Novartis, IPR2021-00816
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`
`
`
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`Key risks 3/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0017
`Regeneron v. Novartis, IPR2021-00816
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`
`
`
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`Key risks 4/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0018
`Regeneron v. Novartis, IPR2021-00816
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`
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`Sterilization spike results —- ETO/H,O,
`
`ee
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0019
`Regeneron v. Novartis, IPR2021-00816
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`
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`Sterilization by ETO — results from technical batch
`
`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0020
`Regeneron v. Novartis, IPR2021-00816
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`
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`Sterilization by EtO (12366 - study-B-09-2609):
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0021
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0022
`Regeneron v. Novartis, IPR2021-00816
`
`
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`Lucentis Stability Strategy
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0023
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Lucentis Primary Stability - a new dimension
`
`In addition to this, another 14’000 syringes are on a development stab program
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0024
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Reasons to believe
`
`Why has NVSa higherlikelihood of success than GNE whichfailed in 2008
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0025
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Clinical use of PFS
`
` i
`
`hy NOVARTIS
`| Lucentis Project Review (EB Confidential
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0026
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Lucentis 1% Formative User Study
`
`Recap of 1° User Study conducted in February 2017
`
`
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`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
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`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0027
`Regeneron v. Novartis, IPR2021-00816
`
`