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`
`
`Global Regulatory CMC
`
`RFBOO2
`0.5 mg/0.05 mL
`Solution for injection in pre-filled syringe
`
`7008027_P83_MB_967_17
`
`Stability Data
`
`Date:
`
`23-Aug-2019
`
`Replaces:
`
`7008027_P83_MB_967_16
`
`Reason for revision: Addition of data (6 M) for alternative process for assembly
`and packaging at Alcon-Couvreur NV and sterilization at
`Addition of data (3 M)
`for a batch manufactured
`
`using silicone oil omar
`
`Numberof pages:
`
`51
`
`Property of Novartis
`Confidential
`May not be used, divulged, published or otherwise disclosed
`without the consent of Novartis
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)0292981 4
`
`Novartis Exhibit 2150.001
`Regeneron v. Novartis, IPR2021-00816
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