`
`
`
`Lucentis PreFilled Syringe
`Project update — ad-hoc GPT
`November 15, 2011
`
`{ ve
`és NOVARTIS
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Executive Summary
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`PFS Development history
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.003
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Key issues and challenges for PFS development
`
`See back-up for 2008 Scientific Advice details
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.004
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Product requirements...
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.005
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`... drive selection of technical option
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.006
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`PFS — Innovation and key developmentpartners
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.007
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Design Verification Highlighted Key Risk
`| PFS strategy modified in May 2011
`
`
`
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.008
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Status November 11, 2011 — Reg Stab batches
`
`New plunger rod, current stopper
`
`'
`| Lucentis Project Review a Confidential gis NOVARTIS
`
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.009
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`Lucentis Processing — much more than EVEMeRuriuaiiiaja
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0010
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`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
`
`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
`
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0013
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Key challenges and progress
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0014
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`Key risks 1/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0015
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`Key risks 2/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0016
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`Key risks 3/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0017
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`
`
`Key risks 4/4
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0018
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Sterilization spike results —- ETO/H,O,
`
`ee
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0019
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Sterilization by ETO — results from technical batch
`
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0020
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`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
`
`
`
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0022
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Lucentis Stability Strategy
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`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
`
`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
`
`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
`
`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
`
`
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01498292
`
`Novartis Exhibit 2144.0027
`Regeneron v. Novartis, IPR2021-00816
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
