`
`From:
`Sent:
`To:
`CC:
`
`juergen.sigg@novartis.com [juergen.sigg@novartis.com]
`5/11/2009 6:08:51 AM
`
`@vetter-pharma.com]
`vetter-pharma.com];•••••••••1@vetter-pharma.com];
`vetter-pharma.com]; Christophe Royer ["cn=christophe royer/ou=ph/o=novartis@ph"];
`ou=ph/o=novartis@ph"]
`
`Subject:
`
`Re: Action item
`
`Dear Christine
`
`this action item came out of our discussion on silicone levels to be evaluated. Based on
`have requested to test silicone levels below the
`level is already the minimum
`
` we
`, while you argued that this
`
`
`
`
`
`This rational is still required, therefore we should not close the action item. We agreed that the rational will be completed
`by the results of the siliconiozation studies which hopefully show that the selected silicone level is also the lowest feasible
`for a robust process in consideration of the
` for Lucentis.
`
`Best regards
`
`Jurgen
`
`Dr. Juergen Sigg
`Novartis Pharma AG
`Novartis Biologics - Process Sciences & Production
`Pharmaceutical Development
`WSJ-340.8.11
`Forum-1
`CH-4056 Basel
`Switzerland
`Phone: +41 61 3243508
`Fax: +41 61 324 74 32
`Email: juergen.sigg(<vnovartis.com
`
`Christine Kleber <christine.kleber@vetter-pharma.com>
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01494800
`
`Novartis Exhibit 2142.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`Christine Kleber
`;~!~!t!~ce~::ber@vetter-
`
`09.05.2009 12:13
`
`:
`Subject Action item
`
`vetter-pharma.com>, christophe.royer@novartis.com, K:
`a)vetter-p arma.com>,
`vetter-pharma.com>
`
`Hi Juergen,
`I'm not sure, what you did expect regarding the following action item.
`
`I 7
`
`I \/ I Siliconization Study
`
`!First overview of rational regarding established levels of silicone at Vetter
`
`115-May-2009
`
`IOpen
`
`Is the explanation given in the development plan sufficient and can we close this action item?
`More details regarding our siliconisation process could follow till end of May.
`
`Kind regards,
`
`
`Vetter Pharma-Fertigung GmbH & Co. KG
`
`Process Development & Implementation
`Schutzenstrasse 87
`88212 Ravensburg
`
`Phone: +49-751-37 00 -2384
`Fax.: +49-751-37 00 - 4002
`E-Mail:
`@vetter-pharma.com
`Internet: www.vetter-pharma.com
`
`CONTAINS CONFIDENTIAL BUSINESS INFORMATION, SUBJECT TO PROTECTIVE ORDER
`
`NOVITC(CH)01494800
`
`Novartis Exhibit 2142.002
`Regeneron v. Novartis, IPR2021-00816
`
`