`Washington~ D.C.
`
`Def ore the Honorable Clark S. Cheney
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN PRE-FILI.ED SYRINGES
`FOR INTRA VITREAL INJECTION AND
`COMPONENTS THEREOF
`
`Investigation No. 337-TA-1207
`
`DECLARATION OF RAYNA VENOOK
`
`I, Rayna Veoook, state and declare as follows:
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`I am presently employed as a Global Team Lead in Regulatory Information Management
`at Genentech, Inc. ("Geneotech") in South San Francisco, California where, among other
`things, I am involved in managing information and data associated with Genentech's
`reguJatory submissions.
`
`I am over the age of 18, of sound mind, and capable of making this declaration. I am
`submitting this declaration based on my own knowledge, personal experience, and my
`duties within the ordinary course of business at Genentech. If called upon, I can
`competently testify to the facts stated in this declaration.
`
`Genentech uses a database caJled the Global Product Regulatory System ("GPRS") to store
`materials relating to its products, including electronic copies of regulatory submissions to
`the United States Food and Drug Administration ("FDA").
`In the normal course of
`Genentech's business, members of my group oversee and manage the process by which
`true and accurate copies of FDA submissions are archived to the GPRS following
`transmission to the agency.
`
`According to Genentech' s standard practice, Supplemental Biologics License Application
`("sBLA") number 125156/S-110 was archived in GPRS on June 17, 2016 and 125156/S-
`117 was archived in GPRS on November 21, 2017.
`
`I understand that copies of Sections 3.2.P 33; 32.P3.5; 3.2.P.3.5.l; 3.2.P.7; 3.2.R; and
`3.2.A. I(Fruh), (Sterigenics), and (Vetter) from the Chemistry, Manufacturing, and
`Controls portions of sBLA 125156/S-1 IO and 125156/S-l l 7 have been produced bearing
`the following Bates labels:
`
`Novartis Exhibit 2198.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
`DLA 125156/S-110
`3.2 .P.3.3
`
`3.2.P.3.S
`
`3.2.P.3.S.l
`
`3 .2 .P .7
`
`3.2.R
`
`3 .2.A. l (Vetter)
`
`3.2.A l (Sterigenics)
`
`3.2.A 1 (Fruh)
`
`BLA 125156/S-117
`3.2.P .3.3
`
`3.2.P.3.5
`
`3.2.P.3.S. l
`
`3.2.P.7
`
`3.2.R
`
`3.2.A.1 (Vetter)
`
`3.2.A 1 (Sterigenics)
`
`3.2.A.1 (Fruh)
`
`GENElTC L207..0003675 -
`GENEITC - 1207-0003682
`GENEITC 1207-0003704 -
`GENElTC - 1207..0003 73 7
`GBNEITC 1207..0003683 -
`GENEITC- 1207..0003703
`GENE1TC_ l207-0003545 -
`GENEITC 1207..0003550
`GENEITC 1207-0003551 -
`GENEITC - 1207..0003630
`GENEITC 1207..0003652 -
`GENEITC- 1207..0003674
`GENEITC 1207..0003644 -
`GENEITC- 1207-0003651
`GENEITC 1207-0003631 -
`GENEITC- 1207..0003643
`
`GENEITC_ 1207-0003481-
`GENEITC 1207-0003488
`GENEITC_ l207-0003503 -
`GENEITC 1207-0003 544
`GENEITC 1207..0003489 -
`GENEITC 1207-0003502
`GENEITC _1207-0003412 -
`GENEITC 1207..0003417
`GENEITC_ 1207-0003418 -
`GENEITC 1207-0003457
`GENEITC _ 1207-0003468 -
`GENEITC 1207-0003480
`GENEITC _ 1207-0003464 -
`GENEITC 1207-0003467
`GENEITC_ l207-0003458 -
`GENElTC 1207-0003463
`
`6.
`
`The Bates-labeled documents listed above are true and correct copies of the corresponding
`sections of sBLA 125156/S-l 10 and 125156/S-l 17 maintained in GPRS.
`
`r declare under penalty of perjury that the foregoing is true and correct.
`
`Executed this 21).day of November, 2020 at _ __,_tf.!..tu..· lulb.u.Yl~"o..L,6,,.__ _ _ _ _ _ , California.
`
`Novartis Exhibit 2198.002
`Regeneron v. Novartis, IPR2021-00816
`
`
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