`Declaration of Stephanie Mendelsohn
`
`Filed on behalf of Patent Owner Genentech, Inc. by:
`
`David L. Cavanaugh (Reg. No. 36,476)
`Owen K. Allen (Reg. No. 71,118)
`Robert J. Gunther, Jr. (Pro Hae Vice filed)
`Lisa J. Pirozzolo (Pro Hae Vice filed)
`Kevin S. Prussia (Pro Hae Vice filed)
`Andrew J. Danford (Pro Hae Vice filed)·
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`1875 Pennsylvania Ave., NW
`Washington, DC 20006
`
`AdamR. Brausa (Reg. No.
`60,287)
`Daralyn J. Durie (Pro Hae Vice
`filed)
`DURIE TANGRI LLP
`217 Leidesdorff Street
`San Francisco, CA 94111
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`CELLTRION, INC.,
`Petitioner,
`
`v.
`
`GENENTECH, INC.,
`Patent Owner.
`
`Case IPR2017-01122
`Patent 7,892,549
`
`DECLARATION OF STEPHANIE MENDELSOHN
`
`Genentech 2069
`Celltrion v. Genentech
`IPR2017-01122
`
`
`
`I, Stephanie Mendelsohn, declare as follows:
`
`1.
`
`I have personal knowledge of the facts set forth in this declaration.
`
`All statements herein made of my own knowledge are true and all statements made
`
`on information and belief are believed to be true.
`
`2.
`
`I am currently Associate General Counsel and Director of Records
`
`and eDiscovery at Genentech. I have worked at Genentech since 2006.
`
`3.
`
`One of my roles at Genentech is to manage the retention of company
`
`records.
`
`4.
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`Pursuant to Genentech's records retention schedule, documentation
`
`relating to clinical trials are maintained in various databases, including an
`
`electronic trial master file ("eTMF") database for company-sponsored clinical
`
`trials. The eTMF database contains records related to the design, management,
`
`monitoring, execution, and outcomes of clinical trials.
`
`5.
`
`Several documents from the eTMF database for Genentech's H0648g
`
`clinical trial have been submitted as exhibits in this proceeding:
`
`a.
`
`Exhibit 2001 is a true and authentic copy of the clinical trial protocol
`
`for the H0648g study dated
`
`.
`
`b.
`
`Exhibit 2007 is a true and authentic copy of the clinical trial protocol
`
`amendment for the H0648g study dated
`
`.
`
`1
`
`
`
`c.
`
`Exhibit 2008 is a true and authentic copy of the final study report for
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`the H0648g study.
`
`6.
`
`Consistent with Genentech's practices, Exhibits 2001, 2007, and 2008
`
`were created at or near the time of the events recorded and were made by someone
`
`with knowledge or from information transmitted by someone with knowledge.
`
`Exhibits 2001, 2007, and 2008 are records kept in the ordinary course of
`
`Genentech's business, and making such records was Genentech's regular practice.
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`7.
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`Pursuant to Genentech's records retention schedule, Genentech also
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`maintains meeting minutes and presentations from executive committees, including
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`the Product Development Committee ("PDC").
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`Such meeting minutes and
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`presentations from the 1990s are maintained in hardcopy files by Genentech' s
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`offsite storage vendor, DataSafe.
`
`8.
`
`Several documents reflecting PDC meeting minutes and presentations
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`from Genentech's DataSafe files have been submitted as exhibits in this
`
`proceeding:
`
`a.
`
`Exhibit 2002 is a true and authentic copy of the minutes from the
`
` meeting of Genentech's PDC.
`
`b.
`
`Exhibit 2003 is a true and authentic copy of the minutes from the
`
` meeting of Genentech's PDC.
`
`2
`
`
`
`c.
`
`Exhibit 2004 is a true and authentic copy of the minutes from the
`
` meeting of Genentech's PDC.
`
`d.
`
`Exhibit 2005 is a true and authentic copy of a presentation from the
`
` meeting ofGenentech's PDC.
`
`9.
`
`Consistent with Genentech's practices, Exhibits 2002, 2003, 2004,
`
`and 2005 were created at or near the time of the events recorded and were made by
`
`someone with knowledge or from information transmitted by someone with
`
`knowledge. Exhibits 2002, 2003, 2004, and 2005 are records kept in the ordinary
`
`course of Genentech's business, and making such records was Genentech's regular
`
`practice.
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`I declare under penalty of perjury of the laws of the United States of
`
`America that the foregoing is true and correct.
`
`Date:
`
`yfeJ~~~c-
`
`Stephanie Mendelsohn
`
`3
`
`