`
`Case: IPR2015-01836
`Patent No. 7,932,268
`
`
`
`Description
`Petitioner’s Opposition To Patent Owner’s
`Contingent Motion To Amend, filed
`September 7, 2016
`
`Guidance for Industry 2002, Estimating the
`Safe Starting Dose in Clinical Trials for
`Therapeutics in Adult Healthy Volunteers
`(2002)
`
`ICH-E4, Dose-Response Information to
`Support Drug Registration (1994)
`
`Reigner & Smith Blesch, “Estimating the
`starting dose for entry into humans:
`principles and practice,” EUR J CLIN
`PHARMACOL, Vol.57, pp. 835–45 (2002)
`
`Deposition Transcript of Thomas A. Baillie,
`Ph.D., D.Sc. (August 25, 2016)
`
`Zusman Suppl. Dec. Supplemental Declaration of Randall J.
`Zusman, M.D.
`
`Deposition Transcript of S. David Kimball,
`Ph.D., (July 11, 2016)
`
`Deposition Transcript of Richard Gregg,
`M.D. (July 26, 2016)
`
`1
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`
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`
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`PENN EX. 2307
`CFAD v. PENN
`IPR2015-01836
`
`
`
`Nickname
`CFAD Opposition
`
`Guidance For
`Industry 2002
`
`ICH-E4
`
`Reigner
`
`Baillie Tr.
`
`Kimball Tr.
`
`Gregg Tr.
`
`Doc. No.
`Paper 30
`
`1042
`
`1043
`
`1044
`
`1056
`
`1045
`
`1052
`
`1053
`
`
`
`
`
`
`
`
`
`Doc. No.
`1054
`
`1055
`
`2001
`
`2020
`
`2021
`
`2024
`
`2078
`
`2079
`
`2080
`
`2095
`
`Nickname
`Sacks Tr.
`
`Rader Tr.
`
`Zusman Tr.
`
`Mayersohn Tr.
`
`002 Addendum
`
`Description
`Deposition Transcript of Frank Sacks, M.D.
`(August 12, 2016)
`
`Deposition Transcript of Daniel J. Rader,
`M.D. (August 23, 2016)
`
`License Agreement University of Pennsylvania Patent License
`Agreement (May 19, 2006)
`
`Deposition Transcript of Randall M.
`Zusman, M.D. (May 19, 2016)
`
`Deposition Transcript of Michael
`Mayersohn, Ph. D. (May 16, 2016)
`
`Baillie Opening Dec. Declaration of Thomas A. Baillie, Ph.D.,
`D.Sc.
`
`BMS-201038 Investigator Brochure General
`Addendum CV145-
`002, Multiple Dose PO (Oct. 1, 1997)
`
`Clinical Study Approval (Mar. 20, 2003)
`
`Abbreviated Clinical Study Report for
`CV145-009 (Jan. 7, 2002)
`
`U.S. Patent No. 6,066,653
`
`
`Rader Approval
`
`009 Report
`
`’653 Patent
`
`
`
`
`
`
`
`
`
`2
`
`
`
`
`
`PENN EX. 2307
`CFAD v. PENN
`IPR2015-01836