`Patent Owner’s Updated Exhibit List
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`FRESENIUS KABI USA, LLC,
`Petitioner,
`
`v.
`
`CEPHALON, INC.,
`Patent Owner.
`______________________
`
`Case IPR2016-00111
`Patent No. 8,895,756 B2
`
`______________________
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`
`
`IPR2016-00111 (Paper No. 16)
`Patent Owner’s Updated Exhibit List
`
`PATENT OWNER’S UPDATED EXHIBIT LIST
`
`EXHIBIT
`
`DESCRIPTION
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`TREANDA® Prescribing Information
`
`“Treanda New Drug Application for the Treatment of
`Chronic Lymphocytic Leukemia Granted Priority
`Review Status by FDA,” Drugs.com (December 3,
`2007)
`File History of U.S. Patent No. 8,609,863
`
`“FDA Approves Treanda,” Drugs.com (March 20,
`2008)
`“Cephalon Receives FDA Approval for Treanda to
`Treat Patients with Relapsed Indolent Non-Hodgkin’s
`Lymphoma,” Drugs.com (October 31, 2008)
`Brad S. Kahl, et al., “Bendamustine Is Effective
`Therapy in Patients with Rituximab-Refractory,
`Indolent B-cell Non-Hodgkin Lymphoma: Results
`From a Multicenter Study,” Cancer 106 (January 1,
`2010)
`K. Sue Robinson, et al., “Phase II Multicenter Study
`of Bendamustine Plus Rituximab in Patients with
`Relapsed Indolent B-Cell and Mantle Cell Non-
`Hodgkin’s Lymphoma,” 26 J. Clin. Oncol. 4473
`(September 20, 2008)
`Wolfgang U. Knauf, et al., “Phase III Randomized
`Study of Bendamustine Compared with Chlorambucil
`in Previously Untreated Patients with Chronic
`Lymphocytic Leukemia,” 27 J. Clin. Oncol. 4278
`(September 10, 2009)
`Wolfgang U. Knauf, et al., “Bendamustine Compared
`with Chlorambucil in Previously Untreated Patients
`with Chronic Lymphocytic Leukaemia: Updated
`Results of a Randomized Phase III Trial,” 159 Brit. J.
`Hematology 67 (August 4, 2012)
`
`1
`
`
`
`IPR2016-00111 (Paper No. 16)
`Patent Owner’s Updated Exhibit List
`
`EXHIBIT
`
`DESCRIPTION
`
`2010
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`Norbert Niederle, et al., “Bendamustine Compared to
`Fludarabine as Second-Line Treatment in Chronic
`Lymphocytic Leukemia,” 92 Ann. Hematology 653
`(January 23, 2013)
`Teva Pharmaceutical Industries Limited, Form 20-F,
`2014
`Teva Pharmaceutical Industries Limited, Form 20-F,
`2011
`Cephalon, Inc., Form 10-K, 2010
`
`Cephalon, Inc., Form 10-K, 2009
`
`Cephalon, Inc., Form 10-K, 2008
`
`Bendamustine, Keating et al., Nature Reviews Drug
`Discovery 7, 473-474 (June 2008)
`Cancer Chemotherapy and Biotherapy: Principles and
`Practice (Dec. 7, 2011)
`CONFIDENTIAL – Agreement between the Parties
`
`2
`
`
`
`Dated: July 26, 2016
`
`IPR2016-00111 (Paper No. 16)
`Patent Owner’s Updated Exhibit List
`
`Respectfully submitted,
`
`KAYE SCHOLER LLP
`
`/s/ Soumitra Deka
`Soumitra (Sam) Deka
`(No. 70,252)
`soumitra.deka@kayescholer.com
`Two Palo Alto Square
`3000 El Camino Real, Suite 400
`Palo Alto, CA 94306
`Tel: (212) 836-8000
`Fax: (212) 836-8689
`Attorneys for Patent Owner
`
`3
`
`
`
`IPR2016-00111 (Paper No. 16)
`Patent Owner’s Updated Exhibit List
`
`CERTIFICATION OF SERVICE
`
`The undersigned hereby certifies that the foregoing PATENT OWNER’S
`
`UPDATED EXHIBIT LIST was served electronically via e-mail on this 26th day
`
`of July, 2016, and directed to:
`
`Counsel for Petitioner
`
`Lawrence Sung
`Neal Seth
`WILEY REIN LLP
`nseth@wileyrein.com
`lsung@wileyrein.com
`
`WILEY REIN LLP
`ATTN: Patent Administration
`1776 K Street NW
`Washington, DC 20006
`
`Dated: July 26, 2016
`
`4
`
`KAYE SCHOLER LLP
`
`By
`
`/Soumitra Deka #70,252
`Soumitra (Sam) Deka
`Two Palo Alto Sq.
`3000 El Camino Real
`Palo Alto, CA 94306
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