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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
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`STEADYMED LTD.
`Petitioner
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`v.
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`UNITED THERAPEUTICS CORPORATION
`Patent Owner
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`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
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`Patent Owner’s Exhibit List as of May 31, 2016
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`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`4825-0169-9884.1
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`Ex #
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`2001
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`2002
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`2003
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`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`2011
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`2012
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`2013
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`2014
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`2015
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`Exhibit Description
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`November 19, 2015 Conference Call Before the Panel
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`Remodulin Label
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`FDA Approval Letter
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`Process Validation Report: (Protocol No.: “VAL 00131”)
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`Process Optimization Report
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`UTC Letter of January 2009 to FDA
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`U.S. Patent No. 8,242,305; the ’305 patent;
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`U.S. Provisional Patent Application No. 61/014,232
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`U.S. Patent No. 8,748,657; the ’657 patent
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`The ’657 patent prosecution history
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`Zumdahl, Chemistry, pp. A25, A36 (1986)
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`Brown, et al., Chemistry: The Central Science, pp. G-2, G-10 (9th ed.
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`2003)
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`Trial testimony of Dr. Williams and Dr. Aristoff
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`Suchocki, et al., Conceptual Chemistry, p. G-6 (2001)
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`U.S. Patent No. 4,668,814; the ’814 patent
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`4825-0169-9884.1
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`2
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`IPR2016-00006
`Patent 8,497,393
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`Patent Owner Docket No. 080618-1601
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`UTC Form 10K 2014 Annual Report
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`Declaration of Liang Gou, Ph.D.
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`Declaration of Rex Mauthe
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`May 10, 2016 Conference Call Before the Panel
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`2016
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`2017
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`2018
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`2019
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`Respectfully submitted,
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`Date: May 31, 2016
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`/Stephen B. Maebius/
`Stephen B. Maebius
`Registration No. 35,264
`Counsel for Patent Owner
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`4825-0169-9884.1
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`3
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`IPR2016-00006
`Patent 8,497,393
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`Attorney Docket No. 080618-1601
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`CERTIFICATE OF SERVICE
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`The undersigned hereby certifies that a copy of the foregoing Patent
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`Owner’s Exhibit List and a copy of Exhibit No. 2019 were served on counsel of
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`record for the Petitioner on May 31, 2016 by delivering a copy via email to Stuart
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`Pollack and Lisa Haile (the counsel of record for the Petitioner) at the following
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`/Stephen B. Maebius/
`Stephen B. Maebius
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`Registration No. 35,264
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`Counsel for Patent Owner
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`address: Steadymed-IPR@dlapiper.com.
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`Date: May. 31, 2016
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`4825-0169-9884.1