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`UT Ex. 2006
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`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`|PR2016-00006
`IPR2016-00006
`
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`manufacturing steps have not changed during the transfer to— and I from the process
`used by UT in Chleago to prepare benzindene triol_
`
`'—l :5" (‘D 0 I3" 9E. 0°_’
`
`‘There IS a release specttication for benztndene tnol that must be achieved tor each
`lot of benzindene triol before it is released for use by UT to prepare treprostinil. This is the
`same speciticatiori that was used by United Therapeutics in our Chicago facility.
`
`2
`2
`
`'
`
`UT Ex. 2006
`UTEx.2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`|PR2016-00006
`IPR2016-00006
`
`
`
`_\';').-'I 2 {-2 72 -.\‘U I U
`
`3 .1ammr_1' 2(.'U'~’)
`Page 3 :3] 15'
`
`—in
`
`
`
`all lots, the total unidentified impurity ievel (%AUC) decreased from triol to UT~l5C
`intermediate.
`
`3
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`UT Ex. 2006
`UT Ex. 2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`IPR2016-00006
`IPR2016-00006
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`_
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`_00135564
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`4
`4 '
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`UT Ex. 2006
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`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`|PR2016-00006
`IPR2016-00006
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`_\';').-'I 2 {-2 72 -.\‘(}1 U
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`3 .1rm££c:rr_ 1' 2(.‘U'~’)
`Page .5 r;;’'rS'
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`5
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`UT Ex. 2006
`UT Ex. 2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`|PR2016-00006
`IPR2016-00006
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`6
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`UT Ex. 2006
`UT Ex. 2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`|PR2016-00006
`IPR2016-00006
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`7
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`UT Ex. 2006
`UT Ex. 2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`IPR2016-00006
`IPR2016-00006
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`8
`8 '
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`UT Ex. 2006
`UTEx.2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
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`9
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`UT Ex. 2006
`UT Ex. 2006
`SteadyMed v. United Therapeutics
`SteadyMed v. United Therapeutics
`|PR2016-00006
`IPR2016-00006