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`FORWARD PHARMA EXHIBIT 1018
`Biogen MA Inc. v. Forward Pharma A/S
`Contested Case 106,023
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`1
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`Sawai (IPR2019-00789), Ex. 1046, p. 001
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`

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`2
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`Sawai (IPR2019-00789), Ex. 1046, p. 002
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`

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`Atty. Dkt, No. 2159.3210001
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`LUKASHEV
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`Appl. No. 12/526,296
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`Men and women 18 to 55 years of age were eligible for the study if they had a
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`diagnosis of RRMSand an Expanded Disability Status Scale ("EDSS") score (a
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`well-known measureofthe disabilities suffered by MS patients) between 0.0 and
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`5.0. Additionally, the patients had to have hadat least 1 relapse within 12 months
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`prior to randomization or gadolinium-enhancing (Gd+)lesions (Gd+ lesionsin the
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`brain are a well-known marker of MS) on brain MRI within six weeks of
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`The patients were randomly assigned to one of four treatment groups for 24 weeks:
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`The primary end point of the Phase 2 clinical trial was the sum of all new Gd+
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`lesions from four brain MRI scans obtained at Weeks 12, 16, 20, and 24. The
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`number of Gd+ lesionsis considered a surrogate end point for clinical efficacy and
`as such is accepted as a primary end point for a proofofconcept study.
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`The secondary end points of the Phase 2 clinical trial included the cumulative
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`number of new Gd+lesions on scans from Weeks4 and 24, the numberof new or
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`newly enlargingT2-hyperintense lesions at Week 24, and the numberof new Tl
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`hypointense lesions at week 24.
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`Additional end points included annualized relapse rate ("ARR") and disability
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`7.
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`Theresults of the Phase2 clinical trial are reported in the peer-reviewed publication
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`of Kappos, L., et al., "Efficacy and safety of oral fumarate in patients with relapsing-remitting
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`multiple sclerosis: a multicentre, randomised, double-blind, placebo-controlled phaseIIb study,"
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`3 S
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`awai (IPR2019-00789), Ex. 1046, p. 003
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`3
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`Sawai (IPR2019-00789), Ex. 1046, p. 003
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`4
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`Sawai (IPR2019-00789), Ex. 1046, p. 004
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`21
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`Sawai (IPR2019-00789), Ex. 1046, p. 005
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`22
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`Sawai (IPR2019-00789), Ex. 1046, p. 006
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`
`
`Exhibit C
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`to Exhibit 1
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`23 .
`oc
`Sawai (IPR2019-00789), Ex. 1046, p. 007
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`23
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`Sawai (IPR2019-00789), Ex. 1046, p. 007
`
`

`

`Sawai (IPR2019-00789), Ex. 1046, p. 008
`‘AISNOA“|‘JOJBIWYOS“y‘UBWIOd*D‘YJOJWWUIT‘fA‘eAOPJAeH
`
`
`TS)NOWNiroaeLe)=)SBadat61740)=)7ieBares)|-2=TOLLANZaNoL
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`‘SISOJ9/OS9/0jnwHuijjiweas-Huisdeyas
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`SULToRlerAiiitol:meal
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`LUE]o]-St-)1OLUILslom[:Y\Co]emmaComte)-20)FA=
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`,Apnjs|]aseydeJosjjnseu
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`24 -
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`VYWOUpuesap;uaBoigAqpaiosuodsApnjs,
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`24
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`Sawai (IPR2019-00789), Ex. 1046, p. 008
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`

`

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`25
`
`Sawai (IPR2019-00789), Ex. 1046, p. 009
`
`(cid:9)
`(cid:9)
`

`

`ayepnsaidy)
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`
`26
`Sawai (IPR2019-00789), Ex. 1046, p. 010
`
`26
`
`Sawai (IPR2019-00789), Ex. 1046, p. 010
`
`

`

`ITONimoye,me)OLLUe
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`27
`
`Sawai (IPR2019-00789), Ex. 1046, p. 011
`
`

`

`Sawai (IPR2019-00789), Ex. 1046, p. 012
`SjuaijedulAyjiqesajo}pueAdeoiiepayesSuowag«Ba
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`28
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`Sawai (IPR2019-00789), Ex. 1046, p. 012
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`Sawai (IPR2019-00789), Ex. 1046, p. 013
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`29
`
`Sawai (IPR2019-00789), Ex. 1046, p. 013
`
`

`

`Sawai (IPR2019-00789), Ex. 1046, p. 014
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`30
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`Sawai (IPR2019-00789), Ex. 1046, p. 014
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`31
`Sawai (IPR2019-00789), Ex. 1046, p. 015
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`31
`
`Sawai (IPR2019-00789), Ex. 1046, p. 015
`
`

`

`Sawai (IPR2019-00789), Ex. 1046, p. 016
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`32
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`Sawai (IPR2019-00789), Ex. 1046, p. 016
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`
`
`Sawai (IPR2019-00789), Ex. 1046, p. 017
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`33
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`Sawai (IPR2019-00789), Ex. 1046, p. 017
`
`

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`34
`Sawai (IPR2019-00789), Ex. 1046, p. 018
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`34
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`Sawai (IPR2019-00789), Ex. 1046, p. 018
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`35
`Sawai (IPR2019-00789), Ex. 1046, p. 019
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`35
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`Sawai (IPR2019-00789), Ex. 1046, p. 019
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`36
`Sawai (IPR2019-00789), Ex. 1046, p. 020
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`36
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`Sawai (IPR2019-00789), Ex. 1046, p. 020
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`37
`Sawai (IPR2019-00789), Ex. 1046, p. 021
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`37
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`Sawai (IPR2019-00789), Ex. 1046, p. 021
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`Sawai (IPR2019-00789), Ex. 1046, p. 022
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`Sawai (IPR2019-00789), Ex. 1046, p. 022
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`Sawai (IPR2019-00789), Ex. 1046, p. 023
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`Sawai (IPR2019-00789), Ex. 1046, p. 024
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`Sawai (IPR2019-00789), Ex. 1046, p. 025
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`Sawai (IPR2019-00789), Ex. 1046, p. 026
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`42
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`Sawai (IPR2019-00789), Ex. 1046, p. 026
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`Sawai (IPR2019-00789), Ex. 1046, p. 027
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`Sawai (IPR2019-00789), Ex. 1046, p. 028
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`Sawai (IPR2019-00789), Ex. 1046, p. 028
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