+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +
`
`KE@J<; IJ8J<I G8J<EJ 8E; JH8;<D8HB F==@:<
`9<=FH< J?< G8J<EJ JH@8C 8E; 8GG<8C 9F8H;
`
`PPPPPPPPPPPPPPPPPPPPPPPPPPP
`
`A8EII<E G?8HD8:<KJ@:8CI’
`@E:)’ Q^T A8EII<E
`G?8HD8:<KJ@:8 EL’
`
`GQdU^d Fg^Ub’
`
`@GH,*,*(**..*
`
`&
`&
`&
`&
`&
`&
`&
`&
`&
`&
`&
`&
`GUdYdY_^Ub)
`PPPPPPPPPPPPPPPPPPPPPPPPPPP&
`
`fc)
`
`DNC8E C89FH8JFH@<I @E:)’
`
`H<GFHJ F= GHF:<<;@E>I
`
`AKE< -*’ ,*,*
`
`H<GFHJ F= GHF:<<;@E>I fYQ dU\US_^VUbU^SU _V
`
`dXU QR_fU(U^dYd\UT SQecU RUV_bU dXU ?_^_bQR\U A_X^
`
`>) EUg’ H_RUbd 8) G_\\_S[’ Q^T BbYcdY^Q D) BQ\Q^’
`
`AeTWUc _V cQYT GQ^U\’ _^ dXU -*dX TQi _V Ae^U ,*,*
`
`Qd dXU X_eb _V +4** ‘)])
`
`:UbdYVYSQdY_^ E_) *2.(**-.-/
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 001
`
`
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +
`
`KE@J<; IJ8J<I G8J<EJ 8E; JH8;<D8HB F==@:<
`9<=FH< J?< G8J<EJ JH@8C 8E; 8GG<8C 9F8H;
`
`PPPPPPPPPPPPPPPPPPPPPPPPPPP
`
`A8EII<E G?8HD8:<KJ@:8CI’
`@E:)’ Q^T A8EII<E
`G?8HD8:<KJ@:8 EL’
`
`GQdU^d Fg^Ub’
`
`@GH,*,*(**..*
`
`&
`&
`&
`&
`&
`&
`&
`&
`&
`&
`&
`&
`GUdYdY_^Ub)
`PPPPPPPPPPPPPPPPPPPPPPPPPPP&
`
`fc)
`
`DNC8E C89FH8JFH@<I @E:)’
`
`H<GFHJ F= GHF:<<;@E>I
`
`AKE< -*’ ,*,*
`
`H<GFHJ F= GHF:<<;@E>I fYQ dU\US_^VUbU^SU _V
`
`dXU QR_fU(U^dYd\UT SQecU RUV_bU dXU ?_^_bQR\U A_X^
`
`>) EUg’ H_RUbd 8) G_\\_S[’ Q^T BbYcdY^Q D) BQ\Q^’
`
`AeTWUc _V cQYT GQ^U\’ _^ dXU -*dX TQi _V Ae^U ,*,*
`
`Qd dXU X_eb _V +4** ‘)])
`
`:UbdYVYSQdY_^ E_) *2.(**-.-/
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 001
`
`
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU ,
`
`8GG<8H8E:<I4
`
`B8JJ<E DK:?@E HFI<ED8E CCG
`9i4 DH) A@J<E;H8 D8C@B
`//* I_edX Jib_^ IdbUUd’ IeYdU ,3**
`:XQb\_ddU’ E_bdX :Qb_\Y^Q ,2,*,(.,+-
`1*.)-..)-+2/
`ZYddi)]Q\Y[7[QddU^)S_]
`
`(Q^T(
`
`B8JJ<E DK:?@E HFI<ED8E CCG
`9i4 DI) >KNC8@E< ?8:?<
`/,/ MUcd D_^b_U IdbUUd
`:XYSQW_’ @\\Y^_Yc 0*0*0
`-+,)*3,)/***
`Wei\QY^U)XQSXU7[QddU^)S_]
`
`Q‘‘UQbUT _^ RUXQ\V _V dXU
`GUdYdY_^Ub5
`
`G8JJ<HIFE 9<CBE8G M<99 8E; JNC<H CCG
`9i4 DH) 8E;H<M ;) :F?<E
`DI) 98H98H8 C) DKCC@E
`++-- 8fU^eU _V dXU 8]UbYSQc
`EUg N_b[’ EN
`+**-0(01+*
`,+,)--0),0*/
`QS_XU^7‘Rgd)S_]
`R]e\\Y^7‘Rgd)S_]
`
`(Q^T(
`
`8B@E >KDG IJH8KII ?8K<H # =<C; CCG
`9i4 DH) HK9<E DKEFO
`Jg_ :_]]UbSU IaeQbU
`,**+ DQb[Ud IdbUUd’ IeYdU .+**
`GXY\QTU\‘XYQ’ GU^^ci\fQ^YQ +3+*-
`
`Q‘‘UQbUT _^ RUXQ\V _V dXU
`GQdU^d Fg^Ub)
`
`8\c_ GbUcU^d4
`
`Dc) AU^^YVUb HUTQ’ AQ^ccU^ @^(?_ecU :_e^cU\
`
`%8\\ ‘QbdYUc Q‘‘UQbUT fYQ dU\US_^VUbU^SU)&
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 002
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU -
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`AK;>< E<M4 >__T QVdUb^__^’ UfUbiR_Ti) 8bU
`
`S_e^cU\ V_b R_dX ‘QbdYUc ‘bUcU^d6
`
`DH) D8C@B4 NUc’ N_eb ?_^_b)
`
`AK;>< E<M4 >bUQd) Di ^Q]U Yc AeTWU A_X^
`
`EUg) @$] Z_Y^UT XUbU Ri ]i S_\\UQWeUc’ AeTWU H_RUbd
`
`G_\\_S[ Q^T AeTWU BbYcdY^Q BQ\Q^)
`
`:_e\T ‘QbdYUc _b S_e^cU\ V_b R_dX ‘QbdYUc
`
`‘\UQcU YTU^dYVi dXU]cU\fUc V_b dXU bUS_bT)
`
`DH) D8C@B4 N_eb ?_^_b’ dXYc Yc AYdU^TbQ
`
`DQ\Y[’ \UQT S_e^cU\ V_b Di\Q^) MYdX ]U Yc RQS[e‘
`
`S_e^cU\’ >ei\QY^U ?QSXU)
`
`DH) :F?<E4 8^T dXU^ V_b GQdU^d Fg^Ub’ dXYc
`
`Yc 8^TbUg :_XU^ Vb_] GQddUbc_^ 9U\[^Q‘’ RQS[e‘
`
`S_e^cU\) MYdX ]U Yc 9QbRQbQ De\\Y^ Vb_] GQddUbc_^
`
`9U\[^Q‘’ \UQT S_e^cU\5 HeRU^ De^_j Vb_] 8[Y^ >e]‘’
`
`RQS[e‘ S_e^cU\ Q^T \YcdU^Y^W Y^ Yc AU^ HUTQ’
`
`Y^(X_ecU S_e^cU\ V_b dXU GQdU^d Fg^Ub)
`
`AK;>< E<M4 >bUQd) JXQ^[ i_e) MU\S_]U
`
`UfUbiR_Ti) >__T QVdUb^__^) MU XQfU Q S_e‘\U _V
`
`YcceUc RUV_bU ec d_TQi Qc @ e^TUbcdQ^T S_bbUSd\i
`
`Vb_] dXU U]QY\ dXQd @ bUSUYfUT) JXU VYbcd Yc dXU
`
`UQci _^U’ c_ \Ud$c T_ dXQd _^U VYbcd) 8^T dXQd Yc
`
`dXQd S_e^cU\ V_b GUdYdY_^Ub XQc bUaeUcdUT QTTYdY_^Q\
`
`RbYUVY^W _^ dXU -+.%Q&’ -,/%T& YcceU gYdX c‘USYVYS
`
`bUVUbU^SU d_ 8‘‘\U VQSd_b 0 Q^T bUaeUcdUT Q _^U(gUU[
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 003
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU .
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`TUQT\Y^U V_b Q VYfU(‘QWU bU‘\i)
`
`GQdU^d Fg^Ub T_Uc ^_d _‘‘_cU dXQd Qc \_^W Qc
`
`dXUi SQ^ WbQ^d (( dXUi SQ^ VY\U Q cY]Y\Qb _^U(gUU[’
`
`V_\\_gY^W gUU[ VYfU(‘QWU cebbU‘\i) ;_ @ e^TUbcdQ^T
`
`dXQd S_bbUSd\i6
`
`DH) D8C@B4 N_eb ?_^_b’ @ dXY^[ WU^UbQ\\i
`
`iUc) @ dXY^[ gXQd dXU bUaeUcd Yc Yc d_ QTTbUcc Q\\
`
`dXU 8‘‘\U VQSd_bc) JXU bUQc_^ gU c‘USYVYSQ\\i ^_dUT
`
`-,/ RUSQecU AQ^ccU^$c TYcSeccY_^ _V -,/ (( ^_b]Q\\i
`
`-,/ Yc Q cdQ^T(Q\_^U cUSdY_^ cU‘QbQdU Vb_] -+.’ Red
`
`dXUi Y^S_b‘_bQdUT -,/ Y^ S_^^USdY_^ gYdX 8‘‘\U
`
`VQSd_b 0’ c_ gU Zecd gQ^dUT d_ ^_dYVi dXU GJ89 gXi
`
`gU gUbU dQ\[Y^W QR_ed -,/ gXU^ YV i_e \__[ Qd dXUYb
`
`dQR\U _V S_^dU^dc’ i_e T_^$d cUU Q c‘USYVYS cUSdY_^
`
`V_b -,/)
`
`I_ dXU bUaeUcd Yc V_b QSdeQ\\i dU^ ‘QWUc V_b
`
`-,/ (( gU\\’ -+.’ 8‘‘\U VQSd_bc + dXb_eWX 0’ gXYSX
`
`g_e\T Y^S_b‘_bQdU Q TYcSeccY_^ _V -,/) 8^T d_ dXU
`
`UhdU^d dXU GJ89 Yc Y^S\Y^UT d_ TYcSecc Q\c_ gXQd @
`
`SQ\\ dXU e]RbU\\Q dUb] "Y^fU^d_bcXY‘’" dU^ ‘QWUc
`
`d_dQ\ QSb_cc dXU R_QbT)
`
`AK;>< E<M4 MU$\\ WUd d_ Y^fU^d_bcXY‘ Y^ Q
`
`]_]U^d’ Red dXYc Yc dXU e^_‘‘_cUT ‘_bdY_^ _V dXYc’
`
`bYWXd’ Yc TUQ\Y^W gYdX dXU 8‘‘\U VQSd_bc) 8^T i_e
`
`gQ^dUT VYfU ‘QWUc V_b dXQd Y^ _^U gUU[ Q^T gU$\\
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 004
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU /
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`TUQ\ gYdX dXU Y^fU^d_bcXY‘ ^Uhd)
`
`DH) D8C@B4 @ dXY^[ gXQd gU$bU Qc[Y^W V_b Yc
`
`gXQd @ U^fYcY_^ Yc ec c‘U^TY^W QR_ed (( YV gU WUd
`
`dU^ ‘QWUc’ ec c‘U^TY^W cUfU^ ‘QWUc _^ dXU 8‘‘\U
`
`VQSd_bc Q^T QR_ed dXbUU _^ dXU Y^fU^d_bcXY‘ YcceUc’
`
`dXU fQcd ]QZ_bYdi) I_ gU$bU Qc[Y^W V_b Q \Ydd\U RYd
`
`]_bU dXQ^ VYfU’ ^_d ^USUccQbY\i (( ^_d dXQd ]eSX
`
`]_bU’ Red Zecd Q S_e‘\U ]_bU ‘QWUc Zecd c_ gU SQ^
`
`QTTbUcc dX_cU YcceUc)
`
`8^T @$\\ ^_dU dXQd dXQd bUaeUcd V_b’ i_e
`
`[^_g’ Qb_e^T QR_ed dU^ ‘QWUc Yc di‘YSQ\ V_b -+.’ -,/
`
`Q^T @ SQ^ ‘b_fYTU ]_bU SQcUc’ @GH SQcUc’ gXUbU Q
`
`cY]Y\Qb bUaeUcd gQc WbQ^dUT) @^ VQSd’ Y^ _^U _V dXU
`
`Di\Q^ SQcUc Yd gQc WbQ^dUT)
`
`AK;>< E<M4 8\\ bYWXd) I_ @ e^TUbcdQ^T
`
`dXQd (( Db) :_XU^’ dXQd AQ^ccU^ T_Uc^$d _‘‘_cU
`
`RbYUVY^W _^ dXQd ‘QbdYSe\Qb YcceU’ QTTYdY_^Q\
`
`RbYUVY^W)
`
`DH) :F?<E4 NUQX) JXYc Yc 8^TbUg) JXQd Yc
`
`S_bbUSd’ ‘b_fYTUT Yd$c \Y]YdUT d_ dXU 8‘‘\U VQSd_bc)
`
`MU bUS_W^YjU dXQd dXU GUdYdY_^Ub TYT^$d XQfU dXU
`
`RU^UVYd _V dXU 8‘‘\U TUSYcY_^ gXU^ Yd VY\UT Ydc
`
`‘UdYdY_^) I_ gU QbU _[Qi gYdX dXQd)
`
`MU T_^$d fYUg Yd Qc Q^ _‘‘_bde^Ydi d_ (( V_b
`
`Q gYTU(bQ^WY^W bU‘\i d_ QTTbUcc Q\\ dXU
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 005
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU 0
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`TYcSbUdY_^Qbi TU^YQ\ YcceUc) 9ed d_ dXU UhdU^d Yd$c
`
`\Y]YdUT d_ 8‘‘\U Q^T QTTbUccY^W dX_cU VQSd_bc’ gU
`
`XQfU ^_ _RZUSdY_^)
`
`AK;>< E<M4 8\\ bYWXd) Db) DQ\Y[’ _^ dXU
`
`Y^fU^d_bcXY‘ YcceU’ T_ @ e^TUbcdQ^T dXYc S_bbUSd\i
`
`Vb_] dXU RbYUV dXQd gU$bU dQ\[Y^W QR_ed (( dXU YcceU
`
`Yc gXUdXUb dXU ‘QdU^d(Y^(ceYd XUbU SQ^ S\QY] dXU
`
`‘bY_bYdi RU^UVYd _V dXU $3+2 ‘b_fYcY_^Q\
`
`Q‘‘\YSQdY_^6 @c dXQd ((
`
`DH) D8C@B4 NUc)
`
`AK;>< E<M4 (( gXQd gU$bU TUQ\Y^W gYdX XUbU6
`
`DH) D8C@B4 @ dXY^[ WU^UbQ\\i Yd$c gXUdXUb
`
`Yd$c Q RU^UVYd _V dXQd ‘b_fYcY_^Q\ Q‘‘\YSQdY_^ _b
`
`gXUdXUb _b ^_d’ RQcUT _^ dXU TYcSeccY_^ dXQd gU ‘ed
`
`Y^ _eb ‘UdYdY_^ Qc gU S_]‘QbU dXU ‘b_fYcY_^Q\
`
`Q‘‘\YSQdY_^ _V dXU S\QY]UT Y^fU^dY_^’ gXUdXUb gXQd$c
`
`G@ 1.’ G@ 1/’ dXU :\Qid_^ bUVUbU^SUc’ @$\\ cQi dXU]
`
`S_\\USdYfU\i’ Yc +*,%Q& ‘bY_b Qbd Q^T gU \Qi _ed gXi
`
`:\Qid_^ Yc’ Y^ _eb fYUg’ +*,%Q& ‘bY_b Qbd _^
`
`‘QWUc ,, d_ ,- _V _eb ‘UdYdY_^)
`
`AK;>< E<M4 HYWXd’ bYWXd) @ e^TUbcdQ^T
`
`dXQd) @d cUU]c d_ ]U Yd$c ]_bU _V Q gbYddU^
`
`TUcSbY‘dY_^ dXQ^ Q^ Y^fU^d_bcXY‘ YcceU QSdeQ\\i)
`
`9ed @ dQ[U dXU ‘_Y^d)
`
`Db) :_XU^’ @ e^TUbcdQ^T AQ^ccU^ _‘‘_cUc
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 006
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU 1
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`QTTYdY_^Q\ RbYUVY^W _^ dXQd)
`
`DH) :F?<E4 NUQX’ dXQd$c S_bbUSd’ N_eb
`
`?_^_b) MXU^ gU VYbcd W_d dXU bUaeUcd Qc[Y^W V_b Q
`
`bU‘\i _^ Y^fU^d_bcXY‘’ gU TYT^$d aeYdU e^TUbcdQ^T
`
`gXQd dXU GUdYdY_^Ub gQc bUVUbbY^W d_)
`
`8c gU e^TUbcdQ^T Yd ^_g’ Yd$c ^_d dXQd dXUi
`
`gQ^d Q bU‘\i d_ QTTbUcc ‘bY_bYdi _b Q gbYddU^
`
`TUcSbY‘dY_^ _V dXU ‘b_fYcY_^Q\) @d$c dXQd dXUi gQ^d
`
`d_ QTTbUcc GQdU^d Fg^Ub$c bUc‘_^cU Y^ IUSdY_^ - _V
`
`dXU ‘bU\Y]Y^Qbi bUc‘_^cU gXUbU gU \Qi _ed RQcUT _^
`
`dXU \UWQ\ (( dXU Q‘‘\YSQR\U \Qg Q^T dXU Y^dbY^cYS
`
`bUS_bT gXi dX_cU dg_ bUVUbU^SUc’ G@ 1. Q^T 1/’ QbU
`
`^_d ‘bY_b Qbd)
`
`8^T YV dXQd$c gXQd GUdYdY_^Ub gQ^dc
`
`d_ bU‘\i d_’ gU T_ _RZUSd d_ dXQd cY^SU UfUbidXY^W
`
`Yc _^ dXU \Qg Q^T _^ dXU Y^dbY^cYS bUS_bT’ dXQd$c
`
`c_]UdXY^W dXQd GUdYdY_^Ub S_e\T XQfU QTTbUccUT Y^
`
`Ydc ‘UdYdY_^ d_ RUWY^ gYdX)
`
`AK;>< E<M4 Db) DQ\Y[)
`
`DH) D8C@B4 IebU) CUd ]U Zecd [Y^T _V WYfU
`
`dXU ‘bUcU^dQdY_^ dXQd [Y^T _V \Qic _ed gXi gU
`
`RU\YUfU (( Q^T i_e QbU S_bbUSd N_eb ?_^_b’ Yd Yc
`
`gXQd Yc Wb_e^T (( gXQd Yc \QRU\UT -’ Wb_e^T , Q^T +,
`
`Y^ Di\Q^$c ‘UdYdY_^ bU‘\i _^ dXQd ‘bY_b Qbd’
`
`‘QWUc ,* Q^T ,/ gXQd gU Y^dU^T d_ bUc‘_^T d_)
`
`8c Q^ QTTYdY_^Q\ ]QddUb’ dXU GJ89 di‘YSQ\\i
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 007
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU 2
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`TUQ\c gYdX dXUcU YcceUc TebY^W dbYQ\ QVdUb gU$fU XQT
`
`Q Ve\\ Q^T VQYb _‘‘_bde^Ydi d_ SXQ\\U^WU dXU
`
`UfYTU^SU) @$\\ SYdU Di\Q^ fUbcec DUbS[’ @GH,*,*(.*5
`
`DUTdb_^YS @GH,*,*(**+-/5 8cc_SYQdUT 9bYdYcX =__Tc’
`
`GC:’ @GH,*+3(/12 Q^T MQdc_^ JXUbQ‘UedYSc’ c_ dXYc Yc
`
`(( @GH,*+1(+0,+)
`
`JXUcU QbU di‘YSQ\\i YcceUc dXQd QbU \UVd V_b
`
`dbYQ\) 8^T Q\c_ Y^ S_^^USdY_^ gYdX dXUcU [Y^Tc _V
`
`S\QY]c’ bU‘\YUc QbU b_edY^U\i WYfU^ d_ dXU GFHG) @^
`
`dXU SQcU _V dXU Di\Q^ fUbcec DUbS[ SQcU’ dXQd$c
`
`GQ‘Ub +-’ dXQd$c dXU bU‘\i ‘Q‘Ub5 dXU 8cc_SYQdUT
`
`9bYdYcX =__Tc SQcU’ GQ‘Ub ,-’ dXQd$c dXU bU‘\i
`
`‘Q‘Ub5 MQdc_^ JXUbQ‘UedYSc’ GQ‘Ub 3’ dXQd Yc Q bU‘\i
`
`‘Q‘Ub5 DUTdb_^YS’ dXQd$c GQ‘Ub +,)
`
`E_g’ deb^Y^W d_ dXU GFHG’ GQdU^d Fg^Ub
`
`bUQ\\i T_Uc^$d TYc‘edU dXQd Di\Q^ XQc ]QTU Ydc
`
`‘bU\Y]Y^Qbi cX_gY^W S_]‘QbUT d_ TYcS\_cUT
`
`‘b_fYcY_^Q\ Q‘‘\YSQdY_^c Q^T dXQd$c _^ GFHG’
`
`‘QWU +*) 8^T gXQd dXUi$bU UVVUSdYfU\i cQiY^W Yc
`
`dXQd gU XQfU Q^ _R\YWQdY_^ d_ ‘bU(Red _b V_bUcUU
`
`gXQd UhQSd\i dXUYb QbWe]U^d Yc Q^T Yd cX_e\T XQfU
`
`RUU^ Y^ _eb ‘UdYdY_^)
`
`CUd ]U Zecd SYdU gXQd DUTdb_^YS$c @GH,*,*
`
`cQic’ +-/’ GQ‘Ub ,,’ V__d^_dU -’ _^ dXQd fUbi YcceU)
`
`">YfU^ dXU GQdU^d Fg^Ub RUQbc dXU RebTU^ _V
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 008
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU 3
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`‘b_TeSY^W UfYTU^SU d_ ce‘‘_bd Ydc Q^dUTQdUT
`
`S_^dU^dY_^c’ gU TUdUb]Y^U GUdYdY_^Ubc TYT ^_d XQfU
`
`Q^ _R\YWQdY_^ d_ ‘bU(U]‘d\i QTTbUcc GQdU^d Fg^Ub$c
`
`UfYTU^SU Y^ Ydc ‘UdYdY_^)"
`
`JXU cQ]U dXY^W gQc cQYT Y^ 9bYdYcX =__Tc
`
`SQcU) JXYc Yc @GH,*+3(/11’ GQ‘Ub ,/ Qd -+) "@^
`
`ce]’ gU QbU e^‘UbceQTUT dXQd GUdYdY_^Ubc gUbU
`
`bUaeYbUT Y^ dXU ‘UdYdY_^ d_ V_bUcUU Q^T ‘bU(Red
`
`GQdU^d Fg^Ub$c QbWe]U^d Q^T UfYTU^SU ‘eb‘_bdY^W d_
`
`cX_g Q bUTeSdY_^ d_ ‘bQSdYSU _V SUbdQY^ ceRZUSd
`
`]QddUb b_eWX\i _^U iUQb RUV_bU dXU VY\Y^W TQdU) JXU
`
`Q^dUTQdY_^ YcceU ^_g XQfY^W RUU^ bQYcUT Ri GQdU^d
`
`Fg^Ub QVdUb GUdYdY_^Ubc ]Ud dXUYb \UWQ\ RebTU^ ]Qi
`
`RU Uh‘\_bUT Qd dbYQ\)"
`
`@ dXY^[ Vb_] Di\Q^$c ‘_Y^d _V fYUg’
`
`S_^cYcdU^d gYdX dXU DUTdb_^YS SQcU Q^T dXU
`
`8cc_SYQdUT 9bYdYcX =__Tc SQcU’ gU XQT ^_ _R\YWQdY_^
`
`d_ V_bUcUU Q^T ‘bU(Red dXYc Y^ _eb _‘U^Y^W ‘Q‘Ubc)
`
`8^T c_ gXQd dXU Sbeh _V dXU YcceU Yc d_TQi’ dXU fUbi
`
`^Qbb_g YcceU Yc gXQd Yc GQdU^d Fg^Ub$c ‘bY^SY‘Q\
`
`RQcYc Vb_] ‘bUfU^dY^W Di\Q^ Vb_] bUc‘_^TY^W WYfU^
`
`gXQd DUTdb_^YS Q^T 8cc_SYQdUT 9bYdYcX =__Tc cQYT
`
`gXU^ Di\Q^ XQT ^_ _R\YWQdY_^ d_ V_bUcUU Q^T ‘bUU]‘d
`
`dXU QbWe]U^dc dXU GQdU^d Fg^Ub ]Q[Uc Y^ S_^^USdY_^
`
`gYdX Q^dUTQdY_^)
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 009
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +*
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`AK;>< E<M4 Db) :_XU^’ i_eb bUc‘_^cU d_
`
`dXQd)
`
`DH) :F?<E4 NUc’ dXQ^[ i_e’ N_eb ?_^_b) MU
`
`XUQbT Q \_d QR_ed dXUcU ‘bY_b @GH SQcUc gXUbU
`
`GUdYdY_^Ub gQc WbQ^dUT dXU _‘‘_bde^Ydi d_ bU‘\i d_
`
`QTTbUcc dXU Q^dUTQdY_^ UfYTU^SU dXQd dXU GQdU^d
`
`Fg^Ub XQT ceR]YddUT gYdX Ydc ‘bU\Y]Y^Qbi bUc‘_^cU)
`
`JXU cYdeQdY_^ XUbU Yc S_]‘\UdU\i TYVVUbU^d)
`
`<fUbidXY^W dXQd Di\Q^ gQ^dc d_ QTTbUcc Y^ dXYc bU‘\i
`
`gQc QfQY\QR\U d_ Yd gXU^ Yd VY\UT dXYc ‘UdYdY_^)
`
`Feb QbWe]U^d Y^ IUSdY_^ - _V dXU ‘bU\Y]Y^Qbi
`
`bUc‘_^cU Yc RQcUT U^dYbU\i _^ dXU Y^dbY^cYS bUS_bT
`
`Q^T dXU Q‘‘\YSQR\U \Qg Q^T _^ Di\Q^$c QT]YccY_^ Q^T
`
`bUS_W^YdY_^ bUQ\\i Y^ Ydc ‘UdYdY_^ dXQd dXU S_^dU^d
`
`_V dXUcU ‘eb‘_bdUT ‘bY_b Qbd bUVUbU^SUc _V
`
`<hXYRYd +**- gUbU ‘bUcU^d gXU^ dXU Q‘‘\YSQ^dc VY\UT
`
`dXU VYbcd ‘b_fYcY_^Q\ Q‘‘\YSQdY_^ RUV_bU dX_cU dg_
`
`QRcdbQSdc gUbU ‘eR\YcXUT)
`
`I_ dXUbU bUQ\\i Yc^$d Q^idXY^W V_b Di\Q^ d_
`
`bU‘\i d_ dXQd Yd S_e\T^$d XQfU QTTbUccUT e‘ Vb_^d)
`
`8WQY^’ Q\\ _V Yd Yc ‘Qbd _V dXU Y^dbY^cYS bUS_bT Q^T
`
`RQcUT _^ dXU Q‘‘\YSQR\U \Qg) I_ dXQd$c bUQ\\i ((
`
`i_e [^_g’ dXQd$c bUQ\\i gXUbU gU cdQ^T XUbU)
`
`JXUbU$c ^_dXY^W ^Ug) JXUbU$c ^_ ^Ug UfYTU^SU dXQd
`
`dXU GQdU^d Fg^Ub ceR]YddUT Y^ Ydc ‘bU\Y]Y^Qbi
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 010
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU ++
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`bUc‘_^cU Q^T c_ Di\Q^ cX_e\T XQfU QTTbUccUT Yd
`
`‘b_]‘d\i) JXQd gQc Ydc RebTU^)
`
`DH) D8C@B4 N_eb ?_^_b’ ]Qi @ RbYUV\i
`
`bUc‘_^T6
`
`AK;>< E<M4 NUc’ ‘\UQcU T_’ Db) DQ\Y[)
`
`DH) D8C@B4 I_ QWQY^’ @$\\ W_ d_ dXU
`
`DUTdb_^YS SQcU)
`
`JXYc Yc ‘QWU ++ Q^T @$] Zecd W_Y^W
`
`d_ bUQT Yd (( TYbUSd\i gXQd gQc cQYT) @^ dXYc SQcU
`
`dXUi gUbU TYcSeccY^W dXU SXQ\\U^WU (( dXU GQdU^d
`
`Fg^Ub SXQ\\U^WUT dXU $110 ‘QdU^d) JXU ‘bY_b
`
`bUVUbU^SU Yc @d_e’ @(d(_(e) @$] bUQTY^W _^ ‘QWU ++)
`
`"JXU RebTU^ d_ cX_g dXQd @d_e Yc ‘bY_b Qbd d_ dXU
`
`$110 ‘QdU^d bUcdc gYdX GUdYdY_^Ubc’" SYdY^W dXU
`
`;i^Q]YS ;bY^[gQbU’ CC: SQcU) JXQd$c dXU cQ]U SQcU
`
`dXQd AQ^ccU^ SYdUc d_ dXYc GFHG)
`
`EUhd \Y^U4 "JXQd cQYT’ RUSQecU GUdYdY_^Ub
`
`XQc ‘bUcU^dUT UfYTU^SU dXQd @d_e gQc VY\UT ‘bY_b d_
`
`dXU VY^TY^W _V dXU $110 ‘QdU^d Q^T dXec aeQ\YVYUT Qc
`
`‘bY_b Qbd e^TUb +*,%U&’ dXU RebTU^ _V ‘b_TeSdY_^
`
`dXU^ cXYVdc d_ GQdU^d Fg^Ub d_ TU]_^cdbQdU dXQd @d_e
`
`Yc Y^TUUT ^_d ‘bY_b Qbd)"
`
`MU’ Ri \__[Y^W Qd dXU ‘b_fYcY_^Q\
`
`Q‘‘\YSQdY_^’ UcdQR\YcXUT Y^ _eb fYUg dXQd gU S_e\T
`
`ecU dXU :\Qid_^ bUVUbU^SUc) JXUi T_^$d SXQ\\U^WU
`
`dXQd ‘Qbd _V dXU Q^Q\icYc) JXU RebTU^ dXU^ cXYVdc
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 011
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +,
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`d_ dXU]) 8^T dXU^ Qc gQc cQYT TebY^W dXU Di\Q^
`
`GXQb]QSUedYSQ\c fUbcec 9_UXbY^WUb SQcU’
`
`@GH,*+0(+/0-’ GQ‘Ub +.’ GQdU^d Fg^Ub RUQbc dXU
`
`RebTU^ _V ‘b__V bUWQbTY^W Ydc Q^dUTQdY^W S_^dU^dY_^)
`
`J_ Qc[ ec d_ ‘bU(Red c_]UdXY^W gXU^ gU T_^$d
`
`UfU^ XQfU dXU RebTU^ _V ‘b__V’ gXU^ gU XQfU dg_
`
`SQcUc dXQd cQYT gU XQfU ^_ _R\YWQdY_^ d_ V_bUcUU Yd’
`
`@ ]UQ^ dXUbU$c S\UQb GJ89 QedX_bYdi _^ gXQd XQ‘‘U^c
`
`dXU ]Y^edU gU UcdQR\YcXUT dXQd :\Qid_^ gQc +*,%Q&
`
`Qbd) 8^T dXU Q^Q\icYc gQc ^_d SXQ\\U^WUT’ Red
`
`bQdXUb dXUi$bU cQiY^W V_b c_]U _dXUb bUQc_^ Q^T dXU
`
`RebTU^ cXYVdc Q^T dXU GJ89 cQic gU T_^$d XQfU d_
`
`V_bUcUU Yd) I_ dXQd$c Di\Q^$c ‘_cYdY_^)
`
`AK;>< E<M4 Db) DQ\Y[’ ‘UbXQ‘c i_e SQ^
`
`U^\YWXdU^ ]U XUbU RUSQecU gU$bU cdY\\ Y^ dXU UQb\i
`
`cdQWUc _V dXYc ‘b_‘_cUT @GH) MXQd ‘bUSYcU\i Yc dXU
`
`Q\\UWQdY_^ _b QbWe]U^d ]QTU dXQd T_Uc ^_d ‘bU(Red
`
`Yd6
`
`DH) D8C@B4 @ dXY^[ gXQd dXUi$bU cQiY^W Yc
`
`dXQd gU (( gU V_SecUT _^ dXU S_]‘UdYdYfU (( dXU
`
`S\QY]c Y^ dXU ‘b_fYcY_^Q\ Q‘‘\YSQdY_^c (( @$] c_bbi’
`
`S_]‘UdYdYfU ‘b_fYcY_^Q\ Q‘‘\YSQdY_^c Q^T TYcS\_cebU
`
`fYc(l(fYc dXU S\QY]c Q^T dXU^ TUdUb]Y^UT gXQd dXU
`
`S_bbUSd ‘bY_bYdi TQdU Yc c_ dXUi gUbU^$d U^dYd\UT d_
`
`RU^UVYd)
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 012
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +-
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`MU dXU^ \__[UT Qd dXU :\Qid_^ bUVUbU^SUc Q^T
`
`cQYT gU\\’ dXQd$c ‘eR\YcXUT RUV_bU gU gXQd gU
`
`RU\YUfU dXU ‘QdU^d Yc U^dYd\UT d_ RU^UVYd V_b’
`
`dXUbUV_bU’ Yd$c +*,%Q&)
`
`MXQd dXUi$bU cQiY^W Yc (( dXQd$c gXQd gU
`
`dXY^[) 9ed gXQd dXUi$bU cQiY^W Yc gU dXU^ XQfU d_
`
`‘bU(Red Yc Y^ UVVUSd dXUYb QbWe]U^d dXQd dXU :\Qid_^
`
`bUVUbU^SU Yc ^_d ‘bY_b Qbd’ dXQd gU g_e\T^$d [^_g
`
`gXQd dXQd ‘_cYdY_^ g_e\T RU e^dY\ GQdU^d Fg^Ub
`
`cdQdUc gXQd Yd Yc)
`
`AK;>< E<M4 8\\ bYWXd) Db) :_XU^’ T_ i_e
`
`gQ^d d_ XQfU Q VY^Q\ bUc‘_^cU d_ dXQd6
`
`DH) :F?<E4 NUc) JXQ^[ i_e’ N_eb ?_^_b)
`
`Jg_ ‘_Y^dc) F^U’ Yd gQc (( Yd Yc Q\gQic dXU
`
`GUdYdY_^Ub$c RebTU^ d_ UcdQR\YcX dXQd Q bUVUbU^SU Yc
`
`‘bY_b Qbd) Db) DQ\Y[ SYdUT ;i^Q]YS ;bY^[gQbU) @d$c
`
`Q\gQic dXU GUdYdY_^Ub$c e\dY]QdU RebTU^ _V
`
`‘UbceQcY_^ d_ UcdQR\YcX dXU bUVUbU^SU Qc ‘bY_b Qbd
`
`Q^T ^_dXY^W (( dXQd RebTU^ ^UfUb cXYVdc)
`
`IUS_^T’ Yd gQc dXU GUdYdY_^Ub$c SX_YSU gXQd
`
`d_ QTTbUcc Q^T gXQd ^_d d_ QTTbUcc Y^ dXUYb
`
`‘UdYdY_^) JXUYb ‘UdYdY_^ bUS_W^YjUc dXQd dXU
`
`Y^fU^d_bc XUbU XQT dXU U^dYbU S_^dU^d _V dXU dg_
`
`bUVUbU^SUc dXQd dXUi bU\i _^ Qc ‘bY_b Qbd Q^T
`
`Y^S\eTUT Y^ dXU ‘QdU^d Q‘‘\YSQdY_^’ dXU ‘b_fYcY_^Q\’
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 013
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +.
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`RUV_bU dX_cU bUVUbU^SUc gUbU Q\\UWUT\i ‘eR\YcXUT
`
`e^TUb \_^W Q^T gU\\(UcdQR\YcXUT SQcU \Qg dXQd cUd
`
`_ed Y^ IUSdY_^ - _V dXU ‘bU\Y]Y^Qbi bUc‘_^cU’ dXQd
`
`]UQ^c dXQd dXUi$bU ^_d ‘bY_b Qbd) MU Uh‘\QY^UT dXQd
`
`Y^ dXU ‘bU\Y]Y^Qbi bUc‘_^cU)
`
`<fUbidXY^W GUdYdY_^Ub ^UUTUT d_ QTTbUcc dXQd
`
`gQc QfQY\QR\U d_ Yd Q^T Y^TUUT’ dXUi (( YV dXUi XQT
`
`(( dXUi cX_e\T XQfU QTTbUccUT YV dXUi gQ^dUT d_)
`
`JXUi SX_cU ^_d d_ Q^T Q bU‘\i Yc^$d Q^ _‘‘_bde^Ydi
`
`V_b dXU] d_ bQYcU dXQd YcceU V_b dXU VYbcd dY]U)
`
`AK;>< E<M4 8\\ bYWXd) JXQ^[ i_e R_dX fUbi
`
`]eSX) @ dXY^[ @ e^TUbcdQ^T gXUbU R_dX ‘QbdYUc cdQ^T
`
`_^ dXYc bYWXd ^_g Q^T gU$bU W_Y^W d_ dQ[U dXU ]QddUb
`
`e^TUb QTfYcU]U^d)
`
`M_e\T Yd RU ‘_ccYR\U d_ bUSUYfU Q b_eWX _b
`
`Uh‘UTYdUT dbQ^cSbY‘d Vb_] dXU S_ebd bU‘_bdUb _^
`
`dXYc6 Db) DQ\Y[ dXbUg Q^ QgVe\ \_d _V SQcUc Qd ]U
`
`Y^ fUbi cX_bd _bTUb dXUbU Q^T @$T \Y[U d_ XQfU Q
`
`SXQ^SU d_ \__[ Qd dXU] RUV_bU S_]Y^W d_ Q VY^Q\
`
`TUSYcY_^ _^ gXUdXUb d_ QedX_bYjU QTTYdY_^Q\
`
`RbYUVY^W)
`
`DH) D8C@B4 N_eb ?_^_b’ dXYc Yc Di\Q^) MU
`
`bUdQY^UT dXU S_ebd bU‘_bdUb) MU gY\\ WUd dXQd d_
`
`i_e Y^ cX_bd _bTUb)
`
`AK;>< E<M4 JXQd$c WbUQd) @ Q‘‘bUSYQdU
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 014
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +/
`
`+
`
`,
`
`-
`
`.
`
`/
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`dXQd)
`
`DH) D8C@B4 M_e\T i_e ‘bUVUb gU VY\U dXU
`
`b_eWX dbQ^cSbY‘d gYdX dXU GJ89 <,< cicdU] _b ]QY\ d_
`
`dbYQ\c7KIGJF)W_f6
`
`AK;>< E<M4 @ dXY^[ i_e SQ^ Zecd ]QY\ Yd d_
`
`dbYQ\c7KIGJF)
`
`DH) D8C@B4 8Rc_\edU\i)
`
`AK;>< E<M4 8^i QTTYdY_^Q\ RecY^Ucc’
`
`WU^d\U]U^’ \QTYUc6
`
`DH) :F?<E4 N_eb ?_^_b’ dXYc Yc 8^TbUg V_b
`
`GQdU^d Fg^Ub)
`
`Aecd gQ^dUT d_ bUaeUcd dXQd YV dXU
`
`9_QbT T_Uc (( Yc Y^S\Y^UT d_ QedX_bYjU Q bU‘\i _^
`
`dXU cUS_^T YcceU’ dXU^ AQ^ccU^ g_e\T \Y[U Q^
`
`_‘‘_bde^Ydi d_ cebbU‘\i) 8\dX_eWX QWQY^’ gU T_^$d
`
`RU\YUfU Q bU‘\i cX_e\T RU QedX_bYjUT _^ dXQd YcceU’
`
`Red YV Yd Yc’ gU gQ^d d_ bUaeUcd dXU _‘‘_bde^Ydi V_b
`
`Q cebbU‘\i Qc gU\\)
`
`DH) D8C@B4 N_eb ?_^_b’ dXYc Yc AYdU^TbQ
`
`DQ\Y[ _V Di\Q^) MU XQfU ^_ _RZUSdY_^ d_ GQdU^d
`
`Fg^Ub WUddY^W UaeQ\ c‘QSU)
`
`AK;>< E<M4 @ e^TUbcdQ^T) JXQ^[ i_e fUbi
`
`]eSX) JXQ^[ i_e fUbi ]eSX V_b i_eb dY]U Q^T i_e$\\
`
`RU XUQbY^W Vb_] ec Y^ TeU S_ebcU) JXQ^[ i_e)
`
`DH) D8C@B4 JXQ^[ i_e)
`
`%:_^VUbU^SU SQ\\ QTZ_eb^UT Qd +4+3 ‘)])&
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 015
`
`
`
`GHF:<<;@E>I ( Ae^U -*’ ,*,*
`
`GQWU +0
`
`:<HJ@=@:8J<
`
`F=
`
`:<HJ@=@<; I?FHJ?8E; H<GFHJ<H
`
`@’ IQ^TbQ C) H_SSQ’ :UbdYVYUT IX_bdXQ^T
`
`HU‘_bdUb _V dXU IdQdU _V @\\Y^_Yc’ :IH CYSU^cU E_)
`
`*2.(**-.-/’ T_ XUbURi SUbdYVi dXQd @
`
`cdU^_WbQ‘XYSQ\\i bU‘_bdUT dXU ‘b_SUUTY^Wc XQT Qd dXU
`
`dQ[Y^W _V cQYT S_^VUbU^SU SQ\\’ Q^T dXQd dXU
`
`V_bUW_Y^W Yc Q dbeU’ S_]‘\UdU’ Q^T QSSebQdU
`
`dbQ^cSbY‘d _V dXU ‘b_SUUTY^Wc Qd cQYT S_^VUbU^SU
`
`SQ\\ Qc Q‘‘UQbc Vb_] ]i cdU^_WbQ‘XYS ^_dUc c_ dQ[U^
`
`Q^T dbQ^cSbYRUT e^TUb ]i ‘Ubc_^Q\ TYbUSdY_^ Q^T
`
`cYW^UT dXYc -*dX TQi _V Ae^U’ ,*,*)
`
`PPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPPP
`
`I8E;H8 C) HF::8’ :IH’ HGH’ HDH’ :HH
`:IH E_) *2.(**-.-/
`<h‘YbQdY_^ ;QdU4 DQi -+’ ,*,+)
`
`+
`
`,
`
`-
`
`. /
`
`0
`
`1
`
`2
`
`3
`
`+*
`
`++
`
`+,
`
`+-
`
`+.
`
`+/
`
`+0
`
`+1
`
`+2
`
`+3
`
`,*
`
`,+
`
`,,
`
`,-
`
`,.
`
`,/
`
`>bUW_bi<TgQbTc’ CC: k M_b\TgYTU :_ebd HU‘_bdY^W
`>bUW_bi<TgQbTc)S_] k 200(.JUQ] ><
`
`Mylan (IPR2020-00440) Ex. 1048 p. 016
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
