`
`7031 6
`
`Page
`
`37
`
`_.Project Page__.
`__
`Project No.
`InvestigatorCate BFcbrect
`
`Subject
`Filed in Book Number/Title
`
`
`Becca
`
`Th
`
`>
`RK
`L247 1STTacken
`7
`ERD Cc
`
`5 Sh
`
`n-
`2.60
`
`£4
`0
`
`f.
`
`1. E-tsfe - Naot
`2. KPa, Ett/Hd
`(._.
`3? >
`LW
`BO pr |
`22°
`Oo
`bo m\
`Aoly
`(\ E fohe A iA ASacit. Cat
`Sbucridl natura |
`foe We:
`aUps
`ez shh w
`Ba o~\ 20 / Nac |
`As
`A
`€foh
`he
`bau
`arctan
`Go
`SE US MW Carcuteahl
`Ke As (po\Erk Ab, feed oh Bu ABBEsalou
`
`
`AL}
`|
`©
`AO |. wal
`°
`\
`"s
`G uA
`a Phos, Siu
`iy
`ace
`>n\ Edt
`“
`solu bo WE ,Nddod
`Oo, Seh4u e+
`ry thea -
`chals ,
`‘Re murA Leal
`d viele t dé s
`pA
`Vo he
`A 4,770
`b.¥ $I solAs odd, A 6.75~{ U_ > g Mnaskdh MF
`rely ACS $0
`CAA fe IT
`ac ly { Phan ote eur
`wphnw
`Live
`EG2ot2 -
`pic.
`A
`£ Wawknia
`cB Lo A
`fad,
`b.
`AD ala
`-C shath. ALA ab {|
`“ErAnrl
`AsHA
`Qo,
`eh beled
`Lh,
`Keowee
`p
`hid - nattror| Ss Fo-
`:
`“SeeludA ow
`Lal
`Ll gahAe
`
`al
`
`Zan)
`
`\
`
`vibe
`
`Ab.4
`
`Lys
`
`~
`
`s&
`
`A AL,
`
`CY)
`
`elloe
`
`7
`Ma th
`Ke ATVee
`
`y
`& icba ye
`. cl
`8"
`ty
`(2 77 oo, a fa
`
`o b ( lo~ | UD. o
`
`4 as atarck
`
`igen
`
`ff
`
`f
`
`A
`
`shFleJ bownS M cal Fon I
`
`/
`
`Z
`
`oo
`
`Countersigned by
`
`Date
`Merck Exhibit 2129, PaBRclco, INC/MRL
`Mylan v. Merck, IPR20284805401/00}
`
`Merck Exhibit 2129, Page 152
`Mylan v. Merck, IPR2020-00040
`
`
`
`Book
`
`7031 6
`
`Page
`
`38
`
`ProjectNo... Project Page
`
`\
`
`DO NOT BEGIN NEW EXPERIMENTSON THIS PAGE.
`
`
`
`{2d Reg 2cor -
`‘A
`ek £2
`
`oo TF
`
`bo
`
`the Sa
`NO pn
`Ee S2o0C |
`
`A
`
`As MS Oc f
`
`lh
`
`|illilllllilllllil|ll
`
`|lllllilllli|ll —
`
`Date
`Merck Exhibit 2129, Page 153
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 153
`Mylan v. Merck, IPR2020-00040
`
`
`
`
`
`
`
`Ogput3eSaseqaauvjGt/‘pee]‘dol
`
`
`
`[w/Bwo;,yesayeudsoudGr/pze]‘woyj}0g
`
`
`
`
`
`Ge
`
`OE
`
`GE
`
`wdd
`
`Merck Exhibit 2129, Page 154
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 154
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\055-0101.D
`
`Sample Name: 70316-037
`
`0.5610g/50ml1 of saturated aq soln
`
`->
`
`Injection Date : 02/11/2002
`Sample Name
`> 70316-037
`
`@«: Operator
`
`: hansen
`
`9:14:02 AM
`
`Seq Line
`Vial No
`
`Inj. No.
`
`1
`:
`> 55
`
`:
`
`:
`
`1
`
`2 pl
`
`Inj. Vol.
`: C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile,
`iml/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`DAD1 C, Sig=210,8 Ref=360,100 (055-0101.D)
`
`0
`DAD1 E, Sig=268,16 Ref=360,100
`
`
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 01/14/2002
`: 1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DADI C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`{min]
`
`Type Width Height
`[min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`1
`5.34 VP
`2
`5.68 BB
`3
`4 13.04 BP
`
`5.463
`1.11
`0.077
`6.661
`1.34
`0.078
`0.081 734.72 3843.763
`0.430
`5.66
`183.469
`
`0.14
`0.16
`95.16
`4.54
`
`0.000000
`0.000000
`1.017704
`0.000000
`
`L-224,715
`
`Signal:
`
`2 DAD] E, Sig=268,16 Ref=360,100
`
`Peak
`#
`
`RT
`(min}
`
`Type Width Height
`{min}
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`5.68 BB
`1
`2 13.07 BP
`
`0.080
`0.404
`
`86.51
`2.76
`
`448.537
`84.451
`
`84.16
`15.84
`
`1.017704
`0.000000
`
`L-224,715
`
`HPLC0157
`
`02/11/2002
`
`9:27:28 AM
`
`*** End of Report ***
`
`.
`Page 1 of 1
`Merck Exhibit 2129, Page 155
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 155
`Mylan v. Merck, IPR2020-00040
`
`
`
`
`
`
`
`9Seq9913STL'P7T
`
`ozpUTes
`
`T-YP00pzwu
`
`STajouwerzegeedywUsTIN)
`
`
`
`LEO-9TEOLIWYN
`
`TONDOUdZONdXa
`
`a
`
`
`
`71202002~97eG
`
`P2°Lout]
`
`
`
`qoedsWOYLSNI
`
`HTdNOwu¢qHaoud
`
`o¢bzD0udNd
`
`89LZEch
`
`ocdLNSATOS
`
`€STSN
`
`ZHL¥6°8LS9HMSésq
`
`2HPLL00c0saudla
`
`
`
`98SO8TPO6P2ov
`
`€°o?ou
`
`
`
`998n000°9LMd
`
`
`
`oasn00°9ad
`
`
`
`92850000000T"0Td40°O00€ab
`
`
`
`=assssssss=ssTSTJENNVYHD============
`
`
`
`ZHNVTO22S2’00PToads
`
`0S‘OT
`
`gP00°€-‘@Dasn
`HTTONN
`
`
`
`
`
`
`
`siajeuezegUOTRISTNbOY-74
`
`
`
`
`
`SsilajeweredHhutssao0r%q-7d
`
`ZHW£6S00S2007as
`
`p8eotIs
`
`ZH00°0710ass
`
`ouMaM
`
`00°Tod0gd
`
`wo00°07Xo
`
`SZajowezedoTdWNAT
`
`
`
`udd9¢1°6dtd
`
`ZHPPCO6ETd
`
`
`
`
`
`wdd9¢z°Q-d@d
`
`
`
`
`
`wo/wdd900S2'0WOWdd
`
`ZH90°00T-cd
`
`
`
`wo/ZH2S290°00TWOZH
`
`Merck Exhibit 2128, Page 156
`Mylan v. Merck, IPR2020-00040
`
`0°0
`
`S°0O°T
`
`S'T
`
`O°?
`
`S°e
`
`O°€
`
`cPego'¢
`
`6T0L*?
`
`0000°T|}
`
`P9Ph'?
`
`Oo
`a
`
`£888 "0
`0€99°T
`
`a
`
`SP0°Sg°S0°9g°9
`GL0°8G°80°6wdd3ao
`
`OQ
`CC
`
`T6960
`
`9976'0
`
`Merck Exhibit 2129, Page 156
`Mylan v. Merck, IPR2020-00040
`
`
`
`
`
`
`
`Tw/SugtTesaqeydsoydSTL9227
`
`eeeeeee
`
`ee
`
`
`
`SzajewezegejeqJuezIND
`
`
`
`LEO-9TEOLGNWN
`
`TOND0UdTONdXa
`
`2HL¥6°8L59HMScsa9SN
`
`
`
`98SOBTP06P2ov
`
`C°0Fou
`
`
`
`ZH9LL002°0saudld
`
`
`
`99sn000°9LMa
`
`
`
`oesn00°9ad
`
`
`
`28S0000000T0Td10°O0€ad
`
`
`
`rARAITAUITA~a7ed
`
`StLouTL
`
`
`
`qoedsWOYLSNI
`
`HTdNOum¢GHd0ud
`
`o¢bzDoudnd
`
`B89LCEGL
`
`ocdLNAATOS
`
`
`
`msssssssssss5T3TSNNVHOsesssssss=ss=
`
`
`
`oesn0S'0TTd
`
`ZHNPT0Z2S7'00PTOSS
`
`aP00°€-Td
`
`HTTONN
`
`
`
`
`
`siajouezeguoT]TSTNboy-7d
`
`0°0
`
`50O°TS‘T
`
`4
`
`Ge
`
`€599'0
`
`98202
`
`ny
`
`Se
`
`g's0°9g°9
`
`Gb
`
`$°80°6wd
`
`Qa
`
`BLbP'T
`
`€LbS'0
`
`
`
`wo/udd90057°0WONdd
`
`
`
`w9/ZH2529000TWOZH
`
`ZH90°00T-cd
`
`Merck Exhibit
`Mylan v. Merck, |
`
`Page 157
`20-00040
`
`yerbaqut
`
`‘MS
`
`ZHW£6S00S2007ds
`
`pseorIS
`
`2H00°0a0ass
`
`ouMGM
`
`00°Tod0gD
`
`wo00°0FXO
`
`
`
`SlejeuezedjoTdYNdT
`
`
`
`wdd9S1°6ald
`
`2HDPCO6ETd
`
`
`
`
`
`wdd9$z°0-d@d
`
`
`
`
`
`szejeweredHutsse.0rg-74
`
`Merck Exhibit 2129, Page 157
`Mylan v. Merck, IPR2020-00040
`
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\060-0101.D
`
`Sample Name: 70316-035
`
`6.37g/50m1 of 146.86 ML and wash
`
`Injection Date
`Sample Name
`
`@::: Operator
`
`02/12/2002
`70316-035
`
`hansen
`
`3:04:29 PM
`
`Seq Line
`Vial No
`
`Inj. No.
`
`Inj. Vol
`C: \HPCHEM\HPLCO157\METHODS\715.M
`Method
`01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile, 1lml/min
`10min 25/75 water/acn; 75/25 from 10 to 14
`waters cl8 symmetry, 250 nm
`
`min
`
`DAD1 C, Sig=210,8 Ref=360,100 (060-0101.D)
`
`BN
`uw
`—_
`wo
`4
`2
`eeee BoeA, he
`
`-
`
`> ©+
`
`~<
`
`ee
`
`4
`2
`0
`DAD1 E, Sig=268,16 Ref=360,100 (060-0101.D
`
`8
`
`
`
`)
`:
`‘ib
`:
`oO
`WERte ae PTa
`6
`8
`10
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`Signal
`01/14/2002
`1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DADI1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`(min]
`
`Type Width Height
`{min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13.
`14
`15
`
`2.44 VB
`3.64 VB
`4.15 BV
`5.16 BV
`5.30 VB
`5.65 BV
`5.88 VV
`6.22 VB
`6.69 BV
`6.97 VV
`7.64 VV
`7.93 VV
`8.24 VV
`8.52 VV
`8.89 VV
`
`289.753
`73.72
`0.060
`713.782
`0.082 135.35
`59.210
`0.090
`9.93
`226.496
`0.086
`41.08
`19.388
`0.075
`4.00
`0.081 240.31 1259.296
`0.092 2.06e3 1.170e4
`0.122
`4.59
`40.838
`0.127
`1.17
`10.716
`0.122
`1.00
`8.968
`0.105
`16.41
`122.782
`0.091
`59.85
`373.427
`0.096
`97.68
`655.861
`0.106
`4.07
`30.668
`0.097
`15.34
`103.325
`
`1.64
`A.04
`0.33
`1.28
`0.11
`7.12
`66.19
`0.23
`0.06
`0.05
`0.69
`2.11
`3.71
`0.17
`0.58
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.331258
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`0.3%¥25
`
`HPLCO157
`
`02/12/2002
`
`3:17:48 PM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 158
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 158
`Mylan v. Merck, IPR2020-00040
`
`
`
`Print of window 38: Current Chromatogram(s)
`
`Current Chromatogram(s}
`DAD1 C, Sig=210,8 Ref=360,100 (U'\VAGILENTIHPLC0157\20020213\061-0101.D)
`
`mAU
`
`~T
`8
`6
`DAD1 E, Sig=268,16 Ref=360,100 (U:\AGILENT\HPLC0157\20020213\061-0101.D)
`2CO-
`
`HPLCO157 02/13/2002 8:33:02 AM hansen
`:
`
`Page 1 of l
`Merck Exhibit 2129, Page 159
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 159
`Mylan v. Merck, IPR2020-00040
`
`
`
`Book
`
`7031 6
`
`Page
`
`39
`
`Subject
`
`Project No. CéProject Page
`[3 FibQe2
`Restricted
`RE Confidentiat
`limited access
`i.
`
`Date
`
`Filed in Book Number/Title
`
`HOIyt
`
`L2245
`
`Fu
`334.
`R2G.0
`4H
` /d11F
`
`
`
`lwophlu
`
`042°
`
`
`
`2
`At ne
`Kensyintt',
`6h
`2D 0
`Airine tec A PABAN-Ww2z TWihce
`s
`YO
`(S_
`Metorek, de Hel
`2\th-lwo
`245
`IS.0
`ik
`EDC
`[2 (3) Bo
`[2
`WAM Went
`On
`AC
`‘| hee|Tevarekbh Se luwe a A N rad J salt ol.
`
`
`
`
`
`+, 6]o AANA EDc
`Ma sequmbillg
`]-30Arn,
`
`Benetton gle Ke 215K fdfbYe-l ho 4r~( Eton
`|
`ol 51 wee,
`drow SS 2s) Nocl.
`ndatrhdrA fear{
`¥,
`J-
`.
`6
`ht
`4g Vall
`A
`OfW
`Wn
`AoPSE SBC 12,
`by dle
`Sela Figen
`ClLHMm
`ub Ao??.. EH Complete
`Wei,
`olmbal Ass. Ae 34 We Oeku
`1 4 te
`uf E7L,-lf ue. Re dissoleA am BN EMMA
`tblA
` /soat Baek WeshA Uf
`4 Sal ERK. DAselud
`10
`ou ED)
`weasnt
`ho. phd
`pole lee
`
`tcl SeedA13, T9900 CoachLincs or cuceds
`
`WE:
`NE dd
`a
`slaw
`Seeych&
`we presat. These bok
`le edu supe Gt stil
`pathy
`ple eat b
`SC
`+> addacrut
`py)
`kk
`2
`oold ¢
`SC] holy
`
`X
`
`4
`
`whe
`
`
`
`:
`
`s
`
`Countersigned by
`
`Merck Exhibit 2129, Paggcl60co. incuA
`Mylan v. Merck, IPR202848768401/00}
`
`Date
`
`Merck Exhibit 2129, Page 160
`Mylan v. Merck, IPR2020-00040
`
`
`
`ook
`
`70316
`
`rece
`
`40
`
`Project No.
`
`Project Page
`
`
`
`DO NOT BEGIN NEW EXPERIMENTSON THIS PAGE.
`
`-
`
`he
`
`chi
`bos
`
`6c wc
`Thh perdles
`we
`
`athek ¢
`Flakes
`ISK b2ucl}
`Ze.
`ate |
`rad
`~o%
`h
`La
`tepru F
`SFsluny
`Pee mw a-3-\
`#
`tochecke Sony
`703 14-039
`Lat 4 foC
`35. S 1626-035. Chee
`he
`AL
`&
`7 Jona
`ec A + tourney
`solid
`Ll lr 1 © he
`fa sh.
`qs.
`(
`on I ~ Fe
`‘aur
`Phys Mus
`70216-0387
`-
`ChalA to
`iy -* ( bor
`g Fbacor - At,
`d
`whe
`like So
`Halpkd
`Bors
`40
`b OA TA:
`\
`¢
`ON
`( M4.
`deck.
`Aa Hl Br rales
`('
`A ‘ore Woe
`
`2 |th20e2—rualebrig Re dnl” FiGE.. > ued Lo tupicd
`Hole pede
`ere
`B59), min
`44 AZ) hn
`Mv
`(
`EST, kar.
`£
`C
`uy ce
`Ls
`5~ sf pf
`cfd
`a
`stydothys Murs
`J malls
`Sheer
`sursce
`de hod ON gs
`Lg EB ZF be
`
`te shp
`25n( Ethel
`‘(lxcd
`cosh A &/ Etc
`
`t
`
`f
`
`dip./4 cy F- sagt
`Frew
`Grn bt
`post
`
`|llIlIiilllMIil |ll
`
`|ll llllillIll ll —
`
`Date
`Merck Exhibit 2129, Page 161
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 161
`Mylan v. Merck, IPR2020-00040
`
`
`
`MERCK & CO., INC.
`R827-L 4/75 ,#
`“DATE
`
`Feb 14, OL
`
`SUBMITTED BY
`
`REQUEST FOR ANALYSIS:
`oTERGSROFOR BATCH #
`oriséss | ouses
`OWE 034
`
`SAMPLE DISPOSITION
`
`MOLECULAR WEIGHT
`
`PROJECT #
`
`EXT
`
`SEND REPORT TO ~
`
`AREA
`
`Qari STRUCTURE
`C-TT4HW pvwuspraty, tf—OZNSOST
`CUI AS mls
`OU30T&
`
`CHEMICAL NAME
`
`( JRETAIN ( JRETURN[ JOISCARD
`
`OTHER TESTS AND COMMENTS
`
`|[TITRATION
`wen
`DISC
`SOLUTION
`
`
`
`UV
`
`SPECIFIC
`RESIDUE
`ROTATION | ON
`
`
`
`
`IGNITION
`
`
`
`
`
`VPC iatnira}
`
`ALL
`MESH
`est ag
`
`TEST
`
`KARL
`TOTAL
`FISCHER ai SOLIDS
`
` HEAVY
`
`
`| ANALYSIS | PSA
`
`
`
`CHN
`
`RESULTS
`
`“DSC
`
`TG
`
`X- RAY
`
`TLC
`
`WRITE
`
`BELOW
`
`THIS
`
`BULK
`
`LINE
`
`
`
`Ox=O1150 ss
`(OX
`Avta%
`Chir
`
`=
`-
`sy)
`’
`-
`as
`onl
`(ores
`On
`~
`C- TUS maf ~ AG .o% “lo
`0O.41
`O.\\ %G
`
`Re
`
`aa.1b
`
`swur
`“nie
`
`=
`
`348 DL
`
`.
`
`7
`
`oer
`
`1
`
`.
`
`7}
`fj
`
`i
`
`.
`(o1ssse)
`Cru ns Maw qu.tt 4o
`
`min
`
`6.18%
`
`VRE LSVWUS
`
`:
`
`_OLISOSe_
`Area
`OT
`OMT
`0.86
`SIU
`Ud
`OA8t <7
`10
`oslo
`WAV
`o.yO%
`VAY
`ONVL
`t.3l
`Osun
`“= 449
`6 oS%
`AL
`fess
`bse
`yA
`(0°
`ose
`lve
`o.tst OwhD 1Oimap > 0.05 &
`1-33
`it
`00%
`W290
`oot
`PP LAB PROC #
`.
`ANALYST
`DATE
`
`mad
`dow ee vob.
`Eel Uo. 1a)z
`
`
`2.0\
`2.04
`
`O61 %
`Or 7 ly
`
`Merck Exhibit 2129, Page 162
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 162
`Mylan v. Merck, IPR2020-00040
`
`
`
`Hansen, Karl
`
`Dorwart, Jason G.
`Thursday, February 21, 2002 11:13 AM
`Hansen, Karl
`RE:
`
`rom:
`ent:
`To:
`Subject:
`
`RRT
`0.95
`0.97
`1.00
`
`Jason
`
`Area%
`0.17%
`0.11%
`99.67%
`
`soeeeOriginal Message-----
`From:
`Hansen, Karl
`Sent:
`Thursday, February 21, 2002 9:34 AM
`To:
`Dorwart, Jason G.
`Subject:
`RE:
`
`How was the chemical purity?
`
`soooOriginal Message-----
`From:
`Dorwart, Jason G.
`
`@ Thursday, February 21, 2002 9:30 AM
`
`0:
`Subject:
`
`Hansen, Karl
`
`Here are the chiral purity results for the Phosphate salt and ML's from NB#70316-039
`
`Solids = 96.02% major
`ML's = 94.22% major
`
`3.98%minor
`5.78% minor
`
`Jason
`
`Merck Exhibit 2129, Page 163
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 163
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLC0157\DATA\067-0101.D
`
`Sample Name: 70316-039
`
`aqueous washes
`
`->
`
`Injection Date : 02/14/2002
`Sample Name
`> 70316-039
`Acq Operator
`: hansen
`
`12:42:50 PM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`: C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC1lO4/Acetonitrile, 1lml/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`:
`:
`:
`:
`
`1
`67
`1
`2 pl
`
`DAD1 C, Sig=210,8 Ref=360,100 (067-0101.D)
`
`2
`0
`DAD1 E, Sig=268,16 Ref=360,100 (067-0101 D)
`
`
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 01/14/2002
`: 1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DAD1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`(min]
`
`Area
`(mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`2.06 BV
`1
`2.20 VV
`2
`2.27 VV
`3.
`2.51 VV
`4
`2.63 VV
`5
`3.19 VV
`6
`3.29 VV
`7
`3.64 VB
`8
`4.02 BV
`9
`5.67 BV
`10
`11°=«5.87 VV
`12
`6.12 VB
`13.
`7.01 BP
`14
`8.60 VB
`15
`9.39 BB
`
`463.151
`94.62
`0.081
`0.046 1.77e3 5194.654
`0.120 2.34e3 2.129e4
`0.176 2.0963 2.414e4
`0.095 1.02e3 5797.346
`0.079
`10.37
`56.353
`0.115
`12.32
`102.662
`0.086
`9.89
`57.430
`0.111
`1.45
`11.322
`0.076
`10.94
`54.555
`0.076
`2.17
`10.401
`0.088 318.25 1791.939
`0.104
`85.48
`613.774
`0.084
`6.19
`33.679
`0.105
`4.35
`33.252
`
`0.77
`8.63
`35.39
`40.12
`9.64
`0.09
`0.17
`0.10
`0.02
`0.09
`0.02
`2.98
`1.02
`0.06
`0.06
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.011273
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`HPLCO157
`
`02/14/2002
`
`12:56:00 PM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 164
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 164
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`Peak
`#
`
`:C:\HPCHEM\HPLCO157\DATA\067-0101.D
`RT
`Type Width Height
`Area
`Area
`([min]
`{(min]
`[mAU*s]
`%
`
`Amount
`mg/ml
`
`Sample Name: 70316-039
`Name
`
`9.90 PP
`16
`17 12.09 VB
`
`0.082
`0.078
`
`2.83
`99.20
`
`14.608
`496.372
`
`0.02
`0.83
`
`0.000000
`0.000000
`
`Signal:
`
`2 DAD1 E, Sig=268,16 Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`[min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`2.05 BV
`1
`0.00
`2
`7.01 BB
`3.
`4 12.09 BB
`
`0.072
`0.000
`0.104
`0.078
`
`4.51
`0.00
`4.85
`8.01
`
`21.712
`0.000
`34.697
`40.019
`
`22.52
`0.00
`35.98
`41.50
`
`0.000000
`0.011273
`0.000000
`0.000000
`
`L~-224,715
`
`*** End of Report ***
`
`HPLCO157
`
`02/14/2002
`
`12:56:00 PM
`
`Page 2 of 2
`Merck Exhibit 2129, Page 165
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 165
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\068-0101.D
`
`Sample Name: 70316-039
`
`5.07g/50m1l of 50.00g ml and wash
`
`->
`
`Injection Date : 02/19/2002
`Sample Name
`: 70316-039
`Acq Operator
`: hansen
`
`10:46:47 AM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`: C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile,
`iml/min
`lOmin 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`:
`:
`:
`:
`
`1
`68
`1
`2 pl
`
`DAD1 C, Sig=210,8 Ref=360,100 (068-0101.D)
`oO}
`6S
`
`vt
`oOKt
`8
`o +
`©N=—
`N o
`>
`3
`=
`o
`PEE$type
`
`DAD1 E, Sig=268,16 Ref=360,100 (068-0101 .D)
`
`
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 01/14/2002
`: 1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DADi C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`[min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13.
`14
`15
`
`0.47 BV
`0.68 VP
`2.61 BV
`2.94 VV
`3.14 VV
`4.01 VV
`4.45 VV
`4.75 VV
`4.97 VV
`5.37 VB
`0.00
`5.93 BV
`6.45 VV
`6.73 VV
`6.90 VV
`
`60.632
`8.68
`0.106
`28.938
`4.08
`0.107
`256.923
`33.82
`0.123
`82.116
`7.44
`0.149
`97.780
`9.65
`0.132
`683.647
`17.12
`0.496
`608.926
`67.86
`0.131
`89.556
`9.61
`0.133
`115.106
`9.37
`0.163
`0.089 1.5463 8643.102
`0.000
`0.00
`0.000
`0.282
`6.93
`154.725
`0.144
`8.21
`85.602
`0.116
`15.35
`128.594
`0.070
`4.66
`22.367
`
`0.50
`0.24
`2.13
`0.68
`0.81
`5.66
`5.04
`0.74
`0.95
`71.60
`0.00
`1.28
`0.71
`1.07
`0.19
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`HPLCO157
`
`02/19/2002
`
`10:59:38 AM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 166
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 166
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`Peak
`#
`
`:C:\HPCHEM\HPLCO157\DATA\068-0101.D
`RT
`Type Width Height
`Area
`Area
`{min}
`(min)
`[mAU*s]
`%
`
`Sample Name: 70316-039
`Name
`
`9.66 PV
`16
`9.96 VV
`17°
`18 10.09 VV
`19 10.18 VV
`20 10.37 VB
`21 10.89 BB
`22 11.89 VV
`23 12.07 VV
`24 12.16 VV
`25 12.44 VV
`26 12.67 VV
`27°12.91 VV
`28 13.12 VB
`
`0.161
`0.100
`0.077
`0.075
`0.079
`0.095
`0.118
`0.077
`0.097
`0.121
`0.121
`0.127
`0.145
`
`1.00
`15.46
`7.07
`4.37
`51.84
`1.22
`2.30
`12.96
`10.05
`1.62
`2.41
`2.32
`6.01
`
`12.317
`108.147
`36.859
`21.152
`260.206
`7.651
`19.265
`66.009
`70.204
`13.435
`20.793
`21.691
`58.331
`
`0.12
`1.05
`0.36
`0.20
`2.52
`0.07
`0.19
`0.64
`0.68
`0.13
`0.20
`0.21
`0.56
`
`Signal:
`
`2 DAD1 E, Sig=268,16 Ref=360,100
`
`Peak
`#
`
`RT
`{[min]
`
`Type Width Height
`{min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`4.12 BB
`1
`5.13 BB
`2
`5.63 BV
`3
`5.87 VP
`4
`7.91 BP
`5
`8.22 BB
`6
`9.96 BV
`7
`8 10.37 VB
`9 13.12 BB
`
`0.088
`0.085
`0.080
`0.078
`0.086
`0.084
`0.085
`0.079
`0.127
`
`1.62
`3.33
`15.60
`21.00
`1.75
`2.60
`2.21
`6.18
`2.76
`
`9.190
`17.950
`80.034
`107.740
`10.195
`15.164
`12.245
`31.036
`22.397
`
`3.00
`5.87
`26.16
`35.21
`3.33
`4.96
`4.00
`10.14
`7.32
`
`. 000000
`. 000000
`. 000000
`. 000000
`000000
`000000
`. 000000
`. 000000
`000000
`000000
`000000
`.000000
`000000
`
`. 000000
`. 000000
`182926
`000000
`. 000000
`000000
`000000
`. 000000
`000000
`
`*** End of Report ***
`
`L-224,715
`
`HPLCO157
`
`02/19/2002
`
`11:35:45 AM
`
`Page 2 of 2
`Merck Exhibit 2129, Page 167
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 167
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\068-0101.D
`
`Sample Name: 70316-039
`
`5.07g/50m1l of 50.00g ml and wash
`
`->
`
`Injection Date : 02/19/2002
`Sample Name
`: 70316-039
`Acq Operator
`> hansen
`
`11:22:57 AM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`: C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile, 1lmli/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`:
`:
`:
`:
`
`1
`68
`1
`2 pl
`
`DAD1 C, Sig=210,8 Ref=360,100 (068-0101.D)
`
`4
`
`DAD1 E, Sig=268,16 Ref=360,100 (068-0101 D)
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 01/14/2002
`: 1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DADI C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`[min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`1
`2
`3
`4
`5
`6
`7
`
`8
`9
`10
`11
`12
`13.
`14
`15
`
`2.43 VP
`3.15 BV
`4.12 BP
`5.13 BV
`5.28 VP
`5.63 BV
`5.87 VV
`
`6.19 VB
`7.62 BV
`7.90 VV
`8.06 VV
`8.22 VV
`8.50 VB
`8.87 BV
`9.05 VB
`
`184.439
`48.45
`0.058
`13.726
`2.32
`0.091
`29.849
`5.26
`0.088
`58.757
`10.91
`0.085
`8.590
`1.68
`0.077
`700.828
`0.080 136.26
`0.082 1.62e3 8255.455
`
`0.109
`0.110
`0.094
`0.053
`0.101
`0.101
`0.102
`0.073
`
`2.77
`5.79
`12.82
`1.56
`22.52
`3.56
`4.00
`1.26
`
`21.703
`45.499
`83.163
`5.439
`159.956
`25.411
`28.711
`5.976
`
`1.78
`0.13
`0.29
`0.57
`0.08
`6.78
`79.81
`
`0.21
`0.44
`0.80
`0.05
`1.55
`0.25
`0.28
`0.06
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.182926
`0.000000
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`ate
`ry
`
`HPLCO157
`
`02/19/2002
`
`11:35:45 AM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 168
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 168
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`Peak
`#
`
`:C:\HPCHEM\HPLC0157\DATA\068-0101.D
`Area
`Area
`RT
`Type Width Height
`{min]
`[min]
`
`{mAU*s]
`
`%
`
`Sample Name: 70316-039
`Name
`
`7.07 VB
`16
`7.45 BV
`17.
`7.63 VV
`18
`7.92 VV
`19
`8.11 VB
`20
`9.07 BV
`21
`9.22 VV
`22
`9.37 VV
`23.
`9.49 VV
`24
`9.71 VB
`25
`26 10.29 PB
`27 11.51 BV
`28 11.73 VV
`29 11.90 VP
`30 12.40 BV
`31 12.67 VV
`32 13.05 VB
`
`0.123
`0.138
`0.133
`0.150
`0.108
`0.093
`0.091
`0.089
`0.086
`0.090
`0.131
`0.114
`0.092
`0.118
`0.111
`0.095
`0.365
`
`0.84
`4.07
`3.48
`3.86
`1.57
`5.73
`1.81
`5.84
`4.01
`3.41
`1.46
`3.48
`3.42
`9.35
`1.16
`1.50
`2.72
`
`183.348
`39.146
`31.944
`42.976
`11.531
`34.086
`70.083
`34.695
`22.802
`247.354
`12.139
`26.805
`80.036
`78.452
`8.880
`9.658
`78.748
`
`1.52
`0.32
`0.26
`0.36
`0.10
`0.28
`0.58
`0.29
`0.19
`2.05
`0.10
`0.22
`0.66
`0.65
`Q.07
`0.08
`0.65
`
`Signal:
`
`2 DADI1 E, Sig=268,16
`
`Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`[min]
`
`Area
`
`Area
`
`[mAU*s]
`
`%
`
`2.94 BP
`1
`3.18 VB
`2
`4.01 BB
`3
`4.45 BP
`4
`5.37 VB
`5
`0.00
`6
`6.73 VV
`7
`7.07 VB
`8
`9.22 BV
`9
`9.38 VP
`10
`9.71 VB
`ll
`12 11.73 BV
`13 13.06 PB
`
`0.122
`0.104
`0.163
`0.114
`0.086
`0.000
`0.096
`0.119
`0.110
`0.163
`0.087
`0.079
`0.256
`
`1.65
`1.38
`1.83
`6.97
`9.02
`0.00
`1.78
`2.57
`1.88
`1.11
`5.08
`1.02
`1.23
`
`14.471
`9.700
`21.120
`52.463
`104.015
`0.000
`11.865
`21.869
`14.103
`13.691
`28.500
`5.164
`22.646
`
`4.53
`3.03
`6.61
`16.41
`32.54
`0.00
`3.71
`6.84
`4.41
`4.28
`8.92
`1.62
`7.09
`
`. 000000
`. 000000
`. 000000
`000000
`000000
`000000
`000000
`. 000000
`000000
`. 000000
`.000000
`.000000
`000000
`. 000000
`.000000
`000000
`000000
`
`.000000
`. 000000
`. 000000
`. 000000
`-000000
`. 000000
`.000000
`. 000000
`000000
`.000000
`000000
`. 000000
`. 000000
`
`*** End of Report ***
`
`L-224,715
`
`HPLCO157
`
`02/19/2002
`
`10:59:38 AM
`
`Page 2 of 2
`Merck Exhibit 2129, Page 169
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 169
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLC0157\DATA\062-0101.D
`
`Sample Name: 70316-0%94
`
`EDC coupling lh at 0 C
`
`->
`
`Injection Date : 02/13/2002
`Sample Name
`: 70316-035
`Acq Operator
`>: hansen
`
`8:29:32 AM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`> C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile,
`Iml/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`:
`>:
`:
`:
`
`1
`62
`1
`2 pl
`
`DAD1 C, Sig=210,8 Ref=360,100 (062-0101 D)
`
`
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 01/14/2002
`: 1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DAD1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`{min]
`
`Type Width Height
`[min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`2.16 BV
`1
`2.28 VV
`2
`2.44 VV
`3.
`2.58 VB
`4
`0.00
`5
`8.59 BP
`6
`9.38 PP
`7
`9.89 BP
`8
`9 11.54 BV
`10 11.91 VV
`11 12.08 VB
`
`13.010
`3.18
`0.062
`0.060 382.63 1520.607
`0.061 116.66
`449.003
`0.088
`20.46
`125.811
`0.000
`0.00
`0.000
`0.080
`2.81
`14.814
`0.104
`1.14
`8.628
`0.093
`2.61
`15.884
`0.110
`1.03
`7.976
`0.077
`55.68
`273.914
`0.081 1.10e3 5609.710
`
`0.16
`18.91
`5.59
`1.56
`0.00
`0.18
`0.11
`0.20
`0.10
`3.41
`69.78
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`HPLCO157
`
`02/13/2002
`
`8:42:47 AM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 170
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 170
`Mylan v. Merck, IPR2020-00040
`
`
`
`:C:\HPCHEM\HPLC0157\DATA\062-0101.D
`Data file
`Signal:
`2 DAD1 E, Sig=268,16 Ref=360,100
`
`Sample Name: 70316-038 44
`,
`
`Peak
`#
`
`RT
`{(min]
`
`Type Width Height
`{min]
`
`Area
`(mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`0.00
`1
`211.91 BV
`3.12.08 VB
`
`0.000
`0.077
`0.079
`
`0.00
`7.27
`92.24
`
`0.000
`35.742
`465.031
`
`0.00
`7.14
`92.86
`
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`*** End of Report ***
`
`HPLCO157
`
`02/13/2002
`
`8:42:47 AM
`
`Page 2 of 2
`Merck Exhibit 2129, Page 171
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 171
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C: \HPCHEM\HPLC0157\DATA\063-0101.D
`
`Sample Name: 70316-035
`
`EDC coupling 2.75h at 0 C
`
`Injection Date
`Name
`Sample
`Acq Operator
`
`02/13/2002
`70316-035
`hansen
`
`10:16:15 AM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`Method
`C: \HPCHEM\HPLCO157\METHODS\715.M
`01/14/2002
`1:00:57 PM
`:
`Last Changed
`lml/min
`75/25 0.1% HC104/Acetonitrile,
`75/25 from 10 to 14 min
`lOmin 25/75 water/acn;
`waters
`cl8 symmetry, 250 nm
`
`DAD1 C, Sig=210,8 Ref=360,100 (063-0101.D)
`
`4
`2
`0
`DAD1 E, Sig=268,16 Ref=360,100 (063-0101.D)
`
`
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`Signal
`01/14/2002
`1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DAD1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`{min}
`
`Type Width Height
`{min]
`
`Area
`[mAU*s]}
`
`Area
`%
`
`Amount
`mg/ml
`
`2.16 BV
`1
`2.27 VV
`2
`2.44 VWV
`3.
`2.58 VB
`4
`0.00
`5
`7.02 BB
`6
`8.60 BP
`7
`9.38 BB
`8
`9.90 BP
`9
`10 11.54 BV
`11 °11.91 VV
`12 12.09 VB
`13 12.78 PB
`
`13.452
`2.98
`0.067
`0.063 502.58 2004.184
`0.061 144.18
`561.382
`0.075
`94.13
`473.539
`0.000
`0.00
`0.000
`0.093
`3.42
`22.671
`0.086
`3.72
`21.564
`0.117
`1.57
`13.351
`0.089
`3.17
`18.353
`0.086
`1.16
`6.516
`0.074
`2.36
`10.846
`0.080 1.36e3 6971.021
`0.204
`8.22
`111.157
`
`0.13
`19.60
`5.49
`4.63
`0.00
`0.22
`0.21
`0.13
`0.18
`0.06
`0.11
`68.16
`1.09
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`HPLCO157
`
`02/13/2002
`
`10:29:30 AM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 172
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 172
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\065-0101.D
`
`‘Sample Name: 70316-039
`
`0.3990gt/50ml of 74.83g methanol filtrate
`
`->
`
`Injection Date : 02/14/2002
`Sample Name
`: 70316-0039
`Acq Operator
`>: hansen
`
`9:58:33 AM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`: C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile,
`Iml/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`1
`:
`: 65
`:
`1
`:
`2 pl
`
`‘
`
`DAD1 C, Sig=210,8 Ref=360, 100 (065-0101.D)
`
`0
`
`2
`
`4
`
`DAD1 E, Sig=268,16 Ref=360,100 (065-0101.D)
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 01/14/2002
`: 1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DAD1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`{min}
`
`Type Width Height
`{[min]
`
`Area
`(mAU* s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`2.43 BB
`1
`5.15 BV
`2
`5.65 BV
`3.
`5.88 VB
`4
`8.25 BP
`5
`6 10.38 BB
`7:12.08 PB
`8 12.94 BB
`
`12.246
`3.25
`0.058
`8.051
`1.41
`0.089
`0.081 269.11 1411.016
`0.078 136.67
`676.410
`0.090
`2.33
`14.869
`0.083
`3.87
`20.999
`0.101
`1.09
`7.926
`0.089
`22.77
`127.373
`
`0.54
`0.35
`61.92
`29.68
`0.65
`0.92
`0.35
`5.59
`
`0.000000
`0.000000
`0.371556
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`HPLCO0157
`
`02/14/2002
`
`10:11:45 AM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 173
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 173
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\064-0101.D
`
`Sample Name: 70316-0039
`
`hydrog after 18h 50C, 40PSI
`
`-?
`
`9:33:56 AM
`
`Injection Date : 02/14/2002
`Sample Name
`> 70316-039
`Acq Operator
`: hansen
`
`Seq Line
`Vial No
`Inj. No
`Inj. Vol.
`; C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 01/14/2002
`1:00:57 PM
`Last Changed
`75/25 0.1% HC104/Acetonitrile,
`iml/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl8 symmetry, 250 nm
`
`1
`64
`1
`2 pl
`
`DAD1 C, Sig=210,8 Ref=360,100 (064-0101.D)
`
`qj 3
`its
`
`B
`noo &
`Q
`Ros
`$8
`38
`IK
`8
`gs
`= es
`a 7
`no
`ws
`N,
`?
`bein fpel
`
`4
`2
`0
`DAD1 E, Sig=268,16 Ref=360,100 (064-0101.D)
`
`6
`
`8
`
`10
`
`12
`
`14
`
`mi
`
`¢©
`©
`
`@
`
`tS
`
`mAU
`600
`500
`400
`300
`200
`100
`0
`
`mAU
`
`600
`500
`
`400
`
`300
`200
`
`
`
`0
`
`0
`
`9a
`
`2
`
`4
`6
`8
`10
`
`
`12
`
`14
`
`mi
`
`Customized Report:karlo
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`Signal
`01/14/2002
`1.000000
`
`1:00:30 PM
`
`Signal:
`
`1 DAD1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`[min]
`
`Area
`[mAU*s]
`
`Area
`
`Amount
`mg/ml
`
`Name
`
`2.17 BV
`1
`2.43 VB
`2
`3.14 BB
`3
`5.15 BV
`4
`5.31 VP
`5
`5.64 BV
`6
`5.89 VB
`7
`6.22 BB
`8
`7.94 PV
`9
`8.26 VV
`10
`8.52 VB
`11
`9.91 PV
`12
`13 10.11 VV
`14 10.40 VP
`15 11.70 BV
`
`5.278
`1.33
`0.060
`70.466
`19.89
`0.055
`9.055
`1.27
`0.111
`45.540
`8.07
`0.088
`11.385
`2.18
`0.079
`0.088 1.36e3 7478.898
`0.078 779.93 3891.804
`0.113
`1.21
`9.728
`0.088
`5.18
`31.008
`0.099
`14.25
`99.158
`0.086
`1.35
`7.644
`0.081
`2.68
`14.072
`0.079
`1.91
`9.602
`0.079
`20.55
`104.739
`0.091
`1.16
`7.237
`
`0.04
`0.55
`0.07
`0.36
`0.09
`58.36
`30.37
`0.08
`0.24
`0.77
`0.06
`0.11
`0.07
`0.82
`0.06
`
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`1.983213
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`0.000000
`
`L-224,715
`
`HPLCO157
`
`02/14/2002
`
`9:47:07 AM
`
`Page 1 of 2
`Merck Exhibit 2129, Page 174
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 174
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`Peak
`#
`
`:C: \HPCHEM\HPLCO157\DATA\064-0101.D
`Area
`Area
`RT
`Type Width Height
`[min]
`([min]
`
`[mAU*s]
`
`%
`
`Sample Name: 70316-039
`Name
`
`16 11.93 VV
`17 12.10 VV
`18 12.18 VB
`19 12.46 BV
`20 12.95 VB
`
`1.74
`0.118
`5.87
`0.080
`4.10
`0.074
`1.40
`0.106
`0.096 148.23
`
`14.323
`31.169
`21.077
`10.325
`942.241
`
`0.11
`0.24
`0.16
`0.08
`7.35
`
`. 000000
`000000
`. 000000
`000000
`000000
`
`Signal:
`
`2 DAD1 E, Sig=268,16
`
`Ref=360,100
`
`Peak
`#
`
`RT
`{[min]
`
`Type Width Height
`[min]
`
`Area
`
`Area
`
`[mAU*s]
`
`%
`
`5.16 BB
`1
`5.64 BV
`2
`5.89 VB
`3
`8.26 BB
`4
`5 10.40 PP
`6 12.96 BB
`
`2.07
`0.088
`0.082 171.21
`0.080
`9.45
`0.099
`1.83
`0.077
`2.42
`0.098
`3.36
`
`11.680
`
`15
`
`000000
`. 983213
`000000
`000000
`000000
`000000
`
`L-224,715
`
`*** End of Report ***
`
`HPLCO157
`
`02/14/2002
`
`9:47:07 AM
`
`Page 2 of 2
`Merck Exhibit 2129, Page 175
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 175
`Mylan v. Merck, IPR2020-00040
`
`
`
`ProjectNo.___-_— Project Page
`> 4Y °
`Page
`7031 6
`Book
`DateASFb2082|Investigator
`oO
`(iu A Race aalt
`BASate
`
`Subject
`
`Filed in Book Number/Title
`
`Fo
`
`6
`is
`L
`\ Cevw
`|
`King rts:
`p
`A ndoot eA
`Jpnael,
`C
`
`.
`Al
`* wre N ERCabn LRaAIT(E -PMesplotc
`1 Pe X
`Fu
`A+ pAL|
`337A
`2
`Od
`22.0
`47
`[1,71
`I$.¢
`
`Pert
`
`dd
`360
`
`+
`1.0
`Lo
`[
`
`ay
`12324- [pF
`2\F4 -
`
`Joo
`
`620
`
`JO}. 1S
`
`12.45
`
`|
`|
`"
`
`Qe, Mel PIE
`Mn
`u2—\
`_ACN
`cath tu<«
`footy Act A
`Prtt VDess.lod
`HCl Cold clay
`Res of Trsrel
`AMSA 42~1 KON tte
`& fri
`aed,
`Mm
`Lok.
`AddeA EdC
`MEly lok
`9 96 cw FAA ved
`Atla Qo whe SBorletelc, Cot wba ef]
`oS) Mala
`~4{{
`oat SaMh cl 2O—-Y
`a
`cathe! Cornporhnts + o
`
`AAGrHyder,oh. methanel J2slorPa[e WPSt He
`
`=
`allu® Bro cleaud. Gl hed oFF
`Ae o9
`~~
`ft
`uc
`(,<+ duykA UK| Mcp
`A-
`2
`Ci bet ‘
`b Cante
`Cal
`ul
`(FV.
`ect
`L224 1s.
`A fs oe,
`SH.
`ld
`4 Re-digsluck
`yp a thast
`(acaba AK.
`Ke dedsalost
`12 St Ett 40(hcA eteBnk VBP.
`wotdl Flese Fm SER tale (EbyA I
`(5 $03
`24. Poy
`(Los en
`. GAS
`O
`i
`sth L
`{
`ha of 4
`3
`—fLE——__ 2) Rb awe
`
`i
`
`f\
`
`fA
`
`4
`
`La
`
`A
`
`nN
`
`Countersigned by ~
`
`:
`Merck Exhibit 2129, FACRCNR
`Mylan v. Merck, IPR2020600064000) NCMPL =
`
`Date
`
`Merck Exhibit 2129, Page 176
`Mylan v. Merck, IPR2020-00040
`
`
`
`Book
`
`7031 6
`
`Page
`
`4?
`
`Project No... _sCéPrroject Page
`
`52
`
`. DO NOT BEGIN NEW EXPERIMENTS ON THIS PAGE.
`
`| Fibacs2
`AAdcd
`‘JO [.-O35
`ae Ay
`|
`ooh d
`ALA GSm1 End 4
`sha
`©
`Vie
`le
`hen,
`TheA—
`
`i
`
`ro,
`lade
`hot
`weshJ
`
`OLane Gon
`
`3
`
`.
`5 fo|
`Miro s&pe
`ir
`RT
`(alu
`Do | ENA).
`
`oh.
`
`'H
`
`ak
`
`AoW No eThSA.
`A} AA,
`TLinmes =
`6934
`
`G2n,
`
`siesu/
`
`che $5 W
`(\ 0 Iu—-0
`
`ow Thal rt eatin
`1
`S pps
`Ih
`g an
`
`wv dre Dies at
`
`S26 ks lis \ [LA
`
`Yao).
`
`ref
`
`qc é
`
`ASVYL
`
`a
`
`re
`
`|fllllIlllilllliI|ll
`
`|llllkllttlt|ll
`
`_—
`
`Date
`Merck Exhibit 2129, Page 177
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 177
`Mylan v. Merck, IPR2020-00040
`
`
`
`SOLUTION
`a TITRATION a c
`
`
`
`
`
`ANALYSIS PSA | DSC : a TG | X-RAY|| TLC | ‘ BULK |_| . MESH || ALL
`
`
`
`ao
`
`aad
`MERCK & CO., INC’.
`R827-L 4/755
`A
`DATE
`=
`°
`Ceo Ue?
`
`SUBMITTED BY
`\S
`
`Ser (4.
`POS
`
`VUSAS
`
`OMPLETE STRUCTURE
`
`.
`
`-
`to
`*
`PPCL #
`23061
`SAMPLE DISPOSITION
`
`*
`
`cet YP ntYT RN we oe SO
` _ a
`TAias so,
`REQUEST FOR ANALYSIS ‘ _
`+
`NOTEBOOK OR BATCH #
`PROJECT #
`[0816 - Ox
`MOLECULAR WEIGHT
`
`:
`
`SEND REPORT TO
`
`7 7
`
`.
`
`ExT
`Cos
`AREA
`
`{ IRETAIN[ JRETURN[ JDISCARO
`
`°
`
`CHEMICAL NAME
`
`ease TOWN be
`C-V24UT 3004 Recomm
`
`,
`
`EMPIRICAL FORMULA
`
`OTHER TESTS AND COMMENTS
`
`test
`
`SOLIDS
`
`-
`
`UV
`
` SPECIFIC
`
`ROTATION
`
`
`IGNITION
`
`|] psehta LJ some
`LOSS ON
`
`
`DRYING
`
`
`
`
`‘
`
`Cc
`
`Ceeeeeaden
`
`
`ANALYSIS
`
`CONTROLS
`
`CHN
`
`ve
`
`DO
`NOT
`WRITE
`BELOW
`THIS
`LINE
`
`RESULTS
`
`ao CORD
`
`Chava
`
`
`4
`
`;
`
`C- 4D, TUN - 44,42 2%
`L- UNS - Sd.08
`
`HQ & wZIy-ir]
`
`Lan
`Avcatte
`
`.
`OA
`OAS
`
`ON “te
`
`005 %
`
`Oo®)
`
`1.08
`
`ON
`
`44.66%
`
`O44L
`
` PP LAB PROC. #
`
`ANALYST
`
`Merck Exhibit 2129, Page 178
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 178
`Mylan v. Merck, IPR2020-00040
`
`
`
`2002022054.001
`
`2/20/02
`
`- 2/21/02
`
`HYDROGENATION OR HIGH PRESSURE REACTION
`
`QIAISY. |
`
`r
`o
`-
`i
`-
`
`
`DUESTED BY Hani BLDG/RM EXT. _) DATEwirbr&*f aG !
`wae
`a
`.
`j
`
`prosectno___*?7//*_provect M ‘2 7h NOTEBOOK- PAGE NO__:’_ 2 fs -
`
`
`“¢/
`
`CHECK HEREIF REACTION IS GMP/GLP 0—STARTINGMATERIAL
`
`NO. 1
`
`MW, | «. an W. AMOUNT_______ G._ MOLES
`
`STRUCTURAL FORMULA:
`
`CATALYsT___-+ CG.
`SOLVENT
`MOLES OF HYDROGEN REQUIRED
`OTHER MATERIALS
`ttl,
`a!
`coe
`REACTION CONDITIONS, ETC.
`{ov ,.
`
`TF,
`
`PRECAUTIONS:
`
`et iC
`,
`ia
`
`_| | Ale
`
`TEMP.
`
`DROP
`
`EMPIRICAL FORMULA:
`SSSSSSSSSSESSSSSSSSESESSSS -
`
`TO BE FILLED IN BY HYDROGENATION LABORATORY
`NotOY moes 42.0/24/ nog,i. eS
`catayst._2. or YK AHI
`Jn le POIs
`
`IPoM
`SOLVENT. LOO
`
`OTHER MATERIALS
`
`
`CELL NO_____ HEATER NO REC. POINT INTERNAL _____ EXTERNAL________ BOMB NO________vesseLsize__~“27ML.
`SHAKER no“/uinen —__ SHAKER TANK —__/7/7 AUX. TANK ______ SYSTEM VOLUME__7ssML.
`C'DH, PRESSURE DROP=— ves.mo.e <2£011__ motes= L274 Las.
`
`DITIONS______ HRS. AT_.22_ CC. MISC. DATA: a
` <=
`
`Ser=|OROF
`
`P.
`
`T
`
`eRNEOAme
`
`RUNBY, }Jonas pateLoi, Qo oor.
`
`DATE
`RUN BY
`Merck Exhibit 2129, Page 179
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 179
`Mylan v. Merck, IPR2020-00040
`
`€
`
`
`ShkiS4 Product Temp
`
`Hist.FIX.PT5407.F_CV
`Hist.FIX.DTS409.F_CV
`ist.F1X.TES403.F_CV
`
`43:39:19
`2/20/02
`
`Shkr54 Pressr
`ShkrS4 H2 Uptake
`
`2002022054.001
`
`Merck Exhibit 2129, Page 180
`Mylan v. Merck, IPR2020-00040
`
`Merck Exhibit 2129, Page 180
`Mylan v. Merck, IPR2020-00040
`
`
`
`Data file
`
`:C:\HPCHEM\HPLCO157\DATA\083-0101.D
`
`Sample Name: 70316-041
`
`12.50g/100m1l of 66.25 g ML's
`
`->
`
`Injection Date : 02/21/2002
`Sample Name
`> 70316-041
`Acq Operator
`: hansen
`
`2:00:19 PM
`
`Seq Line
`Vial No
`Inj. No.
`Inj. Vol.
`: C:\HPCHEM\HPLCO157\METHODS\715.M
`Method
`: 02/21/2002
`7:13:49 AM
`Last Changed
`75/25 0.1% HC104/Acetonitrile, 1ml/min
`10min 25/75 water/acn; 75/25 from 10 to 14 min
`waters cl18 symmetry, 250 nm
`
`1
`:
`: 83
`:
`1
`:
`2 pl
`
`DAD1 C, Sig=210,8 Ref=360,100 (083-0101.D)
`
`:
`
`DAD1 E, Sig=268,16 Ref=360,100 (083-0101.D)
`
`Sorted By
`Calib. Data Modified
`Multiplier
`
`: Signal
`: 02/20/2002
`: 1.000000
`
`3:33:04 PM
`
`Signal:
`
`1 DADI1 C, Sig=210,8 Ref=360,100
`
`Peak
`#
`
`RT
`[min]
`
`Type Width Height
`{min]
`
`Area
`[mAU*s]
`
`Area
`%
`
`Amount
`mg/ml
`
`Name
`
`1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13.
`14
`15
`
`2.43 VB
`3.64 PB
`4.14 PP
`5.17 VP
`5.66 BV
`5.88 VB
`7.64 BV
`7.74 VV
`7.90 VV
`8.08 VV
`8.23 VV
`8.51 VV
`8.89 VV
`9.05 VB
`9.97 PV
`
`135.757
`35.38
`0.059
`540.202
`0.080 105.11
`11.908
`0.085
`2.19
`113.330
`0.084
`20.69
`451.690
`0.097
`71.88
`0.088 2.02e3 1.106e4
`20.081
`2.46
`0.117
`0.072
`4.15
`20.054
`0.111
`14.58
`118.1