CONFIDENTIAL - ATTORNEYS I EYES ONLY
`
`2
`VTDEOTAPED / REA],ÎTMED DEPOSITION
`of .IERRY S. I,iOl,lNSKY, M.D., produced as a
`witness at the instance of Lhe Defendants
`Synthon and Pfizer, and duly sworn, was taken
`in the above-styled and numbered cause on
`Monday, the 15th day of February, 2A16, from
`9;13 a.m. Lo 5:26 p.m., before Pat English
`Arredondo, CSR, RMR, CRR/ CLR in and for the
`State of Texas, reported by machine shorthand
`in realtime translation, at the law offices
`of Duane Morris, 1330 Post Oak Boulevard,
`Suite 800, Houston, Texas. pursuant to the
`Federal Rules of Civif Procedurer that the
`Witness wiff read the deposition,
`
`4
`
`APPEARANCES
`COUNSEL FOR PIÃTNTIFES, TEVA PHARMACEUTICALS
`USA¡ INC., TEVA PHARMACEUTICA], INDUSTRIES,
`LTD., TEVA NEUROSCIENCE,
`INC., and YEDA:
`Mr. John T. Bennett
`Mr. Ken MuelÌer
`GOODç{IN PROCTER, LLP
`Èxchange P.lace
`53 State Street
`Boston, Massachusetts 02109
`Phone: 617 .570. 1000
`j bennett G qoodwinprocter , com
`kmue.Lle¡qa qoodwinprocter. com
`-and-
`Mr. David E, Jenkins
`UTHeafth, Office of Lega.L Affairs
`P.O. Box 20036
`Houston, Texas '11225
`Phone: 713.500.3268
`David. E . JenkinsGuth. tmc. edu
`
`SYNTHON
`
`COUNSEL FOR DEFENDÃNTS SYNTHON
`INC., SYNTHON B.V
`PTIA¡-MACEUTICALS,
`S.R.O,, and PFIZËR, INC. r
`Ms. R. EÌizabeth Brenner-Leifer
`Mr. B¡ett A. Postaf
`ROTHWELL, FIGG, ERNST & MANBECK, P,C.
`607 14th Street, N.!ù., Suite 800
`Washington, D.C.20005
`Ptìonet 242--t83.6040
`ebrenne¡G ¡fem. com
`bpostalGrfem. con
`COUNSÊL FOR DEFENDÀNT MYLAN, ]NC.,
`INC. ANd NA],CO P}ARMA
`MYI,ÄN PHARI.{ACEUT]CALS,
`LTD. :
`Mr. David L. -A¡staett
`PERKINS COIE, LLP
`'
`One East Main Street, Suite 201
`Madison, úlisconsin 53703-5118
`Phone: 608.663.5408
`dans taett laperk.inscoie . com
`
`7 2 3 4 5 6
`
`'7
`
`8 9
`
`10
`
`11
`I2
`13
`I4
`15
`
`16
`
`I'7
`
`18
`
`79
`
`20
`2I
`22
`
`23
`
`24
`
`25
`
`12
`
`3 4 5 6 7
`
`9
`10
`
`11
`
`1"2
`
`13
`
`14
`
`15
`
`I6
`
`I1
`
`1B
`
`19
`2A
`
`2t
`22
`
`23
`
`24
`
`25
`
`IN THE UNTTED STATES
`FOR THE DTSTRICT
`
`D]STRTCT COURT
`OF DEI,AWÄRE
`
`TN RE COPAXONE 40 MG
`
`C.A. No.14-11?1-cMS
`
`CONSOLIDATED CASES
`
`(Consolidated)
`
`*********************************************
`CONFIDENTIAL _ ATTORNEYS' EYES ONLY
`VIDEOTAPED / REAITIMED DEPOSTTION OF
`.]ERRY S. WOTINSKY, M.D.
`FEBRUARY 75, 2076
`**************************
`
`TNDEX
`
`APPEARANCES
`
`WITNESS:
`
`JERRY S. I{OI,INSKY, M.D.
`
`3
`
`PAGE
`
`3
`
`EXAMINATTON BY MS. BRENNER_LEIFER... 12
`
`EXÄMINAT]ON BY MR
`EXÄMTNATION BY MR
`
`ANS?AETT
`
`BENNETT
`
`CHÄNGES AND STGNATI]RE
`
`REPORTER' S CERT]FICATE
`
`220
`241
`
`241
`
`248
`
`I 2 3 4 5 6 '
`
`t B 9
`
`10
`
`11
`
`72
`
`13
`
`74
`
`15
`
`L6
`t1
`18
`
`T9
`
`20
`
`27
`
`22
`23
`
`24
`
`2t)
`
`1 (Pages
`The Little Reporting Company
`(646 ) 650-5055 | www. fittlereporting.
`
`com
`
`1to4)
`
`Lorie L. Marchant, CSR #10523, RMR, CRR, CCRR,
`
`EXHIBIT 1140
`
`WTIIESS: Ar¡ creen, fit.D.
`CASE: Mylanv.Yeda
`CASE NO.: lPR20l5¡06¿3
`DATE: Wednesday, April 06, 2016
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 1
`
`

`
`CONFIDENTIAL - ATTORNEYS I EYES ONLY
`
`6
`
`B
`
`INDEX
`EXHIBITS
`VIDEOTAPED / REALTIMED DEPOSITTON OF
`JERRY S. VüOLTNSKY, M.D.
`TEBRU.ARY 1-5, 201-6
`
`NUMBER
`EXHIBIT 1
`
`EXHIBTT 2
`
`EXHIB]T 3
`
`EXHÍBTT 4
`
`EXHIBIT 5
`
`PAGE
`
`15
`
`16
`
`35
`
`12
`
`83
`
`DESCRIPT]ON
`Subpoena to Testify at a
`Dêposition in a Civil
`Action for Jerry W,
`t{o1insky, M.D., 4 pages
`subpoena to Produce
`Docments, Information, or
`Objects or lo Permit
`Tnspection of Premises in
`a civil AcLion fo¡ Jerry
`W. !ùolinsky, M.D., with
`attacÌûnent, 6 paqes
`curriculum Vitae of Jerry
`s. !ùolinsky, M.D., dated
`1-18-2016, 64 pages
`Exhlbit B-1, work Order
`#1, Bates UTHealth 0002863
`(Draft) MSRD article
`ritled
`"cLAclER: An
`open-1abef , randomizêd,
`multicênter study to
`assess the safety and
`of qlâtiræer
`tolerability
`acetâte 40 mg three-times
`weekly versus 20 mg daily
`in patiênts with
`relapsing-remitLing
`nultiple scle¡osis"' by
`Ílolinsky, Borresên,
`Dietrich, Wynn, Sidi,
`Steinerman, Knappertz,
`Kolodny, Bates
`UTHeaÌtho003045 - 3051
`
`12 3 4 5 6 '
`
`7
`
`B 9
`
`10
`
`11
`
`1-2
`
`74
`15
`
`1.6
`
`1'1
`
`1B
`
`L9
`
`2A
`2I
`
`22
`
`23
`24
`25
`
`INDEX
`EXHIBITS
`(continued)
`VIDEOTAPED / REAf,T]MED DEPOSTTTON OF
`JERRY S. WOLTNSKY, M.D.
`FEBRUARY 15, 201,6
`NOS. 1 - 9, 72 - 2l
`
`5
`
`APPEARANCES
`( Continued )
`COIINSET, FOR DEFENDÄNT A¡4NE.A.], PHå.RMACEUT ] CAJ,S
`
`Mr. Christopher S, Kroon
`DUÄNE MORRIS, ],1,P
`100 Hiqh Street. Suite 2400
`Boston, Massachusetts 42774-1124
`Phone: 857.488.4200
`cskroonGduanemorris. com
`COUNSEI, FOR DEFENDANTS SANDOZ, INC. and
`MOMENTA PHARMACEUTICALS, INC. :
`Mr. christopher P. Gafligan
`RAKOCZY MOLTNO, \4AZZACHT, SlfllK, L],P
`6 t{est Hubb'ard Street, suite 500
`Chicago, Illinois
`60654
`Phone: 312.222.'1 543
`cgalf iqan.armslegal . com
`COUNSEI FOR DEFENDANT DRL DEFENDANTS:
`Mr. Hank Heckel (Present via Telephone)
`BUDD LARNER/ P.C.
`150 John F. Kennedy Parkway
`short Hills, New Jersey 01018-2'703
`Phone: 973.315.4430
`hheckelGbuddlarner. com
`
`VIDEOGRAPHER:
`Mr. Doug Overstreet
`
`COURT REPORTER:
`Ms. Pat English-Arredondo,
`CSR, RMR, CRR, CLR
`
`'l
`
`TNDEX
`NXHTBITS
`(continued)
`VIDEOTAPED / REAI,TIMED DEPOSITION OF
`JERRY S. WO],INSKY, M.D.
`FEBRUÆY 1-5 , 2476
`
`PÀGE
`
`a4
`
`4 5 6 '
`
`7I 9
`
`10
`
`11
`
`1,2
`13
`LA
`
`15
`
`L€,
`
`7'l
`
`1B
`
`19
`
`20
`
`2L
`22
`23
`24
`25
`
`NUMBER
`EXHIBIT 11
`EXHIBIT 12
`
`ÊXHTBTT 13
`
`EXHTBIT 14
`
`EXHTBIT 15
`
`DESCRI PT ION
`( Inadvertentf y skipped)
`study Protocol
`Clinical
`for "Controlled Study -
`Multipfe Sclerosis,
`"
`Study GA-MS-303/ Bates
`UTHeaÌthoO03053 - 3L42
`Health and Quality of
`Life outcomes article
`of a
`titled.
`"Validation
`generaf measure of
`treatment satisf action,
`the Treatment
`Satis faction
`for
`Questionnaire
`(TSQM), using
`Medication
`a nationaf panef study of
`chronic disease, " by
`Atkinson, Sinha, Hass,
`Þr^À:rñ^
`Rowland,Pagesl-13
`Clinical Study Report by
`Jerry Ì/ûolinsky, et af,
`Bates UTHeaftho004065 -
`4250
`chain of e-mai1s dated
`3-17-14 between Wolinsky
`and Vainstein; Re:
`Many
`,
`thanks, Bates
`UTHealth000093
`
`PAGE
`n/m
`L82
`
`186
`
`198
`
`245
`
`1 2 3 4 5 6 '
`
`7
`
`B 9
`
`10
`
`11
`
`12
`
`13
`
`L4
`
`15
`
`16
`It
`
`18
`I9
`
`20
`
`21
`22
`23
`24
`25
`
`86
`
`105
`
`118
`
`n/m
`
`NUMBER
`EXH]BIT 6
`
`EXHIBIT 7
`
`DESCRI PTION
`(Fina.I) MSRD alticÌe
`"GLACIER: h
`titled
`open-1abe1, randomized,
`mullicenter study to
`assess the safety and
`of g.latìramer
`tolerabiÌity
`acelate 40 mg three-times
`weekly versus 20 nq daily
`in patients with
`relapsing-remitting
`multiplê sclerosis," by
`I,üolinsky, Borresen,
`Dietrich, wynn, sidi,
`Steinermn, Knappertz,
`KoÌodny, 7 pages
`Supplemental Figure 1,
`
`Ed9có
`
`¿!
`
`-
`
`¿J
`
`EXHIBIT 8
`
`Chain of e-mails dated
`10-17 t'o 10-18-13 æong
`Wolinsky, Steinerman,
`Kolodny and Everts; Re:
`GßCIER investigator
`fetter, Bates
`UTHeaIth0000168 - 175
`chain of e-nails dâted
`9-12 to 9-17-13 anong
`wolinsky, Sidi, Kolodny
`and Nissim; Re: GI,-ACIER
`abstract for ÃN 2014
`(pIs review), Bates
`UTHealtho007817 - 818
`EXHIBIT 10 (Inadvertently skipped)
`
`EXH]BIT 9
`
`t 2 3 4 5 6 1 I 9
`
`10
`
`11
`
`12
`13
`
`I4
`
`15
`
`16
`
`1'7
`
`18
`
`19
`
`2A
`
`2I
`
`22
`
`23
`24
`25
`
`2 (Pages 5 to B)
`The Little Reporting Company
`(646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 2
`
`

`
`CONFIDENTIAL - ATTORNEYS ' EYES ONLY
`
`o
`
`10
`
`INDEX
`
`(continued)
`VIDEOTAPED / REALTIMED DEPOS]TION OF
`JERRY S. WO],TNSKY. M.D.
`FEBRUARY 15, 2016
`NOS.1-9,72-21
`
`NUMBER
`EXHTBIT 2O
`
`EXHIBIT 21
`
`PAGE
`?11
`
`2IB
`
`DESCRTPTION
`Chain of e-mails dated
`1-2'1 -1,5 among Wolinsky,
`Caxter and Barkeri Re:
`Your manuscript titled
`"Glacier, " Bates
`UTHea1tho000290
`
`Chain of e-maìls dated
`4-22 to 5-4-15 among
`Wolinsky, Carter,
`Steinernan, Knappertz;
`Re: Your submission, with
`attachment, Bates
`UTHea1tho00308 - 313
`
`1 2 3 4 5 6 '
`
`1
`
`I 9
`
`10
`
`11
`
`12
`13
`14
`15
`1,6
`1,1
`18
`\9
`20
`2I
`22
`23
`24
`25
`
`EXHIBITS
`INDEX
`( continued)
`VIDEOTÄPED / REAITIMED DEPOSITTON OF
`JERRY S. 9ÍOLTNSKY, M.D.
`FEBRUARY 15, 201.6
`NOS. 1 - 9, 72 - 21.
`
`NUMBER
`EXH]BIT 16
`
`EXHÎBIT 17
`
`EXHIBTT 18
`
`EXHIBTT 19
`
`DESCR]PTION
`titled
`Mêdscape a¡ticle
`"New clatiramer Dosing
`Conveniênt, Possib.ly
`Safer, in MS'r dated
`5-14-14 by Pauline
`-A¡derson, 3 pages
`E-nail dated 11-2L-L4 lo
`various people f¡om
`Michaêl Calter rith
`Chæeleon; Re: Glacier
`Manuscript Submission -
`Muftiple Sclerosis
`ilournal - Complete, with
`attachment, Bates
`UTHeaIth00 002 2 3
`Chain of e-mails dated
`12-9 to 12-10-14; Re:
`Glacier Manusc¡ipt
`Subnission - Multip.le
`Scferosis,Journal -
`Complete, with
`attachment, Bates
`UTHea1th0000231 - 233
`Cha-in of e-mails dated
`I2-9 to 1,2-25-14ì Rel
`Glacier Manuscllpt
`Subnisslon - Multiple
`Sclerosis Journal -
`Conplête, with
`attachñent, Bates
`UTHealtho000238 - 242
`
`PAGE
`2AA
`
`212
`
`2r3
`
`21-4
`
`11
`
`I2
`
`1 2aJ 4 5 6 1 B 9
`
`THE VIDEOGRAPFIER: We are on
`record February 15, 2016. It's
`9:13 a.m. Beginning of Tape l.
`Will counsel please identifr
`themselves for the record.
`MS. BRENNER-LEIFER: Elizabeth
`Brenner-Leifer from Rothwell Figg
`Emst & Manbeck representing
`defendants, the Synthon defendants and
`the Pfizer defendants.
`MR. POSTAL: Brett Postal also
`from the law firm of Rothwell Figg,
`also representing the Synthon and
`Pfizer defendants.
`MR. ANSTAETT: David Anstaett
`of Perkins Coie representing the Mylan
`defendants.
`MR. KROON: Christopher Kroon,
`Duane Morris, representing the Amneal
`defendants.
`CHRIS GAILIGAN: Chris Galligan
`from Rakoczy Molino Mazzochi Siwik
`representing Sairdoz and Momenta.
`MR. JENKINS: David Jenkins
`representing Dr. Wolinsky in his
`
`official capac\Íy as an employee of
`the University of Texas Health Science
`Center of Houston.
`MR. BENNETT: John Bennett on
`behalf of plaintiffs and the witness.
`With me is my colleague, Ken Mueller.
`THE VIDEOGRAPHER: The court
`reporter will now swear in the
`witness.
`THE REPORTER: Sir, will you
`raise your right hand to be
`administered the oath, please?
`JERRY S. WOLINSKY, M.D.,
`being called as a witness, and having been
`duly swom, testified as follows:
`THE V/ITNESS: I do.
`EXAMINATION
`BY MS. BRENNER-LEIFER:
`a. Good morning, Dr. Wolinsky.
`How are you today?
`A. Good.
`a. Have you ever been deposed
`before?
`A. Pardon?
`a. Have you ever been deposed
`3 (Pages 9 to 12)
`The Little Reporting Company
`(646) 650-5055 | www. littfereportinq.
`
`10
`11
`I2
`13
`74
`15
`76
`I1
`1B
`10
`20
`2L
`22
`
`24
`25
`
`com
`
`1 2 3 4 5 6 '
`
`t I 9
`
`10
`
`11
`
`L2
`
`13
`
`14
`
`15
`
`16
`
`1'7
`18
`
`19
`
`20
`
`21
`
`22
`
`24
`25
`
`1 2 aJ 4 5 6 1 B 9
`
`10
`11
`IZ
`13
`I4
`1q
`I6
`71
`1B
`19
`20
`2I
`22
`23
`24
`25
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 3
`
`

`
`CONFIDENTIAL - ATTORNBYS' EYES ONLY
`
`13
`
`I4
`
`before?
`A. I have.
`a. When were you deposed?
`A. Oh, I don't remember the dates.
`I try to avoid it whenever I can, so about
`five or six times over the 40-some years that
`I've been in this
`
`TTTIITTTTTTTTT
`
`15
`
`J
`
`t6
`
`4 (Pages 13 to 16)
`The Little Reporting Company
`(646) 650-5055 | www. l-ittlereporting. com
`
`1 2 3 4 5 6 1IT
`
`IIIIrIIT
`
`TIT
`
`TTTTI
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 4
`
`

`
`CONFIDENTIAL _ ATTORNEYS' EYES ONLY
`
`L1
`
`1B
`
`Tt
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`TTI
`
`ttII
`IrI
`TI
`
`TIIIIIIItII
`
`79
`
`20
`
`5 (Pages Ll to 20)
`The Littfe Reporting Company
`(646) 650-5055 | www. littlereporting.
`
`com
`
`T
`
`ITITtTIII
`
`I
`
`ITtIIItII
`
`IrTtrTItTIrIIrtI
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 5
`
`

`
`CONFIDENTIAL
`
`ATTORNEYS I EYES ONLY
`
`2T
`
`22
`
`ITTIT
`
`23
`
`24
`
`6 (Pages 2I
`The Little Reporting Company
`(646) 650-5055 | www. littlereportinq.
`
`com
`
`to 24)
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 6
`
`

`
`CONFIDENTTAL
`
`ATTORNEYS I EYES ONLY
`
`25
`
`26
`
`2B
`
`IT
`
`TTTTTIT
`
`ItttIII
`TIIIT
`TI
`
`2'7
`
`I !I
`
`The Little
`(646) 6s0-5055 I
`
`7 (Pages 25 to 28)
`Reporting Company
`www . littlereporting
`
`. com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 7
`
`

`
`CONFIDBNTIAL - ATTORNEYS' EYES ONLY
`
`29
`
`30
`
`!Tif
`
`31
`
`32
`
`TTI
`
`B (Pages 29 to 32)
`The Little Reporting Company
`(646) 650-5055 | www.littlereportinq.com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 8
`
`

`
`34
`
`CONFIDENTIAL - ATTORNEYS' EYES ONLY
`
`I!T ¡
`
`tTIII¡III
`
`IrIT
`TIrTIIII
`TIII
`
`33
`
`TI
`
`¡
`
`1 2 3 4 5 6
`
`'7
`
`35
`
`36
`a. And was it up-to-date when you
`printed it?
`A. It was up-to-date as it ever
`gets.
`a. What do you mean by that?
`A. One could spend their life on
`these documents if you're not carefi¡I.
`a. So you're a medical doctor. Is
`that correct?
`A. That's correct.
`a. And did you do a residency?
`A. I did.
`a. And what was your -- where did
`you do your residency?
`A. University of California
`San Francisco.
`a And what department?
`A. Neurology.
`a. Did you do any additional
`studies after that?
`A. Ididafellowship.
`a. Where?
`A. University of California
`San Francisco.
`a. Also neurology?
`9 (Pages 33 to 36)
`The Little Reporting Company
`(646 ) 650-5055 | www. llttlereporting.
`
`com
`
`B 9
`
`10
`11
`1_2
`13
`14
`15
`76
`1-1
`1B
`79
`20
`2I
`zz
`23
`24
`25
`
`w¿ls
`
`Exhibit No. 3.)
`a. (By Ms. Brenner-Leifer)
`Dr. Wolinsþ, Exhibit 3 was produced by the
`university; and can you identiff this
`document for me, please?
`A. This is my cuniculum vitae and
`printed --
`a. It's dated January 18,2016.
`Is that correct?
`A. That's when it was printed,
`yes.
`
`II
`TIItI
`TtT
`
`TtrTIITIrTIrTII
`
`15
`16
`I1
`1B
`79
`20
`2I
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`23
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`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 9
`
`

`
`CONFIDENTIAL
`
`ATTORNEYS I EYES ONLY
`
`3B
`
`On rhe next page you list your previous
`grants.
`
`Then beginning on Page 13 there
`is atitie caiied "Co-investigator." Is this
`section ofyour curriculum vitae up-to-date,
`do you think?
`A. I think so. It's possible --
`a. And is it accurate?
`A. There may be some inaccuracies
`in this document -
`a. Is there anything that comes to
`mind?
`A. -- but I have no idea where
`they are.
`a. Were you a principal
`investigator for the GLACIER study?
`A. Yes.
`a. I don't see the GLACIER study
`listed here. Could you double-check that for
`me, please?
`A. It's not listed because there
`was no grant.
`a. 'Why wasn't there a grant for
`GLACIER?
`MR. BENNETT: Objection,
`
`40
`
`1 2 3 4 5 6 7I 9
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`A. In experimental neuropathoiogy.
`a. And what does that mean,
`experimental neuropathology?
`A. Well, basically, that the
`research was done in ways that involved
`trying to understand pathologic change and
`the way those come about. It's a very broad
`designation. I specifìcally was studying the
`effects of viruses on the central nervous
`system.
`a. Are you board certified?
`A. I am.
`a Have you been board certified
`continuously in your career?
`A. I'm grandfathered in, and I've
`been continuously certified.
`a. Does that mean you don't have
`to take the exams for recertification?
`A. Those were -- those came into
`effect after I was originally certified.
`a. Lucþ for you.
`A. Yes.
`a. Could you tum to Page l0 of
`your curriculum vitae. At the bottom of the
`page you start listing yow current grants.
`
`39
`
`The LittIe
`(646) 650-5055 I
`
`10 (Pages 37 to 40)
`Reporting Company
`w\,vw . Iittlereporting
`
`. com
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`T 2aJ A 5 6 1 B 9
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 10
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`

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`CONFIDENTIAL - ATTORNEYS I EYES ONLY
`tII
`tt
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`47
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`42
`
`a. Why did - if you know, why
`'ur'ere you asked to be the primary investigator
`ifyou couldn't have an investigational site
`at the university?
`MR. BENNETT: Objection,
`foundation.
`A. It's hard for me to -- I can
`project what others were thinking, and I m
`sure a fair amor.rnt of that thinking was based
`on my expertise and involvement with the
`development of copolymer and COPAXONE over
`quite a long time.
`a. (By Ms.Brenner-Leifer) Were
`there no other investigators in the study
`that had such experience?
`A. No. There are few in existence
`with that experience.
`a Such as who?
`A. Pardon?
`a Who are you referring to that
`
`44
`
`the development rights for copolymer and were
`beginning to move that into the clinical
`trial arena. After the original studies of
`Bomstein.
`a Did you know Dr. Bomstein?
`A. Yes.
`
`!I
`
`6 7I 9
`
`10
`1l-
`L2
`
`1_3
`
`3.4
`15
`76
`77
`18
`19
`20
`2L
`22
`
`24
`25
`
`1 2 a 4 6IIITTIIII
`
`43
`
`have such level of experience with COPAXONE?
`A. Living? Probably no one else.
`Modestly. Perhaps Comi.
`a. Comi? C-O-M-I?
`A. C-O-M-I. In Milan. Although
`his history doesn't go back nearly as far.
`a. So when did you first get
`involved in working on COPAXONE?
`A. It would have been about 7974,
`
`'75.
`
`a And how did that come about?
`A. One of my mentors and
`colleagues was quite involved with early
`developmental work for one ofthe interferons
`and I suspect, on that basis and other
`reasons ofreputation and involvement, was
`sought out to help develop early funding to
`try to bring copolymer-l forward.
`a Do you mean to bring
`copolymer-l forward in the U.S. or in the
`whole world?
`A. In clinical t¡ials.
`a And when did you start working
`with Teva?
`A. When Teva assumed, I believe,
`
`1 a 3 4 q 6 1 8 9
`
`10
`11
`72
`t_3
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`18
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`21-
`22
`23
`24
`25
`
`LI (Pages 4L to 44)
`The Little Reportíng Company
`(646) 650-5055 | www.littlereportingi.com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 11
`
`

`
`CONFIDENTIAL
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`
`45
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`46
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`41
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`4B
`
`ITTTIITTTTTTT
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`72 (Pages 45
`The Little Reporting Company
`(646) 650-5055 | www. littlereporting.
`
`com
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`to 48)
`
`ITTttIIIT
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`III
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 12
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`CONFIDENTTAL _ ATTORNEYS' EYES ONLY
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`50
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`13 (Pages 49 to 52)
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`(646) 650-5055 I www. littlereporting.
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`com
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`The Little
`(646) 6so-5055 I
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`L4 (Pages 53 to 56)
`Reporting Company
`www . littlereporting.
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`com
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 14
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`CONFIDENTIAL
`
`ATTORNEYS' EYES ONLY
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`15 (Pages 51
`The Little Reporting Company
`(646 ) 650-5055 | www. littlereporting.
`
`com
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`to 60)
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 15
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`CONFIDENTIAL _ ATTORNEYS' EYES ONLY
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`6I
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`63
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`
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`
`com
`
`22
`23
`aA
`25
`
`you ever prescribe COPAXONE
`20 mg for use less than daily?
`A. Rarely.
`a Have you ever prescribed
`16 (Pages 6I to 64)
`The Little Reporting Company
`(646 ) 650-5055 | www. littlereporting.
`
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`CONFI DENT IAL
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`ATTORNEYS' EYES ONLY
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`65
`
`66
`
`6B
`
`Brenner-
`Have
`a.
`you heard ofthe term "key opinion leader"?
`A. Yes.
`a. What does that mean?
`A. I think that's used to refer to
`people who in their own community of practice
`are felt to be ones looked up to to help
`individual neurologists or physicians decide
`what to do because they acknowledge their
`experience and/or expertise.
`a Are you an opinion leader for
`COPAXONE?
`A. I think I'm an opinion leader
`for the held of
`sclerosis.
`
`II
`
`3 4 t
`
`r 6 1 B 9
`
`10
`11
`T2
`13
`14
`15
`76
`
`COPAXONE 20 mgs for use three times a week?
`A. Yes.
`a And when did you do that?
`A. I've been doing that for a
`number ofyears for patients who are doing
`extremely well on the drug but are having
`nouble with injection site problems.
`a. And did you do that prior to
`2005?
`A. Probably.
`Actually, I should correct
`myself. I'm sorry. You said three times a
`week. Alternate
`would be correct.
`
`61
`
`1 2 J 4
`
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`The Little Reporting Company
`(646) 650-5055 | www. fittfereporting.
`
`com
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`to 6B)
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 17
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`

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`-70
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`12
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`CONFIDENTIAL
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`
`69
`
`Do you i<now Dr. Omar Khan'/
`I do.
`A.
`What is his reputation in the
`a.
`field?
`A. I think his reputation is
`strong.
`a. And what is your opinion of
`him?
`A. I like Omar. We've known each
`other for a long time, and I think he's a
`very energetic and competent neurologist and
`MS expert.
`
`1I
`
`1B ( Pages 69
`The Little Reporting Company
`(646) 650-5055 | www. littlereporting.
`
`com
`
`to 12)
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 18
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`CONFIDENTIAL - ATTORNEYS I EYES ONLY
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`13
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`14
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`The Lit.tle Reporting Company
`(646) 650-5055 | www. littlereporting.
`
`com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 19
`
`

`
`CONFIDENTIAL - ATTORNEYS I EYES ONLY
`
`11
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`(646) 650-5055 | www. Ìittlereportinq
`
`. com
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 20
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`

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`81
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`82
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`(646) 650-505s I
`
`2L (Pages 81 to 84)
`Reporting Company
`wlvw . littlereporting
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`. com
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 21
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`

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`CONF]DENTIAL
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`B5
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`B6
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`The Little
`(646) 650-5055 I
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`22 (Pages 85 to BB)
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`www . littl-ereporting . com
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 22
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`92
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`(646) 650-5055 I www.littlereportingi.com
`
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`
`24 (Pages 93 to 96)
`The Littfe Reportinq Company
`(646) 650-5055 | www. littlereporting.
`
`com
`
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`(646) 6s0-5055 I
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`25 (Pages 91 to 100)
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`www. littlereporting.
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`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 25
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`

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`CONF] DENTIAL
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`The Littl-e Reporting Company
`(646) 650-5055 | www. Ìittlereporting.
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`com
`
`to 104 )
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 26
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`106
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`(646) 650-505s I
`
`21 (Pages 105 to 108)
`Reporting Company
`www . littlereporting
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`. com
`
`ITItITI¡IrITrIIIrTtIIIrTI
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 27
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`110
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`28 (Pages 109
`The Little Reporting Company
`(646) 650-5055 | www. littl-ereportinq. com
`
`to LL2)
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 28
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`
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`29 (Pages 113 to 116)
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`(646) 650-5055 | www.líttlereporting.com
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 29
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`www . littlereporting
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`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 30
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`

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`31 (Pages L27 to L24)
`The Little Reporting Company
`(646) 650-5055 | www. littfereporting.
`
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`CONFTDENTIAL _ ATTORNEYS' EYES ONLY
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`The Little Reporting Company
`(646) 650-5055 | www.littlereporting.com
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`(646) 650-5055 I
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`33 (Paqes I29 to I32)
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`(646) 650-s055 I
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`ww\r. littlereportinq
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`(646) 650-5055 I
`
`35 (Pages L31 to 140)
`Reporting Company
`ww\iv . I itt lereport ing . com
`
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`

`
`CONFI DENTIAL
`
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`
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`
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`36 (Pages L47 to I44)
`The Little Reporting Company
`(646) 650-5055 | www. litttereporting.
`
`com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 36
`
`

`
`CONFIDENTIAL _ ATTORNEYS f EYES ONLY
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`1-45
`
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`The Little Reporting Company
`(646) 650-5055 | www. littl-ereporting. com
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`r49
`
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`
`38 (Pages I49 to L52)
`The Little Reporting Company
`(646) 650-5055 I www. littlereporting.
`
`com
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`
`39 (Pages 153 to 156)
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`(646 ) 650-5055 I www. littlereport.ing.
`
`com
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`The Little Reporting Company
`(646) 650-5055 | www. litt.lereporting. com
`
`II
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 40
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`

`
`CONFIDENTIAL _ ATTORNEYS I EYES ONLY
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`r61
`
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`
`163
`
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`
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`
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`The Little Reporting Company
`(646) 650-5055 I www.tittlereportinq.com
`
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`
`a. Yes.
`A. Of course. Reviewed for
`preparation of the manuscript, in a
`subsequent talk. At different times.
`a. For the number of moderate and
`severe IRAEs, percent oftotal, I have a
`simple question for you.
`Why were the moderate and
`severe IRAEs grouped together?
`A. Because there were very few
`severe IRAEs.
`a. Why were the moderate and
`severe ISRs grouped together?
`A. Same reason. And the other
`part of the rationale was that those were
`likely to be more meaningful than holding all
`of the mild, moderate and severe IREs
`together as the only analysis.
`a. And that's true for both arms
`of the study, that there are very few IRAEs
`and ISRs?
`A. Yes.
`MR. BENNETT: Objection --
`sorry -- to the form ofthat question.
`a. @y Ms. Brenner-Leifer) And
`42 (Pages 165 to 168)
`The Little Reporting Company
`(646) 650-5055 | www.littlereporting.com
`
`1 2 3 4 5 6 1 B 9
`
`10
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`I2
`13
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`23
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`
`you
`to Exhibit 6,
`please? Page 373, Table 22
`A. I'm there.
`a. Have you reviewed this table
`before the deposition?
`A. Before the deposition?
`
`TTTTTT!
`
`20
`2L
`22
`23
`24
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`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 42
`
`

`
`CONFIDENTIAL - ATTORNEYS I EYES ONLY
`
`769
`
`1_'7 0
`
`all patients available.
`On the other hand, ifyou look
`at the proportion ofthose who reported any
`injections, of those injections which were
`moderate or severe, there were
`proportionately more reported on GA20 than on
`G440. And that's what the table shows.
`a. Do you know how those numbers
`break down between those persons with
`moderate and those persons with severe?
`A. I don't have that data in front
`of me.
`a. Did you ever look at that data?
`A. r did.
`a. And do you recall how those
`numbers broke down between moderate and
`severe?
`A. As I said, there were
`considerably fewer severe than there were
`moderate.
`a. And do you recall how the
`number of severe broke down between the two
`arms of the study?
`A. How -- no.
`a. Do you remember how the number
`
`I12
`
`1 2 3 4
`
`6 1I 9
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`11
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`27
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`24
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`
`that is true for both arms of the study, that
`there are very few moderate and severe IRAEs
`and ISRs?
`A. The numbers are provided in the
`table. In terms of relative numbers, there
`are differences.
`There are differences, one, for
`a relatively simple reason in my mind, and
`that is if one assumes that any particular
`injection could be associated with a mild,
`moderate or severe reaction, then because
`there were more injections in the group on 20
`milligrams, there had to be more reports of
`those; and because there were less injections
`in the 40, there had to be relatively less
`reported injections across all three as any
`injection that caused reaction would be
`reported.
`In fact, proportionately per
`injection, a back-of-the-envelope calculation
`says that essentially equal proportions of
`patients reported something for about halfof
`their injections overall.
`That doesn't mean 50 percent of
`each patient. It's means in aggregate across
`
`IlI
`of moderate ISRs and IRAEs broke down between
`the two arms of the study?
`A. No. I don't have those figures
`in front of me.
`a But you agree that in both
`arms, the 40 mg arm and the 20 mg arm, there
`were very few severe IRAEs and very few
`severe ISRs, correct?
`MR. BENNETT: Objection to the
`form.
`A. There were
`
`,
`
`43 (Pages 169 to L12)
`The Litt.le Reporting Company
`(646) 650-5055 | www. littlereporting.
`
`com
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 43
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`

`
`CONFIDENTIAL
`
`ATTORNEYS' EYES ONLY
`
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`44 (Pages 173 to I16)
`The Little Reporting Company
`(646) 650-5055 | www. tittlereporting.
`
`com
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 44
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`

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`CONFIDENTIAL - ATTORNEYS I EYES ONLY
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`45 (Pages 171 Lo 180)
`The Little Reporting Company
`(646) 650-5055 | www.litt.fereporting.com
`
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 45
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`

`
`CONFIDENTIAL
`
`ATTORNEYS' EYES ONLY
`
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`46 (Pages 181 to 184)
`The Little Reporting Company
`(646) 650-5055 | www. fittlereporting.
`
`com
`
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`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 46
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`

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`CONFIDENTTAL - ATTORNEYS' EYES ONLY
`
`185
`
`186
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`41 (Pages 185 to 188)
`The Little Reporting Company
`(646) 650-5055 I www. l-ittlereporting'. com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 47
`
`

`
`CONFIDENT]AL
`
`ATTORNEYS I EYES ONLY
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`48 (Pages 189 to L92)
`The Little Reporting Company
`(646) 650-5055 | www. littlereporting.
`
`com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 48
`
`

`
`CONFIDENTIAL ATTORNEYS ' EYES ONLY
`
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`(646) 650-5055 | www.littlereporting.com
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 49
`
`

`
`CONFI DENTTAL
`
`ATTORNEYS I EYES ONLY
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`(646) 650-5055 | www. tittlereporting.
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 50
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`The Little Reporting Company
`(646) 650-5055 | www.littlereportingi.com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 51
`
`

`
`CONF]DENTIAL - ATTORNBYS I EYES ONLY
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`(646 ) 650-5055 | www. littlereport
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 52
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`

`
`CONFIDENTIAL - ATTORNEYS I EYES ONLY
`
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`53 (Pages 209 to 2L2)
`The Little Reporting Company
`(646) 650-5055 | www. littlereporting.
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`com
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`MYLAN PHARMS. INC. EXHIBIT 1140 Page 53
`
`

`
`CONF]DENT]AL
`
`ATTORNEYS I EYES ONLY
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`
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`
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`(646) 650-5055 I
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`54 (Pages 2L3 to 216)
`Reporting Company
`\ivww. littlereporting
`
`. com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 54
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`

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`CONFIDENTIAL ATTORNEYS' EYES ONLY
`
`271
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`55 (Pages 271 to 220)
`The Little Reporting Company
`(646) 650-5055 | www.littlereporting.com
`
`MYLAN PHARMS. INC. EXHIBIT 1140 Page 55
`
`

`
`CONFIDENTTAL - ATTORNEYS I EYES ONLY
`
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`a. I take
`morning that you've been treating patients
`with glatiramer acetate for a iong time.
`Correct?
`A. Correct.
`O. And you said that at least as
`of2005, you were occasionally prescribing
`COPAXONE 20 milligram every other day to some
`patients who were having particular problems
`with injection-site reactions. Correct?
`A. Correct.
`MR. BENNETT: Objection.
`a. (By Mr.Anstaett) And I take
`
`224
`
`counseling them to inject every other day
`rather than daily they might experience fewer
`injection site reactions or less lipoatrophy?
`MR. BENNETT: Objection.
`A. At least they would be able to
`continue on the drug by virtue of injecting
`themselves less, less often.
`a
`(By Mr. Anstaett) And you
`certainly wouldn't have encouraged them to
`inject less frequently