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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·
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`·1· · · · · · IN THE UNITED STATES DISTRICT COURT
`· · · · · · · · ·FOR THE DISTRICT OF DELAWARE
`·2· ·- - - - - - - - - - - - - - -x
`· · ·PFIZER INC. and UCB PHARMA· ·:
`·3· ·GMBH· · · · · · · · · · · · ·: C. A. No.
`· · · · · · · · · · · · · · · · · : 1:15-cv-000079(GMS)
`·4· · · · · · · · Plaintiffs,· · ·: Consolidated
`· · ·v.· · · · · · · · · · · · · ·:
`·5· · · · · · · · · · · · · · · · :
`· · ·MYLAN PHARMACEUTICALS INC., :
`·6· · · · · · · · · · · · · · · · :
`· · · · · · · · · Defendant.· · · :
`·7· ·- - - - - - - - - - - - - - -x
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`·8
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`·9· · · · · · · · · · ***CONFIDENTIAL***
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`10
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`11· · · · · · ·Oral deposition of LEONARD J. CHYALL,
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`12· ·Ph.D. taken pursuant to notice, held on Tuesday,
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`13· ·August 23, 2016, at the office of Kilpatrick
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`14· ·Townsend & Stockton, 1114 Avenue of the Americas,
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`15· ·New York, New York, commencing at 9:01 a.m. before
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`16· ·Jamie I. Moskowitz, RPR, CRR, a Registered
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`17· ·Professional Reporter and Notary Public.
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`18· · · · · · · · · · · ·*· ·*· ·*
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PROTECTIVE ORDER MATERIAL
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075A - Page 1
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·A P P E A R A N C E S:
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`·2· ·KILPATRICK TOWNSEND & STOCKTON LLP
`· · ·BY:· D. CLAY HOLLOWAY, ESQUIRE
`·3· ·1100 Peachtree Street Northeast, Suite 2800
`· · ·Atlanta, Georgia· 30309
`·4· ·404.815.6500
`· · ·cholloway@kilpatricktownsend.com
`·5· ·Counsel for the Plaintiff
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`·6
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`·7· ·WHITE & CASE LLP
`· · ·BY:· SILVIA MEDINA, ESQUIRE
`·8· ·BY:· ROBERT E. COUNIHAN, ESQUIRE
`· · ·1155 Avenue of the Americas
`·9· ·New York, New York 10036
`· · ·212.819.8255
`10· ·silvia.medina@whitecase.com
`· · ·rcounihan@whitecase.com
`11· ·Counsel for the Defendant
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PROTECTIVE ORDER MATERIAL
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075A - Page 2
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· · · · · · · · · · ·I· N· D· E X
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`·2· ·Testimony of:· LEONARD J. CHYALL, Ph.D.
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`·3
`· · ·By Mr. Holloway................5
`·4· · · · · · · · · · · · -· ·-· ·-
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`·5· · · · · · · · · E· X· H· I· B· I· T S
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`·6· · · · · · · · · · · · -· ·-· ·-
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`·7· ·EXHIBIT NUMBER· · DESCRIPTION· · · · · · · · · ·PAGE
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`·8· ·Exhibit 1· · · Expert Report of Leonard
`· · · · · · · · · · J. Chyall, Ph.D. Regarding
`·9· · · · · · · · · Validity
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`10· ·Exhibit 1A· · ·Exhibit A
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`11
`· · ·Exhibit 2· · · Rebuttal Expert Report of
`12· · · · · · · · · Leonard J. Chyall, Ph.D.
`· · · · · · · · · · Regarding Validity
`13
`· · ·Exhibit 2A· · ·Exhibit B
`14
`· · ·Exhibit 3· · · Opening Expert Report of
`15· · · · · · · · · David R. Janero, Ph.D.
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`16· ·Exhibit 4· · · United States Patent No.:
`· · · · · · · · · · US 6,858,650 B1
`17
`· · ·Exhibit 5· · · Document entitled
`18· · · · · · · · · Schwarz Pharma AG
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`19· ·Exhibit 6· · · E-mail to Arth from Meese
`· · · · · · · · · · dated 8/3/99
`20
`· · ·Exhibit 7· · · Document entitled
`21· · · · · · · · · Analytical Summary
`· · · · · · · · · · SPM 909 (007)
`22
`· · ·Exhibit 8· · · Gould paper
`23
`· · ·Exhibit 9· · · Document entitled
`24· · · · · · · · · Salt selection for basic drugs
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`25
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PROTECTIVE ORDER MATERIAL
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075A - Page 3
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·EXHIBIT NUMBER· · DESCRIPTION· · · · · · · · · ·PAGE
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`·2· ·Exhibit 10· · ·Document entitled
`· · · · · · · · · · International Application
`·3· · · · · · · · · Published Under the Patent
`· · · · · · · · · · Cooperation Treaty (PCT)
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`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· · · · · · · · ·LEONARD CHYALL, Ph.D., after having
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`·2· · · · been first duly sworn, was examined and
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`·3· · · · testified as follows:
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`·4· ·EXAMINATION BY MR. HOLLOWAY:
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`·5· · · · Q· · · · Dr. Chyall, could you please state
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`·6· ·your name for the record?
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`·7· · · · A· · · · Leonard J. Chyall.
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`·8· · · · Q· · · · And you have been retained as an
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`·9· ·expert witness in this case; is that correct?
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`10· · · · A· · · · Yes, I have.
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`11· · · · Q· · · · Were you retained by White & Case or
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`12· ·by UCB Pharma and/or Pfizer?
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`13· · · · A· · · · I don't remember from the engagement
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`14· ·letter.
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`15· · · · Q· · · · And you provided two reports in this
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`16· ·case, correct?
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`17· · · · A· · · · Yes, sir.
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`18· · · · Q· · · · And when I say "this case," I'm
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`19· ·talking about the case that Pfizer and UCB Pharma
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`20· ·have brought against Mylan, as opposed to the case
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`21· ·where you previously testified before Judge Sleet
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`22· ·concerning fesoterodine; is that fair?
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`23· · · · A· · · · Yes.
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`24· · · · Q· · · · If at any point in time before I hand
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`25· ·you your reports if you'd like to see them, just let
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`YVer1f
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`PROTECTIVE ORDER MATERIAL
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·me know and I will hand them to you, okay?
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`·2· · · · A· · · · Okay.
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`·3· · · · Q· · · · About how many times -- and I don't
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`·4· ·mean to exclude -- let me just start over.
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`·5· · · · · · · · ·How many times including times where
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`·6· ·you have testified have you been retained as an
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`·7· ·expert in the pharmaceutical field?
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`·8· · · · A· · · · With respect to -- I have to think a
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`·9· ·little carefully because I just don't know offhand.
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`10· ·I personally have worked on about 35 projects in the
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`11· ·capacity of an independent consultant.· Nearly all
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`12· ·of them relate to pharmaceuticals.
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`13· · · · Q· · · · And these projects, are you talking
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`14· ·about everything you do in your profession, or are
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`15· ·you limiting it -- are you limiting that to
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`16· ·consulting for attorneys or companies in the patent
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`17· ·context?
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`18· · · · A· · · · The 35 would be everything.· It would
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`19· ·be a smaller number for providing consulting to
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`20· ·attorneys.· But the bulk of the work that I'm doing
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`21· ·now is assisting attorneys understand scientific
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`22· ·matters.· With respect to expert witnessing, I
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`23· ·average about two projects a year, and I probably
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`24· ·have the best numbers there because I know from my
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`25· ·CV where I'm required to list expert testimony.· In
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·any given moments my CV usually contains eight
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`·2· ·matters, so it works out to be about two a year.
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`·3· · · · Q· · · · And do -- I'm looking for a proportion
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`·4· ·of your time spent in a given year.· What's the
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`·5· ·proportion of time spent where you are working with
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`·6· ·attorneys providing technical consulting as you just
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`·7· ·explained versus the other work that you're doing in
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`·8· ·your independent consultancy?
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`·9· · · · A· · · · It's going to vary depending on the
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`10· ·year.· At present more than half.
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`11· · · · Q· · · · And about how long has that been the
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`12· ·case?
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`13· · · · A· · · · For the past two or three years, I
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`14· ·believe.
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`15· · · · Q· · · · What kind of work do you do when
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`16· ·you're not providing assistance to attorneys on
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`17· ·legal matters?
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`18· · · · A· · · · One example that I worked on involved
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`19· ·helping a company troubleshoot an issue with their
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`20· ·manufacturing process.
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`21· · · · Q· · · · And how did you go about helping -- if
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`22· ·the details you can't share with me because they're
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`23· ·confidential or whatever, I don't necessarily want
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`24· ·those, or if they're covered by a privilege that's
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`25· ·beyond what your current counsel has with you.· I'm
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·just trying to get a understanding of the nature of
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`·2· ·the type of work that you would do.
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`·3· · · · A· · · · That's understood.· That's fair.
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`·4· ·There was some product that was not passing their
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`·5· ·quality specification.· And the product had to be --
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`·6· ·could not be sold because of that.· And I was tasked
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`·7· ·with trying to understand why that was so from a
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`·8· ·chemistry perspective.
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`·9· · · · Q· · · · Was this a pharmaceutical product?
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`10· · · · A· · · · It was a personal care product.
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`11· · · · Q· · · · Personal care product.· So was it
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`12· ·something that had to go through any type of FDA
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`13· ·clearance in order to be sold or marketed?
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`14· · · · A· · · · I believe so.· I wasn't involved in
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`15· ·that aspect of it, but I believe that product would
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`16· ·fall under the umbrella of the FDA.
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`17· · · · Q· · · · Was the product already being sold and
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`18· ·then you were helping figure out why it was failing
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`19· ·in the market, or were they trying to get the
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`20· ·product to market and having difficulties doing
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`21· ·that?
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`22· · · · A· · · · It was a commercial product that could
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`23· ·not be released because it had failed an internal
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`24· ·test.
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`25· · · · Q· · · · Okay.· And what was the nature of the
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`www.huseby.comwww.huseby.com
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·science that you worked on in assisting that
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`·2· ·company?
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`·3· · · · A· · · · Related to organic chemistry.· It was
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`·4· ·an aspect of organic chemistry, which is my area of
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`·5· ·expertise.
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`·6· · · · Q· · · · And was it part of the manufacturing
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`·7· ·process, the chemistry, or would it have to do with
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`·8· ·the specific organic molecules in the product that
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`·9· ·were degrading?
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`10· · · · A· · · · I believe that it was due to both.
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`11· · · · Q· · · · In the cases that you have consulted
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`12· ·with -- in the projects where you have consulted
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`13· ·with attorneys, how many of those have related to
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`14· ·the chemistry involving the salts of a
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`15· ·pharmaceutical compound?
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`16· · · · A· · · · Offhand roughly half a dozen, maybe
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`17· ·more.
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`18· · · · Q· · · · Before you started in your
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`19· ·consultancy, did you have any specific experience in
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`20· ·salt chemistry or organic salt chemistry?
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`21· · · · A· · · · Yes.
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`22· · · · Q· · · · And could you describe the nature of
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`23· ·that previous experience?
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`24· · · · A· · · · From the year 2000 until I founded my
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`25· ·own company in 2011, I worked for an expert contract
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·research lab called SSCI.· That lab was in the
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`·2· ·business of conducting salt screens and salt
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`·3· ·selection work for the pharmaceutical industry.· So
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`·4· ·in my capacity as an employee of that company, I did
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`·5· ·a lot of salt screening.
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`·6· · · · Q· · · · And so you were there 11 years?
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`·7· · · · A· · · · I believe so, yes.
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`·8· · · · Q· · · · When you started at -- was it SSCI?
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`·9· · · · A· · · · Yes.
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`10· · · · Q· · · · When you started at SSCI, what was
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`11· ·your job title?
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`12· · · · A· · · · Research chemist, I believe, something
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`13· ·like that.
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`14· · · · Q· · · · What did you do on a daily basis?
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`15· · · · A· · · · It definitely varied.· Because of the
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`16· ·nature of contract research, I had a variety of
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`17· ·different responsibilities.· Some of those
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`18· ·responsibilities included working on protocol
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`19· ·projects on behalf of clients.· I was also involved
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`20· ·in some research and development for the company.
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`21· ·So I didn't really have a routine day there.
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`22· · · · Q· · · · You have talked -- I think you have
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`23· ·said twice now that SSCI was in the contract
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`24· ·chemistry work.· What do you mean by that?
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`25· · · · A· · · · SSCI would be hired by other companies
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 11
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`·1· ·to carry out one aspect of the drug development
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`·2· ·process for that company.· SSCI had a great deal of
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`·3· ·expertise in pharmaceutical solids.· So that type of
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`·4· ·research would be contracted to SSCI to conduct.
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`·5· · · · Q· · · · So -- and part of that work I
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`·6· ·understand would be helping the company that might
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`·7· ·have an active pharmaceutical ingredient to find a
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`·8· ·viable salt so that it could be turned into a
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`·9· ·formulation; is that correct?
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`10· · · · A· · · · That was one aspect of our service
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`11· ·offerings, yes.
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`12· · · · Q· · · · In your 11 years there did you have
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`13· ·experience in that specific aspect of it?
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`14· · · · A· · · · Absolutely, yes.
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`15· · · · Q· · · · So describe the typical case for me
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`16· ·where a pharmaceutical company that's not SSCI comes
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`17· ·to SSCI and says, We need help.
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`18· · · · A· · · · The business model of SSCI was not
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`19· ·cookie cutter in that we had a typical service
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`20· ·offering.· So the research protocols were highly
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`21· ·tailored towards particular clients, and the
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`22· ·particular molecule, and the specific needs that
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`23· ·that client needs be addressed.
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`24· · · · Q· · · · So when a third-party pharmaceutical
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`25· ·company first contacts SSCI, it's not, We need help
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`·1· ·finding a salt?· Is it more specific than that when
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`·2· ·they first contact you?
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`·3· · · · A· · · · Again, it is going to depend.· There
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`·4· ·could be very specific tasks that the pharmaceutical
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`·5· ·company might ask us to do, but some projects were
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`·6· ·extraordinarily general in that -- one example would
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`·7· ·be we have -- we have a very promising, active
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`·8· ·moiety.· Moiety is a term of the art that means a
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`·9· ·group, active group.· We need to render this active
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`10· ·group into a form that's going to be
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`11· ·commercializable.· And we don't know what it is yet.
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`12· ·Can you help us figure that out?
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`13· · · · · · · · ·So salt selection might be on the
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`14· ·list.· Crystal form screening might be on the list.
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`15· ·So those projects tend to be more general than, say,
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`16· ·a project that was highly focused on one particular
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`17· ·thing such as I have an amorphous compound and I
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`18· ·need to crystalize it.· SSCI, would you please help
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`19· ·me crystalize it?· That would be another example of
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`20· ·a project.
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`21· · · · Q· · · · You said crystal form analysis.· Is
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`22· ·that looking for different polymorphs of a crystal?
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`23· · · · A· · · · No.· That project that I -- that
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`24· ·hypothetical project I just mentioned would have
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`25· ·involved trying to render something that wasn't
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 13
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`·1· ·crystalline into a crystalline form.
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`·2· · · · Q· · · · So is that the same thing as when you
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`·3· ·just described having an amorphous compound and
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`·4· ·wanting it made crystalline?
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`·5· · · · A· · · · Correct.· That's one type of research
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`·6· ·project that I worked on.· And you mentioned
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`·7· ·polymorph screens.· That's another type of research
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`·8· ·project that I'm familiar with.
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`·9· · · · Q· · · · But the polymorph screens, that wasn't
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`10· ·what you were referring to when you said, they might
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`11· ·want us to do some crystalline form analysis?
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`12· · · · A· · · · Correct.
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`13· · · · Q· · · · In your own consultancy that you just
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`14· ·started, do you do any salt screen or salt selection
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`15· ·work?
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`16· · · · A· · · · Yes.
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`17· · · · Q· · · · And about how many of those projects
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`18· ·has your firm undertaken in the last five years?
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`19· · · · A· · · · Two, one or two.
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`20· · · · Q· · · · One or two, okay.· And who are they
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`21· ·for?
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`22· · · · A· · · · I'm not at liberty to say, but in
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`23· ·general they are for pharmaceutical companies.
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`24· · · · Q· · · · Were either one of them for UCB?
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`25· · · · · · · · ·MS. MEDINA:· Objection.
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`www.huseby.comwww.huseby.com
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 14
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`·1· · · · · · · · ·THE WITNESS:· I'm not at liberty to
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`·2· · · · say.
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`·3· ·BY MR. HOLLOWAY:
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`·4· · · · Q· · · · So if they were for UCB or Pfizer, I
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`·5· ·would get to know that?
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`·6· · · · · · · · ·MR. COUNIHAN:· Are you talking about
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`·7· · · · privileged information or are you talking about
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`·8· · · · research?
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`·9· · · · · · · · ·MR. HOLLOWAY:· I will tell you that
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`10· · · · this is as far as the question goes.· I'm not
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`11· · · · going to ask any details about what it is or
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`12· · · · anything like that.· I would just like to know
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`13· · · · if either of the salt screening projects he's
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`14· · · · done at his own company have been for UCB or
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`15· · · · Pfizer.
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`16· · · · · · · · ·MR. COUNIHAN:· Yes.· So I'll just
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`17· · · · instruct the witness that he can answer yes or
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`18· · · · no as long as it doesn't reveal any privileged
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`19· · · · information.
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`20· · · · · · · · ·I also -- just out of an abundance of
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`21· · · · caution, I'm not sure whether stuff that
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`22· · · · Dr. Chyall has talked about is confidential,
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`23· · · · but I do want to mark this transcript
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`24· · · · confidential at this point, even though there
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`25· · · · are some automatic provisions in the protective
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 15
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`·1· · · · order you're well aware of regarding
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`·2· · · · confidentiality.
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`·3· · · · · · · · ·So with that instruction, Dr. Chyall,
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`·4· · · · you can answer yes or no.
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`·5· ·BY MR. HOLLOWAY:
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`·6· · · · Q· · · · So I'll go back to it.· Do you
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`·7· ·understand what he's saying you to?
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`·8· · · · A· · · · Yes.
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`·9· · · ·
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`19· · · · Q· · · · So I'm going to leave that, so don't
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`20· ·mistakenly think that my questions have to do with
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`21· ·that project, okay?
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`22· · · · A· · · · Okay.
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`23· · · · Q· · · · So actually I'll make it even easier.
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`24· ·Let's go back to SSCI.
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`25· · · · A· · · · Okay.
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 16
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`·1· · · · Q· · · · Did you ever have an experience at
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`·2· ·SSCI where a pharmaceutical company came in and
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`·3· ·said, we have an active pharmaceutical ingredient;
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`·4· ·we'd like you to find a salt for it?
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`·5· · · · A· · · · Yes.
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`·6· · · · Q· · · · And could you describe for me how that
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`·7· ·process would have worked in your time at SSCI?
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`·8· · · · A· · · · The client would have worked with a
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`·9· ·director of the company to understand specific
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`10· ·issues, in particular the reasons why a salt screen
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`11· ·was being requested.· And based on our expertise if
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`12· ·that basis was reasonable scientifically, then we
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`13· ·would design protocol work that was tailored to that
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`14· ·particular drug.
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`15· · · · Q· · · · When you say to determine if there was
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`16· ·a basis scientifically for going down the salt
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`17· ·screen process, what would be an example of a
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`18· ·nonscientifically sound basis for going through salt
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`19· ·screening?
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`20· · · · A· · · · If the client had generated -- as one
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`21· ·example, if the client had generated a solid that
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`22· ·was amorphous and they felt like they needed the
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`23· ·salt because the amorphous solid wasn't crystalline,
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`24· ·we -- SSCI would say that perhaps the issue is just
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`25· ·that you haven't identified the right conditions to
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075A - Page 16
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 17
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`·1· ·render this amorphous solid into a crystalline
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`·2· ·solid.· So perhaps it would make sense to make sure
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`·3· ·that you're not excluding the drug in its present
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`·4· ·form just based on the fact that you cannot render
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`·5· ·it crystalline.· Perhaps we should try that first.
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`·6· · · · Q· · · · And so assuming that the director at
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`·7· ·SSCI found that there was a scientifically valid
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`·8· ·reason for proceeding down salt screening, how would
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`·9· ·that have played out internally at SSCI going
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`10· ·forward?
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`11· · · · A· · · · We would have asked the company to
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`12· ·provide us with as much information as possible
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`13· ·concerning the scientific characterization that had
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`14· ·been done on that particular drug.· We would be
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`15· ·interested in a whole variety of properties of the
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`16· ·drug substance.
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`17· · · · · · · · ·And then based on the structure and
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`18· ·some other issues that would have been uncovered and
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`19· ·a review of that body of work, directors of the
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`20· ·company would have designed a protocol that laid out
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`21· ·a proposed research program to identify salt forms.
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`22· ·And costs and timing and things like that would have
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`23· ·been included in the protocol.
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`24· · · · Q· · · · What are some of the properties of the
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`25· ·pharmaceutical compound that would have been brought
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 18
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`·1· ·to SSCI, are the properties that you were
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`·2· ·referencing in the body of work that would need to
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`·3· ·be reviewed?
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`·4· · · · A· · · · Well, certainly the structure is
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`·5· ·important.
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`·6· · · · Q· · · · When you say the structure, you mean
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`·7· ·the chemical structure of the molecule?
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`·8· · · · A· · · · Correct, the manner in which the atoms
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`·9· ·are bonded together.· So the solubility of the drug
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`10· ·substance would have been of interest.· We would
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`11· ·have been interested in the types of functional
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`12· ·groups that are present in the molecule.· And I
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`13· ·guess that's part of the structure.· But we would
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`14· ·have had an eye toward the properties with respect
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`15· ·to acid-based chemistry.
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`16· · · · Q· · · · By that you mean like PKA or PKB
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`17· ·values?
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`18· · · · A· · · · Yes.· And any kind of characterization
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`19· ·of the material is the starting point, a liquid or a
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`20· ·solid.· That would have been important.
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`21· · · · · · · · ·Also, any kind of information from the
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`22· ·sponsor of this work with respect to pharmacokinetic
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`23· ·issues, will this be an oral tablet, will it be
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`24· ·administered transdermally, those types of things.
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`25· ·If there's any information that those involved in
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075A - Page 18
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 19
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`·1· ·the pharmacokinetic aspects of the drug could
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`·2· ·provide to us that would guide us in selecting
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`·3· ·starting points, then we would do that.
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`·4· · · · Q· · · · In your experience at SSCI, was it
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`·5· ·more common for a pharmaceutical company to
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`·6· ·investigate oral dosage forms or transdermal dosage
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`·7· ·forms?
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`·8· · · · A· · · · We did a lot of work for different
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`·9· ·delivery mechanisms other than oral.· Certainly we
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`10· ·did a lot of work for all dosage forms, but a lot of
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`11· ·the work we did was indeed directed toward some
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`12· ·rather scientifically interesting delivery devices.
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`13· ·We did work on pharmaceutical stents, lozenges, as
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`14· ·well as transdermal work.· So I have seen a lot of
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`15· ·different types of drugs.
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`16· · · · Q· · · · In the salt screens that you worked on
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`17· ·at SSCI, what was the proportion of oral dosage
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`18· ·forms to the rest?
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`19· · · · A· · · · Certainly more than half.· I'm not
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`20· ·sure exactly.
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`21· · · · Q· · · · You mentioned characterization of the
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`22· ·material, is it a liquid or a solid.· You're
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`23· ·referring there to the starting material that's the
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`24· ·active pharmaceutical moiety that the pharmaceutical
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`25· ·company would have brought to you?
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`www.huseby.comwww.huseby.com
`Huseby, Inc.· Regional CentersHuseby, Inc.· Regional Centers
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`800-333-2082800-333-2082
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`Charlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San FranciscoCharlotte ~ Atlanta ~ Washington, DC ~ New York ~ Houston ~ San Francisco
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`YVer1f
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`Petitioner Mylan Pharmaceuticals Inc. - Exhibit 1075A - Page 19
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`ConfidentialConfidential
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`PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.PFIZER INC., ET AL. vs. MYLAN PHARMACEUTICALS, INC.
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`Leonard J. Chyall on 08/23/2016Leonard J. Chyall on 08/23/2016
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`Page 20
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`·1· · · · A· · · · Correct.
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`·2· · · · Q· · · · If it was a solid, what would be some
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`·3· ·of the characteristics that SSCI would be interested
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`·4· ·in at the beginning of the salt screening phase?
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`·5· · · · A· · · · Certainly the solubility of the solid.
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`·6· · · · Q· · · · Is that it?
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`·7· · · · A· · · · Any kind of stability issues, whether
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`·8· ·it was light sensitive or not.
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`·9· · · · Q· · · · I'm assuming included in this would be
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`10· ·melting point information?
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`11· · · · A· · · · Yes.
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`12· · · · Q· · · · What about DSC i
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