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` UNITED STATES PATENT AND TRADEMARK OFFICE
`
` __________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
` __________________
`
` AMNEAL PHARMACEUTICALS, LLC
`
` Petitioner
`
` vs.
`
` SUPERNUS PHARMACEUTICALS, LLC
`
` Patent Owner
`
` U.S. Patent Nos. 8,394,405,
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` 8,394,406 and 8.206,740
`
` __________________________
`
` Cases IPR2013-00368, IPR2013-00371,
`
` and IPR2013-00372
`
` __________________________
`
` VIDEO DEPOSITION OF JONES WOODROW BRYAN, JR. Ph.D.
`
` Washington, D.C.
`
` Tuesday, April 29, 2014, 9:20 a.m.
`
`Reported by:
`
`Laurie Bangart, RPR, CRR
`
`Ref. No.: 11687
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
`
`

`

` Video Deposition of
`
` JONES WOODROW BRYAN, JR., Ph.D.
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`Page 2
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`Held at the offices of:
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` Paul Hastings
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` 875 15th Street, NW
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` Washington, D.C. 20005
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` (202)551-1700
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` Taken pursuant to notice, before
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` Laurie Bangart, Registered Professional
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` Reporter, Certified Realtime Reporter and
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` Notary public in and for the District of
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` Columbia.
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` A P P E A R A N C E S
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`Page 3
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`ON BEHALF OF PETITIONER AMNEAL PHARMACEUTICALS:
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` Sterne Kessler Goldstein Fox
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` 1100 New York Avenue, NW
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` Washington, D.C. 20005
`
` (202)371-2600
`
` By: Eldora L. Ellison, Ph.D.
`
` eellison@skgf.com
`
` R. Wilson Trey Powers, Ph.D.
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` tpowers@skgf.com
`
`ALSO ON BEHALF OF PATENT OWNER SUPERNUS
`
`PHARMACEUTICALS AND THE WITNESS:
`
` Paul Hastings, LLP
`
` 191 North Wacker Drive, 30th Floor
`
` Chicago, Illinois 60606
`
` (312)499-6064
`
` By: Gregory A. Morris, Ph.D.
`
` gregorymorris@paulhastings.com
`
` Evan Diamond, Esq.
`
` evandiamond@paulhastings.com
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`Page 4
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`(Appearances continued)
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`ALSO ON BEHALF OF PATENT OWNER SUPERNUS
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`PHARMACEUTICALS AND THE WITNESS:
`
` Foley & Lardner, LLP
`
` 3000 K Street, NW
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` Washington, D.C. 20007
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` (202)672-5413
`
` By: Andrew S. Baluch, Esq.
`
` abaluch@foley.com
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`ALSO PRESENT:
`
` Kim Johnson, Videographer
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`

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` EXAMINATION INDEX
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` PAGE
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`EXAMINATION BY MR. POWERS . . . . . . . . . . 7
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`Page 5
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` E X H I B I T S
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`EXHIBIT DESCRIPTION PAGE
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`Exhibit 2148 Develpment and Licensing
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` Agreement . . . . . . . . . . 36
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`Exhibit 2149 Covance Clinical Study Report 40
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`Exhibit 2146 Declaration of Jones W. Bryan 43
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`Exhibit 2036 Development Agreement . . . . 44
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`Exhibit 2147 Periostat XR Timeline . . . . 62
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`Exhibit 2150 Shire Labs Monthly Project
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` Report . . . . . . . . . . . . 126
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`Exhibit 2154 Email from Jones Bryan
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`
`
`
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` . . . . . . . . . 142
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`Exhibit 2155 Letter to
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` dated October 23, 2002 . . . . 145
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`Exhibit 2156 Email from Jennifer Wilson . . 163
`
`Exhibit 2157
`
`
`
` . . . 171
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`Page 6
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` P R O C E E D I N G S
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` THE VIDEOGRAPHER: This is tape
`
` number 1 of the videotaped deposition of
`
` Dr. Jones Bryan, taken in the matter of
`
` Amneal Pharmaceuticals, LLC versus Supernus
`
` Pharmaceuticals, LLC, in the US Patent &
`
` Trademark Office before the Patent Trial &
`
` Appeal Board, case number IPR2013-00368, also
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` IPR 2013-00371 and IPR 2013-00372.
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` This deposition is being held at
`
` Paul Hastings located at 875 15th Street,
`
` Northwest, Washington, D.C. on April 29, 2014
`
` at approximately 9:20. My name is Kim
`
` Johnson. I am the legal video specialist.
`
` The court reporter is Laurie Bangart, both in
`
` association with TransPerfect Legal
`
` Solutions.
`
` Will counsel please introduce
`
` yourselves and state whom you represent.
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` DR. POWERS: Sure. My name is Trey
`
` Powers. I'm from the law firm of Sterne,
`
` Kessler, Goldstein & Fox on behalf of Amneal.
`
` DR. ELLISON: Eldora Ellison also
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` from Sterne Kessler Goldstein & Fox on behalf
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` of Amneal.
`
`TransPerfect Legal Solutions
`212-400-8845 - Depo@TransPerfect.com
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`

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`Page 7
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` DR. MORRIS: Gregory Morris from
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` Paul Hastings on behalf of Supernus and the
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` witness.
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` MR. DIAMOND: Evan Diamond of Paul
`
` Hastings on behalf of Supernus and the
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` witness.
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` MR. BALUCH: Andrew Baluch from
`
` Foley & Lardner on behalf of Supernus and the
`
` witness.
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` THE VIDEOGRAPHER: Would the court
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` reporter please swear in the witness.
`
` JONES WOODROW BRYAN, JR., Ph.D.,
`
` having been first duly sworn, testified
`
` upon his oath as follows:
`
` EXAMINATION BY COUNSEL FOR AMNEAL
`
`BY DR. POWERS:
`
` Q Good morning, Dr. Bryan.
`
` A Good morning.
`
` Q Thank you for being here with us today
`
`morning.
`
` Would you state your full name for the
`
`record?
`
` A Jones Woodrow Bryan, Jr.
`
` Q Okay, and have you been deposed before?
`
` A I have, yes.
`
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` Q So you understand that you're being
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`questioned under oath today?
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` A I do.
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` Q It's important that you give us audible
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`answers, because as you can see, the court
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`reporter will be transcribing your testimony, so
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`we ask that instead of nodding your head or
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`shaking your head, you say yes or no. It's also
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`better if you don't say "uh-huh" or "huh-uh," as
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`opposed to -- or instead of that, just say yes or
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`no.
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` A Okay.
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` Q It's also important that we don't talk
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`over each other. I'll try to let you finish your
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`answer, and if you'd try to let me finish my
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`question, it will be a lot easier for the court
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`reporter.
`
` A Good.
`
` Q And if you don't understand a question
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`that I ask, would you please ask for
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`clarification. If you go forward with your
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`answer, I'll be -- I'll presume that you
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`understood the question.
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` A Right.
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` DR. ELLISON: Can you also speak up
`
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` a little bit, please.
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`BY MR. POWERS:
`
` Q You are very soft spoken, so if you
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`would please speak up a little bit when you give
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`an answer, that would be great.
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` A Okay.
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` Q So we can take regular breaks as long as
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`there are no pending questions. Anytime you need
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`a break, just let me know. As long as there's not
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`a question pending, I'll be happy to take a break.
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` A Will do.
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` Q So this deposition in the IPR context is
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`a little different than a deposition in a
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`litigation. This deposition is meant to be really
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`a conversation between me and you, and your
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`attorney may object, but you can answer the
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`question unless instructed not to.
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` Do you understand?
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` A I do.
`
` Q Okay.
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` Is there any reason you can't give full
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`and truthful testimony today, like medications
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`you're on or anything like that?
`
` A No.
`
` Q Okay. Thank you.
`
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` So let's talk a little bit about your
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`educational background. Where did you attend
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`college?
`
` A Undergraduate degree from Clemson
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`University, and then a Ph.D. in pharmaceutical
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`sciences from the Medical University of South
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`Carolina.
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` Q What did you major in at Clemson?
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` A Zoology.
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` Q Okay, and what year did you graduate?
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` A 1986.
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` Q '86, and you mentioned you had -- you
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`have a Ph.D. from the Medical University of South
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`Carolina.
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` A That's correct.
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` Q What was your discipline?
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` A Pharmaceutical sciences.
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` Q Pharmaceutical sciences, and what years
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`did you attend that university?
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` A 1986 through the end of 1990.
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` Q Okay, and then what did you do after
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`that, after you left the University of -- sorry --
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`the Medical University of South Carolina?
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` A I was employed by Schering-Plough
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`Pharmaceuticals.
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` Q Okay.
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` What year did you start at Schering?
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` A 1991.
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` Q So what did you do between leaving the
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`Medical University of South Carolina and starting
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`with Schering?
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` A I, I finished my, my educational work at
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`MUSC at the end of 1990, so I started early in
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`1991.
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` Q I see, and what was your title at
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`Schering?
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` A I'll have to look back. It was senior
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`scientist I believe was my first official title.
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` Q Okay, and what were your
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`responsibilities at Schering as a senior
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`scientist?
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` A I did initial formulation development
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`work. It was actually in support of the
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`veterinary medicine division of Schering-Plough.
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` Q Okay.
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` What type of -- what kind of dosage
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`forms were you working on at Schering?
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` A I worked on immediate release dosage
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`forms for companion animals.
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` Q All right, and after you left
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`Schering -- so how long were you at Schering?
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` A I was there until 1993.
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` Q Okay, and where did you go after that?
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` A AAI.
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` Q Okay. What is AAI?
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` A It's a contract pharmaceutical services
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`firm.
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` Q Okay. Where is that located?
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` A Wilmington, North Carolina.
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` Q What kind of pharmaceuticals -- what was
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`your role at AAI?
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` A I was a manager of a formulation
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`development group.
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` Q Okay.
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` Did you work on business development at
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`that time?
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` A When I initially joined, I was working
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`on formulation development, and I transitioned
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`into a technical director position, which was a
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`business development function. So I left the
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`project-related formulation group and became
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`really a presenter, business development person
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`representing the formulation development group.
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` Q So why did you -- I'm sorry. Were you
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`finished?
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` A There was a transition from, from a
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`project-oriented formulation development
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`responsibility to a business development
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`responsibility.
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` Q So when you say "business development
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`responsibility," what does that entail?
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` A Talking with prospective customers of
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`AAI.
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` Q Okay.
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` A Presenting the capabilities of the
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`company.
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` Q Selling the company's services?
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` A Right, mm-hmm.
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` Q And why did you leave AAI?
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` A Well, over the ensuing several years at
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`AAI, I continued in business development and
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`developed an expertise in business development and
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`licensing, and joined Shine Pharmaceuticals in
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`January of 2000 to fulfill very much the same
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`role. Shire had formulation drug delivery
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`technology expertise, and I was hired to be their
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`business development person for that function.
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` Q So what was your title when you got to
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`Shire?
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` A Senior director of business development.
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` Q Okay, and you said "very much the same
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`role" at Shire. Does that mean talking to
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`potential customers?
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` A Yes.
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` Q Selling the company's services?
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` A Right.
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` Q Okay, and so what does that, what does
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`that mean, talking to potential customers?
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` A At Shire it was specific to identifying
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`companies that had a need for the application of
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`drug delivery technologies that Shire possessed,
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`and, and discussing a business relationship on how
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`to collaborate on, on working together on product
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`concepts using the Shire drug delivery technology
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`platforms.
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` Q Okay, and what year was that when you
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`got to Shire?
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` A January of 2000.
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` Q Okay, and were you promoted over the --
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` A I was promoted a few years later. I
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`don't remember the exact time frame, but yes, I
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`was promoted.
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` Q Promoted to what?
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` A Vice president of business development,
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`right.
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` Q Were you vice president there at around
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`2002/2003?
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` A I don't remember the specific date. It
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`was sometime between 2000 and end of 2005.
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` Q Okay, and how many vice presidents were
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`there at Shire at the time you were promoted?
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` A I have no idea. Shire, Shire
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`Pharmaceuticals was a growing organization. I
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`don't recall how many specific vice presidents
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`were there.
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` Q More than five?
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` A I don't remember a specific number.
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` Q Was it around -- can you give me a
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`ballpark?
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` A It was more than one.
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` Q More than one. Well, yeah, so do you
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`know how the vice presidents were broken up into
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`categories, types of vice presidents that were
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`there?
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` A I certainly was aware of certain
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`departments where there were vice presidents, but
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`I can't recite the organizational chart to you.
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` Q Okay, that's fine.
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` Was there a vice president, for example,
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`of research and development?
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` A Yes.
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` Q Who was that person; do you remember?
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` DR. MORRIS: Objection. Outside
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` the scope.
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` THE WITNESS: I mean that's not
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` part of my declaration today, but I mean not
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` to recall individuals 14 years ago . . .
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`BY DR. POWERS:
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` Q Do you remember who the person was?
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` DR. MORRIS: Same objection.
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` THE WITNESS: Not specifically. I
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` know individuals that were there during that
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` period of time. I can't -- what particular
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` time frame were you referring to if you can
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` point me to that?
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`BY DR. POWERS:
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` Q Yeah, let's go to 2002.
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` A I don't specifically recall who was head
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`of development at that time.
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` Q Okay.
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` So you said you were promoted to VP at
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`Shire sometime between 2000 and 2005, I think.
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` A That's correct.
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` Q What happened after that? Are you still
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`employed at Shire?
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` A I'm no longer with Shire.
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` Q Okay.
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` So what happened in your career after
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`let's say 2005? What happened?
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` A The division of Shire that I was working
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`for was spun out of the Shire organization to form
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`a stand-alone organization.
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` Q And what's that organization called?
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` A Supernus Pharmaceuticals.
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` Q Okay, and do you own any stock in
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`Supernus?
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` A I do.
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` Q How much stock?
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` A I, I don't think it's pertinent to this
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`discussion. It's not part of my declaration.
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` Q Well, sir, today I get to ask the
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`questions, so if you would please answer mine, I
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`would appreciate it.
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` How much stock do you own in Supernus?
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` DR. MORRIS: Objection, counsel.
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` Outside the scope of this deposition.
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` DR. POWERS: Noted.
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` THE WITNESS: You can find it.
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` It's public record. You can find SEC
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` filings.
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`BY DR. POWERS:
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` Q Okay. Well, I'm asking you.
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` A I don't recall the specific number of
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`shares I have at the moment.
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` Q Can you give me a ballpark?
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` DR. MORRIS: Same objection.
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` THE WITNESS: I don't have a number
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` off the top of my head at the moment.
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`BY DR. POWERS:
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` Q All right. So would you say it's more
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`than 5,000 shares?
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` DR. MORRIS: Same objection.
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` THE WITNESS: I don't recall
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` specific numbers. I'm not --
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`BY DR. POWERS:
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` Q But I'm not asking for a specific
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`number. I'm just asking a ballpark.
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` How many shares do you own in Supernus?
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` DR. MORRIS: Same objection.
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` THE WITNESS: Again, it's public
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` record, you know. You can find what the
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` specific numbers are. No need to speculate.
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`BY DR. POWERS:
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` Q So will you tell me, though, if it's
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`over 5,000 shares? I'm just asking for a ballpark
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`figure of the number of shares you own in
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`Supernus.
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` DR. MORRIS: Same objection and
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` objection to form.
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` THE WITNESS: Again, it's public
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` record. If you're curious about what I own,
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` it's public record. Anyone can go and take a
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` look at it.
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`BY DR. POWERS:
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` Q Do you have an approximate dollar value?
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` A No.
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` Q You don't know or you're refusing to
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`answer the question or --
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` A I don't have a particular dollar value.
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` Q Do you have a ballpark for the dollar
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`value of shares you own in Supernus?
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` DR. MORRIS: Same objection.
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` THE WITNESS: I do not.
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`BY DR. POWERS:
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` Q You have no idea the value of the shares
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`that you own in Supernus?
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` A It's not something I think about day to
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`day, and so no, I don't have an accurate number at
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`the moment.
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` Q Do you have a ballpark number?
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` DR. MORRIS: Same objection.
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` THE WITNESS: I do not.
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`BY DR. POWERS:
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` Q Is it more than $20,000 worth of
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`Supernus stock?
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` A I don't have a specific number for you.
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` Q That's not the question that I asked. I
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`asked if it's more than $20,000 worth of Supernus
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`stock.
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` A I don't see the need to speculate on any
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`dollar amount. I mean, you know, again, it's
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`public record. It's not like I'm sharing anything
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`with you that you can't calculate on your own.
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` Q So at this time here today, you're not
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`willing to tell us if you own more than $20,000
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`worth of Supernus stock?
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` DR. MORRIS: Objection to form.
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` THE WITNESS: I'm here to talk
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` about what's in my declaration for this
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` proceeding, and I don't recall -- in fact, if
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` I could see a copy of my declaration, you
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` could point me to where in the declaration
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` this is a pertinent topic. I'll be glad to
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` address whatever is in the declaration.
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`BY DR. POWERS:
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` Q Dr. Bryan, I'm actually allowed to ask
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`you about things that go to many issues related to
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`your declaration, one of which is bias. Your
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`ownership of Supernus stock goes to that issue,
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`and I find it strange that you aren't willing to
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`share with us the ballpark number of Supernus
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`stock that you own.
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` DR. MORRIS: Objection to form.
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` Argumentative.
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` THE WITNESS: I don't see the point
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` of me speculating on what the actual number
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` is when you can see it in public record.
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` It's an official record.
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`BY DR. POWERS:
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` Q It seems as though you're unwilling to
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`give me any kind of a ballpark number of the
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`shares of Supernus that you own.
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` A Because I can't give you the specific
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`number accurately.
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` Q I'm not asking for specifics. I'm not
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`asking for specifics.
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` A I'm unwilling to share anything that's
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`unspecific when it's something that you can find
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`publicly that is specific.
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` Q So are you unable to answer whether or
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`not you own more than $20,000 worth of Supernus
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`stock?
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` A I am unprepared to give you a specific
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`number, and I'm unwilling to talk about
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`categorical amounts of stock I own and certainly
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`any dollar value associated with that.
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` Q So sitting here today, you're saying
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`you're unwilling to say whether or not you have
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`$20,000 worth of Supernus stock or more?
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` DR. MORRIS: Objection to form.
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` THE WITNESS: I don't see the point
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` of understanding and speculating what the
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` dollar amount is or the number of shares is
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` when, again, it could be verified by public
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` record and be absolutely accurate.
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`BY DR. POWERS:
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` Q So is it possible that you own $50,000
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`worth of Supernus stock or more?
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` A I've answered your question.
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` Q No, you haven't answered my question.
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` A My answer is that I'm unwilling to give
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`an estimate when there is specific information
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`that is publicly available that you can go in,
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`anyone can go in and determine it themselves, and
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`it's not a number that I have specific that I pay
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`attention to day to day.
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` Q Do you own more than $5 worth of
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`Supernus stock?
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` A I'm sure I do. I don't have a specific
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`number, though.
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` Q Do you own more than $5,000 worth of
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`Supernus stock?
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` A You've asked this question several
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`times, and I've given you my answer.
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` Q I haven't asked this question. Do you
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`own more than $5,000 worth of Supernus stock?
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` A I don't know the exact dollar amount
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`that I own.
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` Q Sir, do you own more than $5,000 worth
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`of Supernus stock? Yes or no, or I don't know,
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`which is a fine answer, too.
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` A I don't know. I don't know specifically
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`what I own.
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` Q But you don't know if you own more than
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`$5,000?
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` A I don't know the specific dollar amount
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`of what I own. It's not something I do day to
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`day.
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` Q Okay.
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` So while you were at Shire, did you play
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`a role in formulation development?
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` A Not directly, no.
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` Q Did you ever interpret data related to
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`formulation development?
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` A No, not directly.
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` Q Did you make decisions about strategy
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`related to formulation development?
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` DR. MORRIS: Object to form.
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` THE WITNESS: No.
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`BY DR. POWERS:
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` Q Did you play a role in preclinical
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`formulation decisions?
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` DR. MORRIS: Object to the form. I
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` just want to instruct the witness to slow
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` down a little bit so I can make my
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` objections.
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` THE REPORTER: I did not hear the
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` answer.
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` THE WITNESS: The answer is no.
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`BY DR. POWERS:
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` Q Did you play a role in making regulatory
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`decisions while you were at Shire?
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` DR. MORRIS: Objection to form.
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` THE WITNESS: No.
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`BY DR. POWERS:
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` Q Did you play a role in drug feasibility
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`decisions while you were at Shire?
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` DR. MORRIS: Same objection.
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` THE WITNESS: No.
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`BY DR. POWERS:
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` Q Did you make decisions about drug
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`feasibility and strategy?
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` DR. MORRIS: Same objection.
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` THE WITNESS: No.
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`BY DR. POWERS:
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` Q Did you play a role in dosage form
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`development decisions?
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` DR. MORRIS: Same objections.
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` THE WITNESS: No.
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`BY DR. POWERS:
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` Q Did you ever interpret data on dosage
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`form development and discuss strategy forward with
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`the scientists?
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` DR. MORRIS: Same objection.
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` THE WITNESS: I was not responsible
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` for interpreting data. I received their
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` expert opinion on strategy as a result of
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` their evaluation and generation of data.
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`BY DR. POWERS:
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` Q Okay.
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` Did you ever work on accelerated
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`stability projects?
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` DR. MORRIS: Same objection.
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`BY DR. POWERS:
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` Q In a scientific role?
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` A No.
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` Q While you were at Shire, did you ever
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`work on the validation of analytical methods?
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` A No.
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` Q Did you ever work on any of the
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`preparation of any regulatory documents while you
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`were at Shire?
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` A No.
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` Q Did you ever help oversee the
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`manufacture of GMP batches while you were at
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`Shire?
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` A No.
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` Q Have you ever helped formulate a
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`doxycycline product at any time?
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` DR. MORRIS: Objection. Form.
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` THE WITNESS: Not that I recall.
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`BY DR. POWERS:
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` Q Did you know Rong-Kun Chang?
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` A Yes.
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` Q And he also went by "Richard," right?
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` A Yes.
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` Q How did you know him?
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` A He was a formulator at Shire when I
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`joined, and he worked, worked at Shire, Shire Labs
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`while I was also employed by Shire Labs.
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` Q And how long did you know him? Do you
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`still know him?
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` DR. MORRIS: Objection. Form.
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`BY DR. POWERS:
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` Q Let me just clarify that question.
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` A I knew him then and I know him now. I
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`know of him.
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` Q When is the last time that you spoke to
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`Dr. Chang?
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` A When he was employed with Shire Labs.
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` Q Do you remember when that was, about?
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` A I really don't, but he's been gone a
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`number of years.
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` Q And what about Arash Raoufinia? I have
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`trouble with that name.
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` A As do I.
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` Q Raoufinia. Did you know him?
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` A I did, yes.
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` Q And how did you know him?
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` A He worked within the formulation drug
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`delivery sciences group at Shire when I was there
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`for a period of time.
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` Q About how long did you know him?
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` A I couldn't say specifically. He was, he
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`was part of our team in that, somewhere in the
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`time frame between the January 2000 and 2005, but
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`I can't tell you specifically the dates he was
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`there.
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` Q When was the last time that you spoke to
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`Dr. Raoufinia?
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` A Whenever he left the organization. I
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`haven't really remained in contact with him.
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` Q Did you leave at the same time when
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`Shire was spun out?
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` A I don't recall whether he made the
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`transition from Shire over to Supernus with us or
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`not.
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` Q Same question for Dr. Chang. Was that
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`about the time frame --
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` A He did make a transition from Shire to
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`Supernus, and so he was with Supernus for some
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`period of time post-spinout from Shire, yes. I
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`can't recall how long that was, but he did, he did
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`stay with the organization, the new organization.
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` Q Gotcha, and what about Niraj Shah; did
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`you know him?
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` A I know the name and I remember him. I,
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`I don't recall what time frame. Again, he was, he
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`was at Shire Labs during that period of time, but
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`I don't remember the, the longevity of how long he
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`was with the organization.
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` Q Do you remember what his role was at
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`Shire?
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` A Not specifically, no.
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` Q Do you remember generally what
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`Dr. Shah's role was at Shire?
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` A I know he worked closely with the drug
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`delivery sciences group. In what specific
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`capacity, I don't remember.
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` Q Okay.
`
` When, about, was the last time you spoke
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`to Dr. Shah?
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` A I truly don't recall. It would have
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`been the same sort of time frame where Shire Labs
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`separated from and became Supernus.
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` Q Okay.
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` So it's fair to say you haven't seen any
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`of these gentlemen lately?
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` A Yes, that would be correct.
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` Q Okay.
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` Do you know where they work now, any,
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`any of them?
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` A I really don't, no.
`
` Q Okay.
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` Have you had any communication with
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`Dr. Chang in the past few years since he left
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`Shire?
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` A I haven't. Not that I recall.
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` Q And how about with Dr. Raoufinia; have
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`you had any communication with him since he left
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`Supernus or Shire?
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` A Again, not that I recall, no.
`
` Q And same question for Dr. Shah.
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` A Not that I recall.
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` Q Dr. Bryan, what did you do in preparing
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`for this deposition today?
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` And let me just be clear. I'm not
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`trying to get to any kind of privileged
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`communication between you and your counsel.
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` DR. MORRIS: Objection. I'm going
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` to instruct the witness not to answer on the
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` basis of attorney/client privilege.
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` DR. POWERS: Not to answer the
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` question at all, counsel?
`
` DR. MORRIS: Yeah, if you want to
`
` ask more specific questions, I'll let him
`
` answer, but that's a broad question and could
`
` get into privileged information.
`
`BY DR. POWERS:
`
` Q Dr. Bryan, what documents did you review
`
`in preparation for your deposition today?
`
` DR. MORRIS: Again, I'm going to
`
` instruct the witness not to answer on the
`
` basis of attorney/client privilege. If you
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` want to ask him about a specific document, if
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` he reviewed it, then that would be fine, but
`
` having him char

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