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` UNITED STATES PATENT AND TRADEMARK OFFICE
` ________________________________________
`
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ________________________________________
`
` MYLAN PHARMACEUTICALS INC., et al.,
`
` Petitioner,
`
` v.
`
` MERCK SHARP & DOHME CORP.,
`
` Patent Owner.
`
` __________________________________________
`
` Case IPR2020-00040
` Patent No. 7,326,708 B2
`
` __________________________________________
`
` DEPOSITION OF VICKY VYDRA
`
` APPEARING REMOTELY
`
` November 10, 2020
`
` 10:02 a.m.
`
`Reported by
`
`Rebecca J. Callow, RMR, CRR, RPR, CSR
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`GregoryEdwards, LLC | Worldwide Court Reporting
`GregoryEdwards.com | 866-4Team GE
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`Mylan (IPR2020-00040) Ex. 1032 p. 001
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`
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`Vicky Vydra - November 10, 2020
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`Page 2
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` REMOTE ORAL DEPOSITION OF VICKY VYDRA,
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`produced as a witness at the instance of the
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`Petitioner and duly sworn, was taken in the
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`above-styled and numbered cause on the 10th day of
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`November 2020, from 10:02 a.m. EST, to 11:18 a.m.,
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`before Rebecca J. Callow, Registered Merit
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`Reporter, Certified Realtime Reporter, Registered
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`Professional Reporter and Notary Public for the
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`State of Texas, reported by computerized stenotype
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`machine remotely from Austin, Texas, pursuant to
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`the Federal Rules of Civil Procedure.
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`Vicky Vydra - November 10, 2020
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`Page 3
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` REMOTE APPEARANCES
`
`ON BEHALF OF MYLAN PHARMACEUTICALS, INC.:
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` Katten Muchin Rosenman LLP
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` 550 South Tryon Street
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` Suite 2900
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` Charlotte, North Carolina 28202
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` 704-344-3185
`
` By: Jitendra Malik, Ph.D.
`
` jitty.malik@katten.com
`
`FOR MERCK SHARP & DHOME:
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` Williams & Connolly LLP
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` 725 Twelfth Street, Northwest
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` Washington, D.C. 20005
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` 202-434-5000
`
` Alexander S. Zolan
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` azolan@wc.com
`
` Sean Mahaffy
`
` smahaffy@wc.com
`
` Anthony Sheh
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` asheh@wc.com
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`Vicky Vydra - November 10, 2020
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`Page 4
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` REMOTE APPEARANCES (CONTINUED)
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` MERCK & CO., INC.:
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` 2000 Galloping Hill Road
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` Kenilworth, New Jersey 07033
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` 908-740-4000
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` By: Raynard Yuro
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` ryuro@merck.com
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`Vicky Vydra - November 10, 2020
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`Page 5
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` I N D E X
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` PAGE
`
`VICKY VYDRA
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`Examination by Mr. Malik ..........................7
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`Examination by Mr. Zolan .........................61
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`Court Reporter's Certificate .....................63
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`Signature Page ..................................66
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`Changes and corrections .........................68
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` * * * * *
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`Vicky Vydra - November 10, 2020
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`Page 6
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` E X H I B I T S
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`NO. DESCRIPTION PAGE
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` (None offered)
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` * * * * *
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` Tuesday, November 10, 2020, 10:02 a.m.
`
` P R O C E E D I N G S
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` - - - - -
`
` VICKY VYDRA,
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` called as a witness herein, having
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` been first duly sworn by a Notary Public,
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` was examined and testified as follows:
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` EXAMINATION
`
` BY MR. MALIK:
`
` Q. Good morning, Ms. Vydra. How are you?
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` A. I'm well. How are you?
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` Q. Doing well.
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` Ever been deposed before?
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` A. No. This is my first.
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` Q. Fair enough.
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` Just for the record, will you mind
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`stating your name?
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` A. Sure. My name is Vicky K. Vydra.
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` Q. Okay. I'm sure you've gone over some
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`rules, but I'm just going to remind some of the
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`rules and go over them.
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` You understand today that you are under
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`Mylan (IPR2020-00040) Ex. 1032 p. 007
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`Vicky Vydra - November 10, 2020
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`Page 8
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`oath?
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` A. I do.
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` Q. And you understand today that this
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`penalty -- that this testimony is under penalty of
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`perjury?
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` A. I do.
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` Q. And you understand that you are obligated
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`to answer my questions. Correct?
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` A. That's correct.
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` Q. Any reason today you cannot tell the truth?
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` A. No.
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` Q. Okay. If I ask a question and you don't
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`understand, let me know and I will rephrase it.
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`Fair enough?
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` A. Fair enough.
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` Q. But if you do answer the question, I will
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`assume that you understood the question. Okay?
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` A. Okay.
`
` Q. Now, let me put into the chat room your
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`declaration.
`
` Let me ask you before we begin, do you
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`have any documents in front of you?
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`Vicky Vydra - November 10, 2020
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` A. I only have my copy of the declaration.
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` Q. Is it marked in any way?
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` A. It's not.
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` Q. Okay. What I'm going to do is I'm going to
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`put in the chat room your declaration.
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` A. Where's the chat room?
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` Q. If you click on the bottom and hit "chat."
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` A. Gotcha.
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` Q. And you'll see it. It will pop up.
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` Let me get it.
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` (Pause in proceedings.)
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` BY MR. MALIK:
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` Q. I've uploaded it. It is a copy of your
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`declaration. Let me know when you have it, and
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`download it.
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` A. Okay. I have it.
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` Q. And you can use the hard copy, I don't
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`really mind, or you can use the electronic copy.
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`It's completely up to you, since it's unmarked.
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` The document labeled as Merck
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`Exhibit 2002, that is your declaration. Correct?
`
` A. Yes. That's correct.
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`Vicky Vydra - November 10, 2020
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`Page 10
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` Q. And on page 8, it bears your signature that
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`you signed in or around the -- February 10th, 2020.
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`Is that correct?
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` A. Yes. That's correct.
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` Q. Any corrections to the declaration as you
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`see it sitting here today?
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` A. Are you referring to the electronic or the
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`copy in front of me?
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` Q. They should be identical, but I can -- look
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`at the copy that is in front of you. Do you have
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`any corrections to the document that is in front of
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`you, hard copy?
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` A. I do not.
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` Q. And you understood that 2020 was meant to
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`be a complete statement for any issues you are
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`offering testimony to today. Correct?
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` A. Can you define "issues"?
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` Q. So there are 22 paragraphs in your
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`declaration followed by the declaration of perjury,
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`and there are some exhibits -- or some attachments
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`thereafter.
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` You understood that all 22 paragraphs
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`are supposed to be, I guess, complete as to anything
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`that you are offering testimony to. Correct?
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` A. Yes. That's correct.
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` Q. Are you being compensated to be here today?
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` A. I am not.
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` Q. Okay. And in connection with this IPR, do
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`you understand that during the breaks you are not
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`supposed to talk with your attorney about any
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`testimony or anticipated testimony?
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` A. Yes. I understand.
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` Q. Okay. Now, I understand that you have
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`certain child care obligations that we need to break
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`at 11:30 until whenever. Not a problem for me; I
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`have three young children of my own.
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` Just during that time, I ask that you
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`not talk to your attorneys. You probably have kid
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`stuff to take care of anyway. So just as long as we
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`understand that, there's no issues. And, obviously,
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`if you need more than the 11:30 to 1:00, just let us
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`know, and we'll certainly be happy to accommodate
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`you.
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` Okay. When did Merck first contact you
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`Page 12
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`in connection with your declaration, EX220 -- I'm
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`sorry -- 2001. I'm sorry. 2002.
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` A. So I cannot recall the exact date, but I
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`was contacted by a former colleague first.
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` Q. Okay. Who contacted you?
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` A. Bob Wenslow.
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` Q. Okay. And what did Bob Wenslow tell you?
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` A. That he was trying to contact me or locate
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`me.
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` Q. Okay. Fair enough.
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` And then after Bob Wenslow --
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`Dr. Wenslow contacted you, what did you do?
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` A. I contacted the number that he provided.
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` Q. Okay. And I assume the number that he
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`provided was an attorney at Williams Connolly?
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` A. No. It was actually an attorney at Merck.
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` Q. Okay. I'm not interested in any
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`communication with any attorney, whether it's an
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`attorney at Merck or an attorney at
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`Williams Connolly. I'm not interested in the
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`specific nature of the communication.
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` I assume the attorney at Merck referred
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`you to somebody at Williams Connolly, yes or no.
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` A. Yes. Yes.
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` Q. Who at Williams Connolly, just the name,
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`did you work with?
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` A. So there were several, and I cannot recall
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`last names. But one of the individuals is on the
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`line, Alex. The other one was Tony. But, again,
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`last names allude me.
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` Q. Fair enough. Fair enough.
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` And then, in connection with your
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`declaration, how long did it take -- well, let me ask
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`you, did you write EX2002?
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` A. So I collaborated with counsel.
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` Q. Okay. There are various documents -- well,
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`there are various documents attached to -- and
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`rather than 2002, I'm just going to say "your
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`declaration." Fair enough?
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` A. Fair enough.
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` Q. There are various documents attached to
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`your declaration. When was the last time you saw
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`these documents prior to February 10th, 2020?
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` A. So when was the last time I saw them prior
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`to the declaration? Can you specify?
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` Q. Yes. Exactly.
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` What I'm asking is, obviously, they're
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`attached to your declaration and you saw them in
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`connection with your declaration.
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` Prior to the drafting of your
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`declaration, when was the last time you saw them?
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`Was it when you were at Merck?
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` A. I did see them in preparation for the
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`declaration.
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` Q. Okay. Now, before Dr. Wenslow contacted
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`you, way back when, when was the last time that you
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`saw the documents attached to your declaration?
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`When you were at Merck?
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` A. Back when I was at Merck.
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` Q. So it's been quite a while before
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`Dr. Wenslow contacted you that you saw the documents
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`that are attached to your declaration. Correct?
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` A. It was back when I was at Merck, between
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`2001 and 2006.
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` Q. Okay. And then, in connection with the
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`documents -- and just for the record, when I say
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`Page 15
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`"the documents that are attached to your
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`declaration," I mean -- there again, it's just more
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`for the record -- everything that is attached after
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`the signature page on page 8, which is Appendix A.
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` In connection with the documents that
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`are attached as Appendix -- well, I guess there's an
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`Appendix B, too -- Appendix A and Appendix B, did you
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`select these documents or were they given you?
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` A. So these documents were selected with
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`counsel upon review of material that would be
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`relevant.
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` Q. Okay. And I assume that you read in
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`completion the documents attached as Appendix A and
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`Appendix B?
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` A. I'm sorry. Can you say that question one
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`more time?
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` Q. I assume you thoroughly reviewed the
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`documents that are attached in Appendix A and
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`Appendix B in connection with your declaration?
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` A. That is correct.
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` Q. Okay. Now, other than the documents that
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`are attached to your declaration, did you review any
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`Page 16
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`other documents in connection with this IPR?
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` MR. ZOLAN: Object to form.
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` A. So I did --
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` MR. ZOLAN: What time period?
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` BY MR. MALIK:
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` Q. Well, let's break it up.
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` In connection with drafting your
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`declaration, did you review any other documents --
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`yes or no -- that were not included?
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` A. So when drafting the declaration, did I
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`review any other documents that were related?
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` Q. Yes. But not included in the declaration.
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` A. I -- yes, I did.
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` Q. Okay. Let me ask it this way. And, again,
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`I'm not looking to get into privileged information.
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` Obviously, those documents were not
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`included in your declaration. The only ones you're
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`here to testify about today is what is attached in
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`Appendix A -- correct? -- and B.
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` A. Can you rephrase the question?
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` MR. ZOLAN: Object to form.
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`\\\
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`Page 17
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` BY MR. MALIK:
`
` Q. Sure. Let me get some foundation.
`
` So, obviously, you're being deposed
`
`tomorrow by a larger group of individuals. Correct?
`
` A. Correct.
`
` Q. And you saw some documents.
`
` Okay. I'm not interested in those
`
`documents. What -- all I want to do is confirm that
`
`the testimony you're giving today is limited to the
`
`documents that are attached in Appendix A and
`
`Appendix B. Is that fair?
`
` A. That's correct.
`
` Q. Okay. And then in connection with your
`
`deposition today, have you read anybody else's
`
`deposition transcript?
`
` A. No, I have not.
`
` Q. Have you read anybody else's declaration?
`
` A. No, I have not.
`
` Q. Have you -- other than your attorneys, have
`
`you spoken to anyone in connection with this --
`
`spoken to anyone about this matter?
`
` A. No.
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`Vicky Vydra - November 10, 2020
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`Page 18
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` Q. And let me upload the '708 patent. Let me
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`know when you have that. It's the '708 patent that
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`I'm uploading, Exhibit 1001.
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` A. Okay. I have it.
`
` Q. Okay. Now, if I went through your
`
`declaration, I didn't see -- well, strike that.
`
` Other than paragraph 2, you don't --
`
`and paragraph 1, I guess -- you don't make any
`
`reference to the '708 patent anywhere else. Correct?
`
` Nothing in paragraph 3 through 22.
`
`Well, 21 has it.
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` MR. ZOLAN: Object.
`
` MR. MALIK: Yeah.
`
` BY MR. MALIK:
`
` Q. I'm sorry. I'll withdraw the question.
`
`Let me ask you this:
`
` You're a named inventor on the '708
`
`patent. Correct?
`
` A. That's correct.
`
` Q. When's the last time you talked to
`
`Mr. Cypes?
`
` A. I cannot recall.
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` Q. Okay. When's the last time you talked to
`
`Mr. Chen -- or Dr. Chen?
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` A. I cannot recall.
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` Q. When's the last time you talked to
`
`Dr. Ferlita?
`
` A. 2006 time frame.
`
` Q. Okay. When was the last time you talked to
`
`Dr. Hansen?
`
` A. That, I can't recall.
`
` Q. The last time you talked to -- is it Mr. or
`
`Dr. Lee? I don't really know.
`
` When was the last time you talked to, I
`
`guess, Mr. Lee?
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` A. I can't recall that.
`
` Q. Fair enough. And, obviously, Dr. Wenslow
`
`you recently talked to.
`
` Have you stayed in contact with
`
`Dr. Wenslow through the years?
`
` A. Periodically. Our professions overlapped
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`at times.
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` Q. Okay. When's the last time you spoke to
`
`Dr. Wenslow about sitagliptin?
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`Page 20
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` A. That, I can't recall; outside of him
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`informing me that Merck was trying to contact me.
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` Q. Fair enough. Fair enough.
`
` Let's see. Let's go to your
`
`declaration. So you received -- I'm looking at
`
`paragraph 3.
`
` You received a bachelor of arts degree
`
`from Rutgers University. Correct?
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` A. That's correct.
`
` Q. Okay. And did you do any undergraduate
`
`research while at Rutgers?
`
` A. I did.
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` Q. And what was the nature of the
`
`undergraduate research?
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` A. I was isolating a photosynthetic dimer in
`
`algae.
`
` Q. That did not involve salt formations.
`
`Correct?
`
` A. That's correct.
`
` Q. Okay. And just to be clear, you never went
`
`to grad school. Correct?
`
` A. That's correct.
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` Q. And you don't have a bachelor's of science
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`in chemistry. Correct?
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` A. That is correct. The college offered
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`bachelor's of arts.
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` Q. Fair enough. It didn't offer a BS in
`
`chemistry?
`
` A. Not for chemists.
`
` Q. Okay. And then you graduated in 2001 in
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`June. Correct?
`
` A. That's correct.
`
` Q. And then Merck was your first job out of
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`college. Correct?
`
` A. That's correct.
`
` Q. And it says on paragraph 3 that you were an
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`entry -- I'm sorry.
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` It says you were a staff chemist in the
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`process research department. Correct?
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` A. In paragraph 4, yes. I was a staff
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`chemist.
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` Q. And staff chemist, is that an entry-level
`
`position?
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` A. I cannot recall if that was my exit
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`position or my entry position.
`
` Q. Okay. And in the process of the research
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`department of Merck Research Laboratories, what were
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`you tasked with doing?
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` A. So my primary task was to identify
`
`crystalline materials for key intermediates, or
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`APIs, so salt formation and polymorph screening.
`
` Q. When was the first time you ever did a salt
`
`screen?
`
` A. I'm sorry. Can you clarify?
`
` Q. Sure.
`
` In your last question you said that you
`
`did -- your primary task was to identify crystalline
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`materials and then salt formation and polymorph
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`screening.
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` When you said "salt formation," what
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`did you mean by that?
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` A. Salt screening efforts.
`
` Q. Okay. What is your understanding of "salt
`
`screening"?
`
` A. Can you clarify --
`
` Q. Sure.
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` A. -- what is my understanding?
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` Q. Yes. Sure.
`
` If someone uses the term "salt screen,"
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`what does that mean to you?
`
` MR. ZOLAN: Object to form.
`
` BY MR. MALIK:
`
` Q. Go ahead. Answer.
`
` MR. ZOLAN: Yeah.
`
` THE WITNESS: Okay. Sorry.
`
` MR. ZOLAN: It's all good. When I'm
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`objecting, I'm objecting for the record. But unless
`
`I tell you not to answer, go ahead and answer.
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` THE WITNESS: Thanks for the
`
`clarification.
`
` A. So my understanding of the -- of a salt
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`screen, was that the question?
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` BY MR. MALIK:
`
` Q. Yes.
`
` A. So that was -- in my understanding of that
`
`question, at the time at Merck, my sole task was to
`
`seek salts, crystalline salts, of APIs or key
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`intermediates, to identify counterions, counterbases
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`Vicky Vydra - November 10, 2020
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`that may react, and attempt the experiments.
`
` Q. Now, one way to do salt screens is to do an
`
`acid-base reaction where you react a base and an
`
`acid together. Correct?
`
` MR. ZOLAN: Object to form.
`
` A. So can you clarify the ask there?
`
` BY MR. MALIK:
`
` Q. You understand that a salt can be made by
`
`reacting an acid and a base together. Correct?
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` MR. ZOLAN: Object to form.
`
` A. So I understand that in principle, but it's
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`not as simple as what the literature or what -- you
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`know, what a textbook may indicate. You do have to
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`conduct the experiment because it can be
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`unpredictable.
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` BY MR. MALIK:
`
` Q. Okay. So let me ask you, when was the
`
`first time you did a salt screen?
`
` A. I cannot recall the exact date. It is in
`
`the 2001 time frame when I joined Merck.
`
` Q. Okay. You didn't do a salt screen at --
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`in -- well, in college. Correct?
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` A. I cannot recall that, if I did any salt
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`screens.
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` Q. Do you recall who taught you to do a salt
`
`screen?
`
` A. So I can recall who taught me how to do
`
`salt screens under the Merck processes.
`
` Q. Okay.
`
` A. That was a supervisor of mine.
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` Q. Who was it?
`
` A. Dr. Rick Sidler.
`
` Q. Okay. And how long did it take you to
`
`learn to do a salt screen?
`
` A. That, I can't recall.
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` Q. Do you recall what Dr. Sidler told you
`
`about salt screens?
`
` A. I'm sorry. Can you be more specific?
`
` Q. Sure.
`
` Did he give you an explanation of what
`
`a salt screen was? What's the purpose?
`
` A. I cannot recall the details of the
`
`conversations that we had when I first joined Merck.
`
` Q. Okay. Now, you outlined some experiments
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`in your declaration that are also described in
`
`Appendix A and Appendix B. Correct?
`
` A. Are you referring to a specific paragraph?
`
` Q. Sure. Bear with me.
`
` Paragraph 9.
`
` A. And what was the question regarding
`
`paragraph 9?
`
` Q. I lost track. Give me one minute.
`
` My question is, is now you've described
`
`a salt screen in connection with your declaration
`
`that you did in or around December 12, 2001.
`
`Correct?
`
` A. That is correct.
`
` Q. And that is all, basically, contacting
`
`sitagliptin with -- well, strike that. We'll dig
`
`into it a little bit.
`
` Do you recall what the nature of --
`
`what you were tasked with doing in or around
`
`December 12th in connection with -- 2001, in
`
`connection with L-224715?
`
` A. Do I recall what I was tasked to do?
`
` Q. Yes.
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` A. Was that the question?
`
` Q. Yes.
`
` A. I was tasked to perform a salt screen on
`
`that compound.
`
` Q. Okay. And how long did these experiments
`
`take?
`
` A. So I cannot comment on exact duration
`
`anymore. I do know that, you know, we did conduct
`
`salt screens and it would take, on average, a week
`
`or so to perform the set.
`
` Q. Okay. Now, currently, you are in global
`
`procurement in Bristol Myers Squibb. Correct?
`
` A. Yes. We did have a name change. Now we're
`
`Sourcing Strategy & Procurements.
`
` Q. Fair enough.
`
` Are you still a practicing chemist?
`
` A. I am not.
`
` Q. When did you leave the lab?
`
` A. I would say about ten years ago.
`
` Q. Okay. Let me -- and you had --
`
`December 9th, 2001, in paragraph 9, you'd been out
`
`of school for six months -- correct? -- with a
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`bachelor's of arts when you did these experiments.
`
`Correct?
`
` A. So approximately six months, I was -- I had
`
`graduated from Rutgers and joined Merck. Yes.
`
` Q. Okay. And that's when you eventually did
`
`the salt screen where you, among other acids,
`
`contacted sitagliptin with phosphoric acid.
`
`Correct?
`
` A. So six months after I had started with
`
`Merck, I was actively conducting polymorph and salt
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`screening work. And I had -- in December, I had
`
`picked up the compound sitagliptin and conducted the
`
`salt screen.
`
` Q. Okay. Let me upload one more document.
`
` I'm going to upload Exhibit 2103, which
`
`is the corrected Matzger declaration. And don't
`
`worry, I'm not going to ask you too many questions
`
`about it.
`
` Let me know when you have it.
`
` (Pause in proceedings.)
`
` A. Okay. It's just opening.
`
`\\\
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` BY MR. MALIK:
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` Q. Okay. I take it you have not seen this
`
`document before?
`
` A. No. I have not.
`
` Q. Okay. I'd be very surprised if you had. I
`
`am going to keep my questions very short, to one
`
`paragraph, so don't worry about the fact that
`
`it's --
`
` A. 178 pages.
`
` Q. Yeah. Don't worry about that. It's one
`
`paragraph.
`
` If you wouldn't mind, go to page 36.
`
`Let me know when you're there. Specifically,
`
`paragraph 64. And this is going to be my only
`
`question on this document.
`
` A. Okay. I just hit page 36.
`
` What was the paragraph number?
`
` Q. 64. It's actually on page 37.
`
` Go ahead and read paragraph 64.
`
` A. Okay.
`
` Q. Let me know when you're ready to proceed.
`
` (Document review.)
`
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` A. Okay. I am ready to proceed.
`
` BY MR. MALIK:
`
` Q. Okay. Now, when you did the salt screening
`
`study, you had a BA in chemistry and were six months
`
`out. Correct?
`
` A. Yes.
`
` Q. Now, according to what you see in
`
`paragraph 64, the qualifications on the line --
`
`second line and third line are a doctoral degree in
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`chemistry or related field with at least two years
`
`of lab experience. Do you see that?
`
` A. I do see that.
`
` MR. ZOLAN: Object to form. Scope.
`
`Calls for an expert opinion. Calls for a legal
`
`conclusion.
`
` MR. MALIK: Okay.
`
` MR. ZOLAN: You can answer if you can.
`
` MR. MALIK: I think once you see my
`
`question, Alex, you'll see what I'm getting at.
`
` BY MR. MALIK:
`
` Q. And then later on, do you see it says a
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`master's or a bachelor's degree in a similar field
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`with a commensurate increase in the years of
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`postgraduate -- of their postgraduate experience.
`
` Do you see that?
`
` A. I --
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` MR. ZOLAN: Objection to form. Scope.
`
`Calls for an expert opinion. Calls for legal
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`conclusion.
`
` Go ahead.
`
` BY MR. MALIK:
`
` Q. Do you see that?
`
` A. Um-hmm -- I see it.
`
` Q. Okay. My question on this is that, at the
`
`time when you did the salt screen, you would not
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`have met the definition of a POSA as laid out in
`
`paragraph 64. Correct?
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` MR. ZOLAN: Objection to form. Scope.
`
`Calls for expert testimony. Calls for a legal
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`conclusion.
`
` You can answer.
`
` A. So according to this definition, I had a
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`bachelor's degree in chemistry, but I did not have
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`two years of experience in industry.
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`GregoryEdwards.com | 866-4Team GE
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`Mylan (IPR2020-00040) Ex. 1032 p. 031
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`Vicky Vydra - November 10, 2020
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`Page 32
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` BY MR. MALIK:
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` Q. Okay. You can put that document aside.
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` Now, you work -- did you work with
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`Dr. Hansen during the 2001 time frame, December, as
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`it relates to sitagliptin?
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` I'm not interested in whatever other
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`Merck projects you may have worked on.
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` A. So he was part of the project team. He was
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`the project lead.
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` Q. Did you report to Dr. Hansen as it relates
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`to the sitagliptin project?
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` A. No. I did not have a direct reporting
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`relationship to him.
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` Q. Who did you report to?
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` A. Dr. Rick Sidler.
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` Q. Okay. Do you mind turning to paragraph 2?
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` A. Of?
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` Q. Of your declaration.
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` A. Okay.
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` Q. We can put Dr. Matzger's declaration aside.
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`You will not be asked any more questions on it. So
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`if that's a