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`(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:16)(cid:3)(cid:12)
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`(cid:3)(cid:3)(cid:3)(cid:39)(cid:40)(cid:51)(cid:50)(cid:54)(cid:44)(cid:55)(cid:44)(cid:50)(cid:49)(cid:3)(cid:50)(cid:41)(cid:3)(cid:48)(cid:44)(cid:46)(cid:46)(cid:50)(cid:3)(cid:50)(cid:54)(cid:46)(cid:36)(cid:53)(cid:44)(cid:3)(cid:43)(cid:40)(cid:44)(cid:46)(cid:44)(cid:49)(cid:43)(cid:40)(cid:44)(cid:48)(cid:50)(cid:15)(cid:3)(cid:51)(cid:75)(cid:17)(cid:39)(cid:17)
`(cid:58)(cid:68)(cid:86)(cid:75)(cid:76)(cid:81)(cid:74)(cid:87)(cid:82)(cid:81)(cid:15)(cid:3)(cid:39)(cid:17)(cid:38)(cid:17)
`(cid:48)(cid:68)(cid:92)(cid:3)(cid:21)(cid:15)(cid:3)(cid:21)(cid:19)(cid:20)(cid:28)
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`(cid:45)(cid:82)(cid:69)(cid:3)(cid:49)(cid:82)(cid:17)(cid:3)(cid:20)(cid:24)(cid:27)(cid:26)(cid:19)(cid:19)
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`(cid:55)(cid:54)(cid:42)(cid:3)(cid:53)(cid:72)(cid:83)(cid:82)(cid:85)(cid:87)(cid:76)(cid:81)(cid:74)(cid:3)(cid:16)(cid:3)(cid:58)(cid:82)(cid:85)(cid:79)(cid:71)(cid:90)(cid:76)(cid:71)(cid:72)(cid:3)(cid:3)(cid:3)(cid:3)(cid:3)(cid:27)(cid:26)(cid:26)(cid:16)(cid:26)(cid:19)(cid:21)(cid:16)(cid:28)(cid:24)(cid:27)(cid:19)
`
`Corcept Therapeutics, Inc.
`Exhibit 2009
`Neptune Generics, LLC v. Corcept Therapeutics, Inc.
`Case IPR2018-01494
`Ex. 2009-0001
`
`

`

`MIKKO OSKARI HEIKINHEIMO, Ph.D.
`
`Videotaped Deposition of MIKKO OSKARI
`
`HEIKINHEIMO, Ph.D., held at the offices of:
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`Page 2
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`Massey & Gail, LLP
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`1000 Maine Avenue, Southwest
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`Washington, D.C. 20024
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`Taken pursuant to notice before Tina M.
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`Alfaro, a Notary Public within and for the District
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`of Columbia.
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 2009-0002
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`

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`MIKKO OSKARI HEIKINHEIMO, Ph.D.
`
`APPEARANCES:
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`Page 3
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`ON BEHALF OF THE PETITIONER:
`
`MASSEY & GAIL
`
`BY: CHRISTOPHER MAY, ESQ.
`
`KENNETH GOLDMAN, ESQ.
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`1000 Maine Avenue, S.W.
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`Washington, D.C. 20024
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`ON BEHALF OF THE PATENT OWNER:
`
`LATHAM & WATKINS
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`BY: DAVID FRAZIER, Ph.D., ESQ.
`
`MICHELLE ERNST, ESQ.
`
`555 11th Street, N.W.
`
`Washington, D.C. 20004
`
`ALSO PRESENT: Joshua Harris (Burford Capital)
`
`Eric Stops (Quinn Emanuel)
`
`David Campbell (videographer)
`
`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 2009-0003
`
`

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`Page 4
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
` I N D E X
` EXAMINATION
` WITNESS PAGE
` MIKKO OSKARI HEIKINHEIMO, Ph.D.
` By Mr. Frazier 7
` By Mr. May 116
` EXHIBITS
` HEIKINHEIMO EXHIBITS PAGE
` Exhibit 1 37
` Table
`
` Exhibit 2 50
` Article published in Journal of
` Contraception
`
` Exhibit 3 89
` "Clinical Pharmacology of RU486 and
` Antiprogesterin and Antiglucocorticoid"
`
` Exhibit 4 91
` "Effects of the Antiprogesterone RU486
` in Normal Women"
`
` PREVIOUSLY MARKED EXHIBITS
` HEIKINHEIMO EXHIBITS PAGE
` Exhibit 1001 39
` 348 Patent
`
` Exhibit 1004 26
` Declaration
` Exhibit 1005 9
` Curriculum Vitae
`
` Exhibit 1006 73
` Murphy et al., article from 1993
`
`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 2009-0004
`
`

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`MIKKO OSKARI HEIKINHEIMO, Ph.D.
`PREVIOUSLY MARKED EXHIBITS
`(Cont'd)
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` PETITIONER EXHIBITS
` Exhibit 1007
` Belanoff article
`
` Exhibit 1008
` Sitruk-Ware article
` Exhibit 1010
` Belanoff '953 Patent
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`Page 5
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`PAGE
`59
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`80
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`76
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` Exhibit 1012
` "Plasma Concentrations and Receptor
` Binding of RU486 and Its Metabolites in
` Humans"
` Exhibit 1013
` "Pharmacokinetics of the
` Antiprogesterone RU486 in Women During
` Multiple Dose Administration"
`
`109
`
`102
`
`112
` Exhibit 1014
` "Pharmacokinetics of mifepristone after
` low oral doses"
`
` Exhibit 1023
` Chu and Belanoff article
` Exhibit 1024
` '848 Belanoff application
`
` PATENT OWNER EXHIBITS
`
`69
`
`63
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`PAGE
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`86
` Exhibit 2006
` "Mifepristone: Clinical Pharmacology"
`
`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 2009-0005
`
`

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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
`
` THE VIDEOGRAPHER: This is the start of
`
` media unit No. 1 of the videotaped deposition of
`
` Mikko Oskari Heikinheimo in the matter of Neptune
`
` Generics, LLC versus Concept [sic] Therapeutics,
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` Inc. This is in the United States Patent and
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` Trademark Office before the Patent and Appeal Board,
`
` IPR No. 2018-01494.
`
` This deposition is being held at 1000 Maine
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`09:07:45
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`10
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` Avenue, Southwest, Suite 450, Washington, D.C. 20024
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` on May 2nd, 2019 at approximately 9:07 a.m.
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` specialist. The court reporter today is Tina Alfaro
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` in association with TSG Reporting.
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` Counsel, will you please identify
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` yourselves for the record, and then the witness will
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` be sworn in and we can proceed.
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`09:08:19
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` MR. MAY: Christopher May for the
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`09:08:20
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` Petitioner, Neptune Generics, and with me is Kenneth
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`09:08:22
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` Goldman of Massey & Gail and Joshua Harris of
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` Burford Capital.
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`09:08:26
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` MR. FRAZIER: David Frazier from Latham &
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` Watkins for Corcept. I'm joined today by Michelle
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`09:08:29
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` Ernst, also of Latham & Watkins.
`
`TSG Reporting - Worldwide 877-702-9580
`
`Ex. 2009-0006
`
`

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`Page 7
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` MR. MAY: Should we --
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` MR. FRAZIER: Just observing --
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` MR. STOPS: Eric Stops from Quinn Emanuel.
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` MR. FRAZIER: And to be clear, Eric is not
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` appearing on the record, he's just observing.
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` MR. MAY: Understood.
`
` MIKKO OSKARI HEIKINHEIMO, Ph.D.,
`
` called as a witness herein, having been first duly
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`09:08:46
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` sworn, was examined and testified as follows:
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` EXAMINATION
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` BY MR. FRAZIER:
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` Q. Good morning, Dr. Heikinheimo.
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` A. Good morning.
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` Q. Have you been deposed before?
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` A. Have I been to --
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` Q. Have you been deposed before?
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` A. No.
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` Q. Okay. So you understand that you are under
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` oath today?
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` A. Of course.
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` Q. And -- and there's no reason that you can't
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` testify truthfully, correct?
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` A. No reason.
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`09:09:15
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` Q. Okay. You're not taking any medication or
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 2009-0007
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`

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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
`
` anything that would affect your ability to testify
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`Page 8
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` truthfully, correct?
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` A. No.
`
` Q. All right.
`
` And you understand that we are on an oral
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` record here. We have a court reporter writing down
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` everything we say. So it's important that we get
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` our answers out orally and not just nod or say
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` uh-huh, things like that. Can you do that?
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` A. I understand that.
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` Q. Excellent.
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`09:09:37
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` Also, I'll be asking a number of questions.
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` If at any time you don't understand my question,
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` please ask me to clarify it. If you don't ask me to
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` clarify it, I'll have to assume that you have
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` understood it. Is that fair?
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` A. I understand that.
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` Q. And I'm happy to accommodate any breaks
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` that you need. Just let me know. I would ask that
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` you finish the answering -- if I have a pending
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` question, answer that, but just let me know if you
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` need a break at any time. All right?
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`09:10:00
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` A. That's fine.
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` Q. And then the other thing that -- that your
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 2009-0008
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`

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`MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` counsel's probably already told you, but, of course,
`
` you're not allowed to discuss your testimony with
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` counsel during the breaks. Do you understand that?
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`A. Okay.
`
`Q. All right. Let's look at Exhibit 1005.
`
`A. Thank you.
`
`Let me show you, Doctor, what's been
`
` already marked in this case as Exhibit 1005.
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`09:10:41
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`MR. MAY: Are you planning to independently
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` mark that or we're just going to go with
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` Exhibit 1005?
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`MR. FRAZIER: I think we'll just call
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` them -- if they're already marked, we'll leave them
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` marked as they are. I'm sorry. Is that all right
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`09:10:53
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` with you?
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`MR. MAY: Okay. That's fine.
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` BY MR. FRAZIER:
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`09:11:00
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`Q. All right. And, Doctor, is this a copy of
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`09:11:02
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` your curriculum vitae?
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`09:11:05
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`A. Yep. This is a copy of my curriculum vitae
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` about -- a little bit more than one years old,
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` but...
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`Q. A little more than one year old?
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`A. Yeah.
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 2009-0009
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` Q. And is it a complete copy or just a partial
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` copy?
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` A. It is a -- I believe a complete copy of the
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` CV that I've provided. It's a two-page CV.
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` Q. It's a two-page CV. And I notice
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` there's -- there's no list of publications on this
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` CV?
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` A. Not on this one.
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` Q. Okay. And do you have another version of
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` A. Surely. On my computer.
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` Q. On your computer you have a list, but in
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` A. That depends on the purpose.
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` Q. Okay. And was there a reason that you
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` didn't include the publications on the CV that you
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` used in connection with your declaration in this
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` case?
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` rather than tens of pages. So I didn't come to
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` think of it.
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` Q. So you just didn't think of using the
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`09:12:17
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` version that had your publications on it?
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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`Page 11
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` A. No.
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` Q. All right.
`
` Have you testified as an expert before?
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` A. Not in an occasion like this.
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` Q. Okay. In -- in any sort of proceeding have
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` you acted as an expert witness?
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` A. Not outside of academic events.
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` Q. I see. So are you saying you've been an
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`09:12:46
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` academic consultant?
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` A. Multiple times.
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` Q. And have you ever provided any consulting
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` before?
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` A. No.
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` Q. Now, your CV provides your training and
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`09:13:10
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` background, correct?
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` A. Yes.
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` Q. And your medical training is listed here
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`09:13:16
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` under the heading of "Training"; is that correct?
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` A. Yes.
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` Q. Actually, just for my information, is
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` your -- this CV is written in English. Do you also
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`09:13:27
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` have a Finnish version of the CV, or do you
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`09:13:31
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` typically use the English CV?
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`MIKKO OSKARI HEIKINHEIMO, Ph.D.
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`A. I typically use the English -- English
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` version.
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`Q. And -- and I should just comment, so we're
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` speaking in English today and you're comfortable
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` speaking in the English language for this
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` deposition?
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`A. Yes. And I shall ask if I don't
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` understand.
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`Q. Excellent. Thank you.
`
`Okay. So could you just help me understand
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` your medical training here. When did you begin what
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` would be essentially a medical school type of
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` training?
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`A. That was '83.
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`Q. In 1983?
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`A. 1983.
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`Q. All right. And -- and then it says you
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`09:14:14
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` became a medical doctor in 1989; is that correct?
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`09:14:18
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`20
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`A. Yes. In Finland medical school lasts for
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`09:14:23
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`21
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` six years if you don't take any pauses in between.
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`09:14:27
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`22
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`Q. And is medical school in Finland
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` essentially sort of a combination of an
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`09:14:33
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`24
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` undergraduate general education and then medical
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`09:14:35
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` training on top of that?
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` A. They are sort of combined from the very --
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`Page 13
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` very beginning.
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` Q. Right.
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` And then after your medical school training
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` you specialized in surgery; is that correct?
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` A. No. In obstetrics and gynecology.
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` Q. Okay. It says "Doctor of Medicine in
`
` surgery in 1990." What is that?
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`09:14:59
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` A. That's a Finnish -- Finnish academical
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` degree that one can be awarded after having
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` Q. I see. And so was there a particular
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` specialization for your Doctor of Medicine degree?
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`09:15:21
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` A. So I did my thesis work on the
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`09:15:26
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` pharmacokinetics of mifepristone which was presented
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`09:15:29
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` some 30 years ago.
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`09:15:38
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` Q. And as part of your thesis work, then, did
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`09:15:45
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`19
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` you have specialized training in pharmacokinetics?
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`09:15:47
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`20
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` A. Yes, and, of course, through the research
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` work.
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`09:15:51
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`22
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` Q. What specialized training in
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`09:15:52
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`23
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` pharmacokinetics did you have?
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`09:15:55
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`24
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` A. Courses -- several courses, conference
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`09:16:04
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` attendances, those kinds of things.
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`Ex. 2009-0013
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`MIKKO OSKARI HEIKINHEIMO, Ph.D.
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`THE REPORTER: I'm sorry. I didn't
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` understand.
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`THE WITNESS: Attending various scientific
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` meetings.
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` BY MR. FRAZIER:
`
`Q. And what led you to study mifepristone for
`
` your thesis?
`
`A. I was offered a possibility of doing
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`09:16:24
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` research in a group specializing in female
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`09:16:28
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` healthcare, contraception, family planning, and
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` mifepristone had just been introduced as a new
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` molecule at the time and that was something that the
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` laboratory was working with and I got this project.
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`Q. And was there a particular clinical
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` application of mifepristone that you were interested
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`09:16:52
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` in in 1990?
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`09:16:53
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`A. 1990.
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`09:16:55
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`Q. Or before.
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`09:17:01
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`A. At that time mifepristone was not on the --
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`09:17:04
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`21
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` on the Finnish market or actually was only in the
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`09:17:07
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`22
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` French market. So my thesis work was more
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`09:17:10
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`23
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` theoretical. Of course, it had some sort of
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`09:17:14
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` clinical applications which were -- were discussed
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`09:17:19
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` in the scientific papers.
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`Ex. 2009-0014
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`MIKKO OSKARI HEIKINHEIMO, Ph.D.
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`Q. And in considering the pharmacokinetics of
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` mifepristone that you were studying as part of your
`
` thesis, were you primarily focused on its
`
` antiprogesterone characteristics?
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`A. So my work was -- was on establishing assay
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` methods, looking at -- analyzing the serum levels,
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` looking at the metabolism of -- of mifepristone
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` following single dose and multiple dose
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`09:18:00
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` administrations.
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`Q. And after your thesis on your CV it
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` indicates that you did a postdoctoral fellowship?
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`A. Yes.
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`Q. And what was the subject matter of your
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` postdoctoral fellowship?
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`A. I had two separate study subjects. I was
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`09:18:21
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` looking at the effects of antiprogestins in the
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`09:18:27
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`18
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` Eastern Virginia Medical School using a primate
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`09:18:30
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`19
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` model which was very well established there at the
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`09:18:33
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`20
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` time. I also did some gene expression studies.
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`09:18:38
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`21
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`Q. And what antiprogestins were you looking at
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`09:18:42
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`22
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` as part of your postdoctoral studies?
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`09:18:47
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`A. Mifepristone.
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`09:18:50
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`Q. Any others besides mifepristone?
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`09:18:52
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`A. No.
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` Q. Then it says in 1996 -- or from 1996 to
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` 2007 you held a position at the University of
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`Page 16
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` Helsinki, correct?
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` A. Yes.
`
` Q. And the position was called docent?
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` A. Yes. That's a typical Nordic and German
`
` academical degree. It's like a senior lecturer.
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` Q. And you indicate there that that was in
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` endocrinology?
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` A. Yes.
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` endocrinology as -- as part of that position?
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` A. As theoretical endocrinology. At the same
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` time I was doing the residency in obstetrics and
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` gynecology.
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`09:19:42
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` Q. And were you doing research during that
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` time period when you were a docent?
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`09:19:48
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` A. Yes.
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`09:19:48
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`20
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` Q. And what was the subject area of your
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`09:19:50
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`21
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` research?
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`09:19:55
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` A. During those years family planning,
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`09:19:58
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`23
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` abortion care, long-term reversible contraception.
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`09:20:05
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` Q. Were you still studying mifepristone at
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`09:20:08
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` that point?
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`Ex. 2009-0016
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` A. Partly.
`
` Q. Did there come a time when you stopped
`
` studying mifepristone?
`
` A. There really hasn't come a time.
`
` Q. So you've continued to study mifepristone
`
` continuously from the late 1980s until today; is
`
` that fair?
`
` A. Yes, further developing the clinical
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`09:20:33
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` applications, medical abortion care, special
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` Q. And the endocrine effects you said?
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` A. Uh-huh.
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` Q. And have you done any study of the
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` psychological effects of mifepristone?
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` A. Not directly, no. We have looked at the
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`09:20:58
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`17
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` psychological effects of medical abortion, but --
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`09:21:05
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` but in that way.
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` Q. Have you studied the use of mifepristone
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`09:21:13
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`20
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` for mental health applications?
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`09:21:15
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` A. No.
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`09:21:27
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`22
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` Q. It says from 2004 to 2005 there's a course
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`09:21:32
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`23
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` on university pedagogy. What is that referring to?
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`09:21:37
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`24
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` A. Yeah. That's something which is needed
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`09:21:41
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`25
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` currently for if one wants to aim for academical
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` position -- positions, like a professorship, you
`
` need to show that you have done studies on pedagogy.
`
` Q. And what -- what is involved then in the
`
` course on pedagogy?
`
` A. It was something that one would do along
`
` with their regular work, different teaching methods,
`
` for example.
`
` MR. MAY: Don't you wish we'd had that.
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`09:22:16
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` BY MR. FRAZIER:
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`09:22:16
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`11
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` Q. And was there -- was there classwork
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` involved in that?
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` A. Yes.
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`09:22:20
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`14
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` Q. And what kinds of classes were you taking?
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`09:22:27
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`15
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` A. It was a group of about -- of about 20 --
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`09:22:29
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`16
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` 20 people, you know, being at the sort of senior
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`09:22:34
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`17
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` lecture level teachers. It was fairly new when I
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`09:22:37
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`18
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` did -- when I did that course in 2004. Now it's
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`09:22:42
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`19
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` commonly required.
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`09:22:50
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`20
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` Q. So essentially the coursework was in
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`09:22:52
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`21
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` training you had to be a better instructor; is that
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`09:22:55
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`22
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` the idea?
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`09:22:56
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`23
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` A. Yes.
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`09:22:56
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`24
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` Q. Understood.
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`09:22:59
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`25
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` Then -- then it says from 2007 you were a
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` docent in obstetrics and gynecology, correct?
`
` A. Yes. Or starting from 2007.
`
` Q. And was there coursework in connection with
`
` that position?
`
` A. No. No.
`
` Q. Was there practical training associated
`
` with that?
`
` A. You can become a docent in a clinical
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`09:23:22
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` specialty, for example, in obstetrics and gynecology
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` once you have been a specialist for two years and
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` once you have sort of shown significant scientific
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` merits and it's been evaluated by external
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` evaluators.
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` Q. And then in 2009, 2010 it says you were
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` qualified in medical administration by the Finnish
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` Medical Society; is that correct?
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` A. Yes.
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` Q. And what is that?
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` A. Similarly, a course lasting for about a
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` year that you take along your work, maybe two days
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` per month studying medical administration.
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` Q. And by "medical administration" do you mean
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`09:24:08
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` things like running an office or a hospital?
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` A. Hospital, yeah.
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 2009-0019
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` Q. A hospital.
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` And then in 2007 you had training in good
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` clinical practices?
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` A. Yes.
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` Q. And that's generalized clinical training;
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` is that fair?
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` A. Yes. And it's also an official training
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` needed, you know, to run a clinical -- clinical
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` trials.
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` Q. To run clinical trials, right?
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` A. Uh-huh.
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` Q. So what training did you receive in running
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` clinical trials?
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` A. Coursework, some reading material, and so
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` forth.
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` Q. Any instruction in statistical methods?
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` A. Yes. Yeah.
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` Q. What training did you have in mental
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` health?
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` A. In mental health?
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` Q. Yes.
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` A. Obviously during my medical student there
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` was a fair -- a month of psychiatry, but I'm not a
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` psychiatrist by training.
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
`
` Q. So you had exposure to psychiatry as part
`
` of your medical school training?
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` A. As part of my medical school training.
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` Q. Any -- any further training after medical
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` school in mental health or mental healthcare?
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` A. In our system all specialists need to do
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` general practice for about one year, and obviously
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` there you run into some hands-on situations.
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` Q. Did you have a specific rotation or
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` training period in mental health care, psychiatry as
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` part of your general medical training?
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` A. No.
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` Q. So you're saying that as part of the
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` general medical training there were just patients
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` who came in who had medical -- mental health issues
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` that you would have to deal with as part or your
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` general practice?
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` A. Yes.
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` Q. And would you typically refer such patients
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` to a mental healthcare specialist or clinic?
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` A. That, of course, depends on the severity of
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` a case.
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` Q. So the more severe patients would be
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`09:26:26
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` referred, the less severe --
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
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` A. Yeah, would be treated in the primary
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` healthcare.
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` Q. What is your relationship to Neptune
`
` Generics, the party in this case?
`
` A. The name has become familiar on this -- on
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` these documents that I've seen. No other
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` relationship.
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` Q. And when did you first come into contact
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` with representatives of Neptune?
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` A. Ken Goldman contacted me in early 2018.
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` Q. And had you had any other contacts with
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` representatives of Neptune before early 2018?
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` A. No.
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` Q. And you're being compensated for the
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` services you're providing in connection with this
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` case, correct?
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` A. Well, in order to come here I needed to
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` take time off from work. I'm hoping to be
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` compensated for -- for that certainly.
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` Q. You're being reimbursed for your travel,
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` you're saying?
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` A. Plus the time -- you know, I took unpaid
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` leave from work. So I'm hoping not to make
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` financial loss because of this.
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`TSG Reporting - Worldwide 877-702-9580
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`Ex. 2009-0022
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` MIKKO OSKARI HEIKINHEIMO, Ph.D.
`
` Q. But are you -- are you receiving an hourly
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` consulting fee for your services?
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` A. I believe so, yes.
`
` Q. And how much is that hourly fee?
`
` A. In the contract that we signed previously
`
` it was 400 euros per hour.
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` Q. 400 euros per hour?
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` A. If I recall right, yeah, 400 euros or
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` dollars, yeah. I would have to check that.
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` Q. All right.