` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`Page 1
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`AMNEAL PHARMACEUTICALS LLC, )
` )
` Petitioner, ) CASE NO.
` ) IPR2018-00943
` -v- )
` ) Patent No.
`ALKERMES PHARMA IRELAND ) 7,919,499
`LIMITED, )
` )
` Patent Owner. )
`-----------------------------
`
` The deposition upon oral examination of
`SARA QUINNEY, Ph.D., a witness produced and sworn
`before me, Debbi S. Austin, RMR, CRR, Notary Public in
`and for the County of Hendricks, State of Indiana,
`taken on behalf of the Petitioner at the offices of
`Harrison & Moberly, 10 West Market Street, Suite 700,
`Indianapolis, Indiana, on May 24, 2019, at 9:30 a.m.,
`pursuant to the Federal Rules of Civil Procedure.
`
`Job No. 161382
`
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`ALKERMES EXHIBIT 2057
`Amneal Pharmaceuticals LLC v. Alkermes Pharma Ireland Limited
`IPR2018-00943
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` SARA QUINNEY
` APPEARANCES
`
`FOR THE PETITIONER:
` Michael Stramiello, Ph.D., Esq.
` PAUL HASTINGS
` 875 15th Street, N.W.
` Washington, DC 20005
` Gerard Salvatore, Esq.
` PAUL HASTINGS
` 200 Park Avenue
` New York, NY 10166
`
`FOR THE PATENT OWNER:
` Tedd Van Buskirk, Esq.
` LERNER, DAVID, LITTENBERG,
` KRUMHOLZ & MENTLIK
` 600 South Avenue West
` Westfield, NJ 07090
`
`ALSO PRESENT: John W. Kirkland, Alkermes
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` SARA QUINNEY
` INDEX OF EXAMINATION
` PAGE
`EXAMINATION
` Questions By Mr. Stramiello: 5
`
`Page 3
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` INDEX OF EXHIBITS
`NUM. DESCRIPTION PAGE
`Exhibit 1001 U.S. Patent No. 7,919,499 39
`Exhibit 1010 "Depot Naltrexone: 49
` Long-lasting antagonism of the
` effects of heroin in humans"
`Exhibit 1014 U.S. Patent No. 7,157,102 49
`Exhibit 1062 Declaration of Sara K. Quinney, 30
` Pharm.D., Ph.D. in Support of
` Petitioner's Reply to Patent
` Owner's Response
`Exhibit 1063 Curriculum Vitae 7
`Exhibit 1064 "Effect of liver cirrhosis on 56
` the systemic availability of
` naltrexone in humans"
`Exhibit 1081 "Naltrexone: A review of 55
` existing sustained drug
` delivery systems and emerging
` nano-based systems"
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` SARA QUINNEY
` INDEX OF EXHIBITS (CONT'D.)
`NUM. DESCRIPTION PAGE
`Exhibit 2017 "Naltrexone: Disposition, 52
` metabolism, and effects after
` acute and chronic dosing"
`Exhibit 2028 "Bioequivalence, 60
` Dose-Proportionality, and
` Pharmacokinetics of Naltrexone
` after Oral Administration"
`Exhibit 2038 "Narcotic Antagonists: 57
` Naltrexone Pharmacochemistry
` and Sustained-Release
` Preparations"
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` SARA QUINNEY
` SARA QUINNEY, Ph.D.,
`having been first duly sworn to tell the truth, the
`whole truth, and nothing but the truth, was examined
`and testified as follows:
`EXAMINATION
`BY MR. STRAMIELLO:
`Q Good morning, Dr. Quinney. Would you please state
` and spell your name and home address for the
` record.
`A Sure. It's Sara Quinney, S-A-R-A, Q-U-I-N-N-E-Y,
` and my home address is 2384 Smith Road, Plainfield,
` Indiana.
`Q Thank you.
` And you're here for petitioner, Amneal
` Pharmaceuticals, LLC; correct?
`A Correct.
`Q Do you understand that you're under oath today?
`A Yes.
`Q Is there any reason why you cannot provide honest
` and complete testimony today?
`A No.
`Q Let's go over a few ground rules. First, I plan a
` few breaks. If you need additional ones, please
` just let me know.
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` SARA QUINNEY
` Out of respect for the court reporter, let's
` please try not to talk at the same time. Since our
` conversation is being transcribed, please try not
` to answer questions with nonverbal gestures such as
` nods.
` If you believe you do not fully understand one
` of my questions, would you please ask me for
` clarification before you respond.
`A Yes.
`Q And if you respond to a question, I will assume you
` fully understood the question. Is that fair?
`A That's fair.
`Q Thank you.
` Dr. Quinney, what is your occupation?
`A I'm a clinical pharmacologist.
`Q Have you served as a consultant in any other legal
` proceedings?
`A No, I have not.
`Q Have you ever been deposed before?
`A No.
`Q What did you do to prepare for today's deposition?
`A Throughout the last couple of months, I've been
` reading the articles and reviewing information as
` requested by the legal firm and putting together a
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` SARA QUINNEY
` report.
`Q Are there any materials other than your report that
` you used to prepare for today's deposition?
` MR. VAN BUSKIRK: Objection as to form.
`A Can you rephrase the question, please.
`Q Are there any materials other than your report that
` you used to prepare for today's deposition?
`A Just the materials that were provided in the
` packets, so ...
`Q What packets are you referring to?
`A The documents, the legal -- I'm blanking on the
` name of what I need to call it.
` MR. VAN BUSKIRK: The briefs?
`A The briefs, yes.
`Q Anything else?
`A No.
`Q So do you understand that we're here today
` regarding inter partes review case
` No. IPR2018-00943?
`A Yes.
`Q So we're going to hand you Exhibit 1063. And this
` is your CV; correct?
`A Yes, it is.
`Q Is this CV current?
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`A There has been a few additions since this version,
` a couple of new manuscripts. I believe, have been
` published in the last month or two. And then I've
` had a few students graduate.
`Q What was the subject matter of those manuscripts?
`A One of -- the manuscript -- let's see. The one
` that's not included, the submitted manuscript on
` here has been accepted, and then there's another
` manuscript, looking at the -- it's a randomized
` controlled trial of misoprostol for labor induction
` comparing buccal misoprostol versus vaginal.
`Q Okay. Thank you.
` Have there been any other additions or
` changes?
`A Nothing substantive.
`Q Did you have two Ph.D. advisors?
`A Yes, I did. So Dr. Murry was my original advisor
` at Purdue, and he left and went to Iowa during, I
` think, my second year of graduate school. And I
` worked in Dr. Bosron's lab after that.
`Q What was the focus of your research in Dr. --
`A So it was on carboxylesterase inhibitors or
` substrates, irinotecan and capecitabine for
` colorectal cancer.
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`Q And that was in Dr. Murry's lab?
`A In both. It was a co-mentorship. We started in
` Dr. Murry's lab, and I completed the work in
` Dr. Bosron's lab. He was an expert in
` carboxylesterases.
`Q You're currently affiliated with Indiana
` University; right?
`A Correct.
`Q What is your title there?
`A I'm an assistant professor of obstetrics and
` gynecology.
`Q Anything else?
`A Adjunct professor, assistant professor of -- in the
` division of clinical pharmacology in the department
` of medicine, an adjunct assistant professor in the
` school of bioinformatics and computing, and a
` member of the Center for Computational Biology and
` Bioinformatics, and then associate director of the
` Disease and Therapeutic Response Modeling Program.
`Q Anything else?
`A I don't know if it's on here, because I don't put
` it on a lot. A member of the Indiana University
` Cancer Center. I think that's it. There may be
` others. I'm also an associate with Purdue
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` SARA QUINNEY
` University as an adjunct faculty member in their
` pharmacy practice department.
`Q How long have you been an associate with Purdue
` University as an adjunct in their pharmacy practice
` department?
`A It's been within the last year, I believe.
` Actually, it's not on here either. Unless it's in
` another spot. And I guess on here I have the
` Institute of Personalized Medicine as well.
`Q When was this CV prepared?
`A It would have been prepared in -- probably in
` March.
`Q And you said it does not include that you were an
` associate with Purdue University as an adjunct in
` their pharmacy practice department?
`A Not that I see here. It does include my role as --
` what my role is here with them in being a committee
` member for their candidates, for their Ph.D.
` students, which is why I have the adjunct
` appointment. And the department of pharmacy
` practice is actually located -- the people I work
` with are actually located in Indianapolis, not in
` Lafayette on the main campus.
`Q And you were an adjunct in Purdue University's
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` pharmacy practice department at the time that the
` CV was prepared; correct?
`A That's correct. It just looks like it was left off
` of here.
`Q Do you know why it was left off of there?
`A Probably an oversight by my administrative
` assistant, and I didn't catch it.
`Q Do you have any experience with naltrexone?
`A Not directly until working on this case, other than
` knowing that it's for opioid use disorder.
`Q Do you have any experience indirectly working with
` naltrexone?
`A No, not -- other than knowing that it's used for
` opioid use disorder, no.
`Q Would you say that you know a good deal about
` naltrexone?
` MR. VAN BUSKIRK: Objection as to form.
`A Can you please repeat.
`Q Would you say you know a good deal about
` naltrexone?
` MR. VAN BUSKIRK: Same objection.
`Q Please.
`A My --
` MR. VAN BUSKIRK: You can answer if you
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` understand.
`A -- counsel objected.
` Not prior to this case.
`Q Would you say that you know a good deal about
` naltrexone now?
`A I would say I know a good deal about the
` pharmacokinetics of naltrexone now.
`Q What is the basis for your understanding about the
` pharmacokinetics of naltrexone?
`A Reviewing of the literature.
`Q What literature?
`A Publications prior to -- predominantly prior to
` 2004 that were relevant to this case as well as
` some other documents, the package insert and other
` information on naltrexone from -- in public domain.
`Q Thank you.
` And were those publications provided to you?
`A Not all of them.
`Q Roughly how many of them did you obtain
` independently?
`A Probably 30 or 40. I did a thorough PubMed search
` and even documents that were found -- were provided
` to me, I found independently.
`Q So you did an independent search before documents
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` were provided to you?
`A Correct.
`Q Is there anything else that contributes to your
` basis -- strike that, please.
` Is there anything else that would serve as the
` basis for your understanding about the
` pharmacokinetics of naltrexone?
`A Just general knowledge on pharmacokinetics and drug
` metabolism.
`Q And you mentioned that you reviewed other
` information on naltrexone from the public domain.
` What do you mean by that?
`A So looking at sources like drug bank, looking at
` molecular structure, the package insert, FDA
` documentation.
`Q Do you think you know a good deal about the
` pharmacokinetics of naltrexone as they were known
` in approximately 2004?
`A I believe so.
` MR. VAN BUSKIRK: Objection as to form.
` You can answer.
`A I believe so.
`Q Do you have any experience in formulating drugs?
`A Not directly formulating, but in direct
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` formulations, yes, and as far as understanding the
` pharmacokinetics of formulations.
`Q So you do not consider yourself to have experience
` in formulating drugs; is that correct?
`A I am not a formulation scientist.
`Q Thanks. That's not quite what I asked.
` Do you consider yourself to have experience in
` formulating drugs?
`A I'm unclear about what you mean by "formulating."
`Q What do you interpret the word "formulating" to
` mean?
`A Manufacturing and producing, and no, I don't have
` experience in manufacturing and producing drug
` formulations. I have experience in understanding
` the pharmacokinetics of drugs from different
` formulations.
`Q Do you have any experience in drug design?
`A Yes.
`Q Please explain.
`A So understanding drug design and how formulations
` impact the pharmacokinetics of drugs, I do. I
` understand drug design in pharmaceutical
` development from small molecule identification or
` large molecule identification through phase 3
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` clinical trials or phase 4 clinical trials now.
`Q Do you have any experience with controlled-release
` formulations?
`A Yes.
`Q Please explain.
`A So looking at pharmacokinetics from
` controlled-release formulations, I have experience
` with that as well.
`Q Have you ever been involved in research and
` development efforts that resulted in a drug
` candidate for FDA approval?
`A No, I have not.
`Q Do you have any experience with long-acting
` injectable formulations?
`A From a pharmacokinetics standpoint, yes.
`Q Anything else?
`A I'm not sure I understand what you mean.
`Q Clinically, do you have any experience with
` long-acting injectable formulations?
`A Yes.
`Q Please explain.
`A So many long-acting injectables or
` controlled-release formulations are often used for
` treatments of disorders. For instance, drugs used
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` for birth control are often provided in long-acting
` formulations. It's not -- so the betamethasone
` that we use is not as extended release as the
` naltrexone formulation we're discussing here, but a
` component of that is somewhat long-acting. So I'm
` comfortable with looking at those data as well. A
` lot of the drugs we're using are -- in clinical
` practice now are long-acting.
`Q Clinically, do you have any experience with
` naltrexone?
`A No, I do not.
`Q Do you have any possible conflicts of interest with
` respect to your involvement in this case?
`A No, I do not.
`Q Your CV does not mention naltrexone; correct?
`A I don't believe so.
`Q And it does not mention controlled-release
` formulations either; correct?
`A It might.
`Q I see that you're looking at your CV. Please take
` your time.
`A Thank you.
` Do you mind repeating your question?
`Q Your CV does not mention controlled-release
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` formulations; correct?
` MR. VAN BUSKIRK: Do you mean does it use
` those particular words?
` MR. STRAMIELLO: Counsel, the questions are
` for the witness. Please check the speaking
` objections.
` MR. VAN BUSKIRK: I object to form. Can you
` clarify your question, please.
` MR. STRAMIELLO: Counsel, asking me to clarify
` my question is not a proper objection.
`Q Dr. Quinney, your CV does not mention
` controlled-release formulations; correct?
`A I do not believe it uses the words
` "controlled-release formulations."
`Q Thank you.
` Does it mention controlled-release
` formulations?
`A It does not use the word "controlled-release
` formulations."
`Q I'm asking you a different question. Does your CV
` mention controlled-release formulations?
`A That was the same question.
` MR. VAN BUSKIRK: Objection as to form.
`A I believe. Can you repeat the first question you
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` asked?
`Q Sure. Does your CV mention controlled-release
` formulations?
` MR. VAN BUSKIRK: Asked and answered.
`A It does not use the words "controlled-release
` formulations."
`Q Does it use any other words that relate to
` controlled-release formulations?
`A It does not use terms that are synonyms for
` controlled-release formulations, no, but there are
` some mentions of drugs that may be considered
` extended release.
`Q Since completing your Ph.D., have you ever picked
` up a scientific article, looked at a series of mean
` plasma concentrations that it provides, and then
` calculated an AUC by hand?
`A Yes.
`Q Please explain.
`A Many times we need to estimate data that's not
` available directly in the publications in tables,
` and so many times I will -- if the data is -- the
` AUC or other data is not available in a table or
` precalculated format, I'll pull the data and
` calculate it myself, if it's something I need
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` for -- to know.
`Q Dr. Quinney, before this case, had you ever worked
` with Lerner David?
`A No, I have not.
`Q Are you working with Lerner David on any other
` matters?
`A No, I am not.
`Q Have you served as a consultant for any company
` other than Amneal?
`A No, I have not.
`Q Did you have any relationship with Amneal prior to
` this case?
`A No, I have not.
`Q Have you ever had any financial interest in Amneal?
`A No, I have not.
`Q So I'm probably not going to pronounce this right,
` but you're working together with Dr. Kinam Park on
` this case; right?
`A That's correct.
`Q And I notice that you and Dr. Park both have
` connections to Purdue University. He's a colleague
` of yours, I assume?
`A He's a faculty member in the industrial and
` physical pharmacy group at Purdue.
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`Q Anything else?
`A And we've worked together previously on some
` preliminary studies.
`Q When?
`A It's been several years ago. In around -- between
` 2014 and 2016. We were both involved in the same
` project.
`Q What was that project?
`A Using physiologically based pharmacokinetic
` modeling to understand drug disposition, the
` virtual human project.
`Q Who else was involved with that project?
`A Tong Lei Li and several other faculty members from
` Purdue and the Korean Institute of Science and
` Technology.
`Q Is this on your CV?
`A The presentations are from that project. The
` project did not result in any publications.
`Q Would you please direct me to the presentations
` that you're referring to?
`A On page 13 under regional. There were two at
` Purdue, one in 2014 and one in 2016. On page 19,
` in 2015 in Korea.
`Q Could you please tell me a little more about the
`
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` one in 2015 in Korea.
`A Yeah. So as I said, this was a combined project
` between the Korean Institute of Science and
` Technology, or KIST, and Purdue University and
` Indiana University. And two of the meetings to
` discuss the project were held at Purdue in 2014 and
` 2016, and the -- and the intermediary year in 2015,
` the meeting was held in Korea.
` It was a meeting of investigators who were
` potentially -- who were involved in this project
` and just discussions of potential progress of
` the -- you know, what the progress on the model was
` and the project and whether we would be able to get
` funding. And in the end, we ended up not being
` able to find sufficient funding to continue.
`Q Do you know whether Dr. Park has connections to the
` Korean Institute of Science and Technology?
`A I believe he does, but I don't know exactly what
` those are.
`Q Did this project in 2015 originate with Dr. Park?
`A He was one of the leaders from the Purdue side.
` I'm not sure who it originated with.
`Q How did you get involved with this project?
`A So one of the faculty from Purdue, Ray Galinski,
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` knew both Dr. Park and myself and was familiar with
` my role in physiologically based pharmacokinetic
` modeling and thought it would be beneficial to the
` project and had put us together.
`Q And you had previously worked with Dr. Park;
` correct?
`A With Dr. Park? I don't believe so.
`Q I think just a moment ago you mentioned that you
` and Dr. Park both contributed to presentations in
` 2014?
`A That was regarding this project. The project was
` in the time frame of 2014 to 2016.
`Q I see. Thank you.
` Were you familiar with Dr. Park prior to this
` project with the Korean Institute of Science and
` Technology in 2015?
`A Yes. He was faculty at Purdue. I was a PharmD
` student, and I'm sure he taught in one of my
` courses, although I don't remember which one at
` this point.
`Q And when you say he taught in one of your courses,
` do you mean you were a student in one of his
` classes?
`A I was a student in one of his classes.
`
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`Q Do you remember how large the class was?
`A I think we were close to somewhere between 180 and
` 200 students.
`Q When was the last time you communicated with
` Dr. Park?
`A It's been several months ago.
`Q So the last time you communicated with Dr. Park was
` in 2019?
`A It may have been in January.
`Q Was that communication in writing?
`A Yeah, it would have been an e-mail.
`Q What was the subject of your communication?
` MR. VAN BUSKIRK: Let me just caution the
` witness that if it's not pertaining to this case
` and there's anything confidential, you should tread
` cautiously.
`A I believe it was just discussing common interests
` in students and potentially looking for Fellows for
` our modeling program.
`Q I'm sorry, let me -- did you say common interests
` in students or common interests and students?
`A In students, so students who may have an
` engineering background or a bioengineering
` background would be candidates for our disease and
`
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` SARA QUINNEY
` therapeutic response modeling program, so I
` regularly send e-mails when we are in need of -- or
` when we have open positions or regarding students
` and whether, you know, they have anyone who may be
` interested in continuing in a post doc position.
`Q Were you the one who initiated your last
` communication with Dr. Park?
`A Yes.
`Q Were you looking for him to refer students to you?
`A Yes. It's -- in an e-mail I sent to several
` faculty members.
`Q That e-mail communication to Dr. Park was nothing
` that you would be -- or excuse me, considered to be
` out of the ordinary?
`A No.
`Q Have you ever communicated with Dr. Park about this
` case?
`A Not directly.
`Q What aspects of this case have you indirectly
` communicated with Dr. Park about?
`A The only communication I've had about this case was
` reading his brief and his reply.
`Q So a few minutes ago you mentioned a modeling
` program that you're involved in with Dr. Park;
`
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` correct?
`A No. He is not involved. The modeling program I
` mentioned or was referring to is our disease and
` therapeutic response modeling program, and he is
` not involved in that.
`Q I'm sorry, so when you say "our," who is --
`A So that is Indiana CTSI School of Medicine program.
`Q I see. Thank you.
` And how long has it been in existence?
`A It was 2009 or 2010, I believe. Rob Bies began it
` at Indiana University.
`Q How did you first hear about this case?
`A I was contacted by an employee of Lerner David.
`Q When?
`A In mid March.
`Q Do you remember which employee of Lerner David was
` the one that first contacted you about this case?
`A I believe her name was Nicole.
`Q Do you think Dr. Park advised Nicole to reach out
` to you about consulting in this case?
`A Probably, because he knows my interest and
` expertise in pharmacokinetics.
`Q And you were tasked with supporting Dr. Park's
` testimony; correct?
`
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`A I was tasked with reviewing the information
` provided in the case and coming to my own
` conclusions regarding that.
`Q Are you aware that Dr. Park has testified in quite
` a few patent litigations?
`A No, I'm not.
`Q What can you tell me about Dr. Park's scientific
` background?
`A So his expertise is in formulations of specifically
` extended release products, nanoparticles, and other
` formulations.
`Q Have you ever served as a reviewer on any of his
` article submissions?
`A No, I haven't.
`Q Has he ever served as a reviewer on any of your
` article submissions?
`A No, he hasn't.
`Q Have you ever cited any of Dr. Park's publications?
`A I can't say for certain without reviewing all of my
` citations, but I don't believe I have.
`Q Do you know if he's ever cited any of yours?
`A I do not know.
`Q Okay. And almost ready for a break here. I see
` we've been going for about 40 minutes.
`
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` (A brief recess was taken.)
`BY MR. STRAMIELLO:
`Q Dr. Quinney, are you getting paid for your
` involvement in this case?
`A Yes, I am.
`Q Who is paying you?
`A Lerner David.
`Q What is your consulting fee?
`A It's my typical consulting fee.
`Q What is the amount?
` THE WITNESS: Am I allowed to answer that?
` MR. VAN BUSKIRK: Yeah.
`A $500 an hour.
`Q Okay. I just want to point something out before we
` move forward here. Counsel can instruct you not to
` answer only when it's necessary to preserve a
` privilege or enforce a limitation ordered by the
` board. And right now, none come to mind that are
` applicable. Just so you know. Okay?
`A Okay.
` MR. VAN BUSKIRK: I think she was just looking
` for some guidance, and she's new at this.
` MR. STRAMIELLO: I appreciate that, but you
` know that speaking objections are prohibited;
`
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` right?
` MR. VAN BUSKIRK: I understand. That wasn't
` an objection. I think that our interests in
` getting a clear record are on both sides' best
` interests.
` MR. STRAMIELLO: I'll appreciate it if you
` please keep an eye on the speaking objections.
` MR. VAN BUSKIRK: Noted.
` MR. STRAMIELLO: Thank you.
` And by the way, I think there was an objection
` earlier that was I don't understand the question,
` and that's textbook improper. You recall that;
` right? Just wanted to point it out so moving
` forward, bear it in mind, please. Thank you.
`BY MR. STRAMIELLO:
`Q So Dr. Quinney, you said your consulting fee is
` $500 an hour; correct?
`A Correct.
`Q And you said that's your customary fee?
`A Yes.
`Q Based on what?
`A Based on discussing with others what their fees
` were and then setting a fee.
`Q And with whom did you discuss your fee for this
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` case?
`A Other faculty member who serves as consultants on
` cases.
`Q Would you please identify those faculty members
` with whom you discussed.
`A I'd prefer not.
`Q I'm asking you to please do so.
`A I know there was Brian Overholser and Richard
` Bergstrom.
`Q Have you ever discussed your fee for this case with
` Dr. Park?
`A I may have asked him, knowing that he serves as a
` consultant. I don't recall.
`Q Would that inquiry have been in writing?
`A Probably. Most of our communication is by e-mail.
`Q What do you recall about the way you phrased that
` inquiry to Dr. Park regarding your consulting fee
` for this case?
`A I don't recall.
`Q Do you recall how Dr. Park responded to your
` inquiry?
`A He likely provided me a number that he uses, but I
` don't recall exactly.
`Q In total, how much money do you expect to receive
`
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` in exchange for your services on this case?
`A Probably around 45,000. Is that right? No.
` 25,000. Sorry.
`Q Dr. Quinney, would you please describe to me how
` your declaration was prepared.
`A I reviewed the briefs provided by Lerner David and
` the documents in the brief as well as additional
` information, had some discussions with Lerner David
` regarding how to create the declaration and wrote
` it up as I typically would any other paper, with
` discussions with them about -- regarding the
` formatting of the paper.
`Q And just to be clear, I'm not asking you to reveal
` any of your communications with counse