`PAGES: 1-361
`EXHIBITS: 2049-2052
`UNITED STATES PARENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`************************************
` MILTENYI BIOMEDICINE GmbH and
`MILTENYI BIOTEC INC.,
` Petitioners
`vs.
`
`TRUSTEES OF THE UNIVERSITY OF
`PENNSYLVANIA,
` Patent Owner
`
`Case IPR 2022-00855
` Patent 9,540,445
`************************************
` MILTENYI BIOMEDICINE GmbH and
`MILTENYI BIOTEC INC.,
` Petitioners
`vs.
`
`TRUSTEES OF THE UNIVERSITY OF
`PENNSYLVANIA,
` Patent Owner
`Case IPR 2022-00852
` Patent 9,518,123
`************************************
`DEPOSITION of RICHARD P. JUNGHANG, Ph.D, M.D.
`Friday, January 13, 20238
` 8:54 a.m.
`Held at: Orrick Herrington & Sutcliffe, LLP
` 222 Berkeley Street
`Boston, Massachusetts
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`January 13, 2023
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`2
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`APPEARANCES:
`ORRICK HERRINGTON & SUTCLIFFE, LLP
` John Lu, Esquire
`Elaine Ke, Esquire
`355 S. Grand Avenue
`Suite 2700
`Los Angeles, California 90071
`213-629-2020
`jlu@orrick.com
`eke@orrick.com
`on behalf of the Petitioners
`
`WILLIAMS & CONNOLLY LLP
` Jessamyn S. Berniker, Esquire
`David Kiernan, Esquire
`Ramon J. Ryan, Esquire
`725 Twelfth Street NW
`Washington, District of Columbia 20005
`202-434-5000
`jberniker@wc.com
`dkiernan@wc.com
`rryan@wc.com
`on behalf of the Patent Owner
`
`SAUL EWING, LLP
` Alireza Behrooz, Ph.D., Esquire
`1919 Pennsylvania Avenue NW
`Suite 550
`Washington, District of Columbia 20006-3434
`202-333-8800
`alireza.behrooz@saul.com
`on behalf of the Patent Owner
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`Transcript of Richard P. Junghang, Ph.D, M.D.
`January 13, 2023
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`3
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` I N D E X
` Witness Page
` RICHARD P. JUNGHANG, Ph.D, M.D.
` Examination by Ms. Berniker 4, 351
` Examination by Mr. Lu 338
`
` E X H I B I T S
` Number Description Page
` Exhibit 2049 ClinicalTrials.gov search 107
` results
` Exhibit 2050 Recombinant DNA Advisory 117
` Committee meeting minutes
` dated 2-10-03
` Exhibit 2051 Recombinant DNA Advisory 196
` Committee meeting minutes
` dated 3-16-05
` Exhibit 2052 Article entitled 266
` "Considerations for the
` Clinical Application of
` Chimeric Antigen Receptor
` (CAR) T cells:
` Observations from a
` Recombinant DNA Advisory
` Committee (RAC) Symposium
` June 15, 2010," dated
` 5-1-11
`Original exhibits were retained by the court reporter
` and returned to Ms. Berniker.
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` P R O C E E D I N G S
` - - -
` RICHARD P. JUNGHANG, PH.D, M.D., first
`having been satisfactorily identified by the
`production of his driver's license, duly sworn
`pursuant to Executive Order 144, testified under
`oath as follows in answer to examination BY
`MS. BERNIKER:
` - - -
` Q. Good morning, Doctor.
` A. Good morning.
` Q. My name is Jessamyn Berniker, and I
`represent the patent owners and Novartis in this
`proceeding. Nice to meet you.
` A. Nice to meet you.
` Q. Doctor, I know you have testified before.
`Do you understand that you need to answer
`completely and truthfully today?
` A. Yes, I understand.
` Q. You understand that you are under oath?
` A. I am under oath.
` Q. Is there any reason why you wouldn't be
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`5
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`able to provide full, truthful testimony today?
` A. No.
` Q. You are not on any medications that would
`impair your ability to do so?
` A. No. And I didn't have any vodka this
`morning.
` Q. Excellent. Neither did I.
` I think you have before you a copy of the
`declarations that you submitted in the two
`proceedings in this case? One of them is
`IPR2022-00855, and the other one is
`IPR2022-00852. Do you have those two in front of
`you?
` A. I am looking at different numbers.
` Q. Okay.
` A. I have '445.
` Q. Yes.
` A. And '123.
` Q. Yes. Those are the two patent numbers.
`Right?
` A. Yes, they are.
` Q. Okay. And for purposes of the
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`Transcript of Richard P. Junghang, Ph.D, M.D.
`January 13, 2023
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`6
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`conversation today, I think it might be helpful
`if we named those two different patents with
`something other than a number. But I had
`intended to refer to the '445 patent as the
`composition patent and the '123 patent as the
`cells patent.
` Does that framing make sense to you, or
`would you prefer that I refer to them by patent
`number?
` A. Just patent numbers. I understand the
`difference.
` Q. No problem. Patent number it is.
` And you also have Exhibit 1001 in each
`case, which is the patent itself. Right, sir?
` A. Yes.
` Q. Okay. So feel free to refer to those as
`you need today.
` Doctor, have you reviewed your
`declaration since the time that you signed it?
` A. I did.
` Q. And is it accurate and complete in your
`estimation?
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` A. Yes, it is.
` Q. Are you aware of any error in either of
`the declarations?
` A. No, I am not.
` Q. Is it fair to say that the declaration
`that you submitted for the '445 patent
`encompasses what you submitted in connection with
`the '123 patent but also has extra material?
` A. I can't say that one entirely subsumes
`the other, but there are substantial areas that
`are the same, and some areas that are different.
` Q. Okay. And what did you review in
`preparing these declarations?
` A. I reviewed a large number of exhibits.
` Q. It says in here, if you take a look at
`the '445 patent declaration, which is the one I
`am going to be working off of for most of the
`day, if you take a look at paragraph 18 of the
`declaration.
` It says, "In forming the opinions in this
`declaration, I considered the materials cited in
`this declaration in light of the general
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`8
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`knowledge in the art before December 9, 2011."
` Do you see that?
` A. I see that.
` Q. Did you review or consider any materials
`that are not cited in this declaration in forming
`your opinions?
` A. No. Everything in here is as cited.
` Q. Just to be clear, if I wanted to
`understand what you reviewed in preparing this
`declaration, if I looked at the materials cited,
`that would be a complete set of what you
`reviewed?
` A. That would be a complete set of what I
`reviewed.
` Q. Did you review the file history for any
`of the patents -- either of the patents at issue?
` A. I don't believe I did.
` Q. Did you review the file history for any
`of the parent applications to those patents?
` A. You mean the provisionals?
` Q. Well, we can start with provisionals.
` A. I didn't review those.
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`9
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` Q. Okay. You didn't review the provisional
`applications themselves?
` MR. LU: Objection. Mischaracterizes.
` A. I don't believe.
`BY MS. BERNIKER:
` Q. Did you review any file histories for any
`patents in this patent family?
` MR. LU: Objection. Mischaracterizes.
` Dr. Junghans, if you could pause before
`answering so I can put in my objection, please.
` THE WITNESS: Yes.
` MR. LU: Thank you.
` A. I was aware that there were different
`provisions preceding this. In terms of
`developing priority date, those provisions are
`important, and I understand the difference
`between those provisions. So I guess that would
`mean I am aware of file history.
`BY MS. BERNIKER:
` Q. So I will take this piecemeal to make it
`a little bit easier.
` A. Thank you.
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` Q. There are provisional applications that
`are cited on the face of these patents. Right?
` A. Yes.
` Q. Did you review those provisional
`applications?
` A. I reviewed them to the extent of
`confirming which had sequence data in it and
`which didn't.
` Q. And when I say the word "file history,"
`you understand that when a patent applicant is
`trying to get a patent from the patent office,
`there is an exchange of communications between
`the patent applicant and the patent office?
` A. Yes, I understand.
` Q. And you understand that that is public
`record, called a file history. Right?
` A. I understand.
` Q. And you understand that a patent
`application can have related patent applications
`that are also being prosecuted in front of the
`patent office. Right?
` A. I understand.
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` Q. So in this case, did you understand that
`there were earlier patent applications, not just
`provisional applications but actually patent
`applications, that related to this family?
` Let me make it even easier. If you could
`pull up the '445 patent that you have in front of
`you, sir. If you could turn to the first
`substantive page, page 2.
` And do you see how it says related U.S.
`application data?
` A. Yes.
` Q. And do you see how it mentions
`application number 13-992622?
` A. Yes.
` Q. Did you review the file history for that
`application?
` A. Did I review correspondence between the
`PTO and the owner? No.
` Q. And in terms of forming your opinions,
`did you look at the '445 patent first? Is that
`the first thing you looked at when you started
`developing your opinions, to see what the claim
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`said?
` A. This was a year ago, and I can't be
`certain of the order in which I reviewed the
`patents.
` Q. But do you generally remember that you
`looked at the claim to see what it covered and
`then you went back to look at what the prior art
`taught?
` A. In general, I went through the claims and
`looked at what had prior art, yes.
` Q. Okay. And the date that you use in your
`declaration as the prior art date you say is
`December 9, 2011. Right?
` MR. LU: Objection. Mischaracterizes.
` Dr. Junghans, if you could pause before
`answering, so I need to put in my objection if
`necessary. Thank you.
` MS. BERNIKER: I'm sorry. I actually
`didn't mean to mischaracterize that at all. That
`is entirely inadvertent. I really apologize.
`BY MS. BERNIKER:
` Q. If we could turn to page 21 of your
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`Transcript of Richard P. Junghang, Ph.D, M.D.
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`13
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`declaration, please.
` I am sorry. Paragraph 21 of your
`declaration.
` Maybe I should have had some vodka this
`morning? Let's start a clean question.
` Doctor, if we could look at paragraph 21
`of your declaration. And I am -- Exhibit 1002.
`Again, the default of my questions will be the
`declaration and the '445 patent case, just to be
`clear.
` You say that, "I understand that the
`petitioner contends the '445 patent cannot
`benefit from a December 9, 2010, priority date,
`and the priority date should be December 9,
`2011."
` Do you see that?
` A. I see that.
` Q. Is that the date that you used for
`purposes of your opinions, December 9, 2011?
` A. I used that date, but I also considered
`that my opinions would not change if an earlier
`priority date had been granted.
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` Q. Okay. And are you aware of whether there
`is any art that would not qualify as prior art if
`the December 9, 2010, date had applied?
` A. I need to check. Nothing substantive.
` Q. Okay.
` A. Yes, nothing substantive.
` Q. Nothing leaps out to you in your mind as
`a key prior art reference that you are relying on
`that would not be prior art if December 9, 2010,
`were the right date?
` MR. LU: Objection. Mischaracterizes.
` A. I don't have in mind a specific exclusion
`that would happen by a different prior art date.
`BY MS. BERNIKER:
` Q. Did you analyze the question of whether
`any of the prior art that you are relying on
`would not qualify as prior art if December 9,
`2010, were the right priority date?
` A. I considered, yes, several articles or
`several sets of data, including Malone, Campana,
`Kochenderfer, Davila, Brentjens, all of which had
`priority dates -- had dates prior to the earlier
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`priority date.
` Q. So you do believe that you undertook to
`determine whether all of the prior art that you
`cite was prior to December 9, 2010?
` A. I did examine those things as part of my
`presentation.
` Q. How many hours did you spend in preparing
`your declaration?
` A. I would have to go back and see what I
`had listed. But more than 20 hours, maybe more
`than 30 hours.
` Q. Okay. Could we turn to your CV, please,
`which is at the end of the declaration? And it
`starts on page 195.
` What is the date that you prepared this
`CV? Or how current is it, I guess is the
`question?
` A. Probably late 2020.
` Q. Late 2020?
` A. Yes.
` Q. Did you review it -- sorry, go ahead.
` A. Yes.
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` Q. When you decided to attach it as an
`exhibit to your declaration, did you review it to
`ensure that you felt like it was accurate?
` A. Yes. I mean, this is basically
`historical, most of it. Yes. So this had to be
`from 2020 because I have grants here that started
`in 2020.
` Q. Okay. But is the CV still accurate,
`Doctor?
` A. Yes. I work at Good Samaritan Medical
`Center. I have a small biotech called IT Bio.
`Those are my main work activities.
` Q. Your primary work activities are you work
`at Good Samaritan Medical Center and you have a
`small biotech company, called IT Bio?
` A. Yes, in Cambridge.
` Q. In your declaration, on page 9 -- I am
`sorry. In your declaration, at paragraph 9, you
`describe your experience first at Harvard Medical
`School.
` Do you see that?
` A. Yes.
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` Q. And then at Boston University. Do you
`see that?
` A. Yes.
` Q. And then you say, "I have been an
`associate professor of medicine at Boston
`University school since 2003."
` Do you see that?
` A. Yes.
` Q. And are you still an associate professor
`of medicine at Boston University School of
`Medicine?
` A. I haven't resigned from it; so I just
`carry the title. Prior to COVID, I was attending
`regularly the tumor conferences and so forth.
` Q. What does it mean, in your estimation, to
`be an associate professor of medicine at Boston
`University School of Medicine?
` A. It is a title that -- so that I had when
`I was at Roger Williams Medical Center because
`they were affiliated. And then as -- when I was
`moving to Tufts, I waited to have an associate --
`a professorship appointment there. But that
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`delayed long enough before I ran out of grant
`money, and I left Tufts; so I was left with a
`title from Boston University. But I didn't
`resign from there, and I continued to participate
`in medical conferences.
` Q. So your involvement at Boston University
`medical school is to participate in conferences?
`Is that what you said?
` A. Yes, principally. And also to consult
`with colleagues there.
` Q. Does everybody who attends conferences at
`the BU medical school get to be called an
`associate professor?
` A. No. I think I earned that before. I
`didn't resign, so.
` Q. Okay. And do you know whether they think
`that you are still a professor there?
` A. I didn't ask.
` Q. Do you get paid --
` A. No, no. I never was. I never was. It
`was an affiliation. It wasn't -- I never
`actually worked there. I worked at Roger
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`Williams, and they had an affiliation.
` Q. So you have never been paid by them?
` A. No.
` Q. And have you ever had an office there?
` A. No.
` Q. Have you ever had an email address from
`there?
` A. Yes, I do. I still do.
` Q. You still do?
` A. Rpj@bu.edu.
` Q. Is that an email address that you use
`regularly?
` A. I use it for some -- I receive emails
`through there, that is it.
` Q. You receive emails from the university?
` A. From -- for conferences and so forth.
` Q. When you described where you worked
`earlier, you said you work at Good Samaritan
`Medical Center and that you have a small biotech
`company called IT Bio. Right?
` A. Yes.
` Q. But in your declaration to the patent
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`office, you said, "I have been an associate
`professor of medicine at Boston University School
`of Medicine since 2003."
` Right?
` A. That is what it says.
` Q. You didn't say, "I work at Good Samaritan
`Medical Center and I have a small biotech company
`called IT Bio."
` Right?
` A. Yes, those aren't in here.
` Q. And if you look at the first page of your
`CV, in Appendix A, which is page 195, you say,
`under "biographical précis" --
` A. Précis.
` Q. Précis.
` Is that supposed to be a summary of your
`CV?
` A. Summary of my professional activities and
`experience.
` Q. And the summary that you gave was Richard
`Junghans -- am I pronouncing that right?
` A. Yes.
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` Q. Richard Junghans, president, IT Bio;
`associate professor in hematology/oncology
`division, department of medicine, Boston
`University School of Medicine. Right?
` A. Um-hmm.
` Q. So you hold that out as a summary of what
`you do. Right?
` A. Yes. My interest here was to convey
`things that are relevant to the CAR T technology
`field. And the clinical practice I do at Good
`Samaritan Medical Center is oncology -- it is
`regular, general oncology -- and wouldn't
`distinguish my resume from thousands of other
`people. Whereas, being involved in technology, I
`was focusing on where I had FDA experience. I
`had these grants in the field of immunotherapy
`and so forth.
` So the focus of this, I mean, when I
`apply for clinical jobs, I have a different
`precis, where I am focusing on what types of
`patients I have been involved in the care and so
`forth.
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` So this is focused towards grant
`applications, towards consulting work and so
`forth, in IT -- in biotechnology.
` Q. I guess what I am not clear on --
` A. So I could have said biotechnology
`précis.
` Q. Fair enough, Doctor.
` So what I am not clear on, sir, is why
`you chose to have, in the very first sentence,
`the title you claim you have, associate professor
`in the hematology/oncology division at BU School
`of Medicine given that you have just stated that
`you basically have almost no responsibilities in
`that role.
` A. I had -- I think the issues that come up
`are that you don't necessarily have an on-site
`activity to have an appointment at a university.
`And, I mean, my on-site activities were to
`participate in conferences and contribute in that
`fashion.
` So right now, with the COVID, they didn't
`resume the in-person conferences for a long time.
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`And last I checked, they still hadn't.
` Q. So as of the time that you submitted this
`to the patent office, in 2022, how long had it
`been since you did anything in connection with BU
`School of Medicine?
` A. Well, there is different levels of doing
`nothing. Going to the conferences was something
`that I generally tried to do every week. And
`then when those were closed down during COVID,
`then I didn't. And I intend to resume going to
`those conferences when they are fully activated
`again. So that is a participation.
` The other thing is that I regularly
`collaborate with the oncology team at Boston
`Medical Center, which Boston University
`administers, in terms of specialized patient
`referrals and so forth.
` So I maintain activities. I never was in
`the position of teaching classes or doing rounds
`on that campus. I did have a legitimate
`affiliation.
` Q. It is fair to say that nowhere in your
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`declaration do you articulate what you just
`described about what you do and don't do in
`connection with the Boston University medical
`school?
` A. I don't. I just mention the title.
` Q. And you will agree with me, Doctor,
`that -- sorry. One new question, Doctor.
` Is there anything you are actually
`responsible for doing in connection with that
`title? Or could you absolutely do nothing and
`still keep the title, in your estimation?
` A. I am not sure.
` Q. As far as you know, there is nothing you
`have to do to keep the title except not resign
`it?
` A. That is the way that I would approach it.
`Yes.
` Q. And you feel, sitting here today, that it
`is totally fine for you to characterize yourself
`as an associate professor in the
`hematology/oncology division, department of
`medicine, BU School of Medicine, in the very
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`first sentence of your biographical précis.
`Right?
` A. It is an academic title.
` Q. If I wanted to look up whether you were
`actually an associate professor currently at the
`BU School of Medicine, how would I do that?
` A. Even when I was at Roger Williams Medical
`Center, it wouldn't have listed me that way. It
`was a title that was granted.
` Q. Okay.
` A. So it is never -- it is the title -- the
`title was granted by the department of medicine,
`and I had it on my resume and on my letterhead
`and so forth. But it never entailed being
`on-site at Boston Medical Center. And it would
`not have shown up in a list of faculty at the
`medical center. But I am not sure how they
`handle affiliations.
` Q. So it would not surprise you that if
`someone went to the BU medical school and looked
`in the directory, your name would not appear?
` A. No. It wouldn't.
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` Q. It would not appear?
` A. No.
` Q. And it never has?
` A. No.
` Q. Do you have a close relationship with the
`chief of the hematology/oncology section of the
`BU medical school?
` A. I confer with him fairly often.
` Q. You do?
` A. Yes.
` Q. If we could look at your declaration
`again on paragraph 15, you say that you have been
`a consultant to government and private entities
`including major biotechnology companies.
` Do you see that?
` A. I do.
` Q. Is there a part of your CV where you
`identify which companies those are?
` MS. BERNIKER: Actually, I will withdraw
`that question.
` A. Yes, at the bottom of the précis.
`BY MS. BERNIKER:
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` Q. Okay. When did you first start
`consulting for pharmaceutical companies, Doctor?
` A. Probably 1988. While I was a fellow at
`the National Cancer Institute, Dr. Thomas
`Waldmann, who was a national academy member, was
`my mentor, and he sent me -- I think it was
`either to Biogen or Roche, because I did both of
`those. I am not sure which one was first. And
`spent a day describing antibody therapies.
` That would have been Biogen. And then
`for Roche, it would have had to do with IL-2
`antibodies, IL-2 receptors. IL-2, interleukin-2
`antibodies -- actually, interleukin-2 receptor
`antibodies.
` Q. Do you typically disclose your
`consultancy relationships when you submit
`articles for publication in journals?
` A. I do if there is a conflict, yes.
` Q. Doctor, you have previously testified as
`an expert in multiple cases. Right?
` A. Not multiple. A few.
` Q. At least three. Is that fair?
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` A. Yes.
` Q. Is it more than three?
` A. I don't think so.
` Q. You testified as an expert on behalf of
`Genentech in City of Hope in litigation many
`years ago. Is that right?
` A. That is true.
` Q. Were you working with any members of the
`team that are currently representing Miltenyi in
`this case when you worked on that matter?
` A. No.
` Q. Are you familiar with David Ginler?
` A. Doesn't ring a bell.
` Q. And then you also -- were you an expert
`on behalf of Protein Design Labs at some point?
` A. Yes, I was.
` Q. Were you working with any members of the
`team that currently represent Miltenyi in this
`matter on that case?
` A. I am not aware of it.
` Q. Okay. And you write in your expert
`report that you are being paid your standard
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`consulting rate of $1,500 an hour. Right?
` A. Yes.
` Q. How long has that been your standard
`consulting rate?
` A. I would have to check, but maybe six
`years.
` Q. Has that rate gone down over time,
`Doctor?
` A. I dropped it from $1,750 to $1,500 for
`this case.
` Q. Why did you do that?
` A. I just decided I was interested in the
`project. And the agency that recruited me felt
`as though it would go better with a lower rate.
` Q. So $1,500 an hour is or is not your
`standard consulting rate, Doctor?
` A. It is in a range that is acceptable.
` Q. You were recruited to provide expert
`testimony in this case through an agency. Is
`that right?
` A. Yes.
` Q. What agency was that?
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` A. GLG Consulting. And I don't know its
`exact title.
` Q. How long have you been with them?
` MR. LU: Let me just say, to the extent
`you have any kind of confidentiality agreement
`with GLG, and I am not sure you do, don't reveal
`any confidential information you have with them.
` A. What was the question?
`BY MS. BERNIKER:
` Q. How long have you been affiliated with
`GLG Consulting?
` A. I have done various types of -- I have
`done some hourly work for them, maybe over the
`last five years. I think this is the first time
`that I have done a litigation case.
` Q. Okay. I want to go back to paragraph 4
`of your declaration, Doctor, where you say, "I am
`being compensated at my usual and customary rate
`of $1,500 per hour."
` I think you just testified that you
`lowered your rate at GLG's suggestion in
`connection with this case. Do you believe that
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`it is a true statement to say that you are being
`compensated at your usual and customary rate of
`$1,500 an hour?
` A. I do. It is a range that I would
`consider acceptable.
` Q. You stand by that sentence?
` A. I do.
` Q. What is the range that is acceptable,
`from your perspective?
` A. $1,500 to $2,000.
` Q. Have you ever been the subject of an
`investigation from any of your employers?
` A. I am not sure what that would refer to.
`When I was at Harvard, there was an allegation
`that one of my laboratory personnel had either
`falsified data or done something wrong with
`experiments,