`UNITED STATES PATENT AND TRADEMARK OFFICE
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`- - - - - - - - - - - - - - - - x
`ACRUX DDS PTY LTD. & ACRUX
`:
`LIMITED,
`:
`: Case No.
`: IPR2017-00190
`:
`KAKEN PHARMACEUTICAL CO., LTD. :
`and VALEANT PHARMACEUTICALS
`: U.S. Patent No.
`INTERNATIONAL, INC.
`: 7,214,506
`Patent Owner and Licensee. :
`- - - - - - - - - - - - - - - - X
`
`Petitioners,
`
`v.
`
`Deposition of VINCENT ALEXANDER THOMAS
`Washington, DC
`Friday, October 13, 2017
`9:01 a.m.
`
`Job No.: 161628
`Pages 1 - 78
`Reported by: Debra A. Whitehead
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`ACRUX DDS PTY LTD. et al.
`
`EXHIBIT 1507
`
`IPR Petition for
`
`U.S. Patent No. 7,214,506
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`Page 1 of 102
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`Transcript of Vincent Alexander Thomas
`Conducted on October 13, 2017
`
`2
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` Deposition of VINCENT ALEXANDER THOMAS, held at
`the offices of:
`
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` (202) 408-4000
`
` Pursuant to notice, before Debra A. Whitehead,
`an Approved Reporter of the United States District
`Court and Notary Public of the District of Columbia.
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`3
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` A P P E A R A N C E S
` ON BEHALF OF PETITIONERS:
` LISA N. PHILLIPS, ESQUIRE
` ROTHWELL, FIGG, ERNST & MANBECK, P.C.
` 607 14th Street, NW
` Suite 800
` Washington, DC 20005
` (202) 783-6040
`
`ON BEHALF OF PATENT OWNERS:
` JEFFREY M. JACOBSTEIN, ESQUIRE
` ANTHONY A. HARTMANN, ESQUIRE
` FINNEGAN, HENDERSON, FARABOW,
` GARRETT & DUNNER, LLP
` 901 New York Avenue, NW
` Washington, DC 20001-4413
` (202) 408-4000
`
`ALSO PRESENT:
` TYLER LIU, ESQUIRE, Argentum (Via Phone)
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`4
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` C O N T E N T S
`EXAMINATION OF VINCENT ALEXANDER THOMAS PAGE
` By Ms. Phillips 6
` By Mr. Jacobson 66
` By Ms. Phillips 71
`
` EXHIBITS MARKED IN PRIOR SESSIONS
` (Retained by Counsel)
`KAKEN DEPOSITION EXHIBIT PAGE
` Exhibit 2028 Declaration of Vincent A. 12
` Thomas, CPA, 8/1/17
` Exhibit 2029 Excerpt from Forbes, May 8, 2006 56
` Exhibit 2063 Brandweek Super Brands, 6/21/04, 58
` Featuring America's Top 2000
` Brands
` Exhibit 2091 Jublia Website Printout 62
` Exhibit 2093 Spreadsheet 12
` Exhibit 2094 Monthly Topline Report 041117 12
` Spreadsheet
` Exhibit 2095 Spreadsheet 12
` Exhibit 2098 Schedule 1: Jublia Sales 12
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`5
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` EXHIBITS MARKED IN PRIOR SESSIONS - CONTINUED
`KAKEN DEPOSITION EXHIBIT PAGE
` Exhibit 2099 Schedule 2: U.S. Onychomycosis 12
` Prescriptions
` Exhibit 2106 8/22/17 Evidentiary Declaration 12
` of Vincent A. Thomas, CPA
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`6
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` P R O C E E D I N G S
` VINCENT ALEXANDER THOMAS,
` having been duly sworn, testified as follows:
` EXAMINATION BY COUNSEL FOR PETITIONERS
`BY MS. PHILLIPS:
` Q Good morning, Mr. Thomas.
` A Good morning.
` Q My name is Lisa Phillips, and I represent
`the petitioners in this case.
` How many times have you been deposed?
` A It's in excess of a hundred times.
` Q So you're very familiar with the rules.
`But I just want to go over a few things before we
`get started. Is that okay?
` A That's fine.
` Q I'm going to ask you a series of
`questions. If there's any question that I ask
`that you don't understand or you don't understand
`something within my question, please ask me for
`clarification. Okay?
` A Sure.
` Q If you don't understand, I'll try to
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`7
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`restate the question or clarify it for you. Okay?
` A That's fair.
` Q And if you answer a question, I'm going
`to go on the assumption that you heard the
`question and you understood it. Okay?
` A That's fair.
` Q During the deposition counsel for patent
`owners will probably at some point object to my
`question. When this happens, I want you to be
`clear that unless counsel instructs you not to
`answer the question, you are still required to
`answer my question.
` Do you understand that?
` A I guess. I do understand that I'm here
`to answer questions. Whether I'm required to
`answer at certain points in time, perhaps that's a
`legal issue. But I will do to the best of my
`ability, will answer your questions.
` Q Okay. And of course the exception to
`that is if you believe that the question I've
`asked requires you to reveal information you
`believe is protected by work product or
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`attorney-client privilege.
` A Again, I understand that may be a legal
`issue, and I typically defer to counsel on that.
`But again, I will do my best to answer the
`questions today.
` Q Thank you.
` This is not an endurance test. If you
`need a break, please let me know.
` A I typically take a break about every
`hour, so ...
` Q Okay. That sounds good. As long as it's
`not between a question and answer, I will
`accommodate you.
` Let's see. You understand that you are
`under oath. Correct?
` A I do.
` Q And are there any medications you're
`taking which would prevent you from answering my
`questions accurately and truthfully?
` A Not that I'm aware of.
` Q Are there any issues that would
`prevent -- other issues that would prevent you
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`9
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`from answering my questions accurately and
`truthfully?
` A Not that I'm aware of.
` Q Did you do anything to prepare yourself
`for this deposition?
` A Yes.
` Q What did you do?
` A I prepared the report that I've issued in
`this matter.
` Q Did you do anything else?
` A In advance of today, I've reviewed my
`report, as well as the items that I've cited in
`the report.
` Q And when you say items that you've cited,
`are you referring to the numbered exhibits in your
`report?
` A Yes. And what I've cited in footnotes to
`my report.
` Q And did you meet with counsel to prepare
`for your deposition?
` A I did.
` Q And who, which counsel did you meet with?
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`10
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` A Tony and Jeff.
` Q The gentlemen to your right?
` A The gentlemen to my right, yes.
` Q And was anyone else present when you had
`that meeting?
` A No.
` Q And when did that meeting occur?
` A Yesterday.
` Q For approximately how long did you meet
`with them?
` A I believe it was two hours.
` Q And during that meeting did you speak
`with anyone on the telephone regarding the
`deposition?
` A No.
` Q And have you spoken with anyone at Kaken
`Pharmaceuticals regarding your deposition?
` A I have not.
` Q Have you spoken with anyone from Valeant
`Pharmaceuticals regarding your deposition?
` A I have not.
` Q And when you met with the attorneys, did
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`11
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`you review documents?
` A We -- well, we discussed my report.
` Q And did you review the documents that you
`cited within your report?
` A Not all of the documents.
` Q Do you remember which ones you reviewed?
` A I don't.
` Q Have you served as an expert on behalf of
`Kaken Pharmaceuticals before this case?
` A I have not.
` Q Have you served as an expert on behalf of
`Valeant Pharmaceuticals International before this
`case?
` A I have not.
` Q Have you ever served as a consultant on
`behalf of Kaken Pharmaceuticals outside of the
`litigation context?
` A I have not.
` Q Have you ever served as a consultant on
`behalf of Valeant Pharmaceuticals International
`outside of the litigation context?
` A I have not.
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`12
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` Q All right. I'm going to give to you a
`set of documents that have already been marked --
` A Okay.
` Q -- in this proceeding.
` And those documents are going to be Kaken
`Exhibit 2028, Kaken Exhibit 2093, Kaken Exhibit
`2094, Kaken Exhibit 2095, Kaken Exhibit 2098,
`Kaken Exhibit 2099, and Kaken Exhibit 2106.
` (A discussion was held off the record.)
` (Kaken Exhibit 2028, Exhibit 2093,
`Exhibit 2094, Exhibit 2095, Exhibit 2098, Exhibit
`2099, Exhibit 2106, previously marked, retained by
`counsel.)
`BY MS. PHILLIPS:
` Q So just to correct the record, the only
`exhibit that I did not hand you is Kaken Exhibit
`2028. And I've been informed by your counsel that
`you have a copy of it with you.
` A Okay.
` Q So if we could turn to Kaken Exhibit
`2028, which is your declaration submitted August
`1st, 2017.
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`13
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` A Okay.
` Q And you recognize this document.
` Correct?
` A I do.
` Q And if you turn to Page 19 of 35.
` Is that your signature?
` A Yes. I'm sorry, I was looking at
`different page numbers.
` Q That's okay. I think, let's just set a
`ground rule here. Under the rules in this
`proceeding, the parties have to provide separate
`page numbers at the bottom. If you see the
`bottom, on the bottom left of the document that
`we're looking at right now, it says Page 19 of 35.
` Do you see that?
` A I do.
` Q We're just going to refer to those page
`numbers. I think that will make it easier across
`the board today.
` A That's fair. I appreciate you bringing
`that up. Because when you mentioned page number,
`I looked to the right.
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`14
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` Q I understand. There's many of the
`documents have two sets of page numbers. So if we
`can just get that clear, it's probably easier that
`way.
` A Fair enough.
` Q So I think I asked you if that was your
`signature?
` A I'm not sure you did.
` Q Okay. On Page 19 of 35, in Kaken Exhibit
`2028, is that your signature?
` A That is.
` Q And are there any corrections or changes
`that you would like to make to your declaration
`before we get started?
` A Not as I sit here.
` Q Are you ready?
` A I'm ready.
` Q Great. If you can turn to Paragraph 2 of
`your declaration, which is on Page 3 of 35.
` And you state there in the fourth --
`starting in the fourth line down, quote, Over the
`course of my career I have analyzed economic and
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`Transcript of Vincent Alexander Thomas
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`15
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`financial issues in more than 100 commercial
`disputes, many of which involved patent,
`copyright, trade secret, and trademark
`infringement, period, end quote.
` Do you see that?
` A I do.
` Q And of those 100 commercial disputes that
`you mention there, how many of them were in the
`context of pharmaceuticals?
` A Boy, I would have to -- I don't
`necessarily --
` Q You can give me an approximate number.
` A -- keep count.
` I would estimate over the course of my
`career I worked on maybe 50 pharmaceutical
`matters. But, again, that's not something I keep
`a count of. But certainly it's several. It could
`be more than 50, I would have to go back and
`double-check that.
` Q And in the next sentence you state,
`quote, Many of those assignments have also
`involved complex economic analysis of commercial
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`16
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`success of various products, sophisticated
`valuation analysis, and damages in matters
`involving various pharmaceutical products,
`biotechnology, and drug technologies, period, end
`quote.
` Do you see that?
` A Yes.
` Q And in how many cases, aside from this
`one, have you offered an opinion regarding the
`commercial success of a pharmaceutical product?
` A Well, I worked on one matter that
`involved specifically the assessment of commercial
`success that involved a pharmaceutical.
` I've also worked on more than 20 patent
`infringement matters that have involved
`pharmaceuticals and have involved the assessment
`of the commercial success of those products, as
`well.
` I have also valued pharmaceuticals in
`several matters, which involves assessing the
`value of those products and the value drivers of
`those products.
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`17
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` And also have worked on various matters
`involving issues related to pricing and
`reimbursement and litigations related to those
`matters, that also have involved assessing the
`value drivers for various pharmaceutical products.
` Q In your answer you told me that you
`worked on one matter that involved specifically
`the assessment of commercial success that involved
`a pharmaceutical, but then added that you worked
`on more than 20 patent infringement matters that
`have involved pharmaceuticals and have involved
`the assessment of the commercial success of those
`products.
` Why did you separate out the one matter
`that involved specifically the assessment of
`commercial success?
` A Well, it was specific to, in providing
`opinions specific to commercial success in
`isolation.
` In those other matters, in addition to
`assessing the commercial viability, the commercial
`success of the product, I was dealing with other
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`issues.
` Q I see. So am I correct, then, that you
`have assessed the commercial success of
`pharmaceutical products in approximately 21 cases?
` A At least.
` Q And in those 21 cases, have you ever
`determined that a pharmaceutical product was not a
`commercial success?
` A I'd have to go back and look. I can't
`say as I sit here.
` Q In Paragraph 3 of your declaration, you
`explain your experience in, among other things,
`the review and analysis of licensing agreements.
` Is that right?
` A Yes.
` Q And in connection with your opinions in
`this matter, have you reviewed any license
`agreements?
` A No, I don't believe specific to this
`matter that there were any specific license
`agreements.
` Q But it's your understanding that the '506
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`patent is licensed to Valeant Pharmaceuticals
`International. Is that correct?
` A That I do understand, yes.
` Q But you haven't reviewed that license
`agreement. Is that right?
` A You know, I don't know that I did for
`purposes of this analysis.
` Q When you say you "don't know that you did
`for purposes of this analysis," do you mean that
`you did not consider that license agreement within
`the context of your analysis?
` A I believe it was reviewed in the context
`of the legal papers that were filed in this case,
`but I just had an understanding that through
`those -- review of those documents, that Kaken was
`the owner of the patent and it had licensed it to
`Valeant Pharmaceuticals.
` Q Do you know anything regarding the terms
`of that license agreement?
` A That's not something I studied in
`particular.
` Q So the answer is no?
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` A Not as I sit here, no.
` Q Do you know whether Valeant pays royalty
`payments to Kaken Pharmaceuticals for the
`licensing of the '506 patent?
` A Again, I don't recall specifically what
`the details of the agreement was. I can't say as
`I sit here.
` Q You say you don't recall. So does that
`mean that you actually did review it at some
`point?
` A I reviewed a number of documents, that's
`why I said I'd have to go back and look at my
`file. I have some recollection of looking at the
`legal papers, which may have included the license
`agreement.
` Q But you don't list the license agreement
`in your Exhibit B. Is that correct?
` A I don't. But I list the various legal
`documents. And you included -- perhaps included
`in those may have been the license agreement. I
`certainly cite that in reference, those documents.
`And in fact in Footnote 2 is where I identified
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`Paper 12, which was the decision to institute
`inter partes review, and it was dated May 1, 2017.
` Included in that was a reference to the
`license agreement. I just don't recall if
`attached to that would have been the license
`agreement or not.
` Q Now, in Paragraph 6 of your declaration,
`which appears at the top of Page 5 of 35, you
`state that you, quote, "Further understand that in
`the evaluation of obviousness, certain secondary
`considerations may be contemplated such as
`commercial success, long felt but unmet need,
`failure of others, and unexpected results."
` Do you see that?
` A Yes.
` Q And are you offering any opinion
`regarding whether there was a failure of others
`with respect to the '506 patent?
` A I don't believe so. Although to the
`extent that my economic analysis would weigh in on
`that issue, I guess to that extent, yes.
` I'm providing an economic analysis and
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`the opinions that I've identified here, and the
`support for those opinions. To the extent that my
`opinions would weigh on any of these issues,
`again, to that extent I guess I'm providing
`opinions.
` Q Do you provide separate evidence
`supporting any opinion regarding the failure of
`others with respect to the '506 patent?
` A Only to the extent that it's my economic
`analysis could be used in that regard.
` Q But you haven't offered any specific
`opinion relating to the failure of others in your
`declaration, which is marked Kaken Exhibit 2028.
` Is that right?
` A In terms of the specificity of failure of
`others, I'm not aware. But, again, to the extent
`that my analysis could be used in support of that,
`certainly I am providing those opinions.
` Q Are you offering any specific opinion
`regarding unexpected results relating to the '506
`patent?
` A Once again, I would -- to the extent that
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`my economic analysis weighs on that issue. And,
`again, whether it was unexpected that the use of
`Jublia, its success in the marketplace was so
`pronounced, I guess that could be in support of
`unexpected results, to the extent that it weighs
`on that particular issue.
` Q Do you have any scientific expertise?
` MR. JACOBSTEIN: Objection. Form.
` Q Withdrawn.
` Are you a medical doctor?
` A I am not.
` Q Are you an expert in treating
`onychomycosis?
` A I am not.
` Q Are you an expert in diagnosing
`onychomycosis?
` A I am not.
` Q In the beginning of Paragraph 7 you
`state, quote, During the course of my work in this
`matter, I have examined documents provided to me
`by counsel and other information I have obtained
`from public sources, period, end quote.
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` Do you see that?
` A Yes.
` Q Are all -- withdrawn.
` Have you referenced all of the
`information that you obtained from public sources
`in your Appendix B?
` A Yes.
` Q At the end of Paragraph 8 you state,
`quote, I reserve the right to supplement, amend,
`or alter these opinions based on information that
`hereafter becomes available, including information
`that becomes available prior to and during the
`time this proceeding, period, end quote.
` Do you see that?
` A Yes.
` Q Is this sentence missing something at the
`end?
` A I believe perhaps it's missing time of
`this proceeding. Of.
` Q In Paragraph 9 you begin discussing the
`summary of your opinions. Is that right?
` A That's correct.
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` Q And in that paragraph the second sentence
`reads, quote, Not only did Jublia have over 2
`million prescriptions in just its first two years
`on the market and sales revenue of more than $1
`billion, but it accounted for 60 percent of total
`market revenue in the first full year the product
`was on sale, end quote.
` Do you see that?
` A I do.
` Q And there you reference sales revenue.
`When you say "sales revenue" there, do you mean
`gross sales revenue?
` A Yes.
` Q And does your gross sales revenue include
`sales through all channels?
` MR. JACOBSTEIN: Objection. Form.
` A When you say "all channels," what -- can
`you be more specific?
` Q Okay. Withdrawn.
` Let's refer to your Exhibit 2098. And in
`connection with Exhibit 2098, you might also want
`to refer to Exhibit 2095.
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` Well, let's go back for a moment. Can
`you turn to Kaken Exhibit 2106, which is entitled,
`Evidentiary Declaration of Vincent A. Thomas.
` And if you could turn to Paragraph 5 of
`that declaration.
` A Okay.
` Q You state there, As explained in my
`earlier declaration, Exhibits 2098 and 2099
`reflect my analysis of data provided in two
`documents labeled, and then you list the file
`names, which have been designated as Exhibits 2095
`and 2093 respectively.
` Do you see that?
` A Yes.
` Q And when you prepared -- withdrawn.
` Did you prepare Exhibit 2098?
` A Yes.
` Q And when you prepared Exhibit 2098, did
`you utilize the information that's contained in
`Exhibit 2095 to prepare that exhibit?
` A I did.
` Q And did you prepare Exhibit 2099?
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` A I did, yes.
` Q And when you prepared Exhibit 2099, did
`you utilize the information that's set forth in
`Exhibit 2093 to prepare that exhibit?
` A I did.
` Q And did you prepare Exhibit 2095?
` A Did I prepare Exhibit 2095?
` Q Yes.
` A No.
` Q Do you know who did?
` A This information comes from -- this is
`the information that was received from Kaken, is
`my understanding, that I received through counsel.
` Q Did you specifically request the
`preparation of Exhibit 2095?
` A I -- I requested data that would reflect
`sales of Jublia in comparison to other products in
`the market.
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` Do you know if in addition to ciclopirox,
`Jublia, Kerydin and terbinafine, there are any
`other orally administered products which are
`approved for the treatment of onychomycosis?
` MR. JACOBSTEIN: Objection. Form.
` A I believe there are other products that I
`am aware of. But those other products I
`understand are also approved for treatment of
`other conditions, as well.
` Q But they're also approved for the
`treatment of onychomycosis. Is that correct?
` A I believe that may be the case, yes.
` Q And do you have an understanding as to
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`why -- withdrawn.
` Do you know how many products --
`withdrawn.
` How many products are you aware of that
`are also approved for the treatment of other
`conditions in addition to the treatment of
`onychomycosis?
` A Well, I was referring to -- and the name
`is escaping me right now, in terms of the name of
`the product, that, as I understand it, is approved
`for treating other things, as well.
` I'd have to go back and check. But I am
`just aware of one other.
` Q Do you recall if the name of that
`product -- withdrawn.
` Do you recall if the generic name of that
`product is itraconazole?
` A I'm sorry.
` Q Itraconazole?
` A I believe that's it, yes. Yes. I
`candidly have trouble with a lot of these names.
`But that's my recollection, yes.
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` Q I understand.
`
`
`
`
` Q But you didn't have any involvement in
`defining the market for Jublia. Is that correct?
` A I relied on Valeant's definition of the
`market.
` Q And did you rely -- withdrawn.
` With respect to the information that you
`set forth in your Exhibit 2098, is the only
`information that you relied upon included in
`Exhibit 2095?
` A For Exhibit 2098?
` Q Yes.
` A That's correct, yes.
` Q And with respect to Exhibit 2099, is the
`only information --
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` A Well, I'm sorry.
` Q Withdrawn.
` A And this is two-sided. I apologize. So,
`yes. I only saw the first portion of Exhibit
`2095. But, yes, Exhibit 2095 is what I relied on
`for Exhibit 2098.
` Q What do you mean by you only saw the
`first portion of Exhibit 2095?
` A I'm sorry, we only had the first page. I
`didn't realize this was a double-sided document.
`I just wanted to make sure the record was clear,
`on the first page it ended in October of 2015. So
`I just wanted to make sure that this was a
`complete copy.
` Q But it is the complete copy on the other
`side. Correct?
` A It is, correct. Yes.
` Q Okay. With respect to the information
`that you set forth in your Exhibit 2099, is the
`only information that you relied upon to prepare
`that exhibit included in Exhibit 2093?
` A That is correct.
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` Q Did you see the underlying data that was
`used to prepare Exhibit 2095?
` A I have -- I have seen that data.
` Q And do you list it in your Exhibit B?
` A I do not.
` Q Why not?
` A It was not available to me until after I
`issued my report.
` Q And when did you see that data?
` A Yesterday.
` Q Did you perform a separate analysis of
`the underlying data that you reviewed yesterday
`from the analysis that's set forth in Exhibit
`2095?
` A I did not.
` Q Had you reviewed the underlying data
`prior to signing your declaration which is Kaken
`Exhibit 2028?
` MR. JACOBSTEIN: Objection. Form.
` A I'm sorry?
` Q Withdrawn.
` Have you reviewed the underlying data
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`that was used to prepare Exhibit 2095 prior to
`signing your declaration, which is Kaken Exhibit
`2028?
` A I had not reviewed it prior to signing my
`declaration.
` Q And have you reviewed the underlying data
`that was used to prepare Exhibit 2093?
` A I have not.
` Q I think you might have answered this
`before, but just in case you haven't.
` Did you perform a separate analysis to
`determine what the market -- what products should
`be included in the market definition for Jublia?
` A I relied on -- again, I relied on how
`Valeant used the market, given that they're an
`entity that's selling Jublia, and who their
`competitors are.
` Q So the answer is you didn't perform a
`separate analysis. Is that right?
` A Well, I relied on what Valeant had set
`forth.
` Q And when you say you "relied on what
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`Valeant had set forth," that's with respect to
`both Exhibit 2093 and Exhibit 2095. Is that
`right?
` A I think effectively both cover the same
`types of products, yes.
` Q Can you turn to Exhibit 2094 for a
`moment.
` Have you seen this document before?
` A I have.
` Q Did you use it at all to prepare Exhibit
`2098?
` A I did not.
` Q Did you use it at all to prepare Exhibit
`2099?
` A I did not.
` Q Have you relied on it at all with respect
`to y