`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF NEW JERSEY
`
`ASTRAZENECA PHARMACEUTICALS
`
`LP, et al.,
`
`Plaintiffs/Counterclaim—
`Defendants,
`
`CIVIL ACTION NUMBERS:
`
`-vs-
`
`14—cv—O3547—RMB—KMW
`
`INC.,
`SAGENT PHARMACEUTICALS,
`Defendant/Counterclaim-Plaintiff.
`
`ASTRAZENECA PHARMACEUTICALS
`
`LP, et al.,
`
`Plaintiffs/Counterclaim—
`Defendants,
`
`GLENMARK GENERICS,
`
`INC. , USA,
`
`14-CV-05539-RMB-KMW
`
`Defendant/Counterclaim-Plaintiff.
`
`15-CV-00615-RMB-KMW
`
`Mitchell H. Cohen United States Courthouse
`
`One John F. Gerry Plaza
`Camden, New Jersey 08101
`July 14, 2016
`
`B E F O R E:
`
`THE HONORABLE RENEE MARIE BUMB
`UNITED STATES DISTRICT JUDGE
`AND A JURY
`
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`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 1
`Mylan Pharms. Inc. V. Astrazeneca AB IPR2016-01325
`
`
`
`C)\oQ)‘Q0\U1uhI»K)IA
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`871
`
`A P P E A R A N C E S:
`
`WCCARTfiR &
`
`fiNGR SH
`
`3Y:
`
`John E. Flaherty. Esquire
`Ravin R. Patel, Esqiire
`Attorneys For AstraZeneca
`
`O'MfiLVfiNY & MYERS LLP
`
`QY: Lisa Rarons Pensabene, Esquire
`"ill C. Aitz, Esqiire
`Carolyn Wall, Esqiire
`?ber'e R. Schultz, Esquire
`Daniel O'?oyle, Esqiire
`Eric S. Santoro, Esquire "n House Counsel
`Attorneys for AstraZeneca
`
`CARELLA, %YRNfi, CfiCCH , oLsT« N, %RODY & AGNELLO
`
`3Y: Melissa E. Flax, Esquire
`Christopher J. Biggy, Esquire
`Attorneys for Sagent Pharmaceuticals,
`Generics Inc., USA
`
`FOLEY & LAQDNER LLP
`
`3Y:
`
`Steven J. Rizzi, Esquire
`Liane W. Peterson, Esquire
`Debra Lange, Esquire
`{any Rizkalla, Esquire
`Attorneys for Sagent Pharmaceuticals,
`Generics Inc., USA
`
`Inc., and Glenmark
`
`Inc., and Glenmark
`
`Certified as true and correct as required by Title 28,
`.C., Section 753.
`
`/S/ Theodore M. Formaroli, CSR, CRR
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 2
`
`
`
`3 VYfiSH Mfi{TA
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`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 3
`
`
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`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 4
`
`
`
`DEPOS T ON - MCPESKEY
`
`874
`
`THE DEPUTY CLERK: All rise.
`
`(OPEN COURT, Jily 14, 2016, 9:08 a.m.)
`
`TEE COURT:
`
`Good morning.
`
`RESPONSE: Good morning, Your Honor.
`
`TEE COURT: Have a seat.
`
`Okay. Are we ready to continue with the deposition
`
`testimony?
`
`MS. P"ROHHOLO—MfiLLOWES: Yes, we are, Your Honor.
`
`TEE COJRT: Ms. McCleskey,
`
`come forward.
`
`MR. PRE TAS: Yes, Your Honor.
`
`(Laighter.)
`
`TEE COJRT:
`
`Good morning.
`
`MR. PRE TAS: Good morning.
`
`TEE COJRT: Okay. Whenever you're ready.
`
`MS. P"ROHHOLO—MfiLLOWfiS: We 1e"L o"" at Page 140 of
`
`1
`
`2
`
`3
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`4
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`5
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`6
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`7
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`8
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`9
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`10
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`11
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`12
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`13
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`14
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`15
`
`09MmAM
`
`09MWAM
`
`09MWAM
`
`16 the transcript.
`
`17
`
`18
`
`THE COURT: Yes,
`
`thank you.
`
`MS. P"ROHHOLO—MfiLLOWES: And Ms. Waldron continues
`
`19
`
`the questioning on beha'" o" de"endants.
`
`09MWAM
`
`20
`
`(Deposition read as ‘o1'ows:)
`
`21 Q. Let's get back -o -he documents you kept when you were at
`
`22
`
`the Lombardi Cancer Center.
`
`23
`
`Did I understand you to say that you did keep
`
`24
`
`laboratory notebooks?
`
`09MWAM
`
`25 A.
`
`Yes.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 5
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`875
`
`1 Q.
`
`Did you have any raw data of any kind?
`
`2 A.
`
`It was in the laboratory notebooks.
`
`3 Q.
`
`It would be pasted in the lab notebooks?
`
`4 A.
`
`Why do you think raw data would not be on the same piece
`
`09mmAM
`
`5 of paper as the lab notebook?
`
`6 Q. Actually,
`
`I don't know one way or the other.
`
`I want
`
`to
`
`7
`
`know what your particular procedure was.
`
`8 A. Well, most of the time, you're writing the laboratory
`
`9 notebook.
`
`"‘ you get,
`
`like,
`
`a printout or something,
`
`then you
`
`09mmAM 10 would paste .hat
`
`in -he laboratory notebook.
`
`11 Q.
`
`Got it. Did yoi keep anything on the computer?
`
`12 A.
`
`Yes.
`
`13 Q. What did you keep on the computer?
`
`14 A. Well,
`
`remembering that computers were not as good as they
`
`09n0AM 15
`
`are now, when I got data,
`
`I would have to enter it into the
`
`16 computer,
`
`like,
`
`into a graphing program,
`
`‘or instance, and
`
`17
`
`then it would draw the graph and I would print the graph. But
`
`18
`
`the —— but
`
`the data in the computer was the same as in my --
`
`19 hopefully, as in my lab notebook.
`
`09fl0AM 20 Q.
`
`You didn't create, say, Word files and keep them on a
`
`21
`
`computer?
`
`22 A.
`
`Oh, yes, but that's not data.
`
`23 Q.
`
`Okay.
`
`I see. What
`
`type o" in"ormaLion or documents,
`
`if
`
`24
`
`any, would you have saved on a computer?
`
`09n0AM 25 A.
`
`The dra"Ls o" the paper,
`
`the —— atter " entered the data
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 6
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`876
`
`to make a graph,
`
`that would be saved, of course, but it would
`
`be the data jrom the lab notebook that
`
`entered.
`
`So it's,
`
`like,
`
`a copy and —— and also the graphics tile, picture a
`
`graph.
`
`I don't know how you would say that, but
`
`the graph
`
`09flflAM
`
`itse",
`
`" guess you would say,
`
`that was saved to the computer.
`
`%ut
`
`also, of course, printed it.
`
`Q.
`
`3o you have knowledge as to whether anyone in your group
`
`had documents saved to a computer that had originated from
`
`AstraZeneca?
`
`09fllAM
`
`A.
`
`i don't have knowledge
`
`about anybody else in my group
`
`"I me.
`
`Did you have any documents originating
`
`from AstraZeneca
`
`that related to Ms. McCleskey 1998 saved to a computer?
`
`09fllAM
`
`09fllAM
`
`K3D9K3D9K3D9K33’
`
`Are you speaking about
`
`data?
`
`Anything.
`
`For example
`
`Saved to a computer?
`
`Yeah,
`
`like a statement
`
`o_ proposed investigation --
`
`Oh, no --
`
`—— sample requests?
`
`—— no, no.
`
`Did you have data that
`
`originated from AstraZeneca saved
`
`computer?
`
`Wo.
`
`Did you have any binders or personal notebooks separate
`
`09fllAM
`
`from your lab notebooks in which you kept
`
`information
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 7
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`877
`
`regarding McLeskey 1998?
`
`A.
`
`I had binders with the tumor data,
`
`the tumor measurements
`
`in pictures of mice.
`
`Q.
`
`Any other places where you would have had information
`
`09 HAM
`
`related to McLeskey 1998,
`
`that we haven't talked about?
`
`A.
`
`No.
`
`Q.
`
`Now, you mentioned,
`
`if " understood you correctly,
`
`believe you testified that you destroyed your technical
`
`documents related to McLeskey 1998 in the beginning of
`
`09fl2AM
`
`June 2014;
`
`is that right?
`
`A. Correct.
`
`Q. What did you mean by "destroyed?"
`
`How did you destroy
`
`them?
`
`A.
`
`just threw them in the trash.
`
`09fl2AM
`
`Q.
`
`Just a regular trash bin?
`
`A.
`
`Yeah.
`
`Q. Where was this trash bin?
`
`A.
`
`At my school.
`
`Q. What school?
`
`09fl2AM
`
`A.
`
`The University of Maryland School of Nursing.
`
`Q.
`
`Do you know what happened to the documents after you
`
`threw them in the trash bin?
`
`A.
`
`No.
`
`Q. When you left Lombardi Center and took your technical
`
`09fl2AM
`
`documents with you, was it your understanding that that was
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 8
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`878
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09fl2AM
`
`09fl3AM
`
`B:
`
`okay by the rules,
`
`by Lombardi's policies?
`
`A.
`
`Q.
`
`i didn't have any understanding about that.
`
`Did you know what document retention policies Lombardi
`
`would have had in place at the time?
`
`A.
`
`No.
`
`Q. When you --
`
`I'll just say "you" to start,
`
`and‘
`
`will be talking about
`
`Lombardi Center.
`
`When you got a
`
`document on a project, say,
`
`a
`
`certijicate o_
`
`service or MSDS
`
`or something like that,
`
`what did you do with it?
`
`Where was
`
`something like that kept?
`
`F1 F1
`
`A.
`
`i don't know what a certijicate oj service is.
`
`F1 K)
`
`F: U)
`
`The —— we were required to keep MSDSs
`
`in the notebook
`
`in the lab for all chemicals that we had in the lab,
`
`so that's
`
`FA Q
`
`what we did.
`
`09fl3AM
`
`F: U!
`
`So MSDSs would be kept
`
`in the laboratory notebooks,
`
`H: 0\
`
`correct?
`
`09fl3AM
`
`FA \J
`
`F: G)
`
`F: ‘O
`
`K) C)
`
`K) F1
`
`R)R)
`
`R) h)
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`K) wk
`
`(Reading stopped.)
`
`MR. ERfi TAS:
`
`' apologize.
`
`T{E COJRT: Ask it again.
`
`MS . P"?O'.'.OT.O-M+1T.T.OW+1S :
`
`You have to read —— he
`
`inadvertently reread the question.
`
`T{E COURT: Yes.
`
`(Deposition read as follows:)
`
`Q.
`
`So MSDSs would be kept
`
`in the laboratory notebooks,
`
`09fl3AM
`
`K) U1
`
`correct?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 9
`
`
`
`DfiBOS T ON - MCPfiSKfiY
`
`879
`
`A.
`
`No, not
`
`in —— not where we had the data. We had separate
`
`noteboo< for MSDSs.
`
`.
`
`MSDSs had their own notebook?
`
`That's correct.
`
`"ha: about cerLijica-es o_ analysis?
`
`Didn't usually keep
`
`those.
`
`They're
`
`—— why not?
`
`Didn't
`
`feel that we needed them.
`
`"ho retained custody o:
`
`documents as they came in on the
`
`<ey l998 project?
`
`i don't
`
`know what you're talking about, what documents.
`
`Do you recall how samples got shipped into
`
`-he "aci'ity,
`
`whether,
`
`say,
`
`they went
`
`to a mailroom or a specific sample
`
`depos
`
`itory?
`
`They went
`
`to the mailroom.
`
`And then that —— that would happen?
`
`The mail people would bring them to us.
`
`Would you then keep the samples in your lab?
`
`Yes.
`
`And did I
`
`understand you correctly that at the time you
`
`were a postdoc in
`
`Dr. Kern's lab, you were not aware of the
`
`policies and procedures that Lombardi Center had in place with
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09fl3AM
`
`09flAAM
`
`B:
`
`F1 F1
`
`F1 K)
`
`F: U)
`
`FA Q
`
`F: U!
`
`H: 0\
`
`FA \J
`
`F: G)
`
`F: ‘O
`
`K) C)
`
`K) F1
`
`R)R)
`
`09flAAM
`
`09flAAM
`
`R) h)
`
`regar
`
`d to retention o:
`
`documents;
`
`is that right?
`
`K) wk
`
`A.
`
`No: only was
`
`i not aware o: anything they had in place,
`
`09flAAM
`
`K) U1
`
`was not aware i:
`
`—— whether they had anything in place.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 10
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`880
`
`1 Q.
`
`"‘ you received ancillary paperwork with samples, such as
`
`2
`
`a certijicate oj analysis or something like that, what would
`
`3
`
`4
`
`5
`
`6
`
`09fl5AM
`
`you hav
`
`r cord d th r c ipt oj
`
`-haL document --
`
`(Reading stopped.)
`
`T{E COURT:
`
`"Would you."
`
`(Deposition read as follows:)
`
`7 Q. Would you hav
`
`r cord d th r c ipt of that document
`
`in
`
`8
`
`your laboratory notebook?
`
`9 A.
`
`Wo.
`
`09fl5AM 10 Q.
`
`Did Lombardi
`
`require you to make copies of anything and
`
`11
`
`send them on to a document repository or anything like that?
`
`12 A.
`
`W0.
`
`13 Q.
`
`To your knowledge, were the documents that you were
`
`14
`
`keeping in your lab the only copies?
`
`09fl5AM 15 A.
`
`As tar as " knew.
`
`16 Q.
`
`Are you aware of whether copies were ever made of your
`
`17
`
`laboratory notebooks?
`
`18 A.
`
`think not.
`
`19 Q.
`
`"ho had access to your laboratory notebooks besides you?
`
`O9fl5AM 20 IX.
`
`iDr. Kern.
`
`21 Q.
`
`Anyone else?
`
`22 A. Well,
`
`the other people in the lab would have, had they
`
`23 wanted it, but
`
`I don't know that they ever did --
`
`24
`
`(Reading stopped.)
`
`09fl5AM 25
`
`T{E COURT:
`
`So could have.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 11
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`881
`
`1
`
`2
`
`MR. ERfi TAS:
`
`Pardon me.
`
`(Deposition read as follows:)
`
`3 A. Well,
`
`the other people in the lab could have had they
`
`4 wanted it, but
`
`I don't know what
`
`they ever did —— that they
`
`09fl5AM
`
`5
`
`ever did.
`
`6 Q.
`
`In the conversation that you just referred to, when you
`
`7
`
`communicated with Mr. Trock, what did you discuss with
`
`8 Mr. Trock?
`
`9 A.
`
`He —— I
`
`think he,
`
`I don't remember a whole lot about
`
`the
`
`09flfiAM 10
`
`conversation, but he said that he had been just about
`
`to
`
`11 discard the data from —— from this paper when they called.
`
`12 Q. When who ca"ed?
`
`13 A.
`
`The —— the lawyers that were doing the Teva thing, Mary
`
`14 Burke and company.
`
`09fl6AM 15 Q.
`
`I'm sorry.
`
`I believe you just said,
`
`"Mary 3urke did not
`
`16 ask me not
`
`to destroy documents."
`
`17 A.
`
`She did not say, Don't destroy documents. When she said
`
`18
`
`that,
`
`I do not know.
`
`19 Q. Mary 3urke never told you to preserve your documents
`
`09nfiAM 20
`
`related to McLeskey 1998?
`
`21 A. Correct.
`
`22 Q.
`
`Did anyone Mary 3urke worked with ever tell you not
`
`to --
`
`23 tell you that you must preserve your documents related to
`
`24 McLeskey 1998?
`
`09:16AM 25 A.
`
`No.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 12
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`882
`
`Now,
`
`i believe you said earlier that you recall speaking
`
`with three people at AstraZeneca,
`
`Dr.
`
`Wakeling,
`
`Dr.
`
`Vose,
`
`and
`
`a third person whose name you don't
`
`remember;
`
`is that correct?
`
`Correct.
`
`Do you recall
`
`approximately how many times you spoke with
`
`Dr.
`
`Wakeling?
`
`Twice.
`
`Was
`
`I)
`this via telephone or by some other means o;
`
`communication?
`
`Telephone.
`
`Who called who?
`
`called him.
`
`Both times?
`
`Yes.
`
`Why did you call
`
`Dr.
`
`Wakeling?
`
`The ‘irst time
`
`called to ge
`
`t him to send me the drug
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09flfiAM
`
`09fl7AM
`
`B:
`
`F1 F1
`
`F1 K)
`
`F: U)
`
`FA h
`
`F: U!
`
`H: 0\
`
`09fl7AM
`
`FA \J
`
`and
`
`find out how to administer it
`
`to mice.
`
`The second time
`
`F: G)
`
`called
`
`to tell him we had used the drug he sent
`
`the
`
`first time
`
`F: ‘O
`
`and
`
`that i needed more drug.
`
`09fl7AM
`
`K) C)
`
`Q.
`
`Did Dr. Wakeling require you to
`
`fill out any paperwork or
`
`K) F1
`
`do anything in writing be:
`
`fore you received samples o:
`
`drugs?
`
`R)R)
`
`A.
`
`Wot me.
`
`R) h)
`
`Q.
`
`Did he require that someone
`
`I)
`fill out some sort o;
`
`K) wk
`
`paperwork be:
`
`fore samples would be shipped?
`
`09fl7AM
`
`K) U1
`
`A.
`
`i don't know.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 13
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`883
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09fl7AM
`
`09fiWAM
`
`B:
`
`F1 F1
`
`F1 K)
`
`F: U)
`
`FA Q
`
`Q.
`
`What did Dr.
`
`Wakeling tell you in response to your
`
`request
`
`I)
`that you wanted AstraZeneca to send you samples o;
`
`drugs?
`
`A.
`
`He told me that
`
`should give it to the mice as it
`
`outlined in this paper and that he would ship it.
`
`Q.
`
`3asically, an okay—I'll—take—care—of—it
`
`type thing?
`
`A.
`
`Jm—hum.
`
`Q.
`
`{ow many times did you speak with Dr. Vose?
`
`A.
`
`Once —— that —— assume that he was not
`
`the second —— the
`
`person I don‘: know who it is, but --
`
`Q . Right.
`
`A.
`
`——
`
`know I spoke with him once.
`
`Q.
`
`Did you ever communicate with Dr. Wakeling in writing
`
`either by e—mail or letter?
`
`09fiWAM
`
`F: U!
`
`A.
`
`Not that
`
`reca'l.
`
`FA 0\
`
`FA \J
`
`F: G)
`
`F: ‘O
`
`K) C)
`
`K) F1
`
`R)R)
`
`R) h)
`
`K) wk
`
`K) U1
`
`09fiWAM
`
`09fiWAM
`
`Q.
`
`Okay.
`
`So you said you spoke with Dr. Vose once;
`
`is that
`
`right?
`
`Um—hum.
`
`Was this on the phone?
`
`Yes.
`
`Did you ever have any written communications with him?
`
`Wot
`
`to my —— not that i remember.
`
`On the one incident —— one instance that you did speak
`
`Dr. Vose, who called who?
`
`called him.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 14
`
`
`
`DfiBOS T ON _ MCTI*: SKfiY
`
`884
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09fiWAM
`
`09fl9AM
`
`B:
`
`Q.
`
`"hy did you call Dr. Vose?
`
`A.
`
`Because Dr. Wakeling told me to call him to get
`
`pre‘ormu'ated drug.
`
`Q.
`
`Do i understand that you talked to Dr. Wakeling about
`
`receiving powdered
`
`C
`
`187,780 and Dr. Vose about obtaining
`
`preformulated C
`
`187,780?
`
`A.
`
`At separate times.
`
`Q.
`
`I'm jus- trying to understand.
`
`think " understand the
`
`—— that you talked to these guys about
`
`two di""erenL things.
`
`Do
`
`inderstand correctly that you tal<ed to
`
`F1 F1
`
`Dr. Wakeling about receiving powdered
`
`C
`
`187,780?
`
`F1 K)
`
`A. Correct.
`
`F: U)
`
`FA IA
`
`Q.
`
`And then do i understand correctly that you talked to
`
`Dr. Vose aboit receiving the pre‘ormu'ated C
`
`187,780?
`
`09fl9AM
`
`F: U!
`
`A. Much later.
`
`FA 0\
`
`FA \J
`
`F: G)
`
`Q. Much later? That's a good point.
`
`Do yoi reca11
`
`approximate1y when,
`
`or do you recall the
`
`approximate dates on which you talked to
`
`Dr. Wakeling?
`
`F: ‘O
`
`A.
`
`No.
`
`09fl9AM
`
`K) C)
`
`Q.
`
`Year?
`
`K) F1
`
`A.
`
`i don't know.
`
`R)R)
`
`Q.
`
`But you know you talked to
`
`Dr.
`
`Vose much later.
`
`What do
`
`R) h)
`
`you mean by "much later?"
`
`K) wk
`
`A. When :
`
`talked to Dr.
`
`Wakeling initially,
`
`then he sent me
`
`09fl9AM
`
`K) U1
`
`the drug,
`
`then we used the drug in mice and also in in vitro
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 15
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`885
`
`studies and we used it all up.
`
`So
`
`T don't know how long that
`
`took, but
`
`i would say a matter o:
`
`: months,
`
`anyway, maybe a
`
`year.
`
`Then we needed more drug so
`
`called Dr. Wakeling
`
`again,
`
`that's when he to:
`
`_d me to call
`
`Dr. Vose.
`
`Q.
`
`And the powdered
`
`C
`
`187,780 would have been what you --
`
`what was dissolved in ethanol and then spiked into the peanut
`
`oil?
`
`A. Correct.
`
`Q. When you spoke to
`
`Dr.
`
`Vose,
`
`what did he tell you about
`
`shipping you samples o
`
`" pre"ormulated l82,780?
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09:20AM
`
`09:20AM
`
`B:
`
`F1 F1
`
`A.
`
`{e said he would.
`
`F1 K)
`
`F: U)
`
`FA IA
`
`F: U!
`
`09:20AM
`
`Q.
`
`Did he say anything else?
`
`A. Wot
`
`to my remembrance.
`
`Q.
`
`Did he require that you do anything before he sent
`
`the --
`
`sent
`
`-he "files o" pre
`
`"ormulated
`
`C
`
`187,780?
`
`H: 0\
`
`A.
`
`Wo
`
`FA \J
`
`Q.
`
`Do you know whether anyone in your lab had to complete
`
`F: G)
`
`F: ‘O
`
`any type of paperwork be:
`
`fore AstraZeneca would send the lab
`
`preformulated l82,780?
`
`09:20AM
`
`K) C)
`
`A.
`
`i do not know.
`
`K) F1
`
`R)R)
`
`R) h)
`
`Q.
`
`Who would know?
`
`A.
`
`Possibly Dr. Kern.
`
`Q.
`
`Okay.
`
`And now the third person that you spoke to,
`
`was
`
`K) wk
`
`this be‘ore or a‘
`
`‘ter you talked to Jr.
`
`Vose?
`
`09:21AM
`
`K) U1
`
`A. Aj-er.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 16
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`886
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09:21AM
`
`09:21AM
`
`B:
`
`(35*K3
`
`.
`
`.
`
`Who called who?
`
`called him.
`
`Did you have any communications
`
`in writing with this
`
`third person?
`
`A.
`
`Q.
`
`A.
`
`No.
`
`And what was the purpose o:
`
`calling this third person?
`
`i wanted to
`
`find ou
`
`t what
`
`the —— what was in the drug
`
`because
`
`i was getting ready
`
`to publish a paper.
`
`i was getting
`
`ready to wri'
`
`:e the paper
`
`, actually.
`
`Q.
`
`.And wha
`
`: did he tel
`
`l YOJ?
`
`F1 F1
`
`A.
`
`{e told
`
`me ‘-
`
`F1 K)
`
`Q.
`
`Do you recall the words he used?
`
`F: U)
`
`A.
`
`we
`
`Q p
`
`FA IA
`
`F: U!
`
`09:21AM
`
`.
`
`But he told you all of
`
`the excipients and their
`
`ercentages?
`
`FA 0\
`
`A.
`
`He told me what's in the paper:
`
`10 percent ethanol,
`
`09:21AM
`
`FA \J
`
`F: G)
`
`F: ‘O
`
`K) C)
`
`K) F1
`
`R)R)
`
`R) h)
`
`K) wk
`
`10 percent benzyl benzoate and 10 percent benzyl alcohol
`
`brought
`
`to volume with the castor oil.
`
`(Reading stopped.)
`
`MS.
`
`P"RonnoLo—M
`
`*:TITIOW*:S: Your Honor,
`
`i
`
`think there
`
`was a mista<e in reading that.
`
`THE
`
`CCHIRT:
`
`It‘
`
`s —— no,
`
`the court reporter took it
`
`down correc-ly,
`
`-haL's
`
`_ine.
`
`(Deposition read as
`
`"01
`
`'ows:)
`
`09:21AM
`
`K) U1
`
`Q.
`
`You don
`
`‘t recall wh
`
`I)
`ether or not he specified the units o;
`
`United States District Court
`
`Camden , New Jersey
`
`Astrazeneca Ex. 2049 p. 17
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`887
`
`1 measure?
`
`2 A.
`
`I do not recall.
`
`3 Q.
`
`How did you know to contact this third person?
`
`4 A.
`
`I called the number that was —— that I had been given for
`
`09&QAM
`
`5 Dr. Vose.
`
`6 Q.
`
`And somebody else answered?
`
`7 A.
`
`I don't know if it was somebody else or if it was
`
`8 Dr. Vose.
`
`9 Q.
`
`So there —— you're saying —— i‘ "'m understanding you
`
`09umAM 10 correctly, you believe it's possible that it was Dr. Vose that
`
`11
`
`told you the makeup oj Lhe jormulation but you're not sure?
`
`12 A. Well, it was whoever answered the phone. That's all
`
`13
`
`can say abou- i-.
`
`14 Q.
`
`I see. But you called Dr. Vose's direct line?
`
`09umAM 15 A.
`
`Yeah.
`
`I called the same number
`
`I had called previously
`
`16 to speak with Dr. Vose.
`
`17 Q.
`
`"ho gave you Dr. Vose's phone number?
`
`18 A.
`
`Dr. Wakeling.
`
`19 Q.
`
`"ho gave you Dr. Wakeling's phone number?
`
`09umAM 20 A.
`
`i don't remember.
`
`21 Q.
`
`Do you recall generally how you knew to call Dr. Wakeling
`
`22
`
`that he was the person to call?
`
`23 A.
`
`Either Dr. Lippman or Dr. Kern told me, but
`
`I don't know
`
`24 who or when or anything.
`
`09uBAM 25 Q.
`
`But do I understand you correctly that you —— with regard
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 18
`
`
`
`DfiBOS T
`
`ON _
`
`888
`
`to this third person,
`
`that it was a man?
`
`A.
`
`Q.
`
`Yes.
`
`When you called
`
`Dr. Vose
`
`the
`
`first time,
`
`or when you
`
`calle
`
`d Dr. Vose,
`
`how did you know it was him that answered the
`
`M%23AM
`
`phone
`
`?
`
`A.
`
`Q.
`
`i don't remember.
`
`But you ‘eel
`
`COD"
`
`‘ident that you were speaking to
`
`Dr. Vose
`
`the f
`
`irst time?
`
`09:23AM
`
`A.
`
`Q.
`
`Well,
`
`' certainly believed that
`
`i was.
`
`At
`
`the time,
`
`did yo
`
`i believe that the third person that
`
`you were talking to was
`
`Dr.
`
`Vose?
`
`i don't recall what
`
`f believed.
`
`What do you believe today?
`
`i don't believe
`
`09:23AM
`
`You have no idea who you talked to?
`
`Right.
`
`Did you send As
`
`:raZeneca dra
`
`_,S O
`
`the study protocol
`
`that
`
`you were going
`
`_,O "ollow
`
`Ol’
`
`-he research described in
`
`McLes
`
`<ey 1998?
`
`09:23AM
`
`Did you ever provide your lab notebooks or raw data to
`
`Astra
`
`Zeneca?
`
`Did you record when you received samples from AstraZeneca
`
`09:23AM
`
`ir laboratory notebooks?
`
`United States District Court
`
`Camden,
`
`New Jersey
`
`Astrazeneca Ex. 2049 p. 19
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`889
`
`1 A.
`
`I don't recall.
`
`2 Q. What was your general practice with regard to recording
`
`3
`
`4
`
`receipt of samples at the time you were postdoc in Dr. Kern's
`
`lab?
`
`09uMAM
`
`5 A.
`
`I would unpack them and if they needed refrigeration,
`
`6 would put
`
`them in the refrigerator or the freezer as
`
`7 appropriate.
`
`8 Q.
`
`Did you have a separate practice as to what you would
`
`9
`
`record about
`
`the samples received?
`
`09:24AM 10 A.
`
`No.
`
`11 Q. Was it your understanding from the beginning of your
`
`12 postdoc in Dr. Kern's lab that AstraZeneca was the source of
`
`13
`
`182,780 or was that something you learned later in time?
`
`14 A.
`
`At
`
`the beginning,
`
`I had no idea there was such a thing as
`
`09:24AM 15
`
`182,780.
`
`16 Q.
`
`How did you come to find out that?
`
`How did you come to
`
`17
`
`find out that AstraZeneca would supply 182,780 to the lab?
`
`18 A.
`
`I'm not sure.
`
`19 Q. What do you —— what is your best recollection?
`
`09uMAM 20 A.
`
`We had meetings of all the researchers,
`
`the breast cancer
`
`21
`
`researchers and it may have come up at that, one of those
`
`22 meetings.
`
`23 Q.
`
`From the Lombardi side of things, not
`
`the AstraZeneca
`
`24
`
`side of things, but
`
`from the Lombardi side of things, was
`
`09u5AM 25 procuring samples as simple as calling and asking for them, or
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 20
`
`
`
`DfiBOS T
`
`ON — Mcl
`
`fiSKfiY
`
`890
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`MMZSAM
`
`09:25AM
`
`B:
`
`was there an internal protocol that had to be
`
`followed
`
`first?
`
`A.
`
`Q.
`
`i was not aware o“
`
`an internal
`
`protocol.
`
`Do yo; know how long i-
`
`-ook in between the time you
`
`talked to Dr. Wakeling and
`
`-he Lime Lha- you received the
`
`powdered
`
`C
`
`187,780?
`
`A.
`
`Q.
`
`think it was a matter of
`
`weeks.
`
`Do you recall how long it took
`
`:rom the time you talked
`
`to Dr. Vose to th n r c iv
`
`th pr
`
`fo
`
`rmulated C
`
`187,780?
`
`A.
`
`Probably about
`
`the same.
`
`Q.
`
`And yoi personally do not recall
`
`filling out any
`
`forms or
`
`F1 F1
`
`signing anything in regard to samples,
`
`correct?
`
`F1 K)
`
`A. Correct.
`
`F: U)
`
`FA IA
`
`F: U!
`
`09:25AM
`
`Q.
`
`i want
`
`to make sure we're absolutely on the same page.
`
`So before you s-ar-ed,
`
`at any
`
`time, did you send
`
`AstraZeneca a sLaLemen- o_ proposed investigation
`
`forms?
`
`H: 0\
`
`A.
`
`Wo
`
`FA \J
`
`F: G)
`
`Q.
`
`Do you know whether or not
`
`Dr.
`
`Kern had sent AstraZeneca
`
`a sLa-emenL of proposed investigation
`
`forms?
`
`F: ‘O
`
`A.
`
`Wo
`
`09:25AM
`
`09:26AM
`
`20
`
`21
`
`22
`
`23
`
`24
`
`25
`
`Q.
`
`Wo, you do not know, or no,
`
`he did not?
`
`A.
`
`Wo,
`
`i don't know.
`
`Q.
`
`Did you fill out any other forms
`
`for Astraneneca before
`
`you started your work on McLeskey 1998?
`
`Do you know whether anyone else in your group filled out
`
`United States District Court
`
`Camden , New Jersey
`
`Astrazeneca Ex. 2049 p. 21
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`891
`
`1
`
`any other ‘orms ‘or Astrafleneca?
`
`2 A.
`
`I don't know.
`
`3 Q.
`
`?e‘ore starting the work on --
`
`4 A.
`
`I don't know.
`
`I know nothing.
`
`09umAM
`
`5 Q.
`
`Did you personally ever request any samples from
`
`6 AstraZeneca in writing?
`
`7 A.
`
`No.
`
`8 Q.
`
`Okay.
`
`So you received powdered
`
`C
`
`l87,78O from Dr. Alan
`
`9 Wakeling, correct?
`
`09umAM 10 A. Correct.
`
`11 Q.
`
`Did Dr. Wakeling send the powdered samples directly to
`
`12
`
`you?
`
`13 A.
`
`I don't recall.
`
`I got
`
`them, but
`
`I don't remember who
`
`14
`
`they were addressed to.
`
`09fl%AM 15 Q.
`
`You don't have a speci‘ic recollection o‘ whether they
`
`H 0\
`
`came directly to you or whether Dr. Kern gave them to you?
`
`|~\ \l A.
`
`I opened the pac<age, or I got
`
`the package.
`
`I don't know
`
`H U)
`
`1'
`
`" got
`
`the package from a mailman or ‘rom Dr. Kern.
`
`" don't
`
`H KO
`
`know.
`
`09uflAM 20 Q.
`
`Okay. But you opened the package?
`
`21
`
`.A.
`
`Yeah.
`
`22 Q.
`
`Do you recall approximately when that was when you opened
`
`23 the package?
`
`24 A.
`
`No.
`
`09QNAM 25 Q. Was it in 1997?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 22
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`892
`
`A.
`
`Oh, no.
`
`I
`
`t was way before that.
`
`Q.
`
`Way before
`
`that?
`
`So 1996,
`
`l995?
`
`A.
`
`It was bef
`
`ore 1993.
`
`Q. Qefore 199
`
`3?
`
`A.
`
`Yes.
`
`Q
`
`.
`
`How was the powder sample packaged?
`
`Was it in a —— a
`
`bottle or —— ho
`
`w did it arrive,
`
`do you recall?
`
`A.
`
`think it was just in a little jar.
`
`Q. Would the
`
`receipt of that sample have been logged in the
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`B:
`
`lab?
`
`F1 F1
`
`A.
`
`No.
`
`09:27AM
`
`09:27AM
`
`F1 K)
`
`F: U)
`
`Q.
`
`Now,
`
`if
`
`' understand you correctly,
`
`Dr. Wakeling gave you
`
`information on
`
`administration of
`
`the drug, correct?
`
`FA IA
`
`A. Correct.
`
`09:27AM
`
`F: U!
`
`H: 0\
`
`FA \J
`
`Q.
`
`Did Dr.
`
`Wakeling send you instructions on how '
`
`I)
`formulate the 50—milligram per milliliter concentration o;
`
`C
`
`187,780 and ethanol and peanut oil?
`
`F: G)
`
`A.
`
`ie didn't
`
`send them to me,
`
`I10.
`
`F: ‘O
`
`Q.
`
`Did he send you instructions regarding making the
`
`09:28AM
`
`K) C)
`
`formulation?
`
`K) F1
`
`A.
`
`\o.
`
`R)R)
`
`Q.
`
`ow did you know to do that?
`
`R) h)
`
`A.
`
`e told me
`
`over the phone.
`
`K) wk
`
`K) U1
`
`09:28AM
`
`Q.
`
`Okay.
`
`So
`
`Dr.
`
`Wa<eling told you how to administer it,
`
`and
`
`he also told yo
`
`1 how to make the
`
`formulation that's recorded
`
`United States District Court
`
`Camden , New Jersey
`
`Astrazeneca Ex. 2049 p. 23
`
`
`
`DfiBOS T ON - MCLfiSKfiY
`
`893
`
`in McLeskey 1998 concerning ethanol and peanut oil?
`
`A.
`
`Q.
`
`Exactly.
`
`And you testified earlier,
`
`i think,
`
`that you were
`
`actually the person that had actually dissolved the
`
`09flRAM
`
`C
`
`189,780 in ethanol and then spiked it into the peanut oil?
`
`A. Correct.
`
`Q.
`
`Why did you use a concentration of 50—milligrams per
`
`milliliter?
`
`A.
`
`Because that's what Dr. Wakeling said to do.
`
`09flRAM
`
`Q.
`
`Dr. Wakeling did not discuss any sort o" con"idenLialiLy
`
`with you --
`
`A.
`
`No.
`
`Q.
`
`—— when —— when you spoke with him?
`
`A.
`
`No --
`
`09flRAM
`
`Q.
`
`Sorry, it needs to be verbal.
`
`A.
`
`Sorry, no.
`
`Q.
`
`"‘ you'll turn to Page 698 o‘ ?xhibit 5, do you see a
`
`paragraph headed,
`
`the title Drugs, and then about seven lines
`
`down, w
`
`s
`
`:h
`
`lin d s nt nc
`
`for the experiments depicted
`
`09flBAM
`
`in Figure l,
`
`3 and C, 50—milligram per milliliter
`
`pre
`
`formulated drug in a vehicle o: 10 percent ethanol, 15
`
`percent benzyl benzoate,
`
`10 percent benzyl alcohol brought
`
`to
`
`volume by castor oil was supplied by 3.M. Vose, Zeneca
`
`Pharmaceuticals.
`
`09flBAM
`
`Do you see that?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 24
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`894
`
`1 A.
`
`Yes.
`
`2 Q.
`
`Is this the preformulated drug that we were just
`
`3 discussing that you procured via telephone conference with
`
`4 Dr. Vose?
`
`09:29AM
`
`5 A.
`
`Yes.
`
`6 Q. Approximately when did you receive the preformulated
`
`7
`
`C
`
`187,780 from Dr. Vose?
`
`8 A. All
`
`I can tell you is it was before 1993.
`
`9 Q.
`
`The preformed —— both —— you received both the powdered
`
`09umAM 10
`
`C
`
`and the preformulated C before 1993.
`
`Is that what
`
`11 you're saying?
`
`12 A.
`
`Yes.
`
`13 Q.
`
`How do you know that it was before 1993?
`
`14 A.
`
`In 1993,
`
`I received a facul-y appointment, and then I was
`
`09:%mM 15
`
`no longer a postdoc. And at that point,
`
`the animal
`
`16 experiments were done.
`
`17 Q. Were you the person that opened the package of the
`
`18 preformulated C
`
`187,780?
`
`19 A.
`
`Yes.
`
`09u%mM 20 Q.
`
`Do you recall how many preformulated samples were sent
`
`to
`
`21
`
`you?
`
`22 A.
`
`W0
`
`23 Q.
`
`Do you recall if those samples were in vials?
`
`24 A.
`
`Wo
`
`09:%mM 25 Q.
`
`{ow were —— how were the preformulated samples packaged?
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 25
`
`
`
`DfiBOS T
`
`ON - MCPfiSKfiY
`
`895
`
`C)\oQ)‘Q0\U1uhI»K)IA
`
`09fiNAM
`
`09KflAM
`
`B:
`
`F1 F1
`
`F1 K)
`
`F: U)
`
`A.
`
`I don't recall.
`
`What documentation accompanied the preformulated
`
`C
`
`187,780?
`
`i don't recall.
`
`Do you recall
`
`whether or
`
`not there was documentation
`
`included with the preformulated C
`
`187,780?
`
`i don‘: recall.
`
`Q.
`
`you wanted to try to remember,
`
`who would you talk to?
`
`Nobody.
`
`i mean,
`
`i —— there's nobody.
`
`think it's lost
`
`to posterity.
`
`Q.
`
`So do
`
`i understand correct
`
`ly that at the time you
`
`received the preformulated C
`
`’87,780, you did not know what
`
`excipients were present in the
`
`formulation —— in that
`
`FA Q
`
`formulation?
`
`09KflAM
`
`F: U!
`
`A. Correct.
`
`H: 0\
`
`Q.
`
`Did you have an understanding that the preformulated
`
`FA \J
`
`C
`
`187,780 could not be used
`
`in humans?
`
`F: G)
`
`A.
`
`Nothing we had in our lab could be used in humans.
`
`F: ‘O
`
`K) C)
`
`09KflAM
`
`Q. Were you given speci‘ic
`
`instructions ‘rom AstraZeneca
`
`that it should not be used in
`
`humans?
`
`K) F1
`
`A.
`
`i don't recall.
`
`R)R)
`
`Q.
`
`Turning back to Page 698
`
`in the drug section again, you
`
`R) h)
`
`K) wk
`
`see the text that says,
`
`In a vehicle o:
`
`10 percent ethanol,
`
`l5
`
`percent benzyl benzoate,
`
`10 percent benzyl alcohol brought
`
`to
`
`09KflAM
`
`K) U1
`
`volume with castor oil.
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 26
`
`
`
`DfiBOS T ON - MCPfiSKfiY
`
`896
`
`OWWV0\(MAmNH
`
`09KflAM
`
`09fiflAM
`
`H
`
`Do you recall who actially wrote that text?
`
`T did.
`
`Did you test or analyze the formulation in any way?
`
`Wo.
`
`"ere you told that the preformulated C
`
`’87,78O that you
`
`A.
`
`Q.
`
`A.
`
`Q.
`
`received should not be administered intramuscularly?
`
`A.
`
`Q.
`
`the
`
`i was told to administer it sibcutaneously to my --
`
`When the person who answered Dr. Vose's phone gave you
`
`excipients present
`
`in the preformulated C
`
`187,780,
`
`were
`
`you sworn to secrecy?
`
`H H
`
`A.
`
`No.
`
`H K)
`
`Q.
`
`Why did you want
`
`to include those details in McLeskey
`
`F: U)
`
`1998?
`
`09fiflAM
`
`FA Q
`
`F: U!
`
`FA 0\
`
`FA \J
`
`A.
`
`That's how I was instructed to write a paper when I was
`
`in my predoctoral, was to include such things.
`
`Q.
`
`Have you searched your personal
`
`‘files ‘or all documents
`
`relating to either the powdered
`
`C
`
`187,780 received or the
`
`F: G)
`
`pre
`
`formulated C
`
`187,780 that you received?
`
`F: ‘O
`
`A.
`
`i don't have any personal
`
`"1 es about this.
`
`09fiflAM
`
`K) C)
`
`Q.
`
`Did Z understand you correctly that you do not recall
`
`K) F1
`
`R)R)
`
`whether or not
`
`the person that answered
`
`Dr. Vose's phone told
`
`you that th p rc ntag s w r
`
`in weight
`
`to volume or
`
`R) h)
`
`volume—:o—volume?
`
`K) wk
`
`K) U1
`
`09fiBAM
`
`i do not recall.
`
`Did you assume that th p rc ntag s w r
`
`ith r in weight
`
`United States District Court
`
`Camden, New Jersey
`
`Astrazeneca Ex. 2049 p. 27
`
`
`
`D*'.L’OS T ON - MCT.*'.SK+'.Y
`
`897
`
`to volume or volume—to—volime?
`
`A.
`
`I don't think I ever thought about it one way or the
`
`other.
`
`Q.
`
`Have you thought about it since McLeskey l998 was
`
`09:33AM
`
`published?
`
`A.
`
`Yes, but
`
`I have no basis for knowing which way it was.
`
`Q.
`
`So as you sit here today, you don't know whether or not
`
`th p rc ntag s w r
`
`in weight
`
`to volume or volume—to—volume?
`
`A.
`
`I do not know.
`
`09mBAM
`
`Q.
`
`So what did you mean when you said "These studies
`
`indicate that estrogen independence may be achieved"?
`
`A.
`
`I meant that in our engineered model, we achieved
`
`estrogen—independent
`
`tumor growth in mice through engineering
`
`the cell to express in FGF.
`
`09mBAM
`
`Q.
`
`So in the context of your experiment, you wanted to use
`
`the aromatase inhibitors and
`
`C
`
`187,780 to shut down any
`
`remaining estrogen that might have been present?
`
`A.
`
`Yes.
`
`Q.
`
`And you wanted to shut down any remaining estrogen so
`
`09 MAM
`
`that you could isolate or investigate the estrogen independent
`
`cell