6 - - -
7 Videotape deposition of JAMES
8 HAND, Ph.D., held in the offices of
9 Dechert Price & Rhoads, 1717 Arch Street,
10 Philadelphia, Pennsylvania 19103
11 commencing at 10:15 a.m., on the above
12 date, before Linda Rossi Rios, a
13 Federally Approved Registered
14 Professional Reporter and Notary Public
15 of the Commonwealth of Pennsylvania.
16 - - -
17
ESQUIRE DEPOSITION SERVICES
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15th Floor
1880 John F. Kennedy Boulevard
19
Philadelphia, Pennsylvania 19103
(215) 988-9191
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21
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ESQUIRE DEPOSITION SERVICES
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1 A P P E A R A N C E S :
2
ANAPOL, SCHWARTZ, WEISS, COHAN,
FELDMAN AND SMALLEY, P.C.
3
BY: SOL H. WEISS, ESQUIRE
1900 Delancey Place
4
Philadelphia, Pennsylvania 19103
(215) 735-2098
5
Liaison Counsel for the Plaintiffs
6
THE BEASLEY FIRM
7
BY: JAMES J. McHUGH, ESQUIRE
1125 Walnut Street
8
Philadelphia, Pennsylvania 19107
(215) 592-1000
9
Liaison Counsel for Plaintiffs
10
GREITZER AND LOCKS
11
BY: LEE B. BALEFSKY, ESQUIRE
1500 Walnut Street
12
Philadelphia, Pennsylvania 19102
(215) 893-3403
13
Liaison Counsel for Plaintiffs
14
DECHERT, PRICE & RHOADS
15
BY: HOPE M. FREIWALD, ESQUIRE
1717 Arch Street
16
Philadelphia, Pennsylvania 19103
(215) 994-4000
17
Counsel for Defendant, SmithKline
18
WILLIAMS & CONNOLLY LLP
19
BY: PAUL K. DUEFFERT, ESQUIRE
725 Twelfth Street, N.W.
20
Washington, D.C. 20005
(202) 434-5097
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Counsel for Defendant, Bayer Corp.
22
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1 - - -
2 I N D E X
3 WITNESS PAGE NO.
4 JAMES HAND, Ph.D.
5 By Mr. Weiss 5
6
By Ms. Freiwald 171
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7
E X H I B I T S
8
NO. DESCRIPTION
PAGE NO.
9
Hand-1 Notice of Corporate
10
Deposition
6
11 Hand-2 SB Process & Practice 14
12 Hand-3 Letter Agreement 58
13 Hand-4 Project Strategic Plan 69
14 Hand-5 PRB Review Document 109
15
Hand-6 Letter June 27, 1997
from Jerry Karabelis 126
16
Hand-7 E-mail dated
17
22 January '97
from Marcia Poland 130
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1 DEPOSITION SUPPORT INDEX
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Direction to Witness Not To Answer
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Page Line Page Line
None
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Request For Production of Documents
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Page Line Page Line
15 23
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49 13
98 11
10
11
Stipulations
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Page Line Page Line
172 21
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14
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Questions Marked
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Page Line Page Line
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1 VIDEOGRAPHER: We are now on
2 the record. My name is David
3 Levin. I'm the videographer
4 employed by Esquire Deposition
5 Services, 1880 JFK Boulevard,
6 Philadelphia, Pennsylvania. This
7 is a video deposition for the
8 Court of Common Pleas,
9 Philadelphia County, November term
10 2002, master document number 0001.
11 Today's date is June 18,
12 2002 and the time is 10:16 a.m.
13 This deposition is being held at
14 4000 Bell Atlantic Tower, 1717
15 Arch Street, Philadelphia,
16 Pennsylvania in reference to the
17 Baycol Litigation.
18 The deponent is James Hand,
19 Ph.D. This deposition is being
20 taken on behalf of the plaintiffs.
21 All counsel will be noted on the
22 stenographic record.
23 The court reporter's name is
24
Linda Rossi-Rios and she will now
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1 swear in the witness.
2 - - -
3 JAMES HAND, Ph.D., after
4 having been duly sworn, was
5 examined and testified as follows:
6 - - -
7 EXAMINATION
8 - - -
9 BY MR. WEISS:
10 Q. Good morning, Dr. Hand. My
11 name is Sol Weiss. I represent
12 plaintiffs in the Baycol Litigation that
13 is proceeding in the Court of Common
14 Pleas of Philadelphia County. I'm going
15 to hand you what I'll have marked by the
16 court reporter as Hand-1 which is the
17 Notice of Corporate Deposition.
18 - - -
19 (Whereupon, Exhibit Hand-1
20 was marked for identification.)
21 - - -
22 MS. FREIWALD: Mr. Weiss,
23 this is where I do want to go on
24
the record. We received this
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JAMES HAND, Ph.D.
1 yesterday.
2 MR. WEISS: We can stay on
3 the record. I understand. I'm
4 going to explain it to the
5 witness.
6 MS. FREIWALD: You go ahead
7 and say what you want to say and
8 we'll see where we are.
9 MR. WEISS: Okay. Has that
10 been marked by the court reporter?
11 BY MR. WEISS:
12 Q. Dr. Hand, you have in front
13 of you Exhibit 1. Exhibit 1 is Notice of
14 Corporate Deposition. I'm going to ask
15 you which of the items in this notice
16 you're here to testify to about today.
17 Are you here to testify about item number
18 one, the due diligence conducted prior to
19 the execution of the 7/21/97 co-promotion
20 agreement? And to be more accurate,
21 that's the process by which the due
22 diligence was performed?
23 A. Right. I will -- yeah, I
24
can discuss the process that we undergo
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JAMES HAND, Ph.D.
1 to evaluate opportunities for licensing.
2 Q. Would you also be here to
3 testify with regard to item number five,
4 the process for the due diligence between
5 the July 1997 agreement and the August 6,
6 1999 agreement?
7 A. No. That's -- between the
8 signing of the agreement and '99, no.
9 Q. The second agreement?
10 A. No.
11 Q. Is there anything else here
12 on this list, items one to seven, that
13 you're here to testify to about today?
14 MS. FREIWALD: No, our
15 agreement is with regard to number
16 one.
17 THE WITNESS: No.
18 BY MR. WEISS:
19 Q. Doctor, have you ever
20 testified on behalf of the company
21 before?
22 A. No.
23 MS. FREIWALD: Excuse me.
24
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JAMES HAND, Ph.D.
1 (Interruption.)
2 - - -
3 BY MR. WEISS:
4 Q. Have you ever given a
5 deposition before in any proceeding?
6 A. No.
7 Q. A deposition is a form of
8 discovery in which lawyers ask the
9 witness questions and the answers you
10 give are made under oath as if in a
11 courtroom. If at any time you don't
12 understand my question, let me know and
13 I'll try to rephrase it.
14 A. Okay.
15 Q. Also, you have to give a
16 verbal response because the court
17 reporter is taking down what you say.
18 Even though we have a videographer, we
19 still have to rely on the transcript that
20 is made by the court reporter. So I'm
21 going to ask you to give a verbal
22 response. Okay?
23 A. Yes.
24
Q. It's hard for the court
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JAMES HAND, Ph.D.
1 reporter to take down two people talking
2 at one time. So I'm going to try to
3 allow you to finish your answer before I
4 ask the next question and also ask you to
5 let me to finish my question before you
6 make an answer. Okay?
7 A. Okay.
8 Q. If at any time you want to
9 take a break, let us know. All right?
10 A. Yes.
11 Q. Any time you want to talk to
12 your lawyer for anything, let me know and
13 we'll go off the record. All right?
14 A. Okay.
15 Q. You understand that the
16 testimony you're giving today is binding
17 on your company?
18 A. Yes, I guess so.
19 Q. Can you tell me what
20 position you hold in GSK right now?
21 A. I'm a director of Business
22 Development and Consumer Healthcare.
23 Q. And how long have you held
24
that position?
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JAMES HAND, Ph.D.
1 A. Since January of '99.
2 Q. And before that time, were
3 you employed by the company?
4 A. Meaning? The company
5 meaning?
6 Q. Either Glaxo, SmithKline
7 Beecham?
8 A. Yes.
9 Q. Who were you employed by?
10 A. SmithKline Beecham.
11 Q. And what was your position
12 at the company at that time?
13 A. I held -- at what time is
14 that?
15 Q. We're talking before January
16 of 1999.
17 A. Before January of 1999 I was
18 a director in scientific licensing in
19 pharmaceuticals.
20 Q. How long did you hold that
21 position?
22 A. I moved into that job in the
23 summer of 1990.
24
Q. Prior to that time, were you
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JAMES HAND, Ph.D.
1 employed by SmithKline?
2 A. I was employed by SmithKline
3 Beecham, yes.
4 Q. And what was your position
5 with the company?
6 A. I was an associate --
7 assistant director in research.
8 Q. How long did you hold that
9 position?
10 A. Since December of 1988.
11 Q. Let me ask this question.
12 When was the first time you became
13 employed at SmithKline or its
14 predecessors?
15 A. I moved into SmithKline and
16 French in December of 1988.
17 Q. And who did you work for
18 prior to that time?
19 A. For Wyeth Laboratories.
20 Q. How long did you work for
21 Wyeth?
22 A. I moved to Wyeth in the
23 summer of 1983.
24
Q. Just so the record is
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JAMES HAND, Ph.D.
1 complete, who did you work for before you
2 went to Wyeth?
3 A. I'm not sure of the entity
4 who actually employed me before that.
5 Q. What did you do at Wyeth?
6 A. I was in research.
7 Q. Could you briefly tell us
8 your educational background?
9 A. I have an undergraduate
10 degree in pharmacy and a doctorate in
11 pharmacy, Ph.D.
12 Q. When did you receive your
13 undergraduate degree in pharmacy?
14 A. 1974.
15 Q. And where did you obtain the
16 degree?
17 A. University of Wisconsin.
18 Q. And when did you obtain your
19 doctorate in pharmacy?
20 A. 1981.
21 Q. And from what institution?
22 A. University of Wisconsin.
23 Q. When was the first time you
24
became employed in the pharmaceutical
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JAMES HAND, Ph.D.
1 industry?
2 A. When I went to Wyeth.
3 Q. I'm going to mark as Hand-2,
4 it looks like it's an eleven-page
5 document. I'm not sure they all go
6 together, but we'll discuss it. The
7 title is SB Process & Practice for
8 In-Licensing Development Compounds.
9 That's Hand-2.
10 - - -
11 (Whereupon, Exhibit Hand-2
12 was marked for identification.)
13 - - -
14 BY MR. WEISS:
15 Q. Doctor, are you familiar
16 with this document?
17 A. Yes.
18 Q. And can you tell me what
19 this document purports to do?
20 A. This is a document or
21 process or guideline process that was
22 generated by -- within business
23 development, Worldwide Business
24
Development, to give us a plan for
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JAMES HAND, Ph.D.
1 assessing the value of licensing
2 opportunities which were within one year
3 of the clinic all the way through to
4 launched products. So of necessity it
5 was a very flexible process.
6 Q. Was there a document that
7 preceded this one?
8 A. I believe so, yes. There
9 are iterations of this document.
10 Q. I take it, then, there's
11 been documents that come after March 19,
12 1996. Is that correct?
13 A. Yes.
14 Q. Can you tell me whether
15 there's been a revision to this document,
16 which has been marked Hand-2, prior to
17 August of 1999?
18 A. I don't recall the dates of
19 the revisions exactly.
20 Q. Where would I find the
21 revisions if I went to look for them?
22 A. I believe counsel has them.
23 MR. WEISS: On the record,
24
I'm asking for copies of the
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JAMES HAND, Ph.D.
1 revisions. Maybe at the break we
2 can get one.
3 MS. FREIWALD: On the
4 record, this covers the time
5 period that is relevant to the
6 pre-contract licensure. So I
7 think this is the right document
8 for you to work on today. Okay.
9 MR. WEISS: I would still
10 like to see the subsequent one
11 before we're done today.
12 MS. FREIWALD: Okay.
13 BY MR. WEISS:
14 Q. Was Hand-2 used by the
15 company?
16 A. How do you mean used?
17 Q. Did people inside SB rely on
18 this document in order to determine the
19 prospective value of a potential
20 cross-licensing or co-promotion or joint
21 venture for a new compound?
22 A. You have to restate that
23 again. We relied on it, I'm not sure
24
what that -- what you're referring to
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JAMES HAND, Ph.D.
1 there.
2 Q. I take it Hand-2 is a
3 guideline?
4 A. Yes.
5 Q. And it was in use in March
6 of 1996?
7 A. Yes.
8 Q. Were there any other
9 guidelines that were used at SB to
10 determine whether the company would be
11 involved in the marketing in some fashion
12 of a future product that was not in SB's
13 own pipeline?
14 A. Within SmithKline Beecham?
15 Q. Yes.
16 A. Well, I don't know honestly.
17 This is a business development document.
18 Within business development, this is the
19 process that we followed.
20 Q. Were there other departments
21 other than business development that
22 would be involved in the process of
23 determining the viability of a product
24
for future marketing in the United
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JAMES HAND, Ph.D.
1 States?
2 A. Could you restate that
3 again?
4 Q. Sure. Were there other
5 departments within SB, I use SB as a
6 generic term, that would be involved in
7 the process of determining the viability
8 of marketing a product in the United
9 States?
10 A. Yes.
11 Q. What other departments would
12 there be?
13 A. They are listed within the
14 process document.
15 Q. Did they have their own
16 guidelines or did they use this
17 guideline?
18 A. If there were
19 responsibilities for other departments,
20 they used this document to state who was
21 responsible for various assessments and
22 their roles. Some of those departments
23 are defined in here.
24
Q. We're going to get to that
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JAMES HAND, Ph.D.
1 but my question --
2 A. There may have been
3 processes in other departments of the
4 company. I have no -- I don't know for
5 sure.
6 Q. Who would know in the
7 company?
8 A. I don't know.
9 Q. The introduction says that
10 the in-licensing of development stage
11 compounds represents an important source
12 of future products for SB. Could you
13 tell me on the record what in-licensing
14 means in this document?
15 A. Generally it refers to the
16 acquisition of a product which was not
17 generated within SmithKline Beecham.
18 Q. You say generally. Is that
19 also specifically that's what --
20 A. It could refer to acquiring
21 any compound from within one year of
22 human administration through to marketed
23 products.
24
Q. So I take it if there hadn't
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JAMES HAND, Ph.D.
1 been any human administration, then this
2 guideline wouldn't apply?
3 A. Within one year of human
4 administration.
5 Q. So either way?
6 A. Within one year of human
7 administration.
8 Q. Does that mean one year
9 before or one year after or both?
10 A. I'm not sure of your
11 question again.
12 Q. Well, it says within one
13 year of human administration. Does that
14 mean that the product is planned to be
15 tested on humans within a year or it's
16 already been tested within one year?
17 A. Oh, I see what your question
18 is. No, it's within one year of first
19 entering into human testing.
20 Q. So there already have been
21 some human testing as you understand?
22 A. It's within one year of
23 having entered into human testing. So
24
it's pre-clinical.
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JAMES HAND, Ph.D.
1 Q. Okay. I still don't
2 understand. Maybe it's me. Does that
3 mean there have been tests already on
4 humans or the tests are likely to occur
5 within one year?
6 A. The tests are -- well,
7 they're projected to occur within one
8 year.
9 Q. Thank you. Okay. The next
10 sentence says, The attached diagram,
11 which is the second page, outlines the SB
12 in-licensing process for compounds
13 requiring R&D resources. What does the
14 document mean by R&D resources?
15 A. If Research and Development
16 was going to have to spend any time or
17 work on the project at all, that's R&D
18 resources.
19 Q. And if Research and
20 Development didn't have to be involved,
21 would there be a different algorithm for
22 determining whether or not to accept the
23 product for marketing?
24
A. Yes.
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JAMES HAND, Ph.D.
1 Q. And is there such an
2 algorithm -- is it in existence in 1996?
3 A. I'm not sure what you mean
4 by algorithm. A flow chart?
5 Q. A flow chart.
6 A. I don't know.
7 Q. Who would know?
8 A. I don't know.
9 Q. Can you tell me whether R&D
10 resources were used in evaluating
11 Cerivastatin?
12 A. Yes.
13 Q. They were or they were not?
14 A. Yes.
15 Q. In 1996, did Worldwide
16 Business Development coordinate the due
17 diligence for Cerivastatin?
18 A. Yes.
19 Q. And can you tell us on the
20 record who at Worldwide Business
21 Development was in charge of coordinating
22 the due diligence process?
23 MS. FREIWALD: Object to the
24
form. If you know what he means
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JAMES HAND, Ph.D.
1 by "in charge."
2 THE WITNESS: Yeah, I --
3 you're going to have to restate
4 that, what you mean by "in
5 charge." Obviously if you read
6 the document, due diligence is a
7 very complicated process involving
8 multiple scientists.
9 BY MR. WEISS:
10 Q. I'm sorry, are you finished?
11 I'm sorry to interrupt you.
12 Let me ask it this way. Was
13 there a group within Worldwide Business
14 Development charged with the
15 responsibility of evaluating the
16 viability of marketing Cerivastatin in
17 the United States?
18 A. Restate that again?
19 Q. Sure. Was there a group
20 within Worldwide Business Development
21 charged with the responsibility of
22 evaluating the viability of marketing
23 Cerivastatin in the United States?
24
A. No.
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JAMES HAND, Ph.D.
1 Q. Was there any particular
2 person who had the overall responsibility
3 for SB to evaluate the viability of
4 Cerivastatin to be marketed in the United
5 States?
6 A. Could you restate that
7 again?
8 Q. Sure. Was there any
9 particular person who had the overall
10 responsibility at SB to evaluate the
11 viability of Cerivastatin to be marketed
12 in the United States?
13 A. No.
14 Q. Can you tell me, then, how
15 the process evolved by which the due
16 diligence was performed generally?
17 A. It's laid out in the
18 document. It's a team effort within the
19 company. There are multiple departments
20 as indicated within the process. So it's
21 a team effort that evaluates the
22 opportunity. There is no one individual
23 that does that.
24
Q. Now, this document -- I'm
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JAMES HAND, Ph.D.
1 sorry, are you finished?
2 A. Yes.
3 Q. I apologize.
4 This document on page 3 --
5 on page 1, I'm sorry, the third
6 paragraph, indicates "At each stage of
7 the in-licensing process, the
8 compound/product may be rejected due to
9 lack of scientific merit, unconfirmed
10 data, inadequate patent protection,
11 insufficient commercial potential,
12 unacceptable deal terms."
13 Is that generally the policy
14 that was used at SB for evaluating
15 in-licensing deals? Again, referring to
16 1996.
17 A. Okay. I'm not sure, policy,
18 what you mean by policy. You mean -- you
19 have to restate that or clarify what you
20 mean by policy.
21 Q. Absolutely. This document
22 talks about the in-licensing process.
23 Correct?
24
A. Yes.
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JAMES HAND, Ph.D.
1 Q. That's from when the company
2 first hears of the compound up until the
3 time that an agreement might be reached.
4 Correct?
5 A. Yes.
6 Q. And at any stage of that
7 process, the product may be rejected due
8 to lack of scientific merit. Correct?
9 A. Yes.
10 Q. Now, does lack of scientific
11 merit also include creating an
12 unreasonable risk of side effects?
13 A. Yes.
14 Q. What does unconfirmed data
15 refer to?
16 A. Data from the company
17 provided to us for evaluation at any
18 point that cannot be documented.
19 Q. Documented by a third party?
20 A. No.
21 Q. Documented how?
22 A. Documented by us to confirm
23 whether or not they actually did the
24
study.
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JAMES HAND, Ph.D.
1 Q. What about confirming the
2 results of the study?
3 A. I'm not sure what you mean.
4 Q. Well, is it just the fact
5 that the study was done, or would you
6 have to look to see whether the data that
7 was generated from the study was valid?
8 A. Yes, we evaluated whether or
9 not the data was actually valid. We
10 looked at the protocol and the results.
11 Q. And that would all be part
12 of unconfirmed data. Correct?
13 A. If it wasn't confirmed, we
14 could not do that.
15 Q. Inadequate patent
16 protection, what does that refer to?
17 A. Inadequate patent
18 protection. Provide exclusivity usually.
19 Q. Insufficient commercial
20 potential, what does that refer to?
21 A. Along with the scientific
22 merits, the data underlying the
23 scientific results to give us a product
24
profile. If it didn't make commercial
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JAMES HAND, Ph.D.
1 sense to the company, you wouldn't do it.
2 Q. Would you have to have a
3 certain rate of return for the company in
4 order to proceed?
5 A. I'm not sure -- no, I don't
6 know.
7 Q. Who would know?
8 A. I don't know.
9 Q. Of course, the other issue
10 is unacceptable deal terms. Is that
11 correct?
12 A. Yes.
13 Q. So if you didn't get a deal
14 that was satisfactory to SB, the deal
15 wasn't done. Correct?
16 A. Right.
17 Q. The paragraph goes on to say
18 that although each opportunity is unique,
19 most elements of the process are similar.
20 Do you agree with that statement?
21 A. Yeah.
22 Q. Can you tell me, Dr. Hand,
23 in 1996, were there any other compounds
24
that SB was considering in licensing?
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JAMES HAND, Ph.D.
1 A. What do you mean by
2 "considering"?
3 Q. Were there any other
4 compounds other than Cerivastatin in 1996
5 for which the company was doing due
6 diligence on a compound that it didn't
7 originate from inside the company's R&D?
8 A. I don't recall right now.
9 Q. Would that information be
10 available somewhere?
11 A. I don't know.
12 Q. Are you aware of any other
13 compound prior to Cerivastatin in which
14 this document, Hand-2, was used in
15 determining whether or not the product
16 was viable to market for SB?
17 A. Could you restate that
18 again?
19 Q. Sure. Are you aware of any
20 other compound prior to Cerivastatin in
21 which Hand-2 was used in determining
22 whether or not the product was viable to
23 market for SB?
24
A. I don't recall.
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JAMES HAND, Ph.D.
1 Q. Do you recall ever being --
2 strike it.
3 Were you ever involved prior
4 to Cerivastatin in the process for
5 evaluating a compound for in-licensing?
6 A. Yes.
7 Q. How many?
8 A. I don't recall.
9 Q. More than five?
10 A. I don't recall.
11 Q. You have no recollection
12 whatsoever?
13 A. I don't recall the number.
14 Q. Do you recall what products
15 they were?
16 A. No, I don't recall the
17 chronology.
18 Q. Were any of the products
19 involved that dealt in the field of
20 cardiovascular medicines?
21 A. I don't recall the
22 chronology.
23 Q. Meaning?
24
A. I don't recall the timing
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JAMES HAND, Ph.D.
1 for the use of this document on other
2 opportunities that may have been within
3 my therapeutic area.
4 Q. And what was your
5 therapeutic area?
6 A. Cardiopulmonary.
7 Q. Would Cerivastatin fall into
8 that area?
9 A. Yes.
10 Q. Were you involved in the
11 process to determine whether to
12 in-license Cerivastatin?
13 A. Yes.
14 Q. Could you tell me what your
15 involvement was in a general fashion?
16 A. Excuse me?
17 Q. Could you tell me what your
18 involvement was in a general fashion?
19 A. I was the scientific
20 licensing representative for Worldwide
21 Business Development.
22 Q. Who was the representative
23 from business development?
24
A. Elizabeth Posner.
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1 Q. Do you know what her title
2 was then?
3 A. No.
4 Q. Do you know what her title
5 is now?
6 A. No, I don't know.
7 Q. Is she still with the
8 company?
9 A. I don't know.
10 Q. Had you ever dealt with
11 Elizabeth Posner before Cerivastatin?
12 A. Dealt with her meaning?
13 Q. Interactions with her inside
14 the company?
15 A. Yes.
16 Q. I take it you and she had
17 interactions regarding Cerivastatin?
18 A. Yes.
19 Q. She generated some memos you
20 reviewed?
21 A. I'm not sure what you mean
22 by review.
23 Q. She generated some documents
24
that were used in determining whether or
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JAMES HAND, Ph.D.
1 not to go forward with the co-promotion
2 of Baycol in the United States?
3 A. Yes.
4 Q. Was there anyone else
5 besides yourself from scientific
6 licensing who was involved in the due
7 diligence for Cerivastatin?
8 A. Could you restate that
9 again?
10 Q. Sure. Was there any other
11 person other than yourself from
12 scientific licensing who was involved in
13 the due diligence process for
14 Cerivastatin?
15 A. What do you mean by
16 involved?
17 Q. Who was involved in whatever
18 occurred from the time SB first became
19 aware of a prospect of marketing
20 Cerivastatin in the United States to the
21 time that the co-promotion agreement was
22 signed in 1997?
23 A. Could you restate that?
24
Q. Sure. You were involved
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JAMES HAND, Ph.D.
1 from scientific licensing. Correct?
2 A. Yes.
3 Q. Anyone else in your
4 department involved in the due diligence
5 aspect of determining whether or not SB
6 would market Cerivastatin in the United
7 States?
8 A. Department meaning?
9 Q. Scientific licensing.
10 A. You're going to have to give
11 me that last part again.
12 Q. Okay. No problem.
13 You were involved in
14 scientific licensing, correct, in March
15 of 1996?
16 A. Yes.
17 Q. Is that a department inside
18 Worldwide Business Development?
19 A. Yes.
20 Q. Were you the director of
21 that department?
22 A. I was a director in the
23 department, yes.
24
Q. Who did you report to in
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JAMES HAND, Ph.D.
1 scientific licensing?
2 A. The vice president of
3 scientific licensing.
4 Q. Who was at the time?
5 A. Dr. Brian Morgan.
6 Q. Did anyone report to you in
7 scientific licensing at the time?
8 A. Yes.
9 Q. Who?
10 A. My administrative assistant.
11 Q. His or her name?
12 A. I don't recall her last
13 name.
14 Q. First name?
15 A. Mary Louise.
16 Q. Is she still with the
17 company?
18 A. I don't know.
19 Q. When was the last time you
20 had any interaction with Mary Louise?
21 A. I don't recall.
22 Q. Was Mary Louise involved in
23 the due diligence?
24
MS. FREIWALD: As a
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JAMES HAND, Ph.D.
1 secretary?
2 BY MR. WEISS:
3 Q. Process. Yes.
4 A. What do you mean by
5 involved?
6 Q. Did she have any
7 decision-making responsibility?
8 A. No.
9 Q. You did. Correct?
10 A. Decision-making for what?
11 Q. SB, as to whether or not to
12 go forward?
13 A. At one point in the process
14 I had decision-making responsibility,
15 yes.
16 Q. Did Brian Morgan have any
17 responsibility in this process?
18 A. What do you mean by
19 responsibility?
20 Q. Was he involved in any
21 decision-making function with regard to
22 whether SB was going to enter into a
23 co-promotion agreement with Bayer to
24
market Baycol in the United States?
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1 A. Yes.
2 Q. What was his
3 responsibilities if you recall?
4 A. I don't recall.
5 Q. Is he still with the
6 company?
7 A. No.
8 Q. When did he leave?
9 A. I don't recall the date.
10 Q. Do you know where he went?
11 Employment-wise that is.
12 A. No, I don't.
13 Q. Have you spoke to him since
14 he left the company?
15 A. No.
16 Q. Other than Brian Morgan and
17 yourself, did anyone else within
18 scientific licensing have any
19 responsibility for decision-making having
20 to do with the due diligence of Baycol?
21 A. No.
22 Q. At what point did you have
23 decision-making responsibilities with
24
regard to the due diligence for Baycol?
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1 A. It's defined in the process.
2 Q. Okay. We'll get there.
3 If you look at the -- page 1
4 that says Worldwide Business Development,
5 it indicates that scientific licensing
6 logs in all new opportunities. Do you
7 see that language?
8 A. Yes.
9 Q. What does that mean?
10 A. Scientific licensing was the
11 focal point for outside opportunities
12 coming into the company.
13 Q. Is it still that today?
14 A. No.
15 Q. When did it change?
16 A. Can I go back and answer
17 that differently?
18 Q. Sure.
19 A. I don't know.
20 Q. What is the focal point now
21 if it's not scientific licensing?
22 A. I don't know.
23 Q. When was the last time you
24
knew that scientific licensing was the
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JAMES HAND, Ph.D.
1 focal point for all new opportunities?
2 A. When scientific licensing
3 existed as a function.
4 Q. Did it exist in 1997?
5 A. Yes.
6 Q. Did it exist in 1998?
7 A. Yes.
8 Q. Did it exist in 1999?
9 A. It existed until the merger
10 with GlaxoWellcome.
11 Q. Which was when?
12 A. I don't recall the exact
13 date that the merger was finalized.
14 Q. What year?
15 A. I don't recall.
16 Q. What happened to scientific
17 licensing after the merger?
18 A. The Worldwide Business
19 Development department was restructured
20 as a part of R&D, no longer exists in its
21 previous structure or function.
22 Q. Was there a physical log
23 maintained at scientific licensing for
24
all new opportunities?
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1 A. No, not to my knowledge.
2 Q. What kind of log was there,
3 if any?
4 A. I can only speak to how I
5 tracked licensing opportunities coming in
6 in my area.
7 Q. Why don't you tell us how
8 you did it in your area?
9 A. I had no log.
10 Q. How did you track it?
11 A. In my file.
12 Q. Was there a specific file
13 for new opportunities?
14 A. No.
15 Q. Well, how would you keep
16 track of the opportunities if you didn't
17 have them in a file?
18 A. I had them in a filing
19 cabinet under the name of the company or
20 the opportunity.
21 Q. Let me ask you a question.
22 How long were those documents retained?
23 MS. FREIWALD: Which
24
documents?
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1 BY MR. WEISS:
2 Q. In the cabinet.
3 A. Which cabinet?
4 Q. I think you said you kept
5 the opportunities in a filing cabinet
6 under the name of the company or the
7 opportunity?
8 A. There were many cabinets,
9 many companies.
10 MS. FREIWALD: My objection
11 is to foundation. I think your
12 question assumes there was one way
13 of doing it for every opportunity
14 that was logged in.
15 MR. WEISS: I'm only asking
16 this witness about what he did.
17 MS. FREIWALD: Okay.
18 THE WITNESS: Okay.
19 BY MR. WEISS:
20 Q. You kept them in file
21 cabinets. Right?
22 A. I had file cabinets, yes.
23 Q. My question was, the
24
documents in those file cabinets, how
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1 long were they preserved, how many years?
2 A. Usually -- well, what do you
3 mean by preserved?
4 Q. An opportunity was looked
5 at?
6 A. Yes.
7 Q. It was either accepted or
8 rejected. Correct?
9 A. Yes.
10 Q. When it was rejected, did
11 you throw the file out?
12 A. No.
13 Q. How long did you keep the
14 file?
15 A. I can't recall.
16 Q. Was there a policy on when
17 those documents would be destroyed?
18 A. No.
19 Q. Were documents still in
20 existence in those files just before the
21 merger with Glaxo?
22 MS. FREIWALD: Again, I'm
23 just going to object to the form,
24
Sol, because I think you're
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1 talking very vaguely about
2 documents with any opportunities
3 that were ever in his file. He
4 told you there's no one policy for
5 them, so...
6 BY MR. WEISS:
7 Q. You can answer.
8 A. Can I clarify?
9 Q. Sure.
10 A. I'm getting a little
11 confused. I worked in this department
12 for many years. I met with hundreds of
13 companies a year. Thousands of
14 opportunities per year. The files were
15 large. So when you say did I ever throw
16 a file out, how can I answer that? I
17 mean, a file? Possibly.
18 Q. Let's take, for example,
19 let's make a drug up and call it Super.
20 You may have had two file cabinets filled
21 with materials involving this drug Super.
22 At some point in time SB determined they
23 weren't going to be involved in Super.
24
Now, did you take all the documents, not
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1 just one document, the whole Super file
2 and destroy it or did you just keep it
3 intact?
4 MS. FREIWALD: I'm just
5 going to object to asking a
6 hypothetical question of a fact
7 witness, but if you want to ask
8 him for a question that they
9 didn't license was there a policy
10 of what you did, you can ask him
11 that question.
12 MR. WEISS: I think I've
13 asked that question, but I'll use
14 it in the same language you just
15 did.
16 BY MR. WEISS:
17 Q. So can you answer that
18 question based upon the modification from
19 your lawyer?
20 A. I got to have the question
21 again.
22 Q. Sure. Was there a policy in
23 place for files on a product that you
24
didn't license?
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1 A. A policy for retention?
2 Q. Yes.
3 A. No.
4 Q. So you either kept them or
5 you destroyed them?
6 A. Yes.
7 Q. Whatever you wanted to do.
8 Is that correct?
9 A. Continuing with your
10 hypothetical example --
11 Q. Sure.
12 A. -- I'm getting in trouble
13 here, I guess, but if the opportunity was
14 under a confidentiality agreement and you
15 did not go forward with it, frequently
16 the agreements required that you destroy
17 or return documents.
18 Q. And that's what you did if
19 you had such an agreement. Correct?
20 A. Yes.
21 Q. And if there was no
22 confidentiality agreement, what did you
23 do, if anything, with the documents?
24
A. Personally they were kept in
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1 the file until I needed more file space.
2 And then they were destroyed.
3 Q. At the time of the merger,
4 there was a reorganization?
5 A. Yes.
6 Q. Were there any files that
7 you still had before the merger that fit
8 this category of rejected --
9 A. Didn't license.
10 Q. You didn't license?
11 A. Yes.
12 Q. What happened to those
13 files?
14 A. I don't know.
15 MR. WEISS: Want to take a
16 five-minute break?
17 MS. FREIWALD: Sure.
18 VIDEOGRAPHER: The time is
19 11:02. Off the record.
20 - - -
21 (A recess was taken.)
22 - - -
23 VIDEOGRAPHER: The time is
24
11:13. Back on the record.
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1 BY MR. WEISS:
2 Q. Okay. We're looking at page
3 2 of Hand-2. This is a flow chart.
4 Correct?
5 A. Yes.
6 Q. And this flow chart
7 indicates what goes on in the due
8 diligence -- strike -- this goes in the
9 in-licensing process. Correct?
10 A. Yes.
11 Q. Now, at the top of the flow
12 chart there is an opportunity?
13 A. Yes.
14 Q. And then there is a
15 preliminary evaluation done. Correct?
16 A. Yes.
17 Q. Who does that?
18 A. It's within -- usually
19 within Worldwide Business Development.
20 Q. Were you part of a
21 preliminary evaluation of Cerivastatin?
22 A. Yes.
23 Q. What role did you have?
24
A. I was the scientific
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1 licensing person.
2 Q. What other people were
3 involved in the preliminary evaluation
4 besides yourself?
5 A. When? For Cerivastatin?
6 Q. Yes, sir.
7 A. I don't recall.
8 Q. Do you recall anybody? Was
9 Elizabeth Posner involved?
10 A. Generally not, no. Not in
11 this time.
12 Q. Who would be generally, not
13 by specific name, what kinds of people
14 would be involved in preliminary
15 evaluations?
16 A. It's defined in the process
17 document, but usually I could make phone
18 calls to R&D people or other people in
19 the company on a matrix basis to get
20 their expertise about something that I
21 didn't fully understand, have expertise
22 in.
23 Q. If you had made any
24
handwritten or typed notes or e-mails
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JAMES HAND, Ph.D.
1 during the preliminary evaluation
2 process, where would they be?
3 A. They would be in my e-mail
4 file. The e-mails would obviously.
5 Q. Would that file still be in
6 existence today?
7 A. Yes.
8 Q. Have you searched to see
9 whether such documents are in that file?
10 A. I haven't looked at that
11 file in three years, four years.
12 MR. WEISS: I'm going to ask
13 counsel --
14 MS. FREIWALD: It's been
15 directed. He means he hasn't
16 personally looked through
17 everything. But that will be part
18 of our production.
19 THE WITNESS: Counsel asked
20 me if I had the e-mail file, I
21 found it.
22 MS. FREIWALD: Let's not get
23 into discussions with counsel.
24
THE WITNESS: I found the
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1 file.
2 BY MR. WEISS:
3 Q. If the opportunity passed
4 preliminary evaluation, was there some
5 kind of form that would be generated?
6 A. No.
7 Q. How would someone else
8 inside the company know that the drug had
9 survived preliminary evaluation?
10 A. Preliminary evaluation is
11 very informal. It was basically within
12 scientific licensing and within my
13 expertise to decide whether something was
14 suitable for additional evaluation or
15 not.
16 Q. Are you the person who
17 determined for this drug that it was
18 suitable for further evaluation?
19 A. Yes.
20 Q. In making your preliminary
21 evaluation, let's go over to page 3 of
22 the document, did you obtain and review
23 nonconfidential information from Bayer or
24
Bayer AG?
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JAMES HAND, Ph.D.
1 A. I obtained nonconfidential
2 information. Whether or not I had
3 confidential information at this point, I
4 don't recall.
5 Q. What type of nonconfidential
6 information would you have obtained?
7 A. Discussions with Bayer
8 personnel on the opportunity, what its
9 profile was. You could get information
10 from publicly available databases which
11 the company subscribed on the compound.
12 Q. What kind of databases are
13 we talking about, 1996?
14 A. Pharma Projects.
15 Q. Any others?
16 A. I don't recall at this time.
17 Q. Who owned Pharma Projects?
18 A. I don't know.
19 Q. Did you use Pharma Projects
20 at all?
21 A. Yes.
22 Q. Do you recall whether you
23 used Pharma Projects in connection with
24
Cerivastatin?
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1 A. I don't recall.
2 Q. Do you know what Med-Line
3 is?
4 A. Yes.
5 Q. Is Pharma Project something
6 similar to Med-Line?
7 A. No.
8 Q. How is it different?
9 A. Med-Line is free.
10 Q. Other than the fact that you
11 have to pay for it?
12 A. Yeah, I mean, Pharma
13 Projects is a proprietary database, and I
14 don't know the company that generates it.
15 It lists compounds that are in
16 development by companies around the
17 world.
18 Q. Does it list -- strike that.
19 Does it provide information
20 with regard to the safety profile on the
21 compound?
22 A. Sometimes.
23 Q. Do you know what I mean by
24
safety profile?
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1 A. Safe for animals, safe for
2 humans.
3 Q. Does it list the adverse
4 events that have been reported in either
5 preclinical or clinical trials?
6 A. It's a database with
7 thousands of compounds in it. Very
8 possibly one of them has that information
9 if it's publicly available.
10 Q. Other than Pharma Projects,
11 is there any other database that you used
12 back in 1996?
13 A. Adis Insight. And whether
14 or not we had that at this time, I don't
15 recall.
16 Q. Adis is A-D-I-S?
17 A. Yeah.
18 Q. Adis Insights have the same
19 type of information as Pharma Projects?
20 A. Yes.
21 Q. Is Adis Insights owned by
22 Adis International?
23 A. I don't know who owns --
24
Q. Anything else other than
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JAMES HAND, Ph.D.
1 Adis Insights or Pharma Projects?
2 A. For what? For Cerivastatin
3 or -- I'm not sure what you're asking.
4 Q. In 1996 that you would rely
5 on, you could use to make your
6 preliminary evaluation?
7 A. I would go to literature
8 sources much like Med-Line that you named
9 as well if there was something that I
10 thought might be in there. Or I would go
11 to the library. We had an information
12 resources group who could search dialogue
13 databases, things like that, to try to
14 find abstracts, publications of any sort
15 that are in the public domain.
16 Q. If you did collect that type
17 of material for this drug, Cerivastatin,
18 would you still have it in a file today?
19 A. I don't know. I don't
20 recall.
21 Q. Do you know what happened to
22 the file for Cerivastatin that you had?
23 A. Which file?
24
Q. The due diligence file.
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1 A. I'm not sure that I had a
2 due diligence file.
3 Q. You had a file, I take it,
4 during the time that the drug was under
5 consideration for co-promotion along with
6 other drugs that you talked about
7 earlier?
8 A. It's not a due diligence
9 file. It was a file, Bayer and
10 Opportunities, interactions with Bayer
11 that may have been in there, yes.
12 Q. Is that file still in
13 existence?
14 A. I don't believe so.
15 Q. Do you know when it was
16 destroyed?
17 A. I do not know the exact
18 date.
19 Q. Would it be before -- I'm
20 sorry.
21 A. What happened to it.
22 Q. Would it be before or after
23 the merger with Glaxo?
24
A. You're going to have to
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1 clarify what you mean by before or after
2 the merger. The merger actually took
3 about a year to complete. The department
4 was changed over during that time period.
5 Q. Well, whenever the
6 department was changed over, was the file
7 destroyed before the department was
8 changed over or after?
9 A. After.
10 Q. Was there a policy just to
11 destroy files at that time?
12 A. A policy by whom? You're
13 asking if there was a company policy to
14 destroy files when you change business'
15 departments? That's not fair.
16 Q. I'm trying to be fair and if
17 I'm unfair, I'll try to rephrase the
18 question. What I'm trying to figure out
19 is, why would the file be destroyed after
20 the changeover?
21 A. Because the new department
22 needed filing space.
23 Q. And I take it, then, those
24
files were not archived off site, they
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1 were just destroyed?
2 A. I don't know.
3 Q. Do you know what archiving
4 off site is?
5 A. Yes.
6 Q. While you were employed at
7 SB before the merger, or the effective
8 date of the merger, did you ever archive
9 documents off site?
10 A. Yes.
11 Q. And why would you do that?
12 A. Pardon?
13 Q. Why would it be done?
14 Pursuant to a policy or just because you
15 wanted to?
16 A. Because I wanted to retain
17 those files. They were the subject in
18 some cases of confidentiality agreements
19 that required ten-year storage.
20 Q. Was there any requirement of
21 confidentiality with regard to
22 Cerivastatin?
23 A. I would have to look at the
24
secrecy agreement and see what the
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1 requirement for confidentiality was.
2 Q. I think I have it here. Let
3 me see.
4 MR. WEISS: I'm going to
5 mark a document Hand-3. I'm not
6 sure this is the right agreement
7 or not, but you'll let me know.
8 - - -
9 (Whereupon, Exhibit Hand-3
10 was marked for identification.)
11 - - -
12 MS. FREIWALD: Take your
13 time in reading it.
14 THE WITNESS: No.
15 BY MR. WEISS:
16 Q. Have you seen that document
17 before?
18 A. It's a letter of intent.
19 MS. FREIWALD: I think
20 you're being asked a question.
21 BY MR. WEISS:
22 Q. Have you ever seen this
23 document before?
24
A. I have not seen this one.
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1 Q. Was there a separate secrecy
2 agreement or confidentiality agreement
3 with Bayer?
4 A. This does not appear to be a
5 confidentiality agreement.
6 Q. I understand. My question
7 is, do you know, do you recall whether
8 there was such an agreement with Bayer?
9 A. No, I don't recall.
10 Q. Let me -- I believe there
11 was a May 30, 1996 confidentiality
12 agreement. I've asked for it and I
13 haven't seen it yet. I just asked in a
14 letter to your counsel April the 1st of
15 this year.
16 Assuming there was a
17 confidentiality agreement, would that be
18 a prerequisite for archiving your file on
19 Cerivastatin?
20 A. No, that's a prerequisite
21 for getting confidentiality information
22 from the company.
23 Q. So just because you have a
24
confidentiality agreement doesn't mean
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1 you're going to keep the records for ten
2 years. Is that correct?
3 A. You can keep the records or
4 you can destroy them. Or there's
5 frequently provisions in the agreement.
6 That's why I said I would need to see
7 that to know what the provisions were
8 that we agreed to or would be returned to
9 the company as well.
10 Q. So absent the agreement, you
11 can't tell us. Is that correct?
12 A. Every agreement was
13 different in many cases.
14 Q. Have you looked to see
15 whether that file was archived that you
16 had?
17 A. I personally have not.
18 Q. Have you asked someone to
19 look for it?
20 A. No, I have not.
21 Q. Have you been requested by
22 someone to look for it? Have you
23 personally been requested to look for it?
24
A. No.
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1 Q. Did you maintain a log of
2 documents that were filed that were
3 archived off site?
4 A. When I requested the
5 documents be archived off site, I used to
6 put a letter into the hard copy file
7 stating what was somewhere else.
8 Q. And since you don't have the
9 file, you can't tell us if it was
10 archived. Is that correct?
11 A. Right.
12 Q. So you didn't keep a
13 separate file of stuff that was archived.
14 Correct?
15 A. No, I didn't.
16 Q. Going back to page 3, did
17 you receive any confidential information
18 with regard to Cerivastatin during the
19 time of your preliminary evaluation?
20 A. I don't recall.
21 Q. Do you recall whether you
22 saw a written evaluation from R&D staff?
23 A. No, I did not.
24
Q. What is an operating unit?
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1 Looking at the last sentence of the
2 second paragraph, preliminary evaluation?
3 MS. FREIWALD: I'm sorry,
4 what page are you on?
5 MR. WEISS: Page 3.
6 THE WITNESS: The second
7 paragraph?
8 BY MR. WEISS:
9 Q. The last sentence, "If the
10 product is relevant to a specific
11 operating unit, the operation will be
12 contacted for input."
13 A. I can't provide a specific
14 definition for that.
15 Q. Can you tell me what it
16 means since I've never seen the document
17 before and you have?
18 A. Would you like me to
19 speculate? Is that what you're asking
20 me to do?
21 Q. Well, you've been here
22 designated by the company to testify
23 today. So give me your best shot.
24
A. It's not something which I
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1 was required to do as the scientific
2 licensing person. Because of that, I
3 would rather not speculate on what
4 operating unit defines within the
5 company.
6 Q. This product was not for
7 over-the-counter use. Correct?
8 A. Not at the time we were
9 assessing it.
10 Q. So that consumer healthcare
11 would not be involved. Right?
12 A. I don't recall if consumer
13 healthcare was involved in the initial
14 assessment. I believe there was a
15 thought that statins in general may at
16 some point be available OTC.
17 Q. Were they consulted
18 somewhere downstream in the due diligence
19 process?
20 A. I don't know.
21 Q. Did you ever consult with
22 them?
23 A. I personally did not.
24
Q. The next paragraph says, If
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1 the preliminary, scientific and business
2 evaluations are favorable, the
3 appropriate TAT (or TAT head) will be
4 alerted to the opportunity.
5 What does TAT stand for?
6 A. Therapeutic area team.
7 Q. Was the therapeutic area
8 team consulted in this particular case?
9 A. Not consulted.
10 Q. Alerted?
11 A. Yes.
12 Q. By you?
13 A. Yes.
14 Q. Who did you alert?
15 A. Dr. Bill Matthews who was
16 the TAT head.
17 Q. What area would that be?
18 A. What area?
19 Q. Yes.
20 A. What therapeutic area?
21 Q. Yes.
22 A. Cardiopulmonary.
23 Q. Go back to page 2 for a
24
second. We've talked about the
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1 preliminary evaluation and you were the
2 preliminary evaluator, correct, for
3 Cerivastatin?
4 A. Yes, I coordinated the
5 preliminary evaluation.
6 Q. And you ultimately made the
7 decision to go forward?
8 A. Yes, to the next step.
9 Q. And that was to?
10 A. TAT Alert.
11 Q. All right. You talked to
12 Dr. Matthews. Is that correct?
13 A. Yes.
14 Q. And then according to that,
15 there is a -- according to the flow
16 chart, a dual process goes on after the
17 TAT alert? There is a preliminary
18 commercial evaluation and in-depth
19 scientific evaluation. Is that correct?
20 A. Yes.
21 Q. Were you involved in either
22 aspect of that for Cerivastatin?
23 A. In the scientific
24
evaluation, in-depth scientific
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1 evaluation.
2 Q. And I'm correct that there
3 were two chances to reject the drug
4 before it got there. Is that correct?
5 Preliminary evaluation, if you didn't
6 like it, you could reject it. Correct?
7 A. Yes.
8 Q. The same thing, the TAT
9 alert, the therapeutic area team could
10 say we don't want it?
11 A. Right.
12 Q. So now we go to the in-depth
13 scientific evaluation. Who was the
14 member of the scientific licensing with
15 primary responsibility for this phase of
16 the process?
17 A. Myself.
18 Q. And who was the project --
19 the development project manager assigned
20 by the TAT head?
21 A. I can't recall who the
22 project manager was who was assigned by
23 the TAT head at this point.
24
Q. Who was on the evaluation
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1 team?
2 A. People from the departments
3 defined below and, again, I don't recall
4 all the people on that either.
5 Q. Do you recall any of the
6 people by name?
7 A. I can't recall with
8 confidence. There was probably 15
9 people. So I hope you appreciate it was
10 six years ago.
11 Q. I understand that. I'm just
12 asking if you can recall. Would there be
13 some kind of a document that had the
14 names of the people on it?
15 A. There wasn't a document
16 created specifically listing these are
17 the people on the team.
18 Q. Okay. Were there meetings
19 -- minutes of meetings kept?
20 A. Yes.
21 Q. And would it have the names
22 of the attendees in the meetings?
23 A. Yes, presumably.
24
Q. I take it those documents
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1 were also destroyed because they were a
2 part of the file?
3 A. The documents that were part
4 of my hard copy file were destroyed.
5 Q. Was there electronic file as
6 well?
7 A. I have an e-mail file.
8 Q. Would that also have the
9 minutes electronically?
10 A. I don't know.
11 Q. Did the TAT head also have a
12 file?
13 A. I don't know.
14 Q. Did the development project
15 manager also have a file?
16 A. I don't know. I don't
17 recall. I never saw their file, filing
18 systems.
19 Q. At this particular in-depth
20 scientific evaluation, did you receive
21 confidential information from Bayer --
22 A. Yes.
23 Q. -- if you hadn't already?
24
A. Yes.
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1 Q. What did you receive, if you
2 can recall?
3 A. I don't recall.
4 Q. I'm going to show you a
5 document I'm going to mark as Hand-4.
6 It's called a Product Strategic Plan.
7 - - -
8 (Whereupon, Exhibit Hand-4
9 was marked for identification.)
10 - - -
11 BY MR. WEISS:
12 Q. Did you ever see this
13 document before?
14 A. I don't recall seeing this
15 document.
16 Q. Did you -- can you tell me
17 what, if anything, you recall receiving
18 from Bayer or Bayer AG that allowed you
19 to do an in-depth scientific evaluation?
20 A. Again, I cannot -- it's been
21 six years. I do not recall the precise
22 documents that I received from Bayer.
23 Q. Do you have any general
24
recollection of what those type of
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1 documents would be?
2 A. There were clinical
3 protocols, clinical reports. Preclinical
4 studies.
5 Q. Are you certain you didn't
6 receive Hand-4?
7 A. I may have received this. I
8 just don't recall seeing it. It's an
9 interesting document.
10 Q. Well, there's some
11 handwritten notes from someone in your
12 company that we'll get to later on. Look
13 at the executive summary on page -- it's
14 the last page of the executive summary.
15 There is a number of bulleted items. Do
16 you see that in the same page?
17 A. Operationally the PDU is
18 sponsoring, is that what you're talking
19 about?
20 Q. Yes. Do you recall whether
21 you reviewed the Cerivastatin product
22 monograph?
23 MS. FREIWALD: What is the
24
date of the document?
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1 MR. WEISS: I'm not sure of
2 the date of the document, but I
3 can tell you the document makes
4 reference to a co-promotion
5 with -- a hopeful co-promotion
6 with SmithKline.
7 THE WITNESS: I don't recall
8 the product monograph.
9 BY MR. WEISS:
10 Q. If there was a product
11 monograph, would that be the type of
12 information that you would use back in
13 1997 to do an in-depth scientific
14 evaluation in 1996?
15 A. I'm not sure what the
16 product monograph is.
17 Q. What about Cerivastatin
18 literature and bibliography database, is
19 that something you would be interested in
20 having in order to provide an in-depth
21 scientific evaluation?
22 A. Yes.
23 Q. Do you know whether you got
24
that from Bayer?
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1 A. I don't recall.
2 Q. Would you be interested in a
3 Cerivastatin opinion leader slide
4 compendium in order to do an in-depth
5 scientific evaluation?
6 A. Yes.
7 Q. Do you recall whether you
8 had that?
9 A. I don't recall.
10 MS. FREIWALD: Could we just
11 hold on for a second? You're
12 asking whether he knows he had
13 this?
14 MR. WEISS: Yes.
15 MS. FREIWALD: Between the
16 time of the TAT alert and --
17 MR. WEISS: No, when he did
18 his in-depth scientific
19 evaluation.
20 MS. FREIWALD: Right after
21 the TAT alert in that box you were
22 looking at on page 2?
23 MR. WEISS: Yes. Or before.
24
BY MR. WEISS:
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1 Q. Do you know whether you had
2 seen a Lipid Views internal newsletter?
3 A. I don't recall.
4 Q. Would that be something you
5 would like to look at when you did an
6 in-depth scientific evaluation assuming
7 you knew it existed?
8 A. Yes.
9 MS. FREIWALD: I'm just
10 going to object to the line of
11 questioning because I think
12 without grounding the witness in
13 the time frame, you and he may be
14 talking about different time
15 frames. I think that's unfair.
16 MR. WEISS: I keep referring
17 to the time he did the in-depth
18 scientific evaluation. That's
19 what we're talking about right
20 now. I'm asking whether did he
21 have these documents to review,
22 and if he didn't, whether he would
23 like to have had them in his
24
review. They're my questions.
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1 THE WITNESS: Generally
2 under confidentiality, you want to
3 try and get as much information as
4 possible. If there are documents
5 available, yes, you want to have
6 copies of them.
7 BY MR. WEISS:
8 Q. Were you aware of either the
9 WSCOP or the care studies on statins at
10 the time you did your in-depth scientific
11 evaluation?
12 MS. FREIWALD: Are you
13 looking at a particular page of
14 the document?
15 MR. WEISS: I am.
16 MS. FREIWALD: Could you
17 refer the witness, please?
18 MR. WEISS: Sure. It's
19 under Market Development.
20 MR. DUEFFERT: The Bates
21 number?
22 MR. WEISS: The Bates number
23 is 140395.
24
BY MR. WEISS:
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1 Q. Do you have that in front of
2 you, sir?
3 A. Yes.
4 Q. Were you aware of the west
5 of Scotland coronary prevention study at
6 the time you did your in-depth scientific
7 evaluation?
8 A. What do you mean aware of?
9 If I knew it existed?
10 Q. Yes.
11 A. Yes.
12 Q. Did you know the results of
13 the study at the time you did your
14 in-depth evaluation?
15 A. I don't know. I don't
16 recall whether I knew the results or not.
17 Q. Were you aware of the
18 Scandinavian Cerivastatin Survival Study
19 known as the 4S?
20 A. Yes.
21 Q. At the time you did your
22 in-depth scientific evaluation. Is that
23 correct?
24 A. I don't recall.
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1 Q. If the study was available,
2 would that be something you would want to
3 review in your in-depth evaluation of
4 this product?
5 A. Only if Simvastatin --
6 Cerivastatin was involved in the study.
7 Q. What about the cholesterol
8 and recurrent events trial conducted in
9 the USA and Canada, were you aware of
10 that dealing with Pravastatin?
11 A. No, I was not aware of this
12 trial. I don't recall being aware of it.
13 Q. Would you agree with me that
14 you did not review any long-term clinical
15 study having to do with the safety of
16 Cerivastatin at the time you did your
17 in-depth scientific evaluation?
18 A. I personally?
19 Q. Yes.
20 A. I personally did not review
21 the studies, the long-term clinical
22 studies.
23 Q. Would you agree with me
24
there were no long-term studies for
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1 Cerivastatin as there were for Zocor and
2 Pravachol at the time you did your
3 in-depth scientific evaluation?
4 MS. FREIWALD: I'm just
5 going to object to the form
6 because I don't know what you mean
7 by "as there were with Zocor and
8 Pravachol."
9 MR. WEISS: I'll rephrase
10 the question. Thank you.
11 BY MR. WEISS:
12 Q. The West of Scotland
13 Coronary Prevention study was a published
14 study, correct, at the time that you did
15 your in-depth scientific evaluation?
16 A. You'll have to tell me what
17 date it was published.
18 Q. You said you were aware of
19 it at the time you did your in-depth
20 evaluation?
21 A. I don't know what date it
22 was published.
23 Q. It had to do with Pravachol,
24
though, didn't it, a particular statin?
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1 A. It appears to from this
2 abstract, yes.
3 Q. And the same thing with the
4 4S study, that had to do with
5 Simvastatin. Correct?
6 A. It appears to from this
7 abstract, yes.
8 Q. That was a published study?
9 A. I believe it was published,
10 yes.
11 Q. And there was also a CARE
12 study for Pravastatin?
13 A. It appears to be, yes.
14 Q. Now, there was also a
15 long-term intervention with Pravastatin
16 and ischemic disease, a lipid study,
17 which was scheduled for conclusion in
18 1997. Were you aware of that study at
19 the time you did your in-depth scientific
20 evaluation of Cerivastatin?
21 A. I was not aware of this
22 study.
23 Q. Were you aware of any
24
long-term study that was published
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1 dealing with the safety or efficacy of
2 Cerivastatin at the time you did your
3 in-depth scientific evaluation?
4 A. I don't recall.
5 Q. One way or the other,
6 correct? You have no recollection one
7 way or the other?
8 A. One way or the other whether
9 they were --
10 Q. Either there was one or
11 there wasn't one.
12 A. No, I don't recall.
13 Q. That there was one?
14 A. You have to appreciate that
15 this is not my responsibility at this
16 point. This was the Clinical Development
17 person on the team whose responsibility
18 it was to know about these studies.
19 Q. But that person reported to
20 you?
21 A. No, they did not report to
22 me.
23 Q. Did not? It indicated, if
24
you go back to page 4, it says a member
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1 of SL will take primary responsibility
2 for this phase of the process?
3 A. Right.
4 Q. That's the in-depth
5 scientific evaluation. And you told me
6 that that was you?
7 A. Yes. Responsibility means
8 coordinating this process and making sure
9 that all of the team members are assigned
10 and that they are evaluating the
11 information that is available. You can't
12 expect one person to have an all
13 encompassing knowledge of every one of
14 these therapeutic areas or disciplines
15 within the organization.
16 Q. Would that be something that
17 you would ask Clinical Development to
18 check out to see if there was such a
19 study having to do with Cerivastatin?
20 A. My role in this case was
21 basically as a funnel point to the
22 partner, Bayer. I requested information
23 from them and made sure that information
24
got to the key team members so that they
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1 could evaluate the data that was
2 available on Cerivastatin.
3 Q. Right. So if somebody from
4 Clinical Development said, hey, could you
5 check with Bayer to see if there was a
6 seminal study that they had on the safety
7 and efficacy of Cerivastatin, you were
8 the person to contact Bayer?
9 A. Yes.
10 Q. Who would you contact at
11 Bayer?
12 A. I would contact my
13 counterpart in Bayer business development
14 who was performing the same function on
15 their side.
16 Q. And who would that be?
17 A. I don't recall.
18 Q. Chris Seaton sound familiar,
19 S-E-A-T-O-N?
20 A. Yes. That sounds familiar.
21 Q. Would that be the person you
22 contacted?
23 A. No.
24
Q. Do you know Chris
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1 professionally?
2 A. I know who he is, yes.
3 Q. He's not the person you
4 would have contacted?
5 A. No.
6 Q. Did you have such a
7 conversation, if you recall, with someone
8 from Bayer asking --
9 A. I don't recall asking
10 specifically for a long-term clinical
11 safety and efficacy study on
12 Cerivastatin.
13 Q. Did you know that Bayer
14 regarded Cerivastatin as its opportunity
15 to learn the basics in the lipid
16 regulating market? Were you aware of
17 that?
18 MS. FREIWALD: Are you
19 reading from somewhere?
20 MR. WEISS: Yes. Executive
21 summary. 140384.
22 MR. DUEFFERT: Which
23 paragraph?
24
MR. WEISS: Under high LDL,
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1 it says, "In this regard." Do you
2 see that?
3 MS. FREIWALD: I'm sorry, I
4 don't know -- I can't see where
5 you're reading from. 384?
6 MR. WEISS: Yes.
7 THE WITNESS: I don't know
8 where you're -- you're going to
9 have to rephrase this and tell me
10 where you're reading from.
11 BY MR. WEISS:
12 Q. Sure. I'll give you my
13 highlighted portion so you can see where
14 I am.
15 A. What was your question?
16 Q. My question was, were you
17 aware that Bayer regarded Cerivastatin as
18 its opportunity to learn the basics in
19 the lipid regulating market?
20 A. No, I don't recall that they
21 were being made aware of this paragraph
22 or their intent.
23 Q. Would that be something that
24
you would need to know in order to do an
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1 in-depth scientific evaluation?
2 A. No, I don't see why.
3 Q. So you didn't need to know
4 what level of expertise Bayer had with
5 regard to statin use?
6 MS. FREIWALD: Object to the
7 form.
8 BY MR. WEISS:
9 Q. Or statin efficacy?
10 MS. FREIWALD: Object to the
11 form. I don't think that's what
12 this says. I don't know exactly
13 what this means, but I think
14 you're changing the meaning.
15 BY MR. WEISS:
16 Q. You can answer the question.
17 Did you need to know what level of
18 expertise Bayer had with regard to the
19 safety and/or efficacy of statins?
20 MS. FREIWALD: Did he
21 personally?
22 BY MR. WEISS:
23 Q. The in-depth scientific
24
evaluation process for which he had
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1 primary responsibility in coordinating
2 this process.
3 A. You want to run that
4 question by me again?
5 Q. Sure. Hang on one second,
6 be right with you.
7 Would your company need to
8 know, in making an in-depth scientific
9 evaluation, of the expertise that Bayer
10 had or didn't have with regard to the
11 safety and/or efficacy of its product in
12 the statin market?
13 A. You're going to have to
14 define expertise for me.
15 Q. Whether Bayer knew what the
16 safety profile of its product was at the
17 time you did your study?
18 MR. DUEFFERT: Objection as
19 to form.
20 MS. FREIWALD: I'm going to
21 object to form. You keep calling
22 it his study.
23 MR. WEISS: It's the
24
in-depth scientific evaluation.
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1 MS. FREIWALD: But it's not
2 his study.
3 MR. WEISS: He is the
4 corporate deposition
5 representative who is giving us
6 information about the in-depth
7 scientific evaluation made by SB
8 for this product. That's why I
9 refer to his. You can substitute
10 SmithKline or SB for his. I don't
11 care.
12 MR. DUEFFERT: My objection
13 is, I think there are two
14 different questions at this point.
15 THE WITNESS: I have no idea
16 actually what you're asking. You
17 have to get a little more clear
18 and maybe a little more concise so
19 that I can answer them --
20 BY MR. WEISS:
21 Q. Sure. We'll try to do that
22 for you. Hold on one second.
23 Let me ask it this way: At
24
the time of the in-depth scientific
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1 evaluation, had SmithKline had any
2 expertise with regard to lipid lowering
3 compounds?
4 A. What do you mean by
5 expertise?
6 Q. Did SmithKline have any
7 products in the pipeline or in the
8 marketplace that treated people with high
9 cholesterol?
10 A. There were R&D projects
11 looking at lipid control, lipid factors.
12 Q. Were they statin projects?
13 A. No. Not that I'm aware of.
14 Q. What kind of drugs were
15 they?
16 A. I don't recall all of the
17 targets that R&D had when they were
18 looking for lipid control. One that I
19 recall was "L-P little a," Liper
20 Protein a.
21 Q. What was the proposed
22 benefit of that compound?
23 A. I don't recall.
24
Q. Had anyone at R&D studied
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1 the effect of statins on the human body
2 prior to the time that this in-depth
3 scientific evaluation was done?
4 A. Within SB?
5 Q. Yes.
6 A. I don't know.
7 Q. Was SB relying upon Bayer's
8 knowledge of the effects of statins on
9 the human body for making its in-depth
10 scientific evaluation of Cerivastatin?
11 A. We evaluated the data which
12 Bayer provided us which they had
13 completed, studies they did, clinical
14 studies, preclinical studies, everything
15 that we could get or ask for from them,
16 and that was the basis for our assessment
17 of the safety and efficacy of the
18 compound.
19 Q. Did someone at SmithKline,
20 during the in-depth scientific
21 evaluation, compare the clinical studies
22 that had been completed by Bayer with the
23 clinical studies that had been completed
24
by Merck or any other company that had a
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1 statin already in the marketplace?
2 A. I don't recall such a
3 comparison.
4 Q. Did anyone ever tell you,
5 during this in-depth scientific
6 evaluation, that the studies that were
7 done by Bayer were not adequate?
8 MS. FREIWALD: I think we're
9 now getting into merits. I'm
10 going to -- I think we are, Sol.
11 Because now we're getting into
12 judgments about the adequacy of
13 the study. You'll get that, but
14 not today, today's procedure and I
15 let you go pretty far on that.
16 MR. WEISS: We'll mark that.
17 BY MR. WEISS:
18 Q. Let me ask you this
19 question. Would a comparison of clinical
20 trials from competing products be
21 something that was done at the level of
22 the in-depth scientific evaluation?
23 A. Could you give me that
24
question again?
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1 Q. Sure. Would a comparison of
2 clinical trials from competing products
3 be something that was done at the level
4 of the in-depth scientific evaluation?
5 A. In general, yes.
6 Q. Yes.
7 A. Yes.
8 Q. Do you know whether it was
9 done in this case?
10 A. I don't recall such a
11 comparison.
12 Q. Continuing on page 4 of the
13 document --
14 A. Which document?
15 Q. Hand-2. It goes on to say
16 that the -- that you will coordinate an
17 evaluation team to carry out an in-depth
18 technical assessment of the opportunity
19 and potential for differentiation from
20 the competition. Do you see that?
21 A. Yes.
22 Q. What is the competition for
23 Cerivastatin?
24
A. It depends on what you're
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1 looking at for competition. Marketed
2 products, research products, preclinical.
3 Ones that are coming on in two years, all
4 of that?
5 Q. Is that what is meant by
6 competition in this paragraph?
7 A. This is a general guideline
8 document applying to compounds all the
9 way from preclinical to marketed
10 products. In that case, yeah,
11 differentiation from the competition
12 would apply to anything that was similar
13 stage or would potentially be a
14 competitor to the product under
15 consideration.
16 Q. Was such an analysis
17 performed for Cerivastatin?
18 A. I don't recall seeing the
19 analysis.
20 Q. From that I can presume it
21 wasn't done in this particular case?
22 MS. FREIWALD: That's not
23 what he said.
24
THE WITNESS: That's not
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1 what -- I don't recall seeing such
2 an analysis.
3 BY MR. WEISS:
4 Q. Well, as the member of SL
5 who will take primary responsibility for
6 this phase of the process, would you have
7 seen it if it was around?
8 A. Again, are you speaking in
9 general about the process or are you
10 speaking about Cerivastatin in
11 particular?
12 Q. Cerivastatin in particular.
13 A. I would hope that I would
14 have seen it, yes.
15 Q. The departments involved in
16 the in-depth scientific evaluation
17 include discovery. What is that
18 department?
19 A. Research.
20 Q. Preclinical Development,
21 also research?
22 A. Yes. Research.
23 Q. Clinical Development also
24
research?
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1 A. That's development.
2 Q. Corporate Intellectual
3 Property?
4 A. That's patents.
5 Q. Regulatory Affairs/
6 Compliance, who would that be?
7 A. That would be Regulatory
8 Affairs and Compliance.
9 Q. Do you know who from
10 Regulatory Affairs would have been
11 involved in this process for
12 Cerivastatin?
13 A. I would have to look back at
14 the minutes or -- to identify the people
15 involved on the team.
16 Q. And again, the minutes are
17 -- the hard copies are gone, destroyed,
18 right, only the electronic e-mails are
19 available?
20 A. I don't know what has
21 happened to the hard copies.
22 MS. FREIWALD: For his
23 files.
24
THE WITNESS: For my files.
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1 MR. WEISS: I understand.
2 BY MR. WEISS:
3 Q. Was an external consultant
4 utilized?
5 A. During this phase?
6 Q. Yes, sir.
7 A. Again, this is a while ago,
8 I don't recall, but I think no is the
9 answer.
10 MR. WEISS: We have to
11 change the videotape I understand.
12 So why don't we take a lunch
13 break.
14 MS. FREIWALD: Sure.
15 VIDEOGRAPHER: This
16 concludes tape one of this
17 videotape deposition. The time is
18 12:11. We are off the record.
19 - - -
20 (A recess was taken.)
21 - - -
22 VIDEOGRAPHER: This begins
23 tape two of this videotape
24
deposition. The time is 12:57
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1 p.m. We are on the record.
2 BY MR. WEISS:
3 Q. We're still on page 4 of
4 Hand-2. The next paragraph indicates
5 "During the in-depth scientific
6 evaluation, which results in a formal
7 presentation and discussion at the TAT,"
8 do you recall whether there was a formal
9 presentation made by the in-depth
10 scientific portion for Cerivastatin?
11 A. I don't recall the nature of
12 the presentation.
13 Q. Do you recall whether there
14 was a presentation?
15 A. Yes, there was a discussion.
16 Q. Would there be either slides
17 or an actual written presentation?
18 A. I don't recall in this case,
19 and it could be simply a verbal
20 presentation, it could be slides, it
21 could be a document that was actually
22 created.
23 Q. Let me ask the general
24
question. For other drugs or compounds
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1 that are being evaluated in the same time
2 period, would most of the in-depth
3 scientific evaluations that resulted in
4 formal presentation be in writing either
5 by slides or written materials rather
6 than verbal only?
7 A. It for -- as a general
8 question for anything else that was going
9 on that was being presented to the TAT,
10 it could be in any one of those formats.
11 It could be overhead, it could be slides.
12 In general at the time it was overheads,
13 but it could be written. It could be
14 just me giving a verbal update.
15 Q. Overhead projector, is that
16 what you're talking about?
17 A. Yeah, the transparency.
18 Q. Would the transparency still
19 be in existence?
20 A. No. The transparencies, if
21 they were in existence, would have been
22 in my hard copy file under Bayer.
23 Q. What is the PRB?
24
A. It's the Pharmaceutical
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1 Review Board.
2 Q. And who sits on that board,
3 who sat on that board, excuse me, during
4 the process of the due diligence for
5 Cerivastatin?
6 A. It was the senior executive
7 board for SmithKline Beecham. I don't
8 recall all the members. However, Tamara
9 Howson, my boss, was a PRB member. The
10 head of R&D was a PRB member. The head
11 of Clinical Development was a member.
12 And it was chaired by the chief operating
13 officer. Also the head of regulatory
14 affairs was on there.
15 Q. Who was the head of
16 regulatory affairs during that time
17 period?
18 A. I don't recall.
19 Q. How often did the PRB meet?
20 A. They met regularly
21 throughout the year. I don't recall the
22 exact schedule, but it was roughly once a
23 month.
24
Q. Were you a member of the
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1 PRB?
2 A. Wish I was. No.
3 Q. Were there minutes kept of
4 PRB meetings?
5 A. Yes, I'm sure there are.
6 Q. Did you ever see minutes of
7 the PRB meetings that had to do with
8 Cerivastatin?
9 A. No, I was not on the copy
10 list for PRB minutes.
11 MR. WEISS: Hope, I'm going
12 to ask for the PRB minutes as they
13 relate to Cerivastatin.
14 BY MR. WEISS:
15 Q. Who was the vice president,
16 director of SL at this time?
17 A. That was Brian Morgan.
18 Q. You mentioned, looks like,
19 Tom March, something like that, Tom
20 something was your boss? Who was your
21 boss at the time?
22 A. Brian Morgan.
23 Q. Okay. This says something
24
else in the transcript. That's why --
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1 Tom somebody. Tom Hobson -- Tom Howson?
2 A. Tamara Howson.
3 Q. Tamara Howson. You say he
4 was your boss?
5 A. No, Tamara is a she.
6 Q. Was she your boss?
7 A. She was my boss as well.
8 There's -- Worldwide Business
9 Development, Tamara was the next person,
10 senior vice president, director, WWDB.
11 Q. She reported to?
12 A. To J.P. Garnier.
13 Q. Well, what is the
14 difference between --
15 A. Who was the chief operating
16 officer. Tamara -- within Worldwide
17 Business Development, there were two
18 groups, scientific licensing and business
19 development.
20 Q. Tamara is the business
21 developing side?
22 A. Tamara was with the head of
23 Worldwide Business Department. Worldwide
24
Business Development had two functions
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1 within it, scientific licensing and
2 business development.
3 Q. Dr. Morgan or Brian Morgan,
4 he was?
5 A. The head of scientific
6 licensing.
7 Q. The next paragraph says,
8 "The minimum amount of data consistent
9 with a rational analysis is collected to
10 enable the TAT to endorse the scientific
11 merit of the opportunity," and goes on
12 from there.
13 What is meant by "a rational
14 analysis" in the context of this
15 document?
16 A. They are able to make an
17 informed decision based on the data that
18 we have, enable the TAT to say whether it
19 has scientific merit.
20 Q. In this particular case, did
21 SB have any involvement in the IND or NDA
22 for Cerivastatin?
23 A. At this point?
24 Q. Yes, sir.
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1 A. We didn't have a deal with
2 them at the time, so there wouldn't have
3 been no involvement in any regulatory
4 business going on within Bayer.
5 Q. Did Bayer ask for any help
6 with respect to the IND or NDA from SB
7 before the deal was consummated?
8 A. Not that I'm aware of.
9 Q. Did Bayer ask SB for any
10 input with respect to the IND or NDA or
11 supplemental NDA that might have been
12 submitted for Cerivastatin?
13 MS. FREIWALD: Are we
14 talking about at this point --
15 MR. WEISS: Yes, this point.
16 MS. FREIWALD: I just -- you
17 know, we're getting a little loose
18 on the time frame. We're talking
19 about between the TAT alert and
20 the TAT presentation?
21 MR. WEISS: We're talking
22 about the in-depth scientific
23 evaluation.
24
MS. FREIWALD: As in the box
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1 on page 2?
2 MR. WEISS: As set forth in
3 detail on page 4.
4 MS. FREIWALD: Okay.
5 THE WITNESS: There's
6 nowhere in the process that says
7 that we would be involved in
8 regulatory business of another
9 company, and without a deal in
10 place, you would not do that.
11 BY MR. WEISS:
12 Q. Were you involved in any of
13 the preliminary commercial evaluation for
14 Cerivastatin?
15 A. Only peripherally. I may
16 have been asked a question about science.
17 I don't recall any specific. That was my
18 colleague in business development, that
19 was their part.
20 Q. Who would that person have
21 been?
22 A. That was Elizabeth Posner.
23 Q. The next thing that occurs
24
in the flow chart is the TAT
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1 documentation, page 2 and then turn to
2 page 5. Did you participate in the
3 compilation of a document for the TAT
4 documentation for this drug?
5 A. If the document was
6 compiled, yes, I would have been involved
7 in preparing it.
8 Q. Do you have any recollection
9 whether a document was compiled?
10 A. I can't recall right now.
11 Q. How would we determine
12 whether there was such a document
13 compiled for TAT documentation in this
14 case?
15 A. How would you determine
16 that?
17 Q. How would I, someone looking
18 inside the company today, determine if
19 such a document was, in fact, compiled?
20 A. I don't know how you would
21 do that.
22 Q. Is TAT documentation
23 essential in the process of due diligence
24
in the years 1999 and -- 1996 and 1997,
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1 excuse me?
2 A. Can you clarify what you
3 mean by essential?
4 Q. Could the TAT make a
5 determination as to whether to go forward
6 or reject the project without
7 documentation?
8 A. Yes.
9 Q. It could. Right?
10 A. Yes.
11 Q. How often did that occur in
12 the same time period?
13 A. I don't recall.
14 Q. Based upon this guideline,
15 was it expected that the SL and
16 development project manager would compile
17 a document for TAT presentation? It
18 doesn't say "may." It says "compile."
19 A. In general?
20 Q. Yes, sir.
21 A. As a general part of this
22 process applying to things as a guideline
23 from preclinical all the way through to
24
launched product, yes, it was expected
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1 that you may compile documents, you may
2 attach things together and distribute
3 them. You wouldn't possibly write
4 anything. It would just be information
5 that was compiled and distributed to the
6 TAT members for review.
7 Q. That would include
8 background information such as meeting
9 reports?
10 A. Yes.
11 Q. Were there meeting reports
12 for this drug?
13 A. Yes.
14 Q. And who prepared the
15 reports?
16 A. Whoever was chairing the
17 meeting usually.
18 Q. So, then, would those
19 reports have been sent to the TAT for
20 presentation?
21 A. If they were felt to be
22 relevant, yes.
23 Q. Do you have any recollection
24
that they weren't sent to the TAT for
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1 presentation in this case?
2 A. I don't recall, no.
3 Q. And you would also provide
4 the TAT with the confidential or
5 nonconfidential data?
6 A. If it was felt to be
7 relevant to making a decision, yes.
8 Q. And do you recall one way or
9 the other whether the TAT did or did not
10 receive confidential or nonconfidential
11 data with respect to this drug?
12 A. You have to repeat that,
13 please?
14 Q. Sure. Do you recall one way
15 or the other whether the TAT did or did
16 not receive confidential or
17 nonconfidential data with respect to
18 Cerivastatin?
19 A. Yes.
20 Q. It did?
21 A. Please repeat your question?
22 Q. Do you recall one way or the
23 other whether the TAT did or did not
24
receive confidential or nonconfidential
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1 data with respect to Cerivastatin? Your
2 answer was yes.
3 A. Yes.
4 Q. That means it did get it?
5 A. Yes.
6 Q. "All SB evaluations of the
7 information received from the originating
8 party." Were there evaluations made by
9 SB with respect to Cerivastatin?
10 A. Yes.
11 Q. Were they given to the TAT
12 as part of the presentation or before the
13 presentation?
14 A. I don't know.
15 Q. Who made the SB evaluations?
16 A. Team members. Team members
17 that were -- as described earlier.
18 Q. What did the evaluations
19 include if you can recall?
20 A. As I said, the process, you
21 can view my role and the project
22 manager's role more as orchestra leaders,
23 we orchestrate a large number of expert
24
people who carry out evaluations on their
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1 expert areas. They would provide us with
2 an opinion of the information sent to us
3 by the outside partner, whether it's
4 Bayer or anybody else according to the
5 process, and along with that they would
6 provide some recommendation as to an
7 issue or what needs to be done with the
8 opportunity or whether they saw it was
9 good.
10 Q. I'm going to mark -- I only
11 have one copy. I just want to ask you
12 some questions about it. It's entitled a
13 Cerivastatin PRB Review Document. It's
14 dated January 9, 1997. Then in the
15 bottom it's got a date of April 24, 1997.
16 It's Bates numbers 145830 through 145870.
17 Why don't you mark it as Hand-6 I believe
18 is the next number? Five?
19 MS. FREIWALD: Could we stop
20 the videotape for just one second.
21 VIDEOGRAPHER: The time is
22 1:14. Off the record.
23 - - -
24
(Whereupon, a discussion was
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1 held off the record.)
2 - - -
3 (Whereupon, Exhibit Hand-5
4 was marked for identification.)
5 - - -
6 VIDEOGRAPHER: The time is
7 1:16. Back on the record.
8 BY MR. WEISS:
9 Q. Have you seen that document
10 before?
11 A. I may have.
12 Q. Would that be the kind of
13 document that would be given to the TAT?
14 A. No.
15 Q. What is that document?
16 A. A PRB document.
17 Q. What is the PRB document?
18 A. It's the Pharmaceutical
19 Review Board document as described --
20 Q. Further down the chart?
21 A. -- further down the chart.
22 Q. Okay. Was there a
23 development plan including
24
responsibilities submitted to the TAT for
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1 this drug?
2 A. I don't recall.
3 Q. Was there a statement on the
4 market and product potential submitted to
5 the TAT for this drug?
6 A. I don't recall seeing that,
7 no.
8 Q. And if there was such a
9 document, you would have seen it because
10 you were the coordinator. Correct?
11 A. Yes.
12 Q. The same thing would be true
13 for an outline of the development plan?
14 A. Yes.
15 Q. Was there a list of key
16 issues impacting the product profile and
17 timing?
18 A. Again, I don't recall.
19 Q. And if there was, you would
20 have seen it. Correct?
21 A. Correct.
22 Q. And you don't recall seeing
23 such a document. Correct?
24
A. Not right now, no.
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1 Q. Then we go to the TAT
2 presentation. That's the next thing on
3 the flow chart. Correct?
4 A. Yes.
5 Q. Were you the manager for the
6 presentation?
7 A. Yes.
8 Q. Do you recall how long the
9 presentation took?
10 A. No.
11 Q. Was there a time deadline
12 imposed by Bayer or Bayer AG for TAT
13 approval?
14 A. No.
15 Q. Going back to page 2, there
16 is a PRB STP. Correct?
17 A. Yes.
18 Q. And what is a PRB STP?
19 A. It's a Pharmaceutical Review
20 Board Situation Target Proposal document.
21 STP is a standard document format within
22 SB and continued into GSK.
23 Q. Did you prepare the STP?
24
A. It's not necessary that
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1 there is -- that there actually be a PRB
2 STP. I don't recall whether there was an
3 issue or not that required doing this.
4 Q. But if there was an issue
5 that required preparing an STP, would you
6 have been the person at Worldwide
7 Business Development that would have
8 prepared it?
9 A. No.
10 Q. Who would have been?
11 A. Depending on what the issue
12 was, but the document was presented by a
13 PRB member, the senior vice president of
14 Worldwide Business Development who would
15 have final say on the structure of the
16 STP.
17 Q. And that would have been who
18 again?
19 A. Senior vice president of
20 Worldwide Business Development.
21 Q. Which was at the time?
22 A. Tamara Howson.
23 Q. The next item that appears
24
in the flow sheet is an in-depth
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1 commercial evaluation. Were you involved
2 in that?
3 A. I was not in the commercial
4 group. I was in scientific licensing.
5 Q. That would have been
6 Elizabeth Posner for this particular
7 project?
8 A. It would have been business
9 development led by somebody in business
10 development, who was assigned to the
11 project, either Elizabeth Posner or one
12 of her colleagues.
13 Q. Did you know Jerry
14 Karabelas?
15 A. Yes.
16 Q. Would he have been the
17 person?
18 A. He wasn't in business
19 development.
20 Q. He was not. Okay.
21 What is the SPD marketing
22 research person?
23 A. What is?
24
Q. Yes.
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1 A. Someone in Strategic Product
2 Development Marketing Research.
3 Q. Would there have been a
4 written commercial analysis for
5 Cerivastatin?
6 A. I don't recall seeing it.
7 This may not have necessarily past across
8 my desk.
9 Q. All right. It would have
10 been above your level?
11 A. It just was peripheral to
12 what I was doing. Parallel.
13 Q. You are designated today to
14 come in and testify about what happened
15 procedurally in due diligence. Who would
16 have, in the normal course, received a
17 copy of a written confirmation of an
18 in-depth commercial evaluation?
19 A. The business development
20 person. It says in the process, prepares
21 a sales forecast.
22 Q. If you look at page 10.
23 It's Appendix A.
24
A. Yep.
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1 Q. Is that the copy of the --
2 that would have been prepared?
3 A. I'm not familiar with this
4 document or this appendix in here as
5 exactly what the purpose of this was.
6 This was something that was done by
7 business development in coordination with
8 the R&D market research group, SPD,
9 coordinate their activities for
10 evaluation of market potential. That's
11 under preliminary commercial evaluation
12 for TAT.
13 Q. What is the NPD? Look at
14 page 6.
15 A. That is the new product
16 development.
17 Q. Do you know who the person
18 was in SB in 1996 and 1997 who would have
19 been in charge of that?
20 A. It was the vice president of
21 new product development.
22 Q. Who was?
23 A. I think I recall who it was,
24
but I'm not a hundred percent certain.
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1 Q. Can you tell me who you
2 think it was?
3 A. I think it was David Brand.
4 Q. According to a document I
5 have, David M. Brand was vice president
6 of cardiovascular endocrine business
7 units, U.S. marketing? Is that the same
8 title?
9 MS. FREIWALD: What is the
10 date of your document?
11 MR. WEISS: December 14,
12 2000.
13 THE WITNESS: That's not
14 during this time period.
15 BY MR. WEISS:
16 Q. Huh?
17 A. That's not during this time
18 period.
19 Q. I understand. He changed
20 positions.
21 A. I don't know what David's
22 career has been doing.
23 Q. At the time of your
24
involvement in the due diligence
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1 procedure, do you recall whether there
2 was any uncertainty with respect to
3 Cerivastatin scientific merits?
4 MS. FREIWALD: I think
5 you're getting into the merits
6 here.
7 MR. WEISS: Well --
8 MS. FREIWALD: It's merits.
9 That's what was thought about the
10 compound at the time. It's not
11 process.
12 BY MR. WEISS:
13 Q. If there was uncertainty
14 with regard to the product's scientific
15 merits, would that have been addressed by
16 either the TAT or the PRB?
17 A. To the extent that there
18 were scientific issues associated with
19 the product arisen or found by the team
20 or any of the team members, those would
21 have been elevated as issues or things
22 that needed to be resolved to the senior
23 management committees, which was the TAT
24
and the PRB. It could have been as
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1 simple as doing some sort of genotoxicity
2 test that wasn't completed to our
3 satisfaction or anything.
4 Q. Then there was, according to
5 this flow chart, a PRB document prepared?
6 A. Yes.
7 Q. And that's what we marked?
8 A. That's a PRB document, yes.
9 Q. In the course of your
10 employment with SB during this time
11 period, you have seen a copy of this
12 document?
13 A. I don't recall that specific
14 document, no.
15 Q. Would you have seen similar
16 such documents?
17 A. Yes.
18 Q. Do you recall seeing any
19 other PRB document for Cerivastatin?
20 A. No, I don't.
21 MR. WEISS: Could we have
22 copies of these made later, Hope?
23 MS. FREIWALD: Sure.
24
MR. WEISS: So we keep all
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1 the exhibits together.
2 MS. FREIWALD: Sure.
3 BY MR. WEISS:
4 Q. The next thing is hard to
5 read on page 2, but is that PRB
6 projection or projections?
7 A. It should be in the document
8 on page 7 at the top.
9 Q. It's proposal?
10 A. Right.
11 Q. And that we've marked as
12 Hand-5, right, is one of the proposals?
13 A. This is a, yeah, PRB
14 document, right.
15 Q. According to the flow chart,
16 including the PRB proposal, there are
17 one, two, three, four, five different
18 places in the process where a decision is
19 made either to go forward with the
20 project or reject it. Is that correct?
21 A. If you're following the
22 process in a step-by-step approach, yes,
23 there are multiple places where it could
24
be rejected. However, a project, as I
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1 think it said early on in the document,
2 can be rejected at any point in its
3 evaluation if the scientific merit is not
4 sufficient.
5 Q. Now, after the PRB proposal,
6 there is a dual track due diligence and
7 negotiations. Do you see?
8 A. Yes.
9 Q. Were you involved in either
10 of those tracks?
11 A. In the full due diligence,
12 yes, in the due diligence part.
13 Q. And could you tell us what
14 you did with regard to the due diligence,
15 not the conclusion, but what you did for
16 the due diligence portion?
17 A. It would have been generally
18 my responsibility as a scientific
19 licensing member to coordinate any
20 technical due diligence that was going on
21 with the company. If there were -- at
22 this point you generally had clinical
23 reports, you had summaries which was
24
about all that we would get at this
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1 point. We would get the deep, deep
2 stuff. So you might have a clinical
3 protocol and clinical trial report and
4 the clinical team member may want to see
5 a lot more detail on that. That would
6 happen in the full due diligence which
7 generally required that you went to the
8 company site to be able to go down to
9 their case report forms and very deep
10 detail which is retained only at the
11 company itself.
12 Q. Did you go there personally?
13 A. We took several trips to
14 Germany. I would presume that I had been
15 along on this trip, again, but I can't
16 recall.
17 Q. Do you know who Mark McKlunk
18 was?
19 A. I'm aware of the name.
20 Q. Katherine O'Fe, O apostrophe
21 F-E?
22 A. I know Katherine, yes.
23 Q. Were these people who were
24
working on the scientific side of the due
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1 diligence?
2 A. No.
3 Q. Who worked on the scientific
4 side of the due diligence?
5 A. Members as defined under PRB
6 proposal above and team members from the
7 various departments. Project management
8 discovery development, CIP, law, finance,
9 WSL, manufacturing, any of these groups.
10 Q. Would be involved in the
11 scientific end?
12 A. Discovery, development, CIP
13 if you consider patents scientific.
14 Manufacturing, regulatory affairs were
15 all what I would consider scientific
16 groups amongst others in the company.
17 Q. According to this document,
18 which is marked as Hand-5, the due
19 diligence procedure is essentially
20 complete from the R&D perspective. Was
21 there a separate due diligence done by
22 R&D?
23 A. No. Generally the various
24
groups were asked to indicate whether or
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1 not they had completed -- had sufficient
2 time to complete their due diligence.
3 R&D was one in particular because of the
4 large number of scientific people who are
5 involved in the process from beginning to
6 end, that each one of them had to agree
7 with their senior management that they
8 had completed and knew everything about
9 the compound or project.
10 Q. I'm looking at Exhibit 5,
11 and there is no identification of any
12 individual who was involved in the due
13 diligence. I can tell you that pages
14 Bates number 145848 through 5852 are
15 completely redacted. So I can't tell if
16 those people would appear on that
17 document. Where else would I be able to
18 find a list of the people who were
19 actually involved from the scientific
20 side in the due diligence other than
21 yourself?
22 A. I don't know exactly where
23 you could find a list of these people.
24
Q. And you don't recall who
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1 these people were then. Correct? You
2 have no recollection of who these people
3 were by name?
4 A. I can't give you a list of
5 the people right now.
6 Q. Can you give me any people?
7 A. I'm not trying to be
8 evasive.
9 Q. I didn't suggest that you
10 were.
11 A. The difficulty is, as I
12 said, you know, I worked on a lot of
13 projects, a lot of things with these
14 people, and I just don't recall six or
15 seven years back which individuals were
16 on which projects with me.
17 Q. Was Jerry Karabelas involved
18 at all in the scientific end of the due
19 diligence?
20 A. No.
21 Q. If he would set forth in a
22 letter that there were serious concerns
23 regarding the emerging profile of
24
Cerivastatin, where would he get the
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1 information from?
2 MR. DUEFFERT: Objection.
3 Foundation.
4 BY MR. WEISS:
5 Q. A letter dated June 27, 1997
6 to David Ebsworth from Jerry Karabelas.
7 I'm not going to go into the merits of
8 the letter at this time pursuant to my
9 agreement with Hope, but I want to find
10 out where we can get the information to
11 make the statement. That's the reason
12 why I've asked the question.
13 A. I really have no idea where
14 Jerry Karabelas would have got
15 information to write a letter or a memo
16 to anyone else in or outside of the
17 company about his opinion on how the
18 product was developing.
19 MR. WEISS: I guess I'm just
20 going to have to mark the letter
21 as Hand-6.
22 - - -
23 (Whereupon, Exhibit Hand-6
24 was marked for identification.)
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1 - - -
2 BY MR. WEISS:
3 Q. Have you seen the letter
4 before?
5 A. No.
6 Q. Just take a minute and read
7 that letter to yourself?
8 MR. WEISS: Are we off the
9 record by the way? We can go off.
10 VIDEOGRAPHER: The time is
11 1:42. Off the record.
12 - - -
13 MR. WEISS: Let me state for
14 the stenographer, I have no
15 problem editing the tape to take
16 out the pause.
17 MS. FREIWALD: That's great.
18 MR. WEISS: I had no
19 intention of having the camera on
20 the witness while he read the
21 letter.
22 MS. FREIWALD: That's great.
23 - - -
24
VIDEOGRAPHER: The time is
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1 1:48. Back on the record.
2 BY MR. WEISS:
3 Q. Okay. You've read the
4 letter?
5 A. Yes.
6 Q. And can you tell me who
7 would have supplied the information to
8 Mr. Karabelas --
9 A. No, I can't.
10 Q. -- with regard to the
11 efficacy or safety?
12 A. No, I can't.
13 Q. Do you know who Richard Van
14 Thiel, T-H-I-E-L, was or is?
15 A. No.
16 Q. Jami, J-A-M-I, Rubin,
17 R-U-B-I-N?
18 A. No, I don't know.
19 Q. David Stout?
20 A. Yes, I know David Stout.
21 Q. What was David Stout's
22 position back at the time of due
23 diligence for Cerivastatin?
24
A. I don't know.
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JAMES HAND, Ph.D.
1 Q. Marsha Poland, P-O-L-A-N-D,
2 do you know who she was?
3 A. Yes.
4 Q. What did she do at that
5 particular point in time with the
6 company?
7 A. She was in clinical
8 research.
9 Q. Hamish M. Ross, R-O-S-S, do
10 you know who he was?
11 A. Yes.
12 Q. Who is he?
13 A. He was in development
14 project management.
15 Q. Len M. Selihar,
16 S-E-L-I-H-A-R, do you know who he was or
17 is?
18 A. Yes.
19 Q. And what was he in at that
20 time period?
21 A. He was in strategic product
22 development.
23 Q. Carol Harvey, what was she
24
involved in?
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JAMES HAND, Ph.D.
1 A. She was in strategic product
2 development.
3 Q. James, I think it's Huang,
4 H-U-A-N-G?
5 A. James Huang was in business
6 development.
7 Q. Do you know who Bill
8 Claypool was or is?
9 A. Yes.
10 Q. What job did Bill Claypool
11 have during the time of the due
12 diligence?
13 A. I don't recall his exact
14 title.
15 Q. Would any of the people we
16 just discussed been involved in getting
17 together information that would appear in
18 Exhibit Hand-6, the Karabelas letter to
19 Ebsworth?
20 A. Could you ask that question
21 again?
22 Q. Sure. Would any of the
23 people we've just discussed been involved
24
in getting together information that
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JAMES HAND, Ph.D.
1 would appear in Exhibit Hand-6, the
2 Karabelas letter to Ebsworth?
3 MR. DUEFFERT: Objection.
4 Form and foundation.
5 BY MR. WEISS:
6 Q. And to help you out, I'm
7 going to give you a copy of the e-mail
8 that's been marked -- I'll mark it as
9 Hand-7, is the next exhibit. I only have
10 one copy again, but you can make copies
11 after the fact.
12 A. I don't know --
13 MS. FREIWALD: Wait a
14 second. Since Mr. Weiss is giving
15 you an e-mail, take a minute to
16 look at the e-mail.
17 - - -
18 (Whereupon, Exhibit Hand-7
19 was marked for identification.)
20 - - -
21 THE WITNESS: This doesn't
22 tell me anything. I have no idea
23 what this means. Clinical
24
response for Jerry Karabelas'
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JAMES HAND, Ph.D.
1 questions. I don't know what
2 these questions were, I don't know
3 what the response is. I can't
4 make anything out of this e-mail.
5 BY MR. WEISS:
6 Q. I just want -- they're the
7 names that I read and I thought maybe it
8 might help you.
9 A. Well, yeah, those are people
10 that at this time may have been on -- or
11 involved with the in-licensing process
12 from their various departments, part of
13 the team members.
14 Q. Well, I guess -- what is the
15 Bates number of that at the bottom?
16 MS. FREIWALD: Just so the
17 record is clear, of what, Hand --
18 MR. WEISS: 7. It is
19 130062. And I just found three,
20 four and five, which would be part
21 of 7, that may shed some more
22 light on it for you, sir.
23 MS. FREIWALD: Do you have
24
any other copies of that?
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JAMES HAND, Ph.D.
1 MR. WEISS: No. You can
2 have copies made.
3 MS. FREIWALD: Could we turn
4 the tape off and I can read it
5 over the witness' shoulder?
6 VIDEOGRAPHER: The time is
7 1:53. Off the record.
8 - - -
9 THE WITNESS: This is a copy
10 of this attachment?
11 MR. WEISS: As best I can
12 see because it's consecutively
13 Bates numbers.
14 THE WITNESS: I don't know
15 what that means.
16 MR. WEISS: Well, whoever
17 produced it to us from Glaxo, it's
18 the next document in sequence and
19 they appear to add to the clinical
20 questions that are addressed in
21 the memo.
22 MS. FREIWALD: Are you able
23 to read me back your question?
24
MR. WEISS: Sure I can. The
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JAMES HAND, Ph.D.
1 question is, I just found three
2 four and five which will be part
3 of the exhibit. The question is,
4 whoever produced it to us from
5 Glaxo, it's the next document in
6 sequence, it appears to address
7 the clinical