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