1
`
`
`CIVIL ACTION NUMBER:
` 11-3962
`
` TRIAL
`
` UNITED STATES DISTRICT COURT
` FOR THE DISTRICT OF NEW JERSEY
`__________________________________
`HELSINN HEALTHCARE, S.A. and
`ROCHE PALO ALTO, LLC,
` Plaintiffs,
` -vs-
`DR. REDDY'S LABORATORIES, LTD.,
`DR. REDDY'S LABORATORIES, INC.,
`TEVA PHARMACEUTICALS USA, INC.,
`and TEVA PHARMACEUTICAL
`INDUSTRIES, LTD.
` Defendants.
`__________________________________
` Clarkson S. Fisher United States Courthouse
` 402 East State Street
` Trenton, New Jersey 08608
` June 16, 2015
`B E F O R E: THE HONORABLE MARY L. COOPER
`
`UNITED STATES DISTRICT JUDGE
`
`Certified as True and Correct as required by Title 28, U.S.C.,
`Section 753
`
`/S/ Regina A. Berenato-Tell, CCR, CRR, RMR, RPR
`/S/ Carol Farrell, CCR, CRR, RMR, CCP, RPR, RSA
`
`United States District Court
`Trenton, New Jersey
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`Helsinn Healthcare Exhibit 20(cid:20)(cid:22)
`Dr. Reddy's Laboratories, Ltd., et al. v. Helsinn Healthcare S.A.
`Trial PGR2016-00007
`
`Page 1 of 5
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`1
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`A P P E A R A N C E S:
`
`PAUL HASTINGS
`BY: JOSEPH O'MALLEY, ESQUIRE
` ERIC W. DITTMANN, ESQUIRE
` ISAAC S. ASHKENAZI, ESQUIRE
`SAUL EWING
`BY: CHARLES M. LIZZA, ESQUIRE
`Attorneys for the Plaintiffs
`
`BUDD LARNER
`BY: STUART D. SENDER, ESQUIRE
` MICHAEL H. IMBACUAN, ESQUIRE
` HUA HOWARD WANG, ESQUIRE
` CONSTANCE S. HUTTNER, ESQUIRE
` KENNETH E. CROWELL, ESQUIRE
`Attorneys for the Defendant, Dr. Reddy's Laboratories
`
`WINSTON & STRAWN
`BY: JOVIAL WONG, ESQUIRE
` GEORGE LOMBARDI, ESQUIRE
` JULIA MANO JOHNSON, ESQUIRE
` BRENDAN F. BARKER, ESQUIRE
`LITE DePALMA, GREENBERG, LLC
` BY: MAYRA V. TARANTINO, ESQUIRE
`Attorneys for the Defendant, Teva
`
`United States District Court
`Trenton, New Jersey
`
`Colloquy
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`I N D E X
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`Amidon - Direct
`
`(In open court. June 16, 2015, 9:30 a.m.)
`
`THE COURT: Good morning, all.
`
`ALL: Good morning, your Honor.
`
`THE COURT: I'm going to miss you.
`
` (Laughter.)
`
`THE COURT: Okay. Let's get to work.
`
`MR. DITTMANN: Thank you, your Honor.
`
`DIRECT EXAMINATION CONTINUED BY MR. DITTMANN:
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Doctor. Welcome back.
`
`Good morning.
`
`When we left off yesterday, we were talking about the
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`confidential preformulation data.
`
`Do you remember that?
`
`Yes.
`
`I'd like to talk a little bit about that data in view of
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`A.
`
`Q.
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`some of the prior art we discussed earlier in the day. Okay?
`
`A.
`
`Q.
`
`Okay.
`
`Now, first, do you recall that we were discussing the
`
`Example 13 I.V. formulation from the '333 patent?
`
`A.
`
`Q.
`
`Yes.
`
`Now, based on the confidential preformulation data you've
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`reviewed, do you have any confidence that a palonosetron
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`formulation made in accordance with Example 13 would be able
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`to treat emesis?
`
`A.
`
`No, I do not think that formulation would be an effective
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`United States District Court
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`Trenton, New Jersey
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`Amidon - Direct
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`commercial product, no.
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`And why do you say that?
`
`Q.
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`A.
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`Because it would not be stable. It was at a high dose.
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`And we know that that was unstable from the preformulation
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`report.
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`Q.
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`And are you referring to the 10-milligram-per-milliliter
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`and higher --
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`A.
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`Q.
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`A.
`
`Q.
`
`Yes.
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`-- concentrations we looked at yesterday?
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`Yes.
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`Now, I want to turn next to the Won reference that we
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`also discussed yesterday.
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`Would the confidential preformulation data provide the
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`POSA with any information concerning the appropriateness or
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`inappropriateness of comparing the behaviors of palonosetron
`
`in the Won molecule?
`
`A.
`
`Yes. Yes. That's why I looked at the preformulation
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`report. Formulation is very compound-to-compound dependent,
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`very much dependent on the properties, physical properties,
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`preformulation properties of the API.
`
`MR. DITTMANN: Could we bring up PDX-720, please.
`
`BY MR. DITTMANN:
`
`Q.
`
`A.
`
` Can you explain what we're seeing here, Doctor?
`
` Yes. This is a summary of a comparison that I have
`
`between the properties of palonosetron and the properties of
`
`United States District Court
`
`Trenton, New Jersey
`
`WITNESS DIRECT CROSS REDIRECT RECROSS
`
`GORDON L. AMIDON
`By Mr. Dittmann
`By Mr. Lombardi
`(Videotape Deposition of Patrick DeLuca)
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`United States District Court
`Trenton, New Jersey
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`Page 2 of 5
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`

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`Amidon - Recross
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`DeLuca - Deposition
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`138
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`140
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`judicial notice of it so, you know, we don't need to have it
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`in evidence.
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`THE COURT: If I decide to take judicial notice of
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`it, I'll ask for a copy of it, so let's keep it out of
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`evidence.
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`MR. SENDER: Thank you, Your Honor.
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`THE COURT: Okay.
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`MR. DITTMANN: With that, I have the list which I
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`think reflects what we just discussed, including the Markman
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`report is listed on this.
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`THE COURT: Very well. And when we finish up with
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`the DeLuca deposition excerpts, then and only then, when
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`everybody rests, will I ask you to submit it.
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`MR. DITTMANN: Okay. Thank you, Your Honor.
`
`THE COURT: Yes.
`
`MR. ASHKENAZI: Your Honor, at this time we'd like to
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`play the deposition video of Dr. DeLuca. And if I may hand
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`the Court a binder. It's got -- has -- contains two documents
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`that may be referenced during the --
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`THE COURT: I'll just continue to proceed as I have
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`which is I don't need the binder.
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`MR. ASHKENAZI: Your Honor, Dr. Patrick DeLuca is
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`DRL's formulation expert. According to DRL, Dr. DeLuca is
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`Professor Emeritus in the Department of Pharmaceutical
`
`Sciences.
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`United States District Court
`
`Trenton, New Jersey
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`by plaintiffs where they're saying he admitted various things
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`one way or another. And we think that's something that may be
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`appropriate for briefing, but we don't really think it's
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`something that should be submitted with these -- with the
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`video that's going to be played. We think it's --
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`THE COURT: Well, you're not under any obligation to
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`respond, but I think that they're entitled to be able to place
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`their position on the record as to why this should be
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`admissible, and I'm accepting this and reserving on whether
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`DeLuca and Markman actually are admissible, so their advocacy
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`is, I think, acceptable. And, but you don't have to respond
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`in kind. You can respond as you see fit.
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`MR. ASHKENAZI: Thank you, Your Honor.
`
`Just for the record, DeLuca Deposition Exhibit 1,
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`EX 17 from that exhibit, corresponds with DTX-0345, and DeLuca
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`Deposition Exhibit 4 corresponds with PTX-233, both of which
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`have been already discussed in this case.
`
`Thank you.
`
`THE COURT: How long is this?
`
`MR. ASHKENAZI: This is about 48 minutes, Your Honor.
`
`THE COURT: Okay.
`
`(The video testimony of PATRICK DeLUCA was played.)
`
`Q.
`
`A.
`
`Q.
`
`Good morning, Dr. DeLuca.
`
`Good morning.
`
`Do you consider Dr. Amidon to be an expert in the field
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`United States District Court
`
`Trenton, New Jersey
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`Amidon - Recross
`
`DeLuca - Deposition
`
`139
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`141
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`THE COURT: Just a second, counsel.
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`of the chemical degradation stability of pharmaceuticals?
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`MR. ASHKENAZI: Sure.
`
`THE COURT: I'll tell you when I'm ready.
`
`MR. ASHKENAZI: Um-hum.
`
`THE COURT: Okay. You can go ahead and tell me.
`
`MR. ASHKENAZI: According to DRL, Dr. DeLuca is
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`Professor Emeritus in the Department of Pharmaceutical
`
`Sciences of the College of Pharmacy at the University of
`
`Kentucky. He is a professor and pharmacist with over 50 years
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`of experience in academia and industry.
`
`Dr. DeLuca has conducted extensive research on
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`parenteral and intravenous pharmaceutical formulations and
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`drug product stability.
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`Dr. DeLuca was deposed regarding his opinion, expert
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`opinions in this case.
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`Your Honor, as we did with Dr. Markman, we have
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`prepared a chart identifying the probative value to the extent
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`that DRL still maintains its 403 objection.
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`THE COURT: That's fine.
`
`MR. ASHKENAZI: If I may approach, I'll hand...
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`THE COURT: Yes.
`
`MR. ASHKENAZI: And --
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`MR. SENDER: Your Honor, we object to these
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`submissions on the so-called probative value because, really,
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`all it is is the designations and then, essentially, argument
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`United States District Court
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`Trenton, New Jersey
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`A.
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`Q.
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`I do.
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`Okay. Now, Dr. Amidon, in his report, states that this
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`publication, which is excerpt here at Exhibit 11 to your
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`report, the chemical stability of pharmaceuticals, is used at
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`the FDA. Do you have any knowledge, one way or the other, as
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`to whether that's true?
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`A.
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`Q.
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`A.
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`Q.
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`A.
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`What was true? I'm sorry.
`
`This textbook, Exhibit 11, at the FDA.
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`I -- I would think it would be, yeah.
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`Okay. Why?
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`Because it -- there's -- the approval of the drug product
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`depends on stability, and -- and this is a source of reference
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`for stability and stability testing.
`
`Q.
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`A.
`
`Okay.
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`Oxidation, photolysis, especially those types of, you
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`know, reactions.
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`Q.
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`If you do the preformulation test where you add metal
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`ions --
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`A.
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`Q.
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`Yes.
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`-- to a buffered solution and find no degradation at that
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`point, there's no logical reason to add EDTA to your
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`formulation or --
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`A.
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`Q.
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`Oh, if the solution is stable?
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`Yeah. Can we agree on that?
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`United States District Court
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`Trenton, New Jersey
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`Page 3 of 5
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`

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`DeLuca - Deposition
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`DeLuca - Deposition
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`142
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`144
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`A.
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`Q.
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`A.
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`If there's -- if there's no degradation at all?
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`Yeah.
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`There's no reason to add the stabilizing agent, any
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`stabilizing agent.
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`Q.
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`You don't plan to offer any opinions, in other words,
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`comparing or contrasting palonosetron with other antiemetic
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`molecules that were known in the field in 2003; is that fair?
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`A.
`
`Q.
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`That's correct.
`
`Okay. And you don't plan to offer any opinions comparing
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`or contrasting I.V. formulations of palonosetron with other
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`dosage forms, for example, oral dosage forms, correct?
`
`A.
`
`Q.
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`Do I plan to?
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`Yeah. You're not offering such opinions in your expert
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`reports; is that correct?
`
`A.
`
`Q.
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`No, not in this particular case, I'm certainly not.
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`Your analysis begins with the presumption that your
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`person of ordinary skill has been given palonosetron and asked
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`to prepare an I.V. formulation; is that fair?
`
`A.
`
`That's --
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`THE COURT: Could I stop you there?
`
`(Video stopped.)
`
`THE COURT: The question was "that your," Y-O-U-R,
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`"person of ordinary skill." And so let's back it up and make
`
`sure everybody agrees. You can just nod unless you disagree.
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`there's -- I still have some flexibility in what the final
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`formulation may be, depending on the nature.
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`Q.
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`A.
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`Q.
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`Flexibility, but it's still an I.V. formulation?
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`Yes.
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`You're aware that, following divesting itself of this
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`setron, that Syntex or its successor Roche purchased a
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`different setron for over a billion dollars, correct?
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`A.
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`I can't say at the time, you know, that the report was
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`prepared, I was aware of that.
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`Q.
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`Are you aware of that now from reading Dr. Amidon's
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`report?
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`A.
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`Q.
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`Yeah, I'm aware of that.
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`Can you think of any other occasion in your long
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`experience in the pharmaceutical industry where the big pharma
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`company divested itself of a particular drug in a particular
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`class for reasons other than bad data from clinical trials,
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`only to purchase, thereafter, a different drug in that same
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`class?
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`A.
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`Q.
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`A.
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`I can't say that I'm aware of that.
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`Why do you consider them irrelevant?
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`Because I'm looking at the fact that the patent is
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`covering a formulation I.V. solution of a drug. And whatever
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`that drug is, those opinions would be the same regarding the
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`formulation, the strategy and expectations and the obviousness
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`"Your person of ordinary skill."
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`of -- of the formulation, of the composition.
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`United States District Court
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`Trenton, New Jersey
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`United States District Court
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`Trenton, New Jersey
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`DeLuca - Deposition
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`DeLuca - Deposition
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`143
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`(Video resumed.)
`
`Q.
`
`You don't plan to offer any opinions, in other words,
`
`comparing or contrasting palonosetron with other antiemetic
`
`molecules that were known in the field in 2003; is that fair?
`
`A.
`
`Q.
`
`That's correct.
`
`Okay. And you don't plan to offer any opinions comparing
`
`or contrasting I.V. formulations of palonosetron with other
`
`dosage forms, for example, oral dosage forms, correct?
`
`A.
`
`Q.
`
`Do I plan to?
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`Yeah. You're not offering such opinions in your expert
`
`reports; is that correct?
`
`A.
`
`Q.
`
`No, not in this particular case, I'm certainly not.
`
`Okay. Your analysis begins with the presumption that
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`your person of ordinary skill has been given palonosetron and
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`asked to prepare an I.V. formulation; is that fair?
`
`(Video stopped.)
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`THE COURT: Y-O-U-R, "your person of ordinary skill."
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`In other words, he's got a definition for a person of ordinary
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`skill, and so the question encompasses whatever his definition
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`of POSA is, right?
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`MR. O'MALLEY: Correct, Your Honor.
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`MR. SENDER: Correct.
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`THE COURT: Sorry. Go ahead.
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`(Vide resumed.)
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`A.
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`That's correct. And -- but with the qualification that
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`So, I -- you know, it's -- whatever business decisions
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`that were made don't play a role in the obviousness. The
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`business decisions don't make the formulation strategy,
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`technology, and process any less obvious, and whether the API
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`is less or more potent than another antiemetic agent.
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`So, you know, I guess I had problems with -- because
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`there might be less enthusiasm for the serotonin receptors as
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`opposed to the NK-1 receptors. Certainly, I think there's --
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`there's, certainly, I think, ongoing in pharmaceutical
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`development, there are products now that are in the pipeline,
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`that are in clinical testing, where --
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`(Video stopped.)
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`THE COURT: "Ongoing"?
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`MR. O'MALLEY: Yes.
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`THE COURT: The phrase "I'm going" is actually
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`"ongoing." Where he says, "I think I'm going in
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`pharmaceutical development," what he said was, "I think
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`ongoing in pharmaceutical development." So the transcript was
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`wrong there. And we can get it right. Right?
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`ALL: Yes.
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`THE COURT: Forgive me, but otherwise, you know,
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`we're winding up compounding errors by looking at a transcript
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`that's got errors in it.
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`(Video resumed.)
`
`A.
`
`There's certainly, I think, ongoing in pharmaceutical
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`United States District Court
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`Trenton, New Jersey
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`United States District Court
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`Trenton, New Jersey
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`Page 4 of 5
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`

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`DeLuca - Deposition
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`DeLuca - Deposition
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`162
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`164
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`the relevant prior art section includes an antioxidant,
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`correct?
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`A.
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`Q.
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`That's correct.
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`And have you seen any data indicating that any of those
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`setrons discussed in your relevant prior art section degrade
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`via oxidation?
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`A.
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`Q.
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`No.
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`So, none of the commercial setrons has any excipient that
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`appears to have been added to prevent chemical degradation,
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`correct?
`
`A.
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`Q.
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`That's correct.
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`Have you seen any data to conclude that a properly
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`buffered composition of the Won compound would require EDTA or
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`any other stabilizing agent to prevent oxidation?
`
`A.
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`Q.
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`I have not.
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`Is it your opinion that a POSA, in 2003, would have
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`believed, from the teachings of the '333 patent, that the I.V.
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`solution of Example 13 was stable?
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`A.
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`It doesn't -- in this particular example, it doesn't show
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`any data here with regards to stability.
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`Q.
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`Now, if you return to your expert report, please, at
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`Paragraph 115.
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`Now, in Paragraph 115 of your report, you provide an
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`opinion as to why the claim solutions would be obvious,
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`starting with the prior art labels of the commercial setrons.
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`United States District Court
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`the word "so." Maybe this transcript is correct, maybe it's
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`not. I'd just like to hear it again.
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`(Video resumed.)
`
`A.
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`As long as those components, each individually, were
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`recognized as the -- what they were intended to be used for.
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`So, I want to clarify, over any components. And, certainly,
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`if they are included in the list that we find in Avis or
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`Lachman, that that's what my opinion is here.
`
`(Video stopped.)
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`MR. ASHKENAZI: So, Your Honor, there were two days
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`of deposition. We're just switching to the second half of
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`that deposition.
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`THE COURT: I think we need to discuss what this last
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`discussion was before we leave it because I won't be able to
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`remember it at the end.
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`And there is a chunk of Dr. DeLuca's opinion there that
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`-- I think it's Mr. O'Malley was asking him about, and I'm not
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`clear, from just listening to the exchange back and forth,
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`exactly what Dr. DeLuca was saying in that paragraph.
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`MR. O'MALLEY: Yeah. I will give you my
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`understanding. He seems to be saying, as I understood him,
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`that this notion of the routine formulator, that basically if
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`he looked at any antiemetic formulation that had a tonicifying
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`agent, buffer, stabilizer, and each of those was doing what it
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`was known to do, any -- any formulation under that umbrella
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`United States District Court
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`Trenton, New Jersey
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`Trenton, New Jersey
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`DeLuca - Deposition
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`163
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`165
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`Do you see that?
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`A.
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`Q.
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`Yes.
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`Now, prior to palonosetron, none of the teachings from
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`those prior setrons would lead a person of ordinary skill in
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`2003 to conclude that any buffered commercial formulation of a
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`setron has ever had a oxidation degradation problem, correct?
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`A.
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`Q.
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`That's correct.
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`Now, at Page 41 of your expert report, you talk about an
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`argument that routine development work led to the claimed
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`inventions. Do you see that?
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`A.
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`Q.
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`I see that, Part 12. 126?
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`Yeah. Beginning there and continuing through the end of
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`your expert report. Do you see that?
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`A.
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`Q.
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`Yes.
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`Now, is it your assertion that any setron formulation
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`that included an active ingredient, a buffer, a tonicifying
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`agent, and a stabilizing agent, would have been the result of
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`routine development work and, therefore, non-inventive?
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`A.
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`As long as those components, each individually, were
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`recognized as the -- what they were intended to be used for.
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`So, I want to clarify, over any components. And, certainly,
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`if they are included in the list --
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`THE COURT: Could you stop there and back up?
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`(Video stopped.)
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`THE COURT: I couldn't quite hear him after he said
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`United States District Court
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`Trenton, New Jersey
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`DeLuca - Deposition
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`would be obvious.
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`THE COURT: I may ask for just that small portion of
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`that one expert report go into evidence just so that I can see
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`what the words are that he's used.
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`MR. O'MALLEY: Yeah. The words don't match up that
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`well. It's actually the whole back end of his expert report,
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`but I have no objection to that.
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`MR. SENDER: Yeah. I mean, he specifically was asked
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`about Page 41 and the section that he said -- and
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`Mr. O'Malley's question said from that page to the end of the
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`report which is on Page 43, and he was referring to those
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`three pages, Your Honor.
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`THE COURT: So could we agree that it would be
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`helpful to the Court to put that much of that particular
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`report into evidence?
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`MR. SENDER: Fine with us.
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`MR. O'MALLEY: That's fine with us.
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`THE COURT: Thank you very much.
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`MR. ASHKENAZI: Your Honor, I would just point out
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`that was part of counter­designations from the defendants.
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`THE COURT: I understand.
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`MR. ASHKENAZI: Thank you.
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`THE COURT: Okay. So now we've left at least that
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`report behind for the moment, and the deposition continues.
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`MR. ASHKENAZI: Yes.
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`United States District Court
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`Trenton, New Jersey
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`Page 5 of 5