` UNITED STATES PATENT AND TRADEMARK OFFICE
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` Case Nos. IPR2017-01121, IPR2017-01122
`
`- - - - - - - - - - - - - - - - - - X
`CELLTRION, INC. and PFIZER, INC.,
` Petitioners,
` vs.
`GENENTECH, INC.,
` Patent Owner.
`- - - - - - - - - - - - - - - - - - X
`
` TELEPHONIC DEPOSITION OF SUSAN H. TANNENBAUM, M.D.
` Sunday, April 29, 2018, 10:05 a.m.
` Wilmer Cutler Pickering Hale and Dorr LLP
` 60 State Street
` Boston, Massachusetts 02109
`
` --- Reporter: Kimberly A. Smith, CRR, CRC, RDR ---
` Realtime Systems Administrator
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`Celltrion v. Genentech
`IPR2017-01122
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` APPEARANCES:
`
` Goodwin Procter LLP
` By: Cynthia L. Hardman, Esq. (via telephone)
` The New York Times Building
` 620 Eighth Avenue
` New York, NY 10018
` (212) 813-8800
` chardman@goodwinlaw.com
` and
` Goodwin Procter LLP
` By: Sarah J. Fischer, Esq.
` 100 Northern Avenue
` Boston, MA 02210
` (617) 570-1000
` sfischer@goodwinlaw.com
` for the Petitioner Celltrion, Inc.;
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` APPEARANCES: (continued)
`
` Wilmer Cutler Pickering Hale and Dorr LLP
` By: Kevin S. Prussia, Esq.
` and Stephanie Neely, Esq.
` 60 State Street
` Boston, MA 02109
` (617) 526-6000
` kevin.prussia@wilmerhale.com
` stephanie.neely@wilmerhale.com
` for the Patent Owner.
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`Celltrion, Inc. 1104
`Celltrion v. Genentech
`IPR2017-01122
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`
`
` I N D E X
`
` WITNESS: Susan H. Tannenbaum, M.D.
`
`Page 4
`
` EXAMINATION Page
` By Ms. Hardman 5
`
` EXHIBITS FOR IDENTIFICATION:
` Celltrion Description Page
` Exhibit 1101 11/15/95 Blood article 13
` Exhibit 1102 2/96 Cancer Investigation 19
` abstract
` Exhibit 1103 12/9/96 Genentech press 22
` release
`
` Genentech Description Page
` Exhibit 2144 Witness's supplemental expert 5
` declaration
`
` Original exhibits retained by reporter to be
` returned to Goodwin Procter
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` SUSAN H. TANNENBAUM, M.D.,
` having been satisfactorily identified by the
` production of her driver's license, and
` duly sworn by the court reporter, was deposed
` and testified as follows:
` EXAMINATION
` BY MS. HARDMAN:
` Q. Good morning, Dr. Tannenbaum. My name is
` Cynthia Hardman. I am an attorney at Goodwin
` Procter, and I represent the petitioner, Celltrion,
` in this case. And I am appearing by telephone, as
` you know, and my colleague, Sarah Fischer, is there
` present in the room with the rest of you today.
` A. Good morning.
` MS. HARDMAN: Kevin, do you want to make
` your appearance?
` MR. PRUSSIA: Yes, thank you. Kevin
` Prussia from WilmerHale on behalf of the patent
` owner. Also with me is Stephanie Neely, also from
` my office.
` MS. HARDMAN: Okay.
` BY MS. HARDMAN:
` Q. Well, good morning, Dr. Tannenbaum. I'd
` like to start by asking Sarah if she could hand you
` Exhibit 2144. And if you could just let me know
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`
` when you have that in front of you.
` A. I have that in front of me.
` Q. Thank you. Would you confirm that this is
` the supplemental declaration that you submitted in
` these IPRs?
` A. Yes, this is one of them.
` Q. And just for clarity, the version that we
` have in front of us has the caption for Case
` IPR2017-01121, correct?
` A. Correct.
` Q. And you also submitted a declaration in the
` second IPR, which has the caption IPR2017-01122,
` correct?
` A. I actually don't know the number. But, you
` know, if that's it, then that's it. I don't recall
` the number. I don't have it in front of me.
` Q. But you did, in fact, submit a second
` version of your supplemental declaration; is that
` right?
` A. That is correct.
` MR. PRUSSIA: Object to form.
` THE WITNESS: Sorry.
` BY MS. HARDMAN:
` Q. And were there any substantive differences
` between the two versions of the declarations that
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` you submitted?
` MR. PRUSSIA: Object to form.
` THE WITNESS: Substantive? There was
` some differences, but I don't know what you would
` call substantive.
` BY MS. HARDMAN:
` Q. Did you offer any opinions in one of the
` declarations that are different than the opinions
` you offered in the other declaration?
` A. I don't think so, no.
` Q. Just for convenience and expediency, I'm
` just going to use the version from the 01121 IPR
` today just so that we don't have to juggle a large
` number of documents.
` Would you please turn in this declaration
` to page 32.
` A. I'm there.
` Q. And is that your signature that appears on
` that page?
` A. It is.
` Q. Now, I would like to just start by
` confirming that in forming your opinions in this
` case, you, in fact, conducted your own search of the
` prior art; is that right?
` A. That is correct.
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` Q. Now, if we could turn, please, in your
` declaration to paragraph 31. And that appears on
` page 18.
` A. I'm there.
` Q. Thank you. And you reference in this
` paragraph an Exhibit 2135, which is an abstract that
` presents xenograft results from a study by
` Dr. Slamon; is that correct?
` A. Yes. He was one of the authors.
` Q. And another one of the authors was Hsu,
` H-s-u; is that right?
` A. That's correct.
` Q. Now, you did not cite this reference,
` Exhibit 2135, in your opening declaration, correct?
` A. Correct.
` Q. So this abstract is not something you found
` when you were performing your own prior art search,
` correct?
` A. That is correct. You mean in the initial
` declaration, correct?
` Q. Correct. So Exhibit 2135, is this
` something that the lawyers provided you?
` A. It is.
` Q. And they provided it to you after you had
` completed your original declaration; is that right?
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` A. That is correct.
` Q. Now, in this paragraph 31, you reference a
` conference put on by the American Association of
` Cancer Research in March 1997, correct?
` A. Correct.
` Q. And you did not personally attend that
` conference, right?
` A. I did not.
` Q. And you say here that the abstracts were
` made available at this conference, but that's not
` something that you know from personal knowledge,
` right?
` A. I believe that was said by Dr. Earhart in
` his disclosure.
` Q. But you weren't at the conference, so you
` don't know personally whether the abstracts were, in
` fact, made available at that conference, correct?
` A. It is typically what happens. I've never
` been to a conference where the abstracts haven't
` been published in a book form for the attendees.
` Q. But my question that I'm asking is that
` because you were not at this conference, you do not
` know personally whether the abstracts were, in fact,
` disseminated at that conference, right?
` A. No, I do not know in -- because I wasn't
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` there.
` Q. Now, in your prior art searching for this
` case, did you search for any references that showed
` that anthracyclines were effective against HER2+
` breast cancer?
` A. I read references that disclosed that.
` Q. Are any of those references cited in this
` supplemental declaration in -- if it helps, I can
` remind you that Exhibit A to this declaration lists
` all the materials that you considered for this
` declaration?
` A. I believe that in Baselga '97, they speak
` to anthracycline specifically being active in HER2+
` disease. There may be others as well that are
` listed in here, some of the reviews. But I'd have
` to go through each one if you want me to give you
` more.
` Q. So other than Baselga '97, just sitting
` here right now, do you recall any other references
` in your declaration that discuss the efficacy of
` anthracyclines in HER2+ disease in human patients?
` A. Let me take a look since you're clearly
` interested. I'm trying to decide whether it was in
` the prior declaration or this. But clearly there
` was an MD Anderson one that spoke about it. I'm
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` just trying to look and see.
` Other than my prior deposition, right?
` Because it was --
` Q. You know, if you remember anything from
` your prior declaration that you want to mention,
` that would be fine too. But, you know, we have your
` supplemental declaration here in front of us right
` now.
` A. I just think there were more references in
` that one generally about anthracyclines, as that was
` a significant portion of that declaration. There
` is --
` You're talking about in patients?
` Anthracycline in patients specifically?
` Q. Correct.
` A. Yes. No, I don't see any others here.
` Q. And you mentioned that the Baselga 1997
` reference discusses the efficacy of anthracyclines
` in HER2+ disease.
` Did you mean in clinical studies in
` patients or in preclinical studies?
` A. In clinical studies -- in clinical -- in
` clinical studies in patients. In his paper, yes.
` Q. Just shifting gears a little bit, you're
` aware that Dr. Earhart offered the opinion that a
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` person of ordinary skill in the art could have been
` motivated to combine trastuzumab with paclitaxel
` because that combination satisfied the principles of
` combination chemotherapy, correct?
` A. Yes. I'm aware of his declaration and that
` he stated that.
` Q. Let's turn, if we could, in your declaration
` to paragraph 25, please.
` A. I'm there. Sorry.
` Q. Thank you. And in that paragraph, about
` two-thirds of the way down are -- well, toward the
` bottom you say, "Tellingly, Dr. Earhart does not
` cite any examples of these principles being applied
` to combinations of chemotherapy and biologic agents
` in his declaration," and it goes on.
` Do you see that?
` A. I do.
` Q. Now, in preparing your declaration, did you
` search for any references discussing combinations of
` antibodies with chemotherapy?
` A. I did.
` Q. And did you find any?
` A. I did, in terms of biologics. The reference
` cited here.
` Q. Did you search specifically for references
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` discussing combinations of antibodies with
` chemotherapy?
` A. I was looking for anything that was not
` chemotherapy that was different. And so the
` principles of chemotherapy wouldn't necessarily
` apply.
` Q. Did you consider asking anyone at Genentech
` for any references discussing combinations of
` antibodies as chemotherapy?
` A. I did not.
` Q. Do you consider Genentech to be a pioneer
` in anticancer antibody therapy?
` A. I do.
` MS. HARDMAN: Sarah, would you please
` hand Dr. Tannenbaum Exhibit 1101.
` THE WITNESS: Thank you. I have it.
` BY MS. HARDMAN:
` Q. Thank you. Do you see that this is an
` article from the journal called Blood?
` A. I do.
` Q. And on the top of page 1, do you see that
` the date of the journal is November 15, 1995?
` A. I do.
` Q. And several of the succeeding pages are
` table of contents and the like. And I'd like to go
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` forward to page 11, please.
` A. I'm there.
` Q. And I'd like to discuss the abstract that
` appears in the top left corner. I'd like you to
` take some time, all the time you need, to read
` through that abstract. And just let me know when
` you've read through it, please.
` A. The top left-hand corner? So 206?
` Q. Correct. That's right.
` A. Okay. (The witness examined the document.)
` Okay.
` Q. Okay. Thank you. So the title of this
` Abstract 206 is "IDEC-C2B8 and CHOP
` chemoimmunotherapy of low-grade lymphoma."
` Did I read that correctly?
` A. You did.
` Q. And the first author is -- this is a tricky
` one to pronounce, but I'm going to go with Czuczman,
` C-z-u-c-z-m-a-n, correct?
` A. Correct.
` Q. And do you see that some of these authors
` are affiliated with IDEC Pharmaceuticals Corporation?
` A. I see that.
` Q. And are you aware that at the time of this
` abstract in November 1995 that Genentech was
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` partnering with IDEC on the C2B8 antibody?
` A. I was not aware.
` Q. Were you aware of this abstract when you
` were preparing your opinions in this case?
` A. I was not aware.
` Q. Now, this abstract is talking about a
` clinical study of IDEC-C2B8 with CHOP chemotherapy,
` correct?
` A. Correct.
` Q. And it says that IDEC-C2B8 is a chimeric
` monoclonal anti-CD20 antibody, correct?
` A. Correct.
` Q. What is CHOP?
` A. It's a four-drug regimen: cytoxan, Oncovin,
` vincristine, prednisone.
` (Court reporter inquiry.)
` THE WITNESS: So C is cytoxan. H is
` adriamycin. Oncovin. And prednisone. So that is
` still currently used today.
` BY Ms. HARDMAN:
` Q. And CHOP is considered chemotherapy; is that
` correct?
` A. The prednisone is used in many different
` disorders. It's not specifically chemotherapy.
` But the others are, yes.
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` Q. And just in terms of the abstract where
` it's spelled out what CHOP --
` And CHOP, just for the record, is
` C-H-O-P.
` This abstract specifies that CHOP is
` cyclophosphamide, correct?
` A. Um-hum. Yes.
` Q. Thank you. Doxorubicin, correct?
` A. Correct.
` Q. Vincristine, correct?
` A. Correct.
` Q. And then the prednisone, right?
` A. Correct.
` Q. And the abstract says that currently
` 36 patients have entered this study.
` Do you see that?
` A. I do.
` Q. The authors did not describe any control
` arm for this study; is that right?
` A. They don't specifically call this a Phase I,
` II, or whatever study. But it looks like it's a
` Phase II study. So typically there is no control
` arm.
` Q. And I know you said that you weren't aware
` of this particular abstract when you were preparing
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` your opinions, but were you aware of this study at
` the time you were preparing your opinion?
` A. I am certainly aware of this combination.
` And this specific study? I can't say for sure.
` I mean, there are so many studies mixed into it
` where this antibody was used in conjunction with
` chemotherapy.
` Q. You did not discuss this combination in the
` declaration you submitted in this case, correct?
` A. I did not. As you know, lymphoma is a
` liquid tumor. It's different than solid tumors.
` And so we were looking for more things related to
` solid tumor monoclonal disease.
` Q. Now, turning back to this abstract, it
` provides in here -- or let me start over.
` The abstract specifies the rationale for
` combination of the antibody with CHOP, correct?
` A. Not specifically, but in general terms, yes.
` Q. Well, there's a sentence here that says,
` "The rationale for combination of IDEC-C2B8 with
` CHOP includes:" and it goes on.
` Do you see that?
` A. I do. But we don't know how many studies
` of each of those they're talking about. That's why
` I say in general as opposed to specifics. So when
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` it talks about the --
` Q. The four --
` A. Yes. Go ahead.
` Q. I'm sorry.
` A. No, no. You go ahead.
` Q. The four factors -- Well, it specifies four
` factors that were part of the rationale specified
` here for combining, and the first one it lists is
` single agent efficacy, correct?
` A. Correct.
` Q. The second rationale it lists is non-cross-
` resistant mechanism of action, correct?
` A. Correct.
` Q. The third factor it specifies is synergy
` with chemotherapeutic agents.
` Do you see that?
` A. I do.
` Q. And finally it points out nonoverlapping
` toxicities, correct?
` A. Correct.
` Q. In the final sentences of this abstract,
` it says that "The finding of molecular remissions by
` PCR suggests that the antitumor activity of CHOP and
` IDEC-C2B8 is superior to CHOP therapy alone."
` Did I read that correctly?
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` A. That it suggests that, yes.
` MS. HARDMAN: Let's set this aside. And
` Sarah, if you could please hand out Exhibit 1102.
` THE WITNESS: Thank you.
` BY MS. HARDMAN:
` Q. Just let me know, Dr. Tannenbaum, when you
` have that and you've had a chance to flip through it.
` A. I have it. I'm just trying to find a date.
` I don't see that.
` Q. Okay. Well, let's just go through it
` together and see if we can locate that.
` Do you see that this is an excerpt of
` the journal Cancer Investigation?
` A. I do.
` Q. And is Cancer Investigation a journal that
` you have read?
` A. Not typically. Whether I've seen articles
` in it, I can't say for sure. It's not a typical one
` that I look at.
` Q. Is Cancer Investigation a peer-reviewed
` journal?
` A. I do not know.
` Q. Do you see that the deputy editor at the
` time was somebody from Memorial Sloan-Kettering
` Cancer Center?
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` A. I do.
` Q. And that the senior editors included also
` somebody from Memorial Sloan-Kettering and from the
` National Cancer Institute?
` A. I do.
` Q. Now, in terms of date, do you see this date
` stamp on page 1 from the Health Sciences Library,
` University of Wisconsin, that has a date for
` sometime in February 1996?
` A. I do.
` Q. Let's turn, please, to page 2 and take a
` look at Abstract 53.
` A. So I'm a little confused. Is this the
` abstracts from a meeting, or can you tell me what
` this is? Because I'm not really sure . . .
` Q. Well, what we have here is an excerpt from
` Cancer Investigation. I believe it comes from an
` issue or a volume of Cancer Investigation. Let's
` just focus on the content of the abstract here on
` page 2, if we could.
` Do you see that the title of the abstract
` is "Chemoimmunotherapy of low-grade lymphoma with
` the anti-CD20 antibody IDEC-C2B8 in combination with
` CHOP chemotherapy"?
` A. I do.
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` Q. And do you see that the first author again
` is Dr. Czuczman?
` A. I do.
` Q. And, again, we see that some of the authors
` are affiliated with IDEC Pharmaceuticals, correct?
` A. Correct.
` Q. I'm sorry. I didn't hear that.
` A. Correct.
` Q. Thank you. Now, turning to page 3, in the
` left column about two-thirds of the way down,
` there's a sentence where they again provide the
` rationale for a combination of IDEC-C2B8 with CHOP;
` do you see that?
` A. Not yet. I'm in the left-hand column,
` right?
` Q. Yes. On page 3. Just take your time.
` And once you find it -- the sentence starts, "The
` rationale for combination."
` A. I got it.
` Q. So I'll just read this. It says, "The
` rationale for combination of IDEC-C2B8 with CHOP
` includes: non-cross-resistant mechanisms of action,
` individual efficacy, nonoverlapping toxicities, and
` known synergy with doxorubicin."
` Did I read that correctly?
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` A. Yes.
` Q. And then looking over to the column on the
` right, about midway in that paragraph, there's a
` sentence that says, "No human antimouse or
` antichimeric antibody responses (HAMA/HACA) nor
` unexpected toxicities have been observed for the
` combination of CHOP and antibody."
` Do you see that?
` A. Yes.
` Q. And then at the end of this article, they
` again conclude that the antitumor activity of CHOP
` and the antibody is superior to CHOP therapy alone;
` do you see that?
` A. I don't see that.
` Q. It's the second-to-last sentence on page 3,
` right above the bibliography.
` A. That it's encouraging and suggests, yes, I
` see that.
` Q. And the sentence says in part that the data
` "suggests that the antitumor activity of CHOP and
` IDEC-C2B8 is superior to CHOP therapy alone,"
` correct?
` A. Correct.
` MS. HARDMAN: Okay. Sarah, would you
` please hand out Exhibit 1103.
`
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` THE WITNESS: I have it.
` BY MS. HARDMAN:
` Q. Thank you. Do you see across the top of
` Exhibit 1103 that it says "Genentech: Press
` releases"?
` A. Press releases? Yes.
` Q. And at the bottom of page 1, there's a
` footer that has a website "www.gene.com."
` Do you see that?
` A. Yes.
` Q. Do you know whether "gene.com" is
` Genentech's website?
` A. I do not know.
` Q. I'm sorry?
` A. I don't know.
` Q. Across the back -- up on the top here, do
` you see that it specifies the date as Monday,
` December 9, 1996?
` A. I see it, yes.
` Q. And would you take a moment to read the
` first paragraph of this press release, please.
` A. The first paragraph?
` Q. Yes.
` A. Yes. I've read the first paragraph.
` Q. And in the first paragraph, do you see that
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` Genentech said that it has announced positive final
` results from a pivotal Phase III trial of IDEC-C2B8
` as a single agent in some types of non-Hodgkin's
` lymphoma?
` A. I do.
` Q. And the paragraph also additionally talks
` about final results from a Phase II combination
` trial of the same antibody with CHOP chemotherapy,
` right?
` A. It says that it will be reporting it at the
` annual meeting of the American Society of Hematology,
` yes. Otherwise known as ASH, A-S-H.
` Q. And it says that the results were going to
` be presented today, right?
` A. Correct.
` Q. And, in fact, it says that Dr. Czuczman was
` going to be presenting the results, right?
` A. Yes. Yes.
` Q. Now, if you would take a moment, please, to
` read paragraph 2, which starts, "In Phase III open
` label, single arm testing."
` A. Yes. I've read it.
` Q. And that paragraph says that the Phase III
` testing had generated some information on response
` rate for the antibody, but that median time to
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` disease progression information was not yet
` available, right?
` A. Correct.
` Q. And does this press release describe any
` control on for that Phase III trial?
` A. Could I actually correct that. It's not
` that it's not yet available. It says, "At over nine
` months' median follow-up, the median time to disease
` progression for responders . . . has not yet been
` reached."
` It's available. It just hasn't been
` reached and, therefore, they know the number, and
` that will be presented, clearly.
` Do you understand the difference?
` Q. No. How do they know the number for the
` time to disease progression if it has not yet been
` reached?
` A. Well, they know it's beyond a certain
` number. So a lot of times it's beyond a number that
` one might expect. So the patients are responding.
` The study has gone out to so many months. Those
` responders have not yet reached their time to
` progression. Whereas they know the time to
` progression in the people who haven't responded.
` So, in other words, they're going out so
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` far. The bottom line is, they know the numbers but
` yet they don't know the end number because they're
` still responding.
` Q. Okay.
` A. That data is always presented.
` Q. Reading this --
` A. Okay. Go ahead.
` Q. I'm sorry?
` A. No, no. Go ahead.
` Q. Reading this press release, does it describe
` any control arm for the Phase III trial?
` A. It does not here. But I'd love to see the
` paper because it would surprise me if it wasn't
` there.
` Q. Where it says in the second paragraph,
` "In Phase III open label, single arm testing," does
` the term "single arm" give you any information on
` whether there was a control arm?
` A. It probably means there was only one arm,
` exactly. And everybody's being treated.
` Q. So by "one arm and everybody being
` treated," that means there is no control arm?
` A. I would think so.
` Q. Let's turn, please, to page 2, and looking
` at the first complete paragraph --
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` A. I would just say it would be helpful
` looking at the whole study if you had that, aside
` from that press release, just so that we could say
` that for sure. But that's what it's reading like
` here.
` Q. Okay. I understand. Thanks. I don't have
` the full study at the moment, so we'll just have to
` do our best with the information we have handy.
` So I appreciate that. Thank you.
` So on page 2, looking at the first full
` paragraph, do you see there that there's some quotes
` from a senior vice president at IDEC, who's talking
` about filing a biological license application that
` includes this Phase III clinical study testing?
` A. For use as a single agent, yes.
` Q. Now, let's look down to the last paragraph
` on page 2, please. Do you see there that there are
` quotes from Dr. Sue Hellmann, a Genentech vice
` president of medical affairs at the time of this
` article?
` A. I do.
` Q. And part of what she's quoted as saying
` here is that Genentech is committed to exploring
` further uses for the antibody in combination with
` other anticancer treatments, right?
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` A. Right.
` Q. Now, you read Dr. Hellmann's deposition
` transcript when you were preparing your supplemental
` declaration, correct?
` A. Correct.
` Q. And did you seek to speak with Dr. Hellmann
` regarding her experiences with combinations of
` antibodies and chemotherapy agents?
` A. I did not.
` MS. HARDMAN: I have no further
` questions. But I do have a question for Kevin,
` which is about whether you intend to mark this
` transcript confidential. And we can take it up
` offline, but just because of the short turnaround
` time, we just wanted to check that.
` MR. PRUSSIA: On that question, give me
` a couple minutes to consult.
` MS. HARDMAN: Sure.
` MR. PRUSSIA: But just on whether I have
` questions, I don't have any questions.
` My initial reaction, Cynthia, I don't
` think anything here is confidential. But let me
` just take a second and look at the exhibits you
` marked real quick.
` They seem all to be public, so I think
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` it's fine.
` MS. HARDMAN: Kevin, if you want to
` follow up, you know, at some point this afternoon by
` email, that would be fine too. We just need to know
` prior to our filing tomorrow.
` MR. PRUSSIA: Got it. No problem.
` MS. HARDMAN: So I think we're all done
` from my point of view.
` THE WITNESS: Sounds great.
` MR. PRUSSIA: Same here. All set.
` Thanks very much.
` MS. HARDMAN: Okay. Thanks. Thank you,
` everyone. Thanks, Dr. Tannenbaum. I appreciate
`