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` REMOTE VIDEO CONFERENCE
` CONTINUED VIDEOTAPED DEPOSITION OF
` MAUREEN DONOVAN, Ph.D., Volume 2
`Swisher, Iowa
` April 17, 2020, 9:39 a.m.
`
`Reported by: Michele E. Eddy, RPR, CRR, CLR
`________________________________________________
` DIGITAL EVIDENCE GROUP
` 1730 M Street, NW, Suite 812
` Washington, D.C. 20036
`(202) 232-0646
`
`Page 353
`A P P E A R A N C E S
`
`ON BEHALF OF THE PETITIONER:
` RICHARD J. BERMAN, ESQUIRE
` YELEE Y. KIM, ESQUIRE
` JOSHUA H. HARRIS, ESQUIRE
` Arent Fox LLP
` 1717 K Street, Northwest
` Washington, D.C. 20036
` Telephone: (202) 857-6000
` Richard.Berman@arentfox.com
` Yelee.Kim@arentfox.com
` Joshua.Harris@arentfox.com
`
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`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 352
`Page 354
` UNITED STATES PATENT AND TRADEMARK OFFICE
` ----------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` ----------------------------
` NALOX-1 PHARMACEUTICALS, LLC
`Petitioner
`v.
` ADAPT PHARMA OPERATIONS LIMITED, and
` OPIANT PHARMACEUTICALS, INC.,
`Patent owners
` -----------------------------
` Case No. IPR2019-00685
` Case No. IPR2019-00688
` Case No. IPR2019-00694
`
`ATTENDANCE, Continued
`
`ON BEHALF OF THE PATENT OWNER ADAPT PHARMA OPERATIONS:
` JESSAMYN S. BERNIKER, ESQUIRE
` KEVIN HOAGLAND-HANSON, ESQUIRE
` ANA C. REYES, ESQUIRE
` JESSICA PALMER RYEN, ESQUIRE
` ANTHONY SHEH, ESQUIRE
` Williams & Connolly LLP
` 725 Twelfth Street, Northwest
` Washington, D.C. 20005
` Telephone: (202) 434-5000
` JBerniker@wc.com
` KHoagland-Hanson@wc.com
` AReyes@wc.com
` JRyen@wc.com
` ASheh@wc.com
`
`- AND -
`
` JESSICA TYRUS MACKAY, ESQUIRE
` ANN K. KOTZE, ESQUIRE
` Green, Griffith & Borg-Breen, LLP
` 676 N. Michigan Avenue, #3900
` Chicago, Illinois 60611
` Telephone: (312) 883-8000
` jmackey@greengriffith.com
` akotze@greengriffith.com
`
` EXAMINATION INDEX
`PAGE
`EXAMINATION BY MS. BERNIKER
`
`Page 355
`
`356
`
`E X H I B I T S
`(None marked)
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`1 (Pages 352 to 355)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 1
`
`

`

`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 356
`Page 358
` A I have knowledge of clinical treatments,
`but I don't have a license to practice medicine.
` Q And you wouldn't call yourself a
`clinician, right?
` A No, I don't have a license to practice.
` Q Okay. And in your first declaration you
`characterized yourself as testifying from the
`perspective of the formulator POSA; is that right?
` A That most of my opinions are involved or
`are focused on formulation aspects of these
`patents. I have other expertise, but, again, as
`part of the POSA team that I proposed, most of my
`opinions are focused on the formulation aspects.
` Q Well, why don't we look at paragraph 28
`of your original report, then, because my
`understanding was that you were holding yourself
`out as the formulator part of the POSA. If you
`could turn to paragraph 28 of Exhibit 1002,
`please.
` If we could turn to paragraph 28 on page
`13. It says numbered page 13. Great.
`Do you see in paragraph 28, you say, "I
`
` THE VIDEOGRAPHER: The time is
`
`9:39 a.m., Central Time, on April 17th, 2020.
`
`This is video 1 of volume 2 of the continued video
`
`deposition of Dr. Maureen Donovan.
`
` Will the court reporter please
`
`readminister the oath, and counsel for appearances
`
`will be noted on the stenographic record.
`
`- - -
`
`MAUREEN DONOVAN, Ph.D.,
`
`having been duly sworn, testified as follows:
`
`EXAMINATION BY COUNSEL FOR PATENT OWNER ADAPT PHARMA
`
`BY MS. BERNIKER:
`
` Q Good morning, Doctor.
`
` A Good morning.
`
` Q How are you today?
`
` A I'm fine, thanks.
`
` Q Great, great.
`
` So you understand that you're under oath
`
`this morning, right?
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`4/17/2020
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`P R O C E E D I N G S
`
`April 17, 2020
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`- - -
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`Page 357
`
` A Yes, I do.
` Q And just like you were the last time you
`testified in this proceeding?
` A Yes.
` Q And just like you were when you
`submitted the declarations that you submitted in
`this proceeding?
` A Yes, that's my understanding.
` Q Okay. And I believe you testified to
`this earlier, but you do not have clinical
`expertise in the administration of opioid
`antagonists to treat opioid overdoses, right?
` A I don't have a license to practice as a
`physician. I have -- I was licensed as a
`pharmacist at one point in time in my career.
` Q You don't hold yourself out as having
`clinical expertise, right, Doctor?
` A I have -- I don't have a license to
`practice medicine, but I had a license to practice
`pharmacy.
` Q Do you hold yourself out as a clinical
`expert?
`
`Page 359
`
`have at least the ordinary skill of the
`'formulator' who forms part of the POSA team
`(i.e., the 'Formulator POSA')"?
` Do you see that?
` A I see that.
` Q Okay. And you didn't take the position
`in your declaration that you were speaking from
`the perspective of somebody other than the
`formulator POSA as you defined it, right?
` A Well, again, the POSA is a -- is a team.
`The people on that team, or the individuals as
`part of that team, bring multitudes of information
`into the team. But, again, yes, I am -- my
`opinions are focused or are primarily specific to
`a formulator on the POSA team.
` Q Okay. You didn't purport to represent
`the entire POSA team, right?
` A No, I don't.
` Q Okay. And -- and let's take a look at
`the Jones declaration, please, Exhibit 2201.
` THE VIDEOGRAPHER: That just got sent to
`me now. Hang on.
`
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`2 (Pages 356 to 359)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 2
`
`

`

`4/17/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 360
`Page 362
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` MS. BERNIKER: Okay.
`BY MS. BERNIKER:
` Q You're familiar with Dr. Jones'
`definition of a POSA, right, Doctor?
` A I have seen Dr. Jones' definition of a
`POSA. I'm going to need to refamiliarize myself
`with it.
` Q Sure. And before I -- before I get to
`the details, let me ask you this. You understand
`that Dr. Jones also set forth a definition of a
`POSA, which is a team of individuals, right?
` A Again, I need to see it. I don't have
`enough recollection of his definition to opine on
`it right now.
` Q Okay. Why don't we take a look at
`Dr. Jones' paragraphs 38 through 40.
` THE VIDEOGRAPHER: It's importing right
`now. It's scanning all the pages.
` MS. BERNIKER: Absolutely.
` My apologies, Dan, for missing that one.
` THE VIDEOGRAPHER: No, it's quite all
`right. Thank you for letting me get a head start
`
`Page 361
`with that. Okay. So, there's Jones, 2201. Let's
`pull this up. Okay. Let's exit out of this.
`Pull this up now, which everybody should be able
`to see this. Okay. That's what we have here.
` Okay. What page, counsel?
` MS. BERNIKER: Pages 20 to 21, please.
`Not -- I believe they're --
` THE VIDEOGRAPHER: So 20 and 21, okay.
` Doctor, let me --
` MS. BERNIKER: If you could just give
`the doctor the opportunity to take a look at
`paragraphs 38 through 40.
` THE VIDEOGRAPHER: Doctor, let me know
`when to flip the page.
` THE WITNESS: Okay. Thank you.
` (Document review.)
` Okay. Can you flip the page?
` THE VIDEOGRAPHER: Sure.
` THE WITNESS: (Document review.)
` Okay. I've read that and recalled what
`the -- Dr. Jones' definition of a POSA is. Is
`there a question that you would like me to answer?
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`BY MS. BERNIKER:
` Q Certainly.
` Just like the Nalox-1 POSA definition,
`Dr. Jones' definition is also of a POSA team,
`right?
` A Yes.
` Q And you possess some of the
`qualifications of the team, but you don't purport
`to possess the qualifications of the entire team,
`right?
` A I don't possess the -- I am a member of
`the POSA team proposed in my -- under my
`definition of POSA, and I would be a member of the
`POSA team as defined by Dr. Jones.
` Q You don't represent the complete POSA
`team defined by Dr. Jones, right?
` A Again, that's why we -- why the POSA is
`defined as a team, so that there can be multiple
`members. But I represent a member of the POSA
`team based on my definition of a POSA and I would
`meet the definition of a member of the POSA team
`in Dr. Jones' definition.
`
`Page 363
` Q Okay. But to be clear, Doctor, you
`don't represent the complete POSA team in
`Dr. Jones' definition, right?
` A I represent a member of the POSA team.
` Q So that's a yes?
` A I stand by my statement. I represent a
`member of the POSA team described by Dr. Jones.
` Q But not the complete team, right?
` A You know, POSAs are -- are imaginary
`compilations of expertise based on -- and then we
`try to overlay individuals on them. I'm a member
`of the POSA team as defined by Dr. Jones.
` Q Are you having trouble with my question?
`My question is, you're only part of the team,
`right?
` MR. BERMAN: Objection to form.
` Q It's a yes or no question. You're part
`of the team, not the complete team, right?
` A By definition of "team," there would be
`multiple human members. I would be one of those
`human members.
` Q Because you don't have all of the
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`3 (Pages 360 to 363)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 3
`
`

`

`4/17/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 364
`Page 366
` A Well, the POSA has already been defined
`qualifications. You have some of them, right?
`as a team.
` A Well, as defined, the POSA is defined as
` Q So why can't you just answer me yes, I
`a team, a grouping of individuals who have
`do not?
`expertise. I'm a member of the POSA team as
` A There's multiple individuals who are
`defined by both Dr. Jones and by me.
`part of that team who contribute aspects to the
` Q Let's try this again. You have some but
`team.
`not all of the qualifications of the POSA team as
` Q This is going to be a really long day if
`defined by Dr. Jones, right? This should not be a
`I can't get a clean answer to a very basic
`hard question.
`question so let's make it simpler.
` MR. BERMAN: Objection to form.
` Look at paragraph 40 in front of you.
` A Well, again, I'm -- I'm a member of the
`Among the things in Dr. Jones' definition, "the
`POSA team and I bring my expertise to the POSA
`POSA team would include a medical practitioner
`team. And I recognize that there are other people
`and, thus, would have had knowledge regarding the
`who would bring additional expertise to the team.
`administration of opioid antagonists to treat
` Q Do you or do you not have all of the
`opioid overdoses by medically trained personnel,
`qualifications of the POSA team that Dr. Jones
`first responders, and others in the community, and
`sets forth in his declaration?
`would have had clinical experience with
` A Dr. Jones defines a team, and he chooses
`administering opioid antagonists to overdose
`to pull out specific characteristics of that -- of
`patients."
`that -- of those team members and separate them
` Do you see that?
`into individual paragraphs. That's, you know, an
` A I see that.
`artificial manner of defining the team, and I,
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`Page 365
`again, represent a member of the team who can
`contribute to the POSA team regarding this matter.
` Q Is there some reason you're not
`comfortable testifying that you don't have every
`single one of the qualifications of his POSA team
`even if you just told me five minutes ago that you
`don't have all of the qualifications of your POSA
`team?
` MR. BERMAN: Objection to form.
` A Is there a specific aspect that you want
`to ask about? Again, the POSA team members
`have --
` Q I don't think this is a hard question.
`You've seen the POSA team description. Do you or
`do you not have all of the qualifications of that
`team?
` A I have the qualifications.
` Q You personally.
` A I have the qualifications to be a member
`of the POSA team.
` Q But you don't represent the entire POSA,
`in terms of experience, right?
`
`Page 367
` Q You're not a medical practitioner who
`has had clinical experience administering opioid
`overdoses -- opioid antagonists to overdose
`patients, right, Doctor?
` A As stated in that paragraph, there are
`aspects of the definition in that paragraph that I
`do not have -- I'm not a medically -- well, I --
`I'm a biomedically trained person, but, again, I
`have stated I do not have a license to practice
`medicine so I have not had the ability to directly
`treat patients, but I have many of the other
`understandings of the POSA being defined in this
`paragraph.
` Q One of the things that's required here
`is clinical experience with administering opioid
`antagonists to overdose patients, right?
` A I have not had clinical experience
`administering opioid antagonists to overdose
`patients.
` Q Okay. So it is not fair to say that you
`have all of the qualifications of a POSA under
`Dr. Jones' definition, right?
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`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`4 (Pages 364 to 367)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 4
`
`

`

`4/17/2020
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`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 368
`Page 370
` MR. BERMAN: Objection to form.
` A Again, I -- I have said repeatedly, I
`don't have a license to practice medicine. I have
`agreed that I don't have clinical experience with
`administering opioid antagonists to overdose
`patients, but I am qualified to be a member of the
`POSA team as defined by Dr. Jones.
` Q Okay. I would like you to direct your
`attention, please, to your supplemental
`declaration, Exhibit 1201, please. And if we
`could take a look at footnote 1 on page 6.
` THE VIDEOGRAPHER: Okay. One second.
`1201, supplemental.
` MS. BERNIKER: If we could pull up
`footnote 1, please.
`BY MS. BERNIKER:
` Q This is your supplemental declaration
`that you submitted in this case, right, Doctor?
` A It appears to be, yes.
` Q I want to look at the very last sentence
`of this footnote. You say, "Nevertheless, I have
`the qualifications of a POSA under Dr. Jones' and
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`that team.
` Q Even when you're referring to the
`qualifications that you possess among that team?
` MR. BERMAN: Objection to form.
` A Again, I am a member of the POSA team.
` Q Were you trying to represent to the
`patent office here that you had all of the -- all
`of the qualifications of Dr. Jones' POSA?
` A In -- in my earlier statements, and even
`in Dr. Jones' definition, he describes a POSA
`team, and I meet the qualifications of a member of
`the POSA team.
` Q Were you trying to represent to the
`patent office that you met all of the
`qualifications of the POSA team under Dr. Jones'
`definition?
` A The statement as given in this footnote
`is that I have the qualifications of a member of a
`POSA team.
` Q I don't see the word "member" --
` A Dr. Jones --
` Q -- or "team."
`
`Page 369
`
`Dr. Williams' definitions."
` Do you see that?
` A I see that.
` Q Do you believe that's a fully accurate
`sentence, Doctor?
` A I -- I expect in the same way the term
`"POSA" has been used throughout my report, yes,
`that I'm a member of the POSA team. We -- I did
`not write "POSA team" in all of the references to
`"POSA" in my reports, and so I stand by that. I
`have the qualifications as a member of the POSA
`team under Dr. Jones' and Dr. Williams'
`definitions.
` Q You don't think it would have been more
`accurate to say I have some of the qualifications
`of a POSA team under Dr. Jones' and Dr. Williams'
`definitions?
` A There -- there may have been other ways
`of stating this when I -- but, typically, when I
`am writing reports, the POSA is, in general,
`defined as a team, and it's been my general habit
`to just use the term "POSA" when I'm referring to
`
`Page 371
` A -- defined it -- defined the POSA as a
`team.
` Q Where does it say member and team in the
`sentence?
` A It does not say member and team in the
`sentence.
` Q What it says is "I have the
`qualifications of a POSA," not part of the POSA or
`a member of the POSA, right?
` A The POSA is defined as a team --
` Q Do you think --
` A -- and --
` Q Do you think that it was irrelevant for
`purposes of this footnote whether or not you had
`clinical experience in administering opioid
`overdose -- I'm sorry, in administering naloxone
`to opioid overdose patients?
` A I'm going to have to read the section of
`my report that this footnote refers to.
` Q Sure. Go ahead.
` If we could just zoom out so the doctor
`can see the entire source for the footnote.
`
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`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`5 (Pages 368 to 371)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 5
`
`

`

`4/17/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 372
`Page 374
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`
` A (Document review.)
` Again, I think it's quite clear. My --
`my definition of POSA and Dr. Jones' and
`Dr. Williams' definitions of POSA are slightly
`different, especially regarding the membership
`of -- and qualifications of the person with
`clinical expertise, yet I have the qualifications
`as a member of the POSA team under both my and
`Dr. Jones' definitions.
` Q In this footnote, you were trying to
`address the criticism, as you put it, that
`Dr. Williams and Dr. Jones made about you not
`having consulted with a clinician, right? That's
`what you say in the first sentence of the
`footnote, right?
` A Can you re-ask the question, please?
` Q Sure.
` The purpose of this footnote is to
`address the criticism by Dr. Jones and
`Dr. Williams that you did not consult with a
`clinician.
` A That -- and that -- you know, that is
`
`Page 373
`
`the first sentence, that Dr. Jones and
`Dr. Williams criticized my opinion because neither
`I nor Dr. Hochhaus consulted with a clinician in
`conjunction with our declarations.
` Q That's the context for the footnote.
`That's the first sentence, right?
` A That's the first sentence of the
`footnote.
` Q Okay. And then in your second sentence
`you say while it's my opinion that a POSA team
`"would comprise a team of individuals, including,
`inter alia, professionals with clinical
`expertise."
` Do you see that?
` A I see that.
` Q Okay. And so that continues to be your
`opinion, right, Doctor?
` A Yes, it continues to be my opinion.
` Q And then you say, "I disagree that
`consultation with a clinician was required in
`order to form my opinions in my first declaration
`and herein."
`
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` Do you see that?
` A I see that.
` Q And then you say, "Nevertheless, I have
`the qualifications of a POSA under Dr. Jones' and
`Dr. Williams' definitions."
` Do you see that?
` A I see that.
` Q Do you see how somebody could read that
`as you implying that you in fact have the
`qualifications of the clinician aspect of the
`POSA?
` MR. BERMAN: Objection to form.
` A I don't see how anybody who had read my
`description of my background would have
`misinterpreted that statement.
` Q So your view is that if somebody, upon
`reading this, went back and looked at your CV,
`they would figure out that in fact you didn't have
`that experience, right?
` A No, that's not what I said, because I
`have brief descriptions of my background in both
`my original declaration -- my initial declaration
`
`Page 375
`and my fol- -- my second declaration, both of
`which describe that the expertise and abilities
`that I bring to the POSA team, and having read
`those paragraphs, especially since this footnote
`is within one of those paragraphs, I don't see how
`someone would be confused by the statement there
`and understand that I'm a member of the POSA team.
` Q Those paragraphs are not cited in this
`footnote, are they?
` A Well, the footnote is indicated as part
`of -- if you take the blowup away, please --
` THE VIDEOGRAPHER: Sure.
` A -- as part of paragraph 8, which is
`describing my background and qualifications.
` Q What does the word "nevertheless"
`supposed to mean here?
` A That's what the footnote is referring
`to.
` Q Oh, excuse me. I apologize. Did you
`finish?
` A I did, yes.
` Q Okay.
`
`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`6 (Pages 372 to 375)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 6
`
`

`

`4/17/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 376
`Page 378
` What is the word "nevertheless" supposed
`manner. And I have the qualifications as a member
`to be doing there?
`of that POSA team.
` A Well, "nevertheless" is indicating that
` Q Are you having trouble telling me that a
`there is a continued difference of definition
`statement in your declaration is true?
`for -- for the POSA that I have defined and the
` MR. BERMAN: Objection to form.
`POSA that Dr. Jones and Dr. Williams defined, but
` A I've been explaining --
`beyond recognizing that we continue to differ in
` Q I just want an answer. Is it true? Is
`our -- in our absolute definitions of POSA, the
`this sentence true as written?
`statement is that I would have the qualifications
` A As ex- -- I've been explaining that I
`of a member of the POSA team under Dr. Jones' and
`define a POSA as a POSA -- as a team, and I did
`Dr. Williams' definition.
`not continue in the rest of my declarations to
` Q So I just want to understand that -- you
`always use the term "POSA team." I used the term
`know, we're going to have an argument in front of
`"POSA" with the understanding that it would be
`the patent office soon. You're aware of that, I'm
`recognized that that term meant "POSA team" --
`sure?
` Q Is it true, Doctor?
` A Not of the intricate details, but I'm
` A -- that that's what that statement says.
`aware that there are things that you will be
` Q Is the sentence true?
`bringing to the patent office.
` A The sent- -- the sentence says that I
` Q Certainly.
`have the qualifications as a member of the POSA
` And so, so that the patent office can
`team under Dr. Jones' and Dr. Williams'
`understand how seriously you take your duty of
`definitions.
`candor and truthfulness in these procedures, I
` Q So you're not willing to tell me that
`
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`Page 377
`want to be clear. It is your testimony that the
`sentence "I have the qualifications of a POSA
`under Dr. Jones' and Dr. Williams' definitions" is
`a true sentence. Is that your testimony?
` MR. BERMAN: Objection to form.
` A As I've stated many times, we -- both
`Dr. Jones and Dr. Williams and I have been
`defining the POSA as equivalent to the term "POSA
`team," or that the POSA is a team. And, so,
`simply by that definition, the substitution in
`that sentence of "POSA" for "POSA team" should be
`an automatic.
` Q Your testimony -- I want a clean answer
`to this, please. This shouldn't be hard.
` Is it your testimony that the sentence
`"I have the qualifications of a POSA under
`Dr. Jones' and Dr. Williams' definitions" is a
`true sentence, yes or no?
` A Again, as we have been -- as I have been
`defining a POSA, the POSA is a team of human
`individuals that we try to define, and Dr. Jones
`and Dr. Williams are defining POSA in the same
`
`Page 379
`
`it's true.
` MR. BERMAN: Objection to form.
` A I've told you repeatedly what that
`sentence says in context of how the POSA is being
`defined and how the letters P-O-S-A written in my
`reports are defined, and it's -- the POSA
`indicates a POSA team, and I have qualifications
`to be a member of the POSA team.
` Q If that's what you believe, Doctor, then
`you shouldn't have trouble telling me that you
`believe the sentence is true as written. So let
`me try again.
` Is the sentence true as written?
` MR. BERMAN: Objection to form.
` A The sentence -- the sentence where "I
`have the qualifications of a POSA," which
`indicates I have the qualifications to be a member
`of the POSA team, under Dr. Jones' and
`Dr. Williams' definition, is true.
` Q If we edit the way you just said, it
`becomes true, right?
` MR. BERMAN: Objection to form.
`
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`7 (Pages 376 to 379)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 7
`
`

`

`4/17/2020
`
`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 380
`Page 382
` A I don't understand what you just asked.
` Q So you're not willing to say it's true.
` Q If we -- if the sentence read "I have
`Okay. We'll move on.
`the qualifications of -- to be a member of the
` Why don't we turn to page 22 of your
`POSA team under Dr. Jones' and Dr. Williams'
`supplemental declaration, if we could, footnote
`definition," that sentence is true, right?
`4 -- I'm sorry, footnote 24.
` MR. BERMAN: Objection to form.
` THE VIDEOGRAPHER: What document was
` A I -- if that's the sentence I said,
`that again, counsel?
`which I -- I heard back, I believe, the sentence I
` MS. BERNIKER: This is the same document
`said previously, that it's true that I have the
`we're looking at, Nalox1201.
`qualifications to be a member of the POSA team
` THE VIDEOGRAPHER: Gotcha. Okay.
`under Dr. Jones' and Dr. Williams' definitions.
`Sorry.
` Q To be true, you would have to edit this
` What paragraph or page?
`sentence to change it to "a member of the POSA
` MS. BERNIKER: Page 22, footnote 24.
`team," right?
` That's not the right one. Let me see
` A It's not really an edit because I have
`what I did wrong.
`defined the POSA as a POSA team and so has
` Oh, the pagination is different from
`Dr. Jones and Dr. Williams.
`the -- which one are you looking at? No, no,
` Q So I'm going to try once more, Doctor.
`sorry. I'm sorry, we have the wrong exhibit up.
`Are you willing to tell me under oath today that
`We're looking at Nalox1201.
`you believe the sentence as written in the
` THE VIDEOGRAPHER: That's what I
`declaration is true?
`thought, okay, Nalox1201. Stand by.
` A Well, because the sentence as written,
` Okay. Page 22.
`
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`Page 381
`the term "POSA," consistent with the rest of the
`document, where it's defined that a POSA is a --
`is a team of members, I have the qualifications as
`a member of that team.
` Q I'm going to give you one last try,
`Doctor, because I think I've asked this question,
`like, 15 times, and at some point I have to move
`on. Right now I believe the record reflects that
`you've been unwilling to say that the sentence is
`true. So let me try once more.
` Are you willing to testify today that
`the sentence as written at the end of footnote 1
`is true or are you not willing to give me that --
`to say that today?
` MR. BERMAN: Objection to form.
` A Individual sentences in any document
`have terms that were previously defined or read in
`context with the document from which they were
`obtained, and that's in -- that's in keeping with
`the answer I have been giving you. Previously the
`POSA was defined as a team of members, and I have
`the qualifications as a member of the POSA team.
`
`Page 383
` MS. BERNIKER: If you could just wait
`before you pull it out to give the doctor an
`opportunity to see the context for footnote 24.
` THE WITNESS: Can you go back to page
`21, then. Thank you. (Document review.)
` Okay. You can go to page 22.
` (Document review.)
` Okay. Is there a question?
`BY MS. BERNIKER:
` Q Yes, I'll ask the question. I just
`wanted to give you context so you didn't have to
`look back again.
` Okay. We're looking at footnote 24 on
`page 22, and I want to focus on the second
`sentence. You -- well, let's -- let's start with
`the first sentence. "Contrary to Dr. Jones'
`assertion, a formulator POSA would not have
`expected that a naloxone formulation with BAC and
`EDTA would be unstable."
` Do you see that?
` A I see that.
` Q Just for purposes of our conversation
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`www.DigitalEvidenceGroup.com
`
`Ditigal Evidence Group C'rt 2020
`
`8 (Pages 380 to 383)
`202-232-0646
`
`Opiant Exhibit 2215
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00685, IPR2019-00688, IPR2019-00694
`Page 8
`
`

`

`4/17/2020
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`Nalox-1 Pharma, LLC., v. Opiant Pharma, Inc., et al. Maureen Donovan, Ph.D., Vol. 2
`Page 384
`Page 386
`today, I'm used to using the abbreviation BZK for
`benzalkonium chloride. I know you say BAC in your
`declaration.
` Can we agree that either of them mean
`benzalkonium chloride?
` A Yes, either is fine.
` Q Okay. Great.
` And the next sentence says, "HPE" --
`that's the Handbook of Pharmaceutical Excipients,
`right?
` A Yes.
` Q -- "discloses that BAC and EDTA are
`often used in combination in ophthalmic
`preparations."
` Do you see that?
` A I see that.
` Q And you'll agree with me that the HPE
`doesn't talk about naloxone formulations
`specifically, right?
` A Which part of the HPE?
`