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`Page 1
` UNITED STATES PATENT AND TRADEMARK OFFICE
` __________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________
` PHARMACOSMOS A/S,
` Petitioner,
` vs.
` LUITPOLD PHARMACEUTICALS, INC.
` Patent Owner.
` _________________
`
` Cases IPR2015-01490; Patent 7,754,702 B2
` IPR2015-01493; Patent 8,431,549 B2
`___________________________________________________
`
` VIDEO DEPOSITION OF ADRIANA MANZI, Ph.D.
` Washington, D.C.
` Thursday, May 12, 2016, 8:49 a.m.
`
`Job Number 2295903
`Reported by: Laurie Bangart Donovan, RPR, CRR
`
`212-267-6868
`
`Veritext Legal Solutions
`www.veritext.com
`
`516-608-2400
`
`Pharmacosmos, Exh. 1054, p. 1
`
`

`
`Page 2
`
` Video Deposition of
` Adriana Manzi, Ph.D.
`
`Held at the offices of:
` Foley & Lardner, LLP
` 3000 K Street, NW
` Suite 600
` Washington, D.C. 20007
` (202)672-5300
`
` Taken pursuant to notice, before
` Laurie Bangart Donovan, Registered
` Professional Reporter, Certified Realtime
` Reporter and Notary public in and for the
` District of Columbia.
`
`212-267-6868
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`Veritext Legal Solutions
`www.veritext.com
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`516-608-2400
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`Pharmacosmos, Exh. 1054, p. 2
`
`

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`Page 3
`
` A P P E A R A N C E S
`ON BEHALF OF PETITIONER PHARMACOSMOS A/S:
` Baker Botts, LLP
` 30 Rockefeller Plaza
` New York, New York 10112
` (212)408-2571
` By: Jennifer C. Tempesta, Esq.
` jennifer.tempesta@bakerbotts.com
` Carolyn Pirraglia, Ph.D.
` carolyn.pirraglia@bakerbotts.com
`ON BEHALF OF PATENT OWNER LUITPOLD
`PHARMACEUTICALS, INC.:
` Foley & Lardner, LLP
` 3000 K Street, NW
` Suite 600
` Washington, D.C. 20007
` (202)672-5300
` By: Michael D. Kaminski, Esq.
` mkaminski@foley.com
` Asha Nadipuram, Ph.D.
` anadipuram@foley.com
` Natasha Iyer, Esq.
` niyer@foley.com
`ALSO PRESENT:
` Charlier Widner, videographer
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`Pharmacosmos, Exh. 1054, p. 3
`
`

`
`Page 4
`
` EXAMINATION INDEX
` PAGE
`EXAMINATION BY MS. TEMPESTA . . . . . . . . 6, 96
`EXAMINATION BY MR. KAMINSKI . . . . . . . . . 91
`
` E X H I B I T S
`EXHIBIT DESCRIPTION PAGE
`Exhibit 1 Corrected Declaration of Dr.
` Adriana Manzi, also Exhibit
` 2080 . . . . . . . . . . . . . . 28
`Exhibit 2 Excerpt from Physicians' Desk
` Reference, 2015 edition . . . . . 75
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`
`Pharmacosmos, Exh. 1054, p. 4
`
`

`
`Page 5
`
` P R O C E E D I N G S
` THE VIDEOGRAPHER: We are now on
` record. Please note that the microphones are
` sensitive and may pick up whispering and
` private conversations. Please turn off all
` cell phones or place them away from the
` microphones, as they can interfere with the
` deposition audio. Recording will continue
` until all parties agree to go off record.
` My name is Charley Widner,
` representing Veritext. The date today is
` May 11, 2016 [sic], and the time is
` approximately 8:49 a.m.
` This deposition is being held at
` Foley & Lardner, located at 3000 K Street,
` Northwest, Washington, D.C., 20007, and is
` being taken by the counsel for the
` plaintiffs. The caption of this case is
` Pharmacosmos A/S versus Luitpold
` Pharmaceuticals, Inc. The case is filed in
` the United States Patent & Trademark Office,
` case number IPR2015-01490 (Patent 7754702B2),
` IPR2015-01493 (Patent 8431549B2). The name
` of the witness is Dr. Adriana Manzi.
` At this time the attorneys present
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`Pharmacosmos, Exh. 1054, p. 5
`
`

`
`Page 6
` in the room and attending remotely will
` identify themselves and the parties they
` represent.
` MS. TEMPESTA: Hi. My name is
` Jennifer Tempesta with Baker Botts,
` representing Pharmacosmos. With me here
` today is my colleague, Carolyn Pirraglia.
` I'd just like to note for the
` record that it's May 12. I think the
` videographer said May 11.
` MR. KAMINSKI: My name is Mike
` Kaminski. I'm representing Luitpold, and I
` will be the defending counsel today. With me
` is Asha Nadipuram and Natasha Iyer. We're
` all from Foley & Lardner.
` THE VIDEOGRAPHER: Our court
` reporter, Laurie Bangart, representing
` Veritext, will swear in the witness, and we
` can proceed.
` ADRIANA MANZI, Ph.D.,
` having been first duly sworn, testified
` upon her oath as follows:
` EXAMINATION BY COUNSEL FOR PHARMACOSMOS
`BY MS. TEMPESTA:
` Q Good morning, Dr. Manzi. My name is
`
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`Pharmacosmos, Exh. 1054, p. 6
`
`

`
`Page 7
`Jennifer Tempesta, and I'm going to be asking you
`some questions today.
` Do you understand that you're appearing
`for your deposition today in connection with the
`inter partes reviews of two United States patents?
`Those patent numbers are 7,754,702 and 8,431,549;
`is that correct?
` A Yes.
` Q Is it okay with you if I refer to U.S.
`Patent Number 7,754,702 as the '702 patent today?
` A Yes.
` Q And similarly for US Patent Number
`8,431,549, if I refer to that as the '549 patent?
` A Yes.
` Q Great. Thank you.
` Are you appearing here today as an
`expert on behalf of Luitpold Pharmaceuticals,
`Inc.?
` (Discussion was held off the
` record.)
` THE WITNESS: Yes.
`BY MS. TEMPESTA:
` Q And do you understand Luitpold to be the
`owner of the '702 and the '549 patents?
` A Yes.
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`
`Pharmacosmos, Exh. 1054, p. 7
`
`

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`Page 8
` Q During the deposition today, I might
`refer to "Luitpold" and "patent owner"
`interchangeably.
` Is that okay with you?
` A Yes.
` Q Great.
` Do you understand that you've been sworn
`to testify truthfully today to the best of your
`ability, just as though you were in court?
` A Yes, I do.
` Q Great.
` Is there anything that would prevent you
`from giving truthful and accurate testimony here
`today?
` A No.
` Q Great.
` If you don't understand one of my
`questions, please let me know, and I'll try to
`clarify it, but if you don't say anything, I'll
`assume you understand my question.
` Is that okay?
` A That's okay.
` Q Great, and if you need a break at any
`time today, please say so, and we'll take a break.
` All right?
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`
`Pharmacosmos, Exh. 1054, p. 8
`
`

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`Page 9
`
` A Okay.
` Q Great.
` So what, if anything, have you done to
`prepare for this deposition today?
` A I have reviewed the patents and the
`references.
` Q Anything else?
` A I have prepared with the lawyers.
` Q What lawyers are you referring to?
` A Mike, Asha, Natasha, present here.
` Q For how long did you prepare with them?
` A Within the last two days, a few hours
`each day.
` Q Was that an in-person meeting?
` A Yes, it was.
` Q Did you speak with anyone other than the
`lawyers regarding the deposition?
` A I have not.
` Q Okay. Did you review anything aside
`from the patents and the references in preparation
`for your deposition today?
` A No. Only the references listed in my
`declaration.
` Q What about your declaration? Did you
`review that?
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`Pharmacosmos, Exh. 1054, p. 9
`
`

`
`Page 10
`
` A Yes.
` Q Did you do anything else to prepare for
`your deposition today?
` A Not that I can recall now.
` Q Okay. Where did you obtain your
`undergraduate degree?
` A I did my undergraduate studies in
`Argentina at the University of Buenos Aires.
` Q What degree did you obtain?
` A The, the title there is called
`licenciatura, licenciatura.
` Q In what field?
` A In chemistry.
` Q Did you take any pharmacology classes in
`connection with that degree?
` A For the licenciatura, I did not.
` Q Did you take any immunology classes in
`connection with that degree?
` A For licenciatura I did not.
` Q Did you pursue any other degrees?
` A I did. Actually, the last two years of
`the licenciatura are equated here in the US with a
`master's degree, because you specialize in some
`fields.
` Q And what was your specialty?
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`Pharmacosmos, Exh. 1054, p. 10
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`

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`Page 11
` A I have two specialties. Food sciences
`and industrial chemistry.
` Q Did you continue your education after
`receiving that degree?
` A I did.
` Q And where did you go for that?
` A I did a Ph.D. course at the same
`University of Buenos Aires.
` Q What was your thesis on?
` A It was in polysaccharides.
`P-O-L-Y-S-A-C-C-H-R-I-D-E. I think I missed an A
`somewhere.
` Q What properties of polysaccharides did
`you study?
` A A variety of properties. I studied the
`structure function relationship of different
`groups of polysaccharides.
` Q Did you study the immunogenicity of the
`polysaccharides?
` A Yes, of some of them.
` Q Could you provide an example?
` A Yes. Some of the fractions were studied
`using immunoprecipitation techniques.
` Q In connection with your Ph.D., did you
`take any pharmacology classes?
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`Pharmacosmos, Exh. 1054, p. 11
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`Page 12
`
` A Not that I recall.
` Q Just in general, do you have any
`training in immunology?
` A I'm not an expert in immunology, but I
`work for a long time in the pharmaceutical
`industry, and it was part of our daily work in
`developing products.
` Q What in particular was part of your
`daily work?
` A The understanding of the potential
`immunogenic properties of the products under
`development.
` Q And what immunogenic properties are you,
`are you referring to in general? Can you provide
`some examples?
` A The potential for some of those
`products, in particular, some polysaccharides, for
`initiating immune responses in patients.
` Q And were any of those products iron
`carbohydrates?
` A They were not iron carbohydrates.
` Q Have you conducted any research on iron
`carbohydrates?
` A I have not.
` Q Could you explain in general how an
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`Pharmacosmos, Exh. 1054, p. 12
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`

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`Page 13
`
`immunogenic reaction takes place?
` A Yes. Particular molecule or portions of
`molecule, usually called an epitope, that is not
`present, for instance, in a human being, comes in
`contact with a subject, that person, and is
`recognized as foreign. So it triggers a series of
`events, a cascade of events, and the immune system
`reacts, producing antibodies to destroy the
`foreign entity.
` Q And how does an immunogenic reaction
`lead to an anaphylactoid type reaction?
` A A response is manifested in different
`ways, and anaphylactic reaction has characteristic
`manifestations.
` Q Did you pursue any post-doctoral
`studies?
` A I did.
` Q Where was that?
` A Most of it was at the University of
`California San Diego.
` Q And what did you study?
` A The focus was mainly glycobiology.
` Q Did you conduct any research on iron
`carbohydrates in your post-doctoral labs?
` A Not on iron carbohydrates.
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`Pharmacosmos, Exh. 1054, p. 13
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`

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`Page 14
` Q Okay. With respect to publications,
`have you had any articles published in a
`peer-reviewed journal?
` A Yes.
` Q What year was your last peer-reviewed
`journal published, if you recall?
` A I don't recall exactly. Probably the
`early 2000s.
` Q Do you recall the subject matter of that
`article?
` A The last article? I don't recall the
`order of the articles. Which one are you
`referring to?
` Q Do you believe that your CV has a
`complete list of your publications?
` A I do.
` Q Okay. Have you had any articles that
`you recall published in a peer-reviewed journal
`related to carbohydrate pharmaceuticals?
` A To carbohydrate pharmaceuticals? Most
`of my articles have been published in carbohydrate
`journals, related journals, some of whom include
`both general chemistry and pharmaceuticals.
` Q Have any of them related to the
`immunogenicity of carbohydrates?
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`Pharmacosmos, Exh. 1054, p. 14
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`Page 15
` A It had included references to my prior
`comment on the testing of some fractions for
`immunogenicity.
` Q You believe that was included in your
`publications?
` A Yes.
` Q Okay. Do you recall anything more
`specific with respect to the publication or
`publications that you're referring to relating to
`the immunogenicity of carbohydrates?
` A Publications related to my work in
`polysaccharides and research in polysaccharides
`and their properties included the testing of
`hemagglutinate reactions, as I mentioned before,
`hemagglutination or hemagglutinin reactions.
` Q And did any of those examine the
`immunogenicity of the, of an iron carbohydrate
`complex?
` A No, they did not.
` Q Where do you currently work?
` A I have founded and I direct a company
`called Atheln, A-T-H-E-L-N.
` Q When did you found that company?
` A 2010.
` Q What is your role there?
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`Pharmacosmos, Exh. 1054, p. 15
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`Page 16
` A I'm one of the founders, and I act as
`president and managing director, and I'm one of
`the consultants.
` Q What do you do in your capacity as a
`consultant?
` A I advise clients on the development of
`pharmaceutical products.
` Q Does Atheln -- I'm sorry if I'm not
`pronouncing it correctly -- have any relationship
`with Luitpold?
` A It does not.
` Q Has Atheln received any funding from
`Luitpold?
` A No, it has not.
` Q What about Daichii Sankyo; does Atheln
`have a relationship with them?
` A No, we do not.
` Q Has Atheln received any funding from
`Daichii Sankyo?
` A No.
` Q Do you have any relationship with
`Luitpold or Daichii Sankyo aside from your
`retention as an expert in this matter?
` A I do not.
` Q So you mentioned that as a consultant
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`Pharmacosmos, Exh. 1054, p. 16
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`Page 17
`you advise clients on matters. Do you have any
`involvement with clinical studies?
` A Yes, I do.
` Q What products?
` A A variety of products, mainly biologic
`products.
` Q Any iron carbohydrate complexes?
` A No iron carbohydrate complexes.
` Q Have you ever administered iron
`carbohydrate complexes?
` A I personally have not.
` Q Okay. In your declaration I believe
`you, you use the acronym "CMC."
` What does that stand for?
` A Chemistry manufacturing and controls.
` Q And what's reported in a CMC section of
`an FDA filing?
` A It is reported initially all the process
`development experiments and supporting data to
`make decisions in the production of the
`corresponding product, then all the details about
`the manufacturing of that product and the testing,
`and that includes the stability of that product.
` Q Are adverse events reported in a CMC
`section?
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`Pharmacosmos, Exh. 1054, p. 17
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`Page 18
` A Adverse events are typically reported
`after the clinical trial is done, so they are not
`part of the filing.
` Q Okay. Have you written a CMC section
`for an iron carbohydrate compound?
` A I have not.
` Q In general, do you conduct any X-ray
`diffraction studies for a CMC section?
` A In general? I don't recall right now
`any of the products I developed that require that.
` Q Are you able to read an X-ray
`diffraction trace?
` A I'm not an X-ray expert, so the trace is
`something that an expert would do, the reading of
`a trace.
` Q So for clarity, are you personally able
`to read an X-ray diffraction trace?
` A I am not.
` Q Where did you work prior to founding
`Atheln?
` A A variety of places. I was a professor
`at the university in -- at the University of
`California in San Diego. I directed a core
`facility at the university for carbohydrate
`analysis, and after that I went to the industry.
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`Pharmacosmos, Exh. 1054, p. 18
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`Page 19
` Q In those endeavors, did you work on iron
`carbohydrate complexes at all?
` A I have not.
` Q How many times have you been engaged as
`an expert?
` A Do you mean in a deposition or --
` Q In connection with any legal proceeding.
` A I have been engaged before once.
` Q Can you describe that engagement in
`general?
` A Okay. It was a lawsuit where one
`company sued another company because they thought
`the, the deliverables from that company were not
`up to the quality or standards promised.
` Q And what was your role as an expert in
`that proceeding?
` A My role was to give an opinion as to
`what are the industry standards expected.
` Q And what was the relevant industry?
` A It was biotechnology.
` Q That was the only time you've been
`retained as an expert aside from this matter?
` A Yes, that I recall.
` Q Were you deposed in connection with that
`matter?
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`Pharmacosmos, Exh. 1054, p. 19
`
`

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`Page 20
`
` A I was not.
` Q Have you ever been deposed before today?
` A I have not.
` Q Aside from the expert declarations that
`you submitted in this proceeding, have you ever
`prepared an expert declaration or expert report?
` A I have.
` Q In connection with the industry
`standards issue that you just discussed?
` A In, in another case where I was asked to
`analyze, to evaluate a, the history of data
`related to developing a particular product.
` Q Okay. So just to be clear, so you
`talked about this one matter which was a lawsuit
`related to a quality issue, you were retained as
`an expert.
` A Yes.
` Q Right now you're talking about something
`different?
` A Yes. That was just a technical opinion,
`so I was not an expert. I was not deposed or --
` Q Okay. So you provided a technical
`opinion. Was that a legal proceeding?
` A I am not sure if that resulted in a
`legal proceeding.
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`Pharmacosmos, Exh. 1054, p. 20
`
`

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`Page 21
` Q Okay. Do you recall who retained you in
`that matter?
` A Yes. It was a lawyer from Foley in
`Wisconsin.
` Q Foley & Lardner, the same law firm that
`you're working with today?
` A Yes.
` Q And did that have anything to do with
`patents?
` A No, it did not.
` Q And do you -- are you still currently
`working on that proceeding?
` A No, I am not.
` Q When did that work conclude,
`approximately?
` A I don't recall exact days. It was many
`years ago, around 2007 or 2009.
` Q Okay. Okay, and now just going back to
`the first matter you mentioned relating to the
`quality issue, do you recall who retained you in
`connection with that matter?
` A Yes, a company in Spain.
` Q What's the name of the company?
` A The company is 3P Biopharmaceuticals.
` Q And has that matter concluded, or is it
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`Pharmacosmos, Exh. 1054, p. 21
`
`

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`Page 22
`
`ongoing?
` A I truly don't know if they continued any
`legal proceedings.
` Q When is the last time that you were
`contacted in connection with that matter?
` A I don't recall the dates, but I believe
`approximately 2011 or 2012.
` Q Did you work with a law firm in
`connection with that matter?
` A I did.
` Q Do you recall the name of the law firm?
` A Unfortunately, I don't. It was their
`legal representation in Spain.
` Q Okay. Aside from these two matters that
`we just discussed, have you been retained to
`provide an opinion regarding a legal issue in any
`other proceedings?
` A No.
` Q Have you ever testified at a trial or
`legal proceeding?
` A I did.
` Q In what connection?
` A Related to the first matter I mentioned,
`the, the quality issue in deliverables in Spain.
` Q But you were not deposed in that matter?
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`Pharmacosmos, Exh. 1054, p. 22
`
`

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`Page 23
`
` A No.
` Q You testified in Spain?
` A Yes.
` Q Can you just generally describe the
`subject matter of your testimony that you gave.
` A I answered the judge's questions related
`to the technical aspects of the process under
`discussion.
` Q What was the process under discussion?
` A It was a biotechnology process to
`manufacture a glycoprotein.
` Q Do you know what happened in that matter
`after your testimony? What was the results of
`the -- did the court make a finding in connection
`with your testimony?
` A Not in connection with my testimony that
`I recall. I know the client, the company in
`question mentioned to me after that they were not
`winning the, the case, I guess.
` Q And that was 3P Biopharma?
` A Yes.
` Q Did they tell you anything else or just
`generally that they were not winning the case?
` A Correct, generally.
` Q Okay. To the best of your knowledge,
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`Pharmacosmos, Exh. 1054, p. 23
`
`

`
`Page 24
`did the court or any court ever disqualify you as
`an expert?
` A No.
` Q Okay, and just to close the loop on
`that, to the best of your knowledge, did that
`court or any court ever issue an opinion that
`rejected your testimony for any reason?
` A No.
` Q Aside from that one time that you
`testified at trial, have you ever testified in any
`other legal proceedings?
` A If my divorce trial counts.
` Q I don't think that counts. Anything
`else?
` A No.
` Q Okay. So when were you first contacted
`by Foley & Lardner in connection with these inter
`partes reviews?
` A I don't recall exact date.
` Q Could you provide an estimate? Was it
`sometime in 2015 or 2016?
` A I believe it was around January 2016,
`approximately.
` Q Who did you speak with when they
`contacted you?
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`Pharmacosmos, Exh. 1054, p. 24
`
`

`
`Page 25
`
` A I was called by Thomson Reuters.
` Q Thomson Reuters?
` A Yes.
` Q And what did you discuss with them?
` A Well, I, I'm on their list of experts,
`and they asked me if I would be interested in this
`particular case, described generally what the
`matter was.
` Q How did you get on, if you know, their
`list of potential experts?
` A Thomson Reuters?
` Q Yes.
` A Oh, many years ago.
` Q You provided your name to them, or how
`did that work?
` A I'm sorry. What did you say?
` Q How did you get added to their database
`of potential experts?
` A Oh, when I first started consulting in
`around 2006, I, you know, talking to other people
`in the field and other consultants, I approached
`several companies that do this, have expert list,
`and Thomson Reuters was one of the ones that was
`interested and added my background to their, to
`their expert list.
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`
`Pharmacosmos, Exh. 1054, p. 25
`
`

`
`Page 26
` Q Okay. So after that, you were retained
`by Luitpold as an expert in this matter at some
`point likely around January 2016?
` A Yes. I talked directly with Foley.
` Q Okay. What is the hourly fee that
`you're charging for this matter?
` A For preparation and all of this, $500 an
`hour.
` Q Is that your standard expert witness
`fee?
` A I don't think I have a standard expert
`witness fee, but there is a range of fees,
`depending on if the issue has preparation or
`witnessing at a trial, et cetera.
` Q And what is, what is your range --
`what's the low range of your fees, and what's the
`higher range?
` A The low range is the $500. I'm not sure
`what -- Thomson Reuters has a higher range. It
`could be $800.
` Q And that's for different types of
`activities, for example, appearing at trial?
` A Yes.
` Q Okay. Is there anyone else associated
`with you through your company Atheln that's
`
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`Pharmacosmos, Exh. 1054, p. 26
`
`

`
`Page 27
`
`working with you on this matter?
` A There is no one else.
` Q Okay. So I'm going to provide you with
`an exhibit. Actually, I'm going to give you two.
` These are Exhibit 2080 in this matter.
`They actually both bear the same exhibit number.
`One of them says -- sorry -- "Corrected
`Declaration of Adriana Manzi," and one says
`"Declaration of Adriana Manzi." The Declaration
`of Adriana Manzi appears to be dated March 29,
`2016, and the corrected version appears to be
`dated April 21, 2016.
` A I need my glasses.
` Q Please take a moment to review these,
`and just let me know if you recognize them.
` (Witness peruses documents.)
` THE WITNESS: I do.
`BY MS. TEMPESTA:
` Q Okay. Did you sign both of these
`declarations?
` A I did.
` Q What is the difference between the two
`of them?
` A The only difference was a typo, a number
`transposition in the . . .
`
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`516-608-2400
`
`Pharmacosmos, Exh. 1054, p. 27
`
`

`
`Page 28
` Q So your opinions did not change from one
`to the other with respect to these two
`declarations? The correction was basically to fix
`a typographical error with respect to an exhibit?
` A Correct.
` Q Okay. So I'm going to give you now a
`third document, which is also titled "Corrected
`Declaration of Dr. Adriana Manzi," and this one
`was emailed to us yesterday by Foley & Lardner at
`around noon, and it appears to include handwritten
`changes to your corrected declaration.
` This has not been filed in connection
`with these proceedings, so I'm going to ask the
`court reporter to mark it as Manzi Exhibit 1.
` (Exhibit 1 was marked for
` identification.)
`BY MS. TEMPESTA:
` Q So please just take a look at this
`document and let me know if you recognize it, and
`specifically whether the handwriting within the
`document is your handwriting.
` (Witness peruses document.)
` THE WITNESS: Yes.
`BY MS. TEMPESTA:
` Q When did you make those changes in
`
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`Pharmacosmos, Exh. 1054, p. 28
`
`

`
`Page 29
`
`handwriting?
` A Yesterday.
` Q When you were meeting with counsel to
`prepare for this deposition?
` A Yes.
` Q Why did you make those changes?
` A Because I found a few typos, and during
`my reading of references, I felt the change
`represented better my conclusions.
` Q Okay. So just for clarity, I'd like to
`walk through what was changed.
` So it appears that the first change is
`on page 4, and it appears that you corrected a
`typographical error where the '549 patent number
`was listed, and it should have been the '702
`patent; is that correct?
` A That is correct.
` Q Okay. So then the next change was on
`page 18 in paragraph 29. That also appears to be
`correcting a typographical error with an exhibit
`number. Does that -- is that correct?
` A Yes.
` Q Okay. The next change is on page 23 in
`paragraph 43.
` A Yes.
`
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`Pharmacosmos, Exh. 1054, p. 29
`
`

`
`Page 30
` Q The sentence that was changed originally
`read, "These measurements correspond to the size
`of the entire particle, not the iron core. All
`four of the iron carbohydrate complexes of Funk
`have the same form of iron, iron(III)-hydroxide
`core, the size of which is not measured."
` This has been edited in your declaration
`of yesterday to now read, "It is unclear from Funk
`if these measurements correspond to the size of
`the entire particle or the iron core. All four of
`the iron carbohydrate complexes of Funk have the
`same form of iron, iron(III)-hydroxide core."
` Why did you make that change?
` A Because upon reviewing the references
`while preparing for this, I felt that this change
`represented better my conclusions.
` Q Okay. Was there something in particular
`about Funk that you hadn't noticed before that was
`brought to your attention yesterday that prompted
`you to make that change?
` A No, it was not brought to my attention.
`In rereading the reference and thinking about the
`way it was written, I believe this is a more
`honest representation of what anybody can
`conclude.
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`
`Pharmacosmos, Exh. 1054, p. 30
`
`

`
`Page 31
` Q Okay. So we'll probably talk about Funk
`a little bit more later, but let's get through
`your declaration's changes.
` So it appears that the next change was
`on page 33 at the top of the page.
` A Yes.
` Q This appears to just be an edit to an
`exhibit number. It's a typographical error; is
`that correct?
` A Correct.
` Q Okay, and then the next change appears
`to be on page 35 in para

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