EXHIBIT B
`
`EXHIBIT
`
`/os?
`
`Apotex (IPR2019-00400) Ex. 1039 p. 001
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg:1 Ln:1 - Pg: 21 Ln:14
`
`Annotation:
`1: 1
`
`IN THE UNITED STATES DISTRICT COURT
`FOR THE SOUTHERN DISTRICT OF FLORIDA
`
`2 3 4 5 6 7 8 9
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`2: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`
`CASE NO.
`18-cv-60846-MGC/PMH
`
`)
`
`
`))
`
`UCB, INC., and BIOPHARMA SPRL,
`Plaintiffs,
`
`))
`
`)
`)
`)
`
`)
`
`))
`
`vs.
`APOTEX, INC.,
`Defendant.
`______________________________________________)
`
`HIGHLY CONFIDENTIAL
`VIDEOTAPED DEPOSITION OF DOMENICO FANARA
`FEBRUARY 21, 2019
`New York, New York
`
`TRANSCRIPT of the stenographic notes of
`the videotaped deposition of DOMENICO FANARA in the
`above-entitled matter, as taken by and before
`LORRAINE B. ABATE, a Certified Shorthand Reporter and
`Notary Public of the State of New York and Registered
`Professional Reporter, held at the offices of Fenwick
`& West, 902 Broadway, New York, New York, on February
`21, 2019, commencing at 9:16 a.m., pursuant to
`Notice.
`APPEARANCES:
`FENWICK & WEST, LLP
`Attorneys for the Plaintiffs
`902 Broadway, Suite 14
`New York, New York 10010
`BY: ROBERT COUNIHAN, ESQ.
`(212) 430-2748
`rcounihan@fenwick.com
`KATTEN MUCHIN ROSENMAN, ESQS.
`Attorneys for the Defendant
`550 S. Tyron Street, Suite 2900
`Charlotte, North Carolina28202-4213
`BY: JITENDRA MALIK, ESQ.
`(704)344-3185
`j itty.malik@kattenlaw.com
`
`11/20/2019 4:24 PM
`
`Page 2 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 002
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`ALSO PRESENT:
`Darak Eighty, Videographer
`
`Annotation:
`2:18
`19
`20
`21
`22
`23
`24
`25
`3: 1
`
`•k -k -k -k •)(
`
`IT IS HEREBY STIPULATED AND AGREED, by and
`between counsel for the respective parties hereto,
`that the filing, sealing and certification of the
`within deposition shall be and the same are hereby
`waived.
`IT IS FURTHER STIPULATED AND AGREED that all
`objections, except as to the form of the question,
`shall be reserved to the time of the trial.
`IT IS FURTHER STIPULATED AND AGREED that the
`within deposition may be signed before any Notary
`Public with the same force and effect as if signed
`and sworn to before the Court.
`*****
`
`INDEX
`WITNESS: DOMENICO FANARA
`
`EXAMINATION BY:
`Mr. Malik
`
`■k-k-k-k-k-k-k-k-k-k
`
`EXHIBITS
`
`FANARA
`EXHIBIT 1
`EXHIBIT 2
`
`EXHIBIT 3
`EXHIBIT 4
`
`Notice
`Responses and Objections of UCB, Inc.
`and UCB Biopharma SPRL
`US Patent No. USS 8,633, 194 B2
`Declaration and Power of Attorney
`For Patent Application
`
`PAGE
`7
`
`PAGE
`22
`
`25
`47
`
`48
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`4 : 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`
`11/20/2019 4:24 PM
`
`Page 3 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 003
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`EXHIBIT 5
`4 :18
`19
`20
`21
`22
`23
`24
`25
`5: 1
`9
`
`EXHIBIT 6
`
`EXHIBIT 7
`EXHIBIT 8
`EXHIBIT 9
`
`Document titled Antimicrobial Efficacy
`Of the Parabens in Levocetirizine
`Document titled Antimicrobial Efficacy
`Of the Parabens in Cetrizine Solutions
`Technological Transfer Dossier
`Xyzal Oral Solution Product Detail
`NDA 22-157
`
`80
`
`91
`103
`113
`114
`
`EXHIBITS
`( CONTINUED )
`
`E-Mail dated February 22, 2001
`Memo dated March 27, 2001
`Memo dated November 24, 2003
`E-Mail Chain
`E-Mail Chain
`E-Mail Chain
`E-Mail Chain
`Declaration of Domenico Fanara
`Xyzal Product Literature
`US Patent No. 5,698,558
`**********
`
`PAGE
`130
`132
`136
`140
`145
`147
`149
`155
`167
`170
`
`FANARA
`EXHIBIT 10
`EXHIBIT 11
`EXHIBIT 12
`EXHIBIT 13
`EXHIBIT 14
`EXHIBIT 15
`EXHIBIT 16
`EXHIBIT 17
`EXHIBIT 18
`EXHIBIT 19
`
`Z3
`
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`6: 1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`
`DOMENICO FANARA
`THE VIDEOGRAPHER: Here begins media
`unit No. 1, volume 1 in the video deposition of
`Domenico Fanara in the matter of UCB, Inc. and
`UCB JBiopharma SPRL versus Apotex, Inc. Today's
`date is February 21st, 2019, and the time is
`9::16 a .m.
`This deposition is being held at Fenwick
`& West, LLP. My name is Darak Eighty and the
`court reporter today is Lorraine Abate, both
`associated with Gregory Edwards, LLC.
`Counsel will now state their appearances
`for ■the record.
`MR. COUNIHAN: Robert Counihan from
`Fenwick & West.
`MS. BLANCHARD: Amanda Blanchard, UCB.
`
`11/20/2019 4:24 PM
`
`Page 4 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 004
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PI\/IH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg:1 Ln:1 - Pg: 21 Ln:14 continued...
`
`Annotation:
`6:17
`18
`19
`20
`21
`22
`23
`24
`25
`7: 1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`8: 1
`2
`3
`4
`5
`6
`7
`8
`9
`10
`11
`12
`13
`14
`15
`16
`
`MS. SUTTER: Erica Sutter, Fenwick &
`West.
`MR. MALIK: Jitendra Malik from the law
`firm of Rosenman for Apotex.
`THE VIDEOGRAPHER: Will the court
`reporter please swear in the witness.
`D 0 M E N I CO FANARA,
`Having been first duly sworn by a Notary
`Public of the State of New York, was
`DOMENICO FANARA
`examined and testified as follows:
`EXAMINATION BY MR. MALIK:
`Good morning, Mr. Fanara.
`Q.
`Good morning.
`A.
`Just again, can you state your name.
`Q.
`Domenico Fanara.
`A.
`Your current address?
`Q-
`A.
`Sorry?
`Your current address.
`Q.
`Rue Pont de Soleil — Rue, Street, Pont
`A.
`P-O-N-T de Soleil S-O-L-E-I-L, 2-A 5 — 4520 Wanze,
`This is the city.
`W-A-N-Z-E.
`Are you currently employed?
`Q.
`Yes.
`A.
`Who is your current employer?
`Q.
`UCB.
`A.
`Okay. Mr. Fanara, do you understand
`Q.
`today you're under oath? Do you understand you're
`under oath?
`Yeah.
`A.
`And do you understand today that you're
`Q.
`obligated to answer my questions?
`Yeah.
`A.
`Obviously, I'll ask you a series of
`Q.
`DOMENICO FANARA
`If today you don't understand it, one of
`questions.
`my questions, let me know and I'll try to rephrase.
`Fair enough 7
`Thank you.
`A.
`If not. I'll assume you understood my
`Q-
`Fair enough?
`question.
`Yes.
`A.
`MR. COUNIHAN: So you'll need to -- you
`have to answer verbally for Lorraine's sake.
`THE WITNESS: Okay.
`From time to time, your counsel may
`Q.
`object for the record. But unless instructed not to
`answer, you understand that you're obligated to
`answer my question to the best of your ability?
`Yes.
`A.
`
`11/20/2019 4:24 PM
`
`Page 5 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 005
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`As far as breaks, I try to stop on the
`Q.
`8 :17
`hour every hour. If you want a break, let me know
`18
`and I'll do my best to accommodate you. My only rule
`19
`is if I'm in the middle of a question, you go ahead
`20
`and answer that question and then we'll see what we
`21
`can do about getting you a break. Fair enough?
`22
`Fair.
`A.
`23
`Is there any reason today that you
`Q.
`24
`cannot tell the truth?
`25
`DOMENICO FANARA
`9: 1
`A.
`No.
`Okay. In connection with your
`Q.
`deposition today, who did you meet with, the names;
`did you meet with the attorneys?
`Yes.
`A.
`Okay. Which attorneys?
`Q.
`MR. COUNIHAN: You can identify us by
`name for Lorraine's sake.
`So Bobby and Erica.
`A.
`Okay. Was anyone else present during
`Q.
`your deposition -- was anyone else present during
`your deposition prep?
`Amanda was partially present.
`A.
`Okay. In connection with your
`Q.
`deposition, did you talk to anyone else other than
`the three individuals here?
`No.
`A.
`Have you been deposed before?
`Q-
`No.
`A.
`What is your current position with UCB?
`Q.
`I'm head of technology platform
`A.
`And I'm working into the technical
`innovation.
`operation into the delivery device team.
`You understand today that this matter
`Q.
`DOMENICO FANARA
`concerns levocetirizine, correct?
`Yes.
`A.
`When was the last time you worked with
`Q.
`levocetirizine?
`Maybe more than 10 years ago.
`A.
`So is it fair to say that your current
`Q.
`work doesn't involve levocetirizine?
`A.
`Correct.
`Starting after high school, where did
`Q.
`you get your college degree from?
`University of Liege.
`A.
`Can you spell that, please.
`Q.
`L-I-E-G-E.
`A.
`And what degree did you get?
`Q.
`I don't know what we -- we don't use
`A.
`
`23456789
`
`
`10
`11
`12
`13
`14
`15
`16
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`10: 1
`
`11/20/2019 4:24 PM
`
`Page 6 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 006
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`in the U.S.
`What did you get from the University of
`
`I was pharmacist. Is that what you
`
`Q.
`
`A.
`
`Annotation:
`10:17
`18
`19
`20
`21
`22
`23
`24
`25
`11: 1
`
`Liege?
`
`mean?
`
`get
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`12: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`
`Yeah.
`Q.
`Okay. Sorry.
`A.
`After the University of Liege, did you
`Q-
`any graduate degrees?
`any other degrees.
`DOMENICO FANARA
`a lot of trainings, business
`No. I had
`A.
`trainings and stuff like that, but no other degrees.
`Okay. After you finished at the
`Q.
`of Liege, did you go work for an employer?
`University
`For an employer, yeah.
`A.
`Which employer?
`Q.
`It was a small generic company called
`A.
`Brussels. G-A-L-E-P-H-A-R.
`Galephar
`What year was that?
`Q-
`In 1986.
`A.
`And how long were you at this generic
`Q.
`pharmaceutical company?
`Until 1992, November.
`A.
`at that generic company, did
`And while
`Q-
`or levocetirizine?
`cetirizine
`work
`No.
`A.
`speaking, what kind of
`Generally
`Q.
`was it when you worked at this generic
`proj ects
`without getting into confidentiality?
`company,
`It was mainly slow release formulation
`A.
`of off-patent products.
`And then in 1992, you left the generic
`Q.
`pharmaceutical company, correct?
`A.
`Yeah , and I joined — yeah.
`DOMENICO FANARA
`And who did you join?
`UCB, January 3rd, 1993.
`And what was your first position with
`
`in
`
`you
`
`on
`
`Q.
`A.
`Q.
`
`UCB?
`
`When I joined UCB, I was doing a Ph.D
`A.
`at the University of Brussels while being part of the
`I would say a junior
`team as
`formulation
`scientist.
`Did you finish your Ph.D. in Brussels?
`Q.
`A.
`No.
`Just for the court reporter's sake, just
`Q.
`It makes
`me finish my question, and then answer,
`yes?
`a much cleaner transcript. Fair enough;
`A.
`Yes.
`Q.
`So when you joined UCB, just to
`
`let
`for
`
`be
`
`11/20/2019 4:24 PM
`
`Page 7 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 007
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`clear, you were still -- you were also -- strike
`12 :17
`that.
`18
`Okay. When you first joined UCB in
`19
`1993, what project were you assigned to work on?
`20
`So I was working on my Ph.D., the main
`A.
`21
`topic. And I had side project related to the taste
`22
`masking of oral solid form of cetirizine.
`23
`What was the — let me break that up a
`Q.
`24
`little bit.
`25
`DOMENICO FANARA
`13: 1
`What was the main topic of your —
`The oral absorption of peptide.
`A.
`And just in connection with your Ph.D.,
`Q.
`I assume since it was based on the peptide work, it
`had nothing to do with cetirizine or levocetirizine?
`A.
`No.
`So let's talk about the side project of
`Q.
`taste masking, working with oral cetirizine.
`Was that the first time that you were
`aware — you personally were aware of the compound
`cetirizine?
`What do you mean by being aware?
`A.
`When did you first hear of the compound
`Q.
`cetirizine?
`I heard about the compound because when
`A.
`I joined UCB, it was the biggest project in the
`organization. We just -- yeah.
`MR. COUNIHAN: I'm not sure where we're
`going to go with this point, but can I just
`designate the transcript highly confidential.
`MR. MALIK: Sure.
`MR. COUNIHAN: Thanks.
`MR. MALIK: We're going to go there
`anyway, so yes.
`DOMENICO FANARA
`So the biggest project at the time was
`Q.
`cetirizine; is that correct?
`For UCB, yes.
`A.
`What were you trying to do with
`Q.
`cetirizine?
`Well, as I said, my main project was my
`A.
`Ph.D., but I've been given a side project which was
`trying to develop a formulation minimizing the taste
`of cetirizine, because the taste is very awful.
`And that was the first time you heard of
`Q.
`the compound cetirizine, correct?
`Not that I heard about, but that I
`A.
`worked on.
`Okay. And you didn't invent the
`Q.
`compound cetirizine, correct?
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`
`23456789
`
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`14: 1
`
`11/20/2019 4:24 PM
`
`Page 8 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 008
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`14 :17
`18
`19
`20
`21
`22
`23
`24
`25
`15: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`16: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`
`A.
`No.
`How long did you work on cetirizine?
`Q.
`On this specific project?
`A.
`Q.
`Yes.
`A couple of years.
`A.
`So until about 1995?
`Q.
`Yeah. In fact, it had different steps.
`A.
`So you know, I started on a small project and then it
`evolved, but it's difficult to say how long it was
`DOMENICO FANARA
`really, I mean. But initial project was a couple of
`years.
`Okay. Now, you're aware that cetirizine
`Q.
`has two enantiomers, correct, levocetirizine and
`dextro cetirizine?
`A.
`Yes.
`Okay. When was the first time you were
`Q.
`aware of levocetirizine?
`I don't know. In the Nineties, but I
`A.
`don't recall exactly.
`And just to be clear, you don't claim to
`Q.
`be an inventor of levocetirizine, correct?
`A.
`No.
`Those compounds were known before you
`Q.
`correct?
`got to UCB,
`MR. COUNIHAN: Objection. Form.
`I don't know for levocetirizine.
`A.
`for cetirizine.
`Okay. So you said you worked on a side
`Q.
`project in 1995. And then obviously, continued.
`After 1995, what was your I guess title
`
`I know
`
`at UCB?
`So I took more responsibility within the
`A.
`organization. And I was I think a small group of
`DOMENICO FANARA
`
`In 1995?
`No. It was '96, '97.
`Okay. And what was your title
`
`formulation.
`Q.
`A.
`Q.
`in '96, '97?
`I was heading a formulation group. So
`A.
`was possibly head of formulation, but I was not the
`only formulation group.
`Okay. And when you were in the -- the
`Q.
`head of formulation group -- or strike that.
`In '96, '97, when you were working in
`the formulation group possibly as its head, what
`project were you assigned to work on?
`It was solid form of cetirizine, mainly,
`A.
`plus some early project coming from research.
`
`11/20/2019 4:24 PM
`
`Page 9 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 009
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`16:17
`18
`19
`20
`21
`22
`23
`24
`25
`17: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`18 : 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`
`Was that early project coming from
`Q.
`research related to cetirizine or levocetirizine?
`No.
`A.
`Q.
`Okay. Focusing only on cetirizine, the
`solid form of cetirizine when you were the --
`possibly the head of formulation from '96 to '97,
`what were you tasked with doing?
`A.
`So it was the time we entered in the
`collaboration with U.S. pharma company, and I was
`DOMENICO FANARA
`part of the development team with the -- development
`company.
`the U.S. pharma
`team with
`company?
`Which pharma
`Q.
`A.
`Q.
`strike that.
`
`And what was
`
`interested -- well,
`
`nature of the collaboration
`the
`What was
`to cetirizine?
`as it relates
`MR. COUNIHAN:
`Objection, form,
`and I know you haven't
`Just to be clear.
`talked about the 30(b)(6) aspect of this, but
`with respect to cetirizine, he's certainly only
`testifying to his personal knowledge.
`MR. MALIK: Yeah.
`So we were developing life cycle
`A.
`project on cetirizine.
`management
`What do you mean by life cycle
`Q.
`proj ect?
`management
`New formulation.
`A.
`Were you also at this time working with
`Q.
`levocetirizine?
`No.
`A.
`When did you first start working with
`Q.
`levocetirizine?
`
`with
`
`DOMENICO FANARA
`Should have been early 2000.
`A.
`And why did you start working with
`Q.
`levocetirizine? Was there an impetuous behind it,
`was there some drive to work with levocetirizine
`internally?
`
`MR. COUNIHAN: Objection, form.
`MR. MALIK: Let me rephrase.
`So you said in early 2000, you started
`Q.
`levocetirizine, correct?
`working with
`A.
`Yes.
`Q.
`Why?
`A.
`Because levocetirizine was one of the
`UCB product under development, among others.
`Who asked you to work with
`Q.
`levocetirizine in early 2000?
`
`11/20/2019 4:24 PM
`
`Page 10 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 010
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`18:17
`18
`19
`20
`21
`22
`23
`24
`25
`19: 1
`
`A.
`My management.
`Did they give you a reason why they
`Q.
`wanted you to work with levocetirizine?
`No specific reason.
`A.
`Do you have any understanding as to why
`Q.
`there was interest within UCB to work with
`levocetirizine?
`We were looking at the next generation
`A.
`antihistamine drug.
`DOMENICO FANARA
`Q.
`Antihistamine?
`Yeah. And we had a series of option,
`A.
`one being levocetirizine.
`What were the other options, if you
`Q.
`recall?
`Efletirizine was one of the other
`A.
`options.
`Which one?
`Q.
`Efletirizine.
`A.
`Can you spell that, please.
`Q.
`A.
`E-F-L-E-L-T-I-R-I-Z-I-N-E.
`Efletirizine.
`In early 2000 when you started working
`Q.
`with levocetirizine, what was your position?
`Again, I was head of formulation, but
`A.
`with a broader scope that initial for years before.
`I had more and more people reporting to me, to the
`formulation team.
`And with respect to your work with
`Q.
`levocetirizine early 2000, what were you specifically
`tasked with doing?
`What I was specifically doing on
`A.
`levocetirizine?
`Yeah. What were you asked to do with
`Q.
`DOMENICO FANARA
`levocetirizine?
`To participate in the development of
`A.
`formulation for the commercialization of the product.
`And what specifically were you looking
`Q.
`at in connection with the formulation of a
`commercialization of the product? Were you looking
`at stability, what were you tasked with specifically
`doing?
`I was developing the oral solution with
`A.
`my team.
`And at the time in early 2000, oral
`Q.
`solutions of cetirizine were known, correct?
`Correct.
`A.
`And oral solutions of levocetirizine had
`Q.
`been reported, correct?
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`20: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`
`11/20/2019 4:24 PM
`
`Page 11 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 011
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] FanaraL Domenico
`
`Pg: 1 Ln: 1 - Pg: 21 Ln: 14 continued...
`
`Annotation:
`MR. COUNIHAN: Objection, form.
`20:17
`It was the beginning of the -- so it was
`18
`A.
`19 the beginning of development of it.
`Were you aware of prior reports of using
`Q.
`20
`21 levocetirizine in oral solutions?
`In clinical trial, possibly.
`A.
`22
`Do you have any recollection more
`Q.
`23
`specifically of what the nature of the clinical
`24
`trials using oral solutions of levocetirizine were?
`25
`DOMENICO FANARA
`21: 1
`No.
`A.
`When you use the word oral solution,
`Q.
`what do you mean?
`A composition containing the active
`A.
`ingredient in a water-based system with the flavoring
`agent and a series of excipients that improve the
`palatability of the formulation.
`In early 2000, why was UCB interested in
`Q.
`developing a levocetirizine formulation?
`10
`MR. COUNIHAN: Objection, form.
`11
`We were not interested in developing a
`A.
`12
`13 specific levocetirizine formulation. We were
`14 interested in developing levocetirizine compound.
`
`23456789
`
`Pg: 28 Ln: 2 - Pg: 29 Ln: 20
`
`Annotation:
`And then you also have been designated
`2
`Q.
`as UCB's 30 (b)(6) deponent for topic 14, correct?
`3
`I'm not sure I full understand, but when
`A.
`4
`I see commercial success, I'm not involved in those
`5
`element.
`6
`You said I'm not sure I understand.
`7
`Q.
`What about topic 14 is -- do you not
`8
`understand?
`9
`Why commercial success is part of it. I
`A.
`10
`11 mean...
`Okay. So in connection with topic 14,
`12
`Q.
`you don't believe that you have any information as it
`13
`relates to commercial success?
`14
`Correct.
`A.
`15
`Okay. What about long-felt need, do you
`16
`Q.
`17
`have any —
`What does it mean, long-felt need?
`A.
`18
`Well, let me ask you this; do you have
`19
`Q-
`any understanding of what the term long-felt need
`20
`21
`means?
`No.
`A.
`22
`MR. COUNIHAN: So objection. Calls for
`23
`legal conclusion and you know — well, you can
`24
`
`11/20/2019 4:24 PM
`
`Page 12 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 012
`
`

`

`Text Map Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 28 Ln: 2 - Pg: 29 Ln: 20 continued...
`
`keep asking your questions, or we can just --
`DOMENICO FANARA
`you know, you offered a broad topic here, and
`he's here to talk about aspects of it. If you
`just want me to tell you on the record what
`aspects, we can do that. Is that — would that
`be the most efficient way forward or do you want
`to try and go back and forth with him about the
`legal meanings of some of these terms?
`MR. MALIK: I guess if topic 14 has
`been -- well, I guess if any of the designated
`topics have been narrowed, yeah, I think it
`would be helpful on the record if you tell me
`what specifically he's been designated for.
`MR. COUNIHAN: So for topic 14, he's
`here to testify about unexpected results.
`MR. MALIK: Okay. Just so I'm clear,
`nothing in connection with long-felt need,
`commercial success, copying, industry praise or
`failure of others?
`MR. COUNIHAN: As a 30(b)(6), correct.
`
`Annotation:
`28:25
`29: 1
`
`23456789
`
`
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`
`Pg: 30 Ln: 5-8
`
`Annotation:
`So Mr. Fanara, just to be clear, in
`Q.
`30: 5
`6 connection with topic 14, you are only here to talk
`7 about unexpected results?
`Yes.
`8
`A.
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22
`
`Annotation:
`Okay. Do you have any understanding of
`30: 9
`Q.
`what unexpected results are?
`10
`MR. COUNIHAN: Objection. Calls for
`11
`legal conclusion.
`12
`In the context of trial IP, I have some
`A.
`13
`understanding, yes.
`14
`What is that understanding?
`15
`Q.
`That you run an experiment and you have
`A.
`16
`a result that was not expected at all.
`17
`Okay. Okay.
`18
`Q.
`It is the same meaning as yours?
`19
`A.
`I just want to understand your meaning.
`20
`Q.
`Let me just go a little back to your
`21
`background now.
`22
`You understand that cetirizine is used
`23
`as an API, correct, active pharmaceutical ingredient
`24
`A.
`Yes.
`25
`
`11/20/2019 4:24 PM
`
`Page 13 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 013
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22 continued...
`
`Annotation:
`31: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`32: 1
`
`time you were
`as an active
`
`DOMENICO FANARA
`And you also
`understand that
`Q.
`pharmaceutical
`an active
`levocetirizine is used as
`ingredient,
`correct?
`Yes.
`A.
`And when was the first
`Q.
`cetirizine could
`be used
`aware that
`pharmaceutical ingredient?
`MR. COUNIHAN: Objection. Asked and
`answered.
`I think when I joined UCB, it was
`A.
`already developed as an active ingredient.
`And when was the first time you were
`Q.
`aware that levocetirizine could be used as an active
`pharmaceutical ingredient?
`As I said earlier, possibly the second
`A.
`half of 1995 — after 1995, 2000.
`Have you ever heard of the compound
`Q.
`dextro cetirizine?
`I know cetirizine is a mixture of levo
`A.
`and dextro.
`Okay. And the levo and the dextro can
`Q.
`be separated from each other, correct?
`Correct.
`A.
`Do you have any understanding of the
`Q-
`DOMENICO FANARA
`properties of levocetirizine as it relates to dextro
`cetirizine?
`Can you elaborate your question.
`A.
`Sure. Do you understand that the
`Q.
`levocetirizine is the active isomer and that dextro
`cetirizine is not the active isomer?
`Yes.
`A.
`When did you get this understanding?
`Q.
`At the end of the same period, second
`A.
`half of 1995.
`Do you have any understanding of
`Q.
`cetirizine — well, strike that.
`Do you have any understanding of what
`kind of conditions cetirizine can be used for?
`Broadly, yes.
`A.
`MR. COUNIHAN: Objection, vague.
`Please.
`Q.
`Broadly, yes.
`A.
`What is your understanding?
`Q.
`So it's an antihistamine mean drug that
`A.
`And
`used for allergy, mainly. I know allergies.
`yeah, pollen.
`Okay. Do you have any understanding of
`Q.
`what kind of conditions levocetirizine can be used
`
`23456789
`
`
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`11/20/2019 4:24 PM
`
`Page 14 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 014
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22 continued...
`
`DOMENICO FANARA
`
`Annotation:
`33: 1
`2 for, used to treat?
`A.
`Yes.
`3
`What is your understanding?
`4
`Q.
`Allergies condition.
`A.
`5
`Okay. Do you know why levocetirizine --
`6
`Q.
`7
`well, strike that.
`Is levocetirizine more efficacious than
`8
`cetirizine?
`9
`MR. COUNIHAN: Objection. Calls for
`10
`expert opinion and outside the scope.
`11
`I would say no.
`A.
`12
`Why would you say no?
`13
`Q.
`Because 10 milligram of cetirizine is as
`A.
`14
`active as 5 milligram of levocetirizine.
`15
`Would a 5 milligram sample of cetirizine
`16
`Q.
`be as active as a 5 milligram sample of
`17
`levocetirizine?
`18
`No.
`A.
`19
`Why?
`20
`Q.
`Because as you mentioned earlier.
`A.
`21
`levocetirizine is the active part of the cetirizine.
`22
`Have you ever heard of parabens before?
`23
`Q.
`Yes.
`A.
`24
`When was the first time you first heard
`25
`Q.
`DOMENICO FANARA
`34: 1
`of parabens?
`2
`At the university.
`A.
`3
`Which university?
`4
`Q.
`University of Liege.
`A.
`5
`Liege?
`6
`Q.
`When I did my degree in pharmacy.
`A.
`7
`Okay. Parabens have been known for a
`8
`Q.
`long time, correct?
`9
`Correct.
`A.
`10
`And two of the most common parabens are
`11
`Q.
`methylparaben and propylparaben, correct?
`12
`MR. COUNIHAN: Objection, calls for
`13
`expert testimony.
`14
`There are others. Butylparaben also,
`A.
`15
`butylparaben was used also. But paraben was not the
`16
`only one preservative used in the field.
`17
`Well, let's focus on parabens for a
`18
`Q.
`19 minute.
`In your view, what are the most common
`20
`paraben preservatives that are used?
`21
`The most common is the methyl one.
`A.
`22
`Is propyl also used very commonly?
`23
`Q.
`It's used also, yeah.
`A.
`24
`And you're aware that the combination of
`25
`Q.
`
`11/20/2019 4:24 PM
`
`Page 15 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 015
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22 continued...
`
`Annotation:
`DOMENICO FANARA
`35: 1
`methyl and -- well, when were you first aware that
`methyl and propylparaben could be used together, in
`combination?
`At the university.
`A.
`Q.
`Of Liege?
`Of Liege.
`A.
`Q.
`And do you have any understanding why
`methyl and propylparaben are used in combination with
`each other?
`Not to detail understanding, no.
`A.
`Now, as far as ratios of using
`Q.
`methylparaben and propylparaben, when were you first
`aware that they could be used in the nine to one
`ratio?
`MR. COUNIHAN: Objection, foundation.
`That was UCB, let's say, I would say
`A.
`trick or standard that I found when I joined the
`company. Other product being developed were using
`that situation.
`Were you aware of any other products
`Q.
`that used the nine to one ratio of methylparaben to
`propylparaben?
`No.
`A.
`Okay. Now, when you say that it was a
`Q.
`DOMENICO FANARA
`UCB — I guess the word used was trick.
`I could have said heritage. Heritage.
`A.
`Heritage? Let's go with the word
`Q.
`heritage.
`When you say UCB heritage, what do you
`mean by that?
`I mean that when I joined the company,
`A.
`there was already formulation group, and this group
`was using that, let's say, that ratio. So to me, it
`was something evident from a UCB perspective, to do
`that.
`Which formulation are you referring to;
`Q.
`is it Zyrtec?
`Not necessarily. I mean, we had many
`A.
`other formulation in development. As I said, all the
`product we were developing did not reach the market.
`So we — you know, that situation is very high, so we
`were using liquid formulation for animals as well at
`the early stage, so it was something not necessarily
`commercially available.
`Are you aware of any UCB commercial
`Q.
`formulation — well, strike that.
`In early 2000, were you aware of any UCB
`formulation that had a nine to one ratio of
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`36: 1
`
`11/20/2019 4:24 PM
`
`Page 16 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 016
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22 continued...
`
`Annotation:
`37 : 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`38: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`
`DOMENICO FANARA
`methylparaben to propylparaben?
`Yes.
`A.
`What C'
`Q.
`speaking of?
`A.
`And is
`Q.
`Yes.
`A.
`Okay.
`Q.
`Yes.
`A.
`had a nine
`And it
`Q.
`methylparaben to propylparaben.
`A.
`Correct.
`And
`Q.
`correct?
`Correct.
`A.
`And
`Q-
`A.
`Correct.
`Do you recall what the amount of
`Q.
`methylparaben was in
`Not by heart.
`A.
`Do you have an estimate?
`Q.
`something like that.
`A.
`Do you recall the amount of
`Q.
`propylparaben in
`
`ial formulation are you
`
`that also known as
`
`9
`
`And
`
`was on the market?
`
`to one ratio of
`correct?
`
`was an
`
`oral solution.
`
`uses
`
`, correct?
`
`DOMENICO FANARA
`As I said, it was a nine to one ratio.
`A.
`Okay. Let me just quickly go back to
`Q.
`Fanara Exhibit 2 which is the 30(b)(6) notice, just
`to lay some foundation.
`How did you prepare yourself to be the
`30(b)(6) deponent?
`MR. COUNIHAN: So to the extent this
`calls for privileged information. I'll instruct
`the witness not to answer. You can describe in
`general what types of preparation you did either
`on your own or in connection with any of the
`three of us as your attorneys.
`MR. MALIK: And just to be clear, as a
`general instruction, I'm in no way interested
`with the specifics of the conversations with any
`attorney. I just want to make that very clear.
`MR. COUNIHAN: And I'll also add that
`this was asked and answered in many respects,
`given your earlier questions about meetings and
`phone calls with attorneys, so...
`MR. MALIK: Okay.
`Let me ask you this. In connection with
`Q.
`topic 1, let's start there —
`MR. COUNIHAN: Do you want to take a
`
`11/20/2019 4:24 PM
`
`Page 17 of 39
`
`Apotex (IPR2019-00400) Ex. 1039 p. 017
`
`

`

`TextMap Annotation Digest Report
`Case Name: UCB, Inc. v. Apotex Inc. (18-cv-60846-MGC/PMH)
`Transcript: [2/21/2019] Fanara, Domenico
`
`Pg: 30 Ln: 9 - Pg: 40 Ln: 22 continued...
`
`Annotation:
`39: 1
`
`23456789
`
`DOMENICO FANARA
`
`short break?
`MR. MALIK: Yeah.
`Is now a good time for a break?
`Q.
`Yeah.
`A.
`THE VIDEOGRAPHER: Going off the record.
`The time is 10:02 a.m.
`(There was a recess taken.)
`THE VIDEOGRAPHER: The time is 10:10
`a.m. We're back on the record.
`BY MR. MALIK:
`Mr. Fanara, in connection with the
`Q.
`formulation of Zyrtec, when was the first time you
`were aware of the formulation of Zyrtec, the
`commercialized formulation?
`MR. COUNIHAN: Objection, vague.
`Again, what do you mean by being aware?
`A.
`I was aware because it was on the market, but I was
`not involved in the development of Zyrtec
`formulation.
`Fair enough. When was it on the market?
`Q.
`When were you first aware of it being on the market?
`I would say '94, '95, possibly, or even
`A.
`earlier than that.
`And do you recall --
`Q.
`DOMENICO FANARA
`Which market; U.S., Europe?
`A.
`That's my next question, which markets
`Q.
`were you aware of?
`I think it was first in Europe and then
`A.
`in U.S.
`When was it -- when was Zyrtec -- do you
`Q.
`have any information as to when Zyrtec was
`commercialized in Europe?
`No clear idea. I would say
`A.
`around '93, '95, something like that. Or maybe
`Honestly, I don't recall.
`earlier.
`But it was early 2000?
`Q.
`Yes.
`A.
`And by early 2000, was Zyrtec
`Q.
`commercialized in the U.S.?
`MR. COUNIHAN: Objection. Again, Zyrtec
`questions are outside the scope. I don't want
`to make an objection to every single one, just
`so that we're clear that Zyrtec questions are
`outside the scope of the topics.
`I do think so. I do think so.
`A.
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`23
`24
`25
`40: 1
`
`23456789
`
`10
`11
`12
`13
`14
`15
`16
`17
`18
`19
`20
`21
`22
`
`11/20/2019 4:24 PM
`
`Page 18 of 39
`
`Apotex (IPR2019-00400) Ex