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` UNITED STATES PATENT AND TRADEMARK OFFICE
` --------------------------------------------
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` --------------------------------------------
` MYLAN PHARMACEUTICALS, INC.,
` TEVA PHARMACEUTICALS USA, INC. and
` AKORN, INC.,
` Petitioners,
` v.
` ALLERGAN, INC.
` Patent Owner.
` -------------------------------------------
`
` Case IPR2016-01127 (US 8,685,930 B2)
` Case IPR2016-01128 (US 8,629,111 B2)
` Case IPR2016-01129 (US 8,624,556 B2)
` Case IPR2016-01130 (US 8,633,162 B2)
` Case IPR2016-01131 (US 8,648,048 B2)
` Case IPR2016-01132 (US 9,248,191 B2)
` -------------------------------------------
`
` DEPOSITION OF JOHN D. SHEPPARD, JR., M.D.
` Virginia Beach, Virginia
` Tuesday, June 20, 2017
`
`Reported by:
`Carol L. Naughton, RPR, CCR
`Job No. 125465
`
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`
`MYLAN - EXHIBIT 1037
`Mylan Pharmaceuticals Inc. et al. v. Allergan, Inc.
`IPR2016-01127, -01128, -01129, -01130, -01131, & -01132
`
`

`

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` June 20, 2017
` 5:12 p.m.
`
` Deposition of JOHN D. SHEPPARD, JR.,
`M.D., held at the Holiday Inn Virginia
`Beach - Norfolk Hotel & Conference Center,
`5655 Greenwich Road, Virginia Beach,
`Virginia, before Carol L. Naughton, RPR,
`CCR, a Notary Public of the Commonwealth of
`Virginia, at large.
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`A P P E A R A N C E S:
`WILSON SONSINI GOODRICH & ROSATI
` Attorneys for Petitioner Mylan
` Pharmaceuticals, Inc.
` 701 Fifth Avenue
` Seattle, Washington 98104
` BY: JAD MILLS, ESQ.
` CHRISTINA DASHE, ESQ. (Via phone)
` GRACE WINSCHEL, ESQ. (Via phone)
`CARLSON CASPERS VANDENBURGH LINDQUIST &
`SCHUMAN
` Attorneys for Teva Pharmaceuticals
` USA, Inc.
` 225 South Sixth Street
` Minneapolis, Minnesota 55402
` BY: GARY SPEIER, ESQ. (Via phone)
`FISH & RICHARDSON
` Attorneys for Patent Owner Allergan, Inc.
` 3200 RBC Plaza
` 60 South Sixth Street
` Minneapolis, Minnesota 55402
` BY: TASHA FRANCIS, ESQ.
` DOROTHY WHELAN, ESQ.
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` J. SHEPPARD
` JOHN D. SHEPPARD, JR., M.D.,
` called as a witness, having been duly sworn
` by a Notary Public, was examined and
` testified as follows:
` EXAMINATION
`BY MR. MILLS:
` Q. Good afternoon. Please state your
`name and your business address for the record.
` A. John Sheppard, M.D., Virginia Eye
`Consultants, 241 Corporate Boulevard, a mile
`west of here.
` Q. My name is Jad Mills. I represent
`Mylan Pharmaceuticals, Inc., the petitioner in
`each of the six IPRs that are at issue here
`today. It's nice to meet you.
` A. The same.
` Q. When I say the six IPRs that are at
`issue today, do you understand what I'm talking
`about?
` A. Yes.
` Q. There are -- there are six different
`patents that are at issue; correct?
` A. Correct.
` Q. And so there are six different
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`Patent Office proceedings dealing with the
`patentability of each one of those patents;
`correct?
` A. Yes.
` Q. And you submitted a declaration in
`each of those IPR proceedings dealing with each
`of those patents; correct?
` A. Yes.
` Q. Is it correct that each of those
`declarations are substantially the same?
` A. Yes.
` Q. So just to get it out of the way,
`I'll go ahead and hand it to you.
` It's the wrong one.
` A. Is that '903, or which one is it?
` Q. That one, I only have one copy of.
` Okay.
` A. Thank you, sir.
` Q. So -- and this is specifically --
` A. '191.
` Q. Right. This is for the '191 patent
`in the 1132 IPR. But you said a moment ago the
`declarations are essentially identical?
` A. Other than the cover page.
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` Q. Right. So just for ease of -- as
`we're talking here today, we're going to refer
`to one of the declarations and understand that
`your answers are the same with respect to the
`others?
` A. Yes.
` Q. When did you first find out that you
`would be deposed in the IPR proceedings?
` A. Last year sometime.
` Q. And what did you do to prepare for
`your deposition today?
` A. Reviewed the materials given to me.
` Q. What were the materials that were
`given to you to prepare for the deposition
`today?
` A. They are listed herein.
` Q. So you are referring to your
`declaration; correct?
` A. Yes.
` Q. So I take it that you reviewed your
`declaration in preparation for the deposition
`today?
` A. Yes.
` Q. And then when you said they're
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`listed herein, are you referring to Exhibit B
`to your declaration?
` A. Exhibit A is the curriculum vitae.
`Exhibit B includes patents, declarations,
`articles. Yes.
` Q. Okay. So when you said that you
`reviewed the materials herein in preparation
`for your deposition, you mean your declaration
`and the materials listed in Exhibit B to your
`declaration?
` A. Correct.
` Q. Did you review all of the materials
`in Exhibit B to your declaration in preparation
`for your deposition today?
` A. Yes.
` Q. Did you review each of your
`declarations in preparation for your deposition
`today?
` A. No. I reviewed one of them.
` Q. Do you recall which one it was?
` A. Not right now.
` Q. Does it really matter?
` A. No.
` Q. Because they're all the same?
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` A. Except for the front page.
` Q. Did you meet with anyone in
`preparation for your deposition today?
` A. Yes.
` Q. When did you meet with someone in
`preparation for your deposition today?
` A. In the past, discussed it.
` Q. So my question is: When did you
`have meetings to prepare for your deposition?
`Was it today?
` A. No.
` Q. When was it?
` A. Yesterday and a week ago.
` Q. Were those meetings in person?
` A. Yes and no.
` Q. I take it the meeting yesterday was
`in person, and the meeting a week ago was not
`in person?
` A. Yes.
` Q. Let's talk about the meeting
`yesterday. Who was present at the meeting
`yesterday?
` A. The attorneys seated at my right.
` Q. Both of them were present personally
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`yesterday?
` A. Correct.
` Q. Was there anybody else who attended
`the meetings but not in person yesterday?
` A. No.
` Q. Now let's talk about the meeting
`that was a week ago. Who attended those
`meetings?
` A. Same answer.
` Q. The two attorneys that are here
`today?
` A. Correct.
` Q. And are these attorneys representing
`you in the deposition today?
` A. It's my understanding that they
`represent Allergan.
` Q. Do you also represent Allergan?
` A. I'm a consultant. I'm an expert
`witness.
` Q. You've been hired to provide
`testimony on behalf of Allergan in these
`proceedings; correct?
` A. Correct.
` Q. Your offering of testimony in these
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`proceedings is not the first time that you
`worked for Allergan; correct?
` A. I work for Allergan, but not as an
`expert witness.
` Q. When did you first come to work for
`Allergan?
` A. 25 years ago.
` Q. Can you tell me about that? What
`was that related to?
` A. Same thing I do for 65 other
`companies. I'll conduct clinical research, act
`as a consultant, work on advisory boards and
`give lectures, do meetings, international and
`national forums. It's a common thing for
`clinicians with a considerable amount of
`experience to do.
` Q. Your business relationship with
`Allergan has been continuous over the last 25
`years?
` A. I don't think so. There's gaps in
`between. As now is the custom, there's annual
`contracts signed, and sometimes they don't do
`that until April. So technically four months
`of the year, you're no longer working for
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`anybody if the contract is not signed.
` Q. Tell me about the contracts
`generally. Those are consultation contracts?
` MS. FRANCIS: Object to the form.
` THE WITNESS: All I can say is
` there's contracts for each of the things
` that I mentioned to you. They are all
` different.
`BY MR. MILLS:
` Q. Okay. So let's go through and just
`make a list again. So you said that there were
`contracts for meetings?
` A. Yes. When there's a meeting with an
`international or national forum, you're asked
`to do an advisory board or a lecture or a
`breakfast or lunch meeting, and those are
`generally either CME or promotional, and the
`content varies accordingly. So the contracts
`are different.
` Q. And when you say "CMEs," is that
`continuing education?
` A. Medical education.
` Q. And when you say "promotional," what
`does that mean?
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` A. It means you're discussing a
`specific product in a promotional manner.
` Q. And what is the difference between a
`CME presentation and a promotional
`presentation?
` A. Pretty big difference. With a
`promotional presentation, you can only present
`exactly what's in the slide deck. You cannot
`change the slide deck in any way, shape, or
`form, and you can only talk on label about
`those particular surgical products,
`medications, devices in that presentation.
` Q. And presumably in a CME, you are not
`bound by the label?
` MS. FRANCIS: Object to the form.
` THE WITNESS: It's continuing
` medical education. The topic is not, you
` know, drop or pill or device X. The topic
` is "How do I treat X disease?" So they're
` totally different.
`BY MR. MILLS:
` Q. You've contracted with Allergan in
`the past to give promotional presentations for
`Allergan products; correct?
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` A. Yes.
` Q. Approximately how many times have
`you contracted with Allergan to provide
`promotional presentations for Allergan
`products?
` A. One to three times a year. Minimum
`on the contract is two.
` Q. And that's one to three times a year
`for the past 25 years?
` A. I'm sure some years it's been more
`and some years it's been less. It's very
`similar to contracts I have with dozens of
`other companies.
` Q. Is it fair to say that on the
`average over the last 25 years, you've done
`approximately one to three promotional
`presentations for Allergan products each year?
` A. No. Because there's been years
`without any.
` Q. So you said there are some years
`where there's none and some years where there's
`more?
` A. Correct.
` Q. So on average over the 25 years, how
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`many would you say you do each year?
` A. Depends on which year you're
`averaging. If it's the whole 25 years, it's
`probably about one because it was quite slow at
`the beginning.
` Q. What if we take the last ten years?
`Would the average be higher?
` A. One to three maybe.
` Q. And you have a contract with
`Allergan each year that covers your
`relationship for those promotional
`presentations; correct?
` A. Yes. And only those.
` Q. You might have a different contract
`covering other types of presentations for
`Allergan?
` A. No. I said that I did have another
`contract. It's not "might." I do have another
`contract.
` Q. So right now we're talking about
`just the promotional contract. The promotional
`contract sets out compensation rate?
` A. Correct.
` Q. What is your current compensation
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`rate for Allergan presentations?
` A. It's very complex, and I, frankly,
`don't know what it is, but it's, for me, how
`far away is it from home? So if it's, like,
`local within 25 miles, it's one rate. If it's
`within 100 miles, it's another rate. If it's
`over 100 miles, it's another rate. If it's
`over 250 miles, it's another rate.
` There's so much regulatory input
`there that it's almost impossible to decipher
`the contracts.
` Q. Just as an example, hoping this will
`help your memory, let's just talk about the
`current year. So do you recall -- have you
`given promotional presentations for Allergan in
`the current year?
` A. Yes.
` Q. And tell me when each of those
`occurred.
` A. I did one in Sarasota. That's all
`I've done this year that I remember.
` Q. If we go back to the previous year,
`would you have enough recollection --
` A. It's even less. As I said, I speak
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`for 65 companies. I have 65 promotional
`contracts, plus or minus. I have 65 CME
`contracts. Some companies are active some
`years, and some are very active. I have an
`executive secretary, who you may or may not
`have spoken to, Karen Fowler. She handles all
`this stuff.
` It's a small percentage of my
`daylight time. It's done outside of clinical
`hours. During the clinical hours, I need to be
`seeing patients and doing surgery.
` Q. Approximately how much were you paid
`for the promotional presentation in Sarasota,
`Florida, for Allergan this year?
` MS. FRANCIS: Objection to the form.
` THE WITNESS: Somewhere between
` 1,000 and 3,500 plus expenses.
`BY MR. MILLS:
` Q. And when you do these promotional
`presentations, Allergan covers the cost of your
`travel to the locations?
` A. Expenses, yes.
` Q. And sometimes the presentations are
`held in desirable locations; is that correct?
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` MS. FRANCIS: Objection to the form.
` THE WITNESS: The definition of an
` expert is someone from out of town with a
` briefcase. So I don't know how you define
` desirable. The farther away you go from
` home, the more expert you are. So maybe
` that's desirable to them. I've been asked
` to go to places I don't find desirable at
` all. I would rather give a lecture in my
` backyard, frankly. That's a desirable
` place to me.
`BY MR. MILLS:
` Q. Are the promotional presentations
`that you've given on behalf of Allergan held at
`resort hotels ever?
` A. No. They're not allowed to do that
`anymore. They have very strict pharma limits
`about the amount of money that can be spent on
`a meal. Decades ago, they'd take people to ski
`resorts. All the companies did this. It's
`very different now.
` Q. Why aren't they allowed to do that
`anymore?
` MS. FRANCIS: Objection to form.
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` THE WITNESS: As I said, because of
` pharma regulations.
`BY MR. MILLS:
` Q. You mentioned that you also have a
`contract for giving CME presentations on behalf
`of Allergan?
` A. Correct.
` Q. And you are also compensated for
`those?
` A. Correct.
` Q. How many CME presentations have you
`given for Allergan in the past year?
` A. None.
` Q. What about the year before that?
` A. Don't remember.
` Q. How much are you paid approximately
`when you give a CME presentation for Allergan?
` A. 1,000 to 3,500. I don't remember.
` Q. Approximately how many CME
`presentations have you given for Allergan
`during the course of your career?
` A. One a year for 25 years on average.
`I'll say 25.
` Q. The same question for promotional
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`presentations.
` A. Probably the same.
` Q. So other than CME presentations and
`promotional presentations, have you given other
`presentations for Allergan?
` A. The only other kind of presentation
`I do would be a presentation at the FDA. I
`have not done those for Allergan.
` Q. When you mentioned lunches and
`breakfasts, are those subsets of things you
`might do for a CME or for a promotional
`presentation, or is that something different?
` MS. FRANCIS: Object to the form.
` THE WITNESS: Most of these are for
` dinner. You don't want to interrupt clinic
` hours for doctors. So you don't do these
` very often at breakfast or lunch. At an
` international meeting, everybody is there
` all day. So there are lunch and breakfast
` meetings as well as dinner meetings.
`BY MR. MILLS:
` Q. So the majority of your promotional
`presentations that you've given on behalf of
`Allergan have been given over the course of
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`dinner?
` A. I don't know. If you throw in some
`of the national meetings where they like to do
`breakfast and lunch, that may all average out.
`I really don't keep track of that data.
` Q. You also mentioned advisory boards.
` THE WITNESS: What was that?
` MS. FRANCIS: Who is on the line?
` MR. MILLS: Wilson Sonsini, Grace
` Winschel.
` THE WITNESS: Is that somebody who
` just came on? Who is it?
` MR. MILLS: It's somebody from my
` law firm.
` THE WITNESS: Someone from your
` firm?
` MR. MILLS: Yes.
` THE WITNESS: Who else is on the
` line?
` MR. MILLS: Other attorneys are on
` the line from my law firm or from the other
` petitioners.
` THE WITNESS: Nobody told me that.
` So who is on the phone now?
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` MR. MILLS: We have attorneys from
` Wilson Sonsini. We have attorneys from
` Carlson Caspers.
` THE WITNESS: Okay. Nice to know.
` Thanks.
` MR. MILLS: We set up the phone line
` actually at -- when the deposition was
` supposed to start, and we didn't recall to
` say something later, but the phone is right
` in front of you. The lights are on. We
` weren't trying to keep anything from you.
` THE WITNESS: Could I, like, have a
` list of the names and the firms and who
` they represent?
` MR. MILLS: The appearances are all
` on the record, the transcript.
` THE WITNESS: Where is that?
` (Discussion off the record.)
`BY MR. MILLS:
` Q. You also mentioned your work on
`advisory boards for Allergan.
` Can you tell me about that?
` A. Advisory boards for pharmaceutical
`companies, for surgical companies, for device
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`companies are comprised of, generally speaking,
`from my point of view, eye doctors, either
`optometrists or ophthalmologists who are deemed
`by that particular company as experts in the
`field or, as they call them, KOLs, key opinion
`leaders, and the advisory board is usually a
`half day or a full day meeting around a table
`like this moderated by someone from the company
`and under strict confidentiality outlining
`current and future strategies for product
`development.
` Q. Are you a key opinion leader for
`Allergan?
` A. Yes. And 64 other companies.
` Q. How long have you been a key opinion
`leader for Allergan?
` A. I really don't remember. A long
`time. As with Bausch + Lomb and Novartis and
`Santen, Johnson & Johnson, Alcon.
` Q. You are specifically a key opinion
`leader for Allergan with respect to Restasis;
`correct?
` A. Correct.
` Q. Who are the other key opinion
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`leaders for Allergan's Restasis product?
` A. Dozens and dozens.
` Q. Can you tell me the names that you
`know?
` A. I can give you a couple from each
`group as a sample, if you'd like. The old
`guard would be Peter McDonnell and Chris
`Rapuano.
` Q. Just go ahead and tell me all the
`names you remember.
` A. That's all I remember. The new
`guard would be, like, Chris Starr, Priya Gupta.
` Q. Do you know Eric Donnenfeld?
` A. Yes.
` Q. Is Eric Donnenfeld a key opinion
`leader for Allergan's Restasis product?
` A. Yes. He would be considered in the
`old guard.
` Q. What about Marguerite McDonald?
` A. Same.
` Q. And Kerry Solomon?
` A. Same.
` Q. Hank Perry?
` A. Same.
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` Q. David Hardten?
` A. Same.
` Q. And I think Chris Rapuano, you
`mentioned?
` A. Yes.
` Q. Steve Wilson?
` A. Yes.
` Q. I probably wrote this down wrong,
`but Michael Raizman?
` A. Raizman.
` Q. Raizman?
` A. Yes.
` Q. He's also a key opinion leader for
`Allergan's Restasis product?
` A. Old guard, yes.
` Q. Ed Holland?
` A. Yes.
` Q. That list of people, does that wring
`out the list of what you're calling the old
`guard Allergan Restasis key opinion leaders?
` A. Clearly the majority.
` Q. What is the role of a key opinion
`leader for Allergan's Restasis product?
` MS. FRANCIS: Object to the form.
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` THE WITNESS: We just discussed the
` role of a key opinion leader and an
` advisory board, and that is under
` confidentiality discussing current and
` future strategies.
`BY MR. MILLS:
` Q. Is it your testimony that the role
`of a key opinion leader for Allergan's Restasis
`product is simply to provide advice to
`Allergan?
` MS. FRANCIS: Object to the form.
` THE WITNESS: We're talking about an
` advisory board. Our job is to advise the
` company.
`BY MR. MILLS:
` Q. Other than advising Allergan
`regarding Allergan's Restasis product, is there
`any other role that you and the other key
`opinion leaders for Allergan's Restasis product
`play?
` A. Other than advising, no.
` Q. In your role as a key opinion leader
`for Allergan's Restasis product, do you receive
`briefings on Allergan's franchise positioning?
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` J. SHEPPARD
` MS. FRANCIS: Objection to the form.
` THE WITNESS: Briefings on franchise
` positioning. How would you define
` "franchise positioning"?
`BY MR. MILLS:
` Q. Do you have an understanding as to
`what that phrase might mean?
` A. It can mean any number of things. I
`would have to understand what your question
`involves to better describe it.
` Q. So earlier you said that your
`position as a key opinion leader for Allergan
`involves providing counsel to Allergan.
` So my question now is: Does that
`role also involve you receiving briefings from
`Allergan?
` MS. FRANCIS: Objection to the form.
` THE WITNESS: That sounds very
` military. We just look at ways to benefit
` patients from the point of view of the key
` opinion leader, and we're supposedly
` experts in interacting with patients and
` interacting with other doctors, and the
` idea is to provide strategies for better
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` J. SHEPPARD
` patient than colleague interactions.
` So I think we're briefing them, not
` them briefing us. It's pretty much an open
` forum. They just say talk.
`BY MR. MILLS:
` Q. In your position as an Allergan key
`opinion leader for Restasis, do you receive
`presentations from Allergan about their brand
`messaging?
` MS. FRANCIS: Objection to the form.
` THE WITNESS: Certainly don't
` remember them. Again, it's the other way
` around. They ask the key opinion leaders
` "How would you brand this medicine?"
` "What's the best way to present this
` medicine to patients and to doctors?"
`BY MR. MILLS:
` Q. In your role as a key opinion leader
`for Allergan's Restasis product, does Allergan
`ask you to influence other physicians to have
`those physicians prescribe Restasis to their
`patients?
` A. No.
` Q. Would it be appropriate for Allergan
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` J. SHEPPARD
`to do that?
` A. No. We're educators, not whatever
`the word is that you used. Influenced.
` Q. As a key opinion leader for
`Allergan's Restasis, Allergan expects you to be
`loyal to Restasis; correct?
` MS. FRANCIS: Objection to the form.
` THE WITNESS: You know, I really
` resent answering that question because, for
` some reason, my role has been
` misinterpreted repeatedly. My role is as
` an advisor and an educator. Any other
` implications are not welcome or coveted or
` appreciated.
`BY MR. MILLS:
` Q. Is it correct that if someone had
`said, about you, that as a key opinion leader
`for Allergan's Restasis, that that meant you
`were loyal to Restasis, that's not a
`characterization that you'd appreciate; right?
` A. I'm loyal to my patients. I'm loyal
`to my colleagues. I want to deliver the best
`medicine. If the patient is matched to
`Restasis, then so be it. If the patient is
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`matched to a competitor, so be it.
` Q. If an Allergan employee said, about
`you, because you are a key opinion leader for
`Restasis, that that meant that you would be
`loyal to Restasis, would you find that comment
`to be inappropriate?
` A. Yes. And I would end the
`conversation.
` Q. In your role as a key opinion leader
`for Allergan's Restasis, have you ever been
`asked to describe dry eye treatment as a
`practice builder with economic benefit to other
`eye care professionals?
` MS. FRANCIS: Object to the form.
` THE WITNESS: I've made
` presentations about business modeling that
` benefits patients, practices, the payers,
` and the practitioners, and that has not in
` any way been specific to Restasis.
`BY MR. MILLS:
` Q. When you say "has not in any way
`been specific to Restasis," do you mean that
`it's not exclusive to Restasis or that you've
`never given a presentation about business
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`modeling that had a specific discussion
`actually about Restasis?
` MS. FRANCIS: Objection to the form.
` THE WITNESS: Let's do the first
` part of the question. That was two
` questions. Help me with that.
`BY MR. MILLS:
` Q. Yeah. We'll do them one at a time.
` When you say that you have not --
`that you've done business modeling
`presentations but that they were not in any way
`specific to Restasis, do you mean they're not
`exclusive to Restasis?
` A. I'd never do anything that's
`exclusive to Restasis in a business modeling
`discussion. That would be insanity and
`horrible advice.
` Q. I'm just trying to understand what
`you meant with what you said.
` When you said you haven't done it
`specific to Restasis, are you saying that
`you've never given any presentation in which
`you have described the economic benefits to eye
`care professionals of prescribing Restasis as
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`part of their practice?
` MS. FRANCIS: Objection to the form.
` THE WITNESS: I don't know how there
` could be an economic direct benefit to the
` practice for prescribing Restasis because
` the doctor doesn't make a cent.
`BY MR. MILLS:
` Q. Would it be improper, in your view,
`if Allergan asked you, as a key opinion leader,
`to influence other eye care professionals by
`telling them that dry eye is a practice builder
`with economic benefit?
` A. That is nonspecific to Restasis, and
`there is economic benefit for the practice, the
`doctors, the payers, and the patients. And if
`they get better, they have an economic benefit.
`If the practice does a better job, that has an
`economic benefit because more patients come
`there.
` If the diagnosis is treated quickly
`and expeditiously and the patient stops coming
`back because they're better, then payers
`benefit as well.
` Q. So I'm trying to understand whether
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`or not you have given presentations to other
`eye care professionals in which you have
`advocated for them to diagnose more patients
`with dry eye disease because that would be a
`practice builder and provide economic benefit
`to their practice.
` A. Again, that's two questions. Let's
`do the first part.
` Q. Okay. Have you given presentations
`to other eye care professionals in which you
`have advocated for them to diagnose more
`patients with dry eye disease? I'll stop
`there.
` A. Absolutely. Dry eye is
`underdiagnosed, and it can have extremely bad
`influences upon the outcome of a number of
`things that we do including surgery, medical
`care.
` Q. In your presentations to other eye
`care professionals in which you have advocated
`for them to diagnose more patients with dry eye
`disease, you have told at least some of those
`practitioners that diagnosing more patients
`with dry eye disease could be a practice
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`builder for them; correct?
`

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