throbber
August 19, 2016 Deposition of Tammy Jo Sarnelli
`Patent 8,399,514 B2
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` __________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________________________
`
` COALITION FOR AFFORDABLE DRUGS V LLC; et al.,
` Petitioners
` v.
` BIOGEN MA INC.,
` Patent Owner
` _____________________
` Case IPR2015-01993
` Patent 8,399,514 B2
` __________________________________________
` COMPLETE CAPTION ON PAGE 2
` __________________________________________
`
` DEPOSITION OF TAMMY JO SARNELLI
` Friday, August 19, 2016, 10:37 a.m.
` Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
` Two Seaport Lane
` Boston, Massachusetts 02210
`------ Reporter: Kimberly A. Smith, CRR, RDR ------
` Realtime Systems Administrator
` Henderson Legal Services, Inc.
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`202-220-4158
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`Henderson Legal Services, Inc.
`www.hendersonlegalservices.com
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`Page 1 of 121
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`Coalition Exhibit 1054
`Coalition v. Biogen
`IPR2015-01993
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`August 19, 2016 Deposition of Tammy Jo Sarnelli
`Patent 8,399,514 B2
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` UNITED STATES PATENT AND TRADEMARK OFFICE
` __________________________________________
` BEFORE THE PATENT TRIAL AND APPEAL BOARD
` __________________________________________
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` COALITION FOR AFFORDABLE DRUGS V LLC;
` HAYMAN CREDES MASTER FUND, L.P.;
` HAYMAN ORANGE FUND SPC - PORTFOLIO A;
` HAYMAN CAPITAL MASTER FUND, L.P.;
` HAYMAN CAPITAL MANAGEMENT, L.P.;
` HAYMAN OFFSHORE MANAGEMENT, INC.;
` HAYMAN INVESTMENTS, LLC;
` NXN PARTNERS, LLC;
` IP NAVIGATION GROUP, LLC;
` J KYLE BASS; and ERICH SPANGENBERG,
` Petitioners
` v.
` BIOGEN MA INC.,
` Patent Owner
` _____________________
` Case IPR2015-01993
` Patent 8,399,514 B2
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`August 19, 2016 Deposition of Tammy Jo Sarnelli
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`APPEARANCES:
`
` Carmichael IP, PLLC
` By: Carol A. Spiegel, Esq.
` 8000 Towers Crescent Drive, 13th Floor
` Tysons Corner, VA 22182
` (703) 646-9249
` carol@carmichaelip.com
` for the Petitioners;
`
` Finnegan, Henderson, Farabow, Garrett &
` Dunner, LLP
` By: Erin M. Sommers, Ph.D., Esq.
` 901 New York Avenue, N.W.
` Washington, D.C. 20001-4413
` (202) 408-4000
` erin.sommers@finnegan.com
` for the Patent Owner.
`
`Also Present: Wendy S. Plotkin, Biogen
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`August 19, 2016 Deposition of Tammy Jo Sarnelli
`Patent 8,399,514 B2
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` I N D E X
`
`WITNESS: Tammy Jo Sarnelli
`
`EXAMINATION Page
` Cross-Examination by Ms. Spiegel 6
` AFTERNOON SESSION
` Cross-Examination by Ms. Spiegel 51
`
`EXHIBITS FOR IDENTIFICATION:
`Biogen Description Page
`Exhibit 2080 Sarnelli declaration 8
`Exhibit 2118 2/22/06 IND 73,061 letter 32
`Exhibit 2252 5/3/06 CDT meeting minutes 73
`Exhibit 2275 Study P00012-05-05 report 55
`Exhibit 2281 5/25/07 email with attached 47
` end of Phase 2 meeting info
` package
`Exhibit 2288 10/21/04 Type B meeting 60
` briefing document
`Exhibit 2289 11/19/04 draft reviewer 61
` comments
`Exhibit 2290 PIND 69,852 letter and 63
` meeting minutes
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`EXHIBITS FOR IDENTIFICATION: (continued)
`Biogen Description Page
`Exhibit 2294 12/11/06 FDA comments re 47
` IND 73,061
`Exhibit 2297 10/4/06 letter: Katz/Cohen 80
`Exhibit 2330 BG00012 IND 52
`Exhibit 2331 7/8/05 request for pre-IND 69
` meeting
`Exhibit 2332 6/23/06 request for EOP2 76
` meeting
`Exhibit 2374 CDER Summary Review 67
`Exhibit 2375 FDA Statistical Review and 49
` Evaluation
`
`Original exhibits retained by counsel
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` TAMMY JO SARNELLI,
` having been satisfactorily identified by the
` production of her driver's license, and
` duly sworn by the court reporter, was examined
` and testified as follows:
` CROSS-EXAMINATION
`BY MS. SPIEGEL:
` Q. Good morning, Ms. Sarnelli.
` A. Good morning.
` Q. I'm here with Carmichael IP and I'll be
`asking you a series of questions today. All I ask
`is that you answer to the best of your ability.
`If there's anything about my questions you don't
`understand, please let me know and I'll try and
`rephrase it or restate it to the best of my ability.
` If you need a break at any time, just
`let me know. The only caveat is if I have asked you
`a question, would you please finish answering it
`before we take the break.
` As you know, the court reporter is
`transcribing everything we say, so it's important
`that you give verbal answers -- "yes," "no," rather
`than nodding -- and that we don't talk over each
`other.
` Is that okay?
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` A. That's okay.
` Q. Would you please state your full name for
`the record.
` A. Tammy Jo Sarnelli.
` Q. Do you understand your testimony is under
`oath today?
` A. I do.
` Q. I'll probably refer to multiple sclerosis
`as "MS." Are you okay with that abbreviation?
` A. Yes.
` Q. Is there any reason you can't give full and
`truthful testimony today?
` A. No.
` Q. Are you taking any medications that would
`impair your ability to testify today?
` A. No.
` Q. Have you provided any declarations in any
`other patent matters besides this inter partes
`review proceeding and the interference that you
`cited in Footnote 1 on page 5 of your declaration?
` A. Could I have my declaration?
` Q. Yes, ma'am. You can have your declaration.
` A. Could you restate your question, please.
` Q. Have you provided any declarations in any
`other patent matters besides this IPR proceeding and
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`the interference proceeding cited in Footnote 1 on
`page 5 of your declaration?
` MS. SOMMERS: Counsel, I don't believe
`there's a copy of her declaration in the binder.
`Do you have any extra copies of that?
` MS. SPIEGEL: I'm sorry. I have not had
`a chance to go through the binder.
` MS. SOMMERS: Well, I'm going to need a
`copy, so let's just go off the record really quickly
`and I'll get a copy of that.
` (Recess at 10:40 a.m.,
` resumed at 10:44 a.m.)
` MS. SPIEGEL: Back on.
`BY MS. SPIEGEL:
` Q. I'm handing you a document that has been
`previously marked as Biogen Exhibit 2080. Please
`look at it and just confirm that this is the
`declaration that you submitted in this IPR
`proceeding.
` A. It is.
` Q. Have you provided any declarations in any
`other patent matters besides this IPR proceeding and
`the interference proceeding noted on page 5,
`Footnote 1, of this declaration?
` A. Can you clarify your question. Are you
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`asking other than what's noted here?
` Q. Correct.
` A. No.
` Q. Have you provided any expert reports in any
`patent matters other than what you've done for the
`Biogen IPR?
` A. No.
` Q. Have you done expert reports for matters
`other than patent matters?
` A. No.
` Q. Have you ever been deposed before?
` A. I have been deposed once.
` Q. When?
` A. As noted here, it was a previous
`interference case.
` Q. Do you recall the approximate date?
` A. I don't recall the approximate date.
` Q. But it was in the last two or three months?
` A. I don't recall the months.
` Q. And you said the kind of case was an
`interference proceeding, correct?
` A. As noted on page 5 of my declaration, I
`provided a declaration in that particular instance.
` Q. Did you prepare for your deposition today?
` MS. SOMMERS: And I'll just answer --
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`or I'll just instruct you to be cautious in your
`answers to not reveal any attorney-client
`communications. But otherwise, you can testify
`generally.
` THE WITNESS: Yes.
`BY MS. SPIEGEL:
` Q. And very generally -- I don't want you to
`disclose any direct communications you had with
`counsel -- but what did you do to prepare?
` A. I met with legal counsel.
` Q. Did you meet with counsel who are here
`today?
` A. I did.
` Q. Was there anyone present besides legal
`counsel that's here today?
` A. No.
` Q. When you prepared for your deposition, did
`you review any documents?
` A. I reviewed my declaration.
` Q. Did you review the exhibits that were
`referred to in your declaration?
` A. Those are part of my activities as a
`regulatory custodian. Those are documents that I
`would see.
` Q. Now, some of the documents have certain
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`redactions in them. So I am specifically referring
`to the documents as submitted as exhibits in this
`IPR proceeding.
` A. I provided true and accurate copies to our
`legal team.
` Q. I'm a little confused. Some of the exhibits
`have certain redactions in them. And I'm asking
`whether you reviewed the exhibit with the redactions
`or whether you reviewed the unredacted documents?
` A. I will -- I have provided the documents,
`the full total documents to our legal team.
` Q. Do you recall reviewing anything other than
`documents that were referred to in your declaration?
` A. Not to my knowledge.
` Q. When did you meet in preparation for your
`deposition?
` A. Several days ago.
` Q. About how long did you meet with counsel to
`prepare?
` A. I can't recall how long.
` Q. An hour? More?
` A. Maybe a little over an hour.
` Q. Are there any questions before we get into
`the meat of this?
` A. No.
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` Q. What's the full title of the -- the full
`name of your employer?
` A. Biogen.
` Q. What's your current position there?
` A. Senior director, regulatory affairs.
` Q. How long have you had that position?
` A. I'm going to refer to my declaration.
`I have held that position at Biogen since 2014.
` Q. While we're looking at your declaration,
`can you confirm that it's your signature on page 41
`of 49? And I'm talking about the page numbers in
`the lower left-hand corner.
` A. That is my signature.
` Q. Did you review your declaration before you
`signed it?
` A. I reviewed my declaration before I signed
`it.
` Q. Looking at your declaration, are you aware
`of any errors or mistakes in your declaration?
` A. I'd like to point out two minor revisions.
`Please turn to page 11 of 49 in my declaration.
`I'm sorry. Page 14.
` Q. Page 14, okay.
` A. As noted in paragraph 20, the fourth line
`from the bottom, it notes "May 2006 until February
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`of 2007." That should be March of 2007.
` And the only other revision is on
`page 15 of 49, paragraph 23, there's a word omitted.
`It should be "clinical overview."
` Q. I'm sorry. Would you say that again.
` A. Page 15 of 49.
` Q. Okay.
` A. There seems to be a word missing. There's
`text missing --
` Q. You're referring to the last line?
` A. To the last line.
` Q. You provided a CV at the end of your
`declaration. Are you aware of any errors in your CV
`at pages 43 to 47?
` A. I'm not aware of any errors.
` Q. You have a Bachelor of Arts in biology from
`St. Anselm College, correct?
` A. I do.
` Q. You have a master's degree in public
`administration/healthcare from Suffolk University,
`correct?
` A. Correct.
` Q. From 1988 to 1989, you worked as a research
`technician at the Dana-Farber Cancer Institute,
`correct?
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` A. Correct.
` Q. Did any of your work at the Dana-Farber
`Cancer Institute involve BG-12?
` A. It did not.
` Q. Did any of your work at the Dana-Farber
`Cancer Institute involve multiple sclerosis?
` A. It did not.
` Q. From 1989 to 1995, you worked as a bioassay
`analyst at Biogen, correct?
` A. Correct.
` Q. In paragraph 7 of your declaration -- and
`that would be -- you stated that your duties involved
`method development. What kinds of methods did you
`develop?
` A. That was product-specific method
`development, depending on what was needed for the
`samples to be tested.
` Q. So they were analytical methods?
` A. They were methods to test samples, yes.
` Q. You also stated that you were "closely
`involved in the development and operation of
`computer data tracking programs for test data
`correlation, statistical analysis, and summary
`report generation," correct?
` A. That's what is stated in my declaration.
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` Q. Are you a biostatistician?
` A. I am not.
` Q. Did any of your work as a bioassay analyst
`involve BG-12?
` A. It did not.
` Q. Did any of your work as a bioassay analyst
`involve multiple sclerosis?
` A. It involved the testing of clinical samples
`for patients with multiple sclerosis.
` Q. From 1995 to 1998, you worked as a QC
`bioassay supervisor at Biogen; is that correct?
` A. That is in my declaration.
` Q. What's meant by "QC"?
` A. It is an acronym for "quality control."
` Q. And you are quality controlling analytical
`testing?
` A. I was responsible for the testing, and
`quality control is what the name of the department
`was: quality control bioassay.
` Q. These were analytical tests or patient
`clinical tests?
` A. As it says here, it was "maintaining
`clinical sample receipt and inventory management,
`supervising analysts and assistants in coordinating
`activities and release testing."
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` Q. In paragraph 8 of your declaration, you
`state that you were responsible for "coordinating
`the activities of the QC release testing team."
` What is a QC release testing team?
` A. As noted here, there are analysts and
`assistants, and we were responsible for releasing
`products.
` Q. By "products," you are referring to?
` A. Anything that was under development at that
`moment, which we were responsible for providing
`sample testing.
` Q. So it could be a drug? It could be a
`biologic?
` A. Can you clarify for me how you made that
`distinction between drug and biologic.
` Q. A drug is a small molecule; biologic is a
`much larger organic-based product such as a protein
`or an antibody, an antiserum.
` A. Here, it says whatever products needed to
`be tested, that's what we were testing.
` Q. I was trying to get a clarification on the
`scope of the word "product" as you're using it.
` A. I don't understand your question.
` Q. You said that you were testing products.
` A. Um-hum.
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` Q. And I was looking for, what does "product"
`encompass?
` A. Molecules that we were evaluating at Biogen,
`we would be responsible to do release testing of.
` Q. What do you mean by "reviewed"?
` A. We would review the assay and the
`methodology, as well as the results. That's part of
`a quality control team.
` Q. So when you reviewed the clinical protocols,
`what were you looking for?
` A. We were reviewing them to ensure that we
`understood what our responsibilities were.
` Q. And what were your responsibilities?
` A. Are we referring to still paragraph 8?
` Q. I was referring to your last answer.
` A. As noted here, there are laboratory
`procedures. We implement good manufacturing
`practices. And we were responsible for coordinating
`the activities of release testing.
` Q. Would it be fair to say that you, for
`example, reviewed that good manufacturing practices
`were being maintained?
` A. I don't think it's fair to make such a
`general statement. We review clinical protocols to
`ensure we understand what is required for sample
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`testing.
` Q. Did any of your work as a QC bioassay
`supervisor involve BG-12?
` A. It did not.
` Q. Did any of your work as a QC bioassay
`supervisor involve patients with multiple sclerosis?
` A. It would.
` Q. But not in the context of BG-12
`administration?
` A. No.
` Q. From 1998 to 2000, you worked as a
`regulatory affairs associate at Biogen; is that
`correct?
` A. That is in my declaration.
` Q. Did any of your work as a regulatory
`affairs associate involve BG-12?
` A. It did not.
` Q. Did any of your work as a regulatory
`affairs associate involve patients with MS?
` A. Those are the programs we were evaluating
`at that time, yes.
` Q. And the programs involving patients with MS
`that you were evaluating at that time consisted of
`which programs? In a general nature.
` A. It was highly dependent on what the product
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`was.
` Q. Can you recall an example of a product that
`you were testing with patients with multiple
`sclerosis?
` A. You used the word "testing." As a
`regulatory affairs associate, I'm not responsible
`for testing. I'm responsible for the regulatory
`affairs, as noted here. There is nothing in here to
`suggest testing.
` Q. Can you recall an example of a product that
`you were reviewing for regulatory compliance that was
`being used with patients with multiple sclerosis?
` A. You used the word "regulatory compliance."
`There's no note here that I see of compliance.
`That's not something that I know of in my
`declaration here.
` Q. So what was your involvement with patients
`having multiple sclerosis when you worked as a
`regulatory affairs associate?
` A. I was not involved with patients
`specifically. It's noted here, I was involved in
`evaluating and reviewing material, reviewing and
`submitting filings to the Food and Drug
`Administration, which is part of my job.
` Q. From 2001 to 2002, you worked as a senior
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`regulatory affairs associate at Biogen, correct?
` A. That is in my declaration.
` Q. Did any of your work as a senior regulatory
`affairs associate involve BG-12?
` A. It's not noted in my -- in my declaration.
`I don't -- I don't recall working on that product at
`that time.
` Q. From 2002 to 2005, you worked as a manager
`of regulatory affairs at Biogen; is that correct?
` A. That is correct.
` Q. Do you recall when in 2002 you became a
`regulatory affairs manager?
` A. I do not.
` Q. In paragraph 10 of your declaration, you
`state your duties included the management of new
`product INDs; is that correct?
` A. That's what my declaration states.
` Q. Was one of those new products BG-12?
` A. I don't recall.
` Q. You state that you were the "regulatory
`representative on drug development teams, providing
`regulatory input and strategic guidance for the
`development of new Biogen drug products.
` What do you mean by "regulatory input"?
` A. As my role in regulatory affairs, I would
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`provide assessments in helping the team to look at
`new products.
` Q. In what way?
` A. Filing with regulatory affairs, as you
`noted before, I'm submitting filings to Food and
`Drug -- FDA, which includes investigational drug
`application. So I helped -- that's my work product.
` Q. What do you mean by "strategic guidance"?
` A. It's to help the team assess the guidelines
`that are out there for drug development.
` Q. So this would be a regulatory guidance?
` A. Or guidance in general.
` Q. And what teams did you provide the
`strategic guidance to?
` A. Are you referring to 2002?
` Q. Yes, I am.
` A. There were many Biogen drug products.
`I can't specifically name them all.
` Q. From 2002 [sic] to 2008, you worked as an
`associate director of regulatory affairs at Biogen
`Idec Inc., correct?
` A. Can I correct that? It was 2005 to 2008.
` Q. I'm sorry?
` A. You said 2002.
` Q. I'm sorry. So from 2005 to 2008, you
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`worked as an associate director of regulatory
`affairs at Biogen Idec Inc.; is that correct?
` A. Yes. That's in my declaration.
` Q. According to your CV, page 44, you were
`"responsible for interactions with regulatory
`authorities on new product development."
` What regulatory authorities are you
`referring to?
` A. Given my role, it would be regulatory
`authorities globally.
` Q. Can you give me an example of a regulatory
`authority you dealt with?
` A. The various regulatory authorities globally.
` Q. Could you clarify what some of those
`regulatory authorities globally are?
` A. Well, as noted in my CV, I would submit
`files to the Food and Drug Administration, which is
`the U.S. regulatory authority.
` Q. You referred to global regulatory
`authorities. So there were regulatory authorities
`outside of the U.S., outside of the FDA?
` A. There are global regulatory authorities --
` Q. That you dealt with?
` A. There are authorities that we in our
`regulatory work deal -- work with.
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` Q. Can you give me an example of a regulatory
`authority outside of the FDA that you worked with?
` A. Each country has their own regulatory
`authority.
` Q. According to your CV -- I'm still on
`page 44 of 49 -- you were "responsible for providing
`regulatory input and strategic guidance for new
`products."
` What does "strategic guidance" refer to?
` A. I actually answered that question earlier.
` Q. So same answer? In the summary of your CV
`on page 43, you state that you are a "strong team
`player with experience working in global matrix team
`environment."
` Do you see that?
` A. I see that.
` Q. What is a global matrix team?
` A. That is -- the term "global matrix team" is
`a -- actually a note that we have internally at
`Biogen for working with everyone around the world.
` Q. So it's an internal definition of --
` A. That is an internal definition.
` Q. In your summary of your CV, you state
`"project planning/leadership specifically in
`clinical trial application submissions and marketing
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`applications."
` What does planning/leading marketing
`applications involve?
` A. It's exactly as stated. It's planning
`marketing applications.
` Q. What's a marketing application?
` A. In order for products to be provided to
`patients, they must be reviewed and approved by
`regulatory authorities. Our marketing application
`is exactly that.
` Q. So you're referring to a regulatory market
`as opposed to commercials on television directed to
`a possible patient?
` A. I don't understand your question.
` Q. So when you talk about marketing, you are
`specifically referring to market approval by a
`regulatory agency?
` A. I still need further clarification on your
`question.
` Q. Perhaps we should start again. What is a
`marketing application, as you used the term?
` A. There are two applications. We'll use the
`example of FDA. There's a biological licensing
`application and there's a new drug application.
`There's two applications that we use. We refer to
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`them generally as marketing applications.
` Q. So a marketing application and regulatory
`approval are very intertwined?
` A. In order to obtain approval on a new
`product, you must provide the regulatory authority
`with documents/data. And that is through an
`application to them for review.
` Q. In paragraph 1 of your declaration, you
`state that in your present position, you "provide
`oversight of independent review markets and global
`emerging markets for Tecfidera."
` Do you see that?
` A. For Tecfidera?
` Q. Yes.
` A. I see that.
` Q. From paragraph 1 of your declaration. What
`is an independent review market?
` A. It is a market that requires an independent
`evaluation of a product.
` Q. It seems that you're using the word "market"
`in a very technical sense. When I think of "market,"
`I think of going to the grocery store.
` So could you please clarify your
`definition of "market."
` A. I guess I don't really understand your
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`question. We provide oversight in independent
`review markets. "Markets" is the term that we use.
` Q. I am not familiar with the term "markets"
`as you're using it. I go to the grocery store; I'm
`going to the market. So I'm asking you to help me
`understand what you mean by the term "market" as
`you're using it in your declaration.
` A. So "independent review market," market
`could be the area in which we intend to provide
`product to patients.
` Q. Thank you. What is a global emerging
`market?
` A. There are regions who rely on approvals in
`the independent review markets before they provide
`their approval.
` Q. What type of oversight do you provide?
` A. I am -- my oversight is ensuring that we
`provide the information to the independent review
`markets and the global emerging markets as necessary.
` Q. So the type of information that you're
`providing would be directed towards the market's
`regulatory requirements?
` A. I am -- I am providing oversight to ensure
`that the data that they require, that they have.
` Q. Going back to your CV at page 43, you state
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`that you presently "serve as the regulatory
`representative on Clinical Trial Review Board."
` Do you see that?
` A. I see that.
` Q. What's a Clinical Trial Review Board?
` A. There's a board that reviews clinical
`trials.
` Q. What are the major responsibilities of a
`Clinical Trial Review Board?
` A. Those responsibilities are laid out in a
`standard operating procedure. Without having that
`in front of me, I can't speak to the full totality
`of that.
` Q. Who would be on a Clinical Trial Review
`Board?
` A. That's governed by a standard operating
`procedure.
` Q. Who's responsible for writing the standard
`operating procedure?
` A. That's the responsibility of internal --
`internal people within Biogen.
` Q. You spoke about regulatory people, you
`spoke about clinical people. Are there commercial --
`is there a commercial entity in Biogen that
`participates in the Clinical Trial Review Board?
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` A. Without the SOP in front of me, I can't
`comment on that.
` Q. What do you do as a regulatory
`representative on a Clinical Trial Review Board?
` A. In order to be accurate, I would need the
`SOP in front of me to lay out the roles and
`responsibilities.
` MS. SPIEGEL: This would be a good point
`to take a short break, if you wouldn't mind.
` MS. SOMMERS: No.
` MS. SPIEGEL: Thanks.
` (Recess at 11:18 a.m.,
` resumed at 11:24 a.m.)
`BY MS. SPIEGEL:
` Q. In paragraph 11 of your declaration -- it's
`on page 8 of 49 -- you state that you "first became
`involved with the BG-12 project in or around
`February of 2006," correct?
` A. That's in my declaration.
` Q. And that you "remained involved with the
`BG-12 and Tecfidera projects" through 2014; is that
`corre

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