`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 1
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` UNITED STATES INTERNATIONAL TRADE COMMISSION
`
` WASHINGTON, D.C.
`
` - - - - - - - - - - - - - - - X
`
` In the Matter of :
`
` :
`
` CERTAIN PRE-FILLED SYRINGES : Investigation No.
`
` FOR INTRAVITREAL INJECTION : 337-TA-1207
`
` AND COMPONENTS THEREOF :
`
` - - - - - - - - - - - - - - - X
`
` Remote Deposition
`
` Friday, December 4, 2020
`
` CONFIDENTIAL BUSINESS INFORMATION - SUBJECT TO
`
` PROTECTIVE ORDER
`
` Videotaped deposition of CHRISTOPHER SIMMS
`
`in his personal capacity and as 30(b)(6) witness for
`
`Novartis, called for examination by counsel for
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`Respondent Regeneron in the above-entitled matter,
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`pursuant to notice, the witness being duly sworn by
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`MARY GRACE CASTLEBERRY, a Notary Public in and for
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`the District of Columbia, taken at 8:58 a.m. EST,
`
`Friday, December 4, 2020, and the proceedings being
`
`taken down by Stenotype by MARY GRACE CASTLEBERRY,
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.001
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 2
`
`RPR, and transcribed under her direction.
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`~7 Trustpoint.One Alderson.
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`www.trustpoint.one
`www.aldersonreporting.com
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`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.002
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 3
`
`APPEARANCES:
`
` On behalf of the Complainants Novartis Pharma
`
` AG, Novartis Pharmaceuticals Corporation,
`
` Novartis Technology LLC:
`
` MARK G. DAVIS, ESQ.
`
` Goodwin Procter
`
` The New York Times Building
`
` 620 Eighth Avenue
`
` New York, New York 10018-1405
`
` (212) 813-8800
`
` On behalf of Respondent Regeneron
`
` Pharmaceuticals, Inc.:
`
` PRIYATA Y. PATEL, ESQ.
`
` ROBERT T. VLASIS, III, ESQ.
`
` Weil Gotshal & Manges
`
` 2001 M Street, N.W., Suite 600
`
` Washington, D.C. 20036
`
` (202) 682-7000
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`~7 Trustpoint.One Alderson.
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.003
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 4
`
`APPEARANCES (Continued):
`
` On behalf of the International Trade Commission:
`
` W. PETER GUARNIERI, ESQ.
`
` Investigative Attorney
`
` Office of Unfair Import Investigations
`
` U.S. International Trade Commission
`
` 500 E Street, S.W.
`
` Washington, D.C. 20436
`
` (202) 708-1525
`
` ALSO PRESENT:
`
` JASON AQUI, Videographer
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`~7 Trustpoint.One Alderson.
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.004
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 5
`
` C O N T E N T S
`
`WITNESS EXAMINATION BY COUNSEL FOR
`
`CHRISTOPHER SIMMS REGENERON ITC
`
` BY MS. PATEL 7
`
` BY MR. GUANIERI 90
`
` BY MS. PATEL 94
`
` E X H I B I T S
`
`EXHIBIT NO. PAGE
`
`1 - Notice of Deposition 10
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`2 - LinkedIn profile of Christopher Simms 16
`
`3 - Declaration of Christopher Simms 22
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`~7 Trustpoint.One Alderson.
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`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.005
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 6
`
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` P R O C E E D I N G S
`
` THE VIDEOGRAPHER: We are now on the
`
`record in the matter of Certain Prefilled Syringes
`
`for Intravitreal Injection and Components Thereof.
`
`Today's date is December 4th, 2020. The time on the
`
`video monitor is 8:58 a.m. Eastern Standard Time.
`
` This is the video recorded deposition of
`
`Chris Simms being taken virtually. I'm the camera
`
`operator. My name is Jason Aqui in association with
`
`TrustPoint/Alderson Reporting. The court reporter is
`
`Mary Grace Castleberry also in association with
`
`TrustPoint/Alderson Reporting.
`
` Will all attorneys please identify
`
`themselves and the parties they represent beginning
`
`with the party noticing this proceeding.
`
` MS. PATEL: Good morning. This is Priya
`
`Patel from Weil Gotshal & Manges in Washington, D.C.
`
`representing respondent, Regeneron Pharmaceuticals,
`
`Inc. Also with me today is Robert Vlasis also on
`
`behalf of respondent.
`
` MR. DAVIS: Hi. Mark Davis of Goodwin
`
`Procter on behalf of the complainant, Novartis, and
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.006
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 7
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`the witness, Christopher Simms.
`
` MR. GUARNIERI: And this is Pete Guarnieri
`
`from the Office of Unfair Import Investigations at
`
`the U.S. International Trade Commission.
`
` THE VIDEOGRAPHER: Will the court reporter
`
`please administer the oath.
`
`Whereupon,
`
` CHRISTOPHER SIMMS,
`
`was called as a witness by counsel for Respondent
`
`Regeneron, and having been duly sworn by the Notary
`
`Public, was examined and testified as follows:
`
` EXAMINATION BY COUNSEL FOR RESPONDENT REGENERON
`
`BY MS. PATEL:
`
` Q. Good morning, Mr. Simms.
`
` A. Good morning. How are you?
`
` Q. Good. How are you?
`
` A. Good.
`
` Q. Could you please state your name and
`
`address for the record.
`
` A. Christopher Simms. My address is Madison,
`
`New Jersey. Do you want my full address or just the
`
`town?
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.007
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 17
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` Q. Is this your LinkedIn profile?
`
` A. It's an abbreviated version of my LinkedIn
`
`profile, yes.
`
` Q. So is this not a complete and accurate
`
`representation of your professional and education --
`
`educational background?
`
` MR. DAVIS: Object to form.
`
` THE WITNESS: It's an accurate
`
`representation. The full profile contains more
`
`detail, but it's an accurate representation. The
`
`information contained here is accurate.
`
`BY MS. PATEL:
`
` Q. Okay. Well, let's start with your current
`
`position in Novartis. What is your current title?
`
` A. As shown here, my current title is I'm the
`
`vice president of the U.S. ophthalmics franchise.
`
` Q. And is that -- what's represented here is
`
`what your current title is, is that correct, just to
`
`confirm?
`
` A. Yes.
`
` MR. DAVIS: Object to form.
`
`BY MS. PATEL:
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.008
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 18
`
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` Q. How long have you held this position?
`
` A. Since April this year, April 2020. So
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`seven, eight months.
`
` Q. Okay. What are your responsibilities in
`
`this position?
`
` A. I'm responsible for the commercial
`
`activities for our ophthalmics medicines portfolio.
`
`That includes the two primary brands of BEOVU and
`
`Xiidra.
`
` Q. BEOVU and what was the second one?
`
` A. Xiidra. X-i-i-d-r-a.
`
` Q. And when you say BEOVU, do you mean BEOVU
`
`in the vial presentation or BEOVU in the PFS
`
`presentation or both?
`
` MR. DAVIS: Object to form.
`
` THE WITNESS: I mean BEOVU the brand,
`
`which includes both presentations.
`
`BY MS. PATEL:
`
` Q. What are the groups that you oversee in
`
`your position?
`
` A. I oversee a sales and marketing team for
`
`BEOVU, that supports BEOVU. I also oversee a sales
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.009
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 26
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`is that right?
`
` A. That's correct.
`
` Q. What is your understanding of that based
`
`on?
`
` A. It's based on two factors primarily. One
`
`is feedback from physicians indicating a preference
`
`for a prefilled syringe format. It's also based upon
`
`the observed rate of conversion from the launch of a
`
`prefilled syringe in this particular therapeutic area
`
`a couple of years prior.
`
` Q. Is it your understanding that the
`
`prefilled syringe format is preferable over the vial
`
`format?
`
` A. When -- sorry. Can you clarify, when you
`
`say preferable, who are you referring to who has that
`
`preference?
`
` Q. Providers, customers.
`
` A. Thank you. Yes.
`
` MR. DAVIS: Objection. Compound.
`
`BY MS. PATEL:
`
` Q. When you say that your prior understanding
`
`informs why you think there will be a rapid
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.0010
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 73
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`I
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`BY MS. PATEL:
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` Q. Is the PFS easier to use than the vial?
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` MR. DAVIS: Object to form. Beyond the
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`scope. I'm sorry, just object to form.
`
` THE WITNESS: Easier to use? Can you
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`clarify by -- by whom that you're referring to?
`
`BY MS. PATEL:
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.0011
`Regeneron v. Novartis, IPR2021-00816
`
`
`
` Chris Simms
`
`CONFIDENTIAL BUSINESS INFORMATION
`SUBJECT TO PROTECTIVE ORDER
`
`12/4/2020
`Page 74
`
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` Q. Physicians?
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` A. We believe so, yes.
`
` Q. Does the PFS require fewer steps to
`
`administer the drug?
`
` A. The prefilled syringe requires fewer steps
`
`to prepare the drug for administration, yes.
`
` Q. Do fewer steps mean less opportunity to
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`inadvertently introduce foreign particles into the
`
`eye?
`
` MR. DAVIS: Object to form.
`
` THE WITNESS: I think some assume and
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`presume that, thereby implying potentially a safety
`
`benefit. I'm not aware of any data that
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`substantiates that.
`
`BY MS. PATEL:
`
` Q. So you don't assume that?
`
` MR. DAVIS: Objection.
`
`BY MS. PATEL:
`
` Q. Correct?
`
` MR. DAVIS: Misstates prior testimony.
`
` THE WITNESS: I do assume that fewer steps
`
`are a good thing for a number of reasons. I cannot
`
`~7 Trustpoint.One Alderson.
`
`www.trustpoint.one
`www.aldersonreporting.com
`
`800.FOR.DEPO
`(800.367.3376)
`
`Novartis Exhibit 2272.0012
`Regeneron v. Novartis, IPR2021-00816
`
`