Transcript of Sailaja Machiraju
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`Date: April 29, 2016
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`Case: Altaire Pharmaceuticals, Inc. -v- Paragon Bioteck, Inc. (PTAB)
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`Planet Depos
`Phone: 888-433-3767
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`
`Worldwide Court Reporting | Interpretation | Trial Services
`
`Exhibit 1034, Page 1 of 90
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`
`
`Date: April 29, 2016
`
`Case: Altaire Pharmaceuticals, Inc. -v- Paragon Bioteck, Inc. (PTAB)
`
`Planet Depos
`Phone: 888-433-3767
`Fax: 888-503-3767
`Email: transcripts@planetdepos.com
`Internet: www.planetdepos.com
`
`Worldwide Court Reporting | Interpretation | Trial Services
`
`Exhibit 1034, Page 1 of 90
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` UNITED STATES PATENT AND TRADEMARK OFFICE
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` BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`1
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` - - - - - - - - - - - - - -x
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`ALTAIRE PHARMACEUTICALS, :
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`INC. :
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` Petitioner, : Case PGR2015-00011
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` v. : Patent No. 8,859,623 B1
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`PARAGON BIOTECK, INC., :
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` Patent Owner.
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` - - - - - - - - - - - - - -x
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` Deposition of Sailaja Machiraju
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` Seattle, Washington
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` Friday, April 29, 2016
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` 9:00 a.m.
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` Job No.: 108299
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` Pages: 1 - 74
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` Reported By: Diane Rugh, CCR No. 2399, CRR
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`Exhibit 1034, Page 2 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Deposition of SAILAJA MACHIRAJU, held at the
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` offices of:
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`2
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` WILSON SONSINI GOODRICH & ROSATI
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` 701 Fifth Avenue, Suite 5100
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` Seattle, Washington 98104-7036
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` 206.883.2500
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` Pursuant to notice, before Diane Rugh, CCR No.
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` 2399, CRR.
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`Exhibit 1034, Page 3 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` A P P E A R A N C E S
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` ON BEHALF OF PETITIONER:
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` JONATHAN W.S. ENGLAND, ESQUIRE
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` BLANK ROME LLP
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` 1825 Eye Street NW
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` Washington, DC 20006-5403
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` 202.420.2201
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` ON BEHALF OF PATENT OWNERS:
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` ANDREW BROWN, ESQUIRE
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` SONJA GERRARD, ESQUIRE
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` WILSON SONSINI GOODRICH & ROSATI
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` 701 Fifth Avenue, Suite 5100
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` Seattle, Washington 98104-7036
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` 206.883.2500
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` ALSO PRESENT:
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` Travis L. Sydow, Paragon BioTeck
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`Exhibit 1034, Page 4 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` C O N T E N T S
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`EXAMINATION OF SAILAJA MACHIRAJU PAGE
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`Mr. England 5
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` E X H I B I T S
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` (Previously marked.)
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`Exhibit 1001U.S. Patent 8,859,623 21
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`Exhibit 2008USP Monograph for Phenylephrine 30
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` Hydrochloride Injection
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`Exhibit 2009USP Monograph for Phenylephrine 30
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` Hydrochloride Nasal Jelly
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`Exhibit 2010General Chapter 621, 30
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` Chromatography
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`Exhibit 2021Declaration of Sailaja Machiraju 14
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`Exhibit 2036Resume of Sailaja Machiraju 14
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`Exhibit 2040Sample Information, 59
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` Phenylephrine USP
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`Exhibit 1034, Page 5 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` P R O C E E D I N G S
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` Whereupon,
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` SAILAJA MACHIRAJU
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` being first duly sworn or affirmed to testify to the
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` truth, the whole truth, and nothing but the truth,
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` was examined and testified as follows:
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` EXAMINATION
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` BY MR. ENGLAND:
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` Q Could you please state your name and address
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` for the record.
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` A My name is Sailaja. I live in Portland,
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` 16275 Northwest Schendel, S-c-h-e-n-d-e-l, Avenue,
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` 97006. Portland, Beaverton.
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` MR. BROWN: Can we put appearances on the
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` record?
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` MR. ENGLAND: Sorry for that. My name is
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` Jonathan England, I'm from Blank Rome for Altaire
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` Pharmaceuticals.
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` MR. BROWN: Andy Brown of Wilson Sonsini
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` Goodrich & Rosati on behalf of the patent owner and
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` the witness. With me are Sonja Gerrard and Mike
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`Exhibit 1034, Page 6 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Rosato, both also of Wilson Sonsini, and Travis
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` Sydow who in-house counsel for Paragon.
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` Q Ms. Machiraju, is that a good pronunciation
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`6
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` of your name?
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` A Yes, absolutely.
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` Q Okay. Have you been deposed before?
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` A No.
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` Q So I'm going to set some ground rules for
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` today. I'm going to ask you some questions and
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` hopefully you can give me some answers to the best
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` of your ability. Is that okay?
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` A Okay.
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` Q If at any time you do not understand my
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` questions, just let me know and I'll try to rephrase
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` it in a more appropriate manner.
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` A Okay.
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` Q If you're not done with an answer and I
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` continue to the next question, just let me know and
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` I'll let you complete your answer. It's best for
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` the record if we don't speak over each other.
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` A Sure.
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` Q And then if possible, all your answers
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`Exhibit 1034, Page 7 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` should be audible so the court reporter can take it
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` down and accurately represent what goes on today.
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` A Okay.
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` Q And you understand you're under oath today?
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` A Yes.
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` Q Is there any reason you're not able to give
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` accurate and truthful testimony today?
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` A No.
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` Q Finally, if you need to take a break, just
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` let me know. I would ask that you finish your
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` answer and then we'll take a break. But also in
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` these proceedings you're limited to your discussions
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` with counsel during the break and you should not
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` speak of anything of the substance of your
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` testimony.
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` A I understand, okay.
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` Q Going to a few housekeeping matters, what is
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` your understanding of why you're here today?
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` A I'm here for the deposition for my patent
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` that we have filed.
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` Q So today we're here to discuss your
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` declaration that was submitted in accordance with
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`Exhibit 1034, Page 8 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` the post-grant review of your patent. And that
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` would be patent 8,859,623 which I will refer to as
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` the '623 patent, if that's okay with you.
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` A Yes.
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` Q When were you first contacted by Paragon
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` regarding this post-grant review, just the
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` post-grant review proceeding?
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` MR. BROWN: Objection.
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` Q You can answer.
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` A I don't remember the exact date.
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` Q Okay. Who contacted you about submitting a
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` declaration for this post-grant review?
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` MR. BROWN: I'd just caution you not to
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` reveal the substance of any conversations you may
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` have had with any of the lawyers for Paragon, but
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` you can answer the question that was asked.
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` THE WITNESS: Paragon.
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` Q Paragon, okay.
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` A Yeah.
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` Q And you were contacted by in-house counsel
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` of Paragon?
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` A Yes.
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`Exhibit 1034, Page 9 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q So in preparation for today, what have you
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` done to get ready for this deposition?
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` MR. BROWN: Objection. I'd just caution you
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` not to reveal the substance of any conversations you
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` may have had with counsel.
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` THE WITNESS: Okay. Paragon's attorney and
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` Wilson Sonsini attorney.
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` MR. BROWN: When she asks you to repeat
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` something, she's not asking for clarification, she's
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` asking for actually what you said so she can take
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` what you had said previously.
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` THE WITNESS: Okay.
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` MR. BROWN: It's a little bit different than
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` a normal conversation.
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` THE WITNESS: Okay.
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` Q In preparation for this deposition did you
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` review the '623 patent?
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` A Yes.
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` Q And who did you meet with in preparation for
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` this deposition?
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` A Paragon's attorney and the WSGR attorney.
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` Q And when did you meet with them?
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`Exhibit 1034, Page 10 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` A Yesterday.
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` Q And for about how long?
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` A Just a couple of -- maybe one to two hours.
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` Q And in preparation for this deposition have
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` you spoken with Dr. Lalic?
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` A No.
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` Q Have you ever spoken with Dr. Lalic?
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` A No.
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` Q And what documents have you gone over in
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` preparation for this deposition?
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` A My declaration.
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` Q Solely your declaration?
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` A Yes.
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` Q Did you review any of the exhibits that you
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` discussed in your declaration?
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` A Yes. That was the study that we have, not
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` the exhibits that I have. The study that we had
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` conducted, I have.
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` Q Have you reviewed the petition filed for the
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` post-grant review?
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` A No.
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` Q And have you reviewed any other declarations
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`Exhibit 1034, Page 11 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` or deposition transcripts?
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` A No.
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` Q And in preparation did you review the USP
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`11
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` Monograph?
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` A Yes.
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` Q And did you review the USP General Chapter
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` 621 on Chromatography?
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` A No.
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` Q And have you recently reviewed the results
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` generated by Encompass?
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` A Yes.
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` Q And are you being compensated beyond your
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` normal salary for your deposition testimony here
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` today?
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` A No.
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` Q Are you being compensated for the
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` declaration you submitted beyond your standard
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` compensation?
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` A No.
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` Q Do you expect to be compensated for either
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` of these?
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` A No.
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`Exhibit 1034, Page 12 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q Do you stand to benefit in any way in the
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`12
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` outcome of this proceeding?
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` MR. BROWN: Objection.
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` THE WITNESS: No.
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` Q Let me clarify. Do you expect to gain
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` monetary benefit if the patent is determined valid
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` at the end of this proceeding?
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` A Can you please phrase it in some other
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` words?
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` Q Will you receive either a bonus or monetary
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` compensation at the end of this proceeding, the
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` post-grant review challenge?
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` A No.
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` Q Do you have any remaining ownership interest
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` in the '623 patent?
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` A No.
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` Q Do you receive any royalties derived from
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` products covered by the '623 patent?
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` A No.
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` Q Do you have any ownership interest in
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` Paragon?
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` A No.
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`Exhibit 1034, Page 13 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q Who wrote the declaration?
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` A I drafted my declaration and I submitted the
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` information required to be put in my declaration,
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` and I submitted that to WSGR. And they compiled it
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` and then they sent it back to me, I reviewed it and
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` signed off on it.
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` Q Okay. And have any of your opinions changed
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` since you signed your declaration?
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` A No.
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` Q Have you ever testified at trial before?
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` A Sorry?
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` Q Have you ever testified at trial before?
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` A No.
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` Q And have you ever worked in the role of a
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` consulting or testifying witness?
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` A Can you please repeat the question?
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` Q Have you ever essentially been paid to
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` consult about technology or testify according to a
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` District Court proceeding?
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` A No.
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` Q Going forward, I'm going to hand you what
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` has been previously marked as Exhibits 2021 and
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`Exhibit 1034, Page 14 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` 2036.
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` (Exhibits 2021 and 2036, previously
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` marked, are attached to the transcript.)
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` Q Starting with the document marked Exhibit
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` 2021, do you recognize this document?
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` A Yes.
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` Q What do you recognize it to be?
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` A That's my declaration.
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` Q Have you reviewed it to authenticate it's
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` your declaration?
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` A Yes.
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` Q Do you recognize the document labeled
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` Exhibit 2036?
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` A Yes.
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` Q And what do you recognize that document to
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` be?
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` A This is my resume.
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` Q Are there any notable changes since that was
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` submitted?
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` A No.
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` Q Turning to Page 5 of your declaration, the
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` declaration is dated February 10, 2016. Is this the
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`Exhibit 1034, Page 15 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` date you completed and signed the declaration?
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` A Yes.
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` Q Approximately when was the first version of
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` the declaration you completed? You said you
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` completed a declaration and submitted it to Wilson
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` Sonsini.
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` A Yes.
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` Q Do you know the date?
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` A I don't remember the date.
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` Q Do you know if it was the week -- or do you
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` know if it was in February or in January?
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` A It was in February.
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` Q And did any of your opinions change from the
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` time you submitted your declaration until --
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` A No.
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` MR. BROWN: Let him finish his question
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` before you answer.
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` Q Turning to, I believe it's Page 2 of your
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` declaration, what is your current role at Paragon?
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` And when I say Paragon, you understand it to be
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` Paragon Bioteck; correct?
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` A Yes. I'm the senior research associate at
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`Exhibit 1034, Page 16 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Paragon.
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` Q What does that role include?
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` A That includes taking care of all the
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` in-house research activities as well as contacting
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` the contract manufacturers to find out and designing
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` the experiments and the protocols, and reviewing the
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` reports.
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` Q Let's try to break that down. So first you
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` said that you oversee all research.
`
` A Yes.
`
` Q And so that's all research across Paragon?
`
` A Yes.
`
` Q And do you do any of that research yourself
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` or do you have a team?
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` A If required I do it myself. We have a team
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` as well. And then we -- if required we find out the
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` contact of such organizations and we design the
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` study required based on Paragon's requirements.
`
` Q So Paragon has in-house testing capabilities
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` to do this type of testing that you talk about?
`
` A Yes. We perform it at university if
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` required, Portland State University.
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`Exhibit 1034, Page 17 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q And then you say that you also contract out
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`17
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` research?
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` A Yes.
`
` Q And how do you decide when to contract out
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` research?
`
` A So depends on what study we want to perform.
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` And we have a -- it depends on the study
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` requirements and the past experience of Paragon as
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` well as we find out if -- we check the contract
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` manufacturers and we check if they are compliant
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` with CGMB and if they follow all the regulatory
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` requirements. Our quality department does all those
`
` checks.
`
` Q Are you involved at all in the manufacture
`
` and distribution of pharmaceutical drugs?
`
` A No.
`
` Q You're only on the research side of it?
`
` A Yes.
`
` Q And so generally what are the subjects of
`
` the research that you oversee at Paragon?
`
` A Mostly the GMB part of the regulatory
`
` applications, I take care of that. That also
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`Conducted on April 29, 2016
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` includes the analytical testing part.
`
` Q By saying you "take care," you say you
`
` either do the in-house research or in-house
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` experiments or you design it to be contracted out?
`
` A Yes.
`
` Q And how do you select contract research
`
` organizations?
`
` A We have a quality department. They do their
`
` checks and then they certify the contract
`
` researcher. And then we -- that's how we qualify
`
` the contract research organization.
`
` Q What type of checks are you talking about?
`
` A They perform -- they certify them if they
`
` are compliant with the regulatory bodies, and then
`
` they see if they follow all the CGMP regulations and
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` if they are certified bodies for performing the
`
` required tests.
`
` Q And who does that at Paragon?
`
` A Paragon's quality department, quality
`
` assurance.
`
` Q Are you in charge of the quality assurance
`
` department?
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`Exhibit 1034, Page 19 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` A No, I'm not in charge.
`
` Q Okay. So looking at Paragraph 7 of your
`
` declaration you say that, you state, "I also direct
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`19
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` experiments performed ..."
`
` What does directing experiments entail?
`
` A That means that I contact the contract
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` research organization of what needs to be done,
`
` required in the study.
`
` Q Is that an oral or a written direction?
`
` A That could be both depending on the
`
` requirement of the study. Mostly it would be a
`
` study design protocol from Paragon end, and then we
`
` submit that to the contract research organization
`
` and they design a protocol for the study. We review
`
` it and then we approve the study, myself and the
`
` quality department, we approve it. And then the
`
` study starts.
`
` Q So would it be fair to characterize that as
`
` you submit the initial research design, they submit
`
` a procedure to do it?
`
` A Yes.
`
` Q And then you approve it?
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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`20
`
` A Yes.
`
` Q Okay. And how often do you do these -- or
`
` submit research to contract research companies
`
` annually, we'll say?
`
` A Quite often.
`
` Q Is quite often 10 to 15 or 50 times?
`
` A Fifty.
`
` Q Fifty?
`
` A Yeah.
`
` Q Okay. And do you have any interaction with
`
` suppliers of either the pharmaceutical drugs for the
`
` studies?
`
` A If required.
`
` Q When would it be required?
`
` A If we are trying to establish new
`
` contractors or new suppliers for our products.
`
` Q Okay. And how often do you revalidate
`
` suppliers or contractors?
`
` A Every year. And that's taken care of
`
` quality assurance department.
`
` (Exhibit 1001, previously marked, is
`
` attached to the transcript.)
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`Exhibit 1034, Page 21 of 90
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`
`
`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
`
` Q Okay. I'm handing to you what has been
`
` previously marked Exhibit 1001. Do you recognize
`
`21
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` the document labeled Exhibit 1001?
`
` A Yes.
`
` Q What do you recognize it to be?
`
` A This is the patent that we have filed.
`
` Q Take a second look through it to make sure
`
` that it's there in its entirety.
`
` Turning to Page 1 of the document, you are a
`
` named inventor of the '623 patent; correct?
`
` A Yes.
`
` Q In your opinion, what is the general subject
`
` matter of the '623 patent?
`
` MR. BROWN: Objection, scope.
`
` THE WITNESS: This is outside the scope of
`
` my declaration.
`
` Q You stated that you're a named inventor. I
`
` just want to kind of have your general idea of what
`
` the patent is about.
`
` MR. BROWN: Objection, scope.
`
` MR. ENGLAND: Withdrawn.
`
` Q What aspect of the '623 patent did you
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`Exhibit 1034, Page 22 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` contribute to inventing?
`
` MR. BROWN: Objection, scope.
`
` Q Please answer.
`
` A The research part of it.
`
` Q Could you please be a little bit more
`
` specific?
`
` MR. BROWN: Same objection.
`
` THE WITNESS: The analytical testing.
`
` Q When you say analytical testing, that's
`
` what's generated by the figures?
`
` MR. BROWN: Same objection.
`
` THE WITNESS: That's outside the scope of
`
` the --
`
` Q I'm just trying to figure out when you say
`
` you're a named inventor what part of the patent
`
` you're an inventor of.
`
` MR. BROWN: She said she's a named inventor.
`
` That means her name is on the front of the patent.
`
` That's pretty straightforward. You can have a
`
` little bit of latitude, but --
`
` MR. ENGLAND: This is not going to go deep
`
` into the patent. I just generally want to know what
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`Exhibit 1034, Page 23 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` part she contributed to the patent.
`
` MR. BROWN: I think she's answered that.
`
` Q So you did the analytical research of the
`
`23
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` patent?
`
` A Yes.
`
` Q Okay. And then turning to Page 11 of that
`
` document, down to Column 12, Line 39, it's the first
`
` claim.
`
` What part of the analytical research was
`
` involved in that claim?
`
` MR. BROWN: Objection. Scope, relevance.
`
` THE WITNESS: It's not part of my
`
` declaration. Outside the scope.
`
` Q I still need an answer.
`
` MR. BROWN: Answer to the best of your
`
` ability.
`
` Q You can say very generic.
`
` A I would prefer not to. It's outside the
`
` scope of my declaration.
`
` Q Is there any answer you can give me?
`
` A No.
`
` Q Okay. Let's go back to your declaration.
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`Exhibit 1034, Page 24 of 90
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`
`
`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
`
` On Page 2, Paragraph 8, you state that you selected
`
` Encompass Pharmaceutical Services, Incorporated. If
`
` it's okay with you I'll just refer to it as
`
`24
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` Encompass.
`
` A Yes.
`
` Q What type of services does Encompass
`
` provide?
`
` A It provides the GMP analytical services for
`
` the pharmaceuticals.
`
` Q Does it provide a broad spectrum of testing
`
` analysis for pharmaceutical companies?
`
` A Yes.
`
` Q And how did you select Encompass for this
`
` study?
`
` A We have a past relationship with Encompass,
`
` and then our quality assurance department does all
`
` the review of the compliances and all that, and
`
` makes sure that they are compliant with CGMP
`
` regulations.
`
` Q And when you say the quality assurance
`
` department makes sure they're compliant with all the
`
` GMP practices, do you have firsthand knowledge of
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`Exhibit 1034, Page 25 of 90
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`
`
`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` that or is that from the quality assurance
`
` department?
`
` A I also would have some knowledge of that.
`
` Q And where did you obtain that knowledge
`
` from?
`
` A With my experience. With my experience in
`
` the pharmaceutical industry.
`
` Q Could you please elaborate on that?
`
` A Can you please again --
`
` Q You say that your experience qualifies you
`
` as being GMP compliant. How does your experience in
`
` the pharmaceutical industry --
`
` A Because I have worked for a lot of GMP
`
` related compounds in my past, and then I have worked
`
` for API manufacturers, and I know the regulations
`
` that are required for being compliant with CGMP.
`
` Q And have you seen the labs at Encompass to
`
` assure that they are compliant with GMP?
`
` A I have not.
`
` Q And have you seen any of the procedures or
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` validation that established they're compliant?
`
` A Yes.
`
`PLANET DEPOS
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`Exhibit 1034, Page 26 of 90
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`
`
`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q And when did you see that?
`
` A When we perform the study they submit all
`
` the necessary documents with the report.
`
` Q And you reviewed those documents?
`
` A Yes.
`
` Q And I presume that also includes the
`
` International Conference of Harmonisation of
`
` Technical Requirements for Registration for
`
` Pharmaceuticals for Human Use and the United States
`
` Pharmacopeial Convention Guidelines?
`
` A They submit all the required documents
`
` necessary for performing the particular study.
`
` Q And is that before or after they perform the
`
` study?
`
` A It's before. They state that in the
`
` protocol what are the necessary specifications or
`
` the regulations that they follow for that required
`
` study.
`
` Q So that would have been after you submitted
`
` the study to them and then they would respond with
`
` the protocols when they submit that information?
`
` A Yes.
`
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`Exhibit 1034, Page 27 of 90
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`
`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q Okay. And do you have any other studies
`
` with Encompass currently pending?
`
` A That's outside the scope of my declaration.
`
` Q Your declaration talks about, it says in
`
` Paragraph 9, "We have used Encompass in the past and
`
` are confident in the quality of analytical chemistry
`
` services they provide." So I'm just trying to see
`
` how often you use them.
`
` A We do use them a lot. There are a lot of
`
` studies that are currently ongoing with Encompass.
`
` Q And approximately how many companies do you
`
` use for research?
`
` A It depends on -- for of the analytical
`
` testing it would be only Encompass. And it depends
`
` on the kind of research that we are performing.
`
` Q Going back to that same sentence, "We have
`
` used Encompass in the past," how are you confident
`
` in the quality of analytical chemistry services they
`
` provide?
`
` A I have reviewed the results and the
`
` protocols and the testing that they do, so I am
`
` confident on their results.
`
`PLANET DEPOS
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`Exhibit 1034, Page 28 of 90
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`
`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` Q And do you do any independent validation of
`
` the results?
`
` A Encompass does the validation of their test
`
` results.
`
` Q Does Paragon do any independent validation
`
` of the testing and results?
`
` A No.
`
` Q Why did you not include the validation and
`
` the GMP practices in the papers we discussed earlier
`
` in the submission accompanying your declaration?
`
` MR. BROWN: Objection, foundation.
`
` THE WITNESS: That's outside the scope of my
`
` declaration and that's company's proprietary
`
` information that I would not want to disclose that.
`
` Q So you testified that it conforms to Good
`
` Manufacturing Practices and you state that they
`
` provide documents supporting that. I'm wondering,
`
` or my question is, why didn't those documents
`
` accompany your declaration to establish that they
`
` actually conformed to the report?
`
` MR. BROWN: Objection, form.
`
` THE WITNESS: That's outside the scope of
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`Exhibit 1034, Page 29 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` the declaration.
`
` Q I don't believe that's outside the scope of
`
` the declaration. You are testifying in your
`
` declaration that the laboratories conform to Good
`
` Manufacturing Practice. And I'm inquiring why you
`
` didn't submit the documents that show as the basis
`
` of your statement with the declaration.
`
` A I --
`
` MR. BROWN: Objection. And please answer to
`
` the best of your ability.
`
` THE WITNESS: Anything that would have any
`
` proprietary information of Paragon or Encompass, I
`
` am not allowed to submit those.
`
` MR. ENGLAND: I think this would be a good
`
` time for our first break.
`
` MR. BROWN: Okay.
`
` (Short break.)
`
` Q Going to Paragraph 10 of your declaration,
`
` Page 2, is it a fair characterization to say that
`
` the purpose of the experiment you directed Encompass
`
` to perform was limited to whether or not the
`
` specific HPLC method described in USP the Monograph
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`Exhibit 1034, Page 30 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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` for identification of R-form phenylephrine
`
` hydrochloride was capable of separating
`
` phenylephrine enantiomers?
`
` A Yes.
`
` Q I'm handing you three documents previously
`
` labeled Exhibit 2008, Exhibit 2009 and Exhibit 2010.
`
` (Exhibits 2008, 2009 and 2010, previously
`
` marked, are attached to the transcript.)
`
` Q Here is 2008, here is Exhibit 2009, and here
`
` is Exhibit 2010.
`
` Starting with Exhibit 2008, have you seen
`
` this document before?
`
` A Yes.
`
` Q Just for your point, this is the
`
` Phenylephrine Hydrochloride Injection document?
`
` A Yeah.
`
` Q Okay. What is this document?
`
` A This is the USP Monograph for phenylephrine
`
` injection.
`
` Q And how do you know this?
`
` A This is the standard.
`
` Q Going to Exhibit 2009, have you seen this
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`Exhibit 1034, Page 31 of 90
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`Deposition of Sailaja Machiraju
`Conducted on April 29, 2016
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`31
`
` document before?
`
` A Yes.
`
` Q What is this document?
`
` A This is the USP Monograph for Phenylephrine
`
` Hydrochloride Nasal Jelly.
`
` Q And could you please tell me the difference
`
` between Exhibit 2008 and 2009? I'm sorry, let me be
`
` more specific.
`
` Could you please tell me the difference
`
` between phenylephrine hydrochloride nasal jelly and
`
` phenylephrine hydrochloride injection?
`
` A Both are different formulations.
`
` Q How are they different?
`
` A One is injection, the other one is nasal
`
` jelly.
`
` Q And so what is the formulation for
`
` injection?
`
` A I do not have that information.
`
` Q And what is it for nasal jelly?
`
` A I do not have that information either.
`
` Q So are these for different
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