Deposition of
`Nicholas S. Hill, M.D.
`October 17, 2021
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`UTC
`vs.
`Liquidia Technologies, Inc.
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`IPR2021-00406
`United Therapeutics EX2055
`
`
`Nicholas S. Hill, M.D.
`October 17, 2021
`
`UTC
`vs.
`Liquidia Technologies, Inc.
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`IPR2021-00406
`United Therapeutics EX2055
`
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`
`
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`Nicholas S. Hill, M.D.Nicholas S. Hill, M.D.
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`UTC vs.UTC vs.
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`Liquidia Technologies, Inc.Liquidia Technologies, Inc.
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`·1· · · · · · · · · · · ·IPR2021-00406
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`·2· · · · · · · ·U.S. Patent No. 10,716,793 B2
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`·3· · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
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`·4· · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·5· · · · · · · ·LIQUIDIA TECHNOLOGIES, Inc.,
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`·6· · · · · · · · · · · · Petitioner,
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`·7· · · · · · · · · · · · · · v.
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`·8· · · · · · ·UNITED THERAPEUTICS CORPORATION,
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`·9· · · · · · · · · · · ·Patent Owner.
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`10· · · · · · · · · · · _______________
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`11· · · · · · · · · · · ·IPR2021-00406
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`12· · · · · · · · U.S. Patent No. 10,716,793
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`13· ·------------------------------------------------------
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`14· · · · · · CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`15· · · · · ·DEPOSITION OF NICHOLAS S. HILL, M.D.
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`16· · · · · · · · ·SUNDAY, OCTOBER 17, 2021
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`17· · · · · · · · · 7:00 a.m. - 12:43 p.m.
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`18
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`19· · · · ·Reported Remotely through Videoconference
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`20
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`21· ·Reported by: Patricia Y. Schuler, CSR No. 11949
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`22· ·Job No. 10090045
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`·1· · · · · · · · · · · ·IPR2021-00406
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`·2· · · · · · · ·U.S. Patent No. 10,716,793 B2
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`·3· · · · ·UNITED STATES PATENT AND TRADEMARK OFFICE
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`·4· · · · ·BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`·5· · · · · · · ·LIQUIDIA TECHNOLOGIES, Inc.,
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`·6· · · · · · · · · · · · Petitioner,
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`·7· · · · · · · · · · · · · · v.
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`·8· · · · · · ·UNITED THERAPEUTICS CORPORATION,
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`·9· · · · · · · · · · · ·Patent Owner.
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`10· · · · · · · · · · · _______________
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`11· · · · · · · · · · · ·IPR2021-00406
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`12· · · · · · · · U.S. Patent No. 10,716,793
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`13· ·------------------------------------------------------
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`14· · · · DEPOSITION of NICHOLAS S. HILL, M.D., taken in
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`15· ·the above-entitled matter before PATRICIA Y.
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`16· ·SCHULER, Certified Court Reporter, CSR No. 11949,
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`17· ·taken via remote video teleconference on Sunday,
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`18· ·October 17, 2021, commencing at 7:00 a.m.
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`·1· ·APPEARANCES:
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`·2· ·Attorneys for the Plaintiff:
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`·3· · · · · · ·McDERMOTT WILL & EMERY LLP
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`·4· · · · · · ·BY:· DOUGLAS CARSTEN, ESQ.
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`·5· · · · · · ·BY:· JIAXIAO, ZHANG, ESQ.
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`·6· · · · · · ·18565 Jamboree Road
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`·7· · · · · · ·Suite 250
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`·8· · · · · · ·Irvine, California 92612-2565
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`·9· · · · · · ·(949) 989-6361
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`10· · · · · · ·Jzhang@mwe.com
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`11· ·Attorneys for the Defendant:
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`12· · · · · · ·COOLEY LLP
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`13· · · · · · ·BY:· SANYA SUKDUANG, ESQ.
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`14· · · · · · ·Washington, DC
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`15· · · · · · ·1299 Pennsylvania Avenue, NW
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`16· · · · · · ·Suite 700
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`17· · · · · · ·Washington, D.C. 20004-2400
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`18· · · · · · ·(202) 776.2049
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`19· · · · · · ·SSukduang@cooley.com
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`20· · · · · · · (202) 776.2049
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`21· ·ALSO PRESENT:
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`22· · · · · · ·AMY MAHAN, ESQ.
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`23· · · · · · ·SPENCER BENVENISTE, Legal Video Specialist
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`·1· · · · · · · · · · · · ·I-N-D-E-X
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`·2· ·WITNESS· · · · · · · · · · · · · · · · · EXAMINATION
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`·3· ·NICHOLAS S. HILL, M.D.· · · · · · · · · · · · · PAGE
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`·4· ·MR. CARSTEN· · · · · · · · · · · · · · · · · · · · 5
`· · ·MR. SUKDUANG· · · · · · · · · · · · · · · · · · ·152
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`·6
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`·7· · · · · · · · · · · E X H I B I T S
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`·8· ·EXHIBIT NO.· · · · · DESCRIPTION· · · · · · · · PAGE
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`·9· ·Exhibit 1003· Curriculum Vitae of Nicholas· · · · 11
`· · · · · · · · · ·S. Hill, M.D. (previously marked)
`10
`· · ·Exhibit 1002· Declaration of Nicholas Hill,· · · ·31
`11· · · · · · · · ·M.D.
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`12· ·Exhibit 1029· Information sheet regarding· · · · ·46
`· · · · · · · · · ·Ventavis
`13
`· · ·Exhibit 1009· Articles from the Annals of· · · · ·64
`14· · · · · · · · ·Internal Medicine dated
`· · · · · · · · · ·January 17, 2006
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`· · ·Exhibit 1008· Abstracts from the Journal of the· ·70
`16· · · · · · · · ·American Heart Association
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`17· ·Exhibit 1007· Article entitled "European Heart· · 79
`· · · · · · · · · ·Journal"
`18
`· · ·Exhibit 2036· McLaughlin article regarding· · · ·105
`19· · · · · · · · ·efficacy and safety of
`· · · · · · · · · ·Treprostinil
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`·1· · · · · · · · OCTOBER 17, 2021; 7:00 a.m.
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`·2
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`·3· · · · · · · · · NICHOLAS S. HILL, M.D.
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`·4· · having been administered an oath, was examined and
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`·5· · · · · · · · · ·testified as follows:
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`·6
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`·7· · · · · · · · · · · · EXAMINATION
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`·8· ·BY MR. CARSTEN:
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`·9· · · · Q.· ·Good morning, Dr. Hill.
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`10· · · · A.· ·Good morning.
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`11· · · · Q.· ·Have you ever had your deposition taken
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`12· ·before?
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`13· · · · A.· ·I have.
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`14· · · · Q.· ·You probably know the ground rules, but
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`15· ·first let me introduce myself.· My name is
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`16· ·Doug Carsten.· I represent United Therapeutic in
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`17· ·this litigation -- in this inter partes review
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`18· ·matter.· And I'm going to be asking you a series of
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`19· ·questions today.
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`20· · · · · · ·Do you understand that?
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`21· · · · A.· ·Yes.
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`22· · · · Q.· ·And you understand that you are under
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`23· ·oath, the same as if you were testifying in front
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`24· ·of a judge or jury, correct?
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`25· · · · A.· ·Yes.
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`·1· · · · Q.· ·And is there anyone in the room with you?
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`·2· · · · A.· ·No.
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`·3· · · · Q.· ·Where are you located?
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`·4· · · · A.· ·At my home in -- outside of Boston.
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`·5· · · · Q.· ·Okay.· You said you were going to run off
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`·6· ·and grab a binder before we began the deposition.
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`·7· · · · · · ·What's in that binder?
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`·8· · · · A.· ·Well, there are a number of exhibits. I
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`·9· ·can go through them and just tell you what they are
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`10· ·if you like.
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`11· · · · Q.· ·My concern -- I want to make sure, one,
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`12· ·that you don't have any markings on them.· There
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`13· ·are no handwritten notes on any of them?
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`14· · · · A.· ·No.
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`15· · · · Q.· ·And I presume that the materials include
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`16· ·your declaration plus a number of the exhibits that
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`17· ·are cited therein?
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`18· · · · A.· ·That's correct.
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`19· · · · Q.· ·Anything in that binder apart from your
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`20· ·declaration or materials that are cited therein,
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`21· ·Dr. Hill?
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`22· · · · A.· ·I don't believe so.
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`23· · · · Q.· ·Do you have other --
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`24· · · · · · ·MR. SUKDUANG:· I'm sorry, Doug.· Just --
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`25· ·there is the institution decision.· Just for
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`·1· ·clarity's sake I wanted to let you know that.
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`·2· · · · · · ·MR. CARSTEN:· I appreciate that, Sanya.
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`·3· ·BY MR. CARSTEN:
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`·4· · · · Q.· ·So apart from the institution decision as
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`·5· ·well, are there any other materials that are in
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`·6· ·that binder that are not cited or your declaration?
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`·7· · · · A.· ·Not to my knowledge.
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`·8· · · · Q.· ·Thank you.· Do you have any other
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`·9· ·materials in the room with you; written materials?
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`10· · · · A.· ·I have my cell phone.· That's it.
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`11· · · · Q.· ·Any other open areas of communication?
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`12· · · · A.· ·No.
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`13· · · · Q.· ·Is there any reason that you can't
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`14· ·testify truthfully or accurately today?
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`15· · · · A.· ·No.
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`16· · · · Q.· ·You're not under the influence of
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`17· ·medication, alcohol, or drugs that would impair
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`18· ·your ability to testify truthfully and completely?
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`19· · · · A.· ·None whatsoever.· Not even coffee.
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`20· · · · Q.· ·Wow.· Well, good for you.· I can't say
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`21· ·the same.
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`22· · · · · · ·I am going to endeavor today, Dr. Hill,
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`23· ·to give you clear and complete questions.· Despite
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`24· ·my best efforts, I may fail in that endeavor.
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`25· · · · · · ·If you don't understand one of my
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`·1· ·questions, just let me know and I'll do my best to
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`·2· ·rephrase or figure out what about the question that
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`·3· ·you don't understand and try to it clear up; is
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`·4· ·that fair?
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`·5· · · · A.· ·That's fair.
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`·6· · · · Q.· ·And if you go ahead and give me an answer
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`·7· ·to a question, we're all going to assume that you
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`·8· ·understood that question and answered that
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`·9· ·question; is that fair as well?
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`10· · · · A.· ·Yes.
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`11· · · · Q.· ·We're going to try -- so this is not
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`12· ·videotaped, so some of the crosstalk issues are a
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`13· ·bit mitigated, but we still do have a court
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`14· ·reporter who can only hear one person at a time,
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`15· ·and so if you would do your level best and wait
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`16· ·until I've finished my question and then begin your
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`17· ·answer, and I'll do my level best to let you finish
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`18· ·your answer before I start my next question.· That
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`19· ·will make life easier for both of us, and most
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`20· ·importantly for the court reporter.
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`21· · · · · · ·Can we agree to try our best to do that
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`22· ·today?
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`23· · · · A.· ·I will try.
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`24· · · · Q.· ·I will as well.
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`25· · · · · · ·How did you prepare for your deposition
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`·1· ·today?
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`·2· · · · A.· ·I reviewed the exhibits in the binder,
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`·3· ·including my declaration and the associated
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`·4· ·exhibits, the patents, '212, '793.· Materials
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`·5· ·relating to some abstracts that we'll certainly go
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`·6· ·into.· And there are some other documents in the
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`·7· ·file, but I reviewed -- I reviewed all the
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`·8· ·exhibits.
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`·9· · · · · · ·I spent time with attorney in preparation
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`10· ·that I would estimate is in the range of seven
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`11· ·hours.
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`12· · · · Q.· ·Was that seven hours with the attorney
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`13· ·yesterday?
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`14· · · · A.· ·No.· We started last weekend, and we
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`15· ·spent couple hours of -- on each day last weekend,
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`16· ·and about three hours yesterday.
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`17· · · · Q.· ·And what attorney or attorneys were
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`18· ·present, just by name if you remember them?
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`19· · · · A.· ·The only one I prepared with face to face
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`20· ·was Sanya, and there were -- Ms. Deepa Kannappan.
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`21· ·I don't have her last name down quite right, but
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`22· ·Deepa was communicating via Zoom yesterday for
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`23· ·probably about an hour.
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`24· · · · Q.· ·So the couple of hours each day last
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`25· ·weekend were with Sanya Sukduang; is that right?
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`·1· · · · A.· ·Correct.
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`·2· · · · Q.· ·And the three hours yesterday were also
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`·3· ·with Sanya, as well as for about an hour with
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`·4· ·Deepa; is that correct?
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`·5· · · · A.· ·That is correct.
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`·6· · · · Q.· ·Apart from those meetings with counsel,
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`·7· ·did you talk to anybody else in connection with
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`·8· ·preparing for this deposition?
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`·9· · · · A.· ·No.
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`10· · · · Q.· ·This is not intended to be an endurance
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`11· ·contest, nor is it intended to be a bladder-buster
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`12· ·party.· So to the extent that you need a break at
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`13· ·any point, just let me know and we'll do our best
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`14· ·to accommodate that; is that okay?
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`15· · · · A.· ·That's fine.· Thank you for that.
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`16· · · · Q.· ·And the only restriction there is if
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`17· ·there is a question pending, you have finish and
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`18· ·complete your answer to that question before we can
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`19· ·go ahead and take a break.
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`20· · · · · · ·And I'll endeavor, pretty much on the
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`21· ·hour, hour and a half or so, if you have not called
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`22· ·for one before then to probably take a break, if
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`23· ·that is okay.
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`24· · · · A.· ·That's fine.
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`25· · · · Q.· ·So the way that I would like to try to
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`·1· ·handle exhibits -- we have this -- we're
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`·2· ·participating on this remotely through Zoom.· We
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`·3· ·can pull documents up and cede control to you to
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`·4· ·have it on the screen so we're both looking at the
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`·5· ·same section of the document.· I will try to do
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`·6· ·that.
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`·7· · · · · · ·Of course you have materials in front of
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`·8· ·you in hard copy, and so if for some reason you
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`·9· ·want to refer to those, feel free to.· But I do
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`10· ·want to make a record clearly of what it is you're
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`11· ·referring to or looking at.
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`12· · · · · · ·So let's try to keep it in terms of using
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`13· ·the screen, but again, if you need to look at
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`14· ·something else, feel free to do that.· Just let me
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`15· ·know what it is you're looking at.
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`16· · · · · · ·Can we agree to that?
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`17· · · · A.· ·Yes.
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`18· · · · · · ·(Exhibit 1003 was marked for
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`19· · · · · · ·identification.)
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`20· ·BY MR. CARSTEN:
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`21· · · · Q.· ·So I'd like to turn to your curriculum
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`22· ·vitae that was attached to your declaration.· If I
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`23· ·could have Exhibit 1003 previously marked brought
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`24· ·up on the screen.
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`25· · · · · · ·And feel free to give control to
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`·1· ·Dr. Hill, please, as well.
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`·2· · · · · · ·Do you recognize this document?
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`·3· · · · A.· ·I do.
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`·4· · · · Q.· ·What is this?
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`·5· · · · A.· ·It is a copy of my CV from a little over
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`·6· ·a year ago.
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`·7· · · · Q.· ·And there is a date on the cover page,
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`·8· ·May 2020; is that right?
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`·9· · · · A.· ·Yes.
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`10· · · · Q.· ·And is this CV correct and accurate as of
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`11· ·May 2020?
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`12· · · · A.· ·I believe it is.
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`13· · · · Q.· ·At the 10th page of the PDF document
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`14· ·that's being exhibited here.· Actually, let's go to
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`15· ·the eighth page, please, of the exhibit.· It says
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`16· ·"Research Support."
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`17· · · · · · ·Do you see that?
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`18· · · · A.· ·Yes.
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`19· · · · Q.· ·And what is intended to be reflected here
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`20· ·in research support?
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`21· · · · A.· ·The name of the project or the grantor,
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`22· ·the amount, and the years involved with the
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`23· ·project.
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`24· · · · Q.· ·So these are a complete list of the
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`25· ·companies for which you have performed services
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`·1· ·that have resulted in research support for you up
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`·2· ·through May 2020; is that correct?
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`·3· · · · · · ·MR. SUKDUANG:· Objection; form.
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`·4· · · · · · ·THE WITNESS:· Yes.
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`·5· ·BY MR. CARSTEN:
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`·6· · · · Q.· ·Now, if we go to Page 9 of the document,
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`·7· ·you will see towards the top there is an entry for
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`·8· ·United Therapeutics.· And it's -- the description
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`·9· ·is a randomized trial of subcutaneous UT-15 to
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`10· ·treat patients with severe pulmonary hypertension.
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`11· · · · · · ·Do you see that?
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`12· · · · A.· ·Yes.
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`13· · · · Q.· ·And the amount is $15,000 per PT.· PT
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`14· ·means patient?
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`15· · · · A.· ·That is correct.
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`16· · · · Q.· ·And the time frame was 1998 to 1999,
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`17· ·correct?
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`18· · · · A.· ·Yes.
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`19· · · · Q.· ·You've participated in work with United
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`20· ·Therapeutics for some time; is that correct?
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`21· · · · A.· ·Yes.
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`22· · · · Q.· ·Is this the first project that you recall
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`23· ·working with United Therapeutics on?
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`24· · · · A.· ·It is.
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`25· · · · Q.· ·And just looking further down this
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`·1· ·document, there's another entry for United
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`·2· ·Therapeutics from 2003 to 2005; Transition from IV
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`·3· ·epoprostenol to SC Treprostinil, investigator
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`·4· ·initiated.
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`·5· · · · · · ·Do you see that?
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`·6· · · · A.· ·Yes.
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`·7· · · · Q.· ·And this is not inhaled Treprostinil.
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`·8· ·This has to do with subcutaneous Treprostinil
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`·9· ·administration, correct?
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`10· · · · A.· ·Correct.
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`11· · · · Q.· ·And then a few down from there in 2005,
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`12· ·there's another for United Therapeutics in which
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`13· ·there's a reference to a -- to research involving
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`14· ·using an anesthetic to control site pain during
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`15· ·subcutaneous infusion; is that right?
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`16· · · · A.· ·Yes.· Let's see.· Am I able to scroll?
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`17· ·Because that's not up yet, but I do recall that
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`18· ·project, and the answer is yes.
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`19· · · · Q.· ·Spencer, would you please give Dr. Hill
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`20· ·control of the document to scroll.
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`21· · · · · · ·You should be able to scroll yourself,
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`22· ·Doctor.
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`23· · · · A.· ·Do I have to hit share screen or
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`24· ·something?
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`25· · · · Q.· ·No, I don't think so.
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`·1· · · · A.· ·There it goes.· I probably just overshot
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`·2· ·it.· Yeah.· Now, we've got the study you're talking
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`·3· ·about, the Ropivacaine.
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`·4· · · · Q.· ·And again, that has to do with infused or
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`·5· ·injectable Remodulin Treprostinil and not inhaled
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`·6· ·Treprostinil, correct?
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`·7· · · · A.· ·That's right.
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`·8· · · · Q.· ·And then on the next page, Page 10, there
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`·9· ·is another entry at the top of the page for
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`10· ·evaluation of oral Treprostinil.
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`11· · · · · · ·Do you see that?
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`12· · · · A.· ·Yes.
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`13· · · · Q.· ·And then immediately under that is
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`14· ·project with Lung RX?
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`15· · · · · · ·Do you see that?
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`16· · · · A.· ·Yes.
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`17· · · · Q.· ·Do you know if Lung RX is related to
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`18· ·United Therapeutics in some way?
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`19· · · · A.· ·It is.
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`20· · · · Q.· ·And what's your understanding, to the
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`21· ·extent you have one, of the relationship between
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`22· ·Lung RX and United Therapeutics as of the 2006, '07
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`23· ·time frame?
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`24· · · · A.· ·It was subdivided, I guess is the term I
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`25· ·would use to describe it, from United Therapeutics
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`·1· ·to deal with certain products, including the
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`·2· ·inhaled form.
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`·3· · · · Q.· ·The inhaled form of Treprostinil, sir?
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`·4· · · · A.· ·Yes.
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`·5· · · · Q.· ·Okay.· Thank you.
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`·6· · · · · · ·Was this the first project that you had
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`·7· ·involved the use of inhaled Treprostinil with
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`·8· ·either Lung RX or United Therapeutics?
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`·9· · · · A.· ·Yes.
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`10· · · · Q.· ·And this is starting in the 2006 to '07
`
`11· ·time frame?
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`12· · · · A.· ·Correct.
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`13· · · · Q.· ·Had you had any interactions with Lung RX
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`14· ·or United Therapeutics about inhaled Treprostinil
`
`15· ·before the initiation of this project?
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`16· · · · A.· ·Not to my recollection.
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`17· · · · Q.· ·Now, I notice going through this list,
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`18· ·the latest entry, the last entry, which is at the
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`19· ·bottom of Page 11, is an entry for Gossamer Bio.
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`20· · · · · · ·Do you see that?
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`21· · · · A.· ·Yes.
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`22· · · · Q.· ·And that's a project from 2019 to 2020;
`
`23· ·is that correct?
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`24· · · · A.· ·Yes.
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`25· · · · Q.· ·I noticed that on this list the name
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`·1· ·"Liquidia" does not appear; is that correct?
`
`·2· · · · A.· ·Yes.
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`·3· · · · Q.· ·And in fact, sir, you did have research
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`·4· ·projects that were supported by Liquidia that fall
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`·5· ·within the time frame covered by this tape,
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`·6· ·correct?
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`·7· · · · · · ·MR. SUKDUANG:· Objection; form.
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`·8· ·BY MR. CARSTEN:
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`·9· · · · Q.· ·You can go ahead and answer.
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`10· · · · A.· ·Yes.
`
`11· · · · Q.· ·Why did you not include those Liquidia
`
`12· ·projects on this table in your CV that you've
`
`13· ·testified was complete and accurate as of May 2020?
`
`14· · · · A.· ·The listings here are for studies I
`
`15· ·served as principal investigator on at my site.
`
`16· ·And I have several colleagues who participate in
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`17· ·these trials as well.· And one of my other
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`18· ·colleagues was the principal investigator for that
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`19· ·study at my site.
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`20· · · · · · ·And the reason for was I was chair of the
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`21· ·steering committee for the trial, and Liquidia had
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`22· ·asked that I not serve as site principal
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`23· ·investigator if I had that role.· So one of my
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`24· ·colleagues was in the -- the role as steering
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`25· ·committee chair doesn't appear on my CV either, and
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`·1· ·that's because I followed the Tufts template for
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`·2· ·CVs, and there's no place for putting in roles like
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`·3· ·that.
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`·4· · · · Q.· ·So your testimony is that your CV
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`·5· ·contents are dictated by the rules pertaining to
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`·6· ·the Tufts CV guidelines; is that correct?
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`·7· · · · A.· ·The CV guidelines, yes.
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`·8· · · · Q.· ·Do you have a copy of those CV
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`·9· ·guidelines?
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`10· · · · A.· ·I have it somewhere, yes.
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`11· · · · Q.· ·Or do you know if they are available to
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`12· ·the public online, or are they private documents?
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`13· · · · A.· ·I would imagine it would being difficult
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`14· ·to access them from the public, but I don't think
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`15· ·there's any reason I couldn't forward to them if
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`16· ·you had an interest.
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`17· · · · · · ·MR. CARSTEN:· I do have such an interest,
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`18· ·and so Mr. Sukduang, we'd request that, given the
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`19· ·witness's testimony, that you provide a copy of the
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`20· ·CV guidelines of Tufts University for us to take a
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`21· ·look at.
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`22· · · · · · ·MR. SUKDUANG:· We'll take that under
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`23· ·advisement, but I also want to remind you that this
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`24· ·is an IPR proceeding, not a district court
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`25· ·proceeding, and you have to seek permission for the
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`·1· ·board for discovery.
`
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`UTC vs.UTC vs.
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`·2· · · · · · ·MR. CARSTEN:· I understand that as well.
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`·3· ·Obviously we do have a corresponding district court
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`·4· ·proceeding.· I'm asking as a courtesy.· If you want
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`·5· ·to say no, that's fine to say no.· And if you want
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`·6· ·us to seek leave, we will take that back to the
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`·7· ·client and see what they wish to do, but I think,
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`·8· ·in view of the parallel district court proceeding,
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`·9· ·we'll get it one way or the other.
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`10· · · · · · ·So I'm making the request as a courtesy.
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`11· ·If you wish to do it.· If not, you're perfectly
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`12· ·within your rights to say no, and we would either
`
`13· ·address it with the board or elect not to.
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`14· · · · · · ·MR. SUKDUANG:· Yeah, well, just follow
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`15· ·the proper procedures and we can talk offline.
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`16· · · · · · ·MR. CARSTEN:· We'll talk offline then.
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`17· ·BY MR. CARSTEN:
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`18· · · · Q.· ·Let me get this straight.· This is a
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`19· ·steering committee that directs and controls the
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`20· ·multiple sites of a particular study; is that
`
`21· ·correct?
`
`22· · · · A.· ·The steering committee advises the
`
`23· ·sponsor on the conduct of the study.· It meets
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`24· ·periodically to review the progress of the study,
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`25· ·go over some of the data, address questions that
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`·1· ·come up with the conduct of the study.· It has no
`
`·2· ·governance role over the individual sites.
`
`·3· · · · Q.· ·And so your testimony is that the
`
`·4· ·research support section contains only those
`
`·5· ·studies for which you were a principal
`
`·6· ·investigator; is that correct?
`
`·7· · · · A.· ·That is correct.
`
`·8· · · · Q.· ·You received a remuneration or
`
`·9· ·compensation for your role on the steering
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`10· ·committee, correct?
`
`11· · · · A.· ·I did.
`
`12· · · · Q.· ·You received compensation from Liquidia
`
`13· ·for that role?
`
`14· · · · A.· ·I did.
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`15· · · · Q.· ·Let me ask you:· How long have you worked
`
`16· ·with Liquidia?
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`17· · · · A.· ·I would estimate five or six years.
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`18· · · · Q.· ·In what capacities have you worked with
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`19· ·Liquidia?
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`20· · · · A.· ·As a consultant and as chair of the
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`21· ·steering committee.
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`22· · · · Q.· ·As in the role of a consultant, what work
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`23· ·did you perform for Liquidia?
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`24· · · · · · ·MR. SUKDUANG:· Dr. Hill, I also caution
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`25· ·you not to reveal confidential information.· This
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`UTC vs.UTC vs.
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`·1· ·will be eventually a public record, and you can go
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`·2· ·ahead and answer Mr. Carsten's question with that
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`·3· ·in mind.
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`·4· · · · · · ·THE WITNESS:· Thank you.
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`·5· · · · · · ·I advised them on the creation of the
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`·6· ·study protocols.
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`·7· ·BY MR. CARSTEN:
`
`·8· · · · Q.· ·Anything else in your role as a
`
`·9· ·consultant?
`
`10· · · · A.· ·No.
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`11· · · · Q.· ·As chair of the steering committee, what
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`12· ·was your role with Liquidia?
`
`13· · · · A.· ·To help conduct the meetings of the
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`14· ·steering committee, advising on the progress of the
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`15· ·study and any questions or concerns that came up.
`
`16· · · · · · ·I should add, by the way, that one of my
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`17· ·roles as consultant was to work with them on their
`
`18· ·FDA application for an IND, and I did attend an FDA
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`19· ·meeting with them on that topic.
`
`20· · · · Q.· ·Were you involved in assisting Liquidia
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`21· ·in preparing its NDA submission?
`
`22· · · · A.· ·I did from the perspective of a clinician
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`23· ·to make sure that what went in there made sense
`
`24· ·clinically.
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`25· · · · Q.· ·What do you mean by "make sense
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`·1· ·clinically"?
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`UTC vs.UTC vs.
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`Liquidia Technologies, Inc.Liquidia Technologies, Inc.
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`·2· · · · A.· ·Well, part of their application was in
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`·3· ·relation to the studies that they were proposing to
`
`·4· ·do.· One was a phase one study looking at
`
`·5· ·pharmacokinetics.· And the other was a phase
`
`·6· ·two/three study that was looking at the ability of
`
`·7· ·their LIQ 861 compound to maintain patient
`
`·8· ·stability and its safety profile after
`
`·9· ·transitioning from inhaled Treprostinil TYVASO, the
`
`10· ·UT product, and also as a de novo add-on therapy to
`
`11· ·people on other background therapies.
`
`12· · · · Q.· ·Are you still consulting with -- or
`
`13· ·working at all with United Therapeutics?
`
`14· · · · A.· ·Yes.
`
`15· · · · Q.· ·So you've been working with Liquidia for
`
`16· ·five to six years in a role as a consultant and
`
`17· ·guiding them on clinical trials, as well as their
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`18· ·IND and NDA submission, correct?
`
`19· · · · A.· ·That is correct.
`
`20· · · · Q.· ·You have been working with United
`
`21· ·Therapeutics for over 23 years on their
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`22· ·Treprostinil compound and various both inhaled and
`
`23· ·injectable administrations of Treprostinil,
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`24· ·correct?
`
`25· · · · A.· ·That is correct.
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`·1· · · · Q.· ·What capacities over the last 23 years
`
`·2· ·have you been working with United Therapeutics?
`
`·3· · · · · · ·MR. SUKDUANG:· Objection; form.
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`·4· · · · · · ·THE WITNESS:· I have served as a
`
`·5· ·consultant, mainly on advisory committees.· They
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`·6· ·will convene committees of experts from time to
`
`·7· ·time to address issues that are of concern that
`
`·8· ·they want to get feedback from the clinical
`
`·9· ·community on.· And I have also served as an
`
`10· ·investigator on a number of trials.· At the moment
`
`11· ·there are there is an extension of inhaled TYVASO
`
`12· ·study that is still ongoing on.
`
`13· · · · · · ·And let's see.· We have another on an
`
`14· ·oral prostacyclin, but I'm a coinvestigator, not a
`
`15· ·principal investigator on that one.· So it wouldn't
`
`16· ·end up on my CV.
`
`17· · · · · · ·But this CV is from a little over a year
`
`18· ·ago, so it wouldn't have been entered on this one
`
`19· ·anyway.· We hadn't started that yet.
`
`20· · · · Q.· ·And in connection with your work for
`
`21· ·United Therapeutics, you were exposed to
`
`22· ·information pertaining to United Therapeutics
`
`23· ·clinical trial efforts, correct?
`
`24· · · · · · ·MR. SUKDUANG:· I object to form.
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`25· · · · · · ·You can go ahead and answer, Dr. Hill.
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`·1· · · · · · ·THE WITNESS:· Clinical trial efforts. I
`
`·2· ·wonder if you could be a little bit more specific.
`
`·3· ·BY MR. CARSTEN:
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`·4· · · · Q.· ·Sure.· See, I told you I was going to
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`·5· ·fail in my endeavor to give you clear and
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`·6· ·understandable questions, and true to form I came
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`·7· ·through with shining colors.· So thank you for
`
`·8· ·asking for a clarification.
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`·9· · · · · · ·You, in connection with your work at
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`10· ·United Therapeutics, understand what United
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`11· ·Therapeutics clinical endpoints were, correct?
`
`12· · · · · · ·MR. SUKDUANG:· Objection; form.
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`13· · · · · · ·THE WITNESS:· Clinical endpoints?
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`14· ·BY MR. CARSTEN:
`
`15· · · · Q.· ·Yes.
`
`16· · · · A.· ·Again, I am not too sure how to answer
`
`17· ·that.
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`18· · · · Q.· ·Why are you having difficulty answering
`
`19· ·that question, sir?· You know what clinical
`
`20· ·endpoints are, correct?
`
`21· · · · A.· ·Yes.
`
`22· · · · Q.· ·So why are you having problems answering
`
`23· ·the question?
`
`24· · · · A.· ·Well, it would depend.· I mean, I had
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`25· ·multiple interactions over a number of years, and
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`·1· ·you know, clinical endpoints would have been --
`
`·2· ·would have varied over that time depending on what
`
`·3· ·we were talking about.
`
`·4· · · · · · ·If you are asking in a very general
`
`·5· ·sense, would I be aware of the breadth of those
`
`·6· ·clinical endpoints, the answer would be yes.
`
`·7· · · · Q.· ·And you were aware of how the studies
`
`·8· ·were designed and stated to be implemented,
`
`·9· ·correct?
`
`10· · · · · · ·MR. SUKDUANG:· Objection; form.
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`11· · · · · · ·THE WITNESS:· Yes.
`
`12· ·BY MR. CARSTEN:
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`13· · · · Q.· ·In terms of grants or research support
`
`14· ·from Liquidia in the last five or six years, how
`
`15· ·much money did Liquidia pay you in terms of grants
`
`16· ·or research support or compensation for your
`
`17· ·steering committee membership?
`
`18· · · · A.· ·Well, any grants or research support
`
`19· ·would have gone to the institution and not to me.
`
`20· · · · Q.· ·Do you know how much that is?
`
`21· · · · A.· ·No.
`
`22· · · · · · ·MR. SUKDUANG:· Objection; form.
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`23· ·BY MR. CARSTEN:
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`24· · · · Q.· ·You don't know how much that is.
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`25· · · · A.· ·I do not.
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`UTC vs.UTC vs.
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`Liquidia Technologies, Inc.Liquidia Technologies, Inc.
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`·1· · · · · · ·MR. SUKDUANG:· I'm sorry.· So I'm just
`
`·2· ·going to state for both of you, and I know it's
`
`·3· ·unintentional.
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`·4· · · · · · ·Please pause, Dr. Hill, to allow
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`·5· ·Mr. Carsten to finish.· And, Mr. Carsten, to the
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`·6· ·extent possible, please pause to let Dr. Hill
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`·7· ·finish.
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`·8· · · · · · ·THE WITNESS:· Yeah, you know, I think
`
`·9· ·there is a little delay in the Zoom here.· So I
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`10· ·will have to kind of change my timing a little bit,
`
`11· ·but let me know if it's working.· Because from my
`
`12· ·perspective, I'm pausing, at least most of the
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`13· ·time.· And it seems that it there is some kind of
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`14· ·delay in here.
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`15· ·BY MR. CARSTEN:
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`16· · · · Q.· ·We'll work through that as best as we
`
`17· ·can, but the caution is well taken.
`
`18· · · · · · ·So I'm sorry.· I think where last we left
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`19· ·our heroes here, you didn't know the sum total of
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`20· ·amount that Liquidia had paid to your institution,
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`21
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