throbber
Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30246 Page 1 of 18
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`EXHIBIT 30
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`TO DECLARATION OF CHRISTIANA GARRETT
`IN SUPPORT OF NUVASIVE, INC.’S
`REPLY IN SUPPORT OF
`MOTION FOR PARTIAL SUMMARY JUDGMENT
`AND MOTION TO EXCLUDE EXPERT OPINIONS
`(IMPLANT PATENTS)
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30247 Page 2 of 18
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`· · · · · · · · ·UNITED STATES DISTRICT COURT
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`· · · · · · · · SOUTHERN DISTRICT OF CALIFORNIA
`
`· · · · · · · · · · · SAN DIEGO DIVISION
`

`
`· · ·NUVASIVE, INC., a Delaware
`· · ·corporation,

`· · · · · · · ·Plaintiff,

`· · · · · · · ·v.· · · · · ·Case No. 18-cv-0347-CAB-MDD

`· · ·ALPHATEC HOLDINGS, INC., a
`· · ·Delaware corporation and
`· · ·ALPHATEC SPINE, INC., a
`· · ·California corporation,
`
`· · · · · · · ·Defendants.
`
`· · ·_______________________________________________________
`
`· · · · · HIGHLY CONFIDENTIAL - ATTORNEYS' EYES ONLY
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`· · · · · · ·VIDEOTAPED DEPOSITION OF MIKE ALEALI
`
`· · · · ALPHATEC’S HOLDINGS, INC. RULE 30(b)(6) WITNESS
`
`· · · · · · · · · · ·SAN DIEGO, CALIFORNIA
`
`· · · · · · · · · · · ·OCTOBER 30, 2020
`

`
`· · ·Reported By:
`· · ·PATRICIA Y. SCHULER
`· · ·CSR No. 11949
`

`

`

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`EXHIBIT 30
`Page 43
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30248 Page 3 of 18
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`·1· · · · · · · ·UNITED STATES DISTRICT COURT
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`·2· · · · · · · SOUTHERN DISTRICT OF CALIFORNIA
`
`·3· · · · · · · · · · SAN DIEGO DIVISION
`
`·4
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`·5· ·NUVASIVE, INC., a Delaware
`· · ·corporation,
`·6
`· · · · · · · ·Plaintiff,
`·7
`· · · · · · · ·v.· · · · · ·Case No. 18-cv-0347-CAB-MDD
`·8
`· · ·ALPHATEC HOLDINGS, INC., a
`·9· ·Delaware corporation and
`· · ·ALPHATEC SPINE, INC., a
`10· ·California corporation,
`
`11· · · · · · ·Defendants.
`
`12· ·_______________________________________________________
`
`13· · · · Videotaped deposition of MIKE ALEALI,
`
`14· ·ALPHATEC’S HOLDINGS, INC. RULE 30(b)(6) WITNESS,
`
`15· ·taken on behalf of the Defendants via Zoom, in San
`
`16· ·Diego, California, at 9:13 a.m. and ending at 3:24
`
`17· ·p.m., on October 30, 2020, before PATRICIA Y.
`
`18· ·SCHULER, Certified Shorthand Reporter No. 11949.
`
`19
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`20
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`21
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`22
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`23
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`24
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`25
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`EXHIBIT 30
`Page 44
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30249 Page 4 of 18
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`·1· ·APPEARANCES:
`
`·2· ·FOR PLAINTIFF:
`
`·3· · · · · · ·WILSON SONSINI GOODRICH & ROSATI, P.C.
`
`·4· · · · · · ·BY:· CHRISTINA DASHE, ESQ.
`
`·5· · · · · · ·12235 El Camino Real
`
`·6· · · · · · ·Suite 200
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`·7· · · · · · ·San Diego, California· 92130
`
`·8· · · · · · ·CDashe@wsgr.com
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`·9· ·FOR DEFENDANTS:
`
`10· · · · · · ·WINSTON STRAWN LLP
`
`11· · · · · · ·BY:· SARANYA RAGHAVAN, ESQ.
`
`12· · · · · · ·BY:· NIMALKA WICKRAMASEKERA, ESQ.
`
`13· · · · · · ·333 South Grand Avenue
`
`14· · · · · · ·38th Floor
`
`15· · · · · · ·Los Angeles, California 90071-1543
`
`16· · · · · · ·SRaghavan@winston.com
`
`17
`
`18· ·VIDEOGRAPHER:· DEVON GREEN
`
`19· ·ALSO PRESENT:· JASON HAMILTON
`
`20· · · · · · · · · KATHRYN CORLEW
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`21· · · · · · · · · WILLIAM WARDLAW
`
`22
`
`23
`
`24
`
`25
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`EXHIBIT 30
`Page 45
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30250 Page 5 of 18
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`·1· · · · · · · · · · · · ·I-N-D-E-X
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`·2· ·WITNESS:· · · · · · · · · · · · · · · · ·EXAMINATION
`
`·3· ·MIKE ALEALI· · · · · · · · · · · · · · · · · · ·PAGE
`
`·4· ·MS. DASHE· · · · · · · · · · · · · · · · · · · · · 8
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`·5
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`·6· · · · · · · · · · · E-X-H-I-B-I-T-S
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`·7· ·PLAINTIFF'S· · · · · · · · · · · · · · · · · · ·PAGE
`
`·8· ·Exhibit 1· · ·NuVasive, Inc.'s Third Amended· · · 12
`· · · · · · · · · ·Notice of Deposition of Alphatec
`·9· · · · · · · · ·Holdings, Inc. and Alphatec
`· · · · · · · · · ·Spine, Inc. Pursuant to Rule
`10· · · · · · · · ·30(b)(6)
`
`11· ·Exhibit 2· · ·Excel Spreadsheet Bates-stamped· · ·41
`· · · · · · · · · ·ATEC_LLIF000965880
`12
`· · ·Exhibit 3· · ·Excel Spreadsheet Bates-stamped· · ·41
`13· · · · · · · · ·ATEC_LLIF000965881
`
`14· ·Exhibit 4· · ·Excel Spreadsheet Bates-stamped· · ·42
`· · · · · · · · · ·ATEC_LLIF000965882
`15
`· · ·Exhibit 5· · ·Battalion Lateral Lumbar Spacer· · ·82
`16· · · · · · · · ·System Bates-stamped
`· · · · · · · · · ·ATEC_LLIF000004935 through 942
`17
`· · ·Exhibit 6· · ·Transcend LIF Lateral Interbody· · 106
`18· · · · · · · · ·Spacer System Bates-stamped
`· · · · · · · · · ·ATEC_LLIF000964710 through 717
`19
`· · ·Exhibit 7· · ·LIF Later Interbody Fusion· · · · ·118
`20· · · · · · · · ·Lateral Approach Surgical
`· · · · · · · · · ·Technique Guide Bates-stamped
`21· · · · · · · · ·ATEC_LLIF00167276 through 293
`
`22· ·Exhibit 8· · ·Conduct Internal Training 6.4.9· · 129
`· · · · · · · · · ·Bates-stamped ATEC_LLIF000002354
`23· · · · · · · · ·through 397
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`24
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`25
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`EXHIBIT 30
`Page 46
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30251 Page 6 of 18
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`·1· · · · · · · · E-X-H-I-B-I-T-S (CONTINUED)
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`·2· ·PLAINTIFF'S· · · · · · · · · · · · · · · · · · ·PAGE
`
`·3· ·Exhibit 9· · ·Lateral Lumbar Interbody Fusion· · 144
`· · · · · · · · · ·System Bates-stamped
`·4· · · · · · · · ·ATEC_LLIF000862492 through 542
`
`·5· ·Exhibit 10· · Spine ACE Program Bates-stamped· · 153
`· · · · · · · · · ·ATEC_LLIF000960894 through 912
`·6
`· · ·Exhibit 11· · Risk Management Report· · · · · · ·161
`·7· · · · · · · · ·Bates-stamped ATEC_LLIF 000967995
`· · · · · · · · · ·through 008
`·8
`· · ·Exhibit 12· · Product Requirement· · · · · · · · 164
`·9· · · · · · · · ·Specifications, PRS Bates-stamped
`· · · · · · · · · ·ATEC_LLIF000965064 through 082
`10
`· · ·Exhibit 13· · LIF Parts List Bates-stamped· · · ·169
`11· · · · · · · · ·ATEC_LLIF000964702 through 705
`
`12· ·Exhibit 14· · Press Release dated 10.05.20· · · ·180
`
`13· ·Exhibit 15· · Email dated 07.07.19· · · · · · · ·186
`· · · · · · · · · ·Bates-stamped ATEC_LLIF000970516
`14· · · · · · · · ·and 517
`
`15· ·Exhibit 16· · Market Need/Assessment Request· · ·189
`· · · · · · · · · ·Bates-stamped ATEC_LLIF000003829
`16· · · · · · · · ·through 835
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`17
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`18
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`19
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`20
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`21
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`22
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`23
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`24
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`25
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`EXHIBIT 30
`Page 47
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30252 Page 7 of 18
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`·1· · · SAN DIEGO, CALIFORNIA; FRIDAY, OCTOBER 30, 2020
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`·2· · · · · · · · · · · · ·9:13 a.m.
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`·3· · · · · · ·THE VIDEOGRAPHER:· We are now on the
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`·4· ·record.· Participants should be aware that this
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`·5· ·proceeding is being recorded, and as such, all
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`·6· ·conversations held will be recorded unless there is
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`·7· ·a request and agreement to go off the record.
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`·8· ·Private conversations and/or attorney-client
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`·9· ·interactions should be held outside the presence of
`
`10· ·the remote interface.
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`11· · · · · · ·For the purpose of creating a
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`12· ·witness-only video recording, the witness is being
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`13· ·spotlighted on all video screens while in speaker
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`14· ·view.· We ask that the witness not remove the
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`15· ·spotlight setting during the deposition, as it may
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`16· ·cause other participants to appear on the final
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`17· ·video rather than just the witness.
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`18· · · · · · ·For anyone who does not want the witness
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`19· ·to take up a large part of your screen, you may
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`20· ·click the "gallery view" button the upper right
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`21· ·corner.
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`22· · · · · · ·This is the remote video-recorded
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`23· ·deposition of Michael Aleali.· Today is Friday,
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`24· ·October 30, 2020.· The time is now 16:14 UTC.· We
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`25· ·are here in the matter of NuVasive versus Alphatec
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`EXHIBIT 30
`Page 48
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30253 Page 8 of 18
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`·1· ·Holdings.
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`·2· · · · · · ·My name is Devon Green, remote video
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`·3· ·technician on behalf of U.S. Legal Support.· I am
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`·4· ·not related to any party in this action, nor am I
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`·5· ·financially interested in the outcome.
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`·6· · · · · · ·At this time, will the reporter, Patricia
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`·7· ·Schuler on behalf of U.S. Legal Support, please
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`·8· ·enter the statement for remote proceedings into the
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`·9· ·record.
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`10· · · · · · ·THE REPORTER:· I don't have that
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`11· ·statement.· We're not doing that anymore.
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`12· · · · · · ·THE VIDEOGRAPHER:· Okay.
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`13· · · · · · ·MS. DASHE:· I'm assuming counsel should
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`14· ·be stating their appearances right now.
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`15· · · · · · ·THE VIDEOGRAPHER:· Go ahead.
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`16· · · · · · ·MS. DASHE:· This is Christina Dashe from
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`17· ·Wilson, Sonsini, Goodrich & Rosati on behalf of
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`18· ·Plaintiff NuVasive, Inc.· And with me today is Kate
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`19· ·Corlew of NuVasive, Inc.
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`20· · · · · · ·MS. RAGHAVAN:· This is Saranya Raghavan
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`21· ·from Winston & Strawn on behalf of Defendant
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`22· ·Alphatec.· And with me is Nimalka Wickramasekera,
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`23· ·also from Winston & Strawn, on behalf of Defendant
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`24· ·Alphatec.
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`25
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`EXHIBIT 30
`Page 49
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30254 Page 9 of 18
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`·1· · · · · · · · · · · ·MIKE ALEALI,
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`·2· · having been administered an oath, was examined and
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`·3· · · · · · · · · ·testified as follows:
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`·4
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`·5· · · · · · · · · · · · EXAMINATION
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`·6· ·BY MS. DASHE:
`
`·7· · · · Q.· ·Good morning, Mr. Aleali.
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`·8· · · · A.· ·Good morning.
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`·9· · · · Q.· ·Can you please state and spell your name
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`10· ·for the record?
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`11· · · · A.· ·First name is Mike, M-i-k-e.· Last name
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`12· ·is Aleali, A-l-e-a-l-i.
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`13· · · · Q.· ·What is your current address?
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`14· · · · A.· ·I am at 5 Tortuga, T-o-r-t-u-g-a, second
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`15· ·word is Cay, C-a-y, in Aliso Viejo, California
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`16· ·92656.
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`17· · · · Q.· ·You were deposed in this case
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`18· ·approximately last December, right?
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`19· · · · A.· ·Correct.
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`20· · · · Q.· ·Have you had any depositions since then?
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`21· · · · A.· ·I have not.
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`22· · · · Q.· ·Is this your first time, then, being
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`23· ·deposed remotely?
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`24· · · · A.· ·Yes.
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`25· · · · Q.· ·It's one of my first times, too.· So I
`
`EXHIBIT 30
`Page 50
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30255 Page 10 of
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`·1· ·disc and inserting the interbody and then kind of
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`·2· ·closing out the patient, right?
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`·3· · · · A.· ·That is correct.
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`·4· · · · Q.· ·So we're back at Page 11 here under
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`·5· ·Item 7, "Disc Preparation."· The third bullet down,
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`·6· ·that last bullet, in the last sentence -- or rather
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`·7· ·the last phrase of the last sentence says,
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`·8· ·"Thoroughly prepare the disc space and end plate."
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`·9· · · · · · ·Do you see that?
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`10· · · · · · ·MS. RAGHAVAN:· Objection; out of scope.
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`11· · · · · · ·THE WITNESS:· "Thoroughly prepare the
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`12· ·disc space and end plate."· Yes, I see that.
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`13· ·BY MS. DASHE:
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`14· · · · Q.· ·What specifically does that mean?
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`15· · · · A.· ·Essentially, to take out all the diseased
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`16· ·discs.
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`17· · · · Q.· ·And the end plates we talked about
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`18· ·earlier today, those are -- that is the bone,
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`19· ·right?
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`20· · · · A.· ·Correct.
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`21· · · · Q.· ·Does the surgeon remove the vertebral end
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`22· ·cap before inserting the Alphatec lateral implant?
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`23· · · · A.· ·What do you mean "the end cap"?
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`24· · · · Q.· ·I mean the end cap of the vertebral body.
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`25· ·If you're not familiar with that term, then I think
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`EXHIBIT 30
`Page 51
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30256 Page 11 of
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`·1· ·we can move on.
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`·2· · · · A.· ·Well, "end cap" is just not a term we
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`·3· ·would use or ever heard.
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`·4· · · · Q.· ·My only other question on this front then
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`·5· ·is:· Once the disc space has been prepared for the
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`·6· ·insertion of the implant, is it just bone that is
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`·7· ·basically exposed at that point to slide the
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`·8· ·implant into?· There is no other material in the
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`·9· ·disc space?
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`10· · · · · · ·MS. RAGHAVAN:· Objection; form.
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`11· · · · · · ·THE WITNESS:· You mean like native in the
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`12· ·disc space?
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`13· ·BY MS. DASHE:
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`14· · · · Q.· ·Yes.
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`15· · · · A.· ·Like introduced?
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`16· · · · · · ·So in the disc space, essentially you
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`17· ·want to take out the disc.· You want to take out
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`18· ·the disc material, the cartilaginous material on
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`19· ·the end plate.· Some guys, they like to essentially
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`20· ·like agitate the end plate a little bit to give a
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`21· ·bony bleed; that helps with fusion.
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`22· · · · Q.· ·So Alphatec intends for surgeons
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`23· ·inserting the Battalion lateral or Transcend
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`24· ·lateral end plates to remove basically all the
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`25· ·nonbone material from the disc space prior to
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`EXHIBIT 30
`Page 52
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30257 Page 12 of
`18
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`·1· ·insertion of the implant?
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`·2· · · · · · ·MS. RAGHAVAN:· Objection; out of scope,
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`·3· ·form.
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`·4· · · · · · ·THE WITNESS:· So to remove the disc
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`·5· ·space, essentially -- I mean, you're essentially
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`·6· ·creating a parking spot for the implant to go into
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`·7· ·or the cage.· So you would -- the disc or the
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`·8· ·cartilaginous layer, all of it to be removed from
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`·9· ·the far side of the apophyseal ring, all the way
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`10· ·across to the ipsilateral of the apophyseal ring,
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`11· ·and then insert the implant.
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`12· ·BY MS. DASHE:
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`13· · · · Q.· ·The intention is for the Battalion
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`14· ·lateral or Transcend lateral implants to actually
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`15· ·touch the bone in the disc space that it is being
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`16· ·inserted into, right?
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`17· · · · A.· ·So the ideal is to make the contact with
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`18· ·the apophyseal ring on that outside ring.· Because
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`19· ·if you're just touching the center or if you are
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`20· ·really focused on that center, it is more likely to
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`21· ·subside because that bone is a lot softer.
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`22· · · · Q.· ·Do surgeons ever place an implant --
`
`23· ·excuse me.
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`24· · · · · · ·Do surgeons ever place the Battalion
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`25· ·lateral or Transcend lateral implants in such a
`
`EXHIBIT 30
`Page 53
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30258 Page 13 of
`18
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`·1· ·manner in which they would not contact the
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`·2· ·vertebral bone in the disc space?
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`·3· · · · A.· ·I mean, it has a lot to do -- I mean,
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`·4· ·everyone's end plates are different, convex,
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`·5· ·concave.· They're different shapes.· Everyone's
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`·6· ·anatomy differs, so it's really almost impossible
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`·7· ·to say that.
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`·8· · · · Q.· ·But, again, the intention is for the
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`·9· ·implants to touch the bone so that the
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`10· ·anti-migration chevrons we were talking about can
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`11· ·actually act to prevent migration, right?
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`12· · · · · · ·MS. RAGHAVAN:· Objection; asked and
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`13· ·answered.
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`14· · · · · · ·THE WITNESS:· When you look at bone
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`15· ·models and everything, you see these beautiful,
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`16· ·perfect, completely flat end plates.· That is just
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`17· ·really not, in fact, the case.· Everyone's anatomy
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`18· ·is different, as I said.
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`19· · · · · · ·So with the implant, the goal is, we want
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`20· ·our contacts to be on the outside, on the
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`21· ·apophyseal ring.· But if someone's anatomy is --
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`22· ·you know, they have got these crazy convex end
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`23· ·plates, then it is going to touch the middle of the
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`24· ·center end plate area.
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`25· ·///
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`EXHIBIT 30
`Page 54
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30259 Page 14 of
`18
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`·1· ·BY MS. DASHE:
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`·2· · · · Q.· ·The center end plate area is still bone,
`
`·3· ·though, right?
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`·4· · · · A.· ·It is, but it is a different type of
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`·5· ·bone.
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`·6· · · · Q.· ·If you go to Page 14 of Exhibit 7, Item
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`·7· ·11, "Supplemental Fixation."
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`·8· · · · · · ·Let me know when you are there.
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`·9· · · · A.· ·Yes, I am there.
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`10· · · · Q.· ·Do you agree, then, that the Alphatec's
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`11· ·Battalion lateral and Transcend lateral spacers are
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`12· ·indicated for use with the listed supplemental
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`13· ·Alphatec fixation on Page 14 of Exhibit 7?
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`14· · · · A.· ·Yes, I do.
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`15· · · · Q.· ·Do surgeons ever use Alphatec's
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`16· ·supplemental fixation without also placing an
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`17· ·implant?
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`18· · · · · · ·MS. RAGHAVAN:· Objection; out of scope.
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`19· · · · · · ·THE WITNESS:· So like, for example, let's
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`20· ·say use Arsenal and not put an implant?
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`21· ·BY MS. DASHE:
`
`22· · · · Q.· ·Yes.
`
`23· · · · A.· ·Arsenal, being a pedicle sphere system?
`
`24· · · · Q.· ·Sure.
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`25· · · · A.· ·Yeah.· It's a posterior spinal fusion
`
`EXHIBIT 30
`Page 55
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`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30260 Page 15 of
`18
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`·1· ·that happens quite often.
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`·2· · · · Q.· ·In a lateral surgery, do surgeons ever
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`·3· ·use the supplemental fixation without also placing
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`·4· ·either the Transcend or the Battalion lateral
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`·5· ·implant?
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`·6· · · · · · ·MS. RAGHAVAN:· Objection; out of scope.
`
`·7· · · · · · ·THE WITNESS:· I'm sorry.· I don't quite
`
`·8· ·follow that question.
`
`·9· ·BY MS. DASHE:
`
`10· · · · Q.· ·If a surgeon is doing a spine fusion
`
`11· ·surgery, would they ever only use Alphatec's
`
`12· ·supplemental fixation and not also place one of the
`
`13· ·Battalion lateral or Transcend lateral implants?
`
`14· ·Setting aside the titanium issue.
`
`15· · · · · · ·MS. RAGHAVAN:· Objection; out of scope.
`
`16· · · · · · ·THE WITNESS:· To use the lateral system,
`
`17· ·our ATEC lateral system without a Battalion or
`
`18· ·Transcend cage and then use our posterior fixation?
`
`19· ·BY MS. DASHE:
`
`20· · · · Q.· ·Correct.
`
`21· · · · A.· ·So essentially use someone else's
`
`22· ·interbody?
`
`23· · · · Q.· ·No.· What I am asking is if a surgeon
`
`24· ·performs a lateral procedure, regardless, I guess,
`
`25· ·actually of whose products are used -- they are
`
`EXHIBIT 30
`Page 56
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30261 Page 16 of
`18
`
`·1· · · · · · ·I, PATRICIA Y. SCHULER, a Certified
`
`·2· ·Shorthand Reporter of the State of California, do
`
`·3· ·hereby certify:
`
`·4· · · · · · ·That the foregoing proceedings were taken
`
`·5· ·before me at the time and place herein set forth;
`
`·6· ·that any witnesses in the foregoing proceedings,
`
`·7· ·prior to testifying, were duly sworn; that a
`
`·8· ·verbatim record of the proceedings was made by me
`
`·9· ·using machine shorthand which was thereafter
`
`10· ·transcribed under my direction; that the foregoing
`
`11· ·transcript is a true record of the testimony given.
`
`12· · · · · · ·Further, that if the foregoing pertains
`
`13· ·to the original transcript of a deposition in a
`
`14· ·Federal Case, before completion of the proceedings,
`
`15· ·review of the transcript [X] was [ ] was not
`
`16· ·requested.
`
`17· · · · · · ·I further certify I am neither
`
`18· ·financially interested in the action nor a relative
`
`19· ·or employee of any attorney of party to this
`
`20· ·action.
`
`21· · · · · · ·IN WITNESS WHEREOF, I have this date
`
`22· ·subscribed my name.
`
`23· ·Dated:· November 3, 2020
`
`24· · · · · · · · · · · · · _________________________
`· · · · · · · · · · · · · · PATRICIA Y. SCHULER
`25· · · · · · · · · · · · · CSR NO. 11949
`
`EXHIBIT 30
`Page 57
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30262 Page 17 of
`18
`
`EXHIBIT 30
`Page 58
`
`

`

`Case 3:18-cv-00347-CAB-MDD Document 311-6 Filed 02/26/21 PageID.30263 Page 18 of
`18
`
`EXHIBIT 30
`Page 59
`
`

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