·1· · · · · · ·IN THE UNITED STATES DISTRICT COURT
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`·2· · · · · · · · FOR THE DISTRICT OF DELAWARE
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`·3· ·- - - - - - - - - - - - - x
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`·4· ·ALLERGAN, INC.,· · · · · ·:
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`·5· · · · · ·Plaintiff,· · · · :
`
`·6· ·v.· · · · · · · · · · · · :· C.A. NO. 17-663(JFB)(SEF)
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`·7· ·TARO PHARMACEUTICAL· · · ·:
`
`·8· ·INDUSTRIES LTD., and TARO :
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`·9· ·PHARMACEUTICALS, INC.,· · :
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`10· · · · · ·Defendants.· · · ·:
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`11· ·- - - - - - - - - - - - - x
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`12· · · · · CONFIDENTIAL - UNDER THE PROTECTIVE ORDER
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`13
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`14· · · · Videotaped Deposition of KEVIN WARNER, PH.D.
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`15· · · · · · · · · · · Washington, D.C.
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`16· · · · · · · · · Wednesday, July 18, 2018
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`17· · · · · · · · · · · · · 8:22 a.m.
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`18
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`19· ·Job No.:· 28438
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`20· ·Pages 1 through 349
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`21· ·Reported by:· Cassandra E. Ellis, RPR
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`22
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`AMN1080
`Amneal v. Almirall, LLC
` IPR2019-00207
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`Page 2
`·1· · · · · ·Deposition of KEVIN WARNER, PH.D., held at the
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`·1· · · · · · · · A P P E A R A N C E S
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`Page 3
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`·2· ·offices of Covington & Burling, LLP, 810 10th Street,
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`·2· ·ON BEHALF OF PLAINTIFF:
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`·3· ·Northwest, Washington, D.C.· 20001, pursuant to
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`·3· · · ·CHANSON CHANG, ESQUIRE
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`·4· ·agreement, before Cassandra E. Ellis, Certified Court
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`·4· · · ·JIHONG LOU, ESQUIRE
`
`·5· ·Reporter - Washington, Certified Shorthand Reporter -
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`·5· · · ·COVINGTON & BURLING, LLP
`
`·6· ·Hawai'i, Registered Professional Reporter, Certified
`
`·6· · · ·850 10th Street, Northwest
`
`·7· ·Livenote Reporter, Realtime Systems Administrator, and
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`·7· · · ·Washington, D.C.· 20001
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`·8· ·Notary Public of The District of Columbia.
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`·8· · · ·(202) 662-5708
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`·9
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`·9· · · ·Cchang@cov.com
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`12· ·ON BEHALF OF DEFENDANT:
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`13· · · ·STEPHEN P. BENSON, ESQUIRE
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`14· · · ·KATTEN MUCHIN ROSENMAN, LLP
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`15· · · ·Suite 1900
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`16· · · ·525 W Monroe Street
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`17· · · ·Chicago, Illinois· 60661
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`18· · · ·(312) 902-5200
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`19· · · ·Stephen.benson@kattenlaw.com
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`20
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`21· ·ALSO PRESENT:· Joseph E. Ellis, CLVS, AGCV
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`22· · · ·Shenade Walker
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`·1· · · · · · · · · · · ·C O N T E N T S
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`Page 4
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`·1· · · · · · E X H I B I T S· · C O N T I N U E D
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`Page 5
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`·2· ·EXAMINATION OF KEVIN WARNER, PH.D.· · · · · · · · ·PAGE
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`·2· · · · · · · · (Attached to the Transcript)
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`·3· · · ·By Mr. Benson· · · · · · · · · · · · · · · · · 10
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`·3· ·KEVIN WARNER, PH.D. Deposition Exhibit· · · · · · ·PAGE
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`·4
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`·5
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`·4· ·Exhibit 8· ·1/25/2012 E-mail Bates Stamped· · · · ·158
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`·5· · · ·ALG_ACZ0316758-760
`
`·6· · · · · · · · · · · ·E X H I B I T S
`
`·6· ·Exhibit 9· ·Aczone Reformulation CQAs and Risk· · ·172
`
`·7· · · · · · · · (Attached to the Transcript)
`
`·7· · · ·Mitigation Update Bates Stamped
`
`·8· ·KEVIN WARNER, PH.D. Deposition Exhibit· · · · · · ·PAGE
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`·8· · · ·ALG_ACZ0247034-042
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`·9· ·Exhibit 1· ·US Patent No. 9,517,219 B2 Bates· · · ·15
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`·9· ·Exhibit 10· Dapsone/Adapalene Topical Gel· · · · · 203
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`10· · · ·Stamped ALG_ACZ0000565-577
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`10· · · ·Formulation Summary Bates Stamped
`
`11· ·Exhibit 2· ·Drug Product Information Bates· · · · ·78
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`11· · · ·ALG_ACZO174113-116
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`12· · · ·Stamped ALG_ACZ0264301-338
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`12· ·Exhibit 11· 12/02/2009 Dapsone Suspension· · · · · 208
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`13· ·Exhibit 3· ·Aczone NDA Storyline: Regulatory· · · ·81
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`13· · · ·Product Update Bates Stamped
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`14· · · ·Summary Bates Stamped ALG_ACZ0319637-655
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`14· · · ·ALG_ACZ0222016-021
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`15· ·Exhibit 4· ·2/03/2012 E-Mail from Kevin Warner· · ·113
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`15· ·Exhibit 12· 1/04/2010 Aczone Reformulation· · · · ·222
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`16· · · ·Bates Stamped ALG_ACZ0226268-271
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`16· · · ·Development Bates Stamped ALG_ACZ0246068-085
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`17· ·Exhibit 5· ·Individual Project Agreement Bates· · ·132
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`17· ·Exhibit 13· 2/03/2012 E-Mail from Ajay Parashar· · 229
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`18· · · ·Stamped ALG_ACZ0236790-798
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`18· · · ·Bates Stamped ALG_ACZ0313682-683
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`19· ·Exhibit 6· ·Research Article Bates Stamped· · · · ·149
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`19· ·Exhibit 14· Product Evaluation Bates Stamped· · · ·229
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`20· · · ·ALG_ACZ0375158-165
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`20· · · ·ALG_ACZ0313684-689
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`21· ·Exhibit 7· ·Sepineo P 600 Information Bates· · · · 153
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`22· · · ·Stamped ALG_ACZ0375156-157
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`21
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`·1· · · · · · E X H I B I T S· · C O N T I N U E D
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`·1· · · · · · E X H I B I T S· · C O N T I N U E D
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`Page 7
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`·2· · · · · · · · (Attached to the Transcript)
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`·2· · · · · · · · (Attached to the Transcript)
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`·3· ·KEVIN WARNER, PH.D. Deposition Exhibit· · · · · · ·PAGE
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`·3· ·KEVIN WARNER, PH.D. Deposition Exhibit· · · · · · ·PAGE
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`·4· ·Exhibit 15· Pharmaceutical Development Technical· ·237
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`·4· ·Exhibit 21· Dapsone Gel and Dapsone/ Adapalene· · ·332
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`·5· · · ·Review Aczone Reformulation (Project #1679)
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`·5· · · ·Fixed Dose Combination Gel Formulation
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`·6· · · ·Bates Stamped ALG_ACZ0249690-751
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`·6· · · ·Development Report; Approved Bates Stamped
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`·7· ·Exhibit 16· 3/29/2012 Memorandum PD-TMEMO-00561· · 288
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`·7· · · ·ALG_ACZ0382881-932
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`·8· · · ·Bates Stamped ALG_ACZ0314425-441
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`·8· ·Exhibit 22· Declaration of Kevin S. Warner,· · · · 339
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`·9· ·Exhibit 17· Aczone Reformulation CMC Sub-Team· · · 306
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`·9· · · ·Ph.D. under 37 C.F.R. 4 1.132 Bates Stamped
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`10· · · ·Team Meeting Minutes Bates Stamped
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`10· · · ·ALG_ACZ0000290-294
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`11· · · ·ALG_ACZ0385496
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`12· ·Exhibit 18· Development Report: FPD 137· · · · · · 324
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`13· · · ·Reformulation: Development of 7.5% Dapsone
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`14· · · ·Gel Bates Stamped ALG_ACZ0248334-374
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`15· ·Exhibit 19· 11/07/2012 E-mail from Joan-En Lin· · ·329
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`16· · · ·Bates Stamped ALG_ACZ0200675-676
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`17· ·Exhibit 20· Dapsone Gel and Dapsone/ Adapalene· · ·332
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`18· · · ·Fixed Dose Combination Gel Formulation
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`19· · · ·Development Report; Effective Bates Stamped
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`20· · · ·ALG_ACZ0249762-813
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`Page 346
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`Page 347
`·1· · · CERTIFICATE OF SHORTHAND REPORTER - NOTARY PUBLIC
`
`·2· · · ·I, Cassandra E. Ellis, Registered Professional
`
`·3· ·Reporter, the officer before whom the foregoing
`
`·4· ·proceedings were taken, do hereby certify that the
`
`·5· ·foregoing transcript is a true and correct record of
`
`·6· ·the proceedings; that said proceedings were taken by
`
`·7· ·me stenographically and thereafter reduced to
`
`·8· ·typewriting under my supervision; and that I am
`
`·9· ·neither counsel for, related to, nor employed by any
`
`10· ·of the parties to this case and have no interest,
`
`11· ·financial or otherwise, in its outcome.
`
`12· · · ·IN WITNESS WHEREOF, I have hereunto set my hand
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`13· ·this 30th day of July 2018.
`
`14· ·My commission expires:
`
`15· ·December 14, 2022
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`16
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`17
`
`18· ·__________________________________________________
`
`19· ·CASSANDRA E. ELLIS, CSR-HI, CCR-WA, RPR, CLR, RSA
`
`20· ·NOTARY PUBLIC IN AND FOR THE DISTRICT OF COLUMBIA
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`21
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`22
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`·1· · · · · · · · · E R R A T A· · S H E E T
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`Page 348
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`Page 349
`·1· · · · ·E R R A T A· ·S H E E T· ·C O N T I N U E D
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`·2· · · ·IN RE:· Allergan v. Taro, et al.
`
`·2· · · ·IN RE:· Allergan v. Taro, et al.
`
`·3· ·RETURN BY:· _______________________________________
`
`·3· ·RETURN BY:· _______________________________________
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`·4· ·PAGE· · LINE· · ·CORRECTION AND REASON
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`·4· ·PAGE· · LINE· · ·CORRECTION AND REASON
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`·5· ·____· · ____· · ·__________________________________
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`·5· ·____· · ____· · ·__________________________________
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`·6· ·____· · ____· · ·__________________________________
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`·6· ·____· · ____· · ·__________________________________
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`·7· ·____· · ____· · ·__________________________________
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`·7· ·____· · ____· · ·__________________________________
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`·8· ·____· · ____· · ·__________________________________
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`·8· ·____· · ____· · ·__________________________________
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`·9· ·____· · ____· · ·__________________________________
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`·9· ·____· · ____· · ·__________________________________
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`10· ·____· · ____· · ·__________________________________
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`10· ·____· · ____· · ·__________________________________
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`11· ·____· · ____· · ·__________________________________
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`11· ·____· · ____· · ·__________________________________
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`12· ·____· · ____· · ·__________________________________
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`12· ·____· · ____· · ·__________________________________
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`13· ·____· · ____· · ·__________________________________
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`13· ·____· · ____· · ·__________________________________
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`14· ·____· · ____· · ·__________________________________
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`14· ·____· · ____· · ·__________________________________
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`15· ·____· · ____· · ·__________________________________
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`15· ·____· · ____· · ·__________________________________
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`16· ·____· · ____· · ·__________________________________
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`16· ·____· · ____· · ·__________________________________
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`17· ·____· · ____· · ·__________________________________
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`17· ·____· · ____· · ·__________________________________
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`18· ·____· · ____· · ·__________________________________
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`18· ·____· · ____· · ·__________________________________
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`19· ·____· · ____· · ·__________________________________
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`19· ·____· · ____· · ·__________________________________
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`20· ·____· · ____· · ·__________________________________
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`20· ·____· · ____· · ·__________________________________
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`21· ·______________· ·__________________________________
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`21· ·_______________· __________________________________
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`22· · · ·(DATE)· · · · · · · · · ·(SIGNATURE)
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`22· · · ·(DATE)· · · · · · · · · (SIGNATURE)
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`88
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`