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Exhibit 10.20
CONTRACT CLINICAL RESEARCH AGREEMENT
AMENDMENT #1
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Pursuant to the Contract Clinical Research Agreement between ISTA
Pharmaceuticals (formerly known as Advanced Corneal Systems, Inc.) ("ISTA") and
CroMedica Global Inc. ("CroMedica"), dated May 19, 1999, the following
amendment(s) are hereby accepted by both parties:
CROMEDICA TO ASSUME RESPONSIBILITIES FOR PATIENT ENROLLMENT TRACKING
In reference to Protocol VIT-02-08961X, it is hereby agreed by both parties that
CroMedica will assume the responsibilities for patient enrollment tracking as
outlined in the attached Fee Schedule.
Both parties further agree that the same conditions apply to this Amendment in
the event of termination of the trial as represented by Clause X, Termination of
the main contract.
A revised, Attachment 2, Payment and Performance Schedule is attached herewith
and will replace any previous payment and performance schedules.
ACCEPTANCE OF AMENDMENT TO AGREEMENT BY AND BETWEEN:
SPONSOR: CONTRACTOR:
ISTA PHARMACEUTICALS CROMEDICA GLOBAL INC.
_______________________________ ___________________________
NAME: _______________________ XXX XXXXXXX
TITLE: _______________________ PRESIDENT
_______________________________ ___________________________
DATE DATE
Protocol VIT-02-08961X
CroMedica Project # 1600
Version 1: September 15, 2000
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ATTACHMENT 2
PAYMENT AND PERFORMANCE SCHEDULE
PAYMENT SCHEDULE
Sponsor shall reimburse reasonable costs and expenses at net thirty (30) days
terms upon receipt of invoice and any associated original receipts, and/or at
the occurrence of the below incidents enacted at Sponsor's request, pending
review for acceptableness and/or completeness. All figures are in US dollars:
FIXED-UNIT PRICE PAYMENT STRUCTURE
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REVISED
ORIGINAL ENROLMENT CONTRACT
UNIT COST CONTRACT TRACKING TOTAL
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Up front (20%) $563,525
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Australia Regulatory Submission $10,000 10,000
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CRF Finalization 6,180 8,580
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Site Recruitment:
Canadian 200 2,400
U.S. 240 2,880
Australia 240 2,400
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Initiation Visits:
Canadian 600 7,200
U.S. 720 18,720
Australia 1,080 10,800
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Interim Visits:
Canadian 1,200 183,600
U.S. 1,440 1,156,680
Australia 1,280 124,800
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Unmasked Visits:
Canadian 900 10,800
U.S. 1,080 68,040
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Close Out Visits:
Canadian 900 10,800
U.S. 1,080 81,000
Australia 960 9,600
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Site Audits 2,500 125,000
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Australia Investigator Meeting 12,000 12,000
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Study Training 24,550 24,550
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SAE Management $300 per SAE 81,600
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Database Design 13,500 13,500
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Data Entry:
1/3 Data Entered 50,000 50,000
2/3 Data Entered 50,000 50,000
3/3 Data Entered 50,000 50,000
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Project Management Fee 5,566 139,150
(per month for 25 months)
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Enrolment Tracking:
EFFECTIVE OCTOBER, 2000 2,519.71 120,946
per month for 48 months
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TOTAL CONTRACT $2,817,625 $120,946 $2,938,571
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PASS-THROUGH COSTS: SPONSOR shall reimburse CONTRACTOR for reasonable
pass-through costs (e.g., travel, lodging, meals) at net thirty (30) days term
upon receipt of original receipt(s)/invoice. Interest at 15% shall apply in net
thirty (30) days terms are not satisfied.
