Exhibit 10.26
ISTA PHARMACEUTICALS
ATTACHMENT 2 - REVISED PAYMENT AND PERFORMANCE SCHEDULE
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ADJUSTMENT ADJUSTMENT
REVISED STUDY AMENDMENT 3 AMENDMENT 3 REVISED STUDY
ORIGINAL STUDY ADJUSTMENT TOTAL OCCURRING IN OCCURRING TOTAL
UNIT COST TOTAL AMENDMENT 2 AMENDMENT 2 2001 POST 2001 AMENDMENT #3
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Up front (20%) 563,525.00 563,525.00 563,525.00
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Australia Regulatory
Submission 10,000.00 10,000.00 10,000.00 10,000.00
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CRF Finalization 8,580.00 8,580.00 8,580.00 8,580.00
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Site Recruitment:
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CANADIAN 200.00 2,400.00 2,400.00 2,400.00
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U.S. 240.00 2,880.00 2,880.00 2,880.00
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AUSTRALIA 240.00 2,400.00 2,400.00 2,400.00
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Initiation Visits:
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CANADIAN 600.00 7,200.00 7,200.00 7,200.00
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U.S. 720.00 18,720.00 18,720.00 18,720.00
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AUSTRALIA 1,080.00 10,800.00 10,800.00 10,800.00
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Interim Visits:
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CANADIAN 1,200.00 183,600.00
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U.S. 1,440.00 1,156,680.00
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AUSTRALIA 1,280.00 124,800.00 124,800.00
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AMENDMENT 2
ADD:
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7 additional monitoring visits
per site related to 3 interim
analyses and resolution of
clinical review queries not
originally contracted:
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Canadian
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11 sites x 7 visits 92,400.00 276,000.00
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AMENDMENT #2 ADJUSTMENT:
Per visit rate adjusted to
$1800/visit for visits
occurring post-March, 2001
due to increased patient
population, extensive CRF
changes, increased on site
effort
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58 x $1,200 = 69,600
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53 x $1,800 = 95,400
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120 x $1,800 = 214,200
TOTAL $379,200 22,800.00 80,400.00 379,200.00
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U.S.
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58 sites x 7 visits 584,640.00 1,741,320.00
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AMENDMENT #2 ADJUSTMENT:
Per visit rate adjusted
to $2160/visit for visits
occurring post-March, 2001
due to increased patient
population, extensive CRF
changes, increased on site
effort
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608 x $1,440 = 875,520
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229 x $2,160 = 494,640
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372 x $2,160 = 803,520
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TOTAL $2,173,680 152,640.00 279,720.00 2,173,680.00
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AMENDMENT 3
ADD:
North America: 2.25 visits per
site to take total visits
per site to 22 over life of study
Australia: 5 visits per site
to take total visits per site
to 16 over life of study
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Canadian
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11 sites x 2.25 visits 1,800.00 44,550.00 44,550.00
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U.S.
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58 sites x 2.25 visits 2,160.00 281,880.00 281,880.00
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Australia
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9 sites x 5 visits 1,280.00 57,600.00 182,400.00
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ISTA PHARMACEUTICALS
ATTACHMENT 2 - REVISED PAYMENT AND PERFORMANCE SCHEDULE
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ADJUSTMENT ADJUSTMENT
REVISED STUDY AMENDMENT 3 AMENDMENT 3 REVISED STUDY
ORIGINAL STUDY ADJUSTMENT TOTAL OCCURRING IN OCCURRING TOTAL
UNIT COST TOTAL AMENDMENT 2 AMENDMENT 2 2001 POST 2001 AMENDMENT #3
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REMOVE: Unmasked Visits
North America:
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CANADIAN 900.00 10,800.00 -10,800.00 0.00 0.00
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U.S. 1,080.00 68,040.00 -68,040.00 0.00 0.00
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AMENDMENT 3
Unmasked Visits AUSTRALIA -
INITIAL 6 visits for 6 sites 1,280.00 7,680.00 7,680.00
performed and billed
at regular monitoring
rate for Australia
(same rate of $1280). ADD
ADD'L 6 visits for 6 sites
requested by ISTA
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AMENDMENT 3
ADD: Staff Training
AUSTRALIA - Unmasked
Monitoring Procedures: 1,000.00 1,000.00
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Close Out Visits:
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CANADIAN 900.00 10,800.00 10,800.00 10,800.00
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U.S. 1,080.00 81,000.00 81,000.00 81,000.00
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AUSTRALIA 960.00 9,600.00 9,600.00 9,600.00
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REMOVE: Site Audits 2,500.00 125,000.00 -125,000.00 0.00 0.00
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Australia Investigator
Meeting 12,000.00 12,000.00 12,000.00 12,000.00
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STUDY TRAINING 24,550.00 24,550.00
Amendment, new CRFs,
rescue data - CRAs and 36,640.00 36,640.00
at sites - 2 hours per
site.
($75x 2hr x 11 sites)
Canadian 150.00 1,650.00
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($90x 2 hr x 58 sites) U.S. 180.00 10,440.00
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SAE Management $300 per SAE 81,600.00
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AMENDMENT 2
ADD: SAE Management $500 per SAE 136,000.00 217,600.00 217,600.00
Estimate of 272
additional SAEs
representing an overall
80% SAE rate for the study.
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DATABASE DESIGN
AMENDMENT 2 13,500.00 13,500.00 3,750.00 17,250.00 17,250.00
ADD: Additional 50 hours
at $75/hr for creation &
distribution of new CRF
forms (BCVA & Efficacy)
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Data Entry:
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1/3 Data Entered 50,000.00 50,000.00 50,000.00 50,000.00
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2/3 Data Entered 50,000.00 50,000.00 50,000.00 50,000.00
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3/3 Data Entered 50,000.00 50,000.00 50,000.00 50,000.00
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AMENDMENT 2
ADD: Data Management
Services relating to extra 38,080.00 38,080.00
visit, all pts, at 18
months Original contract
per page value of
$4/pg x 8 pgs x 1190 pts
573,580.00
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AMENDMENT 3
ADD: Additional Data 12,610.00 522,890.000
Management Services
based on 5 add'l pt.
Visits x 9 pages x 1190
pts x $10 per page
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ADD: ADDITIONAL
CODING REQUIREMENTS
"OTHER PROCEDURES" 5,060.00 5,060.00
PERFORMED TO DATE (NOV/01):
Clinical Review
Dept & Physician:
48 hours x $95/hr plus
2 hrs x $250/hr
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ADD: CLINICAL DATA
REVIEW PROCESS: 1 hour
per pt x approx. 96,235.00 96,235.00
1300 pts x $95/hour
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ISTA PHARMACEUTICALS
ATTACHMENT 2 - REVISED PAYMENT AND PERFORMANCE SCHEDULE
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ADJUSTMENT ADJUSTMENT
REVISED STUDY AMENDMENT 3 AMENDMENT 3 REVISED STUDY
ORIGINAL STUDY ADJUSTMENT TOTAL OCCURRING IN OCCURRING TOTAL
UNIT COST TOTAL AMENDMENT 2 AMENDMENT 2 2001 POST 2001 AMENDMENT #3
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ADD: SAE PAGE QC REVIEW: 12,825.00 1,425.00 14,250.00
150 hours x $95/hour
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PROJECT MANAGEMENT FEES
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(per month for 25 months - 5,566.00 139,150.00
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rate reflects
absorption of fees
in up front payment)
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ADD: 15 add'l months 18,075.00 271,125.00 410,275.00
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(extended to September, 2002)
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AMENDMENT 3 800,275.00
ADD: 39 months
October, 2002 - March, 2002 10,000.00 390,000.00
and monthly payment to be
revisited to establish
level continued level
of effort for Project
Management (study extended
to December, 2005)
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AMENDMENT 3
ADD: Senior Management
Services - Dr. Wayne Davis 28,500.00
6 hrs/ wk x 19 weeks to
end of 2001 x $250/hour
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ENROLLMENT TRACKING: 2,519.71 120,946.00 120,946.00 120,946.00
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Effective October, 2000 -
per month for 48 months
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AMENDMENT 3
ADD: Australia 38 hours
to May, 2001 to address
Drug & Saline Expiration 3,760.00 3,760.00
Issue
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TOTAL CONTRACT 2,938,571.00 934,245.00 3,872,816.00 343,110.00 1,658,465.00 5,845,891.00
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AMENDMENT 3 COMBINED TOTAL 2,001,575.00
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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 if net thirty (30) days terms are
not satisfied.
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