ISTA Pharmaceuticals Revised Payment and Performance Schedule (Amendments 2 & 3)

Contract Categories: Business Operations › Services Agreements
Summary

This document outlines the revised payment and performance schedule for a clinical study managed by ISTA Pharmaceuticals, reflecting changes from Amendments 2 and 3. It details updated costs, visit schedules, and adjustments for site recruitment, regulatory submissions, and monitoring visits across Canada, the U.S., and Australia. The schedule specifies increased visit rates and additional monitoring due to expanded patient populations and protocol changes, as well as the removal or addition of certain site visits. The agreement ensures all parties are aware of the revised financial and operational commitments for the study.

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EX-10.26 3 a80129ex10-26.txt EXHIBIT 10.26 Exhibit 10.26 ISTA PHARMACEUTICALS ATTACHMENT 2 - REVISED PAYMENT AND PERFORMANCE SCHEDULE
- ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ Up front (20%) 563,525.00 563,525.00 563,525.00 - ------------------------------------------------------------------------------------------------------------------------------------ Australia Regulatory Submission 10,000.00 10,000.00 10,000.00 10,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ CRF Finalization 8,580.00 8,580.00 8,580.00 8,580.00 - ------------------------------------------------------------------------------------------------------------------------------------ Site Recruitment: - --------------------------------------------------------- --------------- ----------------- CANADIAN 200.00 2,400.00 2,400.00 2,400.00 - --------------------------------------------------------- --------------- ----------------- U.S. 240.00 2,880.00 2,880.00 2,880.00 - --------------------------------------------------------- --------------- ----------------- AUSTRALIA 240.00 2,400.00 2,400.00 2,400.00 - ------------------------------------------------------------------------------------------------------------------------------------ Initiation Visits: - --------------------------------------------------------- --------------- ----------------- CANADIAN 600.00 7,200.00 7,200.00 7,200.00 - --------------------------------------------------------- --------------- ----------------- U.S. 720.00 18,720.00 18,720.00 18,720.00 - --------------------------------------------------------- --------------- ----------------- AUSTRALIA 1,080.00 10,800.00 10,800.00 10,800.00 - ------------------------------------------------------------------------------------------------------------------------------------ Interim Visits: - --------------------------------------------------------- -------------- CANADIAN 1,200.00 183,600.00 - --------------------------------------------------------- -------------- U.S. 1,440.00 1,156,680.00 - --------------------------------------------------------- -------------- AUSTRALIA 1,280.00 124,800.00 124,800.00 - --------------------------------------------------------- -------------- AMENDMENT 2 ADD: - --------------------------------------------------------------------------------------- 7 additional monitoring visits per site related to 3 interim analyses and resolution of clinical review queries not originally contracted: - --------------------------------------------------------------------------------------- Canadian - --------------------------------------------------------------------------------------- 11 sites x 7 visits 92,400.00 276,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ 58 x $1,200 = 69,600 ----------------------------------------------------- 53 x $1,800 = 95,400 ----------------------------------------------------- 120 x $1,800 = 214,200 TOTAL $379,200 22,800.00 80,400.00 379,200.00 - ------------------------------------------------------------------------------------------------------------------------------------ U.S. - ------------------------------------------------------------------------------------------------------------------------------------ 58 sites x 7 visits 584,640.00 1,741,320.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ 608 x $1,440 = 875,520 --------------------------------------------------------------------------------------------------- 229 x $2,160 = 494,640 --------------------------------------------------------------------------------------------------- 372 x $2,160 = 803,520 --------------------------------------------------------------------------------------------------- TOTAL $2,173,680 152,640.00 279,720.00 2,173,680.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ Canadian - ------------------------------------------------------------------------------------------------------------------------------------ 11 sites x 2.25 visits 1,800.00 44,550.00 44,550.00 - ------------------------------------------------------------------------------------------------------------------------------------ U.S. - ------------------------------------------------------------------------------------------------------------------------------------ 58 sites x 2.25 visits 2,160.00 281,880.00 281,880.00 - ------------------------------------------------------------------------------------------------------------------------------------ Australia - ------------------------------------------------------------------------------------------------------------------------------------ 9 sites x 5 visits 1,280.00 57,600.00 182,400.00 - ------------------------------------------------------------------------------------------------------------------------------------
ISTA PHARMACEUTICALS ATTACHMENT 2 - REVISED PAYMENT AND PERFORMANCE SCHEDULE
- ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ REMOVE: Unmasked Visits North America: - ------------------------------------------------------------------------------------------------------------------------------------ CANADIAN 900.00 10,800.00 -10,800.00 0.00 0.00 - ------------------------------------------------------------------------------------------------------------------------------------ U.S. 1,080.00 68,040.00 -68,040.00 0.00 0.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ AMENDMENT 3 ADD: Staff Training AUSTRALIA - Unmasked Monitoring Procedures: 1,000.00 1,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ Close Out Visits: - --------------------------------------------------------- ----------------------------------------------------------- CANADIAN 900.00 10,800.00 10,800.00 10,800.00 - --------------------------------------------------------- ----------------------------------------------------------- U.S. 1,080.00 81,000.00 81,000.00 81,000.00 - --------------------------------------------------------- ----------------------------------------------------------- AUSTRALIA 960.00 9,600.00 9,600.00 9,600.00 - ------------------------------------------------------------------------------------------------------------------------------------ REMOVE: Site Audits 2,500.00 125,000.00 -125,000.00 0.00 0.00 - ------------------------------------------------------------------------------------------------------------------------------------ Australia Investigator Meeting 12,000.00 12,000.00 12,000.00 12,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------- ($90x 2 hr x 58 sites) U.S. 180.00 10,440.00 - ------------------------------------------------------------------------- SAE Management $300 per SAE 81,600.00 - ------------------------------------------------------------------------- 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. - ------------------------------------------------------------------------------------------------------------------------------------ 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) - ------------------------------------------------------------------------------------------------------------------------------------ Data Entry: - ------------------------------------------------------------------------------------------------------------------------------------ 1/3 Data Entered 50,000.00 50,000.00 50,000.00 50,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ 2/3 Data Entered 50,000.00 50,000.00 50,000.00 50,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ 3/3 Data Entered 50,000.00 50,000.00 50,000.00 50,000.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ ADD: CLINICAL DATA REVIEW PROCESS: 1 hour per pt x approx. 96,235.00 96,235.00 1300 pts x $95/hour - ------------------------------------------------------------------------------------------------------------------------------------
ISTA PHARMACEUTICALS ATTACHMENT 2 - REVISED PAYMENT AND PERFORMANCE SCHEDULE
- ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ ADD: SAE PAGE QC REVIEW: 12,825.00 1,425.00 14,250.00 150 hours x $95/hour - ------------------------------------------------------------------------------------------------------------------------------------ PROJECT MANAGEMENT FEES - ------------------------------------------------------------------------------------------------------------------------------------ (per month for 25 months - 5,566.00 139,150.00 - ---------------------------- rate reflects absorption of fees in up front payment) - -------------------------------------------------------------------------------------------------------------------- ADD: 15 add'l months 18,075.00 271,125.00 410,275.00 - ---------------------------- (extended to September, 2002) - ------------------------------------------------------------------------------------------------ ---------------------------------- 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) - ------------------------------------------------------------------------------------------------------------------------------------ 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 - ------------------------------------------------------------------------------------------------------------------------------------ ENROLLMENT TRACKING: 2,519.71 120,946.00 120,946.00 120,946.00 - ----------------------------- Effective October, 2000 - per month for 48 months - ------------------------------------------------------------------------------------------------------------------------------------ AMENDMENT 3 ADD: Australia 38 hours to May, 2001 to address Drug & Saline Expiration 3,760.00 3,760.00 Issue - ------------------------------------------------------------------------------------------------------------------------------------ TOTAL CONTRACT 2,938,571.00 934,245.00 3,872,816.00 343,110.00 1,658,465.00 5,845,891.00 - ------------------------------------------------------------------------------------------------------------------------------------ AMENDMENT 3 COMBINED TOTAL 2,001,575.00 - ------------------------------------------------------------------------------------------------------------------------------------ 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. - ------------------------------------------------------------------------------------------------------------------------------------