- ------------------------------------------------------------------------------------------------------------------------------------ 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. - ------------------------------------------------------------------------------------------------------------------------------------
