Second Amendment to Contract Clinical Research Agreement between ISTA Pharmaceuticals and CroMedica Global Inc.

Contract Categories: Business Operations › Development Agreements
Summary

ISTA Pharmaceuticals and CroMedica Global Inc. have amended their original clinical research agreement to adjust the scope of services and payment terms. The amendment increases the number of monitoring visits, extends project management services, revises estimates for serious adverse event management, and increases data management services, while removing certain monitoring and audit services. It also sets a rate for potential future data collection during a three-year follow-up period. Payment terms and schedules are updated, with ISTA reimbursing CroMedica for reasonable costs within 30 days of invoicing.

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EX-10.21 3 a70567ex10-21.txt EXHIBIT 10.21 1 CONTRACT CLINICAL RESEARCH AGREEMENT AMENDMENT # 2 - -------------------------------------------------------------------------------- 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, and Amendment #1, dated October 11, 2000, the following amendment(s) are hereby accepted by both parties: ADJUSTMENT TO SCOPE OF SERVICES As agreed by both parties, the original scope of services provided by CroMedica Global under the terms of the original contract are hereby revised to reflect the increase in the number of monitoring visits, extension of project management services, a revision to the SAE management estimate and increases to the data management services, while removing unmasked monitoring visits, and the site audit services. A revised Attachment 2, Payment and Performance Schedule is attached hereto and will replace any previous payment and performance schedules. DATA COLLECTION IN FOLLOW UP PERIOD This amendment further recognizes that ISTA may have a future need for Data Management Services in the form of data collection during the 3 year follow up period to the study. Once the scope of services required by ISTA is defined in relation to this follow up period, and should it be the desire of ISTA to engage CroMedica in such work, CroMedica hereby agrees to a today rate of USD $10.00 per CRF page to undertake the additional data collection services. ACCEPTANCE OF AMENDMENT TO AGREEMENT BY AND BETWEEN: SPONSOR: CONTRACTOR: ISTA PHARMACEUTICALS CROMEDICA GLOBAL INC. - ----------------------------------- ----------------------------------- NAME: KEN NEWPORT ----------------------------- TITLE: PRESIDENT ----------------------------- - ----------------------------------- ----------------------------------- DATE DATE 2 ATTACHMENT 2 PAYMENT AND PERFORMANCE SCHEDULE REVISED - NOVEMBER 15, 2000 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
- ---------------------------------------------------------------------------------------------- ORIGINAL REVISED UNIT COST STUDY TOTAL ADJUSTMENT STUDY TOTAL - ---------------------------------------------------------------------------------------------- Up front (20%) $563,525 $563,525 - ---------------------------------------------------------------------------------------------- Australia Regulatory Submission $10,000 10,000 10,000 - ---------------------------------------------------------------------------------------------- CRF Finalization 8,580 8,580 8,580 - ---------------------------------------------------------------------------------------------- Site Recruitment: Canadian 200 2,400 2,400 U.S. 240 2,880 2,880 Australia 240 2,400 2,400 - ---------------------------------------------------------------------------------------------- Initiation Visits: Canadian 600 7,200 7,200 U.S. 720 18,720 18,720 Australia 1,080 10,800 10,800 - ---------------------------------------------------------------------------------------------- Interim Visits: Canadian 1,200 183,600 276,000 U.S. 1,440 1,156,680 1,741,320 Australia 1,280 124,800 124,800 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 1,200 92,400 U.S. 58 sites x 7 visits 1,440 584,640 - ---------------------------------------------------------------------------------------------- REMOVE: Unmasked Visits: Canadian 900 10,800 (10,800) 0 U.S. 1,080 68,040 (68,040) 0 - ---------------------------------------------------------------------------------------------- Close Out Visits: 10,800 Canadian 900 10,800 81,000 U.S. 1,080 81,000 9,600 Australia 960 9,600 - ----------------------------------------------------------------------------------------------
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- ------------------------------------------------------------------------------------------------ ORIGINAL REVISED UNIT COST STUDY TOTAL ADJUSTMENT STUDY TOTAL - ------------------------------------------------------------------------------------------------ REMOVE: Site Audits 2,500 125,000 (125,000) 0 - ------------------------------------------------------------------------------------------------ Australia Investigator Meeting 12,000 12,000 12,000 - ------------------------------------------------------------------------------------------------ Study Training 24,550 24,550 36,640 ADD: Training for Protocol Amendment, new CRFs, rescue data - -- CRAs and at sites -- 2 hours per site. ($75 x 2hr x 11 sites) Canadian 150 1,650 ($90 x 2 hr x 58 sites) U.S. 180 10,440 - ------------------------------------------------------------------------------------------------ SAE Management $300 per SAE 81,600 217,600 ADD: SAE Management Estimate of 272 additional SAEs representing an overall 80% SAE rate for the $500 per SAE 136,000 study. - ------------------------------------------------------------------------------------------------ Database Design 13,500 13,500 17,250 ADD: Additional 50 hours at $75/hr for creation & distribution of new CRF forms (BCVA & Efficacy) 3,750 - ------------------------------------------------------------------------------------------------ Data Entry: 1/3 Data Entered 50,000 50,000 50,000 2/3 Data Entered 50,000 50,000 50,000 3/3 Data Entered 50,000 50,000 50,000 - ------------------------------------------------------------------------------------------------ ADD: Data Management Services relating to extra visit, all pts, at 18 months Original contract per page value 38,080 38,080 of $4/pg x 8 pgs x 1190 pts - ------------------------------------------------------------------------------------------------ Project Management Fees (per month for 25 months - 5,566 139,150 410,275 rate reflects absorption of fees in up front payment) ADD: 15 add'l months 18,075 271,125 (extended to September, 2002) - ------------------------------------------------------------------------------------------------ Enrollment Tracking: Effective October, 2000 - 2,519.71 120,946 120,946 per month for 48 months - ------------------------------------------------------------------------------------------------ TOTAL CONTRACT $2,938,571 $934,245 $3,872,816 - ------------------------------------------------------------------------------------------------
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.