Amendment No. 1 to Contract Clinical Research Agreement between ISTA Pharmaceuticals and CroMedica Global Inc.

Contract Categories: Business Finance › Modification Agreements
Summary

ISTA Pharmaceuticals and CroMedica Global Inc. have amended their original clinical research agreement for Protocol VIT-02-08961X. Under this amendment, CroMedica will now be responsible for tracking patient enrollment, as detailed in a revised payment and performance schedule. The amendment also updates payment terms and conditions, including reimbursement procedures and timelines. All other terms, including those related to contract termination, remain unchanged. This amendment is effective as of September 15, 2000, and is accepted by both parties.

Read More Arrow
EX-10.20 2 a70567ex10-20.txt EXHIBIT 10.20 1 Exhibit 10.20 CONTRACT CLINICAL RESEARCH AGREEMENT AMENDMENT #1 - -------------------------------------------------------------------------------- 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: _______________________ KEN NEWPORT TITLE: _______________________ PRESIDENT _______________________________ ___________________________ DATE DATE Protocol VIT-02-08961X CroMedica Project # 1600 Version 1: September 15, 2000 2 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
- ---------------------------------------------------------------------------------------------- REVISED ORIGINAL ENROLMENT CONTRACT UNIT COST CONTRACT TRACKING TOTAL - ---------------------------------------------------------------------------------------------- Up front (20%) $563,525 - ---------------------------------------------------------------------------------------------- Australia Regulatory Submission $10,000 10,000 - ---------------------------------------------------------------------------------------------- CRF Finalization 6,180 8,580 - ---------------------------------------------------------------------------------------------- Site Recruitment: Canadian 200 2,400 U.S. 240 2,880 Australia 240 2,400 - ---------------------------------------------------------------------------------------------- Initiation Visits: Canadian 600 7,200 U.S. 720 18,720 Australia 1,080 10,800 - ---------------------------------------------------------------------------------------------- Interim Visits: Canadian 1,200 183,600 U.S. 1,440 1,156,680 Australia 1,280 124,800 - ---------------------------------------------------------------------------------------------- Unmasked Visits: Canadian 900 10,800 U.S. 1,080 68,040 - ---------------------------------------------------------------------------------------------- Close Out Visits: Canadian 900 10,800 U.S. 1,080 81,000 Australia 960 9,600 - ---------------------------------------------------------------------------------------------- Site Audits 2,500 125,000 - ---------------------------------------------------------------------------------------------- Australia Investigator Meeting 12,000 12,000 - ---------------------------------------------------------------------------------------------- Study Training 24,550 24,550 - ---------------------------------------------------------------------------------------------- SAE Management $300 per SAE 81,600 - ---------------------------------------------------------------------------------------------- Database Design 13,500 13,500 - ---------------------------------------------------------------------------------------------- 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 - ---------------------------------------------------------------------------------------------- Project Management Fee 5,566 139,150 (per month for 25 months) - ---------------------------------------------------------------------------------------------- Enrolment Tracking: EFFECTIVE OCTOBER, 2000 2,519.71 120,946 per month for 48 months - ---------------------------------------------------------------------------------------------- TOTAL CONTRACT $2,817,625 $120,946 $2,938,571 - ----------------------------------------------------------------------------------------------
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.