Clinical Trial Budget Agreement for UCI Protocol No. 14-25 Between Aethlon and University of California, Irvine
This agreement outlines the budget for a clinical trial led by Dr. Edward Nelson at the University of California, Irvine, studying plasma exosome concentration in cancer patients. It details startup charges, per subject visit costs, and variable protocol-related fees, including administrative, data management, and oversight expenses. The agreement specifies charges for up to 45 subjects, indirect costs, and additional fees for annual renewals and other procedures. The document sets financial terms and obligations for conducting the trial, ensuring both parties understand the costs and payment triggers involved.
Exhibit 10.3
Protocol No.: UCI 14-25 Plasma Exosome Concentration in Cancer Patients Undergoing Treatment
Protocol Target Accrual: 45 PI: Edward Nelson, MD
Short Title: Plasma Exosome Concentration in Cancer Patients Undergoing Treatment
Startup Charges
| Event | Negotiated Charge |
| Protocol Set-Up & Administration Fees (Feasibility, Budget, Medicare Cost Coverage, IRB Application/Doc Prep, IRB Institutional Review Fee, Annual CRC Administrative Fees, and Study Supplies) | 15,105.00 |
| Subtotal: | 15,105.00 | |||
| Overhead Charges @ 0.0%: | 0.00 | |||
| Indirect Costs @ 26.0%: | 3,927.30 | |||
| Total Startup Charges: | 19,032.30 |
Per Subject Visit Charges (Items include 26.0% indirect charges)
| # occurances | Event | # of Subjects | Visit Reimbursement |
| 1 | Phlebotomy | 45 | 84.00 |
| 1 | Cancer Center Data Management | 45 | 1,497.00 |
| 1 | Study Oversight, Coordination, and Biostatistics | 45 | 1,778.00 |
| Total Subject Charges (Maximum) | 3,359.00 |
| Direct Cost Subtotal for (1) Subjects: | 2,665.87 | |||
| Indirect Costs @ 26.0%: | 693.13 | |||
| Total Per Subject Charges for (1) Subjects | 3,359.00 | |||
| Total Per Subject Charges for (45) Subjects | 151,155.00 |
Protocol Related Variable Passthrough Charges (Items include 26.0% indirect charges)
| Event | Negotiated Charge | |||
| Protocol Annual Renewal Prep Fee (Payment triggered at IRB renewal. Includes study project management outside visit activities for sponsor site visits, IRB renewal prep, bill reconciliation, OnCore managment, SAE reporting, IRB modifications, close out and storage, etc.) | 7,000.00 | |||
| IRB Committee Renewal Review Fee | 1,039.50 | |||
| Consent Translation (Pass through cost, based on language and length of document) | TBD | |||
| Other Tests/Procedures not included above | TBD |
