NUMODA PROJECT AGREEMENT FOR PROTOCOL #'s: Lm-LLO-E7-15 and Lm-LLO-E7-07 (Two Trials — TRIAL 1 in India, and TRIAL 2 in the U.S.
Exhibit 10.3
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
NUMODA
PROJECT AGREEMENT FOR PROTOCOL #'s:
Lm-LLO-E7-15 and Lm-LLO-E7-07
(Two Trials — TRIAL 1 in India, and TRIAL 2 in the U.S.
|
Protocol Number: Lm-LLO-E7-15 (conducted in India) Protocol Title: A Randomized, Active Therapy Controlled Phase
2 Study to Assess the Safety and |
|
Protocol Number : Lm-LLO-E7-07 (conducted in the United States) Protocol Title: A Randomized, Single Blind, Placebo Controlled
Phase 2 Study to Assess the Safety |
Pursuant to the Master Agreement entered into by Advaxis, Inc. ("ADVAXIS") and Numoda Corporation ("Numoda") on June 19, 2009 ("MA"), this Project Agreement (PA) and attachments, including:
| A. | Description of Services — Project Specifications |
| B. | Integration Assumptions; Systems, and Reporting Tools |
| C. | Project Budget |
| D. | Payment Schedule/Terms |
| E. | Transfer of Regulatory Obligations |
is entered into and is effective on the Effective Date shown below. Only when specified in the MA, the parties agree that Numoda shall perform the Project Agreement in accordance with and is subject to all the terms and conditions of the MA. The Project Agreement is Incorporated in and made a part of the MA. In the event that a discrepancy exists between the terms of the MA and this PA, this PA shall supersede.
Effective Date: July 1, 2009
The parties agree as follows:
| 1. | Scope of Work: Numoda agrees to provide services for this Study ("Project") as outlined in Attachment A (Description of Services — Project Specifications). The Parties understand Attachments A, B, C and D may need some adjustments after the date of signing this Project Agreement, in order to reflect any material differences between the protocol provided to Numoda and the final protocol. ADVAXIS transfers to Numoda the obligations listed in Attachment E in accordance with 21 CFR §312.52. |
| 2. | Payment: Payments will be made in accordance with Attachment D. Upon final reconciliation, additional services not included in the scope of work, that was mutually agreed to in writing; and having been done, will be billed to ADVAXIS, and any overpayment attributable to services not rendered or costs not incurred, will be refunded to ADVAXIS. |
| 3. | Term: The term of this Project Agreement shall commence on the Effective Date and shall continue until the Project as described in this Project Agreement is completed, unless this Project Agreement is terminated earlier in accordance with the MA. |
| 4. | Contact: Until further notice and for the purpose of this Project Agreement, Numoda's contact within ADVAXIS will be Xxxx Xxxxxxx, and ADVAXIS' contact within Numoda will be Xxxx Xxxxxxx, the Project Controller. |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
| For ADVAXIS: | For Numoda Corporation: | |||
| Sign: | /s/ Xxxx Xxxxxxx | Sign: | /s/ Xxx Xxxxxxxxx | |
| Print: | Xxxx Xxxxxxx | Print: | Xxx Xxxxxxxxx | |
| Title: | EVP: Science & Operations | Title: | COO | |
| Date: | July 8, 2009 | Date: | July 8, 2009 | |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment A:
DESCRIPTION OF SERVICES - PROJECT SPECIFICATIONS
| Overall Assumptions | India Trial | US Trial | ||
| Protocol Number | Xx-XXX-X0-00 | Xx-XXX-X0-00 | ||
| Xxxxx Xxxxx | Xxxxx XX, Xxxxx | Phase II, U.S. | ||
| Compound | ADXS11-001 | ADXS11-0011 | ||
| Number of Sites | 12 | 20 | ||
| Number of Patients Screened | 122 | 88 | ||
| Number of Patients Enrolled | 110 | 80 | ||
| Number of Patients Completed | 110 | 80 | ||
| Country | India Only | USA Only | ||
| Startup (Number of Weeks) From signed PA to FPFV Recruitment (Number of Weeks) (Tria1 #2 totals 36 months for | 13 | 8.5 | ||
| Treatment (Number of Weeks) Recruitment + Treatment) | 13 | 26 | ||
| Closeout (Number of Weeks) | 52 | 130 | ||
| 13 | 8.5 | |||
| Total Project Duration (Weeks) | 91 (21 Mo's) | 173 (40 Mo's) | ||
| GC Project Management Assumptions | ||||
| Number of Status Reports | Unlimited within the | Unlimited within the | ||
| Number of Kick Off Meetings | scope | scope | ||
| Number of Investigator Meetings | 1 | 1 | ||
| Number of Newsletters | 1 | 0 | ||
| Number of Teleconferences (1 Hour Calls) | 21 | 36 | ||
| 91 | 173 | |||
| Monitoring Assumptions | ||||
| Qualification Visits | 12 | 22 | ||
| Site Initiation Visits | 12 | 20 | ||
| Interim Monitoring Visits | 97 | 312 | ||
| Closeout Visits | 12 | 20 | ||
| Information/Data Management Assumptions | ||||
| Total Number of CRF Pages per Patient | 100 | 90 | ||
| Number of Unique CRF Pages per Patient | 20 | 22 | ||
| Total Number of CRF Pages | 11,904 | 11,688 | ||
| Unlimited within the | Unlimited within the | |||
| Total Number of Queries | scope | scope | ||
| Total Number of Users | 30 | 50 | ||
| Number of Interim Analyses | 1 | 2 | ||
| Con Meds per Patient | 10 | 10 | ||
| Diseases per Xxxxxxx | 00 | 00 | ||
| XX’s per Patient | 10 | 10 | ||
| Biostats Assumptions | ||||
| Statistical Analysis Plan | 1 | 1 | ||
| Tables | 24 | 24 | ||
| Listings | 30 | 30 | ||
| Figures | 6 | 6 | ||
| Final Study Report | 1 | 1 |
| Safety Assumptions | ||||
| SAE’s | 40 | 15 | ||
| Safety Database | 1 | 1 | ||
| Estimated Timeline | ||||
| Contract Signed | Jul-09 | Jul-09 | ||
| First Patient Enrolled | Oct-09 | Sep-09 | ||
| Last Patient Enrolled | Jan-10 | Mar-10 | ||
| Last Patient Out | Jan-11 | Sep-12 | ||
| Final Clinical Study Report | Apr-11 | Nov-12 |
Note: The Project Budget in Attachment C is based on the specifications and integration assumptions listed here on Attachment A, and in Attachment B.
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment B:
INTEGRATION ASSUMPTIONS
| Numoda | |||
| Integrations Assumptions | |||
| Single Integrated Portal | 1 | ||
| Custom Integration and Interoperability | 3 | ||
| Ongoing Consolidation & Reconciliation | 1 | ||
| Clinical Project Accounting, Contracting (Vendor Negotiation, Documentation, Monitoring) | 1 | ||
| Systems and Reporting Tools | |||
| Start-up & Regulatory Administration (4 Tool Sets) | 1 | ||
| Project Timelines | |||
| Site Launch Logistics System (SLLS) | |||
| Communication Plan | |||
| Roles and Responsibilities | |||
| Clinical Project Accounting Systems (3 Tool Sets) | 1 | ||
| Key Value Tracking | |||
| Percentage of Completion Reporting | |||
| CPA Procedures | |||
| Planning, Procurement, Contracting (4 Tool Sets) | 1 | ||
| Vendor Contract Status | |||
| Business Analysis Report | |||
| Key Value Points | |||
| Business Integration | |||
| Screening and Enrollment Reporting Tools (9 Tool Sets) | 1 | ||
| Executive Summary | |||
| Enrollment Status | |||
| Subject Status | |||
| Early Termination | |||
| Screen Failure | |||
| Enrollment by Site | |||
| Patient Source Summary | |||
| Site Info | |||
| Team Contact Info | |||
| Document Management System (7 Tool Sets) | 1 | ||
| Protocol and Amendments | |||
| Newsletters | |||
| Training Materials | |||
| Project Management | |||
| Waivers | |||
| Upload | |||
| Remove File | |||
| Monitoring Systems (7 Tool Sets) | 1 | ||
| Data View | |||
| Monitoring Summary | |||
| Query Tracking | |||
| Comments | |||
| Supplies Status For Monitors | |||
| Sync Status Report | |||
| Trip Report Management | |||
| Data Management and Integrations (17 Tool Sets) | 1 | ||
| Data View | |||
| IVR Reconciliation | |||
| Data Extractor | |||
| Edit Checks | |||
| Query Frequency | |||
| Edit Check Frequency | |||
| Query Status Summary | |||
| Coding System | |||
| PI Sign-Off | |||
| AE/Cmed/Med HX Summary | |||
| Various Lab Reconciliation Tools (7) | |||
| Early Safety Signal Detection System (5 Tool Sets) | 1 | ||
| AE/SAE | |||
| Subject Safety Reports | |||
| Subject Status | |||
| Early Terminators | |||
| Site Info | |||
| Supplies Management System (3 Tool Sets) | 1 | ||
| Site Supplies Status | |||
| Site Transaction History | |||
| Site Supplies Summary | |||
| Project Management Administration Tools (11 Tool Sets) | 1 | ||
| User Management | |||
| Login History | |||
| Failed Logins | |||
| Database SQL Tools | |||
| IVR Database View | |||
| Team Contact Management | |||
| Message System Management | |||
| Shipment Address Management | |||
| Document Group Management | |||
| Trip Report Administration | |||
| IVRS Administration | |||
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment C:
| India Trial | US Trial | |||||||
| Standardized Professional Fees | ||||||||
| Start Up, Regulatory & Sites Management | $ | 122,362 | $ | 250,604 | ||||
| Monitoring | $ | 254,613 | $ | 1,268,014 | ||||
| Project Management | $ | 151,469 | $ | 396,950 | ||||
| Data Management | $ | 226,063 | $ | 289,759 | ||||
| Safety, Medical & Scientific Services | $ | 79,898 | $ | 183,446 | ||||
| Biostatistics | $ | 145,460 | $ | 167,804 | ||||
| Medical Writing | $ | 45,000 | $ | 60,000 | ||||
| Total Standardized Professional Fees | $ | 1,024,885 | $ | 2,616,577 | ||||
| Efficiency Credit | $ | (96,848 | ) | |||||
| sub-total | $ | 928,037 | ||||||
| Products | ||||||||
| Role-Based Portals Connecting to Interoperable Neural Network | $ | 30,457 | $ | 55,404 | ||||
| All Custom Complete Integration and Interoperability | $ | 45,943 | $ | 83,323 | ||||
| Ongoing Consolidation and Reconciliation | $ | 21,003 | $ | 37,493 | ||||
| Clinical Project Accounting Vendor Management & Financial Reconciliation | $ | 55,498 | $ | 98,046 | ||||
| Screening and Enrollment System | $ | 16,858 | $ | 25,359 | ||||
| Site Compliance Tools | $ | 34,659 | $ | 55,548 | ||||
| Real Time Reporting Tools (with Document Management System) | $ | 27,202 | $ | 57,072 | ||||
| Integrated, Web-Based Monitoring system (with Centralized Trip Reports) | $ | 28,945 | $ | 68,814 | ||||
| Early Safety Signal Detection System | $ | 32,053 | $ | 57,294 | ||||
| Clinical Project Accounting System | $ | 35,819 | $ | 90,508 | ||||
| Interoperable System for Supplies and Re-Supply Logistics Management | $ | 19,192 | $ | 33,353 | ||||
| IVRS System | $ | 60,264 | $ | 122,963 | ||||
| IVRS Diary Activities | $ | - | $ | - | ||||
| Total Products | $ | 407,891 | $ | 783,176 | ||||
| Efficiency Credit | $ | (113,749 | ) | |||||
| sub-total | $ | 294,142 | ||||||
| Pass-Through Expenses (Estimated) | ||||||||
| EDC | Free | Free | ||||||
| Investigator Fees | $ | 496,650 | $ | 1,002,560 | ||||
| Investigator Meeting Organization | $ | 21,000 | $ | 21,000 | ||||
| Investigator Meeting Travel | $ | 47,565 | $ | 49,350 | ||||
| Monitor Travel | $ | 84,058 | $ | 370,448 | ||||
| Travel to Training Meetings | $ | 2,310 | $ | 34,150 | ||||
| Travel to Client Meetings | $ | 1,050 | $ | 1,050 | ||||
| Travel for Audit Visits | $ | 1,260 | $ | 2,100 | ||||
| Meetings and Teleconferences | $ | 4,778 | $ | 18,199 | ||||
| IVRS Expenses | $ | 22,680 | $ | 57,456 | ||||
| Printing, Shipping and Other | $ | 7,749 | $ | 18,900 | ||||
| Regulatory and EC Fees | $ | 6,300 | $ | 10,500 | ||||
| Translation | $ | 12,600 | $ | 55,260 | ||||
| Lab Fees | $ | 207,900 | $ | 533,845 | ||||
| Drug Supply | $ | - | $ | 124,960 | ||||
| Specialty Lab/ECG | $ | 103,950 | $ | - | ||||
| Central Pathologists | $ | - | $ | 25,200 | ||||
| Other | $ | - | $ | 15,750 | ||||
| Total Pass-Through Expenses | $ | 1,019,850 | $ | 2,340,728 | ||||
| Total Project Cost | $ | 2,242,029 | $ | 5,740,480 | ||||
| Less: Numoda Investment | $ | (250,000 | ) | $ | (100,000 | ) | ||
| Net Total Due from Advaxis | $ | 1,992,029 | $ | 5,640,480 | ||||
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
| Trial Pricing - Advaxis (Two Trial Scenario) | INDIA Trial | Efficiencies from US Trial | Discounted India Trial | US Trial | Grand Total- Both Trials | |||||||||||||||
| Budget Summary | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | |||||||||||||||
| NUMODA GENERAL CONTRACTOR AND INTEGRATION SERVICES: | ||||||||||||||||||||
| Role-Based Portals Connecting to Interoperable Neural Network | $ | 30,457 | $ | (9,359 | ) | $ | 21,098 | $ | 55,404 | $ | 76,502 | |||||||||
| All Custom Complete Integration and Interoperability | $ | 45,943 | $ | (12,673 | ) | $ | 33,270 | $ | 63,323 | $ | 116,593 | |||||||||
| Ongoing Consolidation and Reconciliation | $ | 21,003 | $ | (6,376 | ) | $ | 14,627 | $ | 37,493 | $ | 52,120 | |||||||||
| Planning, Procurement & Contracting | $ | 27,748 | $ | (8,753 | ) | $ | 18,995 | $ | 47,552 | $ | 56,547 | |||||||||
| Clinical Project Accounting Vendor Management, Documentation, Monitoring & Financial Reconciliation | $ | 27,748 | $ | (9,073 | ) | $ | 18,675 | $ | 50,494 | $ | 69,169 | |||||||||
| CLINICAL PROFESSIONAL SERVICES: | ||||||||||||||||||||
| Start Up, Regulatory & Site Management | $ | 122,362 | $ | 0 | $ | 122,362 | $ | 250,604 | $ | 372,966 | ||||||||||
| Monitoring | $ | 254,613 | $ | 0 | $ | 254,613 | $ | 1,288,014 | $ | 1,522,627 | ||||||||||
| Project Management | $ | 151,489 | $ | (49,908 | ) | $ | 101,581 | $ | 396,950 | $ | 498,531 | |||||||||
| Data Management | $ | 226,063 | $ | (46,940 | ) | $ | 179,123 | $ | 289,759 | $ | 468,882 | |||||||||
| Safety, Medical & Scientific Services | $ | 79,898 | $ | 0 | $ | 79,898 | $ | 183,446 | $ | 283,344 | ||||||||||
| Biostatistics & Medical Writing | $ | 190,460 | $ | 0 | $ | 190,460 | $ | 227,804 | $ | 418,264 | ||||||||||
| SUBTOTAL PROFESSIONAL FEES | $ | 1,177,784 | $ | (143,082 | ) | $ | 1,034,702 | $ | 2,890,843 | $ | 3,935,545 | |||||||||
| Budget Summary | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | |||||||||||||||
| NUMODA SYSTEMS AND REPORTING TOOLS: | ||||||||||||||||||||
| Screening and Enrollment systems | $ | 16,858 | $ | (3,804 | ) | $ | 13,054 | $ | 25,359 | $ | 38,413 | |||||||||
| Site compliance Tools | $ | 34,659 | $ | (7,554 | ) | $ | 27,105 | $ | 55,546 | $ | 82,651 | |||||||||
| Real Time Reporting Tools (with Document Management system) | $ | 27,202 | $ | (7,762 | ) | $ | 19,440 | $ | 57,072 | $ | 76,512 | |||||||||
| Integrated, Web-Based Monitoring system (with Centralized Trip Reports) | $ | 28,945 | $ | (9,087 | ) | $ | 19,858 | $ | 66,814 | $ | 86,672 | |||||||||
| Early Safety Signal Detection System | $ | 32,053 | $ | (7,094 | ) | $ | 24,959 | $ | 57,294 | $ | 82,253 | |||||||||
| Clinical Project Accounting System | $ | 35,819 | $ | (10,955 | ) | $ | 24,864 | $ | 90,508 | $ | 115,372 | |||||||||
| Interoperable system for Supplies and Re-Supply Logistics Management | $ | 19,192 | $ | (4,536 | ) | $ | 14,656 | $ | 33,353 | $ | 48,009 | |||||||||
| IVRS System | $ | 60,264 | $ | (16,723 | ) | $ | 43,541 | $ | 122,963 | $ | 156,504 | |||||||||
| IVRS Diary Activities | $ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
| SUBTOTAL NUMODA SYSTEMS AND REPORTING TOOLS | $ | 254,992 | $ | (67,515 | ) | $ | 187,477 | $ | 508,909 | $ | 686,386 | |||||||||
| TOTAL GENERAL CONTRACTOR SERVICES, INTEGRATIONS, PROFESSIONAL FEES, AND SYSTEMS AND TOOLS | $ | 1,432,776 | $ | (210,596 | ) | $ | 1,222,180 | $ | 3,399,752 | $ | 4,621,932 | |||||||||
| Budget Summary | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | Numoda Contract Value | |||||||||||||||
| VALUE ADDED SUPPLIER ITEMS (Estimated) | ||||||||||||||||||||
| EDC | $ | 0 | $ | 0 | $ | 0 | $ | 0 | $ | 0 | ||||||||||
| Investigator Fees | $ | 496,650 | $ | 0 | $ | 496,650 | $ | 1,002,560 | $ | 1,499,210 | ||||||||||
| Investigator Meeting Organization | $ | 21,000 | $ | 0 | $ | 21,000 | $ | 21,000 | $ | 42,000 | ||||||||||
| Investigator Meeting Travel | $ | 47,665 | $ | 0 | $ | 47,565 | $ | 49,350 | $ | 96,915 | ||||||||||
| Monitor Travel | $ | 84,058 | $ | 0 | $ | 84,058 | $ | 370,448 | $ | 454,506 | ||||||||||
| Travel to Training Meetings | $ | 2,310 | $ | 0 | $ | 2,310 | $ | 34,150 | $ | 36,460 | ||||||||||
| Travel to Client Meetings | $ | 1,050 | $ | 0 | $ | 1,050 | $ | 1,050 | $ | 2,100 | ||||||||||
| Travel for Audit Visits | $ | 1,260 | $ | 0 | $ | 1,260 | $ | 2,100 | $ | 3,360 | ||||||||||
| Meetings and Teleconferences | $ | 4,778 | $ | 0 | $ | 4,778 | $ | 18,199 | $ | 22,977 | ||||||||||
| IVRS Expenses | $ | 22,680 | $ | 0 | $ | 22,680 | $ | 57,456 | $ | 80,136 | ||||||||||
| Printing, Shipping and Other | $ | 7,749 | $ | 0 | $ | 7,749 | $ | 18,900 | $ | 26,649 | ||||||||||
| Regulatory and EC Fees | $ | 6,300 | $ | 0 | $ | 6,300 | $ | 10,500 | $ | 16,800 | ||||||||||
| Translation | $ | 12,600 | $ | 0 | $ | 12,600 | $ | 55,260 | $ | 67,850 | ||||||||||
| Lab Fees | $ | 207,900 | $ | 0 | $ | 207,900 | $ | 533,845 | $ | 741,745 | ||||||||||
| Drug Supply | $ | 0 | $ | 0 | $ | 0 | $ | 124,960 | $ | 124,960 | ||||||||||
| Specialty Lab/ECG | $ | 103,850 | $ | 0 | $ | 103,950 | $ | 0 | $ | 103,950 | ||||||||||
| Central Pathologists | $ | 0 | $ | 0 | $ | 0 | $ | 25,200 | $ | 25,200 | ||||||||||
| Other | $ | 0 | $ | 0 | $ | 0 | $ | 15,750 | $ | 15,760 | ||||||||||
| TOTAL ESTIMATED PASS THROUGH COSTS | $ | 1,019,850 | $ | 0 | $ | 1,019,850 | $ | 2,340,728 | $ | 3,360,578 | ||||||||||
| TOTAL PROJECT BUDGET | $ | 2,452,626 | $ | (210,597 | ) | $ | 2,242,029 | $ | 5,740,480 | $ | 7,982,509 | |||||||||
| LESS: NUMODA INVESTMENT | $ | (250,000 | ) | $ | 0 | $ | (250,000 | ) | $ | (100,000 | ) | $ | (350,000 | ) | ||||||
| NET TOTAL DUE from ADVAXIS | $ | 2,202,626 | $ | (210,597 | ) | $ | 1,992,029 | $ | 5,640,480 | $ | 7,632,509 | |||||||||
| -9.56 | % | -10.57 | % | |||||||||||||||||
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Notes TO PROJECT BUDGET:
| (A) | Budget for Trial 1 includes an Efficiency Credit of $210,597 that is given with the understanding that Numoda will be providing services to Advaxis for two trials, as long as Numoda's work on the first Trial has been satisfactory. The actual, final scope of the second trial is yet to be determined, therefore prices for Trial 2 shown above, may be adjusted, if the scope is changed .. |
| (B) | Budget for Trial 1 is based on the protocol dated May 30, 2009. Budget for Trial 2 is based on protocol dated December 3, 2008. |
| (C) | Per the Master Agreement, paragraph 7.0 Change Orders, it is understood that Advaxis may seek to materially change the scope of Services and/or project assumptions agreed upon in the Project Agreement for either trial, such as can occur when there are amendments to the Protocol. Both parties agree to negotiate in good faith to reach an agreement on a budget and assumptions for such changes. |
| (D) | The $350,000 Numoda Investment (which includes the $150,000 Investment committed in previously executed LOI documents between the parties) is payable to Numoda in Advaxis common stock, based on the average of the five (5) days stock price, prior to the execution of a Stock Purchase Agreement. |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment D:
PAYMENT SCHEDULE
| Start-Up Payment (July 15, 2009) | $ | 212,029 |
Trial 1 Lm-LLO-E7-15 (110 patients/12 sites, in India)
| Easy Level Monthly Payment Plan assumes 20 monthly installments of $89,000 each | ||||||
| 2009 – 4 months | $ | 356,000 | ||||
| Beginning Sept. 2009 thru April, 2011 | ||||||
| 2010 – 12 months | $ | 1,068,000 | ||||
| 2011 – 4 months | $ | 356,000 | ||||
| Sub-total Monthly Payments (20) | $ | 1,780,000 | ||||
| TOTAL TRIAL 1 -India | $ | 1,992,029 | ||||
| Start-Up Payment (August 15, 2009) | $ | 564,480 |
Trial 2 Lm-LLO-E7-07 (80 patients/20 sites, in USA)
| 2009 – 3 Months | $ | 423,000 | ||||||
| 2010 – 12 months | Easy Level Monthly Payment Plan assumes 36 monthly installments of $141,000 each | $ | 1,692,000 | |||||
| 2011 – 12 months | Beginning Sept, 2009 thru August, 2012 | $ | 1,692,000 | |||||
| 2012 – 9 months | $ | 1,269,000 | ||||||
| Sub-total Monthly Payments (36) | $ | 5,076,000 | ||||||
| TOTAL TRIAL 2 – US | $ | 5,640,480 |
Notes to Payment Schedule:
| (a) | Monthly Payments are due an the 15th of each month. |
| (b) | Numoda shall mail and/or email invoices to Advaxis per Advaxis' instructions. |
| (c) | Advaxis shall make all payments payable to Numoda Corporation, by wire transfer, EFT, or ACH. Advaxis shall send funds to Harleysville National Bank, as follows: |
| Bank: Harleysville National Bank | |
| ABA Number | - xxxxxxxxx |
| Account Name | - Numoda Corporation |
| Account Number | - xxxxxxxxxx |
| ADVAXIS, INC. | PROTOCOL NUMBER: Lm-LLO-E7-07 & 15, Two Trials |
Attachment E:
Transfer of Regulatory Obligations
1.0 Numode will retain records and reports associated with the Project in accordance with 21 CFR 312.57(b)
2.0 Numoda will conduct the services set forth in this Project Agreement in accordance with Clinical Protocols, Lm-LLO-E7-15 and Lm-LLO-E7-07.
