Amendment #2 to Clinical Research Organization Services Agreement Protocol # ORA-D-015 between Oramed, Inc. and Integrium, LLC
Exhibit 10.2
CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO ORAMED PHARMACEUTICALS INC. IF PUBLICLY DISCLOSED. OMISSIONS ARE DENOTED IN BRACKETS THROUGHOUT THIS EXHIBIT.
Integrium, LLC. | Confidential |
Amendment #2 to Clinical Research Organization Services Agreement
Protocol # ORA-D-015
between Oramed, Inc. and Integrium, LLC
BASIC PROVISIONS
Study Title: (the “Study”): “A Placebo-controlled, Multi-center, Randomized, Phase 2b Study to Evaluate the Efficacy and Safety of ORMD-0801 in Type 2 Diabetes Mellitus Patients with Inadequate Glycemic Control on Oral Therapy”
Protocol: # (the “Protocol”): ORA-D-015, Amendment #3 dated April 4, 2019
Purpose of Amendment: Revision to payment schedule based on actuals invoiced and paid to date as well as revision to future payments based on the Amendment #1 revised contract values. This is essentially an administrative amendment and total contract value is unchanged.
Projected Time Period of the Services: Effective from November 1, 2017 to May 15, 2020.
Revised Study Budget/Payment Schedule:
(a) Revised Budget: Attached Exhibit 3
Original Contract | Amendment #1 | Revised Total | ||||||
Service Fees | $[+] | $[+] | $[+] | |||||
Grants/Site Expenses | $[+] | $[+] | $[+] | |||||
Pass-through Expenses | $[+] | $[+] | $[+] | |||||
Total Cost | $[+] | $[+] | $[+] |
(b) Revised Payment Schedule/Advanced Payments: Payments will be made based on the revised payment schedule, Exhibit 4. All previous payments made by Oramed under the Contract Research Organization Services Agreement will be credited and reconciled with the value of this Amendment #2.
All other provisions of the Clinical Research Organization Services Agreement shall remain unchanged and in effect.
Amendment #2 to Oramed Clinial Research Organization Services Agreement
Protocol # ORA-D-015
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Integrium, LLC. | Confidential |
This Amendment #2 (“Second Amendment”) to the Contract Research Organization Agreement (the “Agreement”) made this 14th day of May, 2019, by and between Oramed Ltd. (“Sponsor”), an Israeli company, with principal offices located at Hi-Tech Park 2/4 Givat-Ram, P.O. Box 39098, Jerusalem, 91390, Israel (“Sponsor”), and Integrium, LLC., a California limited liability company with its principal place of business located at 14351 Myford Road, Suite A, Tustin, CA 92780 (“Integrium”).
WHEREAS, the Agreement by and between Sponsor and Integrium was effective on November 1, 2017; and
WHEREAS, Amendment #1 to the Agreement was effective on April 18, 2019; and
WHEREAS, the parties now enter into this Second Amendment (an “Administrative Amendment”) to the Agreement for the purposes of amending the payment schedule to reflect actual payments received and paid by Oramed as indicated on page one of this Second Amendment; and
NOW, THEREFORE, for good and valuable consideration contained herein, the exchange, receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1. Compensation and Payment
For its performance of the services under this Agreement, Integrium shall receive compensation as set forth in the Payment Schedule included, Exhibit “1”. All invoices shall be paid within thirty (30) days of invoice date. Integrium shall not be responsible for any Study timeline delays, due to lack of payment or late payment from Sponsor.
2. Representations and Warranties of Integrium
Integrium represents and warrants to Sponsor that all of the representations and warranties made by Integrium in the Agreement are true and correct on the date of this Amendment #2 to the Agreement as if made on the date of this Amendment #2.
(Remainder of Page Intentionally Left Blank)
Amendment #2 to Oramed Clinial Research Organization Services Agreement
Protocol # ORA-D-015
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Integrium, LLC. | Confidential |
IN WITNESS THEREOF, this Service Order has been executed by the parties hereto through their duly authorized officers as of the date set forth above.
For and on behalf of | For and on behalf of | ||
Integrium, LLC | Oramed Ltd. | ||
/s/ Jessica Coutu | /s/ Nadav Kidron | /s/ Miriam Kidron | |
By: Jessica Coutu | By: Nadav Kidron | Miriam Kidron | |
Title: Senior V.P., Clinical Operations | Title: CEO | CSO | |
Date: May 20, 2019 | Date: May 20, 2019 |
Amendment #2 to Oramed Clinial Research Organization Services Agreement
Protocol # ORA-D-015
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Integrium, LLC. | Confidential |
Exhibit 1
Study Payment Schedule
Payment Schedule | |||||
Monthly Management Fees | Month | $ Amount | Verification of Milestone Completion/Deliverables | ||
Project Management Fees | November 2017 | $[+] | Paid | ||
Project Management Fees | December 2017 | $[+] | Paid | ||
Project Management Fees | January 2018 | $[+] | Paid | ||
Project Management Fees | February 2018 | $[+] | Paid | ||
Project Management Fees | March 2018 | $[+] | Paid | ||
Project Management Fees | April 2018 | $[+] | Paid | ||
Project Management Fees | May 2018 | $[+] | Paid | ||
Project Management Fees | June 2018 | $[+] | Paid | ||
Project Management Fees | July 2018 | $[+] | Paid | ||
Project Management Fees | August 2018 | $[+] | Paid | ||
Project Management Fees | September 2018 | $[+] | Paid | ||
Project Management Fees | October 2018 | $[+] | Paid | ||
Project Management Fees | November 2018 | $[+] | Paid | ||
Project Management Fees | December 2018 | $[+] | Paid | ||
Project Management Fees | January 2019 | $[+] | Paid | ||
Project Management Fees | February 2019 | $[+] | Paid | ||
Project Management Fees | March 2019 | $[+] | Paid | ||
Project Management Fees | April 2019 | $[+] | Pending | ||
Project Management Fees | May 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | June 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | July 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | August 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | September 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | October 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | November 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | December 2019 | $[+] | Invoiced Monthly | ||
Project Management Fees | January 2020 | $[+] | Invoiced Monthly | ||
Project Management Fees | February 2020 | $[+] | Invoiced Monthly | ||
Project Management Fees | March 2020 | $[+] | Invoiced Monthly | ||
Project Management Fees | April 2020 | $[+] | Invoiced Monthly | ||
Project Management Fees | May 2020 | $[+] | Invoiced Monthly | ||
Total Monthly Management Fees: | $[+] |
4
Integrium, LLC. | Confidential |
Monthly Service Fees | Date | % Total Service Budget | % Milestone Service Budget | $ Amount | Verification of Milestone Completion/Deliverables |
Contract Execution | 12/1/2017 | [+]% | [+]% | $[+] | Paid |
Cohort A: 1st Subject Entered | 4/20/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 25% Subjects Randomized | 6/4/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 50% Subjects Randomized | 7/19/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 75% Subjects Randomized | 9/2/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 100% Subjects Randomized | 3/29/2019 | [+]% | [+]% | $[+] | Paid |
Cohort A: 1st Subject Last Visit | 8/22/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 25% Subjects Last Visit | 10/15/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 50% Subjects Last Visit | 11/29/2018 | [+]% | [+]% | $[+] | Paid |
Cohort A: 75% Subjects Last Visit | 1/13/2019 | [+]% | [+]% | $[+] | paid |
Execution of Amendment 1 | 4/18/2019 | [+]% | [+]% | $[+] | Upon execution of Amendment #1 |
Cohort A: 100% Subjects Last Visit | 8/9/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort A: Database Lock | 2/18/2020 | [+]% | [+]% | $[+] | Database Lock |
Cohort A: Draft Final TLGs | 3/10/2020 | [+]% | [+]% | $[+] | Draft Final TLGs |
Cohort B: 1st Subject Entered | 5/6/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 25% Subjects Randomized | 6/3/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 50% Subjects Randomized | 7/1/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 75% Subjects Randomized | 7/29/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort A: 100% Subjects Randomized | 9/10/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 1st Subject Last Visit | 9/16/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 25% Subjects Last Visit | 10/4/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 50% Subjects Last Visit | 11/1/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 75% Subjects Last Visit | 11/29/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: 100% Subjects Last Visit | 12/17/2019 | [+]% | [+]% | $[+] | Enrollment log |
Cohort B: Database Lock | 2/18/2020 | [+]% | [+]% | $[+] | Database Lock |
Cohort B: Draft Final TLGs | 2/25/2020 | [+]% | [+]% | $[+] | Draft Final TLGs |
Total Milestone Based Services: | [+]% | [+]% | [+]% |
Amendment #2 to Oramed Clinial Research Organization Services Agreement
Protocol # ORA-D-015
5
Integrium, LLC. | Confidential |
Unit Based Payments: Actual Units Invoiced Monthly | % Total Services Budget | # Units | Unit Cost | $ Amount | Verification of Milestone Completion/Deliverables |
SAE Management | [+]% | 19 | $[+] | $[+] | Invoiced monthly as occurred |
Total Unit Based Services: | $[+] | ||||
Total Services: | $[+] | ||||
Pass-through expenses | $ Amount | Verification of Milestone Completion/Deliverables | |||
Monitoring Visit Travel Expenses | $[+] | Invoiced as Actuals Monthly | |||
Investigator Grants | $[+] | Invoiced and Paid in Advance of Payment to Vendor | |||
Site Start-up Costs | $[+] | Invoiced and Paid in Advance of Payment to Sites | |||
Site Advertising | $[+] | Invoiced as Actuals Monthly | |||
Site Archiving Fees | $[+] | Invoiced as Actuals Monthly | |||
IRB Fees | $[+] | Invoiced as Actuals Monthly | |||
Meeting Planner | $[+] | Invoiced and Paid in Advance of Payment to Vendor | |||
Central Lab Vendor | $[+] | Invoiced and Paid in Advance of Payment to Vendor | |||
IWRS Vendor | $[+] | Invoiced and Paid in Advance of Payment to Vendor | |||
EDC Platform Usage Fees | $[+] | Invoiced as Actuals Monthly | |||
Copying/Printing/Supplies | $[+] | Invoiced as Actuals Monthly | |||
Postal & Shipping Fees | $[+] | Invoiced as Actuals Monthly | |||
Sponsor/Internal - Teleconference System | $[+] | Invoiced as Actuals Monthly | |||
Total Pass-through Budget: | $[+] | ||||
Grand Total Budget: | $[+] |
Amendment #2 to Oramed Clinial Research Organization Services Agreement
Protocol # ORA-D-015
6