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

 

1

 

 

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

 

2

 

 

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

3

 

 

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