Document:

Exhibit 10.1

 

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
#1 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: Revise the contract to reflect two Protocol Amendments, which includes the following changes:

 

		●	Subject
                                         number has increased as follows

		○	Cohort
                                         A (the original contract through Protocol Amend #2) increased from 445 screened to 545
                                         screened

		○	Cohort
                                         B (added in Protocol Amend #3) added 145 patients screened

 

[+]

		●	Sites:

		○	Cohort
                                         A: 39 Sites

		○	Cohort
                                         B: 26 Sites

		●	Protocol
                                         Amendment 1,2 added the activities below:

		○	Writing
                                         of 2 Protocol Amendments

		○	Writing
                                         of 2 ICF Amendments

		○	8-month
                                         delay in timeline increasing project management, site management, medical monitoring,
                                         data management and EDC support management

		■	a
                                         3.5-month enrollment hold due to a drug delay

		■	a
                                         4.5 month increase in enrollment due to limited drug supply and addition of placebo arm

		○	Regulatory
                                         processing of 2 Protocol Amendments, IRB submission

		○	Creation
                                         of CSA amendments for the sites

		○	Creation
                                         of 23 additional eCRF pages to replace electronic diary, screen programming and UAT testing

		○	Increased
                                         eCRF pages per complete subject from 106 to 129 increasing data management tasks

		○	Increase
                                         in EDC platform fees for 8 months

		○	Increase
                                         in printing to print paper diaries

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 1

     

    

 

	Integrium, LLC.	Confidential

 

		●	Protocol
                                         Amendment #3 added the activities below:

		○	Writing
                                         of 1 Protocol Amendment

		○	Regulatory
                                         Processing of 1 Protocol Amendment, IRB submission

		○	Revision
                                         of the IWRS system causing a 1.5-month screening delay

		○	Addition
                                         of 3 months of enrollment to enroll the subjects as stated above in 26 active sites

		○	Increase
                                         in the number of monitoring visits to monitor the additional subjects

		○	Separate
                                         Database lock for Cohort A and an additional lock for Cohort B

		○	Revision
                                         to the SAP and the increase in SAS datasets and TLGs, per Ken

		○	Increase
                                         in Investigator Grants

		○	Increase
                                         in IRB processing pass-through fees

		○	Increase
                                         in EDC platform fees for 4.5 months

 

Study
Timeline: Study timeline increased by 12.5 months

		●	Cohort
                                         A: 8 months

		●	Cohort
                                         B: 4.5 months

 

Projected
Time Period of the Services: Effective from November 1, 2017 to May 15, 2020.

 

Study
Specifications Document: Attached Exhibit 2

 

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 #1.

 

All
other provisions of the Service Order shall remain unchanged and in effect.

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 2

     

    

  

	Integrium, LLC.	Confidential

 

This
Amendment #1 (“First Amendment”) to the Contract Research Organization Agreement (the “Agreement”) made
this 18th day of April, 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,
the parties now enter into this First Amendment to the Agreement for the purposes of amending the contract to reflect certain
changes in scope and associated costs as indicated on page one of this First 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. Service
Order

 

Pursuant
to the Agreement, this First Amendment to Agreement is attached to the Agreement, and Integrium and Sponsor each authorize the
other party to attach this First Amendment to the Agreement to the Agreement in its possession.

 

2. Scope
of Services

 

Integrium
shall perform services as required for the execution of the “Protocol”, Exhibit “1” and specification
of the Services as provided in Exhibit “2”. Further revisions to the Protocol and/or any Project Assumptions
may require further revisions to the study budget.

 

3. Compensation
and Payment

 

3.1 For
its performance of the services under this Agreement, Integrium shall receive compensation as set forth in the Budget, Exhibit
“3” and Payment Schedule included, Exhibit “4”. 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.

 

3.2
 Payments to Integrium shall be made to:

 

Integrium,
LLC

100
E. Hanover Avenue

Suite
401

Cedar
Knolls, NJ 07927 USA

Tax
ID#: 33-0796857

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 3

     

    

  

	Integrium, LLC.	Confidential

 

Wiring
Information:

Bank
of the West

4400
MacArthur Blvd

Suite
400

Newport
Beach, CA 92660

 

Routing/ABA
# [+]

Bank
Account # [+]

Bank
Account Name [+]

4. Timelines

 

It
is acknowledged that Sponsor desires to progress the Study at the maximum speed possible, in a manner consistent with good clinical
practices and adherence to FDA regulations. Integrium shall use reasonable best efforts to meet the Timeline for the Study set
forth in Exhibit “A”.

 

5.
 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 #1 to the Agreement as if made on the date of this Amendment #1.

 

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 Director, Contract Administration	Title: CEO                                        CSO
	Date: May 1, 2019	Date: May 1, 2019  

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 4

     

    

  

	Integrium, LLC.	Confidential

 

Integrium/
Oramed

 

Exhibit
1

 

Protocol
Number: ORA-D-015

Amendment
#3

Date:
April 4, 2019

 

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 5

     

    

  

	Integrium, LLC.	Confidential

 

Integrium/Oramed

 

Exhibit
2

 

Study
Specifications

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

 

 

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 6

     

    

  

	Integrium, LLC.	Confidential

 

Study
Specifications Document

 

	Project Identifiers	 
	Sponsor Company	Oramed Ltd.
	Protocol Number	ORA-D-015
	Protocol Title	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
	Investigational Product(s)	ORMD-0801
	Indication	Type 2 Diabetes Mellitus 
	Therapeutic Area	Metabolic
	Study Phase	III
	Sponsor Country	Israel
	Country Locations	US
	 	 
	Study Assumptions	 
	Subjects	 
	# Subjects Screened	[+]
	% Screen Failure Rate	[+]%
	# Screen Failures 	[+]
	# Subjects Entering Run-In Phase	[+]
	% Run-In Failure Rate	[+]%
	# Run-In Failures 	[+]
	# Subjects Entering Treatment Phase	[+]
	% Early Termination Rate	[+]%
	# Early Terminations 	[+]
	# Subjects Complete	[+]
	Sites	 
	# Sites Identified	[+]
	Total Sites Cohort A	[+]
	# Central IRB Sites	[+]
	# Local IRB Sites	[+]
	Total Sites Active Cohort B	[+]
	Enrollment	 
	# Screened/site	[+]
	# Screened/site/week	[+]
	# Enrolled/site	[+]
	# Enrollment Rate (per site/per month)	[+]
	# Randomized/site	[+]
	# Randomization Rate (per site/ month)	[+]

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 7

     

    

  

	Integrium, LLC.	Confidential

 

	Third Party Vendors	 
	Meeting Planner	1
	Central IRB	1
	Central Lab	1
	CGM Monitors/Supply Vendor	1 - Contracted by Sponsor
	Centralized CGM Reader Vendor	1 - Contracted by Sponsor
	eDiary/Glucometer Vendor	1 - Contracted by Sponsor
	Product Packaging & Distribution	1 - Contracted by Sponsor
	IWRS	1 - Contracted by Sponsor
	 	 
	Project Meetings	# Meetings	Assumptions
	Investigator/CRA Training Meeting	[+]	[+]
	Launch Meeting 	[+]	[+]
	Sponsor Team Teleconferences	[+]	[+]
	Internal Team Teleconferences	[+]	[+]
	CRA Teleconferences	[+]	[+]
	 	 
	Monitoring Assumptions	 
	# CRAs	[+]
	# Pre-Study Selection Visits	[+]
	# Initiation Visits	[+]
	 	For sites where PI and Study Coordinator do not attend Invest. Mtg
	# Interim Monitoring Visits	[+]
	Monitoring Interval (Maximum - weeks)	[+]
	# Interim Monitoring Visits/site 	[+]
	# Additional Days on-site/site	[+]
	# 1-day Interim Monitoring Visits	[+]
	# Additional Days 	[+]
	# Close-out Visits	[+]
	 	 
	Safety Assumptions	 
	SAE rate (%)	[+]%
	Estimated # SAEs	[+]
	Estimated # Expedited SAEs	[+]
	Data Management	 
	CRF pgs per randomized patient	[+]
	Unique CRFs/Subject	[+]
	Non-Unique CRFs/Subject 	[+]
	CRF pgs per early term	[+]
	CRF pgs per screen failure	[+]

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 8

     

    

  

	Integrium, LLC.	Confidential

 

	Total CRF Pages	[+]
	Complete subjects	[+]
	Early Terms	[+]
	Screen Failures	[+]
	Total DM Datasets	[+]
	Total Edit Checks	[+]
	Estimated # Total Queries	[+]
	Estimated # Queries/Patient (1/5 pages)	[+]
	Manual Coding	 
	# Medical History/Subject	[+]
	# ConMeds/Subject	[+]
	# AEs/Subject	[+]
	Data Transfers	 
	# Sponsor Transfers	[+]
	 	test, final
	#  Lab Transfers	[+]
	 	test, monthly, final
	# PK Transfers	N/A
	 	 
	# Electronic Diary Lab Transfers	[+]
	 	test, quarterly, final
	# Central CGM Reader Transfers	[+]
	 	test, quarterly, final
	# IWRS Transfers	No charge, integrated with EDC
	 	 
	 	 
	Statistical Analysis	The following assumptions are estimates. The total number of TLGs will be defined upon the finalization of the Statistical Analysis Plan. An amendment to the budget will be issued at that time, if applicable.
	# SAS Datasets	[+]
	Estimated Tables	 
	# Standard and Non-Standard Repeat	[+]
	# Non-Standard Unique	[+]
	Estimated Listings	 
	# Standard and Non-Standard Repeat	[+]
	# Non-Standard Unique	[+]
	Estimated Graphs	 
	# Standard and Non-Standard Repeat	[+]
	# Non-Standard Unique	[+]
	Exploratory Output	 
	# Exploratory Tables	[+]
	# Exploratory Listings	[+]
	# Exploratory Graphs	[+]
	pK Parameters	[+]
	Post-hoc Analysis	[+]

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 9

     

    

  

	Integrium, LLC.	Confidential

 

	EDC – DSG	 
	Number of Screens	 
	Unique Screens	[+]
	Redundant Screens	[+]
	Site Patient Activity Duration (Months)	[+]
	Enrollment Duration (Months)	[+]
	Server Activity Duration (Months)	[+]
	Usage Fee/Help Desk Fees	 	 	 
	Product Usage Fee/Month	$[+]
	Intregrium Archiving Pricing	 
	CD/DVD per site	$[+]
	Clinical Study Report	The budget is based on one draft and one final version of the CSR, assuming there will be no hyperlinking. If hyperlinking and/or additional versions of the CSR are requested, they will be provided at the study hourly rate for the actual additional hours.

  

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 10

     

    

   

	Integrium, LLC.	Confidential

 

	Project Timeline	 	 
	 	 	 	 
	Project Activity	Date	Month #	Week #
	Study Start Date	[+]	[+]	[+]
	Final Protocol Date	[+]	[+]	[+]
	First Patient enrolled at OCRC	[+]	[+]	[+]
	EDC Set-Up Complete	[+]	[+]	[+]
	Investigators' Meeting	[+]	[+]	[+]
	First Patient Screened	[+]	[+]	[+]
	First Patient Enter Run-In Period	[+]	[+]	[+]
	First Patient Enter Part 1 Titration	[+]	[+]	[+]
	First Patient Enter Part 2 Maintenance	[+]	[+]	[+]
	Start of Screening Hold	[+]	[+]	[+]
	End of Screening Hold	[+]	[+]	[+]
	First Patient Last Visit	[+]	[+]	[+]
	Additional Full Placebo at CSM with all required documents	[+]	[+]	[+]
	Additional Full Placebo packaged/ready for shipment to site	[+]	[+]	[+]
	Last Patient Screened Cohort A	[+]	[+]	[+]
	Last Patient Enter Run-In Period Cohort A	[+]	[+]	[+]
	Last Patient Part 1 Titration Cohort A	[+]	[+]	[+]
	Last Patient Enter Part 1 Cohort A	[+]	[+]	[+]
	Last Patient Part 2 Maintenance Cohort A	[+]	[+]	[+]
	Last Patient Last Visit Cohort A	[+]	[+]	[+]
	Last IMV Cohort A	[+]	[+]	[+]
	Cohort A Database Lock	[+]	[+]	[+]
	Cohort A Draft Final TLGs	[+]	[+]	[+]
	Cohort A Final TLGs	[+]	[+]	[+]
	Draft CSR	[+]	[+]	[+]
	Final CSR	[+]	[+]	[+]
	Estimated IWRS Cohort B Go-live Date	[+]	[+]	[+]
	First Subject Screened Cohort B	[+]	[+]	[+]
	First Subject Run-in Cohort B	[+]	[+]	[+]
	First Subject Randomized Cohort B	[+]	[+]	[+]
	First Subject Last Visit Cohort B	[+]	[+]	[+]
	Last Subject Screened Cohort B	[+]	[+]	[+]
	Last Subject Run-in Cohort B	[+]	[+]	[+]
	Last Subject Randomized Cohort B	[+]	[+]	[+]
	Last Subject Last Visit Cohort B	[+]	[+]	[+]
	Last IMV	[+]	[+]	[+]
	Database Lock 	[+]	[+]	[+]
	Draft Final TLGs	[+]	[+]	[+]
	Final TLGs	[+]	[+]	[+]
	Draft CSR	[+]	[+]	[+]
	Final CSR	[+]	[+]	[+]
	CRO End Date	[+]	[+]	[+]
	Total Project Duration (Months)	[+]	 	 
	 	 	 	 
	 	Months	Weeks	Phase
	Start-up	[+]	[+]	I
	Enrollment	[+]	[+]	II
	Treatment	[+]	[+]	III
	LPLV-DBL	[+]	[+]	IV
	DBL-CRO End	[+]	[+]	V
	 	[+]	[+]	 

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 11

     

    

 

	Integrium, LLC.	Confidential

  

Integrium/Oramed

 

EXHIBIT
3 

 

Study
Budget 

 

 

 

 

 

 

 

(Remainder
of Page Intentionally Left Blank)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 12

     

    

 

	Integrium, LLC.	Confidential

 

Study
Budget

 

	 	STUDY
    START-UP	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	1	Project
    Management (Start Up)	$[+]	5.6	Month	$[+]
	2	Develop/Finalize
    Project Management Plan	$[+]	1	Plan	$[+]
	3	Project
    Launch Webcast Meeting/Training	$[+]	1	Meeting	$[+]
	41	Study
    Materials Management	$[+]	39.0	Site	$[+]
	42	Source
    Documentation Development 	$[+]	1.0	Total	$[+]
	43	Site
    Identification	$[+]	41.0	Site	$[+]
	44	Pre-study
    Site Evaluation Visit	$[+]	22.0	Visit	$[+]
	45	Develop/Finalize
    CRA Monitoring Plan	$[+]	1	Plan	$[+]
	46	Study
    Manual/Quality Plan	$[+]	1	Total	$[+]
	47	Data
    Management Plan ("DMP")	$[+]	1	Total	$[+]
	48	Regulatory
    Document Collection - Start Up	$[+]	39.0	Site
    	$[+]
	 	Reg.
    Doc. Collection - Protocol Amendments	$[+]	106.0	Amend*Site	$[+]
	49	Investigator
    Budget/Contract Negotiations	$[+]	39.0	Site
    	$[+]
	 	Site
    CSA Amendments	$[+]	38.0	Site	$[+]
	50	Investigator
    Meeting and Preparation	$[+]	1	Meeting	$[+]
	51	Clinical
    System Set-Up Configuration/Maintenance	$[+]	40	Total	$[+]
	52	Generate
    Randomization Codes	$[+]	1	Randomization	$[+]
	 	STUDY
    START-UP FEES TOTAL	 	 	 	$[+]
	 	EDC
    STUDY START-UP	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	17	eCRF
    Development	$[+]	1.0	Total	$[+]
	18	eCRF
    Completion Instructions	$[+]	1.0	Total	$[+]
	19	Edits
    Specifications and Programming	$[+]	1.0	Total	$[+]
	20	Validate/Test
    Data Entry Screens (UAT)	$[+]	1.0	Total	$[+]
	21	Annotate
    CRF	$[+]	1	Total	$[+]
	22	Clinical
    Database Development-SDTM Dataset Creation/Documentation	$[+]	1.0	Total	$[+]
	23	Platform
    Study Set-up Fee	$[+]	1	Total	$[+]
	24	Database
    Design and Validation Specifications	$[+]	1.0	Database	$[+]
	25	EDC
    Kick-Off Meeting	$[+]	1
    	Meeting	$[+]
	26	Set-up
    Standard Data Entry Screens	$[+]	1.0	Total	$[+]
	27	Training
    Session	$[+]	1
    	Study	$[+]
	28	Project
    Manage all aspects of EDC start-up	$[+]	1
    	Start-up	$[+]
	29	Create
    Enrollment Screen	$[+]	1
    	Total	$[+]
	30	Integrating
    EDC System with IWRS System	$[+]	1
    	Total	$[+]
	31	Data
    Export Programming	$[+]	35.0	Dataset	$[+]
	32	Create
    Custom Reports	$[+]	1
    	Report	$[+]
	33	Register
    users and maintain passwords for life of study (per user (4 per site + 6 for sponsor))	$[+]	162.0	Per
    User	$[+]
	 	EDC
    START-UP FEES TOTAL	 	 	 	$[+]

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 13

     

    

  

	Integrium, LLC.	Confidential

 

	 	CLINICAL
    MONITORING	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	34	Project
    Management (enrollment phase) 	$[+]	15.6	Month	$[+]
	35	Project
    Management (treatment phase) 	$[+]	4.4	Month	$[+]
	36	Project
    Management Study (LPLV to DBL)	$[+]	2.1	Month	$[+]
	37	Project
    Management Study (DBL to CRO end)	$[+]	2.9	Month	$[+]
	38	Sponsor
    Team Teleconferences 	$[+]	66.0	Telecon	$[+]
	39	Internal
    Team Teleconferences 	$[+]	6
    	Telecon	$[+]
	40	CRA
    Teleconferences	$[+]	12
    	Telecon	$[+]
	41a	Trial
    Master File Cohort A	$[+]	40	Site,
    Gen. File	$[+]
	41b	Trial
    Master File Cohort B	$[+]	29	Site,
    Gen. File	$[+]
	42a	Regulatory
    Document Maintenance Cohort A	$[+]	897	Month	$[+]
	42b	Regulatory
    Document Maintenance Cohort B	$[+]	196	Month	$[+]
	43	Site
    Initiation Visits	$[+]	23	Site
    	$[+]
	44a	Site
    Management Cohort A	$[+]	920	Site*Month	$[+]
	44b	Site
    Management Cohort B	$[+]	203	Site*Month	$[+]
	45	Interim
    Monitoring Visits - One Day	$[+]	350	Visit	$[+]
	46	Interim
    Monitoring Visits - Additional Day On-site	$[+]	100	Day	$[+]
	47	Close-out
    Visits	$[+]	39.0	Visit	$[+]
	48a	Site
    Grant Administration Cohort A	$[+]	20.0	Month	$[+]
	48b	Site
    Grant Administration Cohort B	$[+]	5.0	Month	$[+]
	 	CLINICAL
    MONITORING/LOGISTICS SERVICES SUBTOTAL	 	 	 	$[+]
	 	MEDICAL/SAE
    MANAGEMENT	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	49	Medical
    Management	$[+]	22	Month	$[+]
	50	Create
    Safety Plan	$[+]	1	Plan	$[+]
	51	Review
    Protocol Deviation Log	$[+]	22	Month	$[+]
	52	Tracking
    Protocol Waivers	$[+]	22	Month	$[+]
	53	Lab
    Alert/Patient Review	$[+]	22	Month	$[+]
	54	Review
    of AE Data Listings on a Monthly basis	$[+]	22	Month	$[+]
	55	Create
    Safety Database	$[+]	1	Database	$[+]
	62	SAE
    Management	$[+]	19.0	SAE	$[+]
	 	MEDICAL/SAE
    MANAGEMENT SERVICES SUBTOTAL	 	 	 	$[+]
	 	DATA
    MANAGEMENT	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	56	Data
    Entry Activities	$[+]	56,264
    	CRF
    Pg	$[+]
	57	Generate/Track/Resolve
    Queries	$[+]	11253	Query	$[+]
	58	Data
    Cleaning/Manual Listing Review	$[+]	417	Patient	$[+]
	59	Import
    Other Data	$[+]	25
    	Transfer	$[+]
	60	Export
    Data to Sponsor	$[+]	2
    	Transfer	$[+]
	61	Manual
    Coding	$[+]	4170	Manual
    Code	$[+]
	63	Archive
    Study Records, Database	$[+]	1
    	Database	$[+]
	64	Data
    Base Lock Activities - Cohort A	$[+]	1	Total	$[+]
	 	Data
    Base Lock Activities - Cohort B	$[+]	1	Total	$[+]
	 	DATA
    MANAGEMENT FEES SUBTOTAL   	 	 	 	$[+]

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 14

     

    

  

	Integrium, LLC.	Confidential

 

	 	EDC
    SYSTEM MAINTAINANCE	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	65	Coding
    System  (Set-up Cost) [WHO/MEDRA]	$[+]	1
    	Access
    User	$[+]
	66	Third
    Party Data Integrations	$[+]	32
    	Transfer	$[+]
	67	SAS
    Platform (months)	$[+]	30	Month	$[+]
	68	Help
    Desk Support 	$[+]	22	Month	$[+]
	69	Ongoing
    Support Project Management	$[+]	15
    	Month	$[+]
	70	CRF
    Export Programming (Site Archives, eCRFs for Submission)	$[+]	1
    	Total	$[+]
	71	Provide
    End of Study Archives to All Sites and 2 Copies to Sponsor	$[+]	1.0	Total	$[+]
	 	EDC
    SYSTEM SET-UP AND MAINTAINANCE SUBTOTAL	 	 	 	$[+]
	 	BIOSTATISTICAL
    ANALYSIS	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	72	Draft
    & Final Statistical Analysis Plan (SAP)	$[+]	1
    	SAP	$[+]
	73	Analysis
    DataSets	$[+]	17	Dataset	$[+]
	74	Create/Document
    ADaM (Submission Ready) Datasets	$[+]	17	Dataset	$[+]
	75	Statistical
    Programming Deliverables (TLGs)	$[+]	191	T/L/G	$[+]
	76	Generate/QC
    TLFs	$[+]	208	Appendix	$[+]
	77	Output
    Review/Dry Runs	$[+]	3
    	Dry
    Run	$[+]
	78	Post-hoc
    Analysis Hours	$[+]	120
    	Hour	$[+]
	 	BIOSTATISTICAL
    ANALYSIS SUBTOTAL	 	 	 	$[+]
	 	MEDICAL
    WRITING	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	79a	Finalize
    Protocol	$[+]	1	Protocol	$[+]
	79b	Write
    Protocol Amendment	$[+]	3	Amendment	$[+]
	80a	Develop/Finalize  ICF
    	$[+]	1	Total	$[+]
	80b	Develop/Finalize
    ICF Amendment	$[+]	2	Amendment	$[+]
	81	Final
    CSR	$[+]	1
    	Total	$[+]
	 	MEDICAL
    WRITNG SUBTOTAL	 	 	 	$[+]
	 	CRO
    SERVICE FEES GRAND TOTAL	 	 	 	$[+]
	 	PASS
    THROUGH COSTS	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	1	Pre-study
    Site Evaluation Visit	$[+]	22	Visit	$[+]
	2	Site
    Initiation Visit	$[+]	23	Visit	$[+]
	3a	Interim
    Monitoring Visits - One Day	$[+]	350	Visit	$[+]
	3b	Interim
    Monitoring Visits - Additional Day On-site	$[+]	100	Day	$[+]
	4	Close-out
    Visits	$[+]	39	Visit	$[+]
	5	Investigators'
    Meeting Planner	$[+]	1	Meeting	$[+]
	6	Investigator
    Grants	$[+]	 	 	$[+]
	6a	#
    Patients Completed	$[+]	317	Patient	$[+]
	6b	#
    Screen Failures 	$[+]	273	Patient	$[+]
	6c	#
    Run-In Failures 	$[+]	57	Patient	$[+]
	6d	#
    Early Terminations	$[+]	43	Patient	$[+]
	6e	#
    Rescue Visits	$[+]	1	Visit	$[+]
	6f	#
    Unscheduled visits	$[+]	1	Visit	$[+]
	7	Site:
    Advertising/Patient Recruitment	$[+]	39	Site	$[+]
	8	Site:
    Archive Fees	$[+]	39	Site	$[+]
	9	Site:
    Start-up Costs 	$[+]	39	Site	$[+]
	10	Site:
    Estimated Rescue Meds	$[+]	40	Site	$[+]

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 15

     

    

  

	Integrium, LLC.	Confidential

 

	 	PASS
    THROUGH COSTS	UNIT
    COST	UNITS	MEASURE
    OF UNIT	TOTAL
    
	11	Site:
    Regulatory Fee	$[+]	1	Site	$[+]
	12	Site:
    Pharmacy Fee	$[+]	1	Total	$[+]
	13	Central
    Laboratory Fees	$[+]	1.0	Total	$[+]
	14	IWRS
    Fees	$[+]	1	Total	$[+]
	15a	Central
    IRB - Protocol & Advertising Submission	$[+]	1	Protocol	$[+]
	15b	Central
    IRB - Site Submissions	$[+]	39	Protocol	$[+]
	15 	Central
    IRB annual renewal	$[+]	39	Year	$[+]
	15d	Central
    IRB Amendments	$[+]	67	Amendment	$[+]
	15e	Central
    IRB Closeout Fee	$[+]	39	Site	$[+]
	15f	Central
    IRB PI Change	$[+]	1	Site	$[+]
	15g	Central
    IRB - Site Specific Translations	$[+]	2	Translation	$[+]
	15h	Central
    IRB - Advertising Approval	$[+]	4	Approval	$[+]
	16	Mixed
    Meal Tolerance Test Supplies: Ensure 	$[+]	40	Site	$[+]
	17a	EDC
    Platform Product Usage 	$[+]	25	Total	$[+]
	17b	EDC
    Coding System Integration Fee [WHO/MEDRA]	$[+]	1	Total	$[+]
	18	End
    of study archive CDs to sites; 2 copies to Sponsor	$[+]	41	Total	$[+]
	19	Launch
    Binders 	$[+]	40	Binder	$[+]
	20	Regulatory
    Binders	$[+]	40	Binder	$[+]
	21	Copying/
    Printing	$[+]	1	Total	$[+]
	22	Postal
    & Shipping Fees	$[+]	1	Total	$[+]
	23	Sponsor/Internal
    - Teleconferences	$[+]	1	Total	$[+]
	 	PASS-THROUGH
    COSTS TOTAL   	 	 	 	$[+]
	 	PROJECT'S
    OVER-ALL TOTAL COST	 	 	 	$[+]

   

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 16

     

    

  

	Integrium, LLC.	Confidential

 

Exhibit
4

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	$[+]	Invoiced
    Monthly
	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:	$[+]	 
	 	 	 	 	 	 
	Monthly
    Service Fees	Date	%
    Total Service Budget	%
    Milestone Service Budget	$
    Amount	Verification
    of Milestone Completion/Deliverables
	Contract
    Execution	12/1/2017	4.15%	10.48%	$[+]	Paid
	Cohort
    A: 1st Subject Entered	4/20/2018	2.08%	4.18%	$[+]	Paid
	Cohort
    A: 25% Subjects Randomized	6/4/2018	3.46%	6.97%	$[+]	Paid
	Cohort
    A: 50% Subjects Randomized	7/19/2018	3.46%	6.97%	$[+]	Paid
	Cohort
    A: 75% Subjects Randomized	9/2/2018	3.46%	6.97%	$[+]	Paid
	Cohort
    A: 100% Subjects Randomized	3/29/2019	3.46%	6.97%	$[+]	Paid
	Cohort
    A: 1st Subject Last Visit	8/22/2018	2.08%	4.18%	$[+]	Paid
	Cohort
    A: 25% Subjects Last Visit	10/15/2018	2.08%	4.18%	$[+]	Paid

 

    	Amendment #1 to Oramed Clinial Research Organization Services Agreement

Protocol # ORA-D-015
	
 17

     

    

  

	Integrium, LLC.	Confidential

 

	Cohort
    A: 50% Subjects Last Visit	11/29/2018	2.08%	4.18%	$[+]	Paid
	Cohort
    A: 75% Subjects Last Visit	1/13/2019	2.08%	4.18%	$[+]	Billed
    pending payment
	Execution
    of Amendment 1	4/18/2019	2.08%	4.18%	$[+]	Upon
    execution of Amend. #1
	Cohort
    A: 100% Subjects Last Visit	8/9/2019	2.08%	4.18%	$[+]	Enrollment
    log
	Cohort
    A: Database Lock	2/18/2020	4.15%	8.37%	$[+]	Database
    Lock
	Cohort
    A: Draft Final TLGs	3/10/2020	1.80%	3.63%	$[+]	Draft
    Final TLGs
	Cohort
    B: 1st Subject Entered	5/6/2019	0.83%	1.67%	$[+]	Billed
    
	Cohort
    B: 25% Subjects Randomized	6/3/2019	0.97%	1.95%	$[+]	Billed
    
	Cohort
    B: 50% Subjects Randomized	7/1/2019	0.97%	1.95%	$[+]	Billed
    
	Cohort
    B: 75% Subjects Randomized	7/29/2019	0.97%	1.95%	$[+]	Enrollment
    log
	Cohort
    A: 100% Subjects Randomized	9/10/2019	0.97%	1.95%	$[+]	Enrollment
    log
	Cohort
    B: 1st Subject Last Visit	9/16/2019	0.97%	1.95%	$[+]	Billed
	Cohort
    B: 25% Subjects Last Visit	10/4/2019	0.97%	1.95%	$[+]	Enrollment
    log
	Cohort
    B: 50% Subjects Last Visit	11/1/2019	0.97%	1.95%	$[+]	Enrollment
    log
	Cohort
    B: 75% Subjects Last Visit	11/29/2019	0.97%	1.95%	$[+]	Enrollment
    log
	Cohort
    B: 100% Subjects Last Visit	12/17/2019	0.97%	1.95%	$[+]	Enrollment
    log
	Cohort
    B: Database Lock	2/18/2020	1.11%	2.23%	$[+]	Database
    Lock
	Cohort
    B: Draft Final TLGs	2/25/2020	0.48%	0.96%	$[+]	Draft
    Final TLGs
	Total
    Milestone Based Services:	49.59%	100.00%	$[+]	 
	 	 	 	 	 	 
	Unit
    Based Payments: 

    Actual Units Invoiced Monthly	%
    Total Services Budget	#
    Units	Unit
    Cost	$
    Amount	Verification
    of Milestone Completion/Deliverables
	SAE
    Management	0.79%	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 #1 to Oramed Clinial Research Organization Services
Agreement

Protocol # ORA-D-015Exhibit 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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00297-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00297-of-00352.parquet"}]]