Document:

Exhibit 4.9

 

AMENDMENT # 3

 

 

THE SYMBOL
"[****]" DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL
TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION

 

AMENDMENT
TO THE MASTER SERVICE AGREEMENT FOR REDHILL BIOPHARMA LTD.’S RHB R&D PROGRAM

 

 

 

 

	BY AND BETWEEN:	RedHill Biopharma Ltd., with principle place of business at 21 Ha’arba’a St. Tel-Aviv 64739, Israel (herein referred to as the “Client”),
	 	 
	 	 
	AND:	7810962 Canada Inc (doing Business under the name “InSymbiosis”), a body politic and corporate, duly incorporated according to the laws of Canada and with principle place of business at 245 Victoria Ave, Suite 100, Montreal, Quebec, H3Z 2M6, Canada, (herein referred to as the “Provider”),

 

The
Client and the Provider are, in this Agreement, sometimes individually referred to as “Party” and collectively as
the “Parties”.

 

WHEREAS
on 28 April 2011, the Client and the Provider entered into a Master Service Agreement in relation to the Client’s
RHB R&D Program (the “MSA”);

 

WHEREAS
WHEREAS the MSA was scheduled to terminate on April 28, 2015 as per amendment 2 and the parties hereby agree to formally extend
the term of the MSA until April 28, 2016 (the "Extended Period"); and

 

WHEREAS
the Parties have agreed to certain terms and conditions, the whole as is fully set forth below. 

 

 

NOW,
THEREFORE, THE PARTIES HERETO AGREE AS FOLLOWS:

 

		1.	Unless
                                         specifically set out otherwise in this agreement (the “AMENDMENT AGREEMENT”),
                                         the terms of the MSA shall continue to apply.

 

		2.	The
                                         parties hereby agree to formally extend the term of the MSA until April 28, 2016.

 

		3.	During
                                         the term of the Agreement, PROVIDER will charge CLIENT a monthly project management fee
                                         of $US [****]. This monthly project management fee
                                         will be payable each quarter, in advance, upon lawful invoice to be provided by the PROVIDER
                                         to the CLIENT within 21 days of the beginning of the relevant quarter according to the
                                         following payment schedule:

 

    	7810962 Canada Inc

    	CONFIDENTIAL	2	 

    

 

	 •	Payment 1: May 2015 to July 2015
	 •	Payment 2:  August 2015 to October 2015
	 •	Payment 3:  November 2015 to January 2015
	 •	Payment 4:  February 2015 to April 2016

 

 

 

IN
WITNESS WHEREOF, the parties hereto have executed this Amendment Agreement as of the date first herein above mentioned.

 

 

 

REDHILL
BIOPHARMA Ltd.

 

 

 

	/s/ Dror Ben-Asher	 	/s/ Ori Shilo	 
	Per:      Dror Ben-Asher	 	Per:     Ori Shilo	 
	Title:    CEO	 	Title:   VP Finance and Operation
	Date:    May 21, 2015	 	Date:   May 21, 2015	 

 

 

 

PARTY
OF THE FIRST PART

 

 

7810962
Canada Inc.

 

 

Per:     Alain
Guimond

Title:
  Senior Director of R&D

Date:   12May2015

 

 

PARTY
OF THE SECOND PART

 

 

 

 

 

7810962 Canada IncExhibit 4.12

 

Changed Order 4.1 to Clinical Services Agreement

 

Sponsor’s study drug RHB-104

 

This CO#4.1 to the Clinical Services Agreement signed 15 June 2011
(“Clinical Services Agreement”), is by and among:

 

(1) RedHill Biopharma Ltd., having its principle place of business
at 21 Ha’arba’a St., Tel Aviv 64739, Israel (hereafter “SPONSOR”);

 

(2) 7810962 Canada Inc., a Canadian corporation, having its
principal office at 245 Victoria Ave, Suite 100, Montreal, Quebec, H3Z 2M6, Canada (hereinafter "MANAGER");

 

WHEREAS, “SPONSOR” mandated "MANAGER" to enter
into a subcontract with inVentiv Health Clinical to act as a CRO for its Study (as defined in the Clinical Services Agreement)
with an expected termination date of March 2013; however, the study as of the Amendment Effective Date is ongoing;

 

WHEREAS, FURTHER as due to the initial term of the Clinical Services
Agreement being only 2 years, the parties have omitted from the calculation of professional fees an applicable annual inflation
rate therein;

 

WHEREAS, FURTHER the parties now wish to include inflation to account
for the extended term;

 

WHEREAS, FURTHER PharmaNet GmbH has assigned all of their rights,
title and interest in and to the Agreement as of 1 July 2014 to inVentiv Health UK as part of an internal reorganization; and

 

NOW THEREFORE, in exchange of mutual consideration the sufficiency
of which is hereby acknowledged, the parties hereto agree to the following amendment(s) to the Agreement:

 

		1.	As of 1 January 2015 an inflation rate of 2% per year will be included in the calculation of the
professional fees agreed upon in the Clinical Services Agreement.

 

		2.	Except as amended herein, the Clinical Services Agreement remains
in full force and effect.

 

 

     

     

    

 

IN WITNESS WHEREOF, this change Order 4.1 has been executed by the parties hereto through
their duly authorized officers and is effective as the last date below.

 

 

ACCEPTED AND AGREED TO:

 

	RedHill Biopharma Ltd.	For 7810962 Canada Inc.	 
	 	 	 	 
	 	 	 	 
	/s/ Ori Shilo 	 	 	 
	Name: Ori Shilo	 	 	 
	Title: Deputy CEO	 	/s/ Alain Guimond	 
	 	 	Name:  Alain Guimond PhD
	 	 	Title: Senior Director of R&D
	Date: August 9, 2015	 	Date: 06Aug2015	 
	 	 	 	 
	 	 	 	 
	RedHill Biopharma Ltd. 	 	 
	 	 	 	 
	/s/ Uri Hananel Aharon 	 	 	 
	Name: Uri Hananel Aharon	 	 
	Title: Chief Accounting Officer	 	 
	 	 	 	 
	 	 	 	 
	Date: August 9, 2015Exhibit 4.13

 

THE SYMBOL "[****]" DENOTES PLACES WHERE PORTIONS OF THIS DOCUMENT HAVE
BEEN OMIITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. SUCH MATERIAL HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION

 

Change Order 5 to Clinical Services Agreement

 

Client’s study drug RHB-104

 

This Change Order 5 (“Change Order”) to the Clinical
Services Agreement signed 15 June 2011 (“Clinical Services Agreement”), is by and among:

 

		(1)	RedHill Biopharma Ltd., having its principle place of business at 21 Ha’arba’a
St., Tel Aviv 64739, Israel (hereafter “SPONSOR”);

 

		(2)	7810962 Canada Inc., a Canadian corporation, having its principal office
at 245 Victoria Ave, Suite 100, Montreal, Quebec, H3Z 2M6, Canada (hereinafter "MANAGER");

 

WHEREAS, “SPONSOR” mandated "MANAGER"
to enter into a subcontract with inVentiv Health Clinical to act as a CRO for its Study (as defined in the Clinical Services Agreement);

 

 

Is hereby made effective as of September 11, 2015 (“Effective
Date”) and the parties hereby agree as follows:

 

	1.		Change Order 5 to Clinical Services Agreement.

 

This Change
Order constitutes an amendment to the Clinical Services Agreement pursuant to section 3.0 therein. As such, this Change Order is
subject in all respects to the terms and provisions of the Clinical Services Agreement.

 

	2.		Scope of Work

 

In addition to the Services to be provided in the above-referenced
Clinical Services Agreement, Manager will cause inVentiv Health Clinical to perform additional Services for Client’s study
drug RHB-104, in accordance with the Summary of Changes attached hereto and incorporated herein as Exhibit A.

 

	3.		Compensation

 

Under this Change Order, inVentiv Health Clinical’s
Professional Fees have increased by the amount of USD [****], the pass-through costs have increased by USD [****]. The total costs
of the Clinical Services Agreement have increased to USD [****].

 

    	1

     

    

 

Payment due to inVentiv Health Clinical for the Services provided
under this Change Order shall be made pursuant to the Agreement and the revised unit Payment Schedule attached hereto and incorporated
herein as Exhibit B.

 

	4.		Project Period

 

The term of this Change Order shall commence on the date of its execution and shall
continue until the Services as described in the Clinical Services Agreement are completed, unless this Change Order or corresponding
Clinical Services Agreement are terminated early in accordance with the Clinical Services Agreement.

 

 

By their signatures below, the parties hereto agree to the terms of this Change Order and
represent that they are authorized to enter into this Change Order on behalf of their respective companies.

 

 

ACCEPTED AND AGREED TO:

 

	RedHill Biopharma Ltd.	 	For 7810962 Canada Inc.	 
	 	 	 	 
	 	 	 	 
	/s/ Dror Ben-Asher	 	/s/ Alain Guimond	 
	Name: Dror Ben-Asher	 	Name: Alain Guimond	 
	Title: CEO	 	Title: Sr. Director of R&D	 
	 	 	 	 
	 	 	 	 
	Date: October 20, 2015	 	Date: October 19, 2015	 
	 	 	 	 
	 	 	 	 
	/s/ Ori Shilo	 	 	 
	Name: Ori Shilo	 	 	 
	Title: Deputy CEO	 	 	 
	 	 	 	 
	 	 	 	 
	Date: October 20, 2015	 	 	 

 

 

 

    	2

     

    

 

Exhibit A Summary
of Changes

 

 

Study Assumption Changes

Changes to the parameters and assumptions for the study
are defined below. Unless otherwise noted, activities will be performed according to the original contract.

Change Order 5 for 7810962
Canada Inc. /Red Hill Biopharma Ltd.

Overview of major level changes

 

		·	Protocol v8 Amendment

		·	DM-Dose Admin page created for future DSUR preparation requested by RHB Medical Director

		·	Interim IM approved 26Jan15 by RHB

		·	Israel & ANZ Investigator Meeting

		·	Update eCRF to [****] and [****]
based on [****] in Protocol v8 and [****]
with [****]

		·	DM-DSUR report programming for 2015 submission to FDA

		·	Protocol v8 eCRF Changes

		·	[****] & ANZ DM & Safety Monitoring

 

 

 

 

		1.1	Revised Costs

Costs for this study are presented below in two categories,
pass-through costs and professional fees.

		1.1.1	Pass-Through Costs

Pass-through costs are in US dollars and include
those expenses listed below. inVentiv Health Clinical will invoice Client for actual costs in these areas, it being understood
that any pass-through costs in excess of the amounts set out below will require the Client’s prior written approval. inVentiv
Health Clinical will use its best efforts to keep actual costs to reasonable levels through adherence to inVentiv Health Clinical’s
travel policy and prudent negotiation with outside providers. Pass-through costs are presented in the table below:

 

    	3

     

    

 

	Task	
        Current

        (USD)
	 Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	Site Visit Travel	$[****]	$[****]	No change	 
	Investigators' Meeting Organisation	$[****]	$[****]	No change	 
	Kick-off Meeting Travel/Attendance	$[****]	$[****]	No change.	 
	Shipping/Photocopying	$[****]	$[****]	Printing of Protocol v8, Investigator Brochure #10; Mini-protocols; Annotated Protocol v8 eCRF document; Pharmacy manuals; Quest lab chart tool; I/E laminated pocket cards; Protocol v8 IWRS Guidelines; [****] Guidelines DVD	 
	Translation	$[****]	$[****]	Protocol v8 French and Spanish ICFs; French CSSi materials and I/E cards; Study Rationale Slides to French:; Dossier items translation to English	 
	Regulatory Fees	$[****]	$[****]	No change	 
	Ethics Committee Fees	$[****]	$[****]	Protocol v8 and [****] materials	 
	EDC Studies/3G Cards	$[****]	$[****]	No change	 
	DSMB member fees	$[****]	$[****]	No change	 
	EDC Fees (Oracle)	$[****]	$[****]	No Change 	 
	CRA Face to Face Meeting Travel expenses	$[****]	$[****]	No change 	 
	Pass Through Costs	$[****]	$[****]	 	 

 

 

    	4

     

    

		1.1.2	Investigator Grants Costs

	
        Investigator

        Grants
	
        Current 

        (NA USD)
	
        NA

        (USD)
	Assumption Changes influencing the change in the budget	Additional Comments
	$[****]	$[****]	No Change	Estimate only. Will be paid based on actual costs as approved by the Client.

 

		1.1.3	Professional Fees

Based on the parameters and assumptions outlined
in the original proposal, inVentiv Health Clinical fees are categorised by major activity in the table below and in USD:

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	 	 	 	 	 
	Pre-study 

Activities	 	 	 	 
	Case Report Form Preparation/Review	$[****]	$[****]	
        -CRF Pages/book change from 180 to 182

        -Number of unique pages from 30 to 34 for visit schedule; ECG procedures, and Study Drug
        Administration pages
	
        Sr. Data Analyst, India [****]
        hrs; 

        Manager DM [****] hrs
        - N/A; 

        Database Programmer India [****]
        hours; Sr. CRA Israel - [****] hr.

	Data Management Plan Preparation/Review	$[****]	$[****]	
        -CRF Pages/book change from [****]
        to [****] 

        -Number of unique pages from [****]
        to [****] for visit schedule; ECG procedures, and Study Drug Administration pages
	
        DM Data Manager NA[****]
        hrs

        Sr. Data Analyst, India [****]
        hrs

        Database Programmer NA [****]
        hour

	Informed Consent Preparation/Review	$[****]	$[****]	Protocol v8 consents revised for USA, Canada, and Israel; central IRBs; and specific for [****] sites	Israeli GSSU SS specialist- [****] hrs for country-specific changes and [****] site specific ICFs GSSU Mgr. NA = [****] hrs to review and prepare Protocol v8 Country Specific and central IRB  ICFs; GSSU SS Specialist - [****] hrs  for [****] hrs /site ICF for [****] sites

 

    	5

     

    

 

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	 	 	 	 	 
	IRB/Ethics Committee Interactions	$[****]	$[****]	Protocol v8, IB#10, Protocol v8 ICF; and [****] materials submissions	Israeli GSSU SS specialist - [****] hrs for [****] site specific submissions; GSSU SS specialist- [****] hrs ([****]hrs/site for [****] sites)
	Investigators' Meetings	$[****]	$[****]	 Three investigator meetings attended in North America, Israel, and Australia	
        [****] hours NA CRA ([****]
        CRAs at [****] hours avg/each for travel and meeting) [****]
        hours for Clinical Project Monitoring Lead NA (CMPL) for prep, travel, and meeting [****]
        hours for Sr. PM NA for prep, travel, and meeting 

        [****] for Medical Director APA (ANZ IM) 

        [****] hours for Data Manager NA (ANZ IM) [****]
        hrs for one CRA API (Israel IIM) Medical Director WE [****] hours (Israel IIM) 

	Investigator Site Contract	$[****]	$[****]	Changes in the protocol visit schedule and procedures required contract amendments for [****] sites 	Sr. Contracts Associate =[****] hours ([****] hrs/site contract amendments);                                                      PM = [****] hours
	Investigator Recruitment	$[****]	$[****]	No change 	No change
	Project Feasibility 	$[****]	$[****]	No change	No change
	Project Plan Preparation/Review	$[****]	$[****]	No Change 	No change

 

    	6

     

    

 

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	 	 	 	 	 
	Protocol Preparation/Review	$[****]	$[****]	Review of Protocol V8 by Medical Directors, CRAs, Data Management, Regulatory Affairs; Safety Group, and Statisticians	
        Sr CRA Israel [****] hr.
        Sr. Data Analyst India [****] hr. Data Analyst India [****]
        hr. Manager (PM & DM) 12 hours NA [****] Medical Director NA 6 hours [****]
        Sr Regulatory Associate North America [****] hr. [****]
        for Protocol v8 review and conference calls in 2014; NA CMPL [****] hours 

        [****] hrs WE Medical Director [****] for
        Protocol v8 prep and review in 2014, includes interactions with RHB and ISB team members NA CRA [****]
        hours NA Safety Associate II [****] hr. NA Director Reg Affairs [****]
        hr. NA Reg Affairs Associate [****] hr. NA Principal Statistician [****]
        hr. NA Manager [****] hours ([****] PM & [****]
        DM) NA Medical Director [****] hour

        Sr. Database Programmer India [****]
        hours

	Randomization Schedule Preparation	$[****]	$[****]	Protocol v8 required changes to the randomization plan for assigning study drug according to biologics use.	[****] hours Statisticians (Principal Statisticians in NA and India, [****] hours X[****] for discussion and review of randomization changes prior to Protocol v8 finalization) and (Principal Statisticians in NA and India, [****] hours X[****] preparation of revised randomization schedule in 2015 after Protocol v8 was finalized)
	Study-Specific Form Preparation	$[****]	$[****]	No change	No change
	Training - Project-Specific	$[****]	$[****]	Training required for CRA team, and CMPLs for the Dose Administration eCRF page,   	Sr. CRA - [****] hrs - N/A ([****] hrs X [****] CRAs); NA CMPL = 1 hr. ([****] hrs X [****]); 
	Translations	$[****]	$[****]	Revised Protocol v8 ICFs, [****] materials; I/E pocket cards sent to translation service	NA GSSU Manager - [****] HR
	PROMIS	$[****]	$[****]	No change	No change
	Monitoring/Site Management	 	 	 	 
	Data Clean-up	$[****]	$[****]	Protocol v8 decreased the number of patient visits while increasing the number of unique pages	 Decreased number of patient visits and while adding more eCRFs

 

    	7

     

    

 

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	 	 	 	 	 
	Investigator Grant Administration	$[****]	$[****]	No change	The number of costed grants remains at [****] payments.
	Laboratory Report Review	$[****]	$[****]	No Change	. No Change
	Serious/Significant Adverse Event Management	$[****]	$[****]	Addition of [****] sites in [****]- [****] sites in Australia, and [****]sites in New Zealand and two CROs increased costs for [****] 	Safety Manager NA - [****] hrs

Safety Associate II  NA- [****] hrs

Safety Project Coordinator NA- [****] hrs
	Site Management  	$[****]	$[****]	Attendance at Site Teleconferences for Protocol v8; follow-up for IWRS changes conversations; follow-up for conference call training; follow-up for receipt of updated Central Lab manuals & supplies	
        Israeli Sr. CRA [****]
        hrs; 

        NA PM – [****] hrs;
        

        CMPL – [****] hrs
        [****]; NA CRA [****] hr. ([****]
        hr. /site X [****] sites). 

	Remote Monitoring of Site Data	$[****]	$[****]	No Change	No Change
	Site Visits - Pre-study Visits	$[****]	$[****]	
        No change

         
	
        No change

        

	Site Visits - Initiation Visits	$[****]	$[****]	No change	Current costing remains at [****] SIVs. Only costs for visits actually performed will be paid.   Reconciliation of costs and visits will be performed at project end
	Site Visits - Routine Visits conducted on site	$[****]	$[****]	No change	Current costing remains at [****] RMVs. Only costs for visits actually performed will be paid.   Reconciliation of costs and visits will be performed at project end
	Site Visits - Close-out Visits at each site at Study End	$[****]	$[****]	No change	Current costing remains at [****] COVs. Only costs for visits actually performed will be paid.   Reconciliation of costs and visits will be performed at project end
	Study Master File/Project File Set-up and Maintenance	$[****]	$[****]	Filing of Protocol v8 and Investigator Brochure #10 Investigator signature pages and IRB approval documents	 NA GSSU Specialist [****] hrs/site X [****] sites = [****] hrs
	Patient/Site Recruitment	$[****]	$[****]	No change	
        No change

         

 

    	8

     

    

 

 

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption
                                         Changes

                                                                                                                                                      influencing the change in

                                                                                                                                                      the budget
	Additional comments
	 	 	 	 	 
	Client/CRO meeting	$[****]	$[****]	RHB/Israeli Study Coordinator Meeting held in February 2015 	Israeli CRA [****] hours
	Regulatory	$[****]	$[****]	 	 
	Regulatory Documentation Preparation/Review	$[****]	$[****]	No change	No change
	Project Management /Project Tracking	$[****]	$[****]	 	 
	Financial Project Management	$[****]	$[****]	Additional financial management for payment of printer, translator, and Ethics Committee fees for Protocol V8 changes and [****] materials.	Manager, PM, NA [****] hr.
	Project Management	$[****]	$[****]	Protocol v8 and [****] materials weekly updates and action items for site IRB status and approvals and investigator protocol v8 and investigator brochure sign off pages.  Includes notification to [****] of approvals	Israeli GSSU Specialist – [****] hr.([****] hr./ site X [****] sites) NA GSSU Specialist – [****] hrs ( [****]/ site X [****] sites)
	Project Tracking / Communications	$[****]	$[****]	Review of weekly updates for Protocol v8 IRB approvals and to pending action items.  Includes notifications to IWRS.	NA PM - [****] hrs

NA CMPLs [****] hrs
	Vendor Management	$[****]	$[****]	-Add [****] CRO and CRO for [****] for DM and Safety - Increase the number of vendors to 8. -Printer interaction for Protocol v8 printing 	Revised costing includes 8 vendors. 
	Data Management	 	 	 	 
	Database Archiving	$[****]	$[****]	No change	No change
	Data Cleanup (DM)	$[****]	$[****]	Addition of [****] sites in [****], [****] sites in Australia, and [****] sites in New Zealand and two CROs and increase of 30 patients from 240 to 270 patients increases data clean-up costs	
        Data Analyst India [****]
        hrs 

        NA DM Manager [****] hrs

 

    	9

     

    

 

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	 	 	 	 	 
	Data Management: Database Quality Control Inspection	$[****]	$[****]	
        -CRF Pages/book change from [****]
        to [****] pages

        -Number of unique pages from [****]
        to [****]
	
        Data Analyst India - [****]
        hrs

        Quality Associate II, NA - [****]
        hrs

	Database Design	$[****]	$[****]	
        -CRF Pages/book change from [****]
        to [****]-# of unique pages from [****] to [****];
        

        -Addition of [****] sites
        in [****], [****] sites in Australia, and [****]
        sites in New Zealand and two CROs 

        -Increase of 30 patients from 240 to 270 patients

        -Revisions to format Adverse Event data listings for 2015 Data Safety Update Report (DSUR)
        for FDA submission.
	
         

        NA Data Manager - [****]
        hrs 

NA Data Services PM - [****] hrs

        NA Sr. DB Programmer, [****]
        hrs

        DB Programmer India – [****]
        hrs

        Sr. Data Analyst, India [****]
        hrs

	Dictionary Coding	$[****]	$[****]	No Change	No Change
	Edit Check Programming	$[****]	$[****]	Change in eCRF pages for Protocol v8, ECG visits, Study Drug Administration, and DSUR data results in 8 additional edit checks from[****] to [****] in total	
        Sr. Data Analyst, India [****]
        hrs

        Sr. Database Programmer India - [****]
        hrs

        DM Data Mgt Manager NA = [****]
        hr. Principal Statistician NA [****] hrs 

Sr. D/B Programmer NA = [****]
        hrs

        Manager, PM, NA [****]
        hr.

	Electronic Data Import	$[****]	$[****]	The number of data imports increased from [****] to [****]	Sr. Database Programmer India - [****] hrs

Sr. Data Analyst, India [****] hrs
	Case Report Form Data/Document Transfers	$[****]	$[****]	No change	 
	EDC Fees	$[****]	$[****]	No Change	 
	Statistical Analysis and Table Generation	$[****]	$[****]	 	 

 

    	10

     

    

 

	Task	
        Current

        (US Dollars)
	Change Order #5	Assumption Changes influencing the change in the budget	Additional comments
	 	 	 	 	 
	Electronic Data Transfer	$[****]	$[****]	No Change	 
	Interim Analysis/Report Preparation and Review	$[****]	$[****]	No Change	 
	Statistical Analysis Plan Preparation/Review	$[****]	$[****]	No Change	 
	Table Generation	$[****]	$[****]	No Change	 
	Table/Listings Review	$[****]	$[****]	No Change	 
	Clinical Study Report	$[****]	$[****]	 	 
	Clinical Study Report Preparation/Review	$[****]	$[****]	No Change	 
	Team Meetings	$[****]	$[****]	 	 
	Project Team Meetings - Internal Meetings	$[****]	$[****]	
        - GSSU
        team for updates about IRB approvals, protocol v8 questions, amendment and updated IB sign-off page

        -DM Manager and Sr. DB Programmer meeting about Protocol v8 eCRF changes
	
        NA GSSU Manager [****]
        hr.

        Sr. Database Programmer India [****]
        hours

        Data Manager NA [****]
        hours

	Project Team Meetings - Client Teleconferences	$[****]	$[****]	
        - Sponsor conference call with Israeli Sr, CRA about Protocol v8 changes.

        -Sponsor conference call with PM and DM Manager about DSUR data
	
        Israeli Sr. CRA [****]
        hrs

        PM and Data Manager NA [****]
        hours ([****] hour each) - reduced rates decreased the total amount.

	Project Team Meetings - Kick-off Meeting	$[****]	$[****]	Project Team Meetings - Kick-off Meeting with [****] and [****]	NA  Director  - [****] hours

NA Managers X[****] ([****] DM [****] CM) - [****] hrs

Sr. Project Coordinator [****] hours
	Total Direct Costs	$[****]	$[****]	 	 

 

    	11

     

    

 

Total Costs

	Category	Total Costs($)
	
        Current Contract

        (USD)
	
        Change in Scope # 5

        (USD)
	
        Revised Total

        (USD)

	Pass-Through Costs 	$[****]	$[****]	$[****]
	Investigator Grants Costs	$[****]	$[****]	$[****]
	Professional Fees	$[****] 	$[****]	$[****]
	Discount   	-$[****]	$[****]	-$[****]
	Revised Professional Fees	$[****] 	$[****]	$[****]
	Grand Total	$[****] 	$[****]	$[****]

 

    	12

     

    

 

 

 

Exhibit
B Payment Schedule

 

	1.		PAYMENT TERMS

 

		A.	Service Fees: [****]

 

 

 

 

 

 

 

 

 

 

    	13

     

    

 

		B.	

 

	2.		Pass Through Costs:

		(a)	CO#2: Twenty percent (20%) of the average estimated expenses as set forth in the Expenses Estimate
(exclusive of funds for investigator grants), totaling $[****], were paid on execution of
Change Order #2. Prepayment for Out of Pocket Expenses (to be drawn down once paid and replenished once 75% depleted). This process
to continue until the end of the study.

		(b)	CO#3: Twenty percent (20%) of the average estimated expenses as set forth in the Expenses Estimate
(exclusive of funds for investigator grants), totaling $[****], were paid on execution of
Change Order #2. Prepayment for Out of Pocket Expenses (to be drawn down once paid and replenished once 75% depleted). This process
to continue until the end of the study.

		(c)	CO#4: This one-time payment of $[****] (exclusive of funds
for investigator grants), was paid on execution of Change Order #4.

		(d)	CO#5: This is a one-time payment of $[****] (exclusive of
funds for investigator grants), that will be due and payable upon execution of this Agreement.

		(e)	Actual pass-through expenses, as provided in the expenses estimate, will be billed as incurred
by inVentiv Health Clinical

		(f)	Any unused funds will be returned within ninety (90) days from the date of the final reconciliation

 

	3.		Investigator Grants:

		(a)	Twenty percent (20%) of the estimated total of the grant payments of the study, totaling $[****],
were paid on execution of Change Order #2. Prepayment for Investigator Grants (to be drawn down once paid and replenished once
75% depleted). This process to continue until the end of the study.

		(b)	inVentiv Health Clinical will submit invoices in advance for estimated amounts to be paid to investigators
during the next quarter to ensure that adequate funds are available to pay investigator grants

		(c)	inVentiv Health Clinical will not make payments to investigators without having sufficient funds
available in advance.

		(d)	Any unused funds will be returned within ninety (90) days from the date of the final reconciliation

 

	4.		Payment Conditions:

 

		(a)	For all Services, pass through expenses and investigator grants invoiced, payments are due net
thirty (30) days from invoice date as set forth in Terms, Item 2 of the Agreement. In the event of a dispute, all undisputed portions
of the invoice(s) are due within the above stated terms

		(b)	Payments shall be made in the currency identified above and shall be made free of any applicable
local withholding taxes, charges or remittance fees. Invoices will be inclusive of applicable taxes as determined by local laws
and regulations

		(c)	inVentiv Health Clinical reserves the right to charge interest against any unpaid overdue balance
at the rate of one and a half percent (0.5%) per month

		(d)	All services and pass-through payments should be sent via wire or Automated Clearing House (ACH).

 

 

14

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