Document:

rdhl_Ex4_12

		

			Exhibit 4.12

		

		

			 

		

		

			Confidential

		

		
			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 6.1 to Clinical Services Agreement
		

		
			 
		

		
			Client’s study drug RHB-104
		

		
			 
		

		
			This Change Order 6.1 (“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 5320 13th Avenue, Montreal, Quebec, H1X 2X8, 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 July 28, 2016 (“Effective Date”) and the parties hereby agree as follows:
		

		
			 
		

		
			1.    Change Order 6.1 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,  inVentiv Health Clinical will 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 total costs of the Clinical Services Agreement have increased to USD [****].
		

		
			 
		

		
			
		

		
			

		 

		

			1

		

 

		

			Confidential

		

		

		
			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

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						/s/ Dror Ben-Asher

					
					
						/s/ Micha Ben Chorin

					
					
						 

					
					
						/s/ Alain Guimond

				
	
					
						Name: Dror Ben-Asher

					
					
						Micha Ben Chorin

					
					
						 

					
					
						Name: Alain Guimond

				
	
					
						Title:  CEO

					
					
						CFO

					
					
						 

					
					
						Title: V-P R&D

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

				
	
					
						Date: August 31, 2016__________________

					
					
						 

					
					
						Date:  30-August-2016

				

		
			 
		

		
			 
		

		
			 
		

		 

		

			2

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

		
			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 6.1 for 7810962 Canada Inc.  /Red Hill Biopharma Ltd.
		

		
			 
		

		
			Overview of major level changes
		

		
			 
		

			
	
			
				 ·
			

			
	
			
			The fee to add [****]to the DCRA team is $[****]- There are [****]hrs in the [****]month period from [****] through to [****]. The hourly rate is $[****]/hr.

			
	
			
				 ·
			

			
	
			
			Number of DCRAs changed from [****] to [****].

		
			 
		

		
			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:
		

		
			
		

		

		 

		

			 

		

			

					

						11ISB001

					

						7810962 Canada Inc., /RedHill Biopharma Ltd.

					

						28 July 2016

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						

					

					

						© inVentiv Health. All Rights Reserved.

				

		

			 

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

	
					
						

					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Task

					
					
						Current
(USD)

					
					
						Change
Order #6.1

					
					
						Assumption Changes
influencing the
change in the budget

					
					
						Additional
comments

				
	
					
						Site Visit Travel

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Investigators' Meeting Organization

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Kick-off Meeting Travel/Attendance

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Shipping/Photocopying

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Translation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Regulatory Fees

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Ethics Committee Fees

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						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

					
					
						$[****]

					
					
						$[****]

					
					
						 

					
					
						 

				

		
			 
		

		
			
		

		
			

		 

		

			 

		

			

					

						11ISB001

					

						7810962 Canada Inc., /RedHill Biopharma Ltd.

					

						28 July 2016

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						

					

					

						© inVentiv Health. All Rights Reserved.

				

		

			 

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

		

		
			1.1.2        Investigator Grants Costs
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Investigator
Grants

					
					
						Current
(USD)

					
					
						Change
Order #6.1

					
					
						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 #6.1

					
					
						Assumption
Changes
influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						Pre-study Activities

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Case Report Form Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Management Plan Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Informed Consent Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						IRB/Ethics Committee Interactions

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigators' Meetings

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigator Site Contract

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigator Recruitment

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Feasibility 

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Plan Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No Change

					
					
						No change

				

		 

		

			 

		

			

					

						11ISB001

					

						7810962 Canada Inc., /RedHill Biopharma Ltd.

					

						28 July 2016

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						

					

					

						© inVentiv Health. All Rights Reserved.

				

		

			 

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

	

      

        Task

      

    	

      

        Current
(US Dollars)

      

    	

      

        Change
Order #6.1

      

    	

      

        Assumption
Changes
influencing the
change in the
budget

      

    	

      

        Additional comments

      

    
	
					
						

					
						Protocol Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Randomization Schedule Preparation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Study-Specific Form Preparation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Training - Project-Specific

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Translations

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						PROMIS

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Monitoring/Site Management

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Data Clean-up

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigator Grant Administration

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Laboratory Report Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Serious/Significant Adverse Event Management

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Management  

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Remote Monitoring of Site Data

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Pre-study Visits

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Initiation Visits

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Routine Visits conducted on site

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Routine Visits conducted on site – Dedicated NA CRA Program-[****]CRAs

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Routine Visits conducted on site-Dedicated NA CRA Program-[****] CRA

					
					
						$[****]

					
					
						$[****]

					
					
						Dedicated NA CRA Program

					
					
						Adding [****] Dedicated Sr. CRA- $[****]/hr X [****]hrs ([****] hrs over a year X [****] months)

				
	
					
						Site Visits - Close-out Visits at each site at Study End

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Study Master File/Project File Set-up and Maintenance

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				

		 

		

			 

		

			

					

						11ISB001

					

						7810962 Canada Inc., /RedHill Biopharma Ltd.

					

						28 July 2016

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						

					

					

						© inVentiv Health. All Rights Reserved.

				

		

			 

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

	

      

        Task

      

    	

      

        Current
(US Dollars)

      

    	

      

        Change
Order #6.1

      

    	

      

        Assumption
Changes
influencing the
change in the
budget

      

    	

      

        Additional comments

      

    
	
					
						

					
						Patient/Site Recruitment

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Client/CRO meeting

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Regulatory

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Regulatory Documentation Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Management /Project Tracking

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Financial Project Management

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Management

					
					
						$  [****]

					
					
						$  [****]

					
					
						No change

					
					
						No change

				
	
					
						Project Tracking / Communications

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Vendor Management

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Management

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Database Archiving

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Cleanup (DM)

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Management: Database Quality Control Inspection

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Database Design

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Dictionary Coding

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Edit Check Programming

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Electronic Data Import

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Case Report Form Data/Document Transfers

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						EDC Fees

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Statistical Analysis and Table Generation

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Electronic Data Transfer

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				

		 

		

			 

		

			

					

						11ISB001

					

						7810962 Canada Inc., /RedHill Biopharma Ltd.

					

						28 July 2016

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						

					

					

						© inVentiv Health. All Rights Reserved.

				

		

			 

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

	

      

        Task

      

    	

      

        Current
(US Dollars)

      

    	

      

        Change
Order #6.1

      

    	

      

        Assumption
Changes
influencing the
change in the
budget

      

    	

      

        Additional comments

      

    
	
					
						

					
						Interim Analysis/Report Preparation and Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Statistical Analysis Plan Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Table Generation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Table/Listings Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Clinical Study Report

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Clinical Study Report Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Team Meetings

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Project Team Meetings - Internal Meetings

					
					
						$  [****]

					
					
						$  [****]

					
					
						No change

					
					
						No change

				
	
					
						Project Team Meetings - Client Teleconferences

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Team Meetings - Kick-off Meeting

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Total Direct Costs

					
					
						$[****]

					
					
						$[****]

					
					
						 

					
					
						 

				

		
			 
		

		
			Total Costs
		

		
			 
		

			
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Category

					
					
						Total Costs($)

				
	
					
						Current Contract
(USD)

					
					
						Change in Scope # 6.1
(USD)

					
					
						Revised Total
(USD)

				
	
					
						Pass-Through Costs 

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Investigator Grants Costs

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Professional Fees

					
					
						$[****]

					
					
						$[****]

					
					
						$

				
	
					
						Discount

					
					
						-$[****]

					
					
						$[****]

					
					
						-$[****]

				
	
					
						Revised Professional Fees

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Grand Total

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				

		
			 
		

		
			 
		

		
			 
		

		 

		

			 

		

			

					

						11ISB001

					

						7810962 Canada Inc., /RedHill Biopharma Ltd.

					

						28 July 2016

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						 

					

					

						 

				
	

					

						

					

					

						© inVentiv Health. All Rights Reserved.

				

		

			 

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

		
			Exhibit B Payment Schedule
		

		
			1.           PAYMENT TERMS
		

		
			 
		

		
			A.             Service Fees:
		

		
			 
		

		
			Exhibit B
		

		
			inVentiv Health Clinical
		

		
			Milestone Payment Schedule
		

		
			7810962 Canada Inc. (11ISB001)
		

		
			 
		

			
					
						Milestone

					
					
						Original
Agreement

					
					
						CO#2 with
Discount

					
					
						CO#3 with
Discount

					
					
						CO#4 with
Discount

					
					
						CO#5

					
					
						CO#6

					
					
						CO#6.1

					
					
						Total (USD)
with Discount

					
					
						Invoice #

					
					
						Invoice
Amount

					
					
						Paid Amount

				
	
					
						Upon Execution of Contract

					
250,249 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
250,249 
					
					
						11ISB001-001

					
250,249 
					
250,249 
				
	
					
						Upon Execution of CO#3

					
					
						 

					
					
						 

					
904,042 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
904,042 
					
					
						11ISB001-064

					
904,042 
					
904,042 
				
	
					
						Upon Execution of CO#4

					
					
						 

					
					
						 

					
					
						 

					
119,480 
					
					
						 

					
					
						 

					
					
						 

					
119,480 
					
					
						11ISB001-065

					
119,480 
					
119,480 
				
	
					
						Upon Execution of CO#5

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
349,419 
					
					
						 

					
					
						 

					
349,419 
					
					
						0030018998

					
349,419 
					
349,419 
				
	
					
						Upon Execution of CO#6

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
424,093 
					
					
						 

					
424,093 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Completion of Investigator Meeting

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						50% of Site Initiation Visits completed

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Last Site Initiation Visits completed

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Database Release (eCRF release) to Production

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						First Patient In US Trial

					
250,249 
					
					
						-250,249

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						First Patient In European Trial

					
250,249 
					
					
						-250,249

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Last Patient In US Trial

					
344,865 
					
					
						-344,865

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Last Patient In European Trial

					
344,865 
					
					
						-344,865

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						First Patient In

					
					
						 

					
421,712 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
421,712 
					
					
						11ISB001-034/11ISB001-042

					
421,712 
					
421,712 
				
	
					
						Last Patient in

					
					
						 

					
576,327 
					
300,000 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
876,327 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
1,440,477 
					
					
						-192,189

					
1,204,042 
					
119,480 
					
349,419 
					
424,093 
					
0 
					
3,345,322 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						26-week Subject Treatment Period Ends:

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						DBL for all patients completing 26-weeks completed

					
					
						 

					
412,620 
					
280,000 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
692,620 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Study Unblinded after analysis of efficacy part completed

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Draft Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 26 CSR US Trial

					
750,746 
					
					
						-750,746

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 26 CSR European Trial

					
750,746 
					
					
						-750,746

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
1,501,492 
					
					
						-1,088,872

					
280,000 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
692,620 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						52-week Subject Treatment Period ends:

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						DBL for all patients completed

					
					
						 

					
232,364 
					
200,000 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
432,364 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Draft Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 52 CSR US Trial

					
261,441 
					
					
						-261,441

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 52 CSR European Trial

					
261,442 
					
					
						-261,441

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
1 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final CSR

					
					
						 

					
124,981 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
124,981 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Database Lock

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Draft CRF US Trial

					
261,432 
					
0 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
261,432 
					
					
						11ISB001-023

					
261,432 
					
261,432 
				
	
					
						Delivery of Draft CRF European Trial

					
261,432 
					
					
						-261,432

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
1,045,747 
					
					
						-426,969

					
200,000 
					
0 
					
0 
					
0 
					
0 
					
818,778 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Total Milestones

					
3,987,716 
					
					
						-1,708,030

					
1,684,042 
					
119,480 
					
349,419 
					
424,093 
					
0 
					
4,856,720 
					
					
						 

					
2,306,334 
					
2,306,334 
				

		
			 
		

		

		 

		

			Page 9 of 13

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

	
					
						

					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Quarterly Project Management Fee (10 Quarters starting June 16, 2011, ending December 15, 2013: 183,590 USD per quarter) Only Invoiced for 7 quarters

					
1,835,894 
					
					
						-598,157

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
1,237,737 
					
					
						See below

					
1,237,737 
					
1,237,737 
				
	
					
						Monthly Fees for Hold Period: (9 Monthlies starting April 2012, ending December 2012: 15,000 USD per month) Only Invoiced for 6 months

					
					
						 

					
90,000 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
90,000 
					
					
						11ISB001-017

					
90,000 
					
90,000 
				
	
					
						Quarterly Project Management Fee: (8 Quarterly Payments starting January 2014: $173,477.50 USD per quarter) Only invoiced for 4 quarters

					
					
						 

					
1,387,820 
					
					
						-693,909

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
693,911 
					
					
						See below

					
693,911 
					
693,911 
				
	
					
						Quarterly Project Management Fee: (4 Quarterly Payments starting January 2015: $244,147.50 USD per quarter)

					
					
						 

					
					
						 

					
976,590 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
976,590 
					
					
						See below

					
976,590 
					
976,590 
				
	
					
						Quarterly Fees for Dedicated CRA Program (4 Quarters Starting July 2016: $141,364.29 USD per quarter)

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
565,457 
					
					
						 

					
565,457 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Quarterly Fees for Dedicated CRA Program (3 Quarters Starting July 2016: $59,985 USD per quarter)

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
179,955 
					
179,955 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Total Milestone Payments1

					
5,823,610 
					
					
						-828,367

					
1,966,723 
					
119,480 
					
349,419 
					
989,550 
					
179,955 
					
8,600,370 
					
					
						 

					
5,304,572 
					
5,304,572 
				

		
			 
		

		
			1  - Professional fees are net of the 5% discount applied to Original Agreement and CO#1-#4
		

		
			 
		

			
					
						Quarterly Payments

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3rd Quarter 2011

					
					
						11ISB001-002

					
183,590.00 
					
183,590 
				
	
					
						4th Quarter 2011

					
					
						11ISB001-006

					
183,590.00 
					
183,590 
				
	
					
						1st Quarter 2012

					
					
						11ISB001-008

					
183,590.00 
					
183,590 
				
	
					
						1st Quarter 2012 (Reconciled for Amendment #1)

					
					
						11ISB001-017 & 19

					
(47,393.00)
					
(47,393)
				
	
					
						1st Quarter 2013

					
					
						11ISB001-022

					
183,590.00 
					
183,590 
				
	
					
						2nd Quarter 2013

					
					
						11ISB001-027

					
183,590.00 
					
183,590 
				
	
					
						3rd Quarter 2013

					
					
						11ISB001-032

					
183,590.00 
					
183,590 
				
	
					
						4th Quarter 2013

					
					
						11ISB001-032

					
183,590.00 
					
183,590 
				
	
					
						1st Quarter 2014

					
					
						11ISB001-042

					
173,477.50 
					
173,478 
				
	
					
						2nd Quarter 2014

					
					
						11ISB001-045

					
173,477.50 
					
173,478 
				
	
					
						3rd Quarter 2014

					
					
						11ISB001-053

					
173,477.50 
					
173,478 
				
	
					
						4th Quarter 2014

					
					
						11ISB001-058

					
173,478.00 
					
173,478 
				
	
					
						1st Quarter 2015

					
					
						11ISB001-064

					
244,147.50 
					
244,148 
				
	
					
						2nd Quarter 2015

					
					
						0030014002

					
244,147.50 
					
244,148 
				
	
					
						3rd Quarter 2015

					
					
						0030017725

					
244,147.50 
					
244,148 
				
	
					
						4th Quarter 2015

					
					
						0030017726

					
244,147.50 
					
244,148 
				
	
					
						3rd Quarter 2016

					
					
						 

					
141,364.29 
					
					
						 

				
	
					
						4rd Quarter 2016

					
					
						 

					
201,349.29 
					
					
						 

				
	
					
						1st Quarter 2017

					
					
						 

					
201,349.29 
					
					
						 

				
	
					
						2nd Quarter 2017

					
					
						 

					
201,349.29 
					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

				

		
			 
		

		
			

		 

		

			Page 10 of 13

		

 

			

					

						 

					

					

						 

					

					

						 

				
	

					

						

					

					

						Confidential

					

					

						inVentivHealthclinical.com

				

		

			 

		

		

			 

		

		

		
			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 $[****],  was invoiced upon execution of this Agreement. 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 $[****],  was invoiced upon execution of this Agreement. 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 is a one-time payment of $[****] (exclusive of funds for investigator grants), that was invoiced upon execution of this Agreement. 

		
			 
		

			
	
			
				 (d)
			

			
	
			
			CO#5:  This is a one-time payment of $[****] (exclusive of funds for investigator grants), that was invoiced upon execution of this Agreement. 

		
			 
		

			
	
			
				 (e)
			

			
	
			
			CO#6: This is a quarterly payment of [****]for ([****]) Quarters beginning with 1st payment invoiced on or after [****]. First payment invoiced on [****].

		
			 
		

			
	
			
				 (f)
			

			
	
			
			CO#6.1: This is a Quarterly payment of [****]for ([****]) Quarters beginning with 1st payment to be invoiced on [****]or upon execution of this Agreement if the executed date is later than [****]. 

		
			 
		

			
	
			
				 (g)
			

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

		
			 
		

			
	
			
				 (h)
			

			
	
			
			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 $[****],  was invoiced upon commencement of services. 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 (1.5%) per month

		
			 
		

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

		 

		

			Page 11 of 13rdhl_Ex4_13

		

			Exhibit 4.13

		

		

			 

		

		

			Confidential

		

		
			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 6 to Clinical Services Agreement
		

		
			 
		

		
			Client’s study drug RHB-104
		

		
			 
		

		
			This Change Order 6 (“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 507 Place D’Armes , Suite 1101, Montreal, Quebec, H2Y 2W8, 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 May 25, 2016 (“Effective Date”) and the parties hereby agree as follows:
		

		
			 
		

		
			1.    Change Order 6 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 Sponsor’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 total costs of the Clinical Services Agreement have increased to USD [****].
		

		
			 
		

		
			

		 

		

			1

		

 

		

			Confidential

		

		

		
			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.

					
					
						 

					
					
						    

					
					
						7810962 Canada Inc.

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						/s/ Dror Ben-Asher

					
					
						/s/ Micha Ben Chorin

					
					
						 

					
					
						/s/Alain Guimond

				
	
					
						Name: Dror Ben-Asher

					
					
						Micha Ben Chorin

					
					
						 

					
					
						Name: Alain Guimond

				
	
					
						Title:  CEO

					
					
						CFO

					
					
						 

					
					
						Title: V-P R&D

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Date: June 22, 2016                              

					
					
						 

					
					
						 

					
					
						Date: 20-June-2016

				

		
			 
		

		
			 
		

		
			 
		

		 

		

			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 6 for 7810962 Canada Inc.  /Red Hill Biopharma Ltd.
		

		
			 
		

		
			Overview of major level changes
		

		
			 
		

			
	
			
				 ·
			

			
	
			
			[****]:  [****] Dedicated CRAs starts [****] = $[****]/hour * [****]  hours X [****] CRAs = $[****]  ([****]  hours comes from the [****]hours/year / 12mths * [****]mths) ; [****] Dedicated CRA starts [****]=$[****]/hour * [****]  hours X [****] CRA=$[****] ([****]  hours comes from the [****]  hours/year / 12 months * [****]  month) 
[****]= $[****]/hour *[****]  hours *[****] CRAs = $[****]
[****]= $[****]/hour * [****]  hours  ([****] hours comes from [****] hours/year/ 12 months * [****] months ([****])) * [****] CRAs= $[****]

			
	
			
				 ·
			

			
	
			
			The flat rate of $[****] used in the above costing represents a discount to normal and customary rates for the purpose of offsetting inflation costs paid by 7810962 Canada Inc. for the period of [****]through [****]. Future change orders are subject to prevailing rates. 

		
			 
		

		
			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 #6

					
					
						Assumption
Changes
influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						Site Visit Travel

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Investigators' Meeting Organization

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Kick-off Meeting Travel/Attendance

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Shipping/Photocopying

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Translation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Regulatory Fees

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						Ethics Committee Fees

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						 

				
	
					
						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 #6

					
					
						Assumption
Changes
influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						Pre-study Activities

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Case Report Form Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Management Plan Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Informed Consent Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						IRB/Ethics Committee Interactions

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigators' Meetings

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigator Site Contract

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigator Recruitment

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Feasibility 

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Plan Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No Change

					
					
						No change

				
	
					
						Protocol Preparation/Review

					
					
						$[****]

					
					
						$[****].

					
					
						No change

					
					
						No change

				
	
					
						Randomization Schedule Preparation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Study-Specific Form Preparation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Training - Project-Specific

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Translations

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						 

					
					
						 

					
						 

					
					
						 

					
						 

					
					
						 

					
						 

					
						 

					
						 

					
						 

					
					
						 

				

		
			
		

		

		 

		

			5

		

 

		

			 

		

	
					
						

					
						Task

					
					
						Current
(US Dollars)

					
					
						Change
Order #6

					
					
						Assumption
Changes
influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						PROMIS

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Monitoring/Site Management

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Data Clean-up

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Investigator Grant Administration

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Laboratory Report Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Serious/Significant Adverse Event Management

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Management  

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Remote Monitoring of Site Data

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Pre-study Visits

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Initiation Visits

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Routine Visits conducted on site

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Site Visits - Routine Visits conducted on site

					
					
						$[****]

					
					
						$[****]

					
					
						Dedicated NA CRA Program

					
					
						[****]:  [****] Dedicated CRAs starts [****] = $[****]/hr * [****]hrs X [****] CRAs = $[****]  ([****]hrs comes from the [****]hrs/year / 12mths * [****]mths) ; [****] Dedicated CRA starts [****]=$[****]/hr * [****] hrs X [****] CRA=$[****]  ([****] hrs comes from the [****] hrs/year / 12 mths * [****] mth) 
[****] = $[****]/hr *[****]hrs *[****] CRAs = $[****]
[****] = $[****]/hr * [****]hrs * [****] CRAs= $[****]

				
	
					
						Site Visits - Close-out Visits at each site at Study End

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Study Master File/Project File Set-up and Maintenance

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Patient/Site Recruitment

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				

		
			
		

		

		 

		

			6

		

 

		

			 

		

	
					
						

					
						Task

					
					
						Current
(US Dollars)

					
					
						Change
Order #6

					
					
						Assumption
Changes
influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						Client/CRO meeting

					
					
						$[****]

					
					
						$[****]

					
						 

					
					
						No change

					
					
						No change

				
	
					
						Regulatory

					
					
						 

					
					
						 

					
					
						No change

					
					
						No change

				
	
					
						Regulatory Documentation Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Management /Project Tracking

					
					
						 

					
					
						 

					
					
						No change

					
					
						No change

				
	
					
						Financial Project Management

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Management

					
					
						$  [****]

					
					
						$  [****]

					
					
						No change

					
					
						No change

				
	
					
						Project Tracking / Communications

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Vendor Management

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Management

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Database Archiving

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Cleanup (DM)

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Data Management: Database Quality Control Inspection

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Database Design

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Dictionary Coding

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Edit Check Programming

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Electronic Data Import

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Case Report Form Data/Document Transfers

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						EDC Fees

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Statistical Analysis and Table Generation

					
					
						 

					
					
						 

					
					
						No change

					
					
						No change

				

		
			 
		

		
			
		

		
			

		 

		

			7

		

 

		

			 

		

		

		
			 
		

			
					
						Task

					
					
						Current
(US Dollars)

					
					
						Change
Order #6

					
					
						Assumption
Changes
Influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						Task

					
					
						Current
(US Dollars)

					
					
						Change
Order #6

					
					
						Assumption
Changes
influencing the
change in the
budget

					
					
						Additional comments

				
	
					
						Electronic Data Transfer

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Interim Analysis/Report Preparation and Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Statistical Analysis Plan Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Table Generation

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Table/Listings Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Clinical Study Report

					
					
						 

					
					
						 

					
					
						No change

					
					
						No change

				
	
					
						Clinical Study Report Preparation/Review

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Team Meetings

					
					
						 

					
					
						 

					
					
						No change

					
					
						No change

				
	
					
						Project Team Meetings - Internal Meetings

					
					
						$[****]

					
					
						$  [****]

					
					
						No change

					
					
						No change

				
	
					
						Project Team Meetings - Client Teleconferences

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Project Team Meetings - Kick-off Meeting

					
					
						$[****]

					
					
						$[****]

					
					
						No change

					
					
						No change

				
	
					
						Total Direct Costs

					
					
						$[****]

					
					
						$[****]

					
					
						 

					
					
						 

				

		
			 
		

		
			Total Costs
		

		
			 
		

			
					
						

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Category

					
					
						Total Costs($)

				
	
					
						Current Contract
(USD)

					
					
						Change in Scope # 6
(USD)

					
					
						Revised Total
(USD)

				
	
					
						Pass-Through Costs 1

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Investigator Grants Costs

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Professional Fees

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Discount   

					
					
						-$[****] 

					
					
						$[****]

					
					
						-$[****] 

				
	
					
						Revised Professional Fees

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				
	
					
						Grand Total

					
					
						$[****]

					
					
						$[****]

					
					
						$[****]

				

		

			
	
			
				 1
			

			
	
			
			Subsequent to the execution of CO#5.1 between 7810962 Canada Inc. and RedHill Biopharma Ltd., additional EDC Fees in the amount of $[****]were included in CO#5.1 between inVentiv Health and 7810962 Canada Inc, therefore the current actual contracted amount for pass-through is $[****]

		
			 
		

		
			 
		

		 

		

			8

		

 

		

			 

		

		
			Exhibit B Payment Schedule
		

		
			 
		

		
			1.            PAYMENT TERMS
		

		
			 
		

		
			A.           Service Fees:
		

		
			Exhibit B
		

		
			inVentiv Health Clinical
		

		
			Milestone Payment Schedule
		

		
			7810962 Canada Inc. (11ISB001)
		

		
			 
		

			
					
						

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Milestone

					
					
						Original
Agreement

					
					
						CO#2 with
Discount

					
					
						CO#3 with
Discount

					
					
						CO#4 with
Discount

					
					
						CO#5

					
					
						CO#6

					
					
						Total (USD)
with Discount

					
					
						Invoice #

					
					
						Invoice
Amount

					
					
						Paid Amount

				
	
					
						Upon Execution of Contract

					
250,249 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
250,249 
					
					
						11ISB001-001

					
250,249 
					
250,249 
				
	
					
						Upon Execution of CO#3

					
					
						 

					
					
						 

					
904,042 
					
					
						 

					
					
						 

					
					
						 

					
904,042 
					
					
						11ISB001-064

					
904,042 
					
904,042 
				
	
					
						Upon Execution of CO#4

					
					
						 

					
					
						 

					
					
						 

					
119,480 
					
					
						 

					
					
						 

					
119,480 
					
					
						11ISB001-065

					
119,480 
					
119,480 
				
	
					
						Upon Execution of CO#5

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
349,419 
					
					
						 

					
349,419 
					
					
						0030018998

					
349,419 
					
349,419 
				
	
					
						Upon Execution of CO#6

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
424,093 
					
424,093 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Completion of Investigator Meeting

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						50% of Site Initiation Visits completed

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Last Site Initiation Visits completed 

					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Database Release (eCRF release) to Production

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						First Patient In US Trial

					
250,249 
					
					
						-250,249

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						First Patient In European Trial

					
250,249 
					
					
						-250,249

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Last Patient In US Trial

					
344,865 
					
					
						-344,865

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Last Patient In European Trial

					
344,865 
					
					
						-344,865

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						First Patient In

					
					
						 

					
421,712 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
421,712 
					
					
						11ISB001-034/11ISB001-042

					
421,712 
					
421,712 
				
	
					
						Last Patient in

					
					
						 

					
576,327 
					
300,000 
					
					
						 

					
					
						 

					
					
						 

					
876,327 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
1,440,477 
					
					
						-192,189

					
1,204,042 
					
119,480 
					
349,419 
					
424,093 
					
3,345,322 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						26-week Subject Treatment Period Ends:

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						DBL for all patients completing 26-weeks completed

					
					
						 

					
412,620 
					
280,000 
					
					
						 

					
					
						 

					
					
						 

					
692,620 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Study Unblinded after analysis of efficacy part completed

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Draft Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 26 CSR US Trial

					
750,746 
					
					
						-750,746

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 26 CSR European Trial

					
750,746 
					
					
						-750,746

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
1,501,492 
					
					
						-1,088,872

					
280,000 
					
					
						 

					
					
						 

					
					
						 

					
692,620 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						52-week Subject Treatment Period ends:

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						DBL for all patients completed

					
					
						 

					
232,364 
					
200,000 
					
					
						 

					
					
						 

					
					
						 

					
432,364 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Draft Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final Tables, Listings and Graphs

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 52 CSR US Trial

					
261,441 
					
					
						-261,441

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final 52 CSR European Trial

					
261,442 
					
					
						-261,441

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
1 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Final CSR

					
					
						 

					
124,981 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
124,981 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Database Lock

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Delivery of Draft CRF US Trial

					
261,432 
					
0 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
261,432 
					
					
						11ISB001-023

					
261,432 
					
261,432 
				
	
					
						Delivery of Draft CRF European Trial

					
261,432 
					
					
						-261,432

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
0 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
1,045,747 
					
					
						-426,969

					
200,000 
					
0 
					
0 
					
0 
					
818,778 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						Total Milestones

					
3,987,716 
					
					
						-1,708,030

					
1,684,042 
					
119,480 
					
349,419 
					
424,093 
					
4,856,720 
					
					
						 

					
2,306,334 
					
2,306,334 
				

		
			 
		

		
			
		

		
			

		 

		

			9

		

 

		

			 

		

		

		
			 
		

			
					
						 

					
						 

					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Quarterly Project Management Fee (10 Quarters starting June 16, 2011, ending December 15, 2013: 183,590 USD per quarter)
Only Invoiced for 7 quarters

					
1,835,894 
					
					
						-598,157

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
1,237,737 
					
					
						See below

					
1,237,737 
					
1,237,737 
				
	
					
						Monthly Fees for Hold Period: (9 Monthlies starting April 2012, ending December 2012: 15,000 USD per month)
Only Invoiced for 6 months

					
					
						 

					
90,000 
					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
90,000 
					
					
						11ISB001-017

					
90,000 
					
90,000 
				
	
					
						Quarterly Project Management Fee: (8 Quarterly Payments starting January 2014: $173,477.50 USD per quarter) Only 

					
						invoiced for 4 quarters

					
					
						 

					
1,387,820 
					
					
						-693,909

					
					
						 

					
					
						 

					
					
						 

					
693,911 
					
					
						See below

					
693,911 
					
693,911 
				
	
					
						Quarterly Project Management Fee: (4 Quarterly Payments starting January 2015: $244,147.50 USD per quarter)

					
					
						 

					
					
						 

					
976,590 
					
					
						 

					
					
						 

					
					
						 

					
976,590 
					
					
						See below

					
976,590 
					
976,590 
				
	
					
						Quarterly Fees for Dedicated CRA Program (4 Quarters Starting July 2016: $141,364.29 USD per quarter)

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
565,457 
					
565,457 
					
					
						 

					
					
						 

					
					
						 

				
	
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Total Milestone Payments1

					
5,823,610 
					
					
						-828,367

					
1,966,723 
					
119,480 
					
349,419 
					
989,550 
					
8,420,415 
					
					
						 

					
5,304,572 
					
5,304,572 
				

		
			 
		

			
					
						 

				
	
					
						1 - Professional fees are net of the 5% discount applied to Original Agreement and CO#1-#4

				

		
			 
		

			
					
						

					
					
						 

					
					
						 

					
					
						 

				
	
					
						Quarterly Payments

					
					
						 

					
					
						 

					
					
						 

				
	
					
						3rd Quarter 2011

					
					
						11ISB001-002

					
183,590.00 
					
183,590 
				
	
					
						4th Quarter 2011

					
					
						11ISB001-006

					
183,590.00 
					
183,590 
				
	
					
						1st Quarter 2012

					
					
						11ISB001-008

					
183,590.00 
					
183,590 
				
	
					
						1st Quarter 2012 (Reconciled for Amendment #1)

					
					
						11ISB001-017 & 19

					
(47,393.00)
					
(47,393)
				
	
					
						1st Quarter 2013

					
					
						11ISB001-022

					
183,590.00 
					
183,590 
				
	
					
						2nd Quarter 2013

					
					
						11ISB001-027

					
183,590.00 
					
183,590 
				
	
					
						3rd Quarter 2013

					
					
						11ISB001-032

					
183,590.00 
					
183,590 
				
	
					
						4th Quarter 2013

					
					
						11ISB001-032

					
183,590.00 
					
183,590 
				
	
					
						1st Quarter 2014

					
					
						11ISB001-042

					
173,477.50 
					
173,478 
				
	
					
						2nd Quarter 2014

					
					
						11ISB001-045

					
173,477.50 
					
173,478 
				
	
					
						3rd Quarter 2014

					
					
						11ISB001-053

					
173,477.50 
					
173,478 
				
	
					
						4th Quarter 2014

					
					
						11ISB001-058

					
173,478.00 
					
173,478 
				
	
					
						1st Quarter 2015

					
					
						11ISB001-064

					
244,147.50 
					
244,148 
				
	
					
						2nd Quarter 2015

					
					
						0030014002

					
244,147.50 
					
244,148 
				
	
					
						3rd Quarter 2015

					
					
						0030017725

					
244,147.50 
					
244,148 
				
	
					
						4th Quarter 2015

					
					
						0030017726

					
244,147.50 
					
244,148 
				

		
			 
		

		
			 
		

		
			 
		

		
			

		 

		

			10

		

 

		

			 

		

		

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

		
			 
		

		
			(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 $[****], will be invoiced upon commencement of services. 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-half percent (0.5%) per month
		

		
			 
		

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

		 

		

			11

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