Document:

exh_423.htm

Exhibit 4.23

 

 

CONFIDENTIAL

 

CLINICAL TRIALS GLOBAL MASTER SERVICES AGREEMENT AMENDMENT NO. 1

 

This Amendment No. 1 is made effective as of the date last signed below ("Amendment No. 1 Effective Date") by and between RedHill Biopharma, Ltd. ("Client") and Quest Diagnostics Clinical Laboratories, Inc. ("Quest Diagnostics").  This Amendment No. 1 amends the Clinical Trials Global Master Services Agreement dated 27-December-2012 to which both Client and Quest Diagnostics are parties (the "Agreemenf').

1.   The purpose of this Amendment No. 1 is to replace Sections 4.1 and 4.2 of the Agreement with the following language:

4.1.    Client Ownership of Data; Inventions. All data, test results, studies and other information generated by Quest Diagnostics in performing the Services (the "Data") shall be the property of the Client. All proprietary, non-public information concerning (a) the study drug and (b) Client's operations (including basic scientific data, prior clinical or laboratory data, formulation information, and research programs supplied by Client to Quest Diagnostics and not in the public domain) ("Client's Confidential Information") shall be considered confidential and shall remain the sole property of Client. Further, except as otherwise provided in Section 4.2 below, all rights to any discovery or invention conceived (or conceived and reduced to practice) in the direct performance of the work conducted under this Agreement (each, an "Invention") shall belong to Client. Quest Diagnostics shall promptly disclose to Client any Invention arising from this Agreement.  Quest Diagnostics agrees to assign to Client, and hereby does assign to Client, the sole and exclusive ownership of and the entire right, title and interest in any Invention hereunder.  Client agrees to reimburse Quest Diagnostics for any patent application drafting costs incurred by Quest Diagnostics in connection with any Invention assigned to Client arising from this Agreement. Quest Diagnostics may assist Client in any further protection or perfection of such Invention to the extent reasonably necessary at a fee to be negotiated and agreed upon by the parties and paid by Client to Quest Diagnostics.

 

4.2     Quest Diagnostics Intellectual Property. Notwithstanding anything in this Agreement to the contrary, Client and Quest Diagnostics agree that Quest Diagnostics possesses certain intellectual property, including but not limited to inventions, know-how, trade secrets, analytical methods, standard operating procedures, computer technical expertise, software and statistical methodologies originated by Quest Diagnostics prior to or during the Term of this Agreement without benefit of Information provided by Client that is the sole property of Quest Diagnostics ("Quest Diagnostics' Intellectual Property").  Further, to the extent that Quest Diagnostics makes any improvement or addition to Quest Diagnostics' Intellectual Property relating solely to central or diagnostic laboratory analyses and services and/or medical diagnostic assays and methods in the course of performing this Agreement or otherwise, such improvement and/or addition to Quest Diagnostics' Intellectual Property shall be the sole and exclusive property of Quest Diagnostics and Quest Diagnostics shall grant and hereby grants to Client an irrevocable, perpetual, worldwide, non-exclusive, royalty-free, sublicensable, and transferable license to such improvement or addition to Quest Diagnostics' Intellectual Property. For clarity, any improvement or addition to Quest Diagnostics' Intellectual Property utilizing, incorporating, or including any Confidential Information of Client shall be considered an Invention under Section 4.1 owned exclusively by Client, and Quest Diagnostics hereby does assign to Client the sole and exclusive ownership of and the entire right, title and interest in any such improvement, addition or Invention utilizing, incorporating or including any Confidential Information of Client.  Finally, in the course of working

 

RedHill Biopharma, Ltd. I Quest Diagnostics Clinical Laboratories, Inc. 

Clinical Trials Global Master Services Agreement, Amendment No. 1

  

Page 1 of 2

  

CONFIDENTIAL

 

 

with Quest Diagnostics hereunder, Client may become aware of other, non-public information about Quest Diagnostics and its business that Quest Diagnostics considers confidential, which shall be considered confidential and shall remain the sole property of Quest Diagnostics (such information, together with Quest Diagnostics' Intellectual Property, is referred to hereinafter as "Quest Diagnostics Confidential Information").

 

2.     All other terms and conditions of the Agreement shall remain in full force and effect. In the event of any conflict between the terms of the Agreement and this Amendment No. 1, the terms of this Amendment No. 1 shall control.

 

5.              The parties hereto agree to be bound by this Amendment No. 1 as of the Effective Date by their authorized signature below.

 

 

	REDHILL BIOPHARMA LTD. 	 	
QUEST DIAGNOSTICS CLINICAL 

LABORATORIES, INC.

	 	 	 
		 	
	Authorized Signature	 	Authorized Signature
	 	 	 
	Dror Ben-Asher	 	
	Name Printed	 	Name Printed
	 	 	 
	CEO	 	
	Title	 	Title
	 	 	 
	June 19, 2014	 	
	Date	 	Date

 

 

 

 

 

 

 

RedHill Biopharma, Ltd. I Quest Diagnostics Clinical Laboratories, Inc. 

Clinical Trials Global Master Services Agreement, Amendment No. 1

Page 2 of 2exh_424.htm

Exhibit 4.24

 

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

 

Confidential

 

MASTER AGREEMENT WORK ORDER

PROTOCOL # RHB-104-01 (MAP Testing and Other Analysis)

 

RedHlll Blopharma Limited 

21 Ha'arba'a St

Tel-Aviv Israel 64739

 

Protocol Name: A Phase Ill Randomized, Double Blind, Placebo-controlled, Multicenter, Parallel Group Study to Assess the Efficacy and Safety of Fixed-dose Combination RHB-104 in Subjects with Moderately to Severely Active Crohn's Disease

 

	
1) 

	
Contact jnformatlon :

RedHill Blopharma Contact: Patrick Mclean

Quest Diagnostics Project Manager: Mariana Klinger

 

	
2) 

	
Work Order Term:    Effective Date: 10-Oct-2013 [****] 

The term of this work order may be extended an amendment signed by both parties.

 

	
3) 

	
The Estimated Central l.aboratorv Budget dated is attached as Attachment #1 and is incorporated herein by reference.

 

The estimated Study Value is $ [****]

 

See Exhibit A with the expected budget for the study. The actual cost will be based on the actual work that will be done by Quest during the study based on the cost per item in Exhibit A.

 

RedHlll has the right to request Quest to change the couriers utilized for the shipment in Exhibit A with other couriers required by RedHill. If such courier is not currently under a subcontract with Quest Diagnostics, then RedHill shall contract with the courier and provide the shipping information to Quest Diagnostics for shipments and RedHill shall be accountable for any such shipments.

 

	
4) 

	
Affiliates and Subcontractors: In accordance with the Agreement, the following Quest Diagnostics affiliates and subcontractors shall be utilized for services hereunder:

 

	
Affiliate/Subcontractor  Name

	
Service Provided

	

Quest [****]

	
Testing and related services

	

[****]

	
Testing and related services

	

[****]

	

[****]

	

[****]

	

[****]

	
 

	
 

 

 

RedHlll Biopharma Limited and Quest Diagnostics Clinical Laboratories, Inc. 

Work Order for RHB104-01 (MAP Testing and Other Analysis)

  

Page 1 of 4

  

Confidential

 

 

	
5) 

	
Invoices: 

	 	
Electronic Invoices shall be sent to:

	
E-mail address: [****]

	 	
 

	
Attention: [****]

	 	
 

	
Phone number: [****]

CC: [****]

 

	
6)

	
Fee Increases. Fees for testing performed at a Quest Diagnostics laboratory shall not increase for the term of this work order. After the conclusion of such term, Quest Diagnostics may increase fees for its Services provided hereunder and annually thereafter to offset any increased costs of operations by providing thirty (30) days written notice to the Client. Any such increase shall not exceed the annual inflation rate during the previous twelve-month period ending on the last day of the month immediately preceding the effective date of the increase, as measured (i) [****] and (ii) in the United States, by the increase in the Consumer Price Index for All Urban Consumers (CPI-U): U. S. City Average, Medical care.

	
6)

	

For this Work Order only the following language shall apply in support of shipping charges to and from the [****].

The current Work Order budget reflects the total costs for shipping specimens to and from [****] (“[****] Specimen Shipping Charges”) for services provided by [****]. RedHill Biopharma shall pay the [****] Specimen Shipping Charges monthly as invoiced by Quest Diagnostics. Beginning with the April 2014 invoice, Quest Diagnostics will issue RedHill Biopharma a credit (in a separate invoice) in an amount equal to [****] Specimen Shipping Charges that have been invoiced in the prior six (6) months for shipping specimens to and from [****] (“[****]Shipping Credit”). Successive Specimen Shipping Credits shall continue every six (6) months of the duration of the study.

At the conclusion of the study, a final credit will be applied for any remaining months that did not receive the [****] Specimen Shipping Credit.

The fees and services quoted in this Work Order and its attachments and all other terms and conditions for the performance of services for this clinical protocol shall be in accordance with the Clinical Trials Global Master Services Agreement (effective 22-Dec-2012 ) between Quest Diagnostics Clinical Laboratories, Inc. (Quest Diagnostics) and RedHill Biopharma Limited (CLIENT).

 

 

 

 

RedHlll Biopharma Limited and Quest Diagnostics Clinical Laboratories, Inc. 

Work Order for RHB104-01 (MAP Testing and Other Analysis)

  

Page 2 of 4

  

Confidential

 

 

Attachment #1 

Estimated Central Laboratory Budget

 

RHB10-01(CR)(Bid1

vl2).pdf

 

Budget Version 12 Dated 14-Oct-2013

 (23 pages incorporated herein)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

RedHlll Biopharma Limited and Quest Diagnostics Clinical Laboratories, Inc. 

Work Order for RHB104-01 (MAP Testing and Other Analysis)

 

Page 3 of 4

 

 

CONFIDENTIAL

 

 

	 	

 

 

Quest Diagnostics Clinical Trials

Central Laboratory Services Budget

 

 

RedHill Biopharma Limited 

RHB-104-01 (CR) v12 

Version  12 

14-Oct-13

 

	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	 	 	 	 	 	 
	
Prepared for:

	 	

[****]

	
by:

	 	

[****]

	  	 	 	  	 	 
	  	 	 	  	 	 
	
 

	 	 	  	 	 
	
 

	 	 	  	 	 
	  	 	  	  	 	 
	  	 	  	  	 	  
	  	 	  	  	 	  
	
Tel:

	 	

[****]

	
Tel:

	 	

[****]

	  	 	  	
Fax:

	 	

[****]

	
Email:

	 	

[****]

	
Email:

	 	

[****]

	  	 	  	  	 	  
	  	 	  	  	 	  
	  	 	  	  	 	  

 

 

  

Page 1 of 23

  

 

 

14-Oct-13

 

Patrick L. McLean

Product Manager 

RedHill Biopharma Limited 

21 Ha’arba’a St. 

Tel-Aviv Israel 64739

 

	
Regarding: 

	
Centralized Clinical Laboratory and Related Support Services for Protocol RHB-104-01 (CR) v12

 

Dear Patrick :

 

Thank you for the opportunity to submit a revised budget for your study. This budget includes the following changes.

 

	 	
·

	

version 12: Updated patients:visits distribution based on info dated 9-October [****] 

 

Quest Diagnostics Clinical Trials has a commitment to peak performance, superior value for our customers, teamwork, innovation and integrity. We look forward to the opportunity to work with you to demonstrate our dedication to these values.

 

If you have any questions or require further assistance, please feel free to call me.

 

Yours sincerely,

 

 

[****]

Senior Strategic Account Executive

Quest Diagnostics Clinical Trials

 

 

  

Page 2 of 23

  

 

 

 

	
RedHill

Biopharma

Limited

	Quote for Services	

 

Assumptions

Protocol: RHB-104-01 (CR) v12

 

 

 

Assumptions:

 

Global Phase III trial- Israel and US/Canada

 

RHB-104 therapy requires a diagnostic for infection with Mycobacterium avium paratuberculosis in patients with Crohn’s Disease

 

3 countries, [****] sites respectively

[****] screened, [****] baseline to visit [****], and [****] respectively

Canada-US region: [****]

Grand total of [****] 

Grand total of [****]

 

We assume Quest Diagnostics to supply each site with [****].

 

 

Recommended couriers:

Israel- [****]

Canada - [****]

US- [****]

Quest [****]

Courier mapping- [****]

Sites to [****]

Sites to [****]

Sites to [****]

Sites to [****]

Quest [****]

Courier mapping- [****]

Sites to [****]

Sites [****]

Sites to [****]

Sites to [****]

 

 

Transportation budget: Quest Diagnostics does offer a cost-effective solution [****]

 

Warning: Please note that Quest Diagnostics refuse to do [****].

 

  

Page 3 of 23

  

 

Inbound budget (shipments from sites to Quest Diagnostics): [****]

 

 

Worst case scenario: we assume [****] be revised in accordance to validation data.

PK [****]

 

HIV Western Blot-[****]

 

Disclaimer:

[****]

 

 

 

Stored specimen:

For bidding purpose, we assume average storage [****].

Disclaimer: RHB to confirm if QDCT has to include into this budget the fact that [****].

 

 

[****] services -

Note that we have included $25 towards handling charges on top of the [****]

 

 

Week-end shipments from sites [****]

EWP(extreme weather packaging)- [****].

 

 

  

Page 4 of 23

  

	
RedHill Biopharma Limited

	Quote for Services	

 

Change In Scope History 

Protocol: RHB-104-01 (CR) v12

 

	
Category

	
Updated Study Value

	
Previous Study Value *

	
Difference

	
Laboratory Testing

	

[****]

	

[****]

	

[****]

	
Supplies

	

[****]

	

[****]

	

[****]

	
Additional Pass-Through Services

	

[****]

	

[****]

	

[****]

	
Study Management

	

[****]

	

[****]

	

[****]

	
Storage & Services

	

[****]

	

[****]

	

[****]

	
Inbound Transportation

	

[****]

	

[****]

	

[****]

	
Batched Inbound

	

[****]

	

[****]

	

[****]

	
Outbound Transportation

	

[****]

	

[****]

	

[****]

	
Outbound Transportation - Shipping Containers

	

[****]

	

[****]

	

[****]

	
Estimated Central Laboratory Budget:

	

[****]

	

[****]

	

[****]

 

* Budget taken from RedHill Biopharma Limited: RHB-104-01 (CR) version 11

 

  

Page 5 of 23

  

	
RedHill Biopharma Limited

	Quote for Services	

 

Budget Summary

Protocol: RHB-104-01 (CR) v12

 

 

	
Study Duration:

	

[****]

	
Total Investigators:

	

[****]

	  
	  	  	
Total Countries:

	

[****]

	  
	  	  	
Total Visits:

	

[****]

	  
	  	  	
Total Patient-Visits:

	

[****]

	  

 

	  	
Estimated Grand Total Amount

	

[****]

	 
	  	
Average Cost Per Patient-Visit

	

[****]

	 
	  	
Average Cost Per Patient

	

[****]

	 

 

	Budget Summary 1	 	 	 	 
	
Sub-Totals

	
Region

	
Billing Amount

	
Conversion Rate

	
Estimated Total Amount

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	  	
Study Set-up Fees

	

[****]

	

[****]

	

[****]

	  	  	  	  	

[****]

	
Average Cost Per Patient-Visit

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	  	
Study Set-up Fees

	

[****]

	  	  
	  	  	

[****]

	

[****]

	

[****]

	
Average Cost Per Patient

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	  	
Study Set-up Fees

	

[****]

	  	  
	  	  	

[****]

	

[****]

	

[****]

	 	 	 	 	 

 

	Detailed Budget Summary	 	 	 	 
	
Laboratory Testing

	
Region

	
Billing Amount

	
Conversion Rate

	
Estimated Total Amount

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Supplies

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Additional Pass-Through Services

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Storage

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Study Management

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	  	
Study Set-up Fees

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Inbound Transportation

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Outbound Transportation

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	
Shipping Container Transportation

	
Region

	

[****]

	

[****]

	

[****]

	  	
USA, Canada

	

[****]

	

[****]

	

[****]

	  	
Israel

	

[****]

	

[****]

	

[****]

	

[****]

	  	

[****]

	 	 	 	 

 

  

Page 6 of 23

  

	
RedHill Biopharma Limited

	Quote for Services	

 

Detail Summary

Protocol: RHB-104-01 (CR) v12

 

	
Laboratory Testing

	
Region

	
Time Points

	
Quantity

	
Billing

Currency

Unit Price

	
Billing 

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
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USA, Canada

	
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USA, Canada

	
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[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Laboratory Testing Total

	
[****]

 

  

Page 7 of 23

  

 

	
Supplies

	
Region

	
Unit

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Supplies Total

	
[****]

 

  

Page 8 of 23

  

 

	
Additional Pass-Through Services

	
Region

	
Unit

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total 

Amount

	
[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
USA, Canada

	 	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Israel

	  	

[****]

	

[****]

	

[****]

	

[****]

	

[****]

	
Additional Pass-Through Services Total

	

[****]

 

	
Storage

	
Region

	
Aliquots

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

  

Page 9 of 23

  

 

	
Storage

	
Region

	
Aliquots

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Storage Total

	
 

	
[****]

 

  

Page 10 of 23

  

 

	
Study Management

	
Region

	
Unit

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Study Set-up Fees

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Study Set-up Fees

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Study Set-up Fees

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Study Set-up Fees

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Study Management Total

	
[****]

	
Inbound Transportation

	
Region

	
Unit

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Inbound Transportation Total

	
[****]

	
Outbound Transportation

	
Region

	
Unit

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Outbound Transportation Total

	
[****]

	
Shipping Container Transportation

	
Region

	
Unit

	
Quantity

	
Billing

Currency

Unit Price

	
Billing

Amount

	
Conversion 

Rate

	
Estimated 

Total Amount

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
USA, Canada

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Shipping Container Transportation Total

	
[****]

 

 

 

 

 

  

Page 11 of 23

  

 

 

	
RedHill 

Biopharma 

Limited

	Quote for Services	

 

Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

	
Name

	
Screening

 

 

	
Baseline

	
V2

	
V3

	
V4

	
V5

	
V6

	
V7

	
V8

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

 

  

Page 12 of 23

  

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

 

 

	
Name

	
Screening

	
Baseline

	
V2

	
V3

	
V4

	
V5

	
V6

	
V7

	
V8

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

  

Page 13 of 23

  

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

  Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

 

 

	
Name

	
Screening

	
Baseline

	
V2

	
V3

	
V4

	
V5

	
V6

	
V7

	
V8

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
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Page 14 of 23

  

 

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

  Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

 

 

	  	
Screening

	
Baseline

	
V2

	
V3

	
V4

	
V5

	
V6

	
V7

	
V8

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
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Page 15 of 23

  

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

  Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

	
Name

	
V9

	
V10

	
V11

	
V12

	
V13

	
V14

	
Biopsy

	
Sample

	
Sample

	
Susceptibility

	  	  	  	  	  	  	  	  	
Processing

	
processing

	
processing

	
Testing

	  	  	  	  	  	  	  	  	

([****])

	

 – [****] tubes

	

– [****] tubes

	

([****])

	  	  	  	  	  	  	  	  	  	

([****])

	

([****])

	  
	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
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[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

  

Page 16 of 23

  

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

  Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

	
Name

	
V9

	
V10

	
V11

	
V12

	
V13

	
V14

	
Biopsy

	
Sample

	
Sample

	
Susceptibility

	  	  	  	  	  	  	  	  	
Processing

	
processing

	
processing

	
Testing

	  	  	  	  	  	  	  	  	

([****])

	

– [****] tubes

	

– [****] tubes

	

([****])

	  	  	  	  	  	  	  	  	  	

([****])

	

([****])

	  
	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
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[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
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[****]

	  	
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[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

  

Page 17 of 23

  

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

  Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

	
Name

	
V9

	
V10

	
V11

	
V12

	
V13

	
V14

	
Biopsy

	
Sample

	
Sample

	
Susceptibility

	  	  	  	  	  	  	  	  	
Processing

	
processing

	
processing

	
Testing

	  	  	  	  	  	  	  	  	

([****])

	

– [****] tubes

	

– [****] tubes

	

([****])

	  	  	  	  	  	  	  	  	  	

([****])

	

([****])

	  
	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	

[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

  

Page 18 of 23

  

	
RedHill 

Biopharma 

Limited

	Quote for Services	

  

  Test Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Category

	  	
V9

	
V10

	
V11

	
V12

	
V13

	
V14

	
Biopsy

	
Sample

	
Sample

	
Susceptibility

	  	  	  	  	  	  	  	  	
Processing

	
processing

	
processing

	
Testing

	  	  	  	  	  	  	  	  	
([****])

	

– [****] tubes

	

– [****] tubes

	

([****])

	  	  	  	  	  	  	  	  	  	

([****])

	

([****])

	  
	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

 

 

 

  

Page 19 of 23

  

 

	
RedHill Biopharma 

Limited

	Quote for Services	

 

Patient Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Country

 

 

	
Sites

	
Screening

	
Baseline

	
V2

	
V3

	
V4

	
V5

	
V6

	
V7

	
V8

	
V9

	
V10

	
V11

	
V12

	
Calculated Totals:

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	
Canada(Toronto)

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
United States(New York)

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
Israel(Tel Aviv)

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

 

 

  

Page 20 of 23

  

	
RedHill Biopharma 

Limited

	Quote for Services	

  

 

Patient Visit Schedule

All Locations 

Protocol: RHB-104-01 (CR) v12

 

	
Country

	
Sites

	
V13

	
V14

	
Biopsy

	
Sample

	
Sample

	
Susceptibility

	 
	  	  	  	  	
Processing

	
processing

	
processing

	
Testing

	 
	  	  	  	  	

([****])

	

– [****] tubes

	

– [****] tubes

	

([****])

	 
	  	  	  	  	  	

([****])

	

([****])

	  	 
	
Calculated Totals:

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	 
	  	  	  	  	  	  	  	  	 
	
Canada(Toronto)

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	 
	
United States(New York)

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	 
	
Israel(Tel Aviv)

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	
[****]

	 

 

  

Page 21 of 23

  

	
RedHill Biopharma Limited

	Quote for Services	

 

End Notes 

Protocol: RHB-104-01 (CR) v12

 

	Global Summary
	
1

	 	
See Study Specific Assumptions and Pricing Model, herein.  Budget excludes any “TBD” (To Be Determined) items.

	Global Summary - Laboratory Testing (LT)
	
1LT

	 	
Quoted fees reflect Quest Diagnostics Clinical Trials’ Year 2011 Fee Schedule.

	
2LT

	 	
Referral test to be performed by UCF. Fee includes the referral laboratory charge plus a referral fee for sample handling, data entry and result reporting. Any fee increase imposed by the Referral laboratory will be passed on to Client.

	
3LT

	 	
Fees quoted for testing services performed are exclusive of any applicable added Taxes (including Value Added Tax (VAT)).

	
4LT

	 	
The sample testing fees include the receipt of samples into a Quest Diagnostics-owned, affiliate or alliance partner laboratory, the direct costs associated with the laboratory testing of the samples, retention of the unused samples for a maximum of fourteen (14) days, laboratory quality control and global standardisation of equipment, processes, controls and calibrators.

	
5LT

	 	
The sample testing fees also include the distribution of interim result reports (per patient visit) and final result reports to Investigator(s) and/or Clients/CROs as applicable and agreed in the Central Laboratory Worksheet.  Any final result reports issued in hard copy will be sent via standard postal service or (within the continental United States only) Quest Diagnostics-US proprietary courier.

	
6LT

	 	
It is Quest Diagnostics Clinical Trials' (Quest) experience that  investigator sites experience significant challenges producing a peripheral blood smear ( PBS )  of sufficient quality for an appropriate hematology laboratory PBS review. Therefore, it is standard Quest practice to not provide glass slides and to not require the sites to make PBS slides . The performance by Quest of a routine safety CBC analysis (hematology) does involve the occasional review of PBS slides for the white blood cell morphology and differential, red blood cell morphology and platelet evaluation if the instrument or the SOP flags the specimen for a PBS slide review. The PBS slide can be appropriately created and reviewed in the majority of cases by the laboratory from the submitted CBC sample if a review is required. 

	
7LT

	 	
If the protocol requires a PBS slide review then glass microscope slides will be provided to the site(s) for each appropriate visit so that the site can create and provide a PBS to the central laboratory. Protocols where in our experience peripheral blood smears are recommended include significant hematological/bone marrow abnormalities (white or red cell, platelet abnormalities), leukaemia's, HIV clinical trials, sepsis, or other severe illnesses that would be impacting the hematological system. Our scientific affairs and medical affairs teams are available to further discuss the needs of your protocol regarding any requirements for PBS creation by the site or by the laboratory and PBS slide review by the Quest laboratory. Please could you confirm if this protocol requires a peripheral blood smear review or if subjects in this study are expected  to have hematological abnormalities where we would recommend the preparation of peripheral blood smears at the investigator site.

	
8LT

	 	
CBC and Peripheral blood smear pricing are based on assumptions received at the point of preparing this quotation.  Quest Diagnostics reserves the right to adjust these pertinent to further discussion with the customer.

	Global Summary - Supplies (SL)
	
*

	 	
The Supplies total for shipping containers is based on one separate shipment for each patient visit and reflects a “worst case scenario.”  Shipper container costs may be dramatically reduced when sites batch specimens prior to shipment to the laboratory.

	
1SL

	 	
Quest Diagnostics Clinical Trials will determine the price for a 40+ Visit Specific Kit(VSP) once all tubes and details of kit components have been finalized with the sponsor.

	Global Summary - Supplies (ST)
	
1ST

	 	
The “In” fee includes receipt, preparation, storage and entry of specimens into Quest Diagnostics Clinical Trials storage facility and computer system.

	
2ST

	 	
The “Monthly Maintenance” fee includes inventory, storage, temperature monitoring and continuous security coverage at Quest Diagnostics Clinical Trials storage facility.

	
3ST

	 	
The “Pull” fee includes the removal of requested specimens from storage, sorting of specimens prior to shipment (in a manner requested by client, e.g. - by patient, by visit) and the generation of a manifest.

	Global Summary - Study Management (SM)
	
1SM

	 	
The Study Management set-up fees quoted include provision for our standard toxicity and exclusions flagging; and cumulative data transmissions sent weekly via email zip file or SFTP or portals in our standard data file format. The fees do not include any set-up related to storage samples, new testing method set-up's, algorithms, microbiology testing or referral lab data entry. If client requires Quest to add any of these elements or set up additional flagging options and use data files which differ to our standard format, we reserve the right to adjust our set-up fees accordingly.

	
2SM

	 	
The Project Management Study Set-Up fee includes an internal review of the protocol in conjunction with the client's study team and formulation of an agreed Central Laboratory Worksheet signed off by Client and Quest, which lays out detailed specifications for the set-up and management of the study. Quest will design study documents, which include Investigator Manuals in the languages specified in the budget, a Lab Requirement Summary and pictogram, and study specific test Requistion forms in accordance with these specifications, as part of this fee. The design of visit specific specimen collection kits and set-up of Investigator site information is included as part of Project Management set-up.

	
3SM

	 	
The fee Per Visit for Project Management covers ongoing Project Management support, 24/7 investigator assistance/support by Quest Diagnostics CRC Support Team, including the use of toll-free phone lines.  Auto faxing of supply expiry details and inclusion of alerts and delta flagging are also covered by this fee.

	
4SM

	 	
The fee Per Visit for Data Management covers ongoing Data Management support, maintenance of the results database and the actioning and documentation of all necessary data revisions and data transfers up to once per week.

	
5SM

	 	
The fee Per Visit for Logistics covers the expertise and management of the ongoing study logistics, shipment tracking, processing and auditing of courier invoices and the performance management of the courier companies.

	
6SM

	 	
Quest Diagnostics proprietary software Result/ViewTM – web-based version shall be included for the two users per study at no additional charge, more than two users will be charged. This includes training and support by telephone.

	
7SM

	 	
Quest Diagnostics Clinical Trials will charge a per work order fee associated with each pull order. The purpose of this is to maximize the batching of samples whenever they are pulled for regular or ad hoc shipments from sample storage in order to create operational efficiency.

 

 

  

Page 22 of 23

  

 

 

 

	Global Summary - Inbound Transportation (IT)
	
**

	 	
The Inbound Transportation total is representative of individual patient specimen shipments and reflects a “worst case scenario”.  Transportation totals may be dramatically reduced when sites batch specimens prior to shipment to the laboratory.

	
1IT

	 	
The inbound specimen transportation fees are based on typical volumetric weight, and vary by city.  Quest Diagnostics Clinical Trials will bill client actual transport costs, per the invoice of the transport company. Any change to the fee imposed by the courier will be passed on to client. Additional charges for secondary cities, holidays and weekend service may apply.

	
2IT

	 	
The USD ($) Inbound Diagnostic Transportation fees quoted are based on an estimated exchange rate of £1 GBP = $ 1.6022. However, all Inbound Diagnostic Transportation will be billed at the actual £GBP to USD ($) rate ruling in the applicable month as published by UK Customs and Excise. Thus the Inbound Transportation fees may vary from those quoted in this budget in any given month depending on what the actual exchange rate is.

	
3IT

	 	
The Logistics estimates included represent our best recommendations based on recent experience.  We welcome the opportunity to discuss carrier performance and recommendations since the decision on courier selection ultimately resides with the sponsor.

	Global Summary - Outbound Transportation (OT)
	
1OT

	 	
Initial Supply Shipments: Initial shipments will be distributed within ten (10) working days from Client’s approval of the (a) requisition form, (b) Investigator Manual, and (c) receipt of Client’s final Investigator list. Quest Diagnostics’ must also receive Client’s approval of Quest Diagnostics’ verification report (without changes) at least 2 days prior to shipment.

	
2OT

	 	
Please note that Quest Diagnostics Clinical Trials does charge an additional fee for expedited/priority starter pack shipments.

	
3OT

	 	
Shipment of Re-supplies: Re-supply orders will be distributed within five (5) working days of Quest Diagnostics’ receipt of the Request for Supplies form from the Investigator or Client. Any re-supply orders containing special supplies shall be shipped upon supply availability and may require more than a five (5) working day turnaround.

	
4OT

	 	
Quest Diagnostics will use commercially-reasonable efforts to provide re-supply orders with less than five (5) working-days prior notification from Client or the Investigator (“STAT re-orders”).  However, Client will be responsible for all additional labor and transportation charges associated with STAT re-orders.

	
5OT

	 	
The Outbound transportation fees are based on typical volumetric weight.  Quest Diagnostics Clinical Trials will bill client actual transport costs per the invoice of the transport company.  Any change to the fee imposed by the courier will be passed on to client.  Priority shipments, e.g. next-day air are additional.  Fees for outbound supply shipments do not include any imposed tariffs.

	
6OT

	 	
The USD ($) Outbound transportation fees quoted are based on an estimated exchange rate of £1 GBP = $ 1.6022. However, all Outbound Transportation will be billed at the actual £GBP to USD ($) rate ruling in the applicable month as published by UK Customs and Excise. Thus the actual Outbound Transportation fees may vary from those quoted in this budget in any given month depending on what the actual exchange rate is.

	
7OT

	 	
The Logistics estimates included represent our best recommendations based on recent experience.  We welcome the opportunity to discuss carrier performance and recommendations since the decision on courier selection ultimately resides with the sponsor.

 

 

 

 

  

Page 23 of 23

  

Confidential

 

 

  

Attachment #2 

Global Central Laboratory Worksheet

 

 

The Global Central Laboratory Worksheet describes the nature, scope and timelines for Services being specifically performed for a Study. The Global Central Laboratory Worksheet ("CLW") is not attached to this Work Order. Quest Diagnostics will prepare and obtain Client's approval of this document. Upon Client's signature of the CLW and any changes of scope, it will become a part of this Work Order.

 

 

 

 

 

 

 

 

 

RedHlll Biopharma Limited and Quest Diagnostics Clinical Laboratories, Inc. 

Work Order for RHB104-01 (MAP Testing and Other Analysis)

 

Page 4 of 4

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