Addendum to General Services Agreement, Dated December 29, 2010




 [***] DENOTES CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT 
  

 Exhibit 10.6 

 
 



 
  

					
		  	Alchemia Oncology Pty Ltd.	  	
			
		  	BioClinica Addendum #33602_1	  	
			
		  	Medical Imaging Core Laboratory Services in Support of Protocol ACO-002, a Study Entitled: “Randomized double-blind Phase III trial of FOLF(HA)iri, where irinotecan is
administered as “HA-Irinotecan Solution for Infusion” compared with irinotecan in the FOLFIRI regimen for irinotecan-naïve metastatic colorectal cancer patients who relapsed after first or second-line therapy or
progressed while on first-line or second-line therapy.”	  	
			
		  	 Prepared for:
 Alchemia
Oncology Pty Ltd
 3 Hi-Tech Court

Brisbane Technology Park
 Eight Mile Plains QLD,
Australia
	  	
			
		  	 Prepared by:

BioClinica, Inc.
 826 Newtown Yardley
Road
 Newtown, PA 18940
	  	
			
		  	 September 2, 2010 version one
 December 2, 2010 version two
 December 17, 2010 version three
	  	

 This document contains information that is confidential and proprietary to Alchemia Oncology Pty Ltd and
BioClinica, Inc. It has been prepared solely for the information of Alchemia Oncology Pty Ltd and BioClinica, Inc. and therefore should not be duplicated or otherwise made available to third parties. 









			
	Alchemia Oncology Pty Ltd	  	Protocol ACO-002

  

 


	1.	PROJECT SCOPE OF WORK 


Alchemia Oncology Pty Ltd (hereinafter referred to as “ALCHEMIA”) has requested that BioClinica, Inc. and subsidiaries
(hereinafter referred to as “BIOCLINICA”) provide medical imaging core laboratory services in support of Protocol ACO-002. 
 This Addendum serves to document the additional services requested for the study beyond those contained within the following: 

 

	 	•	 	 Agreement #33602 between BIOCLINICA and ALCHEMIA, executed 18 May 2010. 



The Addendum also serves to document the fees for the additional services. 

 

	1.1.	ADDENDUM ASSUMPTIONS 

  

	1.1.1.	Assumptions 

 Table
1.1.1. 
  

					
	 General Study Assumptions
	  	 	  	 
	# of Patients	  	330 Patients	  	60 Additional Patients
	# of Sites	  	 60 Sites:
 Located in Russia, Ukraine, Poland,
 UK, Bulgaria, Australia
	  	No Change
	# of Investigator’s Meetings including location, # of BIOCLINICA representatives attending meeting and # of days assumed for meeting, including travel time	  	 One (1) Meeting: Location to be determined

One (1) Representative
 Two (2) Days
	  	No Change
	Type of imaging Performed	  	Contrast-Enhanced CT of the Chest, Abdomen and Pelvis	  	No Change
			
	 CT Data Assumptions
	  	 Agreement #33602
	  	 Addendum #33602_1

	Total # of Patients with CT	  	100% or 330 Patients	  	60 Additional Patients
	Average # of Timepoints per patient	  	 7 Timepoints: Baseline, 6 Weeks, 12 Weeks,

18 Weeks, 24 Weeks, 30 Weeks, 42 Weeks,
 54 Weeks, 66 Weeks and 78 Weeks
	  	No Change
	Total # of CT Timepoints	  	2,310 Timepoints	  	420 Additional Timepoints
	Average # of Files / Anatomical Regions scanned per timepoint	  	3 Files: Chest, Abdomen and Pelvis	  	No Change
			
	 Quantification Assumptions
	  	 Agreement #33602
	  	 Addendum #33602_1

	Measurement Criteria	  	Uni-dimensional RECIST	  	No Change
	Independent Read Plan	  	Efficacy and Adjudication Review	  	No Change
			
	 Independent Read Assumptions
	  	 Agreement #33602
	  	 Addendum #33602_1

	 Efficacy Read
	  	 Agreement #
	  	 Addendum #33602_1

	# of Timepoints Prepared for Review	  	4,620 Timepoints: 2,310 Timepoints per Reader	  	840 Additional Timepoints. 420 Additional Timepoints per Reader
	# of Independent Reader(s)	  	Two (2) Independent Readers	  	No change
			
	 Adjudication Read
	  	 Agreement #33602
	  	 Addendum #33602_1

	% of Timepoints to be Adjudicated	  	15% or 347 Timepoints	  	15% or 63 Timepoints
	# of Adjudication Readers	  	One (1) Adjudicator	  	No Change
			
	 Read Data Summary
	  	 Agreement #33602
	  	 Addendum #33602_1

	Overall Total # of Timepoints Prepared for Review	  	4,967 Timepoints	  	903 Additional Timepoints


  
  

					
	BioClinica, Inc.	  	1	  	Addendum #33062_1











			
	Alchemia Oncology Pty Ltd	  	Protocol ACO-002

  

 


					
	# of Data Transfers and Frequency, including a test transfer	  	 4 Transfers: Timing to be determined

1 Test Transfer: Timing to be determined
	  	No Change
			
	 Disease Progression Notification Assumptions
	  	 Agreement #33602
	  	 Addendum #33602_1

	# of Notifications	  	 Fax Notification of Disease Progression

to ALCHEMIA and the site
 (assuming 290 notifications)
	  	No Change
			
	 Independent Read Assumptions
	  	 Agreement #33602
	  	 Addendum #33602_1

	BIOCLINICA Project Start	  	April 2010	  	No Change
	First Patient Enrolled	  	August 2010	  	February 2011
	Last Patient Enrolled	  	August 2011	  	March 2012
	Last Patient Out	  	January 2013	  	July 2013
	BIOCLINICA Project Complete	  	March 2013	  	September 2013
	Total Duration of Data Collection	  	31 Months	  	31 Months
No Additional Months
	Total Study Duration	  	36 Months	  	42 Months
6 Additional Months

  

	*	All other assumptions from Original Agreement #33602 will remain the same. 


 

	1.2.	ADDENDUM SERVICES 

  

	1.2.1.	Additional Services 


Please refer to Original Agreement #33602 for a detailed description of the services included in this addendum. 

 

	2.	ADDENDUM PROJECT FEES AND EXPENSES 

  

	2.1.	ADDENDUM PROJECT FEES 


The fees for services detailed within this Addendum are summarized below. BIOCLINICA will only charge pro-rata for work performed at the
rates quoted. 
 As per the original agreement, BIOCLINICA fees will increase annually beginning with month 25 of the project as
defined by the actual (original) project start date. This increase will be equivalent to the percent increase in the U.S. Consumer Price Index (CPI). 
 Table 2.1.1. 
  

																			
	 Section
No
	  	 Services
	  	Unit
Fee	 	  	#
Units	 	  	Additional
Units	 	  	Overall 
Cost
with
Additional
Units	 
		  	Study Preparation Services	  				  				  				  			
						
	 2.1.1.
	  	 Study Set-up (including preparation and set-up of internal regulatory files, network files and required fields in
BioTrackTM)
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.2.
	  	 Site Technical Evaluation and Coordination
	  	 	[***]	  	  	 	60	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.3.
	  	 Imaging Manual and Form Development (Data transmittal forms, imaging guidelines and transmittal instructions) -
CT
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.4.
	  	 Organization of study kit materials and provision to the sites
	  	 	[***]	  	  	 	60	  	  	 	—  	  	  	 	[***]	  

 [***] DENOTES CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT 

  
  

					
	BioClinica, Inc.	  	2	  	Addendum #33062_1











			
	Alchemia Oncology Pty Ltd	  	Protocol ACO-002

  

 


																			
	 Section
No
	  	 Services
	  	Unit
Fee	 	  	#
Units	 	  	Additional
Units	 	  	Overall 
Cost
with
Additional
Units	 
	 2.1.5.
	  	 Preparation for Investigator’s Meeting
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.5.
	  	 Present at one (1) Investigator’s Meeting. One (1) BIOCLINICA representative, two (2) days including travel: Project
Manager
	  	 	[***]	  	  	 	2	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.5.
	  	 Present at one (1) Investigator’s Meeting. One (1) BIOCLINICA representative, two (2) days including travel: Senior
Biomedical, M.D., Ph.D.
	  	 	[***]	  	  	 	2	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.6.
	  	 Development/Set Up of BioTrackTM Web Portal
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.6.
	  	 Maintenance of communication line
	  	 	[***]	  	  	 	36	  	  	 	6	  	  	 	[***]	  
						
	 2.1.7.
	  	 Charter Modifications
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.1.8.
	  	 Web-based training sessions (Assuming two (2) BIOCLINICA representatives)
	  	 	[***]	  	  	 	2	  	  	 	—  	  	  	 	[***]	  
						
	 2.5.2.
	  	 Site Technical Monitoring Visits — one (1) BIOCLINICA representative, two (2) days including travel
	  	 	[***]	  	  	 	2	  	  	 	—  	  	  	 	[***]	  
						
		  	Image Data Services	  				  				  				  			
						
	 2.2.1.
	  	 Log-in of CT image data, including verification to transmittal forms in order to maintain an image data audit
trail
	  	 	[***]	  	  	 	2,310	  	  	 	420	  	  	 	[***]	  
						
	 2.2.2.
	  	 Processing of CT data including QC for image quality and protocol compliance, film
digitization (if necessary), masking, query generation and digital archival
	  				  				  				  			
						
		  	Estimate Timepoint Fee Cost Savings = [***]	  	 	[***]	  	  	 	2,310	  	  	 	420	  	  	 	[***]	  
						
		  	Independent Reading Services	  				  				  				  			
						
	 2.3.1.
	  	 Program reading system, including validation and testing to ensure the system conforms to regulatory requirements and
documentation of all programming and testing
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.3.1.
	  	 Conduct of protocol-specific reader training session at BIOCLINICA
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.3.1.
	  	 Development of Reader Manual and Reader Rules
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.3.2.
	  	 Preparation of timepoint for reading including final QC, uploading and downloading into read system, reading system
maintenance, read monitoring and independent reader support
	  				  				  				  			
						
		  	Tier 1: First Half Timepoints	  	 	[***]	  	  	 	2,484	  	  	 	452	  	  	 	[***]	  
						
		  	Tier 2: Second Half Timepoints	  	 	[***]	  	  	 	2,483	  	  	 	451	  	  	 	[***]	  
						
		  	Estimate Timepoint Fee Cost Savings = [***]	  				  				  	 	—  	  	  			
						
	 2.3.2.
	  	 Notification of disease progression to ALCHEMIA and the site
	  	 	[***]	  	  	 	290	  	  	 	—  	  	  	 	[***]	  
						
	 2.3.3.
	  	 Development and Preparation of Final Study Report
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
		  	Data Management Services	  				  				  				  			
						
	 2.4.1.
	  	 Development/Validation of custom export program
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
						
	 2.4.2.
	  	 Data Cleaning/Maintenance (Running on-going queries prior to scheduled exportation)
	  	 	[***]	  	  	 	27	  	  	 	—  	  	  	 	[***]	  
						
	 2.4.3.
	  	 Data exportation, including final QC prior to submission and follow-up
	  	 	[***]	  	  	 	4	  	  	 	—  	  	  	 	[***]	  

 [***] DENOTES CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT 

  
  

					
	BioClinica, Inc.	  	3	  	Addendum #33062_1











			
	Alchemia Oncology Pty Ltd	  	Protocol ACO-002

  

 


																			
	 Section
No
	  	 Services
	  	Unit
Fee	 	  	#
Units	 	  	Additional
Units	 	  	Overall 
Cost
with
Additional
Units	 
	 2.5.1.
	  	 Project Management Services
  

(Interaction and management of internal cross-functional teams, including documentation of technical issues,
preparation and provision of summary reports)
	  				  				  				  			
		  	Start up period - First 6 study months	  	 	[***]	  	  	 	6	  	  	 	—  	  	  	 	[***]	  
		  	Remaining study months	  	 	[***]	  	  	 	30	  	  	 	6	  	  	 	[***]	  
		  	Additional Project Management for the remainder of the Study (37 months from September 2010 to September 2013)	  	 	[***]	  	  	 	—  	  	  	 	37	  	  	 	[***]	  
						
	 2.5.2.
	  	 Site and Image Data Management Services
  

(Direct site interaction/communication and image data tracking, including filing of study correspondence and
maintaining an image audit trail)
	  				  				  				  			
		  	Start up period - First 6 study months	  	 	[***]	  	  	 	6	  	  	 	—  	  	  	 	[***]	  
		  	Remaining study months	  	 	[***]	  	  	 	25	  	  	 	—  	  	  	 	[***]	  
		  	Additional Site and Image for the remainder of the study (31 months from February 2011 to August 2013	  	 	[***]	  	  	 	—  	  	  	 	31	  	  	 	[***]	  
						
	 2.6.1.
	  	 Project Close-Out Services
  

(Including archival of study materials and images, management of unresolved queries, preparation of materials for
off-site, long-term storage and preparation of final invoice)
	  	 	[***]	  	  	 	1	  	  	 	—  	  	  	 	[***]	  
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 PROJECT TOTAL
	  				  				  				  	 	[***]	  
		  		  				  				  				  	  
	  
	 
	 Project Discount ([***])
	  				  				  				  	 	[***]	  
		  		  				  				  				  	  
	  
	 
	 PROJECT TOTAL — NET OF DISCOUNT
	  				  				  				  	 	[***]	  
		  		  				  				  				  	  
	  
	 

  

	*	In the event BIOCLINICA receives files or series in addition to those listed in the Assumptions Table 1.1.1., the timepoint unit fee may be increased. No such
increase will be applied without the written authorization from ALCHEMIA. 


	**	Discounted Line Item. 


	***	These fees are in addition to the monthly project management and site and image data management fees in agreement #33602. 


 

	2.1.2	Overall Project Budget Summary 

 Table 2.1.2 
  

					
	 	  	Cost
Total	 
	 Project Fees – Agreement #33002 – Net of Discount
	  	 	[***]	  
	 Project Fees – Addendum #33002_1 – Net of Discount
	  	 	[***]	  
		  	  
	  
	 
	 Revised Study Budget (Service Fees)
	  	 	[***]	  
		  	  
	  
	 

 [***] DENOTES CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT 

  
  

					
	BioClinica, Inc.	  	4	  	Addendum #33062_1











			
	Alchemia Oncology Pty Ltd	  	Protocol ACO-002

  

 


	2.2.	ADDENDUM EXPENSES 

  

	2.2.1.	Miscellaneous Expenses 


The estimated project expenses, in this document, unless otherwise specified, do not include reasonable travel expenses nor expenses for
disks, courier, data archival media, forms printing, translation costs, etc. incurred on behalf of ALCHEMIA. Actual expenses will be billed on a monthly basis and will include a 5% administrative fee at the time of billing. Please see the table
below for an estimate of the additional miscellaneous expenses: 
 Table 2.2.1 

 

					
	 Pass-Through Item(s)
	  	Estimated
Cost	 
	 Electronic Data Transfer:
	  			
	 Transport fees @ [***]/transfer (assuming approximately 420 additional transfers)
	  	 	[***]	  
	 Sub-total
	  	 	[***]	  
		  	  
	  
	 
	 % Administrative Fee
	  	 	[***]	  
		  	  
	  
	 
	 Estimated Additional Expenses Total including administrative fee
	  	 	[***]	  
		  	  
	  
	 

  

	2.2.2.	Overall Project Expense Summary 

 Table 2.2.2 
  

					
	 	  	Estimated
Cost	 
	 Expenses including administrative fee – Agreement #33602
	  	 	[***]	  
	 Expenses including administrative fee – Addendum #33602_1
	  	 	[***]	  
		  	  
	  
	 
	 Revised Expenses Budget
	  	 	[***]	  
		  	  
	  
	 

  

	2.2.3.	Reader Professional Fees and Expenses 

 BIOCLINICA will prepare all reader agreements and manage all reader fees for this study. All such expenses will be passed through to ALCHEMIA on a monthly basis. ALCHEMIA will be responsible for any other
read related expenses, including any applicable travel, food and lodging required for the performance of their duties, as described in this document. 
 Table 2.2.3 
  

					
	 Pass-Through Item(s)
	  	Estimated
Cost	 
	 Efficacy: Assuming [***]/hour/reader Assuming 6 timepoints per hour @ 420 timepoints per reader (assuming 2 efficacy
readers – 140 additional hours)
	  	 	[***]	  
	 Adjudication: Assuming [***]/hour/reader Assuming 10 timepoints per hour @ 63 timepoints per adjudicator (assuming 1
adjudicator – 6 additional hours)
	  	 	[***]	  
	 Reader Management Fee ([***])
	  	 	[***]	  
		  	  
	  
	 
	 Estimated Additional Reader Professional Fees and Expenses
	  	 	[***]	  
		  	  
	  
	 

  

	2.2.4.	Overall Reader Professional Fee Summary 

 Table 2.2.4 
  

					
	 	  	Estimated
Cost	 
	 Reader Professional Fee – Agreement #33602
	  	 	[***]	  
	 Reader Professional Fee – Addendum #33602_1
	  	 	[***]	  
		  	  
	  
	 
	 Revised Estimated Reader Professional Fees
	  	 	[***]	  
		  	  
	  
	 


  
  

					
	BioClinica, Inc.	  	5	  	Addendum #33062_1

 [***] DENOTES
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT 










			
	Alchemia Oncology Pty Ltd	  	Protocol ACO-002

  

 


	2.3.	Overall Total Revised Project Budget 

  

					
	 	  	Estimated
Cost	 
	 Project Total / Direct Service Fees
	  	 	[***]	  
	 Pass Through Expenses
	  	 	[***]	  
	 Reader Professional Fees
	  	 	[***]	  
		  	  
	  
	 
	 OVERALL REVISED TOTAL PROJECT
	  	 	[***]	  
		  	  
	  
	 

  

	2.4.	BILLING POLICY 

 The above
mentioned fees will continue to be billed to ALCHEMIA on a monthly basis and will include relevant back-up documentation. 

  
  

					
	BioClinica, Inc.	  	6	  	Addendum #33062_1

 [***] DENOTES
CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT 









	3.	TERMS AND CONDITIONS 

 All
services will be performed by BIOCLINICA as an Addendum to BIOCLINICA Agreement #33062 and all terms and conditions o Agreement #33062 shall apply. 
  

									
	AGREED AND ACCEPTED:	 		 		 	
			
	ALCHEMIA	 		 	BIOCLINICA
					
	By:	 	 /s/ David Green
	 		 	By:	 	 /s/ Mark L. Weinstein

					
	Print:	 	 David Green
	 		 	Print:	 	 Mark L. Weinstein

					
	Title:	 	 CFO & Company Secretary
	 		 	Title:	 	 President & CEO

					
	Date:	 	 29-12-2010
	 		 	Date:	 	 29 Dec 2010