Exhibit 10.3


 


Master Services Agreement Dated


Between Kitov Pharmaceuticals Limited
(Kitov)


and


Java Clincial Research Ltd ( JAVA) 


 


	
        CHANGE ORDER FORM (1)

         

	
        PROTOCOL NUMBER:

         
	K-302-03-01
	
        Kitov CONTACT:

         
	Mr Simcha Rock
	
        SUPPLIER CONTACT:

         
	Ms Ruth Nallen
	
        DATE OF REQUEST: 

         
	26 03 2014
	
        BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST:

         

        The Original MSA dated 04 February refers only to Java Professional
        and Pass through Fees.

        This change order reflects total agree PI Fees for both Republic
        of Ireland and Northern Ireland.

	ROI fees which will be paid in euro to Java Clinical Research
        ltd who will then pass it on to the PIs upon receipt of invoices.
	NI fees will be paid in sterling directly to the single Investigator
        site at Celerion.
	A detailed service agreement will be exchanged directly between
        Kitov Pharmaceuticals and Celerion.

 

	
        IMPACT (estimated effort and/or timeline):

         

        This change order has no impact on effort or timelines.

	
        COST:

        Total additional cost: €669,989.60

         

        Payment Terms:
        Payment details and schedules are detailed in Appendix 1 & 2

         

	Amendment:  This Change Order Form shall constitute a Contract Amendment to the MSA dated 04 February 2014 between Kitov and Java and shall apply only to the revision of PIs fees attached hereto.  In all other respects the terms and conditions of the MSA shall remain in full force and effect and shall be applied to this Contract Amendment.
	
        Kitov Pharmaceuticals Ltd

         

         

         

        /s/ Simcha Rock                             

        (Signature)

         

        26/3/2014                                         

        (Date)

         

         

         
	
        Java

         

         

         

        /s/ Ruth
        Nallen                               

        (Signature)

         

        26/03/2014                                  

        (Date)



 


 





Change order no 1 


Kitov/ Java MSA


        


 





Page 1 of 3
















     


     


    

 


Appendix 1


 





PI Fees Republic
of Ireland 


Fees payable to Java Clinical Research
Ltd


 


 





	Study Reference K-03-01	 	 	 	 	 
	Estimate ROI  Investigator   Costs (Euro)	 	 	 	 	 
	Investigator fees	 	 	72,000.00	 	 	Cost per screen failure: €720 x 100 subjects
	 	 	 	257,500.00	 	 	Cost per randomised subject: €2575 x 100 subjects
	Total	 	 	329,500.00	 	 	 
	Other Investigator Pass through costs	 	 	 	 	 	 
	GP Patient Referral Fee	 	 	7,500.00	 	 	Estimate: 100 patients x €100 per patient
	Community Screening Clinics	 	 	7,500.00	 	 	Estimate: €1000 per site x 10 sites
	ABPM subject lifestyle inconvenience reimbursement	 	 	25,000.00	 	 	Screen failures: 100 x 1 x €50; Randomised subjects: 100 x 4 x €50
	Estimated receipted subject travel expenses	 	 	60,000.00	 	 	Screen failures:100 x 3 visits  x €50; Randomised subjects:100 x 9 visitsx €50
	Total	 	 	100,000.00	 	 	 
	Proposed  payment of PI fees	 	 		 	 	Estimate Invoice  Date 
	Upfront payment of  25%	 	 	82,375.00	 	 	Apr-14
	Payments every 2 months thereafter based on subject visits	 	 	 	 	 	 
	 	 	 	82,375.00	 	 	Jul-04
	 	 	 	82,375.00	 	 	Sep-14
	 	 	 	82,375.00	 	 	Nov-14
	 	 	 	329,500.00	 	 	
	Pass through Fees	 	 	 	 	 	 
	Upfront 25%	 	 	25,000.00	 	 	Apr-14
	 Following SIV completion	 	 	25,000.00	 	 	Jun-14
	Payments every 2 months thereafter based on exepditure	 	 	25,000.00	 	 	Aug-14
	Payments every 2 months thereafter based on exepditure	 	 	25,000.00	 	 	Oct-14
	 	 	 	100,000.00	 	 	








 





 


 





Change order no 1 


Kitov/ Java MSA     


 


Page 2  of
3             








     


     


    




 


Appendix 2





 


PI
Fees Northern Ireland 


Paid
and contracted directly to Celerion 








 





	MSA Kitov/ Celerion	 	Euro	 	 	Sterling	 
	 	 	 	 	 	 	 	 	 
	Patient Management /PI Fees	 	€	217,166.40	 	 	£	180,972.00	 
	 	 	 	 	 	 	 	 	 
	Pass through costs	 	€	6,000.00	 	 	£	5,000.00	 
	 	 	 	 	 	 	 	 	 
	PK sampling	 	€	17,323.20	 	 	£	14,436.00	 
	 	 	 	 	 	 	 	 	 
	Total	 	€	240,489.60	 	 	£	200,408.00	 








 


 





Change order no 1 


Kitov/ Java MSA








 


Page 3  of
3






     


     


    




 





Master Services Agreement Dated


Between Kitov Pharmaceuticals Limited
(Kitov)


and


Java Clinical Research Ltd ( JAVA) 


 


	
        CHANGE ORDER FORM (2)

         

	
        PROTOCOL NUMBER:

         
	KIT-302-03-01
	
        Kitov CONTACT:

         
	Mr Simcha Rock
	
        SUPPLIER CONTACT:

         
	Ms Ruth Nallen
	
        DATE OF REQUEST: 

         
	22 09 2014
	
        BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST:

         

	Project timelines have extended as the study will now be conducted
        in the UK as opposed to the Republic of Ireland as stated in the original MSA. The movement of the study to the UK necessitated
        additional feasibility assessments which resulted in the selection of 4 additional UK sites and a central laboratory in the UK.
        Kitov Pharmaceuticals will contract directly with ACM laboratories so this service is now excluded from the MSA. Kitov will also
        manage PI fees directly with UK sites, so the PI fees itemised in CO 1 will no longer be applicable to this MSA.

 

	Multiple protocol amendments were issued to facilitate recruitment.
        This resulted in the submission of multiple substantial amendment to the UK REC and MHRA. It also resulted in modifications to
        the eCRF and data management plan. Additionally REC approval, by means of submission of a substantial amendment to the REC, was
        required for each of the additional UK sites.

 

         

	
        IMPACT (estimated effort and/or timeline):

         

	Project preparation timelines extended by 4 weeks
	Study conduct time has extended by 20 weeks
	Milestone payments have been restructured as detailed below
        in payment terms

 

         










	COST:


Total additional cost: 


 


€ 96,716.34 Professional Fees


€ 9,968 Pass through Fees


 


Revised budget break down is included in Appendix 1.


Costs will be revisited if recruitment is completed earlier
than 27 March 2015 as detailed in the attached Appendix 1.











 








	GRAND  REVISED TOTAL  PROFESSIONAL FEES 	 	 	664,799.58	 
	less received to date	 	 	204,657.98	 
	 	 	 	 	 
	Balance 	 	 	460,141.60	 
	 	 	 	 	 
	20% following 10 subjects randomised	 	 	92,028.32	 
	10 % following 30  subjects randomised	 	 	46,014.16	 
	10 % following 50 subjects randomised	 	 	46,014.16	 
	10 % following 75 subjects randomised	 	 	46,014.16	 
	10 % following 100 subjects randomised	 	 	46,014.16	 
	10 % following 125 subjects randomised	 	 	46,014.16	 
	10 % following 150 subjects randomised	 	 	46,014.16	 
	10%  following LPLV	 	 	46,014.16	 
	5% following DB lock	 	 	23,007.08	 
	5% following final study Report	 	 	23,007.08	 
	 	 	 	460,141.60	 








 


	Amendment:  This Change Order Form shall constitute a Contract Amendment to the MSA dated 04 February 2014 and Change Order No 1 dated 26 March 2014 between Kitov and Java. In all respects the terms and conditions of the MSA shall remain in full force and effect and shall be applied to this Contract Amendment No 2
	
        Kitov Pharmaceuticals Ltd

         

         

         

        /s/ Simcha Rock                             

        (Signature)

         

        September
        23, 2014                       

        (Date)

         

         

         
	
        Java Clinical Research ltd 

         

         

         

        /s/                                                    

        (Signature)

         

        _________________________

        (Date)



 








Change order no 1 


Kitov/ Java MSA







     Page 1
                                         of 5


     


    

 


Appendix 1


Revised Professional
& Pass through fees


 





	Study Reference K-03-01	 	 	 	 	 
	 	 	 	 	 	 
	Projected Timelines:	 	 	 	 	 
	Project Preparation	14 weeks	18 weeks 	 	January 2014 – Mid-May
    2014
	Study Recruitment and Conduct Period	22 weeks	42 weeks	 	22 June 2014 - 27 March
    2015
	Close out period	12 weeks 	 	 	30 March 2015 - 19 June
    2015
	 	 	 	 	 	 
	Indication:	Hypertension 	 	 	 	 
	 	 	 	 	 	 
	Key Assumptions:	 	 	 	 	 
	Number of patients to be screened	300	 	 	 	 
	Number of patients to be randomised	150	 	 	 	 
	Sites	1 site NI 4 sites
    UK 	 	 	 
	Number of monitoring visits	Estimated pool of
    45 monitoring site visits	 
	Total CRF pages per patient	TBC	 	 	 	 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ACTIVITY	 	RATE	 	 	UNIT	 	EST. REQ.	 	 	ESTIMATED CHARGE	 	 	Comments
	 	 	€	 	 	 	 	Range	 	 	Range €	 	 	 
	Project Preparation	 	 	 	 	 	 	 	 	 	 	 	 	 
	PM project training	 	 	110.00	 	 	hour	 	 	16	 	 	 	1,760.00	 	 	To include protocol, CRF and SOP training
	CRA project training	 	 	85.00	 	 	hour	 	 	16	 	 	 	1,360.00	 	 	To include protocol, CRF and SOP training
	PM project preparation time	 	 	1,760.00	 	 	week	 	 	22	 	 	 	38,720.00	 	 	Includes site contacts/feasibility assessments to ensure all required systems are in place for study initiation, assistance with eCRF development to include advice on required CRF data fields, communication with Kitov Ltd on project related progress/issue
	PM Feasibility & Preparation UK sites	 	 	880.00	 	 	day	 	 	12	 	 	 	10,560.00	 	 	Site & laboratory feasibility and selection activities including  budget and contract negotiations
	CRA project preparation time	 	 	1,360.00	 	 	week	 	 	14	 	 	 	19,040.00	 	 	Includes site contacts/feasibility, communication with Kitov Ltd, collating all study related materials required for initiation, addressing site queries and issues, preparation/customisation of Investigator Study Files and Forms, collection of essential d
	CTA project preparation time	 	 	400.00	 	 	week	 	 	18	 	 	 	7,200.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Preparation total	 	 	 	 	 	 	 	 	 	 	 	 	78,640.00	 	 	 
	Regulatory and Ethics	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Review and submission of CTA to IMB (including submission of responses to any queries raised during review period)	 	 	3,840.00	 	 	submission	 	 	1	 	 	 	3,840.00	 	 	 
	Review and submission of CTA to MHRA (including submission of responses to any queries raised during review period)	 	 	3,840.00	 	 	submission	 	 	1	 	 	 	3,840.00	 	 	 
	Submission of  Substantial Amendment  to MHRA	 	 	120.00	 	 	hour	 	 	38	 	 	 	4,560.00	 	 	12 hours Amen1: 8 hours Ament 2 ;                                            16 hours Amen 3 :12 hours amendment 4
	Submission to National Ethics Committee in Northern Ireland  (including submission of responses to any queries raised during review period)	 	 	2,040.00	 	 	submission	 	 	1	 	 	 	2,040.00	 	 	 
	Submission to National Ethics Committee in Northern Ireland (including submission of responses to any queries	 	 	2,720.00	 	 	submission	 	 	1	 	 	 	2,720.00	 	 	 
	Preparation and submission of substantial amendments to National Ethics Committee in Northern Ireland	 	 	880.00	 	 	submission	 	 	7	 	 	 	6,160.00	 	 	 
	Management of R&D Office Approval, including budget negotiation	 	 	1,760.00	 	 	site	 	 	1	 	 	 	1,760.00	 	 	 




 








Change order no 1 


Kitov/ Java MSA







     Page
                                         2 of 5


     


    

 





	Regulatory total	 	 	 	 	 	 	 	 	 	 	 	 	24,920.00	 	 	Estimate  13 Belfast visits; 32 UK visits
	Clinical Operations	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Assuming 1 Belfast  Centre:  4  UK Regional Centres  -  estimated Monitoring Visit Pool of 45 visits ( 12 visits Belfast : 32UK)) 
	Site Qualification Visits	 	 	680.00	 	 	site	 	 	10	 	 	 	6,800.00	 	 	Site Visit preparation time for pre study visits  -  2 hours. Site Visit preparation time for SIV and close out visit - 4 hours.  Site Qualification and Pre study visit duration - 4 hours. SIV and close out visit duration - 8 hours. Monitoring Visits  pre
	Travel time	 	 	400.00	 	 	site	 	 	6	 	 	 	2,400.00	 	 	 
	Site Qualification Visits UK	 	 	680.00	 	 	site	 	 	4	 	 	 	2,720.00	 	 	 
	Travel time UK	 	 	600.00	 	 	site	 	 	4	 	 	 	2,400.00	 	 	 
	Pre-Study Visits	 	 	850.00	 	 	site	 	 	5	 	 	 	4,250.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	1	 	 	 	200.00	 	 	 
	Travel time UK	 	 	600.00	 	 	visit	 	 	4	 	 	 	2,400.00	 	 	 
	Site Initiation Visits	 	 	1,360.00	 	 	site	 	 	5	 	 	 	6,800.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	1	 	 	 	200.00	 	 	 
	travel time UK	 	 	600.00	 	 	visit	 	 	4	 	 	 	2,400.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Study Monitoring Visits	 	 	2,040.00	 	 	site	 	 	45	 	 	 	91,800.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	13	 	 	 	2,600.00	 	 	 
	Travel time UK	 	 	600.00	 	 	visit	 	 	32	 	 	 	19,200.00	 	 	 
	Study Close-Out Visits	 	 	1,360.00	 	 	site	 	 	5	 	 	 	6,800.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	1	 	 	 	200.00	 	 	 
	Travel time UK	 	 	600.00	 	 	visit	 	 	4	 	 	 	2,400.00	 	 	 
	CRA Site Management	 	 	340.00	 	 	week	 	 	18	 	 	 	6,120.00	 	 	June - Sept 2014
	CRA Site Management	 	 	850.00	 	 	week	 	 	24	 	 	 	20,400.00	 	 	Oct - March 2015
	CRA Site Management	 	 	850.00	 	 	week	 	 	12	 	 	 	10,200.00	 	 	Close out period
	Project Management	 	 	2,200.00	 	 	week	 	 	52	 	 	 	114,400.00	 	 	Internal management of CRAs including advice on recruitment strategies, site related issues, contingency measurement implementation etc; Communication with Kitov Ltd on project progress/study related issues; Management of Third Party Vendors; Management o
	CTA study conduct	 	 	320.00	 	 	week	 	 	52	 	 	 	16,640.00	 	 	Assistance with compilation of return of essential dcoument for TMF, CRA travel arrangements, collation of all pass through costs and study related invoices.





 








Change order no 1 


Kitov/ Java MSA










     Page3 of                                          5


     


    

 








	Clinical Operations	 	 	321,330.00	 	 	 
	Other Services	 	 	 	 	 	 
	Clinical Laboratory Services (Estimate)	 	 	 	 	 	 
	Central Laboratory set up  Fee	 	 	5,874.00	 	 	ACM laboratory contracted directly with Kitov
	Data Management and Statistics	 	 	 	 	 	 
	Biometrics Management	 	 	11,172.00	 	 	 
	Data Management	 	 	42,873.50	 	 	 
	Amendment 1-3	 	 	5,133.50	 	 	 
	Amendment 4	 	 	27,522.00	 	 	 
	eCRF management and hosting	 	 	64,189.25	 	 	 
	Statistics	 	 	37,225.75	 	 	 
	 	 	 	188,116.00	 	 	 
	 	 	 	 	 	 	 
	Pharmacovigilance	 	 	 	 	 	 
	Safety Database Maintenance	 	 	4,000.00	 	 	 
	PhV Specifications	 	 	2,910.00	 	 	 
	SAE Initial/Follow-up Report Processing	 	 	3,600.00	 	 	 
	Expedite SUSARs reporting	 	 	108.00	 	 	 
	Line Listing production	 	 	2,440.00	 	 	 
	Responsible Person - Eudravigilance	 	 	6712.5	 	 	 
	Pharmacovigilance Subtotal	 	 	19,770.50	 	 	 
	 	 	 	 	 	 	 
	Medical Writing	 	 	 	 	 	 
	Clinical Study Report	 	 	14,252.00	 	 	 
	 	 	 	 	 	 	 
	Other Services Subtotal	 	 	222,138.50	 	 	 
	8% overhead	 	 	17,771.08	 	 	 
	 Preparation Regulatory & Clinops Subtotals	 	 	424,890.00	 	 	 
	 	 	 	 	 	 	 
	GRAND TOTAL  PROFESSIONAL FEES	 	 	664,799.58	 	 	 




 


	 	 	 	 	 	 	 
	Other study conduct  costs	 	 	 	 	 	 
	IMB CTA	 	 	1,443.00	 	 	 
	MHRA CTA + amendments	 	 	5,000.00	 	 	 
	Ethics Committe Fees	 	 	3,500.00	 	 	 
	CRA Travel	 	 	28,200.00	 	 	Belfast  site: 1 sites x 4 visits x €300 = €1200 (SQV/PS/SIV/C0)
	 	 	 	 	 	 	Belfast site: 1 x 13 visits x €300 = 3900
	 	 	 	 	 	 	UK sites: 4 sites x 4 visits  €500 =€8000 (SQV/PS/SIV/C0)
	 	 	 	 	 	 	UK sites: 32 x €500 = €16000
	Courier Costs - as per receipted expenses	 	 	8,000.00	 	 	Estimate
	Stationary, Printing, Photocopying for TMF, Investigator Site Files and Ethics Applications ; other	 	 	10,000.00	 	 	 
	Management of PI fees	 	 	9,885.00	 	 	 
	Estimate other pass through costs	 	 	66,028.00	 	 	 




 











Change order no 1 


Kitov/ Java MSA










     Page
                                         4 of
                                         5


     


    







	 	 	 	 	 
	GRAND TOTAL  PROFESSIONAL FEES	 	 	664,799.58	 
	less received to date	 	 	204,657.98	 
	 	 	 	 	 
	Balance	 	 	460,141.60	 
	 	 	 	 	 
	20% following 10 subjects randomised	 	 	92,028.32	 
	10 % following 30  subjects randomised	 	 	46,014.16	 
	10 % following 50 subjects randomised	 	 	46,014.16	 
	10 % following 75 subjects randomised	 	 	46,014.16	 
	10 % following 100 subjects randomised	 	 	46,014.16	 
	10 % following 125 subjects randomised	 	 	46,014.16	 
	10 % following 150 subjects randomised	 	 	46,014.16	 
	10%  following LPLV	 	 	46,014.16	 
	5% following DB lock	 	 	23,007.08	 
	5% following final study Report	 	 	23,007.08	 
	 	 	 	460,141.60	 


 













Change order no 1 


Kitov/ Java MSA







     Page
                                                                                      5 of 5


     


    

 





Master Services Agreement Dated


2nd April 2015


 


Between Kitov Pharmaceuticals Limited
(Kitov)


and


Java Clinical Research Ltd ( JAVA) 


 


	
        CHANGE ORDER FORM (3)

         

	
        PROTOCOL NUMBER:

         
	KIT-302-03-01
	
        Kitov CONTACT:

         
	Mr Simcha Rock
	
        SUPPLIER CONTACT:

         
	Ms Ruth Nallen
	
        DATE OF REQUEST: 

         
	2nd April 2015






 


BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST:


 


		
	·      Project
timelines have been extended as follows: 8 additional weeks in the study conduct 8 weeks interim analysis 




 


		·	The
budget is now reflective of up to 30 additional patients.  




 


		·	The
Monitoring visit schedule has been restructured. The total monitoring visits have increased from 45 to 56; 40 of which are two
day visits and 16 are one day visits. 






		·	3
additional sites in the UK have been included; the budget reflects additional site feasibility assessments and initiation and
close out visits allocated to these new sites.




 


		·	Protocol
amendments were issued to facilitate recruitment. This resulted in the submission of multiple substantial amendment to the UK
REC and MHRA. It also resulted in modifications to the eCRF and data management plan. Additionally REC approval, by means of submission
of a substantial amendment to the REC, was required for each of the additional UK sites.









 


	
        IMPACT (estimated effort and/or timeline):

        As stated above

         

        









	COST:


Total additional cost: 


 


€116,238.18


 


Revised budget break down is included in Appendix 1.







 






    Page 1 of
                                                                                      5


     


    

 





	GRAND TOTAL  PROFESSIONAL FEES 	 	 	781,037.76	 
	Less received to date 	 	 	388,714.62	 
	Invoice due for payment 30 March 2015	 	 	46,014.16	 
	 	 	 	434,728.78	 
	Balance Due 	 	 	346,308.98	 
	Revised Payment schedule ( based on montly resources)	 	 	 	 
	30-Apr-15	 	 	76,957.50	 
	30-Jun-15	 	 	76,957.50	 
	30-Aug-15	 	 	76,957.50	 
	30-Oct-15	 	 	76,957.50	 
	30-Dec-15	 	 	38,478.98	 
	 	 	 	346,308.98	 
	 	 	 	 	 
	 	 	 	 	 








 


	Amendment:  This Change Order Form shall constitute a Contract Amendment to the MSA dated 04 February 2014, Change Order No 1 dated 26 March 2014 and Change Order 2 dated 22 September 2014 between Kitov and Java. In all respects the terms and conditions of the MSA shall remain in full force and effect and shall be applied to this Change Order  No 3.
	
        Kitov Pharmaceuticals Ltd

         

         

         

        /s/ Simcha Rock                             

        (Signature)

         

        April 2,
        2015                                    

        (Date)

         

         

         
	
        Java Clinical Research ltd 

         

         

         

        /s/ Ruth
        Nallen                      

        (Signature)

         

        02 April
        2015                          

        (Date)

	 	 


 


Change order no 1 


Kitov/ Java MSA



 









    Page 2 of
                                                                                      5


     


    

 


Appendix 1


Revised Professional
fees


 





	Study Reference K-03-01	 	 	 	 	 
	 	Agreed V8 	Revised V9	 	 	 
	Projected Timelines:	 	 	 	 	 
	Project Preparation	18 weeks	 	 	January 2014 – Mid-May 2014
	Study Recruitment and Conduct Period	42 weeks	50 weeks	 	22 June 2014 - 05 June  2015
	Interim Analysis Recruitment and Conduct Period	 	8	 	08 June - 03 AUG
	Close out period	12 weeks 	12 weeks	 	03 AUG - 2 Nov	 
	 	 	 	 	 	 
	Indication:	Hypertension 	 	 	 	 
	 	 	 	 	 	 
	Key Assumptions:	 	 	 	 	 
	Number of patients to be screened	300	400	 	 	 
	Number of patients to be randomised 	150	150	 	 	 
	Number of patients randomised  during interim analysis	 	30	 	 	 
	Sites	5 sites	8 Sites	 	 	 
	Number of monitoring visits (180 patients)	Estimated pool of 56 monitoring site visits	 
	 	 	 
	Total CRF pages per patient	TBC	 	 	 	 



 


Change order no 1 


Kitov/ Java MSA



 






    Page 3 of
                                                                                      5


     


    







	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ACTIVITY	 	RATE	 	 	UNIT	 	EST. REQ.	 	 	ESTIMATED CHARGE	 	 	Comments
	 	 	€	 	 	 	 	Range	 	 	Range €	 	 	 
	Project Preparation	 	 	 	 	 	 	 	 	 	 	 	 	 
	PM project training	 	 	110.00	 	 	hour	 	 	16	 	 	 	1,760.00	 	 	To include protocol,
    CRF and SOP training
	CRA project training	 	 	85.00	 	 	hour	 	 	16	 	 	 	1,360.00	 	 	To include protocol, CRF and
    SOP training
	PM project preparation time	 	 	1,760.00	 	 	week	 	 	22	 	 	 	38,720.00	 	 	Includes site contacts/feasibility
    assessments to ensure all required systems are in place for study initiation, assistance with eCRF development to include
    advice on required CRF data fields, communication with Kitov Ltd on project related progress/issue
	PM Feasibility & Preparation
    UK sites	 	 	880.00	 	 	day	 	 	12	 	 	 	10,560.00	 	 	Site & laboratory feasibility
    and selection activities including  budget and contract negotiations
	CRA project preparation time	 	 	1,360.00	 	 	week	 	 	14	 	 	 	19,040.00	 	 	Includes site contacts/feasibility,
    communication with Kitov Ltd, collating all study related materials required for initiation, addressing site queries and issues,
    preparation/customisation of Investigator Study Files and Forms, collection of essential d
	CRA project preparation
    time	 	 	2,040.00	 	 	site	 	 	3	 	 	 	6,120.00	 	 	additional 3 sites
	CTA project preparation time	 	 	400.00	 	 	week	 	 	18	 	 	 	7,200.00	 	 	 
	Preparation
    total	 	 	 	 	 	 	 	 	 	 	 	 	84,760.00	 	 	 
	Regulatory
    and Ethics	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Review and submission of CTA
    to IMB (including submission of responses to any queries raised during review period)	 	 	3,840.00	 	 	submission	 	 	1	 	 	 	3,840.00	 	 	 
	Review and submission of CTA
    to MHRA (including submission of responses to any queries raised during review period)	 	 	3,840.00	 	 	submission	 	 	1	 	 	 	3,840.00	 	 	 
	Submission of  Substantial
    Amendment  to MHRA	 	 	120.00	 	 	hour	 	 	38	 	 	 	4,560.00	 	 	12 hours Amen1: 8 hours Ament
    2 ; 16 hours Amen 3 :12 hours amendment 4
	Submission to National Ethics
    Committee in Northern Ireland  (including
    submission of responses to any queries raised during review period)	 	 	2,040.00	 	 	submission	 	 	1	 	 	 	2,040.00	 	 	 
	Submission to National Ethics
    Committee in Northern Ireland (including submission of responses to any queries	 	 	2,720.00	 	 	submission	 	 	1	 	 	 	2,720.00	 	 	 
	Preparation and
    submission of substantial amendments to National Ethics Committee in Northern Ireland	 	 	880.00	 	 	submission	 	 	12	 	 	 	10,560.00	 	 	 
	Preparation and
    submission of non substantial amendments to National Ethics Committee in Northern Ireland	 	 	220.00	 	 	submission	 	 	25	 	 	 	5,500.00	 	 	 
	Management of R&D Office
    Approval, including budget negotiation	 	 	1,760.00	 	 	site	 	 	1	 	 	 	1,760.00	 	 	 
	Submission fo R&D
    Office Amendment including revised budget negotiaition for QMUH	 	 	880.00	 	 	site	 	 	1	 	 	 	880.00	 	 	 
	Regulatory
    total	 	 	 	 	 	 	 	 	 	 	 	 	35,700.00	 	 	 
	Clinical
    Operations	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Site Qualification Visits	 	 	680.00	 	 	site	 	 	10	 	 	 	6,800.00	 	 	Site Visit preparation time
    for pre study visits  -  2 hours. Site Visit preparation time for SIV and close out visit - 4 hours. Site
    Qualification and Pre study visit duration - 4 hours. SIV and close out visit duration - 8 hours. Monitoring Visits  prep
	Travel time	 	 	400.00	 	 	site	 	 	6	 	 	 	2,400.00	 	 	 
	Site Qualification Visits UK	 	 	680.00	 	 	site	 	 	4	 	 	 	2,720.00	 	 	 
	Travel time UK	 	 	600.00	 	 	site	 	 	4	 	 	 	2,400.00	 	 	 
	Pre-Study Visits	 	 	850.00	 	 	site	 	 	8	 	 	 	6,800.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	1	 	 	 	200.00	 	 	 
	Travel time UK	 	 	200.00	 	 	visit	 	 	4	 	 	 	800.00	 	 	 
	Site Initiation
    Visits	 	 	1,360.00	 	 	site	 	 	8	 	 	 	10,880.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	1	 	 	 	200.00	 	 	 
	travel time UK	 	 	200.00	 	 	visit	 	 	7	 	 	 	1,400.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Study Monitoring
    Visits (2 day visits)	 	 	2,040.00	 	 	site	 	 	40	 	 	 	81,600.00	 	 	 
	Study Monitoring
    Visits (1 day visits)	 	 	1,360.00	 	 	site	 	 	16	 	 	 	21,760.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	7	 	 	 	1,400.00	 	 	 
	Travel time UK	 	 	200.00	 	 	visit	 	 	49	 	 	 	9,800.00	 	 	 
	Study Close-Out
    Visits	 	 	1,360.00	 	 	site	 	 	8	 	 	 	10,880.00	 	 	 
	Travel time Belfast	 	 	200.00	 	 	visit	 	 	1	 	 	 	200.00	 	 	 
	Travel time UK	 	 	200.00	 	 	visit	 	 	7	 	 	 	1,400.00	 	 	 
	CRA Site Management	 	 	340.00	 	 	week	 	 	18	 	 	 	6,120.00	 	 	June - Sept 2014 (2 sites)
	CRA Site Management	 	 	510.00	 	 	week	 	 	12	 	 	 	6,120.00	 	 	Oct - Dec 2014 (5 sites)
	CRA Site Management	 	 	680.00	 	 	week	 	 	28	 	 	 	19,040.00	 	 	Jan - Aug 2015(8 sites) 1 hour
    per site per week
	CRA Site Management	 	 	1,360.00	 	 	week	 	 	12	 	 	 	16,320.00	 	 	Close out period  2
    hours per site per week
	Project Management	 	 	2,200.00	 	 	week	 	 	70	 	 	 	154,000.00	 	 	Internal management of CRAs
    including advice on recruitment strategies, site related issues, contingency measurement implementation etc.; Communication
    with Kitov Ltd on project progress/study related issues; Management of Third Party Vendors; Management
	CTA study conduct	 	 	320.00	 	 	week	 	 	70	 	 	 	22,400.00	 	 	Assistance with compilation of return of essential
    document for TMF, CRA travel arrangements, collation of all pass through costs and study related invoices.








 


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	Clinical
    Operations	 	 	385,640.00	 	 	 
	Other Services	 	 	 	 	 	 
	Clinical
    Laboratory Services (Estimate)	 	 	 	 	 	 
	Central Laboratory set up  Fee	 	 	5,874.00	 	 	ACM laboratory contracted directly
    with Kitov
	Clinical Laboratory Services
    (Estimate) total	 	 	5,874.00	 	 	 
	 	 	 	 	 	 	 
	Data Management
    and Statistics	 	 	 	 	 	 
	Biometrics Management	 	 	15,361.00	 	 	 
	Data Management	 	 	52,313.50	 	 	 
	Statistics	 	 	37,225.75	 	 	 
	Amendment 1-3	 	 	5,133.50	 	 	 
	Amendment 4	 	 	27,522.00	 	 	 
	eCRF management and hosting	 	 	82,148.75	 	 	 
	Data Management
    and Statistics total	 	 	219,704.50	 	 	 
	 	 	 	 	 	 	 
	Pharmacovigilance	 	 	 	 	 	 
	Safety Database Maintenance	 	 	6,857.50	 	 	 
	PhV Specifications	 	 	2,910.00	 	 	 
	SAE Initial/Follow-up Report
    Processing	 	 	 	 	 	3600  only if  SAE
	Expedite SUSARs reporting	 	 	108.00	 	 	 
	Line Listing production	 	 	2,440.00	 	 	 
	Responsible Person - Eudravigilance	 	 	8,300.00	 	 	 
	Pharmacovigilance
    total	 	 	20,615.50	 	 	 
	 	 	 	 	 	 	 
	Medical Writing	 	 	 	 	 	 
	Clinical Study Report	 	 	14,252.00	 	 	 
	Medical Writing
    total	 	 	14,252.00	 	 	 
	Other Services
    Subtotal	 	 	 	 	 	 
	Summary	 	 	 	 	 	 
	Preparation total	 	 	84,760.00	 	 	 
	Regulatory total	 	 	35,700.00	 	 	 
	Clinical Operations total	 	 	385,640.00	 	 	 
	Other
    Services total	 	 	254,572.00	 	 	 
	8%
    overhead	 	 	20,365.76	 	 	 
	 	 	 	 	 	 	 
	GRAND
    TOTAL  PROFESSIONAL FEES	 	 	781,037.76	 	 	 








 


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