Exhibit 10.4


 


SCHEDULE
1


WORK
ORDER 2 


 


This
WORK ORDER dated as of the date of last signature below


 


BETWEEN


 


(1) Kitov
Pharmaceuticals Holdings Ltd., One Azrieli Center, Round Tower, 23rd Floor, Tel Aviv 670110 (hereinafter
referred to as “KITOV”) and


 


(2)
JAVA CLINICAL RESEARCH LIMITED, a company incorporated in Ireland, registered number 311398, with registered office address
88 Harcourt Street , Dublin 2, and located at Denshaw House 21 Lower Baggot Street , Ireland (hereinafter referred to as “JAVA”).


 


WHEREAS
Kitov and JAVA are bound by the terms of the Master Services Agreement dated 04 February 2014 between Kitov and JAVA (the
"Master Services Agreement"), Kitov and JAVA wish to set out the specific details of services to be provided
by JAVA in respect of study


 


Title
of trial: A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of
Amlodipine on Renal and Vascular Function in Subjects with Existing Hypertension Requiring Antihypertensive Therapy


 


	PROTOCOL NO.:	K-302-03-02




 


THE
PARTIES NOW HEREBY AGREE AS FOLLOWS:


 


		1.	JAVA
                                         shall provide the services as outlined in Schedule 2 hereto (the "Services")
                                         in accordance with the timelines set out in Schedule 3 hereto and the terms and conditions
                                         of the Master Services Agreement together with the additional provisions as set out in
                                         the following Schedules:



 


	 	Schedule 1	Timelines
	 	 	 
	 	Schedule 2 	Services Budget and Payment Schedule Java Clinical Research
	 	 	 
	 	Schedule 3 	Services Budget and Payment Schedule CROSNT
	 	 	 
	 	Schedule 4	Payment Plan
	 	 	 
	 	Schedule 5	Personnel / Contacts for Notices and Payments




 






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This
Work Order has an effective date as of the last date of signature and will remain valid until completion of Services described
herein and when Kitov has paid the final invoice in accordance with the terms of the Master Services Agreement, unless otherwise
terminated in accordance with the provisions of Clause 12 of the Master Services Agreement.


 


SIGNED
BY


KITOV
PHARMACEUTICAL HOLDINGS LTDJAVA CLINICAL RESEARCH LTD


 


	Signature:__________________________	 	Signature:__________________________
	 	 	 
	By:________________________________	 	By:________________________________
	(PrintName)                        	 	
	 	 	 
	Title: ______________________________	 	Title: ______________________________
	 	 	 
	Date: ______________________________	 	Date: ______________________________




 






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SCHEDULE
1: TIMELINES


 


The
Work Order is based on the following estimated timelines:


 


	Milestone	 	Target Date
	MHRA Approval	 	September 2016
	October	 	October 2016
	First Site Initiation Visit	 	October 2016
	First Clinical Trial Subject Recruited	 	October 2016
	Last Clinical Trial Subject Recruited	 	17 February 2017
	LPLV	 	31 March 2017
	DB Lock	 	May 2017
	Final Study Report	 	June/ July 2017



 






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SCHEDULE 2: BUDGET JAVA CLINICAL
RESEARCH


	Study
    Reference KIT-302-03-92	 	 	 	 
	 	 	 	 	 
	Projected
    Timelines:	 	 	 	 
	Project
    Preparation	 	15
    weeks 	 	04
    July 2016 - 17 October 2016
	Study
    Recruitment and Conduct Period	 	24
    weeks	 	17
    October 2016 - 31 March 2017 
	 	 	 	 	Last
    patient randomised 17/02/2017 
	 	 	 	 	Last
    Patient Last Visit 31/03/2017 
	Close
    out period	 	13
    weeks	 	13
    March 2017 - 30 June 2017
	 	 	 	 	 
	Indication:	 	Hypertension	 	 
	 	 	 	 	 
	Key
    Assumptions:	 	 	 	 
	Number
    of patients to be screened	 	150	 	 
	Number
    of patients to be randomised	 	105	 	 
	 	 	 	 	 
	Sites	 	10
    sites	 	 
	Number
    of  monitoring visits (150 patients)	 	Estimated
    pool of monitoring visits 55 (5/6)	 	 
	 	 	 	 	 
	Total
    CRF pages per patient	 	TBC	 	 




 





 



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SCHEDULE
3: BUDGET CROSNT 


 


	Biometrics Management	 	Total Cost (EUR)	 
	TOTAL	 	 	15,423.00	 
	 	 	 	 	 
	Data Management	 	Total Cost (EUR)	 
	CRF Design	 	 	3,365.20	 
	Data Management Plan	 	 	3,830.30	 
	Programming and Validation of Database	 	 	10,108.80	 
	Programming and Validation of Consistency Checks	 	 	8,095.20	 
	Data Load set-up	 	 	2,706.00	 
	User acceptance testing	 	 	1,971.20	 
	Data Cleaning	 	 	17,577.20	 
	SAE Reconciliation	 	 	1,033.80	 
	Production of Listing for Medical Review	 	 	873.90	 
	Coding	 	 	3,158.40	 
	Metrics/Tracking Report	 	 	789.60	 
	SAS External Data Load	 	 	1,071.00	 
	Database Lock	 	 	958.80	 
	Database Transfer	 	 	119.00	 
	TMF Management	 	 	714.00	 
	Documentation Archiving	 	 	2,380.00	 
	DM Teleconferences	 	 	1,353.60	 
	TOTAL	 	 	60,106.00	 
	 	 	 	 	 
	eCRF management and hosting	 	Total Cost (EUR)	 
	EDC System setup, documentation and maintenance & Help Desk (2nd level)	 	 	1,249.50	 
	eCRF License fee, hosting, e-Learning and 1st Level Help Desk	 	 	49,461.00	 
	Patient Data Reports	 	 	1,725.50	 
	Implementation & Maintenance of Access Authorisation	 	 	8,131.20	 
	e-Learning User Management	 	 	2,310.00	 
	CD Archives	 	 	163.35	 
	TOTAL	 	 	63,040.55	 
	 	 	 	 	 
	Pharmacovigilance	 	Total Cost (EUR)	 
	Initial Set Up Costs (to include registration with EMA and all competent authorities, Development of Safety Management Plan	 	 	9,270.00	 
	Monthly costs for duration of study for provision of responsible person for PV Qualified medic, PV Governance & Project Quality, Safety database hosting, generation of SAE monthly tracking sheets	 	 	7,416.00	 
	SAE Handling Costs	 	 	2,472.00	 
	Generation and submission of SUSARS listings to Investigators	 	 	103.00	 
	TOTAL	 	 	19,261.00	 
	 	 	 	 	 
	TOTAL	 	 	157,830.55	 
	 	 	 	 	 
	DISCOUNT	 	 	10,881.42	 
	 	 	 	 	 
	TOTAL INCLUDING DISCOUNT	 	 	146,949.13	 






 






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SCHEDULE
4: PAYMENT SCHEDULES


 


Payment
Schedules Java 


Total
Budget €429,521


 


	Step of Payment	 	Percentage	 	 	Due Amount (EUR)	 
	Upfront fee at exchange of  contracts	 	 	30	%	 	 	128, 856	 
	Less Upfront fee at LOI  contracts	 	 	 	 	 	€	50,000.00	 
	Balance due on exchange of contracts	 	 	 	 	 	€	78,856.	 
	Study Conduct period Invoiced monthly
    during randomisation	 	 	50	%	 	€	214,760	 
	LPLV	 	 	10	%	 	€	42,952	 
	DB Lock	 	 	5	%	 	€	21,476	 
	Final study report	 	 	5	%	 	€	21,477	 



 


Payment
Schedules CROSNT 


Total
Budget €146,949.13


 


	Step of Payment	 	Percentage	 	 	Due Amount (EUR)	 
	Upfront fee at exchange of  contracts	 	 	30	%	 	€	44,084.74	 
	Database Go live	 	 	10	%	 	€	14,694.91	 
	Following 25 Subjects randomised	 	 	10	%	 	€	14,694.91	 
	Following 50 Subjects randomised	 	 	10	%	 	€	14,694.91	 
	Following 75 Subjects randomised	 	 	10	%	 	€	14,694.91	 
	Following 100 Subjects randomised	 	 	10	%	 	€	14,694.91	 
	LPLV	 	 	10	%	 	€	14,694.91	 
	DB Lock	 	 	10	%	 	€	14,694.92	 



 






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SCHEDULE
5: Personnel / Contacts for Notices and Payments


 


For;
Java CLINICAL RESEARCH Ltd


 


Ruth
Nallen


Managing
Director


Java
Clinical Research


Denshaw
House


121
Lower baggot street


Dublin
2


Emial;
rnallen@javacr.com


 


For
: KITOV PHARMACEUTICAL HOLDINGS LTD


 


Mr
Simcha Rock


Chief
Financial Officer


One
Azrieli Center, Round Tower,


23rd
Floor,


Tel
Aviv


Israel
670110


Email;
simcha@kitovpharma.com


 


 


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