Document:

EXHIBIT 10.1

 

	Confidential	Execution Copy

 

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.

 

 

development
Services

 

agreEment

 

This
Development Services Agreement (the "Agreement"), is made and entered into,
as of ________________, 2014, by and between Kitov Pharmaceuticals Holdings Ltd., an Israeli
company with offices at Lev Hagiva, 11 Bet Hadfus Street, Jerusalem 95483, Israel (hereinafter “Kitov”);
and Dexcel Ltd., a company incorporated under the laws of Israel, with offices at 1 Dexcel
Street Or Akiva, 3060000, Israel ("Dexcel"). 

 

(Each
of Kitov and Dexcel shall be referred to herein as a "Party" and together as the "Parties") 

 

WHEREAS;
Dexcel is a specialty pharmaceutical company; and

 

WHEREAS;
Kitov is interested in retaining Dexcel's services for the development of the Product, as elaborated in this Agreement, and Dexcel
is interested in providing such services to Kitov; and

 

WHEREAS;
As a consideration for the provisions of the Services (as defined herein below) by Dexcel to Kitov, Kitov shall pay Dexcel the
Consideration, and subject to the terms and conditions set forth in this Agreement, grant Dexcel certain rights as elaborated in
this Agreement; 

 

NOW, THEREFORE,
in consideration of the mutual covenants contained herein, the Parties agree to the following terms and conditions, which set forth
the rights, duties, and obligations of the Parties.

 

		1.	Definitions.

 

		1.1.	“API”- means active pharmaceutical ingredient of Celecoxib and Amoloidpine
Besylate.

 

		1.2.	“API Cost”- shall have the meaning defined in Section ‎5.1.

 

		1.3.	“Commercial Agreement” – shall have the meaning defined in Section
‎4.2.

 

		1.4.	“Confidential Information” means, any information disclosed by one Party (the
“Disclosing Party”) to the other Party (the “Receiving Party”) in connection with this Agreement,
whether orally or in writing or in any other form including, without limitation, computer programs, code, algorithms, names and
expertise of employees and consultants, know-how, trade secrets, formulae, processes, ideas, inventions (whether patentable or
not), schematics and other technical, improvements, business, financial and product development plans, forecasts, strategies and
information or data relating to the Disclosing Party's business, products and technology.

 

    	 

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		1.5.	"Deliverables" – mean the production file as developed by Dexcel as part
of the Services which will allow Kitov to manufacture the Product independently or through a third party, all as detailed and in
accordance with Annex A.

 

		1.6.	“Dexcel IP” - shall have the meaning defined in Section‎8.

 

		1.7.	“Dexcel's Development Updates” - shall have the meaning defined in Section
‎2.5.

 

		1.8.	“Effective Date”- shall mean the date of the last Party to sign this Agreement.

 

		1.9.	“Exchange Rate"- shall mean the ratio at which one (1) U.S. Dollar can be exchanged
for one (1) New Israeli Shekel on the payment date, as determined by the reference rate of the Bank of Israel.

 

		1.10.	“FDA” – the US Food and Drug Administration.

 

		1.11.	“Fee” – shall have the meaning defined in 3.1.

 

		1.12.	“Force Majeure” shall mean an event beyond a Party’s reasonable
control which prevents such Party from performing its obligations hereunder, such events may include, but not be limited to, Acts
of God (including fire, flood, earthquake, storm, hurricane or other natural disaster), war, invasion, act of foreign enemies,
hostilities (regardless of whether war is declared), civil war, rebellion, revolution, insurrection, military or usurped power
or confiscation, terrorist activities, any extraordinary military operation which requires a large military reserve mobilization,
nationalization, governmental activities relating to emergency situations, change in applicable laws, shortages in availability
of raw materials, blockage, embargo, strikes or lockouts.

 

		1.13.	"Full Bio” shall mean a study that is designed to show that the Product
is bioequivalent to the Reference Listed Drugs ("RLD").

 

		1.14.	"Information” - all data inventions, processes, protocols, and formulae (electronic
files, notebooks, reports, etc.) resulting from the Services provided hereunder.

 

		1.15.	“Intellectual Property Rights” means all intellectual property rights, including
patents, copyrights, trademarks, applications, service marks, trade names, applications for any of the foregoing, trade secrets,
mask works, formulae, industrial design rights, rights of priority, know how, concepts, processes, data rights, design flows, methodologies,
and any and all other legal rights protecting proprietary intangible property, whether registerable or not, and whether reduced
to practice or not.

 

		1.16.	"Issuance of Shares" shall have the meaning defined in Section ‎(ii).

 

		1.17.	“Good Manufacturing Practices” or “cGMP” means the principles
and guidelines of good manufacturing practice for medicinal products for human use as defined in 21 CFR 210, 21 CFR 211, and European
Directive 2003/94/EC.

 

		1.18.	“Kitov Data” – means, Kitov Foreground IP, including Patent families embodied
in Patents applications no. 13/026,741, 12/990,724, WO2009/154944 and WO2011/100659, and Kitov's
Confidential Information.

 

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		1.19.	“Kitov Foreground IP”- shall have the meaning defined in Section ‎8.

 

		1.20.	"Lien"- shall have the meaning defined in Section ‎(ii).

 

		1.21.	“Materials”- shall have the meaning defined in Section ‎7.

 

		1.22.	“Milestone Event"- achieving a stage as detailed in Annex C.

 

		1.23.	“NDA” – a New Drug Application to the FDA.

 

		1.24.	“Negotiation Period”– shall have the meaning defined in Section ‎4.

 

		1.25.	"Payment Conversion Notice" – shall have the meaning defined in Section
‎3.3.

 

		1.26.	“Pilot Bio” – shall mean studies to check the bioequivalence of
the Prototype, as detailed in Section 5-8 of Annex A.

 

		1.27.	“Publication” – A press release, filing of legally required notices
and reports or public statement concerning this Agreement and/or any activity in relation thereto.

 

		1.28.	"Product" means the selected Prototype.

 

		1.29.	“Prototype” means a combination solid oral dosage form of Celecoxib and Amlodipine
Besylate as developed under this Agreement in a form of a [****].

 

		1.30.	"RFP" – means Request For Proposal for the development and production of
a combination solid oral dosage form of celecoxib and amlodipine besylate issued by Kitov dated October 29th, 2013.

 

		1.31.	“Services”- shall have the meaning defined in Section ‎2.1. 

 

		1.32.	"Shares Payment Non-Performance"- shall have the meaning defined in Section ‎3.3.

 

		1.33.	“Shares” - shall have the meaning defined in Section ‎(ii).

 

		1.34.	“SOW” – shall have the meaning defined in Section ‎2.1.1.

 

		1.35.	“Term”- shall have the meaning defined in Section ‎14.1.

 

		1.36.	“Timetable”- shall have the meaning defined in Section ‎2.1.2.

 

		1.37.	"Value"- shall have the meaning defined in section 3.1‎(ii).

 

		2.	The Services.

 

		2.1.	Dexcel shall provide formulation development services for a combination [****]
drug product which shall include: performing compatibility testing of APIs with excipients, screening to find at least two Prototypes,
identifying analytical methods for Product analysis, performing Product preliminary stability testing, performing analytical methods
validations, manufacturing pivotal batches and performing stability studies on pivotal batches. The activities under each phase
of the Services shall be provided according to:

 

		2.1.1.	the details as set forth in Statement of Work attached as Annex A to this Agreement
(the "SOW") and serves as integral part thereof.

 

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		2.1.2.	the timetable attached as Annex C to this Agreement (the "Timetable")
and serves as integral part thereof.

 

(Collectively the "Services").

 

Following the Completion of
the Services under the SOW, simultaneously with the completion of Milestone 6 (as set forth in Annex C) and the full payment of
the Consideration to Dexcel, Dexcel shall provide Company with the Deliverables.

 

		2.2.	Dexcel shall provide Kitov with proposals for the performance of Pilot Bio and Full Bio services
to be performed by sub-contractors selected by Dexcel (the “Pilot Bio Proposals” and the “Full Bio
Proposals”). Kitov shall have the right at its sole discretion to accept or reject the Pilot Bio Proposals and the Full
Bio Proposals and to select other contractors to perform the Pilot Bio and Full Bio services or to decide not to perform such services
at all. Prior to making such determinations, Kitov shall consult with Dexcel, however any decision shall be made at Kitov's sole
discretion, and without any liability to Dexcel. For the avoidance of doubt, any delay in Kitov's decisions whether to perform
the Pilot Bio or the Full Bio with Dexcel or with other third party shall respectively delay Dexcel's timeline commitments related
thereto. Dexcel recommends performing a Pilot Bio before commencement of the performance of the Full Bio.

 

		2.3.	All data generated from the provision of the Services, including the scientific report, which are
specifically required and contemplated under the Service protocol, shall be provided to Kitov upon full payment of the Consideration
in accordance with Section ‎3.

 

		2.4.	Other than as expressly provided to the contrary in this Agreement, nothing contained in this Agreement
shall be construed as a warranty on the part of Dexcel that any results or inventions will be achieved by the Services or that
the results of the Services, if any, are or will be of commercial or scientific value to Kitov.

 

		2.5.	At the end of each development milestone (as detailed in the SOW), Dexcel shall provide Kitov a
written notice to inform Kitov that Dexcel concluded the development under such milestone ("Dexcel's Development Update").
Within 7 business days following receipt by Kitov of such Dexcel's Development Update, Kitov shall provide a written statement
to Dexcel, which either confirms Dexcel's Development Update (" Notice of Completion of Milestone"), or
rejects Dexcel's Development Update ("Notice of Rejection"), in which case the Notice of Rejection shall elaborate
in sufficient detail the grounds for the rejection. Following such Notice of Rejection, subject to the provisions of section ‎3.4
herein, and provided that the Notice of Rejection is reasonable and in accordance with customary standard or practice in the industry,
Dexcel shall perform all such actions required to cure such rejections, and resubmit Dexcel's Development Update. The foregoing
process shall be repeated until Kitov provides a Notice of Completion of Milestone. For the avoidance of doubt, in the event that
Kitov has failed to provide Dexcel with any written notice within 7 business days from the date Kitov had received Dexcel's Development
Update, Dexcel Development Update (including the demand for payment of the relevant milestone payment) shall be deemed confirmed
by Kitov.

 

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		2.6.	To the extent carried out by Dexcel or a CRO on Dexcel's behalf, a successful Full Bio shall be
determined in accordance with the following criteria: Pivotal BE Study shall be deemed to be successful if in both analytes (Celecoxib
and Amlodipine) for the following parameters AUC0-t, AUCinf and Cmax, the 90% confidence intervals of the geometric mean Test/Reference
ratios will fall within the limits of 80.00-125.00%.

 

		3.	Consideration

 

		3.1.	The total aggregate consideration due to Dexcel subject to and in accordance with the provisions
hereof in consideration of the Services is detailed as follows:

 

		(i)	US$ 2,000,000, payable in cash, upon occurrence of the Milestone Events as set out in this Section
3 below; (the "Cash Payment") and

 

		(ii)	US$ 1,500,000 payable in Shares to be issued to Dexcel by Kitov, upon occurrence of the Milestone
Events as set out in this Section 3 below (the "Issuance of Shares"), subject to the terms and conditions of this
Section 3.

 

(The Cash Payment and
the Issuance of Shares collectively the "Fee").

 

In this Agreement:

 

"Shares" shall
mean Ordinary Shares of Kitov, with no nominal value, validly issued and registered for trade in the Tel Aviv Stock Exchange ("TASE"),
fully paid, free and clear of (i) any Liens; and (ii) any restrictions with respect to the use, transfer, assignment, resale or
any similar action, excluding only restrictions that are relevant and imposed on Dexcel by Israeli mandatory securities law and
regulation in the event the Shares are issued by a private placement.

  

"Lien" shall
mean any lien, pledge, charge, claim, mortgage, security interest or other encumbrance or any third party/ies right of any sort.

 

"Value" shall
mean, with respect to the Shares to be Issued to Dexcel on the Effective Date, NIS 0.85 per share, and with respect to any other
Issuance of Shares, the average price per share of the Shares, based on their recorded price at the end of the trade on
TASE, during a period of trading 45 days prior to the date of acceptance (or deemed acceptance) by Kitov of Notice of Dexcel's
Development Update as set forth in section ‎2.5 above and on the NIS US$ exchange rate on such date.

 

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The Fee
shall be paid to Dexcel in accordance with the following Table A:

 

	 	Due Date 	Cash 

Amount Due	Shares to be 

Issued to Dexcel  

on Due Date	Payments to 

Kitov 

according to 

Section 4.1 

(Right of 

First 

Negotiation)
	1.	Effective Date 	US$ 500,000	
        Shares in such quantity that the Value
        of which on the date of issuance to Dexcel is equal to US$ 500,000.

         
	 
	2.	Acceptance (or deemed acceptance) by Kitov of Notice of Dexcel's Development Update with respect to Milestone 2 of Annex C 	US$ 500,000	
        Shares in such quantity that the Value
        of which on the date of issuance to Dexcel is equal to US$ 500,000.

         
	US$ 250,000
	3.	 Acceptance (or deemed acceptance) by Kitov of Notice of Dexcel's Development Update with respect to Milestone 5 of Annex C	US$ 500,000	
        Shares in such quantity that the Value
        of which on the date of issuance to Dexcel is equal to US$ 500,000.

         
	US$ 250,000
	4.	Acceptance (or deemed acceptance) by Kitov of Notice of Dexcel's Development Update with respect to Milestone 6 of Annex C- however, the payment due herein shall be at the Completion of the stability study for pivotal batches of 1 month (in accelerated conditions). 	US$ 500,000	 	 

  

Table A

 

		3.2.	Kitov shall be solely and exclusively responsible to timely:

 

		(a)	obtain and maintain any and all corporate, regulatory, third party or other approvals, and to

 

		(b)	undertake and perform any and all corporate and other actions, required under applicable law, regulation
or Kitov articles of association, by-laws, any other binding obligation of Kitov or otherwise,

 

to the extent required in order
to timely issue the Shares to Dexcel in accordance with the terms of this Section 3.

 

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In the event Kitov is not able
to obtain or cause to be obtained any of the above, Kitov shall pay Dexcel a cash payment instead of the applicable Issuance of
Shares, in the amount of the applicable US$ value.

 

In addition, the Parties hereby
agree and understand, that inasmuch as an approval of Kitov's shareholders is required for any Issuance of Shares hereunder, pursuant
to Sections 270(5) and/or 274 of the Israeli Companies Law – 1999 (or any other Sections replacing such Sections or intended
to come in their stead), the approval of Kitov's shareholders shall be a condition precedent to such Issuance of Shares, and in
the event such approval shall not be obtained, Kitov shall pay Dexcel a cash payment instead of the applicable Issuance of Shares,
in the amount of the applicable US$ value.

 

		3.3.	Payment Terms.

 

		3.3.1.	Each Party shall issue an invoice to the other Party with respect of each payment due to such Party
hereunder (including, for the avoidance of doubt, with respect to Issuance of Shares).

 

		3.3.2.	The Cash Payment. The Cash Payment shall be made on a current + 30 days (30 days as of the end
of the calendar month following the month in which the invoice was issued) based on the issuance of valid tax invoice by Dexcel
with respect to each cash amount due.

 

		3.3.3.	The Issuance Shares. (i) The issuance of the Shares shall be subject to the approval of the Tel
Aviv Stock Exchange for the issuance of the Shares. (ii) The issuance of the Shares is pending the execution, delivery, and performance
of any additional document by Dexcel as required by any applicable law and/or corporate governance policy, bylaws or articles of
association (ii) the issuance of the Shares shall be considered timely, if issued up to 30 days as of the Due Date of issuance.

 

		3.3.4.	In the event that any of the Shares are not timely issued to Dexcel, and in accordance with the
other terms of this Section 3, and/or not in a manner that immediately after the issuance Dexcel has full and good title to the
respective Shares free and clear of any Lien ("Shares Payment Non-Performance") and only in case such Shares Payment
Non Performance is not fully cured within 30 days as of the Due Date , Dexcel may notify Kitov in writing, that the respective
portion of the Fee payable in Shares is due, and if not issued within 30 days as of the receipt of such notice by Kitov, then the
respective portion of the Fee shall no longer be payable in Shares but due and payable in cash ("Payment Conversion Notice").Upon
the lapse of 30 days as of the receipt by Kitov of the Payment Conversion Notice, to the extent the Shares Payment Non Performance
was not cured as set forth herein, the respective portion of the Issuance of Shares shall become immediately due and payable in
cash. Upon Kitov's full payment of the sums in lieu of the Shares as detailed in the Payment Conversion Notice, Kitov shall be
released from its obligation to issue the respective portion of the Shares that has not been issued to Dexcel, for which the Payment
Conversion notice was issued. For illustration and clarification purposes, in case a certain Due Date is May 1st, 2015, and pursuant
to this Section 3, within 30 days of such date Kitov is obligated to issue Dexcel Shares at a Value of US$ 500,000, and Kitov has
only issued Dexcel shares in a quantity that the Value of which on the date of their issuance is equal to US$ 300,000, as of June
1st, 2015 Dexcel may send Kitov a Payment Conversion Notice with respect to the remaining US$ 200,000 worth of Shares, and upon
the lapse of 30 days as of receipt of which by Kitov, Kitov shall be obligated to immediately pay Dexcel a cash amount of US$ 200,000,
instead of the issuance of such Shares, unless the applicable portion of the Shares has been issued before the lapse of such 30
days period; such number of Shares shall be determined at the Value on the date of actual issuance thereof.

 

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		3.4.	In the event that Dexcel shall need to repeat any development stage not due to Dexcel’s misconduct
or omission, Kitov shall pay the costs associated with such repetition upon Dexcel written demand. In such case the Timetable shall
be adjusted and deadlines shall be prolonged in accordance with the duration of the repeated stage of development.

 

		3.4.1.	Without derogating from the any provisions of this Agreement, and provided that Kitov has not received
from Dexcel additional services other than the Services, the Fee and the payment obligation as stipulated in Section ‎5‎5
herein, shall constitute the sole and complete compensation due to Dexcel in consideration of the Services.

 

		3.4.2.	With respect to payments under Section 4.1 hereunder, Dexcel shall make the necessary payments
to Kitov within thirty (30) days of the end of the month in which it received the relevant invoice ("Shotef" + 30).

 

		3.4.3.	All cash payments made by and between the Parties under this Agreement shall be in New Israeli
Shekels based on the Exchange Rate as of the date of the payment.

 

		3.4.4.	Any consideration set forth is exclusive of VAT or any other applicable sales tax, which shall
be added to the extent required by law to any consideration set forth herein, Unless Dexcel provides Kitov with an official approval
of the ITA with respect to exemption from tax withholding at source, or provide a certain rate of tax withholding at source, with
respect to the payments made hereunder, Kitov shall withhold at source from any payment due hereunder the maximum rate of tax applicable,
from any amount payable to Dexcel.

 

		4.	Right of First Negotiation and Product Manufacture

 

		4.1.	In consideration of a First Negotiation Right (as defined below) regarding the global rights relating
to marketing of the Product, and in consideration of the right to enter into good faith negotiations with Kitov with respect to
the manufacture of the Product upon completion of Milestone 4 (as set forth in Annex C), Dexcel shall pay to Kitov an amount of
USD 500,000 in instalments in accordance with the milestone payments set forth in Table A hereinabove. The actual Payment
of the foregoing sums shall be made by way of offset by Kitov against sums payable by Kitov to Dexcel on such occasions.

 

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		4.2.	In the event Kitov intends to begin negotiations with any third-party with the objective of entering
into a commercial marketing or licensing agreement with respect of the Product ("Commercial Agreement") Kitov
shall notify Dexcel of its intent to do so. Dexcel shall then have the right, within 21 days of such notification by Kitov, to
notify Kitov whether Dexcel desires to negotiate with Kitov with regard to reaching mutually agreeable and commercially reasonable
terms and conditions for such transaction (the "First Negotiation Right"). If Dexcel notifies Kitov in writing
within such 21day period, that it so desires, then Kitov shall negotiate solely and exclusively with Dexcel in good faith and attempt
to reach mutual agreement upon such terms and conditions for such Commercial Agreement within sixty (60) calendar days thereafter
(the “Negotiation Period”).

  

		4.3.	If Dexcel does not notify Kitov within the said 21 day period of its interest in entering into
such a Commercial Agreement, (for the avoidance of doubt, if Dexcel does not provide any notification regarding the subject matter,
this shall be regarded as a notice of non interest) or if upon expiration of the Negotiation Period the Parties are unable to agree
in good faith upon the terms and conditions thereof, then Kitov shall be free to enter into a Commercial Agreement with any party
on any terms that Kitov determines in its sole discretion, and Kitov shall have no obligation to offer any such terms to Dexcel.

 

		5.	Payment of API and Development Cost

 

		5.1.	Dexcel undertakes, to procure and obtain all API, ancillary chemical or other supplies and products
and any other substances or materials required with sufficient quantities for Dexcel's use in conducting the Services under this
Agreement (the “API Supplies”), provided however, that the cost of the APIs as well as other materials or means required
for Dexcel to perform the Services (the “API Cost”) shall be borne by Kitov. The payment of such API cost shall
be made on a current + 30 days (30 days as of the end of the calendar month following the month in which the invoice was issued)
based on the issuance of valid tax invoice by Dexcel, to be issued by Dexcel upon ordering such API from API suppliers. At Kitov’s
sole discretion, it may, after consulting with Dexcel, elect to procure the API Supplies at its own cost and arrange for their
shipment to Dexcel. Should Dexcel procure the API Supplies, the API Cost shall be paid by Kitov to Dexcel, upon Dexcel written
demand, in addition to the Consideration. As of the Effective Date, Dexcel's estimation of the cost of the API is USD$ 200,000
(two hundred thousand) per pivotal batch. For the avoidance of any doubt, in the event that Kitov elects to procure the API Supplies
at Kitov's own cost and arrangement, Kitov shall be solely liable to the quality and timeline relating to the supply of the API.

 

		5.2.	To the extent carried out by Dexcel or a CRO on behalf of Dexcel, pursuant to Section 2.2. herein,
prior to the commencement of the Pilot Bio and the Full Bio, Kitov shall pay the cost associated with the Pilot Bio and the Full
Bio, based on a formal quote that will be presented to Kitov +12.5% and agreed upon in writing by Kitov. For the avoidance of doubt,
the figures as detailed in Annex B, are only estimated costs. For the avoidance of doubt, Kitov shall only be bound
by any such costs to the extent they are presented in a formal quote and approved by signature of an authorized representative
of Kitov.

  

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		6.	Confidentiality

 

		6.1.	All Confidential Information shall be protected by the Receiving Party from disclosure with the
same degree of care with which the Receiving Party protects its own confidential information from disclosure, but in no event with
less than a reasonable degree of care preventing unauthorized disclosure. The Receiving Party agrees (a) not to disclose Confidential
Information to any Person except to those of its employees, consultants, advisors, directors, or representatives who need to know
Confidential Information in connection with the conduct of its business, and (b) that neither the Receiving Party nor any of its
employees, consultants, advisors, directors, or representatives will use the Confidential Information for any purpose other than
in connection with the conduct of its business pursuant to this Agreement and the Receiving Party shall cause such employees, consultants,
advisors, directors, and representatives to engage in non-disclosure agreements not less restrictive than the provisions of this
Section 6; provided, however, that such restrictions shall not apply if such Confidential Information (i) is or hereafter becomes
public other than by a breach of this Agreement, (ii) was already in the Receiving Party's possession prior to any disclosure of
the Confidential Information to the Receiving Party made by the Disclosing Party (iii) has been or is hereafter obtained by the
Receiving Party from a third party which was not bound by any confidentiality obligation with respect to the Confidential Information,
(iv) is required to be disclosed pursuant to judicial order, but only to the extent of such order and after reasonable notice to
the Disclosing Party, provided that such reasonable notice is possible, so as to allow the Disclosing Party to intervene in any
proceeding leading to such order, or (v) is required to be disclosed by any government authority which regulates the business of
the Receiving Party, but only to the extent of such required disclosure and after reasonable notice to the Disclosing Party provided
that such reasonable notice is possible so as to allow the Disclosing Party to intervene to seek confidential treatment.

 

		6.2.	This Section ‎0 shall survive the termination or expiration of this Agreement for a period
of seven (7) years after the last transfer of Confidential Information hereunder.

 

		7.	Materials

 

Any and all materials, samples,
or products (the "Materials") provided by Kitov to Dexcel, to the extent provided, shall remain the sole and exclusive
property of Kitov. Dexcel shall not use the Materials for any purpose other than as expressly contemplated by this Agreement. Dexcel
will store and handle the Materials according to Kitov instructions and either return to Kitov or destroy the Materials as shall
be instructed by Kitov, in the latter case, Dexcel shall provide certificate of destruction signed by an authorized representative
of Dexcel to that extent.

 

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		8.	Intellectual Property Rights

 

		8.1.	Any Intellectual Property Rights or Confidential Information belonging to either Kitov or Dexcel
prior to the execution of this Agreement will remain the sole property of either Kitov or Dexcel, respectively ("Kitov
Foreground IP" and "Dexcel Foreground IP", respectively).

 

		8.2.	Kitov hereby grants to Dexcel a fully paid, limited, non exclusive, license to use Kitov Data inasmuch
as required for the provision of the Services by Dexcel.

 

		8.3.	Subject to the provisions of sections 8.1 and 8.2 above and without derogating therefrom, any and
all rights, title and interest in any Intellectual Property Rights resulting from any development made by Dexcel which is related
to the Product and embodied in the Deliverables or conceived in connection with the services provided hereunder by Dexcel to Kitov,
which is only applicable for the manufacture, research, development, making of, use, sale, production, commercialisation and distribution
of the Product, shall be jointly and equally (50%/50%) owned by Dexcel and Kitov (the "Joint IP").

 

		8.4.	All rights, title and interest in all Intellectual Property Rights discovered or developed by Dexcel
during the course of the provision of the Services or as a result thereof, which is not Joint IP (i.e., which applicability is
general and not only applicable to the Product), Kitov Foreground IP or the Deliverables, shall be solely owned by Dexcel (the
“Dexcel IP”).

 

		8.5.	Dexcel hereby grants Kitov a non-exclusive, perpetual, non revocable and world-wide license to
any and all Dexcel IP and any and all Joint IP that is required to the making of, sale, production, commercialization, manufacture,
distribution, marketing research and development, of the Product (the "License to Dexcel IP"). For the avoidance
of doubt, the scope of the License to Dexcel IP shall not include any use of Dexcel IP to manufacture, distribution, marketing
or further development of any other product other than the Product, and/or the combination of the Product with additional APIs.

 

		8.6.	Kitov hereby grants Dexcel a fully paid, non-exclusive, perpetual, non revocable and world-wide
license to any and all Joint IP but only to the extent required to allow Dexcel to research, develop, make, have made, register,
import, manufacture, use, sell, offer for sale, produce, commercialise and distribute any product other than the Product.

 

		9.	Data Archives

 

Dexcel will maintain records
of the Information. This Information will be archived in the Dexcel files for 24 months following the completion of the Services,
at which time copy of the data will be transferred to Kitov at Kitov’s expense or disposed of according to Kitov written
instructions. All documents reviewed by Dexcel's quality assurance which are required for regulatory filings will be maintained
by Dexcel without limitation, for not less than 4 years. Kitov may request Dexcel to provide Kitov with the Information or any
part thereof at any time, and Dexcel shall provide such requested Information within a reasonable time.

 

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		10.	Addendums; Change Orders

 

During the course of the Services
under the terms of the Agreement, Kitov may require additional services that pertains to the Services but is outside the scope
of the SOW. Such additional services will be described and quoted in a separate proposed addendum that references this Agreement.
Without derogating from the provisions of Section ‎5 hereinabove, no changes, deletions or additions to the SOW will be considered
valid and bind either of the Parties hereto, without mutual written agreement between Kitov and Dexcel.

 

		11.	Warranties and Undertakings

 

		11.1.	Dexcel makes the following representations, warranties and undertakings to Kitov, with respect
to the Services:

 

		11.1.1.	Dexcel is free to provide Kitov, with the Services upon the terms contained in this Agreement and
the ancillary documents thereof and there are no contracts and/or restrictive covenants preventing full performance of Dexcel's
duties and obligations under this Agreement.

 

		11.1.2.	Dexcel itself or, in the event the Pilot Bio and/or the full Bio is performed by Dexcel’s
sub-contractors, Dexcel's subcontractors (that shall be bound by confidentiality obligations substantially similar to those as
stipulated in this Agreement) has the requisite facilities, personnel, qualifications, knowledge, and experience to perform the
obligations under this Agreement, and Dexcel undertakes to perform the Services under this Agreement in the highest degree of professionalism,
and in the highest quality according to industry standards.

 

		11.1.3.	Dexcel shall provide the Services using adequately skilled personnel having the requisite qualifications,
knowledge, and experience to perform Dexcel's obligations under this Agreement.

 

		11.1.4.	Dexcel shall provide the Services in compliance with all cGMP requirements, where needed.

 

		11.2.	Dexcel makes the following representations, warranties and undertakings to Kitov, with respect
to the Shares:

 

		11.2.1.	Dexcel is aware that the Shares which shall be allocated to them in accordance with the provisions
of this Agreement may be subject to the restrictions of a resale in accordance with the provisions of the Securities Law, 5728
- 1968 and the regulations by virtue thereof.

 

		11.2.2.	Except as set forth in this Agreement, there are no agreements, whether in writing or orally, by
and between Dexcel and a holder of shares in Kitov or others, pertaining to the purchase or sale of securities of Kitov or pertaining
to the voting rights therein.

 

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		11.2.3.	Dexcel undertakes to bear all applicable taxes, including in connection with the issuance of the
Shares to Dexcel.

 

		11.3.	Kitov makes the following representations, warranties and undertakings to Dexcel:

 

		11.3.1.	It is a corporation duly organized and validly existing under the laws of the State of Israel with
the full power to conduct its affairs as currently conducted and contemplated hereunder. All necessary actions have been taken
to enable it to execute and deliver this Agreement and perform its obligations hereunder.

 

		11.3.2.	This Agreement is a valid and binding obligation of Kitov enforceable against both Parties hereto
in accordance with its terms. Kitov has the unencumbered right to enter into this Agreement and to fulfill its duties hereunder.

 

		11.3.3.	Other than as expressly set forth otherwise in this Agreement, no approval, consent, order, authorization
or license by, giving notice to or taking any other action with respect to, any governmental or regulatory authority is required
in connection with the execution and delivery of this Agreement by Kitov and the performance by Kitov of its obligations hereunder.

 

		11.3.4.	With respect to the Kitov Data, Kitov warrants that, as of the Effective Date and to the best of
its knowledge: (a) Kitov owns or has the right to license all relevant rights hereunder, (b) it has not received any communications,
in writing and/or oral, alleging any interference, infringement, misappropriation, or violation (including any claim that Kitov
must license or refrain from using any Intellectual Property Rights of any third party), and (c) it has not received any notice
that any proceedings have been instituted or are pending which challenge any rights of Kitov with respect to the Kitov Data.

 

		11.3.5.	Should Kitov have any concern that the License granted hereunder to Dexcel, may violate or breach
any third parties' right, Kitov shall immediately update Dexcel in writing of such concern.

 

		11.3.6.	Kitov is well aware that Dexcel, in the framework of providing the Services, will not perform any
evaluation of the situation of the Product with respect to third parties’ Intellectual Property Rights and Dexcel makes no
representation or warranty that the launching, selling and marketing the Product in any country will not infringe the Intellectual
Property Rights of any third party. Kitov hereby declares that it will hold Dexcel, its Affiliates, shareholders, officers, directors,
employees and agents harmless for any claims raised from third parties related directly or indirectly from Kitov’s decision
on when to import, launch, sell or market the Product in any country.

 

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		11.3.7.	Kitov shall be solely liable that the issuance of the Shares to Dexcel shall be in accordance with
the Israeli law and all regulations related thereto (including, without limitations the Israeli Securities Law, 5728-1968, and
the regulations related thereto, and the Israeli Stock Exchange regulations (if applicable)).

 

		11.3.8.	The Shares shall be issued to Dexcel, free of any Lien and immediately after the issuance Dexcel
will have full and good title to the respective Shares.

 

		11.4.	The representations and warranties made herein shall be true and correct as of the date of execution
of this agreement, and shall remain true and correct for the duration of the Agreement. Each Party undertakes to promptly notify
the Other Party of any change to any representations and warranties provided hereunder.

 

		12.	Publications 

 

		12.1.	Neither Party shall use the name of the other Party or names of the other Party's employees in
any advertising, PR or sales promotional material or in any other Publication without the prior consent of the other Party.

 

		12.2.	Dexcel acknowledges that Kitov is a publicly traded corporation and is subject to certain reporting
obligations under any applicable laws, and hence Dexcel agrees Kitov has a right to make such Publications as required under any
such applicable laws, provide however, that Kitov shall notify Dexcel and provide such Publication in advance to Dexcel, to allow
Dexcel to provide comments to such publications that shall be taken into account by Kitov, to the extent that the schedule and
the time enable such discovery.

 

		13.	Independent Contractor

 

The Parties expressly declare
and confirm that there shall be no employer-employee relationship between Kitov and Dexcel or any of Dexcel's employees, and/or
anyone on Dexcel’s behalf. This Agreement does not create any partnership, joint venture, or agency relationship between
the Parties.

 

		14.	Term and Termination. 

 

		14.1.	This Agreement will take effect on the Effective Date and shall continue until completion by Dexcel
of the Services (the "Term").

 

		14.2.	Either Party may terminate this Agreement if the other Party is in breach of any provisions hereof
and the breaching Party fails to remedy any such breach within thirty (30) days of the notice of such breach delivered by the non
- breaching Party.

 

		14.3.	This Agreement may be terminated, in whole or in part, by either Party providing ninety (90) days’
written notice to the other Party. In the event of such termination by Dexcel, Dexcel shall fully cooperate with Kitov to transfer
all records, formulations, calculations, know-how developed for the Prototypes to a Kitov to a contractor of Kitov's choosing at
no cost to Kitov, provided however that Dexcel may retain one copy of the said records for archival purposes and to meet regulatory
obligations.

 

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		14.4.	Each Party shall have the right to terminate this Agreement upon the filing or institution of bankruptcy,
reorganisation, liquidation, receivership, rehabilitation or freeze order (“hakpa’at halichim”) proceedings with
respect to the other Party, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other
Party; provided, however, in the case of any involuntary bankruptcy, reorganisation, liquidation, receivership, rehabilitation
or freeze order (“hakpa’at halichim”) or assignment proceeding, such right to terminate shall only become effective
if such other Party consents to the involuntary proceeding or such proceeding is not dismissed within ninety (90) days after the
filing thereof.

 

		14.5.	Termination Consequences 

 

		14.5.1.	Following the termination or expiration of this Agreement:

 

		a.	the license relating to Kitov Data, as stipulated in section ‎8, shall expire,

 

		b.	The Licenses as detailed in sections 8.5 and 8.6 shall survive; and

 

		14.5.2.	The obligation of the Parties contained in Sections 6 (''Confidentiality'') ,7 (''Materials''),
8 ("Intellectual Property") subject to the provisions of section 14.5.1 above, 9 (''Data Archives''), 12 (''Publications''),
14 (''Termination''), 16 (''Indemnification and limitation of Liability''), and 18 (''Miscellaneous'') shall survive the expiration
or earlier termination of this Agreement.

 

		14.5.3.	Upon Termination of this Agreement, at the effective date of termination, all sums owed by either
Party to the other shall become immediately due and payable on such date, and all amounts paid to Dexcel under this Agreement up
to the date of termination shall be considered as non-refundable.

 

		14.5.4.	Upon termination of this Agreement for any other reason, each Party, at the written request of
the other Party, shall immediately return to the other Party all materials, reports, updates, documentation, written instructions,
notes, memoranda, discs or records or other documentation or physical matter of whatsoever nature or description provided by the
other Party, except in the event that such material is owned or licensed by such Party pursuant to the terms of this Agreement,
and provided that each Party shall be allowed to retain one copy for archival purposes.

 

		15.	Audit And Visitation Rights

 

Dexcel agrees to permit Kitov
to visit Dexcel's facilities from time to time, during normal business hours and upon reasonable notice to Dexcel, to monitor the
progress under the terms of this Agreement. A Reasonable time before a FDA visit in Dexcel's facilities, that is designated to
monitor Dexcel's facilities prior to approval of the Product (the ''FDA Visit''), Dexcel shall allow Kitov to audit Dexcel's facilities
to ensure their readiness for the FDA Visit.

 

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		16.	Indemnification and limitation of Liability

 

		16.1.	Subject to the provisions of sub-section ‎1616.4, Kitov
agrees to defend, indemnify and hold Dexcel and its Affiliates harmless from and against any and all demands, claims, actions,
causes of action, assessments, losses, damages, injuries, liabilities, costs and expenses (including, without limitation, reasonable
attorneys’ fees and expenses) of Dexcel and its Affiliates, directly related to, arising out of or resulting from

 

		16.1.1.	any breach or failure of or liability under any of the representations, warranties or covenants
of Kitov contained herein,

 

		16.1.2.	actual or asserted violations of any applicable law by Kitov or its Affiliates,

 

		16.1.3.	any negligent or wrongful act or omission to act by Kitov or its affiliates in any manner in connection
with performance hereunder.

 

		16.2.	Subject to the provisions of sub-sections ‎16‎16.4 and 16.5, Dexcel agrees
to defend, indemnify and hold Kitov and its Affiliates harmless from and against any and all demands, claims, actions, causes of
action, assessments, losses, damages, injuries, liabilities, costs and expenses (including, without limitation, reasonable attorneys’
fees and expenses) of Kitov and its Affiliates, directly related to, arising out of or resulting from:

 

		16.2.1.	any breach or failure of or liability under any of the representations, warranties and covenants
of Dexcel contained herein,

 

		16.2.2.	actual or asserted violations of any applicable law by Dexcel or any of its affiliates or representatives
and

 

		16.2.3.	any negligent or wrongful act or omission to act by Dexcel or its affiliates or representatives
in any manner in connection with performance of the Services hereunder.

 

		16.3.	A Party or any of its Affiliates (the “Indemnitee”) that intends to claim indemnification
under this Section ‎16 with respect to any third party claim or action shall promptly notify the other Party (the “Indemnitor”)
of any loss, claim, damage, or liability arising out of any third party claim or action in respect of which the Indemnitee intends
to claim such indemnification, and the Indemnitor shall assume the defense thereof with counsel of its own choosing; provided,
however, that an Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be paid by the Indemnitor
only, if representation of such Indemnitee by the counsel retained by the Indemnitor, in the opinion of an independent counsel
chosen by both parties, would be inappropriate due to actual or potential differing interests between such Indemnitee and any other
party represented by such counsel in such proceedings. An Indemnitee shall not be entitled to indemnification under this Section
16 if any settlement or compromise of a third party claim is effected by the Indemnitee without the consent of the Indemnitor,
which consent shall not be unreasonably withheld or delayed. An Indemnitee shall not be entitled to indemnification with respect
to any third party claim in an amount in excess of the amount which such third party has unequivocally, without other conditions
and in writing agreed with the Indemnitor it is willing to accept in settlement or compromise of any such third party claim. An
Indemnitor shall not enter into any settlement or compromise of any third party claim or consent to the entry of any judgment or
other order with respect to any claim which does not contain, as a part thereof, an unconditional release of the Indemnitee for
liability for all loss, cost or damage that may arise from such claim or which does contain any injunctive or other non-monetary
relief that might in any way interfere with the future conduct of business by the Indemnitee. The failure by the Indemnitee to
deliver notice to the Indemnitor within a reasonable time after the commencement of any such third party claim or action, if materially
prejudicial to the Indemnitor’s ability to defend such action, shall relieve such Indemnitor of any liability to the Indemnitee
under this Section ‎16. An Indemnitee, and its employees, agents and representatives, shall cooperate fully with the
Indemnitor and its legal representatives, at the Indemnitor’s expense for out-of-pocket costs, in the investigation of any
action, claim or liability covered by this indemnification.

 

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		16.4.	Neither Party shall be liable to the other Party's, indirect or consequential liabilities (including
loss of profits, loss of business, depletion of goodwill and similar losses). Subject to and without derogating with the limitation
of Dexcel's liability as stipulated in section 16.5, and for the avoidance of doubt, any damages actually incurred by a Party as
a result of a third party claim, are not excluded or limited under this Section ‎16 and shall not be considered as indirect
or consequential liabilities.

 

		16.5.	Notwithstanding anything to the contrary in this Agreement, Dexcel's liability for damages shall
in no event exceed the amounts received by Dexcel as consideration in accordance with the provisions of this agreement.

 

		16.6.	Dexcel shall maintain comprehensive general liability insurance, including product liability and
professional liability insurance, in such amounts as each customarily maintains for similar products and activities. Kitov shall
maintain comprehensive general liability insurance, including clinical trial insurance. At the time of entering this agreement,
each Party shall be fully insured and shall duly maintain such insurance during the term of this agreement and thereafter for so
long as it customarily maintains insurance for itself for similar products and activities. Each Party shall provide the other Party
with proof of such insurance upon request.

 

In the event that Kitov shall
perform the Full Bio by itself and (without Dexcel), prior to the commencement of the performance of the Full Bio, Kitov will provide
Dexcel an updated certificate of insurance proving Kitov's then existing insurance. Kitov shall update said insurance policies
such that the insured amount shall be at least USD 5,000,000 per insurance event. Kitov shall add Dexcel as additional insured
to such insurance (i.e. general liability and clinical trial insurance).

 

		17.	Force Majeure

 

		17.1.	If a Party asserts the occurrence of an event of Force Majeure as an excuse for failure to perform
such Party's obligations, then the obligations of the parties hereunder shall be suspended for so long as the Force Majeure event
renders performance of the Agreement impossible; provided, however, that (a) the nonperforming Party shall timely notify the other
Party in writing of the likelihood or actual occurrence of an event of Force Majeure by the nonperforming Party; (b) the nonperforming
Party must reasonably prove that it took all commercially reasonable steps to minimize delay or damages caused by such event; and
(c) the nonperforming Party substantially fulfilled all non-excused obligations, unless the other Party has notified the nonperforming
Party to the contrary.

 

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		17.2.	In the event that such event of Force Majeure continues for a period in excess of sixty (60) days,
the parties agree to undertake good faith discussions with a view to reaching some other mutually acceptable and reasonable arrangement
for alleviating the effects of such Force Majeure. In the event that the parties are unable to agree on such an arrangement, the
other Party shall be entitled to provide immediate written notice of termination to the nonperforming Party.

 

		18.	Miscellaneous. 

 

		18.1.	Either Party's failure or delay in enforcing any of the provisions of this Agreement shall not,
in any way, be construed as a waiver of any such provisions, or prevent either Party thereafter from enforcing each and every other
provision of this Agreement which were previously not enforced;

 

		18.2.	Notices given hereunder including any notifications and approvals pursuant to this Agreement and
any ancillary documents thereto, shall be made in writing and addressed to one of the qualified contact persons, detailed in the
SOW and shall be deemed to have been duly given on the date of personal delivery, on the date of postmark if mailed by certified
or registered mail, or on the date sent by facsimile upon transmission and electronic confirmation of receipt or (if transmitted
and received on a non-business day) on the first business day following transmission and electronic confirmation of receipt, addressed
as set forth above or such other address as either Party may designate to the other in accordance with the aforesaid procedure;

 

		18.3.	This Agreement, including its attachments, constitutes the entire agreement of the Parties hereto
with respect to the subject matters hereof, and supersedes all prior agreements and understandings between the Parties with respect
thereto.

 

		18.4.	In any contradiction between the terms and provisions of the SOW and the terms and provisions of
the RFP, the terms and provisions of the SOW shall prevail.

 

		18.5.	This Agreement shall not be amended, modified, or varied by any oral agreement or representation
other than by a written instrument executed by both Parties by their duly authorized representatives.

 

		18.6.	Neither this Agreement nor any of either Party's rights hereunder, may be assigned or otherwise
transferred by either Party without the prior written consent of the other Party, which consent shall not be unreasonably withheld
or delayed, provided, however, that in the event Kitov is acquired by or merged into a third party, such assignment of rights shall
be deemed to have been made to such third party. Any purported assignment in violation of the preceding sentence shall be void.
Any permitted assignee shall be deemed to have assumed all obligations of its assignor under this Agreement.

 

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		18.7.	If any provision of this Agreement is held invalid or unenforceable by any court of competent jurisdiction,
the other provisions of this Agreement will remain in full force and effect. Any provision of this Agreement held invalid or unenforceable
only in part or degree will remain in full force and effect to the extent not held invalid or unenforceable.

 

		18.8.	The Parties acknowledge that the injury that would be suffered by the other Party as a result of
a breach of the provisions of Sections 6 and 8 of this Agreement would be irreparable and that an award of monetary damages for
such a breach would be an inadequate remedy. Consequently, either Party has the right, in addition to any other rights it may have,
to obtain injunctive relief to restrain any breach or threatened breach or otherwise to specifically enforce any provisions of
Sections 6 and 9 of this Agreement, and such Party will not be obligated to post bond or other security in seeking such relief.

 

		18.9.	This Agreement shall be interpreted and enforced exclusively under the laws of the State of Israel,
without regard to the conflict of laws provisions thereof. The Parties submit to the exclusive jurisdiction of the competent courts
of Tel-Aviv in any dispute related to this Agreement without giving effect to choice of law rules. Notwithstanding the aforesaid,
the Parties shall endeavor in good faith to settle amicably any dispute which may arise between them under or in connection to
this Agreement.

 

		18.10.	This Agreement may be executed in one or more counterparts, each of which will be deemed to be
an original copy of this Agreement and all of which, when taken together, will be deemed to constitute one and the same Agreement.

 

	Dexcel Ltd.	 	Kitov Pharmaceuticals Holdings, Ltd.

 

	By:	/s/ Dan Oren	 	By:	/s/ Simcha Rock
	Name:	Dan Oren	 	Name:	Simcha Rock
	Title:	CEO	 	Title:	CFO
	Date:	March 31, 2014	 	Date:	April 1, 2014

  

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Annex A

 

Statement of Work of solid dosage
formulations [****] of Celecoxib and Amoloidpine
Besylate[****] 

 

API

 

		1.	APIs analytical methods development.

 

		1.1.	Allocate suppliers of the APIs.

		1.2.	Analytical methods development and validation or verification.

		1.3.	APIs Release tests.

 

Formulation Development

 

		2.	Compatibility (API-API and API-Excipeint)

(corresponding to points 1&t
2 in Kitov's RFP)

		1.1.	Compatibility of Celecoxib & Amoloidpine Besylate

		1.2.	Compatibility of each API & excipients

 

		3.	Development of formulation Prototypes of Celecoxib and Amoloidpine Besylate (the ''Prototypes'') (corresponding
to point 3 in Kitov's RFP).

		2.1.	Screening of various formulations.

		2.2.	Selection of the 2 formulation Prototypes to be developed under the Agreement (the ''Selected Prototypes'').

 

		4.	Prototypes' analytical methods development (including pre-validations)

Development of analytical methods for the formulation
Prototypes (in accordance with the ICH guidelines).

 

		5.	Release and stability studies on the Selected Prototypes.

		5.1.	Release tests on the Selected Prototypes.

		5.2.	Stability studies on the Selected Prototypes (Testing at the following time points: 0, 1, 3, 6 months accelerated, 0, 1, 3,
6, 9, 12 months intermediate, and 0, 1, 3, 6, 9, 12 months long term with 18 and 24 months optional ).

 

In the event Kitov decides to perform a Pilot Bio :
Pilot Bio Decision

 

Dexcel highly recommends performing
the Pilot Bio before the performance of the Full Bio.

 

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		6.	1st Pilot Bio-Studies on the Selected Prototypes.

 

2 pilot bio-studies (fast and fed conditions) on
the highest strength[****] :

 

	Pilot Studies	Strength	Study Design
	[****]	Single Centre, Open-Label, Randomized, Single-Dose, 3-Way Crossover, Pilot Bioequivalence Study, Comparing Two Test Formulations [****] with the Compotator Products (Celebrex [****] and Norvasc [****]) Given in Combination in Healthy Volunteers Under Fasting Conditions
	 	Single Centre, Open-Label, Randomized, Single-Dose, 3-Way Crossover, Pilot Bioequivalence Study, Comparing Two Test Formulations [****] with the Compotator Products (Celebrex [****] and Norvasc [****]) Given in Combination in Healthy Volunteers Under Fed Conditions

  

		7.	Reformulation (if required)

According to the results of the Pilot Bio, fine tuning
of the formulations may be necessary. This will be regarded as the "Adjusted Prototype/s".

 

		8.	Release and stability studies on the Adjusted Prototype/s.

8.1. Release tests on the adjusted Prototype.

8.2. Stability studies on the adjusted Prototype
(at least 1 month in accelerated conditions).

 

In the event Kitov decides to perform a Pilot Bio on
the Adjusted Prototypes: - 2nd Pilot Bio Decision

Dexcel highly recommends performing
the Pilot Bio before the performance of the Full Bio.

 

		9.	2nd Pilot Bio-Studies on the adjusted Prototype/s.

2 pilot bio-studies (fast and fed conditions) on
the highest strength ([****]):

 

	Pilot Studies	Strength	Study Design
	[****]	Single Centre, Open-Label, Randomized, Single-Dose, 3-Way Crossover, Pilot Bioequivalence Study, Comparing Two Test Formulations[****] with the Compotator Products (Celebrex [****] and Norvasc [****]) Given in Combination in Healthy Volunteers Under Fasting Conditions
	Single Centre, Open-Label, Randomized, Single-Dose, 3-Way Crossover, Pilot Bioequivalence Study, Comparing Two Test Formulations [****] with the Compotator Products (Celebrex [****] and Norvasc [****]) Given in Combination in Healthy Volunteers Under Fed Conditions

  

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Successful Pilot Bio → Pivotal batch manufacture
& Full Bio decision.

 

Pivotal (registration) batch manufacture, DOE, stability
testing and BE study. 

 

		10.	Design Of Experiment Studies (DOE) (corresponding to point 6 in Kitov's RFP).

Critical Material Attributes
(CMAs) and Critical Process Parameters (CPPs)

will be established using either full design of experiment,
or process range findings.

 

		11.	Pivotal batches manufacture (corresponding to point 4 in Kitov's RFP).

11.1. GMP manufacture of three (3) pivotal scale
(at least 100,000 units) for each of the [****] strengths [****]
equal to a total of [****] batches. API from two vendors for each
drug substance will be used in registration stability lot production.

 

11.2. Packaging of each batch, with two packaging
configurations that will be selected by Kitov and that have shown adequate stability results on pilot scale batches (sections 4&
7 hereinabove) additional packages will require additional fees.

 

		12.	Full validation of the analytical methods for the selected prototype ("Product") 

(corresponding
to point 5 in Kitov's RFP).

  

		13.	Release and stability studies for pivotal batches.

(corresponding to point 4 in Kitov's RFP)

 

Full release of all [****]
batches.

 

Stability studies according to the following:

 

		·	Samples will be stored at 40°C/75% RH , 30°C/65% RH and 25°C/60% RH.

		·	Testing at the following time points: 0, 1, 3, 6 months accelerated, 1, 3, 6, 9, 12 months intermediate, and 1, 3, 6, 9, 12,
18, 24, and 36 months long-term.

		·	Comparative RLD stability testing

		·	ICH- photostability and heat stress stability (Comparable to heat induced forced degradation except in final packaging. For
example, 50oC for two weeks and 70oC for one week to demonstrate temperature excursions during shipping/handling are
unlikely to have an adverse effect on product quality).

 

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		14.	Full Bio study on Pivotal batches 

Dexcel highly recommends on having a PIND meeting
with the FDA before the Full Bio study in order to understand what are the agency’s requirements from the BE studies.

 

The requirements should:

 

		·	No. of Full Bio studies required: 2 studies (Fasting and Fed on [****]
dose) using 24 - 60 healthy volunteers

 

	Pivotal Studies	[****]	Single Centre, Open-Label, Randomized, Single-Dose, 2-Way Crossover, Pivotal Bioequivalence Study, Comparing One Test Formulations [****] with the Compotator Products (Celebrex [****] and Norvasc [****]) Given in Combination in Healthy Volunteers Under Fasting Conditions.
	Single Centre, Open-Label, Randomized, Single-Dose, 2-Way Crossover, Pivotal Bioequivalence Study, Comparing One Test Formulations [****] with the Compotator Products(Celebrex [****] and Norvasc [****]) Given in Combination in Healthy Volunteers Under Fed Conditions

 

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Annex B

General Cost estimation regarding
the Pilot and Full Bio

 

Pilot Bio studies

 

The total estimated cost for the 4 Pilot
Bio studies (2 in the 1st pilot bio + 2 for the 2nd pilot bio) on the higher dosage [****]:
$1,004,000 (cost of each pilot study: $251,000).

  

Full Bio studies on pivotal batches

 

No. of Full Bio studies required:
2 (Fasting and Fed studies on the highest [****] dose).

 

Estimated cost for the Full Bio studies:
$1,450,000 (cost of each full bio study: $725,000)

 

For the avoidance of any doubt, and according
to Section ‎5.2 of the Agreement, the above-mentioned figures are only estimation of costs associated to the Pilot Bio studies
and the Full Bio. A formal quote will be presented to Kitov prior to each study. Dexcel shall charge Kitov such quoted cost+12.5%.

 

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Annex C

 

TIMETABLE 

 

	Milestone
 No.	 	Milestone	 	Time Frame	 	Comments
	 	 	Kick Off	 	 	 	 
	1	 	[****]	 	[****]months from Kick Off	 	 
	2	 	[****]	 	[****]months from Completion of Milestone 1	 	[****]
	3	 	[****]	 	[****]months  from Completion of Milestone 2	 	 
	4	 	[****]	 	[****]months  from Completion of Milestone 3	 	[****]
	5	 	[****]	 	[****]months  from Completion of Milestone 4	 	 
	6	 	[****]	 	[****]months  from Completion of Milestone 5	 	[****]

 

*According to Section 3.4 of the Agreement,
in the event that Dexcel shall need to repeat any development stage, not due to Dexcel’s misconduct or omission, the Timetable
shall be adjusted and deadlines shall be prolonged in accordance with the duration of the repeated stage of Development.

 

    	25EXHIBIT 10.2

 

 

 

Dated 04
February 2014

 

Kitov Pharmaceutical
Limited

 

AND

 

Java Clinical
Research Limited

 

Master Research
Services Agreement

Strictly
Confidential

 

    	 

    	 

    

 

THIS MASTER
SERVICES AGREEMENT (this “AGREEMENT”)

 

BETWEEN:

 

		(1)	Kitov
                                         Pharmaceuticals Limited (“Kitov”) a Company incorporated in Israel and
                                         whose principal place of business and resgistered address is at, 11 Bet Hadfus Street
                                         Jerusalem 95483, Israel.

		(2)	JAVA CLINICAL RESEARCH
LIMITED, a company incorporated in Ireland, registered number 311398, with registered office address 2 Grand Canal Square,
Dublin 2, Fitzwilliam Business Centre, 26/27 Upper Pembroke Street, Dublin 2 ("JAVA");

(each
a "Party" and together the "Parties").

 

RECITALS

 

		(A)	The
                                         Sponsor is concerned with the diagnosis, treatment and prevention of disease and clinical
                                         research for the improvement of healthcare. JAVA is in the business of providing research
                                         services; and

 

		(B)	The
                                         Sponsor and JAVA desire to enter into this Agreement to provide the terms and conditions
                                         upon which the Sponsor may engage JAVA from time-to-time to provide research services
                                         for individual projects by executing individual Work Orders (as defined below) specifying
                                         the details of the services and the related terms and conditions.

 

NOW, IT
IS HEREBY AGREED AS FOLLOWS in consideration of the mutual covenants contained herein:

 

		1.	DEFINITIONS

 

		1.1.	"Applicable
                                         Laws" shall mean all laws, rules and regulations including without limitation,
                                         Good Clinical Practice (“GCP”) that are applicable to the performance by
                                         JAVA of the Services under this Agreement.

 

		1.2.	"Change
                                         Order" shall have the meaning given to the term in Clause 2.3.

 

		1.3.	"Claims"
                                         shall mean all and any claims (whether successful or otherwise), loss, liability, damages
                                         and expenses, including reasonable attorneys' fees and expenses and legal costs.

 

		1.4.	"Confidential
                                         Information" shall mean all confidential and proprietary information, including
                                         without limitation, inventions, specifications, designs, know-how, trade secrets, inventions
                                         (including patent applications covering such inventions), data, information, and any
                                         improvements, modifications, derivations, or compilations thereto that is owned, licensed
                                         by or controlled by the disclosing Party; provided however, that Confidential Information
                                         shall not include any information which is:

 

		1.4.1.	already
                                         known to the receiving Party at the time of disclosure, as evidenced by such Party's
                                         written records, provided such information was not obtained directly or indirectly by
                                         the receiving Party from the disclosing Party pursuant to a confidentiality agreement;

 

		1.4.2.	publicly
                                         known prior to or after disclosure, through no default of the receiving Party;

 

		1.4.3.	disclosed
                                         in good faith to the receiving party by a third party, lawfully and contractually entitled
                                         to make such disclosure; or

 

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		1.4.4.	is
                                         independently discovered without the aid or application of the Confidential Information
                                         as shall be evidenced by the written records of the receiving Party.

 

		1.5.	"Effective
                                         Date" shall mean the date of this Agreement.

 

		1.6.	“GCP”
                                         shall mean the ICH Harmonised Tripartite Guidelines for Good Clinical Practice, and
                                         any subsequent versions thereof.

 

		1.7.	"Intellectual
                                         Property Rights" shall mean all patents, patent applications, copyrights, copyright
                                         applications, trademarks, trade secrets, know-how and other intellectual property rights.

 

		1.8.	"Materials"
                                         shall have the meaning given to the term in Clause 3.1.

 

		1.9.	"Project"
                                         shall have the meaning given to the term in Clause 2.1.1.

 

		1.10.	"Services"
                                         shall have the meaning given to the term in Clause 2.2.2.

 

		1.11.	"Term"
                                         shall have the meaning given to the term in Clause 12.1.

 

		1.12.	"Work
                                         Orders" shall have the meaning given to the term in Clause 2.2.1.

 

		2.	SCOPE
                                         OF THE AGREEMENT, WORK ORDERS AND CHANGE ORDERS

 

		2.1.	Scope
                                         of Agreement and Performance of the Services

 

		2.1.1.	This
                                         Master Agreement allows the Parties to contract for multiple projects and other services
                                         requested by the Sponsor and agreed by JAVA (each a "Project") through
                                         the issuance of multiple Work Orders in accordance with the terms of this Agreement.

 

		2.2.	Work
                                         Orders

 

		2.2.1.	The
                                         specific details of each Project under this Agreement shall be separately negotiated
                                         and agreed by the Parties and specified in writing in substantially the form attached
                                         hereto in Appendix 1 (each a "Work Order").

 

		2.2.2.	Each
                                         Work Order will include details of the services to be provided by JAVA (“Services”),
                                         scope of work, timelines, budget and payment schedule.

 

		2.2.3.	Each
                                         Work Order, upon execution, shall be incorporated into this Agreement and shall be subject
                                         to all of the terms and conditions of this Agreement, in addition to the specific details
                                         set forth in the Work Order.

 

		2.2.4.	To
                                         the extent any terms or provisions of a Work Order conflict with the terms and provisions
                                         of this Agreement, the terms and provisions of this Agreement shall prevail, except to
                                         the extent that the applicable Work Order expressly and specifically states an intent
                                         to supersede the Agreement on a specific matter and such Work Order is signed by both
                                         Parties.

 

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		2.3.	Change
                                         Orders

 

		2.3.1	Any
                                         material change in the details of a Work Order, or the assumptions upon which the Work
                                         Order is based, shall require written amendment to the Work Order in substantially the
                                         form attached hereto in Appendix 2 (a "Change Order").

 

		2.3.2	Each
                                         Change Order shall detail the requested changes to the applicable task, responsibility,
                                         duty, budget, timeline or other matter.

 

		2.3.3	The
                                         Change Order will become effective upon the execution of the Change Order by both Parties.

 

		2.3.4	Both
                                         Parties agree to act in good faith and promptly when considering a Change Order requested
                                         by the other Party.

 

		2.4	Services

 

		2.4.1	JAVA
                                         shall perform the Services in good faith, with due care and skill, in accordance with
                                         the terms of this Agreement, the reasonable instructions of the Sponsor, and with all
                                         Applicable Laws.

 

		2.4.2	The
                                         Sponsor agrees to cooperate with JAVA and provide JAVA with such information and assistance
                                         as JAVA may reasonably require in order to enable or facilitate JAVA duly and punctually
                                         to comply with its obligations under this Agreement and each Work Order.

 

		2.4.3	Except
                                         as expressly stated in this Agreement, all warranties, conditions and terms, whether
                                         express or implied by statute, common law or otherwise (including but not limited to
                                         fitness for purpose and suitability) are hereby excluded to the extent permitted by law.

 

		3.	MATERIALS

 

		3.1	The
                                         Sponsor shall provide JAVA with materials required for the purpose of performing the
                                         Projects (the "Materials").

 

		3.2	JAVA
                                         undertakes that it shall not:

 

		3.2.1	use
                                         the Materials other than for the purpose of performing the Projects;

 

		3.2.2	make
                                         the Materials available to any third party;

 

		3.2.3	allow
                                         access to the Materials by any of its employees or students except those who are directly
                                         involved in performing the Projects;

 

		3.2.4	make
                                         any commercial use of the Materials or any composition made using the Materials; or

 

		3.2.5	analyse
                                         or otherwise attempt to determine the composition of the Materials.

 

		3.3	The
                                         Sponsor warrants that all Materials shall be fit for purpose as envisaged by this Agreement
                                         and that all such Materials may be lawfully used in conducting the Services.

 

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		3.4	Upon
                                         termination of the Agreement, any unused Materials shall, at the Sponsor's option, either
                                         be destroyed by JAVA or returned to the Sponsor, at the Sponsor’s expense.

 

		4.	PAYMENT
                                         OF FEES AND EXPENSES

 

		4.1.	The
                                         fees to be charged by JAVA for each Project performed hereunder (the "Service
                                         Fees") shall be set out in the relevant Work Order.

 

		4.2.	In
                                         consideration of the supply of Services for each Project, the Sponsor shall pay JAVA
                                         the Services Fees and reasonable and necessary vouched expenses incurred in the performance
                                         of the Services as set out in the Work Order on the following basis:

 

		4.2.1.	the
                                         Service Fees and the total cost of each Project and an estimate of the total expenses
                                         to be incurred in relation thereto (the "Total Project Cost") shall
                                         be set out in the relevant Work Order; and

 

		4.2.2.	in
                                         no event shall the Sponsor be required to pay any amount exceeding the Total Project
                                         Cost unless otherwise agreed in writing by both Parties by Change Order(s) (as specified
                                         in Clause 2.3 above).

 

		4.2.3.	Invoices
                                         for fees and expenses shall be issued on a monthly basis and Sponsor shall pay each invoice
                                         within 30 days of receipt.

 

		4.3.	All
                                         sums referred to in each Work Order shall be exclusive of Value Added Tax (VAT). The
                                         Sponsor shall pay all VAT at the rate and in the manner prescribed by law from time to
                                         time.

 

		5.	PERSONNEL

 

		5.1.	JAVA
                                         shall be responsible for ensuring that all personnel which it assigns to each Project
                                         are fully qualified by education, training and experience to perform their respective
                                         obligations under this Agreement and the relevant Work Order ("JAVA Personnel").

 

		5.2.	JAVA
                                         shall remain fully liable for the performance by all JAVA Personnel of JAVA’s obligations
                                         hereunder.

 

		5.3.	The
                                         Sponsor shall be responsible for ensuring that all personnel which it assigns to each
                                         Project (“Sponsor Personnel") are fully qualified by education, training
                                         and experience to perform their respective obligations under this Agreement and the relevant
                                         Work Order.

 

		5.4.	The
                                         Sponsor shall remain fully liable for the performance by all Sponsor Personnel of the
                                         Sponsor’s obligations hereunder.

 

		6.	CONFIDENTIAL
                                         INFORMATION/ANNOUNCEMENTS

 

		6.1.	During
                                         the Term and for a period of 7 (seven) years thereafter, each Party undertakes to maintain
                                         as confidential all Confidential Information disclosed by the other Party to it (the
                                         “Confidential Information") before or after the date of this Agreement.

 

		6.2.	Each
                                         Party shall not without the other Party’s prior written consent:

 

		6.2.1.	use
                                         the Confidential Information for any purpose other than the proper performance of the
                                         Services; or

 

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		6.2.2.	disclose
                                         the Confidential Information to any other person, save those employees, representatives
                                         and agents as may be strictly necessary in order to perform the Services, and provided
                                         that JAVA first ensures that such person is under a duty of confidentiality to JAVA to
                                         protect the Sponsor’s Confidential Information on no less onerous terms than as
                                         set out in this Clause 6.

 

		6.3.	Notwithstanding
                                         the provisions of this Clause 6, Confidential Information may be disclosed to the extent
                                         required by law or as ordered by a court or other regulatory body having competent jurisdiction,
                                         provided that if a Party becomes legally required to disclose any Confidential Information
                                         hereunder, the receiving Party shall give the disclosing Party prompt notice of such
                                         requirement to enable the disclosing Party to seek a protective order or other appropriate
                                         remedy concerning any such disclosure. The receiving Party shall fully co-operate with
                                         the disclosing Party in connection with the disclosing Party’s efforts to obtain
                                         any such order or other remedy. If any such order or other remedy does not fully preclude
                                         disclosure, the receiving Party shall make such disclosure only to the extent that such
                                         disclosure is legally required. JAVA acknowledges that Sponsor is a publicly traded corporation
                                         and is subject to certain reporting obligations under any applicable laws, and hence
                                         JAVA agrees Sponsor has a right to make such publications as required under any such
                                         applicable laws.

 

		6.4.	JAVA
                                         agrees to maintain, as strictly confidential the subject matter of this Agreement and
                                         the fact that the Parties have entered into this Agreement.

 

		6.5.	Upon
                                         termination or expiration of this Agreement, JAVA shall promptly return, or at the Sponsor's
                                         request, destroy all of the Sponsor's Confidential Information.

 

		6.6.	Each
                                         Party shall be entitled to provide a copy of this Agreement (and any related documents)
                                         to a potential third-party acquirer, investor, or other commercialisation partner, provided
                                         that the relevant third party has entered into a confidentiality agreement with the disclosing
                                         Party on terms equivalent hereto.

 

		6.7.	In
                                         relation to all personal data (as defined in the Data Protection Acts 1988 and 2003 as
                                         amended), the Parties shall at all times comply with the Data Protection Acts 1988 and
                                         2003 as amended, and the Parties shall only undertake processing of personal data reasonably
                                         required in connection with the Services and in compliance with law.

 

		6.8.	JAVA
                                         acknowledges that information provided by it to the Sponsor may be the subject of a request
                                         under the Freedom of Information Act, 1997 (“FOI”), as amended. If a request
                                         is made under FOI, the Sponsor shall give JAVA prompt notice of such request to enable
                                         JAVA to seek a protective order or other appropriate remedy concerning any such disclosure.
                                         The Sponsor shall fully co-operate with JAVA in connection with JAVA's efforts to obtain
                                         any such order or other remedy. If any such order or other remedy does not fully preclude
                                         disclosure, the Sponsor shall make such disclosure only to the extent that such disclosure
                                         is legally required.

 

		7.	PROJECT
                                         RESULTS, INTELLECTUAL PROPERTY RIGHTS AND REPORTS

 

		7.1.	JAVA
                                         agrees that:

 

		7.1.1.	all
                                         data, materials and reports, and all rights therein (the "Project Results");
                                         and

 

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		7.1.2.	all
                                         Intellectual Property Rights (the "Project IP");

 

conceived,
created, developed and or otherwise invented as a result of performing the Services shall be owned exclusively by the Sponsor.

 

		7.2.	JAVA
                                         shall assign to the Sponsor all right, title and interest in and to all Project Results
                                         and Project IP and further agrees to execute all such documents, make such applications,
                                         give such assistance and do such acts and things as may be necessary or desirable to
                                         vest in and register or obtain letters patent in the name of the Sponsor and otherwise
                                         to protect and maintain such Project Results and Project IP.

 

		7.3.	JAVA
                                         shall promptly disclose all Project Results and Project IP to the Sponsor and provide
                                         copies of all documents relating to same to the Sponsor at its request at any time during
                                         or after the Term.

 

		7.4.	JAVA
                                         has informed the Sponsor that JAVA possesses certain processes, know-how, trade secrets
                                         and other intellectual assets relating to applicable processing, laboratory analyses,
                                         analytical methods, procedures and techniques, computer technical expertise and software
                                         which have been developed by JAVA prior to the Effective Date and which the Sponsor understands
                                         are applied and utilised by JAVA on an ongoing basis in providing services to clients
                                         (collectively "JAVA Property"). JAVA and the Sponsor agree that the
                                         JAVA Property or any improvements relating to the JAVA Property developed by JAVA pursuant
                                         to this Agreement shall be owned exclusively by JAVA.

 

		7.5.	Subject
                                         to Clause 11, JAVA shall not, without the prior written consent of the Sponsor, disclose
                                         or publish any Project Results or Project IP, or use any Project Results or Project IP
                                         for any purpose other than to perform its obligations hereunder.

 

		7.6.	Reports
                                         and Record Retention

 

		7.6.1.	JAVA
                                         will provide reports in writing on the Services performed (each a "Report")
                                         on a regular basis.

 

		7.6.2.	If
                                         for any reason any Report is not to the satisfaction of the Sponsor acting reasonably,
                                         JAVA shall re-produce such Report to the satisfaction of the Sponsor.

 

		7.6.3.	JAVA
                                         shall maintain all books, records, data, reports, pictures and other documents (both
                                         in electronic and paper form) relating to the Services (the "Records")
                                         for the maximum period required by law (the "Retention Period"). The
                                         Parties agree that all Records shall constitute Sponsor Confidential Information and
                                         the provisions of Clause 6 (Confidentiality) shall apply to all such Records. Upon expiry
                                         of the Retention Period, JAVA shall provide all original Records (both in electronic
                                         and paper form), and all copies thereof, to the Sponsor.

 

		8.	SOPS/REGULATORY
                                         INSPECTIONS

 

		8.1.	Upon
                                         the written request of the Sponsor, JAVA shall provide the Sponsor with a list of all
                                         of JAVA's standard operating procedures ("SOPs") relevant to the Services
                                         to be performed by JAVA hereunder.

 

		8.2.	At
                                         any time during the Term, JAVA shall allow the Sponsor to review all such SOPs, including
                                         any updates thereof, on JAVA's premises.

 

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		8.3.	If
                                         any regulatory agency requests to inspect any books, records, or facilities of JAVA,
                                         relating to the Services, JAVA shall immediately notify the Sponsor (within 1 business
                                         day) and shall promptly notify the Sponsor of the outcome of any such inspection within
                                         5 business days of such outcome becoming known to Service Provider.

 

		9.	REPRESENTATIONS,
                                         WARRANTIES AND COVENANTS

 

		9.1.	JAVA
                                         represents and warrants to the Sponsor that the performance by JAVA of its obligations
                                         hereunder are not inconsistent with and will not breach any third-party obligations.

 

		9.2.	JAVA
                                         covenants that it shall have agreements in place with all servants and agents, that impose
                                         confidentiality obligations on such servants and agents, vest in JAVA any rights such
                                         servants and agents might otherwise have in any Project Results or Project IP, permit
                                         JAVA to assign all such rights to the Sponsor, and otherwise enable JAVA to comply with
                                         the terms of this Agreement and any Work Order hereunder, including without limitation
                                         any timeline set out therein.

 

		10.	INDEMNIFICATION/LIABILITY

 

		10.1.	The
                                         Sponsor shall indemnify and hold harmless JAVA and its employees, agents, officers and
                                         directors from and against any Claims incurred or sustained by JAVA arising out of the
                                         Services performed under this Agreement, except to the extent such Claims arise out of,
                                         or are connected with any:

 

		10.1.1.	breach
                                         of any representation, covenant, warranty or obligation by JAVA under this Agreement;
                                         or

 

		10.1.2.	negligent
                                         act or omission or wilful misconduct on the part of JAVA or any of its agents or employees
                                         in the performance of this Agreement.

 

		10.2.	JAVA
                                         shall indemnify and hold harmless the Sponsor and their respective employees, agents,
                                         officers and directors from and against any Claims incurred or sustained by the Sponsor
                                         arising out of or in connection with any:

 

		10.2.1.	breach
                                         of any representation, covenant, warranty or obligation by JAVA under this Agreement;
                                         or

 

		10.2.2.	negligent
                                         act or omission or wilful misconduct on the part of JAVA or any of its respective employees,
                                         agents, officers and directors in the performance of this Agreement.

 

		10.3.	The
                                         Party seeking an indemnity shall:

 

		10.3.1.	fully
                                         and promptly notify the other Party of any claim or proceedings, or threatened claim
                                         or proceedings;

 

		10.3.2.	permit
                                         the indemnifying Party to take full control of such claim or proceedings, with counsel
                                         of the indemnifying Party's choice, provided that the indemnifying Party shall reasonably
                                         and regularly consult with the Party seeking to be indemnified in relation to the progress
                                         and status of such claim or proceedings;

 

		10.3.3.	co-operate
                                         in the investigation and defence of such claim or proceedings; and

 

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		10.3.4.	take
                                         all reasonable steps to mitigate any loss or liability in respect of any such claim or
                                         proceedings.

 

Neither
the indemnifying Party nor the Party seeking to be indemnified shall acknowledge the validity of, compromise or otherwise settle
any Claim without the prior written consent of the other, which shall not be unreasonably withheld.

 

The
Parties agree that the aggregate liability of either party to the other party under or in connection with this Agreement shall
in no event exceed the total Service Fees paid by the Sponsor to JAVA under this Agreement, provided however, that this limitation
to each other shall not apply to the indemenities set forth in 10.1 and 10.2 hereunder .

 

		10.4.	NOTWITHSTANDING
                                         ANYTHING TO THE CONTRARY IN THIS AGREEMENT, THE SPONSOR AND JAVA SHALL NOT BE LIABLE
                                         TO THE OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR
                                         ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY CONSEQUENTIAL,
                                         SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR LOSS OF CURRENT OR FUTURE
                                         PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND WHETHER OCCASIONED BY THE NEGLIGENCE
                                         OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES OR AGENTS OR OTHERWISE.

 

		10.5.	Nothing
                                         in this Agreement shall limit the liability of either Party for fraud, or limit the liability
                                         of either Party to any third party under applicable laws where any act or omission of
                                         either Party results in death or personal injury.

 

		10.6.	Insurance
                                         

 

JAVA
shall furnish certificates of insurance evidencing the required insurance policies to the Sponsor as soon as practicable after
the Effective Date and within 30 days after renewal of such policies.

 

		11.	PUBLICATION

 

		11.1.	It
                                         is acknowledged and agreed by JAVA that:

 

		11.1.1.	publication
                                         of the Project Results and/or Project IP in whole or in part shall be within the sole
                                         and absolute discretion of the Sponsor;

 

		11.1.2.	JAVA
                                         shall not publish or refer to any Project Results and/or Project IP, in whole or in part,
                                         without the prior written consent of the Sponsor; and

 

		11.1.3.	JAVA
                                         will not use the Sponsor’s name in connection with any publication or promotion
                                         without the Sponsor’s prior written consent.

 

		11.2.	In
                                         the event that such consent is given, prior to publication or communication of any Project
                                         Results and/or Project IP by JAVA, JAVA shall provide to the Sponsor, for its review
                                         and comment, a copy of the relevant abstract, presentation, or paper 30 days before such
                                         abstract, presentation, or paper is submitted for publication.

 

		11.3.	No
                                         release of such abstract, presentation, or paper shall be permitted without the prior
                                         written consent of the Sponsor.

 

		11.4.	The
                                         provisions of this Clause 11 also apply to any amendments that are subsequently requested
                                         by referees or journal editors.

 

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		12.	TERM
                                         and TERMINATION

 

		12.1.	This
                                         Agreement shall commence on the Effective Date and shall continue until terminated by
                                         either Party in accordance with this Clause 12 (the "Term").

 

		12.2.	This
                                         Agreement or any Work Order may be terminated without cause by either Party at any time
                                         during the term of the Agreement on sixty (60) days prior written notice to the other
                                         Party. The written termination shall identify whether this Agreement or a specific Work
                                         Order or Work Orders are being terminated.

 

		12.3.	In
                                         addition to the rights of termination provided for elsewhere in this Agreement, each
                                         Party shall be entitled forthwith to terminate this Agreement by written notice to the
                                         other Party if:

 

		12.3.1.	either
                                         Party commits any material breach of any provisions of this Agreement, and in the case
                                         of a breach capable of remedy, fails to cure the same within 30 days after receipt of
                                         a written notice giving full particulars of the breach and requiring it to be cured;
                                         or

 

		12.3.2.	either
                                         Party goes into liquidation (except for the purposes of amalgamation or reconstruction
                                         and in such manner that the company resulting therefrom effectively agrees to be bound
                                         by or assume the obligations imposed on such party under this Agreement); or

 

		12.3.3.	an
                                         encumbrancer takes possession or a receiver is appointed over any of the property or
                                         assets of either Party; or

 

		12.3.4.	a
                                         Party becomes unable to pay its debts as and when they fall due or is deemed to be unable
                                         to pay its debts as they fall due; or

 

		12.3.5.	any
                                         proceedings are filed or commenced by any Party under bankruptcy, insolvency or debtor
                                         relief laws.

 

		12.4.	Upon
                                         receipt of a termination notice from the Sponsor, JAVA shall cease performing any work
                                         not necessary for the orderly close out of the affected Projects or for the fulfilment
                                         of regulatory requirements.

 

		12.5.	In
                                         the event of termination of this Agreement or any Work Order, each Party will co-operate
                                         in good faith with the other Party to wind-down and terminate or transition, at Sponsors 
                                         discretion, to another service provider, any Services then in progress that are affected
                                         by such termination and will perform such additional acts as are reasonably necessary
                                         in order to effect such wind-down or transition of the Services.  JAVA will provide
                                         to SPONSOR within forty-five (45) days following any Work Order termination date, an
                                         accounting for all Services performed together with reasonable supporting documentation. 
                                         SPONSOR will promptly review such accounting and will notify JAVA in writing of its approval
                                         or will notify CRO of any disputed amounts.  SPONSOR will pay CRO within 30 days
                                         after receipt of the approved accounting or upon mutual agreement of the final amount
                                         due for: (1) all unpaid and undisputed amounts for Services rendered and expenditures
                                         made by JAVA in accordance with this Agreement and the applicable Work Order prior to
                                         the Termination Date; and (2) expenses resulting from reasonable non-cancellable obligations
                                         that JAVA properly incurred for the Services in accordance with a Work Order prior to
                                         receipt of notice of termination and which JAVA used commercially reasonable efforts
                                         to cancel after receipt of notice of termination.

 

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		12.6.	Upon
                                         the termination of this Agreement or any Work Order, JAVA shall deliver to the Sponsor
                                         all Confidential Information and Materials provided by the Sponsor to JAVA for the conduct
                                         of Services under the terminated Work Orders, and JAVA shall also deliver to the Sponsor
                                         all Project IP, Project Results and any other data, information and documentation produced
                                         as the result of Services performed by JAVA under the terminated Work Orders.

 

		13.	MISCELLANEOUS

 

		13.1.	This
                                         Agreement shall be governed by and construed in accordance with Irish laws and, subject
                                         to Clauses 13.2 and 13.3, the Parties submit to the exclusive jurisdiction of the Irish
                                         courts.

 

		13.2.	Resolution
                                         of Disputes: The Parties shall attempt in good faith to resolve promptly any dispute
                                         arising out of or relating to this Agreement by negotiation. If the matter cannot be
                                         resolved in the normal course of business either Party may give the other Party written
                                         notice of any such dispute not resolved, after which the dispute shall be referred to
                                         more senior executives of both Parties, who shall likewise attempt to resolve the dispute.

 

		13.3.	If
                                         the Parties cannot resolve the dispute or difference by referral to a senior representative
                                         of each Party, then within 15 days from the date of such meeting of the senior representatives,
                                         the matter shall be referred to a mediator to be agreed upon by Parties or, failing such
                                         agreement, shall be appointed on the application of either one of the Parties to the
                                         President of the Law Society of England and Wales. The Parties shall use reasonable efforts
                                         to resolve any dispute by mediation for a period of 60 days.

 

		13.4.	No
                                         waiver of any right under this Agreement shall be deemed effective unless contained in
                                         a written document signed by the Party charged with such waiver, and no waiver of any
                                         breach or failure to perform shall be deemed to be a waiver of any future breach or failure
                                         to perform or of any other right arising under this Agreement.

 

		13.5.	Neither
                                         Party to this Agreement shall be liable for delay or failure in the performance of any
                                         of its obligations hereunder to the extent such delay or failure results from causes
                                         beyond its reasonable control, including, without limitation, acts of God, fires, strikes,
                                         acts of war, or intervention of a government authority ("Force Majeure"),
                                         but any such delay or failure shall be remedied by such Party as soon as practicable.

 

		13.6.	JAVA
                                         shall not subcontract with a third party to perform the Services without the prior written
                                         consent of the Sponsor.

 

		13.7.	JAVA
                                         shall not be entitled to assign this Agreement to a third party, without the prior written
                                         consent of the Sponsor, which shall not be unreasonably withheld.

 

		13.8.	This
                                         Agreement shall be binding upon and inure to the benefit of the Parties hereto and their
                                         respective successors and permitted assigns.

 

		13.9.	Nothing
                                         contained in this Agreement is intended or is to be construed to constitute JAVA and
                                         the Sponsor as partners or members of a joint venture. None of the Parties hereto shall
                                         have any express or implied right or authority to assume or create any obligations on
                                         behalf of or in the name of the other Party or to bind the other Party to any contract,
                                         agreement or undertaking with any third party.

 

    	11

    	 

    

 

		13.10.	No
                                         amendment, modification or addition hereto shall be effective or binding on any Party
                                         unless set forth in writing and executed by a duly authorised representative of each
                                         of the Parties.

 

		13.11.	Any
                                         notice to be given under this Agreement shall be sent in writing in writing by recognized
                                         courier or registered mail to each of the Parties stated in this Agreement, in the Sponsor’s
                                         case to to Mr. Simcha Rock, Kitov Pharmaceuticals, Bet Hadfus 11 Jerusalem, or
                                         to such other address(es) as may from time to time be notified by any of the Parties,
                                         in the Sponsor’s case by the office of Corporate and Legal Affairs, to the others
                                         hereunder.

 

		13.12.	Any
                                         notice sent by overnight courier or registered mail shall be deemed to have been delivered
                                         upon receipt by the addressee.

 

		13.13.	If
                                         any provision in this Agreement is agreed by the Parties to be, or is deemed to be, or
                                         becomes invalid, illegal, void or unenforceable under any law that is applicable hereto:-

 

		13.13.1.	such
                                         provision will be deemed to be deleted, and the Parties shall promptly meet and negotiate
                                         in good faith a valid and enforceable replacement for the severed provision which replacement
                                         shall be designed to achieve as nearly as possible the same commercial objective as the
                                         original; and

 

		13.13.2.	the validity, legality and
enforceability of the remaining provisions of this Agreement shall not be impaired or affected in any way.

 

		13.14.	This
                                         Agreement sets forth all of the agreements and understandings between the Parties with
                                         respect to the subject matter hereof, and supersedes and terminates all prior agreements
                                         and understandings between the Parties with respect to the subject matter hereof.

 

		13.15.	At
                                         the request of any of the Parties, the other Party shall (and shall use reasonable efforts
                                         to procure that any other necessary third parties shall) execute and do all such documents,
                                         acts and things as may reasonably be required subsequent to the signing of this Agreement
                                         for assuring to or vesting in the requesting Party the full benefit of the terms hereof.

 

		13.16.	The
                                         provisions of Clauses 1, 6, 7, 9, 10, 11, 12, and 13 shall survive the termination of
                                         this Agreement or any Work Order.

 

		13.17.	This
                                         Agreement may be executed in any number of counterparts, each of which when so executed
                                         shall be deemed to be an original and all of which when taken together shall constitute
                                         this Agreement.

 

    	12

    	 

    

 

IN WITNESS
WHEREOF, the Parties hereto have executed this Agreement.

 

	SIGNED by	 /s/
    Simcha Rock 	 

Chief Financial
Officer

 

for and on
behalf of

KITOV PHARMACEUTICALS
LTD (“Kitov”)

 

DATE: February
9, 2014

 

	SIGNED by	 /s/
    Ruth Nullen 	 

(Managing Director)

 

for and on
behalf of

JAVA CLINICAL
RESEARCH LIMITED 

 

DATE: February
6, 2014

 

    	13

    	 

    

 

APPENDIX
1

WORK ORDER
NO 1

 

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

 

BETWEEN

 

		(1)	Kitov
                                         Pharmaceuticals Limited (“Kitov”) Company incorporated in Israel whose
                                         registered address and principal place of business is at, 11 Bet Hadfus Street, Jerusalem,
                                         Israel.

("Sponsor");
and

 

		(2)	JAVA
                                         CLINICAL RESEARCH LIMITED, a company incorporated in Ireland, registered number 311398,
                                         with registered office address 2 Grand Canal Square, Dublin 2, whose principal place
                                         of business is at Fitzwilliam Business Centre, 26/27 Upper Pembroke Street, Dublin 2
                                         ("JAVA")

 

WHEREAS

 

		A.	The
                                         Sponsor and JAVA are bound by the terms of the Master Services Agreement dated 04 February
                                         2014 between the Sponsor and JAVA (the "Master Services Agreement").

 

The
Sponsor and JAVA wish to set out the specific details of services to be provided by JAVA in respect of A Prospective Randomized
Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy  and Safety
of Amlodipine in Subjects with Hypertension Requiring Antihypertensive Therapy

 

(the
"Project").

 

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
Scope of Services

Schedule 2
Timelines

Schedule 3
Budget and Payment Schedule

Schedule 4
Personnel / Contacts for Notices and Payments

Schedule 5
Protocol

 

		2.	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 the Sponsor 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.

 

    	14

    	 

    

 

SIGNED
BY

 

KITOV PHARMACEUTICALS
LIMITED

 

Signature:  /s/
Simcha Rock     

 

By:       
Simcha Rock                     

(Print
Name)

Title:
          Chief Financial Officer      

 

Date:
         February 9, 2014       

 

JAVA
CLINICAL RESEARCH LIMITED

 

Signature:   /s/
Ruth Nullen       

 

By:        Ruth
Nullen     

(Print
Name)

Title:
Managing Directoe         

 

Date:
    February 6, 2014     

 

    	15

    	 

    

 

SCHEDULE
1: SCOPE OF SERVICES

 

    	16

    	 

    

 

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

 

PROTOCOL
NO.: K-302-03-01

 

Proposed
Allocation of Sponsor - Java- Duties and Functions

 

04
February 2014

 

		I.	Regulatory
                                         and Ethics

 

		II.	Investigator
                                         Relations

 

		III.	IMP
                                         Supplies

 

		IV.	Study
                                         Documentation

 

		V.	Relationship
                                         between Sponsor& Java

 

		VI.	Relationship
                                         with other subcontractors

 

		VII.	Monitor
                                         Activities of Clinical Sites

 

		VIII.	Medical
                                         and coherence review of the CRF following retrieval from the site

 

		IX.	Serious
                                         Adverse Events follow up and reporting

 

		X.	Data
                                         entry, Data Management & Coding

 

		XI.	Statistical
                                         Analysis

 

		XII.	Clinical
                                         Study Report

 

		XIII.	XIV
                                         Medical Monitoring

 

		XIV.	Quality
                                         Assurance 

 

    	17

    	 

    

 

table
of responsibilities: E = Execute; A = Assist; R = Review

 

*
= Subcontracted by Java to a third party Vendor

 

#
= Subcontracted by SPONSOR to a third party Vendor

 

	 	 	Sponsor	 	JAVA
	I              Regulatory
    & Ethics	 	 	 	 
	1.    Provision of all supporting IMP documentation for CTA  submission to IMB and MHRA.	 	E	 	R
	2.    Completion
    of EudraCT Form, compilation of supporting documents (on receipt from relevant parties) into required electronic format for
    submission of Clinical Trial Application to IMB and MHRA, plus submission of responses to any queries raised during review
    period	 	 	 	E
	3.    Submission
    of CTA to National Ethics Committees in Republic and Northern Ireland plus submission of responses to any queries raised during
    review period	 	 	 	E
	4.    Providing
    Sponsor with the final answer given by IMB. MHRA and Ethics Committees	 	 	 	E
	II          Investigator
    Relations	 	 	 	 
	A.
     Selection	 	 	 	 
	1.    Definition
    of investigator selection criteria	 	E	 	 
	2.    Proposal
    of potential investigators and national coordinator	 	 	 	E
	3.    Organization
    of site assessment visits to evaluate the interest and suitability of the centers to participate in the study.	 	 	 	E
	4.    Approval
    of selected investigators	 	A	 	E
	5.    Organization
    of pre-trial visits with all investigators to evaluate the capability of the centers to recruit patients within the time frame,
    advise them of the study requirement and procedures in preparation for Site Initiation	 	 	 	E

 

    	18

    	 

    

 

	 	 	Sponsor	 	JAVA
	B
    Investigator fees	 	 	 	 
	1.    Proposal
    of investigator fees and payment schedule for each involved country	 	A	 	E
	2.    Proposal
    and negotiation of the fees to the investigators	 	 	 	E
	3.    Approval
    of final investigator fees	 	E	 	 
	4.    Management
    of payment of investigator fees and issue of invoices to Sponsor	 	 	 	E
	C.
    Agreement with investigators/institutions	 	 	 	 
	1.    Issue
    of Confidentiality Agreements to be signed by investigators	 	 	 	E
	2.    Identification
    of all the agreements to be obtained before study start	 	A	 	E
	3.    Drawing
    up of all agreements	 	A	 	E
	4.    Submission
    of the agreements to the investigators/institutions for approval and signature	 	 	 	E
	5.    Signature
    of the agreements	 	E	 	A
	6.    Collection
    of specific FDA  documentation  requirements such as 1572 forms as requested by Sponsor	 	R 	 	E
	III        IMP
    Supplies	 	 	 	 
	 	 	 	 	 
	A.
Randomization/allocation of treatments	 	 	 	 
	1.    Programming,
    development of a randomisation list	 	E#	 	 
	2.    Issue
    of decoding envelopes to be sent to investigators for decoding in case of medical emergency	 	E#	 	 
	3.    Allocation
    of treatments through a Central Randomisation system	 	E#	 	 
	4.    Shipment
    of initial  treatment blocks  of IMP to site	 	E#	 	 
	5.    Approval
     of additional reorders form sitesite 	 	R	 	E
	6.    Shipment
    of additional reorders to site	 	E#	 	 

 

    	19

    	 

    

 

	 	 	Sponsor	 	JAVA
	B.
    Management of trial drug supplies	 	 	 	 
	1.    Manufacturing
    of drug supplies (or subcontracting)	 	 E#	 	 
	2.    Management
    of subcontracting for packaging, labeling and shipment to sites	 	 E#	 	 
	3.    Validation
    of labeling regarding administrative and regulatory procedure in each involved country	 	 	 	E
	4.    Submission
    of import license when applicable	 	E#	 	 
	5.    Management
    of all customs issues	 	E#	 	 
	6.    Forwarding
    of required regulatory documentation to Sponsor for allowing the shipment of clinical supplies to each site	 	 	 	E
	C.
    Retrieval and disposal of study drug	 	 	 	 
	1.    Manage
    retrieval of study drug from each site	 	E#	 	E
	2.    Manage
    destruction of study drug.	 	E#	 	 
	3.    Perform
    a reconciliation of all drugs supplied and returned to Sponsor	 	E#	 	E
	IV       Study
    documentation	 	 	 	 
	A.
Drawing up study documents	 	 	 	 
	1.    Final
    protocol	 	E	 	 
	2.    Patient
    Information Leaflet and Informed Consent Form development 	 	R	 	E
	3.    Approval
    of Patient Information Leaflet and Informed Consent Form	 	E	 	 
	4.    eCRF
    development	 	R	 	E*
	5.    Approval
    of eCRF	 	E	 	 
	6.    Printing
    of CRFs, if applicable	 	N/A	 	N/A
	7.    Monitoring
    Guidelines and their update	 	R	 	E
	8.    Approval
    of Monitoring Guidelines	 	E	 	 
	9.    Laboratory
    Operating Manual development	 	 	 	E*
	10. 
    Approval of Laboratory Operating Manual	 	E	 	 
	11. 
    ABPM Manuals development and approval	 	E#	 	R

 

    	20

    	 

    

 

	 	 	Sponsor	 	JAVA
	B.
Filing and archiving of study document	 	 	 	 
	1.    Preparation
    of the Investigator’s Trial Files 	 	 	 	E
	2.    Filing
    of all original administrative study documents according to mutually agreed SOP (Trial Master File)	 	 	 	E
	3.    Provide
    Sponsor on an ongoing basis with:	 	 	 	 
	-
    CRO personnel CVs and Allocation of duties and functions form	 	 	 	E
	-
    Regulatory filing of declaration and any correspondence or contact with Regulatory Authorities	 	 	 	E
	-
    Approval letters or acknowledgement letters of Regulatory Authorities	 	 	 	E
	-
    Approval letters and any correspondence with Ethics committees	 	 	 	E
	-
    Protocol signature page signed by Sponsor and the investigators	 	 	 	E
	-
    Trial and Financial Agreements with Sponsor signed by the investigators	 	 	 	E
	- CVs from site personnel
    and Trial Site Signature forms	 	 	 	E
	-1572
    form and any other FDA documents required by the Sponsor	 	 	 	E
	4.    Ensure
    that patients' names and addresses are masked prior to returning documents to Sponsor but assure that the documents are still
    identifiable with protocol number, patient's initials and number	 	 	 	E
	5.    Assure
    the maintenance and archiving at the trial sites of the Investigators’ Trial Files and CRFs	 	 	 	E
	6.    Provide
    all original documents of the Trial Master File upon request of Sponsor, after database closure	 	 	 	E
	V         Relationship
    between Sponsor and Java 	 	 	 	 
	A.
CRO clinical team	 	 	 	 
	1.    Assignment
    of a clinical team dedicated to the study	 	 	 	E
	2.    Regular
    contacts (teleconference), , between Java and Sponsor representatives; initially weekly  then frequency will depend
    on the ongoing issues to be discussed	 	A	 	E

 

    	21

    	 

    

 

	 	 	Sponsor	 	JAVA
	B. Reporting	 	 	 	 
	1.    Preparation
    and forwarding every week to Sponsor of a study report concerning the status of patients per site : number of patients included,
    dropped out, randomised, treatment ongoing, completed, recruitment rate (% included/to be included)	 	 	 	E
	2.    Preparation
    and forwarding every two months to Sponsor of a report concerning the activities in terms of patient visits to allow payments
    of fees	 	 	 	E
	3.    
    Monthly report of monitoring activities: type and date of visit, report date, problems, actions taken	 	 	 	E
	4.    
    CRF tracking per centre: CRF visits monitored, laboratory results monitored, deviations to protocol, quality of the data,
    number of SAEs will be included in each monitoring report.	 	 	 	E
	VI
        Relationship with the Central Laboratory

        Negotiation
        and signature of agreement with central laboratory 
	 	 	 	E*
	A.   Proposal
    of a central laboratory for 	 	 	 	 
	1.    Biochemistry
    & Haematology Profile	 	 	 	 
	2.    Urine
    Drug Screen	 	 	 	 
	3.    Urinalysis
    & Pregnancy	 	 	 	E*
	4.    Alcohol
    Detection	 	 	 	 
	 	 	 	 	 
	        B.       Preparation
    of 	 	 	 	 
	1.    Investigator
    Laboratory Manual	 	 	 	 
	2.    Multi
    Part Laboratory Reports	 	 	 	E*
	Tailor made request forms
    & patient labelling	 	 	 	 

 

	  C. Collection of specimens 	 	 	 	E*
	1.   Logistics
    and transportation in accordance with ADR regulations under temperature controlled conditions (ambient, +4°C or -20°C).
    	 	 	 	 
	2.   Analysis
    of specimens as required during normal working hours. 	 	 	 	 

 

    	22

    	 

    

 

	 	 	Sponsor	 	JAVA
	   D. Reporting Procedures	 	 	 	
	1.    Authorized
    report on the results from each patient specimen. 	 	 	 	 
	2.    Expert
    medical pathologist support where result interpretation and clinical advice is required. 	 	 	 	E* 
	3.    Post Analysis Storage of Sampl	 	 	 	 
	 	 	 	 	 
	E. Disposing of samples	 	 	 	 
	1.    OpenLabs
    Web Browser enabling Secure 	 	 	 	 
	Access to Patient Results
    over the Internet 	 	 	 	 
	2.    Full
    Extraction of results for all sample post analysis as per client request. 	 	 	 	E*
	3.    Resolution
    of queries in a timely manner,queries relating to sample requests	 	 	 	 
	1.	 	 	 	 
	VII – Monitor activities
    on clinical sites	 	 	 	 
	A.
    Pre-Initiation and Site Initiation Visits	 	 	 	 
	1.    Performing
    site assessment visits	 	 	 	E
	2.    Performing
    pre-study visits	 	 	 	E
	3.    Performing
    all the site initiation visits as soon as possible after obtaining all required regulatory documents	 	 	 	E
	4.    Assure
    that all critical points of the study including scientific, administrative and logistic matters are well understood by all
    members of the study team prior to enrollment of the first patient at a site	 	 	 	E
	5.    Check
    that all study documents and/or material such as eCRF manual, investigator study file, investigator operating manual have
    been forwarded to the investigator prior to the Site Initiation Visit or handed over during the visit	 	 	 	E
	6.    Retrieval
    of any outstanding essential study documents to be signed by the investigator at the latest (if not, study drugs cannot be
    released and the investigator is not allowed to include patients)	 	 	 	E

 

    	23

    	 

    

 

	 	 	Sponsor	 	JAVA
	7.    Management
    of all regulatory and logistical matters with the study pharmacist, if applicable	 	 	 	E
	B. 
    Patient selection and recruitment	 	 	 	 
	1.    Monitor
    patient recruitment at the sites in order to ensure the target number of patients, as defined in the protocol and in accordance
    with the the planned study timelines, is met	 	 	 	E
	2.    Decision
    to increase the number of sites, if needed	 	E	 	 
	C.
  Monitoring	 	 	 	 
	1.    Allocation
    of internal experienced CRAs to monitor the study	 	 	 	E
	2.    Performing
    all monitoring activities related to the study, including investigators’ site monitoring according to Monitoring Guidelines
    and agreed SOPs. The rate of monitoring visits will be defined in the Monitoring Plan.	 	 	 	E
	3.    Monitoring
    of pharmacy  where applicable 	 	 	 	E
	4.    Detection
    and report to Sponsor potential problems as well as possible proposed actions to be discussed with the Sponsor	 	 	 	E
	5.    Verification
    of source documents for 100% of randomised patients for the key-criteria (inclusion/exclusion criteria, primary endpoint assessments,
    AEs (serious and non-serious), drug dispensing record and informed consent forms, reason for premature termination)	 	 	 	E
	6.    
    The monitor will ensure site personnel address all corrections/ discrepancies on the eCRF pages during, or following each
    monitoring visit.  The monitor will also ensure site addresses data queries when generated by CROSNT, as per CROSNT’s
    query handling procedure 	 	 	 	E
	7.    Review
    of biological results filing and  their masking 	 	 	 	E
	8.    Check
    of maintenance and update of the investigatorss trial files at routine monitoring visits	 	 	 	E

 

    	24

    	 

    

 

	 	 	Sponsor	 	JAVA
	9.    Completion
    of a visit report form and forwarding to Sponsor within 10 working days after each visit (site assessment, pre-study, site
    initiation, monitoring, close-out)	 	 	 	E
	10.  Co-monitoring
    visits with the CRO at investigator’s site according to a mutually agreed rhythm described in the Monitoring Plan	 	E	 	 
	D.
    Drug accountability	 	 	 	 
	1.    Check
    of 100% study drug accountability and storage conditions	 	 	 	E
	2.    Check
    that the product is dispensed in conformity with the centralized allocation procedure 	 	 	 	E
	3.    Check
    that Drug Dispensing and Accountability Forms are complete and accurate	 	 	 	E
	E. Study closure	 	 	 	 
	1.    Perform
    close-out visit to the sites on Sponsor’s instruction	 	 	 	E
	2.    Check
    that essential documents are archived properly on site	 	 	 	E
	3.    Collect
    all unused study materials	 	 	 	E
	VIII       Medical
    and coherence review of the eCRF following retrieval from the site	 	 	 	 
	1.    Medical
    review in order to ensure validity and consistency of the information contained within the CRFs, specifically: past medical
    history, inclusion/exclusion criteria, concomitant illnesses, forbidden treatments, clinical examination and vital signs,
    follow-up of adverse events, follow-up of serious adverse events (hospital report...), ancillary examinations.	 	E	 	 
	IX         Serious
    Adverse Events follow up and reporting	 	 	 	 
	1.    Provide
    investigator sites with SAE forms	 	R	 	E*
	2.    Monitoring
    and collection of Serious Adverse Events follow-up and additional documentation such as discharge reports	 	 	 	E
	3.    Eudravigilance
    registration	 	 	 	E*
	4.    Responsible
    Person for Eudravigilance	 	 	 	E*
	5.    Safety
    Database	 	 	 	E*

 

    	25

    	 

    

 

	 	 	Sponsor	 	JAVA
	6.    Review
    of all Serious Adverse Events forms on an ongoing basis	 	 	 	E*
	7.    Shipment
    of SUSARs reports and annual safety reports to Competent Authorities	 	 	 	E*
	8.    Shipment
    of Development Safety Update Reports to Competent Authorities	 	E	 	 
	9.    Shipment
    of SUSARs reports and annual safety reports to Ethics Committees (reports provided by Sponsor)	 	 	 	E
	X     Data-Entry, Data
    management and Coding	 	 	 	 
	A.
    eCRF completion 	 	 	 	 
	1.    The
    monitor will check that all monitored data eCRF are entered in the eCRF database. The monitor will ensure that the Principal
    Investigator signs the eCRF signatory page at the end of the study once all data queries have been addressed	 	 	 	E
	B. Data management
    	 	 	 	 
	1.    CRF
    Design	 	R	 	E*
	2.    Data
    Management Plan	 	R	 	E*
	3.    Programming
    and Validation of Database	 	R	 	E*
	4.    Programming
    and Validation of Consistency Checks	 	R	 	E*
	5.    Data
    Load set-up	 	 	 	E*
	6.    User
    acceptance testing	 	R	 	E*
	7.    CRF/DCF
    Tracking and Archiving	 	 	 	E*
	8.    Lab
    imports	 	 	 	E*
	9.    Data
    Entry	 	 	 	E*
	10.  Data
    Cleaning	 	 	 	E*
	11.  SAE
    Reconciliation	 	 	 	E*
	12.  Production
    of Listing for Medical Review	 	R	 	E*
	13.  Coding	 	 	 	E*
	14.   Metrics/Tracking
    Report	 	 	 	E*
	15.   Documentation
    Archiving	 	 	 	E*
	16.   Database
    Lock	 	 	 	E*
	17.   Database
    Transfer	 	 	 	E*
	XI   Statistical
    analysis	 	 	 	 
	1.    Responsibility
    for statistical analysis other than ABPM	 	R	 	E*

 

    	26

    	 

    

 

	 	 	Sponsor	 	JAVA
	2.    Responsibility
    for statistical analysis of ABPM	 	E	 	 
	XII    Clinical study
    report	 	 	 	 
	            Clinical
    Study Report (excluding ABPM) 	 	R	 	E*
	XIII Medical Monitoring
    	 	 	 	 
	 Primary contact
    for all medical queries	 	E	 	 
	XIV    Quality
    Assurance	 	 	 	 
	1    Issue
    of audit plans for the trial.	 	E	 	 
	2    Conduct
    on site QA audits	 	E	 	 
	3    Implement
    corrective actions and follow up with sites	 	 	 	E

 

SCHEDULE
2-: TIMELINES

 

The Work Order
is based on the following proposed timelines and is is dependent that all supporting documentation for CTA submissions to The
IMB and MHRA are available week commencing 24th February.

 

	Project Preparation	January- April 2014
	EC & CTA Approvals 	May 2014
	First Site Initiation Visit	May 2014
	First Patient First Visit	June 2014
	Last Patient Last Visit	October 2014
	 Data Base Lock 	 TBC ( based on results of interim analysis)  

 

    	27

    	 

    

 

SCHEDULE
3: BUDGET AND PAYMENT SCHEDULE

 

    	28

    	 

    

 

	Study
    Reference K-03-01	 
	 	 
	Projected
    Timelines:	 
	Project Preparation	14 weeks
	Study Recruitment
    and Conduct Period	22 weeks
	Close out period	12 weeks 
	 	 
	Indication:	Hypertension 
	 	 
	Key
    Assumptions:	 
	Number of patients
    to be screened	300
	Number of patients
    to be randomised	150
	Sites	10 sites Republic/Northern
    Ireland
	Number of monitoring
    visits	Estimated pool
    of 60 monitoring site visits
	Total
    CRF pages per patient	TBC
	 	 

 

		 	RATE	 	 		 	EST. REQ.	 	ESTIMATED 

CHARGE	 	 	
	ACTIVITY 	 	€	 	 	UNIT	 	Range	 	Range
    €	 	 	Comments 
	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	 	14	 	 	24,640.00	 	 	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
	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	 	14	 	 	5,600.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Preparation
    total	 	 	 	 	 	 	 	 	 	 	52,400.00	 	 	 
	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 to National Ethics Committee in Repbulic
    of 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	 	 	 
	Management of Site Specific Approvals for all sites	 	 	340.00	 	 	site	 	10	 	 	3,400.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Regulatory
    total	 	 	 	 	 	 	 	 	 	 	15,840.00	 	 	 
	Clinical Operations	 	 	 	 	 	 	 	 	 	 	 	 	 	Assuming 4 Dublin Centres: 6 Regional Centres -  estimated
    Monitoring Visit Pool of 60 site visits
	Site Qualification Visits	 	 	680.00	 	 	site	 	10	 	 	6,800.00	 	 	 
	Travel time	 	 	400.00	 	 	site	 	6	 	 	2,400.00	 	 	Site Visit preparation time for pre study visits and
    monitoring
	Pre-Study Visits	 	 	850.00	 	 	site	 	10	 	 	8,500.00	 	 	visits - 2 hours. Site Visit preparation time for
    SIV and
	Travel time	 	 	400.00	 	 	site	 	6	 	 	2,400.00	 	 	close out visit - 4 hours.  Site Qualification
    and Pre study visit duration - 4 hours.
	Site Initiation Visits	 	 	1,360.00	 	 	site	 	10	 	 	13,600.00	 	 	SIV, monitoring and close out visit duration -
	Travel time	 	 	400.00	 	 	site	 	6	 	 	2,400.00	 	 	 
	Study Monitoring Visits	 	 	1,190.00	 	 	site	 	60	 	 	71,400.00	 	 	 
	Travel time	 	 	400.00	 	 	site	 	6	 	 	2,400.00	 	 	 
	Study Close-Out Visits	 	 	1,360.00	 	 	site	 	10	 	 	13,600.00	 	 	 
	CRA Site Management	 	 	1,020.00	 	 	week	 	34	 	 	34,680.00	 	 	Communication/liaison with Project Manager and site
    personnel on study related issues, progress etc; eCRF review (only as preparation for the monitoring visit); participation
    in project teleconferences, when required.
	Project Management	 	 	2,200.00	 	 	week	 	34	 	 	74,800.00	 	 	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	 	 	400.00	 	 	week	 	34	 	 	13,600.00	 	 	Assistance with compilation of return of essential
    dcoument for TMF, CRA travel arrangements, collation of all pass through costs and study related invoices.
	Clinical Operations	 	 	 	 	 	 	 	 	 	 	246,580.00	 	 	 
	Other Services	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Clinical Laboratory Services (Estimate)	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Sample Analysis	 	 	 	 	 	 	 	 	 	 	37,020.00	 	 	 
	Central Laboratory Fee	 	 	 	 	 	 	 	 	 	 	2,700.00	 	 	 
	Web Browser Access	 	 	 	 	 	 	 	 	 	 	FOC	 	 	 
	Results Extraction	 	 	 	 	 	 	 	 	 	 	300.00	 	 	 
	Sample Collection Logistics Estimate	 	 	 	 	 	 	 	 	 	 	5,000.00	 	 	 
	Clinical Laboratory Services Subtotal	 	 	 	 	 	 	 	 	 	 	45,020.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Data Management and Statistics	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Biometrics Management	 	 	 	 	 	 	 	 	 	 	11,172.00	 	 	 
	Data Management	 	 	 	 	 	 	 	 	 	 	42,873.50	 	 	 
	eCRF management and hosting	 	 	 	 	 	 	 	 	 	 	64,189.25	 	 	 
	Statistics	 	 	 	 	 	 	 	 	 	 	37,225.75	 	 	 
	Data Management and Statistics
    Subtotal	 	 	 	 	 	 	 	 	 	 	155,460.50	 	 	 
	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	 	 	 	 	 	 	 	 	 	 	234,503.00	 	 	 
	8% Overhead	 	 	 	 	 	 	 	 	 	 	18,760.24	 	 	 
	SUBTOTALS	 	 	 	 	 	 	 	 	 	 	253,263.24	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	GRAND TOTAL  PROFESSIONAL
    FEES	 	 	 	 	 	 	 	 	 	 	568,083.24	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Other study conduct  costs	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	IMB CTA	 	 	 	 	 	 	 	 	 	 	1,443.00	 	 	 
	MHRA CTA	 	 	 	 	 	 	 	 	 	 	3,982.00	 	 	 
	Ethics Committe Fees	 	 	 	 	 	 	 	 	 	 	2,350.00	 	 	 
	CRA Travel	 	 	 	 	 	 	 	 	 	 	23,400.00	 	 	Dublin sites 4 sites x 10 visits x €30 per visit
    = €1200
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Regional sites: 6 sites x 2 visits x €250 = €3000
    (SQV/PS)
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Regional sites: 6 sites x 8 visits x €400 = €19,200
	Courier Costs - as per receipted expenses	 	 	 	 	 	 	 	 	 	 	5,000.00	 	 	Estimate
	Stationary, Printing, Photocopying for TMF, Investigator
    Site Files and Ethics Applications	 	 	 	 	 	 	 	 	 	 	10,000.00	 	 	 
	Management of PI fees	 	 	 	 	 	 	 	 	 	 	9,885.00	 	 	 
	Estimate other pass through costs	 	 	 	 	 	 		 	 	 	56,060.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Proposed payment schedule	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	15% upfront fee at exchange of contracts	 	 	 	 	 	 	 	 	 	 	85,212.49	 	 	 
	15% first Competent Authority approval (IMB or MHRA)	 	 	 	 	 	 	 	 	 	 	85,212.49	 	 	 
	10% following 30 subjects randomised	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	10% following 60 subjects randomised	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	10% following 90 subjects randomised	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	10% following 120 subjects randomised	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	10% following 150 subjects randomised	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	10% DB lock	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	10% final study report	 	 	 	 	 	 	 	 	 	 	56,808.32	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	568,083.24	 	 	 
	Pass through fees	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	20 % upfront  fee at exchange of contracts	 	 	 	 	 	 	 	 	 	 	11,212.00	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Monthly based on actual expenses incurred.	 	 	 	 	 	 	 	 	 	 	 	 	 	 

 

    	29

    	 

    

 

SCHEDULE
4 -: PERSONNEL/CONTACTS FOR NOTICES

Sponsor
Personnel

 

	Country	 	Name 	 	Role 	 	Phone	 	Email address
	Israel	  	Simcha Rock	  	CFO	  	+972

        625

        4142
	  	simcha@kitovpharma.com

 

Java
Personnel

 

	Country	 	Name 	 	Role 	 	 Phone 	 	Email address
	Ireland	  	Ruth Nallen	  	Managing Director	  	+353 1 

    6373903	  	rnallen@javacr.com

 

    	30

    	 

    

 

SCHEDULE
5 -: PROTOCOL

 

    	31

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