Document:

Exhibit 10.2

 

EXCLUSIVE LICENSE AGREEMENT

 

THIS AMENDED AND RESTATED
EXCLUSIVE LICENSE AGREEMENT (the “Agreement”) is made in Jerusalem as of this _ day of November 14, 2005 (the
 “Effective Date”).

 

BETWEEN:

 

YISSUM RESEARCH
DEVELOPMENT COMPANY OF THE

HEBREW UNIVERSITY OF JERUSALEM

 

(hereinafter referred to as “Yissum”)

 

AND

 

BIOCANCELL THERAPEUTICS
INC.

A company incorporated under
the laws of the State of Delaware

(formerly known as DBT Biopharmaceuticals Inc.)

(hereinafter referred to as “DBTI”)

 

AND

 

BIOCANCELL THERAPEUTICS
LTD.

a company established
under the laws of the State of Israel 

formerly known as DBT Biopharmaceuticals Ltd.)

(hereinafter referred to as “DBTL”)

 

(DBTI and DBTL collectively hereinafter referred to
as the “Company”)

 

WHEREAS Yissum
is the owner of certain rights, title and interest in and to the Licensed Technology (defined below); and

 

WHEREAS Yissum
and the Company entered into that certain Exclusive License Agreement dated November 17, 2004 pursuant to which Yissum granted
to Company an exclusive worldwide license with rights to grant sublicenses and sub-sublicenses under the Licensed Technology (the
 “Original Agreement”); and

 

WHEREAS Yissum
and the Company wish to amend and restated in full the Original Agreement entered into that certain Exclusive License, in the form
set forth herein.

 

NOW, THEREFORE,
for and in consideration of the premises and other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, Yissum and Company (hereinafter individually as a “Party”; and collectively as the “Parties”)
expressly agree as follows.

 

     

     

    

 

SECTION 1

Recitals and Definitions

 

In this Agreement the following expressions
shall have the corresponding meanings, unless the context otherwise requires:

 

“Affiliate”
shall mean any corporation, partnership, or other entity that at any time during the term of this Agreement directly through one
or more intermediaries Controls or is Controlled by or is under common Control with a party to this Agreement, but only for so
long as the relationship exists. A corporation or other entity shall no longer be an Affiliate when through loss, divestment, dilution
or other reduction of ownership, the requisite Control no longer exists.

 

“Control”
or “Controls” or “Controlled” shall mean: (i) in the case of a corporation, ownership or
control, directly or indirectly, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors;
or (ii) in the case of an entity other than a corporation, ownership or control, directly or indirectly, of more than fifty percent
(50%) of the assets of such entity.

 

“First Commercial
Sale” means in each country, the date the Licensed Product is first sold, marketed, or otherwise made publicly available
for sale. Licensed Products that are distributed or used solely for pre-clinical studies, clinical trials, treatment IND purposes
or any other similar use prior to receiving regulatory approval by the relevant regulatory authority shall not be considered sold,
marketed or made publicly available for sale and shall not constitute First Commercial Sale hereunder.

 

“Licensed
Product” shall mean any product the manufacture, use, sale or importation of which is covered by a Valid Claim.

 

“Licensed
Technology” shall mean the Patents, and any technology, trade secrets, methods, processes, know-how, show-how, formulas,
data, information, inventions, improvements, discoveries or results relating t the Patents, whether patentable or otherwise. Any
future patents, technology, trade secrets, methods, processes, know-how, show-how, formulas, data, information, inventions, improvements,
discoveries or results, relating to the Patents whether or not patentable, will also be considered as Licensed Technology.

 

“Net Sales”
shall mean the gross amount invoiced by Company or Affiliates to third parties, which are not Sublicensee(s), from sales of
Licensed Products in an arm’s length transaction, less (i) discounts allowed in amounts customary in the trade for quantity
purchases, cash payments, or prompt payments, to wholesalers and distributors; (ii) sales, tariff duties and/or use taxes directly
imposed and with reference to particular sales, including VAT; (iii) outbound transportation prepaid or allowed, amounts allowed
or credited on returns, export licenses, import duties, and prepaid freight; (iv) amounts not actually collected by reason of rejection,
return of goods, and retroactive price reductions; and (iv) Third Party Royalties. No deductions shall be made for commissions
paid to individuals whether they are with independent sales agencies or regularly employed by Company and on its payroll or for
cost of collections. In the event of sales not made at “arm’s length”, Net Sales shall be calculated in accordance
with arm’s length prices determined by current market conditions. Yissum will have to establish that sales are not made at
arm’s length on the basis of adequate documentary evidence. Net Sales occur when a Licensed Product is invoiced. Notwithstanding
the immediately preceding sentence, distribution or sales of Licensed Products by Company to its Affiliates shall not be deemed
to be Net Sales unless such Affiliate is the final end user of such Licensed Products.

 

     

     

    

 

“Patents”
shall mean the patents set forth on Appendix 1 attached hereto, together with any and all registered patents covering Licensed
Technology granted whether in the United States of America or any other country, including any and all substitutions for and divisions,
continuations, continuations-in-part, provisionals, and non-provisionals, renewals, reissues, any foreign patent applications and
divisionals or national phase applications which claim priority of any application which issued into one of the patent applications
set forth in Appendix 1.

 

“Research”
shall mean the continued research regarding the Licensed Technology to be conducted pursuant to the Research Plan.

 

“Research
Plan” shall mean the description of the conduct of the Research as attached to this Agreement as Appendix II.

 

“Research
Results” shall mean the Research, including any patents, patent applications, information, material, results, devices
and know-how arising therefrom.

 

“Sublicensee(s)”
shall mean any third party to whom Company has granted a sublicense under the Licensed Technology to manufacture, develop, distribute
and market Licensed Products consistent with the provisions of this Agreement.

 

“Sublicensing
Revenue” shall mean all cash, sublicensing fees, running royalties and other consideration paid to Company by Sublicensee(s)
in consideration for the granting of rights to the Licensed Product and/or Licensed Technology and in connection therewith. Sales
of Licensed Products from Company to Sublicensee(s) shall not be deemed to be Sublicensing Revenue provided that such Sublicensee(s)
is/are not the final end user of the Licensed Products. Notwithstanding the above, Sublicensing Revenues shall exclude (a) payments
used or reimbursed for research, (b) payments used or reimbursed for parent costs, and (c) payments received from the issuance
of debt or equity securities of the Company.

 

“Third
Party Royalties” royalties calculated on any amount invoiced by the Company in connection with the sale of a
Licensed Product and actually paid by the Company to a third party for the right to use patents or other intellectual
property rights of such third party, without which right of use the Company would not be entitled to develop, manufacture and
sell such Licensed Product; provided that the duty to pay royalties to such third party has been established at arm’s-length and in good faith and is set out in a written agreement; and

 

“Valid Claim”
shall mean (i) a claim of an issued Patents which has not expired and which has not been held revoked, invalid or unenforceable
by decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed with the time allowed
for appeal having expired, and which has not been admitted to be invalid through reissue or disclaimer or otherwise; or (ii) any
claim of a pending patent application covering the Licensed Technology, which was filed in good faith and which has been prosecuted
with due diligence.

 

     

     

    

 

SECTION 2

Grant of License

 

2.1           Subject
to the terms of this Agreement, Yissum hereby grants to Company an exclusive, worldwide right and license under the Licensed Technology
to develop, have developed, make, have made, use, manufacture, market, sell, have sold, offer to sell, commercialize, import, export,
sublicense, sub-sublicense and distribute Licensed Products and/or provide services relating thereto (the “License”).

 

2.2           Company
shall have the exclusive right to enter into sublicense agreements with respect to the Licensed Technology. All sublicenses granted
by Company hereunder shall be subject to this Agreement in all respects. Each such sublicense agreement shall include a requirement
that the Sublicensee use its commercially reasonable efforts to bring the subject matter of the sublicense into commercial use.
No sublicense shall relieve Company of any of its obligations under this Agreement. Company shall forward to Yissum a complete
copy of each sublicense agreement (including, without limitation, all amendments and addenda thereto) granted hereunder within
thirty (30) days after execution of such agreement by the parties thereto. In the event that Company has granted more than one
sublicense, any breach by one Sublicensee will not effect any other non-breaching Sublicensee(s), such way that the License and
the sublicense in respect of any non-breaching Sublicensee(s) is not effected.

 

2.3           Notwithstanding
Section 2.1, not later than December 31, 2005 Company shall determine (the “Determination”): (i) to which of
either DBTI or DBTL the License shall be granted (the “DBT Licensee”), or (ii) which indications or components
of the Licensed Technology shall be granted on an exclusive basis to DBTI and which shall be granted on an exclusive basis to DBTL.
Within ten (10) days of the Determination, Company shall provide written notice to Yissum of its determination as aforesaid. Upon
the provision of such notice, the License shall be automatically modified to reflect the Determination and the terms of this Agreement
shall be modified mutatis mutandis to give effect thereto.

 

SECTION 3

Royalties and Reporting

 

3.1           In
consideration of the License granted hereunder, Company shall pay royalties to Yissum in the manner hereinafter provided (the “Royalties”).
Company shall pay to Yissum:

 

(i)          Five
percent (5%) of Net Sales; and

 

(ii)         For
Sublicensing Revenues of up to $30,000,000 per year – Ten Percent (10%); and

 

(iii)        For
Sublicensing Revenues above $30,000,000 per year – Six and One Half Percent (6.5%).

 

3.2           Sixty
(60) days after the end of each 6 month period commencing from the date of the First Commercial Sale, Company shall furnish Yissum
with a bi-annual report (herein the “Periodic Report”) detailing the total sales effected during the reporting
period and the total Royalties and Sub-license Revenues due to Yissum in respect of that period.

 

     

     

    

 

3.3           The
Periodic Reports shall state details of Net Sales and Sublicensing Revenues, including the country in which the sale was made,
the number of Licensed Products, the aggregate Net Sales and Sublicensing Revenues during the period covered by the report and
resulting Royalties due to Yissum for such completed year.

 

3.4           On
the date prescribed for the submission of each Periodic Report, Company shall pay the Royalties and amounts due to Yissum in accordance
with the Periodic Report.

 

3.5           The
value of each sale shall be computed on the date of sale in US Dollars based on the rates published in the Wall Street Journal.
The Royalties shall be computed and paid in US dollars. Payment of Value Added Tax (if applicable) shall be added to each payment
in accordance with the statutory rate in force at such time. In event that Company is prohibited under applicable foreign currency
laws to transact in US Dollars, payment shall be made in New Israeli Shekels according to the representative rate of exchange prevailing
on the date of payment. Subject to applicable law, Company shall be entitled to withhold and deduct from any payment made herein
to Yissum any and all taxes as required by law, and such withheld or deducted amount shall be treated as paid over to Yissum for
purposes of this Agreement, unless Yissum provides Company with an appropriate withholding exemption certificate. Any sum of money
due to Yissum hereunder which is not duly paid shall bear interest from the due date of payment until the actual date of payment
at the maximum rate of default interest prevailing at Bank Leumi in respect of US dollar lines of credit.

 

3.6           Company
shall keep full and correct books of accounts in accordance with General Accepted Accounting Procedures as required by U.S. Accounting
Standards enabling the Royalties to be calculated. Company shall procure that Sublicensee(s), if any, also keep such books of accounts
as aforesaid. Company shall submit to Yissum a report containing all the particulars mentioned in Section 3.3 above in respect
of each Periodic Report detailing the Royalties and Sublicensing Revenues due to it in respect of the period covered by the Periodic
Report. An annual report, authorized by a certified public accountant, shall be submitted not later than sixty (60) days following
the end of each calendar year.

 

3.7           For
five years following the end of the calendar year to which a Periodic Report pertain, Yissum may appoint an independent public
accountant to examine Company’s and Sublicensee(s)’ books of accounts and any report or information relating to the
manufacture, marketing, distribution and sale of the Licensed Products in order to verify the calculation of the Royalties and
Sublicensing Revenue and the accuracy of the information given to Yissum in the aforegoing reports. Such examination shall be made
at Company’s place of business during ordinary business hours with at least fifteen (15) days prior written notice. If an
error greater than five percent (5%) in the reports of Company will be found, Company will bear the full cost of the examination.
Company shall reasonably ensure that Yissum is able to exercise its rights pursuant to this section regarding Sublicensee(s).

 

     

     

    

 

SECTION 4

Development; Commercialization and Research

 

4.1           Company
undertakes, at its own expense, to use its commercially reasonable efforts to carry out the development work necessary to develop
and commercialize the Licensed Technology.

 

4.2           Company
shall provide Yissum with annual reports which shall detail the development results and other related work effected by Company
during the twelve (12) months prior to the report.

 

4.3           Company
shall give Yissum written notice of the First Commercial Sale within thirty (30) days thereof.

 

4.4           (i)          Yissum
shall procure the conduct of the Research at the Laboratory of Prof. Abraham Hochberg and under his supervision and in accordance
with the Research Plan. Company undertakes to finance the performance of the Research in accordance with the budget forming part
of the Research Plan.

 

(ii)         Yissum
shall procure that Company be provided with quarterly reports detailing the results and conclusions of the Research. Yissum shall
procure that appropriate records of the Research are kept in sufficient detail and in good scientific manner.

 

(iii)        The
initial period of the Research shall be for two years and the parties may agree to extend this period. Company may cease the financing
of the Research upon a written notice to Yissum of at least 90 days prior to the cessation of financing. In the event of cessation
of financing of the Research, Company shall reimburse Yissum for: (a) all expenses incurred in relation to the Research prior to
the notice of cessation of the financing of the Research; and (b) all committed outstanding expenses and obligations payable subsequent
to the notice of cessation of the financing, provided such outstanding expenses and obligations were incurred prior to the notice
of cessation.

 

SECTION 5

Ownership

 

All rights in and to
the Licensed Technology shall be owned by Yissum, and Company shall hold the rights granted pursuant to the License hereunder and
make use of them exclusively in accordance with the terms of this Agreement. The Research Results resulting from Research conducted
in accordance with Section 4.4 shall be exclusively owned by Yissum, shall form part of the Licensed Technology and shall be licensed
to the Company under the same terms and conditions of this Agreement.

 

     

     

    

 

SECTION 6

Patents

 

6.1           Company
shall assume full responsibility for and conduct patent prosecution and maintenance of the Patents and will be responsible for
preparing, filing, prosecuting and maintaining all Patents and shall use patent counsel of its own choice, subject to the approval
of Yissum (such approval not to be unreasonably withheld), at Company’s own expense. In the time period until the first round
of financing by Company, the decisions regarding preparing, filing, prosecuting and maintaining all patents will be accepted mutually
by Company and Yissum, after this time period, these decisions will borne only by Company. Company agrees to pay all costs, incident
to the United States and foreign applications, patents and like protection, including all costs incurred for filing, prosecution,
issuance and maintenance fees as well as any costs incurred in filing continuations, continuations-in-part, divisional or related
applications and any re-examination or re-issue proceedings. Company shall file and maintain patent applications corresponding
to the Licensed Technology in such countries as Company in its sole discretion shall select but shall notify and consult with Yissum
as to those countries where it shall not file and maintain patent applications. Upon the completion of Company’s first round
of financing of an amount of at least $2,500,000 (the “Financing”), Company hereby undertakes to reimburse Yissum
for previous documented expenses and costs incurred by Yissum up to 2005 relating to the filing, maintenance and prosecution of
the Patents not to exceed $50,000. Company shall pay such reimbursement in eight (8) equal quarterly installments commencing ninety
(90) days from the date of the Financing.

 

6.2           Company
agrees to keep Yissum informed of filing and prosecutions pursuant to this Section 6 including submitting to Yissum copies of all
official actions, all relevant correspondence with the patent attorneys, applications, continuations, re-examinations, re-issues,
divisionals or like proceedings and responses thereto. Company shall consult with Yissum regarding any abandonment of the prosecution
of patents application within the Patents.

 

6.3           Each
and every patent application as aforesaid in relation to the Licensed Technology shall be registered exclusively in the name of
Yissum at Company’s sole expense, and shall be included automatically within the scope of the License granted pursuant to
the terms of this Agreement.

 

6.4           In
the event that Company decides not to continue prosecution of a Patent application to issuance or maintain any patent application
or patent on technology within the Patents in a certain jurisdiction, Company shall timely notify Yissum in writing in order that
Yissum may continue said prosecution or maintenance of such applications at its option and at its own expense in such jurisdiction.
In the event that (i) Company elects not to file or not to prosecute or to discontinue or to abandon the filing, prosecution and/or
maintenance of the Patents in certain countries (the “Abandoned Countries”) and (ii) Yissum decides to do so at its
expense, then (iii) Yissum shall notify Company in writing of its intention to file, prosecute and/or maintain a patent and Company
shall have a ninety (90) day period to decide whether it wishes to bear the expenses of such actions. In the event the Company
shall notify Yissum that it does not wish to bear the costs of such filing, maintenance and/or prosecution or in absence of a reply
from the Company within the ninety (90) day period, the License shall no longer be applicable in the Abandoned Countries.

 

It is hereby clarified,
if Company fails to notify Yissum in a timely manner as required hereunder, which, for the purpose of this section, shall be the
time, considered reasonably, that would enable Yissum to effectively carry out such filing, prosecution or maintenance of the Patents,
Company shall be considered in default of this Agreement.

 

     

     

    

 

6.5           Company
and its Sublicensee(s) shall mark all products covered by Patents with patent numbers in accordance with the statutory requirements
in the country(ies) of manufacture, use, and sale, and pending the issue of any patents. Company shall ensure that its Sublicensee(s)
comply with the provisions of this section.

 

6.6           Company
undertakes to use commercially reasonable efforts at its own expense to protect against a third party’s infringement of the
Patents and forthwith to advise Yissum upon learning of the infringement. Company shall give Yissum immediate notice of any approach
made to it by a patent examiner and/or attorney in connection with the subject matter of this Agreement. Company shall reply to
such approaches after consultation with Yissum.

 

6.7           Company
shall use its commercially reasonable efforts at its own expense to defend any action, claim or demand made by any entity in connection
with rights in the Patents and/or patents and shall give notice to Yissum immediately upon learning of any such action, claim or
demand as aforesaid. Any assistance that will be requested by Company from Yissum for the purpose of defending any action, claim
or demand made by any entity in connection with rights in the Patents and/or patents, will be provided by Yissum without any additional
charge to Company.

 

6.8           Any
settlement, consent judgment or other voluntary final disposition of any action pursuant to the provisions of this section, shall
not be entered into without consultation with Yissum and the prior written consent of Yissum which shall not be reasonably withheld
or delayed.

 

6.9           Subject
to reimbursement of documented reasonable out-of-pocket expenses incurred by Company in relation to any legal action contemplated
under the provisions of this section, any award in favor of Yissum and/or Company resulting from such legal action shall be divided
by Yissum and the Company pursuant to Section 3.1 as if such award was Sublicensing Revenues. Any recovery of damages by Company
for each such suit shall be applied first in satisfaction of any unreimbursed documented reasonable expenses and legal fees of
Company relating to such suit.

 

SECTION 7

Confidentiality

 

7.1           Licensor
Confidential Information. Company agrees that, without the prior written consent of Yissum, in each case, during the term of
this Agreement, and for three (3) years thereafter, it will keep confidential, and not disclose or use Yissum Confidential Information
(as defined below) other than for the purposes of this Agreement or as detailed below. Company shall treat such Yissum Confidential
Information with the same degree of confidentiality as it keeps its own confidential information, but in all events no less than
a reasonable degree of confidentiality. Company may disclose the Yissum Confidential Information only to employees, consultants
or researchers of Company or of its affiliates who have a “need to know” such information in order to enable Company
to exercise its rights or fulfill its obligations under this Agreement and provided such parties are legally bound by agreements
which impose confidentiality and non-use obligations comparable to those set forth in this Agreement. For purposes of this Agreement.
 “Yissum Confidential Information” means any scientific, technical, trade or business information relating to the subject
matter of this Agreement designated as confidential or which otherwise should reasonably be construed under the circumstances as
being confidential disclosed by or on behalf of Yissum, or any of its employees, consultants or researchers to Company, whether
in oral, written, graphic or machine-readable form, except to the extent such information: (i) was known to Company at the
time it was disclosed, other than by previous disclosure by or on behalf of Yissum or any of its employees, consultants or researchers,
as evidenced by Company’s written records at the time of disclosure; (ii) is at the time of disclosure or later becomes publicly
known under circumstances involving no breach of this Agreement; (iii) is lawfully and in good faith made available to Company
by a third party who is not subject to obligations of confidentiality to Yissum with respect to such information; (iv) is independently
developed by Company without the use of or reference to Yissum Confidential Information, as demonstrated by documentary evidence,
or (v) is disclosed pursuant to a court or administrative order, provided however that Company will first notify Yissum of any
such order and afford Yissum the opportunity to seek a protective order relating to such disclosure.

 

     

     

    

 

Notwithstanding anything
to the contrary in this Section 7.1, Company may disclose Yissum Confidential Information to actual and potential business partners,
collaborators, investors, contractors, service providers and consultants, provided, in each case, that such recipient of Confidential
Information first enters into a legally binding agreement with Company which imposes confidentiality and non-use obligations with
respect to Confidential Information comparable to those set forth in this Agreement for a period of at least five (5) years from
the date of disclosure of Yissum Confidential Information to such recipient.

 

7.2           Company
Confidential Information. Yissum agrees that, without the prior written consent of Company, in each case, during the term of
this Agreement, and for three (3) years thereafter, it will keep confidential, and not disclose or use Company Confidential Information
(as defined below) other than for the purposes of this Agreement. Yissum shall treat such Company Confidential Information with
the same degree of confidentiality as it keeps its own confidential information, but in all events no less than a reasonable degree
of confidentiality. Yissum may disclose the Company Confidential Information only to employees, consultants or researchers of Yissum
or its affiliates who have a “need to know” such information in order to enable Yissum to exercise its rights or fulfill
its obligations under this Agreement and provided such parties are legally bound by agreements which impose confidentiality and
non-use obligations comparable to those set forth in this Agreement. For purposes of this Agreement. “Company Confidential
Information” means any scientific, technical, trade or business information relating to the subject mailer of this Agreement
designated as confidential or which otherwise should reasonably be construed under the circumstances as being confidential disclosed
by or on behalf of Company whether in oral, written, graphic or machine-readable form, except to the extent such information: (i)
was known to Yissum at the time it was disclosed, other than by previous disclosure by or on behalf of Company as evidenced by
Yissum’s written records at the time of disclosure; (ii) is at the time of disclosure or later becomes publicly known under
circumstances involving no breach of this Agreement; (iii) is lawfully and in good faith made available to Yissum by a third party
who is not subject to obligations of confidentiality to Company with respect to such information; (iv) is independently developed
by Yissum without the use of or reference to the Company Confidential Information, as demonstrated by documentary evidence; or
(v) is disclosed pursuant to a court or administrative order, provided however that Yissum will first notify Company of any such
order and afford Company the opportunity to seek a protective order relating to such disclosure.

 

     

     

    

 

7.3           Each
party may disclose the terms of this Agreement to the extent required, in the reasonable opinion of such party’s legal
counsel, to comply with applicable laws, as well as to sublicensees and prospective and current investors, pursuant to
appropriate non-disclosure arrangements. If a party discloses this Agreement or any of the terms hereof in accordance with
this Section 7.3, such party agrees, at its own expense, to seek confidential treatment of portions of this Agreement or such
terms, as may be reasonably requested by the other party.

 

7.4           Without
prejudice to the aforegoing. Yissum agrees that Company shall have the right to mention or reference the Hebrew University of Jerusalem’s
and/or Yissum’s names without obtaining Yissum’s prior consent to the extent the use of such names is reasonably consistent
with Company’s obligations pursuant to Section 4.1 hereof.

 

7.5           The
breach of this section, by any person or entity other than Yissum or Company shall not be deemed a breach of the Agreement, if
Yissum or Company establish that they took all reasonable steps to avoid such breach.

 

7.6           The
expiration or termination of this Agreement shall not release the Parties from their obligations pursuant to this section.

 

7.7           The
provisions of this section shall be subject to permitted publications pursuant to Section 8 herein.

 

SECTION 8

Publications

 

8.1           Yissum
shall ensure that no publications in writing, in scientific journals or orally at scientific conventions relating to the Licensed
Technology are published by it or its Researchers. For the purposes of this Agreement, the term “Researchers” means
Pro. Avraham Hochberg and his scientific research group or other scientific research group whose work is related to the Licensed
Technology.

 

8.2           Notwithstanding
Section 8.1 above, Yissum may allow the Researchers to publish any research, research results or know-how relating to the Licensed
Technology provided that it obtains Company’s prior written consent. Company undertakes to reply to any request by Yissum
for Company’s consent within forty-five (45) days of receiving such request. Company may only decline such request upon reasonable
grounds which shall be fully detailed in writing. In the event that Company does not reply to such request within the forty-five
(45) day period, then Company shall be deemed to have consented to Yissum’s request to allow the Researchers to publish in
the manner contemplated herein.

 

8.3           Should
Company decide not to allow publication as provided in Section 8.2 for reasons which in Yissum’s opinion are unreasonable,
acting reasonably, publication shall be postponed for a period of three (3) months to enable Company to file patent applications.

 

     

     

    

 

8.4           The
provisions of this Section 8 shall not prejudice any other right that Yissum has pursuant to this Agreement and at law.

 

8.5           For
the avoidance of doubt, the provisions of this Section 8 in connection with the prohibition against publication shall not apply
to internal publication by Yissum made in the Hebrew University of Jerusalem for the Researchers and employees subject to Section
7.

 

SECTION 9

Liability and Indemnity

 

9.1           Except
as set forth herein, Yissum expressly disclaims any and all implied or express warranties and makes no express or implied warranties
of merchantability or fitness for any particular purpose of the Licensed Technology contemplated by this Agreement.

 

9.2           Company
shall be solely liable for any loss, injury and/or damage whatsoever caused to its employees and/or any person acting on its behalf
by reason of Company’s acts and/or omissions pursuant to this Agreement and/or by reason of any use made of the Licensed
Technology by Company.

 

9.3           Company
undertakes to indemnify, defend and hold harmless (i) Yissum and any person acting on its behalf and any of its directors,
officers, employees and representatives, and (ii) the Hebrew University
of Jerusalem and any person acting on its behalf and any of its directors, officers, employees and representatives (herein
referred to as “Indemnitees”) from and against any liability including without limitation product liability,
damages, losses or expenses including reasonable legal fees and litigation expenses incurred by or imposed upon the
Indemnitees (collectively, “Losses”) only by reason of Company’s acts and/or omissions and/or which
derive from Company’s use, development, manufacture, marketing, sale and/or sublicensing of the Licensed Technology
except to the extent such Losses are determined to have resulted from the gross negligence or willful misconduct of
Indemnitees.

 

9.4           Company
shall obtain prior to the commencement of clinical trials by Company and prior to the First Commercial Sale, comprehensive general
liability insurance which shall provide:

 

(i)          product
liability coverage,

 

(ii)         contractual
liability coverage for Company’s indemnification under this Agreement and in particular as stated in Section 9.3,
and

 

(iii)        Yissum
as an additional named insured.

 

Upon the commencement
of any clinical trial, Company shall procure and maintain comprehensive clinical trial liability insurance in amounts commensurate
with accepted commercial practice. All required insurance will be at Company’s sole cost and expense.

 

9.5           Company shall provide
Yissum with written evidence of such insurance upon request of Yissum. Company shall ensure that it maintains on a continuous basis
only during the relevant term of this Agreement the foregoing insurance coverage, and shall not cancel or terminate such insurance
with any insurance provider unless it has in place alternative coverage consistent with the foregoing. Company shall provide Yissum
with written notice of any material change in such insurance not later than fifteen (15) days of such change taking effect.

 

     

     

    

 

9.6           Company
shall maintain comprehensive general liability insurance beyond the expiration or termination of this Agreement during the period
that a Licensed Product is being commercialized, distributed or sold by Company and/or any Sublicensee. In the event of early termination
by Yissum, the cost of such general liability insurance for a period of three (3) months following the date of termination will
he borne by Company and thereafter will be borne by Yissum.

 

9.7           Yissum
represents and warrants that to the best of its actual knowledge: (i) the Patents which have been issued and are listed in Appendix
1 are valid and enforceable: (ii) it has the full power to enter into this Agreement, to carry out its obligations under this
Agreement, and to grant the rights granted to Company herein; (iii) it has not previously granted and shall not grant to any third
party any rights which are inconsistent with the rights granted to Company herein, (iv) it has the rights, title, and interest
in and to the Patents, and (v) the Licensed Technology constitutes all of the intellectual property rights developed by Prof. Abraham
Hochberg laboratory in the Hebrew University in the field of H19 and IGF2 gene.

 

9.8           Company
represents that: (i) it has full corporate power and authority to enter into this Agreement and carry out all the provisions of
this Agreement; (ii) it is authorized to execute this Agreement on its behalf; (iii) the person executing this Agreement is duly
authorized to do so; and (iv) no consent, approval or authorization of any other party is required in connection with entering
into this Agreement.

 

SECTION 10

Term and Termination

 

10.1         Unless
earlier terminated, as hereinafter provided, the term of this Agreement shall expire on a country-by-country basis at such time
when no Valid Claim exists, or if no Patent was issued in a country, on the eleventh anniversary of the First Commercial Sale in
such country, thereafter the License in such country shall expire, provided in each case that Company may extend the term of the
Agreement on a country-by-country basis for additional period of one year each by continuing to pay the consideration set forth
in section 3. In countires where a Patent was registered, after the expiration of Patent, Company shall have a perpetual, worldwide,
royalty-free, fully paid-up and sublicenseable License in relation to that Patent.

 

10.2         In
the event of a material default or failure by Company to perform any of the terms, covenants or provisions of this Agreement, Company
shall have ninety (90) days after the giving of written notice of such default by Yissum to correct such default, provided, however,
that if the breach is not capable of being cured within ninety (90) days of such written notice, the Agreement may not be terminated
so long as Company commences and is taking commercially reasonable actions to cure such breach as promptly as practicable. In any
event, if a curable breach has not been cured within ninety (90) days after notice requesting cure, Yissum shall have the right,
at its option, to terminate this Agreement.

 

     

     

    

 

10.3         Yissum
shall have the right, at its option, to terminate this Agreement in the event that Company shall become involved in insolvency,
bankruptcy, liquidation, winding-up or receivership proceedings. Company shall immediately notify Yissum upon commencement of any
bankruptcy, insolvency, liquidation, winding-up or receivership proceedings or the placing of an attachment on its assets.

 

10.4         In
the event of termination of this Agreement for any reason whatsoever, the License shall terminate and all rights to the Licensed
Technology (including Research Results) shall revert to Yissum and Company may make no further use thereof. Notwithstanding the
aforesaid, the expiration or termination of this Agreement shall not release Company from its obligation to carry out any financial
or other obligation which it was liable to perform prior to the Agreement’s expiration or termination, including the payment
of Royalties and Sub-License Revenues.

 

10.5         Upon
termination of this Agreement for any reason, nothing herein shall be construed to release either Party from any obligation that
matured prior to the effective date of such termination; and Articles 1, 5, 7, 8, 9, 10, 11, 12 and 13 shall survive any such termination.

 

10.6         No
termination of this Agreement shall constitute a termination or a waiver of any rights of either Party against the other Party
accruing at or prior to the time of such termination.

 

10.7         Company
shall have the right to terminate this Agreement at any time on three (3) months advance notice to Yissum, and upon payment of
all amounts due to Yissum through the effective date of termination.

 

SECTION 11

Law

 

11.1         The
provisions of this Agreement and everything concerning the relationship between the parties in accordance with this Agreement shall
be governed by the law of the State of Israel and, subject to Section 12 below, jurisdiction shall be granted only to the appropriate
court in Jerusalem. Any and all proceedings, documents and other communications or correspondences between the parties shall be
in the English language.

 

11.2         Notwithstanding
the above, Company hereby agrees that, in the event that no treaty exists upholding the enforceability of temporary orders and/or
judgments issued by Israeli courts in the foreign jurisdiction in which Yissum may require such an order and/or judgment to be
upheld, Yissum may, at its own discretion, elect the place of jurisdiction for the obtaining of orders and/or judgments against
Company. Company undertakes not to object to the enforcement against it of orders and/or judgments issued by any aforesaid jurisdiction
under such circumstances.

 

SECTION 12

Arbitration

 

12.1          All differences
and disputes arising between the parties in connection with this Agreement and/or its interpretation and/or its performance and/or
breach, shall be referred for the decision of a single arbitrator, who shall be appointed by Agreement between the parties.

 

     

     

    

 

12.2         Should
the parties not reach agreement as to the arbitrator’s identity, the arbitrator shall be appointed by the Chairman of the
Israeli Bar Association on the application of either of the parties.

 

12.3         The
arbitration shall be held in Israel. The arbitrator shall not be bound by the civil procedure regulations and laws of evidence,
but shall be bound by the substantive law of Israel and be liable to give grounds for his decision.

 

12.4         The
arbitrator’s decision shall be final and shall bind the parties.

 

SECTION 13

Miscellaneous

 

13.1         This
Agreement shall be binding upon and shall inure to the benefit of Yissum and its assigns and successors in interest, and shall
be binding upon and shall inure to the benefit of Company and its assigns and successors to all or substantially all of its assets
or business to which this Agreement relates, but shall not otherwise be assignable or assigned by Company without prior written
approval by Yissum being first obtained, which approval shall not be unreasonably withheld.

 

13.2         If
any provision of this Agreement shall be declared by a court of competent jurisdiction to be invalid, illegal or incapable of being
enforced in whole or in part, the remaining conditions and provisions or portions thereof shall nevertheless remain in full force
and effect and enforceable to the extent they are valid, legal and enforceably, and no provision shall be deemed dependent upon
any other covenant or provision unless so expressed herein.

 

13.3         Each
Party hereby agrees that it does not intend to violate any public policy, statutory or common law, rule, regulation, treaty or
decision of any government agency or executive body thereof of any country or community or association of countries; that if any
word, sentence, paragraph or clause or combination thereof of this Agreement is found, by a court or executive body with judicial
powers having jurisdiction over this Agreement or any of its Parties hereto, in a final unappealed order to be in violation of
any such provision in any country or community or association of countries, such words, sentences, paragraphs or clauses or combination
shall be inoperative in such country or community or association of countries, and the remainder of this Agreement shall remain
binding upon the Parties hereto.

 

13.4         The
Parties covenant and agree that if a Party fails or neglects for any reason to take advantage of any of the terms provided for
the termination of this Agreement or if a Party, having the right to declare this Agreement terminated, shall fail to do so, any
such failure or neglect by such Party shall not be a waiver or be deemed or be construed to be a waiver of any cause for the termination
of this Agreement subsequently arising, or as a waiver of any of the terms, covenants or conditions of this Agreement or of the
performance thereof. None of the terms, covenants and conditions of this Agreement may be waived by a Party except by its written
consent. A waiver by Yissum of any breach by Company of any provision or condition of this Agreement to be performed by Company
shall not be deemed a waiver of similar or dissimilar provisions or conditions at the same or any prior or subsequent time.

 

     

     

    

 

13.5         This
Agreement contains the entire agreement and understanding of the Parties with respect to the subject matter hereof, supersedes
any prior agreements and understandings with respect thereto and cannot be modified, amended or waived, in whole or in part, except
in writing signed by the Parties.

 

13.6         Each
Party shall bear its own legal expenses involved in the making of this Agreement.

 

13.7         The
headings to the sections in this agreement are for the sake of convenience only and shall not serve in the Agreement’s interpretation.

 

13.8         Company
shall disclose to Yissum any existing agreement and/or arrangement or relationship of any kind between it and employees of Yissum
and/or the Hebrew University of Jerusalem with respect to the Licensed Technology and in connection therewith and shall not enter
into any agreement or arrangement with any employees of Yissum and/or the Hebrew University of Jerusalem, as aforesaid, without
the prior written consent of Yissum.

 

13.9         The
appendixes annexed hereto constitute an integral part hereof and shall be read jointly with its terms and provisions.

 

13.10       The
recitals hereto constitute an integral part hereof. In this Agreement, unless otherwise required or indicated by the context, the
singular shall include the plural and vice-versa, and the masculine gender shall include all other genders.

 

SECTION 14

Notices

 

All notices and communications pursuant
to this Agreement shall be made in writing and sent by registered mail to or served in person at the following addresses:

 

(i)          If
to Yissum:

 

YISSUM RESEARCH DEVELOPMENT COMPANY

OF THE HEBREW UNIVERSITY OF JERUSALEM

Hi-Tech Park, Edmond J. Safra Campus

Givat Ram, P.O.Box 39135, Jerusalem 91390, Israel

 

(ii)         If
to Company:

 

BIOCANCELL PHARMACEUTICALS INC.

2711 Centerville Road,
Suite 400

Wilmington, New Castle County, Delaware, 19808

and

 

BIOCANCELL PHARMACEUTICALS LTD.

Hi-Tech Park, Edmond J. Safra Campus

Givat Ram, P.O.Box 39135, Jerusalem, 91390, Israel

 

or such other address furnished in writing by one Party to
the other. Any notice sent as aforesaid shall be deemed to have been received five (5) days after being posted by registered mail,
or one (1) day following the date of personal service.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK)

 

     

     

    

 

IN WITNESS WHEREOF,
the Parties hereto have executed and delivered this Agreement in multiple originals by their duly authorized officers and representatives
on the respective dates shown below, but effective as of the Effective Date.

 

YISSUM RESEARCH DEVELOPMENT COMPANY

OF THE HEBREW UNIVERSITY OF JERUSALEM

 

	By:	/s/ Herve Bercovier	 	By:	/s/ Reuven Ron
	 	 	 	 	 
	Name:	Prof. Herve Bercovier	 	Name:	Reuven Ron
	 	 	 	 	 
	Title:	Director	 	Title:	VP Marketing
	 	 	 	 	 
	Date:	November 14, 2005	 	Date:	November 14, 2005

 

BIOCANCELL PHARMACEUTICALS INC.

 

	By:	/s/ Avi Barak	 	By:	/s/ Uri Danon
	 	 	 	 	 
	Name:	Avi Barak	 	Name:	Uri Danon
	 	 	 	 	 
	Title:	Chairman	 	Title:	President
	 	 	 	 	 
	Date:	Nov 14, 2005	 	Date:	November 14, 2005

 

BIOCANCELL PHARMACEUTICALS LTD.

 

	By:	/s/ Avi Barak	 	By:	/s/ Uri Danon
	 	 	 	 	 
	Name:	Avi Barak	 	Name:	Uri Danon
	 	 	 	 	 
	Title:	Chairman	 	Title:	President
	 	 	 	 	 
	Date:	Nov 14, 2005	 	Date:	November 14, 2005Exhibit 10.5

 

 

 

 

 

 

 

 

MASTER
SERVICES AGREEMENT FOR

CLINICAL
RESEARCH AND RELATED SERVICES

 

 

 

 

 

 

 

	INC RESEARCH, LLC

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Table of Contents

 

	1.	DEFINITIONS.	3
	 	 
	2.	SERVICES.	6
	 	 
	3.	TRANSFER OF SPONSOR OBLIGATIONS/RESPONSIBILITIES.	7
	 	 
	4.	INVOICING, COMPENSATIONAND PAYMENT.	8
	 	 
	5.	TERM AND TERMINATION.	10
	 	 
	6.	WARRANTIES, INDEMNIFICATION, LIABILITY AND INSURANCE.	11
	 	 
	7.	CONFIDENTIALITY.	13
	 	 
	8.	PROPRIETARY RIGHTS/LICENSURE.	14
	 	 
	9.	RIGHT TO AUDIT.	15
	 	 
	10.	DISCLAIMER	16
	 	 
	11.	NOTICES	16
	 	 
	12.	FORCE MAJEURE	17
	 	 
	13.	GENERAL PROVISIONS	17

 

 

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This MASTER SERVICES AGREEMENT (“Agreement”),
effectively dated as of the last date of authorized signature herein (“Effective Date”), is made by and between BioCancell
Therapeutics Israel Ltd. Together with its Affiliates (“Sponsor”), a company incorporated in Israel, with principal
offices located at 1/3 High-Tech Village, Givat Ram, Jerusalem, Israel, PO Box 39264, Jerusalem 9139102, Israel and INC
Research, LLC, together with its Affiliates (“INC Research”), a Delaware limited liability company, with principal
offices located in the United States at 3201 Beechleaf Court, Suite 600, Raleigh, North Carolina 27604-1547.

 

WITNESSETH:

 

WHEREAS, Sponsor is engaged in the business
of researching and developing pharmaceutical products and/or biotechnological products;

 

WHEREAS, INC Research is engaged in the
business of providing clinical research services, data management, and related services in the pharmaceutical, biotechnology, and
medical device industries;

 

WHEREAS, Sponsor and INC Research desire
to agree on terms which will be applied to govern INC Research’s provision of services for Sponsor (excluding INC Research
Phase I Services as defined in Section 1) in connection with support of clinical investigation, management and/or research of a
particular Study or Studies; and

 

WHEREAS, both Parties desire to comply
with the terms and conditions hereinafter provided in connection with Study research.

 

* * * * * * * * * * * * * * * * * * * *
* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

NOW, THEREFORE, in consideration of the
foregoing and for other good and valuable consideration, the receipt and adequacy of which hereby are mutually acknowledged, the
Parties intending to be legally bound do hereby agree as follows:

 

		1.	DEFINITIONS.

 

Terms contained in this Agreement
shall have the meanings set forth in this section and as they may be defined throughout this Agreement.

 

		1.1	“Affiliates” shall mean any corporation or organization that directly or indirectly
controls, is controlled by or is under common control with such Party. “Control”, “controls”, or “controlled”
shall mean the possession, direct or indirect, of the power to direct, or the power to cause the direction of the management and
policies of an entity, whether through ownership of fifty percent (50%) of voting securities, by contract or otherwise. Any reference
to “INC Research” in this Agreement shall be deemed to include its Affiliates unless otherwise so stated as being applicable
to INC Research, LLC, or an individual Affiliate exclusively. Any reference to “Sponsor” in this Agreement shall be
deemed to include its Affiliates unless otherwise so stated as being applicable to BioCancell Therapeutics Israel Ltd., or an individual
Affiliate exclusively.

 

		1.2	“Applicable Laws and Regulations” shall mean any and all international, national, federal,
state, and local laws and regulations, including, without limitation, the regulations and guidelines of the FDA, the Food, Drug,
and Cosmetic Act and, as applicable, accepted standards of Good Clinical Practice (“GCP”) and International Conference
on Harmonization (“ICH”) guidelines that may be applicable to a Study or the Services.

 

		1.3	“Change Order” shall mean an amendment to a Work Order that captures a change in the
scope of Services or other Study specific parameters, which may include an increase or decrease in the Direct Costs and expenses
and/or any timeline adjustments required due to the change in assumptions. Each Change Order shall be agreed in writing between
the Parties and expressly approved by an authorized individual on behalf of each Party.

 

 

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		1.4	“Clinical Trial Agreement” shall mean the signed contractual agreement between Sponsor
(or INC Research) and the Investigator and/or Site that manages the relationship, financial support and/or proprietary information
during the performance of the Study by such Investigator and/or Site.

 

		1.5	“Commercially Reasonable Efforts” shall mean the efforts and resources which would
be used (including without limitation the promptness in which such efforts and resources would be applied) by a Party, consistent
with generally accepted industry standards, with regard to the activity to be undertaken by such Party.

 

		1.6	“Confidential Information” shall mean all non-public, protected and/or proprietary
information in the broadest sense communicated, observed, or heard, by either Sponsor or INC Research, including either Party's
employees, consultants, agents, Affiliates, and/or the Study-related Investigators and/or Sites, and Third Party Vendors that relates
to past, present or future research, development, processes, protocol(s), financial statements, personnel information, pricing
and/or business activities of the Party disclosing the Confidential Information (hereinafter “the Disclosing Party”)
and its respective systems, procedures, algorithms, and data of which the Party receiving the Confidential Information (the “Receiving
Party”) may construct, acquire, access, or possess by reason of this Agreement. Confidential Information will include any
 “Confidential Information” disclosed previously by a Disclosing Party to a Receiving Party in connection with the discussions
among the Parties with respect to the subject matter of this Agreement. The Parties further agree that Confidential Information
shall include that information discovered during an audit of either Party’s or its respective Affiliates’ facilities.

 

		1.7	“Direct Costs” shall mean the applicable price charged for labor in the performance
of Services to be performed under this Agreement, as set forth in the applicable Work Order.

 

		1.8	“FDA” shall mean the United States Food and Drug Administration.

 

		1.9	“Force Majeure” shall mean an event or occurrence beyond a Party’s control such
as, but not limited to, the following: acts of God, war, threat of war, government retaliation against foreign enemies, government
regulation or advisory, disasters, floods, fire, earthquakes, pandemics, accidents or other casualty, strikes or threats of strikes
(exception: neither Party may terminate or suspend this Agreement for strikes, labor disputes, or work stoppages involving its
respective employees or agents), civil disorder, terrorist acts and/or threats of terrorism, acts of foreign enemies, or curtailment
of transportation services making it illegal, impossible, or commercially impracticable to perform its obligations under this Agreement.

 

		1.10	“INC Research Phase I Services” shall mean Phase I services performed at an INC Research
facility, where INC Research would serve as a Study Investigator/Site.

 

		1.11	“INC Research Property” means work product templates, inventions, processes, know-how,
improvements, trade-secrets, other intellectual property and assets, including, but not limited to INC Research SAS Codes, methods,
procedures and techniques, manuals, personnel information, internal audit training and policies, financial data, technical expertise
and software, which have been or may be independently developed by INC Research and relate to INC Research’s business or
operations.

 

		1.12	“INC Research SAS® Codes” shall mean SAS program codes created by INC Research
to process, analyze, summarize and report clinical trial data to the Sponsor

 

 

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		1.13	“Indemnity Claim” means any matter upon which an indemnified party intends to base
a claim for indemnification.

 

		1.14	“Investigator” means a qualified clinical investigator as defined in ICH E6 4.1.1 engaged
to conduct a clinical investigation of a particular Study and/or Study Product.

 

		1.15	“Party” means either INC Research or Sponsor; and both collectively as “Parties”.

 

		1.16	“Pass Through Costs” shall mean any costs that are not Direct Costs incurred by INC
Research in the performance of Services, including without limitation, such costs as Service-related travel and Third Party Vendor
fees for items such as printing, laboratory fees, shipping and facsimile costs, language translation, telephone charges, advertising,
investigator meeting expenses, and/or other expenses associated with the conduct of the Study. Travel costs include, but are not
limited to, those associated with reasonable transportation, lodging, internet connection, and meals.

 

		1.17	“Protocol” means the particular written protocol including the clinical testing procedures,
conditions, and instructions for conducting a particular Study.

 

		1.18	“Regulatory Authority” shall mean the FDA or any other state or governing national
or multinational regulatory authority or government agency that is equivalent to or has any similar regulatory functions and responsibilities
as the FDA.

 

		1.19	“Services” shall mean the particular clinical research services and other tasks to
be performed by INC Research for a given Study pursuant to this Agreement, as more fully set forth in the Work Order applicable
to such Study.

 

		1.20	“Site” shall mean a hospital, clinic, institution, academic institution, or office
of a practicing physician participating in the conduct of the Study.

 

		1.21	“Sponsor Losses” shall mean third party claims, actions, damages, liabilities, costs
and expenses (including reasonable legal counsel fees and expenses) incurred by Sponsor.

 

		1.22	“Study” or “Studies” shall mean the clinical investigation, management
and/or research activities related to a particular human clinical trial, or similar Sponsor project conducted pursuant to the applicable
Protocol or Sponsor instructions, including any management and oversight thereof.

 

		1.23	“Study Product” means, for a given Study, the therapeutic compound of Sponsor that
is the subject of such Study, as well as any applicable placebo, potential product, or device administered as a result of the Protocol.

 

		1.24	“Study Records” refers to all information regardless of purpose, format, location,
system or origination that is a result of the conduct of a Study and/or performance of Services by INC Research and/or any INC
Research sub-contracted service providers.

 

		1.25	“Third Party Vendor” shall mean any person or party other than INC Research or Sponsor
involved with the provision of services or goods under a Work Order (including but not limited to hospitals, IRBs, laboratories,
pharmacists, Investigators, and/or Sites).

 

		1.26	“Work Order” means an individual project agreement executed between Sponsor and INC
Research for a given Study that: (a) expressly references this Agreement; (b) is made with respect to such specific Study;
(c) is signed by both Parties; and (d) specifies the parameters of and sets forth the details of the clinical research services
to be performed by INC Research in conducting the Study.

 

 

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		2.	SERVICES.

 

		2.1	Work Order. Each Work Order will specify the basic parameters of a Study, including,
without limitation, the scope of work, Study-specific assumptions, estimated time period for completing Services, estimated budget,
payment and currency schedules, resource allocation and/or, as applicable, other specific Services to be performed by INC Research.
Each Work Order is hereby incorporated herein by reference, subject to mutually agreeable Change Orders.

 

An Affiliate
of a Party can enter into, or perform Services in association with, Work Orders under this Agreement with the other Party or an
Affiliate of the other Party, with such Affiliates being bound by the terms and conditions contained herein, and provided that
each of INC Research, LLC or BioCancell Therapeutics Israel Ltd., as applicable, shall remain responsible for the actions and omissions
of its Affiliates.

 

Each Work Order
shall constitute a unique agreement and shall stand alone with respect to any other Work Order entered under this Agreement. The
performance of obligations under any one Work Order shall not affect, and shall at all times be unrelated to, the performance of
any other Work Order entered into under this Agreement. To the extent that terms and/or provisions of a Work Order conflict with
the terms and/or provisions of this Agreement, the terms and/or provisions of this Agreement shall control unless the Work Order
expressly and specifically states otherwise.

 

 

		2.2	Change Orders. In the event Sponsor requests a change in the scope of Services as
originally defined in the Work Order or if there are changes to the assumptions upon which the Work Order is based (including,
but not limited to, changes in an agreed upon starting date for a Study or suspension of the Study by Sponsor), the Parties will
agree to such change in writing prior to engaging in out of scope activities (“Contract Modification”).

 

Once the need
for a potential Contract Modification is identified, INC Research may provide written description of the Contract Modification,
including any resulting impact to the Study budget, through use of a Change Notification Form (CNF). The CNF will be submitted
to Sponsor for verification of the modifications to the scope of Services, and any resulting Study budget implications. Sponsor’s
execution of the CNF shall serve as Sponsor approval and instruction for INC Research to proceed with the modification of Services
(and resulting budget revisions) as set forth in the CNF. The Parties acknowledge that upon signature of the CNF by Sponsor, the
services set forth in the CNF shall be considered Services to be performed by INC Research under the Work Order, and shall therefore
be governed by and subject to the terms and conditions of this Agreement and corresponding Work Order.

 

A Change Order
shall be completed upon the cumulative CNF(s) Direct Cost and Pass Through Costs equaling to or exceeding the threshold amount
as set forth in the requisite Work Order.

 

Notwithstanding
the above, an exception will apply if a modification reasonably involves the safety of a human subject or the integrity of the
Study data, in which case INC Research shall quickly act on the requested change, and when practicable, give notice promptly to
Sponsor by telephone or electronic communication that such scope change occurred and a Contract Modification may be required.

 

 

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CNFs and Change
Orders may be approved and forwarded via hand-delivery, facsimile, electronic mail, portable document format (PDF), or overnight
courier. Absent compelling reasons, Change Order requests will be considered and a response will be affirmatively given to INC
Research within fifteen (15) calendar days of Sponsor's receipt of same. The Parties agree to work together in good faith and use
Commercially Reasonable Efforts to ensure that the Study timelines are not adversely affected, it being understood, however, that
INC Research is under no obligation to perform any out of scope work until a CNF and/or Change Order is agreed to by both Parties.

 

		2.3	Professional Standards. Each Party shall use Commercially Reasonable Efforts to progress
the Study in a timely manner applying professional standards consistent with GCP and in adherence to Applicable Laws and Regulations.

 

The major Study milestones and
target dates will be described in the applicable Work Order. Subject to mutually agreed Change Order(s), both Parties agree that
the Work Order shall set forth a reasonable schedule for the Services to be performed, and each Party will use Commercially Reasonable
Efforts to comply with the timelines stated therein.

 

		2.4	Interruption or Delay. In the event that any Study is placed on hold for a period
of thirty (30) days or more, Sponsor will compensate INC Research for Study obligations actually incurred per the Work Order prior
to such hold period, which could not have been otherwise reasonably mitigated by INC Research. Additionally, the Parties may negotiate
a commercially reasonable fee to compensate INC Research for retention and training of INC Research-assigned resources for the
Study should the Sponsor wish to retain identified resources. Such compensation shall be set forth in a Change Order as described
in Section 2.2 herein.

 

In the event that a milestone-based
Study is interrupted or delayed for any other reasons beyond INC Research’s reasonable control, to the extent that such milestone(s)
are affected INC Research shall be entitled to receive proportional payments in connection with adjusted milestones for work performed
by INC Research until such delay. For the avoidance of doubt, if such interruption or delay was the result of Force Majeure, the
provisions of Section 12 shall apply.

 

Sponsor acknowledges and agrees
that INC Research will require documents, data records, and cooperative efforts (the “Material”) by Sponsor and/or
other designees in order to properly perform the Services outlined in each Work Order, and that INC Research is not responsible
for errors, delays, or other consequences arising from the failure of Sponsor or such designees to provide such Material. In the
event of a delay caused by actions neither directed by nor attributable to INC Research, which affect INC Research’s ability
to meet any timelines, the Parties shall re-negotiate in good faith to amend the targeted dates accordingly.

 

For the sake of clarity, INC Research
shall not be responsible for errors, omissions and/or delays during the conduct of any Study, to the extent such delays are caused
by or result from (i) Sponsor’s actions or omissions, (ii) any actions or omissions of Third Party Vendors except for acts
or omissions by any of INC Research’s Affiliates or any subcontractors who are selected and have been qualified by INC Research
in accordance with INC Research’s standard operating procedures (“INC Research Selected Subcontractors”), (iii)
a Force Majeure event or (iv) any other causes outside the direct control of INC Research. The financial burden of any additional
costs associated with such delays, that could not have been reasonably prevented or mitigated by INC Research, is the responsibility
of Sponsor. For the sake of clarify, Investigators and/or Sites shall not be considered INC Research Selected Contractors under
this agreement.

 

 

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		3.	TRANSFER OF SPONSOR OBLIGATIONS/RESPONSIBILITIES.

 

The
transfer of obligations and/or responsibilities from Sponsor to INC Research pursuant to Applicable Laws and Regulations will
be mutually agreed and set forth in each individual Work Order. Any such regulatory responsibilities
not specifically transferred to INC Research shall remain the regulatory responsibility of Sponsor. Under no circumstance shall
INC Research be required to accept responsibilities and conduct itself contrary to Applicable Laws and Regulations.

 

		4.	INVOICING, COMPENSATIONAND PAYMENT.

 

		4.1	Direct Cost Compensation. In exchange for valuable consideration with regard to INC
Research’s performance of the Services hereunder, Sponsor shall pay INC Research for Direct Costs in accordance with a detailed
budget, and pursuant to invoices, as described in each applicable Work Order.

 

		4.2	Pass Through Cost Compensation. Pass Through Costs to be incurred by INC Research
from Sponsor-approved Third Party Vendors in connection with INC Research’s performance of Services shall be pre-agreed and
described in each applicable Work Order.

 

As set forth in a Work Order,
INC Research may negotiate the Investigator grants, and/or Site Clinical Trial Agreement terms and/or other Study-related agreements
on behalf of Sponsor and at Sponsor’s direction. Sponsor shall be obligated to provide timely feedback in connection with
any such negotiations, and INC Research shall not be responsible for any undue delays attributable to Sponsor’s failure to
provide approvals and timely responses, if Sponsor was properly and promptly notified by INC Research of the need for a timely
response. The initial Investigator grant payment shall be set forth in the Work Order as applicable. As the Study progresses, such
initial grant payment will be applied to Investigator grant fees and other approved Site fees, including payments for screening
failures and non-complete subjects, all as estimated in the applicable Work Order. INC Research will invoice Sponsor in accordance
with each applicable Work Order in a manner that will enable INC Research to make timely payments to the Investigator or Site in
accordance with the applicable Clinical Trial Agreement, unless Sponsor has agreed to make payments directly to the Site or Investigator.
Said fees shall be paid in advance of INC Research’s expectation to pay the Investigator and/or Site, and Sponsor shall be
responsible for any adverse action taken by an Investigator or Site as a result of Sponsor’s failure to pay amounts and other
costs due and payable in a timely manner. INC Research shall have no liability for any failure to make payments if required funding
is not provided to INC Research by Sponsor in advance. Each Clinical Trial Agreement with Investigators shall contain a statement
to that effect. INC Research shall have no duty to pursue collection of allegedly unearned fees paid to Investigators and/or Sites.

 

In addition, Sponsor shall reimburse
INC Research for all costs and expenses incurred by INC Research or others engaged by INC Research on behalf of Sponsor to ensure
patient safety, continuity of treatment and compliance with Applicable Laws and Regulations, to the extent that such costs are
actual, reasonable and verifiable. Such costs may include, but are not limited to, reasonable and customary costs incurred associated
with the diagnosis of an adverse reaction, adverse event or personal injury involving the Study Product or associated with the
applicable Protocol. In the event that an Investigator reasonably assesses that a diagnostic procedure(s) is/are medically necessary
and connected to the Study, then Sponsor shall be required to pay for reasonable costs of said diagnostic procedure(s).

 

		4.3	Invoicing. Sponsor shall render all payments due and payable to INC Research within
thirty (30) days of the receipt of an invoice.

 

All invoices shall be deemed received:
(i) seven (7) days after the date postmarked if sent by mail; (ii) on the date sent if they are sent electronically; or (iii) one
(1) day after the date sent if delivered by overnight delivery service. In the event that any non-disputed amounts remain unpaid
for ten (10) days after the invoice due date, INC Research may stop work on the Services until it receives such past due payment.
However, prior to any such work stoppage, INC Research shall give five (5) business days’ notice of its intent to cease Services
to allow escalation of the issue within Sponsor’s organization and the Parties shall discuss resolution of the nonpayment
of non-disputed amounts in good faith. Other than as may be required under Applicable Laws and Regulations, INC Research shall
have no liability to Sponsor for any costs or damages as a result of such suspension caused by Sponsor’s failure to pay non-disputed
amounts in accordance with the payment terms contained herein.

 

 

	INC RESEARCH, LLC

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If any portion of an invoice is
disputed, then Sponsor shall pay the undisputed amounts according to the payment terms herein. If Sponsor, in good faith identifies
items in an invoice which are disputed, Sponsor will notify INC Research in writing, noting its objection to the disputed item(s)
with specificity, within ten (10) business days of receipt of the invoice. Invoices for which no written objection is received
by INC Research by Sponsor within such ten (10) business day period shall be deemed accepted by Sponsor as true and correct. INC
Research will respond to such written notification within ten (10) business days of receipt of the disputed notification. This
communication exchange will continue until documentation justifying the charge has been provided to Sponsor or until INC Research
reduces or deletes the disputed amount to Sponsor’s reasonable satisfaction. Any dispute over invoiced amounts due that cannot
be resolved by direct good faith negotiation between the parties shall be resolved in accordance with Section 13.9 (Dispute Resolution)
of this Agreement. Should INC Research be required to utilize a third party invoicing service/system as mandated by Sponsor, any
costs associated with such utilization shall be invoiced to Sponsor as incurred, without mark-up.

 

Sponsor shall not withhold payment
of any amounts due and payable under a specific Work Order by reason of any setoff any claim or dispute with INC Research related
to a separate Work Order, or, relating to INC Research’s breach, bankruptcy or otherwise.

 

		4.4	Study Close and Financial Records. Within the latter of (i) ninety (90) days after
the conclusion of the Services; or (ii) sixty (60) days after the receipt of a final invoice from a Third Party Vendor for each
Work Order, INC Research will submit to Sponsor a final invoice with an accounting of all amounts invoiced by INC Research, and
all payments made by Sponsor. Any overpayment by Sponsor shall be credited or refunded to Sponsor by INC Research within thirty
(30) days of the final invoice. Any underpayment by Sponsor shall be paid to INC Research within thirty (30) days after receipt
by Sponsor of such final invoice.

 

INC Research shall keep and maintain
complete and accurate books and records in sufficient detail to determine amounts owed to INC Research hereunder. Such books and
records shall be maintained for at least one (1) year following completion or termination of a Work Order and shall be made available
for inspection, copying and audit by Sponsor in accordance with Section 9 and for the purpose of determining the accuracy of amounts
invoiced.

 

		4.5	Taxes. INC Research shall invoice Sponsor, and Sponsor shall promptly pay or reimburse
INC Research for taxes or duties actually incurred by INC Research which are imposed upon INC Research by any governmental agency,
including, but not limited to Value Added Tax, Stamp Tax and/or General Sales Tax (collectively the “Taxes”),
as a result of and subject to this Agreement with the exception of taxes based on INC Research’s income. If requested by
INC Research, Sponsor shall deliver to INC Research official documentation for such taxes paid.

 

If any payments made by the Parties
under this Agreement become subject to withholding taxes under Applicable Laws and Regulations, each Party shall be authorized
to withhold such taxes as are required under Applicable Laws and Regulations, pay such taxes to the appropriate government authority,
and remit the balance due to the other Party net of such taxes. The Parties agree to cooperate in good faith to qualify the transactions
for any exemptions or reductions in the amount of otherwise applicable withholding tax provided under Applicable Laws and Regulations
(including the provisions of any relevant income tax treaty) and to complete such forms as necessary for such purpose.

 

 

	INC RESEARCH, LLC

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		4.6	Currency. Unless otherwise agreed in the applicable Work Order, Sponsor shall make
all payments to INC Research in United States dollars (“US Currency”), and accordingly INC Research shall invoice Sponsor
for all Direct Costs and Pass Through Costs in US Currency. If Direct Costs are incurred in a currency other than US Currency,
then INC Research and Sponsor will define the mechanism for currency exchange adjustment in the Work Order. If Pass Through Costs
are incurred in a currency differing from US Currency, then INC Research shall invoice Sponsor using the exchange rate published
in oanda.com at the average bid rate on the day the expense invoice is generated by INC Research.

 

		5.	TERM AND TERMINATION.

 

		5.1	General Term. This Agreement shall commence as of the Effective Date and shall continue
for a period of five (5) years, or until earlier terminated as provided below. Any Work Orders in existence as of the date of expiration
or termination of this Agreement shall continue to be governed by the terms and conditions of this Agreement unless such Work Order
is specifically terminated in accordance with the terms herein, or as otherwise mutually agreed in writing by the Parties.

 

		5.2	Termination. Sponsor may terminate this Agreement or any and all associated Work
Order(s) upon sixty (60) days written notice to the other Party. Upon receipt of notice of termination, INC Research shall use
reasonable efforts to avoid incurring additional costs and expenses on the project during the closeout or winding down period.

 

Either Party may terminate this
Agreement or any individual Work Order as follows:

		a)	On written notice effective immediately if the other Party commits a material breach of this Agreement
or a Work Order which cannot be cured, or for a material breach of this Agreement or a Work Order which is capable of cure but
is not cured within thirty (30) days of receipt of written notice from the other Party (“material breach” being defined
herein as failure to substantially comply with any material provision of this Agreement or any Work Order, including without limitation
failure by Sponsor to pay any undisputed portion of an invoice within thirty (30) days of receipt of notice of an overdue invoice);

		b)	On written notice effective immediately if the other Party becomes insolvent, is dissolved or liquidated,
makes a general assignment for the benefit of its creditors, files or has filed against it, a petition in bankruptcy, or has a
receiver appointed for a substantial part of its assets, which petition in bankruptcy or appointment of a receiver is not revoked
within 30 days;

		c)	On written notice effective immediately if the other Party ceases to carry on business or maintain
itself as a going concern; or

		d)	On written notice effective immediately as a result of reasonably compelling scientific evidence
that patient safety is at risk should the Study continue, Study data integrity compromise, and/or reasonable belief that Applicable
Laws and Regulations will be materially violated should this Agreement continue in effect.

		e)	Sponsor may immediately terminate this Agreement if INC Research notifies it of a conflict of interests
as set forth in Section 10.5.

 

 

	INC RESEARCH, LLC

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		5.3	Termination Obligations.

Upon receipt of a termination
notice, the Parties will promptly meet and agree upon any winding down activities and associated costs for any Study prior to the
performance of any additional tasks not otherwise addressed in a Work Order. Costs associated with any winding down period will
be invoiced to Sponsor on fee for service basis using the rates in effect as of the termination date unless otherwise agreed upon
by the Parties. If the Study is suspended or terminated, no further Study subjects shall be enrolled, however, routine follow-up
actions needed to monitor the safety of Study Subjects shall continue subject to Section 5.4.

 

		5.4	Payment Obligations Upon Termination. In the event of termination of any Work Order,
Sponsor will pay to INC Research any Direct Costs and Pass Through Costs incurred and/or actual costs resulting from commitments
(including the fulfillment of any regulatory requirements), which cannot reasonably be cancelled and which were entered into by
INC Research with respect to the Services at the time of notice of termination provided that INC Research has used Commercially
Reasonable Efforts to minimize such costs.

 

In the event of excess payment
to INC Research by Sponsor, INC Research shall either apply such excess payment as a credit against other amounts due and payable
or promptly refund such excess if there are no outstanding payments owed INC Research. Sponsor shall pay INC Research any additional
amounts owed, but not yet paid, for Services performed or expenses incurred up to the effective date of termination.

 

Any payment(s) due and payable
under this Section 5.4 shall be made in accordance with Section 4.3 of this Agreement.

 

		5.5	Study Records Retention. At Sponsor’s request and expense, and following satisfaction
of Sponsor’s obligations, if the provision of INC Research’s Services, and/or Services provided by any INC Research
sub-contracted service providers, under this Agreement are terminated by either Party for any reason, INC Research shall transfer
all regulatory responsibility for the Study Records to Sponsor and provide Sponsor with all applicable Study Records. The transfer
of Study Records will occur within ninety (90) days following the effective date of termination unless otherwise mutually agreed
upon in writing by the Parties. INC Research may elect to retain copies of some or all such Study Records according to INC Research’s
standard practices for preserving its business records and in accordance with Applicable Laws and Regulations. INC Research shall
maintain any such copies of Study Records as Confidential Information of Sponsor.

 

INC Research will not retain any
regulatory responsibility for the Study Records and will not store Sponsor’s Study Records on its premises on Sponsor’s
behalf after the termination or expiration of the Work Order. The Parties may mutually agree to extend Services related to the
Study Records in a Change Order, or in a separate agreement, that details the terms for the extended retention period and compensation
for such retention. In the event that Sponsor is unable or refuses to accept the return of the Study Records for any reason, INC
Research may elect to dispose of any Study Records according to its policies and in a confidential manner unless otherwise prohibited
by Applicable Laws and Regulations. INC Research will demonstrate due diligence in contacting Sponsor to provide notification of
the intention to dispose of Study Records at least ninety (90) days prior to disposition.

 

		6.	WARRANTIES, INDEMNIFICATION, LIABILITY AND INSURANCE.

 

		6.1	Warranties. Each Party Represents and warrants the other that the Services and obligations set forth respectively
in this Agreement will be performed in accordance with all Applicable Laws and Regulations. Sponsor warrants to INC Research that
it will provide accurate and sufficient Materials to INC Research to enable INC Research to carry out the Services hereunder diligently
and in compliance with Applicable Laws and Regulations.

 

 

	INC RESEARCH, LLC

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		6.2	Indemnification by Sponsor. Sponsor shall defend, indemnify, and hold harmless INC
Research, its Affiliates and its and their respective directors, officers, employees, agents and Third Party Vendors from and against
any and all third party losses, claims, actions, damages, liabilities, awards, costs and expenses (including reasonable legal counsel
fees and expenses), whether joint or several, arising from or in connection with this Agreement or the Services contemplated herein,
including without limitation, any Study, Protocol, specifications, or Study Product, performed or administered as a direct result
of this Agreement and or its associated Work Order(s), or any litigation, investigation or other proceeding relating to any of
the foregoing except to the extent the third party losses, actions, damages, liabilities, awards, expenses, costs and claims result
from (i) the negligence or reckless or willful act or omission of INC Research, its Affiliates, or its and their respective directors,
officers, employees or agents; or (ii) any breach of this Agreement by INC Research, its Affiliates, or its and their respective
directors, officers, employees or agents.

 

		6.3	Indemnification by INC Research. INC Research shall defend, indemnify, and hold harmless
Sponsor, its Affiliates and its and their respective directors, officers, employees, and agents from and against any and all Sponsor
Losses, but only to the extent such Sponsor Losses are related to or arise from or in connection with INC Research’s negligence
or intentional misconduct, except to the extent that such Sponsor Losses arise from (i) the negligence or reckless or willful act
or omission of Sponsor, its Affiliates or its and their respective directors, officers, employees or agents; or (ii) any breach
of this Agreement by Sponsor, its Affiliates, or its and their respective directors, officers, employees or agents.

 

		6.4	Indemnification Procedures. The Party seeking indemnity will give the indemnifying
Party prompt written notice of an Indemnity Claim under this Section 6. The indemnified Party shall have the right to participate
jointly with the indemnifying Party, at its own expense, in the defense, settlement or other disposition of any Indemnity Claim.
With respect to any Indemnity Claim relating solely to the payment of money damages and which could not result in the indemnified
Party becoming subject to injunctive or other equitable relief or otherwise adversely affect the business of the indemnified Party
in any manner, and as to which the indemnifying Party shall have acknowledged in writing the obligation to indemnify the indemnified
Party hereunder, the indemnifying Party shall have the sole right to defend, settle or otherwise dispose of such Indemnity Claim,
on such terms as the indemnifying Party, in its sole discretion, shall deem appropriate, provided that the indemnifying Party shall
offer evidence of its ability to pay any damages claimed and with respect to any such settlement shall have obtained the written
release of the indemnified Party from the Indemnity Claim. The indemnifying Party shall obtain the written consent of the indemnified
Party, which shall not be unduly withheld, conditioned or delayed, prior to ceasing to defend, settle or otherwise dispose of any
Indemnity Claim if, as a result thereof, the indemnified Party would become subject to injunctive or other equitable relief or
the business of the indemnified Party would be adversely affected in any manner.

 

		6.5	Third Party Vendor Indemnification. Upon reasonable request by Sponsor-approved Third
Party Vendors utilized in connection with this Agreement, Sponsor shall execute and provide a separate letter of indemnification
with such Third Party Vendors, in a form mutually acceptable to the parties. If requested by Sponsor, and at Sponsor’s expense,
INC Research will assist administratively with the tasks related to this Section 6.5. Notwithstanding the above, INC Research shall
not be required to indemnify any Third Party Vendors required by Sponsor or mutually selected between the Parties to be obtained
in accordance with a Study, and INC Research shall not be responsible for any delays resulting from negotiations involving Sponsor
and Third Party Vendors which are related to the indemnification rights of any such Third Party Vendor.

 

 

	INC RESEARCH, LLC

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		6.6	Limitation of Liability. In no event will either Party be liable for any indirect,
special, incidental or consequential damages in connection with or related to this Agreement (including loss of profits, use, data,
or other economic advantage), howsoever arising, either out of breach of this Agreement, including breach of warranty, or in tort,
even if the other Party has been previously advised of the possibility of such damage. Except in the case where liability may not
be capped under applicable law, each Party’s total liability for damages shall be limited to one and one-half times (1.5x)
the value of the services completed under the applicable Work Order (excluding Pass Through Costs).

 

		6.7	Insurance. Upon written request, each Party shall provide the other with a copy of
its effective Certificate of Insurance or such other documented evidence offering that it has adequate coverage consistent with
human clinical trial industry standards and as specified below.

 

For the entire term of the Agreement,
INC Research shall procure and maintain appropriate insurance with coverage for its own liabilities, and if such insurance policies
are on a "claims made" basis, the insurance should be in effect for an additional period that accounts for the entire
period during which INC Research and/or Sponsor and/or Sponsor affiliates remain legally liable.

 

INC Research’s insurance
policies should at least include the following: (i) workers compensation insurance; (ii) employer liability insurance; (iii)
general liability insurance; (iv) professional liability insurance, including cyber and breach of privacy coverage not less than
US $10,000,000; (v) any other insurance that is required by law in the state in which the INC Research and/or its Affiliates acting
in the capacity of a contract research organization, are registered and/or provide services to or for Sponsor. INC Research shall
promptly provide notice to Sponsor in the event it becomes aware of a material reduction in coverage as stated herein.

 

If requested by Sponsor to contract
with any Third Party Vendors, INC Research shall ensure that such Third Party Vendors are adequately insured and may request a
Certificate of Insurance evidencing the same from such Third Party Vendors.

 

Sponsor represents and warrants
that its Clinical Trials insurance(i) does not have an exclusion for the Study Product, (ii) covers the Study which is the subject
of this Agreement or any Work Order and iii) is compliant with all Applicable Laws and Regulations, standards, and requirements
relative to the performance of Services contemplated under this Agreement . For the avoidance of doubt, Sponsor will arrange for
and purchase Clinical Trials insurance for each applicable Clinical Trial.

 

Sponsor shall maintain a global
Clinical Trials Insurance coverage with a limit of Liability to be mutually agreed as per each applicable Work Order and local
admitted Clinical Trials policies if required with compulsory amounts indicated by local statutory requirements in the country
in which the Clinical Trials are being performed.

 

Sponsor's global Clinical Trials
policy shall be in effect during the term of the applicable Work Order and for at least three (3) years after the termination or
expiration of such Work Order, in either a primary policy or an extended reporting period endorsement. The parties’ liability
shall not be limited to what which is recoverable by insurance.

 

		7.	CONFIDENTIALITY.

 

		7.1	Obligations. Either Sponsor or INC Research may become the recipient of Confidential
Information of the other during the term of this Agreement. The Receiving Party shall treat the Disclosing Party’s Confidential
Information as confidential and proprietary and shall protect it with the same level of prudence and care as it would protect its
own proprietary or confidential information, but in no event less than reasonable care. The Receiving Party shall not disclose
the Confidential Information to any third party except to the extent that they reasonably need to know the disclosed information
to carry out the purposes of this Agreement. Additionally INC Research is authorized to disseminate limited, blinded, and automatized
Protocol or Study information necessary to perform core business functions as well as for the purpose of soliciting and evaluating
Third Party Vendor bids and project costing.

 

 

	INC RESEARCH, LLC

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		7.2	Exceptions. Confidential Information shall not include, and these confidentiality
obligations shall not operate as a restriction on each Party’s right to use, disclose, or otherwise deal with information
which can be proven by the Receiving Party:

 

		a)	was in the Receiving Party’s possession prior to the time it was acquired from the Disclosing
Party and which was not directly or indirectly acquired from the Disclosing Party;

		b)	is or lawfully becomes generally available to the public through no fault of Receiving Party;

		c)	is lawfully and independently made available to the Receiving Party by a third party;

		d)	is released from its confidential status by the Disclosing Party; or

		e)	is independently developed by or for the Receiving Party without the use of the Disclosing Party’s
Confidential Information as evidenced by the Receiving Party’s written records.

 

Nothing in this Agreement shall
be construed to restrict the Parties from disclosing Confidential Information as required by law or court order or other governmental
order or request, provided in each case the Party requested to make such disclosure shall, to the extent permitted by law, timely
inform the other Party and use all Commercially Reasonable Efforts to limit the disclosure and maintain the confidentiality of
such Confidential Information to the extent possible. In addition, the Party required to make such disclosure shall permit the
other Party to attempt to limit such disclosure by appropriate legal means.

 

The Parties acknowledge that Sponsor
is a public company, traded on the Tel-Aviv Stock Exchange Ltd. and as such is subject to disclosure requirements under applicable
laws and regulations (including securities laws), and therefore it shall be entitled to issue public statements in connection with
the engagement hereunder, to the minimal extent required under such laws and regulations. Furthermore it should be noted that the
Confidential Information and the terms of this Agreement may be considered as inside information, as such term is defined under
the Israeli Securities Law – 1968 and regulations promulgated thereunder.

 

		7.3	Term of Confidentiality. These obligations of confidentiality shall remain in effect
for a period of seven (7) years after the expiration or termination of this Agreement.

 

		8.	PROPRIETARY RIGHTS/LICENSURE.

 

		8.1	Ownership. All materials, documents, information, programs and suggestions initially
provided to INC Research by Sponsor or on behalf of Sponsor in connection with any Study shall be the exclusive property of Sponsor.
Any copyrightable work created by INC Research in direct connection with the performance of INC Research’s Services as outlined
in this Agreement and contained in the Study data shall be considered work made for hire, whether published or unpublished, and
all rights therein shall be the property of Sponsor as author and owner of copyright in such particular work. Notwithstanding the
above, Sponsor acknowledges that any INC Research Property that is improved, modified or developed by INC Research under or during
the term of this Agreement shall be the sole and exclusive property of INC Research.

 

		8.2	Publication. Sponsor shall be free to publish or utilize Study data for promotion
or other purposes. At Sponsor’s own expense, Sponsor may request collaboration from INC Research or its Study-related Third
Party Vendors to assist with preparation of the manuscript. If INC Research is required to negotiate and/or execute Clinical Trial
Agreements, Sponsor will consider publication requests initiated by such Study-related Institution(s) and/or Site(s). INC Research
shall have no liability whatsoever for any delay resulting from such Sponsor consideration and response.

 

 

	INC RESEARCH, LLC

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		8.3	Licensure. Sponsor certifies that all relevant required licenses, including but not
limited to those connected with drug dictionaries, and in particular the Uppsala Monitoring Centre and the Medical Dictionary for
Regulatory Activities (MedDRA), shall at all times during the course of this Agreement be in full force and effect. In accordance
with the requisite licensing agreement and validation requirements, Sponsor agrees to provide evidence of such licensure to INC
Research and/or permits INC Research to seek validation from the licensor.

 

		8.4	Software Rights. INC Research may facilitate the distribution of software and associated
software documentation in accordance with this Agreement. INC Research may accordingly grant Sponsor a non-exclusive right to use,
store, disseminate such software and associated program documentation for the sole purpose of conducting a clinical trial for which
INC Research is providing relevant Services.

 

Additionally, Sponsor and INC
Research agree that INC Research SAS Codes shall be deemed INC Research Property as defined herein. Upon request by Sponsor, and
solely to the extent necessary for the utilization by Sponsor of the Services or any work product, INC Research will grant Sponsor
an non-exclusive, nontransferable, non-sublicensable, worldwide, paid-up, royalty-free, right and license to use, reproduce, distribute,
and modify the INC Research SAS Codes for Sponsor’s internal research purposes, with a reservation of rights in INC Research
to use, reproduce, distribute and modify the INC Research SAS Codes.  Unless otherwise agreed in writing between the parties,
Sponsor will not be entitled to receive any enhancements, updates, or new versions of the INC Research SAS Codes.  Additionally,
the SAS Codes are provided to Sponsor as-is and INC Research disclaims any and all warranties pertaining to the SAS Codes. 
Sponsor shall assume any and all liability for any use of and modifications made by Sponsor to the Licensed SAS Codes.

 

		9.	RIGHT TO AUDIT.

 

		9.1	INC Research will permit Sponsor-designated representatives (unless such representatives are competitors
of INC Research) to examine, at a reasonable time and during normal business hours, raw Study data, financials and other relevant
information, which Sponsor may reasonably require in order to confirm that the Study is being conducted in conformance with the
Protocol and in compliance with Applicable Laws and Regulations. Such audits shall be limited to one audit per twelve-month period
at no-cost to Sponsor. Additional audits shall be at Sponsor’s expense. Sponsor will provide INC Research with a minimum
of thirty (30) days advance notice of its intention to conduct such audit in order for INC Research to facilitate the availability
of appropriate staff. INC Research will notify Sponsor as soon as practical if any Regulatory Authority requests an inspection
or commences an unscheduled inspection that includes any aspect of Sponsor’s project(s) in the inspection scope.

 

		9.2	Both Parties shall promptly notify the other Party of any Regulatory Authority inspections, investigation
or inquiry concerning any Study or project of Sponsor for which INC Research is performing Services (“Inspection”).
Where appropriate and permitted by the Regulatory Authority, Sponsor will have the right to be present at any such Inspections
if they occur on INC Research premises. INC Research will have primary responsibility for preparing any responses for Inspections
occurring on INC Research premises and Sponsor shall be responsible for providing information to INC Research required for providing
adequate responses to Inspection findings as required. Sponsor, its agents and consultants shall strictly observe all obligations
of confidentiality concerning any documents, information, data or materials in accordance with Section 7.1 herein. Commercially
reasonable costs associated with hosting and responding to any Inspection (including any preparation, participation, follow-up
and resolution of findings), shall be reimbursed by Sponsor on a time and materials basis.

 

 

	INC RESEARCH, LLC

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		9.3	If, during the course of conducting the Services, INC Research becomes aware of information which
indicates possible fraud/misconduct by an Investigator and/or at a Site, and after a reasonable investigation determines that the
possibility of fraud/misconduct is substantiated, INC Research will promptly inform Sponsor of its findings and present an action
plan for Sponsor's approval. It will be Sponsor’s responsibility to conduct a full investigation outside of the action plan
unless delegated to INC Research by Sponsor, in which case Sponsor shall pay for all reasonable costs incurred by INC Research
to perform such investigation. If fraud or misconduct (hereafter together referred to as “fraud” for purposes of this
section 9.3) is confirmed, then it will be the responsibility of Sponsor to notify the FDA or any other appropriate Regulatory
Authority. After completion of its investigation, Sponsor will provide evidence satisfactory to INC Research either (i) that fraud
was not committed or, (ii) if fraud was committed, that confirms the proper reporting of the fraud to the appropriate Regulatory
Authority. If Sponsor does not investigate the possible fraud within a reasonable time, or if fraud is confirmed by investigation
and Sponsor does not fulfill its obligations to report the fraud within a reasonable time, then INC Research may report its suspicions
of possible fraud to the appropriate Regulatory Authority and notify Sponsor of this action in writing.

 

		10.	DISCLAIMER

 

		10.1	Sponsor acknowledges that the results of the Services to be provided as outlined herein are inherently
uncertain and that, accordingly, there can be no assurance, representation or warranty by INC Research that the Study Product will
be successfully marketed by Sponsor.

 

		10.2	Sponsor acknowledges that INC Research shall not be responsible for the authenticity of the Study
Product.

 

		10.3	Sponsor acknowledges that the terms of this Agreement exclude all implied warranties including,
but not limited to, the implied warranties of merchantability and fitness for a particular purpose.

 

		10.4	Sponsor acknowledges that the Services to be provided by INC Research as outlined herein are based
upon information supplied by INC Research and Sponsor, as well as others, and that INC Research does not guarantee or warrant the
results of such Services to any functions or other standards, except as explicitly set forth herein.

 

		10.5	Independent Contractor; No Conflicts of Interest. INC Research is performing the
Services as an independent contractor and not as an employee, agent, franchise, partner of, or joint venturer with Sponsor. Any
Third Party Vendors are understood to be exercising independent judgment, and shall not be deemed to be employees, subcontractors,
and/or agents of INC Research; and under no circumstance shall INC Research be responsible for the conduct of, or the independent
or medical judgment, of any such third party.

 

INC Research
represents that there is no conflict of interest between performance of this Agreement and the performance of services by INC Research
for any other party that would materially and adversely prevent the performance of Services under this Agreement. In the event
that INC Research believes that there is any such conflict, or any such conflict arises during the term of this Agreement, INC
Research will immediately notify the Sponsor, which may at its sole discretion, terminate this Agreement pursuant to Section 5.2,
without liability to INC Research.

 

 

	INC RESEARCH, LLC

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		11.	NOTICES

 

This Agreement,
including any exhibits, may be amended or modified only by an instrument of equal formality signed by duly authorized representatives
of the respective Parties. All formal or legal notices, requests, demands or other communications hereunder, other than communications
reasonably deemed to be day-to-day within the duties of project management shall be in writing and shall be deemed given if personally
delivered or disseminated by nationally recognized courier or certified mail with return receipt within five (5) days after prior
mailing to the address set forth below:

 

	If to: 	BioCancell Therapeutics Israel Ltd. 
	 	1/3 High-Tech Village, 
	 	Givat Ram, Jerusalem, Israel, 
	 	PO Box 39264, 
	 	Jerusalem 9139102, Israel
	 	 
	If to: 	INC RESEARCH, LLC
	 	Attention: Global Sponsor Solutions
	 	INC Research, LLC
	 	3201 Beechleaf Court
	 	Suite 600 
	 	Raleigh, NC 27604-1547
	 	Phone: 919-876-9300 
	 	Facsimile: 919-882-0425

 

		12.	FORCE MAJEURE

 

The performance
of this Agreement by either Party, in part or in full, may be impacted by a Force Majeure event. In such a case, either Party may
terminate, suspend, or partially perform its obligations under this Agreement, without liability or further obligation, by written
notice to the other Party if such obligations are delayed, prevented, or frustrated by any of the above events, or similar events
or occurrences, to the extent such events or occurrences are beyond the reasonable control of the Party whose reasonable performance
is prevented, made impracticable, or partially curtailed; provided, however, that Sponsor must perform its obligations to pay for
all INC Research non-cancellable expenses incurred as a result of the above events or similar intervening causes. Sponsor also
agrees to pay all reasonable expenses incurred in connection with Sponsor-directed meetings whereby any of the above actions or
threats of actions prevent the attendees from attending or delay the departure of attendees from a designated meeting facility.
Unless otherwise agreed by the Parties in writing, any deadline or time for performance which falls due during or subsequent to
such Force Majeure event shall be automatically extended for a minimum period of time equal to the period of disability.

 

		13.	GENERAL PROVISIONS

 

		13.1	Compliance with Government Regulations. To the extent applicable, both Sponsor and
INC Research shall comply with any applicable validated methodology, generally accepted professional standards of care, and all
Applicable Laws and Regulations of each country where the Services will be conducted, including without limitation ICH Guidelines
for GCP. The Parties will also comply to the extent applicable with the United States Federal anti-kickback statute (42 U.S.C.
1320a-7b), and the related safe harbor regulations. Should any such government regulatory requirements be changed, each Party will
use Commercially Reasonable Efforts to satisfy the new requirements. In the event that compliance with such new regulatory requirements
necessitates a change in the Services, the Parties will evaluate a Contract Modification to be mutually agreed for the changes
in the Services.

 

 

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Both Sponsor
and INC Research warrant that they are, and will remain, in compliance with the Foreign Corrupt Practices Act (“FCPA”)
and/or all other, applicable anti-bribery laws or regulations. A breach of this warranty, will allow the non-breaching Party to
immediately terminate this Agreement and/or any associated Work Order.

 

Nothing contained in this Agreement
shall be construed in any manner as an obligation or inducement for either Party to recommend that any person or entity purchase
the other Party’s products or services, or those of any organization affiliated with the other Party.

 

In the event of a conflict between
the terms of this Agreement and a Work Order, the terms of this Agreement shall prevail unless otherwise so stated in the Work
Order, with the written confirmation of both Parties, in which case the altered terms shall apply only to the Work Order in which
the acknowledgement is explicit and shall not change the terms of this Agreement.

 

		13.2	Qualifications. Each Party hereby represents that it has not been debarred and has
not been convicted of a crime which could lead to debarment under the Generic Drug Enforcement Act of 1992. Each Party hereby represents
that to the best of its knowledge it has not utilized, and will use its reasonable efforts not to utilize, the services of any
individual or legal entity in the performance of Services or obligations under this Agreement that has been convicted of a crime
which could lead to debarment. In the event that INC Research becomes aware that any of its officers, directors or employees has
become debarred, then INC Research shall notify Sponsor promptly.

 

		13.3	Survival of Terms. The rights, duties and obligations under Sections 4, 6, 7, 8,
9, 10, 13 and Appendix A shall survive the termination or expiration of this Agreement.

 

		13.4	Binding Agreement. This Agreement shall be binding upon the Parties hereto and shall
inure to the benefits of the Parties hereto. No modification of this Agreement shall be deemed effective unless engaged in writing
and executed as described herein, and any waiver granted shall not be deemed effective unless in writing, executed by the Party
against whom enforcement of the waiver is sought.

 

		13.5	Data Processing. To the extent the Services involve the processing of personal data
within the European Economic Area (EEA), the parties agree that such processing will be governed by the terms set forth in Appendix
A to this Agreement.

 

		13.6	Entire Agreement. The making, execution, and delivery of this Agreement by INC Research
and Sponsor have been induced by no representations, statements, warranties, or agreements other than those herein expressed. This
Agreement, in conjunction with its attachments, embodies the entire and integrated understanding between the Parties hereto and
supersedes all prior agreements or understandings, negotiations, or representations either written or oral, regarding its subject
matter.

 

		13.7	No Effect to Printed Standard Terms. Regardless of anything to contrary, no printed
standard terms appearing on any proposal, purchase order, invoice, quotation, or other documentation relating to the Services will
be effective in adding to or changing the terms of this Agreement or any Work Order.

 

		13.8	Governing Law. This Agreement shall be governed by and construed and enforced in
accordance with the laws of the State of Delaware, excluding that body of law known as choice of law, and shall be binding upon
the Parties hereto in the United States and worldwide.

 

		13.9	Dispute Resolution. In the event a dispute arises between the Parties over the interpretation
and application of this Agreement, the Parties shall attempt to settle such a dispute first by good faith negotiation and consultation
between themselves with senior representatives with authority to resolve the dispute.

 

 

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If such efforts do not result
in a resolution, and at least thirty (30) days have elapsed since notification of the dispute, then the Parties may next seek to
mediate their dispute using a professional mediator from the American Arbitration Association (AAA). The Parties agree to convene
with the mediator, with senior representatives of the Parties present (having authority to resolve the dispute), for at least one
session.

 

If mediation does not result in
the resolution of a dispute or sixty (60) days have elapsed since the notification of the dispute, the Parties agree to resolve
the dispute through arbitration before a single arbitrator in accordance with the Commercial Arbitration Rules of the AAA, then
pertaining (available at www.adr.org), except where those rules conflict with this provision, in which case this provision controls.
Any court with jurisdiction shall enforce this clause and enter judgment on any award. The arbitrator shall be selected within
ten (10) business days of commencement of the arbitration from the AAA’s National Roster of Arbitrators pursuant to agreement
or through selection procedures administered by the AAA. Within forty-five (45) days of initiation of arbitration, the Parties
shall reach agreement upon and thereafter follow procedures assuring that the arbitration will be concluded and the award rendered
within no more than eight (8) months from selection of the arbitrator or, failing agreement, procedures meeting such time limits
designated by the AAA. The arbitration shall be held in a mutually agreed neutral setting and shall apply the substantive law of
Delaware, except that the interpretation and enforcement of this arbitration provision shall be governed by the Federal Arbitration
Act. The arbitrator shall be bound by the expressed terms of this Agreement. Each Party shall bear their own costs in connection
with any of the remedial actions set forth above.

 

By agreeing to arbitration, the
Parties do not intend to deprive any competent court of such court’s jurisdiction to issue a pre-arbitral injunction, pre-arbitral
attachment or other order in aid of the arbitration proceedings and the enforcement of any award or judgment. Without prejudice
to such provisional remedies in aid of arbitration as may be available under the jurisdiction of a national court, the court of
arbitration shall have full authority to grant provisional remedies and to award damages for failure of any party to respect the
court of arbitration’s order to that effect.

 

		13.10	Waiver. Waiver or forbearance by either Party or the failure by either Party to claim
a breach of any provision of this Agreement or to exercise any right or remedy provided by hereunder, or under Applicable Laws
and Regulations, shall not constitute a waiver with respect to any subsequent breach of this Agreement.

 

		13.11	Severability. If any part, term, provision or provisions of this Agreement shall
be held to be invalid, illegal, unenforceable or in conflict with the law of jurisdiction, the validity, legality and enforceability
of the remaining provisions shall not in any way be affected or impaired thereby.

 

		13.12	Headings Not Controlling. Headings used in this Agreement are for reference purposes
only and shall not be used to modify the meaning of the terms and conditions of this Agreement.

 

		13.13	Counterparts. This Agreement along with any requisite Work Order may be executed
in several counterparts by duly authorized individuals on behalf the Parties, each document of which shall be deemed an original
but all of which shall constitute one and the same instrument.

 

Signatures on following
page.

 

 

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IN WITNESS WHEREOF, the undersigned
have caused this Agreement to be executed by a duly authorized individual on behalf of each requisite Party effective as of the
Effective Date. In the event that the Parties execute this Agreement by exchange of portable document format, other electronically
signed copies or facsimile signed copies, the Parties agree that, upon being signed by both Parties, this Agreement shall become
effective and binding and that such copies will constitute evidence of the existence of this Agreement. Thereafter, the Parties
agree that in connection with request for information that either Party may need from the other related to the Services provided
hereunder, both Parties expressly permit communication via facsimile or electronic means to the extent allowed by Applicable Laws
and Regulations to be disseminated in that manner.

 

	
        INC RESEARCH, LLC

        
	 	BIOCANCELL THERAPEUTICS ISRAEL LTD.
	 	 	 
	 	 	 
	By:	/s/ Andrew I. Shaw	 	By:	/s/ Jonathan Burgin
	Name:	Andrew I. Shaw	 	Name:	Jonathan Burgin
	Title:	Assistant General Counsel	 	Title:	COO & CFO
	Date:	Oct 19, 2017	 	Date:	Oct 25, 2017

 

	
        INC RESEARCH, LLC

        
	 	BIOCANCELL THERAPEUTICS ISRAEL LTD.
	 	 	 
	 	 	 
	By:	/s/ Tony Proctor	 	By:	/s/ Or Dolev
	Name:	Tony Proctor	 	Name:	Or Dolev
	Title:	VP – Business Finance	 	Title:	Controller
	Date:	Oct 19, 2017	 	Date:	Oct 25, 2017

 

 

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APPENDIX A

Data Processing

 

		1.	Scope and Order of Precedence. 

 

This Appendix A (the “Data Processing
Appendix”) concerns the processing of Personal Data (as defined below) as part of the Services provided by INC Research,
as further specified in the Agreement, the applicable work order between Sponsor and INC Research, and all documents, addenda,
schedules and exhibits incorporated therein.

 

This Data Processing Appendix is subject
to the terms of the Agreement. In the event of any conflict between the terms of the Agreement and the terms of this Data Processing
Appendix, the relevant terms of this Data Processing Appendix shall prevail.

 

		2.	Definitions. 

		·	“Model Clauses” means the Standard Clauses for the Transfer of Personal Data
to Processors in Third Countries under Directive 95/46 approved by Commission Decision of February 5, 2010, including Appendices
1 and 2 thereto.

		·	“Personal Data” means any information relating to an identified or identifiable natural
person; an identifiable or identifiable natural person (a “data subject”) is one who can be identified, directly or
indirectly, in particular by reference to an identification number or to one or more factors specific to his/her physical, physiological,
mental, economic, cultural or social identity.

		·	“Privacy and Data Protection Requirements” means Directive 95/46/EC on the protection
of individuals with regard to the processing of Personal Data and on the free movement of such data and the General Data Protection
Regulation 2016/679 as of its effective date of May 25, 2018.

		·	“Data Controller”, “Data Processor” and “Processing” shall
have the meaning as respectively defined under the Privacy and Data Protection Requirements.

 

Other terms have the definitions provided
for them in the Agreement unless otherwise specified herein.

 

		3.	Categories of Personal Data and Purpose of the Personal Data Processing. 

In order to execute the Agreement, and
in particular to perform the Services on behalf of Sponsor, Sponsor authorizes and requests that INC Research process the following
Personal Data:

 

Categories of Personal Data: Personal Data
may include, among other information, personal contact information such as name, address, telephone or mobile number, email address,
and business contact details; information concerning health, family, lifestyle and social circumstances including age, date of
birth, and marital status. Categories of Data Subjects: Data subjects include (i) Sponsor’s representatives and personnel,
such as employees, contractors, collaborators, and partners of the Sponsor; and (ii) patients involved with clinical trials.

 

INC Research shall process Personal Data
solely for the provision of the Services, and shall not otherwise (i) process and use Personal Data for purposes other than those
set forth in the Agreement or as instructed by Sponsor, or (ii) disclose such Personal Data to third parties other than INC Research
Affiliates or its vendors for the aforementioned purposes or as required by law.

 

		4.	Sponsor’s Instructions. 

During the term of the Agreement, Sponsor
may provide instructions to INC Research in addition to those specified in the Agreement with regard to processing of Personal
Data. INC Research will comply with all such instructions without additional charge to the extent necessary for INC Research to
comply with laws applicable to INC Research as a Data Processor in the performance of the Services.

 

 

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		5.	Controller of Data. 

The control of Personal Data remains with
Sponsor, and notwithstanding anything to the contrary, Sponsor will at all times remain the Data Controller for the purposes of
the Services, the Agreement, and this Data Processing Appendix. Sponsor is responsible for compliance with its obligations as Data
Controller under the Privacy and Data Protection Requirements, in particular for justification of any transmission of Personal
Data to INC Research and for its decisions concerning the processing and use of the data.

 

		6.	Rights of Data Subject. 

INC Research will follow Sponsor’s
detailed written instructions to delete, release, correct or block access to Personal Data. INC Research shall pass on to the Sponsor
any requests of an individual data subject to delete, release, correct or block Personal Data processed under the Agreement.

 

		7.	Cross Border and Onward Data Transfer. 

INC Research treats all Personal Data in
a manner consistent with the requirements of the Agreement and this Data Processing Appendix in all locations globally. INC Research’s
information policies, standards and governance practices are managed on a global basis.

 

INC Research acknowledges that some data
handled in providing the Services to the Sponsor may be Personal Data of, or related to, European Union (EU) data subjects. Where
INC Research’s processing of such Personal Data takes place in countries that have not received an "adequacy" finding
pursuant to the Privacy and Data Protection Requirements, INC Research shall ensure that transfers of such Personal Data to INC
Research Affiliates and contractors in such countries are made in compliance with the applicable requirements of the Privacy and
Data Protection Requirements concerning international and onward data transfers.

 

With respect
to data stored or processed in the United States, at all times during the performance of the Services, INC Research, LLC will process
Personal Data originating from the European Economic Community according to the relevant EU-U.S. Privacy Shield Principles. INC
Research has certified its participation with the EU-U.S. Privacy Shield program by adopting the Privacy Shield Principles to its
Data Privacy policies and practices. NC Research’s certification to the Privacy Shield is listed at https://www.privacyshield.gov/list.
In the event of a lapse of INC Research’s Privacy Shield certification status, INC Research will promptly remedy such a lapse
or work with Sponsor to find an alternative means of meeting the adequacy requirements of the Privacy and Data Protection Requirements,
such as executing Model Clauses in accordance with the Privacy and Data Protection Requirements. 

 

With respect
to Personal Data stored by INC Research in data centers in the European Union, INC Research shall ensure compliance by the INC
Research Affiliates and by vendors with the requirements of this Section 7 as follows: (i) INC Research, LLC and the INC Research
Affiliates are subject to a global policy requiring compliance with the relevant Privacy Shield principles and with all applicable
INC Research security and data privacy policies and standards, and further permitting each INC Research Affiliate to enter into
Model Clauses on behalf of INC Research, LLC and the remaining entities as necessary, and (ii) in the case of vendors assisting
in the performance of the Services, by way of contracts with vendors having access to Personal Data which provide that the vendor
will undertake data protection and confidentiality obligations consistent with the Privacy Shield principles and with the INC
Research Vendor Security Standards; further, where a vendor accesses and processes Personal
Data in a country that has not received an “adequacy” finding pursuant to the Privacy and Data Protection Requirements,
INC Research will require the vendor to execute Model Clauses incorporating security requirements consistent with those of this
Data Processing Appendix. 

 

 

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		8.	Affiliates and Vendors. 

Some or all of INC Research’s obligations
under the Agreement may be performed by INC Research Affiliates. INC Research subsidiary handling Personal Data have adopted safeguards
consistent with those of the INC Research subsidiary contracting with a sponsor for INC Research Services.

 

INC Research also may engage third party
vendors to assist in the provision of the Services. All vendors are required to abide by substantially the same obligations as
INC Research under this Data Processing Appendix as applicable to their performance of the Services. Sponsor consents to INC Research’s
use of INC Research Affiliates and vendors in the performance of the Services in accordance with the terms of Sections 7 and 8
above.

 

		9.	Technical and Organizational Measures. 

When processing Personal Data on behalf
of Sponsor in connection with the Services, INC Research shall ensure that it implements and maintains compliance with appropriate
technical and organizational security measures for the processing of such data. In particular, INC Research will implement the
following:

 

		9.1	To prevent unauthorized persons from gaining access to data processing systems in which Personal
Data are processed or used (physical access control), INC Research shall take measures to prevent physical access, such as security
personnel and secured buildings and factory premises.

		9.2	To prevent data processing systems from being used without authorization (system access control),
the following are applied: authentication via passwords and/or two-factor authentication, documented authorization processes, documented
change management processes, and logging of access on several levels. In addition, currently the following security processes are
applied: intrusion detection system, patch and vulnerabilities management, centralized logging and alerting, and firewalls. Logging
is accomplished at system, platform and application levels.

		9.3	To ensure that persons entitled to use a data processing system only have access to the Personal
Data to which they have privilege of access, and that Personal Data cannot be read, copied, modified or removed without authorization
in the course of processing or use and/or after storage (data access control), Personal Data is accessible and manageable only
by properly authorized staff, direct database query access is restricted, and application access rights are established and enforced.

		9.4	To ensure that Personal Data cannot be read, copied, modified or removed without authorization
during electronic transmission or transport, and that it is possible to check and establish to which entities the transfer of Personal
Data by means of data transmission facilities is envisaged (transmission control), INC Research will comply with the following
requirements: transfers of data outside the INC Research systems are encrypted.

		9.5	To ensure that the Personal Data are processed strictly in accordance with the instructions of
the Sponsor, INC Research must comply with the instructions of the Sponsor concerning processing of Personal Data; such instructions
are specified in the Agreement and in this Data Processing Appendix, and may additionally be provided by Sponsor in writing from
time to time.

		9.6	To ensure that Personal Data are protected against accidental destruction or loss, back-ups are
taken on a regular basis; back-ups are encrypted and are secured.

		9.7	To ensure that Personal Data which are collected for different purposes may be processed separately,
data from different sponsors’ environments is logically segregated on INC Research’s systems.

 

		10.	Incident Management and Breach Notification. 

INC Research evaluates and responds to
incidents that create suspicion of unauthorized access to or handling of Personal Data. INC Research’s Global Information
Security Officer (“GISO”) and/or his delegate(s) are informed of such incidents and, depending on the nature of the
activity, define escalation paths and response teams to address those incidents. GISO and/or his delegates will work with Sponsor,
with internal INC Research lines of business, with the appropriate technical teams and, where necessary, with outside law enforcement
to respond to the incident. The goal of the incident response will be to restore the confidentiality, integrity, and availability
of the Personal Data, and to establish root causes and remediation steps.

 

 

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For purposes of this section, “Security
Breach” means the misappropriation of Personal Data located on INC Research systems or electronic media that compromises
the security, confidentiality or integrity of such information. INC Research shall promptly inform Sponsor if INC Research determines
that Personal Data has been subject to a Security Breach (including by an INC Research employee) or any other circumstance in which
Sponsor is required to provide a notification under applicable law, unless otherwise required by law.

 

INC Research shall promptly investigate
any Security Breach and take reasonable measures to identify its root cause(s) and prevent a recurrence. As information is collected
or otherwise becomes available, unless prohibited by law, INC Research will provide Sponsor with a description of the Security
Breach, the type of data that was the subject of the Security Breach, and other information Sponsor may reasonably request concerning
the affected persons. The parties agree to coordinate in good faith on developing the content of any related public statements
or any required notices for the affected persons.

 

		11.	Return and Deletion of Personal Data Upon End of Services or at Sponsor’s Request
(“Data Portability”). 

Following termination of the Services,
INC Research will promptly make Sponsor’s Personal Data as of the date of termination available for export. Following return
of the data and at Sponsor’s request, INC Research will promptly delete or otherwise render inaccessible all copies of Personal
Data, except as may be required by law.

 

		12.	Legally Required Disclosures. 

Except as otherwise required by law, INC
Research will promptly notify Sponsor of any subpoena, judicial, administrative or arbitral order of an executive or administrative
agency or other governmental authority (“demand”) that it receives and which relates to the Personal Data INC Research
is processing on Sponsor’s behalf. At Sponsor’s request, INC Research will provide Sponsor with reasonable information
in its possession that may be responsive to the demand and any assistance reasonably required for Sponsor to respond to the demand
in a timely manner. Sponsor acknowledges that INC Research has no responsibility to interact directly with the entity making the
demand.

 

		13.	Service Analyses. 

INC Research may (i) compile statistical
and other information related to the performance, operation and use of the Services, and (ii) use data from the Services in aggregated
form for security and operations management, to create statistical analyses, and for research and development purposes (clauses
i and ii are collectively referred to as “Service Analyses”). INC Research may make Service Analyses publicly available;
however, Service Analyses will not incorporate Sponsor’s Content or Confidential Information in a form that could serve to
identify Sponsor or any data subject, and Service Analyses do not constitute Personal Data. INC Research retains all intellectual
property rights in Service Analyses.

 

		14.	Communications. 

The person(s) or entity authorized by Sponsor
to issue instructions under this Data Processing Appendix are those specified as contacts under the order for the Services or as
set out in the Agreement. In the event that any of these contacts are changed or permanently unavailable, Sponsor must communicate
this immediately to INC Research in writing, appointing a replacement.

 

 

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