Document:

Exhibit 10.3

 

SUPPLY
AGREEMENT

 

BETWEEN

 

POLYPLUS-TRANSFECTI
ON SA, a company organized under the laws of France (“Polyplus”), having its place of business at Bioparc, Boulevard
Sebastien Brant, 67401 Illkirch (France) hereinafter referred to as “SELLER” or “Seller”

 

AND

 

BIOCANCELL
Therapeutics Israel Ltd, having its registered office at 1/3 High Tech Village, Givat Ram, Jerusalem (Israel), hereinafter referred
to as “BUYER” or “Buyer” (each being referred to individually as a Party and collectively as the Parties)

 

WHEREAS

 

Seller
is a biotechnology company dedicated to the development, manufacturing and marketing of transfection reagents. These chemical
agents make it possible for DNA, interfering ribonucleic acids (siRNA) or proteins to enter into cells.

 

In
particular, Seller is the exclusive licensee of U.S. Patent No. 6,013,240, European Patent No. 0770140 and foreign equivalents
covering the use of Polyethylenimine (PEI), or Polypropylenimine (PPI) or cationic polymers similar in structure thereto for transfecting
cells, as well as compositions comprising these cationic polymers and at least one nucleic acid (hereinafter referred to as the
“Patents”).

 

In
addition, Polyplus owns, has also developed, and is currently developing some know-how relating to methods for manufacturing PEI
and derivatives, including analyses methods. in vivo-jetPEITM, a proprietary product developed and distributed by Polyplus,
is currently manufactured either by Polyplus or by Polyplus subcontractors acting under Polyplus’ instructions. At the present
time, Seller’s subcontractors authorized to manufacture in vivo-jetPEITM in compliance with EC Guideline to GMP and
FDA requirements are <Omitted> (hereinafter: “Product Maker”), in its capacity as a GMP manufacturer of API;
and <Omitted> (hereinafter: “Product Formulator”) in its capacity as a GMP Fill and Finish subcontractor. in
vivo-jetPEITM is dedicated to research or preclinical phases, as well as clinical trials.

 

Buyer
is willing to use in vivo-jetPEITM in human clinical trials and is therefore willing to be regularly supplied with in vivo-jetPEITM
manufactured under GMP standards.

 

Given
the very high distinctiveness of the Product as defined hereinafter in Article 1.15, the Parties, intending to be legally bound,
agree on the establishing of a long-lasting contractual relationship to make easier the regularity and the quality of the supply
of this Product.

 

The
Parties agree to enter into the present agreement (hereinafter: “Supply Agreement”) and into a separate Quality Agreement
with respect to quality matters relating to compliance with GMP and related laws regulation.

 

    	1

    	 

    

 

NOW,
THEREFORE, IT HAS BEEN AGREED AS FOLLOWS:

 

ARTICLE
1

 

DEFINITIONS

 

For
the purposes of this Supply Agreement, the following terms used herein with an initial capital letter shall have the following
respecting meanings, and shall be applicable both to the singular and plural forms:

 

“Affiliate”
shall mean, with respect to a Party, any company or other business entity of which the securities or other ownership interests
representing fifty per cent (50%) or more of the equity or fifty per cent (50%) or more of the ordinary voting power are, at the
time such determination is being made, owned, controlled or held, directly or indirectly, by such Party.

 

“Active
Pharmaceutical Ingredient” (API) (or “Drug Substance”) shall mean any substance or mixture of substances,
intended to be used in the manufacture of a drug product and that, when used in the production of a drug becomes an active ingredient
of the drug product.

 

“Batch”
shall have the meaning ascribed to this term in Appendix II.

 

“Business
Days” means the part of a day from 9 am to 5 pm (“Business Hours”) Monday through Friday, except for French
or Israeli holidays. References to dates or termination of a period which do not fall on a Business Day shall be construed as
references to the immediately subsequent Business Day.

 

“Certificate
of Analysis” shall mean the certificate to be released by the Seller or its accredited subcontractors regarding the
quality and the features of each Batch of Product. This certificate displays the Specifications and the actual test results.

 

“Clinical
Trials” shall mean any investigation in human subjects intended to discover or verify the clinical, pharmacokinetic
(study of the processes of bodily absorption, distribution, metabolism, and excretion of compounds and medicines), and/or other
pharmacodynamic (study of interactions between drugs and living structures) effects of (an) investigational drug(s), and/or to
identify any adverse reactions to (an) investigational drug(s), with the object of ascertaining its(their) safety and/or efficacy.
For the sake of clarity, it is hereby stated that, according to international standards, clinical trials are usually broken down
into the following three steps:

 

Phase
I studies, corresponding to the first time the drug is tested in (a limited number of) humans, and which are primarily concerned
with the drug’s safety, with the purpose of determining how the experimental drug is absorbed, metabolized, and excreted
in humans. Additionally, these studies seek to determine what types of side effects occur as the dosage of the drug is increased.
Any beneficial effects of the drug are also noted.

 

Phase
II studies, generally conducted on a random and blinded basis on several hundred patients, and whose aim is (i) to test the experimental
drug in the patients that have the disease or condition that the drug is expected to improve/cure, (ii) to evaluate the effectiveness
of the drug, and (iii) to determine the correct dosage, that is, the most effective dosage with the least number of side effects
(dose-ranging studies). In general, the purpose of Phase II studies is to provide the sponsor and the competent regulatory agency
with comparative information about the relative safety of the experimental drug, the proper dosage needed to treat the condition,
and the drug’s effectiveness.

 

    	2

    	 

    

 

Phase
III studies, where the experimental drug is tested in several hundred to several thousand patients with the disease/condition
of interest, with this large-scale testing seeking to provide the sponsor as well as the competent regulatory agency with a more
thorough understanding of the drug’s effectiveness, benefits/risks, and range/severity of possible adverse side effects.

 

“Confidential
Information” shall mean any technical or business information furnished by one Party (the “Disclosing Party”)
to the other Party (the “Receiving Party”) in connection with this Supply Agreement, regardless of whether such information
is specifically designated as confidential and regardless of whether such information is in written, oral, electronic or other
form. Such Confidential Information may include, without limitation, the trade secrets, knowhow, inventions, formulations, compositions,
synthesis operating procedures, protocols, technical data or specifications, testing methods, business or financial information,
research and development activities, product and marketing plans, and customer and supplier information. The Confidential Information
shall not include applicable information which the Receiving Party can demonstrate:

 

was
in the public domain prior to the time of its disclosure under this Supply Agreement;

 

entered
the public domain after the time of its disclosure under this Supply Agreement through means other than an unauthorized disclosure
resulting from an act or omission by the Receiving Party;

 

was
independently developed or discovered by the Receiving Party prior to the time of its disclosure under this Supply Agreement,
as demonstrated by contemporaneous written evidence;

 

is
or was disclosed to the Receiving Party at any time, whet her prior to or after the time of its disclosure under this Supply Agreement,
by a third party having no fiduciary relationship with the Disclosing Party and having no obligation of confidentiality with respect
to such Confidential Information; or

 

is
required to be disclosed so as to comply with applicable laws or regulations, or with a court or administrative order, provided
that the Disclosing Party receives, to the extent practicable, prior written notice of such disclosure and the opportunity to
assess the need to disclose and/or limit the scope of disclosure, and that the Receiving Party takes all reasonable and lawful
actions to obtain confidential treatment for such disclosure and, if possible, to minimize the extent of such disclosure.

 

Confidential
Information shall not be deemed to be in the public domain merely because it is embraced by more general information in the public
domain, or merely because individual items of Confidential Information are in the public domain, without a notice or suggestion
associated with such individual items to be combined in the manner suggested by the Disclosing Party.

 

    	3

    	 

    

 

“Drug
Product” shall mean a finished dosage form (e.g., tablet, capsule, solution) that contains an API generally, but not
necessarily, in association with one or more other ingredient.

 

“Drug
Substance”: see “Active Pharmaceutical Ingredient”

 

“Field”
shall mean research applications, in particular, the in-vivo use in Clinical Trials, for phases I,II and Ill of those Clinical
Trials.

 

“GMP”
shall mean Good Manufacturing Practice promulgated by the Regulatory Authorities, as detailed in the Rules Governing Medicinal
Products in the European Community and in the US current Good Manufacturing Practices (CFR210 and 211). These guidelines describe
the requirements for the Quality System under which the API or the Drug Product are manufactured.

 

“Latent
Defect” shall have the meaning ascribed to this term in the Quality Agreement.

 

“Obvious
Defect” shall have the meaning ascribed to this term in the Quality Agreement.

 

“Purchase
Order” shall mean Seller’s quotation executed by Buyer.

 

“Product(s)”
shall mean the in vivo-jetPEITM, manufactured by or on behalf of Seller, in compliance with EU guidelines to GMP and FDA
requirements, according to the applicable Specifications, or any product whose function is accurately equivalent, provided such
product received the prior written approval of the Buyer.

 

“Specifications”
shall mean the applicable specifications in Appendix I or as agreed between Seller and Buyer for the Product delivered to the
Buyer. The applicable specifications are defined in the Purchase Orders. The Specifications may be changed by mutual written agreement
of the Buyer and the Seller in accordance with the Quality Agreement.

 

ARTICLE
2

 

SUBJECT
MATIER OF THE CONTRACT

 

2.1          Subject
to the terms and conditions of this Supply Agreement, Buyer agrees to purchase from Seller at least <Omitted> of the API
needed for use in the Field and Seller agrees to supply Buyer with all amounts of the API as detailed in Purchase Orders which
may be executed by the Parties from time to time. In the event of any conflict between this Supply Agreement and a Purchase Order,
the Purchase Order shall prevail.

 

<Omitted>

 

    	4

    	 

    

 

Seller
agrees to supply Buyer with the Product in compliance with the Specifications and amounts as detailed in the Purchase Orders.

 

2.2          The
Product will be supplied either as the API under lyophilized form or as the Drug Product provided as a sterile aqueous formulated
solution, as shall be detailed in the applicable Purchase Order.

 

2.3          It
is agreed that Buyer may subcontract the Fill and Finish process to obtain the Drug Product directly from <Omitted>

 

<Omitted>

 

The
prices in Appendix II are based on the purchase of a minimum of <Omitted> of the API by Buyer manufactured in accordance
with the Specifications in Appendix I. Should Buyer fail to <Omitted>

 

ARTICLE
3

 

FORECASTS
AND ORDERS

 

General:
On receipt and acceptance of an order from Buyer according to Articles 3.3 and 3.4, the Product will be produced by Seller or
on behalf of Seller and Seller will deliver or have delivered by Product Maker or by Product Formulator each Batch of Product
within the delivery time agreed upon in the applicable Purchase Order.

 

    	5

    	 

    

 

Forecasts:
In order to ensure proper application of § 3.1 hereinabove, Buyer shall provide Seller with written non-binding rolling forecasts
of its requirements of Product for use in the Field regarding Phase I of Clinical Trials, broken down by quarter for the ensuing
12 (twelve) months. Buyer shall provide Seller with written forecasts of its Product requirements for use in the Field under Phase
II and Phase Ill of the Clinical Trials at least 12 (twelve) months before the beginning of each of those new phases, including
cases where there is an overlap of Phases or coupling of one Phase with another (“Fast Track”). Such forecasts shall
be updated every quarter.

 

Orders:
Buyer shall place its firm Purchase Orders at least <Omitted> before the desired delivery date of the API and at least <Omitted>
before the desired delivery date for the Drug Product, for the order of one Batch. For the order of 2 Batches or more, placed
within the same 3 (three) month period, Buyer shall consult Seller and the Parties shall agree upon the applicable delivery time.
The Parties shall agree from time to time on the information to be included in the Purchase Order.

 

Acceptance
of orders: Seller shall fill Buyer’s orders for Product for use in the Field. To the extent they exceed Buyer’s forecast
for such Clinical Trial, Seller shall use its reasonable efforts to fill any portion of the orders exceeding the forecast to the
extent they do not exceed <Omitted> of this forecast. Seller shall have a period of 5 (five) Business days as from receipt
of the Purchase Order by Seller in which to confirm its acceptance of each order. Seller may only reject an order for Product
if it does not conform with the terms and conditions of this Supply Agreement. Only an accepted Purchase Order duly executed by
Buyer shall be considered a valid order from Buyer. Failure to confirm acceptance of a Purchase Order within the aforesaid time
period shall be interpreted as acceptance of the Purchase Order.

 

ARTICLE
4

 

QUALITY;
OTHER SELLER OBLIGATIONS

 

Seller
warrants that all Products sold to Buyer hereunder shall be produced by Buyer and/or Product Maker and/or Product Formulator in
accordance with the latest revision of the EC Guide to Good Manufacturing Practices and of the US cGMP guidelines (CFR 201 and
211), shall be of good and merchantable quality and comply with the applicable Specifications. It is understood that, even if
a Batch of Product meets all Specifications at the time of delivery, its stability will be affected by the passing of time. The
re-test date for a Batch of Product has been settled to 4 years. However, the stability of the Product is much shorter when the
Product is mixed to constitute a compound. Buyer shall be completely responsible for storage and preserving conditions of the
Product after delivery. Likewise, (i) Buyer shall remain responsible for storage conditions of the Product employed by investigators,
inspectors, clinical research coordinators and other persons involved in clinical studies, and undertakes to inform them about
Product features and requirements as to storage and preservation.

 

Promptly
after the time of delivery of Product, Buyer shall verify the quantity and visually inspect the quality of the Product. No claim
for Obvious Defect or shortage in quantity of any individual shipment of Product shall be valid unless made in writing within
ten (10) Business days from the date of delivery of Product, together with Certificates of Analysis, except in the event of Latent
Defects, in which case such claims shall be made within ten (10) Business days from discovery of such Latent Defect. Such written
notice shall explain the non-conformity to Specifications.

 

    	6

    	 

    

 

Seller
shall make up any shortfall and/or replace all Product non-conforming to the requirements of Section 7. (i) and/or Section 4,at
no additional cost to Buyer, within 6 (six) months for the API and 10 (ten) months for the Drug Product.

 

If
a dispute arises concerning conformity of the Product to Specifications, the requirements of Section 7.l(i), or requirements as
agreed to by the Parties, in whole or in part, such dispute shall be referred to a reputable independent testing organization
recognized by the pharmaceutical industry, mutually agreed by the Parties. The fees and expenses of such organization shall be
borne by the losing Party. The settlement of such dispute shall be limited to the loss or damage arising directly from the non-conformity
of the Product without prejudice to any additional remedies that may be perused by the Parties.

 

Both
Parties undertake to comply with the Quality Agreement entered into by the Parties. The Quality Agreement will supersede the present
Supply Agreement in the event of a conflict between the terms of the Quality Agreement and the present Supply Agreement with respect
to quality matters.

 

Seller
will ensure that Product Maker and Product Formulator are maintaining all licenses, registrations and other authorizations as
are required to operate a GMP pharmaceutical manufacturing facility under the Applicable Laws as defined in the Quality Agreement.

 

ARTICLE
5

 

DELIVERY

 

Seller
shall deliver or have delivered by Product Maker or by Product Formulator the Product to the recipient as indicated by Buyer.
The Product shall be packaged in keeping with the nature of the Product in order to maintain its qualities. Risk for the Product
and transfer of title shall pass to Buyer at the time of delivery.

 

Seller
shall provide to Buyer the following documents: (i) the Certificate(s) of Analysis related to the Product (ii) the different “Batch
Production Record(s)” related to the product and (iii) all documents that may be required regarding the GMP or FDA requirements
related to the Product for each delivery at the time of such delivery.

 

Delivery
of the Product will be made EXW, manufacturing premises, INCOTERMS 2000 [the Seller delivers when he places the goods at the disposal
of the Buyer at the Seller’s premises or another named place - not cleared for export and not loaded on any collecting vehicle.
Seller is not responsible for loading the Product or for clearing the Product for export. Buyer bears all costs and risks involved
in taking the Product from the Seller’s premises to the desired destination and the related consequences shall apply even
when Seller accepts to arrange transportation on behalf of Buyer]. The place of delivery will be specified in the applicable Purchase
Order.

 

    	7

    	 

    

 

All
orders of Products shall be delivered by Seller within the time period referred to in the applicable Purchase Order (the “Delivery
Time”).

 

Notwithstanding
the provisions of Article 5.4 above, Seller shall use reasonable commercial efforts to ensure that all orders are delivered within
the Delivery Time agreed in the Purchase Order, especially in those circumstances when Buyer notifies the Seller that the delivery
is of an urgent nature.

 

The
Parties agree and understand that time is of the essence in the delivery of the Products and that any delays will cause harm to
Buyer.

 

If
an order is delivered after the Delivery Time as agreed in the Purchase Order, other than for reasons of force majeure as defined
hereinafter in Article 11.1, Buyer shall be entitled to receive from Seller liquidated damages (hereinafter: “Liquidated
Damages”), which shall be calculated as follows:

 

<Omitted>

 

The
Liquidated Damages shall not be conditional on Buyer proving any loss or damage.

 

The
Liquidated Damages due to Buyer from Seller may be deducted from the price to be paid for the delayed order pursuant to Article
6 herein.

 

ARTICLE
6

 

PRICE
AND PAYMENT CONDITIONS

 

Prices:
The current prices for the Product manufactured according to the Specifications described in Appendix I are set forth in Appendix
II. The prices in Appendix II or in the Purchase Order, as agreed upon between the parties, are exclusive of any taxes and duties,
such as sales, export, import, value-added tax, excise duty, shipping costs, insurance, which shall be added as applicable. All
final prices for an order shall be as set forth in the applicable Purchase Order(s). Seller may require changes in the current
prices to (i) reflect changes in Specifications, Batch s ize, packaging and process alterations pursuant to an agreement entered
into by the Parties (including but not limited to the signature by Buyer of a quotation from Seller) providing for the modification
of the Specifications, of the Batch size, of the packaging or process alterations; or to (ii) comply with changes in the EC Guide
to Good Manufacturing Practices or the US cGMP guidelines (CFR 201 and 211).

 

    	8

    	 

    

 

Invoices:
Seller shall issue an invoice for forty percent (40%) of the nominal amount of each order upon acceptance. The balance, plus or
minus adjustments for the quantity actually delivered shall be invoiced according to milestones payments to be defined between
the Parties at the time of the order, it being specified that in case the Parties fail to reach agreement, the balance shall be
fully paid under the following conditions: thirty percent (30%) on release of the API from the production process, thirty percent
(30%) upon delivery to the Buyer or the Buyer’s nominated contractor or Product Formulator or within forty five (45) days
of the release of the API from the production process whichever is the sooner.

 

Buyer
shall pay invoices in Euros by bank transfer to the account indicated in the invoices. All invoices are to be paid within thirty
(30) days from the date of invoice.

 

Any
payments not made on or before the due date shall accrue interest, from the tenth day following a written payment reminder sent
by Seller to Buyer until paid, at a rate equal to the EURIBOR in effect on the date such payment first became due and payable.

 

Should
payment(s) not be made by the Buyer within eleven (11) days of receipt of a payment reminder, Seller reserves the right to halt
the production process or the formulation process with immediate effect and Seller will not be held liable or responsible to Buyer
for any consequences of such halt nor be deemed to have defaulted under or breached the present Supply Agreement for failure or
delay in fulfilling or performing any term of the Supply Agreement. Buyer shall indemnify Seller from all costs arising out of
such delay in payment and/or halt in the production process or formulation process.

 

Cancellation
for non-payment: Should any payment not be received within 60 days from the invoice date, this Supply Agreement may be cancelled
eo ipso upon Seller’s request.

 

Option
for Fill and Finish Services: On written request from Buyer and receipt of the required technical information from Buyer, Seller
will provide Buyer with a formal sales quotation for Fill and Finish services to produce formulated Drug Product.

 

ARTICLE
7

 

PRODUCT
LIABILITY AND INDEMNIFICATION

 

Warranties:
Seller warrants that: (i) Product(s) sold to Buyer pursuant to this Supply Agreement shall, at the date of delivery, be free from
defective material and workmanship, conform to the Specifications, contain no Latent Defects, satisfy current FDA requirements
and be in compliance with applicable EU legal and regulatory requirements as may be amended from time to time; (ii) Seller has
requisite know-how, required expertise, and experience regarding the Product; (iii) the Product(s) do not infringe any patents,
trademarks or other intellectual property or proprietary rights owned or controlled by any third party; and (iv) no litigation
or threatened litigation exists in connection with the Patent or the other intellectual property rights related to the Products.
However, no representation is made by Seller, expressly or by implication, that the use of the Products in Clinical Trials conducted
by Buyer will not infringe such third party proprietary rights.

 

SELLER
MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, CONCERNING THE PRODUCT, and, in particular, makes no warranty regarding the effectiveness
of the Product once it has been mixed to constitute a compound.

 

    	9

    	 

    

 

Seller’s
indemnification and hold harmless agreement for the benefit of Buyer: Seller shall defend, indemnify and hold Buyer, its Affiliates
and the officers, directors and employees of each harmless from and against any and all claims, demands, loss, damage, liabilities,
settlement amounts, costs or expenses whatsoever (including reasonable attorneys’ fees and costs) arising from any claim,
action or proceeding made or brought against such party by a third party as a result of (a) non-conformity of the Product to the
requirements of Section 7.l(i); (b) violation or infringement of third party intellectual property or other proprietary rights
by the Product; (c) Seller’s intentional act or grave misconduct in performing its obligations herein; or (d) Seller’s
breach of its obligations as detailed herein. SELLER MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED, CONCERNING THIS PROTECTION.

 

Buyer’s
indemnification and hold harmless agreement for the benefit of Seller: Buyer shall defend, indemnify and hold Seller, it’s
Affiliates and the officers, directors and employees of each harmless from and against any and all claims, demands, loss, damage,
liabilities, settlement amounts, costs or expenses whatsoever (including reasonable attorneys’ fees and costs) arising from
any claim, action or proceeding made or brought against such party by a third party as a result of (a) Buyer’s breach of
its obligations as detailed herein, (b) the use of the Product outside the Field, (c) any damage caused by the use of the Product,
except for damage due to a defect in the Product caused, in whole or in part, from the manufacture of the Product, a default in
the storage of the Product prior to delivery in accordance with Article 5, the nonconformity of the Product to the requirements
of Section 7.l(i), or any other breach of this Supply Agreement by the Supplier, but including a defect of the product with which
or into which the Product will be incorporated, mixed or associated, or (d) violation or infringement of third party intellectual
property or other proprietary rights in connection with or resulting from the use of the Products by Buyer. BUYER MAKES NO OTHER
WARRANTY, EXPRESS OR IMPLIED, CONCERNING THIS PROTECTION.

 

Limitations:
The foregoing indemnification and hold harmless undertakings shall be contingent on the observance of the following additional
terms and conditions:

 

The
party claiming indemnification shall have given the indemnifying party prompt and timely notice of the facts and circumstances
having given rise to such claim and shall reasonably co- operate with, inform and assist the latter party in this regard;

 

The
indemnifying party shall have sole control and authority with respect to the defence, settlement or compromise of the claim against
the indemnified party; provided, however, that the indemnifying party shall not agree to any settlement which would materially
and adversely affect the business of the other party without the prior written consent of that party, which consent shall not
be unreasonably withheld.

 

Without
derogating from the provisions of this Article 7 or any other Article in this Supply Agreement, if the Products are found, by
a judgment delivered by a Court of first instance, to be infringing any third party intellectual property rights, or if Seller
has grounds to believe that the Products are infringing any third party intellectual property rights, the Seller, at its sole
expense, may, subject to the prior approval of the Buyer, either (i) replace or modify the affected Products so that they become
non-infringing or (ii) procure the rights to allow Buyer to continue the allegedly infringing use of the Products.

 

    	10

    	 

    

 

Insurance
obligation: The Buyer, as sponsor of the Clinical Trials, shall maintain in effect a policy or policies of insurance providing
protection against the risk of liability associated with any loss, injury or damage arising from the performance of Clinical Trials,
including contractual liability, in amounts and coverage decided upon in its sole discretion, and it shall provide the Seller
with the relevant insurance policy upon Seller’s request.

 

IN
NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY THIRD PARTY FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL OR EXEMPLARY
DAMAGES ARISING FROM ANY CLAIM RELATING TO THIS AGREEMENT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

 

MOREOVER,
SELLER’S LIABILITY AND INDEMNIFICATION UNDERTAKINGS UNDER THIS SUPPLY AGREEMENT AND/OR THE QUALITY AGREEMENT SHALL IN NO
EVENT EXCEED THE TOTAL VALUE OF <Omitted> IN THE AGGREGATE, IT BEING SPECIFIED FOR THE AVOIDANCE OF DOUBT THAT SAID LIMITATION
SHALL NOT APPLY IN CASE OF LIABILITY RESULTING FROM DEATH AND/OR BODY INJURY, IF AND WHEN SUCH LIABILITY MAY NOT BE RESTICTED
UNDER THE APPLICABLE LAW. NOTWITHSTANDING THE FOREGOING, SELLER’S LIABILITY AND INDEMNIFICATION UNDERTAKINGS UNDER THE PROVISIONS
OF SECTION 7.2(b) ABOVE SHALL IN NO EVENT EXCEED THE TOTAL VALUE OF <Omitted> IN THE AGGREGATE.

 

FOR
THE AVOIDANCE OF DOUBT, IT IS SPECI FIED THAT PROVISIONS OF THIS ARTICLE 7 SHALL NOT AFFECT THE APPLICATION OF SECTION 5.7 IN
CASE OF DELAYED ORDERS.

 

ARTICLE
8

 

CONFIDENTIALITY

 

Confidentiality
and non-use covenants: Each Party shall and shall cause its employees, agents or servants engaged in the performance of this Supply
Agreement to: (i) maintain all Confidential Information received from the other Party in strict confidence; (ii) use all such
information solely for purposes of performing this Supply Agreement; and (iii) reproduce such information only to the extent necessary
to perform this Supply Agreement, with all such reproductions being considered Confidential Information. The terms and conditions
hereof shall be considered Confidential Information, unless both Parties agree in writing to disclose certain terms in reply to
a legitimate request by a third party.

 

Return
of documents: Upon the termination of this Supply Agreement by either Party, the Receiving Party shall return to the Disclosing
Party all originals, copies, and summaries of documents, materials, and other tangible manifestations of Confidential Information
in the possession or control of the Receiving Party, except for one copy, which may be kept in the Receiving Party’s legal
archives and stored under secure conditions. The obligations set forth hereunder shall remain in effect for a period of ten (10)
years after receipt of the Confidential Information by the Receiving Party.

 

    	11

    	 

    

 

ARTICLE
9

 

TERM
AND TERMINATION

 

Term:
This Supply Agreement shall enter into force on the date of last signature hereof and shall expire on the earlier (i) <Omitted>;
(ii) the date of delivery to Buyer, of the <Omitted> Batch of Product ordered by Buyer; or (iii) termination in accordance
with the provisions of this Article 9..The Supply Agreement may be extended by mutual agreement.

 

Survival:
Termination, expiration, cancellation or abandonment of this Supply Agreement through any means or for any reason, shall be without
prejudice to the rights and remedies of either Party with respect to any antecedent breach of any of the provisions of this Supply
Agreement. The provisions of Articles 7 (Product Liability and Indemnification), 8 (Confidentiality), 9 (Term and Termination)
and 10 (Intellectual Property Rights) hereof shall survive expiration or termination of this Supply Agreement. If Seller is performing
stability programs on behalf of the Buyer, such stability programs shall be continued after the expiration or termination of this
Supply Agreement, under the terms of the applicable Purchase Order.

 

Termination
for breach: Either Party may terminate this Supply Agreement on written notice to the other Party, with immediate effect, if the
other Party commits a material breach of any of its obligations hereunder which is not cured within thirty (30) days of the other
Party’s written notice of the material breach. The delivery of <Omitted> batches of the Product in the aggregate not
in conformity with the provisions of Section 7.l(i) shall be considered a material breach of this Supply Agreement. Subject to
the provisions of this Agreement, such right of termination shall be without prejudice to any other remedy the non-defaulting
Party may have at law due to the other Party’s breach of its obligations hereunder.

 

Termination
for liquidation: This Supply Agreement may be immediately terminated by a Party if the other Party is dissolved or liquidated,
files or has filed against it a petition under any bankruptcy or insolvency law, makes an assignment for the benefit of its creditors
or has a receiver appointed for all or substantially all of its property.

 

Termination
for Product discontinuation by Seller: After delivering the <Omitted> Batches to Buyer, Seller may terminate this Supply
Agreement on written notice to Buyer, with a twelve (12) months prior written notice, if Seller intends to discontinue the Product.
If Seller terminates the Supply Agreement pursuant to this Article 9.5, Buyer shall be entitled to submit orders for additional
Products during six (6) months as from written notice of termination. If Buyer submits an order between the date of receipt of
the written notice of termination and the expiry of the above- mentioned six (6) months’ delay, the Supply Agreement shall
expire (i) twelve (12) months after the date of receipt of the written notice of termination, or (ii) on the date of delivery
of this last order of Product by Seller, whichever occurs later.

 

    	12

    	 

    

 

<Omitted>
Expiration or termination of this Supply Agreement in whole or in part shall not relieve the Parties of any amounts of moneys
or Product duly owing between them according to the terms of this Supply Agreement. Notwithstanding the aforesaid, if this Supply
Agreement is terminated due to the material breach of Seller pursuant to Section 9.3 or the liquidation of Seller pursuant to
Section 9.4, Buyer in its sole discretion, may decide if it wants Seller to complete any open orders. If this Supply Agreement
is terminated due to the material breach of Seller pursuant to Section 9.3 or the liquidation of Seller pursuant to Section 9.4
and Buyer decides that it does not want Seller to complete any open orders, it is agreed that Buyer shall provide Seller with
a formal written instruction clearly ordering Seller not to complete open orders, signed by a person with the appropriate authority.

 

ARTICLE
10

 

INTELLECTUAL
PROPERTY RIGHTS

 

Intangible
Property: Buyer acknowledges that any and all of Seller ‘s intellectual property rights existing on the date of last signature
hereof including its know-how used or embodied in or in connection with the Product and any parts thereof (hereafter: Seller’s
Background IP Rights) are and shall remain the sole property of Seller.

 

Seller
acknowledges that any and all of Buyer’s intellectual property rights not in connection with the Product and any parts thereof
existing prior to the present Supply Agreement or developed later on are and shall remain the sole property of Buyer.

 

Improvements:
In case Improvements (defined as “any ameliorations that cannot be exploited without infringing Seller’s Background
IP Rights”) to the Product or to its method of manufacture are generated in the performance of the Supply Agreement or of
the Clinical Trials by either Party, all rights on and to these Improvements shall belong to Seller and Seller shall have the
sole right, and at its own discretion, to file patent applications in its own name and at its costs.

 

In
case Improvements to the use of the Product are generated in the performance of the Supply Agreement or of Buyer’s Clinical
Trials by either Party, all rights on and to these Improvements shall belong to the Party which makes such improvements and such
Party shall have the sole right, and at its own discretion, to file patent applications in its own name and at its costs.

 

Any
other improvements or inventions generated by Buyer in the performance of the Clinical Trials will belong to Buyer.

 

Option
for a license: If Buyer, is willing to manufacture, or have a third-party manufacture for Buyer only, Polyethylenimine in compliance
with EU guidelines to GMP and FDA requirements, and therefore to use Seller’s Background IP Rights, Buyer will pay the Upfront
Fee and receive a license as described in Appendix III. The license in Appendix III will become effective on the Effective Date
as defined in Appendix III.

 

    	13

    	 

    

 

ARTICLE
11

 

GENERAL
PROVISIONS

 

Force
Majeure: The failure of either Party to perform any of its obligations hereunder solely by reason of, acts of government, riots,
wars, strikes, natural disaster such as fire, storm and flood or other outside causes beyond its control, shall not be deemed
to be a breach of this Agreement; provided, however, that the Party so prevented from complying herewith shall continue to take
all actions within its power to comply as fully as possible herewith. If such prevent ion continues for a period of more than
sixty (60) days, then either Party may terminate this Supply Agreement, effective upon written notice to the other Party.

 

Assignment:
This Supply Agreement and each and every covenant, term and condition herein is binding upon and inures to the benefit of the
Parties hereto and their respective successors, and may not be assigned or transferred by either Party to a third party. Notwithstanding
the aforesaid, Buyer may assign or transfer this Supply Agreement in whole or in part to an Affiliate.

 

Headings:
Headings are inserted for convenience only and shall not affect the meaning or interpretation of this Supply Agreement.

 

Waiver:
No waiver of any default hereunder by either Party or any failure to enforce any rights hereunder shall be deemed to constitute
a waiver of any subsequent default with respect to the same or any other provision hereof.

 

Severability:
Should any part of this Supply Agreement be held unenforceable or in conflict with the applicable laws or regulations of any jurisdiction,
the invalid or unenforceable part or provision shall be replaced with a provision which accomplishes, to the extent possible the
original business purpose of such part or provision in a valid and enforceable manner, and the remainder of this Supply Agreement
shall remain binding upon the Parties hereto.

 

Notices:
All notices given by one Party to the other shall be delivered by personal delivery, sent by registered air mail or fax to the
other party’s address as first set out hereinabove or to the latest address of such Party as shall have been communicated
to the other Party.

 

Entire
agreement: This Supply Agreement constitutes the entire agreement between the Parties and shall prevail over any other prior understanding
or terms (including Buyer’s general purchase conditions). Any amendment or modification to this Supply Agreement shall be
valid only if made in writing and signed by authorized representatives of the Parties.

 

Signature
page follows:

 

    	14

    	 

    

 

IN
WITNESS WHEREOF, the Parties hereto have caused this Supply Agreement to be executed by their duly authorized representatives
on the day and date written below.

 

Made
and executed in two (2) counterparts, which taken together constitute one and the same instrument, with one copy of each counterpart
having been submitted to each Party.

 

<Omitted>

	 	 	 	 	 
	 	For Polyplus-transfection:
	 	 
	 	Name:	 
	 	 	 
	 	Function:	 
	 	 	 
	 	Date: 	 
	 	 	 
	 	Signature: 	 

 

    	15

    	 

    

 

APPENDIX
I

 

Quality
Controls and Specifications for in vivo-jetPEITM Drug Substance manufactured in compliance with cGMP

 

<Omitted> 

	 	 	 
	Quality
    Control	Method	Specifications
    to Pass Tests
	 <Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	IR
    Identification	Conforms
    to structure	1H
    NMR Identity: peak at 3.3 - 3.6 ppm (4H)
	Appearance	Visual
    test	Amorphous
    white to off-white solid Karl- Fisher method
	Water
    content	(current
    USP <921>)	Measure
    and report
	Residue
    on Ignition	current
    USP <281>	NMT
    1.0%
	Heavy
    metal	current
    USP <233>	quantification
    of 15 heavy metals* Specifications according to USP percentage of in vivo-jetPEITM calculated
	Assay
    (qNMR)	qNMR
    (1H) method	on
    anhydrous basis (to be defined after validation of the analytical method) Acetonitrile: NMT 410 ppm
	Residual
    organic	GC
    method	Methanol:
    NMT 3000 ppm solvent Diethyl ether: NMT 5000 ppm Ethanol: NMT 5000 ppm
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	Side
    chain content	qNMR
    (1H) method	Report
    result
	Microbiological
    limits	Current
    USP <61>	Total
    aerobic count: NMT 100 CFU/g Yeast and molds: NMT 50 CFU/g Absence of E. coli, Salmonella, Staphylococcus aureus, Pseudonomas
    aeruginosa
	Bacterial
    endotoxins	current
    USP<85>	NMT
    0.6 EU/mg
	<Omitted>	<Omitted>	<Omitted>

 

  

    	16

    	 

    

 

Abbreviations:

USP:
United States Pharmacopoeia; RLU: Relative Light Unit; NMT: Not More Than; CFU: Colony Forming Unit; p-TSA: p- toluenesulfonic
acid 

*List of elemental impurities quantitated according to USP <233>: As, Cd, Pb,Hg, Cr, Cu, Mo, Ni, Pd, Pt, V, Os, Rh, Ru,
Ir

 

  

    	17

    	 

    

 

Appendix
II

 

Batch:

 

“Batch”
shall mean a specified quantity of the Product, produced in a process or series of processes so that it is expected to be homogeneous
within specified limits. For the Drug Substance, the quantity of Product in each Batch will be between <Omitted> of Drug
Substance after release. Pricing tables for the supply of in vivo-jetPEITM Drug Substance with the specifications described
in Appendix I- Sequential ordering

 

  Table
1.

 

	Batch
    number	Fully
    invoiced before	Price
    per Batch
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	Total
    (€)	 	<Omitted>

 

  Table
2.

 

	Batch
    number	Fully
    invoiced before	Price
    per Batch
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	Total
    (€)	 	<Omitted>

 

  

    	18

    	 

    

  

Appendix
III

 

<Omitted>

 

<Omitted>

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>

  

<Omitted>

 

 

    	19

    	 

    

 

<Omitted>

  

<Omitted>

  

<Omitted>

  

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>

 

  

    	20

    	 

    

  

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>

 

 

    	21

    	 

    

 

	<Omitted>	<Omitted>

 

 

    	22

    	 

    

 

<Omitted>

 

	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

  

<Omitted>

   

 

 

    	23Exhibit 10.4

 

BI
Contract No. 100704

 

CLINICAL
SUPPLY AGREEMENT

 

This
Clinical Supply Agreement (“Agreement”) is made by and among

 

BioCancell
Therapeutics Israel Ltd. 

1/3
High-Tech VillageGivat Ram

P.O.
Box 39264

Jerusalem

9139102
Israel 

(hereinafter
called “BioCancell”), on one hand

 

and

 

Boehringer
Ingelheim Biopharmaceuticals GmbH 

Binger
Straße 173,

55216
Ingelheim/Rhein

Germany

(hereinafter
called “BI”),

 

and

 

Boehringer
Ingelheim RCV GmbH & Co KG 

Dr.
Boehringer-Gasse 5-11

1121
Vienna

Austria

(hereinafter
called “BI RCV”), on the other hand

 

(hereinafter
BI, BI RCV and BioCancell each shall also be called “Party” and collectively “Parties” as the case may
be).

 

EFFECTIVE
DATE: 3 April 2013

 

    	Page 1 of 56

    	 

    

  

Preamble

 

WHEREAS, BioCancell’s
Affiliated Company BioCancell Ltd. and BI RCV entered into a secrecy agreement (“CDA”) dated as of November 16,
2006, a material transfer agreement (“MTA”) dated as of April 3, 2013 and a Quality Agreement (“QA”)
dated as of September 12, 2013; and

 

WHEREAS,
BioCancell is a biotechnology company engaged in, among other
things, the research and development of cancer treatments and has all rights (whether by ownership or in-licensed) to the Product
(as defined below) and is the owner of a cell line for a manufacturing process for manufacturing the Product; and

 

WHEREAS,
BI RCV performed certain services between April 3, 2013 and
December 31, 2013 for BioCancell Ltd., and effective January 1, 2014 BI RCV performs contract development and manufacturing services
for biopharmaceuticals, owns a proprietary pDNA Technology platform and maintains a staff of trained professionals who are knowledgeable,
experienced and skilled in biopharmaceuticals manufacturing including pDNA on behalf of BI; and

 

WHEREAS,
BioCancell now wishes and BI has agreed to (i) BI’s
performance (by itself and/or its Affiliated Companies) of certain development work relating to the industrial manufacturing of
the Product, including (A) the development of a new Cell Line for the Product, and comparison of the BioCancell Cell Line and
the new Cell Line for cGMP production of the Product using BI’s proprietary pDNA Technology platform, and including (B)
the adaptation of BI’s generic pDNA Technology platform to the Cell Line finally selected by BioCancell during the performance
of the services; and (ii) BI’s manufacturing of the Product for clinical testing (by BI itself and/or its Affiliated Companies)
with the finally selected Cell Line. The services listed in this WHEREAS clause have partially already been started and/or performed
under the MTA.

 

NOW,
THEREFORE, and in consideration of the mutual covenants
set forth in this Agreement, BI and BioCancell, and solely regarding the Services provided until December 31, 2013 also BI
RCV, hereby agree as follows:

 

1             Definitions

 

1.1       
  “Affiliated Companies” 

means
any company or business entity which controls, is controlled by, or is under common control with, either BioCancell or BI. For
purposes of this definition, “control” shall mean the possession, directly or indirectly of the power to direct or
cause the direction of the management and policies of an entity (other than a natural person), whether through the majority ownership
of voting capital stock, by contract or otherwise.

 

1.2
         “Background
IP” 

means
Intellectual Property Rights (i) owned, licensed to or controlled by a Party prior to the effective date of the MTA, or (ii) developed
by a Party outside of the scope of this Agreement without use of the other Party’s Confidential Information.

 

1.3          “Batch” 

shall
have the meaning as set forth in the QA.

 

    	Page 2 of 56

    	 

    

 

1.4          “Batch
Records” 

shall
have the meaning as set forth in the QA.

 

1.5          “BI
Deliverables” 

any
material and documents or results other than the Product to be provided by BI to BioCancell as provided for herein in Section
2.6 and listed in detail in the Project Plan.

 

1.6
        “BI
Improvements” 

shall
have the meaning as set forth in Section 8.2.2.

 

1.7          “BioCancell
Deliverables” 

means
any material and documents to be provided by BioCancell to BI as provided for herein in Section 2.5 and listed in detail in Appendix
1.

 

1.8          “BioCancell
Improvements” 

shall
have the meaning as set forth in Section 8.2.1.

 

1.9          “BIP” 

means
BI’s Affiliated Company, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach, Germany.

 

1.10        “BI
RCV” 

means
BI’s Affiliated Company, Boehringer Ingelheim Pharma RCV GmbH & Co KG, Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria.

 

1.11        “Cell
Line” 

shall
mean the cell line used for the manufacture of clinical trial material which includes the BioCancell proprietary plasmid as further
described in Appendix 1.

 

1.12        “Certificate
of Analysis” (CoA) 

shall have the meaning as set forth in the QA.

 

1.13
      “Certificate
of Compliance” (CoC) 

shall have the meaning as set forth in the QA.

 

1.14
      “cGMP” 

means
current Good Manufacturing Practice regulations as set forth in more detail in the QA.

 

1.15
      “Change of
Control” 

means
the merger with, transfer to or acquisition of beneficial ownership of more than fifty percent (50%) of the outstanding voting
shares of BI or BioCancell respectively and/or its respective Affiliated Companies in a transaction in which the shareholders
of BI or BioCancell do not retain a majority of the voting power in the surviving or acquiring corporation.

 

    	Page 3 of 56

    	 

    

 

1.16
      “Confidential
Information” 

means
any information and materials disclosed by a Party or an Affiliated Company of such Party to the other Party or its Affiliated
Company(ies), which information includes, but is not limited to: all know-how, trade secrets, inventions, non-public patent applications,
processes, concepts, technology regarding the manufacture of biopharmaceuticals, and experimental methods as well as information
concerning the Disclosing Party’s and/or its Affiliated Companies’ financial situation, customers, business plans,
and its or its Affiliated Companies’ research and product designs and other data and information disclosed or exchanged
under the CDA, the MTA and/or this Agreement; as well as the terms of the CDA, the MTA and of this Agreement.

 

1.17
      “Direct Competitor” 

means <Omitted> for
BioCancell a third party (other than any of BI’s Affiliated Companies) developing, manufacturing or selling
pharmaceutical products for the same indication as the Product.

 

1.18
      “Disclosing
Party” 

in
the capacity of disclosing Confidential Information and know-how, each Party is referred to as the Disclosing Party.

 

1.19
      “Effective
Date” 

means
the date of commencement of this Agreement as mentioned on the cover page above.

 

1.20
      “Facility” 

means
either the biotech buildings and all other buildings located at Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria used by BI or
located at Biberach/Riss, Germany used by BI’s Affiliated Company BI RCV and/or BIP in performance of the Project.

 

1.21
      “Health Authorities” 

shall
have the meaning as set forth in the QA, and shall also include the FDA and the EMA, as set forth in the QA.

 

1.22
      “Improvements” 

means
all discoveries and inventions, and all modifications, derivatives and improvements of Background IP or new uses thereof
(whether or not protectable under patent, trademark, copyright or similar laws) that are discovered, developed or reduced to
practice in the performance of this Agreement.

 

1.23
      “IND (or
“IMPD”) 

means
an Investigational New Drug application or an Investigational Medicinal Product Dossier application for the Product, and all associated
documents to support such applications, as submitted or to be submitted to the applicable Health Authorities.

 

1.24
       “Indemnitee” 

shall have the meaning as set forth in Section 7.4.

 

1.25
       “Indemnitor” 

shall have the meaning as set forth in Section 7.4.

 

    	Page 4 of 56

    	 

    

 

1.26
       “Intellectual Property Rights” 

means any and all now known or hereafter existing: (i)rights
associated with works of authorship, including copyrights and moral rights; (ii) trade secret rights; (iii) patent rights, and
industrial property rights; (iv) other proprietary rights in all inventions (whether or not patentable), discoveries, methods,
processes, techniques, specifications, protocols, schematics, diagrams, reagents, compounds, samples, formulation, data, circuit
designs, design layout, databases, data, and other forms of technology; and (v) all registrations, applications, renewals, and
extensions of the foregoing, in each case in any jurisdiction throughout the world, including, but not limited to, inventor’s
certificates, utility models, substitutions, confirmations, reissues, re-examinations, renewals or any like governmental grants
for protection of inventions; and any pending application for any of the foregoing, including any continuation, divisional, substitution,
additions, continuations-in-part, provisional and converted provisional applications, as well as extensions and supplementary protection
certificates based thereon.

 

1.27
       “Latent Defects” 

means non-conformance of the Batches or the Product with the
Specifications proven or reasonably determined by a testing laboratory according to Section 4.1.3, other than Obvious Defects.

 

1.28
       “Losses” 

shall have the meaning set forth in Section 7.3a.

 

1.29
       “Manufacturing Process” 

means BI’s platform process based on the pDNA
Technology, as detailed in Appendix 4, to be adapted to the manufacturing of Product and/or optimized or further developed
by BI during the performance of the Project as provided for in this Agreement.

 

1.30
       “Manufacturer’s Release” 

shall mean BI’s release of a cGMP conforming Batch of
Product (either as drug substance or in the final dosage form as drug product-whichever is the case) in accordance with the QA.

 

1.31
       “Master Batch Record” 

shall have the meaning as set forth in the QA.

 

1.32
       “NDA (or “CTD”) 

means the New Drug Application or Common Technical Document
for the Product, and all associated documents to support such applications, as submitted or to be submitted to the applicable Health
Authorities.

 

1.33
       “Obvious Defects”  

means any non-conformance of the Batches or the Product with
the Specifications which is visible or easily detectable without any analysis in a laboratory.

 

1.34
       “pDNA Technology”  

means the host cell line, vectors, genetic elements,
medium and other materials, as well as the fermentation, harvesting, purification, bulk formulation, and other biopharmaceutical
manufacturing and analytical methods used by BI for generating the Product as detailed in Appendix 4. The pDNA Technology
shall be considered a part of the BI Background IP.

 

    	Page 5 of 56

    	 

    

 

1.35
       “Product” 

means the biopharmaceutical product owned by BioCancell
as detailed in Appendix 1, and formulated either as bulk drug substance or in final dosage form as drug product.

 

1.36
       “Product-Dedicated Equipment” 

shall have the meaning specified in Section 3.2
hereof. Estimates of the Product Dedicated Equipment are included in Appendix 5.

 

1.37
       “Project” 

means the performance of the Services, including without limitation
the development of the Manufacturing Process, if any, for the Product, and the manufacture and supply of Batches, as provided for
under this Agreement.

 

1.38
       “Project Fees” 

shall have the meaning specified in Section 3.1
hereof.

 

1.39
       “Project Manager” 

shall have the meaning specified in Section
2.2.1 hereof.

 

1.40
       “Project Plan” 

means the plan describing the Services to be performed
by BI (by itself or its Affiliated Companies) under the Project, including the Project timeline, attached to this Agreement as
Appendix 2.

 

1.41
       “Project Team” 

shall have the meaning specified in Section
2.2.2 hereof.

 

1.42
       “Raw Materials” 

means raw materials, filters, membranes, consumables
and resins applied in the performance of the Services. Estimates of the Raw Materials are included in Appendix 5.

 

1.43
       “Receiving Party” 

in the capacity of receiving Confidential Information and know-how,
each Party is referred to as the Receiving Party.

 

1.44
       “Representatives” 

means a Party’s Affiliated Companies and its and its Affiliated
Companies’ directors, officers, employees and agents.

 

1.45
       “Service(s)” 

shall mean those certain services performed by BI under this
Agreement as outlined in the Project Plan or otherwise agreed by the Parties in writing (e.g. by a change of the Project Plan).

 

    	Page 6 of 56

    	 

    

 

1.46
       “Specification(s)”  

means all the specifications and tests, analytical methods and/or
limits, and the results thereof, as applicable, within which the Product has to conform to be considered acceptable by BioCancell
for clinical use. The Parties are in agreement, that pursuant to Section 2.7 the preliminary specifications shall be updated into
revised specifications for the release of the Product.

 

1.47
       “Steering Committee”  

shall have the meaning specified in Section
2.2.3 hereof.

 

1.48
       “Territory”  

shall mean the following countries or regions where BioCancell
intends to perform clinical trials with the Product: Israel, USA, and the EU member states.

 

2
            Cooperation between the Parties in the Course of the Project 

 

2.1
         General  

This Agreement sets forth the terms and conditions under which
BI (by itself or its Affiliated Companies) will provide the Services to BioCancell.

 

2.2
         Governance 

2.2.1       Designation of Project Manager

Upon commencement of the Project, BI and
BioCancell will each appoint a project manager (“Project Manager”), who will coordinate and supervise the Project
on its behalf including communication of all instructions and information concerning the Project to the other Party. The
Project Manager will serve as a contact person for the other Party. Each Project Manager will be available on an agreed
(monthly) basis for consultation at prearranged times during the course of the Project. Project Managers shall also be
available for necessary consultations without undue delay. The Project Managers shall be copied on all correspondence by
other Project Team members and all correspondence between the Parties. In the absence of the Project Manager, a substitute
shall be appointed. Additional modes or methods of communication and decision making may be implemented with the mutual
written consent of each Party. Each Party will use reasonable efforts to provide the other Party with ten (10) calendar days
prior written notice of any change in such Party’s Project Manager.

 

2.2.2
      Project Team

		a.	The Parties shall establish a Project Team consisting
of members of its professional staff and their respective Project Manager to (i) ensure the progress of the Project, (ii) coordinate
the performance of the Project, (iii) monitor and review BI’s performance of the Services and BioCancell’s fulfilment
of its obligations, and (iv) facilitate communication among the Parties. Each Project Team member shall have knowledge and ongoing
familiarity with the Project and will possess the authority to make decisions on matters likely to be raised in the Project Team.
Each Party shall have the right to substitute its members of the Project Team as needed from time to time by giving written notice
to the other Party due time in advance.
	 	 	 

		b.	The Project Team shall meet in person or by means of a video conference or teleconference on a
                                                        periodic basis (i) as agreed by the Project Managers after written request for such meeting by either Party, (ii) as
                                                        specified in the Project Plan, as may be amended from time to time, or (iii) within seven (7) calendar days after receipt of
                                                        a written request by one Party to the other Party.

 

    	Page 7 of 56

    	 

    

 

		c.	The Project Team shall oversee the Project. Prior to each
meeting of the Project Team the Parties will distribute to each other written copies of all reasonably necessary materials, data
and information arising out of the conduct of their activities hereunder.

 

		d.	Each Party shall bear its own costs associated with such
meetings and communications.

 

2.2.3      Steering
Committee

		a.	The Parties
                                         shall form a Steering Committee, to which each Party will appoint three (3) executive
                                         employees, all of whom shall be familiar with the Project. Each Party shall have the
                                         right to substitute its members of the Steering Committee as needed from time to time
                                         by giving written notice to the other Party due time in advance. The Steering Committee
                                         may invite the Project Managers, members of the Project Team or other experts of either
                                         Party to present the issues. The initial members of the Steering Committee are listed
                                         in Appendix 6.
	 	 	 

		b.	The Steering Committee is responsible (i) for strategic
oversight and management of the Services and the manufacture of the Product; (ii) to settle disputes or disagreements not resolved
by the Project Team unless otherwise indicated in this Agreement; (iii) to discuss major issues regarding the performance of the
Manufacturing Process which cannot timely be resolved despite efforts of both Parties, and (iv) for approving by written documentation
any major changes to the Services, Project Plan, or budget.
	 	 	 

		c.	The Steering Committee shall meet in person or by means
of a video conference or teleconference within fourteen (14) calendar days after receipt of a written request by one Party to
the other Party. Each Party shall bear its own costs associated with such meetings and communications.
	 	 	 

		d.	The Steering Committee will take action by unanimous consent
of the Parties, with the Representatives of each Party collectively having a single vote, or by a written resolution signed by
all of the Representatives. If the Steering Committee is unable to reach unanimous consent on a particular matter, then the matter
will be referred to senior management of the Parties, who will use good faith efforts to resolve such matter.

 

2.2.4      Documentation

The Parties shall prepare minutes (alternating
responsibility) of the Project Team and Steering Committee meetings as appropriate (in particular to document important
decisions) which shall be circulated promptly following the meeting. If meeting minutes are prepared by one Party they shall
be reviewed by the other Party within fourteen (14) calendar days as of receipt and are deemed accepted unless the other
Party raises objections in writing within such fourteen (14) calendar days’ period.

 

	2.2.5	No Power to amend, modify or waive compliance with Agreement
For the avoidance of doubt, the Project Team and the Steering Committee shall not have any power to amend or modify this Agreement
or waive compliance therewith. Any amendments, modifications or waivers shall be undertaken in accordance with Section 11.2.

 

    	Page 8 of 56

    	 

    

 

2.3
         Performance of the Services by BI; Conduct of the Project
 

Pursuant to the terms and conditions of this Agreement,
BI shall provide the Services (as detailed in Appendix 2) to BioCancell, including, (i) BI’s performance (by itself
and/or its Affiliated Companies) of certain development work relating to the manufacturing of the Product, including (A) the development
of a new Cell Line for the Product, and comparison of the BioCancell cell line and the new Cell Line for cGMP production of the
Product using BI’s proprietary pDNA Technology platform, and (B) the adaptation of BI’s generic pDNA Technology platform
to the Cell Line finally selected by BioCancell during the performance of the services; and (ii) BI’s manufacturing and
supply of the Product for clinical testing (by BI itself and/or its Affiliated Companies) with the finally selected Cell Line.

 

BioCancell acknowledges that the firm period for
reservation of Batches in the BI cGMP Facility is <Omitted>months and that BI firmly reserves the respective Services
in accordance with the Project Plan.

 

BI (as well as BI’s subcontractors) shall use the Project-Dedicated
Equipment solely in connection with the Project and in accordance with the terms and conditions of this Agreement.

 

Each Party shall fully and reasonably cooperate with the other
Party to provide appropriate information and assistance to the other Party in connection with the Project and its performance under
this Agreement, responding in a reasonable and timely manner with respect to all reasonable requests for information and approval.
Neither Party shall be responsible for any delays in its performance of the Project to the extent caused by the other Party’s
failure to provide in a reasonably timely manner any required or necessary information (in particular, but not limited any BI Deliverables
or BioCancell Deliverables) or any approval reasonably requested by the other Party and/or as set forth in the Project Plan.

 

Each Party shall assign a sufficient number of professionally
qualified personnel to perform the Project and shall perform its tasks under this Agreement according to the generally acceptable
professional and then current industry standards and subject to terms and conditions as set forth in this Agreement, at all times
in compliance with the requirements of applicable laws and regulations of the country/ State where the Services are performed and
in accordance with its obligations under Section 6.3. Each Party will use commercially reasonable efforts to achieve the estimated
timelines as laid down in the Project Plan, subject to Section 2.4.

 

2.4
         Changes to the Project Plan (including Additional Services)
 

Services which are agreed to are regarded as firmly ordered
under this Agreement. Changes to the Project Plan (such as, but not limited to, the Services), if any, shall require the written
consent of both Parties.

 

In case that the Parties mutually agree on additional Services
for the benefit of the Project by changing the Project Plan, BI shall perform such additional Services to sustain the progress
of the Project pursuant to conditions and terms related to compensation, time and scope to be mutually agreed upon in writing by
the Parties hereto.

 

In case that the Parties mutually agree to reduce the scope
of the Services, BioCancell shall only be required to pay the relevant fees for such reduced Services.

 

    	Page 9 of 56

    	 

    

 

If changes to the Project Plan (including, but
not limited, changes to the Manufacturing Process or the Specifications), become necessary because of Health Authority
investigations, changes to applicable laws or regulations or otherwise or supply issues regarding Raw Materials and other
equipment required for the performance of the Services, the Parties shall negotiate in good faith on how to proceed. The
Parties acknowledge that if such changes are due to the Facility, BI will typically bear the costs of such changes, and if
such changes are due to the Raw Materials and/or Product-Dedicated Equipment used in the Manufacturing Process, BioCancell
will typically bear them.

 

BioCancell acknowledges that BI has pre-existing commitments
to other customers. Accordingly, in case BioCancell intends to change the Project Plan, BI may not be able to offer BioCancell
additional/different manufacturing slots at the times desired by BioCancell.

 

If any Raw Materials and Project-Dedicated Equipment
is required beyond that provided in Appendix 5, such additional Raw Materials and Project-Dedicated Equipment shall be
subject to the prior approval of BioCancell.

 

2.5
         BioCancell Deliverables  

To the extent not already transferred by
BioCancell, BioCancell shall transfer the BioCancell Deliverables for the Project to BI (or to the Affiliated Company
indicated by BI on behalf of BI) within the timelines laid down in the Project Plan and subject to the terms of this Section
2.5 . Delivery of BioCancell Deliverables shall be made “Delivery Duty Paid” (DDP) Facility as that term is
defined in Incoterms 2010, ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF), and
BI shall use such BioCancell Deliverables solely to conduct the Project in accordance with the Project Plan, this Agreement,
or as otherwise may be agreed to by the Parties in writing. In particular, the BioCancell Deliverables will not be used by BI
in connection with any diagnosis, treatment or any activity in humans. BI’s use of the BioCancell Deliverables will be
in compliance with all applicable laws in the country/ State where the Services are performed and in accordance with its
obligations under Section 6.3. BI accepts the BioCancell Deliverables with the knowledge that BioCancell Deliverables are
experimental. The BioCancell Deliverables may not be transferred or otherwise made available, in whole or in part, by BI to
any other individual, entity or institution, except to its Affiliated Companies, without the prior written consent of
BioCancell, which may be withheld by BioCancell for any reason. Notwithstanding the foregoing, such consent is hereby given
for quality control testing performed by a third party on a blinded basis.

 

The BioCancell Deliverables are the property of BioCancell.
It is agreed that the transfer of the BioCancell Deliverables hereunder shall not constitute a sale of BioCancell Deliverables
or a grant, option or license of any patent or other rights except to allow BI to perform the Project. BioCancell shall retain
and have all right, title and interest in and to the BioCancell Deliverables.

 

BioCancell will inform BI immediately about any safety issues
of which BioCancell becomes aware relating to the handling of the BioCancell Deliverables and the Product, after the date of the
execution of this Agreement.

 

BI shall store the BioCancell Deliverables according to BioCancell’s
instructions. BI shall at all times take commercially reasonable measures to protect the BioCancell Deliverables from loss or damage
and in no event measures less stringent than employed by BI in the protection of its own proprietary materials, and shall promptly
notify BioCancell, if at any time it believes the BioCancell Deliverables have been damaged, lost or stolen. BI shall not be liable
for any loss of the BioCancell Deliverables occurring due to BioCancell’s instructions or other reasons outside of BI’s
sphere of influence (including, but not limited to, events of Force Majeure or lack of stability of the BioCancell Deliverables.

 

    	Page 10 of 56

    	 

    

 

2.6
         BI Deliverables  

BI will deliver the BI Deliverables expressly laid down in detail
in the Project Plan within the timelines laid down in the Project Plan and the QA. Delivery of BI Deliverables by BI shall be made
“ex works” (EXW) Facility, as that term is defined in Incoterms 2010, ICC Rules for the Use of Domestic and International
Trade Terms, ICC Publication No. 715EF).

 

2.7
         Nature of the Project; Specifications  

As the Product has never been produced by BI at the Facility,
BioCancell acknowledges that the Project is experimental in nature and that no favorable or useful results can be assured by BI.

 

Preliminary specifications of the Product shall be set by the Parties after completion of the consolidation runs.

 

No later than
two (2) months after the Manufacturer’s Release of three (3) initial manufacturing runs under cGMP conditions, the Parties
shall in good faith agree on a revision (if necessary) of the preliminary specifications that shall then be the Specifications
for Product manufactured in subsequent manufacturing runs at such scale, and, provided that the Manufacturing Process has not been
materially changed by mutual consent of the Parties, the Project shall no longer be considered experimental in nature and the obligation
of BI to meet the respective Specification shall apply to all future manufacturing runs at such scale.

 

2.8
         Clinical Manufacturing Forecasts  

BioCancell shall provide a quarterly demand forecast for clinical
Product covering the subsequent eighteen (18) months (i.e. update every quarter regarding all demands for the following six quarters).

 

3
            Project Fee and Payments 

 

3.1
         Project Fee  

As consideration for BI’s performance of the
Services, BioCancell shall pay BI the fixed fees set forth in the Billing Plan attached hereto as Appendix 3 or as otherwise
agreed in writing, including the price basis of a certain year (the “Project Fees”), subject to the inflation provisions
of Section 3.3. It is hereby agreed that no payments of Project Fees, or any other payments or consideration will be made or due
from BioCancell to BI RCV, BIP or any other permitted sub-contractors of BI and BI shall be responsible for any payments or consideration
due to such third parties for their performance under this Agreement. Other than the Project Fees, payment of the Product Dedicated
Equipment and Raw Materials, which shall be charged at cost to BioCancell, and BioCancell’s indemnification and/or compensation
obligations as provided for under this Agreement, BioCancell shall not be required to make any additional payments for BI’s
performance and provision of the Services hereunder without BioCancell’s prior written consent.

 

    	Page 11 of 56

    	 

    

 

	 	 	 
	3.2	Product- Dedicated Equipment 
	 	If agreed upon by the Parties in the Project Plan in
    Appendix 5 or otherwise in writing, BI may purchase certain Product-dedicated equipment (“Product Dedicated Equipment”)
    on the account and instructions of BioCancell and at BioCancell’s cost and expense for the manufacture of Product. For
    book keeping, maintenance and insurance purposes, such equipment shall be the property of BI. Notwithstanding the aforesaid,
    the risk of loss in such Product Dedicated Equipment shall be borne by BI. At the termination or expiration time of this Agreement
    Sections 10.3.3. and 10.3.6 shall apply with regards to such Product-Dedicated Equipment.
	 	 
	3.3	Invoicing and Payment 
	 	BI shall invoice BioCancell for Project Fees according
    to the Payment Schedule in the Project Plan.
	 	 
	 	BioCancell shall make payment of all invoiced amounts
    net forty-five (45) calendar days from the date of receipt of BI’s invoice. If BioCancell fails to make timely payment
    when due under this Agreement, interest shall accrue at a fixed annual rate equal to the highest rate of interest quoted as
    the “prime rate” in “The Wall Street Journal” on the day that payment was due. All payments due under
    this Agreement shall be paid in Euros by wire transfer or by such other means agreed to in writing by the Parties. BioCancell
    will provide at least twenty-four (24) hours advance notice to BI of each wire transfer to the bank account identified below
    or such other bank accounts as BI shall designate in writing.
	 	 	 
	 	Account Name:	Boehringer Ingelheim Biopharmaceuticals GmbH
	 	Account Number:	<Omitted>
	 	Bank:	<Omitted>
	 	IBAN Number:	<Omitted>
	 	BIC Number:	<Omitted>
	 	 	 
	 	BI shall pay any and all taxes, duties, fees and/or
    other impositions that may be levied upon BI with regard to the provision of the Services. BioCancell shall be entitled to
    withhold from any payment due to BI under this Agreement any withholding tax amount that BioCancell is required to pay, and
    such withholding shall decrease by an equivalent amount the payment due to BI. In the event of any withholding under this
    Section, BioCancell shall provide receipts of payment of any withheld amounts, or other documents reasonably available, to
    BI.
	 	 
	 	All payments under this Agreement should be understood
    as net payments without value added tax (“VAT”). VAT, if any, should be added to the respective payment. Each
    invoice will show any applicable VAT separately.

  

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	 	The Project Fees will be adjusted (increased or decreased) year
    by year in accordance with the average of (a) the change in a respective consumer index <Omitted> and (b) the average
    change in the respective wages index <Omitted> shown in the respective statistic monthly report <Omitted> Additionally, BI shall be entitled to adjust the prices for Raw
    Materials and services, which are provided for in the Project Plan or agreed to by BioCancell, supplied to BI by third parties
    which are utilized in the performance of the Services at any time in the event that a significant increase in such costs of
    more than ten percent (10%) has occurred over a period of twelve (12) months preceding such adjustment. 
	 	 
	4	Delivery Terms of Product for Clinical Use and Cancellation
    of Orders 
	 	 
	4.1	Delivery Terms 
	4.1.1	Delivery Terms 
	 	BI shall (a) deliver to BioCancell or, (b) as requested by BioCancell
    reasonably in advance, store the Product in accordance with the agreed upon schedule, at the agreed Project Fee price (e.g.
    price set forth in the Project Plan). Delivery of Product by BI shall be made “ex works” (EXW) Facility, as that
    term is defined in Incoterms 2010 ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF).
    BI shall package and arrange for shipment of Product to the delivery address specified by BioCancell, all in accordance with
    the (i) QA; and (ii) any additional instructions of BioCancell according to Appendix 7, provided that BioCancell shall
    hold harmless and indemnify BI from any damages or third party claims arising out of such arrangements for shipment of Product
    in accordance with any additional instructions provided by BioCancell. Each shipment of cGMP Product will include a Certificate
    of Analysis, a Confirmation of Compliance and such other documentation as provided for under the QA and as reasonably required
    to meet all applicable statutory and regulatory requirements for EXW delivery. Delivery of the Product shall be subject to
    quality and other provisions set forth in the QA. The Parties shall cooperate reasonably to obtain all customs licenses or
    permits necessary to have the Product transported to BioCancell (the evaluation of which customs licenses or permits required
    shall be performed by BioCancell). BioCancell is responsible for export control compliance.
	 	 
	4.1.2	Examination for Defects 
	 	BioCancell shall diligently examine all
    Product delivered under this Agreement as soon as practicable after receipt. Notice of all claims arising out of or relating
    to Obvious Defects shall be given in writing to BI within fifteen (15) calendar days after the date of delivery, otherwise,
    such Product shall be considered free of any Obvious Defects as between BI and BioCancell. Notwithstanding the foregoing,
    BioCancell shall make a defective Product available for inspection and shall comply with the requirements of any insurance
    policy covering the Product and BI shall offer BioCancell commercially reasonable assistance, at the cost and expense of BioCancell,
    in pursuing any claims arising out of the transportation of the Product.
	 	 
	 	BioCancell shall have six (6) months from the date of delivery
    of the Product in order to evaluate the Product and accept or reject such delivery for Latent Defects.

  

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	 	If BioCancell determines within such period after reviewing the
    relevant documentation and performing reasonable testing that any Batch/ Product does not meet the Specifications and BI or
    the testing laboratory according to Section 4.1.3 agrees with BioCancell’s assessment, or if a Batch/ Product is
    determined     by BI to be unsuitable for release (hereinafter a “Non-Conforming Batch/Product”), BI shall
    replace such Non-Conforming     Batch/ Product with a conforming Batch/ Product, and BioCancell is required to accept such
    conforming Batch/ Product. BioCancell     may, at its sole discretion, either (a) request that such replacement be done at
    BI’s cost and expense, including the     costs of materials used in the manufacture of such Batch, or (b) withhold
    payment for the relevant Non-Conforming Batch/ Product,     in which case BI shall first issue a credit note for the invoice
    corresponding to such Non Conforming Batch/ Product, including     the costs of materials used in the manufacture of such
    Batch/ Product, and later issue a new invoice at the time of delivery     of the replacement Batch/ Product, or (c) provided
    that BioCancell has already pre-paid a certain amount for the Non-Conforming     Batch/ Product to BI and BI’s
    replacement of such Batch/ Product as set forth in this Section 4.1.2 takes longer than     <Omitted> months from
    confirmation of a Non-Conforming Batch/ Product BioCancell may request from BI to refund the respective     amount of
    BioCancell’s pre-payment. BI shall start the applicable replacement work as soon as reasonably practicable,     such
    that the next available manufacturing slot shall be used by BI to produce the replacement Batch/ Product. In any event
    the production of the replacement Batch/ Product shall start within <Omitted> months after BioCancell’s
    notification     of the defect. After receipt of the replacement Batch/ Product, BioCancell shall destroy all defective
    Batch/ Product and     provide BI with written confirmation of such destruction.
	 	 
	4.1.3	Retesting of Samples; Dispute related to (alleged) defects
	 	In the event BioCancell rejects the Batch/ Product for Obvious
    or Latent Defects, BI shall have the right to sample and retest the Product, which shall be done as soon as practicable. In
    the event of a discrepancy between BioCancell’s and BI’s test results such that one Party’s results fall
    within the Specifications and the other Party’s test results fall outside the Specifications, or there exists a dispute
    over whether such failure is due (in whole or in part) to acts or omissions of BioCancell or any third party after delivery,
    the Parties shall cause a testing laboratory agreeable to both Parties (original cost split 50:50) to perform comparative
    tests and/or analyses on samples of the alleged defective Product. The testing laboratory’s results shall be in writing
    and shall be final and binding save for manifest error on the face of its report. Unless otherwise agreed to by the Parties
    in writing, the costs associated with such testing and review shall be borne by the Party against whom the testing laboratory
    result finally rules and such Party shall reimburse to the other Party the costs advanced to the laboratory pursuant to the
    foregoing cost split. The testing laboratory shall be required to enter into written undertakings of confidentiality no less
    burdensome than set forth or referred to by this Agreement.
	 	 
	 	The Parties agree that during the resolution of any dispute related
    to an alleged defect of a Batch/ Product, BI shall, irrespective of the final allocation of the cost for the replacement of
    such alleged defective Batch/ Product, supply any replacement of such alleged defective Batch/ Product requested by BioCancell
    or credit BioCancell for such replacement Batch/ Product as appropriate in accordance with the provisions of 4.1.2.
	 	 
	4.2	Cancellation / Postponement of Order 
	 	If BioCancell at any time and for any reason cancels or postpones
    the manufacture of any Batches set forth in the Project Plan for the manufacture of Product at the 200 L fermentation scale
    less than <Omitted> months prior to the start of the fermentation (breaking of cell bank vial), BioCancell shall pay
    the following percentages of the Project Fees for such specific Batches, as further stipulated in the table below, unless,
    (i) such cancellation or postponement is due to BI’s material breach of this Agreement, or (ii) a case of Force Majeure,
    or (iii) the Steering Committee unanimously agrees that the cancellation or postponement is due to a technical or scientific
    reason. BioCancell acknowledges that the partial postponement or cancellation of Batches in a campaign may affect the Project
    Fees for the remaining Batches.

  

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	 	Payment in case of cancellation or postponement of the manufacture of any Batches by BioCancell:
	 	 	 	 	 
	 	Time from

    notification of

    BioCancell until

    beginning of

    scheduled

    manufacture of a

    Batch (start of the

    fermentation)	Cancellation by

    BioCancell for

    reasons set forth

    in Section 10.2.2

    (i) (scientific (i.e.

    clinical failure)

    reasons)	Cancellation by

    BioCancell for

    reasons other than as

    set forth in Section

    10.2.2	Postponement

    by BioCancell
	 	 	 	 	 
	 	<Omitted>	<Omitted>	<Omitted>	<Omitted>
	 	<Omitted>	<Omitted>	<Omitted>	<Omitted>
	 	<Omitted>	<Omitted>	<Omitted>	<Omitted>
	 	<Omitted>	<Omitted>	<Omitted>	<Omitted>

	 	 	 
	 	In any event, BI shall use its commercially reasonable
    efforts to use the capacity resulting from the cancellation or postponement of the manufacture of any Batches and to mitigate
    any losses that may incur from such cancellation or postponement, including for the avoidance of doubt, the reapplication
    of Raw Materials and equipment, if possible.
	 	 
	 	In the event BI is able to sell to any third-party
    customer the capacity formerly reserved for BioCancell, BI shall provide financial information of such mitigation efforts
    to BioCancell. The amounts paid to BI for such capacity sold to such third-party shall be deducted from the amounts due to
    BI pursuant to this Section 4.2.
	 	 	 
	5	Use of Project Data; Record Keeping 
	 	 	 
	5.1	Project Data 
	 	a.	BI shall supply BioCancell with all documents, data, results, files
    and information as required under the QA and as may be reasonably requested by BioCancell to comply with any request of any
    applicable regulatory body or to comply with such regulatory body’s requirement, including, but not limited to, those
    related to a IND, IMPD, NDA or CTD; and
	 	 	 
	 	b.	BI shall prepare the draft chemistry, manufacturing and controls
    section of any regulatory filing supporting the clinical development of the Product for the Health Authorities in the United
    States and the European Union according to the QA. BioCancell shall review, finalize and approve the chemistry, manufacturing
    and controls section of any regulatory filing drafted by BI. BI shall timely perform reviews of the chemistry, manufacturing
    and controls section of any such regulatory filing for accuracy of content of such section prior to filing by BioCancell with
    the relevant Health Authorities and other regulatory authorities.

  

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	 	c.	Without derogating from the aforesaid, BI shall provide
    BioCancell with physical access to any and all Product-related documents on-site at BI at mutually agreed times and with copies
    of the following Product-specific documents for each Batch of MCB/WCB and Product:
	 	 	 
	 	 	•	COA
	 	 	•	COC
	 	 	•	Executed Batch Production Records
	 	 	•	Batch genealogy (if applicable)
	 	 	•  	Summary report of all Product-related deviations (Minor Deviations,
    Major Deviations, Planned Deviations, Unplanned Deviations) including confirmed OOS investigations, as applicable, and all
    other reports required under the QA. 
	 	 	BI shall provide BioCancell and its designee with a letter of authorization, in a form acceptable to BioCancell, permitting BioCancell, its designees, the FDA and other regulatory authorities to review and make reference to the Site Master File and/or Drug Master File (Type V) of BI.
	 	 	 
	 	 	BI shall maintain all original documents and data related
    to this Agreement and the Project for at least ten (10) years after Manufacturer ́s Release of a Batch. After such ten
    (10) year period BioCancell shall decide and notify BI in writing whether BI shall (a) provide documentation to BioCancell
    for further storage or (b) destroy such documentation.
	 	 	 
	 	d.	The provisions of this Section 5 shall survive the
    termination or expiration of this Agreement for a period of three (3) years or such longer period required pursuant to applicable
    law.
	 	 	 
	5.2	Record Keeping and Reporting Requirements of BI
	 	a.	BI shall prepare and keep comprehensive and complete
    documents, data, results, files and information regarding the Services it provides to BioCancell, including, but not limited
    to, those related to a IND, IMPD, NDA or CTD, and the manufacture and supply of the Product and the performance of its other
    obligations hereunder. Such documentation shall be prepared and kept in accordance with the cGMP and the requirements of the
    relevant Health Authorities, including the FDA and the EMA. The documentation and records shall include, but shall not be
    limited to the data required by BioCancell for the submission of drug registration applications, those required in order to
    assure compliance with all applicable national and local environmental laws, as well as all other documentation and records
    that may be reasonably required.
	 	 	 
	 	b.	Upon the request of BioCancell, BI shall provide it
    with copies of the documents, data, results, files and information specified in the QA or prepared or kept in accordance with
    this Agreement regarding the Product.
	 	 	 
	6	Representations, Warranties and Indemnification
	 	 
	6.1	Mutual Representations, Warranties and Covenants
	 	Each Party hereby represents and warrants to the other
    Party as follows:
	 	 	 
	 	a.	it is a corporation duly organized and validly existing
    under the laws of the state or other jurisdiction of incorporation or formation; and
	 	 	 
	 	b.	the execution, delivery and performance of this Agreement
    by such Party has been duly authorized by all requisite corporate action; and

  

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	 	c.	it has full corporate authority to enter into this Agreement and
    the Agreement is binding upon it in accordance with its terms.
	 	 	 
	6.2	BioCancell Warranties
	 	BioCancell hereby represents and warrants that:
	 	 
	 	a.	BioCancell is the owner or has the right to provide the BioCancell
    Deliverables, the BioCancell Background IP and all BioCancell Confidential Information under this Agreement and that to the
    best of its knowledge, at the Effective Date, there are no third party rights that will affect supply thereof to BI and/or
    its Affiliated Companies; and
	 	 	 
	 	b.	to the best of its knowledge, at the Effective Date, the BioCancell
    Deliverables, the BioCancell Background IP, and the BioCancell Confidential Information and their use by BI and/or its Affiliated
    Companies do not infringe the Intellectual Property Rights of any third party and BioCancell will promptly notify BI in writing
    should BioCancell become aware of any claims asserting such infringement; and
	 	 	 
	 	c.	BioCancell is not aware of any special or unusual hazards involved
    in handling the BioCancell Deliverables and/or Product of which BioCancell has failed to inform BI and that it will inform
    BI immediately of any changes related thereto after the date of execution of this Agreement; and
	 	 	 
	 	d.	BioCancell has the right to grant BI the licenses stipulated under
    this Agreement; and
	 	 	 
	 	e.	all BioCancell Deliverables are fit for use in a multi-purpose
    manufacturing facility, i.e. are free of adventitious agents (such as bacteriophage); and
	 	 	 
	 	f.	it shall use the Product or documents provided by BI under this
    Agreement in clinical studies and for regulatory purposes, only.
	 	 	 
	6.3	BI Warranties
	 	BI hereby represents and warrants that:
	 	 
	 	a.	BI is entitled to use the Facility for the purposes set forth in
    this Agreement; and
	 	 	 
	 	b.	BI at the Effective Date is not aware of any special or unusual
    hazards that would arise as a result of its carrying out of the Project as planned and BI will promptly notify BioCancell
    in writing should BI become aware of any such hazards; and
	 	 	 
	 	c.	BI has not been debarred, nor is it subject to a pending
    debarment,     and to the best of its knowledge, that it will not use in any capacity in connection with the services under
    this Agreement     any person, who has been debarred pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, or who is
    the subject of a conviction     described in such section. BI agrees to notify BioCancell in writing immediately if it comes
    to its knowledge that BI or any     person who is performing Services is debarred or is the subject of a conviction described
    in section 306, or if any action,     suit, claim, investigation, or proceeding is pending, or to BI’s knowledge, is
    threatened, relating to the debarment     or conviction of BI or any person performing services under this Agreement;
    and
	 	 	 
	 	d.	BI is the owner or has the right to provide and/or disclose, as
    applicable, the BI Background IP, including the pDNA Technology, the Site Master File and/or Drug Master File (Type V) and
    all BI Confidential Information under this Agreement and that to the best of its knowledge, at the Effective Date, the BI
    Background     IP, including the pDNA Technology, and the Site Master File and/or Drug Master File (Type V) do not infringe
    the Intellectual     Property Rights of any third party and BI will promptly notify BioCancell in writing should it become
    aware of any claims     asserting such infringement; and

  

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	 	e.	To the best of its knowledge, (i) as of the Effective Date and
    (ii) as of the commencement of each clinical trial being undertaken by BioCancell (subject to BioCancell providing BI with
    at least thirty (30) days prior written notice of such commencement), the use of Product supplied by BI for use in clinical
    trials in the Territory will not infringe the Intellectual Property Rights of any third party, provided that the BioCancell
    Confidential Information and/or all BioCancell Deliverables provided to BI do not infringe any third party Intellectual Property
    Rights and the use of Product is not subject to third party rights which are unrelated to the manufacture of Product or to
    the pDNA Technology. The aforesaid shall not be considered a representation by BI that the application or combination of any
    BI Background IP with the BioCancell Deliverables will not infringe any third party rights where the Background IP, standing
    alone, would not have infringed such third party rights; and
	 	 	 
	 	f.	BI will not introduce into the Manufacturing Process any technology
    that would infringe, during BI’s performance of the Services or during the license period of a license granted to BioCancell
    pursuant to Section 10.3.8, any third party rights in the European Union or the United States; and
	 	 	 
	 	g.	BI will not make any use of the BioCancell Deliverables, the BioCancell
    Background IP, and the BioCancell Confidential Information except as specifically provided for in this Agreement; and
	 	 	 
	 	h.	the Product: (i) will conform to the Specifications on the date
    of Manufacturer’s Release, (ii) will be manufactured in accordance with and in compliance with the QA, including cGMP,
    and (iii) will be transferred to BioCancell free and clear of any security interests, liens or encumbrances; and
	 	 	 
	 	i.	it will perform its obligations hereunder in a professional and
    workmanlike manner and in compliance with cGMP (if applicable) and it will obtain, maintain and comply with all licenses and
    permits of the Health Authorities and other relevant regulatory authorities required in connection with the provision of Services
    hereunder and the manufacture of the Product; and
	 	 	 
	 	j.	it will be responsible to ensure the compliance with this Agreement
    by BI RCV, BIP and other permitted sub-contractors, will be responsible and liable to BioCancell for the acts and omissions
    of BI RCV, BIP and its other permitted sub-contractors and these representations and warranties apply to BI RCV, BIP and BI’s
    other permitted sub-contractors.
	 	 	 
	 	For avoidance of doubt, all BI liability or indemnification
    obligations that might result from the representations and warranties under this Section6.3 are always subject to the limitations
    set forth in Section 7 of this Agreement.
	 	 	 
	6.4	Disclaimer of Warranties
	 	EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT,
    NEITHER PARTY MAKES ANY WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, WITH RESPECT TO ANY INTELLECTUAL PROPERTY, TECHNOLOGY, RIGHTS,
    RESULTS OF THE PROJECT, THE BIOCANCELL DELIVERABLES OR BI DELIVERABLES OR OTHER SUBJECT MATTER OF THIS AGREEMENT OR THAT THE
    PROJECT WILL RESULT IN A COMMERCIALLY VIABLE PROCESS, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS
    FOR A PARTICULAR PURPOSE.

  

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	7	Liability, Indemnification, Limitations and Insurance
	 	 	 
	7.1	General
	 	BI does not know or control how BioCancell intends
    to use the Product or other results derived under this Agreement in clinical studies. BI understands and accepts that the
    Products manufactured under this Agreement will be used by BioCancell in connection with clinical studies and for regulatory
    purposes.
	 	 	 
	7.2	Disclaimer of Consequential Damages
	 	EXCEPT FOR CASES OF WILFUL MISCONDUCT OF EITHER PARTYAND
    SUCH CASES WHERE A LIMITATION OF LIABILITY AND/OR A LIMITATION OF INDEMNIFICATION OBLIGATIONS IS NOT POSSIBLE UNDER APPLICABLE
    LAW FOR WHICH CASES THERE SHALL BE NO LIMITATION OF LIABILITY AS WELL AS NO LIMITATION OF ANY INDEMNIFICATION OBLIGATION,
    IN NO EVENT, EITHER DIRECTLY OR BY WAY OF INDEMNIFICATION, SHALL A PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INCIDENTAL,
    INDIRECT, EXEMPLARY, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, IRRESPECTIVE OF THE THEORY OF LIABILITY, ARISING FROM OR
    RELATED TO BREACH OF THIS AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY CLAIMS FOR DAMAGES BY THIRD PARTIES, CLAIMS FOR DAMAGES
    BASED UPON LOST PROFITS FOR SALES TO THIRD PARTIES, LOSS OF REPUTATION OR LOSS OF GOOD WILL, EVEN IF THE OTHER PARTY HAS BEEN
    ADVISED OF THE POSSIBLITY OF SUCH DAMAGES.
	 	 	 
	7.3	Liability between the Parties and Indemnification
    obligations of the Parties
	 	 	 	 
	 	a.	Of BI
	 	Subject to the limitations set forth in Section 7.2
    and Section 7.5, BI shall be liable for and indemnify and hold BioCancell and its Representatives harmless 
	 	 	 
	 	-	for any losses,
    damages, costs or expenses including without limitation, reasonable attorney’s fees of any nature (“Losses”)
    incurred or suffered directly by BioCancell or its Representatives; and
	 	 	 	 
	 	-	from and against any third party claims
	 	 	 	 
	 	to the extent such Losses and third party claims arise
    from
	 	 	 	 
	 	(i)	BioCancell’s or its Affiliated Companies’
    use of the BI Background IP and/or BI Confidential Information, and/or reference to the Site Master File and/or Drug Master
    File (Type V) in BioCancell’s regulatory submissions in accordance with this Agreement; and/or
	 	 	 	 
	 	(ii)	BI’s breach of its representations and warranties
    given under this Agreement, and/or
	 	 	 	 
	 	(iii)	BI’s negligence in the performance of its obligations
    under this Agreement and/or BI’s material breach with its obligations under this Agreement, and/or

  

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	 	(iv)	BI’s breach or non-compliance with the requirements
    of any laws and regulations applicable to a biopharmaceutical company operating in Austria and Germany.
	 	 	 	 
	 	Notwithstanding the foregoing, BI shall not be liable
    or have an indemnification obligation hereunder to the extent such third party claims and Losses result from
	 	 	 	 
	 	aa.	BioCancell’s breach of its representations and
    warranties given under this Agreement; and/or
	 	 	 	 
	 	bb.	BioCancell’s negligence in the performance of
    its obligations under this Agreement and/or BioCancell’s material breach of its obligations under this Agreement; and/or
	 	 	 	 
	 	cc.	BioCancell’s or its Affiliated Companies’
    use of the BI Background IP and/or BI Confidential Information and/or reference to the Site Master File and/or Drug Master
    File (Type V) in BioCancell’s regulatory submissions not in accordance with this Agreement.
	 	 	 	 
	 	b.	Of BioCancell
	 	Subject to the limitations set forth in Section 7.2,
    BioCancell shall be liable for and indemnify and hold BI and its Representatives harmless
	 	 	 
	 	-	for any Losses incurred or suffered directly by BI
    or its Representatives; and
	 	 	 
	 	-	from and against any third party claims
	 	 	 
	 	to the extent such Losses and third party claims are
    arising from
	 	 	 
	 	(i)	BI’s and/or its Affiliated Companies’ use
    of BioCancell Deliverables and/or the BioCancell Background IP and/or BioCancell Confidential Information, in accordance with
    this Agreement; and/or
	 	 	 
	 	(ii)	BioCancell’s breach of its representations and
    warranties given under this Agreement; and/or
	 	 	 
	 	(iii)	BioCancell’s negligence in the performance of
    its obligations under this Agreement and/or BioCancell’s material breach of its obligations under this Agreement; and/or
	 	 	 
	 	(iv)	BioCancell’s use of the BI Deliverables and/or
    the Product in humans; and/or
	 	 	 
	 	(v)	BioCancell’s or its Affiliated Companies’
    use of the BI Background IP and/or BI Confidential Information and/or reference to the Site Master File and/or Drug Master
    File (Type V) in breach of this Agreement; and/or
	 	 	 
	 	(vi)	BioCancell’s breach or non-compliance with the
    requirements of any laws and regulations applicable to a marketing authorization holder of the Product.
	 	 	 
	 	Notwithstanding the foregoing, BioCancell shall not
    be liable or have an indemnification obligation hereunder if and to the extent such third party claims and Losses result from
	 	 	 
	 	aa.	BI’s breach of its representations and warranties
    given under this Agreement, and/or
	 	 	 
	 	bb.	BI’s negligence in the performance of its obligations
    under this Agreement and/or BI’s material breach with its obligations under this Agreement; and/or.
	 	 	 
	 	cc.	BI’s breach or non-compliance with the requirements
    of any applicable laws and regulations.

  

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	7.4	Indemnification Procedure
	 	To be eligible to be indemnified under Section 7.3
    , the Party having a right to be indemnified (“Indemnitee”) shall provide the indemnifying Party (“Indemnitor”)
    with prompt notice of the third party claim giving rise to the indemnification obligation pursuant to Section 7.3. and the
    exclusive ability to defend (with the reasonable cooperation of the Indemnitee) or settle any such claim; provided, however,
    that the Indemnitor shall not enter into any settlement that admits fault, wrongdoing or damages without the Intemnitee’s
    written consent, such consent not to be unreasonably withheld or delayed. The Indemnitee shall have the right to participate,
    at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnitor.
    The Indemnitee shall (i) fully cooperate with the Indemnitor in connection with the defense or settlement of the relevant
    claim; and (ii) not make any admission or settlement in connection with the relevant claim without the prior approval of the
    Indemitor.
	 	 	 
	7.5	Limitation of BI’s Liability and Indemnification
    Obligations
	 	<Omitted>
	 	 	 
	 	<Omitted>
	 	 	 
	 	<Omitted>
	 	 	 
	 	<Omitted>

  

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	 	<Omitted>
	 	 	 
	 	<Omitted>
	 	 	 
	 	<Omitted>
	 	 	 
	 	<Omitted>
	 	 	 
	 	<Omitted>
	 	 
	 	<Omitted>
	 	 	 
	7.6	Insurance
	 	BioCancell and BI shall each obtain and/or maintain
    during the term of this Agreement and for a period of five (5) years thereafter, liability insurance in amounts which are
    reasonable and customary in the biopharmaceutical industry for the respective activities (i.e. BI as contract manufacturing
    organisation and BioCancell as sponsor/pharmaceutical company), but no less than US $ 10 Million in the aggregate, and such
    liability insurance shall insure against all mandatory liability, including liability for personal injury, physical injury
    and property damage. BI shall have the right to self-insure at any time if (i) BI self-insures similar agreements with third
    party which provide for the similar extent of services; and (ii) BI’s financial stability will allow for such self-insurance.
    Upon written request, each Party shall provide the other Party with copies of all relevant insurance policies and any changes
    made thereto.
	 	 	 
	8	Intellectual Property
	 	 	 
	8.1	Existing Intellectual Property Rights
	 	BI shall acquire no rights, title or interest whatsoever
    in or to any of the BioCancell Background IP, including, but not limited to, the BioCancell Deliverables, and the Product,
    except as specifically provided for in this Agreement, and BioCancell shall remain at all times the exclusive owner of such
    Background IP.
	 	 	 
	 	BioCancell shall acquire no rights, title or interest
    whatsoever in or to any of BI Background IP, including, but not limited to the pDNA Technology, except as specifically
    provided     for in this Agreement, and BI shall remain at all times the exclusive owner of such BI Background IP
    .

  

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	8.2	New Intellectual Property, Project Results and Licenses
	8.2.1	BioCancell
	 	BioCancell shall have the exclusive ownership of all
    Intellectual Property Rights and other proprietary rights in any Improvements that are solely and directly related to the
    BioCancell Background IP, including the BioCancell Deliverables (unless such BioCancell Deliverables, other than copyrights,
    are in the public domain), and/or the Product, (collectively, “BioCancell Improvements”) deriving from this Agreement.
    BioCancell shall control patent prosecution and maintenance thereof. BI agrees, for no additional consideration, to assign
    and hereby assigns to BioCancell all right title and interest it may have in any BioCancell Improvements. BI shall provide
    reasonable assistance to BioCancell for any action which may be necessary to assign or otherwise transfer any such rights
    to BioCancell Improvements contemplated by this Section 8.2.1. BI shall notify BioCancell within thirty (30) calendar days
    of becoming aware of such BioCancell Improvements.
	 	 	 
	 	In addition, any compensation that may be due to an
    inventor of any BioCancell Improvements who is an employee, consultant or agent of BI under the provisions of applicable labor
    or other applicable laws shall be paid by BI and BI shall not be entitled to any additional compensation from BioCancell in
    this regard.
	 	 	 
	 	BI shall provide BioCancell with access to all relevant
    research documents, data and lab notebooks related to the BioCancell Improvements in order to enable BioCancell to prepare
    and defend patent applications related to the BioCancell Improvements. BI shall provide BioCancell reasonable access to its
    employees, consultants and agents who were involved in the provision of Services hereunder and shall cause such employees,
    consultants and agents to assist BioCancell with the preparation and defense of patent applications related to the BioCancell
    Improvements. BioCancell shall reimburse BI for its direct costs associated with such support (work time, travel costs, etc.).
	 	 	 
	8.2.2	BI
	 	BI shall have the exclusive ownership of all Intellectual
    Property Rights and other proprietary rights in any Improvements that are solely and directly related to the BI Background
    IP, including the pDNA Technology (unless the aforesaid, other than copyrights, are in the public domain) (collectively, “BI
    Improvements”) deriving from this Agreement. BI shall control patent prosecution and maintenance thereof. BioCancell
    agrees to assign and hereby assigns to BI all right, title and interest it may have in any BI Improvements. BioCancell shall
    provide reasonable assistance to BI for any action which may be necessary to assign or otherwise transfer such rights to BI
    Improvements contemplated by this Section 8.2.2.
	 	 	 
	8.2.3	Other IP generated under the Agreement
	 	Any other Intellectual Property Rights generated under
    the terms of this Agreement, including, but not limited to the Manufacturing Process, shall belong to BI and Section 8.2.2
    shall apply accordingly, unless such Intellectual Property Rights are not applicable to any other biopharmaceutical product
    than the Product. The latter shall belong to BioCancell, and Section 8.2.1 shall apply accordingly.
	 	 	 
	8.2.4	License 
	 	BioCancell hereby grants to BI during the term
    of this Agreement and BI hereby accepts for the purpose of pursuing the Project a non-exclusive, non-sublicensable (except
    to BI’s Affiliated Companies and subcontractors of BI pursuant to Section 11.8), royalty-free, license to use the BioCancell
    Background IP and the BioCancell Improvements for the sole purpose to develop the Manufacturing Process, and for the manufacturing
    of the Product for clinical purposes in accordance with this Agreement.

  

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	9	Confidentiality
	 	 
	9.1	During the term hereof and for a period of ten (10)
    years after termination or expiration of this Agreement, Receiving Party agrees to hold all Confidential Information disclosed
    to it or its Affiliated Companies by the Disclosing Party or its Affiliated Companies in strict confidence and to use such
    Confidential Information only in connection with the performance of its obligations under this Agreement, as contemplated
    by or as permitted under this Agreement. Receiving Party shall not use the Disclosing Party’s Confidential Information
    for any purpose other than as permitted in the preceding sentence, reproduce such Confidential Information, or disclose such
    Confidential Information to any third party, without prior approval of Disclosing Party. Receiving Party agrees to protect
    Disclosing Party’s Confidential Information with at least the same degree of care as it normally exercises to protect
    its own proprietary information of a similar nature, but in any case using no less than a reasonable degree of care. Receiving
    Party shall take all appropriate steps to ensure that all of its or its Affiliated Companies’ employees and consultants
    receive Disclosing Party’s Confidential Information only on a need to know basis, within the scope of this Agreement,
    and then, only if such persons are bound by obligations of confidentiality and non-use substantially similar to those under
    this Agreement. For purposes of clarity, the Specifications shall be deemed BioCancell’s Confidential Information and
    proprietary to BioCancell.
	 	 
	9.2	The restrictions of this Agreement regarding Confidential
    Information of the other Party shall not apply to such Confidential Information which: (a) was known to Receiving Party or
    its Affiliated Companies prior to receipt hereunder as evidenced by written records; (b) at the time of disclosure by Disclosing
    Party was generally available to the public, or which after disclosure hereunder becomes generally available to the public
    through no fault attributable to Receiving Party or its Affiliated Companies; (c) is hereafter made available to Receiving
    Party or its Affiliated Companies for use or disclosure by Receiving Party or its Affiliated Companies from any third party
    having a right do so; or (d) is independently developed by Receiving Party or its Affiliated Companies without the use of
    the Disclosing Party’s Confidential Information as evidenced by written records. Further, subject to Receiving Party
    providing Disclosing Party with reasonable advance notice (to the extent possible and permitted by law) and the opportunity
    to challenge, limit or seek a protective order for such disclosure, Receiving Party and/or its Affiliated Companies may make
    such limited disclosure as is required by mandatory law. Receiving Party shall provide Disclosing Party with reasonable assistance
    in any challenge undertaken by Disclosing Party.
	 	 	 
	9.3	Subject to any right to continued use as provided herein
    (such as, but not limited to, license rights), upon Disclosing Party’s written request, Receiving Party agrees to, at
    Receiving Party’s discretion, either deliver to Disclosing Party or destroy all written materials embodying the Confidential
    Information of the Disclosing Party and/or its Affiliated Companies and all materials that constitute such Confidential Information,
    which are in the possession or under the control of Receiving Party or its Affiliated Companies, in each case subject to the
    last sentence of this Section. In the event that Receiving Party elects to destroy the materials, upon destruction of such
    materials, Receiving Party will issue to Disclosing Party a certificate of destruction as proof of compliance with Disclosing
    Party’s request. Receiving Party further agrees not to retain any copies, notes or compilations of any written materials
    pertaining to the Confidential Information received from Disclosing Party or its Affiliated Companies, save that Receiving
    Party may retain one (1) copy of documentary Confidential Information for the sole purpose of monitoring its compliance with
    this Agreement.

  

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	9.4	In the event that either Party is required to file
    this Agreement with Health Authorities or other government agencies (e.g. under Israeli Securities Authority rules), that
    Party shall seek confidential treatment of sensitive information of the Disclosing Party (in particular, but not limited to
    trade secrets, confidential commercial or financial information). The Party required to make the submission will give reasonable
    advance notice to the Disclosing Party of such disclosure requirement in order to enable the Disclosing Party to comment on
    such submission, and shall use reasonable efforts to incorporate the Disclosing Party’s comments in order to secure
    a protective order or confidential treatment of any Confidential Information required to be disclosed.
	 	 	 
	9.5	BI acknowledges that BioCancell is a public company
    and that BioCancell may be required to issue press releases or public announcements with respect to this Agreement and the
    transactions contemplated hereunder. Unless mandatory applicable laws require an immediate public announcement, neither Party
    shall issue any press release or other public announcement with respect to such transactions without the other Party’s
    written consent, such consent not to be unreasonably withheld.
	 	 	 
	10	Term and Termination
	 	 	 
	10.1	Term
	 	This Agreement shall take effect as of the Effective
    Date and shall expire upon completion of the Services, unless terminated earlier in accordance with this Agreement.
	 	 	 
	10.2	Termination of this Agreement
	10.2.1	Termination for convenience
	 	This Agreement may be terminated by BioCancell upon
    the provision of six (6) months prior written notice to BI and by BI upon provision of twenty-four (24) months prior written
    notice to BioCancell. BI’s provision of a termination notice in accordance with the provisions of this Section 10.2.1,
    shall not derogate from the rights of BioCancell to subsequently terminate this Agreement in accordance with the provisions
    of this Section 10.2.1.
	 	 	 
	10.2.2	Termination for scientific or technical reasons
	 	If it is apparent at any stage of the Project that
    it will not be possible to carry out the Project for (i) scientific (i.e. clinical failure) or (ii) process related technical
    reasons (e.g. scale-up of the Manufacturing Process), and the Parties cannot agree in a timely fashion on a change to the
    Project Plan to overcome this issue, BioCancell or in case (ii) above also BI may terminate this Agreement upon thirty (30)
    calendar days prior written notice to the other Party.
	 	 
	10.2.3	Termination for business reasons
	 	If it is apparent to BioCancell at any stage of the
    Project that it will not be possible to carry out the Project for business reasons, BioCancell may terminate this Agreement
    upon the provision of ninety (90) calendar days prior written notice.

  

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	10.2.4	Termination of this Agreement for material breach
	 	This Agreement may be terminated with immediate effect by written
    notice by either Party, if the other Party breaches this Agreement in any material manner and shall have failed to remedy
    such default within one-hundred and eighty (180) calendar days (in case of a failed Batch, the timelines are subject to Section
    4.1.2) after written notice thereof from the terminating Party. For the purpose of clarity, the manufacture of three (3) Non-Conforming
    Batches of Product in a year by BI under this Agreement shall also be considered a material breach of this Agreement by BI.
	 	 
	10.2.5	Termination for bankruptcy
	 	This Agreement may be terminated with immediate effect by written
    notice by either Party, if the other Party is not able to repeatedly fulfill its payment obligations towards its debtors,
    declares bankruptcy, is declared or adjudicated bankrupt, by voluntary or involuntary action goes into liquidation, or dissolves
    or files a petition for bankruptcy or suspension of payments, or enters into a procedure of winding up or dissolution that
    is not dismissed within forty-five (45) calendar days, or a trustee in bankruptcy or receiver or other equivalent entity is
    appointed for the other Party’s property or estate.
	 	 
	10.2.6	Termination due to Change of Control
	 	This Agreement may beterminated with immediate effect by either
    Party upon written notice to the other Party, if either Party undergoes a Change of Control by being taken over by a Direct
    Competitor of the other Party. Pursuant to the aforesaid, either Party may exercise such right to terminate the Agreement
    under     this Section 10.2.5 no later than two (2) months after the notification of the applicable Change of Control. A
    party undergoing     a Change of Control shall notify the other Party of the same.
	 	 
	10.2.7	Termination due to Force Majeure
	 	This Agreement may be terminated by BioCancell upon the provision
    of written notice to BI in accordance with the provisions of Section 11.
	 	 
	10.3	Effect of Termination 
	 	Upon termination or expiration of this Agreement:
	 	 
	10.3.1	Each party shall promptly return to the other all Confidential
    Information of the Disclosing Party then in its possession or under the Receiving Party’s control, or, at the Disclosing
    Party’s request, destroy and thereafter confirm the destruction of such Confidential Information.
	 	 
	10.3.2	If requested by BioCancell, and BI is able to do so, BI shall complete
    the production of all in-process Batches which shall be completed and delivered in accordance with the provisions of this
    Agreement and the QA.
	 	 
	10.3.3	Subject to the provision of Section 10.3.2 and BioCancell ́s
    full payment of all outstanding Project Fees for Services performed by BI up to and until the effect of termination, all other
    Raw Materials and work-in-process shall be delivered to BioCancell by BI “ex works” (EXW) Facility, as that term
    is defined in Incoterms 2010, ICC Rules for the Use of Domestic and International Trade Terms, ICC Publication No. 715EF).
	 	 
	10.3.4	BI shall, at BioCancell’s expense, transfer to BioCancell
    or its nominees, all relevant Product-related cGMP documents, data, results, files and information related to this Agreement,
    in accordance with the QA, including, but not limited to those related to a IND, IMPD, NDA or CTD, within ninety (90) days
    after settlement of all material outstanding payments. Notwithstanding the foregoing, in the event of a material breach by
    BioCancell of its Intellectual Property Rights related obligations including but not limited to Sections 6.2, 8 and 9, BI
    shall provide to BioCancell only such documentation and data required for regulatory purposes.

  

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	10.3.5	(A) Subject to Sections 10.3.5 (B), 10.3.8, 10.3.9,
    10.3.10, and 10.3.11, the amounts due to BI from BioCancell shall be limited to:
	 	(i)	all Project Fees outstanding for Services performed by BI up to
    and until the effect of termination calculated on a pro-rata basis, and
	 	 	 
	 	(ii)	all non-cancellable expenses reasonably incurred by BI in accordance
    with the terms and conditions of this Agreement prior to receipt of such termination notice in respect of the purchase of
    supplies including but not limited to Raw Materials and/or Product-dedicated equipment for use in manufacturing of the Product;
    and
	 	 	 
	 	(iii)	all cancellation costs for scheduled Batches pursuant to and subject
    to Section 4.2; and (iv) wind-down costs for <Omitted> months, not to exceed a total of <Omitted>.
	 	 	 
	 	BI shall use its commercially reasonable efforts to
    mitigate all fees due under this Section and provide financial information of such mitigation efforts to BioCancell. The amounts
    paid to BI for such capacity sold to such third-party shall be deducted from the amounts due to BI pursuant to this Section.
	 	 
	 	(B) For the avoidance of doubt, in the event of termination
    by BI pursuant to Section 10.2.1 (BI termination for convenience) the Parties shall continue to perform the Services in accordance
    with the Project Plan, and BioCancell has not provided a subsequent notice of termination as provided for in Section 10.2.1,
    BioCancell shall pay to BI only the respective fees for such Services, i.e. for the period of <Omitted> months after
    BioCancell’s receipt of written notice.
	 	 	 
	10.3.6	For a period of one hundred eighty (180) calendar days
    following termination for any reason and upon the provision of at least sixty (60) calendar days prior written notice, BioCancell
    shall have the right to purchase for one (1) Euro, take possession of, and remove from the Facility the Product Dedicated
    Equipment, to the extent such Product Dedicated Equipment, all Project Fees outstanding and due up to and until the effect
    of termination and cancellation cost pursuant to Section 4.2 or Section 10.3.11, as applicable, have been paid for by BioCancell,
    as applicable, and in accordance with the terms and conditions of this Section 10.
	 	 	 
	10.3.7	Storage of Product/ Materials
	 	BI’s responsibility to keep and store the Product
    (if any) and/or any materials received or generated under this Agreement shall terminate six (6) months after expiration or
    termination of this Agreement.
	10.3.8	Unless this Agreement was terminated by BI pursuant
    to Sections 10.2.4, 10.2.5 or 10.2.6 due to a material breach by BioCancell, the bankruptcy of BioCancell or a Change of Control
    of BioCancell, or pursuant to Section 10.2.2 for scientific or technical reasons, BI shall provide BioCancell with a license
    to the BI Background IP and the BI Improvements in accordance with the provisions of the pDNA License Agreement to be attached
    hereto as Appendix 4. Additionally, BioCancell may request for a period of twelve (12) month after termination, that BI assist
    BioCancell at BioCancell’s cost and expense with the transfer of the then current Manufacturing Process with a total
    capacity of <Omitted>

  

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	10.3.9	In the event of termination by either Party according
    to Section 10.2.2 (ii) (process related technical reasons) the amounts due to BI from BioCancell shall be limited to:
	 	(i)	all Project Fees outstanding for Services performed by BI up to
    and until the effect of termination calculated on a pro-rata basis; and
	 	 	 
	 	<Omitted>  	wind-down costs for up to <Omitted> months, not to exceed
    a total <Omitted>
	 	 	 
	 	BI shall not be entitled to charge any additional non-cancellable
    expenses.
	 	 	 
	10.3.10	In the event of termination by BI according to Section
    10.2.6 (Change of Control of BioCancell) or termination by BioCancell according to 10.2.4 (material breach by BI) or according
    to 10.2.5 (BI bankruptcy), the amount due to BI from BioCancell shall be limited to: all Project Fees outstanding for Services
    performed by BI up to and until the effect of termination calculated on a pro-rata basis.
	 	In the event of termination by BioCancell according
    to 10.2.4 (material breach by BI) or according to 10.2.5 (BI bankruptcy), BI shall not be entitled to charge
	 	 
	 	(a) any additional non-cancellable expenses or (b)
    any wind-down costs. Further, in the event of termination by BioCancell according to Section 10.2.4 (material breach by BI),
    transfer of the then current Manufacturing Process pursuant to Section 10.3.8 up to a total <Omitted> shall be rendered
    by BI to BioCancell free of charge.
	 	 	 
	10.3.11	In case of a termination by BI according to Section
    10.2.4 (material breach by BioCancell), the amounts due to BI from BioCancell shall be limited to:
	 	(i)	all Project Fees outstanding for Services performed by BI through
    the termination calculated on a pro-rata basis; and
	 	 	 
	 	(ii)	all non-cancellable expenses reasonably incurred by BI in accordance
    with the terms and conditions of this Agreement prior to receipt of such termination in respect of the purchase of supplies
    including but not limited to Raw Materials and/or Product-specific equipment for use in manufacturing of the Product; and
	 	 	 
	 	(iii)	<Omitted> Project Fees for ordered Batches scheduled for
    manufacture (according to the date of the start of fermentation) within a twelve (12) month period from notice of termination;
    and
	 	 	 
	 	<Omitted>	wind-down costs for up to <Omitted> months, not to exceed
    a total <Omitted>
	 	 	 
	 	In addition, BI shall be free to claim damages and
    indemnification in accordance with the terms of this Agreement.
	 	 	 
	10.3.12  	Following payment to BI in accordance with the terms
    and conditions of this Section 10.3 upon the termination of this Agreement, BI shall refund to BioCancell the excess amount,
    if any, of Project Fees pre-paid by BioCancell to BI in accordance with the Billing Plan calculated against the fees owed
    by BioCancell to BI under Section 10.3.
	 	 	 
	10.3.13	Surviving Provisions
	 	As far as not expressly set forth in this Agreement
    all provisions designed to have effect even after the termination or expiration of this Agreement shall survive the termination
    or expiration of this Agreement, in particular Sections 1, 5, 6, 7, 8 (other than sub-section 8.2.4), 9, 10 and 11.

  

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	11	Miscellaneous 
	 	 
	11.1	Force Majeure 
	 	Neither Party shall be in breach of this Agreement if there is
    any failure of performance under this Agreement (except for payment of any amounts due hereunder) occasioned by any act of
    God, fire, act of government or state, war, civil commotion, insurrection, embargo, prevention from or hindrance in obtaining
    energy or other utilities, labor disputes of whatever nature or any other reason beyond the control of either Party; provided,
    however, that the Party affected shall: (i) give prompt written notice to the other Party of the date of commencement of the
    force majeure, the nature thereof, and expected duration; and (ii) use commercially reasonable efforts to avoid or remove
    the force majeure to the extent it is able to do so; and (iii) make up, continue on and complete performance when such cause
    is removed to the extent it is able to do so. In the event BI’s performance of the Services, due to reasons of force
    majeure ceases to be provided under this Agreement for more than three (3) months, or more than twelve (12) months in case
    of an unforeseen supply issue with any Raw Materials, BioCancell shall have the right to terminate this Agreement pursuant
    to Section 10.2.7., and Sections 10.3.1. through 10.3.8 shall apply.
	 	 
	11.2	Prior Agreements 
	 	This Agreement constitutes the entire understanding of the Parties
    with respect to the subject matters contained herein, superseding all prior oral or written understandings or communications
    between the Parties, and it may be modified only by a written agreement signed by the Parties. This Agreement supersedes all
    prior agreements, whether written or oral, with respect to the subject matters contained herein, including the CDA and/or
    MTA. Exchange of any information, including but not limited to the exchange of Confidential Information (as defined herein)
    and the performance of any services (including but not limited to the Services) initiated under the MTA shall be performed
    under the terms of this Agreement only, as of the Effective Date. This Agreement may only be modified or amended in a writing
    duly executed by both Parties.
	 	 
	11.3	No application of the Parties’ General Terms and Conditions
    
	 	The Parties acknowledge that due to the internal guidelines,
    procedures     or systems of a Party it might not be avoidable that communication or documents and the like are issued
    containing a reference     to the general terms and conditions of such Party. Moreover, BI acknowledges that BioCancell for
    such reasons as outlined     in the previous sentence might not be able to avoid the issuance of one or more purchase orders
    (or the like) replicating what     was already agreed upon in this Agreement and which due to technical reasons of the system
    might contain a reference to BioCancell’s     general terms and conditions. Therefore, the Parties agree that the
    general terms and conditions of the Parties shall not     apply, even if reference is made thereto in such purchase order (or
    the like) or any other communication or documents related     to this Agreement.

  

    	Page 29 of 56

    	 

    

  

	 	 
	11.4	Notices 
	 	Any notice required or permitted to be given hereunder by either
    Party shall be in writing and shall be (i) delivered personally, (ii) sent by registered mail, return receipt requested, postage
    prepaid (iii) delivered by facsimile with immediate confirmation of receipt, or (iv) sent by email (which shall only be deemed
    received upon confirmation or acknowledgement by the recipient) to the addresses, e-mail recipients or facsimile numbers set
    forth below:

	 	 
	 	If to BI:
	 	<Omitted>
	 	<Omitted>
	 	<Omitted>
	 	<Omitted>
	 	Attn: <Omitted>
	 	Fax: <Omitted>
	 	E-Mail: <Omitted>
	 	 
	 	Copy to:
	 	<Omitted>
	 	<Omitted>
	 	<Omitted>
	 	Attn.: <Omitted>
	 	Fax: <Omitted>
	 	E-Mail: <Omitted>
	 	 
	 	If to BioCancell:
	 	1/3 High-Tech VillageGivat
    Ram
	 	P.O. Box 39264
	 	Jerusalem
	 	9139102 Israel
	 	Attn: Jonathan Burgin
	 	Fax: +972-722-740-864
	 	E-Mail: jonthan.burgin@biocancell.com
	 	Phone: +972-2-548-6555
	 	Mobile: +972-54-774-5445
	 	 
	 	Copy to:
	 	Rivka Zaibel
	 	CEO
	 	ADRES, Advanced Regulatory Services Ltd.
	 	Golda Meir 3
	 	Ness Ziona
	 	E-Mail: rivkaz@adres.co.il
	 	Phone: +97289319585
	 	Mobile: +972542274003
	 	Fax: +97288539587

 

    	Page 30 of 56

    	 

    

 

	11.5	Dispute Resolution, Applicable Law and Arbitration 
	 	 	 
	11.5.1	Dispute Resolution
	 	Any dispute relating to the validity, performance, construction or interpretation of this Agreement shall first be submitted for resolution to the Steering Committee.
	 	 	 
	11.5.2	Applicable Law
	 	This Agreement shall be exclusively governed by and construed in accordance with the laws of the State of New York without regard to its conflict of laws provisions. The application of the UN Convention on Contracts for the International Sale of Goods is excluded.
	 	 
	11.5.3	Arbitration
	 	The Parties agree that all disputes, claims or controversies arising out of, relating to, or in connection with this Agreement, including any question regarding its formation, existence, validity, enforceability, performance, interpretation, breach or termination, shall be exclusively and finally settled under the Rules of Arbitration of the International Chamber of Commerce (“ICC”) by one arbitrator appointed in accordance with said rules.
	 	 	 
	 	The exclusive place of arbitration shall be Frankfurt am Main, Germany and the proceedings shall be conducted in English language.
	 	 	 
	 	The award for arbitration shall be final and binding and may be enforced in any court of competent
    jurisdiction against BI or BioCancell. Nothing in this Section 11.5.3 shall prevent any Party, before an arbitration has
    commenced hereunder or any time thereafter during such arbitration proceedings, from seeking conservatory measures and
    interim measures, including, but not limited to temporary restraining orders or preliminary injunctions, or their equivalent,
    from any court of competent jurisdiction.
	 	 	 
	 	The Parties further agree that
	 	 	 
	 	a.	except as may be otherwise required by law, neither Party, its witnesses, or the arbitrator may disclose the existence, content, results of the arbitration hereunder without prior written consent of both Parties; and
	 	 	 
	 	b.	neither Party shall be required to give general discovery of documents, but may be required only to produce specific,
    identified documents, or narrow and specific categories of documents, which are relevant to the case and material to its
    outcome and reasonably believed to be in the custody, possession or control of the other Party; and
	 	 	 
	 	c.	decisions ex aequo et bono or in equity are not permissible.
	 	 	 
	 	The costs of the arbitration (including reasonable attorney’s fees and associated costs and expenses)
    shall be borne by the Parties in proportion to the outcome of the arbitration (taking into account the relative success of
    the claims and defenses of the Parties), as ordered by the arbitrator(s).
	 	 	 
	11.6	Waiver 
	 	 	 
	 	No waiver of any term, provision or condition of this Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition or of any other term, provision or condition of this Agreement.

 

    	Page 31 of 56

    	 

    

 

	11.7	Severability 
	 	 	 
	 	If any provision of this Agreement is held to be invalid or unenforceable by a court of competent jurisdiction or an arbitrator all other provisions shall continue in full force and effect. The Parties hereby agree to attempt to substitute for any invalid or unenforceable provision a valid and enforceable provision which achieves to the greatest extent possible the economic legal and commercial objectives of the invalid or unenforceable provision.
	 	 
	11.8	Assignment / Subcontracting 
	 	 
	11.8.1 	Assignment
	 	This Agreement shall be binding upon the successors and permitted assigns of the Parties and the name of a
    Party appearing herein shall be deemed to include the names of its successors and assigns, provided always that, except as
    provided for herein, neither Party shall assign this Agreement in whole or in part. Notwithstanding the aforesaid, (i) either
    Party may, without the other Party’s consent but upon the provision of written notice, assign its rights and
    obligations under this Agreement to any of its Affiliated Companies, or (ii) either Party may, without the other
    Party’s consent but upon the provision of written notice, assign this Agreement in its entirety to its successor to all
    or substantially all of its business or assets to which this Agreement relates, unless such successor is either (a) a Direct
    Competitor or (b) does not have the financial resources to perform such Party’s obligations under this Agreement. In
    case of an assignment, the assigning Party shall immediately notify the other Party about the intended or executed
    assignment, as applicable, and the assignee. Any assignment of this Agreement that is not in conformance with this Section
    11.8 shall be null, void and of no legal effect.
	 	 	 
	11.9	Subcontracting 
	 	 
	 	BI shall be permitted to subcontract portions of the Services to third parties subject to the prior written approval of BioCancell, not to be unreasonably withheld or delayed; provided that BI shall ensure compliance by and remain liable towards BioCancell for such subcontractors’ performance or non-performance of the Services under this Agreement or breach hereof. BioCancell acknowledges and agrees that BI may subcontract all Services and/or parts thereof to BI RCV and/or BIP, as well as specific Services to third parties performing quality control services in accordance with Section 2.5. BI will be responsible and liable to BioCancell for the acts and omissions of BI RCV, BIP and its other permitted sub-contractors.
	 	 
	11.10 	Appendices; Priority of Documents
	 	 
	 	The Appendices attached to this Agreement shall be considered an integral part hereof. In the event of a conflict or ambiguity between any term of this Agreement and an Appendix, the terms of this Agreement shall prevail. Notwithstanding the foregoing, the QA shall supersede this Agreement.
	 	 
	11.11 	Licensing Terms; Amendment to QA
	 	 
	 	The parties agree that they will use their best commercial efforts to (i) amend the QA in order to ensure
    its compliance with applicable Israeli laws and regulations; and (ii) agree upon the terms of the pDNA License Agreement referred
    to in Section 10.3.8 (which agreement will be attached to this Agreement as Appendix 4), within one hundred and twenty
    (120) days of the date of last signature of this Agreement.

--- SIGNATURE PAGE FOLLOWS --- 

 

    	Page 32 of 56

    	 

    

IN WITNESS WHEREOF, the Parties have caused this Agreement
to be executed as of the dates appearing below.

	 	 
	Jerusalem, ________________, ____ 2014	Ingelheim, __________________ 2014
	BioCancell Therapeutics	Boehringer Ingelheim Biopharmaceuticals
	Israel Ltd.	 	GmbH	 	 	 
	By:	 	 	ppa.	 	ppa.	 
	 	 	 	 	 	 	 
		 	 	 	 	 	 
	Name: Jonathan Burgin	 	 	<Omitted>	 	<Omitted>
	Title:   CEO	 	 	<Omitted>	 	<Omitted>
	 	 	 	<Omitted>	 	<Omitted>

	
	

 

	 	 	 	 	 	 	 
	 	 	Vienna, _________________________ 2014	 
	 	 	Boehringer Ingelheim RCV GmbH & Co KG
	 	 	ppa.	 	i.V.	 	 
	 	 	 	 	 	 	 
	 	 	 	 	 	 	 
	 	 	<Omitted>	<Omitted>	 	 
	 	 	<Omitted>	<Omitted>	 	 
	 	 	<Omitted>	 	 	 	 
	 	 	<Omitted>	 	 	 	 

List of Appendices: 

	 	 	 
	 	Appendix 1:	Product description; Cell Line, Product and BioCancell Deliverables; (incl. Requirements for BioCancell Deliverables) and BI Assumptions.
	 	 	 
	 	Appendix 2:	Services, Prices and Project Timeline (including the tasks of the Services covered under the MTA, dd April 3, 2013)
	 	 	 
	 	Appendix 3:	Billing Plan
	 	 	 
	 	Appendix 4:	Licensing Agreement (to be added)
	 	 	 
	 	Appendix 5:	Estimates for Raw Materials and Product-Dedicated Equipment
	 	 	 
	 	Appendix 6:	Project and Steering Committee Members
	 	 	 
	 	Appendix 7:	Shipping and packing instructions agreed by the Parties (to be attached upon agreement of the Parties)

    	Page 33 of 56

    	 

    

Appendix 1:

Product description, Cell Line, Product
and BioCancell Deliverables (incl. Requirements 

for BioCancell Deliverables) and BI Assumptions

1)          Product description 

The product BC-819, <Omitted>is a <Omitted>
(DNA) plasmid <Omitted> The selective initiation of toxin expression results in selective tumor cell destruction via
inhibition of protein synthesis in the tumor cell, enabling highly targeted cancer treatment.

<Omitted>

<Omitted>

	 
	<Omitted>

    	Page 34 of 56

    	 

    

 

	2)	 Deliverables from BioCancell 
	 
	BI RCV assumes that all deliverables will be provided by BioCancell prior to project start.
	 	 	 
	a)	Documents
	 	•	Product description of BC-819 (e.g. sequence of pDNA, MSDS, etc.)
	 	•	Plasmid map (in paper format and in electronic version)
	 	•	IPC and release specifications for drug substance and drug product
	 	•	SOPs of product-specific analytical methods, if applicable
	 	•	Reports on stability studies performed for drug substance and drug product including hold times
	 	•	Provision of the packaging material for drug substance (type of containers and size incl. vendors, part number)
	 	•	Provision of the container closure systems for drug product (type of vials and stoppers, size incl. vendors, part number)
	 	•	Composition of the formulation buffer and bulk concentration
	 	•	Specifications for excipients for drug substance (incl. vendors, part number and quality)
	 	•	Detailed description, technical reports and batch records for the formulation and fill & finish process
	 	•	Maximum daily dose information
	 	•	OEL Report (Occupational Exposure Level) for BC-819
	 	 	 
	b)	Materials 
	 	•	Master (MCB) and/or Working Cell Bank (WCB) for the current E. coli DH5alpha host, including all required certificates and tested for absence of bacteriophage
	 	•	Purified plasmid (including DNA sequence)
	 	•	Samples of intermediates (e.g. loads, pools) for establishing analytical methods
	 	•	Product specific reagents (e.g. antibodies for ELISA), if applicable
	 	•	Drug substance reference material, reference standard & working standard including CoA from a GMP batch
	 	•	3 g pDNA for the establishment of the fill & finish process if available

In case deliverables by BioCancell cannot be supplied as assumed
or assumptions made cannot be verified, the timeline, scope and prices (e.g. activities under a certain task) may be impacted and
may require adjustment.

 

	<Omitted>
	 	<Omitted>
	 	<Omitted>
	 	 
	 	<Omitted>
	 	<Omitted>
	 	 	
	 	 	 
	 	<Omitted>
	 	 	<Omitted>
	 	 	<Omitted>

	 	 	<Omitted>
	 	 	<Omitted>
	 	 	 	 	 
	 	 	<Omitted>
	 	 	<Omitted>
	 	 	<Omitted>
	 	 	<Omitted>
	 	 	 
	 	 	<Omitted>
	 	 	<Omitted>
	 	 	<Omitted>
	 	 	 
	 	 	<Omitted>
	 	 	 
	<Omitted>
	 
	<Omitted>
	 
	<Omitted>

 

    	Page 35 of 56

    	 

    

 

<Omitted>

 

	BI Method	Method from 

former CMO used 

for phase 2 testing	Comments
	<Omitted>	<Omitted>	 
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	 
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

<Omitted>

 

<Omitted>

 

<Omitted>

 

<Omitted>

 

    	Page 36 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 37 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 38 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 39 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 40 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 41 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 42 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 43 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 44 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 45 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 46 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 47 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 48 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

    	Page 49 of 56

    	 

    

 

	Activities / Services included	Price [in €]	BI RCV deliverables
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>
	<Omitted>	<Omitted>	<Omitted>

 

<Omitted>

 

    	Page 50 of 56

    	 

    

 

<Omitted>

 

<Omitted>

 

<Omitted>

 

    	Page 51 of 56

    	 

    

 

<Omitted>

 

    	Page 52 of 56

    	 

    

 

Appendix 4: Licensing Agreement 

 

<Omitted>

 

    	 

    	 

    

 

Appendix 5: Estimates for Raw Materials and Product-Dedicated Equipment 

 

<Omitted>

 

<Omitted>

 

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>
	<Omitted>
	<Omitted>
	<Omitted>

 

<Omitted>

 

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>
	<Omitted>
	<Omitted>
	<Omitted>	<Omitted>

 

<Omitted>

 

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>

 

<Omitted>

 

    	 

    	 

    

 

Appendix 6: Project and Steering Committee
Members 

 

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	 
	<Omitted>	 
	<Omitted>	 
	<Omitted>	 
	<Omitted>	 

 

	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	<Omitted>
	<Omitted>	 

 

    	 

    	 

    

 

Appendix 7: Shipping and packing instructions agreed
by the Parties (to be attached upon agreement of the Parties) 

 

<Omitted>

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00290-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00290-of-00352.parquet"}]]