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Unassociated Document

    
      
         

        EXHIBIT
10.3

         

      

      
        	
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    MASTER
PRODUCT SALE AGREEMENT

    

    This
MASTER PRODUCT SALE AGREEMENT (this “Agreement”) is entered into as of
September 12, 2008 between BioCancell Therapeutics, Ltd., a corporation
organized under the laws of the State of Israel, with a principal business
address at Beck Science Center, 8 Hartom Street, Har Hotzvim, Jerusalem 97775
Israel (“CUSTOMER”), and VGXI USA, a business entity registered in the state of
Texas, having an address at 2700 Research Forest Drive Suite 180, The Woodlands,
Texas 77381, (“VGX”) a DBA of VGX International Inc. at 944-1 Daechi-dong,
Kangnam-ku, Seoul, Korea, with reference to the following facts:

     

    BACKGROUND

    

    A.           VGX
has developed specific expertise and technology relating to production and
testing of DNA plasmids and is in the business of developing, manufacturing and
testing plasmid based products for research and therapeutic benefit, in a manner
complying with cGMP as appropriate.

    

    B.           CUSTOMER
desires to have VGX produce, from time to time, certain quantities of products
for human clinical and/or non-human use (“Contract Materials”), on each
occasion, on the terms and conditions set forth in this Agreement and Purchase
Order therefore.

    

    NOW,
THEREFORE, in consideration of the above premises and the mutual covenants
hereinafter recited, the Parties agree as follows:

    

    1.           Definitions.

    

    When used
in this Agreement, each of the following terms shall have the meanings as set
forth in this Article

    

    1.1.                     “VGX
Background Technology” shall mean VGX proprietary information, trade secrets,
and/or know-how used by VGX in the
performance of this Agreement and owned by VGX prior to the date hereof,
including, but not limited to, information relating to materials, devices and
methods for fermenting bacteria and the purification and testing of DNA
Plasmids.

    

    1.2.                     
“Affiliates” shall mean any corporation, firm, limited liability company,
partnership or other entity, which directly or indirectly controls or is
controlled by or is under the common control with a Party, or any corporation,
firm, limited liability company, partnership or other entity of behalf of which
either Party is acting as an agent, advisor, or distributor.

    

    1.3.                     “Agreement”
shall mean this Master Product Sale Agreement, as amended from time to
time.

    

    1.4.                     “Bill
of Testing” shall be the tests agreed to for each particular Purchase Order. The
Bill of Testing will be considered a draft until mutually agreed upon in writing
for a particular Purchase Order.

    

    1.5.                     “Biosafety
Level I” shall mean a basic level of containment that relies on standard
microbiological practices with no special primary or secondary barriers
recommended other than a sink for hand washing, in which work is done with
defined and characterized strains of viable microorganisms not known to
cause disease in healthy adult humans and classified as such by the relevant
authorities, regulations or law.

    

    
      
        
           

        

        
          
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    1.6.                     “Calendar
Year” shall mean each successive period of twelve (12) consecutive calendar
months commencing on January 1 and ending on December 31.

    

    1.7.                     “Cell
Banking Activities” shall mean the creation, testing, and maintenance of a
Master Cell Bank (MCB) and/or a Manufacturer’s Working Cell
Bank (MWCB) under cGMP conditions, containing copies of the Parent Plasmid, each
of which will meet the Specifications as finalized pursuant to a particular
Purchase Order.

    

    1.8.                     “Commencement
Date” with respect to any particular order, shall mean the first date specified
in the Purchase Order.

    

    1.9.                     “Contract
Materials” shall mean all of the materials to be produced by VGX for CUSTOMER as
specified in a particular Purchase Order including Product. The Parties hereto
will prepare and sign new Purchase Order for each new DNA plasmid that VGX is to
produce hereunder.

    

    1.10.                   “CUSTOMER
Materials” shall mean all materials sent by CUSTOMER to VGX related to this
Agreement and to the applicable Purchase Order and documentation.

    

    1.11.                   “CUSTOMER
Background Technology” shall mean all data, information, know-how, trade
secrets, copyrights, designs, databases, discoveries, improvements and
inventions (whether patentable or not) related to the Information and/or the
CUSTOMER Materials that are owned, licensed or controlled by CUSTOMER or its
Affiliates prior to the date hereof.

    

    1.12.                   ‘‘Direct
Materials Costs” shall mean the cost to VGX of materials utilized in the
performance of Production Services, including freight-in costs, sales and excise
taxes imposed thereon and customs duty and charges levied by government
authorities, and all costs of packaging components.

    

    1.13.                   “External
Testing Costs” shall mean the cost of any tests listed as “contract” on the
draft or final Bill of Testing, as well as any other testing not performed at
the VGX facility.

    

    1.14.                   “FDA”
shall mean the U.S. Food and Drug Administration.

    

    1.15.                   “Good
Laboratory Practices” or “GLP” shall mean prescribed practices and policies
related to all laboratory manufacturing and test methods intended to assure
quality, safety and integrity of the resulting product, with the intent that
such product shall be subject to oversight by U.S. regulatory authorities and
the corresponding authorities of the European Union, Member States of the
European Union, and other countries to the extent they are
applicable.

    

    1.16.                   “Good
Manufacturing Practices” or “GMP” shall mean the good manufacturing
practices required by the U.S. Food and Drug Administration for the manufacture
and testing of pharmaceutical and biological materials, and the corresponding
requirements of the European Union, Member States of the European Union, and
other countries to the extent they are applicable. “cGMP” or “current GMP” shall
mean the GMP practices in effect at a particular time.

    

    
      
        
           

        

        
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    1.17.                   “Information”
means all (a) techniques and data pertaining and/or related to the Contract
Materials, including, but not limited to, ideas, inventions (including
patentable inventions), practices, methods, knowledge, know-how, trade secrets,
skill, experience, documents, apparatus, clinical and regulatory strategies,
test data, including pharmacological, toxicological and clinical test data,
analytical and quality control data, manufacturing, patent and legal data or
descriptions and (b) chemical formulations, compositions of matter, product
samples and assays pertaining and/or related to the Contract
Materials.

    

    1.18.                   “Manufacturer’s
Working Cell Bank” or “MWCB” shall mean viable E. coli containing Parent
Plasmid, cultured from the MCB under GMP conditions, diluted in glycerol and
stored in sealed vials at less than minus sixty degrees Celsius.

    

    1.19.                   “Master
Cell Bank” or “MCB” shall mean viable E. coli containing Parent Plasmid,
transformed directly from CUSTOMER supplied stock under GMP conditions, diluted
in glycerol and stored in sealed vials at less than minus sixty
degrees Celsius.

    

    1.20.                   “Party”
shall mean either CUSTOMER or VGX as the case may be.

    

    1.21.                   “Parent
Plasmid” shall mean the original DNA plasmid construct, prepared by CUSTOMER and
provided to VGX, listed in a particular Purchase Order.

    

    1.22.                   “Person”
shall mean a natural person, a corporation, a partnership, a trust, a joint
venture, any governmental authority or any other entity or
organization.

    

    1.23.                   “Pilot
DNA Services”
shall mean the production of Research DNA at a sufficiently large scale as to
provide a reasonable indication of the growth, quality and yield of a GMP batch
produced with the same cell bank.

    

    1.24.                   “Pilot
DNA” shall mean the Research DNA produced as a result of the Pilot DNA
Services.

    

    1.25.                   “Price”
shall mean the amount payable to VGX in U.S. dollars for the performance of
Production Services hereunder with respect to any Purchase Order.

    

    1.26.                   “Product”
shall mean finished goods in final container/closure or other deliverable listed
as a line item in any Purchase Order to be delivered to CUSTOMER.

    

    1.27.                   “Production
Services” shall mean the activities to be performed by VGX hereunder, which
shall mean the production of the Contract Materials and relevant supporting
documentation accordingly to the Purchase Order.

    

    1.28.                   “Project
Technology” shall mean and include all data, information, know-how, trade
secrets, copyrights, designs, databases, processes, compounds, discoveries, new
uses, improvements and inventions (whether patentable or not) that are
conceived, generated, derived, developed or reduced to practice solely by one
Party or jointly by both Parties and that arise out of the performance of this
Agreement and all patents and other intellectual property rights relating
thereto.

    

    1.29.                   “Purchase
Order” means a purchase order agreement for a
specific project.

    

    
      
        
           

        

        
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    1.30.                   “Research
Cell Bank” or “RCB” shall mean a small cell bank produced under research
conditions used for the production of Research DNA only. This material is
provided “as-is”.

    

    1.31.                   “Research
DNA” shall mean a small amount of DNA prepared by VGX under Research Laboratory
Conditions from the RCB as an initial indication of growth, yield, and quality
characteristics. This material is provided “as-is”

    

    1.32.                   “Research
Laboratory Conditions” shall mean practices and policies generally accepted by
trained scientists to assure quality and integrity of laboratory experiments.
Such practices include, but are not necessarily limited to, aseptic techniques
to avoid microbial contamination, accurate measurements and calculations and
documentation of research results.

    

    1.33.                   “Resuspension
Buffer” shall mean the liquid used to resuspend DNA in the finished Product
and having the composition specified by the CUSTOMER.

    

    1.34.                   “Sample
Plasmid” shall mean a DNA plasmid supplied by CUSTOMER, of sufficiently similar
characteristics to the Parent Plasmid to perform initial quality control assay
evaluations and/or initial process development testing. Sample Plasmid and
Parent Plasmid should be the same plasmid whenever possible to ensure the
validity of the results.

    

    1.35.                   “Specifications”
means, with respect to any Product, the specifications therefore as set forth in
a Purchase Order for such Product.

    

    1.36.                   “Third
Party” means any person or entity other than VGX or CUSTOMER.

    

    2.           Purchase
Orders.

    

    2.1.                     Supply. During the
term of, and subject to the terms and conditions in this Agreement, CUSTOMER may
purchase from, and have Contract Materials produced by, VGX. Neither shall
CUSTOMER have any commitment to purchase any minimum quantity of Contract
Materials nor shall VGX have any commitment to produce and sell any minimum
quantity of Contract Materials. CUSTOMER shall become obligated to purchase, and
VGX shall be obligated to produce Contract Materials only upon execution and
delivery by both VGX and CUSTOMER of a Purchase Order for such Contract
Material, as set forth below.

    

    Neither
VGX nor CUSTOMER may amend a Purchase Order after it has been executed, except
according to the provisions of Section 12 or by mutual agreement in writing as
provided in Section 13.5. CUSTOMER may cancel an existing Purchase Order prior
to the Commencement Date and forfeit any prepayments made for such Purchase
Order. For each new Product that is to be produced by VGX pursuant to this
Agreement, the Parties will prepare and sign a Purchase Order, and upon signing,
such new Purchase Order shall become a part of this Agreement. Each such new
Purchase Order shall specifically reference this Agreement and be signed by both
Parties hereto. Each new Purchase Order will contain project details for the
production and testing of some or all of the Contract
Material.

    

    
      
        
           

        

        
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    2.2.                    Project
Specifications. VGX will produce under cGMP conditions the specified
amounts or number of cycles of Contract Materials and Product. Such Product will
be produced, tested, released and delivered to CUSTOMER according to the
schedule in the Purchase Order. VGX shall ship the Contract Materials
directly to CUSTOMER, or to a recipient address provided by the CUSTOMER to VGX
in writing. VGX will keep in its possession any required documentation,
regulatory retains, and will maintain certain additional samples and/or cell
banks at the request of CUSTOMER for an additional fee (to be determined in the
applicable Purchase Order).

    

    2.3.                    Laboratory Test Production
of Research DNA. To the extent not previously completed with respect
to any Purchase Order, within one (1) week of the Commencement Date, CUSTOMER
will supply VGX with more than fifteen (15) milligrams of each Parent Plasmid or
more than ten (10) vials of a qualified cell bank containing Parent Plasmid for
VGX use and retain. If required, VGX shall perform, under Research Laboratory
Conditions, the experiments listed as scheduled in the particular Purchase Order
to establish optimum fermentation and purification conditions for the Parent
Plasmid, to determine yield, stability, purity and form of the plasmid
DNA.

    

    2.4.                    Modification If Research
Results Not Satisfactory.
If the Research DNA produced pursuant to Section 2.3 above does not meet the
draft productivity or purity standards set forth in the Purchase Order, CUSTOMER
and VGX shall then meet and negotiate, in good faith, appropriate modifications
to the Agreement to address the failure to meet the criteria. VGX will produce
additional Research DNA batches if deemed necessary by mutual written agreement
between VGX and CUSTOMER. The cost of producing the additional batches will be
borne by CUSTOMER if the Research DNA does not meet the draft productivity
or purity standards set forth in the Purchase Order in whole or in part as a
result of the negligence of CUSTOMER. The cost of producing the additional
batches will be borne by VGX, if the Research DNA does not meet the draft
productivity or purity standards set forth in the Purchase Order in whole or in
part as a result of the negligence of VGX. If the Parties dispute whether
Research DNA is conforming or non-conforming, or the reasons for non-conformity,
samples of the batch of Research DNA will be submitted to a mutually acceptable
laboratory or consultant for resolution, whose determination of conformity or
non-conformity, and the cause thereof if non-conforming, shall be binding upon
the Parties. The Party decided to be in the wrong shall bear the costs of such
laboratory or consultant. If the Parties agree that VGX should take other
actions to address the purity or productivity problems, they will also agree
upon the appropriate modifications to the payments and execute on appropriate
amendment. If the Parties are unable to reach an agreement despite good faith
negotiations, either Party may terminate this Agreement or Purchase Order by
written notice to the other.

    

    2.5.                    Testing to Release
Manufacture. If the Research DNA produced meets the standards, VGX shall
produce and perform relevant testing needed to release the MCB and/or MWCB into
its facility, or evaluate and test any CUSTOMER supplied MCB and/or MWCB as
appropriate. Such work shall be performed in accordance with the schedule in the
Purchase Order.

    

    2.6.                    Pilot Production of Research
DNA. To the extent not previously
completed with respect to any Purchase Order, if required, VGX shall perform,
under Research Laboratory Conditions, the Pilot DNA Services as defined in
Section 1.23 above, pursuant to the Specifications set forth in the Purchase
Order.

    

    2.7.                    Finished
Product Production. If the Pilot DNA produced by VGX
meets the standards in the draft Bill of Testing, the final Bill of Testing will
be signed by VGX and the CUSTOMER and attached to the Purchase Order Agreement.
VGX shall then commence with preparing for each Parent Plasmid under GMP
conditions the specified number of production cycles of finished Product. Such
finished Product will be produced, tested, released and delivered to
CUSTOMER according to the schedule in the particular Purchase
Order.

    

    
      
        
           

        

        
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    2.8.                     Pilot Production
Unsatisfactory. If the
Pilot DNA produced by VGX does not meet the standards in the draft Bill of
Testing, VGX and CUSTOMER will discuss the possible amendment of the Bill of
Testing. VGX will produce an additional Pilot DNA batch if deemed necessary
by mutual written agreement between VGX and CUSTOMER. The cost of producing the
additional batch will be borne by CUSTOMER if the Pilot DNA does not meet the
standards in the draft Bill of Testing as a result of the negligence of
CUSTOMER. The cost of producing the additional batches will be borne by VGX, if
the Pilot DNA does not meet the standards in the draft Bill of Testing as a
result of the negligence of VGX. If the Parties dispute whether Pilot DNA is
conforming or non-conforming, or the reasons for non-conformity, samples of the
batch of Pilot DNA will be submitted to a mutually acceptable laboratory or
consultant for resolution, whose determination of conformity or non-conformity,
and the cause thereof if non-conforming, shall be binding upon the Parties. The
Party decided to be in the wrong shall bear the costs of such laboratory or
consultant. If the Parties agree that VGX should take other actions to address
the purity or productivity problems, they will also agree upon the appropriate
modifications to the payments in the Purchase Order and execute an appropriate
amendment. If the Parties are unable to reach an agreement despite good faith
negotiations, either Party may terminate this Agreement or Purchase Order
by written notice to the other.

    

    3.           Materials
and Information.

    

    Promptly after execution
of a Purchase Order pursuant to Section 2.1, CUSTOMER shall deliver to VGX all
materials and Information that are reasonably necessary for VGX to produce and
manufacture the Products, and that such Purchase Order provides are to be
delivered by CUSTOMER to VGX. Information supplied pursuant to this Article 3
shall be in a format acceptable to VGX. CUSTOMER shall bear the risk of loss of,
and damage to, such materials and Information until actual receipt by VGX.
Following their receipt, VGX shall be responsible for the risk of loss of, and
damage to, such materials and Information. Information provided pursuant to this
Article 3 shall be regarded as Confidential Information.

    

    4.           Production.

    

    4.1.                     Performance of Work.
VGX shall produce the Product in accordance with this Agreement, the Purchase
Order therefore, any agreed technical or descriptive specifications, and in
compliance with cGMP and the requirements of any applicable regulatory agency or
other governmental authority and all applicable laws and
regulations.

    

    The
Parties agree that VGX may subcontract the performance of certain production
services necessary for the performance of this Agreement to VGXI Inc. In
addition, subject to CUSTOMER’s prior written consent, VGX may subcontract the
performance of certain testing services necessary for the performance of this
Agreement. CUSTOMER shall agree to VGX’s use of subcontractors, only if they
meet the cGLP regulations. VGX will not change subcontractors without CUSTOMER’S
written approval.

    

    4.2.                      Quality
Control and Assurance.

     

    (i)             VGX
shall manufacture Product in compliance and in accordance with the
Specifications and all applicable laws and regulations. Prior to each shipment
of Product, VGX shall perform quality control testing on Product in accordance
with Specifications as outlined in the Purchase Order. VGX shall, during and
after the term of this Agreement, maintain such records and data that document
its compliance with this Section 4.2 as reasonably requested by CUSTOMER
and as required by law and regulation applicable to the
manufacture of the Product, and shall make such information available to
CUSTOMER upon its request. In performing its obligations under this Agreement,
VGX shall comply with all applicable environmental and health and safety
laws.

    

    
      
        
           

        

        
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    (ii)         
    Subject to the provisions of Section 4.7 below, if the
Parties determine, prior to the delivery of any batch of Product that such
Product fail to meet any of the Specifications, VGX shall, at its sole cost,
either discard the Product and shall bear the loss resulting therefrom, or if it
is possible, correct the deficiency in and/or repackage such batch of Products,
as CUSTOMER may, in its sole discretion, direct.

    

    (iii)             CUSTOMER
shall be entitled to carry out such procedures as CUSTOMER requires for the
analysis and validation of the Products prior to acceptance
thereof.
 

    (iv)             VGX
shall promptly notify CUSTOMER in writing of any major incidents or anomalous
results observed by VGX during the manufacture of the Products. VGX shall take
all reasonable measures to ensure that the affected Products are not released
until the Parties reach agreement on appropriate corrective measures and/or
other actions to be taken by VGX.

    

    4.3.                     Change
Order.

    

    The
Specifications shall be amended to the extent necessary to comply with changes
in applicable laws and/or regulations or the requirements of applicable
regulatory agencies. In addition, the Specifications shall be amended as
CUSTOMER may reasonably request from time to time with the mutual consent of the
Parties. VGX shall not make without CUSTOMER’s prior written consent any change
in (i) the manufacturing facility which would have an impact on the Product or
require submissions to or approvals from any regulatory agency or, (ii) the
manufacturing process. VGX undertakes that any such change(s) shall, in each
case, comply with cGMP, this Agreement, the requirements of all applicable
regulatory agencies and all applicable laws, rules and regulations, including
but not limited to the Federal Food, Drug and Cosmetic Act and the regulations
promulgated pursuant thereto, and without limiting the foregoing, with the
standard of care customary in the industry. In the event such amendment (whether
as a result of changes in applicable laws or the requirements of applicable
regulatory agencies or at CUSTOMER’s reasonable request or otherwise) requires
additional cost or schedule adjustments for the manufacture of the Product
hereunder, the Parties shall agree in good faith on an equitable adjustment to
Price and/or schedule, as appropriate.

    

    4.4.                     Delays
in Production.

    

    Each
Party will promptly notify the other Party in writing if it believes that there
are likely to be changes in the work schedule contained in the Purchase Order.
Such notice will include the reasons for such changes in the schedule and the
proposed new schedule for the incomplete portion of the work. VGX is responsible
for any delays in the production or delivery of Contract Materials except for
delays caused by the lack of delivery by CUSTOMER of material Information or
CUSTOMER Materials in a timely manner, as agreed to in advance. In the event of
any delays in the production or delivery of Contract Materials for which VGX is
responsible pursuant to this Section 4.4, the payment schedule set forth in the
Purchase Order shall be amended accordingly. In addition, the aggregate amount
payable to VGX pursuant to the Purchase Order shall be reduced by 5% per each
month of delay. In the event that a delay is for a period of less than an entire
month, the penalty amount for such partial period shall be adjusted
proportionately (e.g. in the event of a delay of 75 days, the aggregate amount
payable pursuant to the Purchase Order will be reduced by 25%). In the event
that CUSTOMER requests VGX to delay the production or delivery of Contract
Materials, than the aggregate amount payable to VGX pursuant to the Purchase
Order shall be increased by 5% per each month of delay. In the event that a
delay is for a period of less than an entire month, the penalty amount for such
partial period shall be adjusted proportionately.

    

    
      
        
           

        

        
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    A delay
of less then 30 days, at the first month of delay, will not be considered as a
delay.

    

    4.5.                     Audits
by CUSTOMER.

    

    (i)      
        Upon the written request of
CUSTOMER, VGX shall permit CUSTOMER or an independent consulting firm
specializing in pharmaceutical manufacturing facility inspections selected by
CUSTOMER and reasonably acceptable to VGX, at CUSTOMER’S expense, to have access
during VGX normal business hours to inspect such of the records and facilities
of VGX, as may be reasonably necessary to verify that Products manufactured by
VGX are manufactured in accordance with Good Manufacturing Practices and conform
to the Specifications as outlined in a Purchase Order which is dated not more
than twelve (12) months prior to the date of such request. CUSTOMER’s right to
inspection shall continue until twelve (12) months from delivery of the
Products. Only information that is related to this Agreement will be the subject
of such inspection. VGX shall make all efforts to address any GMP or
Specifications deficiencies found by CUSTOMER in such inspection

    

    (ii)    
         CUSTOMER may make a
preproduction inspection of the facilities upon reasonable notice, prior to
signing the first Purchase Order. VGX shall make all good faith efforts to
address any GMP deficiencies found by CUSTOMER in any pre-production inspection.
If deficiencies are addressed to CUSTOMER’s satisfaction in a reasonable time
period, this Agreement or the applicable Purchase Order will continue. If
deficiencies are not addressed to CUSTOMER’s satisfaction, CUSTOMER may
terminate this Agreement or the applicable Purchase Order by written notice to
VGX and neither Party shall have any further liability hereunder as a result of
such termination.

    

    (iii)             CUSTOMER
shall treat all information subject to review under this Section 4.5 in
accordance with the confidentiality provisions of this Agreement, and shall
cause its consultants who review such information to be bound by the same
confidentiality provisions.

    

    4.6.                     Certificate
of Release and Analysis. Concurrent with its delivery of Product, VGX shall deliver to CUSTOMER the
certificate of pharmaceutical release and a written report summarizing
analytical and manufacturing documentation which will include the final
certificate of analysis for such Product.

    

    4.7.                     Non
Conforming Product

    

    (i)              
Upon VGX’s release of a batch of Product, VGXI shall provide CUSTOMER, or
CUSTOMER’s designee, copies of batch records, test results and a certificate of
analysis, if appropriate to the batch, stating the test results from the quality
control assay performed by VGX. Within sixty (60) calendar days after receipt by
CUSTOMER of the documentation, CUSTOMER shall determine whether the Product
conforms to Specifications and has been manufactured in accordance with the
batch record, VGX’s current SOPs, and the Purchase Order.

    

    
      
        
           

        

        
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    (ii)            
 If (i) any batch of Product conforms to the Specifications, or (ii)
CUSTOMER fails to notify VGX within the applicable time period that any batch of
Product does not conform to the Specifications, then CUSTOMER shall be deemed to
have accepted the Product and waived its right to revoke
acceptance.

    

    (iii)             If
CUSTOMER believes any batch of Product does not conform to the Specifications,
it shall notify VGX by telephone, including a detailed explanation of the
non-conformity, and shall confirm such notice in writing via overnight delivery
to VGX. Upon receipt of such notice, VGX will investigate such alleged
non-conformity, and (i) If VGX agrees such Product is non-conforming, deliver to
CUSTOMER a corrective action plan within thirty (30) calendar days after receipt
of CUSTOMER’s written notice of non-conformity, or (ii) if VGX disagrees with
CUSTOMER’s determination that the batch of Product is non-conforming, VGX shall
so notify CUSTOMER by telephone within the thirty (30) calendar day period and
provide CUSTOMER with evidence to substantiate its claim as well as confirm such
notice in writing by overnight delivery.

    

    (iv)             If
the Parties dispute whether Product is conforming or non-conforming, samples of
the batch of Product will be submitted to a mutually acceptable laboratory or
consultant for resolution, whose determination of conformity or non-conformity,
and the cause thereof if non-conforming, shall be binding upon the parties. The
Party decided to be in the wrong shall bear the costs of such laboratory or
consultant.

    

    4.8.                     Remedies for Non Conforming
Product. In the event VGX agrees that the batch of Product is
non-conforming in whole or in part as a result of the negligence of VGX or the
laboratory determines that the shipment of Product is non-conforming in whole or
in part as a result of the negligence of VGX, then CUSTOMER, shall subject to
the provisions of Section 4.4 above, allow VGX at its expense to replace such
non-conforming Product within forty-five (45) calendar days from the date
Product is determined to be non-conforming, and in the event that VGX is unable
to timely replace such non-conforming Product asset forth above, than CUSTOMER,
shall be granted a full refund of the payments paid pursuant to the Purchase
Order. In addition, the due date for the final invoice issued at completion of
production of the Product will be extended until the date at which replacement
Product is released and determined to be conforming by VGX and
CUSTOMER.

    

    4.9.                     Samples and Batch
Records. VGX shall prepare and maintain or cause to be prepared and
maintained batch records and samples, properly stored, from each lot or batch of
Product manufactured and shipped hereunder sufficient to perform each quality
control test identified in the Specifications. Batch records will be reviewed
and approved by VGX and the CUSTOMER prior to commencement of production of
Contract Materials. Any material change to an approved batch record will be
reviewed and approved by VGX and the CUSTOMER prior to said change being
implemented. Any deviation from the manufacturing process specified in the batch
record must be documented in the copy of the batch record for that batch. All
batch records will be made available to CUSTOMER in English upon completion of
each batch. Copies of the batch records will be sent to the CUSTOMER with the
certificate of analysis. All documentation related to the manufacturing of
Contract Materials shall be archived with VGX during and after the
manufacturing, in accordance with its document retention policies and cGMP, for
at least one (1) year after the expiration date of each respective batch
manufactured. CUSTOMER shall be contacted before destruction of any specific
records regarding Contract Materials and shall be given the option to retain
such documents. All batch record and related documentation shall be regarded as
Confidential Information hereunder.

    

    
      
        
           

        

        
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    If a
DMF/BMF will be required by the regulatory authorities (such as the FDA, EMEA
etc), VGX will submit such a file at a time which will be sufficient enough for
these authorities to approve the submission before the full release of the
batch. VGX will provide the CUSTOMER with authorization letter that enables the
regulatory authorities to review the DMF/BMF regarding the production process of
the Product.

    

    4.10.                   Inspections
by Government Agencies.

    

    (i)              
If any governmental agency shall inspect any facility at which any Product is
manufactured or the records with respect to the Production Services or the
compliance by VGX with laws and regulations applicable to the manufacturing of
such Product, VGX shall notify CUSTOMER of such inspection, the results thereof
and, if VGX was required, as a result of any such inspection, to take any
corrective action in order to comply with any applicable law or regulation, any
such action it has taken in response to such requirement.

    

    (ii)           
  VGX will notify CUSTOMER promptly upon receipt of any correspondence
from a regulatory agency, which relates to the Production Services and promptly
provide the CUSTOMER a copy thereof. CUSTOMER shall be entitled to review and
approve in advance VGX’s responses and submissions, but such approval shall not
be unreasonably withheld. In addition and subject to the foregoing, VGX shall
provide to the regulatory agencies all documents and information requested by
such authority, and shall submit to all inquiries, audits and inspections by the
regulatory agencies.

    

    (iii)             VGX
hereby agrees to provide (i) all information and assistance which is
reasonably necessary for or useful in the preparation of comprehensive and
complete regulatory submissions including without limitation applications or
materials required to obtain marketing approval of Product, and (ii) access to
the manufacturing facility and pertinent information to applicable regulatory
agencies inspectors conducting the pre-approval inspection. CUSTOMER shall have
the sole right to prepare and make any such submissions, applications or
materials and shall own any and all rights and interest therein.

    

    5.           Shipment
and Delivery.

    

    5.1.                     Storage. VGX shall
store each batch of Product ordered pursuant to a Purchase Order in accordance
with the specifications in that Purchase Order, or, if not specified therein, in
accordance with good commercial standards. In no case will VGX be responsible
for the storage of a batch for greater than two months from quality release.
Without derogating from the foregoing, VGX shall store the Contract Materials in
accordance with the instructions provided by CUSTOMER from time to time and in
compliance with the requirements of any applicable regulatory agency or other
governmental authority and all applicable laws and regulations.

    

    5.2.                     Packing. VGX shall pack each batch of
Product ordered pursuant to a Purchase Order in accordance with the
specifications in that Purchase Order and as per CUSTOMER instructions, or, if
not specified therein, in accordance with good commercial standards. Such
packaging shall be at VGX’s expense.

    

    5.3.                     Shipment. Delivery
shall take place in the manner and at such times as shall be agreed between the
Parties on the Purchase Order. VGX shall notify CUSTOMER, in writing, not less
than ten (10) business days before shipment of a batch of Product that such
batch will be ready for shipment by the date specified in such notice. CUSTOMER
shall be obligated to notify VGX of the route and carrier by which CUSTOMER
desires such batch to be shipped to it. If VGX receives notice of the route
and carrier by which CUSTOMER desires a batch of Product to be shipped no
later than five (5) business days before the date stated in VGX’s notice to
CUSTOMER, VGX shall ship such batch in accordance with CUSTOMER’s directions;
however, if CUSTOMER fails to notify VGX as provided, VGX may ship such batch of
Product by a carrier and on a route selected by VGX. For purposes of this
Section 5.3, a “business day” is a day when VGX’s
production facilities and administrative offices are generally open for
business. Each Product will be considered suitable for shipment following the
successful completion of all tests listed in the Purchase Order, or sooner if
risk of loss and title are transferred via written request of the
Customer.

    

    
      
        
           

        

        
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      5.4.                      All
customs, duties, taxes, license fees, insurance premiums, and other third Party
expenses relating to the sale or transportation and delivery shall be paid by
CUSTOMER. All shipments shall be shipped FCA VGX by a common carrier designated
by CUSTOMER. VGX shall be responsible for the loading of the Product on
departure and shall bear risk of loss and all costs of such
loading.

      

      5.5                       The
following documents shall be provided by VGX together with each consignment of
Products delivered by it:

      

      (i)           a
statement of the quantity; and

      

      (ii)          a
certificate of analysis and any other document required by the exporting agent
appointed by CUSTOMER.

      

      5.6.                      Notice of Receipt.
Upon receipt of finished Product, CUSTOMER shall notify VGX of its
receipt.

      

      5.7.                      Risk of Loss. Title
to and risk of loss to all Contract Materials and other items shipped by VGX
shall pass to CUSTOMER upon delivery to shipper.

      

      6.        
  Intended Use
Specifications.

      

      6.1.                      CUSTOMER Use Only.
All Contract Materials are being manufactured hereunder exclusively for the
CUSTOMER. The CUSTOMER shall use the Contract Materials only for its own
purposes or studies under CUSTOMER’s control. For the avoidance of doubt, this
Section 6.1 is intended to prevent the resale of the Contract Materials to Third
Parties, and is not intended to limit the use of the Contract Materials by the
CUSTOMER for its own purposes.

      

      6.2.                      CUSTOMER Proprietary
Materials. All CUSTOMER Materials and materials derived from CUSTOMER
Materials shall remain CUSTOMER’s proprietary property. VGX Shall use such
CUSTOMER Materials solely for the purposes of this Agreement and will not
forward CUSTOMER Materials to Third Parties except in connection with work by
approved subcontractors, and subject to the confidentiality undertakings set
forth herein.

      

      6.3.                      CUSTOMER Use. The
CUSTOMER agrees to use the Contract Materials in compliance with all regulations
and laws and warrants, and that such materials shall only be used for commercial
purposes including civil research and development, quality control, clinical
research and/or validation of process steps. The CUSTOMER will maintain full
documentation in accordance with its standard procedures on the use of the
Contract Materials.

       

      
        
           

        

        
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      6.4.                      Other Laws and
Regulations. In performing its obligations under this Agreement, VGX
shall comply with all applicable environmental and health and safety laws. VGX
shall be solely responsible for determining how to carry out these
obligations.

      

      6.5.                      Customer
Responsibility. FDA and ICH guidelines provide that a sponsor seeking a
license is considered the “manufacturer” even if they use a contract
manufacturing organization, and the sponsor is responsible for ensuring GMP
compliance for those activities that have been contracted out (US FDA 21 CFR
600.3(t), ICH Q7A Section 2). Therefore, VGX shall provide Customer, its
employees, agents, and consultants reasonable access to VGX facilities,
records, and personnel in order that appropriate inspections, evaluations,
testing and audits may be carried out. Customer shall notify VGX in writing of
any noted compliance deficiencies during any visit, audit, or at any time when
Customers Contract Materials are being produced, packaged, shipped, or stored.
VGX will use good faith efforts to correct any noted deficiencies in a
reasonable time. Failure to correct any such deficiency to Customer’s reasonable
satisfaction shall be grounds for Customer to terminate this Agreement as
specified in Section 12.3 upon written notice to VGX. Any inspections made by
the CUSTOMER shall not relieve VGX of any of its obligations under this
Agreement.

      

      7.          
Payment

      

      7.1.                      Price. The price
payable by CUSTOMER for all work performed and Contract Materials and Product
delivered pursuant to a Purchase Order shall be the Price specified therefore in
that Purchase Order. All payments made under this Agreement are non-refundable
except as specified in Sections 4 and 12. All Prices set forth in the Purchase
Order shall be inclusive of any and all fees, charges and taxes of any type or
nature.

      

      7.2.                      Invoices. Upon its execution, and concurrent with its
delivery of a Purchase Order unless otherwise specified in the applicable
Purchase Order, VGX shall deliver to CUSTOMER an invoice for one hundred percent
(100%) of the Price stated therein for Pilot DNA Services and twenty percent
(20%) of all other services listed in the Purchase Order. For the avoidance of
doubt, production capacity and Commencement Date will not be considered to be
reserved until such time as Customer has made an appropriate non refundable
payment. Thirty (30) days prior to the scheduled Commencement Date of each line
item of a Purchase Order, VGX shall deliver to CUSTOMER an invoice for thirty
percent (30%) for each line item. Upon, and concurrent with, its delivery of
each Contract Material as specified in the amount and order of a particular
Purchase Order, VGX shall deliver to CUSTOMER an invoice for the remaining fifty
percent (50%) of the Price stated in the Purchase Order for such Contract
Material. Payment for External Testing Costs, shipping costs, and all additional
costs listed in a Purchase Order shall be made within thirty (30) days of
receipt of an invoice therefore from VGX. VGX’s delay or failure to provide
invoices shall not terminate CUSTOMER’s obligation to pay VGX for any Contract
Material including Product delivered to CUSTOMER pursuant to the terms of this
Agreement or the Purchase Order or to pay VGX for any Contract Material or
Product being manufactured pursuant to the terms of this Agreement or any
Purchase Order.

      

      7.3.                      Price Modification. The
amounts set forth in each Purchase Order are based on the number of experiments
and production cycles provided therein. The yield and quality for each
production batch of Contract Material may not be determined prior to
commencement of the Agreement or particular Purchase Order. If after the initial
research and pilot stages are completed the plasmid yield or quality does not
meet the needs of the CUSTOMER, the Parties shall negotiate the steps to take
and appropriate price adjustments as provided in Section 2. If either Party
terminates the Agreement pursuant to Section 2, VGX shall retain all payments
made prior to the date of termination. All Contract Materials for which CUSTOMER
has paid and which have not been shipped to the CUSTOMER prior to the date of
termination, shall be shipped immediately to the CUSTOMER. In any event all
price modifications will be mutually agreed in writing.

      
        
           

        

        
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      7.4.                      Time For Payment. CUSTOMER shall pay VGX the full amount
specified in each invoice within thirty (30) days of date of receipt of the
invoice.

      

      7.5.                      Method of Payment.
All amounts due and payable shall be paid in United States Dollars. Payment
shall be wired via electronic funds transfer to the account specified by VGX in
respect of which payment is made.

      

      7.6.                      Late Payment. If
CUSTOMER fails to pay any amount when due, or VGX fails to refund any amount
when due, it shall pay as a late charge to the other Party an amount equal to
0.67% per month on the amount unpaid, or if less, the maximum amount permitted
by law, such amount to accrue from the date when payment was due until the date
when paid in full. In all cases failure of Customer to provide payment according
to the agreed schedule listed in any Purchase Order will cause VGX to delay the
scheduled Commencement Date of the particular line item by thirty days after
outstanding payments are received, or move the project task to the next
available production slot, at the sole discretion of VGX. Such notification will
be provided to the Customer in writing. However, VGX may resort to the
aforementioned measures only after providing CUSTOMER with written notice of
such default and only if said default is not cured by CUSTOMER within fifteen
(15) calendar days after receipt by the CUSTOMER of written notice of such
default.

      

      8.         
 Warranties.

      

      8.1.                      Representations and Warranties
of Both Parties. Each Party hereby represents and warrants to the other
Party as follows:

      

        
(i)          Such Party is a
corporation duly organized, validly existing and in good standing under the laws
of the jurisdiction in which it is incorporated.

      

       
(ii)          Such Party (i)
has the corporate power and authority and the legal right to enter into this
Agreement and to perform its obligations hereunder, and (ii) has taken all
necessary corporate action on its part to authorize the execution and delivery
of this Agreement and the performance of its obligations hereunder. This
Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, binding obligation, enforceable against such Party
in accordance with its terms.

      

        
(iii)         All necessary
consents, approvals and authorizations of all governmental authorities and other
Persons required to be obtained by such Party in connection with this Agreement
have been obtained.

      

      8.2.                      VGX Representations and
Warranties. VGX hereby covenants,
represents and warrants to CUSTOMER that:

      

      (a)          All
Product will, on the date of delivery by VGX to CUSTOMER, comply with the
applicable laws, regulations and regulatory guidelines, the Specifications
therefor set forth in this Agreement and in the Purchase Order pursuant to which
such Product was ordered.

      

      (b)          Title
to all Product sold hereunder shall pass to CUSTOMER as provided herein free and
clear of any security interest, lien or other encumbrance.

       

      
        
           

        

        
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      (c)         
(i) The execution, delivery and performance of this Agreement does not conflict
with, violate or breach any agreement to which VGX is a party or by which it is
bound or VGX’s constituent documents, (ii) VGX is not prohibited or limited by
any law or agreement (to which it is a party or by which it is bound) from
entering into and performing this Agreement and (iii) the performance of this
Agreement will not create any conflict with any other business or activity
engaged in by VGX.

      

      (d)          The
Production Services will be performed in compliance with this Agreement, cGMP,
the requirements of all applicable regulatory agencies and all applicable laws,
rules and regulations, including but not limited to the Federal Food, Drug and
Cosmetic Act and the regulations promulgated pursuant thereto, and, without
limiting the foregoing, with the standard of care customary in the Product
manufacturing industry.

      

      (e)          The
Production Services will be performed by trained individuals in a professional,
workman-like manner.

      

      (f)         
VGX has obtained, and will maintain in effect throughout the term of this
Agreement, all such approvals, licenses and permits as maybe required under
applicable laws, rules, regulations and requirements to perform the Production
Services hereunder in accordance herewith, and to operate the manufacturing
facility for the Contract Materials for the purposes of manufacturing Contract
Materials under and in accordance with this Agreement for clinical use in human
pharmaceuticals, and it shall during the term of this Agreement comply, at all
times, with the requirements set forth (i) in any such approvals, licenses and
permits and (ii) by relevant authorities and applicable laws, rules and
regulations for its manufacturing facility for manufacture of the Contract
Materials for clinical use in human pharmaceuticals.

      

      8.3.                      Disclaimer of
Warranties. EXCEPT AS EXPRESSLY PROVIDED IN SECTION 8.2. VGX MAKES NO
REPRESENTATION OR WARRANTY AS TO ANY CUSTOMER MATERIALS, EXPRESS OR IMPLIED, AND
VGX SPECIFICALLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, WARRANTY OF FITNESS
FOR A PARTICULAR PURPOSE, WARRANTY OF SYSTEM INTEGRATION, WARRANTY OF
EFFECTIVENESS.

      

      9.         
 Liability,
Indemnification and Insurance.

      

      9.1.                      Limitation on
Liability. Neither Party shall be
liable for any special, consequential, incidental, exemplary or punitive damages
of the other Party.

      

      9.2.                      Responsibility and
Control. VGX and CUSTOMER shall each be solely responsible for the safety
of its own employees, agents, licensees or sublicensees with respect to Product,
and each shall hold the other harmless with regard to any liability for damages
or personal injuries resulting from acts of its respective employees, agents or
servants to the extend that such damages are not due to gross negligence or
willful misconduct of the other Party.

      

      
        9.3.                      Indemnification by
CUSTOMER. CUSTOMER shall indemnify, defend
and hold harmless VGX from all losses, liabilities, damages and expenses
(including reasonable attorneys’ fees and costs) that VGX may suffer or incur as
a result of any claims, demands, actions or other proceedings made or instituted
by any Third Party arising out of (a) any alleged or actual infringement or
other violation of any patents, patent rights, trademarks, trade mark rights,
copyrights, trade secrets, proprietary rights and processes or other such rights
related to the Product except as related to the materials or the process
utilized by VGX in the manufacture of the Product as set forth in Section 9.4
hereof; (d) any alleged or actual loss, damage or injury including death, which
arises from the use of any Product which conforms to the specifications and
warranties set in Section 8.2.; and (c) any negligent act or omission or willful
misconduct by CUSTOMER, its Affiliates or its or their directors, officers,
employees, agents or subcontractors.

         

      

      
        
           

        

        
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      9.4.                      Indemnification by VGX.
Notwithstanding Section 9.1 hereof, VGX shall indemnify, defend and hold
harmless CUSTOMER from all losses, liabilities, damages and expenses (including
reasonable attorneys’ fees and costs) that CUSTOMER may suffer or
incur as a result of any claims, demands, actions or other proceedings made or
instituted by any Third Party arising out of (a) any alleged or actual
infringement or other violations of any patents, patent rights, trade secrets,
proprietary rights or other such rights related to the process utilized by VGX
in the manufacture of the Product; (b) the performance of Production Services;
and (c)any negligent act or omission or willful misconduct by VGX, its
Affiliates or its or their directors, officers, employees, agents or
subcontractors.

      

      9.5.                      Notice and Assistance. An indemnifying Party will
not be obligated to indemnify and hold harmless any indemnified Party unless the
indemnified Party gives the indemnifying Party prompt notice of any claim, suit
or action brought against the indemnified Party, after it becomes aware of it,
allows the indemnifying Party to defend the same (without prejudice to the right
of the indemnified Party to participate at through counsel of its own choosing),
renders the indemnifying Party all assistance reasonably necessary in defending
against such claim, suit or action at the indemnifying Party’s expense, and does
not compromise or settle such claim or action without the indemnifying Party’s
prior written consent.

      

      
        9.6.                    
Insurance. VGX and
CUSTOMER shall maintain comprehensive general liability insurance, during the
term of this Agreement and for one (1) year beyond the
expiration date of the Product, comprehensive general liability insurance on a
claims-made basis, with endorsements for product liability with annual coverage
limits of not less than the value of the Products underlying all active Purchase
Orders, per claim. All of the Parties’ insurance policies shall be issued by
insurers acceptable to the other Party. Each Party shall name the other Party as
an additional insured on its policies with respect to the Party’s liabilities to
the other Party under this Agreement. The minimum level of insurance set forth
herein shall not be construed to create a limit on the Parties’ liability
hereunder. On the Commencement Date, each Party shall furnish to the other Party
a certificate of insurance evidencing such coverage as of such date. Each such
certificate of insurance, as well as any certificates evidencing new or modified
coverages of the insured Party, shall include a provision whereby thirty (30)
days written notice must be received by the other Party prior to coverage
modification or cancellation by either the insured Party or the insurer. In
addition, each Party shall promptly notify the other Party of any cancellation
or modification of such insurance coverage and of any new or modified coverage.
In the case of a modification or cancellation of such coverage, each Party shall
promptly provide the other Party with a new certificate of insurance evidencing
that the Party’s coverage meets the requirements in the first sentence of this
Section 9.6.

      

       

      
        
           

        

        
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      10.   
    Confidentiality.

      

      10.1.                    Confidential
Information. During the term of this Agreement, and for a period of five
(5) years following the expiration or earlier termination hereof, each Party
shall maintain in confidence all information (including samples) and data of a
proprietary or confidential nature, whether in oral, written, graphic,
machine-readable form or in any other form disclosed by the other Party (the
“Confidential Information”), and shall not use, disclose or grant the use of the
Confidential Information except on a need-to-know basis to those directors,
officers, employees, consultants, contractors, governmental regulatory agencies,
(sub)licensees or permitted assignees, to the extent that such disclosure is
reasonably necessary in connection with such Party’s activities as expressly
authorized by this Agreement. To the extent that disclosure is authorized by
this Agreement, prior to disclosure, each Party hereto shall obtain agreement of
any such Person to hold in confidence and not make use of the Confidential
Information for any purpose other than those permitted by this
Agreement.

      

      10.2.                   Terms of
this Agreement. Subject to Section 10.3 below, neither Party shall
disclose any terms or conditions of this Agreement to any Third Party without
the prior consent of the other Party.

      

      10.3.                   Permitted
Disclosures. The confidentiality obligations contained in this Article 10
shall not apply to the extent that (a) the receiving Party (the “Recipient”) is
required (i) to disclose information by applicable law, regulation or order of a
governmental agency or a court of competent jurisdiction, or (ii) to disclose
information to any governmental authority for purposes of obtaining approval to
test or market a Product, provided in either case that the Recipient shall
provide written notice thereof to the other Party and sufficient opportunity to
object to any such disclosure or to request confidential treatment thereof; or
(b) the Recipient can demonstrate that (i) the disclosed information was public
knowledge at the time of such disclosure by the other Party hereunder, or
thereafter became public knowledge, other than as a result of actions of the
Recipient in violation hereof; (ii) the disclosed information was rightfully
known by the Recipient (as shown by its written records) prior to the date of
disclosure to the Recipient by the other Party hereunder; or (iii) the disclosed
information was disclosed to the Recipient on an unrestricted basis from a
source unrelated to any Party to this Agreement and not under a duty of
confidentiality to the other Party. CUSTOMER agrees that VGX may use, subject to
CUSTOMER’s prior written consent (which consent shall not be unreasonably
withheld) CUSTOMER’s corporate name in certain marketing and other
publications and presentations, as example of, but not limited to, a client
list. In addition, CUSTOMER may disclose the terms of this Agreement to
potential investors or business partners.

      

      11.  
      Intellectual
Property

      

      11.1                    Notwithstanding
anything to the contrary, as between the Parties, (i) all VGX Background
Technology, shall remain exclusively owned by VGX, (ii) all CUSTOMER Background
Technology shall remain exclusively owned by CUSTOMER.

      

      11.2.                    Subject
to the restrictions set forth in the license agreement between CUSTOMER and
Yissum Research Development Company of the Hebrew University of Jerusalem Ltd.,
the Parties agree that title to and property in any and all Project Technology
shall be and remain at all times exclusively vested in the Parties as
follows:

      

      (i)     
   Project Technology directly related to improvements in the existing
manufacturing process of the Product shall be exclusively owned by
VGX;

       

      (ii)       
All other Project Technology shall be exclusively owned by CUSTOMER.

      

      11.3.                   Each
Party hereby assigns and transfers to the other Party any Project Technology
that may be created hereunder, to the extent such Project Technology is owned by
the receiving Party, in accordance with and subject to the allocation of
ownership described in Section 11.2 above, and promptly upon the creation of any
such Project Technology, each

       

      
        
           

        

        
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        Party
shall notify the other Party of such Project Technology and furnish to the owner
thereof all related information, details, data and documents. Each Party, at any
time and from time to time upon notice by the owner of the Project Technology,
as promptly as practicable, shall execute and shall cause its employees and
consultants, past or present, to execute, such documents as are necessary and
requested to evidence the ownership provided for in this Agreement, of the
owner’s entire right, title and interest in such inventions and other
properties, including executing any documents necessary for the owner to obtain
United States or foreign letters patent or other intellectual property
protections and rights, executing any transfers of ownership of patent letters
or other intellectual property protections and rights, and executing short form
assignments intended for recording with the U.S. Patent and Trademark Office, or
any other entity.

         

        11.4.                      Each Party has obtained or shall
obtain appropriate written agreements
from all of its respective employees, consultants and subcontractors, without
limitation, and executed at or as of the commencement of employment, consultancy
or engagement, that requires all discoveries and inventions conceived or reduced
to practice, as applicable, by any person during the term of this Agreement to
be promptly reported, fully disclosed and assigned to such Party.

         

        12.            Term
of Agreement,
Renewal,
Termination.

         

        12.1.                      Term. This Agreement
shall commence on the date first written above, and unless earlier terminated in
accordance with the provisions of this Article II, shall continue in full force
and effect until the completion of the Production Services, and in any case as
long as any Purchase Order is in force. Thereafter, the term of this Agreement
shall be renewed tor successive one (1) year periods upon mutual
agreement.

         

        12.2.                      Termination After Research or Pilot Work. Either Party may
terminate this Agreement as provided in Section 2.

         

        12.3.                      Termination for
Cause. If either Party breaches any provision of this Agreement, the
other Party may give written notice to the breaching Party that if the
default is not cured within thirty (30) days of the date of such notice, the
Agreement will be terminated automatically. If the non-breaching Party
gives such notice and the breach is not cured during such thirty (30) day
period, then this Agreement shall terminate automatically at the end of such
thirty (30) day period.

         

        Should
CUSTOMER terminate this Agreement pursuant to this Section 12.3. VGX shall
reimburse to CUSTOMER all monies paid by CUSTOMER in respect of outstanding
uncompleted Purchase Order(s), including any reasonable additional direct costs
incurred while fulfilling CUSTOMERS obligations to produce the Product according
to the Purchase Order(s) under this Agreement, less the cost of those Production
Services performed by VGX, under such Purchase Order(s), which are compliant
with this Agreement and can be exploited by CUSTOMER. Such repayment and VGX
liabilities toward CUSTOMER shall be within the limits stated in section 9.1 in
the event of such a breach.

         

        Should
VGX terminate this Agreement pursuant to this Section 12.3 for breach, then upon
termination CUSTOMER shall pay VGX an amount equal to (i) all amounts due for
completed Purchase Orders, plus (ii) all amounts that were already spent by VGX,
prior to the termination, on any signed and uncompleted Purchase Order. The
terms of this Section will also apply if CUSTOMER reduces the quantities or the
number of batches of products for any signed Purchase Order.

         

        
          
            
               

            

            
              Master Product Sale Agreement Execution Copy – Page 17 

              
                

              

            

            
               

            

          

        

         

      

      
        	
                Execution
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      12.4                    Termination by Mutual
Agreement This Agreement may be terminated at any time by written
agreement of the Parties.

      

      12.5.                   Termination for Violation of
Ethical Principles. If a Party (including its employees, subcontractors,
agents, servants, licensees) uses the Contract Materials in a manner
inconsistent with ethical principles as defined in the Helsinki Declaration by
the World Medical Association, the other Party shall be allowed to terminate
this Agreement and any Purchase Order at any time without prior notice and shall
have no liability to the other Party as a result of such termination. The
provisions of Section 12.3 above regarding the obligation to make payments upon
the breach of this Agreement shall apply.

      

      12.6.                   Termination without
Cause. Either Party may terminate this Agreement by written notice during
any period when no Purchase Order is currently active, meaning (i) no activities
are planned or being performed by VGX for the CUSTOMER, (ii) no Contract
Materials are due to be delivered to the CUSTOMER, (iii) neither Party owes the
other any payment or refund.

      

      12.7.                   Returned Materials.
On the termination of this Agreement, VGX and CUSTOMER each shall return to the
other all information (including the materials) which it possesses or controls
that belongs to the other, or which contains the other Party’s Confidential
Information, except that each may retain a copy solely for record keeping
purposes.

      

      12.8.                   Insolvency. Either
party may terminate this Agreement upon notice to the other if the other party
becomes insolvent, is adjudged bankrupt, applies for judicial or extra-judicial
settlement with its creditors, makes an assignment for the benefit of its
creditors, voluntarily files for bankruptcy or has a receiver or trustee (or the
like) in bankruptcy appointed by reason of its insolvency, or in the event an
involuntary bankruptcy action is filed against the other party and not dismissed
within ninety (90) days, or if the other party becomes the subject of
liquidation or dissolution proceedings or otherwise discontinues
business.

      

      12.9.                   Survival. Articles 8,
9, 10, 11, 12 and 13 shall survive any termination or expiration of this
Agreement.

      

      13.       
Miscellaneous
Provisions.

      

      13.1.                   Successors and
Assigns. Neither this Agreement nor any interest hereunder shall be
assignable by either Party without the written consent of the other (which
approval shall not be unreasonably withheld), and any attempted assignment
without such consent shall be null and void; provided, however, that either
Party may, without consent, assign this Agreement to its successors in the event
of the merger or consolidation of it or the business with which the Product are
associated with another company, including the sale of all or substantially all
of such Party’s stock or assets, provided that the assignee has the abilities to
fulfill all of assignor’s obligations hereunder and the assignee assumes in
writing all of assignor’s rights and obligations hereunder. This
Agreement shall be binding upon the successors and permitted assignees of
the Parties.

      

      13.2.                   Notices. All notices or other communications
required or permitted to be given hereunder shall be in writing and shall be
delivered by hand, courier, or facsimile and confirmed in writing, as
follows:

       

      
        
           

        

        
            Master Product Sale
Agreement Execution Copy – Page 18

          
            

          

        

        
           

        

      

      
        
          
            	
                    Execution
      Copy

                  	
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          If to
VGX, as follows:

           

          VGXI
USA

        

        2700
Research Forest Drive, Suite 180

        The Woodlands,
TX 77381 USA

         

        If to
CUSTOMER, as follows:

         

        BioCancell
Therapeutics, Inc.

        Beck
Science Center, 8 Hartom Street

        Har
Hotzvim, Jerusalem 97775 Israel

         

        or in any
case to such other address or addresses as hereafter shall be furnished as
provided in this Section 13.2 by any Party hereto to the other Party. Any notice
delivered pursuant to this Section 13.2 shall he deemed delivered when (i)
delivered by hand, (ii) sent by facsimile (with written confirmation of
transmission), (iii) seven (7) days following delivery by registered or
certified mail (return receipt requested) or two (2) days following delivery by
an internationally recognized overnight delivery
service, in each case to the appropriate addresses and facsimile numbers set
forth above (or to such other addresses and facsimile numbers as a Party may
designate by notice to the other Party).

         

        13.3.                    Public Disclosure.
Subject to any disclosure requirements under applicable law, regulation or order
of a governmental agency or a court of competent jurisdiction, the Parties
hereto will agree in advance on a press release or any other statement or
communication regarding the subject matter of this Agreement or the transactions
contemplated hereby. In the case of public disclosure of this Agreement, no
reference will be made to the financial terms of this Agreement or the Product
name, quantity, or intended use.

         

        13.4.                    Entire Agreement.
This Agreement and its appendices constitute the entire agreement between the
Parties with respect to the subject matter hereof and supersede all prior
agreements or understandings of the Parties relating thereto.

         

        13.5.                    Amendment. This Agreement may be modified or
amended only by written agreement of the Parties hereto.

         

        13.6.                    Counterparts. This Agreement may be executed
in any number of counterparts, each of which shall be deemed an original but all
of which together shall constitute a single instrument.

         

        13.7.                    Governing Law. Any
dispute arising under or in relation to this Agreement shall be resolved by
arbitration to be held in London, England and to be governed by the London Court
of International Arbitration Rules then in force. Each such arbitration shall be
conducted by a panel of
three arbitrators, one of
whom shall be appointed by each of
CUSTOMER and VGX, and the third arbitrator, who shall be the chairman of the
tribunal, shall be appointed by the two-party appointed
arbitrators.

         

        13.8.                    Captions. All section
titles or captions contained in this Agreement and in any appendix referred to
herein or annexed to this Agreement are for convenience only, shall not be
deemed a part of this Agreement and shall not affect the meaning or
interpretation of this Agreement.

         

         

        
          
            
            

          

          
            Master  Product Sale Agreement  Execution
Copy – Page 19  

            
              

            

          

          
            
            

          

        

         

      

      
        	
                Execution
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      13.9.                  
Construction. This
Agreement shall be deemed to have been drafted by both VGX and CUSTOMER and
shall not be construed against either Party as the draftsperson
hereof.

      

      13.10.                 Expenses. In the event
a dispute between the Parties hereunder is resolved through litigation or other
proceeding or a Party must engage an attorney (including internal counsel) to
enforce its right hereunder, the prevailing Party shall be entitled to
reimbursement of all reasonable fees and disbursements incurred in connection
with such litigation.

      

      13.11.                 Independent
Contractors. Nothing contained herein shall be deemed to create any joint
venture or partnership between the Parties hereto, and, except as is expressly
set forth herein, neither Party shall have any right by virtue of this Agreement
to bind the other Party in any manner whatsoever.

      

      13.12.                 Severability. If any
provision of this Agreement is held to be illegal, invalid or unenforceable
under present or future laws effective while this Agreement remains in effect,
the legality, validity and enforceability of the remaining provisions shall not
be affected thereby, and in lieu of each such illegal, invalid or unenforceable
provision there shall be added automatically, as a part of the document, a
provision that is legal, valid and enforceable, and as similar in terms to such
illegal, invalid or unenforceable provision as may be possible while giving
effect to the benefits and burdens for which the Parties have bargained
hereunder.

      

      13.13.                 Force Majeure.
Neither Party shall be liable to the other for its failure to perform any of its
obligations under this Agreement, during any period in which such performance is
delayed because rendered impracticable or impossible due to earthquakes,
governmental regulation, fire, flood, interruption of supply of key raw
materials, civil disorders, and acts of God. As soon as there is an indication
of an event of force majeure, the Party affected by it will advise the other
Party immediately or as soon as practical of the existence and effect of such
event on this Agreement and about the measures to be taken to mitigate such
effect. The affected Party is obligated to mitigate the effect and damages and
to resume the fulfillment of the contractual obligations as quickly as
possible.

       

      
        
          
          

        

        
          Master Product Sale Agreement Execution Copy – Page 20

          
            

          

        

        
          
          

        

      

       

      
        	
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      IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the date
first above written.

      

      
        
          
            	
                    VGXI
      USA, a DBA of VGX International Inc.

                  
	 
      	 
      
	 
      	 
      
	
                    By:

                  	
                    /s/
      Joon Suelt

                  
	
                    Name:

                  	
                    Joon Suelt

                  
	
                    Title:

                  	
                    Vice President

                  
	 
      	 
      
	 
      	 
      
	
                    BIOCANCEEL
      THERAPEUTICS LTD.

                  
	 
      	 
      
	
                    By:

                  	
                    /s/ Moshe
      Landsberg

                  
	
                    Name:

                  	
                    Moshe Landsberg

                  
	
                    Title:

                  	
                    VP Technology &
  Qh

                  

          

        

      

       

      
        
           

        

        
          Master Product Sale
Agreement Execution Copy – Page 21Unassociated Document

    
      
         

        EXHIBIT
10.4

      

       

      COOPERATION
AND PROJECT FUNDING AGREEMENT

       

      PREAMBLE

       

      Agreement
made this 26th day of May, 2008, by
and

      

      BETWEEN

       

      The
ISRAEL-UNITED STATES BINATIONAL INDUSTRIAL RESEARCH AND DEVELOPMENT FOUNDATION,
a legal entity created by
Agreement between the Government of the State of Israel and the Government of
the United States of America (hereinafter referred to as the
“Foundation”).

      

      AND

      

      BioCancell
Therapeutics Ltd.

      

      AND

       

      Virginia
Biosciences Commercialization Center (VBCC), dba – Virginia-Israel
Biosciences Commercialization
Center

       

      severally
and jointly (hereinafter collectively referred
to as the “Proposer” and separately as the “Participants”).

       

      WHEREAS
the Foundation has been established under an Agreement between the Government of
the State of Israel and the Government of the United States of America to
promote and support joint non-defense industrial research and development
activities of mutual benefit to Israel and the United States, and

       

      WHEREAS
the Proposer has heretofore submitted to the Foundation a proposal (hereinafter
the “Proposal”), entitled “Phase 1 – Safety & dosing Trial for
Pancreatic Cancer Therapy” and on the basis
of the Proposal has applied to the Foundation for certain funding assistance for
the development of the Product therein described; and

       

      WHEREAS
the Foundation has examined and duly approved the Proposal and is willing to
provide certain funding for the implementation of the Proposal on the terms and
conditions hereinafter set forth;

      
        
           

        

        
          1

          
            

          

        

        
           

        

      

       

      
        Now
therefore the parties hereto agree as follows:

      

       

      
        	
                A.

              	
                GENERAL

              

      

      
        	
                A.1.

              	
                The
      preamble to this Agreement shall be deemed an integral part
      hereof.

              

      

       

      
        	
                A.2.

              	
                The
      Participants shall be bound and obliged jointly and severally, as herein
      provided.

              

      

       

      
        	
                A.3.

              	
                The
      Foundation represents that the Executive Director of the Foundation is
      empowered by its Board of Governors to execute this Agreement and to
      perform and cause to be performed all acts under the terms hereof on
      behalf of the Foundation.

              

      

       

      
        	
                A.4.

              	
                The
      following documents are incorporated by reference and made a part of this
      Agreement:

              

      

       

      
        	
                A.4.1.

              	
                The
      Proposal, dated the 29th day of October, 2007, as stamped with the
      Foundation’s approval of the 18th day of December, 2007. Nonetheless,
      should any provision of the Proposal be inconsistent with any
      provision of this Agreement, the provisions of this Agreement shall
      control.

              

      

       

      
        	
                A.4.2.

              	
                BIRD
      Foundation Procedures Handbook.

              

      

       

      
        	
                A.5.

              	
                The
      following definitions shall apply:

              

      

       

      “Affiliate” – is an
entity under common control, controlled by or controlling either of the
Participants

       

      “Agreement” – this
Cooperation and Project Funding Agreement

       

      “Approved Project
Budget” – the schedule of expenses contemplated to be spent by a
Participant as set out in Annex A

       

      “BIRD Foundation
Procedures Handbook” – the most recent
version available as of the date of this Agreement or its copy on the
Foundation’s website

       

      “Calculation Date” – a
point in time at which the calculation of the then current balance due by the
Proposer is made

       

      “Commercial
Transaction” – gross sales derived by the Proposer, either Participant or
any Affiliate

       

      “Conditional Grant” –
funds provided by the Foundation for the implementation of the
Proposal

       

      “Foundation” – The Israel-United States
Binational Industrial Research and Development Foundation, as referred to in the
first paragraph of this Agreement

       

      “Foundation’s pro rata share” – the
percentage of the actual expenditures which the Foundation
provides

      
        
           

        

        
          2

          
            

          

        

        
           

        

      

       

      “Full Repayment to the
Foundation” – the repayment to the
Foundation by the Proposer of its entire obligation pursuant to this Agreement
as determined in accordance with Annex C

       

      “Grant Base Index” – the
index last published prior to the date of payment of each increment of the
grant

       

      “Index” – the U.S.
Consumer Price Index, CPI-U

       

      “Indexed Payments”
– the result of multiplying each grant payment received by the Proposer by the
last known Index on the Calculation Date and dividing by the Grant Base
Index

       

      “Indexed Repayment” –
the result of multiplying the Repayment received by the Foundation by the last
known Index on the Calculation Date and dividing by the Repayment Base
Index

       

      “Intellectual
Property” – patents, copyrights, trademarks, inventions, trade secrets,
confidential information, product design, engineering specifications and
drawings, technical information and all types of computer programs

       

      “Interim Reporting Segment” –
an interim period of time for which technical and fiscal reports need to be
submitted

       

      “Late Payment Interest
Rate” – 4% more than the average prime rate prevailing at the JP Morgan
Chase Bank, N.Y.C. (or any successor bank to that bank), during the period from
the date payment was due until payment is actually made

       

      “License Agreement” –
an agreement between the Proposer, or either Participant, or
any Affiliate of either Participant and a third party, whereby such third party
receives the right to use the Product in exchange for a payment. “License
Agreements” shall not include any license agreements, which Proposer, or either
Participant, or any Affiliate of either Participant enters into as a necessary,
common or convenient means by which products are sole to end-users in the
ordinary course of business

       

      “Participants” – the
term used for the Israeli Company and the U.S.
Company signing this Cooperation and Project Funding agreement

       

      “Product” – the
outcome of the
development work or any derivative thereof carried out by the Proposer pursuant
to the terms of this Agreement, including patented inventions

       

      “Program Plan” –
schedule of program activities as described in the Proposal and as presented in
graphical form (GANTT chart) in Annex D

       

      “Project” – the
process for the development of the Product with the funding assistance of the
Foundation

       

      “Proposal” – the
documents submitted by the Participants to the Foundation describing the
technical and business aspects of the proposed program

       

      “Proposer” – as
defined in the preamble

      
        
           

        

        
          3

          
            

          

        

        
           

        

      

       

      “Repayment” – the
grant repayment due by the Proposer to the Foundation in the event of the
successful completion of the development work and Repayments will be made upon
the successful completion of the project and not as a percentage of future
sales. Successful completion is broadly defined as reaching the phase defined
(in the BIRD CPFA) as the project’s goal; or licensing the technology (or
selling it outright) to a third party and from proceeds derived from the
outright sale of any portion of the Product to a third party or the licensing of
any portion of the Product to a third party

       

      “Repayment Base Index”
– the Index last published prior to the date on which a Repayment is received by
the Foundation from Proposer

       

      “Termination of Product
Development” – the conclusion of the development of the Product pursuant
to and in accordance with the Proposal, including the Product being ready for
commercialization

       

      “Termination of this
Agreement” – termination deriving from the payment by the Proposer of any
and all of its obligations pursuant to Section B, termination resulting from
revocation by the
Foundation of the Agreement, or termination of the Agreement by the Proposer
with the consent of the Foundation, the effective date in each instance being
the earlier of notice from the Foundation that the examination contemplated by
Section K.3. has been completed, or the expiration of one (1) year after the
specific termination event as aforesaid.

       

      “Total Indexed Grant”
– the result of multiplying the total of the Indexed Payments by the appropriate
percentage level from the table shown in Section B.3.1

       

      “Total Indexed
Repayments” – the total of the Indexed Repayments.

       

      
        	
                B.

              	
                PROJECT
      FINANCING

              

      

      
        	
                B.1.

              	
                The
      Foundation hereby agrees to fund, by Conditional Grant, the implementation
      of the Proposal in the maximum sum of $950,000 or 50% of the actual
      expenditures on the Project, as contemplated in the Approved Project
      Budget, whichever is less, and at the times and as may otherwise be set
      forth in Annex B hereto.

              

      

       

      
        	
                B.2.

              	
                The
      Proposer shall provide in timely fashion all
      budgetary funds in excess of those provided hereunder by the
      Foundation.

              

      

       

      
        	
                B.3.

              	
                Proposer
      shall make Repayments to the Foundation in the event of the successful
      completion of the development work. Such Repayments shall be based on the
      conditions as set out in Section B.3.1., Section B.5. and Section
      B.6.

              

      

       

      
        	
                B.3.1.

              	
                The
      Repayments by the Proposer shall
      be made on the following basis upon the successful completion of the
      development work being carried out by Proposer, the Conditional Grant
      provided by the Foundation shall be repayable in accordance with
      Sub Section B.3.1a. unless the provisions of Section B.5 or Section B.6.
      apply, in which event repayment stall be made pursuant to either or
      both of those Sections,
applicable.

              

      

      
        
           

        

        
          4

          
            

          

        

        
           

        

      

       

      
        	
                a)

              	
                Upon
      the successful completion of the development work, the Conditional Grant
      and Other Sums provided to the Proposer by the Foundation shall be repayable by the
      Proposer. Such repayment will be due within 12 months following the
      Project completion (i.e. since the Project duration is for a period of 24
      months, repayment will be due by no later than 36 months from the
      effective date stated in Section O) in an amount equal to the total grant
      paid to Proposer linked to the U.S. Consumer Price Index. Should the
      Proposer request the Foundation to extend the due date of the repayment
      for up to 12 months, the Proposer will then repay to the Foundation on
      this new due date 113% of the total Conditional Grant paid linked to the
      U.S. Consumer Price Index, and so on, pursuant to the
      timeframe and the maximum percentages set forth in the table set out in
      Section B.3.1.b., and to the extent of the monetary obligation described
      in Section B.3.

              

      

      

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  
                                                    
                                                      	
                                                               

                                                            	 	 	
                                                              Maximum Percentage of

                                                            	 
	
                                                              
                                                                Years Following Original

                                                              

                                                            	 	 	
                                                              Conditional Grant to be

                                                            	 
	
                                                              
                                                                Date of Termination of

                                                              

                                                            	 	 	
                                                              Repaid (indexed according to

                                                            	 
	
                                                              Project Development

                                                            	 	 	
                                                              Annex C of this Agreement)

                                                            	 
	 	 	 	 	 
	1	 	 	 	100	%
	
                                                              2

                                                            	 	 	 	113	%
	
                                                              3

                                                            	 	 	 	125	%
	
                                                              4

                                                            	 	 	 	138	%
	
                                                              5
      or more

                                                            	 	 	 	150	%

                                                    

                                                  

                                                

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      
        	
                B.4.

              	
                All
      Repayments due the Foundation shall be calculated on a semi-annual
      calendar basis, and statements, certified by each Participant’s chief
      financial officer (or other senior financial officer acceptable to the
      Foundation), rendered with payment in and within 90 calendar days
      following the end of each semi-annual period. Repayments to the Foundation
      shall commence at the end of the semi-annual period during which the first
      sale was made. All late Repayments shall bear interest at the Late Payment
      Interest Rate.

              

      

       

      
        	
                B.5.

              	
                The
      Proposer shall not sell outright to a third party any portion of the
      Product without the prior written consent of the
    Foundation.

              

      

       

      
        	
                B.5.1.

              	
                The
      Proposer shall furnish to the Foundation reasonable prior notice with
      respect to any proposed sale as referred to in Section B.5., the notice to
      include the name of the prospective purchaser, the price and the other
      terms of the proposed sale, and all other relevant information concerning
      the proposed sale.

              

      

       

      
        	
                B.5.2.

              	
                The
      Foundation shall promptly provide consent to a sale as referred to in
      Section B.5, after receipt and review of the notice referred to above,
      provided that its rights pursuant to this Agreement are fully guaranteed
      to the Foundation’s satisfaction, and that the Foundation is satisfied
      that the proposed sale is at a price and upon terms no less than the
      actual market value of the portion of the Product. The Foundation shall be
      entitled in its sole discretion to designate a representative or
      representatives to review the terms of the proposed sale and to seek to
      determine the actual market value of the Product, and the Proposer shall
      cooperate with, and furnish all pertinent information, to any such
      representative or
representatives.

              

      

      
        
           

        

        
          5

          
            

          

        

        
           

        

      

       

      
        	
                B.5.3.

              	
                Should
      any portion of the Product be sold outright to a third party by the
      Proposer, by either Participant, or by any Affiliate of either
      Participant, one-half of all proceeds of the sale shall be applied as
      received until there has been full repayment to the Foundation of amounts
      due to the Foundation hereunder. If any such sale is (i) in exchange for a
      non-cash asset or (ii) part of the sale of a group of assets, and no
      separate value is assigned by the parties to the portion of the Product
      sold, the Proposer and the Foundation shall seek to agree: as to clause
      (i) the value of the asset received; and as to clause (ii) the portion of
      the consideration reasonably allocatable to the sale. If no such agreement
      is reached within a reasonable time, or if any value assigned by the
      parties is in the view of the Foundation not reasonable under all of the
      circumstances, the matter shall be resolved pursuant to Section M.4. Payments due and
      not made following receipt of proceeds by the Proposer shall bear interest
      at the Late Payment Interest Rate.

              

      

       

      
        	
                B.5.4.

              	
                The
      Proposer shall provide notice to the Foundation, either prior to, or
      immediately after, of any transfer of control of
      either Participant as a result of the sale of shares, or a merger or an
      amalgamation of either of the Participants with any other
      company.

              

      

       

      
        	
                B.5.5.

              	
                In
      the case of any transfer of control of a Participant as referred to in
      Section B.5.4., if that Participant, or in the case of a merger or
      amalgamation if the merged or amalgamated company, terminates the Project
      prior to the Termination of Product Development, such event shall be
      deemed to constitute an outright sale of the Product to a third party
      pursuant to Section B.5.3. notwithstanding any other provision of this
      Agreement.

              

      

       

      
        	
                B.6.

              	
                License
      agreements involving the Product developed in whole or in part during
      this Foundation-supported project shall be subject to Annex
    E.

              

      

       

      
        	
                C.

              	
                CONDUCT
      OF THE PROJECT

              

      

      
        	
                C.1.

              	
                The
      Proposer agrees to do the work set out in the Proposal in accordance with
      good standards relevant to such undertakings, and shall expend funds
      received hereunder only in accordance with such Proposal and the
      requirements of this Agreement.

              

      

       

      
        	
                C.2.

              	
                The
      Proposer agrees to comply with the Program Plan as set forth in Annex
      D.

              

      

       

      
        	
                C.3.

              	
                The
      Proposer hereby appoints Doron Amit as Israel project manager and Donna
      Edmonds as U.S. project manager for the implementation of the project
      during the period of this Agreement and in accordance with the Program
      Plan.

              

      

      
         

        
          	
                  C.4.

                	
                  The
      Proposer shall not make substantial transfers of funds from one budget
      item to another, change key personnel or their duties and
      responsibilities, or diminish their time allocated to the proposed work
      hereunder without prior written approval by the Foundation, which approval
      shall not be unreasonably with
held.

                

        

        
          
             

          

          
            6

            
              

            

          

          
             

          

        

      

      
        	
                C.4.1.

              	
                Should
      any key person be absent from work,
      or should such absence be expected, for 90
      days or more, or should there be any significant reduction in the total
      personnel force assigned the project under the Proposal, the Proposer
      shall forthwith notify the
Foundation.

              

      

       

      
        	
                D.

              	
                REPORTING
      REQUIREMENTS

              

      

      
        	
                D.1.

              	
                The
      Proposer shall submit to the Foundation, in writing, the following
      reports:

              

      

      
        	
                a)

              	
                interim
      fiscal and technical reports to be submitted
      simultaneously within 30 days following the expiration of the first
      6-month period;

              

      

      
        	
                b)

              	
                interim
      fiscal and technical reports to be submitted simultaneously within 30 days
      following the expiration of the second 6-month
  period;

              

      

      
        	
                c)

              	
                interim
      fiscal and technical reports to be submitted simultaneously within 30 days
      following the expiration of the third 6-month
  period;

              

      

      
        
          	
                  d)

                	
                  final
      fiscal and technical reports to be submitted simultaneously within 60 days
      following Termination of Product Development.

                
	 	 

        

      

      
        	
                D.1.1.

              	
                Any
      failure to submit reports in a timely fashion pursuant to Section D.1
      shall be deemed a fundamental breach and a breach for cause pursuant to
      this Agreement.

              

      

       

      
        	
                D.1.2.

              	
                The
      reports to be submitted pursuant to this Section D shall be in form and
      substance in accordance with the most recent Formats for Technical and
      Fiscal Reports, as shown on the Foundation’s web
  site.

              

      

       

      
        	
                D.2.

              	
                Proposer
      shall provide to the Foundation at its expense, briefings on the progress
      of the work hereunder, within 45 days following any request from time to
      time by the Foundation. Such briefings shall be in accordance with such
      form and detail as the Foundation may reasonably
  request.

              

      

       

      
        	
                E.

              	
                PUBLICATIONS

              

      

      
        	
                E.1.

              	
                In
      any publication in scientific or technical journals of data or other
      information derived from the work hereunder, or any publication related to
      the work, but not including product literature or manuals, the support of
      the Foundation shall be
acknowledged.

              

      

       

      
        	
                E.2.

              	
                To
      the extent so required to permit the Foundation free dissemination of
      such publications or information, which the Foundation is privileged to
      disseminate, subject to the limitations of Section F, the Proposer shall
      be deemed hereby to wave any claim with respect to such dissemination for
      infringement of any copyright it may have or may
  obtain.

              

      

       

      
        	
                E.3.

              	
                The
      Proposer shall furnish to the Foundation two (2) copies of all publications
      resulting from Foundation-supported work as soon as possible after
      publication.

              

      

      
        
           

        

        
          7

          
            

          

        

        
           

        

      

       

      
        	
                F.

              	
                PROPRIETARY
      INFORMATION, INTELLECTUAL PROPERTY

              

      

      
        	
                F.1.

              	
                Proprietary
      information, clearly identified as such, submitted to the Foundation in
      the Proposal, in any report or verbally, or obtained by Foundation
      personnel observation pursuant to any request or briefing, shall be
      treated by the Foundation as confidential. At the request of Proposer or
      either Participant, a confidential disclosure agreement may be entered
      into separately by the parties. Nothing contained in the foregoing
      shall restrict the right
      of the Foundation to make public the
      fact of the Foundation’s support for the Project, and the identification
      of the Participants therein. The details of any such publication, except
      for those permitted by the immediately preceding sentence of this Section
      F.1, shall be subject to prior approval by the
    Participants.

              

      

       

      
        	
                F.2.

              	
                The
      Proposer represents and warrants that, to the best of its knowledge,
      information and belief, the Proposer has good, valid and enforceable title
      to all of the Intellectual Property necessary for purposes of
      implementation of the Proposal, free and clear of all third party
      interests, or otherwise possesses adequate rights to use the Intellectual
      Property (subject to the fact that no patent may have been obtained). To
      the best of the Proposer’s knowledge, information and belief, no
      Intellectual Property used or proposed to be used with respect to the
      Proposal infringes upon any Intellectual Property rights of others, and
      the use of such Intellectual Property with respect to the Proposal does
      not constitute an infringement, misappropriation or misuse of any
      intellectual property rights of any third
party.

              

      

       

      
        	
                G.

              	
                PATENTS
      AND ROYALTIES

              

      

      
        	
                G.1.

              	
                If
      Proposer or either of the Participants elects to apply for letters patent
      on any Product developed in whole or in part from performance of
      Foundation-supported activity, such applicant shall, at his own expense,
      so apply in the United States and in Israel, and in such other countries
      and at such times as the Proposer or either of the Participants may deem
      appropriate.

              

      

       

      
        	
                H.

              	
                RIGHTS
      OF THE GOVERNMENTS OF ISRAEL AND THE UNITED
  STATES

              

      

      
        	
                H.1.

              	
                Regardless
      of the patent rights acquired by Participants by mutual agreement or
      pursuant to Section G.1., the Governments of Israel and of the United
      States shall each have a non-exclusive, irrevocable, royalty-free license
      to make or have made, to use or have used, and to sell or have sold any
      such Product specified, throughout the world for all governmental
      purposes: provided, however, that in any contracting situation involving a
      Product made under this Agreement, the Government of Israel shall give
      preference to the Participant retaining the entire right, title, and
      interest in the Product in Israel, and provided that “governmental
      purposes” shall not include manufacture of such Product where it is
      commercially available at reasonable prices. Notwithstanding the
      foregoing, except for military purposes or in emergency situations,
      neither the Government of Israel nor the Government of the United States,
      nor the Foundation, shall have the right to sell or otherwise dispose of
      in any third country any product incorporating the Product or part of the
      Product without the prior written permission of the Participant which
      has acquired
      the entire right and interest in the Product in that third country. Such
      Participant shall not withhold permission where appropriate royalties are
      paid by the Foundation or government(s)
  concerned.

              

      

      
        
           

        

        
          8

          
            

          

        

        
           

        

      

       

      
        	
                H.2.

              	
                In
      addition to the patent rights specified In Section H.1. the Foundation
      reserves for itself and the Governments of Israel and the United States
      the right to use the Product, technical information, data, know-how and
      Intellectual Property arising out of, or developed under, this Agreement
      for any noncommercial purpose, and without
  charge.

              

      

       

      
        	
                H.3.

              	
                In
      order that the rights of the Foundation and the Governments of Israel and
      the United States described herein shall be exercisable, the Participants
      agree that any component, element or other part of the system described as
      the Product in the Preamble to this Agreement, whose use is necessary to
      the full enjoyment of the Product, will be made available, at reasonable
      prices, by the Participants either as a commercially purchasable item, or
      by special arrangement, and will be sold to the Foundation and/or the
      Government of Israel and/or the Government of the United States, also at
      reasonable prices.

              

      

       

      
        	
                H.4.

              	
                Notwithstanding
      the foregoing provisions of this Section H., it is understood and agreed
      that, so long as any Intellectual Property that comprises part or all of
      the Product is marketed by Proposer, by either Participant,
      or by others with the rights to market such Intellectual Property, neither
      the Government of Israel nor the Government of the United States shall
      have the right to obtain a
      license to
      use such Intellectual Property unless the license fee normally imposed in
      the ordinary course of business by either of the Participants or by others
      with the rights to market such Intellectual Property is paid, and the
      standard license agreement is
executed.

              

      

       

      
        	
                I.

              	
                TERMINATION
      OF THE AWARD

              

      

      
        	
                I.1.

              	
                The
      Foundation may revoke the Conditional Grant, in whole or in part, for cause, as defined
      in the laws of the State of New
York.

              

      

       

      
        	
                I.2.

              	
                Upon
      receipt of notice of revocation for a default, which constitutes
      a cause, the Proposer may cure the default in and within thirty (30)
      calendar days after the date of receipt of the
  notice.

              

      

       

      
        	
                I.3.

              	
                Notwithstanding
      any other provision in this Agreement to the contrary, the Foundation
      shall not be obliged to provide any further funding after notice of
      revocation until and unless the said default is cured and so demonstrated
      to the reasonable satisfaction of the
  Foundation.

              

      

       

      
        	
                I.4.

              	
                Should
      the Conditional Grant be revoked for reason of cause, in addition to the
      Foundation’s rights under Section I.5., the Foundation and the Governments
      of Israel and the United States shall continue to be entitled to all of
      their rights pursuant to Section H.

              

      

      

      
        	
                I.5.

              	
                If
      the Foundation shall revoke the Conditional Grant as aforesaid, all funds
      given to Proposer in accordance with Section B.1. shall become due
      immediately, without need for demand. Such funds shall be repaid with
      interest at the Late Payment Interest Rate from the date of notice of the
      revocation.

              

      

       

      
        	
                I.6.

              	
                The
      Proposer may not terminate this Agreement or abandon the Project without
      the prior written consent of the Foundation, which consent
      shall not be unreasonably withheld. The Foundation declares that it will
      furnish such a consent if it is satisfied that, despite good faith
      efforts, the Proposer has not succeeded in developing the Product, or if
      the Product has been developed the Proposer has not succeeded in effecting
      any sales or other commercial exploitation of the Product, except in the
      cases referred to in Section
B.5.5.

              

      

      
        
           

        

        
          9

          
            

          

        

        
           

        

      

       

      
        	
                I.7.

              	
                If
      upon termination of the Project development work for any reason, the
      entire budgeted sum has not been expended, the Proposer shall forthwith
      return to the Foundation its pro rata share
      of such unexpended portion. If not repaid forthwith, such sum shall bear
      interest in accordance with Section
I.5.

              

      

       

      
        	
                J.

              	
                SURVIVAL
      OF PROVISIONS

              

      

      Notwithstanding
revocation or other termination of this Agreement, the following provisions
shall survive such revocation or other termination of this Agreement: Sections
B., D., E., F., G., H., I.3., I.4., I.5., I.7., K., L., M., N., Annex C and
Annex E if, however, the termination of this Agreement derives from the payment
by the Proposer of all of its obligations to the Foundation pursuant to Section
B, the following provisions only shall survive the termination of this
Agreement: Sections E., F., H., K., L. and M.

       

      
        	
                K.

              	
                FINANCIAL
      RECORDS

              

      

      
        	
                K.1.

              	
                The
      Proposer shall maintain business and financial records and books of
      account for the work hereunder identifiable within the framework of the
      business and financial records
      of the Proposer. Such books and records shall be in usual and accepted
      form.

              

      

       

      
        	
                K.2.

              	
                Books
      and records of the work hereunder shall show Proposer’s contribution. Upon
      request by the Foundation, the Proposer shall provide evidence of its
      compliance herewith.

              

      

       

      
        	
                K.3.

              	
                The
      Foundation may examine, or cause to be examined, the financial books,
      vouchers, records and any other documents of the Proposer relating to this
      Agreement at reasonable times and
      intervals and upon reasonable
      notice during the term of this
Agreement.

              

      

       

      
        	
                L.

              	
                SUITS
      AGAINST THE FOUNDATION

              

      

      
        	
                L.1.

              	
                The
      Proposer shall defend all suits brought
      against the Foundation, its officers or personnel, indemnify them for all
      liabilities and costs and otherwise hold
      them harmless on account of any and all claims,
      actions, suits, proceedings and the like arising out of, or
      connected with or resulting from the performance of this Agreement by the
      Proposer, or from the manufacture, sales, distribution or use by the
      Proposer of the Product, whether brought by Proposer or its personnel or
      by third parties.

              

      

       

      
        	
                L.2.

              	
                The
      Proposer agrees that persons employed by it, or otherwise retained by the
      Proposer, if connection with the Project, shall be deemed to be solely its own
      employees or agents, and that no relationship of employer and
      employee or principal and agent shall be created between such employees
      or agents and
      the Foundation, either for purposes of tort liability,
      social benefits, or for any other purpose. The Proposer shall indemnify the
      Foundation and hold it harmless from court costs and legal fees, and for
      any payment, which the Foundation may be obliged to make as a result of a
      cause of action based upon an employee-employer or principal-agent
      relationship as aforesaid.

              

      

      
        
           

        

        
          10

          
            

          

        

        
           

        

      

       

      
        	
                M.

              	
                MISCELLANEOUS
      CONDITIONS

              

      

      
        	
                M.1.

              	
                The
      Foundation makes no representation, by virtue of its funding the work
      hereunder, or receiving any payments or
      royalties as a result of this Agreement, as
      to the safety, value or utility of the Product or the work undertaken, nor
      shall the fact of participation of the Foundation,
      its funding or exercise of its rights hereunder be deemed an endorsement
      of the Product or of the Proposer, nor
      shall the
      name of the Foundation be used for any commercial purpose or be publicized
      in any way by the Proposer except within the strict limits of this
      Agreement.

              

      

       

      
        	
                M.2.

              	
                The
      Proposer may not assign this
      Agreement or any of the work
      undertaken pursuant to it without the prior written
      consent of the Foundation, which consent shall not be unreasonably
      withheld.

              

      

       

      
        	
                M.3.

              	
                This
      Agreement shall be construed under the laws of the State of New York. The
      exclusive forums for the resolution of any dispute
      arising from this Agreement shall be the State of Israel or Washington,
      D.C. in the U.S., as the moving party may elect. Execution of this
      Agreement shall be taken as submission to the forum selected pursuant to
      this Section.

              

      

       

      
        	
                M.4.

              	
                Any dispute concerning the
      subject matter of this Agreement shall be resolved through arbitration,
      unless the Foundation and the other parties to such dispute agree
      otherwise, in writing. If the forum is in Israel, the arbitration
      will be conducted pursuant to the rules of the Israeli Institute for
      Commercial Arbitration. If the forum is in the United States, the
      arbitration will be conducted pursuant to the rules of the American
      Arbitration Association.

              

      

       

      
        	
                M.5.

              	
                Proposer
      undertakes to comply with all applicable laws, rules and regulations of
      the State of Israel and the United Stales of America and any applicable
      State or Commonwealth, and will apply for and obtain all necessary
      licenses and permits for the carrying out of its obligations
      hereunder.

              

      

      

      
        	
                M.6.

              	
                Under
      Israeli law, no stamp duty is required on BIRD Foundation Cooperation and
      Project Funding Agreements.

              

      

      
        
           

        

        
          11

          
            

          

        

        
           

        

      

    

     

    
      	
              M.7.

            	
              Notices,
      communications and reports shall be hand-delivered or mailed by prepaid
      first-class mail (airmail if transmitted internationally) addressed
      to:

            

    

     

    
      	
               
      

            	
              a.

            	
              The
      Israel-U.S. Binational Industrial Research and Development
      Foundation

            

    

    
      
        
          
            
              
                
                  	
                          Office
      Address:

                        	 	
                          Mailing
      Address:

                        
	
                          Kiryat
      Atidim, Building 4

                        	
                           

                        	
                          P.O.
      Box 58054

                        
	
                          Tel
      Aviv 61581

                        	 	
                          Tel
      Aviv 61580

                        
	
                          Israel

                        	 	
                          Israel

                        

                

              

            

          

        

      

    

     

    
      
        	
                
                

              	
                b. 

              	
                BioCancell
      Therapeutics Ltd.

              

      

    

    
      
        
          
            	
                    Office
      Address:

                  	
                     

                  	
                    Mailing
      Address:

                  
	
                    8
      Hartom St

                  	 	
                    8
      Hartom St

                  
	
                    Beck
      Science Center

                  	 	
                    Beck
      Science Center

                  
	
                    Har
      Hotzvim

                  	 	
                    Har
      Hotzvim

                  
	
                    Jerusalem
      91487

                  	 	
                    Jerusalem
      91487

                  
	
                    Israel

                  	 	
                    Israel

                  

          

        

      

    

     

    
      	
               
      

            	
              c.

            	
              Virginia
      Biosciences Commercialization Center (VBCC), dba
      – Virginia-Israel Biosciences Commercialization
      Center

            

    

     

    
      
        
          
            
              	
                      Office
      Address:

                    	 	
                      Mailing
      Address:

                    
	
                      800
      East Leigh Street

                    	 	
                      800
      East Leigh Street

                    
	
                      Richmond,
      VA 23219

                    	 	
                      Richmond,
      VA 23219

                    
	
                      U.S.A.

                    	 	
                      U.S.A.

                    

            

          

        

      

    

     

    
      	
              N. 

            	
              LIMITATION
      ON PAYMENTS

            

    

    Notwithstanding
any contrary interpretation of this Agreement or the Annexes hereto, Proposer's
total obligation hereunder for payments to the Foundation shall not exceed the
amount calculated in accordance with the applicable percentage provided in
Sections B.3.1(a) and (b) in equivalent dollars valued at time of repayment as
determined in accordance with Annex C.

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

     

    
      	
              O.

            	
              EFFECTIVE
      DATE

            

    

    The
effective date of this Agreement shall be the 1st day of January, 2008. The
development work shall commence on the aforementioned date and, unless sooner
terminated by the Foundation in accordance with Section I., the development work
shall terminate 24 months following the effective date.

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      	
                                              Signed
      the day and date above first given

                                            
	 
      	 
      
	
                                              Printed
      Name:

                                            	
                                              Eltan
      Yudilevlon

                                            
	 
      	 
      
	
                                              Signature:

                                            	
                                              /s/
      Eltan Yudilevlon

                                            
	 
      	 
      
	
                                              Title:

                                            	
                                              Executive
      Director

                                            
	 
      	 
      
	
                                              (for
      the BIRD Foundation)

                                            
	 
      	 
      
	
                                              Printed
      Name:

                                            	
                                              /s/Avi Barak

                                            
	 
      	 
      
	
                                              Signature:

                                            	
                                              Avi
      Barak

                                            
	 
      	 
      
	
                                              Title
      :

                                            	
                                              Chief
      Executive Officer

                                            
	 
      	 
      
	
                                              (for
      BioCancell Therapeutics Ltd.)

                                            
	 
      	 
      
	
                                              Printed
      Name:

                                            	
                                              Robert
      T. Skupa

                                            
	 
      	 
      
	
                                              Signature:

                                            	
                                              /s/
      Robert T. Skupa

                                            
	 
      	 
      
	
                                              Title:

                                            	
                                              President

                                            

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

    

    (for
Virginia Biosciences Commercialization Center (VBCC), dba – Virginia-Israel
Biosciences Commercialization Center)

     

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    

     

    

     

    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    

     

    

     

    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    

     

    

     

    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

    
       

      

       

      
        
          
          

        

        
          17

          
            

          

        

        
          
          

        

      

    

     

    ANNEX
B

    PAYMENT
OF CONDITIONAL GRANT

    

    
      
        
          
            
              
                
                  
                    	
                            1.             

                          	
                            First
      Payment – On signing –

                          	
                            Israeli
      Company:

                          	$ 	
                            107,128

                          
	 
      	 
      	
                            U.S.
      Company:

                          	$	
                            66,293

                          

                  

                

              

            

          

        

      

    

     

    
      	
              2.

            	
              Second
      Payment –

            

    

    After
receipt and approval of the first interim technical and fiscal reports for the
first 6-month period, or after actual expenditure, on the project have equaled
or exceeded the required expenditures whichever is later.

     

    
      
        
          
            	
                  	 	
                    Required

                  	 	 	
                    Payment

                  	 
	 
      	 	
                    Expenditure

                  	 	 	 	 
	 
      	 	 	 	 	 	 
	
                    Israeli
      Company:

                  	 	$	267,819	 	 	$ 	107,128	 
	
                    U.S.
      Company:

                  	 	$	165,745	 	 	$	99,447	 

          

        

      

       

    

    However,
if at the required time of submission of the first interim technical and fiscal
reports, work on the project or expenditures thereon prove to be materially
behind plan, in accordance with Annex D and Annex A, respectively, the
Foundation will review the project with Proposer and determine a suitable course of action
with respect to further payments against the Conditional Grant, if
any.

     

    
      	
              3.

            	
              Third
      Payment –

            

    

     

    After
receipt and approval of the second interim technical and fiscal reports for the
second 6-month period, or after actual expenditures on the project have equaled
or exceeded the required expenditure, whichever is later.

     

    
      
        
          	
                	 	
                  Required

                	 	 	
                  Payment

                	 
	 
      	 	
                  Expenditure

                	 	 	 	 
	 	 	 	 	 	 	 
	
                  Israeli
      Company:

                	 	$	535,638	 	 	$	107,128	 
	
                  U.S.
      Company:

                	 	$	414,362	 	 	$	82,872

        

      

    

     

    However,
if at the required time of submission of the second interim technical and fiscal
reports, work on the project or expenditures thereon prove to be materially
behind plan, in accordance with Annex D and Annex A, respectively, the
Foundation will review the project with Proposer and determine a suitable course
of action with respect to further payments against the Conditional Grant, if
any.

     

    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    

     

    
      	
              4.

            	
              Fourth
      Payment –

            

    

     

    After
receipt and approval of the third interim technical and fiscal reports for the
third 6-month period, or after actual expenditures on the project have equaled
or exceeded the required expenditure, whichever is later.

     

    
      
        
          
            
              	 
      	 	
                      Required

                    	 	 	
                      Payment

                    	 
	 
      	 	
                      Expenditure

                       

                    	 	 	 	 
	
                      Israeli
      Company:

                    	 	$	803,457	 	 	$	107,128	 
	
                      U.S.
      Company:

                    	 	$	621,542	 	 	$	82,872	 

            

          

        

      

    

     

    However,
if at the required time of submission of the third interim technical and fiscal
reports, work on the project or expenditures thereon prove to be materially
behind plan, in accordance with Annex D and Annex A, respectively, the
Foundation will review the project with Proposer and determine a suitable course
of action with respect to further payments against the Conditional Grant, if
any.

     

    
      	
              5. 

            	
              Final
      Payment - After receipt and approval of the final technical and fiscal
      reports - the balance due Proposer up to the total sum of the Conditional
      Grant in accordance with Section
B.1.

            

    

     

    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    

     

    ANNEX
C

    LINKAGE
OF CONDITIONAL GRANT REPAYMENTS

     

    The
monies given as a Conditional Grant shall be linked in value, until full
Repayment, to the Index. As each increment of the grant is given, it shall
thereafter be linked to the Grant Base Index. Upon Repayment of any portion of
Proposer's obligations under Section B.3, Section B.5, Section B.6. or Annex
E, such Repayment shall be linked to
the Repayment Base Index.

     

    At any
Calculation Date, Proposer's obligations shall be calculated according to the
following formula:

     

    The Total
Indexed Grant less the Total Indexed Repayments.

     

    
      
        
        

      

      
        20

        
          

        

      

      
        
        

      

    

     

    
      D.4. Program Plan
(GANTT)

    

    

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              	 
      	 	 	1Q07	 	 	 	1Q08	 	 	
                                      2Q08

                                    	 	 	 	1Q08	 	 	 	1Q09	 	 	
                                      2Q09

                                    	 	 	 	2Q09	 	 	 	3Q09	 	 	 	4Q09	 	 	 	1Q10	 	 	
                                      2Q10

                                    	 
	
                                      Receipt
      of BIRD Grant

                                    	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 	 	 	  	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      1.
      Development of IND

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      2.
      Protocol  development

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      3.
      Site contract

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      4.
      Case report forms/ patient consents

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      5.
      IRB/Helsinki Committee submission

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      6.
      Site set up

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      7.
      Per patient enrollment process and fees

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      8.
      PI and faculty training development

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      9.
      Site monitoring and coordination

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      10.
      Site grant administration

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      11.
      Product manufacture and shipping

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      12.
      Marketing communications of the trial

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      13.
      Honoraria, conference materials, attendance

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      14.
      Data collection, management and analysis

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      15.
      Summary and report

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
      	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      Key

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      VIBCC
      only

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      BioCancell
      only (assumes CRO fees are here)

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	
                                      By
      both entities concurrently

                                    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    
      
        
        

      

      
        21

        
          

        

      

      
        
        

      

    

     

    ANNEX
E

    LICENSE
AGREEMENTS

     

    If
the Product becomes
the subject of any license agreement between Proposer, either Participant, or an
Affiliate of either Participant and a third party, the licensor shall pay to the
Foundation 30% of all payments received by it under such license agreement. Payment under this Annex
E shall be deemed payments against Proposer's obligations under Section B.3. In
no event shall this Annex E be construed as requiring payments of any amount
greater than those indicated in Section B.3.)

     

    
      
        
        

      

      
        22

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00150-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00150-of-00352.parquet"}]]