Unassociated Document


     

    
      CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

       

    

    Company
Plasmid DNA Production Agreement


     

    THIS AGREEMENT is effective as
of the 23rd day of
January, 2007 (“Effective Date”).

     

    BY
AND BETWEEN:

     

    BioCancell
Therapeutics Ltd a corporation organized and existing under the laws of the
State of Israel, with its principal offices located at Beck Science Center, 8
Hartom St, Har Hotzvim, Jerusalem 97775 Israel (hereinafter referred to as
“CLIENT”)

     

    AND:


     

    ALTHEA TECHNOLOGIES, INC., a
Delaware corporation, with a place of business located at 11040 Roselle Street,
San Diego, CA 92121 (hereinafter referred to as “ALTHEA”);

     

    WHEREAS CLIENT has
formulations and/or know-how related to each Company Plasmid DNA, as defined
below;


     

    WHEREAS ALTHEA has the
expertise and the manufacturing facility suitable for the Production of Company
Plasmid DNA in a manor complying with cGMP as defined below;


     

    WHEREAS, CLIENT wishes to have
ALTHEA Produce Plasmid DNA and ALTHEA wishes to Produce Plasmid DNA for
CLIENT;


     

    NOW, THEREFORE, in
consideration of the premises and the undertakings, terms, conditions and
covenants set forth below, the parties hereto agree as follows:

    


    Article
1, DEFINITIONS.

     

    
      	
               

            	
              1.1

            	
              AFFILIATE
      of a party hereto shall mean any entity that controls or is controlled by
      such party, or is under common control with such party. For purposes of
      this definition, an entity shall be deemed to control another entity if it
      is able, directly or indirectly, to direct or cause the direction of the
      management and policies of an entity (other than a natural person),
      whether through the majority ownership of voting capital stock, by
      contract or otherwise.

            


    

     

    
      	
               

            	
              1.2

            	
              ALTHEA SOPs shall mean
      ALTHEA’s Standard Operating Procedures, which will be customized on a
      product specific basis, as necessary, for manufacture of Company Plasmid
      DNA. CLIENT will review and approve each product specific SOP prior to
      production of Company Plasmid DNA and any subsequent revisions to these
      SOPs.

            


    

     

    
      	
               

            	
              1.3

            	
              BATCH shall mean a
      specific quantity of Company Plasmid DNA mutually agreed upon between
      CLIENT and ALTHEA, and that (a) is intended to have uniform character and
      quality within specified limits, and (b) is produced according to a single
      manufacturing order during the same cycle of
  manufacture.

            


    

     

    ALTHEA
CONFIDENTIAL

     

    
      
        
        

      

      
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    CONFIDENTIAL TREATMENT REQUESTED
FOR BRACKETED ITEMS

     

     

    
      
        	
              	
                1.4

              	
                cGMP shall mean current
      Good Manufacturing Practices as defined in the FDA rules and regulations,
      21 CFR Parts 210-211, 600 and 610 and the corresponding rules and
      regulations of the EMEA, all as may be amended from time to
      time.

              


      

    

     

    
      
        	
              	
                1.5

              	
                CANCELLATION FEES shall
      mean the fees payable by CLIENT in the event that CLIENT cancels the
      Production of any Batch of Company Plasmid DNA set forth in the Project
      Plan, except in the event of a default by ALTHEA, all as set forth in
      Section 3.3., the Project Plan is enclosed herein as Appendix
      1.

              


      

    

     

    
      	
            	
              1.6 

            	
              CHANGE
      ORDER shall have the meaning assigned to such term in Section
      2.7

            


    

     

    
      
        	
              	
                1.7

              	
                COMPONENTS shall mean
      all Components used by ALTHEA in Production of Company Plasmid DNA under
      this Agreement. Components are listed in the Project Plan such Components
      identified as Components supplied by CLIENT (“CLIENT Supplied Components”)
      and Components supplied by ALTHEA (“ALTHEA Supplied
      Components”).

              


      

    

     

    
      
        	
              	
                1.8

              	
                CONFIDENTIAL INFORMATION
      shall mean all information and data provided by one party to the
      other party except any portion of such information and data
      which:

              


      

    

     

    
      
        	
              	
                (i)

              	
                is
      known to the recipient as evidenced by its written records before receipt
      thereof from the disclosing
party;

              


      

    

     

    
      
        	
              	
                (ii)

              	
                is
      disclosed to the recipient by a third person who has the right to make
      such disclosure;

              


      

    

     

    
      	
            	
              (iii) 

            	
              is
      or becomes part of the public domain through no fault of the
      recipient;

            


    

     

    
      	
            	
              1.9

            	
              EMEA shall mean the
      European Medicines Agency or any successor entity
  thereto.

            


    

     

    
      
        	
              	
                1.10

              	
                FACILITY shall mean
      ALTHEA’s facility located at 11040 Roselle Street, San Diego, CA
      92121.

              


      

    

     

    
      
        	
              	
                1.11

              	
                FDA shall mean the
      United States Food and Drug Administration or any successor entity
      thereto.

              


      

    

     

    
      
        	
              	
                1.12

              	
                FD&C ACT shall mean
      the United States Federal Food, Drug and Cosmetic Act, as may be amended
      from time to time.

              


      

    

     

    
      
        	
              	
                1.13

              	
                Company Plasmid DNA
      shall mean the DTA-H19 plasmid as set forth in the Project Plan to
      be Produced by ALTHEA

              


      

    

     

    
      
        	
              	
                1.14

              	
                IMPROVEMENTS means
      Technology invented, discovered or developed on or after the Effective
      Date.

              


      

    

     

    
      
        	
              	
                1.15

              	
                IND shall mean an
      Investigational New Drug Exemption Application for Company Plasmid DNA, as
      defined in the United States Food and Drug Administration (FDA) rules and
      regulations, 21 CFR.

              


      

    

     

    ALTHEA
CONFIDENTIAL

     

    
      
        
        

      

      
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    CONFIDENTIAL TREATMENT REQUESTED FOR
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                1.16

              	
                LABELING
      shall mean all labels and other written, printed, or graphic matter
      upon: (i) Company Plasmid DNA or any container, carton, or wrapper
      utilized with Company Plasmid DNA or (ii) any written material
      accompanying Company Plasmid
DNA.

              


      

    

     

    
      
        	
              	
                1.17

              	
                MASTER
      BATCH RECORD (MBR) shall mean the formal set of instructions for
      Production of Company Plasmid DNA. The MBR shall be developed and
      maintained in ALTHEA’s standard format by ALTHEA, using CLIENT’s master formula and
      technical support.

              


      

    

     

    
      
        	
              	
                1.18

              	
                PRODUCTION
      or PRODUCE
      shall mean all steps and activities necessary to produce Company
      Plasmid DNA in final form, including without limitation the formulation,
      filling, packaging, inspection, Labeling, testing, quality control and
      release of Company Plasmid DNA by ALTHEA in accordance with this
      Agreement.

              


      

    

     

    
      
        	
              	
                1.19

              	
                PRODUCTION
      PROCESS shall mean the process for Producing the Company Plasmid
      DNA.

              


      

    

     

    
      
        	
              	
                1.20

              	
                PRODUCT
      SPECIFICATION SHEET shall mean a listing of the analytical testing
      and corresponding Specifications, to be performed on the Company Plasmid
      DNA in connection with the release program. The PRODUCT
      SPECIFICATION SHEET is detailed in the Project
  Plan.

              


      

    

     

    
      
        	
              	
                1.21

              	
                PURCHASE
      PRICE shall mean the amount to be paid by CLIENT as specified in
      the Project Plan.

              


      

    

     

    
      
        	
              	
                1.22

              	
                QUALITY
      AGREEMENT shall mean an agreement between ALTHEA and CLIENT that
      defines the quality roles and responsibilities of each
    party.

              


      

    

     

    
      
        	
              	
                1.23

              	
                REGULATORY
      AUTHORITY shall mean those agencies or authorities responsible for
      regulation of Company Plasmid DNA in the United States and overseas.
      ALTHEA shall have no obligation to Produce Company Plasmid DNA in
      compliance with the requirements of a Regulatory Authority not specified
      in the applicable Proposal.

              


      

    

     

    
      
        	
              	
                1.24

              	
                RELEASED
      EXECUTED BATCH RECORD shall mean the completed batch record and
      associate deviation reports, investigation reports, and Certificates of
      Analysis created for each Batch of Company Plasmid
  DNA.

              


      

    

     

    
      
        	
              	
                1.25

              	
                SPECIFICATIONS shall
      mean those specifications set forth in Product Specification Sheet and the
      Master Batch Record for Company Plasmid DNA, and to the extent that ALTHEA
      is required to test the Bulk Drug Substance, for the Bulk Drug
      Substance.

              


      

    

     

    
      
        	
              	
                1.26

              	
                TECHNOLOGY
      means all methods, techniques, trade secrets, copyrights, know-how,
      data, regulatory submissions, and other intellectual property of any kind
      owned by or licensed to CLIENT or ALTHEA, either alone or jointly,
      relating to or necessary or useful for the Production of Company Plasmid
      DNA.

              


      

    

     

    ALTHEA
CONFIDENTIAL

     

    
      
        
        

      

      
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    CONFIDENTIAL TREATMENT REQUESTED FOR
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    Article
2, PERFORMANCE OF OBLIGATIONS.

     

    
      
        	
              	
                2.1

              	
                Initiation: Upon
      execution of this Agreement and the corresponding Project Plan for
      Production of Company Plasmid DNA, ALTHEA shall commence Development of
      such Company Plasmid DNA pursuant to the timeline, amounts and
      specifications as set forth in the Project Plan and as modified from time
      to time by mutual agreement of the
parties.

              


      

    

     

    
      
        	
              	
                2.2

              	
                Performance: ALTHEA
      shall perform its obligations under this Agreement in accordance with the
      terms and conditions of this Agreement, and the applicable Project Plan as
      amended by any effective Change
Orders.

              


      

    

     

    
      
        	
              	
                2.3

              	
                Faclility: ALTHEA shall
      perform all production at the Facility, and shall hold at such facility
      all equipment, components and other items to be used in Production. ALTHEA
      shall maintain at its own expense, the Facility and all equipment required
      for the Production of Company Plasmid DNA in a state of repair and
      operating efficiency consistent with the requirements of cGMP and
      applicable law.

              


      

    

     

    
      
        	
              	
                2.4

              	
                Cleaning and Maintenance:
      ALTHEA shall perform appropriate cleaning under a cleaning
      validation protocol for equipment and Facilities used to Produce cGMP
      batches of Company Plasmid DNA in compliance with cGMP and ALTHEA standard
      operating procedures (SOPs).

              


      

    

     

    
      
        	
              	
                2.5

              	
                Validation: ALTHEA shall
      be responsible for all validation of the Facility, equipment and cleaning
      processes under existing cleaning validation protocols used to Produce
      cGMP batches of the Company Plasmid
DNA.

              


      

    

     

    
      
        	
              	
                2.6

              	
                Documentation: The
      Master Batch Record shall be reviewed and approved by ALTHEA and by CLIENT
      prior to commencement of Production. Any material change to an approved
      Master Batch Record will be reviewed and approved by ALTHEA and by CLIENT
      prior to said change being implemented. Each Batch of Company Plasmid DNA
      shall be Produced by using a copy of the Master Batch Record. Each copy of
      the Master Batch Record for such Batch of Company Plasmid DNA shall be
      assigned a unique batch number. Any deviation from the manufacturing
      process specified in the Master Batch Record must be documented in the
      copy of the Master Batch Record for that Batch. ALTHEA shall provide
      CLIENT with required supporting Development and Production documentation
      in a form reasonably suitable for CLIENT’s submission to the
      FDA.

              


      

    

     

    
      
        	
              	
                2.7

              	
                CHANGE ORDER: If the
      scope of work of the Project Plan changes, then the applicable Project
      Plan may be amended as provided in this section. In the event a required
      modification of the Project Plan is identified by CLIENT or ALTHEA, ALTHEA
      shall provide CLIENT with a Change Order containing a description of the
      required modifications and their effect on the scope, fees and timelines
      specified in the Project Plan (“Change Order”) and will use reasonable
      efforts to do so as soon as practicable. No Change Order will be effective
      unless and until, it has been signed by authorized representatives of both
      parties.

              


      

    

     

    ALTHEA
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    CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

     

     

    
      
        	
              	
                2.8

              	
                Delays in Production:
      ALTHEA shall promptly notify CLIENT in writing if it believes that
      there are likely to be substantial changes in the work schedule contained
      in the Proposal. Such notice shall include the reasons for such changes in
      the schedule and the proposed new schedule for the incomplete portion of
      the Proposal. The party responsible for delays in Production shall be
      determined as follows:

              


      

    

     

    a.  CLIENT is
responsible for delays due to lack of delivery of critical information or
materials in a timely manner to ALTHEA as agreed to in advance

     

    b.  CLIENT is
responsible for delays caused by variable performance of raw materials specified
in advance

     

    d.  ALTHEA is
responsible for delays due to its Facility or compliance systems

     

    e.  ALTHEA is
responsible for complete execution of Production methods as outlined or approved
in advance or in Master Batch Records and responsible for delays due to
inaccurate execution of the Production methods as outlined in advance or in
Master Batch Records. 

     

    f.  Althea is
responsible for delays due to lack of delivery of all materials save the
materials as detailed in section 2.4.a.

     

    
      
        	
              	
                2.9

              	
                Vendor and Supplier Audit and
      Certification: CLIENT will not provide ALTHEA with prior approval
      of ALTHEA’s vendors or suppliers. ALTHEA will be responsible and
      accountable for all actions or omissions by its chosen vendors and
      suppliers. The CLIENT accepts the selection of materials and Components as
      specified in the Project
Plan.

              


      

    

     

    
      
        	
              	
                2.10

              	
                Delivery Terms: ALTHEA
      shall ship all Company Plasmid DNA to CLIENT or to CLIENT’s designated
      consignee. All shipments shall be shipped FCA the Facility by a common
      carrier designated by CLIENT, at CLIENT’s expense; provided,
      however, ALTHEA shall be responsible for the loading of the Company
      Plasmid DNA on departure and shall bear risk of loss and all costs of such
      loading. CLIENT shall procure, at its cost, insurance covering damage or
      loss of Company Plasmid DNA during shipping. All shipping instructions of
      CLIENT shall provide ALTHEA with the name and address of the recipient and
      the desired arrival date of Company Plasmid DNA. ALTHEA shall package the
      Company Plasmid DNA as per CLIENT instructions. Such packaging shall be at
      ALTHEA’s expense.

              


      

    

     

    
      
        	
              	
                2.11

              	
                Exporter of Record:
      CLIENT shall be the exporter of record for any Product shipped out
      of the United States, as CLIENT remains the owner of the
      Product.  CLIENT warrants that all shipments of Product exported
      from the United States will be made in compliance with all applicable
      United States export laws and regulations and all applicable import laws
      and regulations into the country of
deportation.

              


      

    

     

    CLIENT
shall be responsible for obtaining and paying for any licenses or other
governmental authorization(s) necessary for the exportation from the United
States. CLIENT shall select and pay the freight forwarder who shall solely be
CLIENT’s agent.
CLIENT and its freight forwarder shall be solely responsible for preparing and
filing the Shipper’s Export Declaration and any other documentation required for
the export.

     

    ALTHEA
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    CONFIDENTIAL
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              2.12

            	
              Foreign Corrupt Practices Act.
      CLIENT acknowledges that it is not the agent of ALTHEA and
      represents and warrants that it has not, and covenants that it will not,
      pay anything of value to any government employee in connection with the
      resale of the Product.

            


    

     

    
      	
               
      

            	
              2.13

            	
              Deposits and Payment for
      Company Plasmid DNA Production: Pursuant to the execution of this
      Agreement, and the Project Plan and subject to performance of a
      satisfactory preliminary audit by CLIENT, CLIENT shall pay ALTHEA [***]
      described in the Project Plan as a pre-payment. Thereafter, ALTHEA will
      invoice CLIENT upon completion of each project activity as outlined in
      Project Plan. CLIENT shall pay all invoices [***]. Any payment due under
      this Agreement not received within the times noted above shall bear
      interest at the lesser of (a) the maximum rate permitted by law, and (b)
      [***].

            


    

     

    
      
        	
              	
                2.12

              	
                Default in Payment Obligations:
      In addition to all other remedies available to ALTHEA in the event
      of a CLIENT default, if CLIENT fails to make payments as required
      hereunder, ALTHEA may take appropriate measures to assure prompt and full
      payment, including refuse to Produce any Company Plasmid DNA until
      CLIENT’s account is paid in
      full, modify the foregoing terms of payment, place the account on a letter
      of credit basis, require full or partial payment in advance, suspend
      deliveries of Company Plasmid DNA until CLIENT provides assurance of
      performance reasonably satisfactory to ALTHEA, and/or take other
      reasonable means as ALTHEA may determine. However, Althea may resort to
      the aforementioned measures only after providing CLIENT with written
      notice of such default and only if said default is not cured by CLIENT
      within thirty (30) calendar days after receipt by the CLIENT of written
      notice of such default.

              


      

    

     

    
      	
            	
              2.13

            	
              Returns: Company Plasmid
      DNA returned by third parties is the responsibility of
    CLIENT.

            


    

     

    
      
        	
              	
                2.14

              	
                Total Price: the price
      as detailed in the Project Plan shall constitute the total amount payable
      by CLIENT to Althea for all services rendered, whether preformed directly
      or indirectly. Any additional fees must be agreed to in advance through a
      Change Order as described in Section 2.7
above.

              


      

    

    


    Article
3, TERM AND TERMINATION.

     

    
      
        	
              	
                3.1

              	
                Term: This Agreement
      shall commence on the date first above written and will continue until the
      Development and Production, as described in the Project Plan, have been
      completed, unless sooner terminated pursuant to Section 3.2 herein (the
      “Term”).

              


      

    

     

    
      
        	
              	
                3.2

              	
                Termination: This
      Agreement may be terminated at any time upon the occurrence of any of the
      following events:

              


      

    

     

    
      
        	
              	
                3.2.1

              	
                Termination for Breach:
      Either party may terminate this Agreement upon the breach of any
      provision of this Agreement by the other party if such breach is not cured
      by the breaching party within thirty (30) calendar days (or such
      additional time reasonably necessary to cure such default provided the
      breaching party has commenced a cure within the thirty (30) day period and
      is diligently pursuing completion of such cure) after receipt by the
      breaching party of written notice of such default. At the option of the
      non-breaching party, such termination may be with respect to the entire
      Agreement, or only with respect to the aspect of the Company Plasmid DNA
      production project that is subject to the
  breach.

              


      

    

     

    ALTHEA
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                3.2.2

              	
                Termination for Financial
      Matters: This Agreement may be terminated immediately by either
      party by giving the other party written notice thereof in the event such
      other party makes a general assignment for the benefit of its creditors,
      or proceedings of a case are commenced in any court of competent
      jurisdiction by or against such party seeking (a) such party’s
      reorganization, liquidation, dissolution, arrangement or winding up, or
      the composition or readjustment of its debts, (b) the appointment of a
      receiver or trustee for or over such party’s property, or (c) similar
      relief in respect of such party under any law relating to bankruptcy,
      insolvency, reorganization, winding up or composition or adjustment of
      debt, and such proceedings shall continue undismissed, or an order with
      respect to the foregoing shall be entered and continue unstated, for a
      period of more than sixty (60)
days.

              


      

    

     

    
      
        	
                
                

              	
                3.3

              	
                Payment on Termination:
      In the event of cancellation by CLIENT of the Production Activities
      set forth in a Project Plan or in the event of termination of this
      Agreement, [***].

              


      

    

     

    
      
        	
              	
                3.4

              	
                Refund on Termination:
      In the event of termination of this Agreement as a result of any
      breach or default by Althea, CLIENT shall be entitled to
      [***].

              


      

    

     

    
      
        	
              	
                3.5

              	
                Survival: Termination,
      expiration, cancellation or abandonment of this Agreement through any
      means or for any reason, except as set forth in Section 12.1, shall be
      without prejudice to the rights and remedies of either party with respect
      to any antecedent breach of any of the provisions of this Agreement. The
      provisions of Sections 3, 6, 9, 10, 11, 12, 13, 14, and 15 hereof shall
      survive expiration or termination of this
  Agreement.

              


      

    

     

    Article
4, CERTIFICATES OF ANALYSIS AND MANUFACTURING COMPLIANCE.

     

    
      
        	
              	
                4.1

              	
                Certificates of Analysis:
      At CLIENT’s cost and expense
      as detailed in the Project Plan, ALTHEA shall test, or cause to be tested
      by third parties, in accordance with the Specifications, each Batch of
      Company Plasmid DNA Produced pursuant to this Agreement before delivery to
      CLIENT. A certificate of analysis for each Batch delivered shall set forth
      the items tested, Specifications, and test results. ALTHEA shall also
      indicate on the final page of the Executed Batch Record that all batch
      Production and control records have been reviewed and approved by the
      appropriate quality control unit. ALTHEA shall send, or cause to be sent,
      such certificates to CLIENT prior to the shipment of Company Plasmid DNA
      (unless Company Plasmid DNA is shipped under quarantine). CLIENT shall
      test, or cause to be tested, for final release, each Batch of Company
      Plasmid DNA as meeting the Specifications. As required by the FDA (see
      Section 5.2 below), CLIENT assumes full responsibility for final release
      of each Batch of Company Plasmid
DNA.

              


      

    

     

    ALTHEA
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                4.2

              	
                Manufacturing Compliance:
      ALTHEA shall advise CLIENT immediately if an authorized agent of
      any regulatory body visits ALTHEA’s manufacturing facility and makes an
      inquiry regarding ALTHEA’s Production of Company Plasmid DNA for CLIENT.
      Manufacturing deviations and investigations which occur during Production
      of Company Plasmid DNA and which do not cause the Production to be
      non-compliant with cGMP or with specifications, shall not be deemed to
      cause such Company Plasmid DNA to be
  non-conforming.

              


      

    

     

    
      
        	
              	
                4.3

              	
                Reserve Samples: CLIENT
      shall be responsible for obtaining and maintaining sufficient quantities
      of Company Plasmid DNA reserve samples in accordance with
      cGMP.

              


      

    

     

    
      
        	
              	
                4.5

              	
                Distribution Records:
      ALTHEA shall maintain distribution records that contain all of the
      appropriate information as specified in
cGMP.

              


      

    

     

    
      
        	
              	
                4.6

              	
                Customer Complaints:
      CLIENT, as required by cGMP, shall maintain complaint files. All
      specific CLIENT Company Plasmid DNA-related complaints received by ALTHEA
      shall be forwarded to CLIENT. CLIENT shall be responsible for the review
      of the complaint to determine the need for an investigation or the need to
      report to the FDA as required by cGMP. CLIENT shall send to ALTHEA all
      Company Plasmid DNA performance or manufacturing-related complaints which
      require investigation. ALTHEA shall conduct an investigation for each
      Company Plasmid DNA performance or manufacturing-related complaint and
      shall report findings and follow-up of each investigation to CLIENT.
      CLIENT shall make these complaint files available to ALTHEA in the event
      they are required during an FDA
inspection.

              


      

    

     

    
      
        	
              	
                4.7

              	
                Audits: CLIENT, upon
      prior written notice and during normal business hours, shall have the
      right to inspect, twice annually for not more than two (2) days, ALTHEA
      batch records and the portions of ALTHEA’s facility used for Production of
      Company Plasmid DNA. If CLIENT chooses to audit ALTHEA more than two (2)
      times in a calendar year or for more than two (2) days, CLIENT agrees to
      reimburse ALTHEA for ALTHEA’s reasonable expenses incurred in hosting the
      audit. All audited data will be treated as Confidential Information of
      ALTHEA and CLIENT shall not be permitted to remove or copy data without
      ALTHEA’s prior consent. Althea will make its best efforts in order to
      comply with CLIENT’s observations and
comments.

              


      

    

     

    
      
        	
              	
                4.8

              	
                Regulatory Compliance:
      Unless otherwise stated, ALTHEA is responsible for compliance with
      all Federal, State and local laws and regulations (“Regulations”) as they
      apply generally to Production of pharmaceutical products. CLIENT shall be
      responsible for compliance with all Regulations as they apply to all other
      aspects of the use, and sale of Company Plasmid DNA, which responsibility
      shall include, without limitation, all contact with the FDA regarding the
      foregoing.

              


      

    

     

    ALTHEA
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    CONFIDENTIAL
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    Article
5, ACCEPTANCE OF COMPANY PLASMID DNA.


     

    
      	
               
      

            	
              5.1

            	
              Non-Conforming Company Plasmid
      DNA: Upon ALTHEA’s release of either a GMP or non-GMP batch of
      Company Plasmid DNA, ALTHEA shall provide CLIENT, or CLIENT’s designee, copies
      of Master 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 ALTHEA. Within thirty (30) calendar days after
      receipt by CLIENT of the documentation, CLIENT shall determine whether
      Company Plasmid DNA conforms to Specifications and has been manufactured
      in accordance with the Master Batch Record, ALTHEA’s current SOPs, and the
      Proposal.

            


    

     

    
      
        	
              	
                5.1.1

              	
                If
      (a) any Batch of Company Plasmid DNA conforms to the Product Requirements,
      or (b) CLIENT fails to notify ALTHEA within the applicable time period
      that any Batch of Company Plasmid DNA does not conform to the Product
      Requirements, then CLIENT shall be deemed to have accepted the Company
      Plasmid DNA and waived its right to revoke
  acceptance.

              


      

    

     

    
      
        	
              	
                5.1.2

              	
                If
      CLIENT believes any Batch of Company Plasmid DNA does not conform to the
      Product Requirements, it shall notify ALTHEA by telephone, including a
      detailed explanation of the non-conformity, and shall confirm such notice
      in writing via overnight delivery to ALTHEA. Upon receipt of such notice,
      ALTHEA will investigate such alleged non-conformity, and (i) if ALTHEA
      agrees such Company Plasmid DNA is non-conforming, deliver to CLIENT a
      corrective action plan within thirty (30) calendar days after receipt of
      CLIENT’s written notice of
      non-conformity, or such additional time as is reasonably required if such
      investigation or plan requires data from sources other than CLIENT or
      ALTHEA, or (ii) if ALTHEA disagrees with CLIENT’s determination that
      the Batch of Company Plasmid DNA is non-conforming, ALTHEA shall so notify
      CLIENT by telephone within the thirty (30) calendar day period provide
      Client with evidence to substantiate its claim as well as confirm such
      notice in writing by overnight
delivery.

              


      

    

     

    
      
        	
              	
                5.1.3

              	
                If
      the parties dispute whether Company Plasmid DNA is conforming or
      non-conforming, samples of the Batch of Company Plasmid 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 that deemed to be in the wrong shall bear the costs of such
      laboratory or consultant

              


      

    

     

    
      
        	
              	
                5.2

              	
                Remedies for Non Conforming
      Product: In the event ALTHEA agrees that the Batch of Company
      Plasmid DNA is non-conforming in whole or in part as a result of the
      negligence of ALTHEA or the laboratory determines that the shipment of
      Company Plasmid DNA is non-conforming in whole or in part as a result of
      the negligence of ALTHEA, then CLIENT, at its option, shall either (i)
      allow ALTHEA at its expense to replace such non-conforming Company Plasmid
      DNA within forty-five (45) calendar days from the date product is
      determined to be non-conforming, or (ii) be granted a full
      refund of the total Purchase Price of Company Plasmid DNA as stated in the
      Project Plan which includes all services provided by ALTHEA directly or
      indirectly in Production of Company Plasmid DNA. In addition, the due date
      for the final invoice issued at completion of production of Company
      Plasmid DNA will be extended until the date at which replacement Company
      Plasmid DNA is released and determined to be conforming by ALTHEA and
      CLIENT.

              


      

    

     

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    Article 6, COMPANY PLASMID DNA
RECALLS.

     

    
      
        	
              	
                6.1

              	
                Company Plasmid DNA Recalls:
      In the event CLIENT shall be required to recall any Company Plasmid
      DNA because such Company Plasmid DNA may violate local, state or federal
      laws or regulations, the laws or regulations of any applicable foreign
      government or agency or the Company Plasmid DNA Specifications, or in the
      event that CLIENT elects to institute a voluntary recall, CLIENT shall be
      responsible for coordinating such recall. CLIENT promptly shall notify
      ALTHEA if any Company Plasmid DNA is the subject of a recall and provide
      ALTHEA with a copy of all documents relating to such recall. ALTHEA shall
      cooperate with CLIENT in connection with any recall, at CLIENT’s expense. CLIENT
      shall be responsible for all of the costs and expenses of such
      recall.

              


      

    

    


    Article 7, FORCE MAJEURE; FAILURE TO
SUPPLY.

     

    
      
        	
              	
                7.1

              	
                Force Majeure Events:
      Failure of either party to perform under this Agreement shall not
      subject such party to any liability to the other if such failure is caused
      by acts of God, acts of terrorism, fire, explosion, flood, drought, war,
      riot, sabotage, embargo, strikes or other labor trouble, all which are
      beyond said party’s control, or by any cause beyond the reasonable control
      of the affected party, whether or not foreseeable, provided that written
      notice of such event is promptly given to the other party. It is agreed
      that the actions of any government entity performing its duties shall not
      be deemed Force Majeure

              


      

    

     

    
      
        	
              	
                7.2

              	
                Default as a result of Force
      Majeure Events: If a Party fails to meets its obligations as a result of Force Majeure
      Events, the other Party may require said Party meet its obligation,
      in whole or in part at a future date agreed upon in good faith by both
      Parties ALTHEA and CLIENT.

              


      

    

    


    Article 8, CHANGES IN
PRODUCTION.

     

    
      
        	
              	
                8.1

              	
                Changes to Master Batch Records
      and Product Specifications: ALTHEA agrees to inform CLIENT within
      fifteen (15) days of the result of any regulatory development or
      regulatory changes to Company Plasmid DNA-specific SOPs that materially
      affect the Production of Company Plasmid DNA. ALTHEA shall notify CLIENT
      of and require written approval from CLIENT for changes to Master Batch
      Records and Company Plasmid DNA Specifications prior to the Production of
      subsequent Batches of Company Plasmid
DNA.

              


      

    

     

    
      
        	
              	
                8.2

              	
                Product-Specific Changes:
      For the initial Production of Company Plasmid DNA under this
      Agreement, no facility, equipment, process or system changes that are
      required of ALTHEA as a result of requirements set forth by the FDA or any
      other Regulatory Authority shall affect time line and price. For any
      subsequent Production, if facility, equipment, process or system changes
      that are required of ALTHEA as a result of requirements set forth by the
      FDA or any Regulatory Authority, any such regulatory changes which apply
      solely to the Production and supply of one or more Company Plasmid DNAs,
      then CLIENT and ALTHEA will review such requirements and agree in writing
      to such regulatory changes, and agree on additional cost to CLIENT. If an
      agreement as to the additional cost to CLIENT is not reached then this
      agreement may be terminated by either Party. In case of termination in
      accordance with this section CLIENT will be entitled to a refund of all
      moneys paid to ALTHEA. It is agreed that termination under this section is
      not subject to section 3.3.

              


      

    

     

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    Article
9, CONFIDENTIALITY.

     

    
      
        	
              	
                9.1

              	
                Confidentiality: It is
      contemplated that in the course of the performance of this Agreement each
      party may, from time to time, disclose Confidential Information to the
      other. Each party agrees to take all reasonable steps to prevent
      disclosure of Confidential Information to third parties. No provision of
      this Agreement shall be construed so as to preclude disclosure of
      Confidential Information as may be reasonably necessary to secure from any
      governmental agency necessary approvals or licenses or to obtain patents
      with respect to the Company Plasmid
DNA.

              


      

    

     

    
      
        	
              	
                9.2

              	
                Prior Confidentiality
      Agreement: This Agreement, by reference, incorporates the
      Confidentiality Agreement signed by BioCancell Therapeutics Inc., the
      CLIENT’s parent company,
      and its Affiliated Companies, including the CLIENT, as defined therein,
      and ALTHEA on December 11, 2006, and is made a part hereof as though fully
      set forth herein. The Prior Confidentiality Agreement is enclosed herein
      as Appendix 2.

              


      

    

     

    
      
        	
              	
                9.3

              	
                Third Party Disclosure:
      ALTHEA shall be permitted to disclose Company Plasmid DNA
      information to third party developmental and analytical service providers
      in connection with performance of its obligations hereunder provided such
      providers shall be subject to confidentiality agreements. Either party may
      disclose Confidential Information of the disclosing party to those
      Affiliates, agents and consultants who need to know such information to
      accomplish the purposes of this Agreement (collectively, “Permitted
      Recipients”); provided such Permitted Recipients are bound to maintain
      such Confidential Information in
confidence.

              


      

    

     

    
      
        	
              	
                9.4

              	
                Litigation and Governmental
      Disclosure: Each party may disclose Confidential Information
      hereunder to the extent such disclosure is reasonably necessary for
      defending litigation, complying with applicable governmental regulations
      or conducting pre-clinical or clinical trials, provided that if a party is
      required by law or regulation to make any such disclosure of the other
      party’s Confidential Information it will, except where impractical for
      necessary disclosures, for example in the event of a medical emergency,
      give reasonable advance notice to the other party of such disclosure
      requirement and will use good faith efforts to assist such other party to
      secure a protective order or confidential treatment of such Confidential
      Information required to be
disclosed.

              


      

    

     

    
      
        	
              	
                9.5

              	
                Limitation of Disclosure:
      The parties agree that, except as otherwise may be required by
      applicable laws, regulations, rules or orders, including without
      limitation the rules and regulations promulgated by the United States
      Securities and Exchange Commission, and except as may be authorized in
      Section 9.4, no information concerning this Agreement and the transactions
      contemplated herein shall be made public by either party without the prior
      written consent of the other.

              


      

    

     

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                9.6

              	
                Publicity and SEC Filings.
      The parties agree that the public announcement of the execution of
      this Agreement shall only be by one or more press releases mutually agreed
      to by the parties by way of written consent prior to publication. Each
      party agrees that it shall cooperate fully and in a timely manner with the
      other with respect to all disclosures to the Securities and Exchange
      Commission and any other governmental or regulatory agencies, including
      requests for confidential treatment of Confidential Information of either
      party included in any such
disclosure.

              


      

    

     

    
      
        	
              	
                9.7

              	
                Duration of Confidentiality:
      All obligations of confidentiality and non-use imposed upon the
      parties under this Agreement shall expire ten (10) years after the
      expiration or earlier termination of this Agreement; provided, however,
      that Confidential Information which constitutes the trade secrets of a
      party shall be kept confidential indefinitely, subject to the limitations
      set forth in Sections 9.4 through
9.5.

              


      

    

     

    Article
10, INVENTIONS.

     

    
      	
               
      

            	
              10.1

            	
              Existing Intellectual Property:
      Except as the parties may otherwise expressly agree in writing,
      each party shall continue to own its existing patents, trademarks,
      copyrights, trade secrets and other intellectual property, without
      conferring any interests therein on the other party. Without limiting the
      generality of the preceding sentence, CLIENT shall retain all right, title
      and interest arising under the United States Patent Act, the United States
      Trademark Act, the United States Copyright Act and all other applicable
      laws, rules and regulations in and to all Drug Products, Bulk Drug
      Substance, Labeling and trademarks associated therewith (collectively,
      “CLIENT’s Intellectual
      Property”). Neither ALTHEA nor any third party shall acquire any right,
      title or interest in CLIENT’s Intellectual
      Property by virtue of this Agreement or otherwise, except to the extent
      expressly provided herein.

            


    

     

    
      	
               
      

            	
              10.2

            	
              Individually Owned Inventions:
      Except as the parties may otherwise agree in writing, all
      Inventions (as defined herein) which are conceived, reduced to practice,
      or created by a party in the course of performing its obligations under
      this Agreement shall be solely owned and subject to use and exploitation
      by the inventing party without a duty to account to the other party. For
      purposes of this Agreement, “Invention” shall mean information relating to
      any innovation, improvement, development, discovery, computer program,
      device, trade secret, method, know-how, process, technique or the like,
      whether or not written or otherwise fixed in any form or medium,
      regardless of the media on which contained and whether or not patentable
      or copyrightable.

            


    

     

    
      	
               
      

            	
              10.3

            	
              Jointly Owned Inventions:
      All Inventions which are conceived, reduced to practice, or created
      jointly by the parties and/or their respective agents (i.e., employees or
      agents who would be or are properly named as co-inventors under the laws
      of the United States on any patent application claiming such inventions)
      in the course of the performance of this Agreement shall be owned jointly
      by the parties. Each party shall have full rights to exploit such
      Inventions for its own commercial purposes without any obligation to the
      other. The parties shall share equally in the cost of mutually agreed
      patent filings with respect to all such jointly owned Inventions. The
      decision to file for patent coverage on jointly owned Inventions shall be
      mutually agreed upon, and the Parties shall select a mutually acceptable
      patent counsel to file and prosecute patent applications based on such
      joint Inventions.

            


    

     

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              10.4

            	
              Disclaimer: Except as
      otherwise expressly provided herein, nothing contained in this Agreement
      shall be construed or interpreted, either expressly or by implication,
      estoppel or otherwise, as: (i) a grant, transfer or other conveyance by
      either party to the other of any right, title, license or other interest
      of any kind in any of its Inventions or other intellectual property, (ii)
      creating an obligation on the part of either party to make any such grant,
      transfer or other conveyance or (iii) requiring either party to
      participate with the other party in any cooperative development program or
      project of any kind or to continue with any such program or
      project.

            


    

     

    
      	
               
      

            	
              10.5

            	
              Rights in IP: The party owning any
      IP shall have the world wide right to control the drafting, filing,
      prosecution and maintenance of patents covering the Inventions relating to
      such IP, including decisions about the countries in which to file patent
      applications. Patent costs associated with the patent activities described
      in this Section shall be borne by the sole owner. Each party will
      cooperate with the other party in the filing and prosecution of patent
      applications. Such cooperation will include, but not be limited to,
      furnishing supporting data and affidavits for the prosecution of patent
      applications and completing and signing forms needed for the prosecution,
      assignment and maintenance of patent
  applications.

            


    

     

    
      	
               
      

            	
              10.6

            	
              Confidentiality of
      IP: IP
      shall be deemed to be the Confidential Information of the party owning
      such IP. The protection of each party’s Confidential Information is
      described in Article 9. Any disclosure of information by one party to the
      other under the provisions of this Section 10 shall be treated as the
      disclosing party’s Confidential Information under this Agreement. It shall
      be the responsibility of the party preparing a patent application to
      obtain the written permission of the other party to use or disclose the
      other party’s Confidential Information in the patent application before
      the application is filed and for other disclosures made during the
      prosecution of the patent
application.

            


    

    


    Article
11, REPRESENTATIONS AND WARRANTIES.

     

    
      	
               
      

            	
              11.1

            	
              Mutual Representations:
      Each party hereby represents and warrants to the other party that
      (a) the person executing this Agreement is authorized to execute this
      Agreement; (b) this Agreement is legal and valid and the obligations
      binding upon such party are enforceable by their terms; and (c) the
      execution, delivery and performance of this Agreement does not conflict
      with any agreement, instrument or understanding, oral or written, to which
      such party may be bound, nor violate any law or regulation of any court,
      governmental body or administrative or other agency having jurisdiction
      over it.

            


    

     

    
      	
               
      

            	
              11.2

            	
              ALTHEA Warranty: ALTHEA
      represents and warrants that a) Company Plasmid DNA shall be Produced in
      accordance with cGMP. ALTHEA represents and warrants that it has obtained
      (or will obtain prior to Producing Company Plasmid DNA), and will remain
      in compliance with during the term of this Agreement, all permits,
      licenses and other authorizations (the “Permits”) which are required under
      federal, state and local laws, rules and regulations applicable to the
      Production only of Company Plasmid DNA as specified in the Project Plan;
      provided, however, ALTHEA shall have no obligation to obtain Permits
      relating to the sale, marketing, distribution or use of Company Plasmid
      DNA or with respect to the Labeling of Company Plasmid DNA. ALTHEA makes
      no representation or warranty with respect to the sale, marketing,
      distribution or use of the product or as to printed materials supplied by
      CLIENT or its consignee; b) it has the right to implement the Production
      Process and that it has no knowledge of any patents or other intellectual
      rights that would be infringed by Production of Company Plasmid DNA under
      this Agreement, or proprietary rights of third parties which are violated
      by ALTHEA’s performance of the Production Process; c) It has know-how,
      required expertise, experience, has reviewed the product and believes it
      is able to meet specifications and supply it in accordance with time table
      specified in the Proposal.

            


    

     

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              11.3

            	
              Disclaimer of Warranties:
      Except for those warranties set forth in Sections 11.1 and 11.2 of
      this Agreement, ALTHEA makes no warranties, written, oral, express or
      implied, with respect to Company Plasmid DNA or the Development and
      Production of Company Plasmid DNA. ALL OTHER WARRANTIES, EXPRESS OR
      IMPLIED, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
      MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT
      HEREBY ARE DISCLAIMED BY ALTHEA. NO WARRANTIES OF ALTHEA MAY BE CHANGED BY
      ANY REPRESENTATIVES OF ALTHEA. CLIENT accepts Company Plasmid DNA subject
      to the terms hereof.

            


    

     

    
      	
               
      

            	
              11.4

            	
              CLIENT Warranties:
      CLIENT warrants that (a) it has the right to give ALTHEA any
      information provided by CLIENT hereunder, and that ALTHEA has the right to
      use such information for the Production of Company Plasmid DNA, and (b)
      CLIENT has no knowledge of any (i) patents or other intellectual rights
      that would be infringed by ALTHEA’s Production of Company Plasmid DNA
      under this Agreement, or (ii) proprietary rights of third parties which
      would be violated by ALTHEA’s performance hereunder. CLIENT further
      warrants that the Bulk Drug Substance provided to ALTHEA hereunder (1)
      conforms to the Bulk Drug Substance Specifications and (2) is not
      adulterated or misbranded within the meaning of the FD&C
      Act.

            


    

    


    Article
12, LIMITATION OF LIABILITY AND WAIVER OF SUBROGATION.

     

    
      	
               
      

            	
              12.1

            	
              Limitation of Liability:
      CLIENT’s sole and exclusive
      remedy for breach of this Agreement is limited to those remedies set forth
      in Article 5 [***] as stated in the Project Plan. Under no
      circumstances shall ALTHEA be liable for loss of use or profits or other
      collateral, special, consequential or other damages, losses, or expenses,
      including but not limited to the cost of cover or the cost of a recall in
      connection with, or by reason of the Production and delivery of Company
      Plasmid DNA under this Agreement whether such claims are founded in tort
      or contract. All claims by CLIENT for breach or default under this
      Agreement shall be brought within one (1) year after the cause of action
      accrued or shall be deemed waived.

            


    

     

    
      	
               
      

            	
              12.2

            	
              Waiver of Subrogation:
      All ALTHEA Supplied materials and equipment used by ALTHEA in the
      Production of Company Plasmid DNA (collectively, “ALTHEA Property”) shall
      at all times remain the property of ALTHEA and ALTHEA assumes risk of loss
      for such property until delivery of Company Plasmid DNA to a common
      carrier as specified under Section 2.10. ALTHEA hereby waives any and all
      rights of recovery against CLIENT and its Affiliates, and against any of
      their respective directors, officers, employees, agents or
      representatives, for any loss or damage to ALTHEA Property to the extent
      the loss of damage is covered or could be covered by insurance (whether or
      not such insurance is described in this Agreement). CLIENT assumes all
      risk of loss for all CLIENT Supplied Materials, all Bulk Drug Substance
      supplied by CLIENT, and all Company Plasmid DNA [***] (collectively,
      “CLIENT Property”). CLIENT hereby waives any and all rights of recovery
      against ALTHEA and its Affiliates, and against any of their respective
      directors, officers, employees, agents or representatives, for any loss or
      damage to the CLIENT Property to the extent the loss of damage is covered
      or could be covered by insurance (whether or not such insurance is
      described in this Agreement).

            


    

     

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              12.3

            	
              Waiver of Claims: In
      connection with providing Development Services, ALTHEA represents only
      that it will use reasonable care in providing such information solely as
      it relates to development studies, formulation, primary packaging and
      manufacturing process development. ALTHEA makes no representation or
      warranty, and CLIENT expressly waives all claims against ALTHEA and its
      Affiliates, and any of their respective agents or employees, arising out
      of or in connection with any claims relating to the stability, efficacy,
      safety, or toxicity of Company Plasmid DNA developed, formulated, packaged
      or manufactured in accordance with the Development Services provided by
      ALTHEA.

            


    

     

    Article
13, INDEMNIFICATION.

     

    
      	
               
      

            	
              13.1

            	
              CLIENT Indemnification:
      CLIENT shall indemnify, defend and hold harmless ALTHEA and its
      Affiliates, and any of their respective directors, officers, employees,
      subcontractors and agents (collectively the “Indemnified Parties”) from
      and against any and all liabilities, obligations, penalties, claims,
      judgments, demands, actions, disbursements of any kind and nature, suits,
      losses, damages, costs and expenses (including, without limitation,
      reasonable attorney’s fees) arising out of or in connection with property
      damage or personal injury (including without limitation death) of third
      parties (collectively “Claims”) including without limitation Claims
      allegedly resulting solely from (a) CLIENT’s storage,
      promotion, labeling, marketing, distribution, use or sale of Bulk Drug
      Substance or Company Plasmid DNA, (b) CLIENT’s negligence or
      willful misconduct, (c) CLIENT’s breach of this
      Agreement, or (d) any claim that the use, sale, Production, marketing or
      distribution of Bulk Drug Substance or Company Plasmid DNA by ALTHEA or
      CLIENT violates the patent, trademark, copyright or other proprietary
      rights of any third party, except to the extent any of the foregoing (a)
      or (d) is caused in part by the negligence or willful misconduct of the
      Indemnified Parties or solely by the breach by ALTHEA of its obligations
      under this Agreement.

            


    

     

    
      	
               
      

            	
              13.2

            	
              ALTHEA Indemnification:
      ALTHEA shall indemnify, defend and hold harmless CLIENT and its
      Affiliates and any of their respective directors, officers, employees,
      subcontractors and agents from and against a) any and all Claims resulting
      solely from the Indemnified Parties’ negligence or willful misconduct, or
      b) any and all Claims resulting from the ALTHEA’s breach of its
      obligations under this Agreement, or c) any and all Claims resulting form
      Althea’s storage, promotion, labeling, marketing, distribution, use or
      sale of any of the materials required for the production process, or d)
      any and all Claims resulting from Althea’s violation of patent, trademark,
      copyright or other proprietary rights of any third
  party.

            


    

     

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              13.3

            	
              Indemnitee Obligations:
      A party (the “Indemnitee”) which intends to claim indemnification
      under this Article 13 shall promptly notify the other party (the
      “Indemnitor”) in writing of any action, claim or other matter in respect
      of which the Indemnitee or any of its Affiliates, or any of their
      respective directors, officers, employees, subcontractors, or agents,
      intend to claim such indemnification; provided, however, that failure to
      provide such notice within a reasonable period of time shall not relieve
      the Indemnitor of any of its obligations hereunder except to the extent
      the Indemnitor is prejudiced by such failure. The Indemnitee shall permit,
      and shall cause its Affiliates, and their respective directors, officers,
      employees, subcontractors and agents to permit, the Indemnitor, at its
      discretion, to settle any such action, claim or other matter, and the
      Indemnitee agrees to the complete control of such defense or settlement by
      the Indemnitor. Notwithstanding the foregoing, the Indemnitor shall not
      enter into any settlement that would adversely affect the Indemnitee’s
      rights hereunder, or impose any obligations on the Indemnitee in addition
      to those set forth herein, in order for it to exercise such rights,
      without Indemnitee’s prior written consent, which shall not be
      unreasonably withheld or delayed. No such action, claim or other matter
      shall be settled without the prior written consent of the Indemnitor,
      which shall not be unreasonably withheld or delayed. The Indemnitee, its
      Affiliates, and their respective directors, officers, employees,
      subcontractors and agents shall fully cooperate with the Indemnitor and
      its legal representatives in the investigation and defense of any action,
      claim or other matter covered by the indemnification obligations of this
      Article 13. The Indemnitee shall have the right, but not the obligation,
      to be represented in such defense by counsel of its own selection and at
      its own expense.

            


    

     

    
      	
               
      

            	
              13.4

            	
              Injunction: In the event
      that the Production or sale of a Company Plasmid DNA is enjoined due to
      alleged infringement by either party of the proprietary rights of a third
      party, such action shall be deemed a breach of this Agreement by said
      Party and subject to the terms of Article
3.

            


    

    


    Article
14, INSURANCE.

     

    
      	
               
      

            	
              14.1

            	
              CLIENT Insurance: CLIENT
      shall procure and maintain, during the Term of this Agreement and for a
      period one (1) year beyond the
      expiration date of Company Plasmid DNA, Commercial General Liability
      Insurance, including without limitation, Product Liability and Contractual
      Liability coverage (the “CLIENT Insurance”). The CLIENT Insurance shall
      cover amounts not less than [***] combined single limit and shall be
      with an insurance carrier reasonably acceptable to ALTHEA. ALTHEA shall be
      named as an additional insured on the CLIENT Insurance and CLIENT promptly
      shall deliver a certificate of CLIENT Insurance and endorsement of
      additional insured to ALTHEA evidencing such coverage. If CLIENT fails to
      furnish such certificates or endorsements, or if at any time during the
      Term of this Agreement ALTHEA is notified of the cancellation or lapse of
      the CLIENT Insurance, and CLIENT fails to rectify the same within ten (10)
      calendar days after notice from ALTHEA, in addition to all other remedies
      available to ALTHEA hereunder, ALTHEA, at its option, may obtain the
      CLIENT Insurance and CLIENT promptly shall reimburse ALTHEA for the cost
      of the same. Any deductible and/or self insurance retention shall be the
      sole responsibility of CLIENT.

            


    

     

    
      	
               
      

            	
              14.2

            	
              ALTHEA Insurance: ALTHEA
      shall procure and maintain, during the Term of this Agreement and for a
      period of one (1) year beyond the
      expiration date of Company Plasmid DNA, Commercial General Liability
      Insurance, including without limitation, Product Liability and Contractual
      Liability coverage (the “ALTHEA Insurance”). The ALTHEA Insurance shall
      cover amounts not less than [***] combined single limit. CLIENT shall
      be named as an additional insured on the ALTHEA Insurance and ALTHEA
      promptly shall deliver a certificate of ALTHEA Insurance and endorsement
      of additional insured to CLIENT evidencing such coverage. If ALTHEA fails
      to furnish such certificates or endorsements, or if at any time during the
      Term of this Agreement CLIENT is notified of the cancellation or lapse of
      the ALTHEA Insurance, and ALTHEA fails to rectify the same within ten (10)
      calendar days after notice from CLIENT, in addition to all other remedies
      available to CLIENT hereunder, CLIENT, at its option, may obtain the
      ALTHEA Insurance and ALTHEA promptly shall reimburse CLIENT for the cost
      of the same. Any deductible and/or self insurance retention shall be the
      sole responsibility of ALTHEA.

            


    

     

    ALTHEA
CONFIDENTIAL

     

    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

     

    CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

     

     

    Article
15, GENERAL PROVISIONS.


     

    
      	
               
      

            	
              15.1

            	
              Notices: All notices
      hereunder shall be delivered by facsimile (confirmed by overnight
      delivery), or by overnight delivery with a reputable overnight delivery
      service, to the following address of the respective
    parties:

            


    

     

    
      
        	
                If
      to CLIENT:

              	
                BioCancell
      Therapeutics Ltd.

              
	 
      	
                Beck
      Science Center, 8 Hartom St.

              
	 
      	
                Jerusalem,
      97775 Israel

              
	 
      	
                Attn:
      Ran Vigdor

              
	 
      	
                Director,
      Strategic Alliances

              
	 
      	Telephone:	
                +972-2-548-6555

              
	 
      	Facsimile: 	
                +972-2-548-6550

              


      

    

     

    
      
        
          	
                  If
      to ALTHEA:

                	
                  Althea
      Technologies, Inc.

                
	 
      	
                  11040
      Roselle Street

                
	 
      	
                  San
      Diego, CA 92121

                
	 
      	
                  [***]

                
	 
      	
                  [***]

                
	 
      	Telephone: 	
                  (858)
      882-0123

                
	 
      	Facsimile: 	
                  (858)
      882-0133

                


        

      

    

     

    
      For
specific inquiries, the following ALTHEA responsible parties may be contacted
directly:

       

      
        	
                Project
      Manager

              	
                [***]

              
	 
      	 
      
	
                
                  Quality
      Control and

                  Quality Assurance
      Manager

                

              	
                [***]

              
	 
      	 
      
	
                Materials
      Manager

              	
                [***]

              


      

    

     

    
      For
specific inquiries, the following CLIENT responsible parties may be contacted
directly:

    

    


    
      
        	
                Project
      Manager

              	
                Patricia
      Ohana

              
	 
      	 
      
	
                Quality
      Control Manager

              	
                Janet
      Ransom

              
	 
      	 
      
	
                Materials
      Manager

              	
                Patricia
      Ohana

              
	 
      	 
      
	
                Quality
      Assurance Manager

              	
                Janet
      Ransom, Nick Pomato

              


      

    

     

    Notices
shall be effective on the day following the date of transmission if sent by
facsimile, and on the second business day following the date of delivery to the
overnight delivery service if sent by overnight delivery. A party may change its
address listed above by notice to the other party given in accordance with this
section.


     

    
      	
               
      

            	
              15.2

            	
              Entire Agreement; Amendment:
      The parties hereto acknowledge that this Agreement sets forth the
      entire agreement and understanding of the parties and supercedes all prior
      written or oral agreements or understandings with respect to the subject
      matter hereof.  No modification of any of the terms of this
      Agreement, or any amendments thereto, shall be deemed to be valid unless
      in writing and signed by an authorized agent or representative of both
      parties hereto. No course of dealing or usage of trade shall be used to
      modify the terms and conditions
herein.

            


    

     

    ALTHEA CONFIDENTIAL


    
      
        
        

      

      
        17

        
          

        

      

      
        
        

      

    

     

    CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

     

     

    
      	
               
      

            	
              15.3

            	
              Waiver: None of the
      provisions of this Agreement shall be considered waived by any party
      hereto unless such waiver is agreed to, in writing, by authorized agents
      of both parties. The failure of a party to insist upon strict conformance
      to any of the terms and conditions hereof, or failure or delay to exercise
      any rights provided herein or by law shall not be deemed a waiver of any
      rights of any party hereto.

            


    

     

    
      	
               
      

            	
              15.4

            	
              Obligations to Third Parties:
      Each party warrants and represents that this Agreement is not
      inconsistent with any contractual obligations, expressed or implied,
      undertaken with any third party.

            


    

     

    
      	
               
      

            	
              15.5

            	
              Assignment: This
      Agreement shall be binding upon and inure to the benefit of the successors
      or permitted assigns of each of the parties and may not be assigned or
      transferred by either party without the prior written consent of the
      other, except that no consent shall be required in the case of a transfer
      to a wholly-owned subsidiary or transaction involving the merger,
      consolidation or sale of substantially all of the assets of the party
      seeking such assignment or transfer and such transaction relates to the
      business covered by this Agreement and the resulting entity assumes all
      the obligations under this Agreement. ALTHEA may, without such consent,
      assign this Agreement to an Affiliate of ALTHEA, provided that the
      assignee assumes all obligations of ALTHEA under this Agreement. No
      assignment shall relieve any party of responsibility for the performance
      of its obligations hereunder.

            


    

     

    
      	
               
      

            	
              15.6

            	
              Successors and Assigns:
      This Agreement shall be binding upon and shall inure to the benefit
      of the parties hereto, their successors and permitted
    assigns.

            


    

     

    
      	
               
      

            	
              15.7

            	
              Taxes: CLIENT shall pay
      all national, state, municipal or other sales, use excise, import,
      property, value added, or other similar taxes, assessments or tariffs
      assessed upon or levied against the sale of Company Plasmid DNA to CLIENT
      pursuant to this Agreement or the sale or distribution of Company Plasmid
      DNA by CLIENT (or at CLIENT’s sole expense,
      defend against the imposition of such taxes and expenses). ALTHEA shall
      notify CLIENT of any such taxes that any governmental authority is seeking
      to collect from ALTHEA, and CLIENT may assume the defense thereof in
      ALTHEA’s name, if necessary, and ALTHEA agrees to fully cooperate in such
      defense to the extent of the capacity of ALTHEA, at CLIENT’s expense.
      ALTHEA shall pay all national, state, municipal or other taxes on the
      income resulting from the sale by ALTHEA of the Company Plasmid DNA to
      CLIENT under this Agreement, including but not limited to, gross income,
      adjusted gross income, supplemental net income, gross receipts, excess
      profit taxes, or other similar
taxes.

            


    

     

    
      	
               
      

            	
              15.8

            	
              Independent Contractor:
      ALTHEA shall act as an independent contractor for CLIENT in
      providing the services required hereunder and shall not be considered an
      agent of, or joint venturer with, CLIENT. Unless otherwise provided herein
      to the contrary, ALTHEA shall furnish all expertise, labor, supervision,
      machining and equipment necessary for performance hereunder and shall
      obtain and maintain all building and other permits and licenses required
      by public authorities.

            


    

     

    ALTHEA
CONFIDENTIAL

     

    
      
        
        

      

      
        18

        
          

        

      

      
        
        

      

    

     

    CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

     

     

    
      	
               
      

            	
              15.9

            	
              Governing Law: This
      Agreement shall be governed in all respects by the laws of the United
      Kingdom, without regard to the principals of conflicts of laws. The courts
      of the United Kingdom shall have personal jurisdiction over the parties
      hereto in all matters arising hereunder, and venue for such suit will be
      in the County Court, Central
London.

            


    

     

    
      
        	
              	
                15.11

              	
                Severability: In the
      event that any term or provision of this Agreement shall violate any
      applicable statute, ordinance, or rule of law in any jurisdiction in which
      it is used, or otherwise be unenforceable, such provision shall be
      ineffective to the extent of such violation without invalidating any other
      provision hereof.

              


      

    

     

    
      
        	
              	
                15.10

              	
                Headings, Interpretation:
      The headings used in this Agreement are for convenience only and
      are not part of this
Agreement.

              


      

    

    


    IN WITNESS WHEREOF, the
parties hereto have each caused this Company Plasmid DNA Development and
Clinical Supply Agreement to be executed by their duly-authorized
representatives as of the Effective Date above written.

     

    
      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      	
                                              BIOCANCELL
      THERAPEUTICS LTD.

                                            	 
      	
                                              ALTHEA
      TECHNOLOGIES, INC

                                            
	 
      	 
      	 
      
	
                                              By:

                                            	
                                              /s/
      Avi Barak

                                            	 
      	
                                              By:

                                            	
                                              /s/
      W. Alan Moore

                                            
	 
      	 
      	 
      	 
      	 
      
	
                                              Name:

                                            	
                                              Avi
      Barak

                                            	 
      	
                                              Name:

                                            	
                                              W.
      Alan Moore

                                            
	 
      	 
      	 
      	 
      	 
      
	
                                              Title:

                                            	
                                              Chief
      Executive Officer

                                            	 
      	
                                              Title:

                                            	
                                              Exec.
      V.P. and CBO

                                            
	 	 	 	 	 
	 
      	 
      	 
      	 
      	 
      
	
                                              By:

                                            	
                                              /s/
      Amir Hasidim

                                            	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                              Name:

                                            	
                                              Amir
      Hasidim

                                            	 
      	 
      	 
      
	 
      	 
      	 
      	 
      	 
      
	
                                              Title:

                                            	
                                              Chief
      Financial Officer

                                            	 
      	 
      	 
      
	 	 	 	 	 
	 	Jan
      23 2007 	 	 	 


                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

    

     

    ALTHEA CONFIDENTIAL


    
      
        
        

      

      
        19

        
          

        

      

      
        
        

      

    


    Standard
BioCancell Form

    CDA
— Mutual Disclosures

     

    BIOCANCELL

    Patient-Oriented,
Targeted Therapy

     

    MUTUAL
CONFIDENTIAL DISCLOSURE AGREEMENT

     

    THIS MUTUAL CONFIDENTIAL DISCLOSURE
AGREEMENT (the “Agreement”) made as of December 11, 2006 (the “Effective
Date”), is by and between BioCancell Therapeutics, Inc., a Delaware corporation
with a principal business address of Beck Science Center, 8 Hartom St, Har
Hotzvim, Jerusalem 97775 Israel (Tel: 972.2,548.6555;
Fax:  972.2.548.6550) (together with its Affiliated Companies,
“BioCancell”) and Althea Technologies, Inc., a Delaware corporation with a principal business
address of 11040 Roselle Street, San Diego, California 92121 USA (Tel:
858-882-0123; Fax: 858-8820133) (together with its Affiliated Companies,
“Althea”).

     

    
      	
              1.

            	
              Background.

            


    

     

    BioCancell
and Althea intend to engage in discussions for the purpose of evaluating a
potential business or collaborative relationship between the parties
(“Purpose”). In connection with these discussions, it is anticipated that
BioCancell and Althea may disclose certain proprietary and confidential
information This Agreement will govern those disclosures. The party disclosing
Confidential Information (defined below) will be referred to as the “Discloser”
with respect to that Confidential Information; the party from time to time
receiving that Confidential Information will be referred to as the
“Recipient.”

     

    
      	
              2.

            	
              Definitions.

            


    

     

    
      	
               
      

            	
              2.1

            	
              “Confidential
      Information” means any and all non-public scientific, technical, financial
      or business information in whatever form (written, oral or visual)
      possessed or obtained by the Discloser and furnished to the Recipient,
      Confidential Information will include information which (a) Discloser has
      labeled in. writing as confidential or proprietary, (b) is furnished orally or
      visually and is identified by the Discloser at the time of disclosure or
      within fifteen (15) days thereafter as confidential or proprietary.
      However, failure to do so shall not relieve the Recipient from its
      obligations as detailed herein if the confidential nature of the
      information is apparent from the subject matter, or (c) is commonly
      regarded as confidential and/or proprietary in the life sciences
      industry.

            


    

     

    
      	
               
      

            	
              2.2

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

            


    

     

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

       

    

    
      	
              3.

            	
              Obligations.

            


    

     

    The
Recipient agrees that it will (a) hold in confidence all Confidential
Information, (b) use the Confidential Information solely for the Purpose, (c)
treat Confidential Information with the same degree of care it uses to protect
its own Confidential Information but in no event with less than a
reasonable degree of care, and (d) to use Confidential Information solely to
accomplish the Purpose. (e) disclose Confidential Information solely to its
employees or consultants on a need-to-know basis, provided that any mach
employees and consultants are bound by written obligations of confidentiality at
least as restrictive as those set forth herein. (F) not to engage in the
development of any products or technologies which arc in a field similar to the
Confidential Information,

     

    
      	
              4.

            	
              Permitted
      Disclosures.

            


    

     

    The
Recipient may disclose Confidential Information to its responsible employees and
professional advisers with a
bona fide need to know such Confidential Information, but only to the
extent necessary to carry out the Purpose and only if such employees and
professional advisers are advised of the confidential nature of such
Confidential Information and the terms of this Agreement and are bound by a written agreement
or by a legally enforceable code of professional responsibility to protect the
confidentiality of such Confidential Information and where the Recipient will
still be held responsible for any such breach of this Agreement.

     

    In the
event that Recipient is required by law, regulation, rule, act or order of any
governmental authority or agency to disclose Confidential Information, it shall
be entitled to do so provided that it shall first notify Discloser of any such
required disclosure, so that Discloser may seek an appropriate protective order,
and limit such disclosure as far as is possible under applicable law. Recipient
will reasonably cooperate with Discloser in its efforts to seek such a
protective order. Such disclosure shall, however, not relieve Recipient of its
other obligations contained herein.

     

    
      	
              5.

            	
              Exceptions.

            


    

     

    Recipient
will have no obligations of confidentiality and non-use with respect to any
portion of the Confidential Information which:

     

    
      	
               
      

            	
              (a)

            	
              is
      or later becomes generally available to the public by use, publication or
      the like, through no fault of Recipient;
or

            


    

     

    
      	
               
      

            	
              (b)

            	
              is
      rightfully obtained from a third party who
      had the legal right to disclose the same to Recipient;
  or

            


    

     

    
      	
               
      

            	
              (c)

            	
              Recipient
      already possesses, as evidenced by written documentation that predate the
      receipt thereof;

            


    

     

    Information
shall not be deemed to be in the public domain merely
because it may be derived from one or more items which are publicly
]clown,

     

    Notwithstanding
the above, in the event of a reliance on any of the
above three examples for the purposes of a permitted disclosure by the Receiving
Party in accordance with the terms of this Agreement, the burden of proof shall
always be on the Recipient to prove by written documentation that such
disclosure did not include Confidential Information.

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

       

    

    
      	
              6.

            	
              Expiration
      and Termination.

            


    

     

    The term
of this Agreement will be a period of one (1) year following the Effective Date
unless earlier terminated by either party upon fifteen (15) days’ prior written
notice to the other party. The obligations of confidentiality and non-use will
survive any such termination or expiration and continue in full force and effect
for a period of seven (7) years from the date of termination or expiration. Upon
termination or expiration, or upon the demand of Discloser at any time, any and
all paper copies of Confidential Information together with any reports, notes,
memoranda, analyses, electronic copies, compilations, studies or other documents
prepared by Recipient or at Recipient’s direction containing or reflecting any
Confidential Information will be destroyed by Recipient. At the request of
Discloser, Recipient will provide a written certification to Discloser regarding
such destruction. Recipient may, however, retain one (1) copy of Confidential
Information in its confidential files., solely for record purposes.

     

    
      	
              7.

            	
              Representations.

            


    

     

    Discloser
represents and warrants to Recipient that it has the right to enter into this
Agreement and disclose the Confidential Information to Recipient and that it is
not a party to any other agreement or under any obligation to any third party
that would prevent it from entering into this Agreement or disclosing the
Confidential Information hereunder,

     

    
      	
              8.

            	
              Remedies.

            


    

     

    It is
understood and agreed that either party may be irreparably injured by a breach
of this Agreement; that money damages would not be an adequate remedy for
any  such breach; and that either party will be entitled to seek
equitable relief, including injunctive relief, as a remedy for any such breach
or threatened breach of this Agreement, as well as to pursue any and all other
rights and remedies available by law or in equity for such a
breach,

     

    
      	
              9.

            	
              No
      Implied Rights or Licenses.

            


    

     

    It is
understood that no patent right or license or other intellectual property right
is granted by this Agreement except for the Purpose and that the disclosure of
Confidential Information is not an express or implied commitment by Discloser to
grant Recipient any right in and/or to such Confidential
Information.

     

    
      	
              10.

            	
              Counterparts
      and Facsimile Signatures.

            


    

     

    This
Agreement may be executed in one or more counterparts, each of which will be
deemed an original, and all of which together will be deemed to be one and the
same instrument. A facsimile copy of this Agreement, including the signature
pages, will be deemed an original.

     

    
      	
              11.

            	
              Miscellaneous.

            


    

     

    This
Agreement (a) will inure to the benefit of and be binding upon each party and
its respective successors and assigns, (b) will be governed by and construed in
accordance with the laws of the State of Israel without regard to the conflicts
of law provisions thereof. Any dispute arising under or in relation to this
Agreement shall be resolved in the competent court for Tel Aviv-Jaffa district,
and each of the parties hereby submits irrevocably to the jurisdiction of such
court. (e) may only be modified by written agreement of the parties, and (d) may
not be assigned or otherwise transferred by either party without the prior
written consent of the other party; provided, however, that either party may,
without such consent, assign this Agreement to an unrelated third party in
connection with a merger, consolidation or sale of substantially all of its
business to which this Agreement relates. No waiver or modification of this
Agreement will be binding upon either party unless made in writing and signed by
a duty authorized representative of such party, The failure of either party to
enforce at any time or for any period of time the provisions hereof will not be
construed to be a waiver of such provisions or of the right of such party to
enforce each and every such provision.

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

    IN WITNESS WHEREOF, duly
authorized representatives of the parties have executed this Agreement as of the
Effective Date.

     

    
      	
              BioCaueell
      Therapeutics INC.

            	
              Althea
      Technologies, Inc.

            
	 	 
	
              By:  _____________________________________

            	
              By: _____________________________________

            
	
              Print
      Name: Avi Barak

            	
              Print
      Name: W. Alan Moore

            
	
              Title:
      CEO

            	
              Title:
      Exec. V.P. and Chief Business
Officer

            


    

    


     


    
      
        
           

        

         


      

      
        4

        
          

        

      

      
         


      

    


    Quality
Management Agreement- GMP Plasmid Production

     

    Purpose

     

    The
Quality Management Agreement has been developed to define the regulatory
compliance roles and responsibilities of Company and Althea Technologies
(Althea). The Quality Management Agreement shall constitute part of the
agreement between Company and Althea and may be revised from time to time on the
basis of mutual agreement of the parties. In the event of a conflict between the
provisions of the Company Plasmid DNA Production Agreement and Quality
Management Agreement, the provisions of the Company Plasmid DNA Production
Agreement shall prevail.

     

    Definitions

     

    “Agreement” shall mean the
Company Plasmid DNA Production Agreement executed between Company and Althea on
the Effective Date as
defined in the Agreement.

     

    “cGMP” shall mean Current Good
Manufacturing Practices as promulgated under the US Federal Food Drug and
Cosmetic Act and 21CFR sections 210, 211, 600 and 610 and corresponding rules
and regulations of the European Medicines Agency, all as may be amended from
time to time.

     

    “Party” means either Company
or Althea.

     

    “Parties” means both Company
and Althea.

     

    “Products” shall mean Company
drug products and all intermediate precursors.

     

    Regulatory
Activities

     

    Roles
of the parties

     

    Company
will be the holder the IND or equivalent and the holder of the registration
submission and subsequent license, Althea will support these submissions as a
contract manufacturer under the direction of Company.

     

    Regulatory
submissions

     

    Company
will be responsible for the submission of documentation to regulatory
authorities in support of the Products. Althea will provide Company with the
information necessary to complete regulatory submissions and support such
submissions in a timely and effective manner.

     

    Althea
will consult Company on responses, which Company will make, to FDA questions and
requests regarding production processes and product testing relevant to
Althea.

     

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

    Inspections

     

    Company
will inform Althea in a timely fashion when regulatory agencies are seeking to
schedule inspections concerning the Products at Althea’s
facilities.

     

    Company
will be permitted two representatives during the opening, closing and daily wrap
up portions of the regulatory agencies’ inspection at Althea’s
facilities.

     

    Althea’s
communication and commitments with regulatory inspectors will be limited to
matters outside of Company’s regulatory submissions. and Company will be
informed of all such communication and commitments that could impact Company’s
regulatory submissions. Althea will consult Company on responses, which Company
will make. to FDA questions and requests regarding production processes and
product testing. Althea will provide Company with the all necessary assistance
in order to provide FDA with said responses in a timely and effective manner.
Company will determine and make all other responses to regulatory
authorities.

     

    Compliance

     

    Roles
of the parties

     

    Althea,
in its activities under the Agreement, is responsible for compliance with cGMP,
other applicable guidelines and Althea SOPS.

     

    Company,
in its activities under the Agreement, is responsible for compliance with cGMP
and applicable guidelines and with confirming Althea’s compliance with cGMP,
other applicable guidelines and Althea SOPs.

     

    Audits

     

    Company
has the right to perform two audits of Althea facilities, laboratories and
warehouses each year for the purposes of confirming Althea compliance with cGMP,
applicable guidelines and Althea SOPs in the manufacture, testing and validation
of the Product. Each audit will be limited to 2 business days to occur on
mutually agreed dates.

     

    Company
may also perform two annual audits of each Althea subcontractor involved in the
manufacture, testing and validation of the Product, providing that Company
provides Althea with prior written notification of its intent to audit. Althea
wilt provide commercially reasonable efforts to facilitate the scheduling and
execution of Company’s audits of subcontractors.

     

    In
addition to the two annual compliance audits, Company may also audit Althea and
its subcontractors in the event of failure or recall of a product
lot.

     

    At the
conclusion of each audit, Company will hold a wrap up meeting with Althea and/or
its subcontractors to review all significant audit observations.

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

    Within 60
days of each audit it performs at Althea and its subcontractors, Company will
provide Althea with a written report of its observations and recommendations.
Althea and/or its subcontractors will make their best efforts to comply with
Company’s report and provide, within 60 days of receipt of Company’s audit
report, a written response to Company including a response to all Company
observations and details regarding corrective actions.

     

    Documentation

     

    Althea is
responsible for generating and maintaining records of equipment usage, cleaning
and maintenance,

     

    Althea is
responsible for developing documentation to support the manufacturing, testing
and validation of the Product. All documents and procedures which are specific
to the product must be approved by Company prior to implementation. Althea will
provide Company with copies of all documents used in the production, testing and
validation of the Product.

     

    Changes
to documentation will be implemented according to the Change Control section of
this document.

     

    Althea is
responsible for maintaining Product batch production and testing records for the
period of product expiry plus one year. Written authorization from Company QA is
required prior to the movement or destruction of Product records. When Althea is
no longer willing or able to store Product records, Company may have the records
destroyed, or transferred to an alternate storage location at Company’s
expense.

     

    Product
Release

     

    Althea
and Company will each identify a Quality Assurance representative who will
function as the points of contact between the companies for the purposes of
communication regarding product release and regulatory compliance
activities.

     

    Althea
will propose sources for raw materials and components to be used in the
manufacture of the Product. Company will be responsible for approving all
sources and specifications for raw materials and components used in the
manufacture of the Product.

     

    Althea
and Company will mutually upon agree testing specifications for the Product. The
parties will mutually agree in writing to all changes to specification prior to
implementation,

     

    Althea
may subcontract some or all of the Product testing subject to prior written
approval by Company.

     

    Althea is
responsible for control and monitoring of the Product manufacturing process and
production facility.

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

    Althea is
responsible for reviewing product lot records, test results and specifications
and determining whether to reject the lot or issue Althea’s release to Company
QA. Company QA is responsible for the formal release of each Product
lot.

     

    Althea
will issue a Certificate of Analysis and Certification of Compliance to Company
for each lot that receives Althea’s release. The Certificate of Analysis will
contain a summary of the product test methods, specifications and test results.
The Certificate of Compliance will contain statement signed by Althea’s QA
representative stating that the lot has been manufactured and tested in
compliance with cGMP. Althea procedures and applicable guidelines.

     

    Company
may request additional documentation to support its review and release of
Product lots, including but not limited to copies of Batch Production Records,
testing results, raw data from Product testing and in-process test results.
Althea SOPS, validation reports and qualification studies may be reviewed on
site, but are not distributed. These documents are contained within Althea’s
Type V DMF which may be referenced in FDA submissions. Certain aspects of
Althea’s manufacturing process are proprietary and will not be provided directly
to Company. Proprietary manufacturing process information is contained within
Althea’s Type II BMF which may be referenced in FDA submissions. The
aforementioned in no way diminishes Althea responsibility and commitment to
provide Company with the information needed to complete regulatory
submissions.

     

    Company
will make reasonable efforts to release each lot within 90 days of receipt of
the Certificate of Analysis, Certificate of Compliance and requested
documents.

     

    Althea
will store and ship the Product according to written Company instructions and in
compliance with cGMP.

     

    Product
Recall

     

    Company
is responsible for instituting and facilitating a Product recall.

     

    Company
will notify Althea in a timely fashion when a Product recall may be due to
issues related to the manufacturing of the Products.

     

    At
Company’s request and under Company’s direction, Althea will support
communication with regulatory authorities,

     

    Change
Control

     

    All
changes to procedures, documents and equipment used in the manufacture, testing
and validation of the Product must be mutually approved by Althea and Company in
writing prior to implementation.

     

    Validation

     

    All
validation specific to the Product must be executed according to protocols
approved prior to execution by Company.

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

    Althea
will provide Company with copies of all validation reports used to support
manufacture and testing of the Product, upon request.

     

    Investigations

     

    Althea
will notify Company of all excursions, deviations, observations and
investigations which could impact past, current or future lots of the
Product.

     

    Althea
will notify Company of all Product testing failures within 2 business days, and
prior to initiating retesting.

     

    All
investigations concerning the Product and conducted at Althea will be reviewed
and approved by Althea and Company.

     

    Product
Supply

     

    Roles
of the parties

     

    Althea
will perform manufacture, testing and validation of the Products in its
facilities.

     

    Company
is authorized to have 2 representatives present at Althea’s manufacturing
facilities during Product manufacture, testing and/or validation. Additional
Company representatives may be permitted when mutually agreed with
Althea.

     

    Authorization
of production

     

    Manufacture
of the Product at Althea will be authorized in accordance with the
Agreement.

     

    Lot
numbers

     

    Althea is
responsible for assigning and tracking unique identifier numbers to each lot of
raw material, component, product intermediate and Product.

     

    Dates
of production and expiration

     

    The dates
of manufacture will be determined by, and documented in, the Batch Production
Records.

     

    The
expiration date of the Product will be determined by Company.

     

    Dispute
Resolution

     

    Disputes
concerning the acceptability of Product lots or general compliance issues will
be resolved by the Quality Assurance representatives of the Parties. If the
dispute is not resolved after 30 days, either Party may upon written
notification to the other request that the dispute be resolved according to the
provisions of the Agreement.

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

    IN WITNESS WHEREOF, the
parties hereto have each caused this Project Plan to be executed by their
duly-authorized representatives as of Date.

     

    
      	
              BIOCANCELL
      THERAPEUTICS LTD.

            	
              ALTHEA
      TECHNOLOGIES INC

            
	
               

              By: _________________________________________

            	
               

              By:  ________________________________________

            
	
               

              Name:  ______________________________________

            	
               

              Name: ______________________________________

            
	
               

              Title:  _______________________________________

            	
               

              Title: _______________________________________

            
	 	 
	
               

              By:  ________________________________________

            	 
      
	
               

              Name: ______________________________________

            	 
      
	
               

              Title: _______________________________________

            	 
      


    

    


     


    
      
        
           

        

         


      

      
        6

        
          

        

      

      
         


        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    PROJECT
PLAN FOR DTA-H19

     

    PLASMID
DNA PRODUCTION

     

    Prepared
for:

     

    Moshe
Landsberg

     

    VP
Technology and QA

     

    BioCancell
Therapeutics

     

    Beck
Science Center

     

    8
Hartom Street

     

    Hotzvirn

     

    Jerusalem
97775

     

     

    Prepared
by:

     

    Althea
Technologies

    11040
Roselle Street

    San
Diego, CA 92121

    858-882-0123

    858-882-0133
(tax)

     


    
      
        
          NY239,535,890
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        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    TABLE OF
CONTENTS

    

      
        	 	 	 
      	 	
                Page

              	 
	 	1.	 	
                Outline
      of Deliverables

              	 	 	1	 
	 	2.	 	
                Pricing
      Summary.

              	 	 	3	 
	 	3.	 	
                Timing

              	 	 	4	 
	 	4.	 	
                cGMP
      Fill Finish and Components

              	 	 	5	 
	 	5.	 	
                Specifications

              	 	 	6	 
	 	6.	 	
                Payment
      Schedule

              	 	 	14	 
	 	7.	 	
                Authorizations

              	 	 	15	 


      

    

     


    
      
        
           

          NY239,535,890
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        i

        
          

        

      

      
         


        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    1.           Outline of
Deliverables

     

    
      	
               
      

            	
              A.

            	
              BioCancell
      Deliverables Required Prior to Initiation of
    Activities

            


    

     

    
      	
               
      

            	
              1.

            	
              Initial
      Phase (Approximate [***] cGMP Bulk Plasmid
DNA)

            


    

     

    
      	
               
      

            	
              (a)

            	
              Signed
      Project Plan

            


    

     

    
      	
               
      

            	
              (b)

            	
              Minimum
      Required Number of Vials (Received)

            


    

     

    
      	
               
      

            	
              –

            	
              [***]
      vials at [***] mg /
      Vial.

            


    

     

    
      	
               
      

            	
              –

            	
              Up
      to 260 vials or as required at [***] mg I vial to Appropriately
      Supply OC testing and stability study
  requirements.

            


    

     

    
      	
               
      

            	
              (c)

            	
              Payment
      for all outstanding invoices for previous DTA-H19
    Activities

            


    

     

    
      	
               
      

            	
              B.

            	
              Althea
      Deliverables

            


    

     

    
      	
               
      

            	
              1.

            	
              [***]
      Process Development

            


    

     

    
      	
               
      

            	
              (a)

            	
              10L
      Fermentation to provide material for two separate development
      tasks:  Extended washing study with buffer to evaluate
      sufficiency of [***] Column studies to evaluate additional clearance of
      [***] and potential impact on yield. Studies will be conducted
      concurrently following generation of plasmid DNA from 10L
      fermentation.

            


    

     

    
      	
               
      

            	
              2.

            	
              Production
      of approximately [***] cGMP Bulk Plasmid
DNA

            


    

     

    
      	
               
      

            	
              (a)

            	
              Production
      of approximately [***] of bulk cGMP Plasmid
DNA

            


    

     

    
      	
               
      

            	
              (b)

            	
              Not
      less than [***] vials at [***] mg vial, [***] / vial, and the
      appropriate number of vials to supply CC testing and stability study
      requirements (estimated to be 260 vials) meeting EU and US
      requirements.

            


    

     

    
      	
               
      

            	
              (c)

            	
              cGMP
      production & filling Batch Records for
  Review

            


    

     

    
      	
               
      

            	
              (d)

            	
              Released
      GMP Production Batch Records (including deviations, OOS or other
      nonconformance investigations as
applicable).

            


    

     

    
      	
               
      

            	
              (e)

            	
              Certificate
      of Analysis for bulk product including all test
  results.

            


    

     

    
      	
               
      

            	
              (f)

            	
              Released
      Filling Batch Records (including any deviations, DOS or other
      non-conformance investigations as
applicable).

            


    

     

    
      	
               
      

            	
              (g)

            	
              Certificate
      of Analysis for Filled Product including all test
  results.

            


    

     

    
      	
               
      

            	
              (h)

            	
              Certificate
      of Analysis at each Stability Timepoint (Includes stability summary report
      at each time point and copies of raw
data.

            


    

    

      
        
          
             

            NY239,535,890
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          1

          
            

          

        

        
           


          CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

        

      

    

     

    
      	
               
      

            	
              (i)

            	
              Certificate
      of Analysis for End of production purity and identity
    testing.

            


    

     

    
      	
               
      

            	
              C.

            	
              Scope Of
      Work

            


    

     

    The
following section provides a summary of the anticipated scope of work and
component tasks anticipated for the Manufacturing Phase.

     

    
      	
               
      

            	
              1.

            	
              [***]
      Process Development

            


    

    Includes
10L fermentation followed

     

    
      	
               
      

            	
              ·

            	
              Direct
      comparison of current process vs. process with additional [***]
      removal steps

            


    

     

    
      	
               
      

            	
              ·

            	
              [***]

            


    

     

    
      	
               
      

            	
              2.

            	
              GMP
      Production andCharacterization of cGMP Plasmid
  DNA

            


    

     

    
      	
               
      

            	
              (a)

            	
              Preparation
      of Manufacturing Batch Records.

            


    

     

    
      	
               
      

            	
              (b)

            	
              Fermentation
      at 100 L scale (without [***]).

            


    

    Includes
differentially plating end-of-production cells to demonstrate that the construct
is stable (1st fermentation only).

     

    
      	
               
      

            	
              (c)

            	
              Cell
      lysis, using same procedures as with previous DTA-H19
      processing.

            


    

     

    
      	
               
      

            	
              (d)

            	
              Downstream
      processing and separation, using same procedures as with previous DTA-H19
      processing.

            


    

     

    
      	
               
      

            	
              (e)

            	
              Column
      purification using same procedures as with previous DTA-H19 processing
      with the additional step required for [***]
      reduction as was found in step 1 ([***]
      PD).

            


    

     

    
      	
               
      

            	
              (f)

            	
              Standard
      Preparation of bulk formulation for
Filling.

            


    

     

    
      	
               
      

            	
              (g)

            	
              In-process
      testing using same procedures as with previous DTA-H19
      processing.

            


    

     

    
      	
               
      

            	
              (h)

            	
              Final
      CC testing and release using same procedures as with previous DTA-H19
      processing.

            


    

     

    
      	
               
      

            	
              (i)

            	
              Batch
      record release and CA audit.

            


    

     

    Note:  Bulk drug
substance to be stored [***].

     

    
      	
               
      

            	
              3.

            	
              Final
      Fill/Finish:

            


    

     

    
      	
               
      

            	
              (a)

            	
              Fill
      [***]

            


    

     

    
      	
               
      

            	
              (b)

            	
              Documentation
      preparation

            


    

    

      
        
          
            


            CONFIDENTIAL                                                                    


            NY239,535,890
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          2

          
            

          

        

        
           


          CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

        

      

    

     

    
      	
               
      

            	
              (c)

            	
              Release
      testing using same procedures as with previous DTA-H19
      processing.

            


    

     

    
      	
               
      

            	
              (d)

            	
              Sterile
      filtration using same procedures as with previous DTA-H19
      processing.

            


    

     

    
      	
               
      

            	
              (e)

            	
              Aseptic
      Filling.

            


    

     

    
      	
               
      

            	
              (f)

            	
              Stopper
      & Seal with same components used with previous DTA-H19
      filling.

            


    

     

    Note:  The product
fill must be performed within [***] from the end of purification. This is the
maximum storage period for this Drug Substance before filling.

     

    4.           Stability
Study:

     

    Drug
Product will be placed on a three (3) Year Stability Study under a protocol
prepared according to ICH guidelines. Stability Study includes generation of
stability protocol and stability summary report at each timepoint. Study
parameters are outlined below:

     

    
      	
              TEMP

            	
              0

            	
              3

            	
              6

            	
              9

            	
              12

            	
              18

            	
              24

            	
              36

            
	
              [***]

            	
              1-3

            	
              1-2

            	
              1-2

            	
              1-2

            	
              1-3

            	
              1-2

            	
              1-3

            	
              1-3

            
	
              [***]

            	
              1-3

            	
              1-2

            	
              1-2

            	
              1-2

            	
              1-3

            	
              1-2

            	
              1-3

            	
              1-3

            


    

     

    Note:  T-0 is
release

     

    1 =
Appearance, cone, HPLC, gel electrophoresis, A260/280 ratio, 2 = [***], 3 =
Sterility.

     

    Includes
shipping of two vials (1 at [***] degrees and 1 at [***] degrees) to
BioCancell for potency testing. BioCaneell to pay shipping costs.

     

    
      	
              2.

            	
              Pricing
      Summary.

            


    

     

    The
pricing of DTA-I-11 9 Plasmid DNA manufacturing is subject to the following
conditions:

     

    Pricing
for the activities and deliverables described in Section 1 for the Production of
DTA-H1 9 Plasmid DNA manufacturing is valid until 31 December,
2008.

     

    
      	
              
                Pricing:  PD
      and Manufacturing Phases of DTA-H19 Plasmid DNA
      Production

              

            
	
              
                 

                Activity
      or Component

              

            	
              
                 

                #
      Units/Runs

              

            	
              
                 

                Pricing

              

            	
              
                Discount
      / Credit

              

            	
              
                 

                Total
      Price

              

            
	
              [***]
      PD Study

            	
              1

            	
              [***]

            	
              -

            	
              [***]

            
	
              Bulk
      production (- [***] g cGMP Plasmid DNA)*

            	
              3

            	
              [***]

            	
              [***]

            	
              [***]

            
	
              Aseptic
      Fill ( 3 [***]
      vials + -260 vials QC/Stability)

            	
              1

            	 
      	 
      	 
      
	
              Stability
      Protocol and testing

            	
              1

            	 
      	 
      	 
      
	 
      	 
      	
              Sub
      Total

            	
              [***]

            
	 
      	 
      	 
      	 
      	 
      
	
              Total
      Proposed

            	 
      	
              [***]

            	
              [***]

            	
              [***]

            


    

    


    Note:  Discount for
Bulk production Includes Reversing Previous Credit of [***].

    

      
        
          
            


            CONFIDENTIAL                                                                    


            NY239,535,890
v2

          

           


        

        
          3

          
            

          

        

        
           


          CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

        

      

    

     

    
      	
              3.

            	
              Timing

            


    

     

    Note:  BioCancell
and Althea will mutually agree upon a final timeline for production and delivery
of vialed product after review of the [***] process development
study.

     

    
      	
               

              Activity

            	
              Estimated
      Completion Date

              (Range)

            
	
              [***]
      Process Development Study

            	
              December
      2008 - January 2009

            
	
              Receive
      and Release Raw Materials, Excipients & Components

            	
              February
      - March 2009

            
	
              Draft
      cGMP fermentation and purification master Batch Records Sent to BioCancell
      for comments

            	
              February
      1st -
      10th
      2009

            
	
              Draft
      Master Batch Records comments sent back to Althea by BioCancell
      QA

            	
              February
      10th-15th
      2009

            
	
              Revised
      Master Batch record sent back to BioCancell for QA
    signature

            	
              February
      15th-25th
      2009

            
	
              Master
      Batch Record Approved and signed by BioCancell OA'

            	
              February
      2009

            
	
              cGMP
      Product Fermentation (supplemental material)

            	
              March
      2009

            
	
              cGMP
      Product Purification

            	
              March-April
      2009

            
	
              QC
      Testing of bulk Drug Substance

            	
              April
      2009

            
	
              cGMP
      Bulk Release

            	
              May
      2009

            
	
              Draft
      cGMP fill Master Batch Records Sent to BioCancell for
    comments

            	
              March
      15-30th
      2009

            
	
              Draft
      Master Batch Records comments sent back to Althea by BioCancell
      QA

            	
              April
      10111-15th
      2009

            
	
              Revised
      Master Batch record sent back to BioCancell for CA
    signature.

            	
              April
      15'x-
      20th
      2009

            
	
              Master
      Batch Record Approved and signed by BioCancell QA"

            	
              April
      21a1-25th
      2009

            
	
              Product
      Fill

            	
              May
      2009

            
	
              Initiation
      of QC Release Testing

            	
              May
      2009

            
	
              Initiation
      of Stability Program

            	
              May
      2009

            
	
              Fully
      Released Product & Completed Master Batch Records.

            	
              June
      2009

            
	
              Ship
      Released Final Product to BioCancell, per distribution instructions
      (Shipping and handling charges to be invoiced directly to
      BioCancell).

            	
              June
      2009

            


    

    

      
        
          
            


            CONFIDENTIAL                                                                    


            NY239,535,890
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          4

          
            

          

        

        
           


          CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

        

      

    

    4.           cGMP Fill Finish and
Components

     

    
      	
              Components

            	
              Size

            	
              Type

            	
              Vendor

            	
              Part
      Number

            	
              Supplied
      by

            
	
              Vial

            	
              
                [***]

              

            	
              Glass

            	
              Wheaton

            	
              RM-198

            	
              Althea

            
	
              Stoppers

            	
              
                [***]

              

            	
              Gray
      Butyl

            	
              Wheaton

            	
              RM-196

            	
              Althea

            
	
              Seals

            	
              [***]

            	
              Blue
      Tear off

            	
              Wheaton

            	
              RM-359

            	
              Althea

            
	
              Filters

            	
              [***]

            	
              N/A

            	
              Millipore

            	
              TBD

            	
              Althea

            


    

     

    

      
        
          
            


            CONFIDENTIAL                                                                    


            NY239,535,890
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          5

          
            

          

        

        
           


          CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

        

      



    5.     Specifications

     

    Lot No.:
FUR-XXXX

     

    CERTIFICATE
OF RESULTS FOR cGMP DRUG
SUBSTANCE

     

    
      	
              Plasmid:  _____________________________________

            	
              Prepared
      for:   ____________________________________

            
	
              Part
      No. of
      Preparation: __________________________             

            	
              Lot
      No. of Preparation: 
  _____________________________

            


    

    


    
      	
              Test

            	
              *Specification

            
	
              Identity

            	 
      	 
      
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	 
      	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	
              Purity

            	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	 
      	 
      


    

    




    
      
        
          


          CONFIDENTIAL                                                                    


          NY239,535,890
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        6

        
          

        

      

      
         


        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    


    
      	
              Safety

            	
              

                [***]

              

              [***]

            	
                    
                [***]

              

            
	
              Bioburden

            	
              [***]

            	
              [***]

            
	
              Appearance

            	
              [***]

            	
              [***]

            
	
              pH

            	
              [***]

            	
              [***]

            
	
              Conductivity

            	
              [***]

            	
              [***]

            
	
              Osmolality

            	
              [***]

            	
              [***]

            
	
              Concentration

            	
              [***]

            	
              [***]

            


    

    


    Attachments:  Plasmid
Map, Agarose Gel Electrophoresis and HPLC Results

     

    Sponsor’s
required specifications.

     

    Caution:  For
investigational Use Only

     

    Plasmid
Map:

     

    Insert
Plasmid map here

     

    Agarose
Gel Electrophoresis Result:

    1   2   3   4   5

     

    Insert
gel here

     

    Sample
Description

     

    Lane
1:  Supercoiled Ladder

     

    Lane
2:  Uncut, 0.5 _g load

     

    Lane
3:  1 Kb Ext DNA Ladder

     

    Lane
4:  Cut with Enzyme a and Enzyme 2,

     

    1.0 μg
load

     


    
      
        
          


          CONFIDENTIAL                                                                    


          NY239,535,890
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        7

        
          

        

      

      
         


        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    


    
      	
              bp

            	
              Kilobases

            
	
              —
      16.210

            	
              —
      10.0

            
	
              —
      14.174

            	
              —
      8.0

            
	
              —
      12.138

            	
              —
      6.0

            
	
              —
      10.102

            	
              —
      5.0

            
	
              —
      8066

            	
              —
      4.0

            
	
              —
      7045

            	
              —3.0

            
	
              —
      6030

            	
              —
      2.0

            
	
              —
      5012

            	
              —
      1.0

            
	
              —
      3990

            	
              —
      0.5

            
	
              —
      2972

            	 
      
	
              —
      2067

            	 
      
	 
      	 
      
	
              Supercoiled
      DNA Ladder

            	
              1
      Kb DNA Ladder

            


    

    



    
      
        
          


          CONFIDENTIAL                                                                    


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v2

        

         


      

      
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        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    Lot No.:
FUR-XXXX

     

    CERTIFICATE
OF RESULTS FOR cGMP DRUG
PRODUCT

     

    
      	
              Plasmid:  _______________________________________

            	
              Prepared
      for: ___________________________________

            
	
              Part
      No. of
Preparation: ____________________________ 

            	
              Lot
      No. of
  Preparation:  ___________________________

            


    

    


    
      	
              
                Test

              

            	
              *Specification

            
	
              Identity

            	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	 
      	
              [***]

            
	
              Purity

            	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	
              Security

            	
              [***]

            	
              [***]

            
	
              B
      & F Microbial Testing

            	
              [***]

            	
              [***]

            
	
              Safety

            	
              [***]

            	
              [***]

            
	
              Potency
      (performed by client)

            	
              [***]

            	
              [***]

            
	
              General

              Safety

            	
              [***]

            	
              [***]

            
	
              Appearance

            	
              [***]

            	
              [***]

            
	
              pH

            	
              [***]

            	
              [***]

            
	
              Conductivity

            	
              [***]

            	
              [***]

            
	
              Osmolality

            	
              [***]

            	
              [***]

            
	
              Concentration

            	
              [***]

            	
              [***]

            


    


    
      
        
          


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        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    

    


    Attachments;
Plasmid Map, Agarose Gel Electrophoresis and H PLC Result

     

    Sponsor's
required specifications.

     

    Caution:
For Investigational Use Only

     

     

    Plasmid
Map:

     

    Insert
Plasmid map here

    Agurose
Gel Electrophoresis Result:

     

    1 2 3 4
5

     

    Insert
gel here

     

    
      	
              Sample Description

            
	
              Lane
      1:  Supercoiled Ladder

            
	
              Lane
      2: Uncut, 0.5  ̈g
    load

            
	
              Lane
      3: 1 Kb Ext DNA Ladder

            
	
              Lane
      4: Cut with Enzyme 1, 1.0 ̈g
    load

            
	
              Lane
      5; Cut with Enzyme l and Enzyme 2, 1.0 ug load

            
	
              Supercoiled
      DNA
      Ladder                                                      I
      Kb DNA Ladder

            


    

    


    
      	
              bp

            	
              Kilobases

            
	
              —
      16.210

            	
              —
      10.0

            
	
              —
      14.174

            	
              —
      8.0

            
	
              —
      12.138

            	
              —
      6.0

            
	
              —
      10.102

            	
              —
      5.0

            
	
              —
      8066

            	
              —
      4.0

            
	
              —
      7045

            	
              —3.0

            
	
              —
      6030

            	
              —
      2.0

            
	
              —
      5012

            	
              —
      1.0

            
	
              —
      3990

            	
              —
      0.5

            
	
              —
      2972

            	 
      
	
              —
      2067

            	 
      
	 
      	 
      
	
              Supercoiled
      DNA Ladder

            	
              1
      Kb DNA Ladder

            


    

    



    
      
        
          


          CONFIDENTIAL                                                                    


          NY239,535,890
v2

        

         


      

      
        10

        
          

        

      

      
         


        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    CERTIFICATE
OF RESULTS FOR cGMP DRUG
PRODUCT

     

    
      	
              Plasmid: 
      ______________________________________

            	
              Prepared
      for:  ___________________________________

            
	
              Part
      No. of Preparation: ___________________________

            	
              Lot
      No. of
      Preparation:   ___________________________

            


    

    


    
      	
              
                Test

              

            	
              *Specification

            
	
              Identity

            	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	 
      	 
      	
              [***]

            
	
              Purity

            	
              [***]

            	
              [***]

            
	 
      	
              [***]

            	
              [***]

            
	
               

               

               

              Sterility

            	
              [***]

            	
              [***]

            
	
              Safety

            	
              [***]

            	
              [***]

            
	
              Appearance

            	
              [***]

            	
              [***]

            
	
              Concentration

              Potency

              (performed
      by client)

            	
              [***]

            	
              [***]

            
	 
      	 
      	 
      


    

    



    
      
        
          


          CONFIDENTIAL                                                                    


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v2

        

         


      

      
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        CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

      

    


    


    6.           Payment
Schedule

     

    Althea
will recognize the milestones identified in the Table below as they are
completed and will invoice BioCancell according to the timing presented in the
Table below:

     

    Note: Should the [***] process
development study results dictate a change in scope mutually agreed upon by
BioCancell and Althea, the project total and payment schedule are subject to
change. Should the [***] process development study require more that the current
quote of three weeks for three PD staff, Althea and BioCancell will mutually
agree upon a flat weekly rate to extend the study, in which case the project
total and payment schedule are subject to change.

     

    
      	
              Milestones

            	
              Amount

            	
              Invoicing
      Date/Amt

              (US
      $)

            
	
              Activity
      Total

              Reverse
      Credit

              TOTAL

            	
              [***]

            	 
      
	 
      	 
      	 
      
	
              Initial
      Payment equal to [***] of Project

              Total

            	
              [***]

            	
              [***]

            
	
              Ÿ[***] PD
      Study

            	
              [***]

            	 
      
	
              ŸManufacturing
      Batch Records

            	
              [***]

            	 
      
	
              ŸCompletion of
      Fermentation

            	
              [***]

            	
              [***]

            
	
              ŸCompletion of
      Purification

            	
              [***]

            	 
      
	
              ŸBulk Release
      Testing

            	
              [***]

            	
              [***]

            
	
              ŸFill/Finish Batch
      Records

            	
              [***]

            
	
              ŸFi11

            	
              [***]

            
	
              ŸQC Testing of Drug
      Product

            	
              [***]

            
	
              ŸRelease of cGMP
      material and Executed Batch Records

            	
              [***]

            
	
              ŸInitiation of
      Stability Study

            	
              [***]

            
	
              ŸAt each stability
      timepoint (7)

            	
              [***]

            


    

    


     

    Penalty: BioCancell and Althea
will review the results of the [***] process development study and agree upon
the timeline for completion of all manufacturing tasks. Althea will agree to a
penalty of up to [***] of the Project Total ( less the PD Study amount of [***]
as mutually agreed upon at the time of process development study review and the
establishment of the new timeline for completion of all manufacturing
tasks.

    

      
        
          
            


            CONFIDENTIAL                                                                    


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v2

          

           


        

        
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          CONFIDENTIAL
TREATMENT REQUESTED FOR BRACKETED ITEMS

        

      

    

     

    7.     Authorizations

     

    IN WITNESS WHEREOF, the
parties hereto have each caused this Project Plan under the existing Agreement
to be executed by their duly-authorized representatives as of December 14,
2008.

     

    
      	
              BIOCANCELL

            	
              ALTHEA
      TECHNOLOGIES, INC.

            
	
              By:                                                                

            	
              By:                                                                 

            
	
              Name:                                                                

            	
              Name:                                                                 

            
	
              Title:                                                                

            	
              Title:                                                                 

            
	
              By:                                                                

            	
              By:                                                                 

            
	
              Name:                                                                

            	
              Name:                                                                 

            
	
              Title:                                                                

            	
              Title:                                                                 

            


    


    
      
        
          


          CONFIDENTIAL                                                                    


          NY239,535,890
v2

        

         


      

      
        13