Unassociated Document


     

    EXHIBIT 10.7

     

    
      
        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

                      Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

                      www.biocancell.com
      info@biocancell.com

                    


            

          

        

      

    

     

    AGREEMENT

     

    Between

     

    BioCancell
Therapeutics Ltd.

    Beck
Science Center, 8 Hartom St.

    Jerusalem
97775, Israel 

    (Hereinafter:
“BioCancell”)

     

    And
between

     

    BCG
Oncology P.C.

    16620 N
40th St. Suite E

    Phoenix,
Arizona, USA 85032

    (Hereinafter:
“the Clinical Trial
Site”)

     

    BioCancell
and the Clinical Trial
Site shall be hereinafter collectively referred to in this Agreement as
“Parties”; each
one of which also referred to as “Party”.

     

    
      	
              Whereas 

            	
              BioCancell
      has expressed its interest in carrying out, managing and funding the
      clinical trial the subject of which being “Phase 2b, Multicenter Trial of
      Intravesical DTA-H19/PEI in Patients with Intermediate-Risk Superficial
      Bladder Cancer”, bearing protocol no. Br.-07-01, a copy of which is
      attached as Appendix A hereto (hereinafter: “the Trial”);
      and

            
	 	 
	
              Whereas 

            	
              The
      Clinical
      Trial Site
      has declared it holds the proper facilities and staff required to perform
      the Trial, and that it is willing to put such facilities and staff at the
      disposal of BioCancell, for the purpose of performing the Trial;
      and

            
	 	 
	
              Whereas 

            	
              The
      Parties agree that BioCancell shall maintain any and all management
      authorities with regard to the performance of the Trial in all of its
      stages; and

            
	 	 
	
              Whereas 

            	
              BioCancell
      has agreed to pay the Clinical
      Trial Site
      the consideration, specified in Appendix C hereto, for the performance of
      all the undertakings of the Clinical
      Trial Site
      under this Agreement; all, according to the terms and conditions of this
      Agreement

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

    
       

      NOW, THEREFORE, it is
hereby declared and agreed between the parties as follows: 

       

      
        	1.	
                General

              


      

    

     

    
      	
            	1.1.	
              The
      preface and appendices to this Agreement constitute an integral part
      hereof.

            


    

     

    
      	
            	1.2.	
              Titles
      of the sections in this Agreement shall be used for terms of reference
      only, and could be used for the interpretation of this
      Agreement.

            


    

     

    
      	
            	1.3.	
              This
      Agreement contains the entire understanding of the Parties and the
      Principle Investigator with respect to the subject matter hereof, and
      supersedes all prior or pre-existing negotiations, declarations,
      presentations, commitments and/or agreements, whether written or oral,
      whether explicit or implied, between the Parties and the Principle
      Investigator, with respect to such subject
  matter.

            


    

     

    
      	
            	1.4.	
              In
      the event of a contradiction between this Agreement and any of the terms
      of its appendices, the terms and conditions of this Agreement shall
      prevail.

            


    

     

    
      	
            	1.5.	
              Anything
      in this Agreement denoting the singular shall also denote the plural, and
      anything denoting the feminine gender shall also denote the masculine
      gender, and vice versa, insofar as no other meaning is inferred by the
      context.

            


    

     

    
      	2.	
              Appendices

            


    

     

    The
appendices to the Agreement are:

     

    
      	
            	2.1.	
              Appendix
      A: The Trial Protocol

            


    

     

    
      	
            	2.2.	
              Appendix
      B: The Trial Personnel Clearance

            


    

     

    
      	
            	2.3.	
              Appendix
      C: The Consideration

            


    

     

    
      	
            	2.4.	
              Appendix
      D: The Trial Documents and Related
Activities

            


    

     

    
      	3.	
              Definitions

            


    

     

    In this
Agreement, the following terms shall have the specific meaning attributed to
them in the table below:

     

    
      	
              The Agreement
      

            	
              This
      agreement and its appendices.

            
	 	 
	
              Serious Adverse
      

            	
              As
      defined in the Trial Protocol and in the Guidelines.

            
	 	 
	
              Event Monitors
      

            	
              Any
      body or person/s nominated by, or representing BioCancell and/or any
      company of the BioCancell Group to monitor the Trial (i.e., conduct
      on-site audits for Good Clinical Practices compliance).

            
	 	 
	
              Completed CRF
      

            	
              A
      CRF having, according to the sole and absolute discretion of BioCancell
      and/or any third party appointed by BioCancell, no discrepancies in its
      details and no unanswered queries.

            
	 	 
	
              CRF 

            	
              Case
      Report Forms containing any and all data of the Subjects, which has been
      gathered during the Trial. The CRF shall be in hardcopy
      format.

            
	 	 
	
              The End of the
      Trial

            	
              The
      point in time, in which a Completed CRF has been submitted to BioCancell
      by the Principal Investigator, as defined herein, for all the Subjects
      participating in the Trial, or the date of termination of the Trial
      according to the terms and conditions of the Agreement; the earlier of the
      two.

            
	 	 
	
              FDA 

            	
              The
      United States of America Food and Drug
  Administration.

            


    

    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	
              The Helsinki
      Declaration

            	
              The
      1964 Declaration of Helsinki regarding the recommendations guiding
      physicians in bio-medical research involving human beings, as amended in
      Tokyo, 1975.

            
	 	 
	
              ICH-GCP

            	
              The
      International Conference on Harmonisation (ICH) E6 Good Clinical Practices
      (GCP) Guidelines.

            
	 	 
	
              IND

            	
              Investigational
      New Drug Application (US code of Federal Regulations 21 CFR Part
      312).

            
	 	 
	
              Inspector/s

            	
              Any
      inspecting body legally authorized to perform inspections in clinical
      trials, including, inter alia, the FDA or any other state regulated
      medical authority.

            
	 	 
	
              IRB

            	
              Institutional
      Review Board, a committee that operates in accordance with 21 CFR Part 56
      to provide oversight to the trial with respect to assurance of subject
      safety and subjects rights under the law who are participating in a
      research study.

            
	 	 
	
              Invention Rights
      

            	
              Any
      and all intellectual property rights, relating to the Trial Data or to the
      BioCancell Data, including, inter alia, the right to register and/or own
      any inventions stemming directly or indirectly from the Trial Data and/or
      the BioCancell Data. Without derogating from the generality of the above,
      the Invention Rights shall include, inter alia, patents, information,
      data, know-how, formulas, concepts, tests, drawings, specifications,
      applications, designs and trade secrets, methodologies, engineering and
      manufacturing processes and research processes, stemming directly or
      indirectly from the BioCancell Data, and/or the Trial
  Data.

            
	 	 
	
              Investigator
      Brochure

            	
              A
      document, which is submitted along with the Trial Protocol to the FDA; the
      content of which is outlined in the ICH-GCP Guidelines.

            
	 	 
	
              Publications

            	
              All
      publications, manuscripts, abstracts and papers relating directly or
      indirectly to the subject matter of the Trial, and which were initiated or
      composed directly or indirectly, in whole or in part, by the Principal
      Investigator and/or by the Clinical Trial Site and/or by any of the Trial
      Personnel.

            
	 	 
	
              BioCancell
      Data

            	
              Any
      and all information provided by BioCancell or by the BioCancell Group to
      the Clinical Trial Site, Principal Investigator or any member of the Trial
      Personnel with regard to the Trial, including, without limitation, the
      Trial Protocol and the Investigator Brochure which shall be the sole
      property of the BioCancell Group.

            
	 	 
	
              The BioCancell
      Group

            	
              The
      group of companies consisting of BioCancell Therapeutics, Inc and
      BioCancell Therapeutics Ltd.

            
	 	 
	
              The
      Product(s)

            	
              DTA-H19/PEI

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	
              The
    Reports

            	
              Any
      and all reports required by BioCancell, by any state regulated medical
      authority, or by any applicable laws, rules, regulations or
      guidelines.

            
	 	 
	
              The
    Subjects

            	
              A
      group of persons chosen by the Principal Investigator to participate in
      the Trial and who signed a written informed consent for the participation
      in the Trial, all according to the criteria established in the Trial
      Protocol.

            
	 	 
	
              The Trial
      Data

            	
              Any
      and all clinical data, technical information, records, files and materials
      relating to the Trial, including the Trial Documents, case report forms,
      source documents (such as subjects charts and physical notes), as well as
      other related data generated during or as a result of the Trial which
      shall be the sole property of the BioCancell Group.

            
	 	 
	
              Trial Documents
      

            	
              Any
      and all documents required by BioCancell, the FDA, the Clinical Trial Site
      or any applicable laws, rules, regulations or ICH-GCP,
      for the initiation, performance and completion of the Trial; without
      derogating from the generality of the above, the Trial Documents shall
      include any and all documents specified in Appendix D to this
      Agreement.

            
	 	 
	
              Trial
      Personnel

            	
              The
      medical and administrative staff involved in the Trial, including those
      who shall be employed by the Clinical Trial Site and cleared according to
      the undertaking attached to this Agreement as Appendix
  B.

            
	 	 
	
              The Trial
      Protocol

            	
              A
      document that describes the objective(s), design, methodology, statistical
      considerations, and organization of the Trial. The Trial Protocol usually
      also gives the background and rationale for the trial, but these could be
      provided in other protocol referenced documents. Throughout this Agreement
      the term Trial Protocol refers to the protocol and its amendments, which
      are attached to this Agreement as Appendix
A.

            


    

     

    
      	4.	
              Precedent
      Condition

            


    

     

    The
Parties hereby agree and undertake that the Agreement shall not enter into
effect before any of following cumulative approvals have been granted
(hereinafter: “the Approvals”):

     

    
      	
            	4.1.	
              The
      approval of the Trial Protocol by the Clinical Trial Site’s Institutional
      Review Board (IRB);

            


    

     

    
      	
            	4.2.	
              Thirty
      days after the submission of the Investigational New Drug (IND)
      Application to the FDA and no clinical hold letter issued by the FDA,
      and

            


    

     

    
      	
            	4.3.	
              The
      approval of the Agreement in general, its budget and Appendix C in
      particular.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	5.	
              The Principal
      Investigator

            


    

     

    
      	
            	5.1.	
              Donald
      Lamm, M.D. of the Clinical Trial Site (hereinafter: “the Principal
      Investigator”)
      has agreed to serve as the principal investigator of the
    Trial

            


    

     

    
      	
            	5.2.	
              The
      Principal Investigator undertakes to perform the Trial in compliance with
      the following: (a) the Trial Protocol, (b) ICH-GCP Guidelines, (c) the
      instructions and the terms specified in the approval of the Clinical Trial
      Site’s IRB, (e) the Helsinki Declaration, (f) US FDA Code of Federal
      Regulations (g) written instructions and prescriptions issued by
      BioCancell regarding the Trial and/or the Product; all as may be amended
      from time to time, and (h) the requirements in accordance with the FDA
      Form 1572 “Statement of
Investigator.”

            


    

     

    
      	
            	5.3.	
              The
      Principal Investigator has declared that he holds the professional ability
      and credentials required for performing the Trial in accordance with the
      Trial Protocol and any applicable laws, rules, regulations and guidelines,
      all as detailed above.

            


    

     

    
      	
            	5.4.	
              In
      the event that the Principal Investigator, for any reason whatsoever,
      shall be unable to conduct the Trial, or shall cease to be available for
      the performance of the undertakings set forth in this Agreement, the
      Clinical Trial Site shall use its best efforts to appoint, within 20 days,
      a successor investigator whose identity shall be approved in advance by
      BioCancell (the “Successor
      Investigator”).
      Such Successor Investigator shall undertake all the duties and
      responsibilities of the Principal Investigator as detailed in the
      Agreement. Should the Clinical Trial Site not be able to appoint a
      Successor Investigator, or if the appointed Successor Investigator is not
      acceptable by BioCancell, either party shall be entitled to terminate this
      Agreement forthwith and without further
  liability.

            


    

     

    
      	
            	5.5.	
              In
      the event of the replacement of the Principal Investigator, as described
      under this Section 5, the Principal Investigator shall have no claim
      towards BioCancell and/or the Clinical Trial Site and/or any third party
      acting on their behalf in direct or indirect connection with such
      replacement.

            


    

     

    
      	6.	
              Clinical Trial Site
      undertaking

            


    

     

    
      	
            	6.1.	
              The
      Clinical Trial Site represents that it has the requisite skills,
      knowledge, experience and human resources to undertake and conduct the
      Trial in accordance with the provisions of this
  Agreement

            


    

     

    
      	
            	6.2.	
              The
      Clinical Trial Site undertakes to perform the Trial in compliance with the
      following: (a) the Trial Protocol, (b) ICH-GCP Guidelines, (c) the
      instructions and the terms specified in the approval of the Clinical Trial
      Site’s IRB, (e) the Helsinki Declaration, (f) US FDA Code of Federal
      Regulations (g) written instructions and prescriptions issued by
      BioCancell regarding the Trial and/or the Product; all as may be amended
      from time to time.

            


    

     

    
      	
            	6.3.	
              The
      Clinical Trial Site hereby undertakes to furnish BioCancell, the Principal
      Investigator and all of the Trial Personnel with the facilities and
      personnel necessary for the adequate performance of the Trial according to
      the terms and

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    conditions
of the Trial Protocol, and to fully collaborate with the Principal Investigator,
BioCancell, and/or any other third party nominated by BioCancell, with regard to
performing its duties hereunder.

     

    
      	7.	
              BioCancell
      Undertaking

            


    

     

    
      	
            	7.1.	
              BioCancell
      hereby undertakes to allow the Principal Investigator to use the
      BioCancell Data, exclusively for the purpose of performing the Trial,
      during the Term of This Agreement and according to the terms and
      conditions of this Agreement.

            


    

     

    The
Principal Investigator shall strictly abide by any and all instructions given to
him by BioCancell with regard to the BioCancell Data, while recognizing that
BioCancell or any other company from the BioCancell Group was and shall remain,
during the Term of this Agreement and thereafter, the sole and exclusive owner
of any and all rights in the BioCancell Data and the Trial Data, and the use
thereof.

     

    
      	
            	7.2	
              BioCancell
      shall remunerate the Clinical Trial Site, the Principal Investigator and
      the Trial Personnel, according to the terms of Appendix C hereto, for all
      services rendered.

            


    

     

    
      	8.	
              Consideration

            


    

     

    In
consideration for the performance of all of the tasks, duties and undertakings
of the Principal Investigator, the Trial Personnel and the Clinical Trial Site
under this Agreement, BioCancell hereby undertakes to pay the Clinical Trial
Site the amount specified in Appendix C hereto, according to the installments,
timetable and manner specified therein.

     

    
      	9.	
              Product
      Supply

            


    

     

    
      	
            	9.1.	
              BioCancell
      will, at its own expense, supply to the Clinical Trial Site all necessary
      quantities of the drugs to be used in the Trial, and only for the purposes
      as described in the Protocol. Any surplus shall be returned to BioCancell
      without delay, upon completion of the Trial or termination of this
      agreement for any reason whichever is the
  earlier.

            


    

     

    
      	
            	9.2.	
              The
      Clinical Trial Site will ensure that the Product is managed and stored in
      accordance with GCP and with any special instructions issued by
      BioCancell. The Clinical Trial Site will maintain proper records of
      receipts, dispensing and returns of the
Product.

            


    

     

    
      	10.	
              Trial Personnel Compliance and
      Clearance

            


    

     

    
      	
            	10.1.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      exercise their best efforts so that
      the Trial Personnel shall abide by: (a) the Trial Protocol, (b) ICH-GCP
      Guidelines, (c) the instructions and the terms specified in the approval
      of the Clinical Trial Site’s IRB, (e) the Helsinki Declaration, (f) US FDA
      Code of Federal Regulations (g) written instructions and
      prescriptions

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    issued by
BioCancell regarding the Trial and/or the Product, all as may be amended from
time to time. 

     

    
      	
            	10.2.	
              Trial
      Personal Clearance:

            


    

     

    
      	
            	10.2.1.	
              The
      Clinical Trial Site and the Principal Investigator shall deploy all
      possible efforts to see to it that none of the Trial Personnel (including
      the Principal Investigator and any other investigators) are debarred by
      the FDA in any capacity whatsoever, and that none of the Trial Personnel
      appear in the FDA debarment list detailing all firms or persons debarred
      pursuant to Section 306 (a) and (b) of the Federal Food, Drug, and
      Cosmetic Act (21 U.S.C. 335 (a) and (b), as published in the Federal
      Registrar from time to time.

            


    

     

    
      	
            	10.2.2.	
              The
      Clinical Trial Site and the Principal Investigator shall provide
      BioCancell with the written confirmation thereof, in a form attached as
      Appendix B hereto.

            


    

     

    
      	11.	
              Compliance with the Trial
      Budget and Cooperation with BioCancell
    Subcontractors

            


    

     

    
      	
            	11.1.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      perform the Trial in accordance with the budget of the Trial, as such term
      is derived from Appendix C hereto (hereinafter: “the Trial
      Budget”)
      and not to deviate therefrom without the prior written approval of
      BioCancell in relation thereto.

            


    

     

    
      	
            	11.2.	
              The
      Clinical Trial Site hereby undertakes that any deviation from the Trial
      Budget without the prior written consent of BioCancell shall be born by
      the Clinical Trial Site.

            


    

     

    
      	
            	11.3.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      fully cooperate with any and all sub-contractors nominated by BioCancell
      for the purpose of the Trial, including, inter alia, clinical research
      organizations, logistics companies, laboratories,
  etc.

            


    

     

    
      	12.	
              Trial
      Documents

            


    

     

    
      	
            	12.1.	
              The
      Principal Investigator shall prepare and submit the Trial
      Documents.

            


    

     

    
      	
            	12.2.	
              The
      Principal Investigator shall perform all the activities specified in
      Appendix D hereto.

            


    

     

    
      	
            	12.3.	
              Any
      and all amendments to the Trial Protocol shall be performed only after
      securing the approval of BioCancell and the competent regulatory
      authority.

            


    

     

    
      	13.	
              Confidentiality

            


    

     

    
      	
            	13.1.	
              The
      Parties and the Principal Investigator hereby agree and undertake that
      they are aware that the BioCancell Data and the Trial Data (hereinafter,
      jointly and severally “the Confidential
      Information”)
      are confidential information, and that BioCancell has disclosed such
      Confidential Information to the Clinical Trial Site and Principal
      Investigator for the sole purpose of conducting the
  Trial.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	
            	13.2.	
              The
      Parties and the Principal Investigator hereby agree and undertake that
      they are aware that the Confidential Information is the sole and exclusive
      property of BioCancell and/or any other company from the BioCancell Group.
      Accordingly, The Principal Investigator shall retain the Confidential
      Information under the strictest safeguarding and not use, disclose or
      divulge the Confidential Information in part or in whole, directly or
      indirectly, for a period of seven (7)
years.

            


    

     

    
      	
            	13.3.	
              The
      Clinical Trial Site and the Principal Investigator shall maintain the
      confidentiality of the Confidential Information using the same degree of
      care used by them in relation to their own confidential information, and
      shall, without limitation, keep the Confidential Information in a safe and
      separate place and not make any copies thereof (whether in hardcopy or
      electronic file) unless first receiving BioCancell’s written
      consent.

            


    

     

    
      	
            	13.4.	
              The
      Clinical Trial Site and the Principal Investigator hereby further
      undertake to limit access to the Confidential Information to the Trial
      Personnel and any third parties on a
      “need to know basis” only, and cause such Trial Personnel and third
      parties to accept, in writing, the undertaking of the Principal
      Investigator in relation to the Confidential Information under this
      Agreement, as a condition precedent for receipt of any part of the
      Confidential Information.

            


    

     

    
      	
            	13.5.	
              At
      the request of BioCancell, the Clinical Trial Site and the Principal
      Investigator shall forthwith return to BioCancell the Confidential
      Information or any part thereof.

            


    

     

    
      	
            	13.6.	
              The
      Clinical Trial Site and the Principal Investigator hereby state that they
      are aware of the fact that any unauthorized disclosure or use of the
      Confidential Information shall cause immediate and/or irreparable injury
      to BioCancell, and that BioCancell cannot be adequately compensated for
      such injury in monetary damages. Thus, in order to safeguard BioCancell
      from any possible breach of confidentiality, the Principal Investigator
      and the Clinical Trial Site hereby undertake that BioCancell would he
      permitted to obtain, from any Court or Tribunal, any temporary or
      permanent injunction relief, necessary to prevent such unauthorized
      disclosure or use or peril thereof, and hereby renounce filing and/or
      submitting any objection to any request by BioCancell or by any company
      from the BioCancell Group, relating to such temporary or permanent
      injunction.

            


    

     

    
      	
            	13.7.	
              For
      the avoidance of any doubt, it is hereby clarified that such an
      undertaking is supplementary to and will not prejudice any right or
      remedy, which is or shall be available to BioCancell under any applicable
      law or agreement.

            


    

     

    
      	
            	13.8.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      exercise their best efforts to see to it that the Trial Personnel shall
      abide by the undertakings set forth in this Section
  13.

            


    

     

    
      	
            	13.9.	
              In
      the event that the Clinical Trial Site and the Principal Investigator are
      required by law, regulation, rule, act or order of any governmental
      authority or agency to disclose Confidential Information, they shall be
      entitled to do so provided that it shall first notify BioCancell of any
      such required disclosure, so

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    that
BioCancell may seek an appropriate protective order, and limit such disclosure
as far as is possible under applicable law. The Clinical Trial Site and the
Principal Investigator will reasonably cooperate with BioCancell in its efforts
to seek such a protective order. Such disclosure shall, however, not relieve the
Clinical Trial Site and the Principal Investigator of their other obligations
contained herein.

     

    
      	14.	
              Invention
      Rights

            


    

     

    
      	
            	14.1.	
              The
      Clinical Trial Site and the Principal Investigator hereby acknowledge that
      the idea and initiative for the Trial were exclusively those of
      BioCancell, and that the involvement of the Clinical Trial Site and the
      Principal Investigator in the Trial is strictly the consequence of their
      nomination by BioCancell.

            


    

     

    
      	
            	14.2.	
              The
      Parties and the Principal Investigator hereby irrevocably agree and
      undertake that the Confidential Information, except for medical records of
      the Subjects, is the exclusive property of BioCancell, may be freely
      utilized by BioCancell in any manner it sees fit. Notwithstanding the
      above, BioCancell shall have the right to review Subjects’ medical records
      to verify entries in the CRFs. BioCancell hereby undertakes full
      responsibility to ensure the safekeeping of patients’ confidentiality and
      personal data and shall be full responsible for taking every measure to
      apply this commitment.

            


    

     

    
      	
            	14.3.	
              The
      Parties and the Principal Investigator hereby irrevocably agree and
      undertake that the Invention Rights shall be the absolute and exclusive
      property of BioCancell and that BioCancell shall have unrestricted free
      right to use such Invention Rights.

            


    

     

    
      	
            	14.4.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      disclose to BioCancell any and all applicable information relating to
      Invention Rights and exercise their best efforts with regards to
      registration of the Inventions Rights on the name of BioCancell and/or a
      name designated in writing by BioCancell, if and to the extent requested
      to do so by BioCancell.

            


    

     

    
      	
            	14.5.	
              If
      by operation of law or for any reason, any Invention Rights to be owned by
      BioCancell pursuant to this Section 14 are not automatically deemed
      proprietary BioCancell upon their creation, the Clinical Trial Site and
      the Principal Investigator hereby further undertake to cause the Trial
      Personnel to irrevocably grant and assign all such intellectual property
      rights to BioCancell. The Clinical Trial Site warrants that it has and
      will continue to have agreements with its personnel, including any Trial
      Personnel, to effectuate the terms of this section and it shall enforce
      such agreements to provide BioCancell with the benefit of this
      section.

            


    

     

    
      	15.	
              Inspections

            


    

     

    
      	
            	15.1.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      allow the Monitors to perform monitoring visits in all sites related to
      the Trial, during or after the Trial, and assist the Monitors in their
      duties. For the avoidance of doubt, it is hereby clarified that the
      Monitors shall be entitled to monitor
and/or

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    inspect
among others the Trial Documents and Trial Data as well as to insure compliance
with the Trial Protocol.

     

    
      	
            	15.2.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      allow the Inspectors to perform inspections of all sites related to the
      Trial, during or after the Trial (and each such inspection shall
      hereinafter be referred to as: “an Inspection”), and to assist the
      Inspectors in their duties, if and to the extent requested to do so
      by the Inspectors.

            


    

     

    
      	
            	15.3.	
              The
      Clinical Trial Site and the Principal Investigator shall immediately
      inform BioCancell in the event of an Inspection and/or upon gaining
      knowledge of any intention to perform an Inspection. The Clinical Trial
      Site and the Principal Investigator shall provide BioCancell with copies
      of any inquiries, correspondence or communications to or from any such
      Inspectors.

            


    

     

    
      	16.	
              Publications

            


    

     

    
      	
            	16.1.	
              BioCancell
      covenants that it will not at any time, without first obtaining the
      consent in writing of the Clinical Trial Site (which consent may by
      refused or granted in its absolute discretion), use the Clinical Trial
      Site’s name or the name of the Principal Investigator or otherwise
      disclose the fact of their involvement in the performance of the Trial in
      any advertising, publicity or publication. However, BioCancell may use the
      name of the Clinical Trial Site and/or the Principal Investigator for
      listing the Trial on
clinicaltrials.gov.

            


    

     

    
      	
            	16.2.	
              Publication
      of the Trial and/or its results, in whole or in part, shall be within the
      sole and absolute discretion of BioCancell. The Clinical Trial Site, the
      Principal Investigator or the Trial Personnel, and any employees and/or
      officers and/or representatives of any of the foregoing shall not publish
      or refer to the Trial and/or its results, in whole or in part, without
      obtaining the prior consent BioCancell in writing. BioCancell reserves the
      right to reject any such request, at its sole discretion. For the
      avoidance of doubt BioCancell has the right, at all times, to publish any
      article or data generated from the services rendered under this
      Agreement.

            


    

     

    
      	17.	
              Reports

            


    

     

    
      	
            	17.1.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      submit the Reports to BioCancell and/or to competent
      authorities.

            


    

     

    
      	
            	17.2.	
              The
      Clinical Trial Site and the Principal Investigator hereby undertake to
      disclose in the Reports any and all data provided to them by BioCancell,
      in accordance with any applicable laws, rules, regulations and guidelines,
      including, inter alia, safety data.

            


    

     

    
      	
            	17.3.	
              The
      Clinical Trial Site will cause the Principal Investigator to provide
      BioCancell, within 45 (forty five) days of the end of each period of three
      (3) months during the period of the Trial, with a written report on the
      progress of the Trial in the said
period.

            


    

     

    
      	
            	17.4.	
              45
      (forty five) days following the End of the Trial, the Principal
      Investigator shall submit to BioCancell a summary report, which shall
      include, in a full and

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    detailed
manner, a declaration regarding the activities performed during the Trial and
the results obtained therein.

     

    
      	18.	
              Serious Adverse
      Event

            


    

     

    
      	
            	18.1.	
              In
      the event one or more of the Subjects sustains any Serious Adverse Event
      related to the Trial, the Principal Investigator shall inform BioCancell
      and the Clinical Trial Site’ IRB.

            


    

     

    
      	
            	18.2.	
              The
      Principal Investigator shall report such Serious Adverse Event in the
      timetable and manner prescribed in the Trial
  Protocol.

            


    

     

    
      	
            	18.3.	
              In
      the event of the occurrence of a Serious Adverse Event at another Clinical
      Trial Site that resulted in the submission of a Safety Report to the FDA,
      BioCancell will notify the Principal Investigator who in turn provide such
      notification to the Clinical Trial Site’
IRB.

            


    

     

    
      	19.	
              The Legal Status of the
      Clinical Trial Site and the Principal
  Investigator

            


    

     

    
      	
            	19.1.	
              The
      Parties and the Principal Investigator hereby agree that the relationship
      between BioCancell, on one hand, and the Clinical Trial Site and the
      Principal Investigator, on the other hand, are that of a client and an
      independent contractor, with the Clinical Trial Site and the Principal
      Investigator lacking any capacity whatsoever to legally bind BioCancell to
      a relationship of employer-employee, principal-agent or any other legal
      relationship differing from that of a client and an independent
      contractor.

            


    

     

    
      	
            	19.2.	
              Should
      any court of law rule in a manner opposed to Section 19.1 above, the
      Clinical Trial Site and the Principal Investigator, jointly and severally,
      hereby undertake to indemnify BioCancell with regards to the respective
      damage caused by each of them separately due to such a
    ruling.

            


    

     

    
      	20.	
              Term and
      Termination

            


    

     

    
      	
            	20.1.	
              This
      Agreement shall be in full force until the completion of the
      study.

            


    

     

    
      	
            	20.2.	
              The
      Parties may bring this Agreement to an early end at any time, in writing,
      by prior notice of at least 30 (thirty) days, upon the occurrence of one
      (or more) of the following events:

            


    

     

    
      	
            	20.2.1.	
              The
      FDA has placed the Trial on clinical
hold.

            


    

     

    
      	
            	20.2.2.	
              BioCancell
      decides upon its sole and absolute discretion to bring the Trial to an
      end. For the sake of good order, the Parties and the Principal
      Investigator hereby state and undertake that they are aware, and agree,
      that BioCancell is entitled to terminate this Agreement, upon its sole and
      absolute discretion, at any moment whatsoever; and in this case no party
      hereto shall have any claim whatsoever towards BioCancell and/or any other
      company from the BioCancell Group with regard to such early
      termination.

            


    

     

    
      	
            	20.2.3.	
              A
      Party and/or the Principal Investigator is found to be in breach of this
      Agreement and does not cure such breach within a period of 30
      (thirty)

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    days
following receipt of a notice in writing from any of the other Parties in
relation thereto.

     

    
      	
            	20.2.4.	
              A
      Party and/or the Principal Investigator enter into bankruptcy or
      liquidation proceedings or a receiver is appointed over part or all of
      their assets, and such proceedings are not ceased within a period of 45
      (forty five) days following receipt by such Party of a written notice in
      relation thereto from any or all of the other Parties.
  

            


    

     

    
      	
            	20.3.	
              In
      the event of termination of this agreement the Parties and the Principal
      Investigator shall bring the Trial to an end as
  follows:

            


    

     

    
      	
            	20.3.1.	
              Any
      and all Confidential Information and remaining supply of Product shall be
      returned to BioCancell.

            


    

     

    
      	
            	20.3.2.	
              The
      Parties and the Principal Investigator shall cooperate in swiftly
      dispersing the Subjects and Trial Personnel, if the need arises, while
      preserving the latest Trial Data and providing as many Completed
      CRF’s as
      possible, and all to the satisfaction of
  BioCancell.

            


    

     

    
      	
            	20.4.	
              The
      obligation of the Parties and the Principal Investigator pursuant to
      sections 13, 14, 16, 17, and 21 shall survive termination of this
      Agreement.

            


    

     

    
      	21.	
              Insurance and
      Indemnification

            


    

     

    
      	
            	21.1.	
              BioCancell
      has agreed to insure the Subjects, the Trial Personnel, the Principal
      Investigator and the Clinical Trial
Site.

            


    

     

    
      	
            	21.2.	
              BioCancell
      has agreed to indemnify the Trial Personnel, the Principal Investigator
      and the Clinical Trial Site according to the terms of Sub-Section 21.3
      below (hereinafter each of them shall also be referred to as: the
      “Indemnitee”)
      for damages arising as a direct result of their involvement in the
      performance of the Trial (hereinafter: the “Damages”),
      provided that the damages are not as a result of an expected side effect
      of the Products and subject to the conditions detailed
    herein:

            


    

     

    
      	
            	21.2.1.	
              The
      Damages are not caused as a result of negligence or misconduct of the
      Indemnitee;

            


    

     

    
      	
            	21.2.2.	
              The
      Indemnitee performed the Trial in accordance with the Trial Protocol and
      the additional requirements set in this
  Agreement;

            


    

     

    
      	
            	21.3.	
              Promptly
      after receipt by the Indemnitee of a notice of the commencement of any
      claim, action, suit, proceeding or investigation in respect of which
      indemnity may be sought pursuant to this Section 21 (hereinafter: the
      “Claim”),
      the Indemnitee shall provide a notice to BioCancell, in writing,
      describing in reasonable detail the facts and circumstances upon which the
      asserted Claim for indemnification is based, and shall thereafter keep
      BioCancell reasonably informed with respect thereto. BioCancell shall have
      the right to assume the defense of any Claim, at its sole discretion. In
      any event, the Indemnitee shall cooperate with BioCancell in the defense
      of any Claim for which BioCancell assumes the defense. BioCancell shall
      not be liable for the settlement by the Indemnitee of any Claim affected
      without the consent of BioCancell.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    BioCancell
shall be entitled to enter into any settlement of a Claim at its sole
discretion.

     

    
      	22.	
              Notices

            


    

     

    
      	
            	22.1.	
              Notices
      to be given by one Party to another shall be in the English language, and
      shall be deemed properly given if reduced to writing and transmitted to
      the Party’s address appearing on the first page of this Agreement, by air
      courier or by certified registered mail - all to be effective 3 (three)
      days after their sending date, or by facsimile with confirmation receipt -
      to be effective at the first business day following the date of
      transmission.

            


    

     

    
      	
            	22.2.	
              However,
      a notice shall be considered properly given, only in case a copy thereof
      was communicated as follows:

            


    

     

    
      	
              Notice
      to BioCancell

            	
              Notice
      to Clinical Trial Site

            
	
              BioCancell
      Therapeutics Ltd.

            	
              BCG
      Oncology

            
	
              Beck
      Science Center, 8 Hartom St.

            	
              16620
      N 40th. St. Suite E

            
	
              Jerusalem,
      97775 Israel

            	
              Phoenix,
      AZ 85032

            
	
              Attn:
      Ran Vigdor

            	
              Attn:
      Dr. Donald Lamm

            
	
              Director,
      Strategic Alliances

            	
              Principal
      Investigator

            
	
              Telephone:
      +972-2-548-6555

            	
              Telephone:
      (602) 493-6626

            
	
              Facsimile:
      +972-2-548-6550

            	
              Facsimile:
      (602) 996-1383

            


    

     

    
      	
            	22.3.	
              The
      addresses of the Parties, listed in page 1 of this Agreement, shall be
      subject to any change of such address notified in writing by one Party to
      the other, according to the procedure stipulated in this
      Section

            


    

     

    
      	23.	
              Miscellanies

            


    

     

    
      	
            	23.1.	
              Expenses
      of the Parties. Each Party and the Principal Investigator shall bear all
      its own expenses, including the expenses of its attorneys, in connection
      with the negotiation, execution and performance of this
      Agreement.

            


    

     

    
      	
            	23.2.	
              Waiver
      and forbearance. No rights of any Party shall be prejudiced or restricted
      by any indulgence or forbearance, to any other person or entity, and no
      waiver by any Party in respect of any breach shall operate as a waiver in
      respect of any subsequent breach.

            


    

     

    
      	
            	23.3.	
              Governing
      law and jurisdiction. This Agreement shall be exclusively governed by the
      Laws of the State of Israel. Any and all disputes arising hereunder shall
      be resolved by a competent court having jurisdiction over such matters in
      the Tel-Aviv Jaffa District, Israel

            


    

     

    
      	
            	23.4.	
              Assignment.
      This Agreement shall not be assigned, without the prior written consent of
      all of the other Parties, save for an assignment of rights by BioCancell
      to any company within the BioCancell
Group.

            


    

     

    
      	
            	23.5.	
              Counterparts.
      This Agreement and any amendment hereto may be executed in multiple
      counterparts, each of which shall be deemed an original agreement and all
      of which shall constitute one and the same
  agreement.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	
            	23.6.	
              Amendments.
      Modification or amendment to this Agreement shall only be valid if
      performed by a written instrument, signed by all Parties to this
      Agreement.

            


    

     

    
      	
            	23.7.	
              Severability.
      If any provision of this Agreement is determined by a court of competent
      jurisdiction to be invalid, illegal, or unenforceable, that determination
      shall not affect any other provision of this Agreement, and each such
      other provision shall be construed and enforced as if the invalid,
      illegal, or unenforceable provision were not contained
    herein.

            


    

     

    [Remainder of page left
intentionally blank. Signature page follows.]

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly
executed and each of the undersigned hereby warrants and represents that he or
she has been and is, on the date of this Agreement, duly authorized by all
necessary and appropriate action to execute this Agreement.

     

    IN
WITNESS WHEREOF, the parties have executed this Agreement as at the date first
above written:

     

    
      	
              BioCancell
      Therapeutics Ltd.

            	 	
              BCG
      Oncology, P.C.

            
	 	 	 
	
              By:

            	
              /s/
      Avi Barak

            	 	
              By:

            	
              /s/
      Mary Heeley

            
	
              Print
      Name: Avi Barak

            	 	
              Print
      Name: Mary Heeley

            
	
              Title:
      Chief Executive Officer

            	 	
              Title:
      Clinical Research Coordinator

            
	 	 	 
	
              By:

            	
              /s/
      Patricia Ohana

            	 	 	 
	
              Print
      Name: Patricia Ohana

            	 	 
	
              Title:
      VP Clinical Trial

            	 	 


    

     

    I the
undersigned, Dr. Donald Lamm, hereby declare and confirm that I have read
and understood the Agreement. I hereby agree to be appointed as the Principal
Investigator of the Trial on behalf of the Clinical Triad Site, and accept and
undertake to comply with all the terms, conditions, provisions, instructions and
stipulations set forth in the Agreement, including, without limitation,
provisions referring to the Parties.

     

    
      	
              /s/
      Donald Lamm

            	 	 	 
	
              The Principal
      Investigator

            	 	 


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    Appendix
A

     

    The Trial
Protocol

    See attached
separately

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    Appendix
B

     

    The Trial Personnel
Clearance 

    An Undertaking with regard
to a Clinical Trial’s Personnel

     

    We, the
undersigned, hereby warrant and undertake in relation of clinical trial bearing
protocol number BC-07-01, researching "Phase 2b, Multicenter Trial of
Intravesical DTA-H19/PEI in Patients with Intermediate-Risk Superficial Bladder
Cancer”, that we have not, we do not and we will not use nor employ, in any
capacity, the services of any person debarred under Section 306 (a) or (b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335 (a) and (b)), or
debarred under the Israeli Physicians Ordinance [New Version], 1976 or pursuant
to any other applicable law.

     

    
      	
              /s/
      Donald Lamm

            	 	
              /s/
      BCG

            
	
              The
      Principal Investigator

            	 	
              The
      Clinical Trial Site

            


    

    


    11/12/2007

    Date

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    Appendix
C

     

    The
Consideration

     

    
      	1.	
              Terms and
      Definitions

            


    

     

    In this
Appendix C terms shall have the meaning assigned to them in the Agreement. The
following terms shall have the meanings assigned to them hereunder:

     

    
      	
              Complete
      Screening

            	
              A
      Screening of a Subject in which all examinations and/or tests and/or
      treatment and/or evaluations included in the Screening process, as
      detailed in the Trial Protocol, have been performed and the data collected
      and registered in the CRF

            
	 	 
	
              Complete Evaluation Visit or
      Complete Treatment Visit

            	
              A
      Visit of a Participating Subject in which all examinations and/or tests
      and/or treatment and/or evaluations scheduled for the visit have been
      performed, as detailed in the Trial Protocol, and the data collected and
      registered in the CRF 

            
	 	 
	
              Evaluation
      Visit

            	
              Any
      Visit, as defined below, of visits 7, 11, 15, and 19 as these visits are
      numbered and defined in the Trial Protocol.

            
	 	 
	
              Participating
      Subject

            	
              A
      Subject who that has undergone Screening, as defined below, and was
      determined to meet the requirements specified in the Trial protocol
      and who is participating in the Trial according to the terms and
      conditions of the Trial Protocol

            
	 	 
	
              Screening

            	
              A
      series of tests and examinations as defined in table 4 of the Trial
      Protocol designed to evaluate a Subject’s suitability for participating in
      the Trial, as detailed in the Trial Protocol.

            
	 	 
	
              Treatment Visit
      

            	
              Visits
      during which treatment assessments are performed but for which clinical
      laboratory specimens are not collected as defined in the clinical protocol
      including visits scheduled for Weeks 1-3, 5-6, 11-12,
    23-24.

            
	 	 
	
              Treatment visit with Clinical
      Labs 

            	
              Visits
      during which treatment assessments are performed and for which clinical
      laboratory specimens are collected as defined in the clinical protocol
      including visits scheduled for Weeks 4, 13, 25, and 37

            
	 	 
	
              Clinical Response
      Visit

            	
              Visit
      in which disease assessments are performed as defined in the clinical
      protocol including visits scheduled for Weeks 9, 22, 34, and
      46.

            
	 	 
	
              US $ 

            	
              United
      States Dollars

            


    

     

    
      	2.	
              The
      Consideration

            


    

     

    
      	
            	2.1.	
              In
      consideration for the performance, in good faith, by the Principal
      Investigator and the Clinical Trial Site, of all of their undertakings
      under this Agreement, BioCancell hereby undertakes to pay to the Clinical
      Trial Site the following amounts:

            


    

     

    
      	
            	2.1.1.	
              An
      amount of US $1020 (one thousand and twenty US dollars) for a Complete
      Screening of every Subject; and

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	
            	2.1.2.	
              An
      amount of US $762 (seven hundred and sixty two US Dollars) for a Complete
      Treatment Visit of every Participating Subject;
  and

            


    

     

    
      	
            	2.1.3.	
              An
      amount of US $882 (eight hundred eighty two US dollars) for a Treatment
      visit with Clinical Labs of every Participating
  Subject;

            


    

     

    
      	
            	2.1.4.	
              An
      amount of US $630 (eight hundred eighty two US dollars) for a Clinical
      Response Visit for every Participating Subject
  and

            


    

     

    
      	
            	2.1.5.	
              A
      one time fee of $4,500 for Phase 2
insurance.

            


    

     

    In
addition, the following procedures will be invoiced if the procedure is not
covered by the patient’s insurance or if the patient is uninsured.

     

    
      	
              Office
      Cystoscopy

            	 	
              $

            	
              646.15

            	 
	
              Office
      Biopsy

            	 	
              $

            	
              745.82

            	 
	
              Bostwick
      Biopsy Reading

            	 	
              $

            	
              190.00

            	 
	
              Bostwick
      Urine cytology

            	 	
              $

            	
              440.00

            	 
	
              Hospital
      Cystoscopy with Biopsy

            	 	 	 	 
	
              (estimate)

            	 	
              $

            	
              l,300.00

            	 


    

     

    
      	3.	
              Limitation of
      Payments

            


    

     

    
      	
            	3.1.	
              For
      the avoidance of doubt, it is hereby declared and agreed that BioCancell
      shall not pay any additional payments or any other amounts, which are not
      clearly mentioned and specified in section 2
  above.

            


    

     

    
      	
            	3.2.	
              It
      is further clarified that the amounts specified in section 2 above include
      payment by BioCancell for all services rendered from the Clinical Trial
      Site including but not limited to office services, Trial Personal required
      for performing the Trial including the Principal Investigator, physicians,
      nurses, receptionists and study coordinator, use of the Clinical Trial
      Site’s facilities, and all tests, procedures, examinations and evaluations
      as detailed in the Trial protocol.

            


    

     

    
      	
            	3.3.	
              The
      considerations do not include cost of clinical laboratory hematology,
      chemistry, or urinalysis which will be performed by BioCancell’s
      sub-contractor/s or shipment of slides to BioCancell for
      analysis.

            


    

     

    
      	4.	
              Terms of
      Payment

            


    

     

    
      	
            	4.1.	
              The
      Clinical Trial Site shall send an invoice at the end of each calendar
      quarter (31 March, 30 June, 30 September, and 31 December) detailing the
      Complete Screening, Complete Treatment Visits and Complete Evaluation
      Visits (together hereinafter: “Complete
      Visits”)
      performed as well as on which Subjects or Participating Subjects the
      relevant Complete Visit was
performed.

            


    

     

    
      	
            	4.2.	
              Payments
      detailed in section 2.1.4 and 2.1.5 shall be conditioned upon payment for
      Complete Visits and shall be included in the first invoice sent by the
      Clinical Trial Site.

            


    

     

    
      	
            	4.3.	
              Payment
      shall be maid by BioCancell within 30 (thirty) days of receipt of the
      Clinical Trial Site’s invoice.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	
            	4.4.	
              All
      Payments shall be performed in the last day of the calendar year during
      which the relevant payment date occurred. (Occurrence of the relevant
      payment date shall be at the termination and completion of the stage and
      conditions of which entitles the Clinical Trial Site for payment according
      to this Appendix C).

            


    

     

    
      	
            	4.5.	
              Immediately
      upon receiving the payment as per the issued invoice the Clinical Trial
      Site will provide BioCancell with a receipt approving the
      payment.

            


    

     

    
      	5.	
              Currency of
      Payments

            


    

     

    All of
the payments subject of this Appendix C shall be performed by BioCancell to the
Clinical Trial Site in US$.

     

    
      	6.	
              General Observations and
      Clarifications

            


    

     

    For the
sake of good order it is hereby clarified that, unless otherwise agreed upon in
writing by BioCancell:

     

    
      	
            	6.1.	
              No
      payment would be performed for any activities performed by the Principal
      Investigator and/or by the Clinical Trial Site, prior to the commencement
      of the Trial.

            


    

     

    
      	
            	6.2.	
              Without
      derogating from any right of BioCancell, in the event that no Completed
      CRF’s are provided to BioCancell, regarding a Subject, in relation to
      which BioCancell has performed payments to the Clinical Trial Site,
      BioCancell shall be entitled to perform one of the following three,
      according to its absolute
discretion:

            


    

     

    
      	
            	6.2.1.	
              Write-off
      the amount paid by BioCancell in relation to Subject(s) for which no
      Completed CRFs have been provided (hereinafter: “the Return
      Amount”)
      from the amount remaining due to the Clinical Trial Site by BioCancell
      according to this Agreement (hereinafter: “the Remaining
      Amount”).

            


    

     

    
      	
            	6.2.2.	
              Order
      the Clinical Trial Site, in writing, to pay BioCancell the Return Amount
      within a period no longer than 45 (forty-five) days from the End of the
      Trial. The Clinical Trial Site hereby undertakes that it shall pay the
      Return Amount, as specified above, and renounces any contentions and/or
      claims whatsoever in relation
thereto.

            


    

     

    
      	
            	6.2.3.	
              In
      the event that the Return Amount shall exceed the Remaining Amount,
      BioCancell shall be entitled to exercise its rights under the above
      sub-sections 6.3.1 and 6.3.2 in concert, to the extent that BioCancell
      shall fully collect the Return Amount from the Clinical Trial
      Site.

            


    

     

    
      	
            	6.3.	
              No
      advance payments would be performed by BioCancell to the Clinical Trial
      Site.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    Appendix
D

     

    The Trial Documents and
Related Activities

     

    The Trial
Documents shall include, inter alia, all the documents set forth in the
Guidelines, as well as the documents specified hereunder.

     

    Any and
all terms not specifically defined in this Appendix shall have the meaning
attributed to them in the Agreement.

     

    Prior to the initiation of the Trial:


     

    
      	1.	
              The
      executed signature page of the Trial Protocol;
  and

            


    

     

    
      	2.	
              Investigator
      Brochure; and

            


    

     

    
      	3.	
              The
      current curriculum vitae of the Principal Investigator;
  and

            


    

     

    
      	4.	
              The
      list of all sub-investigators, all of which necessarily being listed on
      either the FDA form no. 1572, or on the Principal Investigator's Statement
      Form; and

            


    

     

    
      	5.	
              The
      written approval of the Clinical Trial Site Institutional Review Board,
      indicating that it has reviewed and approved the Trial Protocol;
      and

            


    

     

    
      	6.	
              The
      written approval of the Clinical Trial Site Institutional Review Board
      with regards to the content of all publicity and advertisements, related
      to the Trial, which are to be performed prior to the commencement of the
      Trial; and

            


    

     

    
      	7.	
              A
      list of all participants in the Institutional Review Board, convened in
      relation to the Trial (hereinafter: “the Institutional Review
      Board”);
      and

            


    

     

    
      	
            	7.1.	
              Should
      the Principal Investigator be a member of the Institutional Review Board,
      the written Statement of the chairman of the Institutional Review Board
      confirming that the Principal Investigator did not participate in the
      voting, relating to the Trial, during the hearing of the said
      Institutional Review Board; and

            


    

     

    
      	
            	7.2.	
              A
      financial disclosure form, confirming that the Principal Investigator
      holds no financial interests in
BioCancell.

            


    

     

    While conducting the
Trial:

     

    
      	1.	
              A
      review of all the Trial Documents and verification the accuracy and
      completeness thereof in relation to the source documents, on which the
      above documents were based; and

            


    

     

    
      	2.	
              Preparation
      os such reports as required by the Clinical Trial Site’s
    IRB.

            


    

     

    
      	3.	
              Reporting
      of Serious Adverse Events to the Sponsor in accordance with the Clinical
      Protocol.

            


    

     

    
      	4.	
              Maintain
      adequate records of Subjects identification, clinical observations, as
      well as study drug receipt and dispensation (hereinafter: “the
      Records”),
      in accordance with any applicable laws, rules, regulations and guidelines,
      as amended from time to time. In any event, the Principal Investigator and
      BioCancell shall maintain the Records for a period of no less than 2 (two)
      years following the submission of the Biologics License Application to the
      FDA for licensure of the Product.

            


    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    
      	
              

            	
              8
      Hartom St, Jerusalem Israel 97775

              Phone:
      +972-2-548-6555 Fax: +972-2-548-6550

              www.biocancell.com
      info@biocancell.com

            


    

     

    
      	5.	
              Compare
      the data in the CRF with the source documents relating to each subject
      participating in the Trial, and confirm the accuracy of the CRF;
      and

            


    

     

    
      	6.	
              Maintain
      a log, documenting the Product(s) provided to each subject during the
      Trial; and

            


    

     

    
      	7.	
              Report
      no later than 7 (seven) days before additional quantities of Product(s)
      are required to proceed with the
Trial.

            


    

     

    
      	8.	
              Complete
      all CRFs

            


    

     

    
      	9.	
              Re-validate
      the approval of the relevant IRB, within a reasonable time prior to its
      expiration date.

            


    

     

    
      	10.	
              A
      written detailed periodic report on the progress of the Trial in the said
      period (section 17.3 of the
Agreement).

            


    

     

    At the end of the
Trial:

     

    
      	1.	
              All
      Completed CRFs;

            


    

     

    
      	2.	
              A
      summary report, which shall include, in a full and detailed manner, a
      declaration regarding the activities performed during the Trial and the
      results obtained therein (section 17.4 of the
  Agreement).