Unassociated Document


    
      
        
          	
                  

                	
                  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

    


    Hadasit
Medical Research Services and Development Ltd.

    Hadassah
Ein-Kerem Hospital

    P.O.Box
12000

    Jerusalem,
Israel

    


    (Hereinafter:
“the Medical
Center”)

     

    BioCancell
and the Medical Center 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. BC-07-01, a copy of which is
      attached as Appendix A hereto (hereinafter: “the Trial”); and

              
	 
      	 	 
      
	
                Whereas

              	 	
                The
      Medical Center is a wholly owned subsidiary of Hadassah Medical
      Organization (hereinafter: “HMO”) and is authorized
      to enter this Agreement and to utilize HMO’s
      facilities, employees and agents for the purpose of this Agreement;
      and

              
	 
      	 	 
      
	
                Whereas

              	 	
                The
      Medical Center wishes to conduct the Trial, and has declared that HMO
      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 the management authorities
      with regard to the performance of the Trial in all of its stages subject
      to the Protocol, HMO internal procedures and Privacy limitations;
      and

              


      

    

     

    
      Hadassah–agreement

    


    
      
         


      

      
         


        
          

        

      

      
         


      

    

    

      
        
          
            	
                    

                  	
                    8
      Hartom St, Jerusalem Israel 97775

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

                    www.biocancell.com info@biocancell.com

                  


          

        

      

       

    

    
      
        	
                Whereas

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

              


      

    

     

    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 not 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, whereas on medical issues, the Protocol (Appendix A) prevails
      this Agreement.

              


      

      
        	
                
                

              	
                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: Schedule 4 of the Guidelines.

              


      

      
        	
                
                

              	
                2.5.

              	
                Appendix
      E: 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).

                      


              

            

          

        

      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        
          	
                  Completed
      CRF

                	 	
                  A
      CRF having, according to the 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.

                
	
                  The
      Guidelines

                	 	
                  Ministry
      of Health guidelines entitled “Clinical Trials of Human Subjects” as may
      be amended and modified from time to time.

                
	
                  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

                	 	
                  Harmonized
      Tripartite Guideline for Good Clinical Practice as may be amended and
      modified from time to time.

                
	
                  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 MOH, FDA or any other state regulated
      medical authority.

                
	
                  Invention
      Rights

                	 	
                  (i)
      Any and all intellectual property rights, relating to the Trial Data
      and/or to the BioCancell Data, including, inter alia, all data, reports,
      inventions, discoveries, formulas, concepts, tests, drawings,
      specifications, applications, designs and trade secrets, methodologies,
      engineering and manufacturing processes and research processes or results
      generated, arrived at, developed or reduced to practice by the Medical
      Center and/or the Principal Investigator during the course of, or arising
      from the Trial, the right to register and/or own any inventions stemming
      directly or indirectly from the Trial Data and/or the BioCancell Data,
      with the exception of Trial Subjects personal and confidential medical
      records and hospital records.

                
	 
      	 	
                  (ii)
      All patents, copyrights, know-how, trademarks, and other intellectual
      property in and/or covering such data, reports, invention, discoveries and
      results as referred to above.

                
	
                  Investigator
      Brochure

                	 	
                  A
      document, which is submitted along with the Trial Protocol to the relevant
      Helsinki Committee and FDA, and the content of which is outlined in the
      GCP Guidelines.

                


        

      

       

      Hadassah–agreement

      


      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      


      
        
          
            	
                    

                  	
                    8
      Hartom St, Jerusalem Israel 97775

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

                    www.biocancell.com info@biocancell.com

                  


          

        

      

       

      
        
          	
                  Medical
      Center Helsinki Committee

                	 	
                  A
      committee appointed pursuant to the National Health Regulations and whose
      role is to approve any and all medical experiments on humans conducted by
      the Medical Center.

                
	
                  Ministry
      of Health Approval

                	 	
                  Approval
      from the Director General of the Ministry of Health, or whomever he/she
      has delegated the authority to for this purpose, for the performance of
      the Trial at the Medical Center, according to the National Health
      Regulations and the Guidelines.

                
	
                  Ministry
      of Health / MOH

                	 	
                  The
      Israeli Ministry of Health.

                
	
                  National
      Health Regulations

                	 	
                  Israel
      National Health Regulations (Clinical Trials on Human Subjects), 1980 as
      may be amended from time to time.

                
	
                  Publications

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

                
	
                  The
      BioCancell Data

                	 	
                  Any
      and all information provided by BioCancell or by the BioCancell Group to
      the Medical Center, 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
      Guidelines

                	 	
                  Ministry
      of Health guidelines entitled “Clinical Trials of Human Subjects” as may
      be amended and modified from time to time.

                
	
                  The
      Product(s)

                	 	
                  DTA-H19/PEI

                
	
                  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, and be subject to
      confidentiality obligations imposed under the Guidelines and ICH-GCP and
      National Health Regulations.

                


        

      

       

      Hadassah–agreement

      


      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      


      
        
          
            	
                    

                  	
                    8
      Hartom St, Jerusalem Israel 97775

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

                    www.biocancell.com info@biocancell.com

                  


          

        

      

       

      
        
          	
                  Trial
      Documents

                	 	
                  Any
      and all documents required by BioCancell, the MOH, the Medical Center or
      any applicable laws, rules, regulations or guidelines, 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 E to this Agreement subject to
      confidentiality obligations imposed under the Guidelines and ICH-GCP and
      National Health Regulations.

                
	
                  Trial
      Personnel

                	 	
                  The
      medical and administrative staff involved in the Trial, including those
      who shall be employed by HMO 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
      Conditions

              


      

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

      
        	
                
                

              	
                4.1.

              	
                The
      approval of the Trial Protocol by the Medical Center Helsinki Committee
      and the MOH, if such approval is required by the Guidelines;
      and

              


      

      
        	
                
                

              	
                4.2.

              	
                The
      approval of the Agreement in general, its budget and Appendix C in
      particular, by the MOH and the committee of engagement with commercial
      companies in accordance Section 9 of the Guidelines;
  and

              


      

      
        	
                
                

              	
                4.3.

              	
                The
      approval of the Trial Protocol, Investigator Brochure and related
      documents by the FDA.

              


      

       

      
        	
                5.

              	
                The
      Principal Investigator

              


      

      
        	
                
                

              	
                5.1.

              	
                Dr.
      Vladimir Yutkin MD, of HMO (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) the Guidelines, (c) the
      instructions and the terms specified in the approval of the Medical Center
      Helsinki Committee, (d) the ICH-GCP, (e) the Helsinki Declaration, (f) the
      applicable laws, rules and regulations regulating such studies which are
      applicable in Israel, (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.” Every PI at each site must sign
      this form for submission to the
FDA.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
                
                

              	
                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
      Medical Center shall use its best efforts to appoint, within 30 days of
      the Investigator becoming unable to conduct the Trial, a suitably
      qualified 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 Medical Center 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 and at no cost to Biocancell, save for any payments for work
      already performed and for documented out-of-pocket costs arising from
      non-cancellable commitments incurred prior to such
      termination.

              


      

      
        	
                
                

              	
                5.5.

              	
                In
      the event of the replacement of the Principal Investigator, as described
      under this Section 5.4, the Principal Investigator shall have no claim
      towards BioCancell and/or the Medical Center and/or any third party acting
      on their behalf in direct or indirect connection with such
      replacement.

              


      

       

      
        	
                6.

              	
                Medical
      Center undertakings

              


      

      
        	
                
                

              	
                6.1.

              	
                The
      Medical Center represents that HMO has the requisite skills, knowledge,
      experience, facilities, resources and appropriately qualified human
      resources to undertake and conduct the Trial in accordance with the
      provisions of this Agreement.

              


      

      
        	
                
                

              	
                6.2.

              	
                The
      Medical Center and HMO undertake that the Trial shall be conducted in an
      efficient, diligent, professional and timely manner and in compliance with
      the following: (a) the Trial Protocol, (b) the Guidelines, (c) the
      instructions and the terms specified in the approval of the Medical Center
      Helsinki Committee, (d) the ICH-GCP, (e) the Helsinki Declaration, (f) the
      applicable laws, rules and regulations regulating such studies which are
      applicable in Israel, and (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
      Medical Center and the Principal Investigator shall conduct the Trial and
      maintain records and data during and after the term of this Agreement in
      compliance with all applicable laws, rules, regulations and guidelines and
      the requirements of any governmental authority regulating such
      trials.

              


      

      
        	
                
                

              	
                6.4.

              	
                The
      Medical Center and HMO hereby undertake 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 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.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
                7.

              	
                BioCancell
      Undertakings

              


      

      
        	
                
                

              	
                7.1.

              	
                BioCancell
      hereby undertakes to allow the Principal Investigator to use the BioCancell
      Data, on a need-to-know basis, 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 Medical Center, the Principal Investigator and the
      Trial Personnel, according to the terms of Appendix C hereto, for all
      services rendered.

              


      

      
        	
                
                

              	
                7.3.

              	
                BioCancell
      represents that it is the sole owner of any and all intellectual property
      rights of the Product and that the execution and delivery of this
      Agreement does not infringe any third parties rights and/or any
      law.

              


      

       

      
        	
                8.

              	
                Parties
      Mutual Undertakings

              


      

      
        	
                
                

              	
                8.1.

              	
                The
      Principal Investigator will be responsible for obtaining the written
      informed consent of each of the Subjects, or his or her authorized legal
      representative, before his or her participation in the Trial. The form of
      the informed consent shall be drafted by BioCancell and approved by the
      Principal Investigator. 

                Without
      derogating from the generality of the foregoing, it is agreed that such
      informed consent shall be obtained: (i) in circumstances in which the
      prospective Subject (or his or her representative as aforesaid) is given
      reasonable and sufficient opportunity to consider whether or not to
      participate in the Trial and which minimize the possibility of coercion
      and/or undue influence; and (ii) in compliance with all applicable laws,
      regulations, standards and
guidelines.

              


      

      
        	
                
                

              	
                8.2.

              	
                All
      Parties to this Agreement undertake securing all individually identifiable
      health information and keeping that information with the highest possible
      degree of confidentiality and protection from disclosure. Accordingly, all
      Subjects identifiable health information shall at all times be treated as
      confidential by all parties involved in the execution of the Trial in
      accordance with the Applicable Laws and any regulations and rules
      promulgated subsequently. The Parties agree to take such additional steps
      and/or to negotiate such amendments to this Agreement as may be required
      to ensure compliance with any laws, the Guidelines and Regulations and any
      rules promulgated subsequently. Any such amendment must be informed by
      either Party to the other Party.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
                
                

              	
                8.3.

              	
                Without
      derogating from the aforesaid, the Investigator shall notify Biocancell at
      the earliest possible time of any deviations from the Trial Protocol that
      are necessary to protect the safety, rights or welfare of the
      Subjects.

              


      

      
        	
                
                

              	
                8.4.

              	
                It
      is hereby agreed that any undertaking of the Medical Center and/or HMO and
      its employees, including the Principal Investigator hereunder whatsoever,
      is subject to any restrictions and/or limitations deemed necessary by the
      Medical Center and/or HMO and its employees, including the Principal
      Investigator in their sole discretion, to comply with the above
      provisions. It is hereby made expressly clear that no Subjects’ 
      identifiable information will be provided, or made available, to
      BioCancell or any party acting on its behalf, without prior written
      consent of the Subject.

              


      

      
        	
                
                

              	
                8.5.

              	
                Nothing
      contained in this Agreement shall be construed as a warranty by the
      Medical Center and/or HMO and its employees, including the Principal
      Investigator, that the results of the Trial will be useful or commercially
      exploitable or of any value whatsoever. In addition, and without
      derogating from the aforementioned the Medical Center and/or HMO and its
      employees, including the Principal Investigator disclaim all warranties,
      either express or implied, with respect to the Trial and any products,
      including the Product, that incorporate, integrate or are designed based
      in whole or part, on the Trial Data and Reports, including without
      limitation implied warranties of merchantability, efficacy and fitness for
      a particular purpose. The entire risk arising out of the production and
      use of the Trial Data, the Reports and the Product and any accompanying
      materials remains solely with BioCancell, and BioCancell shall be solely
      responsible for any use of the Trial Data, the Reports and/or the
      Product.

              


      

      
        	
                
                

              	
                8.6.

              	
                Nothing
      contained herein shall be construed as casting upon the Medical Center
      and/or HMO and its employees, including the Principal Investigator an
      undertaking to purchase any equipment for purpose of the performing the
      Trial or for improving its existing
equipment.

              


      

       

      
        	
                9.

              	
                Consideration

              


      

      
        	
                
                

              	
                9.1.

              	
                In
      consideration for the performance of all of the tasks, duties and
      undertakings of the Principal Investigator, the Trial Personnel and the
      Medical Center under this Agreement, BioCancell hereby undertakes to pay
      the Medical Center the amount specified in Appendix C hereto, according to
      the installments, timetable and manner specified therein. For the removal
      of doubt, the consideration set out in Appendix C hereto constitutes the
      only consideration payable by Biocancell under this Agreement for the
      conduct of the Trial, with the exception of Indemnification or unless
      defined otherwise in this
Agreement.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
                
                

              	
                9.2.

              	
                If
      Biocancell is required by applicable law to make any tax deduction, tax
      withholding or similar payment from any amount paid or payable by
      Biocancell on account of income tax, tax on profit or any other taxes of a
      similar nature imposed on the Medical Center (“Withholding Tax”) under this Agreement, then
      Biocancell shall notify the Medical Center of this requirement and shall
      deduct the Withholding Tax from the payments referred to above, as
      prescribed by applicable law and shall provide the Institution as soon as
      practicable with the receipts or other documents issued by the tax
      authorities evidencing payment of the Withholding Tax, so that the Medical
      Center may claim an appropriate tax credit from the relevant tax
      authorities. Alternatively, the Medical Center shall provide BioCancell
      with the appropriate Tax Exemption at Source approvals from the relevant
      tax authorities.

              


      

       

      
        	
                10.

              	
                Product
      Supply

              


      

      
        	
                
                

              	
                10.1.

              	
                BioCancell
      will, at its own expense, supply to the Medical Center 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,
      at BioCancell expense, without delay, upon completion of the Trial or
      termination of this Agreement for any reason whichever is the
      earlier.

              


      

      
        	
                
                

              	
                10.2.

              	
                The
      Medical Center will ensure that the Product is managed and stored in
      accordance with GCP and with any special instructions issued by
      BioCancell. Any use of any drugs under the Trial, including the Product,
      shall only be made via HMO’s
      internal pharmacy and shall be subjected to its procedures. HMO internal
      pharmacy and the Principal Investigator will maintain proper records of
      receipts, dispensing and returns of the
Product.

              


      

      
        	
                
                

              	
                10.3.

              	
                BioCancell
      will continue to supply the Product after the termination of the Trial
      and/or Agreement to the patients participating in the trial in accordance
      with Appendix D.

              


      

       

      
        	
                11.

              	
                Trial
      Personnel Compliance and Clearance

              


      

      
        	
                
                

              	
                11.1.

              	
                The
      Medical Center and the Principal Investigator hereby undertake to exercise
      their best efforts so that the Trial Personnel shall abide by : (a) the
      Trial Protocol, (b) the Guidelines, (c) the instructions and the terms
      specified in the approval of the Medical Center Helsinki Committee, (d)
      the ICH-GCP, (e) the Helsinki Declaration, (f) the applicable laws, rules
      and regulations regulating such studies which are applicable in Israel,
      and (g) written instructions and prescriptions issued by BioCancell
      regarding the Trial and/or the Product; all as may be amended from time to
      time.

              


      

      
        	
                
                

              	
                11.2.

              	
                The
      Trial will also be conducted in accordance with the “Statement of
      Investigator” (FDA form no. 1572).

              


      

      
        	
                
                

              	
                11.3.

              	
                Trial
      Personal Clearance:

              


      

      
        	
                
                

              	
                11.3.1.

              	
                The
      Medical Center and the Principal Investigator shall deploy all possible
      efforts that none of the Trial Personnel (including the Principal
      Investigator and any other investigators) are debarred by the FDA or by
      the MOH in any capacity whatsoever, and that (1) 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; and (2) none of the Trial Personnel are
      debarred according to the terms and conditions of the Israeli Physicians
      Ordinance [New Version], 1976 or pursuant to any other applicable
      law.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
                
                

              	
                11.3.2.

              	
                The
      Medical Center and the Principal Investigator shall provide BioCancell
      with the written confirmation thereof, in a form attached as Appendix B
      hereto.

              


      

       

      
        	
                12.

              	
                Compliance
      with the Trial Budget and Cooperation with BioCancell
      Sub-Contractors

              


      

      
        	
                
                

              	
                12.1.

              	
                The
      Medical Center 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.

              


      

      
        	
                
                

              	
                12.2.

              	
                The
      Medical Center 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.

              


      

       

      
        	
                13.

              	
                Trial
      Documents

              


      

      
        	
                
                

              	
                13.1.

              	
                The
      Principal Investigator shall prepare and submit the Trial
      Documents.

              


      

      
        	
                
                

              	
                13.2.

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

              


      

      
        	
                
                

              	
                13.3.

              	
                Any
      and all amendments to the Trial Protocol shall be performed only after
      securing the approval of BioCancell and the competent regulatory
      authority. Insofar as permitted by applicable legislation, BioCancell is
      entitled to alter or amend the Protocol and/ or other documents related to
      the Trial, subject to prior written notice to the Principal Investigator
      and the Medical Center of at least fourteen (14) days prior to such
      amendment application to the Medical Center Helsinki Committee. The
      Medical Center and the Principal Investigator shall act in accordance with
      these alterations or amendments. BioCancell shall incur all costs and fees
      levied by the Medical Center Helsinki Committee for the purpose of such
      amendment of the Protocol.

              


      

       

      
        	
                14.

              	
                Confidentiality

              


      

      
        	
                
                

              	
                14.1.

              	
                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 Medical Center and Principal Investigator
      for the sole purpose of conducting the
Trial.

              


      

      
        	
                
                

              	
                14.2.

              	
                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 five (5)
years.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

       

      
        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

      

       

      
        	
                 

              	
                14.3.

              	
                The
      Medical Center 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
      prior written consent.

              


      

      
        	
                
                

              	
                14.4.

              	
                The
      Medical Center 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.

              


      

      
        	
                
                

              	
                14.5.

              	
                At
      the request of BioCancell, the Medical Center and the Principal
      Investigator shall forthwith return to BioCancell the Confidential
      Information or any part thereof, in accordance with Section 13.3
      above.

              


      

      
        	
                
                

              	
                14.6.

              	
                The
      Medical Center 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 Medical Center hereby undertake that BioCancell would be 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.

              


      

      
        	
                
                

              	
                14.7.

              	
                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.

              


      

      
        	
                
                

              	
                14.8.

              	
                The
      Medical Center 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
14.

              


      

      
        	
                
                

              	
                14.9.

              	
                In
      the event that the Medical Center 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 reasonably attempt to first
      notify BioCancell of any such required disclosure, and limit such
      disclosure as far as is possible under applicable law. Such disclosure
      shall, however, not relieve the Medical Center and the Principal
      Investigator of their other obligations contained
  herein.

              


      

       

      
        	
                15.

              	
                Invention
      Rights

              


      

      
        	
                
                

              	
                15.1.

              	
                The
      Medical Center 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 Medical Center and the Principal
      Investigator in the Trial is strictly the consequence of their nomination
      by BioCancell.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                15.2.

              	
                The
      Parties and the Principal Investigator hereby irrevocably agree and
      undertake that the Confidential Information, except for medical records of
      the Subjects and subject to Confidentiality, 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, subject to the limitations stated in Section 8, to verify
      entries in the CRF’s.
      BioCancell hereby undertakes full responsibility to ensure the safekeeping
      of patients’
      confidentiality and personal data and shall be fully responsible for
      taking every measure to apply this
commitment.

              


      

      
        	
              	
                15.3.

              	
                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.

              


      

      
        	
              	
                15.4.

              	
                The
      Medical Center 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 and at BioCancell’s
      expense.

              


      

      
        	
              	
                15.5.

              	
                If
      by operation of law or for any reason, any Invention Rights to be owned by
      BioCancell pursuant to this Section 15 are not automatically deemed
      proprietary BioCancell upon their creation, the Medical Center and the
      Principal Investigator hereby further undertake to cause the Trial
      Personnel to, irrevocably grant and assign all such intellectual property
      rights to BioCancell, at BioCancell expense in relation to filling and
      submitting applications to the relevant
  authorities.

              


      

      
        	
              	
                15.6.

              	
                Nothing
      contained herein shall be deemed to grant the Investigator and the Medical
      Center a license to use BioCancells’
      Invention Rights and IP for any purposes whatsoever except for the
      performance of the Trial pursuant
hereto.

              


      

       

      
        	
                16. 
    

              	
                Inspections

              


      

      
        	
              	
                16.1.

              	
                The
      Medical Center and the Principal Investigator hereby undertake to allow
      the monitors to perform monitoring visits in all sites related to the
      Trial subject to a prior reasonable notice and during HMO working hours
      (Sunday-Thursday 8 a.m. to 4 p.m. with the exclusion of holidays) 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 inspect among others the Trial Documents and
      Trial Data as well as to insure compliance with the Trial Protocol,
      subject to the confidentiality conditions set in this
      Agreement.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                16.2.

              	
                The
      Medical Center 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”) in order to
      determine their adequacy, to examine all data, documents, records, work
      product relating to the Trial, to validate case reports against original
      data in its files and to make copies of such data, documents and records
      and to monitor work preformed to the extent relevant or necessary to
      ascertain compliance thereof with the Trial Protocol, applicable laws,
      rules, regulations, guidelines and the terms of this Agreement. The
      Medical Center and the Principal Investigator also undertake to assist the
      Inspectors in their duties, if and to the extent requested to do so by the
      Inspectors.

              


      

      
        	
              	
                16.3.

              	
                The
      Medical Center 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 Medical Center and the
      Principal Investigator shall provide BioCancell with copies of any
      inquiries, correspondence or communications to or from any such
      Inspectors.

              


      

      
        	
              	
                16.4.

              	
                The
      Medical Center and/or the Investigator shall promptly notify Biocancell in
      writing if any regulatory authority schedules an inspection or, without
      scheduling, commences an inspection as aforesaid and shall promptly
      provide Biocancell with a copy of correspondence or observations made by
      such regulatory authority relating to the Trial and/or resulting from any
      such Inspection.

              


      

      
        	
              	
                16.5.

              	
                The
      Medical Center and the Investigator shall take any reasonable action
      requested by BioCancell to cure deficiencies noted during an audit or
      inspection.

              


      

       

      
        	
                17.

              	
                Publications

              


      

      
        	
              	
                17.1.

              	
                BioCancell
      covenants that it will not at any time, without first obtaining the
      consent in writing of the Medical Center (which consent may by refused or
      granted in its absolute discretion), use the Medical Center’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 Medical Center and/or the Principal Investigator for listing
      the Trail on clinicaltrials.gov.
      which shall include merely a disclosure that shall be limited to the fact
      that the Trial has been executed in HMO under the supervision of the
      Principal Investigator. BioCancell shall include appropriate
      acknowledgement and credit reflecting the contribution of the Principal
      Investigator, HMO and the Trial Personnel in any publication relating to
      the Trial in whatever media, in accordance with customary scientific
      practice.

              


      

      
        	
              	
                17.2.

              	
                Publication
      of the Trial and/or its results, in whole or in part, shall be within the
      sole and absolute discretion of BioCancell. The Medical Center, 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 of 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.
      Subject to the foregoing, following termination of the Trial, and in the
      absence of any publication within a period of one calendar year, Principal
      Investigator shall be entitled to make a publication providing notice to
      BioCancell and suspending such publication for a period of thirty (30)
      days in order to enable BioCancell to safeguard any Intellectual Property,
      extendable for an additional period of thirty (30) days. After theses two
      extensions, the Principal Investigator shall have the liberty to make such
      publication.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                17.3.

              	
                Without
      derogating from this Section 17, BioCancell hereby undertakes to abide by
      the rules of publications issued by the MOH and set forth in Section 2 of
      Appendix D attached hereto.

              


      

       

      
        	
                18.

              	
                Reports

              


      

      
        	
              	
                18.1.

              	
                Each
      of the Medical Center and the Investigator shall: (i) prepare and maintain
      complete and accurate written records, accounts, notes, reports and data
      of the Trial, including source data and case report forms (on case report
      forms supplied by Biocancell) in accordance with the Trial Protocol and
      applicable laws, regulations and guidelines (the “Reports”); and (ii) retain all such
      Reports after completion of the Trial for such periods as determined by
      any applicable law or regulation, but no less than 15 (fifteen) years, at
      no additional cost to Biocancell. Upon termination of the retention
      period, the Medical Center shall transfer all Reports to Biocancell,
      subject to confidentiality obligation as stated under this Agreement or if
      so requested by Biocancell, destroy such Reports. In no event shall any
      such Reports be discarded or destroyed without first notifying Biocancell
      and subject to BioCancell indication within thirty (30) days subsequent to
      the aforesaid notification.

              


      

      
        	
              	
                18.2.

              	
                The
      Medical Center and the Principal Investigator hereby undertake to submit
      the Reports to BioCancell and/or to competent authorities, whether Israeli
      or foreign.

              


      

      
        	
              	
                18.3.

              	
                The
      Medical Center 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.

              


      

      
        	
              	
                18.4.

              	
                The
      Medical Center 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.

              


      

      
        	
              	
                18.5. 
      

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

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
                19.

              	
                Serious
      Adverse Event

              


      

      
        	
              	
                19.1.

              	
                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 Medical Center Helsinki Committee and/or the Medical Center
      management and/or the authorized national health
    authorities.

              


      

      
        	
              	
                19.2.

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

              


      

      
        	
              	
                19.3.

              	
                In
      the occurrence of a Serious Adverse Event the Principal Investigator and
      the Medical Center Helsinki Committee shall be entitled to immediately
      cease the performance of the Trial, pending a prior notice of at least 24
      hours to BioCancell regarding such decision and its
    execution.

              


      

      
        	
              	
                19.4.

              	
                In
      the occurrence of a Serious Adverse Event BioCancell will immediately take
      all measures at their disposal to evaluate the risk to the Subjects and/or
      other patients and will instruct the Principal Investigator which measures
      to take with regard to that risk.

              


      

      
        	
              	
                19.5.

              	
                BioCancell
      has an obligation, as the trial sponsor, to notify each investigator,
      including the Principal Investigator of any Serious Adverse Events that
      are reported by any site during the trial that are submitted to the FDA in
      a safety report. Each Principal Investigator is obligated to provide these
      reports to the appropriate Helsinki
Committee.

              


      

       

      
        	
                20.

              	
                The
      Legal Status of the Medical Center and the Principal
      Investigator

              


      

      
        	
              	
                20.1.

              	
                The
      Parties and the Principal Investigator hereby agree that the relationship
      between BioCancell, on one hand, and the Medical Center and the Principal
      Investigator, on the other hand, are that of a client and an independent
      contractor, with the Medical Center 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.

              


      

       

      
        	
                21.

              	
                Term
      and Termination

              


      

      
        	
              	
                21.1.

              	
                This
      Agreement shall be in full force and effect as of the latter of either:
      (a) the date of its execution by the last Party and (b) the date the
      Approvals have been granted; and until the End of the Trial (and the
      period in which this Agreement shall be in full force and effect shall be
      referred to in this Agreement as “the Term of this
      Agreement”).

              


      

      
        	
              	
                21.2.

              	
                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:

              


      

      
        	
              	
                21.2.1.

              	
                The
      MOH has voided its approval granted for the performance of the Trial or
      has conditioned the approval by conditions which the Medical Center and/or
      the Principal Investigator, as the case may be, have notified BioCancell
      that they are unable to comply
with.

              


      

      
        	
              	
                21.2.2.

              	
                The
      FDA has placed the Trial on clinical
hold.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                21.2.3.

              	
                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.

              


      

      
        	
              	
                21.2.4.

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

              


      

      
        	
              	
                21.2.5.

              	
                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.

              


      

      
        	
              	
                21.3.

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

              


      

      
        
        

      

      
        	
              	
                21.3.1.

              	
                Any
      and all Confidential Information and remaining supply of Product shall be
      returned to BioCancell, as defined in Section 14
  above.

              


      

      
        	
              	
                21.3.2.

              	
                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.

              


      

      
        	
              	
                21.3.3.

              	
                BioCancell
      shall pay the Medical Center all out-of-pocket and none-cancelable
      commitments incurred by the Medical Center prior to such
      termination.

              


      

      
        	
              	
                21.4.

              	
                The
      obligation of the Parties and the Principal Investigator pursuant to
      sections 14,
      15, 17, and 22 shall survive termination of this
      Agreement.

              


      

      
        
        

      

       

      
        	
                22.

              	
                Insurance
      and Indemnification

              


      

      
        	
              	
                22.1.

              	
                BioCancell
      has agreed to insure, in accordance with the terms and conditions set
      forth in Appendix D attached hereto, the Subjects, the Trial Personnel,
      the Principal Investigator and the Medical Center. BioCancell shall
      provide for a sufficient product liability and/or clinical trial insurance
      cover and all the necessary documents which prove the evidence of cover of
      the above-mentioned liability to the Medical Center. BioCancell warrants
      and undertakes that it has purchased, and shall maintain during the entire
      term of the Agreement and for all relevant times subsequent thereto
      (including under applicable statues of limitation), of at least the same
      level of coverage for the whole period of the Trial, sufficient insurance
      coverage for the Trial and for BioCancell’s
      liabilities hereunder, which insurance coverage shall be satisfactory to
      the Medical Center. BioCancell further undertakes that the Medical Center,
      the Principal Investigator, HMO, and the Trial Personnel will be included
      as co-insured in such insurance policy/ies. The insurance policy/ies shall
      have a discovery period of seven (7) years. Thirty (30) days prior to the
      each Insurance Certificate expiry date, BioCancell shall provide the
      Investigator with a new certificate that meets the requirements
      above.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      
        

          
            
              
                	
                        

                      	
                        8
      Hartom St, Jerusalem Israel 97775

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

                        www.biocancell.com info@biocancell.com

                      


              

            

          

           

        

        
          	
                	
                  22.2.

                	
                  BioCancell
      has agreed to indemnify the Trial Personnel, HMO, the Principal
      Investigator and/or the Medical Center according to the terms of
      Sub-Section 22.3 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:

                


        

        
          	
                	
                  22.2.1.

                	
                  The
      Damages are not caused as a result of negligence or misconduct of the
      Indemnitee to the extent that such damage was caused or increased by the
      negligence or willful misconduct of an
  Indemnitee;

                


        

        
          	
                	
                  22.2.2.

                	
                  The
      Indemnitee performed the Trial in accordance with the Trial Protocol
      ;

                


        

        
          	
                	
                  22.3.

                	
                  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 22 (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 within the specified period of time
      under law. In any event, the Indemnitee shall cooperate with BioCancell in
      the defense of any Claim for which BioCancell assumes the defense of
      behalf of all Parties, including the Principal Investigator and Trial
      Personnel. BioCancell shall not be liable for the settlement by the
      Indemnitee of any Claim affected without the consent of BioCancell.
      BioCancell shall be entitled to enter into any settlement of a Claim at
      its sole discretion. BioCancell may not assume the blame or liability of
      the Medical Center, Trial Personnel or the PI without their prior written
      consent.

                


        

      

       

      
        	
                23.

              	
                Limitation
      of Liability

              


      

      
        	
              	
                23.1.

              	
                Neither
      Party shall be liable (whether under contract, tort (including negligence)
      or otherwise) to the other party, or any third party for any indirect,
      incidental or consequential damages, including, without limitation, any
      loss or damage to business earnings, lost profits or goodwill and lost or
      damaged data or documentation, suffered by any person, arising from and/or
      related with and/or connection to this Agreement even if such party is
      advised of the possibility of such
damages.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                23.2.

              	
                Without
      derogating from the above, and except in the event of medical malpractice
      to the Subjects, if the Medical Center or the Principal Investigator or
      the Trial Personnel are found liable (whether under contract, tort
      (including negligence) or otherwise), then the cumulative liability
      thereof for all claims whatsoever related to the Trial or the Product or
      otherwise arising out of this Agreement, shall not exceed a total
      consideration actually paid to it under this Agreement. This limitation of
      liability is intended to apply to all claims of BioCancell without regard
      to which other provisions of this Agreement have been breached or have
      proved ineffective.

              


      

       

      
        	
                24.

              	
                Notices

              


      

      
        	
              	
                24.1.

              	
                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,
      provided that submission has been on a working day at HMO (Sunday-Thursday
      8 a.m. to 4 p.m. with the exclusion of holidays) and acceptance shall be
      construed as te subsequent working
day.

              


      

      
        	
              	
                24.2.

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

              


      

       

      
        
          
            
              	
                      Notice
      to BioCancell

                    	
                      Notice
      to Medical Center

                    
	
                      BioCancell
      Therapeutics Ltd.

                    	
                      Hadasit
      Medical Research Services

                    
	
                      Beck
      Science Center, 8 Hartom St.

                    	
                      and
      Development Ltd.

                    
	
                      Jerusalem,
      97775 Israel

                    	
                      Kiryat
      Hadassah

                    
	
                      Attn:
      Ran Vigdor

                    	
                      P.O.Box
      12000

                    
	
                      Director,
      Strategic Alliances

                    	
                      Jerusalem
      91120

                    
	
                      Telephone:    +972-2-548-6555

                    	
                      Attn:_Mrs.
      Carole Grumbach

                    
	
                      Facsimile:     +972-2-548-6550

                    	
                      VP
      Finance & Contracts

                    
	 
      	
                      Telephone:
      +972-2-6778757

                    
	 
      	
                      Facsimile:
      +972-2-6437712

                    


            

          

        

      

       

      
        	
              	
                24.3. 
      

              	
                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.

              


      

       

      
        	
                25.

              	
                Miscellanies

              


      

      
        	
              	
                25.1.

              	
                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.

              


      

      
        	
              	
                25.2.

              	
                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.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                25.3.

              	
                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 Jerusalem District, Israel

              


      

      
        	
              	
                25.4.

              	
                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 and subject to the assignee
      assuming all BioCancell obligations under this
  Agreement.

              


      

      
        	
              	
                25.5.

              	
                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.

              


      

      
        	
              	
                25.6.

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

              


      

      
        	
              	
                25.7.

              	
                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.]

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      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.

                                                	 
      	
                                                  Hadasit
      Medical  Research  Services

                                                  and
      Development Ltd.

                                                
	 
      	 
      	 
      	 
      	 
      
	
                                                  By:

                                                	/s/
      Avi Barak	 
      	
                                                  By:

                                                	[Illegible] 
      
	 	 	 	
                                                   

                                                
	
                                                  Print
      Name: Avi Barak

                                                	 
      	
                                                  Print Name: 

                                                	[Illegible] 
      
	 	 	 	 
	
                                                  Title:
      CEO

                                                	 
      	
                                                  Title:

                                                	 
	 
      	 
      	 
      	 
      	 
      
	
                                                  By:

                                                	/s/
      Patricia Ohana	 
      	
                                                  By:

                                                	 
      
	 	 	 	 
	
                                                  Print
      Name: Patricia Ohana

                                                	 
      	
                                                  Print Name:

                                                	 
      
	 	 	 	 
	
                                                  Title:_VP
      Clinical Development

                                                	 
      	
                                                  Title:

                                                	 
      


                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      I the
undersigned, Dr. Vladimir Yutkin MD, 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 Medical Center, 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/
      Vladimir Yutkin

                  
	
                    The
      Principal Investigator

                  


          

        

      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      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

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      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.

      


      
        
          
            
              
                	 
      	 	 
      
	
                        The
      Principal Investigator

                      	 	
                        The
      Medical
Center

                      


              

            

          

        

      

      


      
        
          
            	 
      
	
                    Date

                  


          

        

      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      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

                	 	
                  Any
      Visit, as defined below, of visits 1-6, 8-10, 12-14, and 16-18 as these
      visits are numbered and defined in the Trial Protocol.

                
	
                  Visit

                	 	
                  Any
      one of the scheduled nineteen (19) visits of a Participating Subject
      as detailed in table 4 and 5 of the Trial
  Protocol.

                


        

      

      


      
        	
                2.

              	
                The
      Consideration

              


      

      
        	
              	
                2.1.

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

              


      

       

      
        
          
            
              
                
                  
                    
                      
                        	
                                Visit
      #

                              	 
      	
                                Procedure

                              	 
      	
                                Costs
      of

                                procedure (NIS)

                              	 
      	
                                Total costs

                                per visit

                              
	
                                Screening

                              	 
      	
                                Urine
      cytology

                              	 
      	
                                140

                              	 
      	 
      
	 
      	 
      	
                                Video
      cystoscopy

                              	 
      	
                                370

                              	 
      	 
      
	 
      	 
      	
                                Histology
      & Pathology

                              	 
      	
                                180

                              	 
      	 
      
	 
      	 
      	
                                Doctor’s
      fee

                              	 
      	
                                1,000

                              	 
      	 
      
	 
      	 
      	
                                Study
      nurse

                              	 
      	
                                250

                              	 
      	 
      
	 
      	 
      	
                                Study
      coordinator

                              	 
      	
                                250

                              	 
      	 
      
	 
      	 
      	
                                TUR

                              	 
      	
                                960

                              	 
      	
                                3,150

                              


                      

                    

                  

                

              

            

          

        

         

        Hadassah–agreement

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

        

          
            
              
                	
                        

                      	
                        8
      Hartom St, Jerusalem Israel 97775

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

                        www.biocancell.com info@biocancell.com

                      


              

            

          

           

        

        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  	Visit
      # 1	 	 	 	 	 	 
	
                                                           

                                                        	 	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 2 	 	 	 	 	 	 
	
                                                           

                                                        	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 	 	 	 	 	 	 
	
                                                          Visit
      # 3

                                                        	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 	 	 	 	 	 	 
	
                                                          Visit
      # 4

                                                        	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                          Visit
      # 5

                                                        	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                          Visit
      # 6

                                                        	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                          Visit
      # 7

                                                        	 
      	
                                                          Urine
      cytology

                                                        	 
      	
                                                          140

                                                        	 
      	 
      
	 
      	 
      	
                                                          Video
      cystoscopy

                                                        	 
      	
                                                          370

                                                        	 
      	 
      
	 
      	 
      	
                                                          Histology
      & Pathology

                                                        	 
      	
                                                          180

                                                        	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          500

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          TUR

                                                        	 
      	
                                                          960

                                                        	 
      	
                                                          2,650

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                          Total
      per first treatment period

                                                        	 
      	
                                                          13,300

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                          Visit
      # 8

                                                        	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                          Visit
      # 9

                                                        	 
      	 
      	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Doctor’s
      fee

                                                        	 
      	
                                                          750

                                                        	 
      	 
      
	 
      	 
      	
                                                          Study
      nurse (Drug administration &

                                                        	 
      	
                                                          250

                                                        	 
      	 
      
	 
      	 
      	
                                                          blood
      sampling)

                                                        	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                          Study
      coordinator

                                                        	 
      	
                                                          250

                                                        	 
      	
                                                          1,250

                                                        


                                                

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

         

        Hadassah–agreement

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

        

          
            
              
                	
                        

                      	
                        8
      Hartom St, Jerusalem Israel 97775

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

                        www.biocancell.com info@biocancell.com

                      


              

            

          

           

        

        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        
                                          
                                            
                                              
                                                
                                                  
                                                    
                                                      
                                                        
                                                          
                                                            	Visit
      # 10 	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                                    Visit
      # 11

                                                                  	 
      	
                                                                    Urine
      cytology

                                                                  	 
      	
                                                                    140

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Video
      cystoscopy

                                                                  	 
      	
                                                                    370

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    500

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,510

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 12 	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 13 	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 14 	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                                    Visit
      # 15

                                                                  	 
      	
                                                                    Urine
      cytology

                                                                  	 
      	
                                                                    140

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Video
      cystoscopy

                                                                  	 
      	
                                                                    370

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    500

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,510

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 16	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 17 	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	Visit
      # 18 	 	 	 	 	 	 
	
                                                                     

                                                                  	 
      	
                                                                    Doctor’s
      fee

                                                                  	 
      	
                                                                    750

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    Study
      nurse (Drug administration &

                                                                  	 
      	
                                                                    250

                                                                  	 
      	 
      
	 
      	 
      	
                                                                    blood
      sampling)

                                                                  	 
      	 
      	 
      	 
      
	 
      	 
      	
                                                                    Study
      coordinator

                                                                  	 
      	
                                                                    250

                                                                  	 
      	
                                                                    1,250

                                                                  


                                                          

                                                        

                                                      

                                                    

                                                  

                                                

                                              

                                            

                                          

                                        

                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

         

        Hadassah–agreement

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

        

          
            
              
                	
                        

                      	
                        8
      Hartom St, Jerusalem Israel 97775

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

                        www.biocancell.com info@biocancell.com

                      


              

            

          

           

        

        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  
                                    
                                      
                                        	
                                                Visit
      # 19

                                              	 
      	
                                                Urine
      cytology

                                              	 
      	
                                                140

                                              	 
      	 
      
	 
      	 
      	
                                                Video
      cystoscopy

                                              	 
      	
                                                370

                                              	 
      	 
      
	 
      	 
      	
                                                Doctor’s
      fee

                                              	 
      	
                                                500

                                              	 
      	 
      
	 
      	 
      	
                                                Study
      nurse

                                              	 
      	
                                                250

                                              	 
      	 
      
	 
      	 
      	
                                                Study
      coordinator

                                              	 
      	
                                                250

                                              	 
      	
                                                1,510

                                              
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                Total
      per continued treatment period (if no recurrence)

                                              	 
      	 
      	 
      	 
      	 
      	
                                                15,780

                                              
	 
      	 
      	 
      	 
      	 
      	 
      	 
      
	
                                                Total
      per first treatment period & continued treatment
period

                                              	 
      	 
      	 
      	
                                                13,300

                                                +

                                                15,780

                                              	 
      	
                                                29,080

                                              
	 	 	 	 	 	 	 
	
                                                General

                                              	 
      	
                                                Unscheduled
      Histology & Pathology (if applicable)

                                              	 
      	
                                                180

                                              	 
      	
                                                180

                                              
	 	 	 	 	 	 	 
	
                                                General

                                              	 
      	
                                                Unscheduled
      Video cystoscopy

                                              	 
      	
                                                370

                                              	 
      	
                                                370

                                              
	 	 	 	 	 	 	 
	
                                                General

                                              	 
      	
                                                Unscheduled
      TUR

                                              	 
      	960
      	 
      	
                                                960

                                              
	 	 	 	 	 	 	 
	
                                                Pharmacy

                                              	 
      	 
      	 
      	
                                                500
      US $

                                              	 
      	
                                                500
      US
$

                                              


                                      

                                    

                                  

                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      * Blood
work and Urine analysis will be perform by an external central Lab (the costs
will be covered by the sponsor).

       

      
        	
                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 Medical Center
      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 Medical Center’s
      facilities, and all tests, procedures, examinations and evaluations as
      detailed in the Trial protocol.

              


      

      
        	
                
                

              	
                3.3.

              	
                The
      considerations do not include cost of analysis of hematology and chemistry
      samples which will be performed by BioCancell’s
      sub-contractor/s.

              


      

       

      
        	
                4. 

              	
                Terms
      of Payment

              


      

      
        	
              	
                4.1.

              	
                The
      Medical Center shall send an invoice at the end of each calendar quarter
      (31/3, 30/6, 30/9, and 31/12) 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.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                4.2.

              	
                Payments
      detailed in section 2 shall be conditioned upon payment for Complete
      Visits and shall be included in the first invoice sent by the Medical
      Center.

              


      

      
        	
              	
                4.3.

              	
                Payment
      shall be made by BioCancell within 30 (thirty)
      days of receipt of the Medical Center’s
invoice.

              


      

      
        	
              	
                4.4.

              	
                Immediately
      upon receiving the payment as per the issued invoice the Medical Center
      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
Medical Center in NIS (New Israel Shekel) and shall be subject to VAT, if
applicable.

       

      
        	
                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 Medical Center, 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 Medical Center, BioCancell
      shall be entitled to perform one of the following
  three,:

              


      

      
        
          	
                	
                  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 Medical Center by BioCancell according to this
      Agreement (hereinafter: “the Remaining
      Amount”).

                


        

      

      
        
          	
                	
                  6.2.2.

                	
                  Order
      the Medical Center, 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 Medical Center 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 6.2.1 and 6.2.2 in concert, to the extent that BioCancell
      shall fully collect the Return Amount from the Medical
    Center.

                


        

      

      
        	
              	
                6.3.

              	
                No
      advance payments would be performed by BioCancell to the Medical
      Center.

              


      

      
        	
              	
                6.4.

              	
                Any
      amount payable hereunder, which has not been made upon its due date of
      payment, shall bear interest from the date such payment is due until the
      date of its actual payment shall bear the maximum interest charged by Bank
      Leumi Le Israel B.M. for unapproved
overdrafts.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

             

          

        

        Appendix D

      

      


      Schedule
4 of the
Guidelines

       

      
        
          
            
              
                
                  	
                          Title
      of the trial: “Phase 2b, Multicenter Trial of Intravesical DTA-HI9/PEI in
      Patients with
      Intermediate-Risk Superficial Bladder Cancer”

                        
	
                          The
      protocol name and number: BC-07-01

                        
	 
	
                          Name
      of the investigational product: DTA-HI9/PEI

                        
	 
	
                          Name
      of the Principal Investigator:

                        	
                          Department:

                        
	 
      	
                          Urology

                        
	
                          Name
      of the medical institution:

                        
	
                          The
      Sponsor’s
      name and address: BioCancell Therapeutics Ltd., Beck Science Center, 8
      Hartom St., Jerusalem 97775,
Israel

                        


                

              

            

          

        

      

       

      
        	
                1.

              	
                Sponsor
      undertaking

              


      

      The
Sponsor undertakes to act in accordance with the local and international law for
clinical trials, and in particular with regard to the following
issues:

      
        
          	
                	
                  1.1.1.

                	
                  Responsibility
      for the safety and good order of the investigational
    product;

                


        

      

      
        	
              	
                1.1.2. 

              	
                Supply
      of information regarding the trial;

              


      

      
        
          	
                	
                  1.1.3. 

                	
                  Notice
      to the Ministry of Health regarding the performance of a multi­centre
      trial in Israel; 

                


        

        
          	
                	
                  1.1.4.

                	
                  Monitoring
      the trial process;

                


        

        
          	
                	
                  1.1.5.

                	
                  Safety
      reports;

                


        

      

      
        
          	
                	
                  1.1.6. 

                	
                  Accountability
      in respect of the investigational product;

                
	 	
                  
                    1.1.7.

                  

                	
                  Retention
      of documents.

                


        

      

       

      
        	
                2.

              	
                The
      Sponsor undertakes that if it shall decide to publish the results of the
      clinical trial in scientific literature, it shall publish them in full and
      without taking matters out of their
context.

              


      

       

      
        	
                3. 

              	
                Insurance:

              


      

      
        	
              	
                3.1.

              	
                The
      Sponsor undertakes to insure its legal liability pursuant to the laws of
      the State of Israel against claims that may be filed by subjects in the
      clinical trial and/or third party claims - all in connection with the
      clinical trial, whether in the period of conducting the clinical trial or
      thereafter. The insurance shall be extended to include the legal liability
      of the medical institution and/or the clinical trial personnel and/or the
      Principal Investigator (hereinafter referred to as “the
      parties conducting the trial”) deriving from their involvement in the
      conduct of the clinical trial, subject to an exception of an act committed
      negligently or an intentional deviation from the clinical trial
      protocol.

              


      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      
        	
              	
                3.2.

              	
                The
      Sponsor shall be given notice of any claim or any potential claim
      immediately after such comes to the knowledge of the medical institution
      or the Principal Investigator.

              


      

      
        	
              	
                3.3.

              	
                The
      Principal Investigator, the medical institution and its employees shall
      give the Sponsor, upon its written request, reasonable support in any
      event of a claim that may be filed against it as
  aforesaid.

              


      

       

      
        	
                4.

              	
                The
      Sponsor undertakes to supply the medical institution with the
      investigational product throughout the period of the clinical trial until
      the conclusion thereof, free of charge. Furthermore, the Sponsor
      undertakes to pay all additional costs deriving from the conduct of the
      clinical trial, provided that such costs do not derive from the regular
      medical treatment of the sickness.

              


      

       

      
        	
                5.

              	
                If
      after the termination of the clinical trial it is ascertained and
      recommended by the Principal Investigator that the welfare of the patient
      participating in the clinical trial necessitates continuation of his
      treatment with the investigational product and there is no other
      appropriate alternative medical treatment, the Sponsor undertakes to also
      continue supplying the investigational product, without charge, after the
      termination of the clinical trial for a period of three years, except in
      one of the following cases:

              


      

      
        	
              	
                5.1.

              	
                The
      investigational product was approved for marketing in the State of Israel
      after its registration for its requested scope and it can be obtained from
      the sick fund with which the patient is
insured.

              


      

      
        	
              	
                5.2.

              	
                The
      development of the product was discontinued or the results of the clinical
      trials were unsuccessful.

              


      

      
        	
              	
                5.3.

              	
                The
      administration of the investigational product for the said protracted
      period is likely to harm the patient’s
      health, since there is insufficient information regarding the safety of
      the product administered over the long
term.

              


      

      
        	
              	
                5.4.

              	
                Where
      the investigational product is not a medical preparation, such as:
      cosmetic products / food / food additive / herbal
  remedy.

              


      

       

      The
decision as to the continuation of administering the investigational product is
given to the medical institution’s Helsinki Committee (“the Helsinki Committee”), that is entitled to re-examine its
determination from time to time. The Principal Investigator and the Sponsor have
a right of appeal against such decision to the Ministry of Health’s
director-general or such person as empowered by him in such regard.

       

      
        	
                6.

              	
                The
      continued administration of the investigational product after termination
      of the clinical trial is subject to the following terms and
      conditions:

              


      

      
        	
              	
                6.1.

              	
                The
      continued treatment shall be given within the context of an orderly
      monitoring protocol that shall be written by the Principal Investigator
      and approved by the Sponsor and the Helsinki
  Committee.

              


      

      
         

        Hadassah–agreement

         

        
          
            
            

          

          
            
            

            
              

            

          

          
            
            

          

        

        


          
            
              
                	
                        

                      	
                        8
      Hartom St, Jerusalem Israel 97775

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

                        www.biocancell.com info@biocancell.com

                      


              

            

          

           

        

        
          	
                	
                  6.2.

                	
                  The
      Principal Investigator is responsible for continuing to routinely monitor
      the subject’s
      medical condition and to report to the Helsinki Committee any exceptional
      events that occur during the ongoing treatment, as is the norm in clinical
      trials.

                


        

      

      The
principal investigator shall report to the Helsinki Committee at least once a
year as to the progress of the subject’s
treatment.

      The
medical institution in which the ongoing treatment shall be given shall attend
to appropriate insurance cover for the liability of the medical institution and
the Principal Investigator vis-a-vis the patient, in respect of the continuation
of administering the investigational product after the termination of the
clinical trial.

       

      
        	
                7.

              	
                This
      Appendix constitutes an integral part of the agreement between the company
      sponsoring the clinical trial and the medical
  institution.

              


      

       

      
        
          
            
              
                
                  
                    
                      
                        
                          
                            
                              
                                
                                  	
                                          BioCancell
      Therapeutics Ltd.

                                        	 
      	
                                          Hadasit
      Medical  Research  Services

                                          and
      Development Ltd.

                                        
	 
      	 
      	 
      	 
      	 
      
	
                                          By:

                                        	/s/
      Avi Barak	 
      	
                                          By:

                                        	[Illegible] 
      
	 	 	 	 	 
	
                                          Print
      Name: Avi Barak

                                        	 
      	
                                          Print Name: 

                                        	[Illegible] 
      
	 	 	 	 
	
                                          Title:
      CEO

                                        	 
      	
                                          Title:

                                        	 
	 
      	 
      	 
      	 
      	 
      
	
                                          By:

                                        	/s/
      Patricia Ohana	 
      	
                                          By:

                                        	 
      
	 	 	 	 	 
	
                                          Print
      Name: Patricia Ohana

                                        	 
      	
                                          Print Name:

                                        	 
      
	 	 	 	 
	
                                          Title:
      VP Clinical Development

                                        	 
      	
                                          Title:

                                        	 
      


                                

                              

                            

                          

                        

                      

                    

                  

                

              

            

          

        

      

       

      I the
undersigned, Dr. Vladimir Yutkin MD, hereby declare and confirm that I have read
and understood this Appendix D.

       

      
        
          
            	/s/
      Vladimir Yutkin
	
                    The
      Principal Investigator

                  


          

        

      

       

      Hadassah–agreement

       

      
        
          
             


          

          
             


            
              

            

          

          
             


          

        

      

      

        
          
            
              	
                      

                    	
                      8
      Hartom St, Jerusalem Israel 97775

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

                      www.biocancell.com info@biocancell.com

                    


            

          

        

         

      

      Appendix
E


       

      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 Medical Center Helsinki Committee, indicating that
      it has reviewed and approved the Trial Protocol;
  and

                


        

      

      
        
          	
                  6.

                	
                  The
      written approval of the MOH 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 Helsinki Committee, convened in relation
      to the Trial 
      (hereinafter:
      “the Helsinki
      Committee”);
    and

                


        

      

      
        
          	
                	
                  7.1.

                	
                  Should
      the Principal Investigator be a member of the Helsinki Committee,
      the written
      Statement of the chairman of the Helsinki Committee confirming
      that the
      Principal Investigator did not participate in the voting, relating to the
      Trial, during
      the hearing of the said Helsinki Committee;
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.

              	
                Report
      to the Medical Center Helsinki Committee of any Severe Adverse Events, as
      such terms are defined in the Trial Protocol, to the Subject(s), in
      accordance with the Guidelines; and

              


      

      
        	
                3.

              	
                Report
      to the Medical Center Helsinki Committee of any deviation from the Trial
      Protocol; and

              


      

      
        	
                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 15 (fifteen) years following the end
      of the Trial.

              


      

       

      Hadassah–agreement

       

      
        
          
          

        

        
          
          

          
            

          

        

        
          
          

        

      

      

        
          
            
              	
                      

                    	
                      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 Helsinki Committee to the Trial, 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).

              


      

       

      Hadassah–agreement