Unassociated Document


    AMENDMENT
      NO. 3 TO CLINICAL TRIAL AGREEMENT

     

    This
      AMENDMENT NO. 3 TO CLINICAL TRIAL AGREEMENT (this “Amendment
      3”)
      is
      made and entered into as of April 1, 2006 by and between Gentium S.p.A.
      (successor in interest to Crinos Industria Farmacobiologica S.p.A.), an Italian
      joint stock corporation having an office at Piazza II Settembre 2, 22079 Villa
      Guardia (Como), Italy (the “Company”)
      and
      Dana-Farber/Partners Cancer Care, Inc., a non-profit corporation having an
      office at 44 Binney Street, Boston, Massachusetts, 02115, USA (“DFPCC”).

     

    WHEREAS,
      the Company and DFPCC entered into a Clinical Trial Agreement dated December
      27,
      1999 (the “Original
      Clinical Trial Agreement”),
      an
      Amendment No. 1 to Clinical Trial Agreement dated October 19, 2000, and an
      Amendment No. 2 to Clinical Trial Agreement dated January 28, 2004 (the Original
      Clinical Trial Agreement as so amended being the “Clinical
      Trial Agreement”),
      which
      relates to the conduct of a clinical study of Defibrotide in accordance with
      the
      study protocol entitled “Defibrotide for Hematopoietic Stem Cell Transplant
      (SCT) Patients with Severe Hepatic Veno-Occlusive Disease (VOD): A Randomized
      Phase I/II Study to Determine the Effective Dose;” and

     

    WHEREAS,
      the Company and DFPCC wish to amend the Clinical Trial Agreement to provide
      for
      DFPCC to provide certain additional services, for which the Company will pay
      DFPCC;

     

    NOW,
      THEREFORE, in consideration of the mutual agreements, promises and covenants
      provided herein, the Company and DFPCC hereby agree to amend the Clinical Trial
      Agreement as follows.

     

    Section
      1. DFPCC
      hereby agrees to provide the additional services set forth on Schedule A
      attached hereto. The Company hereby agrees to pay DFPCC the amounts set forth
      on
      Schedule A attached hereto in consideration for DFPCC providing such
      services.

     

    Section
      2. This
      Amendment No. 3 supersedes and merges all prior understanding between the
      Company and DFPCC with respect to the subject matter hereof. This Amendment
      No.
      3 and the Clinical Trial Agreement shall hereinafter be read and construed
      together as a single document and all references to the Clinical Trial Agreement
      in the Clinical Trial Agreement or in any other document shall hereafter refer
      to the Clinical Trial Agreement as amended by this Amendment No. 3. To the
      extent that the provisions of this Amendment No. 3 conflict with the provisions
      of the Clinical Trial Agreement, the provisions of this Amendment No. 3 shall
      supersede and control such conflicting provision in the Clinical Trial
      Agreement.

     

    Section
      3. This
      Amendment No. 3 may be executed in counterpart and each shall have the same
      force and effect as an original.

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

     


    IN
      WITNESS WHEREOF, the Company and DFPCC have caused this Amendment No. 3 to
      be
      duly executed as of the day and year first above written.

    
      	 	 	 
	 	GENTIUM
              S.P.A.
	 
 	 
 	 
 
	 	By:  	/s/
              Laura
              Iris
              Ferro                         
              
	 	Name: Laura
              Ferro
	 	
              Title:
                Chairperson,
                President and Chief Executive
                Officer

            


    

     

    
      	 	 	 
	 	DANA-FARBER/PARTNERS
              CANCER CARE, INC.
	 
 	 
 	 
 
	 	By:  	/s/
              Mary E.
              Melloni                             
              
	 	Name: Mary E. Melloni, RN, JD,
              MBA
	 	Title:
              Clinical Trial Contracts Negotiator


    

    


    Attachment

     

     

    


    
      
         

      

      
         

        
          

        

      

      
         

      

    

     

    Schedule
      A

     

    Support
      is requested for completion of the DFCI
      99-118 Defibrotide for Hematopoietic Stem Cell Transplant (SCT) Patients with
      Severe Hepatic Veno-Occlusive Disease (VOD): A Randomized Study to Determine
      the
      Effective Dose clinical
      trial. This support is required to:


     

    1)
      Complete contractual subsites payment for patients enrolled to the study
      ($238,840). Such amount refers to data collection, closing activities and
      additional cost incurred by subsites that were contracted to participate in
      the
      study.

     

    2)
      Provide salary support for data collection, site monitoring, study management,
      database finalization ($35,000)


     

    3)
      Provide salary support for statistical analysis of data for manuscript
      ($15,000)


     

    The
      anticipated time to close above activities is six months. (Commencement date
      on
      April 1, 2006 and estimated termination date on December 31, 2006). At the
      time
      of the closing appropriate and complete documentations for the services rendered
      will be provided to Gentium SpA.