Document:

EXHIBIT
      10.3.1

    

    

    FIRST
      AMENDMENT TO THE

    DISTRIBUTION

    AND

    MANUFACTURING
      SERVICES AGREEMENT

    BETWEEN

    LEVPHARMA

    AND

    SANQUIN

    

    

    THIS
      FIRST AMENDMENT is entered into effective as of the latest of the dates of
      signatures hereunder by and between the Parties to the DISTRIBUTION AND
      MANUFACTURING SERVICES AGREEMENT BETWEEN LEVPHARMA AND SANQUIN dated January
      16,
      2004 (the “AGREEMENT”): LEV PHARMACEUTICALS, INC., a corporation formed under
      the laws of the state of Delaware, having an address at 236 Old Lancaster Road,
      Merion Station, Pennsylvania 19066 (“LEVPHARMA”) and the SANQUIN BLOOD SUPPLY
      FOUNDATION, a not-for-profit organization formed under the laws of The
      Netherlands, having an address at Plesmanlaan 125, 1066 CX, Amsterdam, The
      Netherlands, acting for the purposes of the AGREEMENT through its Plasma
      Products Division, (“SANQUIN”).

    

    
      	
              1.

            	
              The
                Parties agree to amend the AGREEMENT as
                follows:

            

    

    

    Under
      ARTICLE
      I - DEFINITIONS,

    

    paragraph
      1.14 “TERRITORY” shall be modified to read as follows:

    

    “1.14
      “TERRITORY” shall mean Israel and all countries in North, Central and South
      America with the exception of the Dutch Overseas Territories, Argentina, and
      Brazil. The Territory may be expanded in accordance with the provisions in
      Sections 2.1 and/or 2.2(a) of this Agreement.”

    

    2.    Ratification.
      The
      AGREEMENT is ratified and confirmed and shall continue in full force and effect
      as amended hereby.

    

    3.    Counterparts.
      This
      FIRST AMENDMENT may be executed in two or more counterparts, and by different
      parties hereto on separate counterparts, each of which shall be deemed an
      original, but all of which together shall constitute one and the same
      instrument. This FIRST AMENDMENT may be executed by facsimile with original
      signatures to follow.

    

    IN
      WITNESS WHEREOF, the Parties have caused this FIRST AMENDMENT to the AGREEMENT
      to be executed by their duly authorized representatives.

    

    
      	 	 	 
	 	LEVPHARMA
	 
 	 
 	 
 
	Date: 	By:  	/s/ Y.
              T.
              Wachtfogel
	 	
              

            
	 	Its: 
Chief
              Scientific Officer

    

     

    
      	 	 	 
	 	SANQUIN
	 
 	 
 	 
 
	Date: 30-01-06	By:  	/s/ Dr.
              T. J.
              F. Bunnen
	 	
              

            
	 	Its: 
              Chairman of the Executive BoardEXHIBIT
      10.3.2

    

    CONFIDENTIAL
      TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS EXHIBIT. THE COPY FILED
      HEREWITH OMITS THE INFORMATION SUBJECT TO THE CONFIDENTIALITY REQUEST. OMISSIONS
      ARE DESIGNATED AS * . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED
      SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 

    

    AMENDMENT
      NO. 2 TO

    DISTRIBUTION
      AND MANUFACTURING

    SERVICES
      AGREEMENT

    

    This
      Amendment No. 2 to Distribution and Manufacturing Services Agreement is made
      as
      of January 31, 2006 (this “Amendment”)
      and
      amends the Distribution and Manufacturing Services Agreement, dated as of
      January 16, 2004, by and between Lev Development Corp.(formerly known as Lev
      Pharmaceuticals, Inc.), a Delaware corporation (“LEVPHARMA”),
      and
      Sanquin Blood Supply Foundation (“SANQUIN”),
      a
      not-for-profit corporation organized under the laws of The Netherlands, as
      amended by a First Amendment (the “Original
      Agreement”
and
      together with this Amendment, the “Agreement”).
      Terms
      used in this Amendment without definition shall have the meanings given them
      in
      the Agreement.

    

    WHEREAS,
      LEVPHARMA and SANQUIN entered into the Original Agreement in January 2004;
      

    

    WHEREAS,
      the parties to the Original Agreement desire to amend the Original Agreement
      as
      more fully set forth herein to reflect developments in the relationship between
      the parties and the status of the manufacturing of the Product.

    

    NOW
      THEREFORE, in consideration of the premises and the agreements hereinafter
      set
      forth, and for other good and valuable consideration, the receipt and
      sufficiency of which are hereby acknowledged by the each of the parties, the
      parties hereby amend the Original Agreement as follows:

    

    1. Preamble.
      The
      Preamble to the Agreement is hereby amended by deleting the address for Lev
      Development Corp. and replacing it with the following address: 122 East 42nd
      Street, Suite 2606,  New
      York,
      New York 10168.

    

    2. Section
      3.2: Pre-approval.
      Section
      3.2 of the Agreement is hereby amended by adding the following new section
      (d):

    

    “(d)
      Commencing with the first calendar quarter in 2006, LEVPHARMA shall provide
      to
      SANQUIN within 45 days after the end of the calendar quarter, written progress
      reports on the status of the Clinical Study.”

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    3. Section
      4.1(a): Supply for the Clinical Study.
      Section
      4.1(a) of the Agreement is hereby amended by deleting the third and fourth
      sentence in their entirety and replacing them with the following:

    

      “SANQUIN
      shall provide an additional * Units to LEVPHARMA by March 1, 2006. In addition,
      SANQUIN will provide the remaining * Units to LEVPHARMA in accordance with
      Schedule
      4.1(a)
      attached
      hereto.”

    

    

    4. Section
      4.1(c)(ii): Scale Up.
      Section
      4.1(c)(ii) of the Agreement is hereby amended by deleting the language in
      Section 4.1(c)(ii) in its entirety and replacing it with the
      following:

    

    “SANQUIN
      agrees to perform an analysis of the feasibility of scaling up the production
      of
      the Product and provide the results of this analysis to LEVPHARMA no later
      than
      May 30, 2006. The parties shall then make a mutual decision on whether or not
      to
      scale up the production of the Product (the “Scale
      Up”).
      In
      the event that a Scale Up is agreed to, the Parties shall negotiate in good
      faith to reach an agreement on the details of the Scale Up. Such agreement
      shall
      also include timelines as to when (a) clinical trial material and (b) commercial
      product from Scale Up shall be available, which timelines shall be dependent,
      among other things, upon the volume decided upon for Scale Up. Parties shall
      use
      best efforts to conclude such agreement by July 30, 2006. 

     

    5. Section
      4.1(e): Clinical Study Specifications and Manufacturing
      Standards. 

    a. Section
      4.1(e) of the Agreement is hereby amended by deleting the first sentence in
      its
      entirety and replacing it with the following: “The Product for the Clinical
      Study shall be manufactured by SANQUIN according to the Clinical Specifications
      and Manufacturing Standards described in the Investigational New Drug
      Application No. 11838 and in any subsequent amendments thereto (collectively,
      the “IND
      Application”).
      Once
      the manufacturing of the conformance lots has commenced, the processes and
      procedures used to manufacture said lots shall supersede the Clinical
      Specifications and Manufacturing Standards described in the IND
      Application.”

    

    b. All
      references in the Agreement to Exhibit 1 and/or the Quality Agreement are hereby
      deleted and are replaced with a reference to “the Clinical Specifications and
      Manufacturing Standards described in Section 4.1(e)”.

    

    6. Section
      5.1: Purchase
      Price.
      Section
      5.1 of the Agreement is hereby amended by changing the words “recovered plasma”
into “plasma” wherever these words appear in the language. 

     

    7. Section
      5.2(a): Product Supplied for Clinical Study.
      Section
      5.2(a) of the Agreement is hereby amended by deleting the last sentence in
      its
      entirety and replacing it with the following language:

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    

    “The
      loan
      from SANQUIN to LEVPHARMA in the amount of the Purchase Price will be interest
      free and due on January 16, 2014, provided, however, upon Regulatory Approval
      in
      the US, the loan will be cancelled and SANQUIN will provide a release of any
      and
      all security interests granted by LEVPHARMA to SANQUIN. In the event that the
      agreement is terminated prior to either the receipt of Regulatory Approval
      of
      the Product or January 16, 2014, the loan shall become due immediately.”

     

    8. Section
      12.2: Termination.
      Section
      12.2 of the Agreement is hereby amended by deleting the language in Section
      12.2(a)(i) in its entirety and replacing it with the following language:

     

    

    “(i)
      LEVPHARMA after receiving complete and timely support and cooperation from
      SANQUIN fails to complete the enrollment (to be interpreted here as “last
      patient treated”)(the “Enrollment
      Completion”)
      of the
      Clinical Study by July 1, 2007, provided,
      however,
      that
      completion of either the Acute Study (Part A) or the Prophylaxis Study (Part
      B),
      shall constitute Enrollment Completion, or”

     

    9. Article
      XXII: Notices.
      Article
      XXII of the Agreement is hereby amended by adding the following language in
      subsection (d) after the address for LEVPHARMA and before the address for
      SANQUIN:

     

    “With
      a
      mandatory copy to:

    Lev
      Pharmaceuticals, Inc.

    122
      East
      42nd
      Street

    Suite
      2606

    New
      York,
      New York 10168

    Attention:
      Joshua D. Schein, CEO

    Telephone:
      (212) 682-3096”

     

    10. Full
      Force and Effect.
      Except
      to the extent the Original Agreement is modified by this Amendment, the other
      terms and provisions of the Original Agreement shall remain unmodified and
      in
      full force and effect. In the event of a conflict between the terms of the
      Original Agreement and the terms of this Amendment, the terms of this Amendment
      shall prevail. 

     

    

    IN
      WITNESS WHEREOF, the parties hereto have executed this Amendment No. 2 to
      Distribution and Manufacturing Services Agreement as of the date first above
      written. 

    

    LEV
      DEVELOPMENT CORP.

     

    By: 
      /s/
      Joshua D. Schein

      
        

      

    

    Joshua
      D.
      Schein, Ph.D.

    Chief
      Executive Officer

     

    SANQUIN
      BLOOD SUPPY FOUNDATION

     

    By: 
      /s/
      T. J.
      F. Buunen

      
        

      

    

    T.
      J. F.
      Buunen

    Chairman
      of the Executive Board

     

    
      
         

      

      
         

        
          

        

      

      
         

      

    

    Schedule
      4.1(a)

    

    

    Production
      Timetable for * Units pursuant to Section 4.1(a) of the Distribution and
      Manufacturing Services Agreement dated January 16, 2004, as amended. The Product
      volume for each time point shall be produced and ready for delivery no later
      than the dates listed below:

     

    
      
        	
                Date:

              	 	
                Production
                  (units)

              	 
	
                June
                  30, 2006

              	 	 	
                *

              	 
	
                September
                  30, 2006

              	 	 	
                *

              	 
	
                December
                  31, 2006

              	 	 	
                *

              	 
	
                March
                  31, 2007

              	 	 	
                *

              	 
	
                June
                  30, 2007

              	 	 	
                *

              	 
	
                September
                  30, 2007

              	 	 	
                *

              	 
	
                Total

              	 	 	
                *

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