ex10-49.htm


    
 

    Exhibit
      10.49


    Execution
      Version


     

    


     

     

     

    SUPPLY
      & DISTRIBUTION AGREEMENT


     

    Between


     

    IMMTECH
      PHARMACEUTICALS, INC.


     

    AND


     

    PAR
      PHARMACEUTICAL, INC.

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     

     


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


     

    


    
      	
               Table
                of Contents 

            
	 	 
	ARTICLE
              I - DEFINITIONS 	
               3

            
	 	 
	ARTICLE
              II – EFFECTIVE DATE ; CONTROLLING TERMS 	
               5

            
	 	 
	ARTICLE
              III – COMMERCIAL SUPPLY 	
               5

            
	 	 
	ARTICLE
              IV – PRODUCT QUALITY AND REGULATORY MATTERS	
               7

            
	 	 
	ARTICLE
              V - REPRESENTATIONS, WARRANTIES AND COVENANTS 	
               10

            


    

     

     

     

     

     

     

     

     

     

     

     

     

    
      


    


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    


    SUPPLY
      AGREEMENT

     

    This
      Supply Agreement (this “Supply Agreement”) is made and entered into as of
      June 11, 2007 (the “Effective Date”), by and between Immtech
      Pharmaceuticals, Inc., a Delaware corporation with its principal place of
      business at 150 Fairway Drive, Vernon Hills, IL 60061 (“Immtech”), and Par
      Pharmaceutical, Inc., a Delaware corporation having a principal place of
      business at 300 Tice Boulevard, Woodcliff Lake, New Jersey 07677
      (“Par”).  Immtech and Par may be referred to herein individually as a
“Party”, or collectively as the “Parties”.  All capitalized terms used
      in this Supply Agreement shall have the meaning ascribed to them in the
      Licensing Agreement (as defined below) to which this Supply Agreement is an
      Exhibit.

     

    Recitals

     

    Whereas,
      Immtech and Par have entered into a Licensing Agreement, dated as of the date
      hereof (the “Licensing Agreement”);

     

    Whereas,
      Immtech has expertise manufacturing pharmaceutical products for infectious
      diseases; and

     

    Whereas,
      Par desires to purchase from Immtech, and Immtech desires to manufacture and
      sell to Par, the Product all on the terms and conditions set forth
      herein.

     

    Now,
      Therefore, in consideration of the
      foregoing and the covenants and promises contained herein, the Parties hereby
      agree as follows:

     

    ARTICLE
      I - DEFINITIONS

     

    Section
      1    Definitions.  For
      purposes of this Agreement, the following terms shall have the meanings set
      forth below:

     

    1.1          
      “Administrative Costs” means all costs related to conducting a recall in
      accordance with Applicable Laws.

     

    1.2          
      “Applicable Laws” means all laws, ordinances, rules and regulations within the
      Territory applicable to the Manufacturing and Packaging of the Product or any
      aspect thereof and the obligations of Immtech or Par, as the context requires
      under this Agreement, including, without limitation, (i) all applicable federal,
      state and local laws and regulations of each Territory; (ii) the U.S. Federal
      Food, Drug and Cosmetic Act, and (iii) the cGMPs.

    


     


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


                                   
      1.3           “Batch”
means defined quantity of finished drug product which has been Manufactured
      and
      Packaged in accordance with the Specifications.

     

                                   
      1.4           “Calendar
      Quarter” means a period of three (3) consecutive months commencing on January 1,
      April 1, July 1 or October 1 of any calendar year.

     

                                    1.5           “COA”
      means Certificate of Analysis.

     

    1.6          “Commencement
      Date” means the first date upon which FDA approves pafuramidine maleate for the
      treatment of PCP.

     

    1.7          “Contract
      Year” means each consecutive twelve (12) month period beginning on the
      Commencement Date.

     

    1.8          “Defective
      Product” means Product that is not releasable.

     

    1.9          “Delivery
      Date” means the date on which Immtech shall tender the relevant Batch(es) to
      Par. Each Delivery Date shall be specified by Par on the relevant Purchase
      Order
      and confirmed by Immtech as set forth in Section 3.4.

     

    1.10            “Firm
      Commitment” means a binding commitment in writing made by Par to purchase
      Product in accordance with Section 3.1.

     

    1.11            “Manufacture”
      means all operations of receipt of materials, production, packaging, labeling,
      quality control, release of drug product.

     

    1.12            “Manufacture
      Date” means the date that pafuramidine first comes into contact with another
      ingredient during the manufacturing process of drug product.

     

    1.13            “Manufacturing
      Release Record(s)” means a) all completed production/Batch records; b) all
      quality control test/request forms (result worksheets) and associated data;
      c)
      dynamic monitoring performed during processing; d) any alert/action
      notifications generated during processing; e) any planned or unplanned
      deviations associated with the Product; f) any out of Specification result
      investigations associated with the Product; g) the Certificate of Analysis
      for
      the Batch comparing testing to Specifications; and h) the appropriate
      disposition notification for the Batch.

     

    1.14            “Nonconformity”
      means a deficiency in characteristic, documentation or procedure, which renders
      the quality of the Product non acceptable or not in accordance with specified
      requirements.

     

    1.15            “Packaging”
      means Primary Packaging and Secondary Packaging.

     

    1.16            “Primary
      Packag(ing)” means material intended to contain and protect drug product during
      handling, storage and transport.

     

    1.17            “Purchase
      Order” shall have the meaning set forth in Section 3.2.

     

    1.18            
      “Rolling Forecast” shall have the meaning set forth in Section 3.1.

     


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    
      1.19            “Secondary
        Packag(ing)” means packaging material that does not come into contact with drug
        product.

       

      1.20            “Specification”
        means the specifications for the Product attached hereto as Exhibit A in
        draft
        form until the Commencement Date and made a part of hereof, as determined
        in accordance with the analytical methodology set forth therein, as such
        specifications may be amended from time to time.

    

     

    1.21            “Unit”
      means each individually Packaged unit of Product.


     

    ARTICLE
      II – EFFECTIVE DATE; CONTROLLING TERMS

    


    Section
      2.1  Effective Date

    


    This
      Agreement shall automatically become effective as of the Execution Date of
      the
      Licensing Agreement.

    


    Section
      2.2   Controlling Terms

    


    This
      Agreement is governed by the terms of the Licensing Agreement and all of such
      terms apply to and control this Supply Agreement.  For any terms that
      may be interpreted to conflict between the two agreements, the terms of the
      Licensing Agreement shall control.

     

    ARTICLE
      III – COMMERCIAL SUPPLY

     

    Section
      3.1    Forecasts

     

    On
      or
      before the fifteenth (15th) day of each calendar month following the
      Commencement Date and at least four months prior to the first Delivery Date,
      Par
      shall furnish to Immtech a written twelve (12) month rolling forecast of the
      quantities of Product that Par intends to order from Immtech during such period
      (“Rolling Forecast”). The first 3 months of such Rolling Forecast shall
      constitute a binding commitment for the quantities of Product specified therein
      (“Firm Commitment”) and the following 9 months of the Rolling Forecast shall be
      non-binding, good faith estimates.

     

    Section
      3.2    Purchase
      Orders

     

    At
      least
      quarterly, Par shall submit purchase orders for the Firm Commitment portion
      of
      the Rolling Forecast, which specify the actual number of Units to be
      Manufactured and Packaged, and the requested Delivery Dates for each Batch
      (“Purchase Order”).  Product shall be ordered by Par only in writing.
 Immtech will not accept verbal orders of any kind for the production of
      Product. Par shall submit each Purchase Order to Immtech at least ninety (90)
      days in advance of the earliest Delivery Date requested in the Purchase
      Order.  Immtech will confirm such Delivery Dates within fifteen (15)
      business days of receipt of the Purchase Order and will use commercially best
      efforts to ensure the


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


     

    Product
      is delivered by the Delivery Dates specified in the Purchase
      Orders.  [****]. In the event of a conflict between the terms of any
      Purchase Order and this Agreement, this Agreement shall control. Notwithstanding
      the foregoing, during any calendar quarter, Immtech shall be required to supply
      Par with quantities of Product up to one hundred twenty-five percent (125%)
      of
      the forecasts submitted by Par in respect of such period; provided,
however, that if Par submits Purchase Orders that exceed one hundred
      twenty-five percent (125%) of the forecasts submitted by Par in respect of
      such
      period, then Immtech shall use commercially reasonable efforts to supply Par
      with such excess quantities of the Product.

     

     Section
      3.3    Product
      Supply

     

    All
      Product supplied hereunder shall be manufactured by Immtech in accordance with
      the Specifications and cGMPs as determined using the manufacturing process
      described in Immtech’s NDA for the Product.  Immtech will utilize a
      documented system of procedures for the control of changes to the
      Specifications.  Any significant changes shall be reviewed and
      approved by both Parties prior to implementation.  Immtech will be
      responsible for labeling and packaging of product for final distribution,
      utilizing trademarks and artwork provided by Par to Immtech in accordance with
      the Licensing Agreement.

     

    Section
      3.4    Product
      Delivery

     

    All
      Purchase Orders will contain the
      following information: (i) the precise quantity of Product desired and required
      Delivery Dates, (ii) desired packaging and quantities by package (e.g., bottles
      of 28, bottles of 500, sample blisters of 14), (iii) the anticipated shipping
      destination for Product and (iv) such other information as Par wishes to provide
      or that Immtech might find necessary or useful in completing a specific work
      order.  Product shall be delivered F.O.B. North American shipping
      destination (with the specific destination to be determined by Par), freight
      prepaid by Immtech, no earlier than fourteen (14) days prior to the requested
      Delivery Date, and no later than the Delivery Date. Each shipment of the Product
      shall be accompanied by relevant COAs and an invoice.  Par will then
      own such inventories.  Par will assume all operational and financial
      responsibility for processing and handling returned inventories due to product
      expiry.

     

    Section
      3.5    Payment

     

    For
      the quantities to be supplied by
      Immtech, Par shall pay Immtech the Transfer Price.  Par shall use
      commercially reasonable efforts to pay for Product delivered within thirty
      (30)
      days of the date of invoice or receipt of the Product, whichever shall last
      occur, and in no event later than forty-five (45) days from such later date;
      provided, however, that Par shall not be obligated to pay for any
      shipment of Product disputed under Section 4.4 during the pendency of such
      dispute.

    


    


    


    


    


    ****
      Material omitted pursuant to a request for confidential treatment under Rule
      24b-2 of the Exchange Act of 1934.  Material filed separately with the
      Securities and Exchange Commission.


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    ARTICLE
      IV – PRODUCT QUALITY AND REGULATORY MATTERS

    


    Section
      4.1 Specification(s) of Product

    


    Product
      will be Packaged, labeled and handled by Immtech in accordance with the
      Specifications.

    


    Section
      4.2  Unmodified Product

    


    Immtech
      agrees to inform Par of any changes to the Specifications that may impact final
      product release and Immtech agrees to continue to supply unmodified Product
      to
      Par as ordered under the terms of and subject to the conditions and limitations
      of this Agreement for a minimum of two (2) years.

    


    Section
      4.3(a)  Product Quality

    


    Immtech
      covenants that the Product shall be manufactured, Packaged, tested, stored
      and
      handled in accordance with the Specifications, the Act and all relevant FDA
      regulations, guidelines and guidances, including cGMPs.

    


    Immtech
      warrants that neither it, nor its vendors, will engage in any act which causes
      any Product produced for Par to become adulterated, and agrees that such Product
      will not be adulterated, within the meaning of the federal Food, Drug and
      Cosmetic Act, as amended, when Product is delivered to Par.

    


       
      Section 4.3(b)  Quality Control

    


    Immtech
      will take all steps reasonably necessary to ensure that it has contracted with
      Third Party manufacturers with the facilities, equipment, instrumentation,
      resources and trained personnel to provide all raw materials, in-process and
      product assays, analysis and other testing, as compliance with cGMP may require
      in connection with Immtech’s supply of Product.  Immtech shall provide
      a COA for each lot of Product supplied hereunder at the time of
      shipment.

    


    Immtech
      shall maintain complete and accurate documentation of all validation data,
      stability testing data, batch records, quality control and laboratory testing
      and any other data required under cGMP in connection with the supply of Product
      hereunder.

    


    Section
      4.4     Defective Product

    


    Within
      at
      most thirty (30) days of delivery of Batches of the Product, Par shall notify
      Immtech of any Nonconformity of the delivered batches with the Specifications.
      Any Product received by Par from Immtech that has not been rejected by Par
      within thirty (30) days after receipt shall be deemed to have been accepted;
      provided, however, that other than with respect to defects or
      other non-compliance plainly observable from a visual inspection, any acceptance
      or deemed acceptance shall not adversely affect or otherwise diminish Par’s
      rights to receive shipments of the Product in compliance with the requirements
      of Section 4,1, 4.3(a), 4.3(b) or 5.1.  In the event of any



    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

     

    Nonconformity
      of the delivered batches of the Product, (i) Immtech shall deliver to Par
      replacement Batches of Product conforming to the Specifications within thirty
      (30) days of receipt of such Nonconformity notice from Par and (ii) Par shall
      destroy the delivered batches, the costs of which shall be borne by
      Immtech.

    


    In
      the
      event of a disagreement between the Parties as to whether the Product meets
      the
      Specifications, the Parties shall cause a mutually acceptable independent
      laboratory to review records, test data and to perform the tests and/or analyses
      set forth in the Specifications on samples of the alleged Defective
      Product.  The independent laboratory’s results shall be final and
      binding.  Unless otherwise agreed to by the Parties in writing, the
      costs associated with such testing and review shall be borne by the Party which
      was incorrect about whether the Product meets the Specifications.

    


       
Section
      4.5    Facility
      Access

    


    Upon
      written request and permission from Immtech, Par, through its employees,
      consultants or other representatives will have the right during normal business
      hours and at a time mutually agreed to inspect Immtech’s or its subcontractors’
or Affiliates’ manufacturing operations to determine whether or not Immtech is
      complying in all respects with its obligations hereunder.  Par
      warrants that all such inspections and audits shall be carried out in a manner
      calculated not to unreasonably interfere with Immtech’s, its subcontractors’ or
      its Affiliates’ conduct of business and to insure the continued confidentiality
      of Immtech’s business and technical information. Further, Par agrees to comply
      with all of Immtech’s safety and security requirements during any visits to the
      Immtech, its subcontractors’, or Affiliates’ facilities.  Par agrees
      to make promptly available to Immtech any external reports from such facility
      visit(s).

    


       
Section
      4.6    Manufacturing
      Release Records and Data

    


    Following
      the Manufacture of each Batch of Product, and upon written request as required,
      Immtech shall provide Par with properly completed copies of all Manufacturing
      Release Records, including Manufacturing and Packaging Batch records prepared
      in
      accordance with the Specifications.

    


       
      Section 4.7    Recordkeeping

    


    Immtech
      shall maintain true and accurate books, records, test and laboratory data,
      reports and all other information relating to Manufacturing and Packaging under
      this Agreement, including all information required to be maintained by the
      Specifications and all Applicable Laws. Such information shall be maintained
      in
      forms, notebooks and records for a period of at least two (2) years from the
      relevant finished Product expiration date or longer if required under Applicable
      Laws.

    


    Section
      4.8  Finished Product Compliance

    


    Upon
      Product delivery by Immtech and acceptance by Par and pursuant to the Licensing
      Agreement, Par shall be thereafter solely responsible for compliance with all
      


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


     Applicable
      Laws related to any subsequent labeling, packaging, and
      any required testing of Product.

     

     Section
      4.9 Governmental Inspections and Requests

    


     Immtech
      shall immediately advise Par if an authorized agent of any Regulatory Authority
      visits either Immtech or any Manufacturing Facility related to the Manufacturing
      or Packaging of the Product.  Immtech shall furnish to Par a copy of
      the portions of the report relevant to the Product by such Regulatory Authority,
      if any, within ten (10) days of Immtech’s receipt of such
      report.  Further, upon receipt of a Regulatory Authority request to
      inspect the Facilities or audit Immtech’s books and records with respect to
      Manufacturing and Testing under this Agreement, Immtech shall immediately notify
      Par, and shall provide Par with a copy of any written document received from
      such Regulatory Authority related to the Product. To the extent related to
      Manufacturing or Packaging hereunder, Immtech shall provide to Par a copy of
      any
      proposed written response to any such inspection related to the Product prior
      to
      its submission and a reasonable opportunity for Par to review such
      response.

    


    Section
      4.10    Product
      Complaints

    


    Par
      will
      notify Immtech within 5 calendar days of any customer complaints that relate
      to
      the Manufacture or Packaging of the Product in accordance with the Licensing
      Agreement.  Immtech shall conduct internal investigations to determine
      the validity of the complaint.  Immtech will use commercially
      reasonable efforts to report the findings of such investigation to Par within
      10
      business days of notification.  Any ADE reporting will be in
      accordance with Section 9 of the Licensing Agreement.  Par will be
      responsible for customer response communications and will promptly deliver
      copies of such responses to Immtech.  Any complaint received by
      Immtech that relates to the Product will be forwarded to Par within 5 calendar
      days.

    


    Section
      4.11    Recall

    


    In
      the
      event Immtech believes a recall, field alert, Product withdrawal or field
      correction may be necessary with respect to any Product provided under this
      Agreement, Immtech shall immediately notify Par in writing.  Immtech
      will not act to initiate a recall, field alert, Product withdrawal or field
      correction without the express prior written approval of Par, unless otherwise
      required by Applicable Laws and Immtech shall provide all necessary cooperation
      and assistance to Par.  In the event Par believes a recall, field
      alert, Product withdrawal or field correction may be necessary with respect
      to
      any Product provided under this Agreement, Par shall immediately notify Immtech
      in writing. Par will not act to initiate a recall, field alert, Product
      withdrawal or field correction without the express prior written approval of
      Immtech, unless otherwise required by Applicable Laws and Immtech shall provide
      all necessary cooperation and assistance to Par.  Immtech shall be
      responsible for any recall, field alert, Product withdrawal or field correction;
      provided, however, that the cost of any recall, field alert,
      Product withdrawal or field correction shall be borne equally by the Parties,
      except to the extent such recall, field alert, Product withdrawal or field
      correction is caused by either Immtech’s or Par’s breach of its warranties,
      representations or obligations under this Agreement, the Licensing
      Agreement


    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


     or
      Applicable Laws or its negligence or willful misconduct, in which case such
      cost
      shall be borne by the responsible Party.  For purposes hereof, such
      cost shall be limited to reasonable, actual and documented Administrative Costs
      incurred by the Parties for such recall, withdrawal or correction, and
      replacement of the Defective Product to be recalled.  In the event of
      a recall, Par shall provide to Immtech copies of distribution records in its
      control and shall otherwise reasonably cooperate with Immtech in respect of
      any
      such recall.

     

    ARTICLE
      V - REPRESENTATIONS, WARRANTIES AND COVENANTS

    


    Section
      5.    Limited
      Warranty

    


    Immtech
      represents and warrants to Par that at the time of delivery of the Product
      and
      through label expiry date, provided that Par or any of affiliates, customers,
      and or third parties, handle and/or store Product per specifications, cGMP,
      USP
      requirements, such Product will conform to and will have been Manufactured
      and
      Packaged in conformance with the Specifications and Applicable
      Laws.

    


    THE
      LIMITED WARRANTY SET FORTH IN THIS SECTION 5.1 AND SECTIONS 4.1, 4.3(A) AND
      4.3(B) IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
      WARRANTY OF MERCHANTABILITY, WARRANTY OF NON-INFRINGEMENT AND ANY WARRANTY
      OF
      FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED IN THIS
      SECTION 5.1 AND SECTIONS 4.1, 4.3(A) AND 4.3(B), IMMTECH MAKES NO OTHER
      WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE MANUFACTURING OR
      PACKAGING OF THE PRODUCT.

    


    Section
      5.2    Release
      Responsibility.

    


    Immtech,
      as the Party responsible for release of the finished Product, warrants that
      it
      will not release any Batch of Product if the required final Product testing
      indicates that the Product does not comply with the Specifications.

    


    Section
      5.3    Existence and
      Power

    


    Each
      Party hereby represents and warrants to the other Party that such Party (i)
      is
      duly organized, validly existing and in good standing under the laws of the
      state in which it is organized, (ii) has the corporate power and authority
      and
      the legal right to own and operate its property and assets, and to carry on
      its
      business as it is now being conducted, and (iii) is in compliance with all
      requirements of applicable law, except to the extent that any noncompliance
      would not materially adversely affect such Party’s ability to perform its
      obligations under the Agreement.

    


    Section
      5.4     Authorization
      and Enforcement of Obligations

    


    Each
      Party hereby represents and warrants to the other Party that such Party (i)
      has
      the corporate power and authority and the legal right to enter into this
      Agreement and to 

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

     

     

    perform
      its obligations hereunder and thereunder and (ii) has taken all necessary action
      on its part to authorize the execution and delivery of the Agreement and the
      performance of its obligations hereunder. The Agreement has been duly executed
      and delivered on behalf of such Party, and constitutes a legal, valid, binding
      obligation, enforceable against such Party in accordance with its
      terms.

    


    Section
      5.5    No
      Conflict

    


    Each
      Party hereby represents and warrants to the other Party that the execution
      and
      delivery of this Agreement and the performance of such Party’s obligations
      hereunder (i) to not conflict with or violate any requirement of Applicable
      Laws
      or any material contractual obligation of such Party and (ii) do not materially
      conflict with, or constitute a material default or require any consent under,
      any material contractual obligation of such Party.

     

    ARTICLE
      VI – TERM AND TERMINATION

    


    Section
      6.1         
Term.  This Agreement shall commence on the Effective Date and
      continue for a period that shall extend until the
      termination of the Licensing Agreement.

     

    Section
      6.2           
Termination for Breach.

     

    If
      either
      Party commits a material breach or material default in the performance or
      observance of any of its obligations under this Agreement, and such breach
      or
      default continues for a period of sixty (60) days after delivery by the other
      Party of written notice reasonably detailing such breach or default, then the
      non-breaching or non-defaulting Party shall have the right to terminate this
      Agreement, with immediate effect, by giving written notice to the breaching
      or
      defaulting Party.  The Parties shall retain all rights and remedies
      (at law or in equity) in respect of any breach hereof.

     

    Section
      6.3.          Effects of
      Termination.

     

    In
      the
      event of expiration of the applicable Term or termination of this Agreement,
      all
      rights and obligations of the parties hereunder shall cease, except that
      termination or expiration shall not: (i) release either party from any liability
      or obligation that at such time shall already have accrued or be owed, that
      is
      caused by an improper termination or that thereafter accrues from a breach
      or
      default prior to the effective date of such expiration or termination; and
      (ii)
      affect in any way the survival of any other right, duty or obligation of either
      party hereto that is expressly stated elsewhere in this Agreement to survive
      such expiration or termination.

    


    


    [Signature
      Page Follows]

     

     

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    IN
      WITNESS WHEREOF, the Parties hereto
      have caused this Agreement to be executed by their duly authorized
      representatives as of the day and year first above written.

    
      
 

      
        	 	
                IMMTECH
                  PHARMACEUTICALS, INC.

              
	 	
                By:     
                  /s/ Eric L.
                  Sorkin                                                                 
                  
Name:   
                  Eric L. Sorkin

                Title:      
                  Chairman and Chief Executive Officer

              
	 	 
	 	 
	 	
                PAR
                  PHARMACEUTICAL, INC.

              
	 	
                By:    
                  /s/ John
                  MacPhee                                                                 
                  
Name:     John
                  MacPhee

                Title:        President,
                  Branded Products Division