Unassociated Document


    AGREEMENT
      FOR THE PURCHASE AND SALE

    OF
      BLOOD PLASMA

    


    


    THIS
      AGREEMENT (the “Agreement”) is made and entered into this July 12, 2007, by and
      between LEV
      PHARMACEUTICALS, INC,
      a
      Delaware corporation, with its principal place of business at 675 Third Avenue,
      Suite 2200, New York, NY 10017 (“Purchaser”) and DCI
      MANAGEMENT GROUP LLC,
      a
      Delaware Limited Liability Corporation with its principal place of business
      at
      1019 Fort Salonga Road, Suite 109, Northport, NY 11768 (“Seller”).

    


    


    ARTICLE
      1. RECITALS

    


    This
      Agreement is made on the basis of the following facts:

    


    1.1 Definition
      of Plasma.
      The
      term “Plasma” as used in this Agreement shall refer to the production of normal
      source plasma (as defined by the U.S. Food and Drug Administration (“FDA”) in 21
      C.F.R. 640.40) to be derived from automated plasmapheresis procedures conducted
      at Seller’s FDA-approved and IQPP-certified Plasma donor centers (the
“Centers”), which Centers shall be operated by Seller , all of which Plasma,
      collected and released by Seller shall comply with the specifications set forth
      herein, specifically those specifications set forth in the Source Plasma
      Specifications and Contract Manufacturing Agreement (hereafter, the
“Specifications”), attached hereto as Exhibit A and otherwise in compliance with
      all Applicable Laws. As used herein, “Applicable Laws” means all applicable
      federal, state and local laws, regulations, rules, requirements and directives,
      including applicable current Good Manufacturing Practices (“cGMPS”), including
      all specifications and procedures for plasma sourcing, plasma testing, and
      in
      process testing and all applicable FDA laws, requirements, regulations,
      guidelines, licenses and directives, now in effect and as may be amended from
      time to time during the term of this Agreement.

    


    ARTICLE
      2. TERMS
      OF SALE

    


    2.1 Agreement
      to Purchase and Sell.
      During
      the 24 month period commencing upon the date of signing of this Agreement,
      the
      Seller will give its best efforts to supply to Purchaser a total of * * * liters
      of Plasma (the ‘first * * * liters). Thereafter, Seller will use its best
      efforts to supply the minimum quantities of Plasma indicated below. This total
      includes production from current existing centers and 1 future center (the
‘New
      Center’). Exhibit ‘C’ below contains a list of Seller’s existing centers. The
      New Center is estimated to be opened by the Seller by the end of 2007 with
      some
      Plasma produced by the New Center designated to the Purchaser. The Plasma from
      the New Center is estimated to be available after FDA approvals are obtained
      by
      the end of 2008 or beginning of 2009. The proposed delivery schedule is below.
      

    


    Proposed
      Delivery Schedule: From Existing Centers

    


    July,
      2007-December, 2007:
      * * *
Liters

    Actual
      volume and schedule for 2007 will be determined by August 15, 2007. This will
      include an estimated monthly shipping schedule.

    
      
 

      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

     

    From
      Existing and New Centers (combined):

    


    January,
      2008-December, 2008: Minimum *
      * *
Liters.
      Plasma
      for 2008 will come from the New Center and from existing centers. Plasma from
      the New Center collected in 2007 and 2008 as applied against the committed
      volumes for 2007 and 2008 will not be released to Purchaser until FDA licensure
      is obtained for the New Center. * * * Accordingly, during 2008 a minimum of
      * *
      * liters of Plasma will be supplied from existing centers only.

    


    January,
      2009-December, 2009: Minimum *
      * *
Liters
      

    


    January,
      2010-December, 2010: Minimum *
      * *
Liters
      

    January,
      2011-December, 2011: Minimum *
      * *
Liters
      

    


    Note:
      For the yearly periods beginning in January, 2009 thru December 2011, Seller
      will provide the Purchaser a more specific range with estimated monthly
      production. This information will be given to Purchaser by September 30 of
      the
      prior year.

    


    Note:
      For all periods above, Seller will use its best efforts to supply +/- 10% of
      the
      volumes indicated.

    


    Note:
      Any
      additional volume desired by Purchaser above the Minimum requirements provided
      above must be presented to Seller and reviewed by Seller and mutually agreed
      to
      by Purchaser and Seller by June 30 of the prior year.

    


    2.2 Price
      and Payment.

    


    2.2.1 Prices

    


    Initial
      *
      * *
Liters
      (the First *
      *
      *)
      collected (from either existing centers or the New
      Center):

    


    IQPP
      Automated Source Plasma *
      * *
      /liter FOB Center *

    


    Note:
      The
      price paid by Purchaser will be * * * /Liter as long as Seller is bearing the
      cost of the 2 required NAT tests. See Section 3.2 below.

    


    Volume
      over initial *
      * *
Liters
      collected (from either existing centers or the New
      Center):

    


    IQPP
      Automated Source Plasma *
      * *
      /liter FOB Center Initial price after threshold of * * * Liters is
      reached.

    


    Note:
      The
      price paid by Purchaser will be * * * plus any required NAT testing provided
      by
      Seller. See Section 3.2 below.

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

       

    

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

    *
      This
      price * * * will be in effect for the first * * * Liters. As soon as that
      threshold is reached the price is reduced to the lower price of * * * until
      December 31 of that year.

    


    The
      price
      for subsequent years will be reviewed by October 31st
      of the
      prior year and mutually agreed to between the parties. * * * 

    


    All
      prices are FOB Center. Transportation charges to RxCrossroads will be the
      responsibility of the Purchaser except as noted below for New Centers - centers
      that have not yet been licensed by the FDA. If Purchaser does not have an
      account at RxCrossroads Seller will arrange for transportation and storage
      (if
      required) and charge Purchaser at cost. The charges will be indicated on each
      invoice.

    


    The
      costs
      of any additional testing or other procedures required by FDA, QPP or any other
      regulatory authority or the Purchaser other than as contemplated hereunder
      (including the Specifications) shall be added to the per liter prices as stated
      above and will not be included in the annual increase calculations based on
      costs to be incurred by Seller. Correspondingly, in the event that Purchaser
      reduces or eliminates any testing or other quality procedure so as to result
      in
      an actual decrease in Seller’s incurred costs to procure, store, provide or
      supply the Plasma hereunder, the price then in effect under this Agreement
      shall
      be proportionately decreased to reflect all of Seller’s corresponding cost
      savings.

    


    New
      Center: The
      Seller will open a New Center to meet the current and future requirements of
      the
      Purchaser. The Purchaser shall purchase plasma from the New Center (the
“Pre-Licensed Product”) prior to the center’s receipt of FDA approval. Once FDA
      approval has been obtained and the Pre-Licensed Product conforms to the
      Specifications, it shall be deemed to be Plasma. For the avoidance of doubt,
      plasma that is delivered to Purchaser and becomes in conformity with the
      Specifications later than 36 months after the date it is collected, shall not
      be
      deemed to be Plasma. * * * such payment to be made within fifteen (15) days
      after receipt of a valid and accurate monthly invoice. * * * Such payment will
      be made within Fifteen (15) days after receipt by the Purchaser of the Seller’s
      invoice. A late fee of 18% per Annum will be applied to all late invoice
      payments.

    


    In
      the
      event that the Pre-Licensed Product has not been deemed to be Plasma within
      36
      months of the date the Pre-Licensed Product was collected, the * * *.


    


    The
      price
      and volume commitments for the Pre-Licensed Plasma will be based on the * *
      * as
      per the terms of this agreement. * * *, the Purchaser shall be responsible
      for
      all NAT testing costs as stated below

    


    The
      Seller will be responsible for all storage charges at RxCrossroads until *
      *
      *.

    


    2.2.2
      Terms / Title.
      Payment
      for Plasma collected from Seller’s existing centers shall be Cash in Advance
      (immediately available US funds) wired into Seller’s designated bank account on
      a monthly basis as follows: 

    a)
      The
      first payment of * * * will be due at signing to cover the first * * * liters
      shipped.

    b)
      In the
      month before the last of the initial * * * liters is shipped, the following
      procedure will be initiated on a monthly basis. The Seller will issue a
      pro-forma invoice to the Purchaser covering the estimated monthly total volume
      to be shipped to the Purchaser in the following month. This invoice will be
      forwarded to the Purchaser by the 15th
      of the
      month prior to the shipments. 

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

    c)
      The
      Purchaser will then transfer the invoiced amount as available funds in the
      Seller’s bank account by the 20th
      of the
      month prior to the shipments. (Within 5 days of purchaser’s receipt of invoice)
      The wiring instructions are in Exhibit D at the end of this
      agreement.

    d)
      During
      the shipment month previously invoiced and paid for by the Purchaser, the Seller
      will issue invoices against the received funds. These invoices will represent
      the actual amount shipped from the center and the Seller will provide the
      Purchaser a running total of funds used against the monies previously
      received.

    e)
      If, at
      the end of the month, there are unapplied funds on the Purchaser’s side, these
      funds will be applied to the following month shipments.

    f)
      If at
      the end of the month, the Seller has shipped more plasma than covered by the
      monies previously received, the Seller will request that the Purchaser make
      immediate transfer to the Seller’s bank account for the difference.

    g)
      If any
      shipment to the Purchaser is made from Seller’s center to * * * as specified in
      section 3.2 below, because the * * *, this will be considered a sale to the
      Purchaser on the day of shipment and the payment will be applied immediately
      against monies received. In this event, the Seller will be * * *.

    h)
      Clean
      and unrestricted title to Plasma shipped to Purchaser transfers at the Seller’s
      center upon execution of Bill of Lading (BOL) with RxCrossroads. This covers
      shipments directly to Purchaser * * *. Since title transfers to Purchaser upon
      execution of Bill of Lading at Seller’s center, any damages sustained beyond
      that point, even if shipped under Seller’s account, will be the responsibility
      of the Purchaser. 

    


    2.2.3 Shipment
      Costs.
      Purchaser agrees to bear all costs of shipments, freight, insurance and all
      governmental taxes and duties incurred during shipping of the Plasma sold
      hereunder from the Centers to Purchaser’s receiving terminal (RxCrossroads) * *
      *. It is agreed that the shipments from the plasma centers will be bi-weekly
      or
      weekly depending on the volume at each of Seller’s Centers designated to
      Purchaser. 

    


    2.3 Term
      of the Agreement.
      The
      term of this Agreement shall be fifty-four (54) months commencing on the date
      first set forth above and ending on December 31, 2011 (the “Initial Term”). The
      Initial Term and any renewal term shall, collectively, be referred to herein
      as
      the “Term”. 

    


    2.4
       Purchase
      of Closing Inventory

    At
      the
      termination or expiration of this agreement, the Seller is obligated to sell,
      and Purchaser is obligated to buy from the Seller, the Seller’s inventory of
      source Plasma collected at the Centers by Seller for Purchaser prior to the
      termination or expiration of this Agreement, provided such Plasma meets all
      specifications set forth in this Agreement, and such Plasma shall be purchased
      at the same price that Purchaser was paying Seller prior to the termination
      or
      expiration of the Agreement. Any volumes collected by the Seller for the
      Purchaser during the 60 day period prior to such termination or expiration
      to
      meet the minimum commitment during the last year of the Agreement will be the
      sole Closing Inventory and will be accepted by Purchaser when all required
      testing is complete. In no event shall the total Closing Inventory which
      Purchaser may be obligated to purchase exceed the minimum quantity specified
      in
      Section 2.1 of this Agreement.

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

    


    ARTICLE
      3. GENERAL
      PROVISIONS

    


    3.1 Specifications.
      Seller
      warrants and agrees that all Plasma sold to Purchaser hereunder will meet the
      Purchaser’s Specifications, as well as the following requirements and
      conditions:

    


    The
      Seller's centers must be approved plasma centers and licensed by the Food and
      Drug Administration (FDA) utilizing an approved system of procedures. The Seller
      acknowledges that they have received a full, complete and accurate copy of
      the
      Purchaser’s Specifications as in effect as of the date of this agreement (see
      Exhibit A). The Seller also agrees to have all of their plasma Centers QPP
      certified (quality plasma program as defined by PPTA) and to maintain that
      certification for the entire term (including renewal periods) of this agreement.
      Any FDA licensed Center, that is not QPP certified during any portion of this
      agreement can be excluded from supplying plasma to Purchaser, but the lost
      plasma volume, at the Sellers option, may be replaced from one or more other
      centers operated by the Seller that are approved plasma centers, and that meet
      Purchaser specifications (including QPP certification).

    


    The
      Seller represents and warrants that all plasma sold to Purchaser under this
      agreement will be collected, processed, tested, stored, packaged, labeled and
      shipped in strict accordance with the Purchaser’s Specifications and all
      Applicable Laws. 

    


    If
      any of
      the Seller's Centers are closed as a result of regulatory sanctions placed
      on
      the Seller's Centers by the FDA, or if any Center is found by Purchaser to
      be
      clearly deficient, the Seller will have 30 working days to provide, in writing,
      a corrective action plan acceptable to Purchaser. If the action plan is
      unacceptable, or if the Seller's Center cannot provide Plasma within 60 days
      of
      a closure, this Agreement, at the Seller's option, can be modified to eliminate
      such center and replace it with one or more other approved plasma centers owned
      by the Seller that meet Purchaser’s Specifications within 60 days of any such
      modification of this agreement. If Seller requests an additional Center to
      be
      added to this agreement, Purchaser agrees to inspect and approve, if the Center
      meets Purchaser’s specification, any such additional center within ten (10)
      working days. Purchaser and Seller agree to give best efforts to complete all
      documentation within the ten (10) day period. 

    


    The
      Seller shall operate each Center in accordance with its FDA-approved Standard
      Operating Procedure (SOP). Seller further warrants that each Center shall be
      operated in full compliance with all applicable immigration and labor laws
      and
      regulations, including, but not limited to, satisfactory compliance with I-9
      documentation and regulations. 

    


    Seller
      agrees to permit Purchaser and any authorized representative of Purchaser,
      the
      FDA, and any State or local governmental agency to conduct inspections of the
      centers and testing facilities at any time for the purposes of ensuring
      compliance with this Agreement or with all Applicable Laws and regulatory
      requirements, and will permit them to review all records kept by Seller
      regarding the collection, storage, processing and shipment of source Plasma.
      Purchaser, at its sole option and expense, shall have the right to make and
      retain copies of all such records kept by Seller. The Seller agrees to provide
      Purchaser with copies of all written reports (including FDA 483's) and
      correspondence between the Seller's centers and any governmental agency
      regarding any such inspection or review of records within thirty (30) days
      of
      the issuance of any such report. Not supplying these reports to Purchaser within
      60 days after written request is received from Purchaser will constitute a
      breach and will be grounds for the early termination of this agreement.


     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

    
       

      
        
          
          

        

        
          5

          
            

          

        

        
          
          

        

         

      

    

    In
      the
      event that the costs incurred by the Seller in the collection, packaging,
      sampling, labeling, testing, processing or storage of plasma are increased
      or
      decreased to any extent above or below the cost in effect as of the date of
      this
      Agreement as a result of a modification by Purchaser of the specification,
      than
      the purchase price per liter shall be increased or decreased to the extent
      properly allocable to the plasma sold to Purchaser under this agreement, using
      generally accepted cost accounting principles. In the event a governmental
      mandated program significantly affects the Seller's costs, then the parties
      will
      negotiate how the costs or savings will be shared. All cost allocations are
      independent of section 2.2 of this Agreement.

    


    3.2 Testing:
      

    


    Serology:
      The
      Seller will supply all ELISA testing: (HIV 1⁄2, HBsAg, and HCV) at its current
      laboratory.

    


    NAT:
      PCR
      testing as specified above shall be performed by:

    


    National
      Genetics Institute (“NGI”)

    2311
      Pontius Avenue

    Los
      Angeles, CA 90064

    


    Seller’s
      collection centers currently send NAT (nucleic acid test) samples to NGI using
      Seller’s NAT sample packing and shipment procedures and materials. 

    


    For
      2007,
      to expedite delivery to Purchaser, Purchaser agrees to require NAT testing
      only
      for NAT-HIV-1 and NAT-HCV using Seller’s account at NGI. The Purchaser agrees
      that for plasma that is NAT tested using Seller’s accounts, there will be an
      additional charge of * * * per Liter. This charge will include all supplies
      and
      materials required to ship samples and complete the NAT testing. Seller will
      send samples to NGI using the Purchaser supplied FEDEX account number. If the
      Seller’s costs for these tests increase, Purchaser agrees to pay the additional
      costs.

     

    After
      2007, Purchaser has the option to establish a separate account with NGI that
      will be used by Seller to submit NAT samples for source plasma designated for
      Purchaser. A Data Interchange Agreement between NGI, Purchaser, and Seller
      must
      be established in order to facilitate NAT testing and result reporting to Seller
      and Purchaser. This agreement will establish a new NGI account number to be
      used
      by Seller to test plasma units for Purchaser. As per FDA requirements, Seller
      requires only NAT-HCV and NAT-HIV-1 results from NGI before shipment. Purchaser
      may wish to test additionally for NAT-HBV and/or NAT-HAV and/or PARVO. Seller
      will send samples to NGI using the Purchaser supplied FEDEX account number.
      Any
      additional test results may require adjustment to pricing and delivery
      schedules. Please note that * * * will be charged to Purchaser at the contract
      price per Liter. Seller will invoice Purchaser for all such units * * *; the
      invoice will include a detailed listing of the units and volume involved. This
      invoice will be issued to Purchaser on a quarterly basis for the volume * *
      *.
      Purchaser may inspect the Seller’s Center’s * * * during any inspection of
      Seller’s Centers. Also, please note that for any units * * *.

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    
      	
              1.

            	
              NGI
                will report directly to Seller, under either Seller’s account or the
                aforementioned new NGI account number to be established for the Purchaser,
                the required NAT test results (NAT HIV-1 and NAT HCV) and, if using
                the
                Purchaser’s account, whatever the current Purchaser required additional
                test (NAT-HAV and/or NAT-HBV and/or PARVO) that Supplier must have
                before
                shipment. 

            


    

    


    
      	
              2.

            	
              In
                the event that the Purchaser has established an account for NAT testing,
                NGI will make available all test results to Seller and to Purchaser
                as
                specified in the aforementioned Data Interchange Agreement to be
                established.

            


    

    


    If
      the
      Purchaser’s account is established and utilized, all costs associated with NAT
      testing including sample shipments, sample packaging supplies, and air freight
      will be the responsibility of the Purchaser. The Purchaser will supply a FEDEX
      airfreight account number to the Seller for this use.

    


    The
      Seller agrees that samples for PCR testing * * *. PCR samples from qualified
      donors * * *. PCR results, with the exception of re-tests, are expected to
      be
      received within 21 days of sample submission to NGI. Except as stated in the
      following paragraph relating to * * *, the Seller shall properly store such
      plasma until such time that all applicable tests are performed and completed,
      and shall ship such plasma to Purchaser, only at such time that the applicable
      test results are received 

    


    *
      *
      *:
      It
      is
      agreed that in the event * * *, Seller shall ship Purchaser plasma to
      RxCrossroads * * *. Purchaser will pay all charges associated with the shipment
      and storage of plasma shipped to RxCrossroads. * * * a final invoice including
      these charges will be issued to Purchaser and applied against the monthly
      advance. 

    


    Purchaser
      shall not be obligated to buy or pay for any Plasma pursuant to this agreement
      or any option under this agreement, which does not, in all respects, comply
      with
      the applicable Purchaser Specifications and Applicable Laws. 

    


    3.3 Shipping
      of Plasma.
      Plasma
      shall be packed by Seller in such a manner as to prevent damage to the Plasma
      or
      Plasma containers during shipping and shall be shipped by RxCrossroads subject
      to such other conditions set forth in the Specifications, and any other written
      instructions provided by Purchaser. No Plasma shall be released pursuant to
      this
      Agreement unless and until such Plasma fully complies with the Specifications
      and Applicable Laws and Seller shall be responsible for ensuring compliance
      with
      all such Specifications. The parties agree that there may be * * *.


     

    3.4 Licenses,
      Permits and Approvals.
      Seller
      represents and warrants that it has obtained and shall continue to possess
      during the Term hereof, a current, valid and unrevoked license from CBER
      authorizing and qualifying Seller to conduct automated plasmapheresis as well
      as
      any special programs to be pursued by Seller at any or all of the Centers
      identified herein, as well as a license permitting Seller to produce and ship
      Plasma related products derived from the automated plasmapheresis operations
      conducted at the Centers. In addition, Seller represents and warrants that
      it
      shall maintain for the Term of this Agreement, all other local, state and
      federal licenses, permits and approvals required to operate the Center and,
      as a
      condition precedent to the commencement of Purchaser’s performance of its
      obligations hereunder, Seller agrees to furnish a copy of all such licenses,
      permits, and approvals to Purchaser.

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
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    ARTICLE
      4. PERSONNEL
      AND MATERIAL TO BE FURNISHED BY SELLER 

    


    The
      Seller agrees to furnish all managerial, administrative, medical and
      professional personnel (including persons qualified to conduct plasmapheresis
      operation) required to produce the projected output of plasma set forth in
      Article 2.1 hereof. In addition, the Seller agrees to provide, at its own cost
      and expense, all facilities, equipment, materials and softgoods needed to
      produce plasma at each of the Seller’s centers.

    


    ARTICLE
      5. MISCELLANEOUS
      PROVISIONS

    


    5.1 Relationship
      of the Parties.
      The
      relationship between Purchaser and Seller is, and during the term hereof shall
      be, that of buyer and seller. Seller is in no way the partner, legal
      representative or agent of Purchaser for any purpose whatsoever and has no
      right
      or authority to incur, assume, or create, in writing or otherwise, any warranty,
      liability or obligation of any kind, expressed or implied, in the name of,
      or on
      behalf of Purchaser.

    


    5.2 Omitted
      

    


    5.3 Right
      of Renewal.
      At the
      expiration of the Initial Term, Purchaser and the Seller have the option to
      renew this agreement for one (1) year using as a base price the 2011 contract
      price for plasma which must then be adjusted within the agreed to range.
      Thereafter, if mutually agreed to, the agreement may be extended by one year
      options. All renewal options must be exercised on or before June 1st
      of the
      expiration year and must be evidence by a written statement executed by both
      parties. 

    


    5.4 Indemnification
      The
      Seller and Purchaser hereby indemnify and agree to hold harmless each other
      and
      its respective affiliates, agents, employees, officers and directors, from
      and
      against any and all claims, losses, liabilities, damages, attorney's fees,
      costs
      and expenses which may be sustained by and/or claimed against the other party
      by
      virtue of the negligent performance of services rendered by the other party,
      the
      willful misconduct by the other party or its officers, employees or agents,
      or
      any representation or warranty contained in this agreement being breached,
      untrue or materially misleading, by omission or otherwise. It being understood,
      however, that the financial liability under this section shall be limited to
      the
      extent of each party's insurance coverage, if such coverage is in effect and
      in
      accordance with any requirements under this agreement at the time a claim is
      asserted under this section.

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    

     

    The
      obligations to indemnify, defend and hold harmless set forth in this Section
      shall not apply to the Party to be indemnified (the “Indemnified Party”) unless
      the Indemnified Party (i) notifies the Party providing such indemnification
      (the
“Indemnifying Party”) as soon as practicable of any matters in respect of which
      the indemnity may apply and of which the Indemnified Party has knowledge; (ii)
      gives the Indemnifying Party, at the Indemnifying Party’s option, full
      opportunity to control the response thereto and the defense thereof, including
      any agreement relating to the settlement thereof, provided that the Indemnifying
      Party shall not settle any such claim or action without the prior written
      consent of the Indemnified Party (which consent shall not be unreasonably
      withheld or delayed) or such settlement include as an unconditional term thereof
      the giving by the claimant of an unconditional release from all liability in
      favor of the Indemnified Party; and (iii) cooperates with the Indemnifying
      Party, at the Indemnifying Party’s cost and expense, in the defense or
      settlement thereof. Notwithstanding the foregoing, the indemnification
      obligations hereunder shall not be relieved hereunder for failure to do the
      foregoing, or delay with so doing, unless the Indemnifying Party is materially
      prejudiced thereby. In addition, the Indemnified Party may, at its own expense,
      participate in its defense of any claim. 

    


    5.5 Insurance
      The
      Seller represents and warrants that they will maintain, at all times during
      the
      term of this agreement, property damage, general liability, product liability
      insurance against loss or damage caused by negligent performance of services
      rendered by Seller, or by the non-conforming or negligent preparation of Plasma
      or Plasma products, and such insurance shall not contain any contractual
      exclusion and which shall cover the Seller's liability assumed under this
      agreement, in an amount not less than * * * per occurrence and * * * in the
      aggregate amounts. 

    


    5.6 Default

    


    5.6.1 Rights
      and Remedies  

    


    5.6.1.
      a Nonpayment:
      Subject
      to Section 5.6.3, in the event that the Purchaser fails to transfer funds to
      the
      Seller according to the terms and schedule set forth in Section 2.2.2, then
      upon
      notice of such event, the Purchaser will be in breach of this agreement.
      Correction of breach for non-payment must be made by Purchaser within 10
      business days or

    


    
      	
            	a)	
              Except
                as provided in Section 5.6.1.a(b),Seller will have no further obligation
                to sell Plasma to Purchaser, and

            


    

    


    
      
        	
              	b)	
                Purchaser
                  will be liable to purchase from Seller (and Seller shall deliver)
                  the
                  minimum amounts of Plasma specified to be delivered during the
                  balance of
                  the Term of this Agreement. Seller will make reasonable endeavors
                  to sell
                  the contracted Plasma to third parties and Purchaser will be liable
                  for
                  all differences, if any, between contracted sales price and actual
                  price
                  received by Seller. It is understood that Seller will have additional
                  testing and administrative expenses to test and prepare contracted
                  Plasma
                  for another customer; these costs will also be the responsibility
                  of the
                  Purchaser.

              


      

    

    


    5.6.1.
      b Other
      Remedies:
      In the
      event the Seller or Purchaser is in breach of any provision, other than
      Non-payment by Purchaser which is covered above in Section 5.6.1.a, or is in
      default of any other obligation under this agreement, or in the event of any
      representation or warranty contained in this agreement is breached, untrue
      or
      materially misleading, by omission or otherwise, and such breach remains uncured
      following thirty (30) days’ written notice to the breaching party, the
      non-breaching party shall have the right to immediately terminate this agreement
      upon written notice to the breaching party. In addition, Purchaser or the Seller
      shall have the right to exercise any and all other rights and remedies available
      to it, whether arising at law or in equity or arising under this agreement.
      

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    5.6.2 Remedies
      Cumulative;
      No Waiver

    The
      rights and remedies available to Purchaser or the Seller under this agreement
      or
      any other agreement among the parties are cumulative and the exercise of any
      right or remedy shall not preclude or dismiss Purchaser's or the Seller's right
      to pursue any other or additional right or remedy, including, without
      limitation, any claim for damages. The failure to exercise any right or remedy
      in the event of any breach or default shall not constitute a waiver or adversely
      affect Purchaser's or the Seller's right to exercise any right or remedy in
      the
      future for the same or any other breach or default in the future.

    


    5.6.3
      Termination
      Right:  Notwithstanding
      anything else set forth in this Agreement, the Parties agree that Purchaser
      shall have the right to terminate this Agreement (a) upon written notice by
      supplying to Seller a copy of any press release and/or US Government
      notification that Purchaser has not received regulatory approval in the U.S.
      for
      the commercialization of its lead product candidate (C1-INH for the treatment of
hereditary
      angioedema)
      on or
      before December 31, 2008 or (b) upon written notice in the event that, prior
      to
      December 31, 2008, Purchaser does not enter into a financing or loan arrangement
      or an issuance by Purchaser of a secondary stock offering providing it with
      additional funds sufficient to cover the purchase price for First * * * liters
      of Plasma. In either such event, Purchaser must complete the purchase of an
      initial amount of * * * Liters total as described herein (minimum * * * Liters
      from existing centers and up to * * * Liters from Seller’s ‘new’ center - a
      total of * * * Liters). If Purchaser desires, Seller can assist in reselling
      any
      plasma purchased by the Purchaser that is no longer needed by the Purchaser.
      In
      that event, the Purchaser will be responsible to the Seller for any amount
      that
      is the difference in the selling price then obtained by the Seller and the
      net
      contracted price (including NAT testing) for such initial * * * Liters * *
      *
      /Liter). This amount shall be payable within ten (10) days of notice by
      Purchaser to Seller of termination. 

    


    5.6.4
      Effect of Termination. The
      provisions of this Agreement which by their nature would continue beyond any
      termination or expiration of this Agreement, including without limitation the
      parties’ representations and warranties and Sections 5.4, and 5.6 - 5.20 shall
      survive any termination or expiration of this Agreement to the degree necessary
      to permit their complete fulfillment or discharge.

    


    5.7 Force
      Majeure.
      The
      performance of Purchaser and Seller hereunder is subject to all contingencies
      except those beyond the direct control of Purchaser and the Seller including,
      without being limited to, the following:

    


    5.7.1 Strikes,
      or other labor disputes or labor troubles of any kind;

    


    5.7.2 Hurricanes,
      floods, earthquakes, droughts, or accidents;

    


    5.7.3 Commotions,
      insurrections, riots, wars, or consequences of war;

    


    5.7.4 Acts
      of
      God or perils of the sea;

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    5.7.5 Rules,
      laws, orders, actions, quotas, embargoes, seizures, regulations, restrictions,
      or actions of any governmental agency or divisions thereof, or rejections by
      inspectors or retentions of goods by customs authorities;

    


    5.7.6 Breakdowns
      in manufacturing machinery, casualties, fires, loss of goods in public or
      private warehouses, provided, however, that such breakdowns, casualties, fires
      or losses are not the result of Purchaser’s or Seller’s intentional
      acts;

    


    5.7.7 Shortages
      of, or failure, by third parties to deliver materials and
      merchandise;

    


    5.7.8 In
      any
      such event, Purchaser and Seller shall have the right, at its good faith and
      election and without incurring any liability for such occurrence or event
      to:

    


    a. Notify
      other party of its intention and mutually agree between the parties to perform
      a
      modified or restricted agreement and perform the Agreement as so restricted
      or
      modified because of any of the foregoing contingencies. In the event the parties
      hereto mutually agree to perform a modified or restricted Agreement, the
      restricted or modified performance shall operate as a complete discharge of
      any
      obligations hereunder which are inconsistent with such modification or
      restriction; or

    


    b. Perform
      the Agreement within a reasonable time after the causes of nonperformance or
      delay have terminated.

    


    5.8 Notices.
      All
      notices or other communications required or permitted to be given or made under
      this Agreement may be effected by personal delivery in writing, which shall
      then
      be deemed communicated the same day as the personal delivery thereof, or by
      registered or certified mail, postage prepaid, return receipt requested, which
      shall then be deemed communicated five (5) days from the mailing thereof.
      Notices shall be addressed to the parties at the address given below or at
      such
      address as the respective parties may hereafter designate to the other in
      writing:

    


    


    


    
      	If
              addressed to Purchaser:	
              Legal
                Department 
                LEV
                  PHARMACEUTICALS, INC.

                675
                  Third Avenue

                Suite
                  2200

                New
                  York, NY 10017    

              

            


    

    


    
      	If
              addressed to Seller:	
              DCI
                Management Group LLC

              
                Attn:
                  Ira London

                1019
                  Fort Salonga Road

                Suite
                  109

                Northport,
                  NY 11768

              

            


    

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

     

    5.9 Applicable
      Law.
      This
      Agreement shall be governed by and construed in accordance with the substantive
      and procedural laws of the State of New York without giving effect to the
      principles of conflicts of law as applied in the State of New York.

    


    5.10 Effectiveness
      of Agreement.
      This
      Agreement shall become effective only upon execution and acceptance by Purchaser
      and Seller.

    


    5.11 Integration
      Clause.
      This
      Agreement and all exhibits and attachments constitute the entire agreements,
      understandings, representations, conditions, warranties, and covenants made
      between the parties hereto. Unless set forth herein, neither party shall be
      liable for any representation made to the other, and all modifications and
      amendments hereto must be in writing. No amendment to this Agreement shall
      be
      binding on either party unless in writing and signed by both parties.


    


    5.12 Multiple
      Originals.
      This
      Agreement may be executed simultaneously or in one or more counterparts, each
      of
      which shall be deemed an original, but all of which together shall constitute
      one and the same instrument.

    


    5.13 Partial
      Invalidation.
      In the
      event any provision of this Agreement shall for any reason be or become void
      or
      unenforceable, the remaining provisions shall continue in full force and effect,
      and under no circumstances shall an unenforceable provision have any effect
      upon
      any provision which is otherwise enforceable.

    


    5.14 Paragraph
      Headings.
      The
      subject headings of the paragraphs and subparagraphs of this Agreement are
      included for the purposes of convenience only, and shall not affect the
      construction or interpretation of any of its provisions.

    


    5.15 Assignability.
      Except
      as otherwise set forth herein, this Agreement shall not be assignable by either
      party hereto, either voluntarily or by operation of law or otherwise, without
      the prior written consent of the other party. Such prohibition on the assignment
      of rights under this Agreement shall be operable to the extent permitted by
      law.
      Any assignment without prior written consent is void. Notwithstanding the
      foregoing, Purchaser may assign or transfer this Agreement (i) to a successor
      entity, solely in the event of an acquisition or merger by or with another
      entity, upon ten (10) days prior written notice to Seller; or (ii) to an
      Affiliate of the Purchaser. 

    


    5.16 Successors
      and Assigns.
      This
      Agreement shall be binding upon and inure to the benefit of the parties hereto,
      their successors and assigns, subject to the provisions of Article 5.15
      above.

    


    5.17 Third
      Party Rights.
      Except
      for such corporation(s), firm(s), partnership(s) or other legal entity(ies)
      affiliated with Seller which operate and/or manage the Center, nothing in this
      Agreement, whether expressed or implied, is intended to confer any right or
      remedies under or by reason of this Agreement of any persons other than the
      parties to it and their respective successors and assigns, nor is this Agreement
      intended to relieve or discharge the obligation or liability of any third
      persons to any party to this Agreement, nor shall any provision give any third
      persons any right of subrogation or action over or against any party to this
      Agreement.

     

     

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 

    

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

    


    5.18 Arbitration.
      Any
      disputes or claims arising under or in connection with this Agreement, including
      pricing, the interpretation or application of this Agreement, shall be settled
      by arbitration in accordance with the rules of the American Arbitration
      Association then in force. If the parties cannot agree upon a single arbitrator
      within ten (10) days after demand by either of them for arbitration, then each
      party shall select one arbitrator from a list of arbitrators supplied by the
      American Arbitration Association. The two arbitrators so selected shall then
      choose a third arbitrator in order that the dispute may be finally resolved
      by a
      majority of the panel of three arbitrators so selected. The decision of the
      arbitrator or arbitrators shall be final and binding upon the parties both
      as to
      law and fact. The expense of the arbitration shall be shared equally by the
      parties, unless the arbitration award states that the expense shall be otherwise
      assessed. Any such arbitration shall take place in New York, NY.

    


    5.19 Authority
      to Execute.
      Seller
      is not a party to, nor is it bound by any agreement which precludes or otherwise
      restricts the performance of its obligations hereunder. Seller represent and
      warrants that it has the right, legal capacity and authority to enter into
      this
      Agreement and that the execution of this Agreement has been duly
      authorized.

    


    5.20 Confidentiality.
      Purchaser and the Seller and its employees and agents shall hold in confidence
      any and all documents, materials and information provided to Seller by
      Purchaser, including but not limited to the terms and conditions of this
      Agreement. Seller agrees that it will not disclose, except to their employees
      and agents on a need-to-know basis, any such information or documents described
      herein at any time during, or after termination of this Agreement, without
      the
      prior written consent of Purchaser. The requirements of this Paragraph shall
      not
      apply to information which is publicly disclosed by Purchaser. In addition
      to
      the above, both Seller and Purchaser shall fully comply with the U.S. Department
      of Health and Human Services’ regulations on "Privacy Standards for Individually
      Identifiable Health Information," which comprise 45 C.F.R. §§ 160.101 through
      164.534, promulgated pursuant to the Health Insurance Portability and
      Accountability Act of 1996 (“HIPAA”).

    


    IN
      WITNESS WHEREOF, the parties hereto have entered into this Agreement on the
      date
      first set forth above.

    


    


    PURCHASER:
      LEV PHARMACEUTICALS, INC.

     

    
      	By 	/s/
              Judson Cooper	 
	Name
              	Judson
              Cooper	 
	Title
              	Chairman	 


    

     

    SELLER:
      DCI MANAGEMENT GROUP, LLC

    
       

      
        	By 	/s/
                Ira London	 
	Name
                	Ira
                London	 
	Title
                	 	 


      

       

    

      

    
      [*CONFIDENTIAL
        TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
        SUCH
        PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
        HAS
        BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    


    EXHIBIT
      A - PLASMA SPECIFICATIONS

    


    LEV
      PHARMACEUTICALS, INC.

    SOURCE
      PLASMA SPECIFICATIONS:

    


    a)
      Origin of Plasma:
      Human
      Source Plasma collected from donors at USA-FDA licensed donor center(s). Each
      donor center must adhere to PPTA (iQPP) voluntary standards. Plasma must be
      collected as Source Plasma as defined by the FDA in 21 CFR Part 640 Subpart
      G,
      Source Plasma 640.60.

    


    b)
      Selection/Exclusion
      Criteria for Donors (Donations): The
      selection/exclusion criteria used for determining donor eligibility was
      performed in accordance to the current SOP’s of the collecting facility at the
      time of donation from donors meeting all donor screening and donor selection
      criteria. Plasma must be collected from donors who fulfill all requirements
      as
      Qualified Donors as defined by iQPP standards and in accordance with 21 CFR
      Part
      640 Subpart G, Source Plasma Suitable Donors 640.63.

    


    c)
      Examination
      and Interview of Donors: The
      donor
      examination and/or interview was performed in accordance to the current SOP’s of
      the collecting facility and performed in accordance with all US requirements
      at
      the time of donation.

    


    d)
      Screening
      Tests on Individual Donations:
      Testing
      requirements as described in 21 CFR 640.67 and 640.71 must be met and shall
      meet
      the following criteria:

    

      
        	
                TEST

              	
                TEST
                  RESULT

              
	
                Anti
                  HIV 1⁄2

              	
                Non-reactive

              
	
                HBsAg

              	
                Non-reactive

              
	
                Anti-HCV

              	
                Non-reactive

              
	
                HIV
                  NAT

              	
                Negative

              
	
                HCV
                  NAT

              	
                Negative

              
	
                Syphilis

              	
                Negative
                  or Non-reactive donor

              
	
                Atypical
                  Antibody

              	
                Negative
                  donor

              


      

    

     

    A
      list of
      all current test kits or methods shall be submitted to Lev Pharmaceuticals,
      and
      updated in the event a test or method is changed.

    


    For
      Lookbacks and notification for destruction of plasma notification must be made
      to Lev Pharmaceuticals:

    


    
      	
              §

            	
              Within
                three working days upon receipt of reactive or positive test results
                from
                a donor from whom prior or subsequent units have been shipped to
                Lev
                Pharmaceuticals

            


    

    
      	
              §

            	
              Within
                one working day of notification of Post Donation Information resulting
                in
                product recalls or seizure concerning units shipped to Lev
                Pharmaceuticals

            


    

    
      	
              §

            	
              Within
                three working days of receipt of Post Donation Information not resulting
                in a seizure or recall (e.g. tattoo, body piercing, high risk
                behavior)

            


    

     

     

    
      
        [*CONFIDENTIAL
          TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
          SUCH
          PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
          HAS
          BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

      
        
          
          

        

        
          14

          
            

          

        

        
          
          

        

      

    

     

    e)
      Density: The
      density of plasma must be 1.026.

    


    f)
      Shelf
      life:
      Each
      bottle must have at least a remaining shelf life of 5 years as of
      delivery.

    


    g)
      System
      to Trace Donations:
      Supplier
      shall maintain systems that all donations are traceable to the individual
      donors.

    


    h)
      Plasma
      Collection System:
      Source
      Plasma collection in bottles in accordance to current SOP’s of the collecting
      facility at the time of donation. Plasma must be collected in bottles that
      fulfill all requirements sited by the FDA in 21 CFR Part 640 Subpart G, Source
      Plasma 640.64(b). Plasma collection must fulfill all additional requirements
      as
      defined by the FDA in 21 CFR Part 640 Subpart G, Source Plasma 640.64. * *
      *

     

    Plasma
      units that fall into one of the following categories is unacceptable for
      shipment to Lev Pharmaceuticals:

    


    
      	
              §

            	
              Units
                with reactive or positive viral marker test results; Prior or subsequent
                units from donors that have been found to be reactive/positive for
                required testing

            


    

    
      	
              §

            	
              Hemolyzed
                or lipemic units

            


    

    
      	
              §

            	
              Units
                with frozen plasma on the outside of the
                container

            


    

    
      	
              §

            	
              Broken
                or contaminated units

            


    

    
      	
              §

            	
              Untested
                or units with incomplete testing

            


    

    
      	
              §

            	
              Orphan
                units

            


    

    
      	
              §

            	
              Units
                having errors that breech traceability such as units that cannot
                be traced
                back to an individual donor

            


    

    


    i)
      Plasma
      Storage and Transport: Source
      Plasma must be frozen by cooling rapidly at -20oC or colder, as soon as possible
      and at the latest within 24h of collection. When rapidly frozen, the temperature
      must reach -20 °C or less (≤ -20 °C) inside the plasma within 60 minutes. Plasma
      storage and transportation has been maintained at -20oC or colder. The Seller
      will provide one additional sample for each unit shipped to Purchaser with
      the
      Shipment.

    


    j)
      Quality
      Specifications - Documentation:
      Each
      bottle has been labeled with at least the following information:

    •
      Supplier
      name and license #

    •
      Plasma
      Type

    •
      Unit Identification
      will be by means of barcode unit number type CODE128

    •
      Volume

    •
      Anticoagulant
      composition

    •
      Storage
      temperature

    •
      Expiration
      date 

    •
      Plasma
      bottle lot number (on bottle)

     

     

    
      
        [*CONFIDENTIAL
          TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT. EACH
          SUCH
          PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK [***],
          HAS
          BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

      
        
          
          

        

        
          15

          
            

          

        

        
          
          

        

      

    

     

    •
      Plasma shipment documentation (packing list) shall
      include:

    •
      Collecting
      facility’s name and address

    •
      Plasma
      Type

    •
      Product/Unit
      identification 

    •
      Volume

    •
      Collection date

    •
      Testing
      statement

    


    Each
      shipment of Plasma must be accompanied by a Certificate of Quality (see Exhibit
      B below) along with routine shipment documentation including plasma Packing
      Forms. 

    


    k)
      Electronic
      data of shipment: Every
      shipment will include a shipment diskette that includes a number of files
      containing information about the shipment. Included in these files is the
      following information:

    


    •
      Unique
      shipment number (Format Center ID + Shipment Number e.g., * * *
      0672)

    •
      Carton number
      for each unit (Format: contained in field consisting of year number + carton
      number e.g. 20070123 is Carton 0123 from 2007))

    •
      Unit
      number (Format is 2 character unique Center ID + 7 digit unit number; e.g.,
      * *
      * 1234567)

    •
      Center
      identification (Integrated into unit number - first two alpha characters of
      unit
      number are Center unique ID; e.g., * * * 1234567 is from * * * center) - See
      table in Exhibit C

    •
      Donor
      identification (Donor Number Format: 5 characters numeric; e.g.,
      12345)

    •
      Quantity
      (volume) (Format: in liters to 3 decimal places; e.g., 0.877)

    •
      Donation
      date (Format YYYYMMDD; e.g., 20070423 would be donation date
      04/23/2007)

     

    
       

      
        
          [*CONFIDENTIAL
            TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
            EACH SUCH
            PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK
            [***], HAS
            BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

        
          
            
            

          

          
            16

            
              

            

          

          
            
            

          

        

      

    

     

    Exhibit
      B -
      CERTIFICATE
      OF QUALITY (SAMPLE)

    


    *
      * *


    
       

       

      
        
          [*CONFIDENTIAL
            TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
            EACH SUCH
            PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK
            [***], HAS
            BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

        
          
            
            

          

          
            17

            
              

            

          

          
            
            

          

        

      

    

    
 

    CERTIFICATE
      OF COMPLIANCE (SAMPLE)

    


    *
      * *


    


    
       

      
        
          [*CONFIDENTIAL
            TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
            EACH SUCH
            PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK
            [***], HAS
            BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

        
          
            
            

          

          
            18

            
              

            

          

          
            
            

          

           

        

      

    

    EXHIBIT
      C - LIST OF DCI EXISTING CENTERS (AS OF 07/05/2007)

    


    *
      * *


     

    
       

      
        
          [*CONFIDENTIAL
            TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
            EACH SUCH
            PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK
            [***], HAS
            BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

        
          
            
            

          

          
            19

            
              

            

          

          
            
            

          

        

      

    

     

    Exhibit
      D - Wiring Instructions to pay the Seller:

    


    
       

      
        
          [*CONFIDENTIAL
            TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.
            EACH SUCH
            PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK
            [***], HAS
            BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.] 
 

        
          
            
            

          

          
            20