January
      29, 2007

    


    


    John
      Stockmal 

    Director
      of Project Management 

    Protalex,
      Inc.

    145
      Union
      Square Drive

    New
      Hope,
      PA 18938

    


    Telephone:
      215.862.9720

    Fax:
      215.
      862.6614

    Email:
      jstockmal@protalex.com

    


    PREX8000:
      This
      service estimate is executable if signed and returned within 30
      days.

    


    Service
      Estimate

    
      
        

      

    

    Process
      Transfer and Manufacture of Two Clinical Batches of
      PRTX-100

     

    Objective:

    


    Protalex,
      Inc. (“Protalex” or “Client”) has requested that AAIPharma Inc. (“AAIPharma”)
      manufacture two (2) batches of lyophilized PRTX-100
      in a
      5-mL vial for Phase I clinical studies according to the formulation, process
      and
      specifications provided by Protalex. Protalex is responsible for release of
      the
      batches for clinical use. The AAIPharma Safety Department has assigned a level
      2
      safety rating for PRTX-100. 

    


    Summation
      of Services:

    


    
      	
              Process
                Transfer and Manufacture of Engineering Batch

            	 	 	 	 
	
              Manufacture
                of Two (2) Clinical Batches

            	 	 	 	 
	
              Stability
                Program for Two (2) Clinical Batches

            	 	 	 	 
	
              Project
                Management

            	 	 	 	 
	 	 	 	 	 
	
              Total
                Estimated Cost

            	 	$	XXXX*	 


    

    *Note:
      Excludes Materials and Specialty Items.

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    


    THE
      TERMS
      AND PROVISIONS OF THE FOLLOWING ATTACHED APPENDICIES ARE INCORPORATED HEREIN
      BY
      REFERENCE AND SHALL BE BINDING ON THE PARTIES:

    


    
      	
              APPENDIX
                I 

            	DESCRIPTION OF SERVICES 
	
              APPENDIX
                II 

            	PAYMENT SCHEDULE AND TERMS 
	
              APPENDIX
                III 

            	GENERAL TERMS AND
              CONDITIONS 


    

       

    THE
      SERVICES DESCRIBED IN THIS SERVICE ESTIMATE, INCLUDING THE APPENDICES HERETO,
      SHALL BE REFERRED TO HEREIN AS THE "SERVICES."

    


    THE
      PHARMACEUTICAL PRODUCT TO BE MANUFACTURED PURSUANT TO THIS SERVICE ESTIMATE
      SHALL BE REFERRED TO HEREIN AS THE "PRODUCT." 

    


    THIS
      SERVICE ESTIMATE SHALL BECOME BINDING ON THE PARTIES IF SIGNED BY AN AUTHORIZED
      REPRESENTATIVE OF PROTALEX, INC.
      AND
      RETURNED TO AAIPHARMA WITHIN 30 DAYS OF THE DATE HEREOF.

     

    
      	AAIPharma
              Inc. 	 	Protalex,
              Inc. 
	 	 	 
	 	 	 
	Reviewed and Approved by: 	 	Printed Name of Authorized
              Representative 
	Beth Balkcum 	 	 
	Manager, Product Development, 	 	 
	Project Management 	 	 
	 	 	 
	 	 	 
	Date 	 	Signature 
	 	 	 
	 	 	 
	Reviewed and Approved by: 	 	Date 
	Lee Karras 	 	 
	Senior Vice President,
              Pharmaceutical 	 	 
	Operations 	 	 
	 	 	 
	 	 	 
	Date 	 	Purchase Order Number 
	 	 	 
	Please return signed document
              to: 	 	 
	Baron Bowers 	 	 
	Project Manager, Product Development
              Group 	 	 
	AAIPharma
              Inc. 	 	Telephone: 843.746.2513 
	4221 Faber Place
              Drive 	 	Facsimile: 843.746.2550 
	Charleston, SC 
              29405 	 	E-mail:
              baron.bowers@aaipharma.com 


    

            

     

    
      	
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    Appendix
      I

    Description
      of Services

    


    
      	I.	
              Project
                Responsibility

            


    

    


    
      	 	
              A.

            	
              Client
                will supply AAIPharma with sufficient quantities of Active Pharmaceutical
                Ingredient (“API”) and a current MSDS. Note:
                Client will supply the API accompanied by a Certificate of Analysis
                (COA)
                and a release statement or a COA from an independent laboratory in
                order
                for AAIPharma to perform limited release testing.
                

            


    

    


    
      	 	
              B.

            	
              AAIPharma
                will perform the following tests to release the API: identification
                and
                appearance. Note:
                A
                change order may be necessary if additional release testing is required
                by
                AAIPharma. AAIPharma will release a single lot of API to be used
                in the
                engineering and clinical batches. 

            


    

    


    
      	
            	C.	
              AAIPharma
                will source sufficient amounts of packaging components and materials
                on
                behalf of Client for use in the activities described herein. The
                costs
                will be passed-through to Client plus 15% for sourcing and
                handling.

            


    

    


    
      	
            	D.	
              AAIPharma
                will perform full COA testing per USP or specification for all raw
                materials and packaging components.

            


    

    


    
      	II.	
              Process
                Transfer and Engineering
                Batch

            


    

    


    AAIPharma
      will

    
      	 	
              ·

            	
              Review
                all technical documentation provided by Protalex.

            


    

    
      	 	
              ·

            	
              Generate
                appropriate test procedures and specifications for manufacturing
                PRTX-100.

            


    

    
      	 	
              ·

            	
              Prepare
                and issue a batch record to manufacture an engineering batch of
                PRTX-100.

            


    

    
      	 	
              ·

            	
              Set-up
                AAIPharma equipment as appropriate for the Protalex-specified packaging
                components and perform trial runs to optimize the operating parameters
                of
                the filling equipment (Note:
                If AAIPharma does not purchase the components directly, then Protalex
                will
                be responsible for sourcing the components in packaging configurations
                suitable for AAIPharma gross cleaning
                equipment).

            


    

    
      	 	
              ·

            	
              Compound,
                aseptically fill and lyophilize one full-scale engineering (test)
                batch as
                outlined in the batch record; if API is limited, AAIPharma will use
                surrogate material or placebo to fill the shelves of the
                lyophilizer.

            


    

    
      	 	
              ·

            	
              Perform
                appropriate in-process testing (pH, appearance, bioburden, fill weight
                and
                concentration via UV 280).

            


    

    
      	 	
              ·

            	
              Test
                the batch according to specifications agreed upon in writing by Protalex
                and AAIPharma. AAIPharma will test the batch for concentration by
                UV280,
                appearance, pH, isoelectric focusing (IEF), SDS-PAGE, Size Exclusion
                Chromatography (SEC), PX1 Binding Affinity (ELISA), concentration
                by
                mBCA,
                moisture (cKF), completeness, clarity, and color of solution after
                reconstitution, reconstitution time, content uniformity, analytical
                content (the appropriate method is to be determined) and particulate
                matter (via HIAC). 

            


    

    
      	 	
              ·

            	
              Perform
                cleaning verification testing.

            


    

    
      	 	
              ·

            	
              Dispose
                of any remaining vials (Note:
                The engineering batch will not be packaged or labeled for clinical
                use).

            


    

    
      	 	
              ·

            	
              Complete
                the batch record (Note:
                AAIPharma QA approval is not required for master or executed copies
                of
                engineering batch records). 

            


    

     

     

    
      	
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          	Estimated
                  Cost for Section
                  II 	 	$	XXXX	 


        

      

    

     

    III. Clinical
      Batch Manufacture

    


    AAIPharma
      will:

    
      	 	
              ·

            	
              Prepare
                the master batch record - to be approved by
                Protalex.

            


    

    
      	 	
              ·

            	
              Compound,
                aseptically fill and lyophilize two (2) batches of PRTX-100 in a
                5-mL vial
                (Batch sizes: approximately 2,000
                vials).

            


    

    
      	 	
              ·

            	
              Perform
                appropriate in-process testing during manufacturing (i.e. pH, appearance,
                bioburden, fill weight and concentration via UV
                280).

            


    

    
      	 	
              ·

            	
              Release
                the batches according to specifications agreed upon in writing by
                Protalex
                and AAIPharma. AAIPharma will test the batches for concentration
                by UV280,
                appearance, pH, isoelectric focusing (IEF), SDS-PAGE, Size Exclusion
                Chromatography (SEC), PX1 Binding Affinity (ELISA), concentration
                by
                mBCA,
                moisture (cKF), completeness, clarity, and color of solution after
                reconstitution, reconstitution time, content uniformity, analytical
                content (the appropriate method is to be determined), particulate
                matter
                (via HIAC), endotoxin and sterility.


            


    

    
      	 	
              ·

            	
              Perform
                cleaning verification testing.

            


    

    
      	 	
              ·

            	
              Inspect,
                label and package the vials - 100% visual inspection; Protalex to
                approve
                label copy in writing or provide finished labels with an approved
                proof
                copy.

            


    

    
      	 	
              ·

            	
              Complete
                the batch records and issue a copy to
                Protalex.

            


    

    
      	 	
              ·

            	
              Ship
                the batches FOB to Protalex or a designated site as a single shipment.
                Each additional shipment will incur an additional $XXXX
                handling charge. 

            


    

     

    
      	Estimated Cost for Section
              III 	
              $XXXX
                per batch or
                $XXXX 

            


    

     

     

    
      	
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    IV. Stability
      Program for Clinical Batches

    


    AAIPharma
      will set stability for two (2) lots of PRTX-100. Stability evaluations will
      be
      performed on the drug product. Data reports will be provided as generated for
      each time point and a final report will be issued at the end of the study.
      A
      stability protocol will be developed by AAIPharma and reviewed and accepted
      in
      writing by Protalex. The stability protocol and analytical testing are described
      in the following table:

    


    
      	
              TESTS
                PERFORMED

            
	
              1. Appearance

            
	
              2. pH

            
	
              3. Concentration
                by UV280 or mBCA

            
	
              4. Completeness,
                clarity and color of solution

            
	
              5. Moisture
                (cKF)

            
	
              6. PXI
                Binding Affinity (ELISA)

            
	
              7. SEC

            
	
              8. SDS-PAGE

            
	
              9. Particulate
                matter (HIAC)

            
	
              10. Sterility
                

            


    

    


    SAMPLING
      SCHEDULE 

    
      	
              Time
                (Months)

            	 	
              25°C/60%
                RH

            	 	
              30°C/65%
                RH

            	 	
              40°C/75%
                RH

            	 
	
              0

            	 	
              Tests
                1-10

            
	
              1

            	 	 	
              Tests
                1-9

            	 	 	
              HOLD*

            	 	 	
              Tests
                1-9

            	 
	
              3

            	 	 	
              Tests
                1-9

            	 	 	
              HOLD*

            	 	 	
              Tests
                1-9

            	 
	
              6

            	 	 	
              Tests
                1-9

            	 	 	
              HOLD*

            	 	 	
              Tests
                1-9

            	 
	
              9

            	 	 	
              Tests
                1-9

            	 	 	
              HOLD*

            	 	 	
              N/A

            	 
	
              12

            	 	 	
              Tests
                1-10

            	 	 	
              HOLD*

            	 	 	
              N/A

            	 
	
              18

            	 	 	
              Tests
                1-9

            	 	 	
              N/A

            	 	 	
              N/A

            	 
	
              24

            	 	 	
              Tests
                1-10

            	 	 	
              N/A

            	 	 	
              N/A

            	 


    

    


    *HOLD
      samples will only be tested if significant change occurs during the 6 months
      storage at 40°C/75%
      RH,
      or if requested by Protalex, at an additional cost.

    


    
      	Estimated Cost for Section
              IV 	
              $XXXX
                per batch or $XXXX1 

            


    

    


    1Note:
      this cost assumes the batches will be placed on stability at separate times.
      

     

    
      
        	V.	
                Project
                  Management

              


      

      


      AAIPharma
        will assign a Project Manager to communicate project progress, track projects
        and facilitate project team meetings. Teleconferences will be held as needed
        between the project team and Protalex. The Project Manager will provide e-mail
        communications to Protalex updating the progress on any projects
        in-process.

       

    

     

    
      	
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    Appendix
      II

    Payment
      Schedule and Terms

    


    The
      estimated cost for the activities outlined in this contract is $XXXX.
      Materials and packaging components will be passed through to Client at cost
      plus
      15%. A summary of the breakdown costs is as follows: 

    


    
      	
              Service
                

              Agreement
                Section

            	
              Service
                Agreement Description

            	
              Estimated
                Cost

            
	
              Section
                I.

            	
              Project
                Responsibility

            	
              Cost
                plus 15%

            
	
              Section
                II.

            	
              Engineering
                Batch Manufacture

            	
              $XXXX

            
	
              Section
                III.

            	
              Clinical
                Batch Manufacture (2)

            	
              $XXXX

            
	
              Section
                IV.

            	
              Stability
                Program (2)

            	
              $XXXX

            


    

    


    In
      addition, Client will be charged for all out-of-pocket costs and/or expenses
      associated with the activities outlined herein. Such costs and expenses shall
      include required raw materials, travel and shipping expenses, and lab supplies
      such as columns, standards and chemicals unavailable from Client. All documented
      and reasonable out-of-pocket costs and/or expenses will be billed at cost plus
      15%. Actual costs based on vendor invoices plus 15% will be
      invoiced.

    


    AAIPharma
      will provide Client with copies of raw data upon request. These data will be
      provided at a charge of $XXXX for non-chromatographic projects and $XXXX for
      chromatographic projects. 

    


    AAIPharma
      will revise the final reports once at no additional charge upon Client’s
      request. Additional revisions to final reports will be conducted at $XXXX per
      hour. Client will not be charged for revisions required due to AAIPharma
      error.

    


    AAIPharma
      will notify Client should testing yield aberrant or out-of-specification data.
      All work (including time spent reviewing the investigation with laboratory
      management and quality assurance personnel) associated with laboratory
      investigations that are not due to AAIPharma’s error will be charged to Client
      at $XXXX per hour. Client also agrees to pay for any re-tests that confirm
      the
      original test results including marginal pass/fail results.

    


    AAIPharma
      will perform all testing per the methods indicated. Should method optimization
      or development be required, Client will be notified and, upon approval, method
      optimization/development will be conducted at $XXXX per hour.

    


    Stability
      setup and storage charges are due and payable upon initiation of the study.
      These fees are not refundable. Client will be entitled to terminate the project
      at any time with thirty (30) days prior written notice. Any revisions to the
      stability protocol made after the initiation of the study will be charged to
      Client at $XXXX per hour. 

    


    This
      cost
      estimate is based on the information available and AAIPharma’s experience with
      the procedures involved. AAIPharma reserves the right to revise this Agreement
      should the scope of the project change. Any changes in the scope or the nature
      of the work covered by this service Agreement must be mutually agreed to and
      confirmed by a written change order.

     

     

    
      	
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    PAYMENT
      SCHEDULE

     

    
      	
              Payment

            	 	
              Payment
                Description

            	 	
              Amount

            
	
              1

            	 	
              Prepayment
                Due Upon Signature of Contract

            	 	
              $XXXX

            
	
              2

            	 	
              Engineering
                Batch Manufacture

            	 	
              $XXXX

            
	
              3

            	 	
              First
                Clinical Batch is Released by AAIPharma Quality Assurance

            	 	
              $XXXX

            
	
              4

            	 	
              Second
                Clinical Batch is Released by AAIPharma Quality Assurance

            	 	
              $XXXX

            
	
              5

            	 	
              Stability
                Program Initiated for Clinical Batch #1

            	 	
              $XXXX

            
	
              6

            	 	
              6
                Month Stability Report is Issued for Clinical Batch #1

            	 	
              $XXXX

            
	
              7

            	 	
              12
                Month Stability Report is Issued for Clinical Batch #1

            	 	
              $XXXX

            
	
              8

            	 	
              18
                Month Stability Report is Issued for Clinical Batch #1

            	 	
              $XXXX

            
	
              9

            	 	
              24
                Month Stability Report is Issued for Clinical Batch #1

            	 	
              $XXXX

            
	
              10

            	 	
              Stability
                Program Initiated for Clinical Batch #2

            	 	
              $XXXX

            
	
              11

            	 	
              6
                Month Stability Report is Issued for Clinical Batch #2

            	 	
              $XXXX

            
	
              12

            	 	
              12
                Month Stability Report is Issued for Clinical Batch #2

            	 	
              $XXXX

            
	
              13

            	 	
              18
                Month Stability Report is Issued for Clinical Batch #2

            	 	
              $XXXX

            
	
              14

            	 	
              24
                Month Stability Report is Issued for Clinical Batch #2

            	 	
              $XXXX

            


    

     

     

    
      	
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    Appendix
      III

    General
      Terms and Conditions

    


    
      	
              a.
                Requirements Client
                will supply AAIPharma with this Service Estimate, or a copy of it,
                signed
                by the appropriate authorized Client representative. Client will
                also
                supply AAIPharma with a purchase order number and prepayment in the
                amount
                of $XXXX.

               

              b.
                Invoicing Unless
                otherwise agreed, AAIPharma will invoice Client pursuant to the Payment
                Schedule and Terms set forth in Appendix II. All invoices are due
                and
                payable upon receipt and are subject to 1.5% interest monthly after
                thirty
                (30) days from the date of the respective invoice. In the event of
                default
                in the payment for services rendered, Client shall be responsible
                for all
                collection fees and expenses incurred by AAIPharma, including reasonable
                attorney’s fees.

               

              c.
                Good Manufacturing Practices AAIPharma
                operates its manufacturing facilities in compliance with applicable,
                current Good Manufacturing Practices and AAIPharma internal standard
                operating procedures, and is registered with the Food and Drug
                Administration, Registration Numbers 10-49418, 10-58430, 19-54450
                and
                10-55790 (Wilmington, NC; Research Triangle Park, NC; Shawnee, Kansas
                and
                Charleston, SC; respectively).

               

              d.
                Amendment
                No
                addition to or modification of this Service Estimate shall be effective
                unless made in writing and signed by both parties, except the parties
                may
                orally agree to a change order (encompassing a change in project
                scope or
                definition) for additional services providing the associated fee
                for such
                additional services does not exceed 10% of the relevant portion of
                the
                project cost. AAIPharma will confirm in writing any such oral change
                order, and Client will be responsible for payment for such additional
                services.

               

              e.
                Termination Client
                shall be entitled to terminate or cancel the project at any time
                on thirty
                (30) days' written notice received by AAIPharma prior to the respective
                scheduled manufacturing date. In the event of such termination or
                cancellation, Client will be obligated to pay only for the cost of
                work,
                materials and services used for the project through the effective
                date of
                the cancellation, reasonable project shut down costs, and AAIPharma's
                cost
                of all materials and services previously acquired or contracted for
                and
                which cannot be utilized in other day-to-day operations.
                In
                addition, a cancellation fee in the amount of $XXXX(50%
                of the estimated project cost set forth in Appendix II (the “Project
                Cost”) shall
                be due to AAIPharma should Client provide AAIPharma less than thirty
                (30)
                days and more than ten (10) days notice of such termination or
                cancellation in writing. Client shall pay to AAIPharma a cancellation
                fee
                in the amount of $XXXX(75%
                of the Project Cost)
                should it provide AAIPharma ten (10) days or less notice of such
                termination or cancellation in writing. Such Project Cost payments
                will be
                invoiced as provided hereunder. Client shall not be charged a cancellation
                fee for any manufacturing orders canceled if a written notice of
                cancellation is received by AAIPharma more than thirty (30) days
                before
                the scheduled clinical supplies manufacturing.

               

              f.
                Delivery Schedule Delivery
                dates, if any, in this Service Estimate are approximations. AAIPharma
                shall not be liable for, nor shall AAIPharma be in breach of its
                obligations to Client because of any delivery made within reasonable
                time
                of the estimated delivery date.

               

              g.
                Safety
                information
                To
                ensure the safe handling, storage, usage, shipment and disposal of
                chemicals and other materials provide to AAIPharma by Client, Client
                warrants that it will provide AAIPharma with all necessary safety
                information (including, without limitation, Material Safety Data
                Sheets).
                Client is responsible for labeling and all other information relevant
                to
                the chemicals, materials, drug product and placebo (“Materials”), as
                appropriate.

            


    

     

     

    
      	
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      h.
        Warranty
        AAIPharma warrants that all services performed by it hereunder conform to
        the
        requirements set forth in this Service Estimate. The foregoing warranty is
        made
        to Client only and is not transferable. AAIPHARMA MAKES NO WARRANTIES, EITHER
        EXPRESS, IMPLIED OR OTHERWISE, EXCEPT THOSE HEREIN EXPRESSLY PROVIDED. AAIPHARMA
        SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS
        FOR A
        PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT AND ANY WARRANTY, EXPRESS
        OR
        IMPLIED, THAT THE ACTUAL SCIENTIFIC OR PHARMACEUTICAL RESULTS OF THE SERVICES
        HEREUNDER WILL NECESSARILY MEET CLIENT’S DESIRED SCIENTIFIC OR OTHER
        RESULTS.

       

      i.
        Liability Limitation
        AAIPharma will perform all services hereunder according to good scientific
        practices and in conformity with relevant cGMP's. The parties agree that
        AAIPharma's entire liability for performing these services is limited to
        the
        amount of compensation received from Client pursuant to this Service Estimate.
        Notwithstanding anything in this Service Estimate or otherwise to the contrary,
        in no event shall AAIPharma or its affiliates be liable under any theory,
        including negligence, for lost profits, or special, incidental, consequential,
        indirect, punitive or exemplary damages.

       

      j.
        Indemnification Client
        shall defend, indemnify and hold harmless AAIPharma, its directors, officers,
        employees, agents and representatives from any claims, proceedings or
        investigations arising out of or in connection with the services preformed
        hereunder including, without limitation, amounts paid in settlement of claims,
        proceedings or investigations, and shall bear all expenses, fees or costs
        in
        connection therewith (“Loss”), provided that such Loss is not the result of
        AAIPharma’s gross negligence or willful misconduct.

       

      k.
        Proprietary Information and Technology Client
        will own all data and written reports arising out of this project and all
        chemical entities supplied by Client or prepared for Client in this project
        upon
        payment for Services. Any patent or other intellectual property rights directly
        resulting from information supplied by Client to AAIPharma in the performance
        of
        this project will be assigned to Client. Notwithstanding the foregoing,
        AAIPharma shall retain ownership of any inventions, processes, techniques,
        improvements, know-how, trade secrets, discoveries and other intellectual
        properties and other assets which have been, or will be, developed by AAIPharma
        independent of the services and this Service Estimate (hereinafter, “AAIPharma
        Proprietary Technology”). In the event Client chooses to further develop and/or
        commercialize a technology comprising, in whole or in part, AAIPharma
        Proprietary Technology, Client must first obtain a license from AAIPharma
        to use
        such AAIPharma Proprietary Technology. Such license agreement shall be
        memorialized in a separate writing containing mutually agreeable terms
        negotiated in good faith by AAIPharma and Client. Client agrees to indemnify
        AAIPharma against any liability for infringement of any patent or other
        intellectual property rights arising from Client-directed services or
        Client-supplied information in the performance of this project.

       

      l.
        Nondisclosure AAIPharma
        agrees, for a period of five (5) years from the date hereof, that, except
        to the
        extent required by law, regulation, judicial requirement, or regulatory agency,
        it will not itself use, or provide or disclose to any third party, any
        information, data, or documents which were specifically developed or generated
        by AAIPharma for Client other than any AAIPharma Proprietary Technology
        incorporated therein.

       

      m.
        Excluded Materials Notwithstanding
        the nondisclosure section set forth above, information, data, or documents
        developed or generated by AAIPharma for its internal use or for third parties
        other than Client is not restricted by the ownership rights to be transferred
        to
        Client herein. Further, data and technology relating to the synthesis of
        raw
        material and dosage forms other than Client’s product is not restricted by this
        Agreement for AAIPharma's subsequent use.

       

      n.
        Choice of Law This
        Service Estimate shall be interpreted and construed in accordance with the
        laws
        of the State of Delaware, without the application of its choice of law
        provisions to the contrary.

       

      o.
        Force Majeure
        AAIPharma shall not be liable for any failure to meet its obligations under
        this
        Agreement due to any cause beyond AAIPharma’s reasonable control, including,
        without limitation, acts of public enemy, acts of any governmental authority,
        including governmental laws, ordinances, rules and regulations whether or
        not
        valid, acts of God, including hurricanes, floods, epidemics and severe weather,
        quarantine restrictions, strikes or lockouts, labor disputes or shortages,
        embargoes, war, riot, malicious acts or damage, accidents, interruption of
        supplies, equipment malfunction or failure of electrical supply or other
        utilities.

       

      p.
        Inspection Both
        parties recognize that proper authorities may request that AAIPharma produce
        records, data, or materials related to Client products during the course
        of, or
        as the subject of, an inspection. In such instances, AAIPharma will notify
        AAIPharma’s contact at Client of such regulatory inspection.

       

      q.
        Survival Paragraphs
        e, h, i, j, k, l, n and q of this Appendix III shall survive the expiration,
        cancellation or termination of this Service Agreement.

       

      r.
        Samples Unless
        otherwise set forth herein, after performance of the services contemplated
        hereunder, AAIPharma will retain any Materials for a period of two (2) months.
        After that time, such Materials will automatically be returned to Client
        or
        destroyed by appropriate means in Wilmington, NC. Please initial and date
        one
        selection:

       

      Client
        would like for AAIPharma to ______return_____ destroy the remaining
        samples.

       

      If
        the
        disposition of the samples is not indicated, the samples will be returned
        to
        Client at the end of the 2-month retain period. All shipping charges will
        be
        charged to the Client.

       

       

      
        	
                PRTX8000

              	
                Page 9
                  of 9

              	
                01/29/2007

              


         

        
          
            Confidential