Document:

Unassociated Document

    CONFIDENTIAL
      TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF

    THIS
      DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY

    FILED
      WITH THE COMMISSION.***

    

    

    

    

    Exhibit
      10.9

     

    CONFORMED
      COPY

    

    CONTRACT
      MANUFACTURE 

    AGREEMENT

    

    

    THIS
      AGREEMENT is made the 25 day of August 2005

    

    BETWEEN

     

    
      	
              (1)

            	
              UCB
                Pharma Limited,
                registered number 00209905, having its registered office at 208 Bath
                Road,
                Slough, Berkshire, SL1 3WE (“UCB”);

            

    

    

    
      	
              (2)

            	
              Celltech
                Manufacturing Services Limited,
                registered number 4066383, having its registered office at 208 Bath
                Road,
                Slough, Berkshire SL1 3WE (“INYX”);
                and

            

    

    

    
      	
              (3)

            	
              INYX,
                INC,
                a
                corporation organised under the laws of Nevada whose principal office
                is
                at 825 Third Avenue, 40th Floor, New York, United States (“Parent
                Guarantor”).

            

    

    

    RECITALS:

    

    
      	
              (A)

            	
              INYX
                carries on the business of, inter alia, manufacture, assembly and
                packaging of pharmaceutical
                products.

            

    

    

    
      	
              (B)

            	
              UCB
                wishes INYX to manufacture the Products (as hereinafter defined)
                and INYX
                is willing to manufacture the Products on the terms and conditions
                hereinafter set out.

            

    

    

    THE
      PARTIES AGREE AS FOLLOWS:

    

    
      	
              1.

            	
              DEFINTIONS

            

    

    
      
        	 	 

      

      
        	
                1.1

              	
                In
                  this Agreement the following terms shall have the following meanings
                  unless the context otherwise
                  requires:

              

      

    

    

    
      
        	 	
                “Affiliates”

              	
                means
                  in respect of each party any company which at the relevant time
                  is a
                  subsidiary of that party’s holding company or any subsidiary of such a
                  subsidiary, and where such party is a “subsidiary” of another company, its
                  “holding company”, if that other company: (a) holds a majority of the
                  voting rights in it; or, (b) is a member of it and has the right
                  to
                  appoint or remove a majority of its board of directors; or, (c)
                  is a
                  member of it and controls alone, pursuant to an agreement with
                  other
                  shareholders or members, a majority of the voting rights in it,
                  or if it
                  is a subsidiary of a party which is itself a subsidiary of that
                  other
                  Company. In this definition, “party” includes any body corporate;
                  

              
	 	 	 

      

       

       

      
        
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                  “Ashton
                    Facility”

                	
                  means
                    the manufacturing facility as described in the Sale
                    and Purchase Agreement
                    between the parties, dated [__
                    August
                    2005] and includes any other INYX facility which may be used
                    from time to
                    time pursuant to Article 4.1;

                
	 	 	 
	 	
                  “Batch”

                	
                  means
                    a uniquely identified or identifiable quantity of raw materials,
                    starting
                    materials, packaging materials or Product which has been processed
                    in one
                    process or series of processes to the extent that such quantity
                    could be
                    expected to be homogeneous;

                
	 	 	 
	 	
                  “Business
                    Days”

                	
                  means
                    any day Monday to Friday on which the banks in London are generally
                    open
                    for business;

                
	 	 	 
	 	
                  “Central
                    Warehouse”

                	
                  means
                    the Dunstable facility or any other warehouse situated in England
                    as
                    notified by UCB to INYX in writing from time to time;

                
	 	 	 
	 	
                  “Certificate
                    of Conformance”

                	
                  means
                    a document signed by a Qualified Person stating and confirming
                    that the
                    Product(s) to which such document refers has been Manufactured
                    in
                    accordance with the Specifications and GMP or materials to which
                    such
                    document refers meet the Specifications; 

                
	 	 	 
	 	
                  “Completion
                    Date”

                	
                  means
                    the Completion Date as defined in the Sale and Purchase
                    Agreement;

                
	 	 	 
	 	
                  “Contract
                    Year”

                	
                  means
                    each consecutive 12 month period from the Completion
                    Date;

                
	 	 	 
	 	
                  “Cost
                    of Production”

                	
                  means,
                    as relevant to the context in which the phrase is used, both
                    the
                    individual and overall cost of material, labour and overheads
                    to INYX in
                    Manufacturing the Product;

                
	 	 	 
	 	
                  “Data”

                   

                	
                  means
                    master data, transactional data (including but not limited to,
                    forecasts,
                    replenishment plans, production and capacity plans, procurement
                    schedules,
                    receipts and shipments, stock, quality data and batch
                    records);

                
	 	 	 
	 	
                  “Force
                    Majeure”

                	
                  means,
                    in relation to either party, any failure of suppliers or machinery
                    (which
                    for the avoidance of doubt shall include all information technology,
                    software and hardware related to such machinery), strike, lock-out
                    or
                    other form of industrial action, civil commotion, act of God,
                    fire,
                    explosion, flood,
                    failure
                    of utilities, war
                    or hostilities, acts of Government or Government appointed agents,
                    embargoes or other export restrictions, or perils of the sea,
                    or any
                    circumstance beyond the reasonable control of that
                    party;

                
	 	 	 
	 	
                  “Firm
                    Period”

                	
                  means
                    the binding element of the Forecast as set out in Article 7.2,
                    being the
                    first three (3) months of the Forecast; first (1st)
                    month 100% of
                    the Forecast
                    is
                    binding, second (2nd)
                    month
                    of
                    the Forecast
                    is
                    80% binding, third (3rd)
                    month 60%
                    of
                    the Forecast
                    is
                    binding;

                
	 	 	 
	 	
                  “Forecast”

                	
                  has
                    the meaning given to it in Article 7.2;

                
	 	 	 

        

         

         

        
          
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                    “GMP”

                  	
                    means,
                      as relevant to the Product, the principles and guidelines of
                      good
                      manufacturing practice as contained in either directive 2001/83/EC
                      (medicinal products for human use) or directive 91/412/EEC
                      (medicinal
                      products for veterinary use), as such principles and guidelines
                      are
                      interpreted and expanded in “The Rules Governing Medicinal Products in the
                      European Community, Volume IV. Good Manufacturing Practice
                      for Medicinal
                      Products”, together with those rules and guidelines contained in the
                      Orange Book;

                  
	 	 	 
	 	
                    “GMP
                      Agreement”

                  	
                    means
                      the agreement (attached to this Agreement as Schedule 1) between
                      the
                      parties governing the GMP principles to be respected in the
                      Manufacture of
                      the Products and setting out or otherwise identifying the Specifications
                      for and technical terms and conditions for the Manufacture
                      of the Products
                      and complying with those rules and guidelines contained in
                      the Orange
                      Book;

                  
	 	 	 
	 	
                    “Information”

                  	
                    means
                      any information, technology, know-how, data or commercial information
                      of a
                      proprietary or confidential nature, including without limiting
                      the
                      foregoing, Technical Information and price data disclosed pursuant
                      to or
                      in connection with this Agreement or as a consequence of it,
                      whether
                      orally or in writing;

                  
	 	 	 
	 	
                    “Initial
                      Term”

                  	
                    means
                      a period commencing from the Completion Date and expiring at
                      the end of
                      the fifth (5th)
                      Contract Year following such Completion Date; 

                  
	 	 	 
	 	
                    “Manufacture”

                  	
                    means
                      the production of the Product from the Raw Materials and shall,
                      where
                      relevant, include purchase, manufacturing, formulating, assembling,
                      packaging, label, artwork, storage at the Ashton Facility,
                      handling,
                      testing and quality control and quality assurance, logistics,
                      technical
                      support and regulatory support, and “Manufactured”,
                      “Manufacturing”
                      and “Manufacturer”
                      shall be interpreted accordingly;

                  
	 	 	 
	 	
                    “Orange
                      Book”

                  	
                    means
                      the publication “Rules and Guidance for Pharmaceutical Manufacturers and
                      Distributors 2002” published by the Medicines and Healthcare Products
                      Regulatory Agency including any subsequent edition thereof,
                      as such
                      publication might be amended or reissued from time to time; 

                  
	 	 	 
	 	
                    “Presentation”

                  	
                    means
                      the presentations specified in Schedule 2 in which the Products
                      are to be
                      marketed, distributed, sold or used;

                  
	 	 	 
	 	
                    “Process
                      Improvements”

                  	
                    means
                      all improvements, modifications or adaptations to any process
                      employed by
                      INYX and at any time during the continuance of this Agreement
                      used in the
                      conduct of Manufacture, and not exclusively capable of employment
                      in the
                      Manufacture of the Product;

                  
	 	 	 
	 	
                    “Products”

                  	
                    means
                      the products specified and described in Schedule 2 and “Product”
                      shall mean any one of them;

                  
	 	 	 
	 	
                    “Purchaser”

                  	
                    means
                      INYX Europe Limited, a company registered in England whose
                      registered
                      office is at 6 Seymour Court, Manor Park, Runcorn, Cheshire
                      WA7
                      1SY;

                  
	 	 	 

          

           

           

          
            
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                    “Purchaser’s
                      Group”

                  	
                    the
                      Purchaser and any subsidiary or holding company of the Purchaser
                      or of any
                      holding company or subsidiary of such holding company or
                      subsidiary;

                  
	 	 	 
	 	
                    “Qualified
                      Person”

                  	
                    means
                      the person so designated in accordance with EC Directive 2001/83/EC
                      and
                      employed by INYX or UCB as the case may be;

                  
	 	 	 
	 	
                    “Raw
                      Materials”

                  	
                    means
                      the raw materials specified in the Specifications and any other
                      raw
                      materials ingredients and excipients and packaging or other
                      components
                      which are required by INYX to conduct the Manufacture;

                  
	 	 	 
	 	
                    “Regulatory
                      Approval”

                  	
                    means
                      any product licence, marketing authorisation or clinical trials
                      certificate issued by the relevant Regulatory Authority and
                      in terms
                      permitting, as appropriate, the importation, distribution,
                      sale, marketing
                      or use of the Product and for the avoidance of doubt shall
                      not include any
                      authority to perform “special” manufacturing or dispensing services
                      pursuant to any order made under the Medicines Act 1968, which
                      authority
                      is commonly referred to as a “specials licence”;

                  
	 	 	 
	 	
                    “Regulatory
                      Authority”

                  	
                    means
                      the United Kingdom Medicines and Healthcare Products Regulatory
                      Agency or
                      any equivalent competent body in any jurisdiction as relevant
                      to the
                      Products and the territories in which the Products are to be
                      marketed or
                      used;

                  
	 	 	 
	 	
                    “Sale
                      and Purchase Agreement”

                  	
                    means
                      the agreement for the sale and purchase of the entire issued
                      share capital
                      of INYX between UCB, Purchaser and the Parent Guarantor dated
                      25 August
                      2005; 

                  
	 	 	 
	 	
                    “Service
                      Agreement”

                  	
                    means
                      the agreement for the performance and supply of services at
                      the Ashton
                      Facility, entered into between the parties, dated 25 August
                      2005;

                  
	 	 	 
	 	
                    “SKU”

                  	
                    means
                      stock keeping unit;

                  
	 	 	 
	 	
                    “Specifications”

                  	
                    means
                      the specifications for the Product as specified in the GMP
                      Agreement;
                      

                  
	 	 	 
	 	
                    “Technical
                      Information”

                  	
                    means
                      all know-how, registration data, experience, instructions,
                      standards,
                      methods, test and trial results, manufacturing processes, hazard
                      assessments, quality control standards, formulae, specifications,
                      storage
                      data, samples, drawings, designs, descriptions of packaging
                      materials and
                      all other relevant information relating to the Product or the
                      design,
                      Manufacture, storage or use of the Product;

                  
	 	 	 
	 	
                    “Trade
                      Mark(s)”

                  	
                    means
                      the trade mark(s) set out in Schedule
                      2
                      which are either owned by UCB or to which UCB has the necessary
                      right of
                      use; and

                  
	 	 	 
	 	
                    “Validation”

                  	
                    means
                      the process of proving, in accordance with the principles of
                      GMP, the
                      reproducibility, efficacy, and repeatability of any procedure,
                      process,
                      equipment, material, testing equipment, test, activity or system
                      and the
                      ability thereof to achieve the result which is intended to
                      be achieved, as
                      further detailed in the GMP
                      Agreement.

                  

          

        

      

    

     

     

    
      
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              1.2

            	
              Any
                reference in this Agreement to “writing” or cognate expressions includes a
                reference to mail, cable, facsimile transmission or comparable means
                of
                communication.

            

    

    
      
        	 	 

      

      
        	
                1.3

              	
                Words
                  in this Agreement importing the singular meaning shall where the
                  context
                  so admits include the plural meaning and vice
                  versa.

              

      

    

    
      
        	 	 

      

      
        	
                1.4

              	
                The
                  headings in this Agreement are for convenience only and shall not
                  affect
                  its interpretation.

              

      

    

    
      
        	 	 

      

      
        	
                2.

              	
                Condition
                  Precedent

              

      

    

    This
      Agreement shall commence on the Completion Date on condition that the Sale
      and
      Purchase Agreement is completed. If for any reason the Completion Date does
      not
      occur and the Sale and Purchase Agreement does not complete, this Agreement
      shall terminate with immediate effect with no liability for any party in respect
      of any breach including future breach.

    
      
        	 	 

      

      
        	
                3.

              	
                Validation
                  & Changes

              

      

    

    
      
        	 	 	 

      

      
        	 	
                3.1

              	
                The
                  process for the Manufacture of the Products has been validated
                  and agreed
                  by the parties as set out in the GMP Agreement. In the event that
                  any
                  additional Validation work is required as a result of any change
                  to the
                  method of manufacture or equipment used in the Manufacture then
                  the
                  parties shall agree how the cost thereof shall be apportioned between
                  them. 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                3.2

              	
                Where
                  a party (the initiator party) requires or requests any changes
                  to be made
                  to the artwork utilised on or to the validation of any of the Products
                  it
                  will give not less than three (3) months notice thereof to the
                  other
                  party. Any costs incurred by the initiator party as a result of
                  such
                  change shall be borne by it together with the cost of any packaging
                  materials that are written off as a result of such changes. For
                  the avoidance of doubt the parties shall bear the costs equally
                  between
                  them of any changes to such artwork as a result of or in connection
                  with
                  the sale of Ashton Facility.

              

      

    

    
      
        	 	 

      

      
        	
                4.

              	
                Contract
                  Manufacture 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.1

              	
                UCB
                  hereby exclusively appoints INYX to Manufacture the requirements
                  for the
                  Products of UCB and of UCB’s Affiliates, with the exception of ***, at the
                  Ashton Facility and UCB shall ensure that UCB’s Affiliates shall use INYX
                  as exclusive manufacturer of the Products required by UCB’s Affiliates;
                  provided INYX can, from time to time, use its other manufacturing
                  facilities with the prior written consent of UCB, such consent
                  not to be
                  unreasonably withheld or delayed, and INYX accepts such appointment.
                  During the period of this Agreement INYX will Manufacture for UCB
                  the
                  Product in accordance with this Agreement and the GMP Agreement,
                  and UCB
                  shall acquire its requirements for the Product from
                  INYX.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.2

              	
                INYX
                  shall Manufacture the Products in compliance with the technical
                  provisions
                  of the Service Agreement between the parties. For the avoidance
                  of doubt,
                  the price of such Manufacture shall be included in the price for
                  the
                  Products as set out in Schedule
                  2
                  to
                  this Agreement.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.3

              	
                INYX
                  covenants that:

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.3.1

              	
                it
                  has, and will use reasonable commercial endeavours to maintain
                  during the
                  term of this Agreement, a manufacturer’s licence in accordance with
                  section 8 of the Medicines Act 1968 as amended from time to time
                  and will
                  inform UCB of all inspections by the Relevant Authorities and of
                  their
                  findings which relate to or are relevant to the
                  Product;

              

      

    

    
      
        	 	 	 

      

       

       

      
        
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                4.3.2

              	
                it
                  will conduct the Manufacture in accordance with the GMP
                  Agreement;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.3.3

              	
                any
                  Raw Materials employed by INYX in the Manufacture and not supplied
                  by or
                  on behalf of UCB will at the time of use comply with the Specifications
                  and the GMP Agreement;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.3.4

              	
                it
                  will allow, at least twice during any twelve (12) month period
                  of this
                  Agreement and during normal business hours and upon reasonable
                  notice,
                  authorised representatives of UCB and/or representatives of any
                  Government
                  or Regulatory Authority acting on UCB’s behalf to inspect the relevant
                  parts of the Ashton Facility where the Manufacture of the Product
                  is
                  carried out or the Product or Raw Materials are stored and to inspect
                  the
                  process of Manufacture. To the extent that any cost is incurred
                  as a
                  direct result of such inspection the reasonable out of pocket costs
                  of
                  such inspection shall be payable by UCB. Notwithstanding the foregoing,
                  INYX’s obligation to allow such visitors is on condition that: (a) UCB
                  procures that such visitors agree in writing to observe the requirements
                  of INYX regarding security, health and safety, confidentiality
                  or any
                  other applicable regulations at the relevant premises; (b) any
                  visit shall
                  be under the specific supervision of INYX (without relieving any
                  visitors
                  of any obligations with respect to any damage or injury caused
                  by them);
                  (c) UCB indemnifies and shall keep indemnified INYX against any
                  damage to
                  INYX’s property or any personal injury which is caused by any act or
                  omission of any of UCB’s employees or authorised agents or nominated
                  visitors on INYX’s premises; and (d) UCB uses its best endeavours to
                  ensure that any visit is of minimal disruption to INYX’s day to day
                  business. INYX shall promptly inform UCB of any visit or inspection
                  of or
                  at the Ashton Facility by any Government or Regulatory Authority,
                  including the results of such inspection and possible remedies
                  imposed by
                  such authorities. Compliance with any such imposed remedies shall
                  automatically become part of INYX’s obligations under this
                  Agreement;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.3.5

              	
                it
                  will upon written request and at the cost of UCB supply UCB with
                  reasonable quantities of samples of the Product Manufactured by
                  it
                  provided that no Manufacture is required primarily for the purpose
                  of
                  providing UCB with the said samples. INYX shall retain a quantity
                  of
                  samples of each production Batch of the Products equal to twice
                  the amount
                  reasonably required to conduct the relevant
                  analysis;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.3.6

              	
                it
                  shall retain for a maximum of six (6) years manufacturing, analytical
                  and
                  distribution records and shall retain such samples of the Products
                  as are
                  required by, and in the manner and for the duration specified by
                  the GMP
                  Agreement. During the said six (6) year period, it shall make such
                  records
                  available to UCB upon reasonable notice. Upon INYX deciding to
                  dispose of
                  such records or samples, INYX shall notify UCB of such decision
                  taken by
                  INYX. In the absence of any response from UCB within three (3)
                  months of
                  notification, INYX may destroy or otherwise dispose of the said
                  records or
                  such samples as it sees fit;
                  and

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.4

              	
                INYX
                  may at any time undertake any change to the Ashton Facility or
                  equipment
                  provided that any such change shall not be of detriment to the
                  Product. In
                  the event that any such change will necessitate or make desirable
                  a
                  variation to any Regulatory Approval for the Product then INYX
                  will notify
                  the proposed change in writing to UCB, such change not to be carried
                  out
                  without prior written consent from UCB, not to be unreasonably
                  withheld or
                  delayed. UCB will use all reasonable endeavours to obtain such
                  required or
                  desired variation. Any costs associated with the change will be
                  to the
                  account of INYX. Should such variation not be obtained for any
                  reason, and
                  should as a result INYX be unable to Manufacture the Product in
                  or on the
                  changed premises or facilities or equipment, then the parties shall
                  enter
                  into bona fide discussions with a view to agreeing upon such alternative
                  arrangements as may be fair and reasonable.

              

      

       

      
        
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        	 	4.5	UCB covenants
                that:

      

    

     

    
      	 	
              4.5.1

            	
              it
                has and will maintain throughout the term of this Agreement appropriate
                Regulatory Approvals for the Product for the United Kingdom and for
                any
                other jurisdiction or territory for which the Product is being
                Manufactured or in which the Product is to be marketed distributed
                sold or
                used;

            

    

    
      
        	 	 	 

      

      
        	 	
                4.5.2

              	
                prior
                  to entering into this Agreement it will be responsible for assessing
                  and
                  confirms that it has assessed the competence of INYX to carry out
                  the
                  Manufacture of the Product in accordance with GMP as set out in
                  the GMP
                  Agreement;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.5.3

              	
                any
                  Raw Materials and other products to be provided by it shall comply
                  with
                  the Specifications and where appropriate shall be accompanied by
                  a
                  Certificate of Conformance from
                  UCB;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.5.4

              	
                it
                  has notified INYX of any special requirements in respect of record-keeping
                  that may be necessary to comply with UCB’s adverse event/defect/recall
                  procedure; and 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                4.5.5

              	
                it
                  shall notify INYX of any hazards to the health or safety of any
                  personnel
                  of INYX and UCB shall keep INYX so advised throughout the continuance
                  of
                  this Agreement, whether such hazards or possibilities are inherent
                  in the
                  Product or otherwise. 

              

      

    

    
      
        	 	 

      

      
        	
                5.

              	
                GMP
                  Agreement and Technical
                  Information

              

      

    

    
      
        	 	 	 

      

      
        	 	
                5.1

              	
                The
                  respective responsibilities of INYX and UCB relating to the Manufacture
                  of
                  the Product, the way in which each Batch of the Product is to be
                  Manufactured and checked for compliance with and adherence to the
                  appropriate Specifications and GMP, the responsibility for purchasing
                  materials, testing and releasing materials and undertaking production
                  and
                  quality control including in-process controls as well as sampling
                  and
                  analysis shall be as specified in the GMP Agreement. The provisions
                  of the
                  GMP Agreement shall prevail over any conflicting provisions set
                  out in
                  Articles 3 and 4 of this
                  Agreement.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                5.2

              	
                Subject
                  to UCB complying in all respects with its relevant obligations
                  under this
                  Agreement and the GMP Agreement, INYX shall be responsible for
                  ensuring
                  the safe operation of the process of Manufacture of the Product
                  at the
                  Ashton Facility and in particular that the Technical Information
                  supplied
                  by UCB can be safely used at the Ashton
                  Facility.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                5.3

              	
                Any
                  alteration to the GMP Agreement must be agreed in writing between
                  the
                  parties.

              

      

    

    
      
        	 	 

      

      
        	
                6.

              	
                Duration

              

      

    

    
      
        	 	 	 

      

      
        	 	
                6.1

              	
                Unless
                  sooner terminated as hereinafter provided, this Agreement shall
                  come into
                  force on the Completion Date hereof and shall continue in force
                  for the
                  Initial Term and thereafter for consecutive one (1) year periods,
                  unless
                  terminated by either party giving to the other not less than twelve
                  (12)
                  months’ written notice prior to the end of the Initial Term or any renewal
                  term (for the avoidance of doubt, the date on which this Agreement
                  shall
                  terminate under such notice shall not be before the end of the
                  Initial
                  Term).

              

      

    

    
      
        	 	 

      

      
        	
                7.

              	
                Supply
                  Chain Management

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.1

              	
                Except
                  as otherwise set out in the Service Agreement, supply chain management
                  for
                  the Products shall occur in accordance with the principles set
                  out in this
                  Article 7.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.2

              	
                UCB
                  shall provide INYX with a monthly rolling forecast for the volume
                  of
                  Products on a line by line basis per SKU for eighteen (18) months
                  (the
                  “Forecast”).
                  The Forecast will be sent by UCB to INYX each month by no later
                  than the
                  seventh (7th) day of each calendar month. Each Forecast shall be
                  binding
                  as follows: 

              

      

    

     

     

     

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        7

        
          

        

      

      
        
        

      

    

     

    7.2.1 first
      (1st)
      month
      forecast: 100% of the Forecast;

     

    7.2.2 second
      (2nd)
      month
      forecast: 80% of the Forecast;
      and

     

    7.2.3 third
      (3rd)
      month
      forecast: 60% of the Forecast.

     

    
      	 	
              7.3

            	
              UCB
                will determine the stock policy per SKU. The stock policy will set
                the
                minimum Product stock level at two (2) months stock and the maximum
                stock
                level at four (4) months stock per SKU, unless agreed otherwise.
                The stock
                policy will be revised on a six (6) monthly basis. UCB shall provide
                INYX
                with written notice of the stock policy per SKU as soon as is reasonably
                practicable after the stock policy is
                revised.

            

    

    
      
        	 	 	 

      

      
        	 	
                7.4

              	
                UCB
                  shall provide INYX on a weekly basis with written notice of the
                  stock
                  levels per SKU and by
                  location.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.5

              	
                INYX
                  will calculate a replenishment plan for the Products on a monthly
                  basis
                  using the Firm Period, the actual stock and the stock policy. INYX
                  shall
                  provide to UCB in writing the replenishment plan by no later than
                  the
                  fourteenth (14th) day of each calendar month. The replenishment
                  plan will
                  then be discussed in a monthly meeting between the parties and
                  agreed for
                  acceptance by the parties. The replenishment plan shall detail
                  replenishment on a weekly basis and the replenishment plan shall
                  be firm
                  in terms of timing and quantity on a monthly
                  basis.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.6

              	
                The
                  Products shall be supplied to UCB ex-works (Incoterms 2000). Unless
                  specified otherwise risk in each Batch of the Product shall pass
                  to UCB on
                  delivery provided that ownership in each Batch of the Product shall
                  remain
                  vested in INYX until payment is received from UCB in respect of
                  that Batch
                  of the Product. For the avoidance of doubt ownership in each Batch
                  of the
                  Product shall pass to UCB when payment is made in accordance with
                  the
                  provisions of Article 9.2.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.7

              	
                INYX
                  shall certify each Batch of Products within fifteen (15) Business
                  Days for
                  sterile Products and seven (7) Business Days for non-sterile Products
                  after complete batch receipt at the Central Warehouse and INYX
                  shall
                  supply a Certificate of Conformance with each Batch of the Product.
                  If a
                  Batch is not released within the timeframes mentioned, UCB shall
                  have the
                  right to return the Product to Ashton Facility at INYX’s
                  costs.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.8

              	
                All
                  Products shall be delivered and released to the Central Warehouse
                  with a
                  shelf-life of at least ninety per cent. (90%) of their original
                  shelf-life
                  or sixteen (16) months for short shelf-life products (for the avoidance
                  of
                  doubt products with a short shelf life are products with a shelf
                  life of
                  two (2) years). All Product stock delivered to the Central Warehouse
                  with
                  a shorter shelf-life will be subject to
                  negotiation.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                7.9

              	
                UCB
                  shall inspect and/or test the Product as soon as practicable following
                  delivery. Subject to Article 7.6, failure by INYX to Manufacture
                  the
                  Product in accordance with Specifications shall be the only reason
                  for
                  which UCB may reject the Product. If UCB wishes to reject any delivery
                  of
                  Product it must notify INYX within thirty (30) days of whichever
                  is the
                  later of receipt of the Product or receipt of the relevant Certificate
                  of
                  Conformance and such notification must be in writing and include
                  a
                  detailed indication of the reasons for rejection. UCB shall be
                  deemed to
                  have accepted the Product and shall not be entitled to reject the
                  same
                  unless it provides such written notification within the said period
                  of
                  thirty (30) days. INYX shall notify UCB within fifteen (15) days
                  of
                  receipt of such notification of rejection whether it accepts UCB’s claim.
                  If INYX does not accept the claim or UCB disagrees then an independent
                  laboratory mutually agreed by the parties (or failing agreement
                  the
                  Medicines and Healthcare Products Regulatory Agency Laboratory
                  in
                  Edinburgh) shall be requested to analyse an appropriate amount
                  of the
                  Product from the Batch or Batches in dispute. The independent laboratory
                  shall act as expert not arbitrator and the cost of its analysis
                  shall be
                  paid by the party against whom the laboratory findings were made.
                  Two
                  samples shall be supplied, one by UCB from the Batches in question
                  and one
                  by INYX from any samples that it has retained. The results of the
                  said
                  analysis shall be binding on the parties. Pending resolution of
                  the
                  dispute, and upon UCB’s request, INYX shall supply a replacement Batch of
                  Product forthwith and in any event within forty five (45) days
                  at the cost
                  specified in and otherwise upon the terms of this Agreement.
                  

              

      

    

    
      
        	 	 	 

      

       

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          8

          
            

          

        

        
          
          

        

      

       

      
        	 	
                7.10

              	
                If:

              

      

    

    
      	 	
              (a)

            	
              the
                outcome of the process specified in Article 7.8 is that the independent
                laboratory determines that the Product does not conform to the
                Specifications due to the breach of any terms of this Agreement by
                INYX;
                or 

            

    

    
      
        	 	 	 

      

      
        	 	
                (b)

              	
                if
                  INYX accepts that the Product does not conform to the Specifications
                  due
                  to the breach of any terms of this Agreement by
                  INYX,

              

      

    

     

    INYX
      shall Manufacture and deliver to UCB a sufficient quantity of the Product to
      replace the defective Batch or Batches. If the independent laboratory determines
      that the relevant Batches of Product were Manufactured in accordance with the
      Specifications or that any defect did not arise due to the breach of any terms
      of this Agreement by INYX, INYX shall have no liability or obligation to UCB
      in
      respect of such Batches. 

     

    
      	
              8.

            	
              Intellectual
                Property and
                Improvements

            

    

    
      
        	 	 	 

      

      
        	 	
                8.1

              	
                UCB
                  hereby authorises INYX to use the Trade Marks and UCB’s other intellectual
                  property on or in relation to the Products for the purpose only
                  of
                  exercising its rights and performing its obligations under this
                  Agreement.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                8.2

              	
                Each
                  party hereby acknowledges that it shall not acquire any rights
                  in respect
                  of any of the other party’s intellectual property in relation to the
                  Products or the Manufacture thereof or of the goodwill associated
                  therewith.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                8.3

              	
                Except
                  as is necessary for the proper performance of this Agreement by
                  the
                  parties, no licence, express or implied, is granted by this Agreement
                  by
                  either party to the other under any of its intellectual property
                  rights.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                8.4

              	
                Title
                  to and property in all Manufacturing Records (as defined below)
                  and
                  Process Improvements generated by INYX directly in connection with
                  the
                  Manufacture
                  of the Products
                  shall be and remain at all times exclusively vested in UCB, and
                  INYX
                  hereby disclaims any right thereto; provided that INYX shall be
                  entitled
                  to a royalty-free, irrevocable licence to use the Process Improvements
                  in
                  its business.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                8.5

              	
                The
                  Manufacturing Records (which shall include but not be limited to
                  all Batch
                  documentation and Validation data) shall be treated as Information
                  of UCB
                  and shall not be used or disclosed by INYX other than for the purposes
                  of
                  this Agreement and where necessary for disclosing to the relevant
                  regulatory authorities in order to comply with regulatory requirements
                  relating to the Product and its Manufacture by
                  INYX.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                8.6

              	
                No
                  Process Improvements shall be employed by INYX in the Manufacture
                  of the
                  Products unless the terms upon which such Process Improvements
                  are to be
                  employed by INYX have been agreed with
                  UCB.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                8.7

              	
                Title
                  to and property in all Data shall be and remain at all times exclusively
                  vested in INYX and UCB hereby disclaims any right thereto; provided
                  that
                  UCB shall be entitled to a royalty-free, irrevocable licence to
                  use and to
                  copy the Data and INYX undertakes to grant to UCB unlimited access
                  to the
                  Data.

              

      

    

    
      
        	 	 

      

      
        	
                9.

              	
                Prices

              

      

    

    
      
        	 	 	 

      

      
        	 	
                9.1

              	
                All
                  orders for the Product for delivery from the Completion Date will
                  (subject
                  to Article 9.3 below) be at the price(s) set out in Schedule
                  2.
                  

              

      

    

    
      
        	 	 	 

      

       

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          9

          
            

          

        

        
          
          

        

      

       

      
        	 	
                9.2

              	
                ***

              

      

    

    

    Year
      1:
  ***

    Year
      2:  ***

    Year
      3:  ***

    Year
      4:  ***

    Year
      5:  ***

     

    
      	 	
              9.3

            	
              Invoices
                will be submitted to UCB when the Product has been delivered in accordance
                with Article 7.5. INYX will invoice UCB on a monthly basis for the
                goods
                delivered during the term of this Agreement. UCB will pay to INYX
                the full
                invoice value for the Product in Pounds Sterling (£) within thirty (30)
                days of invoice date. If INYX so requires payment will be made direct
                into
                INYX’s bank account by bank transfer and upon written request by INYX,
                INYX will provide UCB with the necessary details of INYX’s bank account
                and will take whatever actions are necessary to facilitate payment
                by bank
                transfer. In the event of a delay of more than seven (7) days in
                collection of the Products when they have been notified to UCB as
                being
                available for collection INYX reserves the right to make charges
                for
                storage.

            

    

    
      
        	 	 	 

      

      
        	 	
                9.4

              	
                If
                  as a result of any inspection of INYX’s premises as referred to in Article
                  4.3.4 or otherwise a requirement is imposed by a competent authority
                  which
                  leads to or requires a change in the Cost of Production or to the
                  Specification of the Product then upon written notification by
                  INYX to UCB
                  INYX and UCB will meet to discuss any increase to the price of
                  the
                  Product, the date upon which such price increase will take effect
                  and any
                  other consequences arising from such changes. If within one (1)
                  month of
                  the said notification by INYX the parties are unable to agree an
                  increased
                  price for the relevant Product, the price of such Product shall
                  be
                  increased
                  by the amount of the increase of
                  the Cost of Production of that Product or by the amount required
                  to comply
                  with the Specification of that Product. However, if such change
                  is the
                  result of non-compliance with GMP by INYX, then INYX shall pay
                  for such
                  change.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                9.5

              	
                The
                  parties shall each use their respective reasonable endeavours throughout
                  the term of this Agreement to seek improvements in the process
                  for
                  Manufacture of the Products, the purchasing of Raw Materials and
                  the
                  ordering, delivery and invoicing of the Products so that where
                  possible
                  the prices for the Products set out in Schedule
                  2
                  or
                  as adjusted from time to time can be reduced and the benefit of
                  the
                  savings shared equally between the parties hereto. UCB shall have
                  the
                  right to assist in the feasibility study of any such improvement
                  project.
                  INYX will disclose to UCB all information needed for any such feasibility
                  study. UCB shall have the right (at UCB’s cost) to audit and have audited
                  INYX’s books pertaining to this Agreement with the sole purpose of
                  monitoring the cost improvement. This right shall be exercised
                  upon
                  reasonable notice. 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                9.6

              	
                In
                  the event that any of UCB’s customers (including UCB Affiliates) finds
                  itself in an out-of-stock situation for any Product for more than
                  three
                  (3) weeks as a result of the breach of any terms of this Agreement
                  by
                  INYX, INYX shall pay UCB compensation equal to UCB’s gross profit for the
                  period (excluding the first three (3) weeks referred to above)
                  where such
                  out-of-stock situation continues to exist. The gross profit for
                  these
                  purposes will be calculated on the basis of the forecasted net
                  sales minus
                  the COGS for the Product concerned for that customer. The provisions
                  of
                  this Article are without prejudice to UCB’s rights under Article 10.1
                  hereafter. For the avoidance of doubt INYX shall not be liable
                  for an
                  out-of-stock situation resulting from lack of availability of the
                  materials and components unless such out-of-stock situation is
                  a result of
                  the breach of any terms of this Agreement by
                  INYX.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                9.7

              	
                INYX
                  may
                  review the price annually and enter into negotiations with UCB
                  to increase
                  the price of Product to take account of any increased Cost of Production
                  or Raw Material costs provided that such review shall not occur
                  prior to
                  twenty four (24) months after the Completion Date and thereafter
                  shall not
                  occur more than one time during any period of twelve (12) months
                  during
                  the term of this Agreement.  If
                  the parties are unable to agree an increased price the price shall
                  be
                  increased
                  by the amount of the increase from the date of the previous price
                  review
                  (or in the case of the first price review, the Completion Date)
                  of the
                  Prices Indices of the United Kingdom Output for Products of Manufacturing
                  Industries other than food beverages and tobacco manufacturing
                  industries
                  (commonly referred to as the “Manufacturers (Other) Index”) published by
                  the office of National Statistics or any successor or replacement
                  Index.
                  Any increase will be supported by a detailed costs breakdown which
                  will
                  include supplier documentation in respect of any material
                  increase.

              

      

    

    
      
        	 	 

      

       

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          10

          
            

          

        

        
          
          

        

      

       

      
        	
                10.

              	
                LIMITATION
                  OF LIABILITY AND INDEMNITY -
                  GENERAL

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.1

              	
                Subject
                  to Article 10.3, neither party shall in any circumstances be liable
                  to the
                  other party nor any third party for any consequential or indirect
                  loss,
                  except where an out-of-stock situation caused by the breach of
                  any terms
                  of this Agreement by INYX results in UCB having lost or having
                  to
                  indemnify customers. 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.2

              	
                Subject
                  to the provisions of Article 10.3 hereof, INYX shall indemnify
                  and shall
                  keep UCB indemnified and hold it harmless against any and all third
                  party
                  actions, claims, judgments, damages, law suits costs or expenses
                  or
                  professional fees brought against, suffered or incurred by UCB
                  resulting
                  from a breach of contract by INYX Provided That the provisions
                  of this
                  Article 10.2 shall not apply to any event which would constitute
                  a breach
                  of contract for which a remedy is provided to UCB elsewhere in
                  this
                  agreement including, but not limited to, Articles 7.8, 9.6 and
                  12.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.3

              	
                Notwithstanding
                  any other provision of this Agreement, neither party limits its
                  liability
                  for:

              

      

      
         

        
          	 	
                  (a)

                	
                  negligence
                    or fraud by it or its employees or its subcontractors;
                    or

                

        

        
          	 	
                  (b)

                	
                  death
                    or personal injury caused by its negligence or that of its employees,
                    agents or subcontractors (as
                    applicable).

                

        

      

    

     

    
      	 	
              10.4

            	
              Subject
                to Article 10.3, the total aggregate liability of INYX arising under
                this
                Agreement (including but not limited to INYX’s liability in connection
                with Articles 9.5, 10.1 and 11.1) shall not exceed the following
                amounts:

            

    

      

    
      
        	 	
                (a)

              	***;

      

      
        	 	
                (b)

              	
                ***;
                  and

              

      

    

    
      	 	
              (c)

            	
              ***

            

    

    
      
        	 	 	 

      

      
        	 	
                10.5

              	
                Subject
                  to the provisions of Article 10.3 hereof, UCB shall indemnify and
                  shall
                  keep INYX indemnified and hold it harmless against any and all
                  third party
                  claims, actions, judgements, damages, lawsuits, costs or expenses
                  or
                  professional fees brought against suffered or incurred by INYX
                  in relation
                  to or arising out of the storage, sale, distribution or use of
                  the
                  Product, resulting from a breach of contract by UCB.
                  

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.6

              	
                Subject
                  to Article 10.3 and 10.12, the total aggregate liability of UCB
                  arising
                  under this Agreement shall not exceed the following
                  amounts:

              

      

    

    
        

      
        
          	 	
                  (a)

                	***;

        

        
          	 	
                  (b)

                	
                  ***;
                    and

                

        

      

      
        	 	
                (c)

              	
                ***

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.7

              	
                The
                  party claiming the benefit of any indemnity hereunder must promptly
                  notify
                  the other of any claim, not accept any compromise or settlement
                  of such
                  claim or take any material steps in relation to such claim without
                  the
                  prior consent of the other party and shall co-operate fully with
                  the other
                  party in the handling of any such
                  claim.

              

      

    

    
      
        	 	 	 

      

       

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          11

          
            

          

        

        
          
          

        

      

       

      
        	 	
                10.8

              	
                Each
                  Party undertakes to ensure that it has in place product liability
                  insurance with a reputable insurer in an amount appropriate for
                  its
                  business and products of the type the subject of this Agreement,
                  and for
                  its obligations under this Agreement. At either party’s request the other
                  party shall provide evidence of the existence and maintenance of
                  such
                  cover.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.9

              	
                Each
                  Party will have appropriate inventory and Stock in Transit insurance,
                  as
                  is customary for the
                  industry.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.10

              	
                Nothing
                  in this Article 10 shall in any way reduce or affect each party’s general
                  duty to mitigate loss suffered by
                  it.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                10.11

              	
                The
                  parties acknowledge and agree that clause 8.8 of the Sale and Purchase
                  Agreement contains provisions which limit the liability of INYX
                  for the
                  specified time and in specified circumstances which are a direct
                  result of
                  the temporary closure of the Sterile Production Unit (as defined
                  therein)
                  prior to Completion or within a period of 45 days following
                  Completion.

              

      

    

    
      
        	 	 

      

      
        	
                11.

              	
                Confidentiality

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.1

              	
                Each
                  party (“Discloser”)
                  agrees to maintain as secret and confidential all Information obtained
                  from the other (“Recipient”)
                  both pursuant to this Agreement and prior to and in contemplation
                  of it,
                  to respect Discloser’s proprietary rights therein, to use the same
                  exclusively for the purpose of this Agreement and for no other
                  use and to
                  disclose the same only to those of its professional advisers, including
                  legal financial and risk assessment advisers, authorised sub-contractors
                  and employees to whom and to the extent that such disclosure is
                  reasonably
                  necessary for the purpose of this Agreement. Furthermore, Recipient
                  agrees
                  to maintain as secret and confidential all other information obtained
                  from
                  Discloser which the Discloser has designated as
                  confidential.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.2

              	
                The
                  foregoing obligations of Article 11.1 above shall not apply to
                  Information
                  which:

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.2.1

              	
                the
                  Recipient can prove by documentary evidence was already in its
                  possession
                  and at its free disposal before disclosure by
                  Discloser;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.2.2

              	
                is
                  subsequently lawfully disclosed to the Recipient without any obligations
                  of confidence by a third party who has not derived it directly
                  or
                  indirectly from the Discloser or any of the Discloser’s Affiliates;
                  or

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.3

              	
                is
                  or becomes generally available to the public (in printed publications
                  in
                  general circulation) through no act or default of Recipient or
                  its agents
                  or employees.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.4

              	
                Discloser
                  is required to disclose by
                  law.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                11.5

              	
                Recipient
                  shall allow access to the Discloser’s Information exclusively to those of
                  its employees who have reasonable need to see and use it for the
                  purposes
                  of this Agreement and shall inform each of the said employees of
                  the
                  confidential nature of the Information and of the obligations on
                  Recipient
                  in respect thereof and ensure that each of its employees having
                  access to
                  the Information is contractually bound by obligations of confidentiality
                  and shall take such steps as may be necessary to enforce such
                  obligations.

              

      

    

    
      
        	 	 

      

      
        	
                12.

              	
                Adverse
                  Drug Events and Product
                  Recalls

              

      

    

    
      
        	 	 	 

      

      
        	 	
                12.1

              	
                UCB
                  shall be responsible for conducting any recall of defective Products
                  and
                  INYX shall co-operate with and give all reasonable assistance to
                  UCB in
                  conducting any such recall in accordance with the provisions of
                  the GMP
                  Agreement. The costs and expenses of such recall shall be met by
                  UCB
                  except where such recall is a result of any negligent act or omission
                  on
                  INYX’s part, in which event, INYX shall meet all costs and expenses
                  thereof.

              

      

    

    
      
        	 	 	 

      

       

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          12

          
            

          

        

        
          
          

        

      

       

      
        	 	
                12.2

              	
                Each
                  Party shall keep the other informed of any adverse drug event involving
                  the Products or products containing the same active ingredient
                  as the
                  Products coming to their attention and able to be disclosed to
                  the other.
                  

              

      

    

    
      
        	 	 	 

      

      
        	 	
                12.3

              	
                Each
                  party shall keep the other informed of any material change or event
                  in the
                  market relevant to the Products coming to their attention and able
                  to be
                  disclosed to the other.

              

      

    

    
      
        	 	 

      

      
        	
                13.

              	
                Termination

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.1

              	
                Either
                  party may forthwith terminate this Agreement by written notice
                  to the
                  other if:

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.2

              	
                that
                  other party is in material breach of any of the provisions of this
                  Agreement and, in the case of a breach capable of remedy, fails
                  to remedy
                  the same within ninety (90) days or within one hundred and twenty
                  (120)
                  days if concerning the sterile production unit in the Ashton Facility
                  of
                  receipt of a written notice specifying the breach and requiring
                  its
                  remedy; or

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.3

              	
                an
                  encumbrancer takes possession or a receiver is appointed over any
                  of the
                  property or assets of that other party;
                  or

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.4

              	
                that
                  other party makes any voluntary arrangement with its creditors
                  or becomes
                  subject to an administration order;
                  or

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.5

              	
                that
                  other party goes into liquidation except for the purposes of amalgamation
                  or reconstruction and in such manner that the company resulting
                  therefrom
                  effectively agrees to be bound by or assume the obligations imposed
                  on
                  that other party under this
                  Agreement.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.6

              	
                For
                  the purposes of Article 13.1 a breach shall be considered capable
                  of
                  remedy if the party in breach can comply with the provision in
                  question in
                  all respects other than as to the time of performance provided
                  that time
                  of performance is not of the
                  essence.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.7

              	
                Any
                  waiver by either party of a breach of any provision of this Agreement
                  shall not be considered a waiver of any subsequent breach of the
                  same or
                  any other provision.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.8

              	
                The
                  rights to terminate this Agreement given by this Article 13 shall
                  be
                  without prejudice to any other right or remedy of either party
                  in respect
                  of the breach concerned (if any) or any other
                  breach.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                13.9

              	
                ***

              

      

    

    
      
        	 	 

      

      
        	
                14.

              	
                Consequences
                  of Termination

              

      

    

    
      	 	
              14.1

            	
              Termination
                of this Agreement for any reason shall not bring to an end any provisions
                of this Agreement which, in order to give effect to their meaning,
                need to
                survive its termination and such provisions shall remain in full
                force and
                effect thereafter and in particular but without limiting the scope
                of the
                foregoing obligations of the parties under Articles 9, 11, 12, 13,
                14, 18,
                20, 21, 22, 23, and this Article
                14.

            

    

    
      	 	
              14.2

            	
              On
                termination of this Agreement for any
                reason:

            

    

    
      
        	 	 	 

      

      
        	 	
                14.2.1

              	
                INYX
                  shall at UCB’s option either immediately cease Manufacture or complete
                  Manufacture of all Products which have been ordered prior to the
                  date of
                  termination of this Agreement and UCB shall notify INYX of its
                  election on
                  termination of this
                  Agreement;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                14.2.2

              	
                subject
                  to Article 14.2.1 each party shall deliver up to the other all
                  materials,
                  reports, and other documents (including copies thereof) in its
                  possession
                  or control containing Information of the other party, and each
                  will cease
                  to make use of the other’s
                  Information;

              

      

       

       

      
        
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            TREATMENT

        

        
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        	 	14.2.3	UCB shall pay INYX for all Products which are
                subject to
                the Firm Period and which have been ordered in accordance with the
                replenishment plan at prices then prevailing and shall take delivery
                of
                such Product as soon as possible when it is notified by INYX that
                it is
                available for collection;

      

    

     

    
      	 	
              14.3

            	
              UCB
                will be obliged to purchase and shall pay INYX
                for:

            

    

    
      
        
          	 	 	 

        

        
          	 	
                  (a)

                	all stocks of Raw Materials purchased by INYX
                  in
                  accordance with Article 7 with a maximum of three (3) months forecast
                  at a
                  price equal to the book value or the cost thereof, whichever is
                  lower;
                  and

        

        
          	 	 	 

        

        
          	 	
                  (b)

                	
                  all
                    work in progress purchased by INYX in accordance with Article
                    14.2.1 at
                    prices then prevailing.

                

        

      

    

    
      
        	 	 	 

      

      
        	 	
                14.4

              	
                UCB
                  will collect all Raw Materials and all work in progress free of
                  charge. In
                  case of withdrawal of the Product under Article 13.5, the same
                  principles
                  shall apply.

              

      

    

    
      
        	 	 

      

      
        	
                15.

              	
                Escalation
                  Provisions 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                15.1

              	
                In
                  the event only it is specified herein that these escalation provisions
                  shall apply to any dispute or disagreement being and remaining
                  unresolved,
                  then until resolution
                  thereof:

              

      

    

    
      
        	 	 	 

      

      
        	 	
                15.2

              	
                the
                  parties shall as soon as reasonably practicable commence good faith
                  negotiations to resolve the dispute or
                  disagreement;

              

      

    

    
      
        	 	 	 

      

      
        	 	
                15.3

              	
                should
                  such good faith negotiations not take place or should such good
                  faith
                  negotiations not resolve the dispute or disagreement within a reasonable
                  period, but in any event within twenty one (21) days of commencement
                  of
                  the negotiations, the dispute or disagreement shall immediately
                  be
                  referred to the respective senior management of the parties for
                  their
                  resolution (for the avoidance of doubt senior management for UCB
                  is head
                  of GTSO and for INYX is VP Global Sales & Marketing);
                  and

              

      

    

    
      
        	 	 	 

      

      
        	 	
                15.4

              	
                should
                  the respective senior management of the parties fail to resolve
                  the
                  dispute or disagreement within fourteen (14) days of it being referred
                  to
                  them, then either party may by written notice to the other forthwith
                  terminate this Agreement, and neither party shall be liable to
                  the other
                  in respect of any consequence of such
                  termination.

              

      

    

    
      
        	 	 

      

      
        	
                16.

              	
                Force
                  Majeure

              

      

    

    
      
        	 	 	 

      

      
        	 	
                16.1

              	
                If
                  either party is affected by Force Majeure it shall forthwith notify
                  the
                  other party of the nature and extent
                  thereof.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                16.2

              	
                Each
                  party shall be deemed not to be in breach of this Agreement, nor
                  otherwise
                  be liable to the other by reason of any delay in performance, or
                  non-performance, of any of its obligations hereunder to the extent
                  that
                  such delay or non-performance is due to any Force Majeure of which
                  it has
                  notified the other party and the time for performance of that obligation
                  shall be extended
                  accordingly.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                16.3

              	
                If
                  the Force Majeure in question prevails for a continuous period
                  in excess
                  of three (3) months, the parties shall enter into bona fide discussions
                  with a view to agreeing upon such alternative arrangements as may
                  be fair
                  and reasonable. If the parties cannot agree such alternative arrangements
                  then either party shall be entitled to terminate this Agreement
                  immediately by written
                  notice.

              

      

    

    
      
        	 	 

      

       

       

      
        
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                17.

              	
                Notices

              

      

    

    
      
        	 	 	 

      

      
        	 	
                17.1

              	
                Any
                  notice or other information required or authorised by this Agreement
                  to be
                  given by either party to the other may be given by hand or sent
                  to the
                  other by first class registered pre-paid post, telex, facsimile
                  transmission or comparable means of communication. Service of any
                  legal
                  proceedings concerning or arising out of this Agreement shall be
                  effected
                  by causing the same to be delivered to the secretary of the party
                  to be
                  served at its registered office, or to such other address as may
                  be
                  notified by the party concerned in writing from time to
                  time.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                17.2

              	
                Any
                  notice or other information given by post pursuant to Article 17.1
                  which
                  is not returned to the sender as undelivered shall be deemed to
                  have been
                  given on the third day after the envelope containing the same was
                  so
                  posted. Proof that the envelope containing any such notice or information
                  was properly addressed, pre-paid, registered and posted, and that
                  it has
                  not been so returned to the sender, shall be sufficient evidence
                  that such
                  notice or information has been duly
                  given.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                17.3

              	
                Any
                  notice or other information sent by telex, cable, facsimile transmission
                  or comparable means of communication shall be deemed to have been
                  duly
                  sent on the date of transmission, provided that a confirming copy
                  thereof
                  is sent by first class registered pre-paid post to the other party
                  at the
                  address referred to in Article 17.1 within twenty four (24) hours
                  after
                  transmission.

              

      

    

    
      
        	 	 

      

      
        	
                18.

              	
                Liaison

              

      

    

    
      
        	 	 	 

      

      
        	 	
                18.1

              	
                Upon
                  signature of this Agreement the parties will each identify in writing
                  the
                  person responsible for the day to day operation of this Agreement
                  including purchasing, RA, QA, QC, SCM, IS/IT, Production,
                  Artwork.

              

      

    

    
      
        	 	 

      

      
        	
                19.

              	
                Material
                  Adverse Impact

              

      

    

    
      
        	 	 	 

      

      
        	 	
                19.1

              	
                Should
                  there occur any event or circumstance which is not the result of
                  any act
                  or omission of INYX and which INYX reasonably believes has a material
                  adverse affect on its ability to Manufacture or on its business
                  generally,
                  then the parties shall, at INYX’s request, meet to discuss in good faith
                  the possible consequences of any such event or circumstance and
                  its
                  implications for INYX and its business. Should the parties not
                  reach
                  agreement reasonably acceptable to INYX regarding their ongoing
                  relationship in light of the said event or circumstance, then either
                  party
                  may, by three (3) months’ notice to the other party, terminate this
                  Agreement.

              

      

    

    
      
        	 	 

      

      
        	
                20.

              	
                Non-solicitation
                  of Employees

              

      

    

    
      
        	 	 	 

      

      
        	 	
                20.1

              	
                UCB
                  shall not during the term of this Agreement nor for a period of
                  one (1)
                  year after its expiry or termination for whatever reason whether
                  directly
                  or indirectly and in any capacity whatsoever (whether on its own
                  behalf or
                  on behalf of any other person or firm) solicit the services of
                  or approach
                  any employee or officer of INYX with a view to recruiting that
                  person for
                  the purposes of employment.

              

      

    

    
      
        	 	 	 

      

      
        	 	
                20.2

              	
                INYX
                  shall not during the term of this Agreement nor for a period of
                  one (1)
                  year after its expiry or termination for whatever reason whether
                  directly
                  or indirectly and in any capacity whatsoever (whether on its own
                  behalf or
                  on behalf of any other person or firm) solicit the services of
                  or approach
                  any employee or officer of UCB with a view to recruiting that person
                  for
                  the purposes of employment.

              

      

    

    
      
        	 	 

      

      
        	
                21.

              	
                ***

              

      

    

    
      
        	 	 

      

       

       

      
        
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                22.

              	
                General

              

      

    

    
      
        	 	 	 

      

      
        	 	
                22.1

              	
                INYX
                  may assign the benefit of this Agreement to any other member of
                  the
                  Purchaser’s Group or to any lender or holder of debt securities issued by
                  any member of the Purchaser’s Group for the time being or any agent of
                  such lender or holder and if it does
                  so:

              

      

    

    
      
        
          	 	 	 

        

        
          	 	
                  22.1.1

                	
                  the
                    assignee may enforce the obligations on the part of UCB under
                    this
                    Agreement as if it had been named in this Agreement or therein
                    as
                    INYX

                

        

      

      
        
          	 	 	 

        

        
          	 	
                  22.1.2

                	
                  as
                    between UCB and INYX, UCB may nevertheless
                    enforce this Agreement against INYX as
                    if the assignment had not
                    occurred;

                

        

    

    
      
        
          
            	 	 	 

          

          
            	 	
                    22.1.3

                  	
                    the
                      assignment shall not in any way operate so as to increase the
                      liability of
                      INYX or
                      UCB; and

                  

          

        

        
          
            	 	 	 

          

          
            	 	
                    22.1.4

                  	
                    the
                      assignee will not be liable or obligated in any way by reason
                      of such
                      assignment or exercising the rights so
                      assigned.

                  

          

      

    

    
      
        	 	 	A liquidator or administrator, or any receiver
                or other
                person or entity entitled to enforce any security or rights under
                this
                Agreement may enter into any other assignment or transfer of any
                such
                rights, provided that such assignment shall not in any way operate
                so as
                to increase the liability of UCB or INYX.

      

      
        	 	 	 

      

      
        	 	 	Except as permitted by this Clause 22.1 none of
                the
                rights or obligations under this Agreement shall be assigned or
                transferred by either party without the prior written consent of
                the
                other.

      

      
        	 	 	 

      

      
        	 	
                22.2

              	
                Nothing
                  in this Agreement shall create, or be deemed to create, a partnership
                  between the parties. 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                22.3

              	
                This
                  Agreement, the GMP Agreement and the Service Agreement and other
                  Schedules
                  contain the entire agreement between the parties with respect to
                  its
                  subject matter, supersedes all previous agreements and understandings
                  between the parties, and may not be modified except by an instrument
                  in
                  writing signed by the duly authorised representatives of the parties.
                  

              

      

    

    
      
        	 	 	 

      

      
        	 	
                22.4

              	
                Each
                  party acknowledges that, in entering into this Agreement, it does
                  not do
                  so on the basis of or in reliance on any representation, warranty
                  or other
                  provision except as expressly provided in this Agreement, and accordingly
                  all conditions, warranties or other terms implied by statute or
                  common law
                  are hereby excluded to the fullest extent permitted by law.
                  

              

      

    

    
      
        	 	 	 

      

      
        	 	
                22.5

              	
                If
                  any provision of this Agreement is agreed by the parties to be
                  or is held
                  by any court or other competent authority to be void or unenforceable
                  in
                  whole or part, the other provisions of this Agreement and the remainder
                  of
                  the affected provisions shall continue to be valid save that such
                  illegal
                  void or unenforceable provision or part thereof shall be deemed
                  to be
                  excised herefrom. 

              

      

    

    
      
        	 	 	 

      

      
        	 	
                22.6

              	
                This
                  Agreement shall be governed by and construed in all respects in
                  accordance
                  with the laws of England, and the parties hereby submit to the
                  exclusive
                  jurisdiction of the English courts.

              

      

    

    
      
        	 	 

      

      
        	
                23.

              	
                PARENT
                  GUARANTEE

              

      

    

    
      
        	 	 	 

      

      
        	 	
                23.1

              	
                The
                  Parent Guarantor, as primary obligor, unconditionally and irrevocably
                  guarantees, by way of continuing guarantee to UCB, the payment
                  and
                  performance by INYX, when due, of all amounts and obligations under
                  this
                  Agreement. This guarantee shall remain in full force and effect
                  until all
                  such amounts and obligations have been irrevocably paid and discharged
                  in
                  full. 

              

      

    

    
      
        	 	 	 

      

       

       

      
        
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                23.2

              	
                The
                  Parent Guarantor’s obligations under this
                  clause:

              

      

    

    
      
        	 	 	 

      

      
        	 	 	 

      

      
        	 	
                23.3

              	
                constitute
                  direct, primary and unconditional obligations to pay on demand
                  by UCB any
                  sum which INYX is liable to pay under this Agreement and to perform
                  on
                  demand any obligation of INYX under this Agreement without requiring
                  UCB
                  first to take any steps against INYX or any other person;
                  and

              

      

    

    
      
        	 	 	 

      

      
        	 	
                23.4

              	
                shall
                  not be affected by any matter or thing which but for this provision
                  might
                  operate to affect or prejudice those obligations,
                  including:

              

      

    

    
      
        
          	 	 	 

        

        
          	 	
                  (a)

                	any time or indulgence granted to, or composition
                  with,
                  INYX or any other person; or

        

        
          	 	 	 

        

        
          	 	
                  (b)

                	
                  any
                    amendment of this Agreement;
                    or

                

        

      

    

    
      
        	 	 	 

      

      
        	 	
                (c)

              	the taking, variation, renewal or release of,
                or refusal
                or neglect to perfect or enforce, any right, remedy or security against
                INYX or any other person; or

      

      
        	 	 	 

      

      
        	 	
                (d)

              	
                any
                  legal limitation, disability or other circumstance relating to
                  INYX or any
                  unenforceability or invalidity of any obligation of INYX under
                  this
                  Agreement.

              

      

    

     

    
      	
              24.

            	
              COUNTERPARTS

            

    

     

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

    

    IN
      WITNESS whereof this Agreement has been executed by the duly authorised
      representatives of the parties the day and year first above written

    

    

    
      
        CONFIDENTIAL
          TREATMENT

      

      
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      For
        and on behalf of

      UCB
        PHARMA LTD

      

      

      
        	
                Signed
                  : 

              	
                PETER
                  NICHOLLS

              	
                H
                  S BAINS

              
	 	 	 
	
                Name
                  :

              	
                PETER
                  NICHOLLS

              	
                H
                  S BAINS

              
	 	 	 
	
                Title
                  :

              	
                DIRECTOR

              	
                DIRECTOR

              

      

      

      

      For
        and on behalf of 

      CELLTECH
        MANUFACTURING SERVICES LIMITED

      

      
        	
                Signed
                  :

              	
                PETER
                  NICHOLLS

              	
                MARK
                  GLYN HARDY

              
	 	 	 
	
                Name
                  :

              	
                PETER
                  NICHOLLS

              	
                MARK
                  GLYN HARDY

              
	 	 	 
	
                Title
                  :

              	
                DIRECTOR

              	
                DIRECTOR

              

      

      

      

      For
        and on behalf of 

      INYX,
        INC

      

      
        	
                Signed : 

              	
                JACK
                  KACHKAR

              	 
	 	 	 
	
                Name
                  :

              	
                JACK
                  KACHKAR

              	 
	 	 	 
	
                Title
                  :

              	
                CHAIRMAN
                  AND CEO

              	 

      

      

 

      
        
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    SCHEDULE
      1

    

    GMP-AGREEMENT
      FOR PHARMACEUTICAL PRODUCTS

    

    ON
      CONTRACT MANUFACTURE

    

    

    BETWEEN  UCB
      Pharma Ltd (“UCB”)

    

    

    AND  Ashton
      Pharmaceuticals Limited (“CONTRACT
      ACCEPTOR”),
      with
      registered offices at Ashton

    

    WHEREAS
      the parties wish to set out the respective duties of UCB and CONTRACT ACCEPTOR
      with respect to Good Manufacturing Practices (GMP);

    

    WHEREAS
      on ______date____________ the Parties have entered into a Contract Manufacturing
      Agreement for the PRODUCTS (the “FRAME
      AGREEMENT”);

    

    NOW
      THEREFORE THE PARTIES HAVE AGREED AS FOLLOWS:

    

    1. Scope
      of this Agreement

    

    This
      GMP-AGREEMENT contains the respective obligations of UCB and CONTRACT ACCEPTOR
      with respect to GMP to be respected for the manufacture of the PRODUCTS as
      set
      out herein. The GMP requirements for the manufacture, storage and quality,
      as
      well as the duties and responsibilities of UCB and CONTRACT ACCEPTOR relating
      to
      the manufacture of the PRODUCT are defined in detail in the ECcGMP’s guidelines
      (Guide to Good Manufacturing Practice for Medicinal PRODUCT in the European
      Community, volume IV). These Guidelines (including all defined terms) are an
      integral part of this Agreement.

    

    This
      GMP-AGREEMENT relates to the manufacture of the following PRODUCT(s), further
      described in Exhibit
      1
      to this
      GMP-AGREEMENT and hereinafter referred to as “PRODUCT(S)”:

     

    
      	
              PRODUCT(S)

            	
              GALENICAL
                FORM

            	
              DOSAGE

            
	 	
              Refer
                to exhibit 1

            	 

    

     

    Contacts
      for this GMP-AGREEMENT until further notification:

    

    
      	
              At
                UCB:

            	
              D
                Killick (Quality Assurance Manager - Qualified Person)

            
	
              At
                CONTRACT
                ACCEPTOR :

            	
              E.
                Prady (Head of Quality - Qualified
                Person)

            

    

     

    2. RESPONSIBILITIES

    

    Under
      the
      terms and conditions hereinafter set out, UCB
      appoints
CONTRACT
      ACCEPTOR
      to
      perform and conduct with respect to the PRODUCT(S) all the operations which
      are
      marked with “X” in the column titled CONTRACT ACCEPTOR in the matrix of
      responsibilities herebelow.

     

    
      
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          TREATMENT

      

      
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    During
      the term of this GMP-AGREEMENT, CONTRACT
      ACCEPTOR
      undertakes that it shall manufacture and/or pack and/or control the quality
      of
      the PRODUCT(S) and conduct CONTRACT
      ACCEPTOR’s
      operations in strict compliance with:

     

    
      
        	i)	 	the current Good Manufacturing
                Practices; and
	 	 	 
	ii)	 	the formula, technical
                specifications, manufacturing processes and quality control and release
                procedures described in the relevant exhibits
                attached.

      
 

    N/A
      shall
      mean: “not applicable”.

    

      
        
          	
                  A.

                	
                  General

                	 	 
	 	 	
                  UCB

                	
                  CONTRACT
                    ACCEPTOR

                
	 	
                  Valid
                    manufacturing licence available

                	
                   

                	
                  X

                
	
                  .

                	
                  Formulation
                    / data sheet

                	
                  X

                	
                   

                
	 	
                  Manufacturing
                    procedures / batch sheets

                	 	
                  X

                
	 	
                  Registered
                    formula, process, etc.

                	
                  X

                	
                   

                
	 	
                  Scale-up
                    procedures

                	
                   

                	
                  X

                
	 	
                  Validation
                    master plan

                	 	
                  X

                
	 	
                  Validation
                    protocol

                	 	
                  X

                
	 	
                  Validation
                    report

                	 	
                  X

                
	 	
                  Validation
                    procedures

                	
                   

                	
                  X

                
	 	
                  Analytical
                    specifications and methods and IPC (In process control)

                	
                  X

                	 
	 	
                  Validation
                    of analysis methods

                	 	
                  X

                
	 	
                  Specific
                    procedures relating to product incl. safety, occupational health,
                    security, storage and transport conditions

                	
                   

                	
                  X

                
	 	
                  Labelling
                    instructions

                	
                   

                	
                  X

                
	 	
                  Cleaning
                    procedures

                	 	
                  X

                
	 	
                  Validation
                    of cleaning procedures prior to production 

                	 	
                  X

                
	 	
                  Validation
                    of cleaning procedures after production

                	 	
                  X

                
	 	
                  Stability
                    testing

                	 	
                  X

                
	 	
                  Stability
                    protocol

                	 	
                  X

                
	 	
                  Stability
                    test methods

                	 	
                  X

                
	 	
                  Stability
                    report

                	 	
                  X

                
	 	 	 	 
	
                  B.

                	
                  Bulk
                    Manufacture

                	 	 
	 	 	
                  UCB

                	
                  CONTRACT
                    ACCEPTOR

                
	
                  B.1

                	
                  Raw
                    Materials

                	 	 
	 	
                  Purchase
                    of excipients or raw materials.

                	
                   

                	
                  X

                
	 	
                  Supplier
                    evaluation

                	 	
                  X

                
	 	
                  Analysis
                    

                	
                   

                	
                  X

                
	 	
                  Release

                	 	
                  X

                
	 	
                  Storage
                    of reference samples 

                	
                   

                	
                  X

                
	 	
                  Procurement
                    / order free of charge of active substance

                	
                  NA

                	
                  NA

                
	 	
                  Analysis
                    

                	
                  NA

                	
                  NA

                
	 	
                  Release

                	
                  NA

                	
                  NA

                
	 	
                  Identity
                    control of active substance

                	 	
                  X

                
	 	
                  Storage
                    of reference sample 

                	
                   

                	
                  X

                
	
                  B.2

                	
                  Manufacture

                	 	 
	 	
                  Validation
                    of scale-up/manufacturing process

                	 	
                  X

                
	 	
                  Master
                    of Manufacturing formula

                	 	
                  X

                
	 	
                  Master
                    of Processing instructions

                	 	
                  X

                
	 	
                  Manufacture
                    following agreed procedure

                	 	
                  X

                
	 	
                  Allocation
                    of batch numbers for bulk

                	
                   

                	
                  X

                
	 	 	
                  UCB

                	
                  CONTRACT
                    ACCEPTOR

                

        

         

         

        
          
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                    B.3

                  	
                    Analysis
                      and controls

                  	 	 
	 	
                    Perform
                      in process - controls

                  	 	
                    X

                  
	 	
                    Validate
                      the methods of analysis for new products

                  	 	
                    X

                  
	 	
                    Purchase
                      of necessary reference standards

                  	 	
                    X

                  
	 	
                    Analysis

                  	
                     

                  	
                    X

                  
	 	
                    Release
                      for packaging

                  	
                     

                  	
                    X

                  
	 	
                    Storage
                      of reference sample

                  	
                     

                  	
                    X

                  
	 	
                    Certificate
                      of Conformance

                  	
                     

                  	
                    X

                  
	 	 	 	 
	
                    C.

                  	
                    Primary
                      Packaging / Semi-finished Product

                  	 	 
	 	 	
                    UCB

                  	
                    CONTRACT
                      ACCEPTOR

                  
	
                    C.1

                  	
                    Packaging
                      Components

                  	 	 
	 	
                    Specifications
                      for unprinted primary packaging materials (unprinted PPM)

                  	
                    X

                  	 
	 	
                    Supplier
                      evaluation

                  	 	
                    X

                  
	 	
                    Procurement
                      of unprinted PPM

                  	
                     

                  	
                    X

                  
	 	
                    Methods
                      of testing unprinted PPM

                  	 	
                    X

                  
	 	
                    Specifications
                      for printed primary packaging materials 

                  	
                    X

                  	 
	 	
                    Specifications
                      for text/Artwork

                  	
                    X

                  	 
	 	
                    Supplier
                      evaluation

                  	 	
                    X

                  
	 	
                    Procurement
                      of printed PPM

                  	 	
                    X

                  
	 	
                    Methods
                      of testing printed PPM

                  	 	
                    X

                  
	 	
                    Testing
                      

                  	
                     

                  	
                    X

                  
	 	
                    Release

                  	 	
                    X

                  
	 	
                    Allocation
                      of batch numbers for PPM

                  	
                     

                  	
                    X

                  
	 	
                    Storage
                      of reference samples 

                  	
                     

                  	
                    X

                  
	 	 	 	 
	
                    C.2

                  	
                    Primary
                      packaging

                  	 	 
	 	
                    Allocation
                      of batch numbers

                  	
                     

                  	
                    X

                  
	 	
                    Allocation
                      of expiry dates

                  	 	
                    X

                  
	 	
                    Code
                      to be used

                  	 	
                    X

                  
	 	
                    Master
                      of packaging instructions

                  	 	
                    X

                  
	 	
                    Control
                      of the semi-finished product (S.F.P.)

                  	
                     

                  	
                    X

                  
	 	
                    Release
                      of the S.F.P. for Final Packaging

                  	
                     

                  	
                    X

                  
	 	
                    Storage
                      of reference samples for the S.F.P.

                  	
                     

                  	
                    X

                  
	 	
                    Performing
                      stability studies in final packages

                  	
                     

                  	
                    X

                  
	 	 	 	 
	
                    D.

                  	
                    Secondary
                      Packaging / Finished Product

                  
	 	 	
                    UCB

                  	
                    CONTRACT
                      ACCEPTOR

                  
	
                    D.1

                  	
                    Secondary
                      Packaging Components

                  	 	 
	 	
                    Specifications
                      for printed secondary packaging materials (text) (printed
                      SPM)/artwork

                  	
                    X

                  	
                      

                  
	 	
                    Specifications
                      for printed SPM (physical)

                  	 	
                    X

                  
	 	
                    Methods
                      of testing printed SPM

                  	 	
                    X

                  
	 	
                    Supplier
                      evaluation

                  	 	
                    X

                  
	 	
                    Procurement
                      of printed SPM

                  	
                     

                  	
                    X

                  
	 	
                    Control

                  	
                     

                  	
                    X

                  
	 	
                    Release
                      for use

                  	 	
                    X

                  
	 	
                    Allocation
                      of batch numbers for printed SPM

                  	
                     

                  	
                    X

                  
	 	
                    Storage
                      of reference samples 

                  	
                     

                  	
                    X

                  

          

           

           

          
            
              CONFIDENTIAL
                TREATMENT

            

            
              21

              
                

              

            

            
              
              

            

          

           

          
            	
                    D.2

                  	
                    Secondary
                      Packaging

                  	 	 
	
                    D.2.1

                  	
                    Allocation
                      of batch numbers

                  	 	
                    X

                  
	
                    D.2.2

                  	
                    Allocation
                      of expiry dates

                  	 	
                    X

                  
	
                    D.2.3

                  	
                    Code
                      to be used

                  	 	
                    X

                  
	
                    D.2.4

                  	
                    Master
                      of packaging instructions

                  	 	
                    X

                  
	
                    D.2.5

                  	
                    Paletisation
                      instructions

                  	
                    X

                  	 
	
                    D.2.6

                  	
                    Master
                      of shipping label

                  	 	
                    X

                  
	
                    D.2.7

                  	
                    Test
                      of the finished product

                  	
                     

                  	
                    X

                  
	
                    D.2.8

                  	
                    Issue
                      certificate of quality

                  	 	
                    X

                  
	
                    D.2.9

                  	
                    QP
                      Certification of the finished product....

                  	
                     

                  	
                    X

                  
	
                    D.2.10

                  	
                    Release
                      of the finished product for sale/distribution to market

                  	
                    X

                  	 
	
                    D.2.11

                  	
                    Storage
                      of reference/ retention samples for the finished product

                  	
                     

                  	
                    X

                  

          

        

      

    

     

    
      
        	
                3.

              	
                PERFORMANCE
                  INSTRUCTIONS 

              

      

    

    

    UCB
      shall
      supply the formulation, procedures and analytical specifications; these are
      binding on CONTRACT
      ACCEPTOR.
      Changes
      may be made only with the written consent of UCB
      following due change control procedures at either end. Deviations from the
      process or the control procedure must be brought to the attention of
UCB
      and the
      release for shipment of the relevant batch requires the written consent of
      UCB.

    

    
      	
              4.

            	
              MATERIALS

            

    

    

    The
      active substances and excipients have to fulfil the requirements of UCB
      (specifications, methods of testing, authorised supplier). Any deviation from
      the specifications or requirements must have the prior written approval of
      UCB.

    Any
      reference standard for testing must be accompanied by a CoA listing storage
      requirements, expiration date and any correction factor that needs to be
      applied.

    

    CONTRACT
      ACCEPTOR shall be responsible that all its deliveries of such material are
      clearly and visibly labelled with all necessary markings. This applies in
      particular to the PRODUCT names, which have to be identical with the information
      laid down in specifications, manufacturing and packaging instructions, storage
      instructions, remarks on quarantine and warning indications.

    

    Goods
      supplied to the Buyer by the Seller will not contain materials of animal origin
      and no animal derived reagents will be used in their manufacture. Provided
      that
      in the event Goods are supplied to the Buyer which do not comply with above,
      then the Seller will confirm, by production of a relevant certificate, that
      the
      Goods comply with the European Pharmacopoeia General Chapter 5.2.8 “Minimising
      the risk of transmitting animal spongiform encephalopathy agents via medical
      products”.

    

    
      	
              5.

            	
              ANALYSIS
                AND TESTS

            

    

    

    CONTRACT
      ACCEPTOR has to perform the analysis and tests according to the specifications
      and methods defined by UCB. 

    A
      batch
      specific analytical report or certificate of conformance containing the recorded
      results of the analysis is to be provided for every single delivery of the
      end
      PRODUCT. The certificate lay-out and content must conform with the requirements
      of UCB.

    

    Label
      Component specifications: CONTRACT ACCEPTOR will only use labels and labelling
      approved in writing by UCB.

    

     

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        22

        
          

        

      

      
        
        

      

    

    
 

    
      	
              6.

            	
              DOCUMENTATION

            

    

    

    Masters

    Master
      Batch Records shall mean the documents used by CONTRACT ACCEPTOR as technical
      instructions and records to manufacture, pack and test the PRODUCTS. Those
      documents will be based on information provided by UCB. CONTRACT ACCEPTOR is
      authorised to transcribe those documents into its own format, provided they
      will
      be approved in writing by UCB prior to use.

    

    Manufacture
      and expiry dates 

    The
      date
      of manufacture is the first day of compounding the PRODUCT. UCB provides the
      rules to allow CONTRACT ACCEPTOR to calculate the expiration date for the
      batches to be manufactured.

    

    Manufacturing
      and equipment data 

    CONTRACT
      ACCEPTOR is responsible for the safe keeping and retention of records of machine
      usage (previous PRODUCT manufactured in non-dedicated machinery), cleaning,
      maintenance, calibration, raw material batch numbers and certification, IPC
      results and parameters, test results in accordance with all applicable laws,
      rules, regulations and guidelines.

    

    Retention

    CONTRACT
      ACCEPTOR will retain, at minimum, batch production records, quality control
      records, validation data and other documentation including investigation reports
      for at least one (1) year beyond the expiration date of the finished product
      lot, or as otherwise required by applicable law. All such documents, records
      and
      reports must be maintained by CONTRACT ACCEPTOR in such a manner that they
      are
      readily retrievable and stored in an environment suitable to prevent damage
      or
      loss. CONTRACT ACCEPTOR shall provide copies of all such documents and
      information to UCB or its designee, as reasonably requested, within five (5
      )
      Business Days.

    

    
      	
              7.

            	
              DEVIATIONS
                AND INVESTIGATIONS

            

    

    

    A
      deviation is defined as any abnormal event that may occur during the processing
      of a batch, or is a departure from Specifications, approved Master Batch Record
      or Method of testing.

    

    Any
      deviation that occurs must be documented in the batch record. The significant
      deviations will be forwarded to UCB in conjunction with the Certificate of
      Conformity / Analysis).

    

    Excepted
      as provided in sections “Complaints” and “Stability”, CONTRACT ACCEPTOR must
      notify UCB within five (5) Business Days of the occurrence of a confirmed out-of
      specification (“OOS”)
      result
      or major process deviation (deviations potentially effecting product quality,
      safety, identity, purity or efficacy) relating to the PRODUCT. A confirmed
      OOS
      result is defined as a result from a raw material, in-process, or finished
      product testing which does not meet specifications. 

    All
      Quality decisions regarding any such out-of-specification result or major
      process deviation involving the PRODUCT shall be made by CONTRACT ACCEPTOR
      in
      consultation with UCB. In all cases, UCB will have the final review and decision
      making responsibility as to the impact of the deviation(s) on the PRODUCT;
      this
      includes the disposition of the affected batch. Reworking or reprocessing
      protocols require UCB approval prior to execution. All investigations must
      be
      completed, documented and approved by CONTRACT ACCEPTOR prior to issuance of
      a
      Certificate of Compliance or a Certificate of Conformance. A copy of the
      completed investigation must be provided to UCB prior to PRODUCT release by
      CONTRACT ACCEPTOR.

    

    CONTRACT
      ACCEPTOR will notify UCB in writing of any batch of PRODUCT rejected by CONTRACT
      ACCEPTOR.

    

    CONTRACT
      ACCEPTOR will notify UCB in writing of any problems that may impact or
      invalidate a batch previously shipped to UCB or its Affiliates or Agents.

    

    Some
      deviations or investigations may require additional testing, stability or
      validation be conducted. This work will be performed as agreed by both
      parties.

     

     

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        23

        
          

        

      

      
        
        

      

    

    
 

    
      	
              8.

            	
              RELEASE

            

    

    

    CONTRACT
      ACCEPTOR shall ensure and certify that the PRODUCT has been made according
      to
      cGMP’s, specifications and methods documented in the Master Batch Record. This
      includes a complete and thorough review of the executed batch record. The
      certificate issued by CONTRACT ACCEPTOR will show the batch numbers and
      quantities in each shipment.

    

    The
      final
      market release will be undertaken by UCB based on his internal procedures and
      the data and documentation provided by CONTRACT ACCEPTOR. UCB or its affiliates
      may perform confirmatory testing to validate any CONTRACT ACCEPTOR’s
      data.

    

    
      	
              9.

            	
              REFERENCE
                SAMPLES AND RETENTION
                SAMPLES

            

    

    

    CONTRACT
      ACCEPTOR will retain samples of Raw Materials (except water, compressed gasses
      and highly volatile compounds) and Active ingredients for at least one year
      beyond the expiration of the PRODUCT in which used and will retain samples
      of
      the PRODUCT for at least one year beyond its expiration. The amount retained
      shall be three times the quantity required to carry out all of the testing
      required to meet the specifications.

    CONTRACT
      ACCEPTOR shall keep those samples at the disposal of UCB and the competent
      authorities pertaining to the manufacture and analysis of the PRODUCT and shall
      not dispose thereof unless so authorised in writing by UCB

    
      

      
        	
                10.

              	
                STABILITY
                  TESTING 

              

      

       

    

    Processing
      of the stability data is the responsibility of CONTRACT ACCEPTOR. 

    CONTRACT
      ACCEPTOR is obliged to provide UCB with the results of the tests available.
      So
      far as test methods are not available from UCB, CONTRACT ACCEPTOR has to provide
      the validated methods of analysis to be used. Microbiological tests have to
      be
      carried out in addition to the chemical stability which UCB shall
      specify.

    

    Routine
      stability

    

    CONTRACT
      ACCEPTOR is responsible for maintaining a routine stability programme for the
      PRODUCT and to provide UCB with a stability report at least once a year. The
      stability protocol will be agreed to in writing by UCB. At a minimum, one lot
      of
      each strength and in each package type (smallest to largest) of PRODUCT will
      be
      placed on stability each year for products on the market. Any change to the
      stability programme/protocol must be approved by UCB.

    

    Development
      and validation batches stability

    

    CONTRACT
      ACCEPTOR is responsible for performing any stability required to support the
      PRODUCT. The stability protocol will be agreed to in writing by UCB. Any change
      to the stability protocol must be approved by UCB. Results will be reported
      within 14 calendar days following the scheduled pull date.

    

    Testing
      intervals

    For
      finished packaged product stability, if the product remains unpackaged (i.e.,
      bulk storage) for more than 30 days, the time zero data (data generated at
      the
      start of the stability study) must be generated by new analysis rather than
      extracted from release testing results.

    

    For
      stability samples requiring testing at the three months or longer intervals
      (including at the expiry test station/label expiry date) the tests must be
      initiated within 14 calendar days following the scheduled pull
      date.

    

    Monthly
      stability samples must be pulled no earlier than seven (7) days prior to the
      last day of the month in which the sample expires.

    
 

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        24

        
          

        

      

      
        
        

      

    

     

    Stability
      failures

    

    CONTRACT
      ACCEPTOR must report any confirmed problem or out-of-specification results
      relating to the PRODUCT lot to UCB within five (5) Business Day of the
      occurrence. CONTRACT ACCEPTOR must use its best efforts to complete and document
      an investigation with regard to any such out-of-specification result within
      20
      Business Days of the initial out-of-specification result. If the investigation
      will exceed 20 Business Days, CONTRACT ACCEPTOR must provide UCB with an interim
      report, including the test investigation. A copy of the final investigation
      report must be forwarded to UCB within five (5) Business Days of completion
      of
      the investigation. CONTRACT ACCEPTOR must provide UCB with information regarding
      any investigation requested by UCB as agreed upon by both parties.

    

    UCB
      and
      CONTRACT ACCEPTOR must investigate any significant trends (those which indicate
      future testing may yield OOS results) regarding the PRODUCT in an effort to
      determine the cause of the trend. Any such trends identified by CONTRACT
      ACCEPTOR must be reported to UCB within five (5) Business Days of identification
      of the trend. CONTRACT ACCEPTOR must provide UCB with a report discussing the
      facts and CONTRACT ACCEPTOR’s conclusions within five (5) Business Days of
      completion of the investigation. Any such trends identified by UCB will be
      reported to CONTRACT ACCEPTOR within five (5) Business Days of identification
      of
      the trend. CONTRACT ACCEPTOR must use its best efforts to assist UCB in
      completion of an investigation discussing the facts and
      conclusions.

    
      
        

        
          	
                  11.

                	
                  VALIDATION/QUALIFICATION
                    

                

        

      

    

     

    Both
      parties agree to the following Validation/Qualification Policy. 

    

    UCB
      representatives shall have the right to attend the manufacture of validation
      and
      launch batches.

    

    Equipment
      and facilities/utilities qualification/validation shall be performed for
      process, packaging, analytical methods, cleaning, and computerised systems.
      Process Validation shall consist of prospective performance on at least three
      consecutive production batches and must be conducted with commercial
      production/analytical processes and equipment.

    

    Manufacturer
      will not use any validation protocol or issue a report unless UCB have first
      approved such validation protocol or report. UCB will approve or reject all
      protocols and validation reports within fifteen (15) Business Days of
      receipt.

    

    Cleaning
      Validation shall involve three replicate runs of cleaning procedure for PRODUCT
      contact equipment during Process and Packaging Validation, except for dedicated
      equipment which will require one verification run of the cleaning procedure.
      

    

    The
      cleaning procedure and analytical methodology will be reviewed by both parties
      before the first Product Batches are manufactured.

    

    Revalidation
      shall be performed for significant changes to existing manufacturing processes,
      packaging, analysis, etc. (as determined by UCB). UCB shall have the right
      to
      required full or partial revalidation for changes made to the validated PRODUCT,
      based on a shared change control system and an assessment of the significance
      of
      the change. CONTRACT ACCEPTOR will notify UCB of any planned changes to a
      validated process or associated procedures sufficiently in advance to allow
      UCB
      an opportunity to assess the change(s) and any ramifications. No changes shall
      be made to the validated process or PRODUCT without prior written consent of
      UCB. The number of batches required for revalidation will be determined by
      UCB
      and CONTRACT ACCEPTOR based on the significance of the change.

    
      
        
           

          
 

          
            
              CONFIDENTIAL
                TREATMENT

            

            
              25

              
                

              

            

            
              
              

            

             

          

          
            	
                    12.

                  	
                    DISPUTE
                      RESOLUTION

                  

          

        

      

       

    

    In
      the
      event that a dispute arises between CONTRACT ACCEPTOR and UCB in the analysis
      of
      the PRODUCTs, the resolution will proceed in stages. The first stage requires
      direct communication between analysts from both parties to determine that the
      methods of analysis are the same and are being executed in the same manner
      at
      both sites. Second, carefully controlled, split samples should be sent from
      one
      site to the other for analysis in an attempt to reach agreement. Should there
      be
      a failure to achieve resolution, analysts from both parties will be required
      to
      communicate to work through the analysis of a mutually agreeable sample. If
      these actions fail to achieve resolution, and only after these avenues have
      been
      exhausted, a qualified referee laboratory will be used to achieve resolution.
      This laboratory must be agreeable to both parties prior to use. The results
      from
      this referee laboratory will be used to determine resolution, but whatever
      the
      outcome, UCB retains the right to determine PRODUCT release status. The payment
      for engaging the referee laboratory shall be negotiated between the
      parties.

    
      
        
          

          
            	
                    13.

                  	
                    AUDITS
                      AND
                      INSPECTIONS

                  

          

        

      

       

    

    CONTRACT
      ACCEPTOR shall permit duly authorised representatives of UCB upon reasonable
      notice during normal working hours to inspect the premises, the machinery and
      all activities related to the manufacture of the PRODUCT to ensure that the
      GMP
      rules are observed and during such inspections UCB shall be permitted to inspect
      all documents relating to the PRODUCT.

    

    CONTRACT
      ACCEPTOR shall allow inspections (if any) from the competent authorities in
      accordance with Directive 2001/83/ECC and/or in accordance with local
      regulations. 

    

    CONTRACT
      ACCEPTOR will notify UCB and vice-versa without delay of any planned inspection
      which impacts the PRODUCT.

    

    CONTRACT
      ACCEPTOR shall promptly provide UCB with copies of all correspondence between
      CONTRACT ACCEPTOR and any regulatory authorities regarding the MANUFACTURING
      of
      the PRODUCT.

    

    CONTRACT
      ACCEPTOR shall inform UCB of any relevant information following any inspection
      that could impact on the future supply of the PRODUCT.

    

    UCB
      and
      CONTRACT ACCEPTOR may accept audits of vendors for any material involved in
      the
      manufacture of the PRODUCT from the other party. The party that performed the
      audit is responsible for providing an audit status statement and all appropriate
      documentation to the other party upon request. Alternatively, UCB may determine
      it necessary to audit a specific vendor. In this case, UCB will coordinate
      and
      schedule the audit with CONTRACT ACCEPTOR.

    
      
        
          

          
            	
                    14.

                  	
                    REGULATORY
                      CONTACTS

                  

          

           

        

      

    

    UCB
      shall
      be solely responsible for all contacts and communications with any regulatory
      agency with respect to all matters relating to the PRODUCT. 

    

    Unless
      required by law or a regulatory agency, CONTRACT ACCEPTOR shall have no contacts
      or communication with any regulatory agency regarding the PRODUCT without the
      consent of UCB which consent shall not be unreasonably withheld or delayed.
      CONTRACT ACCEPTOR shall notify UCB promptly, and in no event later than one
      Business Day, after CONTRACT ACCEPTOR receives any contact or communication
      from
      any regulatory agency regarding the PRODUCT.

    

    CONTRACT
      ACCEPTOR shall provide UCB with copies of all communications received from
      or
      sent to any regulatory agency, with respect to the PRODUCT within one
      (1)Business Day after receipt or sending of the communication, as the case
      may
      be.

     

     

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        26

        
          

        

      

      
        
        

      

    

    
 

    CONTRACT
      ACCEPTOR shall inform UCB of any inquiry from a regulatory agency specifically
      relating to PRODUCT and shall allow the UCB representative at its discretion
      to
      participate in any further contacts or communications relating to the PRODUCT
      if
      reasonably practicable. CONTRACT ACCEPTOR will secure agreement from UCB, which
      shall not be unreasonably withheld or delayed, prior to making a commitment
      to a
      regulatory agency regarding the PRODUCT. CONTRACT ACCEPTOR shall comply with
      all
      reasonable requests and comments by UCB with respect to all contacts and
      communications with a regulatory agency relating to the PRODUCT.

    
      
        
          

          
            	
                    15.

                  	
                    COMPLAINTS
                      AND ADVERSE EVENTS
                      HANDLING

                  

          

        

      

       

    

    Complaints
      brought to the attention of UCB have to be directly and without delay passed
      on
      to CONTRACT ACCEPTOR and vice versa.

    

    CONTRACT
      ACCEPTOR shall investigate and document Product complaints forwarded to CONTRACT
      ACCEPTOR by UCB. CONTRACT ACCEPTOR shall comply with UCB requests in connection
      with the investigation of any Product complaint, as agreed upon by both parties.
      CONTRACT ACCEPTOR must provide UCB with information regarding any Product
      complaint investigation requested by UCB, as agreed upon by both
      parties.

    

    CONTRACT
      ACCEPTOR shall complete and document the product complaint investigation within
      30 Business Days after initial receipt of the complaint by CONTRACT ACCEPTOR,
      unless otherwise agreed by UCB. If the investigation will exceed 30 Business
      Days, CONTRACT ACCEPTOR must provide UCB with an interim report, including
      test
      results to date and a target completion date, on or before the 30th Business
      Day
      of the investigation. CONTRACT ACCEPTOR must complete the complaint
      investigation within 60 Business Days after initial receipt of the complaint
      by
      CONTRACT ACCEPTOR. CONTRACT ACCEPTOR must forward a copy of the final
      investigation report to UCB within five (5) Business Days after the completion
      of the investigation. UCB shall be responsible for determining, in its
      reasonable discretion, when a complaint investigation has been completed and
      shall have sole responsibility for responding to the complainant (if
      applicable).

    

    CONTRACT
      ACCEPTOR shall notify UCB of an out-of-specification result pertaining to a
      complaint sample within two (2) Business Day of the occurrence of the
      out-of-specification result. Any out-of-specification results relating to the
      product complaint sample must be investigated as described in section
“Stability”.

    

    CONTRACT
      ACCEPTOR shall retain unused Product complaint samples conditions for a minimum
      of 90 calendar days after a copy of the complaint investigation report has
      been
      sent to UCB.

    
      
        
          

          
            	
                    16.

                  	
                    RECALLS

                  

          

        

      

       

    

    UCB
      shall
      have sole responsibility for initiating and managing any recall of the PRODUCT.
      UCB shall notify CONTRACT ACCEPTOR prior to initiating any recall of the
      PRODUCT. 

    

    Upon
      receiving, from any governmental or regulatory authority having jurisdiction,
      any direction to recall any of the PRODUCT from the market, the receiving party
      shall immediately notify the other party.

    
      
        
          

          
            	
                    17.

                  	
                    CONTROL
                      DOCUMENTS AND CHANGE CONTROL
                      IMPLEMENTATION

                  

          

        

      

    

    

    Any
      change(s) made to the Specifications, Master Production and Control records
      or
      other established control documents including but not limited to the
      manufacturing process and/or analytical methods which may affect the quality
      or
      performance of the PRODUCT or exceed validation parameters or regulatory filings
      must be approved by UCB in writing, prior to implementation for routine
      production or release of any lot made after the revision. Documents referenced
      in this section must be amended as required by the PRODUCT application or
      licence or as required by applicable laws, rules, regulations, or regulatory
      agencies.

     

     

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        27

        
          

        

      

      
        
        

      

    

    
 

    Both
      parties shall obtain all regulatory approvals prior to
      implementation.

    

    Change
      control documentation initiated by CONTRACT ACCEPTOR will be forwarded to UCB.
      UCB will process the change via UCB change management procedure and provide
      notification of approval/rejection to CONTRACT ACCEPTOR within 10 Business
      Days.
      If more than 10 days elapse, UCB will notify CONTRACT ACCEPTOR and a revised
      completion date will be agreed upon.

    

    Change
      control documentation initiated by UCB will be forwarded to CONTRACT ACCEPTOR
      for their evaluation. If CONTRACT ACCEPTOR agrees with proposed change, UCB
      will
      approve proposed change and provide CONTRACT ACCEPTOR with UCB approval.
      CONTRACT ACCEPTOR will then process and approve the change through CONTRACT
      ACCEPTOR’s change control system within 10 Business Days. If more than 10 days
      elapse, CONTRACT ACCEPTOR will notify UCB and a revised completion date will
      be
      agreed upon.

    
      
        
          

          
            	
                    18.

                  	
                    ANNUAL
                      PRODUCT REVIEWS

                  

          

        

      

       

    

    CONTRACT
      ACCEPTOR shall prepare an Annual Product Review (“APR”)
      for
      the PRODUCT covering the activities executed during the review
      period.

    

    This
      report will be a review of any changes in the manufacturing, packaging, testing,
      or validation of the product in the previous year; a summary of lots made,
      released, and rejected; a stability report. Also, control charting or trend
      analysis of key product parameters will be performed on an annual basis. Any
      abnormalities will be explained in the annual review.
      

    

    A
      copy
      must be forwarded to UCB within 10 Business Days after completion of the
      APR.

    

    The
      APR
      shall be completed within 30 days of its due date, established by a schedule
      mutually agreed upon by both parties.

    
      
        
          

          
            	
                    19.

                  	
                    QUALITY

                  

          

        

      

    

    

    CONTRACT
      ACCEPTOR shall refrain from any activity which could adversely affect the
      quality of the PRODUCT.

    

    Should
      CONTRACT ACCEPTOR become aware of any issue that could affect the quality,
      safety identity, purity or efficacy of any UCB product produced at his plant,
      he
      will notify UCB in writing within two (2) Business Days of the
      discovery.

    
      
        
          

          
            	
                    20.

                  	
                    TRANSFER
                      OF TASKS TO THIRD PARTIES OR TO ANOTHER
                      SITE

                  

          

        

      

       

    

    CONTRACT
      ACCEPTOR shall not transfer or subcontract any of the manufacturing, packaging,
      storing, testing (in-process, release, stability) of the PRODUCT to other sites
      or third parties without the prior written agreement of UCB, with the exception
      of the list of subcontractors listed in annexe. 

    Validation
      testing may be conducted by a Third Party contractor chosen by
      Manufacturer.

    
      
        
          

          
            	
                    21.

                  	
                    GENERAL
                      TERMS AND
                      CONDITIONS

                  

          

        

      

       

    

    Materials
      Check

    Unused
      materials received from UCB:

    
      	 	
              q

            	
              are
                and remain property of UCB, 

            

    

    
      	 	
              q

            	
              mode
                of disposal :

               

              to
                be returned to UCB or

               

              to
                be destroyed by CONTRACT
                ACCEPTOR.

            

    

     

     

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        28

        
          

        

      

      
        
        

      

    

    

    Upon
      expiration or termination of this Agreement for any reason whatsoever, CONTRACT
      ACCEPTOR shall return to UCB all documentation handed over to him;

     

    batch
      documents, samples, etc. shall be kept:

     

    
      	 	
              q

            	
              at
                UCB;

            

    

    
      	 	
              q

            	
              at
                CONTRACT ACCEPTOR
for a period of (see point 3 -
                Retention).

            

    

     

    

    Changes
      to this GMP-AGREEMENT

    

    Any
      additions, changes or cancellations of parts of this GMP-AGREEMENT are to be
      made in written form such modifications will involve version control of the
      document. Modifications shall be conducted through the designated Quality
      Assurance representatives of both companies.

    

    Duration

    

    Unless
      provided otherwise in a FRAME AGREEMENT (if any) between the Parties dated
      ________, this GMP-AGREEMENT is valid for an undetermined period of time.
      Termination terms are as stipulated in the FRAME AGREEMENT. This GMP-AGREEMENT
      shall automatically come to an end simultaneously with the FRAME AGREEMENT.
      Any
      section of this agreement which has a predefinite retention, survival or
      maintenance period (for example raw date storage, product complaints, sample
      retention) shall survive the termination of this Agreement for the period
      defined in the appropriate section.

    

    Storage

    

    CONTRACT
      ACCEPTOR shall store the active substances, auxiliary and packaging materials
      as
      well as the (finished) product in suitable, if necessary, air conditioned rooms
      under sufficient control so as to prevent their deterioration and
      theft.

    

    Confidentiality

    

    Both
      parties will treat as confidential all data supplied by the other in connexion
      with the Manufacture/Control of the PRODUCT.

    

    Security

    

    CONTRACT
      ACCEPTOR has and will maintain controlled access to his premises.

    
      
        
          

          
            	
                    22.

                  	
                    VALIDATION/QUALIFICATION
                      

                  

          

        

      

       

    22. DOCUMENTS
      TO BE SUPPLIED TO UCB

    

    CONTRACT
      ACCEPTOR shall supply the following documents to UCB and shall keep the validity
      of the documents under 22.1 and 22.2 in force throughout the duration of the
      GMP-AGREEMENT:  

     

    
      
        	 	 	 	On request  	Always 
	
                22.1

              	 	
                Copy
                  of latest manufacturing licence from the relevant governmental
                  or other
                  competent authorities

              	
                [
                  ]

              	
                [X]

              
	
                22.2

              	 	
                Copy
                  of site master file (at contract signature, and at every
                  renewal)

              	
                [X]

              	
                [
                  ]

              

      

       

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          29

          
            

          

        

        
          
          

        

      

       

      
        
          	
                  22.3

                	 	
                  Recipe
                    (complete formula) CONTRACT ACCEPTOR applies (once, before starting
                    and at
                    every new version)

                	
                  [X]

                	
                  [
                    ]

                
	
                  22.4

                	 	
                  Copy
                    of the manufacturing instructions (batch sheets) including the
                    in-process
                    controls in place (once, before starting) 

                	
                  [X]

                	
                  [
                    ]

                
	
                  22.5 

                	 	
                  (at
                    every new version)

                	
                  [
                    ]

                	
                  [x]

                
	
                  22.6 

                	 	
                  Data
                    on the validated method of analysis used including the specifications
                    

                	 	 
	 	 	
                  - Active
                    ingredients

                	
                  [X]

                	
                  [
                    ]

                
	 	 	
                  - The
                    excipients

                	
                  [X]

                	
                  [
                    ]

                
	 	 	
                  - The
                    primary packaging material

                	
                  [X]

                	
                  [
                    ]

                
	 	 	
                  - The
                    finished PRODUCT (finished pack)

                	
                  [X]

                	
                  [
                    ]

                
	
                  22.7

                	 	
                  Results
                    of the stability data when applicable

                	
                   

                   

                	 	
                  [X]

                
	
                  22.8

                	 	
                  With
                    every batch of the end PRODUCT(s), CONTRACT ACCEPTOR shall
                    address

                	 	 
	 	 	
                  - Batch-specific
                    analytical report

                	
                  [X]

                	
                  [
                    ]

                
	 	 	
                  - Batch-specific
                    certificate of conformance

                  To
                    the Quality Assurance Department of UCB

                	
                  [
                    ]

                	
                  [X]

                
	
                  22.9

                	 	
                  Certification
                    by a qualified person of the Quality Assurance Department of
                    performance
                    of a review of the batch documentation including the IPC and
                    monitoring
                    data and of the completeness and conformity of the
                    results.

                	
                  [
                    ]

                	
                  [X]

                
	 	 	
                  CONTRACT
                    ACCEPTOR immediately inform UCB in the event of significant deviations
                    observed during production, quality control and/or batch record
                    review.

                	
                  [
                    ]

                	
                  [X]

                

        

         

         

        
          
            CONFIDENTIAL
              TREATMENT

          

          
            30

            
              

            

          

          
            
            

          

        

         

        
          	
                  22.10

                	 	
                  Result
                    of analysis (measured results) for the following items used for
                    the
                    batches concerned

                	 	 
	 	 	
                  - Active
                    ingredients

                	
                  [X]

                	
                  [
                    ]

                
	 	 	
                  - Excipients

                	
                  [X]

                	
                  [
                    ]

                
	 	 	
                  _
                    Primary packing materials

                	
                  [X]

                	
                  [
                    ]

                

        

      

    

     

    Done
      in
      two copies, each party having received its copy.

     

    

      
        	
                CONTRACT
                  ACCEPTOR

              	 	
                UCB

              
	 	 	 
	
                /s/
                  Jack Kachkar

              	 	
                /s/
                  H.S. Bains

              
	
                Name:
                  Dr. Jack Kachkar

              	 	
                Name:
                  Harb Bains   

              
	
                Title:
                  Director

              	 	
                Title:
                  Director

              

      

       

      
 

      
        	
                
                  /s/
                    Jack Kachkar

                

              	 	
                /s/
                  Marc Glyn Hardy

              
	
                Name:
                  Jack Kachkar

              	 	
                Name:
                  Marc Glyn Hardy

              
	
                Title:
                  Chairman and CEO

              	 	
                Title:
                  Director

              
	 	 	 
	 	 	 
	
                Place:

              	 	
                Place:

              
	
                Date:

              	 	
                Date:

              

      

      

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        31

        
          

        

      

      
        
        

      

    

     

    LIST
      OF EXHIBITS TO THE GMP-AGREEMENT BETWEEN UCB AND CONTRACT
      ACCEPTOR

     

    

      
        	
                Exhibit
                  1:

              	
                The
                  PRODUCT.

              

      

      
         

        
          	 	
                  Product
                    formulation

                

        

      

      
        	 	
                Product
                  specification

              

      

      
        	 	
                (Master)
                  manufacturing instructions/Bill of Materials or
                  equivalent

              

      

      
        	 	
                QC
                  method of analysis (including stability methods if
                  any)

              

      

      
        	 	
                Storage
                  conditions

              

      

      
        	 	
                Shelf
                  life - bulk - finished product

              

      

      
        	 	
                Primary
                  container 

              

      

      
        
          	 	
                  Shipping
                    conditions

                

        

        
          	 	 

        

      

      
        

          
            	
                    Exhibit
                      2:

                  	
                    
                      The
                        RAW MATERIALS
                        supplied by UCB
                        including starting materials reagents, solvents, process
                        aids and primary
                        packaging.

                    

                  

          

          
             

          

        

        
          
            	 	
                    List

                  

          

        

      

      
        	 	
                Specifications

              

      

      
        	 	
                Methods
                  of analysis

              

      

      
        	 	
                Storage
                  conditions

              

      

      
        	 	
                Shelf
                  life 

              

      

      
        	 	
                Approved/authorized/certified
                  suppliers/manufacturers

              

      

      
        	 	
                Scientific
                  data necessary for cleaning validation (LD50, toxicity, solubility,
                  product dose per patient)

              

      

      
        	 	
                Toxicity
                  data (material safety data sheet)

              

      

       

      
        
          	
                  Exhibit
                    3:

                	
                  The
                    RAW MATERIALS
                    supplied by CONTRACT
                    ACCEPTOR

                

        

        
           

        

      

      
        	 	
                List

              

      

      
        	 	
                Specifications

              

      

      
        	 	
                Methods
                  of analysis

              

      

      
        	 	
                TSE/solvent
                  information

              

      

      
        	 	
                Approved/authorised/certified
                  suppliers/manufacturers

              

      

       

      
        
          	
                  Exhibit
                    4:

                	
                  PACKAGING
                    MATERIALS

                

        

        
           

        

      

      
        
          	
                  Exhibit
                    5:

                	
                  REWORKING

                

        

        
           

        

      

      
        
          	
                  Exhibit
                    6:

                	
                  ADMINISTRATIVE
                    INFORMATION

                

        

        
           

        

      

      Contract
        prepared by:

       

      Primary
        contact people

      UCB

      David
        Killick

      Quality
        Assurance Manager

      UCB

      Unit
        11-14 Foster Avenue

      Woodside
        Park

      Dunstable

      Bedfordshire

      LU5
        5TA

      Tel:
        +44
        (0) 1582 813120

      Fax:
        +44
        (0) 1582 813151

      e-mail:
        david.killick@celltechgroup.com

      after
        16/05/05 : e-mail: david.killick@ucb-group.com

       

      
        
          CONFIDENTIAL
            TREATMENT

        

        
          32

          
            

          

        

        
          
          

        

      

       

      It
        is the responsibility of both parties to keep this contact list up to
        date.

       

      The
        exhibits may be updated independently from the core agreement. The revised
        versions shall become part of this Agreement when they have been agreed in
        accordance with Article 22.3 of the Agreement.

       

      UCB
        will
        be responsible for the maintenance of exhibits and for ensuring that the
        information is in compliance with the Marketing Authorisations.

       

      UCB
        will
        provide specific information and will advise CONTRACT ACCEPTOR of any changes
        through formalised change control procedures.

    

    

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        33

        
          

        

      

      
        
        

      

    

     

    EXHIBIT
      1: FINISHED PRODUCT SPECIFICATIONS.

    ***

    

    

    
      
        CONFIDENTIAL
          TREATMENT

      

      
        
        

        
          

        

      

      
        
        

      

    

    

    SCHEDULE
      2

    Product
      Details and Prices

    

    ***

     

     

    
      
        CONFIDENTIAL
          TREATMENTTHE JACKSON RIVERS COMPANIES

                            STOCK PURCHASE AGREEMENT

      This Stock Purchase Agreement  ("Agreement") is made as of the 31st day of
August,  2005, by and between Jeffrey W. Flannery (the  "Purchaser"),  Dennis N.
Lauzon (the  "Seller"),  and The Jackson Rivers Company,  a Florida  corporation
(the "Company").

                                    RECITALS

      A. The Seller owns  960,000  shares (the  "Shares")  of Series A Preferred
Stock,  $0.001 par value per share,  which Shares are convertible into shares of
the Compan's Common Stock,  $.00001 par value per share (the "Common Stock") (as
converted,  the  "Conversion  Shares")  in  accordance  with  the  terms  of the
Company's Articles of Incorporation,  as amended.  The Shares and the Conversion
Shares are collectively referred to as the "Securities."

      B.  The  Seller  desires  to sell the  Shares  to the  Purchaser,  and the
Purchaser  desires to  purchase  the Shares  from the  Seller,  on the terms and
subject to the conditions set forth herein.

                                    AGREEMENT

      It is agreed as follows:

      1. PURCHASE AND SALE OF SHARES. In reliance upon the  representations  and
warranties of the Seller and the Purchaser  contained  herein and subject to the
terms and conditions set forth herein, at Closing, the Purchaser shall purchase,
and the Seller shall sell to the  Purchaser,  the Shares,  for  $60,000.00  (the
"Purchase  Price") in the form of  $15,000.00  in cash and a secured note in the
principal amount of $45,000.00 in the form attached hereto as Exhibit A.

      2. CLOSING(S).

            2.1 Date and Time.  Subject to all of the terms and  conditions  set
forth in this  Agreement  being  satisfied,  the  closing  of the sale of Shares
contemplated by this Agreement (the  "Closing")  shall take place at the offices
of the Seller's  counsel or at such other place as the Seller and the  Purchaser
shall agree in writing  concurrently  with the execution of this  Agreement (the
"Closing Date").

            2.2  Deliveries  by  Purchaser.  The  Purchaser  shall  deliver  the
following to the Seller:

                  2.2.1 A check in the amount of $15,000.00.

                  2.2.2 A secured note in the principal  amount of $45,000.00 in
the form  attached  hereto  as  Exhibit A (the  "Note"),  duly  executed  by the
Purchaser.

                                       1
<PAGE>

                  2.2.3 A pledge agreement (the "Pledge  Agreement") in the form
attached hereto as Exhibit B, duly executed by the Purchaser.

            2.3  Deliveries by Seller.  At the Closing,  the Seller will deliver
the following to the Purchaser:

                  2.3.1 The certificates  representing the Shares, duly endorsed
or delivered with blank stock powers appropriately  executed, in the name of the
Purchaser,  against  delivery  to the Seller by the  Purchaser  of the items set
forth in paragraph 2.2 above.

                  2.3.2 The Pledge Agreement, duly executed by the Seller.

                  2.3.3 The complete original articles of incorporation, bylaws,
minutes,  and other corporate books and records,  all as amended to date, of the
Company.

                  2.3.4 A list of all SEC and EDGAR codes for the Company.

                  2.3.5  Resignation  of Dennis N.  Lauzon as  President,  Chief
Financial Officer and Chief Executive Officer of the Company.

                  2.3.6 Resolutions of the board of directors appointing Jeffrey
W. Flannery as, Chief Executive  Officer,  Chief Financial Officer and Secretary
of the Company.

                  2.3.7  Resignation  of  Nicholas  A.  Cortese as a  Secretary,
Treasurer and Director of the Company.

                  2.3.8 Resolutions of the board of directors appointing Jeffrey
W. Flannery as a director of the Company.

      3. REPRESENTATIONS AND WARRANTIES OF THE SELLER.

      As a material inducement to the Purchaser to enter into this Agreement and
to purchase the Shares,  the Seller  represents  and warrants that the following
statements  are true and correct in all material  respects as of the date hereof
and will be true and correct in all  material  respects  at  Closing,  except as
expressly qualified or modified herein.

            3.1  Organization  and Good  Standing.  The Company is a corporation
duly  organized,  validly  existing,  and in good standing under the laws of the
State of Florida and has full  corporate  power and  authority to enter into and
perform its obligations  under this Agreement,  and to own its properties and to
carry on its business as presently  conducted  and as proposed to be  conducted.
The Company is duly  qualified to do business as a foreign  corporation in every
jurisdiction  in which the failure to so qualify  would have a material  adverse
effect upon the Company.  The Seller has the requisite  power to enter into this
Agreement,  the Note, the Pledge  Agreement and any other document  executed and
delivered by Seller in connection with the transactions contemplated hereunder.

                                       2
<PAGE>

            3.2 Validity of  Transactions.  This  Agreement,  and each  document
executed  and  delivered  by the  Seller  in  connection  with the  transactions
contemplated  by  this  Agreement,  have  been  duly  authorized,  executed  and
delivered by the Seller and is each the valid and legally binding  obligation of
the  Seller,  enforceable  in  accordance  with its terms,  except as limited by
applicable bankruptcy,  insolvency  reorganization and moratorium laws and other
laws  affecting  enforcement  of  creditor's  rights  generally  and by  general
principles of equity.

            3.3 Valid Issuance of Shares.  The Shares that are being sold to the
Purchaser  hereunder are duly and validly issued,  fully paid and  nonassessable
and free of restrictions on transfer,  other than restrictions on transfer under
this Agreement and under  applicable  federal and state securities laws, will be
free of all other liens and adverse claims. The Company has reserved  sufficient
Common  Stock for  issuance  of the  Conversion  Shares upon  conversion  of the
Shares.  Upon  conversion  of the  Shares  in  accordance  with the terms of the
Company's  certificate  of  incorporation,  as amended to date,  the  Conversion
Shares  will be  validly  issued,  fully  paid  and  nonassessable  and  free of
restrictions  on transfer,  other than than  restrictions on transfer under this
Agreement and under  applicable  federal and state securities laws, will be free
of all other liens and adverse claims.

            3.4 Title to Shares.  The Seller is the sole  record and  beneficial
owner of the  Shares,  free  and  clear of all  liens,  encumbrances,  equities,
assessments  and  claims,  and,  upon  delivery  of the Shares by the Seller and
payment  of the  Purchase  Price  in  full  by the  Purchaser  pursuant  to this
Agreement,  the Seller will transfer to the  Purchaser  valid legal title to the
Shares  (and the  underlying  Conversion  Shares),  free and clear of all liens,
encumbrances, equities, assessments and claims.

            3.5 No Violation.  The execution,  delivery and  performance of this
Agreement  will not  violate  any law or any  order of any  court or  government
agency  applicable  to the  Company,  as the case  may be,  or the  Articles  of
Incorporation or Bylaws of the Company,  and will not result in any breach of or
default under, or, except as expressly  provided herein,  result in the creation
of any encumbrance  upon any of the assets of the Company  pursuant to the terms
of any  agreement or instrument by which the Company or any of its assets may be
bound. No approval of or filing with any governmental  authority is required for
the Company to enter into, execute or perform this Agreement.

            3.6 SEC Reports and Financial Statements.  The Company has delivered
or made  available to the  Purchaser  accurate and  complete  copies  (excluding
copies of exhibits) of each report,  registration statement and definitive proxy
statement filed by the Company with the SEC since June 30, 2003.  (collectively,
with  all  information  incorporated  by  reference  therein  or  deemed  to  be
incorporated by reference  therein,  the "SEC Reports").  The information in the
SEC Reports,  taken as a whole, was true and correct in all material respects as
of the filing date and did not contain any untrue  statement of a material  fact
or omit to state a  material  fact  necessary  in  order to make the  statements
therein,  in  light  of the  circumstances  under  which  they  were  made,  not
misleading.

            3.7  Securities  Law  Compliance.   Assuming  the  accuracy  of  the
representations  and  warranties of the Purchaser set forth in Section 4 of this
Agreement,  the offer,  sale and delivery of the Shares (and the delivery of the
Conversion  Shares upon  conversion  of the Shares) will  constitute an exempted
transaction  under the  Securities  Act of 1933,  as  amended  and now in effect
("Securities Act"), and registration of the Shares or the underlying  Conversion
Shares under the  Securities  Act is not  required.  The Company shall make such
filings as may be necessary to comply with the Federal  securities  laws and the
blue sky laws of any state, which filings will be made in a timely manner.

                                       3
<PAGE>

            3.8  Qualifications,   Legal  and  Investment.  All  authorizations,
approvals,  or permits, if any, of any governmental authority or regulatory body
of the United States including "blue sky" filings in any state that are required
in connection with the lawful sale of the Shares pursuant to this Agreement have
been or will be, on a timely  basis,  duly obtained and are  effective.  No stop
order or other  order  enjoining  the sale of the Shares have been issued and no
proceedings  for such  purpose are pending or, to the  knowledge  of the Seller,
threatened by the SEC, or any commissioner of corporations or similar officer of
any state having  jurisdiction over this transaction.  The sale of the Shares is
legally  permitted  by all laws and  regulations  to which  the  Purchaser,  the
Seller, and the Company are subject.

      4. REPRESENTATIONS AND WARRANTIES OF THE PURCHASER.

      The Purchaser hereby represents,  warrants,  and covenants with the Seller
as follows:

            4.1 Legal Power. The Purchaser has the requisite power to enter into
this Agreement,  to purchase the Shares hereunder,  and to carry out and perform
its obligations under the terms of this Agreement.

            4.2 Due  Execution.  This  Agreement  has  been  duly  executed  and
delivered by Purchaser, and, upon due execution and delivery by the Seller, this
Agreement will be a valid and binding agreement of the Purchaser.

            4.3 Receipt and Review of SEC Reports. The Purchaser represents that
it has  received  and  reviewed  the SEC  Reports  and have been  given full and
complete access to the Company for the purpose of obtaining such  information as
the  Purchaser or its  qualified  representative  have  reasonably  requested in
connection  with the decision to purchase the Shares.  The Purchaser  represents
that it has been  afforded the  opportunity  to ask questions of the officers of
the Company regarding its business  prospects and the Shares (and the underlying
Conversion  Shares),  all as the Purchaser or its qualified  representative have
found necessary to make an informed  investment decision to purchase the Shares.
Purchaser  understands  that its  investment in the  Securities  involves a high
degree of risk. Purchaser has sought such accounting, legal and tax advice as he
considered necessary to make an informed investment decision with respect to its
acquisition of the Securities.

            4.4 Restricted  Securities.  The Purchaser has been advised that the
Securities  have not been  registered  under  the  Securities  Act or any  other
applicable  securities  laws and that the  Shares  are  being  offered  and sold
pursuant to the so-called  "Section 4(1 1/2)  exemption" of the Securities  Act,
and that the Seller's  reliance upon the so-called  "Section 4(1 1/2) exemption"
is predicated in part on the Purchaser's representations as contained herein.

                                       4
<PAGE>

                  4.4.1 The  Purchaser  is an  "accredited  investor" as defined
under Rule 501 under the Securities Act.

                  4.4.2 The Purchaser  acknowledges that the Securities have not
been registered under the Securities Act or the securities laws of any state and
are being offered, and will be sold, pursuant to applicable exemptions from such
registration for nonpublic offerings and will be sold as "restricted securities"
as  defined  by  Rule  144  promulgated  pursuant  to the  Securities  Act.  The
Securities may not be resold in the absence of an effective registration thereof
under the Securities Act and applicable  state  securities  laws unless,  in the
opinion of the Company's counsel,  an applicable  exemption from registration is
available.

                  4.4.3 The  Purchaser is acquiring the  Securities  for its own
account,  for  investment  purposes  only and not with a view to, or for sale in
connection  with, a  distribution,  as that term is used in Section 2(11) of the
Securities  Act,  in  a  manner  which  would  require  registration  under  the
Securities Act or any state securities laws.

                  4.4.4 The Purchaser understands that the certificates or other
instruments representing the Securities, except as set forth below, shall bear a
restrictive  legend in  substantially  the  following  form (and a stop transfer
order may be placed against transfer of such stock certificates):

      THE  SECURITIES   EVIDENCED  BY  THIS   CERTIFICATE  HAVE  NOT  BEEN
      REGISTERED  UNDER THE  SECURITIES  ACT OF 1933,  AS AMENDED,  OR THE
      SECURITIES LAWS OF ANY STATE.  THE SECURITIES HAVE BEEN ACQUIRED FOR
      INVESTMENT  AND  MAY NOT BE SOLD OR  TRANSFERRED  FOR  VALUE  IN THE
      ABSENCE OF AN EFFECTIVE  REGISTRATION  THEREOF UNDER THE  SECURITIES
      ACT  OF  1933  AND/OR  THE   SECURITIES  ACT  OF  ANY  STATE  HAVING
      JURISDICTION OR AN OPINION OF COUNSEL  ACCEPTABLE TO THE CORPORATION
      THAT SUCH REGISTRATION IS NOT REQUIRED UNDER SUCH ACT OR ACTS.

The legend  set forth  above  shall be removed  and the  Company  shall  issue a
certificate without such legend to the holder of the Securities upon which it is
stamped,  if,  unless  otherwise  required by state  securities  laws,  (i) such
Securities  are  registered  for  sale  under  the  Securities  Act,  or (ii) in
connection  with a sale  transaction,  such holder  provides the Company with an
opinion of counsel, in a generally  acceptable form, to the effect that a public
sale,  assignment or transfer of the Securities may be made without registration
under the Securities Act.

                  4.4.5 The  Purchaser  acknowledges  that an  investment in the
Securities is not liquid and is transferable only under limited conditions.  The
Purchaser  acknowledges  that such Securities must be held  indefinitely  unless
they are  subsequently  registered under the Securities Act or an exemption from
such registration is available. The Purchaser is aware of the provisions of Rule
144  promulgated  under the  Securities  Act,  which permits  limited  resale of
securities  purchased  in a private  placement  subject to the  satisfaction  of
certain  conditions  and that such Rule is not now available and, in the future,
may not become available for resale of the Securities.

                                       5
<PAGE>

            4.5 Purchaser  Sophistication  and Ability to Bear Risk of Loss. The
Purchaser  acknowledges  that it is able to protect its  interests in connection
with  the  acquisition  of the  Securities  and can bear  the  economic  risk of
investment in such  securities  without  producing a material  adverse change in
Purchaser's financial condition.  The Purchaser otherwise has such knowledge and
experience in financial or business matters that it is capable of evaluating the
merits and risks of the investment in the Securities.

            4.6 Purchases by Groups.  The Purchaser  represents,  warrants,  and
covenants  that it is not acquiring the Securities as part of a group within the
meaning of Section 13(d)(3) of the Securities Exchange Act of 1934, as amended.

      5. COVENANTS.

            5.1 Further Assurances; Cooperation. Each party hereto will, before,
at, and after the Closing,  execute and deliver such  instruments  and take such
other actions as the other party or parties,  as the case may be, may reasonably
require in order to carry out the intent of this Agreement. Without limiting the
generality of the  foregoing,  at any time after the Closing,  at the request of
the Company or the Purchaser, and without further consideration,  the Seller (a)
will  execute  and  deliver  such  instruments  of sale,  transfer,  conveyance,
assignment and confirmation and take such action as the Company or the Purchaser
may  reasonably  deem  necessary  or  desirable  in  order  to more  effectively
transfer,  convey and assign to the  Purchaser,  and to confirm the  Purchaser's
title to, the  Shares,  and (b) will  execute  such  documents  as and take such
action  as the  Company  or the  Purchaser  may  reasonably  deem  necessary  or
desirable  in order to prepare and file any future SEC Reports  that the Company
seeks to file with the Securities and Exchange  Commission  under the Securities
Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended.

            5.2  Covenants  of the  Purchaser.  Until  the Note has been paid in
full,  the  Purchaser  shall not directly or  indirectly,  offer,  issue,  sell,
contract to sell  (including,  without  limitation,  any short sale),  grant any
option for the sale of, pledge,  or otherwise  dispose of or transfer any of the
Securities.

            5.3 Covenants of the Company.  Until the Note has been paid in full,
the Company shall not do any of the following  without the prior written consent
of the Seller,  and such action taken by the Company  without the prior  written
consent of the Seller shall be void ab initio):

                  5.3.1  Amend  any  of the  terms  of the  Company's  Series  A
Preferred Stock; or

                  5.3.2  Issue any  shares  of any class or series of  preferred
stock (including the Series B Preferred Stock) of the Company.

      6. MISCELLANEOUS.

            6.1 Governing Law. This Agreement shall be governed by and construed
under the laws of the State of California. Each party hereby irrevocably submits
to the exclusive  jurisdiction  of the state and federal  courts  sitting in the
county of San Diego,  State of California,  for the  adjudication of any dispute
hereunder or in connection herewith or with any transaction  contemplated hereby
or discussed herein and hereby  irrevocably  waives, and agrees not to assert in
any suit, action or proceeding,  any claim that it is not personally  subject to
the  jurisdiction  of any such court,  that such suit,  action or  proceeding is
improper.  Each party hereby  irrevocably waives personal service of process and
consents  to process  being  served in any such suit,  action or  proceeding  by
mailing a copy  thereof to such party at the address in effect for notices to it
under  this  Note  and  agrees  that  such  service  shall  constitute  good and
sufficient service of process and notice thereof. Nothing contained herein shall
be deemed to limit in any way any right to serve process in any manner permitted
by law.

                                       6
<PAGE>

            6.2 Successors and Assigns.  Except as otherwise  expressly provided
herein,  the  provisions  hereof  shall  inure to the benefit of, and be binding
upon, the successors,  assigns,  heirs,  executors,  and  administrators  of the
parties hereto.

            6.3 Entire  Agreement.  This  Agreement and the Exhibits  hereto and
thereto,  and  the  other  documents  delivered  pursuant  hereto  and  thereto,
constitute  the full and entire  understanding  and agreement  among the parties
with regard to the subjects  hereof and no party shall be liable or bound to any
other  party in any manner by any  representations,  warranties,  covenants,  or
agreements  except as specifically set forth herein or therein.  Nothing in this
Agreement,  express or implied, is intended to confer upon any party, other than
the parties  hereto and their  respective  successors  and assigns,  any rights,
remedies,  obligations,  or  liabilities  under or by reason of this  Agreement,
except as expressly provided herein.

            6.4  Severability.  In case any provision of this Agreement shall be
invalid,  illegal,  or  unenforceable,  it shall to the extent  practicable,  be
modified so as to make it valid,  legal and  enforceable and to retain as nearly
as  practicable  the intent of the  parties,  and the  validity,  legality,  and
enforceability  of the remaining  provisions shall not in any way be affected or
impaired thereby.

            6.5 Amendment and Waiver.  Except as otherwise  provided herein, any
term of this  Agreement may be amended,  and the  observance of any term of this
Agreement may be waived (either  generally or in a particular  instance,  either
retroactively  or  prospectively,  and either for a specified  period of time or
indefinitely),  with the written  consent of the Seller and the  Purchaser.  Any
amendment or waiver  effected in  accordance  with this Section shall be binding
upon  each  future  holder  of  any  security  purchased  under  this  Agreement
(including  securities  into which such  securities have been converted) and the
Seller.

                                       7
<PAGE>

            6.6  Notices.  All  notices  and other  communications  required  or
permitted  hereunder  shall be in writing and shall be effective  when delivered
personally,  or sent by telex or telecopier (with receipt  confirmed),  provided
that a copy is mailed by registered  mail,  return  receipt  requested,  or when
received by the  addressee,  if sent by Express Mail,  Federal  Express or other
express  delivery  service  (receipt  requested) in each case to the appropriate
address set forth below:

            If to the Seller:      Dennis N. Lauzon
                                   402 Broadway, Suite 400
                                   San Diego, CA  92101

            If to the Purchaser:   Jeffrey W. Flannery
                                   4275 Executive Square, Suite 215
                                   La Jolla, CA 92037

            If to the Company:     The Jackson Rivers Company
                                   402 Broadway, Suite 400
                                   San Diego, CA  92101

            6.7  Titles  and  Subtitles.   The  titles  of  the  paragraphs  and
subparagraphs  of this  Agreement are for  convenience of reference only and are
not to be considered in construing this Agreement.

                  [REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

                                       8
<PAGE>

      IN WITNESS  WHEREOF,  the parties have executed  this  Agreement as of the
date first set forth above.

PURCHASER:                                  Jeffrey W. Flannery

                                            /s/ Jeffrey W. Flannery
                                            ------------------------------------

SELLER:                                     Dennis N. Lauzon

                                            /s/ Dennis N. Lauzon
                                            ------------------------------------

COMPANY:                                    The Jackson Rivers Company

                                            /s/ Dennis N. Lauzon
                                            ------------------------------------
                                            By: Dennis N. Lauzon
                                                President

                  (Signature Page to Stock Purchase Agreement)

                                       9

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