Document:

Exhibit
      10.7

    
 

    
      	
               Allen
&
                Overy
                LLP

            
	 
	
              Allen
                & Overy LLP

            
	 
	
              MORTGAGE
                OF SHARES

            
	
              Between

               

              INYX,
                INC.

               

              and

               

              WESTERNBANK
                PUERTO RICO

               

               

            
	
                       
                August 2005

            

    

    

    

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

        
           

        

      

    

    

     

    CONTENTS

     

    ClausePage

     

    

      
        	
                1

              	
                 

              	
                Interpretation

              	
                 

              	
                1

              	
                 

              
	
                2

              	
                 

              	
                Creation
                  of Security

              	
                 

              	
                3

              	
                 

              
	
                3

              	
                 

              	
                Representations

              	
                 

              	
                3

              	
                 

              
	
                4

              	
                 

              	
                Restrictions
                  on dealings

              	
                 

              	
                4

              	
                 

              
	
                5

              	
                 

              	
                Shares

              	
                 

              	
                4

              	
                 

              
	
                6

              	
                 

              	
                When
                  Security becomes enforceable

              	
                 

              	
                6

              	
                 

              
	
                7

              	
                 

              	
                Enforcement
                  of Security

              	
                 

              	
                6

              	
                 

              
	
                8

              	
                 

              	
                Receiver

              	
                 

              	
                7

              	
                 

              
	
                9

              	
                 

              	
                Powers
                  of Receiver

              	
                 

              	
                8

              	
                 

              
	
                10

              	
                 

              	
                Application
                  of proceeds

              	
                 

              	
                9

              	
                 

              
	
                11

              	
                 

              	
                Expenses
                  and indemnity

              	
                 

              	
                10

              	
                 

              
	
                12

              	
                 

              	
                Delegation

              	
                 

              	
                10

              	
                 

              
	
                13

              	
                 

              	
                Further
                  assurances

              	
                 

              	
                10

              	
                 

              
	
                14

              	
                 

              	
                Power
                  of attorney

              	
                 

              	
                11

              	
                 

              
	
                15

              	
                 

              	
                Preservation
                  of Security

              	
                 

              	
                11

              	
                 

              
	
                16

              	
                 

              	
                Changes
                  to the Parties

              	
                 

              	
                12

              	
                 

              
	
                17

              	
                 

              	
                Miscellaneous

              	
                 

              	
                13

              	
                 

              
	
                18

              	
                 

              	
                Release

              	
                 

              	
                13

              	
                 

              
	
                19

              	
                 

              	
                Notices

              	
                 

              	
                13

              	
                 

              
	
                20

              	
                 

              	
                Language

              	
                 

              	
                14

              	
                 

              
	
                21

              	
                 

              	
                Severability

              	
                 

              	
                14

              	
                 

              
	
                22

              	
                 

              	
                Waivers
                  and remedies cumulative

              	
                 

              	
                14

              	
                 

              
	
                23

              	
                 

              	
                Counterparts

              	
                 

              	
                15

              	
                 

              
	
                24

              	
                 

              	
                Governing
                  law

              	
                 

              	
                15

              	
                 

              
	
                25

              	
                 

              	
                Enforcement

              	
                 

              	
                15

              	
                 

              
	 	 	 	 	 	 
	
                Signatories 

              	 	 	
                17

              	 

      

    

     

     

    
      
        
        

      

      
        
        

        
          

        

      

      
        
        

      

    

    

     

      THIS
      DEED
      is dated
                  August,
      2005

     

      BETWEEN:

     

    
      	(1)  	
              INYX,
                INC.
                (a corporation registered in Nevada, USA) (the Chargor);
                and

            

    

     

    
      	(2)  	
              WESTERNBANK
                PUERTO RICO
                (the Lender).

            

    

     

      BACKGROUND:

     

    
      	(A)  	
              The
                Chargor enters into this Deed in connection with the Credit Agreement
                (as
                defined below).

            

    

     

    
      	(B)  	
              It
                is intended that this document takes effect as a deed notwithstanding
                the
                fact that a party may only execute this document under
                hand.

            

    

     

      IT
      IS AGREED as
      follows:

     

    
      	1.  	
              INTERPRETATION

            

    

     

    
      	1.1  	
              Definitions

            

    

     

    In
      this
      Deed:

     

    Act
      means
      the Law of Property Act 1925.

     

    Borrowers
      means
      the
      Chargor, Inyx USA Limited (a company incorporated in the Isle of Man), INyx
      Pharma Limited the Company and Celltech Manufacturing Services Limited (to
      be
      renamed Ashton Pharmaceuticals Limited) each a Borrower.

     

    Company
      means
      INyX Europe Limited, a limited liability company incorporated in England with
      registered number 5370001.

     

    Credit
      Agreement
      means
      the loan and security agreement dated as of on or about 31st
      August
      2005 between the Company and Celltech Manufacturing Services Limited as
      borrowers and the Lender.

     

    Financing
      Agreement means
      an
      agreement defined as a Financing Agreement in each of the Credit Agreement
      and
      Parent Credit Agreement.

     

    Obligor
      means
      each Borrower, the Chargor and any other Subsidiary of the Company which has
      given any guarantee or security interest in favour of the Lender in respect
      of
      the liabilities of the Company or the Borrowers under the Financing
      Agreements.

     

    Parent
      Credit Agreement means
      the
      loan and security agreement dated as of 31 March 2005 as amended and
      supplemented from time to time (including without limitation, as amended on
      11
      May 2005) between the Chargor, Inyx USA Limited and INyx Pharma Limited as
      borrowers and the Lender.

     

    Party
      means a
      party to this Deed.

     

    Receiver
      means an
      administrative receiver, a receiver and manager or a receiver, in each case,
      appointed under this Deed.

     

    
      
        
        

      

      
        1

        
          

        

      

      
        
        

      

    

    Related
      Rights means:

     

    
      
        	
              	(a)	
                any
                  dividend or interest paid or payable;

              

      

    

     

    
      
        	
              	(b)	
                any
                  right, money or property accruing or offered at any time by way
                  of
                  redemption, substitution, exchange, bonus or preference, under
                  option
                  rights or otherwise;

              

      

    

     

    in
      relation to that stock, share, debenture, bond or other security.

     

    Secured
      Liabilities
      means
      all present and future obligations and liabilities (whether actual or contingent
      and whether owed jointly or severally or in any other capacity whatsoever)
      of
      each Obligor to the Lender, except for any obligation which, if it were so
      included, would result in this Deed contravening any law (including
      Section 151 of the Companies Act 1985).

     

    Security
      Assets
      means
      all assets of the Chargor the subject of any security created by this
      Deed.

     

    Security
      Period
      means
      the period beginning on the date of this Deed and ending on the date on which
      all the Secured Liabilities have been unconditionally and irrevocably paid
      and
      discharged in full.

     

    Shares
      means
      all
      of the issued shares in the share capital of the Company.

     

    
      	1.2  	
              Construction

            

    

     

    
      	(a)  	
              Words
                and expressions defined in the Credit Agreement have, unless expressly
                defined in this Deed, the same meaning when used in this
                Deed.

            

    

     

    
      	(b)  	
              The
                principles of construction set out in the first paragraph of
                Section 1 (Definitions) of the Credit Agreement will apply
                to this
                Deed as if they were set out in this
                Deed.

            

    

     

    
      	(c)  	
              (i)   
                The
                term Financing
                Agreement
                includes all amendments and supplements including supplements providing
                for further advances; and

            

    

     

    
      	(ii) 
               	
              the
                term this
                Security
                means any security created by this
                Deed.

            

    

     

    
      	(d)  	
              Any
                covenant of the Chargor under this Deed (other than a payment obligation)
                remains in force during the Security
                Period.

            

    

     

    
      	(e)  	
              If
                the Lender considers that an amount paid to it under a Financing
                Agreement
                is capable of being avoided or otherwise set aside on the liquidation
                or
                administration of the payer or otherwise, then that amount will not
                be
                considered to have been irrevocably paid for the purposes of this
                Deed.

            

    

     

    
      	(f)  	
              Unless
                the context otherwise requires, a reference to a Security Asset
                includes:

            

    

     

    
      	(i)  
               	
              the
                proceeds of sale of that Security Asset;
                and

            

    

     

    
      	(ii) 
               	
              any
                present and future asset of that
                type.

            

    

     

    
      
        
        

      

      
        2

        
          

        

      

      
        
        

      

    

     

    
      	2.  	
              CREATION
                OF SECURITY

            

    

     

    
      	2.1  	
              General

            

    

     

    All
      the
      security created under this Deed:

     

    
      	(a)  	
              is
                created in favour of the Lender;

            

    

     

    
      	(b)  	
              is
                security for the payment of all the Secured Liabilities;
                and

            

    

     

    
      	(c)  	
              is
                made with full title guarantee in accordance with the Law of Property
                (Miscellaneous Provisions) Act
                1994.

            

    

     

    
      	2.2  	
              Security

            

    

     

    The
      Chargor charges:

     

    
      	(a)  	
              by
                way of a first equitable mortgage all the Shares owned by it or held
                by
                any nominee on its behalf; and

            

    

     

    
      	(b)  	
              by
                way of a first fixed charge, all Related
                Rights.

            

    

     

    
      	3.  	
              REPRESENTATIONS

            

    

     

    
      	3.1  	
              Representations

            

    

     

    The
      Chargor makes the representations set out in this Clause to the
      Lender.

     

    
      	3.2  	
              Status

            

    

     

    It
      is a
      corporation duly organised and of good standing under the laws of the
      jurisdiction of its incorporation.

     

    
      	3.3  	
              Powers
                and authorities

            

    

     

    It
      has
      the power to enter into and perform, and has taken all necessary action to
      authorise the entry into and performance of, this Deed and the transactions
      contemplated by this Deed.

     

    
      	3.4  	
              Legal
                validity

            

    

     

    Subject
      to any qualifications as to matters of law contained in any legal opinion
      provided to the Lender in connection with the Financing Agreements, this Deed
      constitutes its legally valid, binding and enforceable obligation.

     

    
      	3.5  	
              Non-conflict

            

    

     

    The
      entry
      into and performance by it of, and the transactions contemplated by, this Deed
      do not and will not conflict with:

     

    
      	(a)  	
              any
                law or regulation applicable to it;
                or

            

    

     

    
      	(b)  	
              its
                constitutional documents; or

            

    

     

    
      	(c)  	
              any
                document which is binding upon it or any of its assets in any material
                respect.

            

    

     

     

    
      
        
        

      

      
        3

        
          

        

      

      
        
        

      

    

     

    
      	3.6  	
              Authorisations

            

    

     

    All
      authorisations required by it in connection with the entry into, performance,
      validity and enforceability of, and the transactions contemplated by, this
      Deed
      have been obtained or effected (as appropriate) and are in full force and
      effect.

     

    
      	3.7  	
              Nature
                of security

            

    

     

    This
      Deed
      creates those security interests it purports to create and is not liable to
      be
      avoided or otherwise set aside on its
      liquidation or administration or otherwise.

     

    
      	3.8  	
              Shares

            

    

     

    
      	(a)  	
              The
                Shares are fully paid;

            

    

     

    
      	(b)  	
              the
                Shares
                represent the whole of the issued share capital of the Company;
                and

            

    

     

    
      	(c)  	
              the
                Chargor is the sole legal and beneficial owner of the
                Shares.

            

    

     

    
      	3.9  	
              Times
                for making representations

            

    

     

    
      	(a)  	
              The
                representations set out in this Deed are made on the date of this
                Deed.

            

    

     

    
      	(b)  	
              Each
                representation under this Deed is deemed to be repeated by the Chargor
                on
                the date of each advance of a loan or issue of a letter of credit
                under
                the Credit Agreement. 

            

    

     

    
      	(c)  	
              When
                a representation is repeated, it is applied to the circumstances
                existing
                at the time of repetition.

            

    

     

    
      	4.  	
              RESTRICTIONS
                ON DEALINGS

            

    

     

    The
      Chargor must not:

     

    
      	(a)  	
              create
                or allow to subsist any security interest (other than this Deed)
                on any
                Security Asset; or

            

    

     

    
      	(b)  	
              sell,
                transfer, licence, lease or otherwise dispose of any Security
                Asset.

            

    

     

    
      	5.  	
              SHARES

            

    

     

    
      	5.1  	
              Deposit

            

    

     

    The
      Chargor must:

     

    
      	(a)  	
              immediately
                deposit with the Lender,
                or as the Lender
                may direct, all certificates and other documents of title or evidence
                of
                ownership in relation to any
                Security Asset;
                and

            

    

     

    
      	(b)  	
              promptly
                execute in blank and deliver to the Lender
                all share transfers and other documents which may be requested by
                the
                Lender
                in
                order to enable the Lender
                or
                its nominees to be registered as the owner or otherwise obtain a
                legal
                title to any
                Security Asset following an Event of Default.

            

    

     

     

    
      
        
        

      

      
        4

        
          

        

      

      
        
        

      

    

     

    
      	5.2  	
              Changes
                to rights

            

    

     

    The
      Chargor must
      not
      take or allow the taking of any action on its behalf which may result in the
      rights attaching to any Security Asset being altered or further shares in the
      Company being issued.

     

    
      	5.3  	
              Calls

            

    

     

    
      	(a)  	
              The
                Chargor must pay all calls or other payments due and payable in respect
                of
                any
                Security Asset.

            

    

     

    
      	(b)  	
              If
                the Chargor fails to do so, the Lender
                may pay the calls or other payments on behalf of the
                Chargor. The
                Chargor must immediately on request reimburse the Lender
                for any payment made by the Lender
                under this Subclause.

            

    

     

    
      	5.4  	
              Other
                obligations in respect of Security
                Assets

            

    

     

    
      	(a)  	
              (i)
                The
                Chargor must comply with all requests for information relating to
                any
                Security Asset which is within its knowledge and which it is required
                to
                comply with by any law (including section 212 of the Companies
                Act 1985) or its constitutional documents. If it fails to
                do so, the
                Lender may elect to provide any information which it may have on
                behalf of
                the Chargor.

            

    

     

    
      	(ii)  	
              The
                Chargor must promptly supply a copy to the Lender of any information
                referred to in subparagraph (i)
                above.

            

    

     

    
      	(b)  	
              The
                Chargor must comply with all other conditions and obligations assumed
                by
                it in respect of any of Security
                Asset.

            

    

     

    
      	(c)  	
              The
                Lender is not obliged to:

            

    

     

    
      	(i)  	
              perform
                any obligation of the Chargor; 

            

    

     

    
      	(ii)  	
              make
                any payment;

            

    

     

    
      	(iii)  	
              make
                any enquiry as to the nature or sufficiency of any payment received
                by it
                or the Chargor; or 

            

    

     

    
      	(iv)  	
              present
                or file any claim or take any other action to collect or enforce
                the
                payment of any amount to which it may be entitled under this
                Deed,

            

    

     

    in
      respect of any Security Asset.

     

    
      	5.5  	
              Voting
                rights

            

    

     

    
      	(a)  	
              Before
                this Security becomes enforceable, the voting rights, powers and
                other
                rights in respect of the Security Assets will be exercised in any
                manner
                which the Chargor
                may direct in writing.

            

    

     

    
      	(b)  	
              The
                Chargor must indemnify the Lender against any loss or liability incurred
                by the Lender as a consequence of the Lender acting in respect of
                the
                Security Assets on the direction of the
                Chargor.

            

    

     

     

    
      
        
        

      

      
        5

        
          

        

      

      
        
        

      

    

     

    
      	(c)  	
              After
                this Security has become enforceable, the Lender
                may exercise (in the name of the Chargor
                and without any further consent or authority on the part of
                the Chargor)
                any voting rights and any powers or rights which may be exercised
                by the
                legal or beneficial owner of any Investment, any person who is the
                holder
                of any Investment or otherwise.

            

    

     

    
      	6.  	
              WHEN
                SECURITY BECOMES
                ENFORCEABLE

            

    

     

    
      	6.1  	
              Event
                of Default

            

    

     

    This
      Security will become immediately enforceable if an Event of Default is
      continuing and the Lender gives notice to the Chargor that this Security is
      enforceable.

     

    
      	6.2  	
              Enforcement

            

    

     

    After
      this Security has become enforceable, the Lender
      may in
      its absolute discretion enforce all or any part of this Security in any manner
      it sees fit.

     

    
      	7.  	
              ENFORCEMENT
                OF SECURITY

            

    

     

    
      	7.1  	
              General

            

    

     

    
      	(a)  	
              The
                power of sale and any other power conferred on a mortgage by law
                (including under section 101 of the Act) will be immediately exercisable
                at any time after this Security has become
                enforceable.

            

    

     

    
      	(b)  	
              For
                the purposes of all powers implied by law, the Secured Liabilities
                are
                deemed to have become due and payable on the date of this Deed.
                

            

    

     

    
      	(c)  	
              Any
                restriction on the power of sale or the right of a mortgagee to
                consolidate mortgages conferred by law (including under section 93
                of the
                Act) does not apply to this
                Security.

            

    

     

    
      	7.2  	
              No
                liability as mortgagee in
                possession

            

    

     

    Neither
      the Lender
      nor any
      Receiver will be liable, by reason of entering into possession of a Security
      Asset:

     

    
      	(a)  	
              to
                account as mortgagee in possession or for any loss on realisation;
                or
                

            

    

     

    
      	(b)  	
              for
                any default or omission for which a mortgagee in possession might
                be
                liable.

            

    

     

    
      	7.3  	
              Privileges

            

    

     

    Each
      Receiver and the Lender
      is
      entitled to all the rights, powers, privileges and immunities conferred by
      law
      on mortgagees and receivers duly appointed under any law (including the
      Act).

     

    
      	7.4  	
              Protection
                of third parties

            

    

     

    No
      person
      (including a purchaser) dealing with the Lender
      or a
      Receiver or its or his agents will be concerned to enquire:

     

    
      	(a)  	
              whether
                the Secured Liabilities have become payable;

            

    

     

     

    
      
        
        

      

      
        6

        
          

        

      

      
        
        

      

    

     

    
      	(b)  	
              whether
                any power which the Lender
                or
                a Receiver is purporting to exercise has become exercisable or is
                being
                properly exercised; 

            

    

     

    
      	(c)  	
              whether
                any money remains due under the Financing Agreements;
                or

            

    

     

    
      	(d)  	
              how
                any money paid to the Lender
                or
                to that Receiver is to be applied.

            

    

     

    
      	7.5  	
              Redemption
                of prior mortgages

            

    

     

    
      	(a)  	
              At
                any time after this Security has become enforceable, the Lender
                may:

            

    

     

    
      	(i)  	
              redeem
                any prior security interest against any Security Asset;
                and/or

            

    

     

    
      	(ii)  	
              procure
                the transfer of that security interest to itself;
                and/or

            

    

     

    
      	(iii)  	
              settle
                and pass the accounts of the prior mortgagee, chargee or encumbrancer;
                any
                accounts so settled and passed will be, in the absence of manifest
                error,
                conclusive and binding on the
                Chargor.

            

    

     

    
      	(b)  	
              The
                Chargor must pay to the Lender,
                immediately on demand, the costs and expenses incurred by the Lender
                in
                connection with any such redemption and/or transfer, including the
                payment
                of any principal or interest.

            

    

     

    
      	7.6  	
              Contingencies

            

    

     

    If
      this
      Security is enforced at a time when no amount is due under the Financing
      Agreements but at a time when amounts may or will become due, the Lender
      (or the
      Receiver) may pay the proceeds of any recoveries effected by it into a suspense
      account.

     

    
      	8.  	
              RECEIVER

            

    

     

    
      	8.1  	
              Appointment
                of Receiver

            

    

     

    
      	(a)  	
              Except
                as provided below, the Lender
                may appoint any one or more persons to be a Receiver of all or any
                part of
                the Security Assets if:

            

    

     

    
      	(i)  	
              this
                Security has become enforceable; or

            

    

     

    
      	(ii)  	
              the
                Chargor so requests the Lender
                in
                writing at any time.

            

    

     

    
      	(b)  	
              Any
                appointment under paragraph (a)
                above
                may be by deed, under seal or in writing under its
                hand.

            

    

     

    
      	(c)  	
              Any
                restriction on the right of a mortgagee to appoint a Receiver conferred
                by
                law (including under section 109(1) of the Act) does not apply to
                this
                Deed.

            

    

     

    
      	(d)  	
              The
                Lender is not entitled to appoint a Receiver solely as a result of
                obtaining a moratorium (or anything done with a view to obtaining
                a
                moratorium) under the Insolvency Act 2000 except with the leave of
                the
                court.

            

    

     

    
      	8.2  	
              Removal

            

    

     

    The
      Lender
      may by
      writing under its hand (subject to any requirement for an order of the court
      in
      the case of an administrative receiver) remove any Receiver appointed by it
      and
      may, whenever it thinks fit, appoint a new Receiver in the place of any Receiver
      whose appointment may for any reason have terminated.

     

     

    
      
        
        

      

      
        7

        
          

        

      

      
        
        

      

    

     

    
      	8.3  	
              Remuneration

            

    

     

    The
      Lender
      may fix
      the remuneration of any Receiver appointed by it and the maximum rate imposed
      by
      any law (including under section 109(6) of the Act) will not apply.

     

    
      	8.4  	
              Agent
                of the Chargor

            

    

     

    
      	(a)  	
              A
                Receiver will be deemed to be the agent of the Chargor for all purposes
                and accordingly will be deemed to be in the same position as a Receiver
                duly appointed by a mortgagee under the Act. The Chargor alone
                is
                responsible for the contracts, engagements, acts, omissions, defaults
                and
                losses of a Receiver and for liabilities incurred by a
                Receiver.

            

    

     

    
      	(b)  	
              The
                Lender will
                incur no liability (either to the Chargor or to any other person)
                by
                reason of the appointment of a Receiver or for any other
                reason.

            

    

     

    
      	8.5  	
              Relationship
                with Lender

            

    

     

    To
      the
      fullest extent allowed by law, any right, power or discretion conferred by
      this
      Deed (either expressly or impliedly) or by law on a Receiver may after this
      Security becomes enforceable be exercised by the Lender
      in
      relation to any Security Asset without first appointing a Receiver and
      notwithstanding the appointment of a Receiver.

     

    
      	9.  	
              POWERS
                OF RECEIVER

            

    

     

    
      	9.1  	
              General

            

    

     

    
      	(a)  	
              A
                Receiver has all of the rights, powers and discretions set out below
                in
                this Clause in addition to those conferred on it by any law,
                including all the rights, powers and discretions conferred on a receiver
                under the Act and a receiver or an administrative receiver under
                the
                Insolvency Act, 1986.

            

    

     

    
      	(b)  	
              If
                there is more than one Receiver holding office at the same time,
                each
                Receiver may (unless the document appointing him states otherwise)
                exercise all of the powers conferred on a Receiver under this Deed
                individually and to the exclusion of any other
                Receiver.

            

    

     

    
      	9.2  	
              Possession

            

    

     

    A
      Receiver may take immediate possession of, get in and collect any Security
      Asset.

     

    
      	9.3  	
              Employees

            

    

     

    A
      Receiver may appoint and discharge managers, officers, agents, accountants,
      employees and others for the purposes of this Deed upon such terms as to
      remuneration or otherwise as he thinks fit.

     

    
      	9.4  	
              Borrow
                money

            

    

     

    A
      Receiver may raise and borrow money either unsecured or on the security of
      any
      Security Asset either in priority to this Security or otherwise and generally
      on
      any terms and for whatever purpose which he thinks fit. 

     

     

    
      
        
        

      

      
        8

        
          

        

      

      
        
        

      

    

     

    
      	9.5  	
              Sale
                of assets

            

    

     

    
      	(a)  	
              A
                Receiver may sell, exchange, convert into money and realise any Security
                Asset by public auction or private contract and generally in any
                manner
                and on any terms which he thinks fit.

            

    

     

    
      	(b)  	
              The
                consideration for any such transaction may consist of cash, debentures
                or
                other obligations, shares, stock or other valuable consideration
                and any
                such consideration may be payable in a lump sum or by instalments
                spread
                over any period which he thinks fit.

            

    

     

    
      	9.6  	
              Compromise

            

    

     

    A
      Receiver may settle, adjust, refer to arbitration, compromise and arrange any
      claim, account, dispute, question or demand with or by any person who is or
      claims to be a creditor of the Chargor or relating in any way to any Security
      Asset.

     

    
      	9.7  	
              Legal
                actions

            

    

     

    A
      Receiver may bring, prosecute, enforce, defend and abandon any action, suit
      or
      proceedings in relation to any Security Asset which he thinks fit.

     

    
      	9.8  	
              Receipts

            

    

     

    A
      Receiver may give a valid receipt for any moneys and execute any assurance
      or
      thing which may be proper or desirable for realising any Security
      Asset.

     

    
      	9.9  	
              Delegation

            

    

     

    A
      Receiver may delegate his powers in accordance with this Deed.

     

    
      	9.10  	
              Other
                powers

            

    

     

    A
      Receiver may:

     

    
      	(a)  	
              do
                all other acts and things which he may consider desirable or necessary
                for
                realising any Security Asset or incidental or conducive to any of
                the
                rights, powers or discretions conferred on a Receiver under or by
                virtue
                of this Deed or law;

            

    

     

    
      	(b)  	
              exercise
                in relation to any Security Asset all the powers, authorities and
                things
                which he would be capable of exercising if he were the absolute beneficial
                owner of that Security Asset; and

            

    

     

    
      	(c)  	
              use
                the name of the Chargor for any of the above
                purposes.

            

    

     

    
      	10.  	
              APPLICATION
                OF PROCEEDS

            

    

     

    Any
      moneys received by the Lender
      or any
      Receiver after this Security has become enforceable must be applied in the
      following order of priority:

     

    
      	(a)  	
              in
                or towards payment of or provision for all costs and expenses incurred
                by
                the Lender
                or
                any Receiver under or in connection with this Deed and of all remuneration
                due to any Receiver under or in connection with this
                Deed;

            

    

     

    
      	(b)  	
              in
                or towards payment of or provision for the Secured Liabilities;
                and

            

    

     

     

    
      
        
        

      

      
        9

        
          

        

      

      
        
        

      

    

     

    
      	(c)  	
              in
                payment of the surplus (if any) to the Chargor or other person entitled
                to
                it.

            

    

     

    This
      Clause is subject to the payment of any claims having priority over this
      Security. This Clause does not prejudice the right of the
      Lender
      to
      recover any shortfall from the Chargor.

     

    
      	11.  	
              EXPENSES
                AND INDEMNITY

            

    

     

    The
      Chargor must:

     

    
      	(a)  	
              immediately
                on demand pay all costs and expenses (including legal fees) incurred
                in
                connection with this Deed by the Lender,
                any Receiver, attorney, manager, agent or other person appointed
                by the
                Lender
                under this Deed; and 

            

    

     

    
      	(b)  	
              keep
                each of them indemnified against any failure or delay in paying those
                costs or expenses.

            

    

     

    
      	12.  	
              DELEGATION

            

    

     

    
      	12.1  	
              Power
                of Attorney

            

    

     

    The
      Lender
      or any
      Receiver may delegate by power of attorney or in any other manner to any person
      any right, power or discretion exercisable by it under this Deed. 

     

    
      	12.2  	
              Interest
                Periods

            

    

     

    Any
      such
      delegation may be made upon any terms (including power to sub-delegate) which
      the Lender
      or any
      Receiver may think fit. 

     

    
      	12.3  	
              Liability

            

    

     

    Neither
      the Lender
      nor any
      Receiver will be in any way liable or responsible to the Chargor for any loss
      or
      liability arising from any act, default, omission or misconduct on the part
      of
      any delegate or sub-delegate.

     

    
      	13.  	
              FURTHER
                ASSURANCES

            

    

     

    The
      Chargor must, at its own expense, take whatever action the Lender
      or a
      Receiver may require for:

     

    
      	(a)  	
              creating,
                perfecting or protecting any security intended to be created by this
                Deed;
                or

            

    

     

    
      	(b)  	
              facilitating
                the realisation of any Security Asset, or the exercise of any right,
                power
                or discretion exercisable, by the Lender
                or
                any Receiver or any of its delegates or sub-delegates in respect
                of any
                Security Asset.

            

    

     

    This
      includes:

     

    
      	(i)  	
              the
                execution of any transfer, conveyance, assignment or assurance of
                any
                property, whether to the Lender
                or
                to its nominee; or 

            

    

     

    
      	(ii)  	
              the
                giving of any notice, order or direction and the making of any
                registration, 

            

    

     

    which,
      in
      any such case, the Lender
      may
      think expedient.

     

     

    
      
        
        

      

      
        10

        
          

        

      

      
        
        

      

    

     

    
      	14.  	
              POWER
                OF ATTORNEY

            

    

     

    The
      Chargor, by way of security, irrevocably and severally appoints the Lender,
      each
      Receiver and any of its delegates or sub-delegates to be its attorney to take
      any action which the Chargor is obliged to take under this Deed. The Chargor
      ratifies and confirms whatever any attorney does or purports to do under its
      appointment under this Clause.

     

    
      	15.  	
              PRESERVATION
                OF SECURITY

            

    

     

    
      	15.1  	
              Continuing
                security

            

    

     

    This
      Security is continuing and will extend to the ultimate balance of the Secured
      Liabilities regardless of any intermediate payment or discharge in whole or
      in
      part.

     

    
      	15.2  	
              Reinstatement

            

    

     

    If
      any
      payment by an Obligor or discharge given by the Lender (whether in respect
      of
      the obligations of any Obligor or any security for those obligations or
      otherwise) is avoided or reduced as a result of insolvency, liquidation,
      administration or any similar event:

     

    
      	(a)  	
              the
                liability of the Chargor shall continue as if the payment, discharge,
                avoidance or reduction had not occurred;
                and

            

    

     

    
      	(b)  	
              the
                Lender shall be entitled to recover the value or amount of that security
                or payment from the Chargor, as if the payment, discharge, avoidance
                or
                reduction had not occurred.

            

    

     

    
      	15.3  	
              Waiver
                of defences

            

    

     

    The
      obligations of the Chargor under this Deed will not be affected by any act,
      omission or thing which, but for this provision, would reduce, release or
      prejudice any of its obligations under this Deed (whether or not known to the
      Chargor or the Lender). This includes:

     

    
      	(a)  	
              any
                time or waiver granted to, or composition with, any
                person;

            

    

     

    
      	(b)  	
              the
                release of any person under the terms of any composition or
                arrangement;

            

    

     

    
      	(c)  	
              the
                taking, variation, compromise, exchange, renewal or release of, or
                refusal
                or neglect to perfect, take up or enforce, any rights against, or
                security
                over assets of, any person;

            

    

     

    
      	(d)  	
              any
                non-presentation or non-observance of any formality or other requirement
                in respect of any instruments or any failure to realise the full
                value of
                any security;

            

    

     

    
      	(e)  	
              any
                incapacity or lack of power, authority or legal personality of or
                dissolution or change in the members or status of any
                person;

            

    

     

    
      	(f)  	
              any
                amendment (however fundamental) of a Financing Agreement or any other
                document or security; 

            

    

     

    
      	(g)  	
              any
                unenforceability, illegality, invalidity or non-provability of any
                obligation of any person under any Financing Agreement or any other
                document or security; or

            

    

     

    
      	(h)  	
              any
                insolvency or similar proceedings.

            

    

     

     

    
      
        
        

      

      
        11

        
          

        

      

      
        
        

      

    

     

    
      	15.4  	
              Immediate
                recourse

            

    

     

    The
      Chargor waives any right it may have of first requiring the Lender (or any
      trustee or agent on its behalf) to proceed against or enforce any other rights
      or security or claim payment from any person before claiming from the Chargor
      under this Deed. This waiver applies irrespective of any law or any provision
      of
      a Financing Agreement to the contrary.

     

    
      	15.5  	
              Appropriations

            

    

     

    The
      Lender (or any trustee or agent on its behalf) may at any time during the
      Security Period without affecting the liability of the Chargor under this
      Deed:

     

    
      	(a)  	
               
                (i)  refrain
                from applying or enforcing any other moneys, security or rights held
                or
                received by the Lender (or any trustee or agent on its behalf) in
                respect
                of those amounts; or

            

    

     

    
      	(ii) 	
              apply
                and enforce the same in such manner and order as it sees fit (whether
                against those amounts or otherwise);
                and

            

    

     

    
      	(b)  	
              hold
                in an interest bearing suspense account any moneys received from
                the
                Chargor or on account of the liability of the Chargor under this
                Deed.

            

    

     

    
      	15.6  	
              Additional
                security

            

    

     

    This
      Security is in addition to and is not in any way prejudiced by any other
      security now or subsequently held by the Lender.

     

    
      	15.7  	
              Deferral
                of Chargor's rights

            

    

     

    Until
      all
      the Secured Liabilities have been irrevocably paid in full and unless the Lender
      otherwise directs, the Chargor will not exercise any rights which it may have
      by
      reason of performance by it of its obligations under the Financing
      Agreements:

     

    
      	(a)  	
              to
                be indemnified by any Obligor;

            

    

     

    
      	(b)  	
              to
                claim any contribution from any other guarantor of any Obligor's
                obligations under the Financing Agreements;
                and/or

            

    

     

    
      	(c)  	
              to
                take the benefit (in whole or in part and whether by way of subrogation
                or
                otherwise) of any of the Lender's rights under the Financing Agreements
                or
                of any other guarantee or security taken pursuant to, or in connection
                with, the Financing Agreements by the
                Lender.

            

    

     

    
      	16.  	
              CHANGES
                TO THE PARTIES

            

    

     

    
      	16.1  	
              The
                Chargor

            

    

     

    The
      Chargor may not assign or transfer any of its rights or obligations under this
      Deed without the prior consent of the Lender.

     

    
      	16.2  	
              The
                Lender

            

    

     

    
      	(a)  	
              The
                Lender may assign or otherwise dispose of all or any of its rights
                under
                this Deed in accordance with the Financing Agreements to which it
                is a
                party.

            

    

     

     

    
      
        
        

      

      
        12

        
          

        

      

      
        
        

      

    

     

    
      	(b)  	
              References
                to the Lender in this Deed include any successor Lender appointed
                under
                the Credit Agreement.

            

    

     

    
      	17.  	
              MISCELLANEOUS

            

    

     

    
      	17.1  	
              Covenant
                to pay

            

    

     

    The
      Chargor must pay or discharge the Secured Liabilities in the manner provided
      for
      in the Financing Agreements.

     

    
      	17.2  	
              Tacking

            

    

     

    The
      Lender
      must perform its obligations under the Credit Agreement (including any
      obligation to make available further advances).

     

    
      	17.3  	
              New
                Accounts

            

    

     

    
      	(a)  	
              If
                any subsequent charge or other interest affects any Security Asset,
                the
                Lender may open a new account with the
                Chargor.

            

    

     

    
      	(b)  	
              If
                the Lender does not open a new account, it will nevertheless be treated
                as
                if it had done so at the time when it received or was deemed to have
                received notice of that charge or other
                account.

            

    

     

    
      	(c)  	
              As
                from that time all payments made to the Lender will be credited or
                be
                treated as having been credited to the new account and will not operate
                to
                reduce any Secured Liability.

            

    

     

    
      	17.4  	
              Time
                deposits

            

    

     

    Without
      prejudice to any right of set-off the
      Lender
      may have
      under any other Financing Agreement or otherwise, if any time deposit matures
      on
      any account the Chargor has with the Lender within the Security Period
      when:

     

    
      	(a)  	
              this
                Security has become enforceable;
                and

            

    

     

    
      	(b)  	
              no
                Secured Liability is due and
                payable,

            

    

     

    that
      time
      deposit will automatically be renewed for any further maturity which
the
      Lender
      considers appropriate.

     

    
      	18.  	
              RELEASE

            

    

     

    At
      the
      end of the Security Period but not otherwise, the Lender must, at the request
      and cost of the Chargor, take whatever action is necessary to release
the
      Security
      Assets from this Security.

     

    
      	19.  	
              NOTICES

            

    

     

    
      	19.1  	
              In
                writing

            

    

     

    
      	(a)  	
              Any
                communication in connection with this Deed must be in writing and,
                unless
                otherwise stated, may be given in person, by post, telex or
                fax.

            

    

     

     

    
      
        
        

      

      
        13

        
          

        

      

      
        
        

      

    

     

    
      	(b)  	
              Unless
                it is agreed to the contrary, any consent or agreement required under
                this
                Deed must be given in writing.

            

    

     

    
      	19.2  	
              Contact
                details

            

    

     

    
      	(a)  	
              The
                contact details of the Chargor for all notices in connection with
                this
                Agreement are the same as those set out in the Credit Agreement for
                the
                Company.

            

    

     

    
      	(b)  	
              The
                contact details of the Lender all notices in connection with this
                Agreement are the same as those set out in the Credit Agreement for
                the
                Lender.

            

    

     

    
      	(c)  	
              Any
                Party may change its contact details by giving five Business Days'
                notice
                to the Lender or (in the case of the Lender) to the other
                Party.

            

    

     

    
      	(d)  	
              Where
                the Lender nominates a particular department or officer to receive
                a
                notice, a notice will not be effective if it fails to specify that
                department or officer.

            

    

     

    
      	19.3  	
              Effectiveness

            

    

     

    
      	(a)  	
              Except
                as provided below, any notice in connection with this Deed will be
                deemed
                to be given as follows:

            

    

     

    
      	(i)  
               	
              if
                delivered in person, at the time of
                delivery;

            

    

     

    
      	(ii) 
                	
              if
                posted, five days after being deposited in the post, postage prepaid,
                in a
                correctly addressed envelope; and

            

    

     

    
      	(iii)  	
              if
                by fax, when received in legible
                form.

            

    

     

    
      	(b)  	
              A
                communication given under paragraph (a)
                above
                but received on a non-working day or after business hours in the
                place of
                receipt will only be deemed to be given on the next working day in
                that
                place.

            

    

     

    
      	20.  	
              LANGUAGE

            

    

     

    Any
      notice given in connection with this Deed must be in English.

     

    
      	21.  	
              SEVERABILITY

            

    

     

    If
      a term
      of this Deed is or becomes illegal, invalid or unenforceable in any
      jurisdiction, that will not affect:

     

    
      	(a)  	
              the
                legality, validity or enforceability in that jurisdiction of any
                other
                term of this Deed; or

            

    

     

    
      	(b)  	
              the
                legality, validity or enforceability in any other jurisdiction of
                that or
                any other term of this Deed.

            

    

     

    
      	22.  	
              WAIVERS
                AND REMEDIES CUMULATIVE

            

    

     

    The
      rights of the Lender under this Deed:

     

    
      	(a)  	
              may
                be exercised as often as necessary;

            

    

     

     

    
      
        
        

      

      
        14

        
          

        

      

      
        
        

      

    

     

    
      	(b)  	
              are
                cumulative and not exclusive of its rights under the general law;
                and

            

    

     

    
      	(c)  	
              may
                be waived only in writing and
                specifically.

            

    

     

    Delay
      in
      exercising or non-exercise of any right is not a waiver of that
      right.

     

    
      	23.  	
              COUNTERPARTS

            

    

     

    This
      Deed
      may be executed in any number of counterparts. This has the same effect as
      if
      the signatures on the counterparts were on a single copy of this
      Deed.

     

    
      	24.  	
              GOVERNING
                LAW

            

    

     

    This
      Deed
      is governed by English law.

     

    
      	25.  	
              ENFORCEMENT

            

    

     

    
      	25.1  	
              Jurisdiction

            

    

     

    
      	(a)  	
              The
                English courts have exclusive jurisdiction to settle any dispute
                in
                connection with this Deed.

            

    

     

    
      	(b)  	
              The
                English courts are the most appropriate and convenient courts to
                settle
                any such dispute and the Chargor waives objection to those courts
                on the
                grounds of inconvenient forum or otherwise in relation to proceedings
                in
                connection with this Deed. 

            

    

     

    
      	(c)  	
              This
                Clause is for the benefit of the Lender only. To the extent allowed
                by
                law, the Lender may take: 

            

    

     

    
      	(i)  	
              proceedings
                in any other court; and

            

    

     

    
      	(ii)  	
              concurrent
                proceedings in any number of
                jurisdictions.

            

    

     

    
      	25.2  	
              Service
                of process

            

    

     

    
      	(a)  	
              The
                Chargor irrevocably appoints the Company as its agent under this
                Deed for
                service of process in any proceedings before the English
                courts.

            

    

     

    
      	(b)  	
              If
                the Company is unable for any reason to act as agent for service
                of
                process, the Chargor must immediately appoint another agent on terms
                acceptable to the Lender. Failing this, the Lender may appoint another
                agent for this purpose.

            

    

     

    
      	(c)  	
              The
                Chargor agrees that failure by a process agent to notify it of any
                process
                will not invalidate the relevant
                proceedings.

            

    

     

    
      	(d)  	
              This
                Clause does not affect any other method of service allowed by
                law.

            

    

     

    
      	25.3  	
              Waiver
                of immunity

            

    

     

    The
      Chargor irrevocably and unconditionally:

     

    
      	(a)  	
              agrees
                not to claim any immunity from proceedings brought by the Lender
                against
                it in relation to this Deed and to ensure that no such claim is made
                on
                its behalf;

            

    

     

     

    
      
        
        

      

      
        15

        
          

        

      

      
        
        

      

    

     

    
      	(b)  	
              consents
                generally to the giving of any relief or the issue of any process
                in
                connection with those proceedings;
                and

            

    

     

    
      	(c)  	
              waives
                all rights of immunity in respect of it or its
                assets.

            

    

     

    THIS
      DEED has
      been
      entered into as a deed on the date stated at the beginning of this
      Deed.

    

    
      
        
        

      

      
        16

        
          

        

      

      
        
        

      

    

    

     

    SIGNATORIES

     

     

    
      	 Chargor	 	 
	 	 	 
	 EXECUTED as
              a DEED
              by	 )	
              /s/
                Jack Kachkar

            
	 INYX, INC.
              acting by	 )	
              Jack
                Kachkar

            
	 	 )	
              Chairman,
                CEO, Director

            
	 and	 )	 
	 	 )	 
	 acting under the authority of	 )	 
	 that corporation	 )	 
	 	 	 
	 	 	 
	Lender	 )	 
	 	 	 
	WESTERNBANK
              PUERTO RICO	 )	 
	 	 	 
	By:
              /s/ Miguel A. Vazquez	 )	 
	
              Miguel
                A. Vazquez

            	 	 
	
              President
                Business Credit Div.

            	 	 

    

     

     

     

    
      
        
        

      

      
        17Exhibit
      10.8

    

      CONFIDENTIAL
        TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF

      THIS
        DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN SEPARATELY

      FILED
        WITH THE COMMISSION.***

       

      
        

      

      Table
        of contents

      
        
          	Clause
                  heading and number	Page
                  number

        

        
          
            

          

        

         

        
          
            	
                    1.

                  	
                    DEFINITIONS
                      AND INTERPRETATIONS

                  	
                    4

                  
	 	 	 
	
                    2.

                  	
                    COMMENCEMENT
                      AND TERM

                  	
                    7

                  
	 	 	 
	
                    3.

                  	
                    THE
                      SERVICES

                  	
                    7

                  
	 	 	 
	
                    4.

                  	
                    APPLICATION
                      OF TERMS

                  	
                    8

                  
	 	 	 
	
                    5.

                  	
                    THE
                      SUPPLIER’S REPRESENTATIVE

                  	
                    8

                  
	 	 	 
	
                    6.

                  	
                    THE
                      CLIENT’S REPRESENTATIVE

                  	
                    9

                  
	 	 	 
	
                    7.

                  	
                    GOVERNANCE

                  	
                    9

                  
	 	 	 
	
                    8.

                  	
                    REVIEW
                      MEETINGS

                  	
                    10

                  
	 	 	 
	
                    9.

                  	
                    WARRANTIES
                      AND LIABILITY

                  	
                    10

                  
	 	 	 
	
                    10.

                  	
                    PRICE

                  	
                    10

                  
	 	 	 
	
                    11.

                  	
                    SALES
                      TAX

                  	
                    11

                  
	 	 	 
	
                    12.

                  	
                    PAYMENT

                  	
                    11

                  
	 	 	 
	
                    13.

                  	
                    DATA
                      OWNERSHIP AND ACCESS

                  	
                    11

                  
	 	 	 
	
                    14.

                  	
                    INFORMATION
                      AND ASSISTANCE

                  	
                    12

                  
	 	 	 
	
                    15.

                  	
                    INTELLECTUAL
                      PROPERTY

                  	
                    12

                  
	 	 	 
	
                    16.

                  	
                    CO-OPERATION
                      AND SECURITY PROCEDURES

                  	
                    13

                  
	 	 	 
	
                    17.

                  	
                    CONFIDENTIALITY

                  	
                    13

                  
	 	 	 
	
                    18.

                  	
                    TERMINATION
                      FOR CAUSE

                  	
                    15

                  
	 	 	 
	
                    19.

                  	
                    TERMINATION
                      WITHOUT CAUSE

                  	
                    15

                  
	 	 	 
	
                    20.

                  	
                    CONSEQUENCES
                      OF TERMINATION

                  	
                    15

                  
	 	 	 
	
                    21.

                  	
                    NON-SOLICITATION

                  	
                    16

                  
	 	 	 
	
                    22.

                  	
                    LIMITATION
                      OF LIABILITY AND INDEMNITY

                  	
                    16

                  
	 	 	 
	
                    23.

                  	
                    CHANGE
                      CONTROL

                  	
                    17

                  
	 	 	 
	
                    24.

                  	
                    INSURANCE

                  	
                    18

                  
	 	 	 
	
                    25.

                  	
                    FORCE
                      MAJEURE

                  	
                    18

                  

          

           

          
            
              
                CONFIDENTIAL
                  TREATMENT

              

            

            
              
              

              
                

              

            

            
              
              

            

          

           

          
            	
                    26.

                  	
                    ASSIGNMENT

                  	
                    18

                  
	 	 	 
	
                    27.

                  	
                    SUB-CONTRACTING
                      TO AFFILIATES

                  	
                    19

                  
	 	 	 
	
                    28.

                  	
                    WAIVER

                  	
                    19

                  
	 	 	 
	
                    29.

                  	
                    ENTIRE
                      AGREEMENT

                  	
                    19

                  
	 	 	 
	
                    30.

                  	
                    NOTICES

                  	
                    19

                  
	 	 	 
	
                    31.

                  	
                    SEVERABILITY

                  	
                    20

                  
	 	 	 
	
                    32.

                  	
                    FURTHER
                      ENDEAVOURS

                  	
                    20

                  
	 	 	 
	
                    33.

                  	
                    COUNTERPARTS

                  	
                    20

                  
	 	 	 
	
                    34.

                  	
                    NO
                      PARTNERSHIP/AGENCY

                  	
                    20

                  
	 	 	 
	
                    35.

                  	
                    CONTRACTS
                      (RIGHTS OF THIRD PARTIES) ACT 1999

                  	
                    20

                  
	 	 	 
	
                    36.

                  	
                    PARENT
                      GUARANTEE

                  	
                    20

                  
	 	 	 
	
                    37.

                  	
                    LAW

                  	
                    21

                  
	 	 	 
	
                    SIGNATURE
                      PAGE

                  	
                    22

                  
	 	 
	
                    SCHEDULE
                      1

                  	
                    24

                  
	 	 
	
                    The
                      Services

                  	
                    24

                  
	 	 
	
                    SCHEDULE
                      2

                  	
                    42

                  
	 	 
	
                    GMP
                      AGREEMENT

                  	
                    42

                  
	 	 
	
                    SCHEDULE
                      4

                  	
                    57

                  
	 	 
	
                    LIST
                      OF BOUGHT IN PRODUCTS

                  	
                    59

                  
	 	 
	
                    SCHEDULE
                      5

                  	
                    58

                  
	 	 
	
                    LIST
                      OF MANUFACTURED PRODUCTS

                  	
                    58

                  
	 	 
	
                    SCHEDULE
                      6

                  	
                    59

                  
	 	 
	
                    LIST
                      OF RA LICENCES

                  	
                    60

                  
	 	 
	
                    SCHEDULE
                      7

                  	
                    62

                  
	 	 
	
                    EXAMPLE
                      SLA

                  	
                    63

                  

          

        

      

       

      
         

        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          
          

          
            

          

        

        
          
          

        

      

      CONFORMED
        COPY

       

      

      DATED
        25
        AUGUST 2005

      

       

      

      

      

      (1)
        CELLTECH
        MANUFACTURING SERVICES LIMITED

       

      

      (2)
        UCB
        PHARMA LIMITED

      

      and

      

      (3)
        INYX
        INC

      
 

      

      
        

      

       

      LONG
        TERM SERVICES AGREEMENT

       

      
        

      

       

      

      

      

       

      100
        Fetter Lane

      London
        EC4A 1BN

       

      Tel:
        020-7242 1011 • Fax: 020-7894
        6520

       

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          3

          
            

          

        

        
          
          

        

      

       

      THIS
        AGREEMENT
        is made
        the 25
        day of
August
        2005

       

      BETWEEN:

       

      
        	(1)    	
                CELLTECH
                  MANUFACTURING SERVICES LIMITED registered
                  in England with company number 4066383 which has its registered
                  office at
                  208 Bath Road, Slough, Berkshire SL1 3WE (the “Supplier”);
                  

              

      

       

      
        	(2)    	
                UCB
                  PHARMA LIMITED
                  registered in England with company number 00209905 which has its
                  registered office at 208
                  Bath Road, Slough, Berkshire SL1 3WE (the “Client”);
                  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”).

              

      

       

      WHEREAS:

       

      
        	(A)    	
                The
                  Supplier has been selected by the Client and the Supplier has agreed
                  to
                  provide the services set out in Schedule 1 under the terms of this
                  agreement (“the
                  Agreement”).

              

      

       

      NOW
        IT IS HEREBY AGREED
        as
        follows:

       

      
        	1.    	
                DEFINITIONS
                  AND INTERPRETATIONS

              

      

       

      
        	1.1   	
                In
                  this Agreement (except where the context otherwise requires) the
                  words and
                  expressions shall have the following
                  meanings:

              

      

       

      
        
          	 	
                  “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 its holding company
                    if that company: (a) holds a majority of the voting rights in
                    it; (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;

                   

                
	 	
                  “Bought
                    in Product”

                   

                	
                  means
                    the bought in products listed at Schedule 3 to which certain
                    Services
                    apply;
                    

                   

                
	 	
                  “Business
                    Day”

                   

                	
                  means
                    a day other than Saturday, Sunday and public holidays in England
                    and Wales
                    when clearing banks are open for business;

                   

                
	 	
                  “Client
                    Data”

                   

                	
                  means
                    all data, databases, information, graphics, text or other materials
                    in any
                    electronic or tangible medium which are generated by the Supplier
                    or
                    Client (including, for the avoidance of doubt, customer master
                    data,
                    product master data (BOM routing-costing sheet), transactional
                    data
                    (stock-reception-shipments-production plans - production orders
                    -
                    shipment), exclusively in respect of the Services provided to
                    the Client
                    under this Agreement;

                   

                

        

         

        
          
            
              CONFIDENTIAL
                TREATMENT

            

          

          
            4

            
              

            

          

          
            
            

          

        

         

        
          
            	 	
                    “Client’s
                      Representative”

                     

                  	
                    means
                      the representative of the Client as appointed and with the
                      authority
                      specified in cause 6
                      and named in respect of each Service in Schedule 1;

                     

                  
	 	
                    “CMC”

                     

                  	
                    means
                      Control Manufacturing Chemical;

                     

                  
	 	
                    “Completion
                      Date”

                     

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

                     

                  
	 	
                    “Confidential
                      Information”

                     

                  	
                    has
                      the meaning set out in Clause 17.1.1;

                     

                  
	 	
                    “Expiry
                      Date”

                     

                  	
                    means
                      the fifth anniversary of the Completion Date unless the agreement
                      is
                      extended in accordance with Clause 2.2;
                      

                     

                  
	 	
                    “Force
                      Majeure”

                     

                  	
                    means
                      circumstances beyond the reasonable control of the Supplier
                      including
                      without limitation, acts of God, governmental actions, war
                      or national
                      emergency, acts of terrorism, protests, riot, civil commotion,
                      fire,
                      explosion, flood, epidemic, or restraints or delays affecting
                      carriers or
                      inability or delay in obtaining supplies of adequate or suitable
                      material;

                     

                  
	 	
                    “GMP”

                     

                  	
                    means,
                      as relevant to the Bought in 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 between the parties governing the GMP principles
                      to be
                      respected in relation to the Bought in Product and setting
                      out or
                      otherwise identifying the specifications for and technical
                      terms and
                      conditions for the assembly of the Bought in Products and complying
                      with
                      those rules and guidelines contained in the Orange Book as
                      set out in
                      Schedule 2;

                     

                  
	 	
                    “Intellectual
                      Property”

                     

                  	
                    means
                      copyright, patents, trademarks, service marks, database rights,
                      design
                      rights (whether registered or unregistered) and all other similar
                      proprietary rights as may exist anywhere in the world;

                     

                  
	 	
                    “Management
                      Fee”

                     

                  	
                    means
                      the annual fee of *** (subject to adjustment under Clause 10)
                      payable to
                      the Supplier by the Client for the Services; 

                     

                  
	 	
                    “Manufactured
                      Goods”

                     

                  	
                    means
                      the manufactured goods listed at Schedule 4;

                     

                  

          

           

          
            
              
                CONFIDENTIAL
                  TREATMENT

              

            

            
              5

              
                

              

            

            
              
              

            

          

           

          
            
              	 	
                      “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;

                       

                    
	 	
                      “Premises”

                       

                    	
                      means
                        all premises at which the Client or the Supplier, as the
                        case may be,
                        requires the use of Services as at the Completion Date;

                       

                    
	 	
                      “Price”

                       

                    	
                      has
                        the meaning given to it in Clause 10;

                       

                    
	 	
                      “Purchased
                        Materials”

                       

                    	
                      means
                        active ingredients and components consisting of Client own
                        finished
                        products which are manufactured, assembled or managed by
                        Supplier;
                        

                       

                    
	 	
                      “Purchaser”

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

                       

                    
	 	
                      “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;

                       

                    
	 	
                      “Sale
                        and Purchase Agreement”

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

                       

                    
	 	
                      “Sales
                        Tax”

                       

                    	
                      means
                        any sales, purchase or turnover tax as may be applicable
                        in any relevant
                        jurisdiction, including without limitation value added tax
                        chargeable
                        under or pursuant to the EC Sixth Directive (77/388/EEC);

                       

                    
	 	
                      “Services”

                       

                    	
                      means
                        the services set out in Schedule 1 and “Service”
                        means any one of them (including but not limited to the specified
                        services
                        relating to the
                        Bought In Products and the Purchased Materials);
                        

                       

                    
	 	
                      “SKU”

                       

                    	
                      means
                        stock keeping unit;

                       

                    
	 	
                      “Supplier
                        Data”

                       

                    	
                      means
                        all data, databases, information, graphics, text or other
                        materials in any
                        electronic or tangible medium owned and controlled by the
                        Supplier and
                        which are not exclusively related to the provision of the
                        Services to the
                        Client under this Agreement;

                       

                    
	
                    	
                      “The
                        Supplier’s Representative”

                       

                    	
                      means
                        the representative of the Supplier as appointed and with
                        the authority
                        specified in Clause 5
                        and named in respect of each relevant Service in Schedule
                        1;

                       

                    

            

             

            
              
                
                  CONFIDENTIAL
                    TREATMENT

                

              

              
                6

                
                  

                

              

              
                
                

              

            

             

            
              	 	
                      “Term”

                       

                    	
                      means
                        the period of this Agreement as set out in Clause 2;
                        and

                       

                    
	 	
                      “Year”

                       

                    	
                      means
                        any calendar year during the Term commencing on the Completion
                        Date and
                        each anniversary thereafter. 

                       

                    

            

          

        

      

       

      
        	1.2   	
                In
                  this Agreement, unless the context otherwise
                  requires:

              

      

       

      
        	1.2.1    	
                references
                  to this Agreement include its Recitals and the
                  Schedules;

              

      

       

      
        	1.2.2    	
                references
                  to Clauses, Sub-clauses and Schedules are to the clauses, sub-clauses
                  of
                  the appendix and schedules to this Agreement, as amended in accordance
                  with this Agreement;

              

      

       

      
        	1.2.3    	
                the
                  Clause and Schedule headings are for convenience only and shall
                  not affect
                  the interpretation of this
                  Agreement;

              

      

       

      
        	1.2.4    	
                words
                  implying the singular include the plural and vice versa and words
                  implying
                  a gender include every gender; and

              

      

       

      
        	1.2.5    	
                references
                  to a person include an individual, firm, company, corporation,
                  unincorporated body of people, or any agency of the above.
                  

              

      

       

      
        	2.    	
                COMMENCEMENT
                  AND TERM

              

      

       

      
        	2.1   	
                This
                  Agreement shall commence on the Completion Date on condition that
                  the SPA
                  is completed. If for any reason the Completion Date does not occur
                  and the
                  SPA does not complete, this Agreement shall terminate with immediate
                  effect with no liability for any party in respect of any breach
                  including
                  future breach. 

              

      

       

      
        	2.2   	
                Subject
                  to earlier termination in accordance with Clauses 2.1, 18
                  and 19,
                  or extension in accordance with Clause 2.3,
                  this Agreement will continue in force until the Expiry Date.
                  

              

      

       

      
        	2.3   	
                The
                  parties may by agreement in writing extend the Term by up to a
                  further
                  year (thereby changing the Expiry Date) at any time by the Client
                  giving
                  the Supplier notice at least six (6) months prior to the current
                  Expiry
                  Date, and the Supplier shall confirm its acceptance or refusal
                  at least
                  five (5) months prior to the current Expiry
                  Date.

              

      

       

      
        	3.    	
                THE
                  SERVICES 

              

      

       

      
        	3.1   	
                In
                  consideration of the Management Fee the Supplier shall provide
                  the Client
                  with the Services as fully set out in Schedule 1 in accordance
                  with the
                  terms of this Agreement. 

              

      

       

      
        	3.2   	
                From
                  time to time the Client may request services other than the Services
                  from
                  the Supplier and the Supplier may supply such other services on
                  terms to
                  be agreed between the parties.

              

      

       

      
        	3.3   	
                The
                  Services in respect of Bought In Products will be provided in accordance
                  with the GMP Agreement as annexed at Schedule
                  2.

              

      

       

      
        	3.4   	
                Subject
                  to Clauses 26 and 27 it is understood and agreed that the Supplier
                  may use
                  third parties to provide the respective Services with the consent
                  of
                  Client (such consent not to be unreasonably withheld or delayed)
                  but the
                  Supplier shall be and shall remain entirely responsible for the
                  conduct of
                  such third parties and the provision of such Services.
                  

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          7

          
            

          

        

        
          
          

        

      

       

      
        	3.5   	
                In
                  the event of any material failure by the Supplier to provide the
                  Services
                  in accordance with the terms and conditions of this Agreement,
                  the
                  Supplier shall:

              

      

       

      
        	
                3.5.1    

              	
                as
                  soon as is reasonably practicable, notify the Client of such failure
                  by
                  written notice and the Supplier shall use reasonable endeavours
                  to rectify
                  the failure including applying reasonable additional resources
                  to provide
                  the Services in accordance with this Agreement;
                  and

              

      

       

      
        	3.5.2    	
                implement
                  reasonable procedures necessary to prevent the recurrence of such
                  failure.

              

      

       

      If
        the
        failure is not rectified within 15 (fifteen) Business Days of the notice
        referred to in paragraph 3.5.1 above, the Client may elect to:

       

      
        	3.5.3    	
                treat
                  such failure as a dispute which shall be dealt with by the procedure
                  set
                  out in Clause 7; or

              

      

       

      
        	3.5.4    	
                give
                  notice to the Supplier in accordance with Clause
                  18.1.

              

      

       

      
        	3.6   	
                The
                  Client and the Supplier acknowledge that the Services to be provided
                  or
                  made available under this Agreement may require amendment or modification
                  from time to time. If the Services need amending or modifying,
                  the Client
                  and the Supplier shall follow the change control procedure in accordance
                  with Clause 23.

              

      

       

      
        	4.    	
                APPLICATION
                  OF TERMS

              

      

       

      
        	4.1   	
                Subject
                  to any variation under Clause 4.2,
                  the terms and conditions set out in this Agreement shall govern
                  the
                  contract between the Supplier and the Client for the provision
                  of
                  Services, including to the exclusion of all other terms and conditions,
                  any oral or written quotation, purchase order, acceptance or
                  acknowledgement of an order by the Client, any specification not
                  set out
                  in this Agreement or any other document (whether or not referred
                  to in
                  this Agreement) or any purported attempt by the Supplier to impose
                  or
                  incorporate its own terms and
                  conditions.

              

      

       

      
        	4.2   	
                The
                  terms and conditions set out in this Agreement apply to the provision
                  of
                  all Services by the Supplier to the Client and any variation to
                  these
                  conditions and any representations about the Services shall have
                  no effect
                  unless expressly agreed in writing and signed by both the Supplier’s
                  Representative and the Client’s Representative.

              

      

       

      
        	5.    	
                THE
                  SUPPLIER’S REPRESENTATIVE

              

      

       

      
        	5.1   	
                The
                  Supplier shall appoint a Supplier’s Representative with effect from the
                  Completion Date in respect of each Service as set out in Schedule
                  1. Any
                  notice, information or communication given or made to the Supplier
                  Representative shall be deemed to have been given or made to the
                  Supplier.
                  The Supplier shall ensure that the Supplier’s Representative, or a
                  competent deputy duly authorised to act on the Supplier’s behalf, is
                  available for consultation with the Supplier at all
                  times.

              

      

       

      
        	5.2   	
                The
                  Supplier’s Representative at the Completion Date shall be the person
                  stated in Schedule 1 as being the Supplier’s Representative. The Supplier
                  shall promptly notify the Client of any subsequent replacement
                  appointment
                  and the address and telephone number of the replacement Supplier’s
                  Representative.

              

      

       

      
        	5.3   	
                Until
                  notice of a subsequent replacement appointment shall have been
                  given by
                  the Supplier, the Client shall be entitled to treat as the Supplier’s
                  Representative the last person identified as such to the Client
                  by the
                  Supplier in accordance with this
                  Agreement.

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          8

          
            

          

        

        
          
          

        

      

       

      
        	6.    	
                THE
                  CLIENT’S REPRESENTATIVE

              

      

       

      
        	6.1   	
                The
                  Client shall appoint a Client’s Representative with effect from the
                  Completion Date in respect of each Service as set out in Schedule
                  1. Any
                  notice, information or communication given or made to the Client’s
                  Representative shall be deemed to have been given or made to the
                  Client.
                  The Client shall ensure that the Client’s Representative, or a competent
                  deputy duly authorised to act on the Client’s behalf, is available for
                  consultation with the Supplier at all
                  times.

              

      

       

      
        	6.2   	
                The
                  Client’s Representative at the Completion Date shall be the person stated
                  in Schedule 1 as being the Client’s Representative. The Client shall
                  promptly notify the Supplier of any subsequent replacement appointment
                  and
                  the address and telephone number of the replacement Client’s
                  Representative.

              

      

       

      
        	6.3   	
                Until
                  notice of a subsequent replacement appointment shall have been
                  given by
                  the Client, the Supplier shall be entitled to treat as Client’s
                  Representative the last person identified as such to the Supplier
                  by the
                  Client in accordance with this
                  Agreement.

              

      

       

      
        	7.    	
                GOVERNANCE

              

      

       

      
        	7.1   	
                The
                  governance of this contract will be undertaken between the parties
                  as
                  follows: 

              

      

       

      
        	7.1.1    	
                Operational
                  issues will initially be dealt with at operational level by the
                  operational staff.

              

      

       

      
        	7.1.2    	
                In
                  the case of any dispute between operational staff, the matter will
                  be
                  notified by the operational operating staff in writing to the Client’s
                  Representative and Supplier’s Representative. The Client’s Representative
                  and Supplier’s Representative will act in good faith to resolve the
                  dispute for fifteen (15) Business Days from the date that the Client’s
                  Representative and Supplier’s Representative received such written
                  notice.

              

      

       

      
        	7.1.3    	
                In
                  undertaking the negotiations specified in paragraph 7.1.2 above,
                  the
                  Client Representative and Supplier Representative will have the
                  capacity
                  to amend this Agreement in accordance with the terms of this Agreement
                  in
                  terms of new or revised products, inventory policies and service
                  level
                  agreements with Affiliates.

              

      

       

      
        	7.1.4    	
                If
                  or to the extent that the matter is not resolved by the Client’s
                  Representative and the Supplier’s Representative in accordance with
                  paragraph 7.1.2, above the matter will be referred to T Kelly,
                  Global
                  Manufacturing Manager for the Client and VP Global Sales & Marketing
                  for the Supplier who will aim to resolve the matter in good faith
                  for a
                  further 15 (fifteen) Business Days.

              

      

       

      
        
          	7.2   	
                  If
                    the matter remains unresolved after 15 (fifteen) Business Days
                    from the
                    date that it was notified to the persons specified in Clause
                    7.1.4, above
                    the dispute will be submitted to an Independent Arbitrator for
                    determination and, in the absence of manifest error, his determination
                    shall be conclusive and binding on the parties. The proper charges
                    and
                    disbursements of the Independent Arbitrator shall be paid and
                    borne on
                    each occasion by the parties concerned in such proportions as
                    the
                    Independent Arbitrator may in his absolute discretion consider
                    fair and
                    reasonable.

                

        

        
          	 	 

        

        
          	 	For the purposes of this Clause “Independent
                  Arbitrator”
                  means an industry expert independent of the parties who has specialised
                  in
                  arbitration and mediation practice for at least 10 years and who
                  shall be
                  appointed by agreement between the relevant
                  parties.

        

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          9

          
            

          

        

        
          
          

        

      

       

      
        	8.    	
                REVIEW
                  MEETINGS

              

      

       

      
        	8.1   	
                The
                  Supplier’s Representative and the Client’s Representative shall meet
                  regularly (and at least once every two (2) months) in accordance
                  with a
                  timetable to be agreed between them to review the provision of
                  the
                  Services. They will also meet twice a year specifically to discuss
                  the
                  policy-related subjects including, but not limited to, performance
                  of
                  suppliers, stock policy and coverage
                  strategy.

              

      

       

      
        	9.    	
                WARRANTIES
                  AND LIABILITY

              

      

       

      
        	9.1   	
                The
                  Supplier warrants that (subject to the other provisions of this
                  Agreement)
                  it
                  will use reasonable skill and care in providing the Services.
                  

              

      

       

      
        	9.2   	
                In
                  the event that any of the Client’s customers (including Affiliates) finds
                  itself in an out-of-stock situation for any Bought In Product for
                  more
                  than three weeks as a result of the breach of any terms of this
                  agreement
                  by the Supplier, the Supplier shall pay the Client an amount equal
                  to the
                  Client’s gross profit for the period 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 cost of gross
                  sales for
                  the Bought In Product concerned for that customer. For the avoidance
                  of
                  doubt, the Supplier shall not be liable for an out-of-stock situation
                  resulting from lack of availability of any Bought In Product or
                  Purchased
                  Materials unless such out-of-stock situation is a result of the
                  breach of
                  any terms of this Agreement by the Supplier including the Supplier
                  providing unreasonable forecasts or failing to manage the chain
                  supply.

              

      

       

      
        	9.3   	
                Where
                  the Supplier fails to provide the Services as a result of the breach
                  of
                  any terms of this Agreement by the Supplier and such failure directly
                  results in a loss of customers for the Client, the Supplier shall
                  compensate the Client for its loss in an amount equal to the Client’s
                  gross profit on a budgeted basis for such customers for the following
                  twelve (12) months. 

              

      

       

      
        	9.4   	
                Nothing
                  in this Clause 9 shall in any way reduce or affect each party’s general
                  duty to mitigate loss suffered by
                  it.

              

      

       

      
        	10.   	
                PRICE

              

      

       

      
        	10.1   	
                The
                  Price shall be the Management Fee and any other amount agreed between
                  the
                  parties in connection with any other services provided by the Supplier
                  to
                  the Client in accordance with Clause 3.2 and, unless otherwise
                  agreed in
                  writing by both the Supplier and the Client, the Price shall be
                  exclusive
                  of Value Added Tax but inclusive of all other
                  charges.

              

      

       

      
        
          	10.2   	
                  If
                    the Term of the Agreement is extended in accordance with Clause
                    2.2, the
                    Management Fee will be subject to renegotiation between the parties
                    on
                    request by the Supplier prior to the commencement of such extended
                    term.

                

        

         

        
          	10.3   	The Supplier may review the Price annually and
                  enter into
                  negotiations with the Client to increase the Price to take account
                  of any
                  increased cost of Manufactured Goods, Bought In Products, Purchased
                  Materials or raw material costs provided that such review shall
                  not occur
                  prior to 24 (twenty four) months after the Completion Date and
                  thereafter
                  shall not occur more than one time during any period of 12 (twelve)
                  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 replacement Index. Any change shall
                  be
                  supported by a detailed costs breakdown which shall include supplier
                  documentation in respect of any material
                  increase.

        

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          10

          
            

          

        

        
          
          

        

      

       

      
        	11.   	
                SALES
                  TAX

              

      

       

      
        	11.1   	
                If
                  any Sales Tax is properly chargeable in respect of any supply made
                  by a
                  party under this Agreement, the other party shall pay the amount
                  of that
                  Sales Tax against issue of a proper Sales Tax invoice by the invoicing
                  party.

              

      

       

      
        	11.2   	
                Without
                  limiting Clause 11.1 each amount stated as payable by a party under
                  this
                  Agreement is exclusive of Sales Tax (if any) and is to be construed
                  as a
                  reference to that amount plus any Sales Tax in respect of
                  it.

              

      

       

      
        	12.   	
                PAYMENT

              

      

       

      
        	12.1   	
                The
                  Supplier will invoice the Client monthly in arrears in respect
                  of the
                  Price. 

              

      

       

      
        	12.2   	
                Invoices
                  for goods and carriage in respect of Bought in Products and Purchased
                  Materials will be sent directly to the Client by the relevant third
                  party.
                  

              

      

       

      
        	12.3   	
                The
                  Client shall pay all invoices due under the Agreement within thirty
                  (30)
                  days of the date of each invoice.

              

      

       

      
        	12.4   	
                Subject
                  to sub-clauses 12.5
                  and 12.6
                  the Client shall make all payments due under this Agreement without
                  any
                  deduction whether by way of set-off, counterclaim, discount or
                  abatement
                  or otherwise unless the Client has a valid court order requiring
                  an amount
                  equal to such deduction to be paid by the Supplier to the
                  Client.

              

      

       

      
        	12.5   	
                If
                  any part of the Price is subject to a bona fide dispute between
                  the
                  Supplier and the Client, the following provisions shall
                  apply:

              

      

       

      
        	12.5.1    	
                each
                  party shall notify the other party within five (5) Business Days
                  after the
                  date on which the Price is due of any disputed items and shall
                  describe in
                  reasonable detail its reasons for disputing each item;
                  and

              

      

       

      
        	12.5.2    	
                within
                  five (5) Business Days after the other party has received the notice,
                  the
                  parties shall seek to reach settlement on the items that are the
                  subject
                  of the dispute in accordance with Clause
                  7.

              

      

       

      
        	12.6   	
                If
                  the Client fails to pay the Supplier any sum due pursuant to the
                  Agreement, including sums subject to
                  a
                  bona fide dispute once such dispute is resolved
                  and if it is determined that the Client should have paid such sum,
                  the
                  Client will be liable to pay interest to the Supplier on such sum
                  from the
                  due date for payment at the annual rate of two per cent. above
                  the base
                  lending rate from time to time of European Central Bank accruing
                  on a
                  daily basis until payment is made whether before or after any judgment.
                  The Supplier reserves the right to claim interest under the Late
                  Payment
                  of Commercial Debts (Interest) Act
                  1998.

              

      

       

      
        	13.   	
                DATA
                  OWNERSHIP AND ACCESS

              

      

       

      
        	13.1   	
                The
                  Client acknowledges that all rights in the Supplier Data vest in
                  the
                  Supplier or its licensors. If, at any time and from time to time,
                  through
                  the performance of the Services, the Client is deemed to be the
                  first
                  owner of any database or other proprietary right in any of the
                  Supplier
                  Data, the Client shall immediately assign those rights in writing
                  to the
                  Supplier upon the Supplier’s request and at the Supplier’s cost. To the
                  extent that the Client requires the right to use any Supplier Data
                  to
                  perform its obligations under this Agreement, the Supplier hereby
                  grants
                  to the Client a royalty free and irrevocable licence to use the
                  Supplier
                  data for the purposes of performing its obligations under this
                  Agreement.

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          11

          
            

          

        

        
          
          

        

      

       

      
        	13.2   	
                The
                  Supplier acknowledges that all rights in the Client Data vest in
                  the
                  Client or its licensors. If, at any time and from time to time,
                  through
                  the performance of the Services, the Supplier is deemed to be the
                  first
                  owner of any database or other proprietary right in any of the
                  Client
                  Data, the Supplier shall immediately assign those rights in writing
                  to the
                  Supplier upon the Client’s request and at the Client’s cost. To the extent
                  that Supplier requires the right to use any Client Data to perform
                  its
                  obligations under this Agreement, the Client hereby grants to the
                  Supplier
                  a royalty-free and irrevocable licence to use the Client Data for
                  the
                  purpose of performing its obligations under this
                  Agreement.

              

      

       

      
        	13.3   	
                Neither
                  party shall store, reproduce, disclose, adapt, distribute or otherwise
                  use
                  the other party’s data except where necessary for the performance of its
                  obligations under this Agreement, or otherwise without the prior
                  written
                  consent of the other party.

              

      

       

      
        	13.4   	
                The
                  Client shall not delete, remove or alter any copyright, trade mark
                  or
                  database right notices contained within or relating to any Supplier
                  Data.
                  

              

      

       

      
        	13.5   	
                The
                  Supplier shall not delete, remove or alter any copyright, trade
                  mark or
                  database right notices contained within or relating to any Client
                  Data.

              

      

       

      
        	14.   	
                INFORMATION
                  AND ASSISTANCE

              

      

       

      
        	14.1   	
                Each
                  party shall use all reasonable endeavours to provide the other
                  party with
                  all software, documents, data, manuals and other materials in any
                  medium
                  and format which are in its possession or control at the Completion
                  Date
                  and which the other party requires in order to enable it to make
                  proper
                  use of the Services, subject always to prior contract, copyright
                  or
                  confidentiality obligations owed to third
                  parties.

              

      

       

      
        	14.2   	
                If
                  the Client’s unreasonable failure to furnish any information set out in
                  Clauses 14.1 or 16 unreasonable refusal or to allow access set
                  out in
                  Clause 16 renders the Supplier’s ability to provide the relevant Service
                  unreasonably difficult, the Supplier may withhold its provision
                  of such
                  Service to the Client for so long as, and to the extent that, such
                  unreasonable failure by the Client has such effect, without liability
                  on
                  the part of the Supplier.

              

      

       

      
        	15.   	
                INTELLECTUAL
                  PROPERTY

              

      

       

      
        	15.1   	
                Where,
                  for the proper enjoyment of the Services as envisaged by the parties
                  under
                  this Agreement, it is necessary for the Client to use any Intellectual
                  Property which is owned by the Supplier or one of the Supplier’s suppliers
                  or sub-contractors, the Supplier shall grant to the Client, or
                  shall use
                  reasonable endeavours to procure that the Client is granted by
                  such
                  supplier or sub-contractor, (without charge to the Client and for
                  the
                  exclusive benefit of the Client) a non-exclusive royalty-free licence
                  (excluding the right to sub-licence) to use, adapt, maintain and
                  support
                  such Intellectual Property for the purpose of the proper enjoyment
                  of the
                  Services as envisaged by this Agreement during the Term.
                  

              

      

       

      
        	15.2   	
                Where
                  in connection with the provision of the Services the Supplier reasonably
                  requires the use of any Intellectual Property or any of the materials
                  specified in Clause 15.4 below owned by the Client, or one of the
                  Client’s
                  suppliers or sub-contractors, the Client shall grant to the Supplier,
                  or
                  shall use reasonable endeavours to procure that the Supplier is
                  granted by
                  such supplier or sub-contractor, (without charge to the Supplier
                  and for
                  the exclusive benefit of the Supplier) a non-exclusive royalty
                  free
                  licence, with the right to sub-licence to use, adapt, maintain
                  and support
                  such Intellectual Property for use in connection with the provision
                  of the
                  Services during the Term. 

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          12

          
            

          

        

        
          
          

        

      

       

      
        	15.3   	
                Neither
                  the Client nor the Supplier shall by virtue of this Agreement derive
                  any
                  rights, or any right of use or access to any Intellectual Property
                  used or
                  owned by the other party other than those rights of use expressly
                  stated
                  in this Agreement.

              

      

       

      
        	15.4   	
                Where
                  the Supplier creates any work, design, data, invention or improvement
                  specifically for the Client in connection with the provision of
                  the
                  Services or its obligations under this Agreement, ownership of
                  such works,
                  designs, data, inventions and improvements including all Intellectual
                  Property rights therein shall vest in the Client upon their creation
                  and
                  any right, title or interest which may be vested in the Supplier
                  is hereby
                  assigned to the Client with the intent that all such Intellectual
                  Property
                  rights shall be the sole and absolute property of the
                  Client.

              

      

       

      
        	16.   	
                CO-OPERATION
                  AND SECURITY PROCEDURES

              

      

       

      
        	16.1   	
                During
                  the continuance of this Agreement, each party
                  shall:

              

      

       

      
        	16.1.1    	
                subject
                  to its security procedures, allow the other party and its authorised
                  personnel access to the Premises at all times as is reasonably
                  required by
                  the other party to enable it to comply with its obligations under
                  this
                  Agreement. The Client’s Representative and Supplier’s Representative shall
                  have the right to refuse to admit to, or order the removal from,
                  the
                  Premises any person employed by or acting on behalf of the other
                  party
                  who, in his reasonable opinion, is not a fit and proper person
                  to be at
                  the Premises. This shall not relieve the either party of its obligations
                  under this Agreement; and

              

      

       

      
        	16.1.2    	
                provide
                  the other party with any information and facilities as the other
                  party may
                  reasonably request to enable it to perform its obligations under
                  this
                  Agreement.

              

      

       

      
        	16.2   	
                Each
                  party shall ensure that its employees, agents and subcontractors
                  shall,
                  whilst at the Premises, cause as little interference with, and
                  inconvenience to, the business of the other party as reasonably
                  possible.

              

      

       

      
        	16.3   	
                Each
                  party acknowledges that it has been supplied with a copy of the
                  other
                  party’s rules regarding access to the Premises and automated systems,
                  security, and health and safety. Each party agrees to comply with
                  these
                  rules, and any additional rules made known to it from time to time
                  by the
                  other party together with all applicable statutory rules and regulations
                  regarding these matters. Each party will ensure that its employees,
                  agents
                  and subcontractors engaged in the provision of the Services also
                  comply
                  with these rules and regulations.

              

      

       

      
        	17.   	
                CONFIDENTIALITY

              

      

       

      
        	17.1   	
                Each
                  party (the “Recipient”)
                  agrees:

              

      

       

      
        	17.1.1    	
                to
                  treat as confidential all information obtained from the other party
                  (the
                  “Disclosing
                  Party”)
                  in
                  any medium or format (whether marked “confidential” or not) which the
                  Recipient receives from the Disclosing Party either directly or
                  from any
                  person, firm, company or organisation associated with the Disclosing
                  Party, which concerns the business, operations or customers of
                  any or all
                  of the Disclosing Party and its Affiliates (“Confidential
                  Information”);

              

      

       

      
        	17.1.2    	
                not
                  to use any Confidential Information for its own purposes or to
                  obtain a
                  commercial, trading, investment, financial or other advantage but
                  shall
                  only use such Confidential Information for the sole purpose of
                  performing
                  its obligations under this
                  Agreement;

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          13

          
            

          

        

        
          
          

        

      

       

      
        	17.1.3    	
                not
                  to disclose or reveal any Confidential Information to any other
                  person
                  other than its directors, officers, employees or professional advisers
                  who
                  have a need to know the same in connection with the provision of
                  the
                  Services and/or this Agreement (and then only to the extent so
                  necessary)
                  provided always that it shall be directly responsible to the Disclosing
                  Party for
                  any breach of the confidentiality undertakings set out in this
                  Clause 17
                  by any such person;

              

      

       

      
        	17.1.4    	
                before
                  disclosing any Confidential Information to any person pursuant
                  to Clause
                  17.1.3 to ensure such person has provided the Disclosing
                  Party
                  with a written undertaking agreeing to be bound by the provisions
                  of this
                  Clause 17 in the same manner as it is or such similar duty of
                  confidentiality;

              

      

       

      
        	17.1.5    	
                upon
                  termination of this Agreement, in any event, at any time on written
                  request from the Disclosing Party to return to the Disclosing
                  Party the
                  Confidential Information and/or of all notes and memoranda prepared
                  by it
                  in relation to any of the Confidential Information without keeping
                  any
                  copies, extracts or other reproductions thereof and to produce
                  a
                  declaration signed by a duly authorised officer certifying that
                  all such
                  records and/or documents of any kind have been returned;
                  and

              

      

       

      
        	17.1.6    	
                promptly
                  to notify the Disclosing
                  Party if
                  any Confidential Information is required to be disclosed by it
                  by reason
                  of law or government or other regulation and co-operate fully with
                  the
                  Disclosing
                  Party
                  regarding the manner of such disclosure so as to keep such Confidential
                  Information confidential.

              

      

       

      
        	17.2   	
                This
                  Clause 17 shall not apply to any Confidential Information which
                  either
                  party can show (as evidenced by written record predating such
                  disclosure):

              

      

       

      
        	17.2.1    	
                was
                  known to it before such information was imparted to it by the Disclosing
                  Party or
                  any of its subsidiaries, holding companies or subsidiaries of it
                  holding
                  companies; or

              

      

       

      
        	17.2.2    	
                at
                  the time of the disclosure is in or subsequently comes into the
                  public
                  domain (other than by an act or omission or breach by it of its
                  obligations herein); or

              

      

       

      
        	17.2.3    	
                is
                  lawfully received by it without restriction on disclosure or use
                  from a
                  third party having the lawful right to do so;
                  or

              

      

       

      
        	17.2.4    	
                is
                  developed by it without access to or use or knowledge of the Confidential
                  Information imparted by the Disclosing
                  Party or
                  any of its subsidiaries, holding companies or subsidiaries of it
                  holding
                  companies, to it; or

              

      

       

      
        	17.2.5    	
                is
                  required to be disclosed by law, regulations, statute, judgment
                  or by any
                  supervisory or regulatory body.

              

      

       

      
        	17.3   	
                All
                  Confidential
                  Information whether
                  in documentary or electronic format provided by the Client to the
                  Supplier
                  under this Agreement shall remain the property of the Client and
                  may be
                  used by the Supplier for the purpose of providing Services  under
                  this Agreement but not otherwise. 

              

      

       

      
        	17.4   	
                All
                  Confidential
                  Information whether
                  in documentary or electronic format provided by the Supplier to
                  the Client
                  under this Agreement shall remain the property of the Supplier
                  and may be
                  used by the Client for the purpose of providing Services under
                  this
                  Agreement but not otherwise.

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          14

          
            

          

        

        
          
          

        

      

       

      
        	18.   	
                TERMINATION
                  FOR CAUSE

              

      

       

      This
        Agreement may be terminated for cause in whole by either party in the following
        circumstances, with immediate effect, from the date of service on the other
        of
        written notice if:

       

      
        	18.1   	
                the
                  other party is in breach of any material obligation under this
                  Agreement
                  which for the avoidance of doubt includes a failure to provide
                  the
                  Services as required in accordance with the key performance indicators
                  in
                  Schedule 1 other than in accordance with the terms of this Agreement
                  and,
                  if the breach is capable of remedy, that party has failed to remedy
                  such
                  breach within fifteen (15) Business Days of receipt of notice from
                  the
                  other party to do so;

              

      

       

      
        	18.2   	
                the
                  other party being a company is unable to pay its debts or becomes
                  insolvent or a resolution is passed or an order is made for the
                  winding up
                  or dissolution of the other party (otherwise than for the purpose
                  of
                  solvent amalgamation or reconstruction) or the other becomes subject
                  to an
                  administration order or a receiver or administrative receiver or
                  similar
                  officer is appointed over or an encumbrancer takes possession of
                  any of
                  the other’s property or the Client’s equipment or the other party enters
                  into or proposes any composition or arrangement with its creditors
                  generally or anything analogous to the foregoing occurs in any
                  applicable
                  jurisdiction; and

              

      

       

      
        	18.3   	
                the
                  other party ceases or threatens to cease to carry on business in
                  the
                  United Kingdom.

              

      

       

      
        	19.   	
                TERMINATION
                  WITHOUT CAUSE

              

      

       

      
        
          	19.1   	
                  Subject
                    to Clause 19.2 below, either party may terminate this Agreement
                    at any
                    time by giving not less than twelve (12) months’ written notice to the
                    other party such notice to expire not earlier than the fifth
                    (5th)
                    anniversary of the Completion
                    Date.

                

        

        
          	 	 

        

        
          	19.2   	The Client shall have the right to terminate
                  the Services
                  in connection with the following products at any time by giving
                  not less
                  than 6 (six) months’ written notice to the
                  Supplier:

        

      

       

      
        
          	19.2.1    	
                  ***;

                

        

        
          	 	 

        

        
          	19.2.2    	***; and

        

        
          	 	 

        

        
          	19.2.3    	***.

        

      

        

      
        	20.   	
                CONSEQUENCES
                  OF TERMINATION

              

      

       

      
        	20.1   	
                Expiry
                  or earlier termination of this Agreement for whatever reason shall
                  not
                  affect any rights or obligations of either party which have arisen
                  prior
                  to the date of such expiry or earlier
                  termination.

              

      

       

      
        	20.2   	
                Upon
                  expiry or earlier termination of this Agreement for whatever reason
                  the
                  Client shall immediately pay to the Supplier all arrears of the
                  Price
                  determined on a pro-rata basis by reference to the number of months
                  the
                  Services have been provided and in respect of any other services
                  which
                  have been provided. 

              

      

       

      
        	20.3   	
                Upon
                  termination of this Agreement and subject to any agreement to the
                  contrary, the Client and the Supplier shall each, at the written
                  request
                  of the other, surrender up to the party all property of the other
                  which is
                  then in its possession or control insofar as such property has
                  been made
                  available to it for the purposes of this
                  Agreement.

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          15

          
            

          

        

        
          
          

        

      

       

      
        
          	21.   	
                  NON-SOLICITATION

                

        

        
          	     	 

        

        
          	 	Neither party shall (except with the prior written
                  consent of the other) during the Term, and for a period of one
                  year
                  thereafter, solicit the services of any staff of the other party
                  who have
                  been engaged in the provision of the Services or the management
                  of this
                  Agreement or any significant part thereof either as principal,
                  agent,
                  employee, independent contractor or any other form of employment
                  or
                  engagement other than by means of a national advertising campaign
                  open to
                  all-comers and not specifically targeted at such staff of the other
                  party.

        

      

       

      
        	22.   	
                LIMITATION
                  OF LIABILITY AND INDEMNITY

              

      

       

      
        	22.1   	
                Subject
                  to Clause 9,
                  the following provisions set out the entire financial liability
                  of the
                  Supplier (including any liability for the acts or omissions of
                  its
                  employees, agents and sub-contractors) to the Client in respect
                  of any
                  breach of this Agreement.

              

      

       

      
        	22.2   	
                For
                  the avoidance of doubt, the Supplier shall have no liability in
                  respect of
                  any loss or damage arising directly or indirectly as a result of
                  the
                  Supplier providing the Services in accordance with this Agreement
                  or in
                  accordance with any specification or formula provided or approved
                  by the
                  Client. 

              

      

       

      
        	22.3   	
                Notwithstanding
                  any other provision of this Agreement, neither party limits its
                  liability:

              

      

       

      
        	22.3.1    	
                for
                  negligence or fraud or fraudulent
                  misrepresentation
                  by
                  it or its employees or
                  subcontractors;

              

      

       

      
        
          	22.3.2    	
                  for
                    death or personal injury caused by its negligence or that of
                    its
                    employees, agents or subcontractors (as applicable);
                    or

                

        

        
          	 	 

        

        
          	
                  22.3.3    

                	
                  for
                    any sums claimable by way of an account of
                    profits.

                

        

      

       

      
        	22.4   	
                For
                  the avoidance of doubt, the Client shall have no liability in respect
                  of
                  any loss or damage arising directly or indirectly as a result of
                  the
                  Client carrying out its obligations in accordance with the terms
                  of this
                  Agreement.

              

      

       

      
        	22.5   	
                Except
                  as provided in Clause 9,
                  neither party shall in any circumstances have any liability to
                  the other
                  in respect of consequential or indirect
                  loss.

              

      

       

      
        	22.6   	
                The
                  Supplier hereby indemnifies and shall keep indemnified the Client
                  and hold
                  it harmless against any and all third party claims, actions, judgments,
                  damages, lawsuits, costs or expenses or professional fees incurred
                  by the
                  Client in relation to, or arising out of, the Services, resulting
                  from a
                  material breach of contract by the
                  Supplier.

              

      

       

      
        	22.7   	
                The
                  Client hereby indemnifies and shall keep indemnified Supplier and
                  hold it
                  harmless against any and all third party claims, actions, judgments,
                  damages, lawsuits, costs or expenses or professional fees brought
                  against
                  suffered or incurred by the Supplier in relation to, or arising
                  out of,
                  the Services or use of the Bought in Product, resulting from a
                  material
                  breach of contract by the Client.

              

      

       

      
        	22.8   	
                Subject
                  to Clause 22.4, the total aggregate liability of the Supplier in
                  respect
                  of any claim under this Agreement shall not exceed:
                  

              

      

       

      
        
          	22.8.1    	
                  ***;

                

        

        
          	 	 

        

        
          	22.8.2    	***; and

        

        
          	 	 

        

        
          	22.8.3    	***.

        

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          16

          
            

          

        

        
          
          

        

      

       

      
        	22.9   	
                Subject
                  to Clause 22.4, the total aggregate liability of Client in respect
                  of any
                  claim under this Agreement shall not
                  exceed:

              

      

       

      
        
          	22.9.1    	
                  ***;

                

        

        
          	 	 

        

        
          	22.9.2    	***; and

        

        
          	 	 

        

        
          	22.9.3    	***.

        

      

       

      
        	22.10   	
                Each
                  party shall take all reasonable steps to mitigate the loss and
                  damage it
                  incurs in relation to any claim or action (whether for negligence,
                  breach
                  of contract, misrepresentation, under any indemnity or otherwise)
                  which it
                  brings against the other.

              

      

       

      
        	22.11  
	
                The
                  indemnities given in this Clause 22 shall be subject
                  to:

              

      

       

      
        	22.11.1    	
                the
                  indemnified party informing the indemnifying party of the relevant
                  matter
                  as soon as possible and in any event no later than five (5) Business
                  Days
                  after the indemnified party has become aware of such event;
                  

              

      

       

      
        	22.11.2    	
                the
                  indemnifying party being entitled to conduct the defence of, or
                  otherwise
                  handle, the relevant matter;

              

      

       

      
        	22.11.3    	
                the
                  indemnified party making no admission with respect to such matter
                  and
                  otherwise doing nothing that prejudices the indemnifying party’s defence
                  or handling thereof; and

              

      

       

      
        	22.11.4    	
                the
                  indemnified party providing the indemnifying party with all reasonable
                  assistance in such defence or handling of the relevant
                  matter.

              

      

       

      
        	22.12   	
                The
                  parties acknowledge and agree that clause 8.8 of the Sale and Purchase
                  Agreement contains provisions which limit the liability of INYX
                  for a
                  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.

              

      

       

      
        	23.   	
                CHANGE
                  CONTROL

              

      

       

      
        	23.1   	
                Either
                  party may propose any change to the scope of the Services  by
                  written notice to the other specifying the proposed change in reasonable
                  detail (“Change
                  Request”).

              

      

       

      
        	23.2   	
                Within
                  fourteen (14) days after sending or receiving a Change Request,
                  the
                  recipient (“Recipient”)
                  shall provide the other party in writing with a brief proposal
                  including
                  an approximation of the possible costs, and an overview of the
                  likely
                  impact upon the provision of the
                  Services.

              

      

       

      
        	23.3   	
                The
                  other party will review the Recipient’s proposal and, within seven (7)
                  days after its receipt, notify the Recipient in writing of its
                  acceptance
                  or rejection of the proposal.

              

      

       

      
        	23.4   	
                Both
                  parties shall act in good faith in relation to Change
                  Requests.

              

      

       

      
        	23.5   	
                If
                  any changes are necessary to respond to an emergency, then the
                  affected
                  party shall notify the other of the need for an urgent change,
                  and the
                  parties shall use all reasonable endeavours to make the change,
                  taking
                  account of all the commercial circumstances at the time, and the
                  parties
                  shall then document the change and retrospectively prepare a change
                  description which the parties shall agree, acting in good
                  faith.

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          17

          
            

          

        

        
          
          

        

      

       

      
        	23.6   	
                Except
                  as set out in Clause 23.5, neither party shall have any obligation
                  to
                  commence work in connection with any change to the scope of the
                  Services until
                  the relevant Change Request has been accepted in writing by the
                  other
                  party.

              

      

       

      
        	24.   	
                INSURANCE

              

      

       

      Each
        party shall maintain for the duration of this Agreement insurance in an amount
        reasonably adequate to cover its obligations hereunder, and, upon reasonable
        request, each party will provide to the other party a certificate of insurance
        showing that such insurance is in place.

       

      
        	25.   	
                FORCE
                  MAJEURE

              

      

       

      
        	25.1   	
                If
                  either party is affected by Force Majeure it shall forthwith notify
                  the
                  other party of the nature and extent
                  thereof.

              

      

       

      
        	25.2   	
                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. The affected party shall use its
                  reasonable
                  endeavours to limit the effect of that delay or non-performance
                  on the
                  other party.

              

      

       

      
        	25.3   	
                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. 

              

      

       

      
        	26.   	
                ASSIGNMENT

              

      

       

      
        	26.1   	
                The
                  Supplier 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:

              

      

       

      
        	26.1.1    	
                the
                  assignee may enforce the obligations on the part of the Client
                  under this
                  Agreement as if it had been named in this Agreement or therein
                  as the
                  Supplier;

              

      

       

      
        	26.1.2    	
                as
                  between the Client and the Supplier, the Client may nevertheless
                  enforce
                  this Agreement against the Supplier as if the assignment had not
                  occurred;
                  

              

      

       

      
        	26.1.3    	
                the
                  assignment shall not in any way operate so as to increase the liability
                  of
                  the Supplier or the Client; and

              

      

       

      
        	26.1.4    	
                the
                  assignee will not be liable or obligated in any way by reason of
                  such
                  assignment or exercising the rights so
                  assigned.

              

      

       

      
        	
                26.2   

              	
                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 the Client or the
                  Supplier.

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          18

          
            

          

        

        
          
          

        

      

       

      
        	26.3  	
                Except
                  as permitted by this Clause 26,
                  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.

              

      

       

      
        	27.   	
                SUB-CONTRACTING
                  TO AFFILIATES

              

      

       

      In
        providing the Services, the Supplier may sub-contract the whole or any part
        or
        parts of the Services to its Affiliates with the prior written consent of
        the
        Client, such consent not to be unreasonably withheld or delayed.
        Notwithstanding the foregoing, nothing herein shall prohibit the Supplier
        from
        utilising the services of any third parties customarily utilised in connection
        with the provision of the Services it provides, or which are otherwise used
        by
        it in the ordinary course of business for performance of similar functions,
        but
        the Supplier shall be responsible for the performance of such third
        parties.

       

      
        	28.   	
                WAIVER

              

      

       

      Any
        failure of or delay by either party in relation to the exercise of its rights
        under this Agreement shall not constitute a waiver of such rights and any
        waiver
        in respect of one act or omission shall not operate as a waiver in respect
        of
        any other or future acts or omissions. No
        provision may be waived except in writing and signed by a duly authorised
        representative of each of the parties.

       

      
        	29.   	
                ENTIRE
                  AGREEMENT

              

      

       

      This
        Agreement and the documents referred to in it constitute the entire
        understanding between the parties in relation to its subject matter. Any
        amendment to this Agreement shall not be effective unless in writing and
        signed
        by a duly authorised representative of each of the parties.

       

      
        	30.   	
                NOTICES

              

      

       

      
        
          	30.1   	
                  Any
                    notice or other document to be served under this agreement may
                    be
                    delivered or sent by post or facsimile process to the party to
                    be served
                    at its address set out below:

                

        

        
          	 	 

        

        
          	 	
                  to
                    the Client at:

                  208
                    Bath Road Slough, Berkshire SL1 3WE

                  Marked
                    for attention of Company Secretary

                   

                  
                    to
                      the Supplier at:

                    
                      6
                        Seymour Court, Manor Park, Runcorn, Cheshire WA7 1SY

                      
                        Marked
                          for attention of Jack Kachkar,

                         

                        or
                          at any other address or facsimile number or to any other
                          addressee as it may have notified to the other party in
                          accordance with
                          this Clause 30. Any notice or other document sent by post
                          shall be sent by
                          prepaid first class recorded delivery post (if within the
                          United Kingdom)
                          or by prepaid airmail (if
                          elsewhere).

                      

                    

                  

                

        

      

       

      
        	30.2   	
                In
                  proving service of a notice or document it shall be sufficient
                  to prove
                  that delivery was made or that the envelope containing the notice
                  or
                  document was properly addressed and posted (either by prepaid first
                  class
                  recorded delivery post or by prepaid airmail, as the case may be)
                  or that
                  the facsimile message was properly addressed and despatched, as
                  the case
                  may be, provided that if the day of service is not a Business Day
                  or
                  service takes place after 5.p.m. on a Business Day, then the notice
                  shall
                  be deemed to be served on the following Business Day.
                  

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          19

          
            

          

        

        
          
          

        

      

       

      
        	31.   	
                SEVERABILITY

              

      

       

      If
        any
        provision of this Agreement is found by any court, tribunal or administrative
        body of competent jurisdiction to be wholly or partly illegal, invalid, void,
        voidable, unenforceable or unreasonable it shall, to the extent of such
        illegality, invalidity, voidness, voidability, unenforceability or
        unreasonableness, be deemed severable and the remaining provisions of the
        Agreement and the remainder of such provision shall continue in full force
        and
        effect
        and will
        be binding on the parties as if the unenforceable provisions had never been
        contained herein.
        Notwithstanding
        the foregoing: (i) if any term of this Agreement is or becomes unenforceable
        in
        any jurisdiction, that shall not affect the legality, validity or enforceability
        in other jurisdictions of that or any other provision of this Agreement;
        and
        (ii) if any portion of this Agreement shall be held to be unenforceable but
        would be enforceable if deleted in part or reduced in application, such portion
        shall apply with such deletion or modification as may be necessary to make
        it
        enforceable. In
        the
        event of severance of a provision so fundamental as to prevent the
        accomplishment of the purpose of the Agreement, the parties shall promptly
        commence good faith negotiations to remedy such invalidity.

       

      
        	32.   	
                FURTHER
                  ENDEAVOURS

              

      

       

      Each
        party undertakes, at the request and cost and expense of the other party,
        to
        sign all documents and to do all other acts, which may be necessary to give
        full
        effect to this Agreement.

       

      
        	33.   	
                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.

       

      
        	34.   	
                NO
                  PARTNERSHIP/AGENCY

              

      

       

      Nothing
        in this Agreement is intended to or shall operate to create a partnership
        or
        joint venture of any kind between the parties or to authorise either party
        to
        act as agent for the other party and neither party shall have authority to
        act
        in the name or on behalf of or otherwise to bind the other party in any way
        (including but not limited to the making of any representations or warranty
        the
        assumption of any obligation or liability and the exercise of any right or
        power).

       

      
        	35.   	
                CONTRACTS
                  (RIGHTS OF THIRD PARTIES) ACT
                  1999

              

      

       

      Except
        as
        expressly stated in this agreement a person who is not a party to this Agreement
        may not enforce any of its terms under the Contracts
        (Rights of Third Parties) Act 1999.

       

      
        	36.   	
                PARENT
                  GUARANTEE

              

      

       

      
        
          	36.1   	
                  The
                    Parent Guarantor, as primary obligor, unconditionally and irrevocably
                    guarantees, by way of continuing guarantee to the Client, the
                    payment and
                    performance by the Supplier, 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.

                

        

        
          	 	 

        

        
          	36.2   	The Parent Guarantor’s obligations under this
                  Clause:

        

      

       

      
        	36.2.1    	
                constitute
                  direct, primary and unconditional obligations to pay on demand
                  by the
                  Client any sum which the Supplier is liable to pay under this Agreement
                  and to perform on demand any obligation of the Supplier under this
                  Agreement without requiring the Client first to take any steps
                  against the
                  Supplier or any other person; and

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          20

          
            

          

        

        
          
          

        

      

       

      
        	36.2.2    	
                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, the Supplier 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 the Supplier or any other person; or
	 	 	 
	 	(d)	any legal limitation, disability or
                other
                circumstance relating to the Supplier or any unenforceability or
                invalidity of any obligation of the Supplier under this
                Agreement.

      

       

      
        	37.    	
                LAW

              

      

       

      This
        Agreement shall be governed by English law and the parties hereby submit
        to the
        exclusive jurisdiction of the English Courts.

       

      IN
        WITNESS
        whereof
        the parties have signed this Agreement the day and year first above
        written

      

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          21

          
            

          

        

        
          
          

        

      

      SIGNATURE
        PAGE

      

      

      
        	
                SIGNED
                  by P
                  G NICHOLLS

                for
                  and on behalf of UCB
                  PHARMA LIMITED

                 

                WITNESS:

                Signature
                  MARK
                  GLYN HARDY

                Name
                  MARK
                  GLYN HARDY

                Address
                  208
                  BATH ROAD
SLOUGH
BERKSHIRE
SL1
                  3WE

                Occupation
                  SOLICITOR

                (PLEASE
                  COMPLETE IN CAPITALS)

              	
                P
                  G NICHOLLS

                (Signature)

                25
                  AUGUST
                  2005

                (Date)

              

      

       

      

      

      
        	
                SIGNED
                  by MARK
                  GLYN HARDY

                for
                  and on behalf of 

                CELLTECH
                  MANUFACTURING SERVICES LIMITED

                 

                WITNESS:

                Signature
                  H
                  S BAINS

                Name
                  H
                  S BAINS

                Address
                  208
                  BATH ROAD
SLOUGH
BERKSHIRE
SL1
                  3WE 

                Occupation
                  ACCOUNTANT

                (PLEASE
                  COMPLETE IN CAPITALS)

              	
                MARK
                  GLYN HARDY

                (Signature)

                25
                  AUGUST 2005

                (Date)

              

      

      

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          22

          
            

          

        

        
          
          

        

      

       

      
        	
                SIGNED
                  by JACK
                  KACHKAR

                for
                  and on behalf of INYX,
                  INC.

                 

                WITNESS:

                Signature
                  DOUGLAS
                  BROWN

                Name
                  DOUGLAS
                  BROWN

                Address
                  STURDY’S
TASTON
OXON
                  OX7 3JL
UK

                Occupation
                  BUSINESSMAN

                (PLEASE
                  COMPLETE IN CAPITALS)

              	
                JACK
                  KACHKAR

                (Signature)

                25
                  AUGUST 2005

                (Date)

              

      

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          23

          
            

          

        

        
          
          

          
          

        

      

      SCHEDULE
        1

       

      The
        Services

       

      Supplier
        will
        provide full services as set out below (the Services):

       

      
        	1.    	
                PURCHASING

              

      

       

      Bought
        in
        Products: Supplier shall provide the services set out in the Responsibility
        Matrix below in respect of the Bought in Products. 

       

      Manufactured
        Goods: Supplier shall provide the services set out in the Responsibility
        Matrix
        below in respect of the Manufactured Goods.

       

      Supplier
        will continue to provide a full service in managing the manufacture and supply
        of Bought-In Products (BIP)
        and
        part BIPs, including the introduction of any new products, new market
        presentations or changes in manufacture or supply source. Client will continue
        the contractual relationship with BIP and part-BIP manufacturers. 

       

      Supplier
        will purchase and provide materials to part-BIP manufacturers. Suppliers
        of
        Purchased Materials and part-BIP manufacturers will invoice Supplier directly.
        

       

      Supplier
        will negotiate all terms including price, contracting and transacting directly
        with suppliers for the non-BIP Purchased Materials and take responsibility
        for
        introducing change within the supply base. 

       

      Client
        can provide Supplier with initial policies for purchased materials replenishment
        and stockholding together with an approved and licensed vendor list and
        thereafter key performance indicators can be used to ensure the operational
        good
        purchasing practice and formal biannual meetings can review and act on supplier
        performance and risk. 

       

      Consisting
        of:-

       

      
        	1.1    	
                Responsibility
                  Matrix

              

      

       

      
        	
                Purchasing

              	
                Client

              	
                Supplier

              
	
                Purchasing
                  and Procurement Data Maintenance in Gemms, Sage and
                  Manugistics.

              	 	
                X

              
	
                Agree
                  BIP Replenishment Plan Policy

              	
                X

              	 
	
                Purchased
                  Materials Replenishment Plan

              	 	
                X

              
	
                Purchased
                  Materials Inventory Mngt Policy

              	 	
                X

              
	
                Create,
                  Communicate and Expedite Supplier Schedules

              	 	
                X

              
	
                Purchase
                  Order Entry

              	 	
                X

              
	
                Communicate
                  Supplier Forecasts 

              	 	
                X

              
	
                Issue
                  approved finished product artwork

              	
                X

              	 
	
                Implement
                  artwork changes through suppliers

              	 	
                X

              
	
                Shipping
                  Documentation and Import / Export Licences

              	 	
                X

              
	
                BIP
                  Vendor Selection

              	
                X

              	 
	
                BIP
                  Price Negotiation

              	
                X

              	 
	
                BIP
                  Supplier Agreements

              	
                X

              	 
	
                Transfer
                  UCB Licenced Purchased Materials Approved Vendor List to Supplier
                  cGMP

              	
                X

              	
                X

              
	
                Licenced
                  Purchased Materials Supplier Agreements

              	 	
                X

              
	
                Non-licenced
                  Purchased Materials Vendor Selection

              	 	
                X

              
	
                Non-BIP
                  Supplier Agreements

              	 	
                X

              
	
                New
                  Vendor Qualification

              	 	
                X

              
	
                Supplier
                  Performance Measurement

              	 	
                X

              
	
                Perform
                  Supplier Visits and Audits

              	 	
                X

              
	
                Purchase
                  Price Variance Management

              	 	
                X

              

      

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          24

          
            

          

        

        
          
          

        

      

       

      
        	1.2    	
                Description
                  of Services

              

      

       

      Materials
        Replenishment

       

      In
        respect of Purchased Material, Supplier will run, interpret and act on the
        materials replenishment plan generated by enterprise resource planning software
        (Oracle) in accordance with Supplier’s own policy. 

       

      In
        respect of Bought-In Products Supplier will run, interpret and act on the
        materials replenishment plan generated by enterprise resource planning software
        (Manugistics), in accordance with Supplier’s own policy. 

       

      The
        materials replenishment process will be strictly subject to Client approved
        vendor list (Supplier
        Status Listing),
        which
        will be provided by Client to Supplier, which will also become the
        responsibility of Supplier after divestment.

       

      On
        demand, Supplier will provide the Client with the procurement plan in respect
        of
        Purchased Materials and the procurement plan in respect of Bought-In Products,
        for each specifically requested supplier or material SKU in monthly buckets,
        for
        the following 12 months, showing expected receipts and planned
        deliveries.

       

      Artwork

       

      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 Manufactured Goods
        or
        Bought in 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 Client shall bear the costs of any changes to such artwork as a result
        of
        or in connection with the sale of Ashton facility.

       

      Client
        will give approved artwork to Supplier. Supplier will take responsibility
        for
        implementing new artwork through suppliers. 

       

      Any
        Services for promotional artwork undertaken by Supplier for Client will be
        on an
        ad hoc basis and controlled through Client purchase orders for discrete
        jobs.

       

      Materials
        Stockholding

       

      In
        accordance with the supply chain service:

       

      The
        first
        three (3) months of the Client forecast will be deemed firm with respect
        to
        procuring materials. Client will however underwrite the purchase of materials
        with longer lead-times where advance purchase is required to meet demand
        and
        where the suppliers minimum order quantity exceeds demand. Supplier will
        provide
        a list of all materials with a lead-time longer than three (3) months, these
        items will be reviewed at a monthly meeting with a view to Client identifying
        where these purchases would not be appropriate. Supplier will also provide
        a
        monthly short dated stock report for review at this meeting. Client will
        underwrite these materials and will reimburse Supplier should such materials
        subsequently become obsolete or exceed their shelf life. On an annual basis
        Client and Supplier will review overall product cycle times in order to agree
        purchase policies and procedures.

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          25

          
            

          

        

        
          
          

        

      

      Supplier
        Resource and Relationship Management

       

      For
        Purchased Materials suppliers, financial and operational transactions together
        with contractual relationships will be the responsibility of Supplier and
        Purchased Materials are for Supplier’s account. Client may from time to time and
        where appropriate underwrite strategically extended purchase commitments
        (for
        example, prolonged campaigns of key active ingredients).

       

      Supplier
        will create supplier schedules and communicate these to third party suppliers.
        Supplier will expedite deliveries in order to meet the requirements of the
        plan.

       

      Supplier
        will perform visits of key third party suppliers as appropriate to the needs
        of
        the business. 

       

      Sourcing

       

      During
        the normal course of business, Supplier will conduct price and supply
        negotiations with new and existing vendors and once agreed, Supplier will
        update
        Oracle material standard costs, which will be available to Client on
        request.

       

      Either
        party may request an addition or deletion from the approved vendor list,
        such
        request is not to be unreasonably withheld or delayed. The timescale
        expectations for qualification of a new supplier is three (3) months from
        agreement of such new supplier’s prices. The change and qualification costs will
        be for the account of the party requesting the change. Supplier’s schedule of
        rates will be agreed in advance.

       

      Supplier
        will qualify new vendors in a timely manner in order to achieve both supply
        and
        cost improvement targets. Qualification may involve but is not limited to
        machine trials, compliance and equivalence statements and eventual inclusion
        onto Supplier’s approved vendor list. Once qualified, use of that supplier’s
        material shall be at Supplier’s own risk.

       

      Supplier
        will implement and maintain supply agreements with third party suppliers
        whenever appropriate and will work with Client in good faith to achieve an
        appropriate level of contractual cover.

       

      Client
        will be responsible for sourcing and purchasing from Bought in Product
        manufacturers whilst Supplier will be responsible for the procurement and
        data
        maintenance of purchasing and procurement information within the Client Sage
        and
        Manugistics systems.

       

      Cost
        Control and Reduction

       

      Supplier
        and Client will set up on a yearly basis a continuous improvement programme.
        The
        programme will focus on issues agreed between Supplier and Client that will
        lead
        to improvements in cost and service (shorter lead times for materials or
        products - improvement of the reliability, responsiveness, quality and
        information supply as appropriate).

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          26

          
            

          

        

        
          
          

        

      

       

      Every
        improvement idea will be analysed through a feasibility study in joint
        cooperation and will be followed by appropriate financial calculation using
        Net
        present value (NPV)
        in to
        evaluate the benefits of the improvement idea. 

       

      The
        improvement programme will be executed in joint effort in terms of objective,
        target, implementation planning and resource allocation and for that purpose
        all
        relevant information will be accessible to Client in order to analyse and
        evaluate the improvement programme. 

       

      Supplier
        and Client will work together to achieve benefits that are shared equally
        between the parties. The basis of such calculation will be the 2005
        budget.

       

      ***

       

      Purchasing
        Regulatory Requirements

       

      The
        Supplier shall:

       

      (a)    obtain
        import licences and licences for controlled drugs;

       

      (b)    obtain
        and generate any relevant shipping documents; and

       

      (c)    obtain
        all approvals required for the import of unlicenced medicinal
        products***.

       

      Client
        will provide Supplier with an approved vendor list (the Supplier
        Status Listing)
        and
        this will be adhered to in accordance with GMP guidelines. Supplier will
        be
        responsible for maintaining this list and for adding any new vendors or deleting
        vendors whose services are no longer required.

       

      
        	1.3    	
                Governance

              

      

       

      For
        Purchasing:-

       

      Client
        Representative is David Harrison.

       

      Supplier
        Representative is Jeanette McCormack.

       

      
        
          
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        	1.4    	
                Documents

              

      

       

      
        	
                Purchasing
                  Reports

              	
                On
                  Request

              	
                Frequency
                  of

                Supply

              
	
                Approved
                  Vendor List

              	 	
                On
                  update

              
	
                Supplier
                  Schedules

              	
                yes

              	 
	
                Material
                  Demand Plan (item level)

              	
                yes

              	 
	
                Supplier
                  Spend Data (item level if required)

              	
                yes

              	 
	
                Stock
                  (item level)

              	
                yes

              	 
	
                PPV
                  report

              	
                monthly

              	
                Quarterly
                  review

              

      

       

      
        	1.5    	
                Exceptions

              

      

       

      For
        the
        following goods the Client will perform the purchasing function and the Supplier
        will perform the procurement function:

       

      
        	·  	
                ***

              

      

       

      
        	1.6    	
                Key
                  Performance Indicators
                  (KPI)

              

      

       

      
        	
                KPI

              	
                Indicator

              	
                Target

              	
                On
                  Request

              
	
                PPV
                  report

              	
                Invoice
                  cost

                minus
                  standard

                cost
                  for 

                purchased
                  

                material

              	
                Neutral
                  PPV

              	
                Quarterly

              

      

       

      
        	2.    	
                REGULATORY
                  AFFAIRS

              

      

       

      Consisting
        of:

       

      
        	2.1    	
                Responsibility
                  Matrix

              

      

       

      ***

       

      
        	2.2    	
                Description
                  of Services

              

      

       

      Regulatory
        affairs will cover the licences listed in Schedule 5.

       

      Support
        for Marketing Authorizations 

       

      Supplier
        regulatory affairs to liaise with other Supplier departments as necessary
        to
        coordinate any CMC changes / updates to the licences and keep Client regulatory
        affairs updated on any potential variations related to CMC aspect of the
        products which may be initiated by the manufacturing site. 

       

      Supplier
        shall provide the appropriate data to Client to support the change within
        a
        reasonable timeframe.

       

      Client
        shall submit applications to the Regulatory Agencies and provide Supplier
        with
        updates on the progress of the applications. Client shall inform Supplier
        of
        approvals/rejections of applications 

       

      Supplier
        shall inform the appropriate people within Supplier of Regulatory Agency
        decisions

       

      
        
          
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      To
        aid
        better visibility, regular communication from Supplier shall update Client
        with
        CMC related activities.

       

      Client
        regulatory affairs shall formally request Supplier to support any CMC related
        changes to licences (e.g. stability data for renewals in Ireland or increasing
        shelf life, etc).

       

      CMC
        support for global products (such as Equasym, Equasym XL and Xyrem) by Supplier
        regulatory affairs will be limited for a period of two (2) years, after which
        it
        will be subject to re-negotiation.

       

      Site
        licences

       

      All
        Site
        licences listed in Annex 3 are currently held at the Supplier site. Supplier
        will continue to maintain these licences as required. Supplier will inform
        Client of any proposed changes to the Client Site licences.

       

      
        
          
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      Maintenance
        of the product licences

       

      Supplier
        will maintain those product licences listed in Annex 2. In addition, Supplier
        will continue to maintain the product licence for Ergometrine Maleate Tablets
        BP
        50 mcg until stock has been exhausted (following stock exhaustion the Marketing
        Authorization will be transferred to Client). 

       

      Manufacturing
        compliance

       

      Supplier
        will check manufacturing and testing documents against the licenced details
        for
        products manufactured at Supplier. The final QP release for all products
        will be
        carried out by Client.

       

      Controlled
        Drugs licences

       

      Supplier
        will maintain the Controlled Drugs licences listed in Annex 4 and update
        as
        appropriate. In addition, Supplier will apply to import controlled drugs
        in line
        with site requirements, as requested and Client will apply for export
        licences.

       

      Project
        Teams

       

      Supplier
        will sit on project teams relevant to Client products and feedback information
        from these meetings to Client. 

       

      Specials
        Licences

       

      Supplier
        will maintain the products supplied under a ‘Specials’ licence.

       

      
        	2.3    	
                Governance

              

      

       

      For
        Regulatory Affairs:-

       

      Client
        Representative is Iftikhar Ali.

       

      Supplier
        Representative is Anita Murray.

       

      
        	2.4    	
                Documents

              

      

       

      
        	
                Document

              	
                On
                  Request

              	
                Frequency
                  of

                Supply

              
	
                Variation/renewal
                  package

              	
                X

              	 
	
                Update
                  licence documents

              	 	
                Following
                  change

              
	
                Site
                  Licences

              	
                X

              	 

      

       

      
        	2.5    	
                Key
                  Performance Indicators

              

      

       

      
        	
                KPI

              	
                Indicator

              	
                Target

              	
                On
                  Request

              
	
                Provision
                  of

                appropriate
                  data 

              	
                Number
                  of

                questions
                  from 

                Agency

              	
                Agency
                  approval

              	
                Quarterly

              

      

       

      
        
          
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              TREATMENT

          

        

        
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        	3.    	
                SUPPLY
                  CHAIN MANAGEMENT

              

      

       

      Consisting
        of:

       

      3.1    Responsibility
        Matrix

       

      
        	 	
                Supply
                  Chain Management

              	
                Client

              	
                Supplier

              
	
                B.1

              	
                Provide
                  Monthly Forecast

              	
                X

              	 
	
                B.2

              	
                Enter
                  Forecast in Manugistics (UK - EIRE - France - Germany)

              	
                X

              	 
	 	
                Enter
                  Forecast in Manugistics (Other Territories)

              	 	
                X

              
	 	
                Provide
                  weekly/monthly sales figures

              	
                X

              	 
	
                B.3

              	
                Order
                  Entry - Stock allocation for 3rd
                  Party Export

              	
                X

              	 
	
                B.4

              	
                Credit
                  Mngt 3rd
                  Party Export 

              	
                X

              	 
	
                B.5

              	
                Determine
                  Sales and Operation Plan Policy

              	
                X

              	 
	
                B.6

              	
                Create
                  Sales and Operational Plan

              	 	
                X

              
	
                B.7

              	
                Determine
                  Replenishment Plan Policy

              	
                X

              	 
	
                B.8

              	
                Create
                  Replenishment Plan

              	 	
                X

              
	
                B.9

              	
                Create
                  Production Plan

              	 	
                X

              
	
                B.10

              	
                Create
                  Capacity Plan

              	 	
                X

              
	
                B.11

              	
                Determine
                  Quota Policy 

              	
                X

              	 
	
                B.12

              	
                Mngt
                  of Quota System 

              	 	
                X

              
	
                B.13

              	
                Determine
                  Finished products Inventory Policy

              	
                X

              	 
	
                B.14

              	
                Determine
                  Cycle Count Policy (Dunstable)

              	
                X

              	 
	
                B.15

              	
                Apply
                  Cycle Counting (Dunstable)

              	
                X

              	 
	
                B.16

              	
                Apply
                  Finished products Inventory Management according to Client
                  Policy

              	 	
                X

              
	
                B.17

              	
                Distribute
                  Reporting (See Sections 7 and 8)

              	
                X

              	
                X

              
	
                B.18

              	
                Draft
                  and Apply SLA with Affiliates 

              	 	
                X

              
	
                B.19

              	
                Shipping
                  Documentation (Dispatch Note - CoA)

              	 	
                X

              
	
                B20

              	
                Manage
                  the supply chain for Xyrem including the introduction of the new
                  formulation planned for 2006/7

              	 	
                X

              
	
                B21

              	
                Manage
                  name change

              	
                X

              	
                X

              
	 	
                Artwork

              	
                X

              	
                X

              
	 	
                Provision
                  of Style Guide

              	
                X

              	 
	 	
                Change
                  Control Request based on Template (Manufactured and Bought In)
                  with
                  annotated copy artwork

              	
                X

              	 
	 	
                Generation
                  and Design of Artwork (Manufactured Goods and Bought In)

              	 	
                X

              
	 	
                Insertion
                  of component code/pharmacode where applicable

              	 	
                X

              
	 	
                Approval
                  of Artwork (Manufactured Goods and Bought In)

              	
                X

              	
                X

              
	 	
                Printing
                  of Artwork

              	 	
                X

              
	 	
                Change
                  Control Request for SPC’s

              	
                X

              	 
	 	
                Generation
                  of new statement of product characteristics (SPC) or amendment
                  current
                  SPC

              	 	
                X

              
	 	
                Approval
                  of SPC

              	
                X

              	 
	 	
                Job
                  Sheet raised for promotional artworks (brochures etc)

              	
                X

              	 
	 	
                Quote
                  provided for Promotional Artwork

              	 	
                X

              
	 	
                Approval
                  Granted for Promotional Artwork

              	
                X

              	 
	 	
                Generation/amendment
                  of promotional artwork

              	 	
                X

              
	 	
                Approval
                  of promotional artwork

              	
                X

              	 
	 	
                Arrange
                  printing of promotional material (if in original quote)

              	 	
                X

              

      

       

      3.2    Description
        of Services

       

      Demand 

       

      3rd
        Party Demand

       

      
        
          
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      Client
        will make the order entry service for third party customers based on
        instructions given by Client’s international trade group in Slough. Supply of
        unforcasted demand will be subject to negotiation of leadtimes within
        forty-eight (48) hours where possible however, where material supplies to
        meet
        this demand have to be negotiated it is accepted that this could take at
        least
        five (5) working days.

       

      Forecasting

       

      Supplier
        will record forecasts coming from Client Affiliates (with exception of the
        identified territories) in Manugistics. Those forecast will be provided by
        Client on a monthly basis - first week of the month - by SKU - in Monthly
        Buckets - with a Horizon of minimum of eighteen (18) Months.

       

      The
        first
        three (3) months of such forecast will be deemed firm with respect to procuring
        materials. Client will however underwrite the purchase of materials with
        longer
        lead-times where advance purchase is required to meet demand and where
        Supplier’s minimum order quantity exceeds demand. Supplier will provide a list
        of all materials with a lead-time longer than three (3) months; these items
        will
        be reviewed at the monthly demand and supply meeting with a view to Client
        identifying where these purchases would not be appropriate. Supplier will
        also
        provide a monthly short dated stock report for review at this meeting. Client
        will underwrite these materials and will reimburse Supplier should they
        subsequently become obsolete or exceed their shelf life. On an annual basis
        Client and Supplier will review overall product cycle times in order to agree
        purchase policies and procedures.

       

      Client
        and Supplier will review jointly on a monthly as appropriate basis the
        forecasted demand against supply and relevant KPI’s. The meeting will take place
        at Supplier - Slough on alternate months. During this meeting the Client
        portfolio will be discussed in terms of new product launches - product
        promotions - product extensions (SKU level) - pricing changes and impact
        on
        demand - discontinuation of SKU - regulatory changes - replacements of products.
        The planning policies: coverage - lead-times - allocated volumes will be
        discussed accordingly.

       

      Planning
        

       

      Sales
        and Operational Plan (S&OP)

       

      Client
        and Supplier will jointly agree on the S&OP policy and
        implementation.

       

      Client
        and Supplier will meet on an a quarterly basis for the S&OP meeting relating
        to Client critical products (for example: Xyrem - Equasym - Dipentum). During
        this meeting Supplier will inform Client about demand vs capacity, coverage
        of
        stock. Client portfolio will be discussed in terms of new product launches,
        product promotions, product extensions (SKU level), pricing changes and impact
        on demand, discontinuation of SKU, regulatory changes and replacements of
        products. The planning policies: coverage, lead-times and allocated volumes
        will
        be discussed accordingly. 

       

      Replenishment
        Plan

       

      Client
        will provide weekly/monthly sales figures at the and of each week/month as
        appropriate which together with the forecast data will enable a replenishment
        plan to be formulated.

       

      Supplier
        will provide Client on a monthly basis a replenishment plan. This plan will
        be
        provided in the second week of each month (by Affiliate or third party, by
        SKU,
        in Weekly Buckets and with an Horizon minimum of eighteen (18)
        months.

       

      
        
          
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              TREATMENT

          

        

        
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      Supplier
        will provide Client on a monthly basis a report which measures the replenishment
        planning accuracy (planned replenishment vs policy) and the replenishment
        planning execution accuracy (planned replenishment vs actual replenishment).
        Any
        deviation will be explained by reason codes.

       

      Production
        - Capacity Plan

       

      Supplier
        will provide Client on request the demand on production - capacity plan.
        This
        plan will be expressed per work centre, by SKU excluding third party details,
        in
        Weekly Buckets, with an Horizon of twelve (12) months, available capacity
        and
        production batches (quantities).

       

      Inventory
        Management 

       

      Supplier
        will review on a six (6) monthly basis with Client the inventory policy rules.
        The inventory policy rules will determine the safety stock level of each
        SKU
        considering the following criteria:

       

      
        	·    	
                product
                  lead-time including material
                  procurement;

              

      

       

      
        	·    	
                function
                  of demand reliability (forecast accuracy) - replenishment reliability
                  -
                  lead-time reliability - inventory accuracy reliability - production
                  process reliability;

              

      

       

      
        	·    	
                service
                  level will be defined in the Affiliate SLA and according to the
                  definition
                  of product availability. Target annual service level will be 98.5%
                  (Target
                  Annual Service Level);

              

      

       

      
        	·    	
                If
                  Target Annual Service Level not met both parties will review the
                  causes
                  and agree an action plan improve the
                  service.

              

      

       

      Maximum
        Stock Level:

       

      Supplier
        will supply and Client will accept product in complete batch sizes. Supplier
        will review with Client a maximum stock level by SKU at the central warehouse
        and warehouse in the territories on a six (6) monthly basis. Supplier will
        notify Client when full batch deliveries will exceed these targets.

       

      All
        products excluding bought in products will be delivered and released to the
        central warehouse with a shelf life of at least 90% of
        their
        original shelf life or
        85% of
        their original shelf life for short shelf products (two (2) years and less).
        All
        stock delivered to the central warehouse with a shorter shelf live will be
        subject to negotiation.

       

      Client
        on
        a six (6) monthly basis will determine together with Supplier the maximum
        WIP
        level for the next six (6) months. In the case that Client ceases the sale
        of an
        SKU or product, Client will compensate Supplier for the materials purchased
        and
        WIP up to an agreed maximum. 

       

      Stock
        Monitoring:

       

      Supplier
        will monitor Client stock (central and regional (Affiliate)) on a weekly
        /
        monthly basis dependent on SKU and report the stock levels by SKU and status
        (Quarantine - Released) - Supplier will report Stock by Week or Month - by
        SKU -
        by Location - by Status. Supplier will notify Client of potential problems
        with
        stocks in the market and will confirm the replenishment plan to recover the
        supply situation.

       

      
        
          
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              TREATMENT

          

        

        
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      Supplier
        will set up and manage a quota system for the relevant products in order
        to
        distribute the volumes throughout the markets. The policy - principles and
        rules
        of the quota system will be discussed and agreed in consensus with Client.
        

       

      Release
        of Finished Goods:

       

      Client
        products will be supplied ex-works and become Client ownership on collection
        from Supplier. Supplier will certify all batches of manufactured goods within
        fifteen (15) working days for sterile products and seven (7) days for
        non-sterile products after complete batch receipt at central warehouse. If
        batches are not release with the timeframes mentioned Client has the right
        to
        return the product to Supplier at their costs.

       

      Transport
        

       

      Supplier
        is responsible for the replenishment plan. Transport and distribution to
        the
        central warehouse and territories will be the responsibility of Client. Supplier
        will supply ex works. Supplier will coordinate with Client central warehouse
        to
        agree collection schedules.

       

      Supplier
        will be responsible for the organization of transport for incoming goods
        (raw
        materials - packaging - components).

       

      Supplier
        will supply certificates of analysis and other document required by applicable
        law (UK and International for exports) for all shipments to the central
        warehouse as detailed in the GMP/Technical Agreement.

       

      Distribution
        from the central warehouse to UK or export markets will be the responsibility
        of
        Client. Client will be responsible for all distribution export documentation.
        Supplier will cooperate where relevant by providing the necessary information
        needed for export documentation (Certificate of Analysis - Certificate of
        Origin)

       

      If
        goods
        need to be returned to Supplier premises for quality reasons, Supplier is
        responsible for all logistic costs and reprocessing cost.

       

      Value
        Added Logistics

       

      Supplier
        will provide value added logistics (repack - re-label - destruction) on an
        ad
        hoc basis. For this service Client will ask Supplier a special procurement
        order
        and the price will be fixed in due time.

       

      Supplier
        will provide Client with an activity report to approve the work, which will
        form
        the basis for invoicing.

       

      Artwork
        

       

      Client
        will advise Supplier of the required artwork generation/changes using the
        electronic change control notification (CCN).
        It is
        the responsibility of Client to ensure all required fields are completed.
        A copy
        of the current approved artwork annotated with changes in the form of a PDF
        will
        be provided with the CCN.

       

      Supplier
        will update the artwork and add component and pharma codes where
        applicable.

       

      Supplier
        will update the artwork tracker. Artwork tracker will either be on a shared
        drive or supplied by PDF file on a weekly basis. 

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          34

          
            

          

        

        
          
          

        

      

      Supplier
        will provide a first draft review to Client regulatory in PDF format within
        three (3) days of receipt of CCN. If further changes are required Client
        will
        update the PDF with electronic notelets.

       

      Once
        technically approved Supplier will then place the PDF master artwork in the
        regulatory approval folder. (Longer term if Client cannot access the server
        this
        will be by e mail). 

       

      Supplier
        will co-ordinate the update with Supplier technical support.

       

      Client
        will then approve the master PDF, place in the approved folder and advise
        Supplier via e mail of the approval.

       

      Approved
        artwork will then be implemented in line with regulatory requirements (max
        six
        (6) months) and in agreement with Client.

       

      Artwork
        (design and printing) will be part of the product cost.

       

      If
        Artwork changes are initiated by Supplier all related write off cost will
        be
        charge to Supplier.

       

      If
        Artwork changes are initiated by Client all related write off cost will be
        charge to Client. All write off cost will be identified and agreed with
        Client.

       

      Client
        reserves the right to transfer the responsibility of Artwork (design and
        generation) to Client for following products (Xyrem - Equasym XL/IR - Dipentum)
        at any time.

       

      Affiliates
        Service Level Agreements (SLA)

       

      Supplier
        will set up a SLA agreement with the Client Affiliates to determine the specific
        rules applicable for Inventory Management, Replenishment and Distribution.
        This
        SLA will be reviewed on a six (6) monthly basis. This SLA will contain following
        topics:

       

      
        	·    	
                Planning
                  Principles;

              

      

       

      
        	·    	
                Planning
                  Calendar;

              

      

       

      
        	·    	
                Shipping
                  - & Delivery Specification;

              

      

       

      
        	·    	
                Packaging
                  Specifications;

              

      

       

      
        	·    	
                Labelling
                  Specifications;

              

      

       

      
        	·    	
                Prewholesaling
                  Specifications;

              

      

       

      
        	·    	
                Contact
                  People;

              

      

       

      
        	·    	
                Discontinuation
                  Principles;

              

      

       

      
        	
                ·    

              	
                Product
                  Information; and

              

      

       

      
        	·    	
                Artwork
                  Process.

              

      

       

      An
        example of an SLA in included in Schedule 6.

       

      Continuous
        Improvement 

       

      
        
          
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      Supplier
        and Client will set up on a yearly basis a continuous improvement programme.
        The
        programme will focus on issues agreed between Supplier and Client that will
        lead
        to improvements in cost and in service (shorter lead times for materials
        or
        products, improvement of the reliability, responsiveness, quality and
        information supply as appropriate).

       

      Every
        improvement idea will be analysed through a feasibility study in joint
        cooperation (to be completed within two (2) months) and will be followed
        by
        appropriate financial calculation using net present value (NPV)
        to
        evaluate the benefits of the improvement idea (to be completed within three
        (3)
        months). 

       

      The
        approved improvement idea will be implemented by Supplier within a timeframe
        less than six (6) months after approval. The cost savings will be expressed
        in
        cost of goods sales. The cost savings will be shared 50/50 between Client
        and
        Supplier. 

       

      3.3    Governance

       

      For
        supply chain management the Client representative is B Ginger/B
        Standart.

       

      For
        supply chain management the Supplier representative is T Weeks.

       

      3.4    Documents

       

      
        	
                SCM
                  Document

              	
                On
                  Request

              	
                Frequency
                  of Supply

              
	
                Forecasting

              	
                X

              	 
	
                Replenishment
                  Plan

              	 	
                Monthly

              
	
                Production
                  Plan

              	
                X

              	 
	
                Procurement
                  Plan

              	
                X

              	 
	
                Capacity
                  Plan

              	
                X

              	 
	
                Sales
                  & Operational Plan

              	 	
                Quarterly

              
	
                Stock
                  Status Report

              	 	
                Weekly
                  / Monthly

              
	
                Artwork
                  Report

              	
                X

              	 
	
                Value
                  Added Logistics Report

              	
                X

              	 

      

       

      3.5    Key
        Performance Indicators (KPIs)

       

      In
        order
        to measure the performance of the business following KPI will be used. Supplier
        will calculate those KPI’s on a monthly basis and provide Client with the actual
        performance of those KPI vs the Target

      

      
        	
                KPI

              	
                Target

              	
                On
                  Request

              	
                Frequency

              
	
                Forecast
                  Accuracy

              	
                70%

              	 	
                Monthly:
                  6th
                  working day

              
	
                Days
                  of Supply

              	
                95%

              	 	
                Monthly:
                  6th
                  working day

              
	
                Days
                  of Supply (Brian Ginger)

              	 	 	
                Monthly:
                  6th
                  working day

              
	
                Replenishment
                  Accuracy

              	
                98%

              	 	
                Monthly:
                  6th
                  working day

              
	
                Out
                  of stock

              	
                98.5%

              	 	
                Monthly:
                  6th
                  working day

              
	
                Inventory
                  At Risk - Write off (WIP - RM and Components)

              	 	 	
                Monthly:
                  6th
                  working day 

              
	
                Delivery
                  with Appropriate Shelf Life 90% - 16 Month

              	
                99.5%

              	 	
                Monthly:
                  6th
                  working day

              
	
                Respect
                  of Maximum Stock level

              	
                99.5%

              	 	
                Monthly:
                  6th
                  working day

              

      

      

      
        
          
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      Forecast
        Accuracy 

      

      The
        difference between actual demand and the forecast made previously three (3)
        months for a given time period. 

      

      Formula:
        Forecast AccuracyM
        = 1 -
        ABS[(SM
        -
        FM-3)
        /
        SM]

      

      Days
        of Supply 

      

      Formula:

      

      Current
        on hand (approved) inventory / average daily forecast for the next three
        (3)
        months. Number of SKU’s at or above target (minimum stock level in days) = Hit.

      Percentage
        shows the number of SKU with a cover higher than the target/total number
        of
        SKU.

       

      Replenishment
        Accuracy

      

      It
        computes the difference, in terms of quantity per SKU and timeliness, between
        the order placed previously by Client and the effective shipment from Supplier
        for a given time period.

      

      Formula:
        Replenishment Accuracy = delivered quantity on time and in full / promised
        quantity according replenishment plan 

      

      Inventory
        at risk 

      

      Expressed
        in €, it represents the inventory that is short-dated or will expire before it
        will be sold.

      

      It
        considers products with no movement in the last twelve (12) months.

      

      Write
        Off

      

      Expressed
        in €, it represents the inventory that is authorised to be discarded/destroyed
        due to expiration, damage or returned product. 

       

      Out
        of stock: 

      

      Product
        Availability

      

      The
        total
        number of stock days in the month is the number of SKU’s produced by the site
        multiplied by the number of working days in the month.

      

      The
        number of working days in the month is considered as thirty (30) days for
        all
        months for the purposes of this calculation. 

      

      The
        number of stock out days is the total number of all stock out days for each
        SKU
        during the month.

      
         

        
          
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      Formula:

      

      Product
        Availability = total
        stock days - total stock out days
        X
        100

      total
        stock days

      

      Delivery
        with appropriate shelf life 90% or sixteen (16) months

      

      It
        measures the percentage of batches delivered with the shelf life either above
        90% of total shelf life or sixteen (16) months.

      

      Formula:
        

      

      Delivery
        with appropriate shelf life = batches delivered with appropriate shelf
        life/total number of batches delivered.

      

      Respect
        of Maximum Stock Level

      

      Formula:

      

      Current
        on hand (approved) inventory / average daily forecast for the next three
        (3)
        months 

      

      Number
        of
        SKU’s at or below target (maximum stock level in days) = HIT

      

      The
        percentage shows the number of SKU with a cover higher than the target/Total
        number of SKU.

      

      4.    INFORMATION
        TECHNOLOGY

       

      Including:

       

      4.1    Responsibility
        Matrix

       

      
        
          	
                  IT
                    

                	
                  Client

                	
                  Supplier

                
	
                  Helpdesk

                	 	 
	
                  Definition
                    of shared services and required support model and associated
                    SLA.

                	
                  X

                	
                  X

                
	 	 	 
	
                  Manugistics

                	 	 
	
                  Manugistics
                    Interfaces Free Stocks - Daily

                	 	
                  X

                
	
                  Manugistics
                    Interfaces Quarantine Stocks - Daily

                	 	
                  X

                
	
                  Manugistics
                    Interfaces Purchase Orders - Daily

                	 	
                  X

                
	
                  Manugistics
                    Interfaces Sales Orders - Daily

                	 	
                  X

                
	
                  Manugistics
                    Interfaces Sales History - Monthly

                  Produces
                    the statistical forecast. 

                	 	
                  X

                
	
                  Manugistics
                    Support

                	 	
                  X

                
	
                  Manugistics
                    New User/Refresher Training

                	 	
                  X

                
	
                  Manugistics
                    Reports via Discoverer (KG) written developed/maintained
                    IT

                	 	
                  X

                
	
                  Manugistics
                    Data Integrity Checks - Daily. If not checked will lead to sales
                    history
                    problems

                	 	
                  X

                
	
                  Manugistics
                    - User Creation/Maintenance

                	 	
                  X

                
	
                  Retention
                    or transition Client site dependence on Manugistics to another
                    solution

                	
                  X

                	
                  X

                

        

         

        
          
            
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                  Sage
                    - Dunstable

                	 	 
	
                  Sage Supporting
                    EDI In/Out for new/amended products/customers

                	 	
                  X

                
	
                  Sage
                    - support customer service with EDI In/Out usage and resolve
                    errors
                    reports

                	 	
                  X

                
	
                  Define
                    transition plan (see below)

                	 	 
	 	 	 
	
                  EDI
                    - Dunstable

                	 	 
	
                  EDI -
                    Responsible for support of In/Out interfaces on Gentran - 3 times
                    a
                    day

                	 	
                  X

                
	
                  EDI
                    - Creation of new customers/products

                	 	
                  X

                
	
                  EDI
                    Support Handover if required (one Month)

                	
                  X

                	
                  X

                
	
                  EDI
                    new customer access required to Sage test system

                	
                  X

                	
                  X

                
	 	 	 
	
                  Visa

                	 	 
	
                  Visa
                    interfaces - Weekly monthly 

                	 	
                  X

                
	
                  Changes
                    to interfaces in terms of data or frequency

                	 	
                  X

                

        

      

       

      4.2    Description
        of Services

       

      Helpdesk

       

      Client
        end users or the Supplier IT department will raise calls with the Client
        international helpdesk on behalf of shared service applications for Manugistics-
        Sterling Commerce EDI-SAGE EDI In/Out and Oracle Gemms.

       

      Monthly
        helpdesk reports will be sent to the Supplier IT manager and SLA performance
        will be monitored between Supplier and Client IT managers. Support calls
        placed
        with the Client international helpdesk will aim to be resolved within eight
        (8)
        hours (see 4.4).

       

      The
        Client helpdesk will be solely used by the Supplier for the resolution of
        issues
        related to shared service applications or infrastructure.

       

      Manugistics

       

      Manugistics
        is an MRP forecasting application - hosted and supported by the Supplier
        - but
        accessed by Slough, Nanterre, Sindorf and Dublin Client sites.

       

      Each
        business day (with the exception of UK bank holidays) the Supplier IT department
        will perform daily checks to ensure all services and interfaces are available
        and complete and that application performance is satisfactory. 

       

      The
        Client Sage system provides on a daily basis daily and historic sales data,
        which is fed into the Manugistics system. The Client IT department will perform
        daily checks to ensure that this interface is functioning.

       

      The
        Supplier will back up the Manugistics database up each evening as part of
        a six
        (6) week backup/strategy schedule. The Supplier will hold backup tapes in
        a
        fireproof store in another part of the site.

       

      The
        Manugistics test database will be refreshed from the live database either
        upon
        request or periodically as determined by Supplier IT personnel.

       

      
        
          
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      The
        Supplier IT department will provide telephone and email support to the Client
        on
        request. The Client will route Manugistics helpdesk calls to the Supplier
        IT
        department via the Client international helpdesk.

       

      The
        Supplier will acknowledge the international helpdesk within four (4) working
        hours and resolve all incidents within eight (8) working hours. UK bank holidays
        will be treated as non working hours.

       

      Client
        Sage System / Supplier Oracle Gemms System

       

      Sage
        is
        the legacy financial application used by legacy Celltech sites in the UK
        and
        hosted in Slough. A small number of Supplier users have access to this system
        and use it for specific purposes.

       

      Oracle
        Gemms is the Supplier ERP system hosted at Supplier site.

       

      Supplier
        site users will require continued access to the Sage system to raise purchase
        orders for Bought in Products. This amounts to approximately twenty (20)
        orders
        per week.

       

      Client
        Dunstable site users will require continued access to Supplier Oracle Gemms
        to
        move stock from a transient location (TRANS) to Client Dunstable
        site.

       

      Once
        certain stock has been approved for sale following QP release the associated
        stock transaction data is moved from the Supplier Oracle Gemms system to
        the
        Client Sage system by a Client Dunstable site user.

       

      The
        Client Dunstable user will raise a purchase order, which is sent to the Supplier
        customer services operation via email. Associated product will be shipped
        via
        the Oracle Gemms system and the transfer price invoiced via the Supplier
        Oracle
        Financials system.

       

      The
        Supplier will make sure that such transactions are highly synchronised to
        ensure
        data accuracy in both systems. The Supplier and Client IT departments will
        check
        the system interfaces on a daily basis and make sure that stock/sales/purchase
        orders between the Client Sage system and Supplier Oracle Gemms system are
        synchronised

       

      Incidents
        relating to either system will be acknowledged within four (4) working hours
        and
        resolved within eight (8) working hours by Client and Supplier IT departments.
        UK bank holidays will be treated as non working hours.

       

      Sterling
        Commerce EDI - Dunstable

       

      The
        EDI
        system is hosted at the Client Rochester site and accessed and used by Supplier
        IT staff who are responsible for managing the application of EDI services
        to the
        legacy Celltech UK business. 

       

      Supplier
        will perform ad-hoc communication between Rochester EDI team and Supplier
        of any
        proposed downtime or changes to system.

       

      The
        Supplier will perform exception testing via email alerts of failure due to
        data
        discrepancies. Resolution will involve use of Sterling Commerce Tools and
        communication with customer services and customers.

       

      Supplier
        will perform training and support of customer services using EDI In/Out
        Modules.

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          40

          
            

          

        

        
          
          

        

      

       

      Supplier
        will acknowledge the Helpdesk call within four (4) working hours and resolve
        any
        issues within eight (8) working hours. UK bank holidays will be treated as
        non
        working hours.

       

      The
        Supplier will escalate any calls to Sterling Commerce or Hewlett Packard
        due to
        product or hardware problems as per contracts with vendors.

       

      VISA

       

      The
        Supplier will provide Client on a daily basis transactional data including
        inventory, sales orders, shipments, invoices, stock movements and goods receipt
        according to the Client’s specifications and technology needs.

       

      4.3    Governance

       

      For
        IT
        Supplier representative is P Shaw

       

      For
        IT
        Client representative is K Faulkner

       

      4.4    Key
        Performance Indicators

       

      
        	
                KPI

              	
                Indicator

              	
                Target

              	
                On
                  Request

              
	
                Support
                  Calls 

                for
                  Shared

                Services

              	
                Resolution
                  Time

              	
                eight
                  (8) working hours of 

                receiving
                  call

              	 

      

       

      
        
          
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              TREATMENT

          

        

        
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      SCHEDULE 2

       

      GMP
        Agreement

       

      GMP
        Agreement For Quality Services Relating To Pharmaceutical Products On Toll
        Manufacture (Brought In Products)

       

      BETWEEN         UCB
        Pharma Ltd (UCB)

      

      AND            CONTRACT
        ACCEPTOR,
        with
        registered offices at Supplier

      

      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 Toll Manufacturing
        Agreement for the PRODUCTS (the “FRAME
        AGREEMENT”);

      

      NOW
        THEREFORE THE PARTIES HAVE AGREED AS FOLLOWS:

      

      1.    SCOPE
        OF THE 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 - last edition). 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
                  Kiillick. (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.

      

      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

       

      
        
          
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              TREATMENT

          

        

        
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          	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

                	 	 

        

         

        
          
            	 	 	
                    CONTRACT

                    GIVER

                  	
                    CONTRACT
                      ACCEPTOR

                  
	 	
                    Valid
                      applicable licence available

                  	
                     

                  	
                    X

                  
	
                    .

                  	
                    Formulation
                      / data sheet

                  	
                    NA

                  	
                    NA

                  
	 	
                    Manufacturing
                      procedures / batch sheets

                  	
                    NA

                  	
                    NA

                  
	 	
                    Registered
                      formula, process, etc.

                  	
                    NA

                  	
                    NA

                  
	 	
                    Scale-up
                      procedures

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      master plan

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      protocol

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      report

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      procedures

                  	
                    NA

                  	
                    NA

                  
	 	
                    Analytical
                      specifications and methods and IPC (In process control)

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      of analysis methods

                  	
                    NA

                  	
                    NA

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

                  	 	
                     

                    X

                  
	 	
                    Labelling
                      instructions

                  	
                    NA

                  	
                    NA

                  
	 	
                    Cleaning
                      procedures

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      of cleaning procedures prior to production 

                  	
                    NA

                  	
                    NA

                  
	 	
                    Validation
                      of cleaning procedures after production

                  	
                    NA

                  	
                    NA

                  
	 	
                    Stability
                      testing

                  	 	
                    X

                  
	 	
                    Stability
                      protocol

                  	 	
                    X

                  
	 	
                    Stability
                      test methods

                  	
                    X

                  	 
	 	
                    Stability
                      report

                  	 	
                    X

                  

          

           

          
            	 	
                    Bulk
                      Manufacture

                  	 	 

          

           

          
            	 	 	
                    CONTRACT

                    GIVER

                  	
                    CONTRACT
                      ACCEPTOR

                  
	
                     

                    B.1

                  	
                     

                    Raw
                      Materials

                  	 	 
	 	
                    Purchase
                      of excipients or raw materials.

                  	
                    NA

                  	
                    NA

                  
	 	
                    Supplier
                      evaluation

                  	
                    NA

                  	
                    NA

                  
	 	
                    Analysis
                      

                  	
                    NA

                  	
                    NA

                  
	 	
                    Release

                  	
                    NA

                  	
                    NA

                  
	 	
                    Storage
                      of reference samples 

                  	
                    NA

                  	
                    NA

                  
	 	
                    Procurement
                      / order free of charge of active substance

                  	
                    NA

                  	
                    NA

                  
	 	
                    Analysis
                      

                  	
                    NA

                  	
                    NA

                  
	 	
                    Release

                  	
                    NA

                  	
                    NA

                  
	 	
                    Identity
                      control of active substance

                  	
                    NA

                  	
                    NA

                  
	 	
                    Storage
                      of reference sample 

                  	
                    NA

                  	
                    NA

                  
	
                    B.2

                  	
                    Manufacture

                  	 	 
	 	
                    Validation
                      of scale-up/manufacturing process

                  	
                    NA

                  	
                    NA

                  
	 	
                    Master
                      of Manufacturing formula

                  	
                    NA

                  	
                    NA

                  
	 	
                    Master
                      of Processing instructions

                  	
                    NA

                  	
                    NA

                  
	 	
                    Manufacture
                      following agreed procedure

                  	
                    NA

                  	
                    NA

                  
	 	
                    Allocation
                      of batch numbers for bulk

                  	
                    NA

                  	
                    NA

                  

          

        

      

       

      
        
          
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              TREATMENT

          

        

        
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                  CONTRACT

                  GIVER

                	
                  CONTRACT
                    ACCEPTOR

                
	
                   

                  B.3

                	
                   

                  Analysis
                    and controls

                	 	 
	 	
                  Perform
                    in process - controls

                	
                  NA

                	
                  NA

                
	 	
                  Validate
                    the methods of analysis for new products

                	
                  NA

                	
                  NA

                
	 	
                  Purchase
                    of necessary reference standards

                	
                  NA

                	
                  NA

                
	 	
                  Analysis

                	
                  NA

                	
                  NA

                
	 	
                  Release
                    for packaging

                	
                  NA

                	
                  NA

                
	 	
                  Storage
                    of reference sample

                	
                  NA

                	
                  NA

                
	 	
                  Certificate
                    of analysis

                	
                  NA

                	
                  NA

                

        

         

        
          
            	
                    C.

                  	
                    Primary
                      Packaging / Semi-finished Product

                  	 	 

          

           

          
            	 	 	
                    CONTRACT

                    GIVER

                  	
                    CONTRACT
                      ACCEPTOR

                  
	
                     

                    C.1

                  	
                     

                    Packaging
                      Components

                  	 	 
	 	
                    Specifications
                      for unprinted primary packaging materials (unprinted PPM)

                  	
                    NA

                  	
                    NA

                  
	 	
                    Supplier
                      evaluation

                  	
                    NA

                  	
                    NA

                  
	 	
                    Procurement
                      of unprinted PPM

                  	
                    NA

                  	
                    NA

                  
	 	
                    Methods
                      of testing unprinted PPM

                  	
                    NA

                  	
                    NA

                  
	 	
                    Specifications
                      for printed primary packaging materials 

                  	
                    NA

                  	
                    NA

                  
	 	
                    Specifications
                      for text/Artwork

                  	
                    NA

                  	
                    NA

                  
	 	
                    Supplier
                      evaluation

                  	
                    NA

                  	
                    NA

                  
	 	
                    Procurement
                      of printed PPM

                  	
                    NA

                  	
                    NA

                  
	 	
                    Methods
                      of testing printed PPM

                  	
                    NA

                  	
                    NA

                  
	 	
                    Testing
                      

                  	
                    NA

                  	
                    NA

                  
	 	
                    Release

                  	
                    NA

                  	
                    NA

                  
	 	
                    Allocation
                      of batch numbers for PPM

                  	
                    NA

                  	
                    NA

                  
	 	
                    Storage
                      of reference samples 

                  	
                    NA

                  	
                    NA

                  
	 	 	 	 
	
                     

                    C.2

                  	
                     

                    Primary
                      packaging

                  	 	 
	 	
                    Allocation
                      of batch numbers

                  	
                    NA

                  	
                    NA

                  
	 	
                    Allocation
                      of expiry dates

                  	
                    NA

                  	
                    NA

                  
	 	
                    Code
                      to be used

                  	
                    NA

                  	
                    NA

                  
	 	
                    Master
                      of packaging instructions

                  	
                    NA

                  	
                    NA

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

                  	
                    NA

                  	
                    NA

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

                  	
                    NA

                  	
                    NA

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

                  	
                    NA

                  	
                    NA

                  
	 	
                    Performing
                      stability studies in final packages

                  	 	
                    X

                  

          

        

      

       

      
        
          	
                  D.

                	
                  Secondary
                    Packaging / Finished
                    Product

                

        

         

        
          	 	 	
                  CONTRACT

                  GIVER

                	
                  CONTRACT
                    ACCEPTOR

                
	
                   

                  D.1

                	
                   

                  Secondary
                    Packaging Components

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

                	
                  NA

                	
                  NA

                
	 	
                  Specifications
                    for printed SPM (physical)

                	
                  NA

                	
                  NA

                
	 	
                  Methods
                    of testing printed SPM

                	
                  NA

                	
                  NA

                
	 	
                  Supplier
                    evaluation

                	
                  NA

                	
                  NA

                
	 	
                  Procurement
                    of printed SPM

                	
                  NA

                	
                  NA

                
	 	
                  Control

                	
                  NA

                	
                  NA

                
	 	
                  Release
                    for use

                	
                  NA

                	
                  NA

                
	 	
                  Allocation
                    of batch numbers for printed SPM

                	
                  NA

                	
                  NA

                
	 	
                  Storage
                    of reference samples 

                	
                  NA

                	
                  NA

                

        

      

       

      
        
          
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              TREATMENT

          

        

        
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                D.2

              	
                 

                Secondary
                  Packaging

              	 	 
	
                D.2.1

              	
                Allocation
                  of batch numbers

              	
                NA

              	
                NA

              
	
                D.2.2

              	
                Allocation
                  of expiry dates

              	
                NA

              	
                NA

              
	
                D.2.3

              	
                Code
                  to be used

              	
                NA

              	
                NA

              
	
                D.2.4

              	
                Master
                  of packaging instructions

              	
                NA

              	
                NA

              
	
                D.2.5

              	
                Paletisation
                  instructions

              	
                NA

              	
                NA

              
	
                D.2.6

              	
                Master
                  of shipping label

              	
                NA

              	
                NA

              
	
                D.2.7

              	
                Test
                  of the finished product (EU)

              	
                 

              	
                X

              
	
                D.2.8

              	
                Issue
                  certificate of quality

              	 	
                X

              
	
                D.2.9

              	
                QP
                  Certification of the finished product....

              	
                NA

              	
                NA

              
	
                D.2.10

              	
                Release
                  of the finished product for sale/distribution to market

              	
                NA

              	
                NA

              
	
                D.2.11

              	
                Storage
                  of reference/ retention samples for the finished product

              	
                NA

              	
                NA

              

      

       

      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.

      

      
        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 analysis 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

      

      
        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.

      

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          45

          
            

          

        

        
          
          

        

      

      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 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 5 (five) working
        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 Analysis. 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

          

        

        
          46

          
            

          

        

        
          
          

        

      

      
        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 program 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 program/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 fourteen (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 thirty (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 (3) months or longer intervals
        (including at the expiry test station/label expiry date) the tests must be
        initiated within fourteen (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

          

        

        
          47

          
            

          

        

        
          
          

        

      

      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
        twenty (20) business days of the initial out-of-specification result. If
        the
        investigation will exceed twenty (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 computerized 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. UCB will approve or reject all protocols and validation reports
        within
        fifteen (15) working 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 process,
        packaging, analytical, 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

          

        

        
          48

          
            

          

        

        
          
          

        

      

       

      
        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
        (1)
        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

          

        

        
          49

          
            

          

        

        
          
          

        

      

      CONTRACT
        ACCEPTOR shall inform UCB of any inquiry from a regulatory agency specifically
        relating to PRODUCT and shall allow 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 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
        thirty (30) business days after initial receipt of the complaint by CONTRACT
        ACCEPTOR, unless otherwise agreed by UCB. If the investigation will exceed
        thirty (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 sixty (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 days 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 ninety (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

          

        

        
          50

          
            

          

        

        
          
          

        

      

      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 ten (10) business
        days. If more than ten (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 ten (10) business days. If more than ten
        (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 ten (10) business days after completion of
        the
        APR.

       

      The
        APR
        shall be completed within thirty (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.

       

      CONTRACT
        ACCEPTOR shall not use UCB product equipment to manufacture any product
        containing any of the following compounds without UCB written prior consent:
        

       

      ***

       

      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) working days hours 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

       

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          51

          
            

          

        

        
          
          

        

      

       

      q  are
        and
        remain property of UCB, 

       

      q  mode
        of
        disposal :

       

      to
        be
        returned to UCB or

       

      to
        be
        destroyed by CONTRACT
        ACCEPTOR.

       

      Upon
        expiration or termination of the 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,
        in the
        conditions specified in appendix XXX.

      

      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.   DOCUMENTS
        TO BE SUPPLIED TO UCB

      

      CONTRACT
        ACCEPTOR shall supply the following documents to UCB and shall keep the validity
        of the documents under 5.1 and 5.2 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]

                   

                

        

         

        
          
            
              CONFIDENTIAL
                TREATMENT

            

          

          
            52

            
              

            

          

          
            
            

          

        

         

        
          
            	
                    22.2.

                     

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

                  	
                    [X]

                     

                  	
                    [
                      ]

                     

                  
	
                    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]

                     

                  	
                    [
                      ]

                  
	 	
                    (at
                      every new version)

                  	
                    [
                      ]

                     

                  	
                    [x]

                     

                  
	 	
                    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]

                  	
                    [
                      ]

                  
	
                    22.5.

                     

                  	
                    Results
                      of the stability data when applicable

                  	
                  	
                    [X]

                  
	
                    22.6.

                     

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

                  	 	 
	 	
                    – 
                      Batch-specific analytical report

                  	
                    [X]

                  	
                    [
                      ]

                  
	 	– 
Batch-specific
                    certificate of analysis	 	 
	 	 	 	 
	 	
                    To
                      the Quality Assurance Department of UCB

                  	
                    [
                      ]

                  	
                    [X]

                  

          

            

          
            
              	
                      22.7.

                       

                    	
                      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]

                    
	
                      22.8.

                       

                    	
                      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.

      

      
        
          
            CONFIDENTIAL
              TREATMENT

          

        

        
          53

          
            

          

        

        
          
          

        

      

       

      
        
          	CONTRACT
                  ACCEPTOR	 	UCB
	 	 	 
	
                  ____________________

                	 	
                  _____________________ 

                
	
                  Name:

                	 	
                  Name:
                    

                
	
                  Title:

                	 	
                  Title:

                
	 	 	 
	 	 	 
	 	 	 
	 	 	 
	
                  ____________________

                	 	
                  _____________________

                
	
                  Name:

                	 	
                  Name:
                    

                
	
                  Title:

                	 	
                  Title:

                
	 	 	 
	 	 	 
	
                  Place:

                	 	
                  Place:

                
	
                  Date:

                	 	
                  Date:
                    

                

        

      
        
          
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      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

       

      
        
          
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      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

       

      Second
        contact people

       

      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 become part of the agreement (WHEN ?)

       

      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.

       

       

      
        
          
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      SCHEDULE
        3

       

      ***

      

       

      
        
          
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      SCHEDULE
        4

       

       

      List
        of
        Manufactured Products 

       

      

       

      ***

       

      

      
        
          
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      SCHEDULE
        5

       

      

      ***

      
        
          
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      Annex
        3

      

      ***

      
         

        
          
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      Annex
        4

      

      ***

       

      

       

      
        
          
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      SCHEDULE
        6

       

      

      ***

      
         

        
          
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      Appendix
        I

       

      

      ***

       

      
        
          
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      Appendix
        II

       

      ***

       

       

      
        
          
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