Exhibit 10.28


 


CONFIDENTIAL TREATMENT REQUESTED:


Portions of this Exhibit have been redacted
pursuant to a request for confidential treatment under Rule 24b-2 of the
General Rules and Regulations under the Securities Exchange Act of 1934,
as amended.  Such redacted portions have been replaced with “{***}” in this Exhibit.  An unredacted version of this document has
been filed separately with the Securities and Exchange Commission along with
the request for confidential treatment.


 


This
Amendment Agreement is made this 25th day of February 2005


 


BETWEEN


 


CAMBRIDGE
LABORATORIES LIMITED, a company organised and
existing under the laws of England and having its registered office at 17
Hanover Square, London W1S 1HU, Great Britain, and trading as CAMBRIDGE LABORATORIES IRELAND having its principal place of
business at Alexandra
House, The Sweepstakes, Ballsbridge, Dublin 4


 


Hereinafter  “Cambridge”


 


SYNKEM
S.A.S. a company organised and existing under the laws of
France with registered offices at 47 Rue de Longvic, 12300 Chenove, France.


 


Hereinafter “Synkem”


 


RECITALS


 


Cambridge
Laboratories Limited was formerly called Cambridge Selfcare Diagnostics
Limited.


 


Cambridge is
establishing a branch office in Ireland called Cambridge Laboratories Ireland (“Cambridge
Ireland”), that ,will become an affiliated company under common ownership with
Cambridge. Cambridge and Synkem entered into an. agreement on 31 July 1998
for the exclusive supply to Cambridge by Synkem of the active ingredient
tetrabenazine (hereinafter “the Supply Agreement”).


 


Cambridge and
Synkem entered into an agreement on 01 May 2003 for the preparation and
maintenance of a Drug Master File for the active ingredient tetrabenazine
(hereinafter “the DMF Agreement’).


 


The parties have
discussed the possibility of transferring the rights and obligations of
Cambridge to Cambridge Ireland, as well as of amending certain of the pricing
and supply aspects of the Supply Agreement and the DMF Agreement.


 


The parties
therefore have decided to enter into this amendment agreement (the “Amendment
Agreement’) to amend aspects of both the Supply Agreement and the DMF Agreement
as set forth herein.


 


Terms beginning
with a capital letter in this Amendment Agreement and which are not defined
herein shall have the meaning ascribed to them in the Supply Agreement or the
DMF Agreement, as applicable.


 

















 


THE
PARTIES AGREE as follows


 


1.                                      Assignment
to Cambridge Ireland. Synkem hereby agrees that Cambridge may assign its
rights and obligations under the Supply Agreement, the DMF Agreement and this
Amendment Agreement to Cambridge Ireland following incorporation of Cambridge
Ireland as an affiliated company under common ownership with Cambridge,
provided that Cambridge notifies Synkem as soon as Cambridge Ireland has been
incorporated as an affiliate under common ownership and that Cambridge
guarantees to Synkem the compliance by Cambridge Ireland of all of the
provisions of the Supply Agreement, the DMF Agreement and this Amendment
Agreement. .


 


2.                                      Compound
Price.
Article 3 of the Supply Agreement is hereby deleted. Save as set forth in
clause 3 below, the price Cambridge is to pay to Synkem for the Compound shall
be determined in accordance with the scale set forth in Part A of Schedule
1 hereto.


 


3.                                      Validation
of MII Process. In connection with the work of validation of the MII
process, Cambridge shall be responsible for paying Synkem the sum of {***}† in
consideration for the validation of the MII processes to FDA standards in
support of the NDA for the Finished Product. Cambridge will also reimburse
Synkem the sum of {***}† for the costs of purchase from Interor of
approximately three tonnes of MII 172, the validation of this production and
the storage thereof at Synkem. Synkem shall use such three tonnes of MII 172
purchased from Interor solely for the manufacture of the Compound and the
validation data for the update of the Tetrabenazine Drug Master File. For the
sake of clarity Cambridge shall own the MII process validation data and all
rights pertaining to that data. The price to be paid by Cambridge for any
Compound incorporating the above-mentioned three tonnes of MII 172 shall be as
set forth in Part B of Schedule 1 hereto.


 


4.                                      Currency. Notwithstanding anything to
the contrary in the Supply Agreement, the currency of payment shall be the
Euro.


 


5.                                      Payment. Article 4 of the Supply
Agreement shall be deleted and replaced with the following:


 


“Cambridge shall
pay for each consignment of the Compound in full, by bank transfer in Euro,
within thirty (30) days of the date of the invoice sent by Synkem regarding
such consignment which invoice shall be sent on or after the delivery of the
consignment.”


 


6.                                      Delivery
Terms.
Articles 2.5 and 2.6 of the Supply Agreement shall be deleted and replaced with
the following:


 


“All consignments
of the Product shill be delivered CIP (Incoterms 2000) to Cambridge’s Finished
Product manufacturer in the EU, the name and address of such manufacturer to be
provided to Synkem by Cambridge by at least two weeks before the requested
delivery date.


 






† Represents material which
has been redacted and filed separately with the Securities and Exchange
Commission pursuant to a request for confidential treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


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7.                                      Compound
Specifications. A third sentence shall be added to the end of Article 8.1
of the Supply Agreement as follows:


 


“The
specifications described in Schedule 1 attached hereto may be amended from time
to time by mutual agreement of the parties recorded in writing and signed by
appropriately authorised representatives.”


 


8.                                      Batch
Size.
By derogation to Article 2.4 of the Supply Agreement, one batch of the
Compound shall amount to approximately three hundred kilograms (300 kg).


 


9.                                      Term. The initial term of five
years referred to in Article 11 of the Supply Agreement shall be extended
for a further five (5) years commencing on Commencement Date of this
Amendment Agreement being the date that appears at the top of this Amendment
Agreement.


 


10.                               All other conditions of the
Supply Agreement and the DMF Agreement shall remain unchanged and shall
continue to apply.


 


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


 


For and
on behalf of

CAMBRIDGE LABORATORIES LIMITED

trading as

CAMBRIDGE LABORATORIES IRELAND


 


	
  Signed

  	
  :

  	
   

  	
  /s/ Mark P. Evans

  
	
   

  	
   

  	
   

  	
   

  
	
  Name

  	
  :

  	
   

  	
  Mark P. Evans

  
	
   

  	
   

  	
   

  	
   

  
	
  Title

  	
  :

  	
   

  	
  CEO

  



 


For and
on behalf of 

SYNKEM S.A.S


 


	
  Signed

  	
  :

  	
   

  	
  /s/ T.
  Schwitzguebel

  
	
   

  	
   

  	
   

  	
   

  
	
  Name

  	
  :

  	
   

  	
  T.
  Schwitzguebel

  
	
   

  	
   

  	
   

  	
   

  
	
  Title

  	
  :

  	
   

  	
  Director
  Operations

  



 


3

















 


SCHEDULE
1


 


PRICES


 


Part A
— Prices for Compound after Synkem has used the three tonnes of MII 172
purchased from Interor under Article 3 of the Amendment Agreement


 


For up to {***}†
kg/year: {***}† / kg


 


If Cambridges
orders between {***}† kg and {***}† kg per year: the average price per kg will
be {***}† / kg


 


If Cambridges
orders between {***}† kg and {***}† kg per year. the average price per kg will
be : {***}† /kg


 


If Cambridges
orders over {***} kg per year, the average price per kg will be : {***}† / kg


 


Yearly quantities
are the quantities that will be delivered during the same calendar year (from January to
December). Each order must be for a minimum of at least one batch, which must
be ordered at least six months prior to the requested delivery date. Synkem
shall make its best efforts but shall not be obliged to supply more than seven
batches within any six month period (for orders exceeding seven batches, the
parties shall renegotiate delivery dates).


 


Part B
Prices adjustment for Compound incorporating the three tonnes of MII 172
purchased from Interor under Article 3 of the Amendment Agreement


 


About 770 kg of
MII are needed to manufacture two 300 kg batches of Compound. The validated MII
will be used to manufacture the Compound from 2004 until 2007 according to
Cambridge’s forecasts, provided the MII 172 stability is sufficient. The cost
of the MII 172 used in such Compound batches (about {***}† per kg of
Compound) will be subtracted from the above Compound prices until the stock of
MII 172 is consumed.


 


For example, the
Compound price applicable to orders under {***}† kg of Compound per year will
be : {***}† = {***}†/kg


 






† Represents material which has been redacted and
filed separately with the Securities and Exchange Commission pursuant to a
request for confidential treatment pursuant to
Rule 24b-2 under the Securities Exchange Act of 1934, as amended.


 


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