Document:

Exhibit 10.27

 

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.

 

SUPPLY
AGREEMENT

 

This
Agreement is made between :

 

CAMBRIDGE
LABORATORIES, a division of Cambridge
Selfcare Diagnostics Limited, a company organised and existing under the laws
of England, with offices at Richmond House, Old Brewery Court, Sandyford Road,
Newcastle upon Tyne NE2 1XG, GREAT BRITAIN

 

“CAMBRIDGE”

 

and

 

PLASTO.
S.A. (SYNKEM Division),
a company organised- and existing under the laws of France with registered
offices at 47 Rue de Longvic, 21300 CHENOVE, FRANCE

 

“SYNKEM”

 

WHEREAS

 

1)             CAMBRIDGE is marketing a pharmaceutical product containing Tetrabenazine
as active ingredient.

 

2)             CAMBRIDGE wishes SYNKEM to manufacture and supply Tetrabenazine in bulk
form and SYNKEM is willing to manufacture and supply such compound to CAMBRIDGE
upon the terms and conditions hereof.

 

NOW,
THEREFORE THE PARTIES HERETO AGREE AS FOLLOWS :

 

Article 1

Definitions

 

	
  “COMPOUND”

  	
  means Tetrabenazine in bulk powder form;

  
	
   

  	
   

  
	
  “FINISHED PRODUCT”

  	
  means the product in finished pharmaceutical form
  manufactured from the COMPOUND supplied hereunder;

  
	
   

  	
   

  
	
  “FORCE
  MAJEURE”

  	
  means,
  in relation to either party, any circumstances beyond the reasonable control
  of that party and not caused by such party (including, without limitation,
  governmental orders or restriction, war, warlike condition, revolution, riot,
  internal or external strike, lock out, other forms of industrial action,
  fire, flood);

  

 

 

Article 2

Supply

 

2.1          During the term
of this Agreement, SYNKEM shall supply CAMBRIDGE with such quantities of the
COMPOUND as will be ordered by CAMBRIDGE in accordance with the provisions
hereof.

 

SYNKEM
shall manufacture the COMPOUND in accordance with cGMP and will maintain the
appropriate manufacturing approvals as laid down by the relevant regulatory
authorities.

 

2.2          All orders for
the COMPOUND shall be placed by CAMBRIDGE no less than six months before the
requested delivery date.

 

2.3          CAMBRIDGE shall
on an annual rolling forecast basis, updated quarterly, provide SYNKEM with
purchase forecasts.

 

Any
modification to a firm purchase order sent by CAMBRIDGE shall require the
written consent of both parties.

 

2.4          Each order shall
amount to a whole number of batches of the COMPOUND.

 

One
batch of the COMPOUND amounts to approximately 100 kg, being understood that
the precise quantity corresponding to one batch might vary slightly from one
batch to another because of differences in the yield of each manufacturing run.
This amount may be adjusted later taking into account the exact yield of the
future manufacturing runs made by SYNKEM pursuant to this Agreement.

 

2.5          All consignments
of the COMPOUND shall be governed by the “CIP Nottingham” 1990 ICC INCOTERM,
including, without limitation, its provisions for the passing of risks.

 

2.6          The exact place
of delivery shall be Boots Contract Manufacturing (“BCM”), Receiving Dock, D95
Building, 1 Thane Road, Nottingham, 2NG 3AA, Great Britain.

 

2.7          Each batch of
COMPOUND shall be accompanied by an analytical certificate prepared by SYNKEM
showing, the actual analytical data and the COMPOUND’s batch number. A copy of
the analytical certificate shall be send to CAMBRIDGE together with the
relevant invoice at CAMBRIDGE’s address mentioned in Article 22.

 

2

 

Article 3

Price

 

3.1          The price for the
first {***}† kilograms of the COMPOUND supplied hereunder (including the three
validation batches) shall be GBP {***}† per kilogram ;
thereafter and until June 2001, the price of the COMPOUND supplied
hereunder shall be GBP {***}† per kilogram.

 

The
parties shall then negotiate diligently and in good faith a price for the
COMPOUND delivered after the end of June 2001. If despite such good faith
negotiations the parties are unable to agree upon a revised price by the end of
June 2001, either party may terminate this Agreement by sending three months’
written notice to the other party during which the unadjusted price shall
apply.

 

3.2          The prices quoted
in 3.1 have been agreed on the basis of an exchange rate of GBP £1 to FRF 9.6
(the “Agreed Rate”). If, on the date SYNKEM raises the relevant invoice, the
Agreed Rate and the latest monthly average rate between FRF and GBP quoted by
Natexis Multidevise Database are further apart than 2.5%, the supply price
shall, for that invoice, be adjusted by applying the exact percentage
difference between the Agreed Rate and such average rate.

 

When
the French Franc is replaced by the Euro as the unit of currency in France, the
GBP:Euro exchange rate governing the pricing mechanism for the COMPOUND will be
fixed so that the price for the COMPOUND remains the same as what it should
have been in GBPs had the change in currency not have occurred.

 

3.3          The price quoted
for the first {***}† kg includes:

 

·              full
validated analytical methods for the raw materials including each intermediate
and the bulk COMPOUND;

 

·              NMR/HPLC/IR/MASS
SPEC/MP where appropriate;

 

·              residual
solvents analysis for chloroform, methylene chloride, methanol and ethanol;

 

·              the
writing of SOP procedures for the production of the 100 kg batches.

 

The
price does not include:

 

·              polymorphism
study of the COMPOUND using different solvents;

 

·              stability
testing;

 

·              accelerated
degradation studies of the COMPOUND.

 

If
the parties so decide, these studies may be implemented by SYNKEM at cost
price.

 

†
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.

 

3

 

Article 4

Payment

 

CAMBRIDGE
shall pay each consignment of the COMPOUND by bank transfer in GB Pounds:

 

·              {***}† shall be paid upon ordering the relevant consignment of COMPOUND ;

 

·              {***}† shall be paid within 30 calendar days of the end of the month during
which the relevant invoice was raised.

 

Article 5

Exclusive rights

 

5.1          SYNKEM shall not
enter into agreements to supply the COMPOUND to a third party and shall, after
the termination of this Agreement, remain bound by the obligations mentioned in
Article 14 for the time period set forth in that Article 14.

 

5.2          CAMBRIDGE shall
purchase all its requirements of the COMPOUND from SYNKEM and shall refrain
from manufacturing the COMPOUND or having the same manufactured by a third
party.

 

Notwithstanding
the foregoing, after CAMBRIDGE has purchased a minimum of {***}† kg of COMPOUND from SYNKEM, CAMBRIDGE shall be entitled to enter into
a supply agreement with a third party which shall act as a second source
supplier provided that CAMBRIDGE shall continue to purchase at least{***}† of its requirements of COMPOUND from SYNKEM.

 

SYNKEM
shall provide CAMBRIDGE with all data available at SYNKEM regarding analytical
methods and improvements made to the manufacturing process to enable that third
party to manufacture the COMPOUND provided that such third party shall be bound
by confidentiality obligations similar to those contained in this Agreement and
CAMBRIDGE shall be liable to SYNKEM for any breach thereof by such third party.

 

Article 6

Major changes to the manufacturing process

 

6.1          In the event of
SYNKEM proposing major changes to the manufacturing process of the COMPOUND,
SYNKEM shall inform CAMBRIDGE of these proposed process changes and shall not
institute these process changes without CAMBRIDGE’s prior written consent.
Together with its proposal, SYNKEM shall indicate to CAMBRIDGE the conditions
upon which CAMBRIDGE may be entitled to use such changes after termination of
this Agreement.

 

CAMBRIDGE
shall be responsible at its own cost for having those changes approved by the
relevant regulatory authorities.

 

†
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.

 

4

 

6.2          In the event the
approved process changes generate an increase in the yield of the manufacture
of the COMPOUND or a decrease in the production costs, SYNKEM and CAMBRIDGE
shall equally share the corresponding benefit.

 

Article 7

Regulatory obligations

 

7.1          Upon request,
SYNKEM shall provide to CAMBRIDGE all the relevant data required by CAMBRIDGE
to enable CAMBRIDGE to submit a complete IND&NDA submission to the US Food
and Drug Administration and CTX or MAA to the relevant European Authorities for
the COMPOUND. CAMBRIDGE shall be responsible for writing said IND, NDA, CTX,
MAA applications at its own cost. CAMBRIDGE shall use such data given by SYNKEM
only for the purpose of drafting said applications for the COMPOUND and
submitting the same to the relevant health authorities. Without prejudice to
the provisions of Clause 6.1, CAMBRIDGE, as the holder of all the above
applications, shall be the owner of all the COMPOUND related data and information
appearing or referred to in said applications.

 

7.2          If requested by
regulatory authorities or by CAMBRIDGE, SYNKEM shall accept and permit an
inspection by CAMBRIDGE or the relevant regulatory authorities, at reasonable
time and upon reasonable prior notice, of its facilities where the COMPOUND is
manufactured or stored and of the manufacturing records pertaining to the
manufacture of the COMPOUND.

 

7.3          Regarding
inspections requested and made by CAMBRIDGE:

 

·              CAMBRIDGE
shall, before making any such inspection, give full details of the reason of
such inspection and of all matters which will be dealt with during such
inspection. This information shall be provided to SYNKEM in written form.

 

·              Any
information which may come to CAMBRIDGE’s knowledge during such inspection
shall be subject to the secrecy provisions of Article 14.

 

Article 8

Warranty, liability and indemnification

 

8.1          SYNKEM warrants
that the COMPOUND manufactured and supplied hereunder shall meet the
specifications described in Schedule 1 attached hereto and is of the same
quality than the 1 kg kilo lab sample as accepted by CAMBRIDGE. SYNKEM
DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING WITHOUT
LIMITATION THE WARRANTY OF SATISFACTORY QUALITY AND THE WARRANTY OF FITNESS FOR
A PARTICULAR PURPOSE.

 

8.2          Subject to Clause
8.3, CAMBRIDGE’s EXCLUSIVE REMEDY FOR ANY FAILURE OF THE COMPOUND TO MEET THE
QUALITY REQUIREMENTS DESCRIBED IN 8.1 SHALL BE THE REPLACEMENT OR REFUND
PURSUANT TO CLAUSE 9.2. IN NO CASE SHALL SYNKEM BE LIABLE TO CAMBRIDGE FOR
INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES.

 

5

 

8.3          (a)           SYNKEM shall indemnify and
hold CAMBRIDGE harmless from and against any and all liability, damage, cost or
expense (including reasonable attorneys’ fees) arising out of third party
claims based upon failure by SYNKEM to supply COMPOUND which meets the quality
requirements described in 8.1 above, such failure to be acknowledged as the
cause of the third party’s damage by a court of competent jurisdiction or the
parties hereto by mutual written agreement.

 

(b)           SYNKEM shall not
be liable hereunder for failure of the COMPOUND to meet the quality
requirements described in 8.1 hereof if CAMBRIDGE has not tested the COMPOUND
pursuant to Clause 9.1 before using the same or if, despite such tests
evidencing a failure of the COMPOUND to meet such quality requirements,
CAMBRIDGE has decided to use it or sell the FINISHED PRODUCT made from such
COMPOUND.

 

8.4          CAMBRIDGE shall
indemnify and hold SYNKEM harmless from and against any and all liability,
damage, cost and expenses (including reasonable attorneys’ fees) arising out of
third party claims other than those based upon failure by SYNKEM to supply
COMPOUND which meets the quality requirements described in 8.1 above, including
without limitation faulty manufacture, labelling or promotion of the FINISHED
PRODUCT by CAMBRIDGE or its sub-contractors or licensees.

 

8.5          CAMBRIDGE
warrants and represents that the manufacture and supply of COMPOUND hereunder
shall not infringe any patent or other intellectual proprietary rights and
CAMBRIDGE shall indemnify and hold SYNKEM harmless against any and all
liability, damage, cost and expenses (including reasonable attorneys’ fees)
resulting from any alleged infringement. However, this shall not apply if and
to the extent that the manufacturing process (or portion thereof) has been
designed by SYNKEM and infringes a third party patent claiming such process.

 

8.6          The indemnities
set forth in this Article 8 are subject to the condition that the party
seeking indemnity notifies the other party (the “Indemnifying Party”) without
delay of the bringing or threat of any claim or legal proceedings against or
involving or implicating the Indemnifying Party and :

 

(a)           abide by such
reasonable instructions as the Indemnifying Party may issue concerning the
conduct of such claim or the defence of such proceedings; and

 

(b)           does not make
without the Indemnifying Party’s express written consent any admission of
liability to a claimant or plaintiff or his, her or its legal representative or
insurer in respect of such claim, threatened claim, proceedings or threatened
proceedings; and

 

(c)           does not make
without the Indemnifying Party’s express written consent any settlement or
compromise of such claim, threatened claim, proceedings or threatened
proceedings.

 

Article 9

Defective COMPOUND

 

9.1          (a)           Upon delivery, CAMBRIDGE shall
inspect the COMPOUND according to the relevant analytical methods set forth in
Schedule 1 attached hereto. If the COMPOUND 

 

6

 

delivered
does not conform with the quality requirements described in 8.1 above,
CAMBRIDGE may reject such COMPOUND by notifying SYNKEM within thirty days from
the date of delivery to CAMBRIDGE.

 

(b)           Hidden defects
not revealed by the above inspection which cause the COMPOUND not to conform
with the quality requirements described in 8.1 above shall be notified to
SYNKEM immediately upon discovery. In such event, CAMBRIDGE may reject such
COMPOUND by notifying SYNKEM within thirty (30) days from the date of such
discovery.

 

9.2          After the
consultation and agreement among the parties, the quantity of COMPOUND which
was rejected under Clause 9.1 (“Defective COMPOUND”) shall be replaced by
SYNKEM with the same quantity of COMPOUND which meets the quality requirements
described in 8.1 above by one of the following procedures which is acceptable
to CAMBRIDGE:

 

(a)           SYNKEM shall, at
no additional cost to CAMBRIDGE, reprocess the Defective COMPOUND within such
period of time as will be reasonably agreed upon by the parties by following a
reworking procedure acceptable to CAMBRIDGE and in compliance with the relevant
DMF for the COMPOUND.

 

Any
loss of COMPOUND resulting from this procedure shall, if such substance had
been already paid by CAMBRIDGE, be replaced by an equivalent quantity of new
COMPOUND or give rise to a compensation by SYNKEM for the COMPOUND lost at the
applicable price (as specified in Clause 3.1), at CAMBRIDGE’s option.

 

(b)           SYNKEM shall
carry out new production of the COMPOUND at no additional cost to CAMBRIDGE
within such period of time as will be reasonably agreed upon by the parties.

 

9.3          In the event that
CAMBRIDGE destroys or disposes of the Defective COMPOUND (or FINISHED PRODUCT
containing the Defective COMPOUND), this shall be done in full compliance with
local and national laws and regulations. In no event shall CAMBRIDGE destroy or
dispose of the Defective COMPOUND without SYNKEM’s prior written consent.

 

Article 10

Insurance

 

10.1        At all times this
contract is in effect, each of CAMBRIDGE and SYNKEM shall maintain product
liability insurance in an amount of not less than {***}† in the case of
CAMBRIDGE or {***}† in the case of SYNKEM so as to cover any liability it may incur
pursuant to Article 8.

 

10.2        Each party hereto
shall upon request at all reasonable times provide the other with a certificate
of insurance as evidence of such insurance. In the event that such insurance is
significantly reduced or restricted, terminated or otherwise not renewed, the
affected party shall immediately notify the other.

 

† 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.

 

7

 

Article 11

Term

 

This
Agreement shall come into effect on the date of its complete signature by both
parties and, subject to the provisions for anticipatory termination herein
contained, shall remain in force for an initial term of five years.

 

It
shall thereafter continue for an indefinite period unless and until terminated
by either party giving not less than eighteen (18) months prior written notice,
such notice to be effective at the end, of the initial term or at any time
thereafter.

 

Article 12

Anticipatory termination

 

12.1        If either party
shall at any time fail to abide by any of the provisions of this Agreement, the
other party shall have the right to terminate this Agreement on thirty (30)
days’ prior written notice to the defaulting party specifying the default
complained of, provided, however, if said defaulting party cures the default
complained of within the said thirty (30) day period, the Agreement will
continue in full force and effect as if no default had occurred.

 

12.2        Either party may
terminate this Agreement at any time by giving written notice with immediate
effect to the other party if the other party is declared bankrupt or insolvent,
or makes an assignment for the benefit of creditors, or if a receiver is
appointed, or any procedures are commenced, voluntarily or involuntarily, by or
against a party under any bankruptcy or similar law and such procedure is not dismissed
within sixty days of its commencement.

 

Article 13

Consequences of termination

 

Upon
termination of this Agreement pursuant to its provisions or the provisions of
the applicable law:

 

13.1        SYNKEM shall
manufacture and supply those quantities of the COMPOUND ordered by CAMBRIDGE
prior to such termination and CAMBRIDGE shall pay the then current supply price
(as determined pursuant to Article 3) for such COMPOUND ;

 

13.2        Termination shall
be without prejudice to (i) any remedies which either party may then or
thereafter have under this Agreement or at law or in equity (including without
limitation possible damages) and (ii) either party’s right to obtain
performance of any obligation provided for in this Agreement which survives
termination by its terms or by a fair interpretation thereof.

 

13.3.
Termination shall not relieve the parties of their obligations that would
survive termination by a reasonable interpretation of this Agreement including
Articles 8, 14 and 17.

 

13.4.
On termination, SYNKEM shall return to CAMBRIDGE all documentation samples
given to them referring to the COMPOUND, except for one copy of each document
which may be retained by SYNKEM for reference should a dispute arise in the
future about the COMPOUND.

 

8

 

Article 14

Secrecy

 

14.1        Each party hereto
(“RECIPIENT”) agrees that it will (i) maintain in good faith the
confidentiality of any and all proprietary or confidential information
disclosed by the other party (“DISCLOSER”) and (ii) refrain from using the
same except for the purpose of implementing this Agreement. These obligations
shall survive termination of this Agreement for any reason for a period of
twenty years from the termination date. When CAMBRIDGE is the DISCLOSER, the term
“information” includes, without limitation, all information relating to the
COMPOUND or to the manufacturing process of the COMPOUND disclosed by CAMBRIDGE
to SYNKEM.

 

14.2        These obligations
shall not apply to confidential information in respect of which RECIPIENT can
prove that such information (i) is or becomes public knowledge through no
breach hereof or (ii) was in RECIPIENT’s possession prior to disclosure by
DISCLOSER and was not obtained directly or indirectly from DISCLOSER or (iii) is
lawfully acquired from a third party who did not obtain it directly or
indirectly from DISCLOSER or (iv) is required to be disclosed by law or
any relevant regulatory authority.

 

14.3        RECIPIENT shall,
on demand on termination of this Agreement for any reason provided by this
Agreement or by law, return to DISCLOSER all documents and other tangible
mediums of expression embodying DISCLOSER’s information and shall keep no
summary or copy thereof except for one copy to be retained in DISCLOSER’s
confidential files for evidence purposes.

 

Article 15

Force Majeure

 

15.1        Should either
party be affected by FORCE MAJEURE, it shall without delay notify the other
party of the nature and extent thereof.

 

15.2        Neither party
shall be deemed to be in breach of this Agreement or 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 recognised FORCE MAJEURE of which it has notified the other party, and
the time of performance for that obligation shall be extended accordingly.

 

Article 16

Hardship

 

Should
the action of third parties, economic, regulatory conditions, FDA regulatory
requirements or other conditions outside the control of either party create a
situation in which the effect of any provision hereof is severely inequitable
to that party, then the parties agree to negotiate in good faith for the
revision of the relevant provisions hereof as may be reasonably required by the
affected party or parties.

 

Either
party desiring to negotiate for revision in accordance with this Article shall
give the other party a statement in writing setting forth the circumstances of
the hardship suffered from with a request for a meeting of representatives at a
time and place convenient to the other party within 

 

9

 

thirty
(30) days of the request. The other party shall not unreasonably withhold its
agreement to meet and negotiate.

 

If
the parties fail to agree on new terms within thirty days of the first meeting
on this issue, the party having requested renegotiation shall be entitled to
terminate this Agreement with immediate effect.

 

Article 17

Governing Law

 

This
Agreement shall be governed by and construed in accordance with the laws of
England without reference to choice of law principles.

 

Article 18

Jurisdiction

 

Any
claim, controversy or dispute arising between the parties hereto in connection
with or with respect to this Agreement which is not resolved through mutual
good faith efforts and negotiation shall be resolved by the English courts
which shall have non exclusive jurisdiction.

 

Article 19

Entire agreement

 

19.1        This Agreement
shall exclude all of SYNKEM’s general terms and conditions of supply and all of
CAMBRIDGE’s general terms and conditions of purchase.

 

19.2        This Agreement
(including all Schedules attached hereto) expresses the entire understanding of
the parties with respect to the subject matter hereof and supersedes all prior
offers, negotiations, agreements and correspondence.

 

Article 20

Assignment

 

No
party hereto may assign its rights or obligations hereunder without prior
written consent of the other party.

 

Article 21

Amendments

 

No
amendment, changes, modifications or alterations of the terms and conditions of
this Agreement shall be effective unless in writing and duly executed by both
parties.

 

Article 22

Notices

 

Any
notices or other communication to be given by one party to the other pursuant
to this Agreement shall be in writing and shall be given by sending the same by
registered letter, express courier, cable or facsimile transmission to the
address of the relevant party as set out 

 

10

 

below
or such other address as the addressee may notify the addresser in writing from
time to time.

 

	
  PLASTO SA (SYNKEM DIVISION)

  	
  CAMBRIDGE LABORATORIES

  
	
  47 rue de Longvic

  	
  Richmond. House,
  Old Brewery Court

  
	
  21300 Chenôve

  	
  Sandyford Road

  
	
  France

  	
  Newcastle upon Tyne NE2 1XG 

  
	
   

  	
  Great Britain

  
	
   

  	
   

  
	
  Fax
  : +33.380 447420

  	
  Fax
  : +44 191 222 1006

  

 

Article 23

Severability

 

Should
any part of this Supply Agreement be held unenforceable or in conflict with the
applicable laws or regulations of any jurisdiction, the invalid or
unenforceable part or provision shall be replaced with a provision which
accomplishes, to the extent possible, the original business purpose of such
invalid or unenforceable part or provision in a commercially reasonable, valid
and enforceable manner, and the remainder of this Supply Agreement shall remain
binding upon the parties hereto.

 

Article 24

General provisions

 

24.1        Failure by either
party to respond to any proposal or statement made by the other party shall not
be deemed to be consent thereto nor operate so as to modify the nature, effects
or extent of any obligation under this Agreement.

 

24.2        Failure by either
party to exercise or enforce any right conferred to it by this Agreement shall
not be considered a waiver nor operate so as to preclude the exercise or
enforcement thereof at any subsequent time or on any subsequent occasion.

 

24.3        This document is
not an offer and shall not constitute a contract unless signed by both parties.

 

24.4        Unless the
context otherwise requires, the words in singular shall be deemed to include
the plural and vice-versa.

 

24.5        Title headings
have been inserted for convenience only and shall not be used in interpreting
this Agreement.

 

Made
in duplicate

 

	
  CAMBRIDGE LABORATORIES

  	
   

  	
  PLASTO S.A. (SYNKEM Division) (Division of Cambridge
  Selfcare Diagnostics Limited)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Date :

  	
  24th July 1998

  	
   

  	
  Date :

  	
  31st July 1998

  

 

11

 

	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Signature :

  	
  /s/ Diana Boyd

  	
   

  	
  Signature:

  	
  /s/ Jean-François Colas

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name :

  	
  Diana Boyd

  	
   

  	
  Name:

  	
  Colas, Jean- François

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Position
  :

  	
  Company
  Secretary

  	
   

  	
  Position
  :

  	
  Directeur
  Industriel

  

 

12Exhibit 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.

 

2

 

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.

 

4

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