Certain portions of this Exhibit have been omitted pursuant to a
request for “Confidential Treatment” under Rule 24b-2 of the Securities and
Exchange Commission.  Such portions have
been redacted and bracketed in the request and appear as [*] in the text of
this Exhibit.  The omitted confidential
information has been filed with the Securities and Exchange Commission.


 


Exhibit 4.55


 


	
   

  	
  

  	
  PRIVATE
  & 

  CONFIDENTIAL

  
	
   

  



 


THIS LICENCE AND DISTRIBUTION AGREEMENT is made on                        2002                      



 


BETWEEN


 


(1)           LAXDALE
LIMITED, a Company incorporated in Scotland under the Companies Acts (Company
Number: SC179838), having its place of business at Kings Park House, Laurelhill
Business Park, Stirling, FK7 9JQ (“Laxdale”);


 


and


 


(2)           JUSTE,
S.A.Q.F., a Company incorporated in Spain under the Companies Acts, having a
place of business at Julio Camba, 7, 28028 Madrid, Spain (“Juste”)


 


WHEREAS


 


(A)          Laxdale
has developed and is the owner of certain IP Rights (as after defined)
including the Licensed Patent (as after defined) and the Trade Mark (as after
defined) in relation to the Licensed Product (as after defined) for the
treatment inter  alia of Huntington’s Disease;


 


(B)           Laxdale
has agreed to appoint Juste as its distributor in the Territory (as after
defined) on an exclusive basis and insofar as necessary to perform its
obligations as distributor to license Juste under the Licensed Patent and the
Trade Mark and Juste has agreed to accept such licence and appointment on the
terms and conditions of this Agreement


 


NOW THEREFORE IT IS HEREBY AGREED AS FOLLOWS:


 


1.                             Definitions
and interpretation


 


1.1                           In this
Agreement, unless the context requires otherwise, the following words and
expressions shall bear the following meanings:


 


	
  “Associated Company”

  	
   

  	
  means any firm, company
  or entity controlled by, controlling or under common control with Juste. For
  this purpose “control” shall mean direct or indirect beneficial ownership of
  50% or more of the voting shares, or a 50% or greater interest in the income,
  of such firm, company or entity, or such other relationship as, in fact
  constitutes actual control;

  
	
   

  	
   

  	
   

  
	
  “Change of Control”

  	
   

  	
  means a change of
  control in relation to Juste. “Control” for these purposes means the power of
  a person to secure:

  



 


LAXDALE LTD, KINGS
PARK HOUSE, LAURELHILL BUSINESS PARK, POLMAISE
ROAD, STIRLING, UK FK7 9JQ TEL:+44 (0)1786 476000 FAX:+44 (0)1786 473137 E-MAIL:
admin@laxdale.co.uk


 


REGISTERED IN
SCOTLAND NO. 179838 
REGISTERED OFFICE: KINGS PARK HOUSE, LAURELHILL BUSINESS PARK, POLMAISE
ROAD, STIRLING, UK FK7 9JQ


 





















 


	
   

  	
   

  	
  (i) by means of holding
  shares or the possession of voting power in or in relation to that or any
  other body corporate; or

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii) by virtue of any powers conferred by the
  articles of association or other document regulating that or any other body
  corporate

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  that the affairs of the first mentioned body
  corporate are conducted in accordance with the wishes of that person;

  
	
   

  	
   

  	
   

  
	
  “Effective Date”

  	
   

  	
  means the last date of signature hereof by or on
  behalf of each of the parties hereto by persons duly and expressly
  authorised;

  
	
   

  	
   

  	
   

  
	
  “EMEA”

  	
   

  	
  means the European Agency for the Evaluation of
  Medical Products or such successor or replacement body as may from time to
  time supersede it;

  
	
   

  	
   

  	
   

  
	
  “Field of Use”

  	
   

  	
  means the marketing, distribution and Sale of
  Licensed Product for the therapeutic treatment of Huntington’s Disease it
  being acknowledged that the Field of Use may be widened in the future in the
  sole discretion of Laxdale to include Spino-cerebellar atrophy; Progressive
  Supranuclear Palsy; Fragile X and Friedreich’s ataxia.

  
	
   

  	
   

  	
   

  
	
  “IP Rights”

  	
   

  	
  means all patents, registered designs, unregistered
  design rights, copyrights, topography rights, trade marks, trade names,
  logos, trade secrets and know-how, moral rights, supplementary protection
  certificates, petty patents, utility models, applications for any of the
  above and the right to make applications and any and all other intellectual
  or industrial property rights of any description (and rights of a similar
  nature) anywhere in the world,

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (i) existing now or at
  any time in the future; and

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii) whether or not registered or registrable;

  
	
   

  	
   

  	
   

  
	
  “Improvements”

  	
   

  	
  means all improvements or modifications or
  adaptations to the Licensed Product which may be made or acquired by either
  party during the Term (as after defined);

  
	
   

  	
   

  	
   

  
	
  “Major Improvement”

  	
   

  	
  means all improvements or modifications or
  adaptations to the Licensed Product which requires completion of a clinical
  program for its

  



 


2





















 


	
   

  	
   

  	
  development in order to obtain a marketing
  authorisation within the Territory and within the Field of Use;

  
	
   

  	
   

  	
   

  
	
  “Minor Improvement”

  	
   

  	
  means all improvements or modifications or
  adaptations to the Licensed Product which only require standard pharmacokinetic,
  bioequivalance or similar such studies in order to satisfy its addition to
  the marketing authorisation of the existing Licensed Product within the Field
  of Use;

  
	
   

  	
   

  	
   

  
	
  “Launch Date”

  	
   

  	
  means immediately following pricing reimbursement
  approval within the territory;

  
	
   

  	
   

  	
   

  
	
  “Marketing Year”

  	
   

  	
  means each 12 month period beginning from the month
  of the Launch Date within the Territory;

  
	
   

  	
   

  	
   

  
	
  “Milestones”

  	
   

  	
  means each of the milestones set out in the
  Schedule;

  
	
   

  	
   

  	
   

  
	
  “Milestone Payments”

  	
   

  	
  means the sums due to Laxdale against the
  performance of the Milestones in the Timetable (as after defined) as more
  particularly detailed in the Schedule;

  
	
   

  	
   

  	
   

  
	
  “Minimum Sales”

  	
   

  	
  means the minimum sales to be achieved by Juste as
  set out in the Schedule;

  
	
   

  	
   

  	
   

  
	
  “Order Acknowledgement”

  	
   

  	
  means a written acknowledgement of any Purchase
  Order from Laxdale containing details such as price, delivery dates and
  quantities agreed by Laxdale;

  
	
   

  	
   

  	
   

  
	
  “Orphan Drug
  Designation”

  	
   

  	
  means the orphan designation for the Licensed
  Product in the treatment of Huntington’s disease issued by the EMEA Committee
  for Orphan Medicinal Products on 27 October 2000.

  
	
   

  	
   

  	
   

  
	
  “Licensed Patent”

  	
   

  	
  means:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (i) the patent applications referred to in the
  Schedule including any amended or divided applications;

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii) all patent applications that may be filed in
  the Territory by or on behalf of Laxdale which are based on or claim priority
  from such patent applications including any amended or divided

  



 


3





















 


	
   

  	
   

  	
  applications;

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (iii) all patents actually granted pursuant to any
  such patent applications, including any amended or divided applications;

  
	
   

  	
   

  	
   

  
	
  “Licensed Product”

  	
   

  	
  means Units of the product sold by Juste in the
  Field of Use which fall within the claims of the Licensed Patent or the
  Orphan Drug Designation and approved for marketing by EMEA.

  
	
   

  	
   

  	
   

  
	
  “Purchase Order”

  	
   

  	
  means an irrevocable written order (and any
  amendments to same accepted by Laxdale) from Juste to Laxdale for the
  purchase of Licensed Products for sale by Juste in a format approved in
  advance by Laxdale;

  
	
   

  	
   

  	
   

  
	
  “Quarter”

  	
   

  	
  means each period of 3 months in each year of the
  Term, the first quarter commencing at the start of the month during which the
  Licensed Product is first sold;

  
	
   

  	
   

  	
   

  
	
  “Royalties”

  	
   

  	
  means royalties payable to Laxdale in each Marketing
  Year under this Agreement as detailed in Clause 11;

  
	
   

  	
   

  	
   

  
	
  “Sales”

  	
   

  	
  means the sale or other disposal of Licensed
  Products (whether or not title is transferred and whether or not for value)
  and “Sold” shall be construed accordingly;

  
	
   

  	
   

  	
   

  
	
  “Net Sales Value”

  	
   

  	
  means the price of Licensed Products calculated as
  follows and net of Value Added Tax or any other equivalent sales taxes or
  duties:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (i) in the case of an arm’s length Sale, the Sales
  Value shall be the gross price charged or invoiced to third party purchasers
  in respect of Licensed Products Sold;

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii) in the case of any Sale or disposal of Licensed
  Products which is not an arm’s length sale, the Sales Value shall be the open
  market price for the Licensed Product in the country to which the Licensed
  Product is supplied; and

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (iii) the Sales Value shall also include any and all
  lump sums or other benefits whether in cash or in kind receivable by Juste
  from any third party in consideration of the Sale and/or distribution of

  



 


4





















 


	
   

  	
   

  	
  Licensed Products;

  
	
   

  	
   

  	
   

  
	
  “Term”

  	
   

  	
  means the term of this Agreement as detailed in
  Clause 2.1;

  
	
   

  	
   

  	
   

  
	
  “Territory”

  	
   

  	
  means Spain and Portugal only;

  
	
   

  	
   

  	
   

  
	
  “Timetable”

  	
   

  	
  means the timetable set out in Part 1 of the
  Schedule detailing the Milestones and Milestone Payments;

  
	
   

  	
   

  	
   

  
	
  “Total Net Sales Value”

  	
   

  	
  means the aggregate Net Sales Value of all Sales of
  the Licensed Product by Juste to the date of the relevant calculation;

  
	
   

  	
   

  	
   

  
	
  “Trade Mark”

  	
   

  	
  means the trade mark to be selected by Laxdale prior
  to the Launch Date with which Licensed Products shall be branded;

  
	
   

  	
   

  	
   

  
	
  Unit

  	
   

  	
  means the standard pack size (for 28 or 30 days
  treatment) containing capsules of 500mg of the Licensed Product.

  



 


1.2                           References
in this Agreement to the singular shall (except where the context requires
otherwise) include a reference to the plural (and vice versa) and references to
one gender shall include a reference to all other genders. References to
Clauses and the Schedule are to the clauses and schedule of this Agreement.
Headings used in this Agreement are for convenience only and shall not affect
interpretation.


 


2.                             Term


 


2.1                           This
Agreement shall come into force on the Effective Date and subject to
termination in accordance with Clause 23 shall continue until the later to
expire of a period of 10 years or the expiry of the last of the Licensed Patent
or the expiry of Orphan Drug Designation in the Territory.


 


2.2                           Notwithstanding
Clause 2.1 above and so long as Juste fulfil the required minimum sales as set
out in the Schedule, this Agreement shall automatically be prolonged for
additional periods of five (5) years each, if not terminated by either party by
giving six (6) months written notice.


 


5





















 


3.                             Appointment
and scope of rights


 


3.1                           Subject
to the terms of this Agreement, Laxdale hereby grants to Juste an exclusive,
non-transferable licence to market, distribute and sell Licensed Products in the Territory within the Field of
Use only and under the Licensed Patent and Trade Mark and Orphan Drug
Designation. Juste shall not be entitled to sub-license or sub-contract any of
its rights hereunder without Laxdale’s prior written consent. It is
acknowledged by Juste that Laxdale hereby expressly reserves the exclusive
right to market, distribute and sell (either itself or by way of licensing a
third party) Licensed Products within the Field of Use in any country in the
World other than the Territory.


 


3.2                           Juste
and Laxdale agree to execute such formal licence agreements (if any) as may be
required by relevant patent registry from time to time and to do such other
acts and things as may be necessary for the purpose of registering the licence
granted in terms of this Agreement in the Territory. To avoid any doubt, no
development, evaluation, manufacturing or production or other rights of any
nature under the Licensed Patent or Trade Mark are granted under this
Agreement.


 


3.3                           Juste
shall not represent or hold itself out as Laxdale’s agent for the sales of the
Licensed Products or as being entitled to bind Laxdale in any way provided
always that Juste shall be entitled to describe itself as Laxdale’s authorised
distributor for the Licensed Products.


 


3.4                           Juste
shall not sell any of the Licensed Products which it purchases from Laxdale
through sales agents or to sub-distributors without the prior written consent
of Laxdale and no sub-licensing or sub-contracting shall be permitted hereunder
without the prior written consent of Laxdale.


 


4.                             Exclusivity
and Minimum Sales


 


4.1                           Juste
shall throughout the Term purchase Licensed Products from Laxdale and Laxdale
agrees to sell the same to Juste for sale within the Territory in the Field of
Use subject to the terms and conditions of this Agreement.


 


4.2                           It is a
material term of this Agreement that Juste achieves the Minimum Sales.


 


4.3                           The
Minimum Sales are set out in Schedule 1.


 


4.4                           If
Juste fails to achieve the Minimum Sales in any 2 consecutive years, Laxdale
shall be entitled to terminate this Agreement with immediate effect and shall
be free to appoint new distributors, agents and/or licensees in the Territory
(on a non-exclusive or exclusive basis) and/or proceed with the marketing,
distribution and sale of the Licensed Products in the Territory on its own
account, as it deems appropriate


 


5.                             Supply
of the Licensed Products


 


5.1                           With
effect from the Launch Date, Juste shall provide Laxdale with a forecast of its
Licensed Product requirements for the following 12 month period and shall during
every Quarter of each such year during the Term provide Laxdale with an updated
forecast for the year following the date of such forecast. Such forecast shall
take the form of a written schedule and shall specify all details of
anticipated sales and inventory requirements and shall be calculated and presented in a true and accurate
manner. Such forecast shall not be binding upon either Laxdale or Juste and
shall be for information only.


 


6





















 


5.2                           All
orders for the purchase of the Licensed Products shall be made by Juste
submitting a Purchase Order each quarter for supply in the next 6 months. Such
Purchase Orders shall become binding once they have been accepted by Laxdale
and an Order Acknowledgement issued. Laxdale shall use its reasonable
endeavours to comply with Juste’s requirements under Purchase Orders provided
that Purchase Orders placed are within the terms of the applicable forecast.
However, Juste shall not be in breach of any requirement to make the Minimum
Sales if such failure is due to Laxdale’s rejection of Purchase Orders which
would otherwise have allowed Juste to achieve such Minimum Sales.


 


5.3                           At the
time of submitting the relevant Order Acknowledgement, Laxdale shall inform
Juste of Laxdale’s estimated delivery date for consignments and shall endeavour
to deliver the Licensed Products within 6 months of the date of the Order
Acknowledgement. Notwithstanding any such delivery date, time of delivery shall
not be of the essence under this Agreement. Delivery of the Licensed Products
shall be made to one location in the Territory as agreed by Laxdale and Juste.
(the “Delivery Location”)


 


5.4                           For the
avoidance of doubt, at the end of the first year of this Agreement following
the Launch Date and at the end of each year thereafter the parties may review
this ordering process with a view to modifying or adapting it from time to time
for the benefit of the parties.


 


5.6                           In
addition to the Royalties to be paid by Juste to Laxdale in terms of this Agreement,
Licensed Product will be invoiced to Juste at cost that shall not exceed Thirty
(30) Euro per unit of Finished Pack plus 10%. Invoices are due for payment
within 30 days from the invoice date.


 


6.                             Approvals


 


6.1                           Subject
to Clause 6.2 it shall be Laxdale’s responsibility (at its own cost) to manage
the clinical trials and to obtain regulatory approval of the Licensed Product
for the treatment of Huntington’s Disease and in this respect Laxdale shall
submit the relevant dossier to EMEA for the purposes of obtaining marketing
authorisation for the treatment of Huntington’s Disease.   For the avoidance of doubt, ownership of the
results of all such trials and clinical or other data arising from such
clinical trials shall vest in and remain vested in Laxdale.


 


6.2                           Laxdale
shall be responsible for any other indications within the Field of Use other
than the treatment of Huntington’s Disease and shall at its sole discretion
prepare and be responsible for the conduct of clinical trials and at Laxdale’s
sole discretion shall be responsible for securing regulatory approval in the
Territory.


 


6.3                           Juste
shall in respect of each and every order for the Licensed Products submitted
hereunder, be responsible for complying with the laws in the Territory
applicable to marketing, distributing and selling the Licensed Products
pursuant to this Agreement, effecting any registrations, and paying all
applicable customs duties, taxes and other costs in respect of the marketing,
distribution and sale of the Licensed Products in the Territory.


 


6.4                           Juste
shall not at any time nor under any circumstance do anything (whether directly
or indirectly) to interfere with or prejudice the Orphan Drug Designation of
the Licensed Product or with EMEA’s or any other regulatory body’s approval of
the Licensed Product.


 


7





















 


Juste shall (at the
request of Laxdale from time to time) do all such acts and things as may be
necessary to assist Laxdale with obtaining and maintaining all necessary
regulatory approvals of the Licensed Product. In this respect, Juste shall
promptly provide all information, data, sales figures and other information
that Laxdale may request to prepare the annual and other reports and other
documentation to be submitted to EMEA or other regulatory authority from time
to time.


 


6.5                           For the
avoidance of doubt, failure by Juste to comply with any of the provisions of
Clauses 6.3 and 6.4 will amount to a material breach of this Agreement and
Laxdale shall be entitled to terminate this Agreement in accordance with Clause
23.


 


7                              Duties
of Juste


 


7.1                           Without
prejudice to its obligation to achieve Minimum Sales, Juste shall use best
endeavours to sell the Licensed Products and to maximise orders for the
Licensed Product in terms of its exclusive appointment under this Agreement.


 


7.2                           Juste
shall use best endeavours to enhance the reputation and acceptance of the
Licensed Product amongst customers and prospective customers within the
Territory and in this respect Juste shall jointly agree with Laxdale, after the
Effective Date, but prior to the Launch Date, the key promotional messages.
Juste shall be consistent in its use of the agreed messages and shall use them,
as appropriate, for all sales literature, promotional or other marketing materials
in relation to the Licensed Product. A copy of all materials shall be delivered
to Laxdale.


 


7.3                           Juste
shall refrain from taking any action that would damage the reputation and
standing of Laxdale and/or the Licensed Product.


 


7.4                           Juste
shall not re-sell, ship, export or otherwise dispose of the Licensed Products
in any manner which may or would violate applicable export laws and/or
regulations in the Territory.


 


7.5                           To
avoid any doubt, all costs and expenses incurred by Juste in carrying out its
obligations under this Agreement, shall be borne solely and exclusively by
Juste. In addition, all expenses incurred by Juste acting in its capacity as
exclusive distributor shall be borne solely by Juste.


 


7.6                           Juste
shall promptly bring to Laxdale’s notice any information or knowledge received
or gained by it which is likely to be of interest, use or benefit to Laxdale in
relation to the development, marketability or sale of the Licensed Product or
otherwise.


 


7.7                           Juste
shall provide and maintain to Laxdale’s reasonable satisfaction operating
facilities and a service organisation adequate and competent to provide support
and service in respect of the Licensed Products within the Territory, and to
promote, distribute and sell the Licensed Products effectively within the
Territory and to customers.


 


7.8                           Juste
shall at all times ensure that it maintains an adequate stock of the Licensed
Products for sale to customers within the Territory.


 


8





















 


7.9                           Juste
shall at all times in relation to the Licensed Products describe itself solely
as the “authorised distributor of Laxdale Limited” and all such descriptions or
references to Juste shall be in a form acceptable to Laxdale. Juste shall
ensure that Laxdale’s approved logo appears prominently on all promotional
material.


 


7.10                         Juste
shall respect and protect Laxdale’s copyright (and other related rights) in all
sales literature, marketing, promotional and/or other materials provided by
Laxdale.  For the avoidance of doubt, Juste
shall not be permitted to copy any such sales literature or other such
materials except strictly for the purpose of performing its obligations under
this Agreement subject always to the prior written consent of Laxdale (which
shall not be unreasonably withheld or delayed).


 


7.11                         Juste
shall be responsible for training its employees in the successful sale of the
Licensed Products.


 


7.12                         Juste
shall at all times keep Laxdale fully appraised of the progress of its
marketing and promotional activities including providing regular quarterly
reports in writing of activity in the preceding quarter and proposed activity
in the forthcoming quarter and all other information as may reasonably be
requested by Laxdale from time to time. Juste shall meet with Laxdale when
reasonably requested from time to time by Laxdale in order to discuss progress
as aforesaid.


 


7.13                         Juste
shall notify Laxdale in writing of all serious adverse events occurring in
relation to the Licensed Product within 48 hours of Juste becoming aware of
such events.


 


8                              Duties
of Laxdale


 


8.1                           Throughout
the Term and subject to the satisfactory performance by Juste of its
obligations hereunder, Laxdale shall:


 


8.1.1                        suitably
package the Licensed Product subject at all times to EMEA approval for shipment
it being acknowledged and agreed by Juste that it shall not in any way tamper
with the packaging or labelling of the Licensed Product as provided to it by
Laxdale.  For the avoidance of doubt, all
applicable charges for shipping, insurance duties, excise taxes, tariffs and
assessments shall be Juste’s sole responsibility in respect of any Purchase
Orders by Juste;


 


8.1.2                        supply and
sell the Licensed Products to Juste upon the terms and conditions set forth in
this Agreement together with all necessary and appropriate documentation,
warnings and instructions in English as may be required in accordance with the
relevant regulatory approvals from time to time; and


 


8.1.3                        jointly
agree with Juste the key promotional messages to be used by Juste in relation
to the Licensed Product in the performance of its obligations hereunder as
detailed in Clause 7.2.


 


9                              Milestone
Payments


 


9.1                           In
consideration of the grant of the rights under this Agreement, Juste shall pay
Laxdale, the Milestone Payments within 30 days of achievement of each of the
Milestones respectively and Laxdale shall promptly confirm in writing the
achievement of each


 


9





















 


Milestone to Juste.
Milestone Payments are exclusive of applicable VAT which shall be payable in
addition thereto.


 


9.2                           For the
avoidance of doubt, Milestone Payments are non-refundable and shall not
constitute an advance on Royalties payable hereunder.


 


10                            Royalties


 


10.3                         In
addition to the Milestone Payments, Juste shall pay to Laxdale Royalties in
accordance with this Clause 10 and Clause 11.


 


10.4                         Royalties
shall be calculated as a percentage of the Net Sales Value of all Licensed
Products Sold by Juste in the Territory at the respective rates set out in the
Schedule and are applicable in each Marketing Year.


 


10.5                         In
relation to Sales of Licensed Products to any Associated Company, the Net Sales
Value shall be deemed to be the price at which the Licensed Products are
thereafter Sold by an Associated Company to a non-Associated Company in that
part of the Territory and where any such subsequent Sale is not at arm’s
length, the Sales Value shall be the open market price in that part of the
Territory.


 


10.6                         Royalties
shall be paid within 30 days of the end of each Quarter based upon Sales invoiced
by Juste in such preceding Quarter. All Payments of Royalties shall be
accompanied by a statement giving details of the calculation to be prepared
pursuant to Clause 12.2.


 


11                            Payments


 


11.3                         All
payments hereunder shall be paid by electronic transfer to Laxdale’s bank
account at Bank of Scotland or to such other bank account as may be notified to
Juste from time to time.


 


11.4                         All
payments hereunder shall be made in Euro without deduction or set off of any
kind.  Where the price on which the
Royalties or other payments are calculated are received by Juste in a currency
other than Euro, such sums shall be converted to Euro at the rate of exchange
between Euro and that other currency set out in the London edition of The
Financial Times on the last day of that Quarter in which such payments are
received, or if such date is not a day upon which The Financial Times is
published the next day on which it is published. Juste shall use reasonable
endeavours to use rights under any applicable double taxation treaty (if any)
to minimise any taxation liability to sums payable under this Clause 11.


 


11.5                         Unless
specifically stated otherwise, all payments are exclusive of Value Added Tax
and all other applicable taxes and/or duties which shall be payable if
applicable at the relevant rate from time to time by Juste.


 


11.6                         Without
prejudice to any other right or remedy of Laxdale, if any sum due by Juste is
not paid within the relevant time period specified in this Agreement, interest
shall be payable from the last date for payment under this Agreement until
actual payment (whether before or after judgement) at a rate of four (4)% per
annum above the base rate of the Bank of


 


10





















 


Scotland from time
to time together with all expenses (including legal fees) which Laxdale may
incur in recovering the sum outstanding.


 


12                            Accounts


 


12.1                         Juste
shall keep at its office at the address on the front of this Agreement (or such
other address as may be agreed by the parties from time to time), detailed,
accurate and separate records and accounts showing the calculation of the
Royalties payable to Laxdale in respect of the Licensed Products and all other
payments payable by Juste hereunder. Such records shall be in a form which
allows accurate checks to be made and shall be supported by all relevant
vouchers, invoices, Purchase Orders, Order Acknowledgements, delivery notes and
the like and shall be properly cross referenced.


 


12.2                         Juste
shall within 5 working days after the last day of each Quarter in each year of
this Agreement deliver to Laxdale a true and complete statement of all Licensed
Products Sold during the period ended on each such date (or any part thereof in
the first month following the Launch Date or last month of this Agreement)
which shall include details of all Royalties and other sums payable in respect
of such period.


 


12.3                         Juste
shall permit any duly authorised representatives of Laxdale or its auditors (or
other parties to whom Laxdale requires to account) access to such records,
accounts and statements of Juste upon reasonable notice and shall provide such
information and explanations as such representatives shall require to verify
the statements rendered by Juste in terms of this Agreement and shall also
permit such representatives to take copies of and extracts from such records,
accounts and statements for the purpose of verification. Notwithstanding expiry
or termination of this Agreement for any reason such access shall be given, as
aforesaid, until all outstanding claims have been settled to the satisfaction
of both parties.   If any inspection by
Laxdale as aforesaid reveals an under calculation or underpayment of 5% or more
of Royalties due to Laxdale, the costs of such inspection shall be borne by
Juste.


 


12.4                         Juste
shall at its own expense obtain and render to Laxdale (upon Laxdale’s request)
a certificate by Juste’s external auditors certifying that the statements
produced pursuant to Clause 12.2 to Laxdale are a true and accurate account of
the sums due to Laxdale hereunder.


 


13.                           Title
and Risk


 


13.1                         Property
and title in and to all Products supplied to Juste shall remain with Laxdale
until all monies for Cost of the Finished Product due by Juste to Laxdale
(including interest and charges) have been paid in full.  Juste shall keep all such Products safe and
shall store them so that they are readily identifiable as Laxdale’s Products
until all such monies are so paid.


 


13.2                         If Juste
fails to pay any sums due to Laxdale by the due date for payment, then in
addition (and without prejudice) to any other remedies available to Laxdale
under this Agreement or otherwise, Laxdale shall be entitled to repossess the
Products.   Juste shall assist and shall
allow Laxdale to repossess the Products and for this purpose shall admit or
procure the admission of Laxdale (or its employees or authorised
representatives) to the premises in which the Products are located.


 


11





















 


13.3                         Notwithstanding
the provisions of Clause 13.1, risk of loss or damage to the Products shall
pass to Juste upon delivery by Laxdale to the Delivery Location in terms of
Clause 5.4 and Juste shall be responsible for insuring the Products
accordingly.


 


14.                           Inspection


 


Subject to Clause
15, Juste shall have a period of 7 working days from receipt of the Licensed
Products to confirm that the quantity of Licensed Products received is correct
and that the Licensed Products otherwise conform to the relevant Purchase
Order. If Juste fails so to notify Laxdale, the quantity and shipment shall be
deemed to be correct and accepted by Juste. In the event that Juste notifies
Laxdale that the quantities are not correct (or the shipment is otherwise not
in conformance with the relevant Purchase Order) and Laxdale is satisfied that
any such shortage or non-conformity has not occurred in transit or at any time
thereafter, Laxdale shall despatch as soon as reasonably practicable at its own
expense the number of Licensed Products necessary to complete the Purchase
Order.


 


15.                           Warranty


 


15.1                         Subject
as herein provided, Laxdale warrants to Juste that until a Licensed Product has
reached its expiry date as indicated on it, it shall conform to the
specification for the Licensed Product and shall be manufactured by third party
contractors in accordance with all the relevant regulations in compliant
facilities. Juste’s sole and exclusive remedy in the event of any such defect
(proven to Laxdale’s satisfaction) shall be limited to the replacement of the
defective Licensed or refund of the price of the Licensed Product at Laxdale’s
sole option and expense. For the avoidance of doubt, the foregoing warranty
shall not apply to Licensed Products which are subject to misuse, mishandling,
failure to follow instructions, damage during shipment (whether caused by the
carrier or any other third party), improper storage or deliberate damage by
Juste or any third party or any other cause outwith the reasonable control of
Laxdale.


 


15.2                         Juste
shall notify Laxdale promptly in writing of any suspected breach of warranty
and Laxdale may request Juste to ship the Licensed Product purporting to be
defective to Laxdale prepaid and at Juste’s risk. Laxdale’s prior written
authorisation shall be required in respect of all such returns. If Laxdale is
satisfied that the Licensed Product is defective as claimed, Laxdale shall take
the appropriate action and shall bear the cost of shipment to Juste of the
replacement Licensed Product.


 


15.3                         Laxdale
shall have no other liability to Juste or any third party in the event of a
breach of the warranty contained herein.


 


16.                           Exclusion
of liability


 


16.1                         Neither
parry shall be liable to the other in respect of any indirect or consequential
or special loss or damage or loss of profits including but not limited to loss
of production, business, revenue or goodwill, anticipated savings or delays
whether due to negligence or otherwise under this Agreement.


 


16.2                         If Juste
receives any third party claims in respect of death or personal injury alleged
to have been caused by Licensed Products sold by Juste under this Agreement,
Laxdale shall handle all such claims including but not limited to the defence
and/or settlement thereof.


 


12





















 


Juste shall (a)
promptly notify Laxdale on any claims against Juste being made and allow
Laxdale to handle them; (b) make no admissions or statements in respect of such
claims without Laxdale’s consent, except insofar as required to do so by law
(and then only subject to prior consultation with Laxdale where this is
reasonably practicable); and (c) fully and effectively co-operate and provide
reasonable assistance to Laxdale in relation to the handling of such claims at
Laxdale’s reasonable expense.


 


16.3                         Subject
to Clause 16.1, each party shall fully and effectively indemnify the other in
respect of all losses, claims, damages, liabilities and expenses arising out of
the negligence of the other or of the other’s employees provided that


 


16.3.1                      the
indemnified party takes reasonable steps to mitigate its losses; and


 


16.3.2                      where any
party indemnified under the terms of this Clause 16.3 seeks indemnification in
respect of a third party claim, such third party claims shall be handled on
like terms mutatis  mutandis to those contained in Clause 16.2 to
the effect that the indemnified party allows the indemnifying party to handle
such claims on those terms.


 


16.4                         Laxdale
shall during the Term maintain comprehensive insurance cover with a reputable
insurer in sufficient terms to cover Laxdale’s potential liability to Juste
pursuant to the terms of this Agreement. Laxdale shall promptly present
evidence as to the existence of such insurance cover and the payment of
relevant premiums to Juste at Juste’s request from time to time.


 


16.5                         Juste
shall during the Term and for a period of ten (10) years thereafter maintain
comprehensive insurance cover, with a reputable insurer in sufficient terms to
cover Juste’s potential liability to Laxdale pursuant to the terms of this
Agreement. Juste shall promptly present evidence as to the existence of such
insurance cover and the payment of the relevant premiums to Laxdale at Laxdale’s
request from time to time.


 


17.                           Trade
marks


 


17.1                         The Trade
Mark shall be used by Juste only on or in respect of the Licensed Product and
no other trade name or trade mark shall be used by Juste on or in relation to
the Licensed Product. The use by Juste of the Trade Mark shall not confer on
Juste (nor on any other person) nor give rise to or create any right, title or
interest in the Trade Mark contrary to the rights of Laxdale. Juste hereby
agrees that it shall not claim nor commit any other person to claim any right,
title or interest in or to the Trade Mark or to any trade name or trade mark of
Laxdale and shall promptly cease to use the Trade Mark and all such other trade
marks or other trade name immediately upon termination of this Agreement for
any reason whatsoever subject to Clause 22.


 


17.2                         Juste
shall not change, obscure or interfere with the Trade Mark or any trade name or
trade mark which appears or may appear on the Licensed Products or packaging,
sales literature, promotional materials or other materials approved by Laxdale
from time to time.


 


17.3                         Juste
recognises that the Trade Mark used on or relative to the Licensed Product (and
any other rights attaching to the Licensed Product) are the property of Laxdale
and Juste will take all such steps as are practicable to ensure that the
property in the Trade Mark in the Territory shall vest in and remain vested in
Laxdale. Juste shall from time to time render


 


13





















 


all reasonable
assistance to Laxdale in connection with the registration of the Trade Mark or
any other trade name or trade mark as may be required by Laxdale.


 


17.4                         Juste
shall ensure that all Licensed Product related materials including but not
limited to sales literature, catalogues, price lists and other Licensed Product
related materials created by Juste from time to time shall contain a legible
statement announcing the proprietorship of the Licensed Patent and the Trade
Mark, in a form acceptable to Laxdale.


 


18.                           Improvements


 


18.1                         Without
prejudice to Clause 3.2, if, during the Term, Juste develops or conceives any
Improvement, then it shall forthwith notify Laxdale in writing of such Improvement
and shall disclose all necessary information to permit exploitation by Laxdale
of such Improvement in connection with the Licensed Product.


 


18.2                         Laxdale
shall have an irrevocable, perpetual, non-exclusive, worldwide royalty-free
licence to use all Improvements which Juste is due to disclose to Laxdale in
terms of Clause 18.1 and to work under all IP Rights in respect thereof.


 


18.3                         If during
the Term, Laxdale conceives or develops any Major Improvement (as defined)
Juste shall have the option to obtain a new licence and distribution agreement
from Laxdale in relation to said Major Improvement and on terms no less
favourable than those contained within this Agreement. Said agreement shall be
subject to Juste being satisfied (acting reasonably) that any Major Improvement
has successfully demonstrated a statistically significant improvement when
compared to the Licensed Product in this Agreement and said option shall be
exercisable by Juste on the following basis:


 


18.3.1                      Laxdale
shall give written notice to Juste of the results from clinical trials for a
product consisting of the Major Improvement and Juste shall have fourteen (14)
days to give written notice to Laxdale to exercise its option to enter into
negotiations for a new licence and distribution agreement in relation to said
Major Improvement. In the event no such notice is given to Laxdale by Juste,
the option in this Clause 18.3 shall be deemed to have expired and it shall be
at Laxdale’s sole discretion whether to enter negotiations with Juste.


 


18.3.2                      Upon receipt
by Laxdale of notice, in accordance with Clause 18.3.1, Laxdale and Juste shall
negotiate, in good faith, the terms of a licence and distribution agreement
(subject always to the terms of Clause 18.3). In the event the terms of an agreement
have not been reached within eight (8) weeks of receipt by Laxdale of the
foregoing notice from Juste, then all negotiations shall terminate and Laxdale
shall be entitled in its sole discretion to appoint a third party distributor
in the Territory for a product that incorporates said Major Improvement.


 


18.4                         If during
the Term, Laxdale conceives or develops any Minor Improvement (as defined),
Juste shall have the automatic right to have said Minor Improvement included
within the Field of Use and within the Territory and subject to the same
conditions as set forth in this Agreement.


 


14





















 


19.                           Intellectual
Property


 


19.1                         Other
than as expressly provided herein nothing contained in this Agreement shall be
construed as conferring or vesting any right, title or interest in or to any of
the Licensed Patent, the Trade Mark or other IP Rights in or relating to the
Licensed Product in favour of Juste or any other third party.


 


19.2                         Laxdale
gives no warranty to Juste that the use or sale by it of the Licensed Products
will not infringe the IP Rights of any third party and Laxdale shall not be
required under any circumstance to indemnify Juste or any third party with
regard to any loss, cost, injury or damage incurred or suffered by Juste or
such third party in respect of any such infringement. However, Laxdale asserts
that it is unaware as of the effective date of any such third party rights with
respect to the Product within the Territory.


 


19.3                         Juste
shall forthwith advise Laxdale of any infringement or purported infringement of
the Licensed Patent, the Trade Mark and/or any other IP Rights of Laxdale of
which it becomes aware. Laxdale shall in its sole discretion decide whether to
take any action (at its own expense) against any infringement or purported
infringement of the foregoing which comes to its knowledge. Juste shall
promptly give Laxdale all reasonable assistance in relation to such proceedings
(including becoming a party to them, if so requested by Laxdale), upon being
indemnified by Laxdale in respect of any reasonable costs and in that event any
damages, profits or other compensation received from such proceedings shall
belong to Laxdale (subject to Juste’s right to be recompensed for its
reasonable costs as aforesaid). For the avoidance of doubt, nothing in this
Agreement shall entitle Juste to take action in respect of any infringement of
the Licensed Patent, the Trade Mark or any other IP Rights (whether relating to
the Licensed Product or otherwise) which are owned by Laxdale without the prior
written permission of Laxdale.


 


20.                           Confidential
information


 


Neither Juste nor
Laxdale shall either during the Term (or any extension thereof) or thereafter,
disclose to any third party (other than in the proper course of business to its
professional advisers) any confidential business information of the other
whether relating to the Licensed Product, any IP Rights relating to the
Licensed Product, (including but not limited to the Licensed Patent and/or the
Trade Mark), any aspect of (or the existence of) this Agreement, or in relation
to each others’ business including but not limited to trade secrets,
proprietary information or any information relating to the business affairs of
each other. For the avoidance of doubt, the aforesaid restriction shall not
apply to information which is in the public domain at the Effective Date, which
enters the public domain thereafter through no fault of Juste or Laxdale as the
case may be, or any information required to be disclosed by law or other
regulatory authority.


 


21.                           Press
Releases


 


Subject to clause
20, during the term of this Agreement each party has the right to approve the
wording of any press release relating to the terms of this Agreement or in
relation to the Licensed Product. Neither party shall use the other party’s
name without their prior written consent.


 


15





















 


22.                           Force
majeure


 


22.1                         If either
of the parties is prevented or delayed by force majeure from the performance of
any of its obligations under this Agreement (the “Defaulting Party”), and gives
written notice to the other party (the “Non-Defaulting Party”) specifying the
matters constituting force majeure and (where possible to predict) the period
for which such prevention or delay shall continue, then the party in question
shall be excused from the performance or the punctual performance (as the case
may be) of the relevant obligation as from the date of such notice for so long
as such cause of prevention or delay to its relevant obligations shall
continue.


 


22.2                         The
parties shall co-operate with each other and the Defaulting Party shall use its
utmost endeavours to make alternative arrangements to enable the relevant
obligations to be performed and if such relevant alternative arrangements are
not arranged or if they are not arranged to the satisfaction of the
Non-Defaulting Party, the Non-Defaulting Party may make alternative
arrangements to enable such obligations to be performed.


 


23.                           Termination


 


23.1                         Subject
as provided herein, Laxdale may terminate this Agreement by written notice to
Juste with immediate effect upon the occurrence of any of the following events:


 


23.1.1                      liquidation,
receivership, appointment of an administrator of Juste or the institution of
insolvency proceedings or any general composition, formal or informal, with or
for the benefit of creditors;


 


23.1.2                      Change of
Control of Juste or Juste ceasing or threatening to cease carrying on its
business or a substantial part thereof;


 


23.1.3                      failure by
Juste to pay any sum due within ninety (90) days of the due date for payment;


 


23.1.4                      if Juste challenges and/or
assists any third party to challenge the IP Rights (including the Licensed
Patent and/or the Trade Mark) of Laxdale; or


 


23.1.5                      if during the
Term it comes to the attention of Laxdale that Juste is concerned or involved
in the marketing, distribution or sale of any product which competes with the
Licensed Product.


 


23.1.6                      Failure by
Juste to meet the terms of Clause 4.4


 


23.2                         Either
party may by written notice to the other terminate this Agreement with
immediate effect in the event of a material breach of any of the provisions of
this Agreement which cannot be remedied or if it can be remedied remains
unremedied on the expiry of 28 days after notice is given by the other party
specifying the nature of the breach and the action required to remedy same.


 


24.                           Effect
of termination


 


24.1                         In the event
of termination or expiry of this Agreement for any reason:-


 


16





















 


24.1.1                      Juste’s
appointment and right to sell the Licensed Products hereunder shall
automatically terminate other than in relation to Licensed Products for which
binding orders have been received by Juste which Juste shall be entitled to
fulfil unless Laxdale has terminated under Clause 23 and Laxdale shall be
entitled to repossess all Licensed Products for which binding orders have not
been received by Juste and/or which Juste is not entitled to sell as aforesaid
(subject to payment by Laxdale for any such repossessed Licensed Products which
Juste has paid for at cost);


 


24.1.2                      Laxdale
shall not be liable to deliver to Juste any Licensed Products ordered by Juste
and which have been accepted by Laxdale by Order Acknowledgements prior to the
date of termination unless and until arrangements acceptable to Laxdale
providing for guaranteed payment are made by Juste;


 


24.1.3                      all sums due
to Laxdale as at the date of termination (excluding sums in respect of any
Purchase Orders) shall immediately become due and payable within 14 days;


 


24.1.4                      Juste shall
return to Laxdale all correspondence, documents and other property provided by
Laxdale (or any of its representatives or agents) which may be in Juste’s
possession or under its control including all Licensed Products, the title of
which have not passed to Juste.


 


24.2                         Termination
or expiry of this Agreement for any reason whatsoever shall not affect any
rights of the parties in relation to the period prior to the date of
termination or expiry and/or which due to their nature are due to be performed
or observed following such termination including but not limited to Clauses
[7,10,11,12,15,16,19,20,and 24 ].


 


25.                           General


 


25.1                         Juste
shall not be entitled to transfer, assign or sub-license any of its rights or
obligations under this Agreement without the prior written consent of Laxdale.
Laxdale shall be entitled to transfer, assign or sub-license any of its rights
or obligations under this Agreement to a company within its group of companies
as defined by the Companies Act 1985 (the “Act”) or to its holding company (as
defined in the Act) or a company within the group of companies of its holding
company or companies.


 


25.2                         This
Agreement constitutes the entire agreement and understanding between the
parties hereto regarding its subject matter and cancels, terminates and
supersedes any and all prior agreements and understandings of any nature
(written, oral or otherwise) relating to such subject matter but that without
excluding either party’s liability for fraud or fraudulent misrepresentation.
Any variation or addition to the provisions of this Agreement shall not be
effective unless reduced to writing and signed by or on behalf of the parties
hereto by a person duly authorised to do so.


 


25.3                         The
relationship between the parties in relation to the subject matter of this
Agreement is as described in this Agreement and no employment, partnership,
joint venture or agency relationship shall be deemed to exist between the
parties and neither shall have the power to bind or pledge the credit of the
other.


 


25.4                         Failure
by either party to enforce at any time any of the provisions of this Agreement,
exercise any option provided herein shall not constitute a waiver of such
provision or


 


17





















 


option, nor affect
the validity of this Agreement or any part thereof, or the right of the willing
party to enforce thereafter each and every such provision or option.


 


25.5                         If any
provision of this Agreement is held to be invalid or unenforceable, the
remainder of this Agreement shall continue in full force and effect.


 


25.6                         Any
notice or other document to be given under this Agreement shall be in writing
and shall be deemed to have been duly given if left at or sent by hand or by
registered post; or by facsimile or by other electronic media to a party at the
address set out herein for such party or such other address as one party may
from time to time designate by written notice to the other. Any such notice or
other document shall be deemed to have been received by the addressee two
working days following despatch if the notice or other document is sent by
registered post, or simultaneously with the delivery or transmission if sent by
hand or other electronic means.


 


18





















 


26.                           Applicable
law and jurisdiction


 


This Agreement shall be
governed by and construed in accordance with English law. The parties hereby
submit to the non-exclusive jurisdiction of the English courts.


 


AS WITNESS the hand of the parties thereto the date
and year first before written.


 


	
  Signed for and on behalf of

  LAXDALE LIMITED

  Director

  
	
  at         Stirling

  
	
   

  	
  /s/ [ILLEGIBLE]

  	
   

  
	
  On       29/11/02

  
	
   

  
	
  Signed for and on behalf of

  JUSTE S.A.Q.F

  
	
  Director

  
	
  at        Madrid

  
	
   

  	
  /s/ Denis Cussidy

  	
   

  
	
  on       9/12/02

  
	
   

  
	
  Director/Company Secretary

  
	
  at

  
	
   

  	
   

  	
   

  
	
  on

  



 


19





















 


Schedule


 


1.             Minimum
Sales:


 


Year 1 – [*] Units of the
Licensed Product per annum


 


Year 2 – [*] Units of the
Licensed Product per annum


 


Year 3 – [*] Units of the
Licensed Product per annum


 


Year 4 – [*] Units of the
Licensed Product per annum


 


Year 5 and subsequent
years – [*] Units of the Licensed Product per annum


 


2.             Licensed
Patent:


 


Patent number EPO
00900733.3


 


International filing
date: 21.1.00


 


3.             Royalties:


 


(i)            [*]%
of the Net Sales Value for the relevant Licensed Product in each Marketing year
on Total Net Sales Value up to 3 million Euro;


 


(ii)           [*]%
of the Net Sales Value for the relevant Licensed Product in each Marketing year
on Total Net Sales Value over 3 million Euro but up to 6 million Euro;


 


(iii)          [*]%
of the Net Sales Value for the relevant Licensed Product in each Marketing year
on Total Net Sales Value over 6 million Euro.


 


4.             Timetable


 


	
  Milestone

  	
   

  	
  Milestone Payments

  
	
   

  	
   

  	
   

  
	
  Milestone 1 – on
  the Effective date

  	
   

  	
  Euro

  	
  [*]

  
	
   

  	
   

  	
   

  
	
  Milestone 2 –
  written approval of an accepted reimbursement price by the Spanish
  authorities to Juste for the Licensed Product

  	
   

  	
  Euro

  	
  [*]

  
	
   

  	
   

  	
   

  
	
  Milestone 3  Launch Date of the Licensed Product in the
  Territory

  	
   

  	
  Euro

  	
  [*]

  



 


20