Document:

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 4.54

 

 

	
   

  	
  

  	
  PRIVATE
  & 

  CONFIDENTIAL

  
	
   

  

 

THIS LICENCE AND DISTRIBUTION AGREEMENT is made on
20/12 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)           LINK
PHARMACEUTICALS LIMITED, (“Link”), a Company incorporated in England under the
Companies Acts (Company Number: 2530982), having its place of business at
Bishops Weald House, Albion Way, Horsham, West Sussex RH12 1AH

 

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 Link as its exclusive distributor in the Territory (as
after defined) on an exclusive basis and insofar as necessary to perform its
obligations as distributor to license Link under the Licensed Patent and the
Trade Mark and Link 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:

 

	
  “Additional Field”

  	
   

  	
  means the treatment of depression;

  
	
   

  	
   

  	
   

  
	
  “Associated Company”

  	
   

  	
  means any firm, company or entity controlled by,
  controlling or under common control with Link. 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;

  

 

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

 

 

	
  “Change of Control”

  	
   

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

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (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;

  
	
   

  	
   

  	
   

  
	
  “Cost of Finished Pack”

  	
   

  	
  means the cost of Finished Pack in relation to the
  Licensed Product incurred by Laxdale to include materials and delivery to the
  Delivery Location (as after defined). For the avoidance of doubt the Cost of
  Finished Pack shall not exceed £20 per Unit plus 10% in the first year and
  shall be reviewed annually;

  
	
   

  	
   

  	
   

  
	
  “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,

  

 

2

 

	
   

  	
   

  	
  (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 within the Field of Use 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 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 a date to be agreed between the parties hereto
  which shall be no later than six (6) months following approval of the
  Licensed Product by the EMEA;

  
	
   

  	
   

  	
   

  
	
  “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 Part 1 of 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 Part 1 of the Schedule;

  
	
   

  	
   

  	
   

  
	
  “Minimum Sales”

  	
   

  	
  means the minimum sales to be achieved by Link as
  set out in Part 1 of 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;

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  means the orphan designation for the Licensed

  

 

3

 

	
  “Orphan Drug Designation”

  	
   

  	
  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 Part 1 of 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
  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 Link 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 Link to Laxdale for the purchase
  of Licensed Products for sale by Link 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 under this
  Agreement as detailed in Clause 10;

  
	
   

  	
   

  	
   

  
	
  “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 and after deduction of normal trade discounts actually granted):

  

 

4

 

	
   

  	
   

  	
  (i)  in the case of an arm’s length Sale,
  the Net 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 Net 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 Net Sales Value shall also
  include any and all lump sums or other benefits whether in cash or in kind
  receivable by Link from any third party in consideration of the Sale and/or
  distribution of Licensed Products;

  
	
   

  	
   

  	
   

  
	
  “Term”

  	
   

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

  
	
   

  	
   

  	
   

  
	
  “Termination Minimum Sales”

  	
   

  	
  means the termination minimum sales as set out in
  Part 1 of the Schedule

  
	
   

  	
   

  	
   

  
	
  “Territory”

  	
   

  	
  means the United Kingdom and the Republic of
  Ireland;

  
	
   

  	
   

  	
   

  
	
  “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 Link 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.

 

5

 

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
expiry or termination of this Agreement, the parties may enter into a separate
Trade Mark licence in relation to the distribution of Licensed Products under
the Trade Mark provided that any such trade mark licence shall be negotiated,
in good faith, by the parties and the parties shall intimate their wish (or
otherwise) to enter into such an agreement at least 18 months prior to the
scheduled expiry of the Term.

 

3.                             Appointment
and scope of rights

 

3.1                           Subject
to the terms of this Agreement, Laxdale hereby grants to Link an exclusive,
nontransferable 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 and Link shall in consideration pay the
royalties as outlined in the Schedule. Link shall not be entitled to
sub-license or sub-contract any of its rights hereunder without Laxdale’s prior
written consent, such consent not to be unreasonably withheld. It is acknowledged
by Link 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                           In the
event, during the Term of this Agreement, Laxdale is in a position to appoint a
distributor for the Licensed Product, in the Additional Field, and subject
always to Link having performed all of its obligations under this Agreement to
the satisfaction of Laxdale and not being in breach of this Agreement, Link
shall have the option to negotiate the terms of a licence and distribution
agreement for such a product on the following basis:

 

3.2.1                        Laxdale
shall give written notice of its intention to appoint a distributor for such a Licensed
Product to Link and Link shall have fourteen (14) days to give written notice
to Laxdale to exercise its option to enter into negotiations.  In the event no such notice is given to
Laxdale by Link, the option in this Clause 3.2 shall be deemed to have expired and
it shall be at Laxdale’s sole discretion whether to enter into negotiations
with Link.

 

3.2.2                        Upon
receipt by Laxdale of notice, in accordance with Clause 3.2.1, Laxdale and Link
shall negotiate, in good faith, the terms of a licence and distribution
agreement.  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 Link, then all negotiations shall terminate.

 

3.3                           Link
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.

 

6

 

3.4                           Link 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 Link shall be entitled to describe itself as Laxdale’s authorised
distributor for the Licensed Products.

 

3.5                           Link
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, such consent not to be
unreasonably withheld.

 

4.                             Exclusivity
and Minimum Sales

 

4.1                           Link
shall throughout the Term purchase Licensed Products from Laxdale and Laxdale agrees
to sell the same to Link 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 Link achieves the Minimum Sales.

 

4.3                           The
Minimum Sales are set out in the Schedule.

 

4.4                           If Link
fails to achieve the Minimum Sales in any 2 consecutive years, Laxdale shall be
entitled to convert Link’s exclusive appointment herein to a non-exclusive
appointment and shall be free to appoint new distributors, agents and/or
licensees in the Territory and/or proceed with the marketing, distribution and
sale of the Licensed Products in the Territory on its own account, as it deems
appropriate.

 

4.5                           Notwithstanding
Clause 4.4, if Link fails to achieve the Termination 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.

 

4.6                           The
Parties shall after the first full Marketing Year and, at any time during the
Term of the Agreement in the situation where additional trial data within the
Field of Use becomes available after the Launch Date or where a directly
competing product is launched within the Territory, meet to discuss any
appropriate alterations that should be made to the Minimum Sales or Termination
Minimum Sales on the basis that, if no agreement is reached in this regard the
definition of Minimum Sales and Termination Minimum Sales shall remain
unaltered.

 

5.                             Supply
of the Licensed Products

 

5.1                           With
effect from the Launch Date, Link 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 Link and shall be for information only.

 

7

 

5.2                           All
orders for the purchase of the Licensed Products shall be made by Link
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 no later than 10 working days after the
receipt of the Purchase Order by Laxdale from Link. Laxdale shall use its
reasonable endeavours to comply with Link’s requirements under Purchase Orders
provided that Purchase Orders placed are within 10% of the terms of the
applicable forecast. However, Link 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 Link to achieve such Minimum Sales

 

5.3                           At the
time of submitting the relevant Order Acknowledgement, Laxdale shall inform
Link of Laxdale’s estimated delivery date for consignments and shall use all
reasonable endeavours 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 Link said address to be: UDG Limited, Amber Park, Bernstowe Lane,
South Normananton, Derbyshire, DE55 2FH or such other address as may be agreed
between the parties hereto (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.

 

5.5                           In
addition to the Royalties to be paid by Link to Laxdale in terms of this
Agreement, Licensed Product will be invoiced to Link at the Cost of Finished Pack
(as defined). Invoices are due for payment within 30 days from the invoice
date.

 

6.                             Approvals

 

6.1                           Subject
to Clause 6.2 it shall be solely Laxdale’s responsibility 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
a full, compliant 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                           Link
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.

 

8

 

6.4                           Link
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. Link 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, Link shall
promptly provide all information, data, sales figures and other information
that Laxdale may reasonably 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 Link 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 Link

 

7.1                           Without
prejudice to its obligation to achieve Minimum Sales, Link shall use all reasonable
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                           Link
shall use all reasonable endeavours to enhance the reputation and acceptance of
the Licensed Product amongst customers and prospective customers within the
Territory and in this respect Link shall jointly agree with Laxdale, after the
Effective Date but prior to the Launch Date the key promotional messages.  Link shall be consistent in its use of the agreed
key messages and shall use them, as appropriate, for all sales, literature, promotional,
marketing and other materials in relation to the Licensed Product. A copy of all
sales literature shall be delivered to Laxdale.

 

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

 

7.4                           Link
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                           All costs and expenses incurred by
Link in carrying out its obligations under this Agreement, shall be borne
solely and exclusively by Link.  In
addition, all expenses incurred by Link acting in its capacity as exclusive
distributor shall be borne solely by Link.

 

7.6                           Link
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                           Link
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.

 

9

 

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

 

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

 

7.10                         Link
shall respect and, in accordance with Clauses 17 and 19 hereof, 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, Link 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                         Link
shall be responsible for training its employees in the successful sale of the
Licensed Product.

 

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

 

7.13                         Link
shall notify Laxdale in writing of all serious adverse events occurring in
relation to the Licensed Product within 24 hours of Link becoming aware of such
events. To further specify Link’s obligations in this regard, the parties
hereto agree to enter into a separate technical agreement concerning inter alia, all drug safety aspects in relation to this Agreement (the “Technical
Agreement”).

 

8.                             Duties
of Laxdale

 

8.1                           Throughout
the Term and subject to the satisfactory performance by Link 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 Link that it shall not in any way tamper
with the packaging or labelling of the Licensed Product as provided to it by
Laxdale it being agreed that further provisions in this regard shall be
included in the Technical Agreement. For the avoidance of doubt, all applicable
charges for shipping, insurance duties, excise taxes, tariffs and assessments
shall be Link’s sole responsibility in respect of any Purchase Orders by Link;

 

8.1.2                        supply and
sell the Licensed Products to Link 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;

 

10

 

8.1.3                        assist
Link with the key promotional messages to be used by Link in relation to the Licensed
Product in the performance of its obligations hereunder as detailed in Clause 7.2;

 

8.1.4                        provide
Link with a copy of summary sections of the dossier submitted to EMEA referred to
in Clause 6.1; and

 

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

 

9.                             Milestone
Payments

 

9.1                           In
consideration of the grant of the rights under this Agreement, Link shall pay
Laxdale the Milestone Payments within 14 days of written notice and proof from
Laxdale of the achievement of each of the Milestones respectively. 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.

 

9.3                           In the
event that the indication approved for the Licensed Product by EMEA is
restricted or limited to a treatment period of less than twelve months then the
parties shall re-negotiate in good faith the further Milestone Payments within
1 (one Month) of the approval being notified to Link by Laxdale.

 

10.0                         Royalties

 

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

 

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

 

10.3                         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.

 

10.4                         Royalties
shall be paid within 30 days of the end of each Quarter based upon Sales invoiced
by Link 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

 

1 1.1                        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
Link from time to time.

 

11.2                         All
payments hereunder shall be made in pounds Sterling without deduction or set
off of any kind. Where the price on which the Royalties or other payments are
calculated are received by Link in a currency other than Sterling, such sums
shall be converted to Sterling at the rate of exchange between Sterling 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. Link 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.

 

11.3                         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 Link.

 

11.4                         Without
prejudice to any other right or remedy of Laxdale, if any sum due by Link 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 3% per annum
above the base rate of the Bank of 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                         Link
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 and
accurate records and accounts showing the calculation of the Royalties payable
to Laxdale in respect of the Licensed Products and all other payments payable
by Link 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.

 

12.2                         Link
shall within 10 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 Quarter 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 Quarter.

 

12.3                         Not more
than once in any calendar year, Link shall permit any duly authorised representatives
of Laxdale or its auditors access to such records, accounts and statements of
Link upon 10 working days notice and shall provide reasonable information and cooperation
as such representatives shall require to verify the statements rendered by Link
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 Link.

 

12

 

13.                           Title
and Risk

 

13.1                         Property
and title in and to all Products supplied to Link shall remain with Laxdale
until all monies due by Link to Laxdale for the Cost of Finished Packs of
Licensed Products (including interest and charges) have been paid in full. Link
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 Link
fails to pay any sums due to Laxdale for the Licensed Products 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. Link 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.

 

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

 

14.                           Inspection

 

Subject to Clause
15, Link shall have a period of 7 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. In the
event that Link notifies Laxdale that the quantities are not correct (or the shipment
is otherwise not in conformance with the relevant Purchase Order) and any such
shortage or non-conformity has not occurred following the receipt of the
Licensed Products by Link, Laxdale shall despatch as soon as reasonably
practicable at its own expense the number of Licensed Products necessary to
complete the Purchase Order.

 

15.                           Warranties

 

15.1                         Subject
as herein provided and subject to Clause 16.2, Laxdale warrants to Link 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 relevant
regulations in compliant facilities. Link’s sole and exclusive remedy in the
event of any such defect shall be limited to the replacement of the defective
Licensed Product 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
Link or any third party or any other cause outside the reasonable control of
Laxdale.

 

15.2                         Laxdale
warrants to Link that it shall use all reasonable efforts to obtain (a) full
regulatory approval from EMEA for the Licensed Product; and (b) a granted
patent for the Licensed Product to cover the Territory.

 

13

 

16.                           Exclusion of liability

 

16.1                         Neither
party 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 Link
receives any third party claims in respect of death or personal injury alleged
to have been caused by Licensed Products sold by Link under this Agreement,
Laxdale shall handle all such claims including but not limited to the defence
and/or settlement thereof. Link shall (a) promptly notify Laxdale on any claims
against Link 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 or in connection with this
Agreement and which are caused by any wrongful acts of the indemnifying party 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 Link 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 Link
at Link’s request from time to time. The amount of the foregoing insurance
cover shall be no less than £5,000,000 (five million pounds sterling).

 

16.5                         Link
shall during the Term maintain comprehensive insurance cover, with a reputable insurer
in sufficient terms to cover Link’s potential liability to Laxdale pursuant to
the terms of this Agreement. Link 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. The amount of the foregoing
insurance cover shall be no less than £5,000,000 (five million pounds
sterling).

 

17.                           Trade
marks

 

17.1                         The Trade
Mark shall be used by Link only on or in respect of the Licensed Product and no
other trade name or trade mark shall be used by Link on or in relation to the
Licensed Product. The use by Link of the Trade Mark shall not confer on Link
(nor on any other

 

14

 

 

person) nor give rise to
or create any right, title or interest in the Trade Mark contrary to the rights
of Laxdale. Link 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                         Link
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                         Link
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. Link shall from time to time and at the cost of Laxdale render 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                         Link
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 Link 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, Link 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 Link 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 Link 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 Link 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 Link on the following
basis:

 

18.3.1                      Laxdale
shall give written notice to Link of the results from clinical trials for a
product consisting of the Major Improvement and Link 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 Link, 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 into negotiations with Link.

 

18.3.2                      Upon receipt
by Laxdale of notice, in accordance with Clause 18.3.1, Laxdale and Link shall
negotiate, in good faith, the terms of a licence and distribution agreement
(subject

 

15

 

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 Link,
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. Link 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.

 

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 Link or any other third party.

 

19.2                         Laxdale
warrants to Link that at the Effective Date and to the best of it’s knowledge
it is the sole owner of or has the right to use all the intellectual property
rights in the Licensed Product. Laxdale shall indemnify and hold Link harmless
against any liability, expense, loss, damage or injury arising out of or in
connection with a claim against Link that the Licensed Product infringes .

 

19.3                         Link
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. 
Link 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 Link’s right to be recompensed
for its reasonable costs as
aforesaid). In the event Laxdale, in its sole discretion, decides to take no
action Link shall be entitled to take such action as it sees fit. To avoid any
doubt any action so taken by Link shall be at its own expense and Link shall
indemnify Laxdale in relation to any costs, claims or damages incurred by
Laxdale as a result of Link taking such action.

 

20.                           Confidential
information

 

Neither Link 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 Link or Laxdale as the
case may be, or any information required to be disclosed by law or other
regulatory authority.

 

16

 

21.                           Press
Releases

 

Subject to clause 20,
during the term of this Agreement Laxdale and Link 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 in the Territory. Neither Laxdale or Link
shall use the other party’s name without their prior written consent.

 

22.                           Force
majeure

 

22.1                         If either
Laxdale or Link 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                         Laxdale
and Link shall co-operate with each other and the Defaulting Party shall use
its reasonable 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 or Link may terminate this Agreement by written notice
to the other with immediate effect upon the occurrence of any of the following
events:

 

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

 

23.1.2                      the other party ceasing or
threatening to cease carrying on its business or a substantial part thereof;

 

23.1.3                      Change of
Control of the other party provided that the new shareholder is a direct competitor
of the other party;

 

23.1.4                      failure by
Link to pay any sum due within 90 days of the due date for payment;

 

23.1.5                      if either
party commits 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.

 

23.1.5                      Laxdale may
terminate this Agreement on 30 days’ written notice if: Link challenges and/or
assists any third party to challenge the IP Rights (including the Licensed
Patent and/or the Trade Mark) of Laxdale; or

 

17

 

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

 

23.1.7                      Failure by
Link to meet the terms of Clause 4.5 hereof.

 

24.                           Effect
of termination

 

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

 

24.1.1                      Link’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 Link which Link shall be entitled to
fulfil. Laxdale shall be entitled to repossess all Licensed Products for which
binding orders have not been received by Link and/or which Link is not entitled
to sell as aforesaid (subject to prior repayment by Laxdale for any such
repossessed Licensed Products which Link has paid for);

 

24.1.2                      Laxdale
shall not be liable to deliver to Link any Licensed Products ordered by Link
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 Link;

 

24.1.3                      all sums due
to either party 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                      Either party
shall return to the other all correspondence, documents and other property provided
under the Agreement.

 

24.1.5.                     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.                           Governing
Law and Dispute Resolution.

 

25.1                         All
matters arising out of or in connection with this Agreement shall be governed
by the law of England. In the event of any controversy or claim arising out of,
relating to or in connection with Clauses 23.1.5 and 23.1.6 of this Agreement,
the parties shall try to settle their differences amicably between themselves
first, by referring the disputed matter to the respective heads of sales and
marketing of each party and, if not resolved by the sales and marketing heads,
by referring the disputed matter to the respective Chief Executive Officers of
each party. Either party may initiate such informal dispute resolution by
sending written notice of the dispute to the other party, and, within 30 days
after such notice, such representatives of the parties shall meet for attempted
resolution by good faith negotiations. If such personnel are unable to resolve
a dispute within 30 days of their first meeting of such negotiations, the
parties shall submit the dispute to mediation if either party requests this in
writing. The parties are free to decide the format and procedure for
non-binding mediation. The mediation proceedings and any documents prepared for
such proceedings shall be without prejudice to the legal position of either
party and the parties shall use best endeavours to attend a mediation hearing
within two (2) months of the

 

18

 

mediation procedure first
being requested in writing. The mediation procedure shall be non-binding and,
unless agreed by both parties, the mediator/facilitator will not be requested
to give any views or report on the relevant merits relating to the dispute. The
mediation hearing shall take place in the UK and be conducted in English. Each
party shall bear its own costs of the mediation, with the costs of the mediator
and other joint costs being borne by the parties equally. In the event that the
mediation procedure has not satisfactorily resolved the dispute within two (2)
months of it first being requested, the dispute shall then be decided by the
relevant English court.

 

26.                           General

 

26.1                         Link
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,
such consent not to be unreasonably withheld. 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.

 

26.2                         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.

 

26.3                         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.

 

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

 

26.5                         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.

 

26.6                         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.

 

19

 

27.                           Applicable
law and jurisdiction

 

Subject to the dispute
resolution term at clause 25, all matters arising out of or in connection with this
Agreement shall be governed by and construed in accordance with English law.
The parties hereby submit to the 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 19 December 2002

  
	
   

  
	
   

  
	
  Signed for and on behalf of

  
	
   

  
	
  LINK PHARMACEUTICALS LIMITED

  
	
  Director

  
	
  at [ILLEGIBLE]

  	
  /s/ [ILLEGIBLE]

  
	
   

  
	
  on 20 December 2002

  

 

20

 

Schedule

 

1(a)         Minimum
Sales:

 

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

 

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

 

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

 

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

 

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

 

l(b)          Termination
Minimum Sales

 

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

 

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

 

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

 

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

 

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

 

2.             Licensed
Patent:

 

Patent number: EPO 00900733.3

 

International Filing Date: 21.1.00

 

Status: pending

 

3.             Royalties:

 

(i)            [*]%
of the Net Sales Value for the relevant Licensed Product where the Total Net
Sales Value at the time of the relevant Sale being made is less than £ 3
million in each Marketing Year;

 

(ii)           [*]%
of the Net Sales Value for the relevant Licensed Product where the Total Net
Sales Value at the time of the relevant Sale being made exceeds £ 3 million and where the relevant
sale being made is less than £6 million in each Marketing Year;

 

21

 

(iii)          [*]%
of the Net Sales Value for the relevant Licensed Product where the Total Net
Sales Value at the time of the relevant Sale being made exceeds £ 6 million in
each Marketing Year.

 

4.             Timetable

 

	
  Contribution
  to Research and Development of the Licensed Product Milestones

  	
   

  	
  Milestone
  Payments

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 1 –
  contribution for past development of the Licensed Product due on the
  Effective date

  	
   

  	
  £

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 2 –
  contribution to the development of a complete and compliant dossier and due
  on submission of the dossier to the EMEA by Laxdale

  	
   

  	
  £

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 3 –
  contribution to the development of the complete and compliant dossier due on
  formal written regulatory approval of Licensed Product by EMEA for use in
  Huntington’s Disease

  	
   

  	
  £

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 4 –
  contribution to the research and development of the Licensed Product due on
  the Launch Date of Licensed Product in the Territory

  	
   

  	
  £

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 5 –
  final contribution to the research and development of the Licensed Product
  due on Net Sales Value reaching £2,000,000

  	
   

  	
  £

  	
  [*]

  	
   

  

 

22Certain 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

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00082-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00082-of-00352.parquet"}]]