Exhibit 4.51


 


DATED


2004


 


 


LAXDALE LIMITED


 


- AND -


 


SCARISTA LIMITED


 










 


EXCLUSIVE PATENT AND


KNOW-HOW AGREEMENT


 


EXPLOITATION OF PRODUCTS BY
SCARISTA


 










 


AGREED FORM DOCUMENT


 





















 


THIS AGREEMENT is made the                                day
of                                       2004


BETWEEN


 


(1)                                 LAXDALE
LIMITED a company registered in Scotland whose
registered office is at Kings Park House, Laurelhill Business Park, Polmaise
Road, Stirling FK7 9JQ (“Laxdale”); and


 


(2)                                 SCARISTA
LIMITED a company registered under number 71829
whose registered office is at 1st Floor, 28 Victoria Street,
Douglas, Isle of Man IM1 2LE (“Scarista”).


 


RECITALS


 


(A)                               Laxdale
is a research and development company and commercialisation company in the
pharmaceutical industry which owns certain inventions and know-how.


 


(B)                               Scarista
is a company which owns, licences and commercialises inventions, know-how and
other intellectual property which have applications in medicine.


 


(C)                               Scarista
and Laxdale wish to co-operate in the exploitation of intellectual property and
patent rights and know-how in their respective territories and entered into two
agreements each dated 24 March 2000 pursuant to the first of which
Scarista granted to Laxdale certain rights which had been granted to Scarista
by Scotia Holdings plc, and pursuant to the second of which each granted to the
other licences of certain intellectual property for designated fields of use
and territories (together the “Previous Agreements”).


 


(D)                               Scarista
and Laxdale subject to the terms and conditions contained herein wish to enter
into a new agreement (“this Agreement”).


 


1





















 


TERMS AGREED


 


1.                                      Definitions


 


	
  In this Agreement:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  “Affiliate”

  	
   

  	
  means any firm, person or company which
  controls, is controlled by or is under common control with a party to this
  Agreement and for the purpose of this definition the term “control” means the
  possession, directly or indirectly of the power to direct or cause the
  direction of the management and policies of such firm, person or company
  whether through the ownership of voting securities, by contract or otherwise
  or the ownership either directly or indirectly of 50% or more of the voting
  securities of such firm, person or company;

  
	
   

  	
   

  	
   

  
	
  “a Distributor”

  	
   

  	
  means a
  distributor under the terms of a Distributor Agreement;

  
	
   

  	
   

  	
   

  
	
  “a Distributor Agreement”

  	
   

  	
  means
  an agreement which allows a third party to purchase from Scarista (or a
  Licensee of Scarista) and distribute the Products as finished packaged goods;

  
	
   

  	
   

  	
   

  
	
  “the Effective Date”

  	
   

  	
  means
  the date of this Agreement;

  
	
   

  	
   

  	
   

  
	
  “EMEA”

  	
   

  	
  means
  the European Medicines Evaluation Agency;

  
	
   

  	
   

  	
   

  
	
  “EU”

  	
   

  	
  means
  European Union;

  



 


2





















 


	
  “European Union”

  	
   

  	
  means all the current member states of the
  European Union or any other countries which shall subsequently accede to the
  membership of the European Union;

  
	
   

  	
   

  	
   

  
	
  “FDA”

  	
   

  	
  means
  the United States Food and Drug Agency Administration;

  
	
   

  	
   

  	
   

  
	
  “the Field of Use”

  	
   

  	
  means
  any and all psychiatric and Central Nervous System disorders, including pain;

  
	
   

  	
   

  	
   

  
	
  “the Improvements”

  	
   

  	
  means
  any improvement, enhancement or modification to a Product or its method of
  manufacture within the Field of Use;

  
	
   

  	
   

  	
   

  
	
  “Intellectual Property”

  	
   

  	
  means
  Patents, Orphan Drug Designations, marketing authorisations, confidential
  information, Laxdale Know-how or other intellectual rights and Improvements
  developed pursuant to Clause 4.2, owned by or licensed to Laxdale;

  
	
   

  	
   

  	
   

  
	
  “Know-how”

  	
   

  	
  means
  all secret and substantial Know-how, experience, drawings, designs and all
  other technical and other information including but not limited to data (to
  include without limitation clinical data forming part of any Regulatory
  Dossier), formulae, ideas, inventions, procedures for experiments and tests,
  manufacturing processes, specifications and techniques;

  



 


3





















 


	
  “LAX-101”

  	
   

  	
  means
  ethyl-eicosapentaenoate (ethyl-EPA) of greater than 90% purity as the active
  ingredient

  
	
   

  	
   

  	
   

  
	
  “the Laxdale Know-how”

  	
   

  	
  means
  all Know-how used by Laxdale in connection with the Patents set out in the
  Schedule;

  
	
   

  	
   

  	
   

  
	
  “the Laxdale Territory”

  	
   

  	
  means
  Canada, the United States of America, the European Union and Japan;.

  
	
   

  	
   

  	
   

  
	
  “Licence”

  	
   

  	
  means
  any form of Agreement or arrangement other than a Distributor Agreement which
  occurs when Scarista does not sell Product itself to the relevant third party
  but permits such a Third Party to manufacture and/or sell or otherwise
  commercialise Products in the Scarista Territory;

  
	
   

  	
   

  	
   

  
	
  “Licensee”

  	
   

  	
  means
  a licensee under the terms of a Licence;

  
	
   

  	
   

  	
   

  
	
  “the Net Sales Value”

  	
   

  	
  means the gross invoice price of Products sold by
  Scarista (or a wholly owned subsidiary)in the Scarista Territory(in each case
  other than pursuant to a Licence, Sub-license or a Distributor Agreement) to
  a Third Party (“Customer”) less the following items to the extent they are
  included in the invoice price

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (i)

  	
  normal and reasonable discounts actually granted;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii)

  	
  freight, shipment and insurance costs directly
  incurred by Scarista (or a wholly owned subsidiary) in transporting Products
  to Customers;

  



 


4





















 


	
   

  	
   

  	
  (iii)

  	
  taxes, tariffs, trade or ordinary discounts
  actually granted, government rebates, amounts repaid or credited because of
  return of goods (but excluding any free samples given to Customers);

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (iv)

  	
  customs duties and other governmental charges
  incurred in connection with the sale, exportation or importation of the
  Products.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  For the avoidance of doubt a sale of Products by
  Scarista (or a wholly owned subsidiary) involving a supply margin of 10% or
  less shall not fall within the defined terms “Net Sales Value” or “Net Income”
  for the purposes of this Agreement

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  If Scarista sells Products in any transaction
  which is not at arm’s length the Net Sales Value shall not be the price as
  charged, invoiced or received but shall be the open market price in the part
  of the world where the transaction was effected.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  The transfer or sale of Products to a wholly owned
  subsidiary shall not be considered a sale. In such cases, the Net Sales Value
  shall be determined based on the invoiced sale price by the wholly owned
  subsidiary to the Customer, less the deductions allowed by this clause.

  
	
   

  	
   

  	
   

  
	
  “Net Income”

  	
   

  	
  means all income received by Scarista with respect
  to commercial exploitation of the Patents or Orphan Drug Designation and the
  associated Scarista Know-how 

  



 


5





















 


	
   

  	
   

  	
  in the Scarista Territory. Such Net Income shall
  include: a) when a Product is sold by Scarista (or a wholly owned subsidiary)
  directly to a Third Party, Net Income shall equal Net Sales Value as defined
  separately; b) when a Product is sold by a Third Party (or an Affiliate which
  is not a wholly owned subsidiary) under a Licence, Sub-License or Distributor
  Agreement, then Net Income shall equal all income received by Scarista from
  any source under such an agreement whether in the form of profit-sharing,
  royalties, license fees, share issues which shall be valued at time of
  disposal(in cases where Scarista shares are
  subscribed for)and on acquisition (in cases where Scarista is paid a
  milestone by way of shares in a Third Party), milestone payments, outright sale of the
  Intellectual Property.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  If Scarista receives income in any transaction
  which is not at arm’s length the Net Income shall not be the price as charged
  invoiced or received but shall be the open market price in the part of the
  world where the transaction was effected.

  
	
   

  	
   

  	
   

  
	
  “Patents”

  	
   

  	
  means
  the patents or patent applications as described in the Schedule (including
  any and all divisions, continuations, continuations in part, extensions,
  substitutions, renewals, registrations, revalidations, re-issues thereof or
  additions thereto and including supplementary certificates of protection or
  similar of or to any such patent or patent application), together

  



 


6





















 


	
   

  	
   

  	
  with
  all Patents which may be granted pursuant to any such patent applications;

  
	
   

  	
   

  	
   

  
	
  “Products”

  	
   

  	
  means
  a pharmaceutical product within the Field of Use within the scope of any of
  the Patents or Orphan Drug Designation or utilising a not insubstantial part
  of the Laxdale Know-how and/or the Intellectual Property of Laxdale;

  
	
   

  	
   

  	
   

  
	
  “Orphan Drug Designation”

  	
   

  	
  means
  the orphan drug designation of the approval process for a Product as granted
  by a Regulatory Authority;

  
	
   

  	
   

  	
   

  
	
  “Regulatory Approval”

  	
   

  	
  the
  grant of all necessary governmental and regulatory approvals by a Regulatory
  Authority to sell Product in any country within the Scarista Territory
  including without limitation approval approvals required for pricing and
  reimbursements (if appropriate);

  
	
   

  	
   

  	
   

  
	
  “Regulatory Authority”

  	
   

  	
  the FDA or similar governmental or other agency in
  a country having authority to grant a Regulatory Approval;

  
	
   

  	
   

  	
   

  
	
  “Regulatory Dossier”

  	
   

  	
  means
  a dossier and all formal responses and submissions to any questions or issues
  raised by a Regulatory Authority in response to such a Regulatory Dossier
  once submitted which contains all the relevant information relating to a drug
  which is required by a Regulatory Authority as the case may be. Such a
  dossier will normally contain

  



 


7





















 


	
   

  	
   

  	
  information
  about the chemistry, formulation, manufacture, toxicology, pharmacology,
  pharmacokinetics and clinical studies related to a drug;

  
	
   

  	
   

  	
   

  
	
  “the Scarista Know-how”

  	
   

  	
  means
  all Know-how used by Scarista in connection with the Patents set out in the
  Schedule;

  
	
   

  	
   

  	
   

  
	
  “the Scarista Licence”

  	
   

  	
  means
  the licence of even date hereto granted by Scarista to Laxdale in terms of
  which Laxdale is entitled to exploit certain patents and intellectual
  property in the Laxdale Territory;

  
	
   

  	
   

  	
   

  
	
  “the Scarista Territory”

  	
   

  	
  means
  world-wide except those countries which comprise the Laxdale Territory from
  time to time;

  
	
   

  	
   

  	
   

  
	
  “the Schedule”

  	
   

  	
  means
  the Schedule to this Agreement which set out details of the Patents
  covered by this Agreement and which forms an integral part of this Agreement;

  
	
   

  	
   

  	
   

  
	
  “Sub-Licence”

  	
   

  	
  means
  any form of agreement or arrangement which occurs when Scarista permits a
  Third Party to manufacture and sell or otherwise commercialise Products
  (other than via a Distributor Agreement) in the Scarista Territory;

  
	
   

  	
   

  	
   

  
	
  “Sub-Licensee”

  	
   

  	
  means
  any Third Party granted a Sub-license to sell or otherwise commercialise
  Product under a Sub-license;

  



 


8





















 


	
  “Third Party”

  	
   

  	
  means
  any party which is not an Affiliate or wholly owned subsidiary of the
  relevant party ;

  
	
   

  	
   

  	
   

  
	
  “the Trade Marks”

  	
   

  	
  means
  such trade marks, brands, signs or logos which are applied to the Products;

  
	
   

  	
   

  	
   

  
	
  “USA”

  	
   

  	
  means
  United States of America;

  



 


2.                                      Grant of Rights


 


2.1.1                      Within the Field of Use Laxdale hereby grants
to Scarista the exclusive right and licence (save in respect of Laxdale which
shall retain the same right) under the Patents, Orphan Drug Designation, the
Laxdale Know-how and the Intellectual Property of Laxdale to develop, to have
developed, to make, to have made and to use (other than to market and sell), pharmaceutical products (including Products) on a world wide basis. To the
extent that either  Laxdale or Scarista
wish to develop, to have developed, to make, to have made and to use (other
than to market and sell), pharmaceutical products
(including Products)
on a world wide basis in either of the other respective territory they shall
consult with each other with a view to not prejudicing either of their mutual
interests


 


2.1.2                      Within the Field of Use, Laxdale
hereby grants to Scarista the exclusive right and licence under the Patents,
the  Laxdale Know-How and the
Intellectual Property of Laxdale to market, sell and distribute pharmaceutical products (including Products) in the Scarista Territory.


 


2.2                                 Laxdale
and Scarista acknowledge that it is in their mutual commercial interests to
exploit the Patents set out in the Schedule together with the Know-how in
a co-operative and collaborative manner and, without limitation, neither
Scarista nor Laxdale (or any of their respective Affiliates) will endeavour to
enter into any form


 


9





















 


of exclusive purchase or supply agreement with any
Third Party in respect of the Products within the Field of Use which could
materially hinder or prevent the other party rights hereunder contracting with
such Third Party.


 


2.3                                 Licensing
and Sub-Licensing and Distributorship


 


Scarista may grant Licences or Distributor Agreements
under the licences granted pursuant to Clause 2.1 above, (including a right
under the Licence to grant further Sub-licences on the same terms granted by
this Clause), on condition that:-


 


(a)                                  any such Licence or Distributor Agreement shall include like
obligations and undertakings on the part of the Licensee or Distributor as are
contained in this Agreement; provided, for the avoidance of doubt, that
Scarista shall remain solely responsible to Laxdale in respect of the payment
of royalties pursuant to this Agreement;


 


(b)                                 any such Licence or Distributor Agreement shall not exceed in scope
or duration, the scope and duration of the licences granted hereunder;


 


(c)                                  Scarista shall be responsible to Laxdale for any failure of its
Licensees or Distributors to observe and perform the terms and conditions of
their Licence or Distributor Agreement;


 


(d)                                 Scarista shall provide to Laxdale details of who it has granted
Licences (and details of any Sub-licences granted by its Licensees) or
Distributor Agreements, together with a copy of the clauses, schedules and/or
definitions of each Licence, Sub-licence or Distributor Agreement it grants,
which are relevant to the payments of royalties on Net Sales Value specified in
clause 5.1  within thirty (30) days of
the respective dates of execution of such Licence, Sub-licence or Distributor
Agreement;


 


(e)                                  Scarista’s Licences and Distributor Agreements will provide for
automatic termination of the Licence or Distributorship Agreement in the event
of a challenge by the Licensee or distributor to the validity of any of the
Patents licensed thereunder; and


 


10





















 


(f)                                    the conditions contained in this Clause 2.3
shall not apply to any Licences or Distributor Agreements entered into by
Scarista at the date hereof


 


2.4                                 Formal Licences


 


The
parties agree to execute such formal licences and other documents and take such
other action as each party reasonably requires from time to time for
registration with Patent Offices and/or other relevant authorities or otherwise
to give effect to this Agreement at the expense of the requesting party.  Until the grant of any such licence the
parties shall so far as legally possible have the same rights and obligations
towards each other as if such licence has been granted.  In the event of any conflict in meaning
between any such licence and the provisions of this Agreement, the provisions
of this Agreement shall prevail.  The
parties shall use their reasonable endeavours to ensure that, to the extent
permitted by relevant authorities, this Agreement shall not form part of any
public record.


 


3.                                      Know-how


 


3.1                                 Forthwith after the Effective Date from time to time as reasonably
requested  Laxdale shall disclose to
Scarista the Laxdale Know-how and Scarista shall disclose to Laxdale the
Scarista Know-how which it is at liberty to disclose.  All Know-how furnished by either party shall
be subject to the provisions of Clause 7, (Confidentiality) and shall be used
by the recipient party only for the purposes of this Agreement.


 


3.2                                 Scarista
shall be entitled to have full access on reasonable notice to Regulatory
Dossiers in Laxdale’s possession and control, for any Product and to use or
adapt them for the purposes of this Agreement and at its own expense in the
Scarista Territory without payment to Laxdale save as set out in Clause 5 of
this Agreement. For the avoidance of doubt all Scarista sub-licensees of the
Intellectual Property in the Scarista Territory in terms of this Agreement
shall also be entitled to have full access via Scarista on reasonable notice to
all such Regulatory Dossier without payment.


 


11





















 


4.                                      Improvements


 


4.1                                 If during the term of this
Agreement Scarista develops or conceives any Improvement or receives the
benefit of a licence of any Improvement then  Scarista shall grant to Laxdale
a non-exclusive licence for severable Improvements (provided it is entitled to
do so) or an exclusive licence for non-severable Improvements (provided it is
entitled to do so) for the  Laxdale
Territory until termination or expiry of this Agreement together with the
right to grant sub-licences or distributor agreements pursuant to such
Improvement licence(s)and there shall be no further payment to Scarista save
for any payment due pursuant to the Scarista Licence.


 


4.2                                 If during the term of this Agreement, Laxdale develops or conceives
any Improvement or receives the benefit of a licence of any Improvement the
rights to the use and exploitation of such Improvements shall be granted to
Scarista at no additional cost automatically under the same terms and
conditions set forth in Clause 2.1 save that where Laxdale receives the benefit
of a non-exclusive licence then Scarista shall only be entitled to receive a
non-exclusive sub-licence hereunder.


 


4.3                                 Improvements arising from the work carried out by either party alone
shall remain the exclusive property of that party subject to any grant of any
licence provided herein.


 


4.4                                 When Improvements are identified by either party, the parties will
endeavour to collaborate to secure their optimum commercialisation


 


5.                                      Payment


 


5.1                                 Scarista, in consideration of the rights granted to it under Clause
2.1 and 4.2 shall during the term of this Agreement pay to Laxdale a royalty of
5% on the Net Income


 


12





















 


received from
arising from exploitation or sale of Products sold within the Scarista
Territory PROVIDED THAT no royalty shall be due and payable in relation to
sales of a Product in a country which is part of the Scarista Territory on the later of (i) expiry of the
last Patent relating to the Product in such country; (ii) expiry of any
regulatory exclusivity relating to the Product in such country; (iii) the
Laxdale Know how ceasing to be secret and substantial in such country. For the avoidance of doubt, if any Product referred to under this
Clause 5.1 attracts any other payment or royalty payable by Scarista to Laxdale
the maximum aggregate amount payable by Scarista to Laxdale whether pursuant to
this Agreement or otherwise in respect of such Products shall be 5% of the Net
Income for the relevant Product.


 


5.2                                 Payment due under Clause 5.1 shall be made within thirty (30) days
after the end of each calendar quarter in respect of any Net Income received by
Scarista.


 


5.3                                 All sums due under this Agreement


 


5.3.1                      are exclusive of any value added tax which shall be payable;


 


5.3.2                      shall be paid in pounds sterling to the credit of a bank account to
be designated in writing by Laxdale. In the event that Scarista receives monies
in currencies other than pounds sterling (and in respect of which a royalty is
payable to Laxdale) conversion of such monies into pounds sterling shall be
calculated:-


 


5.3.2.1                                     in the case of each royalty payment at the rate of exchange ruling
in London on the last day of the calendar quarter in respect of which the
payment is due;


 


5.3.2.2                                     in the case of all other payments at the rate of exchange ruling on
the day payment is made or due whichever is earlier.


 


13





















 


5.3.3                      shall be made after deduction of taxes, charges and other duties,
(including any withholding or other income taxes) required to be made by law it
being acknowledged that Scarista shall provide reasonable assistance to Laxdale
in recovering any such taxes charges or other duties paid where appropriate.


 


5.4                                 Scarista shall pay interest on any overdue payments at 2% above the
base lending rate of The Bank of Scotland in force from the time payment was
due to the date when the payment is actually received by Laxdale’s bank.


 


6.                                      Records and Reports


 


6.1                                 Scarista agrees to keep true and accurate records of account
containing all data necessary for the determination of payments made under Clause
5.1 which records and books and accounts shall upon reasonable notice by
Laxdale (but not more than once in any calendar year) be open at all reasonable
times during business hours for inspection by Laxdale or its nominated
representative for the purpose of verifying the accuracy of the reports under
this Agreement.  Laxdale or its nominated
representative may take copies of the records and books of accounts but shall
not disclose any information relating to the business or affairs of Scarista
other than such information as properly should have been contained in any
statement required to be furnished. 
Laxdale shall be solely responsible for the costs of inspection unless
any reports disclose a shortfall in payments made of more than 5% in respect of
any 12 month period in which event Scarista 
shall reimburse Laxdale its reasonable costs of inspection and shall,
where appropriate, immediately pay Laxdale all royalties due in relation to any
shortfall disclosed by the inspection.


 


6.2                                 Scarista shall submit to Laxdale within thirty (30) days after the
end of each calendar quarter a statement setting forth with respect to its
operations during that


 


14





















 


period the
quantity of the Products made or sold by it in accordance with the terms hereof
and the respective Net Income.


 


7.                                      Confidentiality


 


7.1                                 Each party agrees to maintain secret and confidential all
information obtained from the other pursuant to this Agreement or obtained
pursuant to the Previous Licence (as defined in clause 12.1) including the
Know-how and Regulatory Dossiers, to respect the other’s proprietary rights in
it, to use it exclusively for the purpose of this Agreement or the Scarista
Licecnce (as the case may be) and to disclose the same only to those of its
employees to whom and to the extent that such disclosure is reasonably
necessary for the purpose of this Agreement.


 


7.2                                 The parties shall be entitled to disclose confidential information
belonging to the other to actual or potential customers for Products to the
extent that such disclosure is reasonably necessary to promote the sale or use
of the Products in accordance with the terms hereof and on the basis that said
confidential information so disclosed is only disclosed subject to
confidentiality provisions no less onerous than the party making the disclosure
would use in relation to disclosure of its own confidential information to a
third party.


 


7.3                                 The parties shall take all reasonable steps to minimise the risk of
disclosure of the information obtained from the other pursuant to this
Agreement and shall ensure that all its employees who have access to any
information of the other shall be made aware of and subject to these
obligations and shall further procure that so far as is reasonably practicable
all such employees shall enter into written undertakings in a form previously
approved by the other party.


 


7.4                                 The obligations imposed by this Clause shall not apply to any
information which:


 


15





















 


7.4.1                      is at the date of this Agreement in the public domain or later comes
into the public domain otherwise than by reason of breach of the recipient’s
obligations under this Agreement or Previous Agreements ;


 


7.4.2                      is prior to disclosure under this Agreement in the possession of the
recipient free of any obligation of confidentiality or Previous Agreements;


 


7.4.3                      subsequent to disclosure under this Agreement becomes lawfully
available to the recipient from a source independent of the supplier; or


 


7.4.4                      is independently developed by the recipient without recourse to any
information supplied by the supplier.


 


7.5                                 The obligations imposed by this Clause shall survive the variation,
renewal, expiration or termination of this Agreement.


 


8.                                      Obligations


 


8.1                                 Upon Laxdale achieving a Regulatory Approval of a Product in the
Laxdale Territory, Scarista shall at its cost, use its Reasonable Commercial
Efforts to obtain a Regulatory Approval in those countries of the
Scarista Territory (whether by entering into a Licensing or Distributor
Agreement or otherwise) where Scarista, at its reasonable discretion,
determines it is commercially feasible


 


8.2                                 Subject to Clause 8.7 (where applicable) upon Regulatory Approval
being given within the Scarista Territory for a Product (an “Approved Territory”)
Scarista at its cost, in such Approved Territory shall, if it so reasonably
determines it is commercially feasible, use its Reasonable Commercial Efforts
to:


 


8.2.1                      maximise the sale marketing and distribution of the Products
throughout the Scarista Territory;


 


16





















 


8.2.2                      ensure that all licences, approvals 
and consents required or desirable for the use, importation, marketing,
sale and distribution of the Products in the Scarista Territory; are obtained
as soon as reasonably practicable


 


8.2.3                      permit Laxdale’s duly authorised representatives at all reasonable
times by prior appointment but not more than once in any calendar year to enter
any premises where Products are being manufactured or stored in order to verify
its compliance with its obligations under this Agreement;


 


8.2.4                      apply the Trade Mark 
registered by Laxdale on a royalty free basis in respect of each Product
and Scarista will reimburse Laxdale for the cost of maintaining such Trade Mark
in the Scarista Territory;


 


8.3                                 Scarista shall pay all renewal fees in respect of the Patents in the
Scarista Territory as and when due. If Scarista elects not to pay renewal fees
for any of said Patents it shall give Laxdale 3 months written notice and its
licence of said Patent or Patents in terms of this Agreement shall
automatically come to an end. If Laxdale wishes to abandon any application or
not to maintain any of the Patents set out in the Schedule it shall give
three months’ advance written notice to Scarista in which case Scarista may
assume responsibility for the payment of all renewal fees in relation to the
relevant Patent, in which event the relevant Patent application or Patent shall
be assigned to it and royalties shall no longer be payable by Scarista in
respect of any use or exploitation of such Patent.


 


8.4                                 Laxdale and Scarista shall, acting in good faith and on similar terms
to the Manufacturing Letter of Intent dated 16th January 2003entered
into between the parties, enter into an exclusive purchase agreement in respect
of the supply of finished dosage form for Products with Regulatory Approval as
may be appropriate and agreed between the parties, on terms such that Laxdale
is obliged to supply such finished dosage form to Scarista at cost plus 5% on
an “ex-works” basis for so


 


17





















 


long as
Laxdale itself has the right to be supplied with  such finished dosage form by its
manufacturer(s).


 


8.5                                 Each party shall:


 


8.5.1                      provide the other party, at the other party’s expense, such
reasonable assistance as the other party may reasonably require in connection
with the obtaining of the other party’s patents and the preservation of any
related Intellectual Property;


 


8.5.2                      assist the other, at the other party’s expense, in the selection of
potential licensing parties and will provide the other with all reasonable
support necessary to conclude licensing agreements in terms of preparation of
reports, technical data, meeting appropriate representatives of such potential
parties and allowing access to each others facilities as shall be considered
normal and reasonable.  The parties
recognise that a common and unified approach to the commercialisation of the
Patents outlined in the Schedule is in both their interests;


 


8.5.3                      pay all renewal fees in respect of any of its patents or patent
applications in relation to any of its Improvements in its territory it elects
to maintain.


 


8.6                                 Scarista shall promptly provide all information as reasonably
requested by Laxdale from time to time on its commercialisation activities but
shall provide a formal written report on its commercialisation activities to
Laxdale once a calendar year. Such reports may be tabled at board meetings of
Laxdale. Laxdale may request the attendance of a representative of Scarista by
telephone or in person as Scarista may determine at such board meetings
together with such other personnel as may be agreed between Laxdale and
Scarista.


 


18





















 


8.7                                 For the purposes of this Clause 8,
“Reasonable Commercial Efforts” shall mean efforts consistent with
clinical, regulatory and commercialisation efforts for products of similar
performance and potential as would be undertaken in the pharmaceutical
industry. For
the avoidance of doubt Scarista shall be deemed to have used Reasonable
Commercial Efforts for the purposes of Clause 8.1 if the board of directors of Scarista
determines, acting reasonably, in good faith either that (i) it is not
commercially or (on an objective and documented basis) scientifically viable
for the foreseeable future to sell a Product (ii) there are objective,
documented concerns about patient safety such that it is not appropriate to
sell a Product.


 


9.                                       Reversion of Rights 


 


9.1                                 Scarista will have the rights to research, develop and commercialise
Products covered by any or all of the Patents listed in the Schedule, the Know how
and the Intellectual Property in the Scarista Territory set out in Clause 2.1
but, subject to the following provisions of Clauses  8 and 9, will not be under an obligation to
do so. Unless, within 2 years of approval of a Product in the EU or USA, Scarista
has provided Laxdale with realistic and properly detailed plans (“Commercialisation
Plans”) for the commercialisation of such 
Product which has been developed by Laxdale then Laxdale shall have the
option of proposing to Scarista a Commercialisation Plan of its own for the
exploitation of said Product in all or any part of the Scarista territory.


 


9.2                                 Following Laxdale’s proposal in terms of Clause 9.1, Scarista shall
have a period of six months in which to accept said Commercialisation Plan for
exploitation of said Product and must agree to commence implementation of said
Commercialisation Plan within 6 months of acceptance. If Scarista elects to
accept and implement said Commercialisation Plan for said Product at it cos tin
all or any part of the Scarista Territory, Scarista shall have the right to
modify the Commercialisation Plan and


 


19





















 


Scarista shall
pay royalties to Laxdale in respect of said Product in terms of Clause 5.1.


 


9.3                                 If following said six month acceptance period referred to in Clause
9.2, Scarista does not accept said Commercialisation Plan in respect of said
Product, Laxdale may, in its sole discretion elect to commercialise said
Product itself in the Scarista Territory in which event Scarista shall grant a
licence to Laxdale to do so and Laxdale shall pay to Scarista a 5% royalty on
Net Income received from said Product within the Scarista Territory and the
other terms of such licence in respect of the relevant Product shall be substantially
similar to the terms hereof but with the parties reversed.


 


10.                               Infringement of Licensed Rights


 


10.1                           Each party shall immediately give notice in writing to the other
party of any infringement of any of the other party’s Patents or of any
inadvertent disclosure or unauthorised use of the other party’s Know-how which
comes to its knowledge. Each party shall give such assistance as is reasonably
requested to assist the other in the prevention of any such infringement of its
rights.  Subject to Clause 10.2 below
neither party shall institute any legal proceedings without the prior written
consent of the party who is the proprietor of the rights.


 


10.2                           If the rights owner fails to institute legal proceedings or take
such steps considered necessary or appropriate by the other party to prevent
infringement of the rights owner’s 
Patents or misuse of its Know-how within a reasonable period in the
circumstances after being notified of such infringement or misuse, the other
party  shall be entitled to do all such
things as it shall consider proper to prevent such infringement and in
particular shall have the right to institute or defend legal proceedings (and
retain any damages awarded) on giving at least 3 working days’ prior written
notice to the other party  of its
intention to do so.  Both parties hereby
consent to the use of its name by the other in legal proceedings instituted or


 


20





















 


defended in
accordance with this sub-clause in so far as it is necessary for the
prosecution or defence of such proceedings provided that the party instituting
the proceedings in accordance with this sub-clause shall indemnify the other
against all costs awarded against it.


 


11.                               Warranties and Liability 


 


11.1                           To the best of each party’s knowledge and belief the exercise of the
rights granted to or to be granted to the other under this Agreement will not
result in the infringement of valid patents of third parties or misuse of
confidential information belonging to third parties. Subject thereto no other
warranty is given in this respect. Nothing in this Agreement shall be construed
as a representation, warranty or promise by one party as to the utility or
validity of its Patents or its Know-how and all terms, conditions, warranties and
representations which would otherwise be implied in this regard, whether by
statute or otherwise, are hereby excluded.


 


11.2                           If at any time during this Agreement either party directly or
indirectly opposes or assists any third party to oppose the grant of any patent
pursuant to any patent application of the other party or disputes or directly
or indirectly assists any third party to dispute the validity of any of the
other party’s Patents the other party shall be entitled to determine with
immediate effect all or any of the licences as granted under this Agreement by
notice in writing.


 


11.3                           Each party shall or shall procure that its Distributors or Licencees
shall maintain adequate product liability insurance in respect of their
respective territory and shall ensure that the other party’s interest is noted
on the policy and shall supply the other party with a copy of such insurance
policy upon request.


 


11.4                           For the avoidance of doubt, neither party shall be liable to the
other in relation to any consequential loss suffered by the other party
pursuant to this agreement including (but not limited to) any loss of profit
incurred by said party save and


 


21





















 


except in
connection with a claim for damages for breach of exclusivity, non payment of
royalties, or breach of Clause 8.3 or unlawful termination.


 


12.                               Term
and Termination 


 


12.1                           This Agreement shall come into force on the Effective Date at which
time the Previous Agreements shall be terminated and of no further effect.
Notwithstanding the foregoing it is acknowledged and agreed between the parties
that any Licences, Sub-licences or Distributor Agreements entered into by
Scarista pursuant to the Previous Agreements shall remain in full force and
effect and shall be covered by this Agreement.


 


12.2                           Unless terminated earlier in accordance with the provisions of this
Agreement, this Agreement shall expire in any country in the Scarista Territory
in respect of a Product upon cessation of all obligations to pay royalties
under Clause 5 in that country and thereafter Scarista shall have a fully paid
up royalty free non exclusive licence in respect of the relevant Product in
that country and Scarista shall be entitled to use the Patents, the Laxdale
Know-How, and the Laxdale Intellectual Property in respect of the relevant
Product without further payment.


 


12.3                           Subject to this Agreement being terminated in terms of Clause 12.4,
the use by Scarista of the Regulatory Dossiers shall survive termination of
this Agreement for the Products in relation to which all payments due in terms
of this Agreement have ceased.


 


12.4                           Either party shall be entitled to
terminate this Agreement forthwith by notice in writing to the other if the
other commits a material breach of this Agreement and fails to remedy the same
within ninety (90) days after receipt of a written notice of the breach
requiring remedy of the same.


 


22





















 


12.5                           In the event that Laxdale
terminates this Agreement pursuant to Clause 12.4:


 


12.5.1                Scarista’s rights
under this Agreement shall terminate;


 


12.5.2                Scarista
shall promptly return
to Laxdale all technical and other material in its possession relating to the
Products and the Laxdale Intellectual Property and all copies of such material;


 


12.5.3                subject to Clause 12.5.4, Scarista shall
remain entitled to sell its remaining stock as at the date of termination of
Products provided that it continues to pay royalties in the manner prescribed
in this Agreement;


 


12.5.4                Laxdale shall have the option to purchase all
remaining stock as at the date of termination of Scarista’s Products exercisable by notice
in writing within thirty (30) days after termination.  Laxdale shall pay a price equivalent to the
cost price of the Products plus 10%;and


 


12.5.5                Scarista shall, so far
as it is contractually able, grant Laxdale the right of access the Regulatory
Dossiers for Products within the Scarista Territory that have then received
Regulatory Approval and  Scarista shall
immediately assign to Laxdale at no cost to Laxdale all Scarista’s right ,title
and interest in any Trade Marks it has in any part of the Scarista Territory
for Products which have then received Regulatory Approval in the Scarista
Territory.


 


12.6                           In the event that Scarista
terminates this Agreement pursuant to Clause 12.4:


 


12.6.1                all Scarista’s  rights under this Agreement shall continue
with full force and effect but Scarista shall no longer be obliged to pay any
sums under Clause 5 where such sums fall due after the date of termination;


 


23





















 


12.6.2                all Laxdale’s’s rights
to Scarista’’s Improvements shall cease;


 


12.6.3                Laxdale shall promptly return to Scarista all
technical and other material in its possession relating to Scarsita’s
Improvements to the Products and the Intellectual Property and all copies of
such material;


 


13.                               Force Majeure


 


13.1                           If either party to this Agreement is prevented or delayed by reason
of Force Majeure in the performance of any of its obligations under this
Agreement other than an obligation to pay money by reason of Force Majeure, and
if such party gives written notice to the other party specifying the matters
constituting Force Majeure, together with such evidence as it reasonably can
give and specifying the period for which it is estimated that such prevention
or delay will continue, the party in question will be excused from the
performance or the punctual performance as the case may be as from the date of
such notice for so long as such cause of prevention or delay shall continue.


 


13.2                           For the purposes of this Agreement “Force Majeure” shall be deemed
to be any cause affecting performance of the Agreement arising from or
attributable to acts, events, permissions or accidents beyond the reasonable
control of the party obliged to perform and without limiting the generality
thereof shall include the following:


 


13.2.1                  strikes, lock-outs or industrial action;


 


13.2.2                  civil commotion, riot, invasion, war or preparation for war;


 


13.2.3                  fire, explosion, storm, flood, earthquake, subsidence, epidemic or
other natural or physical disaster;


 


24





















 


13.2.4                  impossibility of transport;


 


13.2.5                  political interference with the normal operations of any party.


 


14.                               Remedies


 


The remedies
available to the parties under this Agreement shall be without prejudice to any
other rights, either at common law or under statute, which each may have
against the other.


 


15.                               Waiver


 


The failure of
either party to enforce or exercise, at any time or for any period of time, any
term of or any right arising pursuant to this Agreement does not constitute and
shall not be construed as a waiver of such term or right and shall in no way
affect that party’s right later to enforce or exercise it.


 


16.                               Severability


 


The invalidity
or unenforceability of any term of or any right arising pursuant to this
Agreement shall not in any way affect the remaining terms or rights and the
remaining terms shall be construed as if such invalid or enforceable term or
right did not exist.


 


17.                               Notices


 


Any notice
required or permitted to be given under this Agreement shall be delivered by
hand or sent by recorded delivery mail or by facsimile to the other party at
its address set out above or to such other address which it has previously
notified to the sending party and shall be deemed to have been given when
actually received or, if sent by recorded delivery mail and returned “gone away”
or to like effect, on return of such recorded delivery mail.


 


25





















 


18.                               Assignment


 


18.1                           This Agreement is personal to the parties and the parties may not
assign, transfer or otherwise part with this Agreement or any right or
obligation under it without the prior written consent of the other (such
consent not to be unreasonable withheld or delayed).


 


18.2                           If either party wishes to transfer its rights to a third party which
is a subsidiary of it or which has the same or similar shareholders, then it
shall do so only after receiving the written agreement of the other party (said
agreement not to be unreasonably withheld) and only on entering into an
agreement with the third party which preserves the rights of the other party as
set out in this Agreement


 


19.                               No Agency/Joint Venture


 


The
relationship of the parties is that of independent contractors and nothing in
this Agreement can be construed so as to constitute them as partners or joint
venturers or to empower either party to act for, bind or otherwise create or
assume any other obligation on behalf of the other party.


 


20.                               Clause
Headings


 


Clause
headings are purely for ease of reference and do not form part of or affect the
interpretation of this Agreement.


 


21.                               Schedules


 


The Schedules
referred to form part of this Agreement.


 


22.                               No other terms


 


The Parties
acknowledge that they are not relying on any agreement, understanding,
arrangement or representation relating to the subject matter of this Agreement
which is not


 


26





















 


expressly set
out in this Agreement and that this Agreement supersedes all prior oral or
written agreements, understandings or arrangements between them relating to
such subject.  No amendment to this
Agreement shall take effect unless it has been signed by the authorised
representatives of the Parties.


 


23.                               Law
and Jurisdiction


 


The
construction, validity and performance of this Agreement is governed by the
Laws of England and the parties hereby submit to the exclusive jurisdiction of
the English Courts.


 


IN WITNESS WHEREOF the Parties have executed this document as an agreement the day and
year first above written.


 


 


	
  SIGNED by

  	
             )

  
	
   

  	
   

  
	
  for and on behalf of

  	
  )

  
	
   

  	
   

  
	
  SCARISTA LIMITED

  	
                      )

  
	
   

  	
   

  
	
  in the presence of:

  	
  )

  
	
   

  	
   

  
	
   

  	
   

  
	
  SIGNED by

  	
             )

  
	
   

  	
   

  
	
  for and on behalf of

  	
  )

  
	
   

  	
   

  
	
  LAXDALE LIMITED

  	
                      )

  
	
   

  	
  )

  
	
  in the presence of:

  	
   

  



 


27





















 


THE SCHEDULE 


 


 


	
  Patent

  	
   

  	
  Date

  	
   

  	
  Description

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PCT/GB00/00164

  	
   

  	
  21/01/00

  	
   

  	
  Highly purified ethyl EPA and other EPA
  derivatives

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PCT/GB00/02681

  	
   

  	
  11/07/00

  	
   

  	
  EFAs and homocysteine lowerers (folic,
  B12 and pyridoxine)

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GB 99055417.3

  	
   

  	
   

  	
   

  	
  Diagnostic test, PLA2 assay

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PCT/GB00/03926

  	
   

  	
   

  	
   

  	
  Treatment of Fatigue and Stroke

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PCT/GB00/02717

  	
   

  	
  11 July 2000

  	
   

  	
  Highly purified EPA arachidonic acid

  



 


28