Document:

Exhibit 4.50

DATED

     2004

 

 

SCARISTA LIMITED

 

- AND -

 

LAXDALE LIMITED

 

 

 

EXCLUSIVE PATENT AND

KNOW-HOW AGREEMENT

 

 

EXPLOITATION OF PRODUCTS BY
LAXDALE

 

 

 

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 in the pharmaceutical
industry which develops and commercialises its own IP and IP licensed in or
obtained from other parties and which wishes to exploit certain inventions and
know-how originated by or owned by Scarista.

 

(B)                                Scarista is a company which holds and commercialises Intellectual
Property relevant to the pharmaceutical industry. Scarista has originated and
owns certain intellectual property and patent rights and know how in inventions
and formulations which have application 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, (as hereinafter defined) and entered into two agreements each
dated 24th 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”).

 

1

 

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

 

TERMS AGREED

 

1.              Definitions

 

In this Agreement, unless specifically stated to the
contrary:

 

	
  “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 Laxdale (or a Licensee
  of Laxdale) and distribute the Products as finished packaged goods;

  
	
   

  	
   

  
	
  “the
  Effective Date”

  	
  means the
  date of this Agreement;

  

 

2

 

	
  “EMEA”

  	
  means the
  European Agency for the Evaluation of Medicinal Products;

  
	
   

  	
   

  
	
  “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;

  
	
   

  	
   

  
	
  “EU”

  	
  means the
  European Union;

  
	
   

  	
   

  
	
  “FDA”

  	
  means the
  United States Food and Drug Administration;

  
	
   

  	
   

  
	
  “the Field
  of Use”

  	
  means any
  and all psychiatric and central nervous system disorders, including pain;

  
	
   

  	
   

  
	
  “Holding
  Company”

  	
  means a
  holding company within the meaning of sections 736 and 736a of the Companies
  Act 1985

  
	
   

  	
   

  
	
  “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, Scarista Know-how or other intellectual rights and Improvements
  developed pursuant to Clause 4.2, owned by or licensed to Scarista;

  
	
   

  	
   

  
	
  “Know-how”

  	
  means all
  secret and substantial know-how, experience, drawings, designs and all other
  technical and other information including but not limited to

  

 

3

 

	
   

  	
  data,
  formulae, ideas, inventions, procedures for experiments and tests,
  manufacturing processes, specifications and techniques;

  
	
   

  	
   

  
	
  “LAX-101”

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

  
	
   

  	
   

  
	
  “Licence”

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

  
	
   

  	
   

  
	
  “Licensee”

  	
  means a
  licensee under the terms of a Licence;

  
	
   

  	
   

  
	
  “the Laxdale
  Know-how”

  	
  means all
  Know-how owned by Laxdale in connection with the Patents and Orphan Drug
  Designation;

  
	
   

  	
   

  
	
  “the Laxdale
  Licence”

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

  
	
   

  	
   

  
	
  “the Laxdale
  Territory”

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

  
	
   

  	
   

  
	
  “the Net
  Sales Value”

  	
  means the
  gross invoice price of Products sold by Laxdale(or a wholly owned subsidiary)
  (in each case other than pursuant to a Licence, Sub-license or a Distributor
  Agreement) to a Third Party (“Customer”) 

  

 

4

 

	
   

  	
  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 Laxdale (or a wholly owned
  subsidiary) in transporting Products to Customers;

   

  (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 supply of Products by Laxdale (or a
  wholly owned subsidiary) (i) involving a supply margin of 10% or less;
  or (ii) to one of its current Sub-licensees on current terms shall not
  fall within the defined terms “Net Sales Value” or “Net Income” for the
  purposes of this Agreement.

  
	
   

  	
   

  
	
   

  	
  If Laxdale
  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

  

 

5

 

	
   

  	
  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 Laxdale with respect to commercial exploitation of the
  Patents or Orphan Drug Designation and the associated Scarista Know-how in
  the Laxdale Territory. Such Net Income shall include: a) when a Product is
  sold by Laxdale (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 Laxdale 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 and on the terms of such
  disposal (in cases where Laxdale shares are subscribed for)and on acquisition
  (in cases where Laxdale is paid a milestone by way of a shares in a Third
  Party), milestone payments, outright sale of the Intellectual Property.

  
	
   

  	
   

  
	
   

  	
  If Laxdale
  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.

  

 

6

 

	
  “Nutricia
  Licences”

  	
  means the
  licences granted by Scotia Holdings Plc to Nutricia International BV
  (“Nutricia”) dated 31 December 1998 and 16 August 1999 respectively
  (in each case in relation to the fields defined within those licence
  agreements).

  
	
   

  	
   

  
	
  “Nutricia
  IP”

  	
  means patent
  case numbers 37, 51, 71, 98 and 110 as detailed in the Schedule licensed
  to Nutricia under the Nutricia Licences.

  
	
   

  	
   

  
	
  “Nutricia”

  	
  means
  Nutricia International BV (registered number 27112523 in the Netherlands
  Commercial Register) whose registered office/principal place of business is
  at Euste, Startionsstroat 18b, 2712 HM Zoetemeer.

  
	
   

  	
   

  
	
  “Orphan Drug
  Designation”

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

  
	
   

  	
   

  
	
  “Patents”

  	
  means the
  patents or patent applications as described in Schedule 1 (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 with all Patents which
  may be granted pursuant to any such patent applications;

  

 

7

 

	
  “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 Scarista Know-how and/or the Intellectual Property of Scarista;

  
	
   

  	
   

  
	
  “Regulatory
  Approval”

  	
  the grant of
  all necessary governmental and regulatory approvals by a Regulatory Authority
  to sell Product in any country of the Laxdale Territory including without
  limitation 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 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 and Orphan Drug
  Designation;

  

 

8

 

	
  “the
  Scarista Territory”

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

  
	
   

  	
   

  
	
  “Schedule 1”

  	
  means
  Schedule 1 which sets out details of the Patents dealt with in this
  Agreement and which forms an integral part of this Agreement;

  
	
   

  	
   

  
	
  “Schedule 2”

  	
  means
  Schedule 2 as referred to in Clause 5.3;

  
	
   

  	
   

  
	
  “Schedule 3”

  	
  means
  Schedule 3 as referred to in Clause 12.1.2;

  
	
   

  	
   

  
	
  “Sub-license”

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

  
	
   

  	
   

  
	
  “Sub-Licensee”

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

  
	
   

  	
   

  
	
  “Third
  Party”

  	
  means any
  party which is not an Affiliate or wholly owned subsidiary of Laxdale or
  Scarista;

  
	
   

  	
   

  
	
  “the Trade
  Marks”

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

  

 

2.                          Grant of
Rights

 

	
   

  	
  2.1.1

  	
  Within the
  Field of Use Scarista hereby grants to Laxdale the exclusive right and
  licence (save in respect of Scarista which shall retain the same right) under
  the Patents Orphan Drug Designation, the Scarista Know-

  

 

9

 

	
   

  	
   

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

  
	
   

  	
   

  	
   

  
	
  2.2

  	
  Scarista and Laxdale acknowledge that it
  is in their mutual commercial interests to exploit the Patents set out in
  Schedule 1 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
  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 contracting with such Third Party.

  
	
   

  	
   

  
	
  2.3

  	
  In the event that Scarista has, or
  subsequently does, license a Product within the Scarista Territory and a
  country or countries designated in such licence then becomes part of the
  Laxdale Territory then in such circumstances such licence shall, provided the
  same was granted on an arms length bona fide basis, continue with full force
  and effect (notwithstanding Clause 2.1.2) in respect of such Licence for the
  Product and indication(s) and in respect of such country or countries
  detailed therein but in all other respects such country or countries shall
  fall within the definition of Laxdale Territory and shall be subject to
  Laxdale’s rights set out in Clause 2.1.2.

  

 

10

 

	
  2.4

  	
  Licensing and Sub-licensing and
  Distributorship

  
	
   

  	
   

  
	
   

  	
  Laxdale may grant Licences or enter into
  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 Laxdale shall remain solely responsible to Scarista 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)

  	
  Laxdale
  shall be responsible to Scarista for any failure of Licensees or Distributors
  to observe and perform the terms and conditions of their Licence or
  Distributor Agreements;

  
	
   

  	
   

  	
   

  
	
   

  	
  (d)

  	
  Laxdale shall provide to Scarista details of who it
  has granted Licences, (and details of any Sub-licences granted by its
  Licensees) or Distributor Agreements to together with a copy of the clauses,
  schedules and/or definitions of each Licence, Sub-licence and Distributor
  Agreement it grants which are relevant to the payment of sums due to Scarista
  under clauses 5.2 and 5.3 within thirty (30) days of the respective dates of
  execution of such Licence, Sub-licence or Distributor agreement;

  
	
   

  	
   

  	
   

  
	
   

  	
  (e)

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

  

 

11

 

	
   

  	
  (f)

  	
  the conditions contained in this Clause 2.4
  shall not apply to any Licences or Distributor Agreements entered into by
  Laxdale at the date hereof.

  
	
   

  	
   

  	
   

  
	
  2.5

  	
  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 Scarista shall disclose to Laxdale the
  Scarista Know-how and Laxdale shall disclose to Scarista the Laxdale 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. For the avoidance of doubt all Scarista licensees of the
  Intellectual Property in the Scarista Territory in terms of this 

  

 

12

 

	
   

  	
   

  	
  Agreement
  shall also be entitled to have full access via Scarista on reasonable notice
  to all such Regulatory Dossier without payment.

  
	
   

  	
   

  	
   

  
	
  4.

  	
  Improvements

  
	
   

  	
   

  	
   

  
	
   

  	
  4.1

  	
  If during the term of this Agreement
  Laxdale develops or conceives any Improvement or receives the benefit of a
  licence of any Improvement
  then Laxdale shall grant to Scarista 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 Scarista 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 Laxdale save for any payment due pursuant to the Laxdale
  Licence.

  
	
   

  	
   

  	
   

  
	
   

  	
  4.2

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

  

 

13

 

	
  5.

  	
  Payment

  
	
   

  	
   

  	
   

  
	
   

  	
  5.1

  	
  Laxdale, upon the Effective Date, shall
  pay to Scarista a signing fee in the amount of £500,000.

  
	
   

  	
   

  	
   

  
	
   

  	
  5.2

  	
  Laxdale, in consideration of the rights
  granted to it under Clause 2.1, 2.3 and 4.2 of this Agreement shall during
  the term of this Agreement pay to Scarista a royalty of 5% on the Net Income
  received from exploitation or sale of Products within the Laxdale 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 Laxdale 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 Scarista Know how ceasing to be secret
  and substantial in such country. For the avoidance of doubt all Net Income
  accruing to Laxdale from the Effective Date will be subject to this Clause 5.
  Further, and also for the avoidance of doubt, if any Product referred to
  under this Clause 5.2 attracts any other payment or royalty payable by
  Laxdale to Scarista whether pursuant to this Agreement, the Laxdale Licence,
  or otherwise the maximum aggregate amount payable by Laxdale to Scarista in
  respect of such Products shall be 5% of the Net Income.

  
	
   

  	
   

  	
   

  
	
   

  	
  5.3

  	
  Laxdale, in consideration of Scarista renegotiating
  the terms of the licence agreement between the parties hereto dated 24
  March 2000 wherein the Intellectual Property set out in Schedule 2
  was transferred to Laxdale shall during the term of this Agreement pay to
  Scarista 5% of the Net Income arising from the sale or exploitation of
  Products within the Laxdale Territory PROVIDED THAT no royalty shall be due
  and payable under this Clause in relation to the exploitation or sale of a
  Product in a country which is part of the Laxdale Territory on the later of
  (i) expiry of the last Patent (which for this purpose shall be a Patent
  set out in Schedule 2) relating to the Product in such country;
  (ii) expiry of any regulatory exclusivity relating to the Product in
  such country; (iii) the relevant Know how ceasing to be secret and
  substantial in such country. For the avoidance of doubt, if any Product

  

 

14

 

	
   

  	
   

  	
  referred to under this Clause 5.3 attracts any other
  payment or royalty payable by Laxdale to Scarista whether pursuant to this
  Agreement, the Laxdale Licence, or otherwise the maximum aggregate amount
  payable by Laxdale to Scarista whether pursuant to this Agreement or
  otherwise shall be 5% of the Net Income for the relevant Product. For the
  purposes of this Clause 5.3 the terms;

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  “Net Income” shall have the same meaning as ascribed
  to it in this Agreement;

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  “Product(s)” shall mean a pharmaceutical product
  within the Field of Use within the scope of any Regulatory or Orphan Drug
  exclusivity or of the patents or patent applications set out in
  Schedule 2.

  
	
   

  	
   

  	
   

  
	
   

  	
  5.4

  	
  Payment due under Clauses 5.2 and 5.3 shall be made
  within thirty (30) days after the end of each calendar quarter in respect of
  any Net Income received by Laxdale.

  
	
   

  	
   

  	
   

  
	
   

  	
  5.5

  	
  All sums due under this Agreement:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  5.5.1

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  5.5.2

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  5.5.2.1

  	
  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;

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
  5.5.2.2

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

  

 

15

 

	
   

  	
   

  	
  5.5.3

  	
  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 the party making such payments with deductions shall
  provide reasonable assistance to the other party in recovering any such taxes
  charges or other duties paid where appropriate.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.6

  	
  Laxdale
  shall in respect of payments to be made by it hereunder, 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 the other party’s bank.

  
	
   

  	
   

  	
   

  
	
  6.

  	
  Records and Reports

  
	
   

  	
   

  	
   

  
	
   

  	
  6.1

  	
  Laxdale agrees to keep true and accurate
  records of account containing all data necessary for the determination of
  payments made under Clauses 5.2 and 5.3 which records and books and accounts
  shall upon reasonable notice by Scarista (but not more than once in any
  calendar year)be open at all reasonable times during business hours for
  inspection by Scarista or its nominated representative for the purpose of
  verifying the accuracy of the reports under this Agreement. Scarista 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
  Laxdale other than such information as properly should have been contained in
  any statement required to be furnished. Scarista 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 Laxdale shall reimburse Scarista its reasonable costs of inspection and
  shall, where appropriate, immediately pay Scarista all royalties due in
  relation to any shortfall disclosed by the inspection.

  
	
   

  	
   

  	
   

  
	
   

  	
  6.2

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

  

 

16

 

	
   

  	
   

  	
  period the quantity of 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
  13.1) including 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 Laxdale Licence (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 the 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:

  

 

17

 

	
   

  	
   

  	
  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 or Previous Agreements in the possession of the recipient free of
  any obligation of confidentiality;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  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

  	
  Subject to Clause 8.3 below, Laxdale
  hereby agrees and undertakes with Scarista that (except as may be agreed in
  writing by Scarista) Laxdale or its Holding Company (as the case may be)
  shall use its Reasonable Commercial Efforts (as defined in Clause 8.3 below)
  to:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  pursue the completion of the LAX-101
  Phase III Trial with a view to applying for an FDA Approval for the
  indication of Huntington’s Disease in the USA;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  prepare and submit a New Drug Application
  for the treatment of Huntington’s Disease in the USA using LAX-101 (the “US
  HD NDA”) upon successful completion of the LAX-101 Phase III Trial; and

  

 

18

 

	
   

  	
   

  	
  (c)

  	
  secure an FDA Approval for the treatment
  of Huntington’s Disease in the USA with LAX-101 upon acceptance by the FDA of
  the US HD NDA.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.2

  	
  Subject to Clause 8.3 below, Laxdale
  hereby agrees and undertakes with Scarista that (except as may be agreed in
  writing by Scarista) Laxdale or its Holding Company (as the case may be)
  shall use its Reasonable Commercial Efforts to:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)

  	
  prepare and submit a Marketing
  Authorisation Application for the treatment of Huntington’s Disease in Europe
  with Lax-101 (the “EU HD NDA”);

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)

  	
  secure an EMEA/EU Approval for the
  treatment of Huntington’s Disease in Europe with LAX-101 upon acceptance by
  the EMEA of the EU HD NDA; and

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (c)

  	
  pursue completion of clinical trials,
  prepare and submit a New Drug Application or a Marketing Authorisation
  Application (as the case may be) and secure Regulatory Approval for
  Intellectual Property concerning indications other than Huntington’s Disease
  (“Non HD IP Products”) provided that the obligation in this Sub-clause (c)
  may be deferred by Laxdale (but not any transferee of or successor to
  Laxdale) until such time as Laxdale has secured either (i) FDA Approval for
  the treatment of Huntington’s Disease in the USA using LAX-101; or (ii)
  ratification by the European Union of the EMEA approval of marketing for
  Huntington’s Disease in Europe using LAX-101.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (d)

  	
  to maximise the marketing, sale and
  distribution of a Product in each case country of the Laxdale Territory
  following any such Regulatory Approval of such Product required for such
  country.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.3

  	
  For the
  purposes of Clauses 8.1 and 8.2, “Reasonable Commercial Efforts” shall mean
  efforts consistent with clinical, regulatory and commercialisation efforts
  for 

  

 

19

 

	
   

  	
   

  	
  products of
  similar performance and potential as would be undertaken in the
  pharmaceutical industry. For
  the avoidance of doubt Laxdale shall be deemed to have used Reasonable
  Commercial Efforts for the purposes of Clause 8.1 and /or 8.2 (as the case
  may be) if the board of directors of Laxdale or its Holding Company
  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 develop or sell LAX-101 for Huntington’s
  Disease in the USA or the EU (as the case may be); (ii) there are
  objective, documented concerns about patient safety such that it is not
  appropriate to develop or sell LAX-101 for Huntington’s Disease in the USA or
  the EU (as the case may be) or (iii) it is not commercially or (on an
  objective and documented basis) scientifically viable for the foreseeable
  future to develop or sell Non-HD IP Products.

  
	
   

  	
   

  	
   

  
	
   

  	
  8.4

  	
  Laxdale shall permit Scarista’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;

  
	
   

  	
   

  	
   

  
	
   

  	
  8.5

  	
  Laxdale shall liaise with Scarista’s
  patent agents with regard to the maintenance of granted Patents and secure as
  far as reasonably possible appropriate claims for the filed but not yet
  granted Patents, and pay directly to the relevant patent authorities or
  agents all fees in respect of the Patents set out in the Schedule 1 in
  the Laxdale Territory as and when due. If Laxdale elects not to pay fees for
  any of said Patents it shall give Scarista 3 months’ prior written notice and
  its licence of said Patent or Patents in terms of this Agreement shall
  automatically come to an end. If Scarista wishes to abandon any application
  or not to maintain any of the Patents set out in the Schedule it shall
  give three months’ prior written notice to Laxdale in which case Laxdale may
  assume responsibility for the payment of all 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 by payable by Laxdale in respect
  of any use or exploitation of such Patent.

  

 

20

 

	
   

  	
  8.6

  	
  Each party shall:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  8.6.1

  	
  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;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  8.6.2

  	
  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 Schedule 1 is in both their interests. ;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  8.6.3

  	
  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.

  
	
   

  	
   

  	
   

  
	
   

  	
  8.7

  	
  Laxdale shall promptly upon request
  provide all information as reasonably requested by Scarista from time to time
  on its development activities but shall provide a formal written report on
  its development activities to Scarista annually upon receiving a formal
  written request from Scarista. Such reports may be tabled at board meetings of
  Scarista. Scarista may request the attendance of one technical representative
  of Laxdale by telephone at up to four such board meetings per year (or
  otherwise as may be agreed between the parties from time to time) together
  with such other personnel as may be agreed between Laxdale and Scarista no
  more than four board meetings per annum.

  

 

21

 

	
   

  	
  8.8

  	
  The provisions of this Agreement are
  subject at all times to the rights of Nutricia under the Nutricia Licences in
  respect of the Nutricia IP. No actions which might in any way affect the
  validity of the Nutricia IP shall be taken by either party and shall include
  but not be restricted to any decision to abandon maintenance of the Nutricia
  IP.

  
	
   

  	
   

  	
   

  
	
  9.

  	
  Supply of Finished Dosage Form by Laxdale

  
	
   

  	
   

  
	
   

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

  
	
   

  	
   

  
	
  10.

  	
  Use of Trade Mark by Scarista

  
	
   

  	
   

  
	
   

  	
  Laxdale shall permit Scarista to use on a
  royalty free basis any such Trade Mark in the Scarista Territory which
  Laxdale or its Holding Company has registered and is maintaining in respect
  of each Product and Scarista will reimburse Laxdale for the cost of
  maintaining such Trade Mark in the Scarista Territory.

  
	
   

  	
   

  
	
  11.

  	
  Infringement of Licensed Rights 

  
	
   

  	
   

  	
   

  
	
   

  	
  11.1

  	
  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 11.2 below 

  

 

22

 

	
   

  	
   

  	
  neither party shall institute any legal
  proceedings without the prior written consent of the party who is the
  proprietor of the rights.

  
	
   

  	
   

  	
   

  
	
   

  	
  11.2

  	
  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 7
  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 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.

  
	
   

  	
   

  	
   

  
	
  12.

  	
  Warranties and Liability 

  
	
   

  	
   

  
	
   

  	
  12.1

  	
  Scarista Warrants that:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  12.1.1

  	
  save in
  respect of the Nutricia Licences it is free to enter into this Agreement in
  its own rights and that there are no rights exercisable by or obligations
  owed to any third party which may prevent or restrict it from entering into
  this Agreement;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  12.1.2

  	
  save in
  respect of those Licences which Scarista has entered into at the date hereof
  and as listed in Schedule 3 it has not disclosed to any third party
  other than under written obligation of confidence any of the Scarista
  Know-How or the subject matter thereof;

  

 

23

 

	
   

  	
   

  	
  12.1.3

  	
  it is the absolute
  beneficial and legal owner of the Patents and Scarista Know- How;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  12.1.4

  	
  all
  Intellectual Property and Know How owned by or licensed to Scarista in the
  Field of Use which is, or could reasonably be seen to be, useful in respect
  of the potential research, development, manufacture and/or sale of LAX-101
  for Huntington’s disease, depression and schizophrenia is licensed to Laxdale
  hereunder in the Field of Use;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  12.1.5

  	
  Laxdale is
  not, nor has it been, in breach of any agreement with Scarista at any time;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  12.1.6

  	
  it (and its
  Affiliates) have not carried out any research or development in the Field of
  Use since March 24th 2000

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  12.2

  	
  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.

  
	
   

  	
   

  	
   

  
	
   

  	
  12.3

  	
  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.

  
	
   

  	
   

  	
   

  
	
   

  	
  12.4

  	
  Each party shall or shall procure that
  its Distributors or Licencees shall maintain adequate product liability
  insurance in their respective territory and shall use reasonable endeavours
  to ensure that the other party’s interest is noted on the policy 

  

 

24

 

	
   

  	
   

  	
  and shall supply the other party with a
  copy of such insurance policy upon request (if available).

  
	
   

  	
   

  	
   

  
	
   

  	
  12.5

  	
  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 except in connection with a
  claim for damages for breach of exclusivity, non-payment of royalties, or
  breach of Clause 8.5 or unlawful termination.

  
	
   

  	
   

  	
   

  
	
  13.

  	
  Term and Termination 

  
	
   

  	
   

  	
   

  
	
   

  	
  13.1

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

  
	
   

  	
   

  	
   

  
	
   

  	
  13.2

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

  
	
   

  	
   

  	
   

  
	
   

  	
  13.3

  	
  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.

  

 

25

 

	
   

  	
  13.4

  	
  In the event that Scarista terminates
  this Agreement pursuant to Clause 13.3:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.4.1

  	
  all Laxdale’s rights under this Agreement shall
  terminate;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.4.2

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.4.3

  	
  subject to Clause 13.4.4, Laxdale 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;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.4.4

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.4.5

  	
  Scarista shall retain the right to access the
  Regulatory Dossiers for Products which have then received Regulatory Approval
  already provided by Laxdale under this Agreement and Laxdale shall
  immediately assign to Scarista at no cost to Scarista all Laxdale’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.

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  13.5

  	
  In the event that Laxdale terminates this
  Agreement pursuant to Clause 13.3:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.5.1

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  13.5.2

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

  

 

26

 

	
   

  	
   

  	
  13.5.3

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

  
	
   

  	
   

  	
   

  	
   

  
	
  14.

  	
  Force Majeure

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  14.1

  	
  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.

  
	
   

  	
   

  	
   

  
	
   

  	
  14.2

  	
  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:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  14.2.1

  	
  strikes, lock-outs or industrial action;

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  14.2.2

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  14.2.3

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

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  14.2.4

  	
  impossibility of transport;

  

 

27

 

	
   

  	
   

  	
  14.2.5

  	
  political interference with the normal
  operations of any party.

  
	
   

  	
   

  	
   

  	
   

  
	
  15.

  	
  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.

  
	
   

  	
   

  
	
  16.

  	
  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.

  
	
   

  	
   

  
	
  17.

  	
  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.

  
	
   

  	
   

  
	
  18.

  	
  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.

  

 

28

 

	
  19.

  	
  Assignment

  
	
   

  	
   

  	
   

  
	
   

  	
  19.1

  	
  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 unreasonably wiheld or delayed).

  
	
   

  	
   

  	
   

  
	
   

  	
  19.2

  	
  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

  
	
   

  	
   

  	
   

  
	
  20.

  	
  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.

  
	
   

  	
   

  
	
  21.

  	
  Clause Headings

  
	
   

  	
   

  
	
   

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

  
	
   

  	
   

  
	
  22.

  	
  Schedules

  
	
   

  	
   

  
	
   

  	
  The Schedules referred to forms part of
  this Agreement.

  
	
   

  	
   

  
	
  23.

  	
  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

  

 

29

 

	
   

  	
  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.

  
	
   

  	
   

  
	
  24.

  	
  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:

  	
  )

  

 

30

 

SCHEDULE 1 

 

 

(as attached)

 

31

 

R&G 40260 Case 37 High Vitamin
E plus Oil

 

	
  Austria

  	
   

  	
  EP(AT)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  France

  	
   

  	
  EP(FR)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Belgium

  	
   

  	
  EP(BE)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  UK

  	
   

  	
  EP(UK)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Germany

  	
   

  	
  EP(DE)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Greece

  	
   

  	
  EP(GR)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Italy*

  	
   

  	
  EP(IT)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Luxembourg

  	
   

  	
  EP(LU)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Netherlands

  	
   

  	
  EP(NL)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Spain

  	
   

  	
  EP(ES)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Sweden

  	
   

  	
  EP(SE)0 347 056

  	
   

  	
  26.5.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Canada*

  	
   

  	
  CA 1334004

  	
   

  	
  17.1.95

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Ireland

  	
   

  	
  IE 63303

  	
   

  	
  12.6.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Japan*

  	
   

  	
  JP 2796838

  	
   

  	
  7.6.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA*

  	
   

  	
  US 4977187

  	
   

  	
  11.12.90

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA div*

  	
   

  	
  US 5120760

  	
   

  	
  9.6.92

  	
   

  	
  Granted

  	
   

  	
   

  

 

1

 

	
  R&G 40261 Case 38 - Memory Loss

  
	
   

  
	
  Austria

  	
   

  	
  EP(AT)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Belgium

  	
   

  	
  EP(BE)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  France

  	
   

  	
  EP(FR)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  UK

  	
   

  	
  EP(UK)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Germany

  	
   

  	
  EP(DE)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Greece

  	
   

  	
  EP(GR)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Italy*

  	
   

  	
  EP(IT)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Luxembourg

  	
   

  	
  EP(LU)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Netherlands

  	
   

  	
  EP(NL)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Spain

  	
   

  	
  EP(ES)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Sweden

  	
   

  	
  EP(SE)0 296 751

  	
   

  	
  15.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Ireland

  	
   

  	
  IE 63386

  	
   

  	
  16.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Japan*

  	
   

  	
  JP 2070571

  	
   

  	
  22.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA*

  	
   

  	
  US 5198468

  	
   

  	
  30.3.93

  	
   

  	
  Granted

  	
   

  	
   

  

 

2

 

	
  R&G 40262 case 71 schizophrenia

  
	
   

  
	
  Austria

  	
   

  	
  EP(AT)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Belgium

  	
   

  	
  EP(BE)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Denmark

  	
   

  	
  EP(DK)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  France

  	
   

  	
  EP(FR)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  UK

  	
   

  	
  EP(UK)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Germany

  	
   

  	
  EP(DE)0 599 576
  69305723.8

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Greece

  	
   

  	
  EP(GR)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Ireland

  	
   

  	
  EP(IE)0 599 576
  E70486

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Italy*

  	
   

  	
  EP(IT)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Luxembourg

  	
   

  	
  EP(LU)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Netherlands

  	
   

  	
  EP(NL)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Portugal

  	
   

  	
  EP(PT)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Spain

  	
   

  	
  EP(ES)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Sweden

  	
   

  	
  EP(SE)0 599 576

  	
   

  	
  22.11.93

  	
   

  	
  Granted

  	
   

  	
   

  
	
  EPO
  div

  	
   

  	
  EP
  0 733 360

  	
   

  	
  22.11.93

  	
   

  	
  Abandoned
  July 2000

  	
   

  	
   

  
	
  Canada

  	
   

  	
  CA
  2109777

  	
   

  	
  23.11.93

  	
   

  	
  Abandoned
  November 2000 notice from CAPO received dated 24.12.2001

  	
   

  	
   

  
	
  Japan

  	
   

  	
  JP
  6-199663

  	
   

  	
  26.11.93

  	
   

  	
  Abandoned
  August 2000

  	
   

  	
   

  
	
  USA*

  	
   

  	
  US 5516800

  	
   

  	
  14.5.96

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA div

  	
   

  	
  US 08/604444

  	
   

  	
  21.2.96

  	
   

  	
  Abandoned 6.11.96 - failure to prosecute

  	
   

  	
   

  

 

3

 

	
  R&G 40263

  Case 104 Huntington’s Chorea - use of GLA or DGLA in the treatment of HC

  
	
  EPO

  (Scarista Limited)

  	
   

  	
  EP 0 766 961

  	
   

  	
  26.9.96

  	
   

  	
  Pending - exam
  report Feb 1999, response filed May 1999. Second report response
  October 2001. Waiting for next report by EPO.

  	
   

  	
   

  
	
  Canada*

  	
   

  	
  CA 2186673

  	
   

  	
  27.9.96

  	
   

  	
  Pending. Exam
  requested 2003

  	
   

  	
   

  
	
  USA*

  	
   

  	
  US 5 837 731

  	
   

  	
  26.9.96

  	
   

  	
  Granted

  	
   

  	
   

  

 

4

 

	
  R&G 40264Case 107 - PEG Fatty Acid Esters

  
	
   

  
	
  UK

  	
   

  	
  GB9706061.0

  GB2 311 533

  	
   

  	
  24.3.97

  	
   

  	
  Granted - first
  exam report issued March 1999. Response filed Sept 1999 to bring roughly
  into line with PCT claims. Granted 8.12.99 - composition claims. No
  limitation on disease to be treated.

  	
   

  	
   

  
	
  EPO (Scarista)

  	
   

  	
  EP97908372.2

  	
   

  	
  19.3.97

  	
   

  	
  granted. Claims as PCT application

  	
   

  	
   

  
	
  Canada

  	
   

  	
  CA 2249578

  	
   

  	
  19.3.97

  	
   

  	
  Pending.

  	
   

  	
   

  
	
  USA*

  	
   

  	
  09/155,550

  6,610,740

  	
   

  	
  19.3.97

  	
   

  	
  Granted

  	
   

  	
   

  

 

5

 

	
  R&G 40265 case 109 niacin to diagnose schizophrenia by topical
  application

  
	
  EPO (all
  states) (Scarista)

  	
   

  	
  EP97924128.8

  	
   

  	
  29.5.97

  	
   

  	
  Granted

  1st report - amended to 2nd medical use claims. 2nd
  report, lack of inventive step. Filed declaration from US case in reply. Also
  changed claims a little as examiner objected on clarity to “niacin” and
  “ester”.

  	
   

  	
   

  
	
  Canada

  	
   

  	
  2256394

  	
   

  	
  29.5.97

  	
   

  	
  Pending

  	
   

  	
   

  
	
  Japan

  	
   

  	
  541863/97

  	
   

  	
  29.5.97

  	
   

  	
  pending - exam
  fee due 29.5.04

  	
   

  	
   

  
	
  USA*

  	
   

  	
  09/147,113

  	
   

  	
  29.5.97

  	
   

  	
  Abandoned April 2004. Continuation application
  filed Aug 2000 with same serial no and same filing date. Fees paid.

  Further action - sent declaration of DH for reply to this. Waiting for news.
  Possible interview discussed. Not possible in time so a second continuation
  application filed with new serial no....

  	
   

  	
   

  
	
  USA
  (2nd continuation)*

  	
   

  	
  10/384065

  	
   

  	
  10.3.2003

  	
   

  	
  continuation
  of 09/147,113.

  Abandoned April 2004

  	
   

  	
   

  

 

6

 

	
  R&G 40266 case 116 EPA and schizophrenia

  
	
   

  
	
  Canada

  	
   

  	
  2268257

  	
   

  	
  7.10.97

  	
   

  	
  Examination
  requested 2003

  	
   

  	
   

  
	
  Czech Republic

  	
   

  	
  PV1154-99

  	
   

  	
  7.10.97

  	
   

  	
  Granted - back
  renewal fees due by September 10th 2004

  	
   

  	
   

  
	
  EPO (Scarista)

  	
   

  	
  0956013

  	
   

  	
  7.10.97

  	
   

  	
  Granted. 1st
  report - relies on Efamol cases and cancer case for composition per se. Filed
  reply along lines of AU claims.

  	
   

  	
   

  
	
  Hungary

  	
   

  	
  P0000419

  	
   

  	
  7.10.97

  	
   

  	
  pending -
  search report issued. Examination requested no news since 2001

  	
   

  	
   

  
	
  Japan

  	
   

  	
  518086/98

  	
   

  	
  7.10.97

  	
   

  	
  Pending - exam
  not requested yet

  	
   

  	
   

  
	
  Poland*

  	
   

  	
  P333423

  	
   

  	
  7.10.97

  	
   

  	
  Pending - no
  news

  	
   

  	
   

  
	
  Slovakia

  	
   

  	
  PV0448-99S

  	
   

  	
  7.10.97

  	
   

  	
  Examination
  report issued - sent local attorneys AU accepted claims, but no amendments
  filed just yet

  	
   

  	
   

  
	
  USA*

  	
   

  	
  6,331,568

  	
   

  	
  7.10.97

  	
   

  	
  GRANTED

  IDS filed July 1999 report issued

  election made to treatment of schizophrenia - method only claims

  	
   

  	
   

  
	
  USA* div#1

  (40266.us05)

  	
   

  	
  09/956,509

  10/428,020 is the refiled number

  	
   

  	
  18.9.01

  	
   

  	
  composition
  claims

  application published 30.5.2002

  objections raised. Continuation application filed May 2nd
  2003

  claims limited to EPA, SA combination

  	
   

  	
   

  
	
  USA* div#2

  (40266.us03)

  	
   

  	
  6624195

  pub: US-2003-0045578A1

  	
   

  	
  18.9.01

  	
   

  	
  granted

  to treatment of depression,

  application published 9.5.2002

  	
   

  	
   

  
	
  USA* div#3

  (40266.us04)

  	
   

  	
  10/617,184

  	
   

  	
  2.5.03
  (divisional)

  	
   

  	
  Alzheimers,
  dementia and tardive dyskinesia divided from 09/956,739

  	
   

  	
   

  

 

7

 

	
  R&G 40267 case 123/126 depression and anxiety and DHA

  
	
   

  
	
  PCT

  	
   

  	
  PCT/GB98/01260

  WO 98/48788

  	
   

  	
  23.4.98

  	
   

  	
  National
  phases now - USA only

  	
   

  	
   

  
	
  US

  	
   

  	
  09/403754

  	
   

  	
  23.4.98

  	
   

  	
  1st
  Exam report response filed: 9.11.00

  Further official action (final) - due 7.5.01,
  extendable to 7.8.01.

  Lapsed by failure to reply 2001

  	
   

  	
   

  

 

8

 

	
  R&G 40268case 1 lithium Anti-Alzheimers

  
	
  Austria

  	
   

  	
  EP(AT) 0234733

  E69378

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Belgium

  	
   

  	
  EP(BE) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  France

  	
   

  	
  EP(FR) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Germany*

  	
   

  	
  EP(DE) 0234733

  P3774449.6

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Greece

  	
   

  	
  EP(GR) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Italy*

  	
   

  	
  EP(IT) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Luxembourg

  	
   

  	
  EP(LU) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Netherlands

  	
   

  	
  EP(NL) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Spain

  	
   

  	
  EP(ES) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Sweden

  	
   

  	
  EP(SE) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  UK

  	
   

  	
  EP(UK) 0234733

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Ireland

  	
   

  	
  IE 59606

  	
   

  	
  26.1.87

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA

  	
   

  	
  US 4753964

  	
   

  	
  28.6.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA div

  	
   

  	
  US 4810497

  	
   

  	
  7.3.89

  	
   

  	
  Granted

  	
   

  	
   

  

 

9

 

	
  R&G 42497 (Case 45) n-3 and n-6 EFA in treatment of ME

  
	
   

  
	
  EP(UK)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  EP(AT)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(BE)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  Canada

  	
   

  	
  1338683

  	
   

  	
   

  	
   

  	
  lapsed
  2000

  	
   

  	
   

  
	
  EP(FR)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(DE)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  Ireland

  	
   

  	
  63225

  	
   

  	
  24.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(IT)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  Japan*

  	
   

  	
  2893460

  	
   

  	
   

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(LU)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(NL)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(SE)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  EP(CH)*

  	
   

  	
  0364094

  	
   

  	
  30.8.89

  	
   

  	
  granted

  	
   

  	
   

  
	
  USA*

  	
   

  	
  5116871

  	
   

  	
  24.8.89

  	
   

  	
  granted

  	
   

  	
   

  

 

10

 

	
  R&G 42547 (Case 88) Ascorbyl GLA -
  used in many applications, not just neurological disorders

  
	
  Austria*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Belgium*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Denmark*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  France*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  United Kingdom*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Germany*

  	
   

  	
  0675120

  69523654.7

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Greece*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Ireland*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Italy*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Luxembourg*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Netherlands*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Portugal*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Spain*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Sweden*

  	
   

  	
  0675120

  	
   

  	
  1.3.95

  	
   

  	
  Granted (with
  only v. minor amendment to claim 1)

  	
   

  	
   

  
	
  Canada*

  	
   

  	
  2143603

  	
   

  	
  28.2.95

  	
   

  	
  Pending

  exam request filed

  	
   

  	
   

  
	
  Finland

  	
   

  	
  950909

  	
   

  	
  28.2.95

  	
   

  	
  Pending

  	
   

  	
   

  
	
  Japan*

  	
   

  	
  7-309753

  	
   

  	
  24.2.1995

  	
   

  	
  pending

  exam requested

  	
   

  	
   

  
	
  US

  	
   

  	
  5847000

  	
   

  	
  2.3.98

  	
   

  	
  Granted

  continuation of 8/388667 (dead)

  	
   

  	
   

  
	
  US divisional*

  	
   

  	
  6177470

  	
   

  	
  2.3.98

  	
   

  	
  Granted

  	
   

  	
   

  

 

11

 

	
  R&G 42926 (Case 105) Niacin esters

  
	
   

  
	
  Canada*

  	
   

  	
  2220091

  	
   

  	
  1.5.96

  	
   

  	
  Pending

  exam fee due 1.5.03

  	
   

  	
   

  
	
  EP

  (Scarista Limited)

  	
   

  	
  0823887

  	
   

  	
  1.5.96

  	
   

  	
  Accepted -
  first examination report issued and second exam reports. Restricted claims
  filed.

  	
   

  	
   

  
	
  Japan

  	
   

  	
  8-533122

  	
   

  	
  1.5.96

  	
   

  	
  pending

  	
   

  	
   

  
	
  USA*

  	
   

  	
  6015821

  	
   

  	
  1.5.96

  	
   

  	
  Granted. Assignment to Scotia Holdings plc recorded March 2002

  	
   

  	
   

  

 

12

 

	
  R&G 42927 (Case J) Lipophilic Lithium

  
	
   

  
	
  Austria

  	
   

  	
  E65182

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Belgium

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Canada

  	
   

  	
  1306944

  	
   

  	
  26.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Denmark

  	
   

  	
  173068

  	
   

  	
  26.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  France

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Germany

  	
   

  	
  P3863678.6

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Greece

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Ireland

  	
   

  	
  60568

  	
   

  	
  24.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Italy*

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Japan*

  	
   

  	
  2699083

  	
   

  	
  26.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Luxembourg

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Netherlands

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Spain

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  Sweden

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  UK

  	
   

  	
  289204

  	
   

  	
  20.4.88

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA*

  	
   

  	
  5252333

  	
   

  	
  29.3.89

  	
   

  	
  Granted

  	
   

  	
   

  
	
  USA*

  	
   

  	
  5422115

  	
   

  	
  20.1.92

  	
   

  	
  Granted

  	
   

  	
   

  

 

13

 

	
  R&G - 44051 (Case 51) - Oil and Selenium

  
	
   

  
	
  country

  	
   

  	
  patent no

  	
   

  	
  filing date

  	
   

  	
  status

  	
   

  	
   

  
	
  AUSTRIA

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  BELGIUM

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  CANADA*

  	
   

  	
  2033823-7

  	
   

  	
  9.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  DENMARK

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  EP (all except GR & ES)

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  pharm. comp., swiss style

  
	
  FRANCE

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  GB

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  GERMANY

  	
   

  	
  P69100724.1-08

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  renewal query sorted out - paid
  March 2002

  
	
  GREECE

  	
   

  	
  3010633

  EP(GR) 0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  different from rest of Europe - method of
  preparation

  
	
  IRELAND

  	
   

  	
  67622

  	
   

  	
  8.1.91

  	
   

  	
  Granted

  	
   

  	
  pharm. comp., swiss style, method of
  therapy, method of preparation

  
	
  ITALY*

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  JAPAN*

  	
   

  	
  3008213

  	
   

  	
  17.1.91

  	
   

  	
  Granted

  	
   

  	
  pharm. comp. - no English copy of granted
  claims

  
	
  LUXEMBOURG

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  NETHERLANDS

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  SPAIN

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  different from rest of Europe - method of
  preparation

  
	
  SWEDEN

  	
   

  	
  0440341

  	
   

  	
  14.1.91

  	
   

  	
  Granted

  	
   

  	
  -

  
	
  USA*

  	
   

  	
  5116624

  	
   

  	
  26.5.92

  	
   

  	
  Granted

  	
   

  	
  pharm. comp.
  and method of treatment

  

 

	
  R&G - 44053 Case 108 1-Carbon Linkers-

  
	
   

  
	
  Country

  	
   

  	
  patent no

  	
   

  	
  filing date

  	
   

  	
  status

  	
   

  	
   

  
	
  CANADA*

  	
   

  	
  2218702

  	
   

  	
  1.5.96

  	
   

  	
  pending

  	
   

  	
   

  
	
  ESTONIA

  	
   

  	
  P9700281

  	
   

  	
  1.5.96

  	
   

  	
  pending

  	
   

  	
  OK - only 12 claims filed

  
	
  EUROPEAN

  (Scarista)

  	
   

  	
  0823895

  	
   

  	
  1.5.96

  	
   

  	
  pending

  	
   

  	
  exam report- we filed response 12.2.2002.
  Filed data on efficacy - prior papers. Uncertainty as to commercially-driven
  amendment which seemed too restrictive. Scope broadened, but we have yet to
  convince EP on support of claim.

  
	
  GB

  	
   

  	
  9517107

  	
   

  	
  21.8.95

  	
   

  	
  Dead

  	
   

  	
  status lapsed -
  priority application

  
	
  GB

  	
   

  	
  9605440.8

  	
   

  	
  15.3.96

  	
   

  	
  Dead

  	
   

  	
  status lapsed -
  priority application

  
	
  HUNGARY

  	
   

  	
  P9802308

  	
   

  	
  1.5.96

  	
   

  	
  pending

  	
   

  	
  OK

  
	
  JAPAN

  	
   

  	
  8-533120

  	
   

  	
  1.5.96

  	
   

  	
  pending

  	
   

  	
  Exam requested – April ‘03

  
	
  POLAND*

  	
   

  	
  P.323176

  	
   

  	
  1.5.96

  	
   

  	
  Abandoned

  	
   

  	
  Abandoned
  Jan ‘04 – unable to overcome sufficiency objections

  
	
  USA*

  Kilpatrick & Stockton - see case 97!

  	
   

  	
  6245811

  	
   

  	
  1.5.96

  	
   

  	
  granted

  	
   

  	
  parent
  abandoned. This is the divisional application, now granted to the combination
  of any bioactive with UFA - note there is no specific claim to the UFA-UFA
  combination. Commercial division by Scotia to abandon the parent to the
  UFA-UFA combination. There is a proviso to deal with double patenting over
  US6015821 (42926 - niacin esters case 105) Confirmed in name of Scotia
  Holdings plc

  

 

14

 

	
  R&G 44052 Case 98 -
  Dyslexia

  
	
   

  
	
  CANADA

  	
   

  	
  2195979

  	
   

  	
  24.5.96

  	
   

  	
  pending

  	
   

  	
   

  
	
  EUROPEAN

  Assigned to Nutricia

  	
   

  	
  0774962

  	
   

  	
  24.5.96

  	
   

  	
  IS issues over
  poor night vision in dyslexics

  Instructed to drop on 28 Jan 2002 NO
  ACTION TAKEN

  Restitutio application filed 21.5.02

  Grounds due 8.7.02 with response

  fee has been paid. Granted 21.4.2004. national
  phase translations due 21.7.04

  	
   

  	
   

  
	
  EP(UK)

  	
   

  	
  0774962

  	
   

  	
  24.5.96

  	
   

  	
  Valid and 2004
  renewal paid by someone! (not Scarista via CPA or R&G)

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  FINLAND

  	
   

  	
  970298

  	
   

  	
  24.5.96

  	
   

  	
  Abandoned
  March 2002

  Reinstated May 2002

  Reabandoned - Numico indication not to proceed indicated May 23rd
  2002.

  	
   

  	
   

  
	
  JAPAN

  	
   

  	
  8-535515

  	
   

  	
  24.5.96

  	
   

  	
  Pending ?? exam
  fee due 24.5.2003

  Was it paid??

  	
   

  	
   

  
	
  USA

  	
   

  	
  6150411

  	
   

  	
  24.5.96

  	
   

  	
  Granted - to treatment of dyslexia

  granted to Stordy. No recordal of assignment to Scotia Holdings plc.

  licensed to Nutricia

  	
   

  	
   

  

 

15

 

	
  R&G - 44054 (Case
  110) Dyspraxia using AA and/or DHA

  
	
   

  
	
  Country

  	
   

  	
  patent no

  	
   

  	
  filing date

  	
   

  	
  status

  	
   

  	
   

  
	
  CANADA

  	
   

  	
  2263839

  	
   

  	
  26.8.1997

  	
   

  	
  lapsed

  	
   

  	
  exam fee Aug 02 not
  paid by Scarista nor by Nutricia

  
	
  EUROPEAN

  (recorded transfer to Scarista Limited)

  	
   

  	
  0956011

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Decision to Grant

  26.06.02
  where was it validated? If not listed below it is because the CPA fees were
  returned - patent never validated there.

  
	
  EP(UK)

  	
   

  	
  0956011

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  validated

  
	
  EP(IE)

  	
   

  	
  0956011

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  validated

  
	
  EP(DE)

  	
   

  	
  0956011

  69713620.5

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  Validated? Not sure

  
	
  EP(FR)

  	
   

  	
  0956011

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  Validated? Not sure

  
	
  EP(LU)

  	
   

  	
  0956011

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  Validated? Not sure

  
	
  EP(MC)

  	
   

  	
  0956011

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  Validated? Not sure

  
	
  JAPAN

  	
   

  	
  10-511369

  	
   

  	
   

  	
   

  	
  Pending??

  	
   

  	
  request exam by 26.8.04

  
	
  USA

  	
   

  	
  6184251

  	
   

  	
  26.8.1997

  	
   

  	
  granted

  	
   

  	
  changed
  claims for local practice

  

 

16

 

	
  R&G 44309 (Case 97) -
  diols

  

 

	
  Country

  	
   

  	
  APPN. NO.

  	
   

  	
  Official Number

  	
   

  	
  Expiry Date & Comments

  	
   

  	
   

  
	
  Canada*

  	
   

  	
  2218699

  	
   

  	
  2218699

  	
   

  	
  01/05/20016

  	
   

  	
   

  
	
  Czech

  	
   

  	
  PV3414-97

  	
   

  	
  PV3414-97

  	
   

  	
  response filed May ‘02 - various
  amendments proposed - waiting to receive confirmation of claims presently on
  file

  	
   

  	
   

  
	
  Estonia

  	
   

  	
  P9700275

  	
   

  	
  P9700275.5

  	
   

  	
  01/05/2016

  	
   

  	
   

  
	
  European

  	
   

  	
  96912139.1

  	
   

  	
  0823889

  	
   

  	
  01/05/2016 (recordal sent to EPO - 18
  April ‘02) 51(6) to file - claims now in

  - see letter to Mehar in: V:\Aparkes\letters\LETS04\April\44309

  - Laxdale.doc, re. why we got
  the protection we did

  	
   

  	
   

  
	
  Hungary

  	
   

  	
  P9802384

  	
   

  	
  P9802384

  	
   

  	
  01/05/2016

  	
   

  	
   

  
	
  Japan

  	
   

  	
  8-533121

  	
   

  	
  8-533121

  	
   

  	
  Exam requested - April ‘03

  	
   

  	
   

  
	
  Poland*

  	
   

  	
  P.324152

  	
   

  	
  P.323152

  	
   

  	
  Amended claims filed 19-3-03 to

  UFA-UFA for use in
  therapy and UFA-indomethacin conjugates - have to limit to examples disclosed
  in the spec. with physical & efficacy data.

  	
   

  	
   

  
	
  Slovakia

  	
   

  	
  PV1469-97

  	
   

  	
  PV1469-97

  	
   

  	
  manufacture claims 8 &16 deleted
  (April ‘02)

  per se claims 6 & 7 deleted (May ‘02)

  	
   

  	
   

  
	
  USA

  	
   

  	
  08/945667

  	
   

  	
  6555700

  	
   

  	
  Granted to Scotia Holdings plc but
  application on file May 03 to record assignment to Scarista

  had tel. con. with USPTO (19 March 2002) and they confirmed recordal to
  Scotia Holdings plc. elected product claims (July ‘02). Continuation
  application did not have new number.

  - see letter to Mehar in: V:\Aparkes\letters\LETS04\April\44309

  - Laxdale.doc, re. why we got
  the protection we did

  	
   

  	
   

  

 

17

 

SCHEDULE 2

 

	
  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

  

 

 

SCHEDULE  3 Scarsita licence details

 

	
  Contracting Party

  	
   

  	
  Date of Execution

  	
   

  	
  Territory covered

  	
   

  	
  Field of Use

  
	
  Orphan Australia

  	
   

  	
  30th June 2003

  	
   

  	
  Australia and New Zealand

  	
   

  	
  Huntington’s disease

  
	
  Medison Pharma

  	
   

  	
  20th February 2003

  	
   

  	
  Israel

  	
   

  	
  Huntington’s disease

  
	
  Scil Biomedicals GMBH

  	
   

  	
  26th March 2003

  	
   

  	
  Poland, Hungary, The Czech Republic, Slovakia,
  Turkey and Switzerland

  	
   

  	
  Huntington’s diseaseExhibit 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

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