Exhibit 4.48


 


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


 


 


	
  THIS
  LICENCE AGREEMENT is made on

  	
   

  	
  2003

  



 


BETWEEN


 


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


 


and


 


(2)                                  [*],
a Company incorporated in Japan, having its place of business at [*], Japan (“[*]”)


 


WHEREAS


 


(A)                              Laxdale
is developing a
pharmaceutical product containing ethyl icosapentate (“ethyl EPA”) for the
treatment of neurological and psychiatric disorders, and is the owner or licensee (with a right to sub-licence) of the Licensed Patent and Laxdale Know-How (both as after defined)  in
relation to such
product for the treatment inter alia of Huntington’s
Disease, other “triplet repeat” neurological disorders (as after defined), depression
and schizophrenia and
dementia;


 


(B)                                As at
the Effective Date [*] has developed and is selling a pharmaceutical product containing ethyl EPA under the brandname [*] for the use in cardiovascular indications outwith the Field of Use proposed
in this Agreement;


 


(C)                                [*] is desirous of developing such product for
the treatment of neurological and psychiatric disorders and obtaining rights
and licenses from Laxdale to develop, and sell such product in the Territory
under the Licensed Patent and Laxdale Know-How, and Laxdale
is willing to grant
such rights and licenses to [*] under the terms and conditions set forth below.


 


NOW THEREFORE
IT IS HEREBY AGREED AS FOLLOWS:


 


1.                                                                                       Definitions and interpretation


 


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


 





















 


	
  “Additional
  Field”

  	
   

  	
  means the scope of the use of pharmaceutical
  products containing ethyl EPA for neurological and
  psychiatric indications other than those detailed in the Field of Use and which indications are covered
  by the Licensed Patents (as after defined);

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Bridging Strategy”

  	
   

  	
  means a development strategy for a new drug application that utilizes the
  Laxdale Approved Registration Dossier (as after defined) and the Laxdale
  Know-How, and if needed, in which only a bridging study is conducted to
  extrapolate the efficacy data and/or safety data in the Laxdale Approved
  Registration Dossier to the Territory;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Change of
  Control”

  	
   

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

  

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

  

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

  

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

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Confidential Information”

  	
   

  	
  means any and all confidential and proprietary information of a party
  hereto disclosed by such party to the other party, including the Laxdale
  Know-How, Joint Know-How and the [*] Know-How (as after defined) under the
  terms of this Agreement, provided that such information is delivered in
  written form and marked “Confidential” at the time of disclosure or, if oral,
  is reduced to written form, marked “Confidential” and delivered to the other
  party within thirty (30) days after disclosure. The terms and conditions and
  the existence of this Agreement, other information in relation to each others’
  business including but not limited to trade secrets, proprietary information
  or any information relating to the business affairs of each other shall be
  included in the Confidential Information.

  	
   

  



 


2





















 


	
  “Development Plan”

  	
   

  	
  means a summary plan in English directed to studies and works performed
  for the purpose of filing an application for a regulatory authorization for a
  particular indication of the Licensed Product established by [*] pursuant to
  Clause 4. Notwithstanding the foregoing, [*] shall be obliged, on request by Laxdale,
  to supply Laxdale with a copy of any current or updated plan in detail then
  available in Japanese and Laxdale shall be responsible for any translation
  costs incurred by Laxdale in relation to said plan.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Effective
  Date”

  	
   

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

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “EMEA”

  	
   

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

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “FDA”

  	
   

  	
  means the US
  Food and Drug Administration or such successor or replacement body as may
  from time to time supersede it;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Field of
  Use”

  	
   

  	
  means the scope of the use of
  pharmaceutical products containing ethyl EPA for the
  therapeutic treatment of Huntington’s Disease and other “triplet repeat”
  disorders, (spino-cerebellar
  atrophy type 1,2,4,5,6,7,8,10, progressive supranuclear palsy, Fragile X
  syndrome, Friedrich’s ataxia (SCA9), Machado-Joseph Disease (SCA3),
  Denatorubro-pallidolysian atrophy), and depression, schizophrenia and dementia;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Force
  Majeure”

  	
   

  	
  means any cause arising from or attributable to
  acts, events or omissions beyond the reasonable control of either party
  including but not limited to any act of government or government department,
  act of God, flood, fire, explosion or earthquake, strike, walk— out, lock-out
  or industrial dispute (except where such strike, walk-out, lock-out or
  industrial dispute are initiated by or participated in by the relevant party’s
  own employees or contractors) but always excepting any non payment of sums
  due under this Agreement;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Improvements”

  	
   

  	
  means all
  improvements or modifications or adaptations to the Licensed Product which
  may be

  	
   

  



 


3





















 


	
   

  	
   

  	
  made or
  acquired by either party arising from the development of the Licensed Product during the Term (as after defined). [*]’s Improvement shall specifically
  exclude any improvement made or acquired arising from the development of
  pharmaceutical products containing ethyl EPA for the use outside the Field of
  Use or outside the Additional Field;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Joint Know-How”

  	
   

  	
  means any technical and scientific information, data and know-how on a
  Licensed Product generated by or on behalf of [*], based upon the Bridging
  Strategy, which may be utilised in a [*] Approved Registration Dossier (as
  after defined). For the avoidance of doubt, Joint Know-How shall exclude (i) anything
  specifically covered by [*] Know-How or (ii) any technical and scientific
  information, data and know-how generated by or on behalf of [*] prior to the
  Effective Date.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Laxdale Know-How”

  	
   

  	
  means any technical and scientific information, data and know-how
  generated prior to the Effective Date or to be generated by or on behalf of
  Laxdale or that Laxdale has or is to have a right to license to [*] hereunder
  arising from the development of the ethyl EPA within the Field of Use and the
  Additional Field if any indication within the Additional Field is licensed to
  [*] pursuant to Clause 3.2.2 or 3.3 hereof. Laxdale Know-How shall
  specifically include the Laxdale Approved Registration Dossier.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Licensed
  Patents “

  	
   

  	
  means patent applications and patents in the Territory equivalent to the
  following: 

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (i)   the
  patent applications referred to in Schedule 1 including
  any amended or divided applications;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (ii)   all
  patent applications that may be filed by or on behalf of Laxdale or that may
  be licensed to Laxdale during the Term in the Field of Use or in the Additional Field subject to
  [*] being granted a licence from Laxdale pursuant to Clause 3.2.2 or 3.3
  hereof, as well as those based on or claim priority
  from such patent applications including any amended or divided applications;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (iii)   all patents actually
  granted pursuant to any

  	
   

  



 


4





















 


	
   

  	
   

  	
  such patent
  applications
  described in item (i) or (ii) above, including any
  amended or divided applications;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Licensed
  Product”

  	
   

  	
  means any pharmaceutical product
  containing ethyl EPA on an indication by indication basis to be developed within
  the Field of Use (i) which indication is covered by a Licensed Patent, and/or
  (ii) which indication has obtained or is to obtain the regulatory approval
  based upon the Approved Registration Dossier containing any Laxdale Know-How.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Milestones”

  	
   

  	
  means each
  of the milestones set out in Part 2 of Schedule 2;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Milestone
  Payments”

  	
   

  	
  means the
  sums due to Laxdale against the performance of the Milestones as more
  particularly detailed in Part 2 of Schedule 2;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “[*] Know-How”

  	
   

  	
  means any technical and scientific information, data and know-how on a
  Licensed Product or the [*] Indication generated by or on behalf of [*] in a [*]
  Approved Registration Dossier which Approved Registration Dossier is deemed
  to be the result of the development based upon a development strategy other
  than the Bridging Strategy. [*] Know-How shall exclude any technical and
  scientific information, data and know-how generated prior to the Effective
  Date.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Net Sales”

  	
   

  	
  means the total of amounts invoiced or
  otherwise billed to the wholesaler of the Licensed Product by [*] or its
  permitted sub-licensees or any other third party permitted to supply the
  Licensed Product to the wholesaler and net of Value Added Tax or any other
  equivalent sales taxes or duties and after deduction of (a) rebates, normal
  trade discounts, credits and refunds actually granted and made to customers
  for returned goods, (b) warehousing, transportation and insurance costs
  incidental to the Sale of the Licensed Products.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Both parties shall discuss and determine in good faith the specific
  market data sources required to be used in the calculation of the Sales
  arising from each indication of the Licensed Products sold by [*] and/or its
  permitted sub-licensees and the

  	
   

  



 


5





















 


	
   

  	
   

  	
  detailed calculation method to obtain the Net Sales for each indication
  of the Licensed Product before such Licensed Product is launched in the
  Territory.For the avoidance of doubt, in any case, the Net Sales shall
  specifically exclude any net sales arising from [*]’s sale of pharmaceutical
  products containing ethyl EPA for the use outside the Field of Use;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Orphan Drug
  Designation”

  	
   

  	
  means the
  orphan designation for the Licensed Product in the treatment of Huntington’s Disease
  issued by the Office of Orphan Products Development, under authority of FDA,
  on 6 April 2000 and the EMEA Committee for Orphan Medicinal Products on
  27 October 2000;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Quarterly Period”

  	
   

  	
  means each period of three (3) months in each year of the Term,
  respectively beginning from 1 January, 1 April, 1 July and 1 October.
  The first Quarterly Period is any three (3) month period in which the first
  Licensed Product is launched in the Territory;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Registration Dossier”

  	
   

  	
  means a package of information and data submitted for the purpose of
  filing a new drug application to the competent authority (the EMEA and/or FDA
  in the case of Laxdale Registration Dossier and to the competent authority in
  the Territory in the case of [*] Registration Dossier) with respect to any
  pharmaceutical product containing ethyl EPA on an indication by indication
  basis within the Field of Use and [*] Indication. The Registration Dossier
  includes data and information submitted in accordance with the request by
  such authority from time to time in the process of the examination of such
  product or the [*] Indication.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  The “Approved Registration Dossier” used in this Agreement means a final
  package of all information and data based upon which the competent authority
  has approved such product or the [*] Indication.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Royalties”

  	
   

  	
  means royalties payable to Laxdale under this Agreement as detailed in
  Clause 10 and Part 1 of Schedule 2;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Sales”

  	
   

  	
  means the
  sale of the Licensed Products by [*] or a permitted sub-licensee (including co-marketer)

  	
   

  



 


6





















 


	
   

  	
   

  	
  to independent third parties, and “Sold” shall be
  construed accordingly;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Term”

  	
   

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

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Territory”

  	
   

  	
  means Japan;

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  “Year”

  	
   

  	
  means each
  12 month period beginning from 1 January during the Term in which the
  first Licensed Product is launched in the Territory.

  	
   

  



 


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


 


2.                                                                                       Term


 


2.1                                                                                 This Agreement shall come into force on the Effective Date and
subject to termination in accordance with Clause 19 or any other termination provision of this
Agreement, shall continue until [*]’s obligation to pay the
Royalties expires in accordance with Clause 10.3.


 


3.                                                                                       Appointment and scope of rights


 


3.1.1                                                                        Subject to the terms of this
Agreement, Laxdale hereby grants to [*] the exclusive rights and licences in
the Territory and within the Field of Use to develop, use, offer to sell, sell
and distribute the Licensed Products under the Licensed Patent and Laxdale
Know-How. It is acknowledged by [*] that Laxdale hereby expressly reserves the
exclusive right to market, distribute and sell (either itself or by way of
licensing a third party) Licensed Products in any country in the world other than
the Territory or, subject to the provisions of Clauses 3.2 and 3.3, outwith the
Field of Use in any country in the world including the Territory and [*]


 


7





















 


shall be expressly
prohibited from marketing, distributing and selling (either itself or through a
third party) Licensed Products in any country in the world other than the
Territory.


 


Laxdale
acknowledges and agrees that the manufacture of the Licensed Products by [*]
(its contract manufacturer or sublicensee) without the license thereof from
Laxdale does not constitute any infringement of the Licensed Patents in respect
of this Agreement.


 


3.1.2                                                                        [*] shall be entitled to grant to
any third parties a sublicense with respect to any rights or licenses granted
to [*] pursuant to Clause 3.1.1 hereof; provided, however, that [*] shall be
responsible for causing such sub-licensees to observe any applicable
obligations hereunder including but not limited to the royalty payments
detailed herein.


 


3.2                                                                                 In the event, during the Term of
this Agreement, Laxdale has a right to appoint a licensee for any indication in
the Additional Field (“Indication”) under the Licensed Patent and/or Laxdale
Know-How in the Territory, and subject always to [*] having performed all of
its obligations under this Agreement and not being in breach of this Agreement,
[*] shall have the option to negotiate the condition for including the
Indication in the Field of Use on the following basis:


 


3.2.1                                                                        Laxdale shall give a written notice
of its intention to appoint a licensee for the Indication in the Territory to [*]
with (i) sufficient clinical data (including efficacy and safety  data) and information on such Indication to
enable [*] to evaluate the feasibility to develop the Indication  and (ii) the proposed amount of the milestone
payments and the royalty payments.  [*]
shall have four (4) months from the receipt of such notice and data and
information from Laxdale to give written notice to Laxdale to exercise its
option to enter into negotiations described in Clause 3.2.2.  In the event no such notice is given to
Laxdale by [*], the option in this Clause 3.2 shall be deemed to have expired
and it shall be at Laxdale’s sole discretion whether or not to enter into
negotiations with [*] or a third party of its choosing.


 


3.2.2                                                                        Upon receipt by Laxdale of notice from
[*] in accordance with Clause 3.2.1, Laxdale and [*] shall negotiate, in good
faith, the milestone and royalty payments to apply to said licence of said
Indication.  The amount of such payments
which shall, unless the Indication is of greater commercial value than the
total commercial value of the indications within the Field of Use licensed in
terms of this Agreement, be no higher than those contained in this Agreement,
shall be agreed upon between the parties taking into consideration the
potential commercial value of the Indication. 
After the milestone payments and royalty payments are agreed upon by the
parties, the Indication shall be included in the Field of Use and governed by
this Agreement.  In the event the amount
of milestone payments and royalty payments has not been agreed within two (2)
months of receipt by Laxdale of the foregoing notice from [*], Laxdale may
commercialise said Indication itself or license said Indication to any third
party on terms no more favourable than those offered to [*].


 


3.3                                                                                 [*] shall not develop an indication
in the Additional Field without first having obtained the written consent of
Laxdale, which consent shall not be unreasonably delayed or withheld by Laxdale.  If said consent is forthcoming from Laxdale, [*]
may exclusively develop and commercialize an indication in the Additional Field
(“[*] Indication”) which, subject to Clause 15.2, shall be owned solely by [*].  [*] shall not, develop, use, offer to sell,


 


8





















 


sell or distribute
the [*] Indication outside the Territory. 
The right of [*] to exclusively develop, manufacture and have
manufactured, use, offer to sell, sell and distribute the [*] Indication within
the Territory shall be subject to:


 


3.3.1                                                                        an agreement being reached in good
faith between Laxdale and [*] in relation to royalty payments payable to
Laxdale for sales of the [*] Indication within the Territory by [*] or its
permitted sub-licensees, it being acknowledged that if such an agreement is not
reached within four (4) months of [*] and Laxdale entering into said
negotiations, [*] may not develop, use, offer to sell, sell or distribute the [*]
Indication within the Territory; and


 


3.3.2                                                                        [*] granting Laxdale an exclusive
licence to develop, manufacture, have manufactured, use, offer to sell, sell or
distribute the [*] Indication and its related [*] Know-How outside the
Territory.  This licence shall be subject
to an agreement being reached in relation to royalties payable by Laxdale to [*]
in relation to its sales of the [*] Indication which royalties shall be no
greater than fifty percent (50%) of the royalty rate provided for in Part 1 of Schedule 2
 of this Agreement.


 


3.3.3                                                                        In the event that both parties do
not reach an agreement pursuant to Clause 3.3.1 or 3.3.2 above within  four (4) months of [*] and Laxdale entering
into the negotiation with respect thereto,  both parties agree not to develop or
commercialize by itself or through a third party such indication in the
Additional Field that [*] desires to develop.


 


3.4                                                                                 [*] and Laxdale agree to execute
such formal licence agreements (if any) as may be required by relevant patent
registries from time to time and to do such other acts and things as may be
necessary for the purpose of registering the exclusive licences
(Senyo-Jisshiken) granted in terms of this Agreement.  Further, Laxdale warrants that any licensor
of any patent included in the Licensed Patents agrees that [*] will register
such exclusive license (Senyo-Jisshiken) in the relevant patent registries, and
Laxdale shall cause the licensor to take the necessary procedures for this
purpose.


 


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


 


4                                                                                          Development


 


4.1                                                                                 [*] may develop the Licensed Product
in the most cost-and time-effective manner that [*] deems appropriate, such as
under the Bridging Strategy using the Laxdale Approved Registration Dossier,
which will include the adoption of a development strategy provided by [*] for
an application for the competent approval in the Territory that maximizes the
utilization of the Laxdale Know-How where appropriate.


 


9





















 


4.2                                                                                 Subject always to the
confidentiality provisions contained in Clause 8.1.2, Laxdale shall provide [*]
with the Laxdale Registration Dossier as soon as practicable after the
submission thereof to the EMEA and/or the FDA. 
Further and also subject to the provisions of Clause 8.1.2, Laxdale
shall provide [*], upon [*]’s request, with the Laxdale Know-How other than the
Laxdale Registration Dossier, including without limitation pre-clinical and
clinical data that have not yet been submitted to the EMEA or the FDA and data
and information relating to the Licensed Patents within the Field of Use.


 


4.3                                                                                 [*] shall evaluate the Laxdale
Registration Dossier to study the feasibility to develop the Licensed Product
under the Bridging Strategy in addition to any other means [*] deems
appropriate.  [*] may determine at its
discretion whether it develops the Licensed Product or not, based on such
evaluation results and/or any other circumstances such as the requirements of
the market, or regulations and medical practices in the Territory of such
Licensed Product. [*] shall notify Laxdale of its determination as to the
development of the Licensed Product by six (6) months after the date when
Laxdale obtains a regulatory approval for the Licensed Product based upon such
Laxdale Registration Dossier from the EMEA and/or FDA.  In the event that [*] decides not to develop
a Licensed Product, [*] shall provide the reasons for the decision with the
notification.  Laxdale shall be entitled (a)
to remove the indication from the Field of Use that [*] decides not to so
develop and; (b) to develop, manufacture, have manufactured, use, offer to
sell, sell or distribute said indication by itself or through a third party within
the Territory if Laxdale’s evaluation of the market and related issues does not
agree with that of [*].  Further, if [*]
elects, in terms of this Clause, not to develop the Licensed Product within any
indication in the Field of Use, this Agreement shall terminate and be of no
further effect.


 


Notwithstanding the
foregoing, in the event that [*] notifies Laxdale, before Laxdale obtains a
regulatory approval for such Licensed Product, that [*] will not develop a
Licensed Product for an indication within the Field of Use for a reason of
possible adverse influences on the sales of [*] arising from the pharmaceutical
products containing ethyl EPA outside the Field of Use and the reason is
justifiable to Laxdale, Laxdale shall not, thereafter, commercialize said
indication by itself or a third party within the Territory.  If the reason is not justifiable to Laxdale,
both parties shall negotiate and determine in good faith how to deal with said
indication.  The negotiation in said case
shall be decided within four (4) months, it being acknowledged that if such
negotiation is not completed within four (4) months, Laxdale shall be entitled
to (a) remove the indication from the Field of Use that [*] decides not so to
develop and; (b) develop, manufacture, have manufactured, use, offer to sell,
sell or distribute said indication by itself or through a third party within
the Territory.


 


4.4                                                                                 [*] shall establish and submit to
Laxdale a Development Plan with respect to the Licensed Product which [*]
determines to develop pursuant to Clause 4.3 above.  In such a case, [*] shall use commercially
reasonable efforts to develop the Licensed Product in accordance with the
Development Plan.  The Development Plan
may be reviewed and revised from time to time.


 


5.                                                                                       Approvals


 


5.1                                                                                 Subject to Laxdale completing its
obligations under Clause 5.3, [*] shall use its commercially reasonable efforts
to develop and manage the clinical trials and submit a


 


10





















 


[*] Registration
Dossier for the Licensed Product to be developed by [*] pursuant to Clause 4.3
above to the competent authorities in the Territory, with a view to obtaining regulatory
approval for the Licensed Product in the Territory. Notwithstanding the
foregoing, all local clinical trials in the Territory to be conducted based
upon the Bridging Strategy, or any other development strategy, using the
Laxdale Approved Registration Dossier shall be subject to Laxdale’s prior
written approval.  For the purpose of
obtaining the prior approval from Laxdale, [*] shall submit in English, a
summary of such local clinical trial protocol to Laxdale. Laxdale and [*] shall
use their best efforts to have such protocol approved within one (1) month
after receipt by Laxdale of the summary from [*], and Laxdale shall not
unreasonably withhold such approval unless such trials are likely to adversely
affect the commercialisation of the Licensed Product in any country outwith the
Territory.  In the event that Laxdale
does not give the approval within such one (1) month period without a
reasonable reason, [*] may commence such local clinical trial.  [*] shall provide the full details of such
local clinical trial protocol in Japanese to Laxdale, if so requested by
Laxdale after obtaining such prior approval thereof (it being agreed by Laxdale
that Laxdale shall be responsible for any translation costs incurred by Laxdale
in relation to the full details of said clinical trial protocol).  All costs or expenses incurred in relation to
such local clinical trials or otherwise for the development of the Licensed
Product by [*] shall be paid for fully by [*] alone. As soon as practicable
after completion of any local clinical trials for such Licensed Product a
summary of the results of all such trials shall be supplied in English by [*]
to Laxdale.If so requested by Laxdale the full results shall be supplied to
Laxdale by [*] in Japanese, it being agreed that Laxdale shall be responsible
for any translation costs incurred. Subject to the provisions of Clause 16, [*]
shall at its own expense have the right to use the Laxdale Know-How for
registration purposes in Japan.


 


5.2.1                                                                        The Joint Know-How shall be jointly
owned by Laxdale and [*] and, both during and after the Term of this Agreement,
Laxdale may utilise said Joint Know-How on a royalty free basis outside the
Territory as it sees fit in its sole discretion.  [*] may share its own half share in the
ownership of such Joint Know-How with Nippon Suisan Kaisha, Ltd. (having a
principal place of business at 6-2 Otemachi 2-chome, Chiyoda-ku, Tokyo
100-8686, Japan).   Provided, however,
that in the event that this Agreement is terminated by [*] pursuant to Clause
19.1.1 and/or 19.1.2, the ownership and license provided for in this Clause
5.2.1 shall cease to exist and revert to [*]. In the event that this Agreement is
terminated by Laxdale pursuant to Clause19.1.1 and/or 19.1.2 Laxdale’s rights
in said Joint Know-How provided for in this Clause 5.2.1 shall continue.


 


5.2.2                                                                        [*] Know-How shall belong
exclusively to [*].  [*] shall grant
Laxdale the exclusive license to develop, manufacture, have manufactured, use,
offer to sell, sell or distribute the Licensed Product in the world outside the
Territory under the [*] Know-How.  This
license shall be subject to an agreement being reached in relation to royalties
payable by Laxdale to [*] in terms of Clause 3.3.2.   Provided, however, that in the event that
this Agreement is terminated by [*] pursuant to Clause 19.1.1 and/or 19.1.2,
the license granted to Laxdale in this Clause 5.2.2 shall cease to exist and
revert to [*].


 


5.2.3                                                                        In any event  neither party shall be obliged to provide the
other with any information and data in relation to the pharmaceutical products
containing ethyl EPA developed and/or commercialized by the other party for any
indication outside the Field of Use and outside the Additional Field.


 


11





















 


5.3                                                                                 Laxdale shall use its commercially reasonable efforts, either by
itself or through a third party, to develop and manage the clinical trials and
submit a Laxdale
Registration Dossier to the FDA and/or EMEA, with a
view to obtaining regulatory
approval for the marketing of the Licensed Product within the Field of Use. For the avoidance of doubt, ownership of the results of all such
trials and clinical or other data arising from such clinical trials shall vest
and remain vested in Laxdale.


 


5.4                                                                                 [*] shall be responsible for complying with the laws in the
Territory applicable to manufacturing, marketing, distributing and selling the
Licensed Products pursuant to this Agreement, effecting any registrations and
paying all applicable customs duties, taxes and other costs in respect of the
manufacturing, marketing, distribution and sale of the Licensed Products in the
Territory.  Without prejudice to the
foregoing generality, [*] shall be solely responsible for the manufacture and
packaging of the Licensed Product within the Field of Use within the Territory
subject at all times to appropriate regulatory approval.


 


5.5                                                                                 [*] shall not at any time nor under any circumstance do anything
(whether directly or indirectly) to interfere with or prejudice the Orphan Drug
Designation of the Licensed Product or with EMEA’s or FDA’s or any other
regulatory body’s approval of the Licensed Product.   [*] shall (at the request of Laxdale from
time to time) provide Laxdale with the Joint Know-How in obtaining and
maintaining all necessary regulatory approvals of the Licensed Product.


 


5.6                                                                                 For the avoidance of doubt, failure by [*] to comply with any
of the provisions of   Clause 5.5 will
amount to a material breach of this Agreement and Laxdale shall be
entitled to terminate this Agreement in accordance with Clause 19.


 


6.                                                                                       Duties of [*]


 


6.1                                                                                 It shall be a material term of this Agreement that [*] shall use its commercially reasonable endeavours to sell the Licensed Products to be developed by [*] pursuant to
Clause 4.3 hereof, and to maximise sales for the
Licensed Product under this Agreement.


 


6.2                                                                                 [*] shall have sole responsibility for the marketing of the Licensed
Product in the Territory and, in this regard, [*] shall use its commercially reasonable endeavours to enhance the reputation and acceptance of
the Licensed Product amongst customers and prospective customers within the
Territory and, further to this obligation, [*] shall jointly agree with Laxdale
key promotional messages in relation to the Licensed Products taking into account the market
features, medical practices and the regulations in or of the Territory.  [*] shall be consistent in
its use of the agreed key messages and shall use them, as appropriate, for all
sales, literature, promotional, marketing and other materials in relation to
the Licensed Product to
the extent practicably acceptable in the Territory taking into account the
market features, medical practices and the regulations in or of the Territory.  A copy of all sales
literature shall be delivered to Laxdale.


 


6.3                                                                                 [*] shall refrain from taking any action that would damage the
reputation and standing of Laxdale and/or the Licensed Product.


 


12





















 


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


 


6.5                                                                                 All costs and expenses incurred by [*] in carrying out its
obligations under this Agreement shall be borne solely and exclusively by [*] save to the extent expressly
indicated to the contrary.  Without prejudice to the foregoing
generality, all expenses incurred by [*] in the manufacturing and marketing of the
Licensed Products in the Territory shall be borne
solely by [*].


 


6.6                                                                                 [*] shall promptly bring to Laxdale’s notice any information or
knowledge received or gained by it which is likely to be of interest, use or
benefit to Laxdale in relation to the development, marketability or sale of the
Licensed Product in the
Territory, save as such disclosure is prohibited by a confidentiality
obligation to a third party.


 


6.7                                                                                 [*] shall respect and, in accordance with Clause 15 hereof, properly use
Laxdale’s copyright (and other related rights) in all sales literature,
marketing, promotional and/or other materials provided by Laxdale.  For the avoidance of doubt, [*] shall not be
permitted to copy any such sales literature or other such materials except
strictly for the purpose of performing its obligations under this Agreement
subject always to the prior written consent of Laxdale (which shall not be
unreasonably withheld or delayed).


 


7.                                                                                       Reporting of Adverse Events


 


7.1                                                                                 Each party shall provide the other
party in writing with information on serious adverse events that might be
related to the Licensed Product in a manner to be agreed between both parties.


 


7.2                                                                                 Both parties shall formalise the
reporting procedures for serious adverse events discovered during clinical
studies no later than on the date of commencement of the first clinical study
under the Agreement by means of a separate agreement concerning reporting of
such adverse events, if so required by the regulations and guidelines of ICH,
FDA, EMEA and the competent authority. 
Furthermore, the parties shall formalise the reporting procedures for
adverse events discovered after the launch of the Licensed Product no later
than three (3) months before the first delivery of the Licensed Product by
means of a separate agreement concerning reporting of adverse events, if so
required by the regulations and guidelines of ICH, FDA, EMEA and the competent
authority.  Such agreements shall comply
with any and all regulations and guidelines of ICH, FDA, EMEA and the competent
authority in the Territory.


 


7.3                                                                                 Notwithstanding any provisions to
the contrary in this Agreement, each party may use, on a royalty free basis,
the information on adverse events which is received from the other  party hereunder,  only for the purpose of reporting to the
competent authority in its own territory pursuant to the regulations.


 


8.                                                                                       Duties of Laxdale


 


8.1                                                                                 Throughout the Term and subject to the performance by [*] of its
obligations hereunder, Laxdale shall:


 


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8.1.1                                                                        assist [*] with the key promotional messages to be used by [*] in
relation to the Licensed Product in the performance of its obligations
hereunder as detailed in Clause 6.2, and provide [*] with a copy of all sales literature, if any, prepared by
Laxdale in relation to the Licensed Product;


 


8.1.2                                                                        provide [*] with a copy of the Laxdale Registration Dossier submitted to EMEA and/or FDA referred to in Clause 5.3 ; and


 


8.1.2.1                                                               provide [*], upon reasonable request
by [*], with other Laxdale Know-How except for information covered by any confidentiality or other contractual obligations owed by Laxdale
to third parties;


 


8.1.3                                                                        promptly bring to [*]’s notice any
information or knowledge received or gained by it which is likely to be of
interest, use or benefit to [*] in relation to the marketability or sale of the
Licensed Product or otherwise in the world outside the Territory, save as such
disclosure is prohibited by a confidentiality obligation to a third party; and


 


8.1.4                                                                        not at any time nor under any
circumstance (a) do anything (whether directly or indirectly) to interfere with
or prejudice (i) the development and the marketing of any pharmaceutical
product containing ethyl EPA including the Licensed Products by [*] and (ii)
any regulatory approval thereof, or (b) take any action that would damage the
reputation and standing of [*] and/or any pharmaceutical product containing
ethyl EPA including the Licensed Product in the Territory.


 


9.                                                                                       Milestone Payments 


 


9.1                                                                                 In consideration of the grant of the rights and licenses to [*]
under this Agreement, [*] shall pay Laxdale the Milestone Payments as detailed in Schedule 2
attached hereto. [*] shall not be obliged to pay any Milestone
Payment that is outstanding by the termination of this Agreement due to any
cause not attributable to [*].


 


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


 


10.                                                                                 Royalties 


 


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


 


10.2                                                                           Royalties shall be calculated as a percentage of the Net Sales of
all Licensed Products Sold in the Territory at the respective rates set out in Schedule 2  which are applicable in each Year.


 


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Laxdale shall
inform [*], by the end of Quarterly Period, of any change in the status of the
patents and patent applications within the Licensed Patents in the Territory
for [*]’s royalty calculation.


 


10.3                                                                           Royalties provided in this Clause 10
shall be paid by [*], on an indication by indication basis, until the later of:
(a) the date when the Licensed Product ceases to be covered by one or more of
the granted claims of the Licensed Patents or; (b) the date when ten (10) years
have lapsed from the date when such Licensed Product is launched in the
Territory.


 


10.4                                                                           Royalties shall be paid within thirty (30) working
days of the end of each Quarterly Period based upon the Net Sales
in such preceding Quarterly
Period.  All
Payments of Royalties shall be accompanied by a statement giving details of the
calculation to be prepared pursuant to Clause 12.2.


 


10.5                                                                           Notwithstanding the provisions of
Clause 15.3 hereof, in the event that the development, formulation, use, offer
for sale, sale and/or distribution of the Licensed Product is found to infringe
any third party’s intellectual property rights and as the result of the
settlement pursuant to Clause 15.5.1 or 15.5.2 [*] is required to pay royalties
or any other payments to such third party for the licenses under such
intellectual property rights, then fifty percent (50%) of the payments actually
paid by [*] to such third party during the Term shall be deductible from the
Royalties paid to Laxdale under this Agreement provided, that, in no event
shall the amount of any deduction under this Clause 10.5 by [*] in any
Quarterly Period be more than  half of
the Royalty amount paid by [*] to Laxdale during said Quarterly Period.


 


10.6                                                                           In any event [*] shall not be
obliged to pay to Laxdale any royalty with respect to any pharmaceutical
products containing ethyl EPA for any indication outside the Field of Use and outside
the Additional Field.


 


11.                                                                                 Payments


 


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


 


11.2                                                                           All Milestone payments in accordance with Clause 9 hereof
shall be made in US Dollars and all Royalty payments in accordance with Clause 10 hereof
shall be made in Japanese Yen.


 


11.3                                                                           All payments to be made by [*] hereunder, whether Milestone Payments, Royalty or
otherwise, and such payment amounts described herein are
exclusive of Value Added Tax and inclusive of all other applicable taxes and/or
duties including
withholding tax which shall be payable if applicable at
the relevant rate from time to time by [*].  
[*] shall withhold any such taxes and shall pay the withheld amounts to
the competent tax office in Japan on behalf of Laxdale.  [*] shall as promptly and practicably as
possible send to Laxdale official receipts of such tax payments.  [*] shall file with the competent tax office
in Japan on behalf of Laxdale any and all documents which will allow for
reduction in the rate of the withholding tax imposed on Laxdale, as provided
under the tax convention between the U.K. and Japan.


 


15





















 


11.4                                                                           Without prejudice to any other right or remedy of Laxdale, if any
sum due by [*] is not paid within the relevant time period specified in this
Agreement, interest shall be payable from the last date for payment under this
Agreement until actual payment (whether before or after judgement) at a rate of
three percent (3%) per annum above the base rate of the Bank of Scotland from time to
time together with all expenses (including legal fees) which Laxdale may incur
in recovering the sum outstanding.


 


12.                                                                                 Accounts 


 


12.1                                                                           [*] shall keep at its office at the address on the front of this
Agreement (or such other address as may be agreed by the parties from time to
time), detailed and accurate records and accounts showing the calculation of
the Royalties payable to Laxdale in respect of the Licensed Products and all
other payments payable by [*] hereunder for six (6) years after each respective actual
payment of such Royalties or other payment.  Such records shall be complete and accurate records in sufficient
detail to enable Laxdale to confirm the accuracy of the amounts of the
Royalties paid by [*] hereunder.


 


12.2                                                                           [*] shall within thirty (30) working days after the last day of each
Quarterly Period in each Year of this Agreement deliver to Laxdale a true and complete
statement of all Licensed Products Sold during the Quarterly Period ended
on each such last date (or any part thereof in the last month of this Agreement) which
shall include details of all Royalties and other sums payable in respect of
such Quarterly Period.


 


12.3                                                                           At the time to be agreed upon
between both parties, but not more than once in any Year, [*]
shall permit any duly authorised representatives of Laxdale or an independent public accountant
appointed by Laxdale and approved by [*] access to such
records, accounts and statements of [*] and shall provide reasonable
information and cooperation as such representatives shall require to verify the
statements rendered by [*] in terms of this Agreement and shall also permit
such representatives to take copies of and extracts from such records, accounts
and statements for the purpose of verification subject to the provisions of Article 16
hereof. 
Notwithstanding expiry or termination of this Agreement for any reason
such access shall be given, as aforesaid, until all outstanding claims have
been settled to the satisfaction of both parties.  If any inspection by Laxdale as aforesaid
reveals an under calculation or underpayment of five percent (5%) or more of
Royalties due to Laxdale, the costs of such inspection shall be borne by [*]
and any such underpayment shall immediately be payable by [*] to Laxdale.


 


13.                                                                                 Warranties and Liability


 


13.1                                                                           Notwithstanding any provisions of this Agreement expressly or impliedly
to the contrary effect, Laxdale shall not under any circumstances be
responsible or liable for any, loss, damage, costs or other liability
whatsoever (“Losses”) which [*] or any third party may incur as a result of the use of the
Licensed Products to be
developed by [*] pursuant to


 


16





















 


Clause 4.3 hereof except for the Losses arising
out of or in connection with Laxdale’s (and its employees’) gross negligence or
wilful misconduct, or breach of any obligation or warranty contained herein, and [*] shall indemnify Laxdale accordingly and at all times shall
maintain insurance to cover any such liability.


 


13.2                                                                           Notwithstanding any provisions of this Agreement expressly or
impliedly to the contrary effect, [*] shall not under any circumstances be
responsible or liable for any Losses which Laxdale or any third
party may incur as a result of the use of [*] Know-How or Joint Know-How except for the Losses arising out of
or in connection with [*]’s  (and its
employees’) gross negligence or wilful misconduct, or breach of any obligation
or warranty contained herein, and Laxdale
shall indemnify [*] accordingly and at all times shall maintain insurance to cover any
such liability.


 


13.3.1                                                                  Laxdale represents and warrants that
Laxdale, to the best of its knowledge and having taken all reasonable steps, have
collected and compiled, or shall collect and compile, any data contained in the
Laxdale Registration Dossier in compliance with the relevant laws and ICH
regulations and guidelines including GLP and GCP and shall perform adequate
quality control and quality assurance thereon.


 


13.3.2                                                                  [*] represents and warrants that [*],
to the best of its knowledge and having taken all reasonable steps, shall
collect and compile any data contained in the Joint Know-How and the [*]
Know-How in compliance with the relevant laws and ICH regulations and
guidelines including GLP and GCP and shall perform adequate quality control and
quality assurance thereon.


 


13.4                                                                           Laxdale represents
and warrants to [*] that it shall use its commercially reasonable efforts to obtain (a) either itself or by way of a
licence to a third party, regulatory approval from EMEA and/or FDA for the
Licensed Product; and (b) either itself or by way of a licence from a third
party, any patent or
patent application which covers the Licensed Product in the Territory.


 


13.5                                                                           [*] represents
and warrants to Laxdale that it shall use its commercially
reasonable efforts to obtain regulatory approval for the Licensed Product to be developed by [*] pursuant to
Clause 4.3 in accordance with the Development Plan within
the Territory.


 


13.6                                                                           Subject to Clauses 13.1 and 13.2, each party shall fully and effectively
indemnify the other in respect of all Losses arising out of the gross negligence or wilful misconduct of the party or of the party’s employees, or breach of the party or of the party’s employees of the obligation or warranty
contained herein provided that:


 


13.6.1                                                                  the indemnified party takes reasonable steps to mitigate its Losses; and


 


13.6.2                                                                  where any party indemnified under the terms of this Clause 13.6 seeks
indemnification in respect of a third party claim, the indemnified party allows
the indemnifying party to handle such claims.


 


17





















 


13.7                                                                           Neither party shall be liable to the other in respect of any
indirect or consequential or special loss or damage or loss of profits
including but not limited to loss of production, business, revenue or goodwill,
anticipated savings or delays, except for the party’s (and its employees’) gross negligence or wilful
misconduct, or breach of any obligation or warranty contained herein.


 


14.                                                                                 Improvements


 


14.1                                                                           If, during the Term, [*] develops or conceives any Improvement, then
it shall forthwith notify Laxdale in writing of such Improvement and shall
disclose all necessary information to permit exploitation by Laxdale of such
Improvement in connection with the Licensed Product.


 


14.2                                                                           Laxdale shall have an irrevocable, non-exclusive, worldwide royalty-free
licence to use all Improvements which [*] is due to disclose to Laxdale in terms of
Clause 14.1, for the
Licensed Product within the Field of Use in the world outside the Territory.  Provided, however, that in the event that
this Agreement is terminated by [*] pursuant to Clause 19.1.1 and/or 19.1.2,
the license granted to Laxdale in this Clause 14.2 shall cease to exist and
revert to [*].


 


14.3                                                                           If during the Term, Laxdale conceives or develops any Improvement, [*] shall
have the automatic right to have said Improvement included within the Field of
Use and within the Territory without any additional payment and subject to all of the provisions of this
Agreement.  Provided, however, that in the
event that this Agreement terminates in terms of Clause 4.3 or is terminated by
Laxdale pursuant to Clause 19.1 or 19.2 or by [*] pursuant to Clause 19.3, the
right granted to [*] in this Clause 14.3 shall cease to exist and revert to
Laxdale.


 


15.                                                                                 Intellectual Property


 


15.1                                                                           Laxdale represents and warrants that
(a) Laxdale has the right to grant the licenses granted to [*] under this
Agreement and will use reasonable best efforts to maintain any licenses
acquired by Laxdale from the third party with respect to the Licensed Patent
and the Laxdale Know-How, (b) Laxdale will, and will cause its licensor of the
Licensed Patent to, use reasonable best efforts to prosecute patent
applications within the Licensed Patents, and obtain patents as a result
thereof, (c) Laxdale will, and will cause its licensor of the Licensed Patent
to, use reasonable best efforts to maintain the Licensed Patents and; (d) as of
the Effective Date, no claim has been made or is pending or, to the best
knowledge of Laxdale, is threatened against Laxdale relative to the Licensed
Patents and/or the Laxdale Know-How alleging infringement or misappropriation
of any patent, copyright or other proprietary right of any third party.


 


15.2                                                                           Other than as expressly provided herein nothing contained in this
Agreement shall be construed as conferring or vesting any right, title or
interest in or to any of the Licensed Patent in or relating to the
Licensed Product in favour of  [*] or any
other third party.


 


15.3                                                                           Laxdale gives no warranty to [*] that the use or sale by it of the
Licensed Products will not infringe any intellectual property rights of any third party
and Laxdale shall not be


 


18





















 


required under any circumstance to indemnify [*] or any
third party with regard to any loss, cost, injury or damage incurred or
suffered by [*] or such third party in respect of any  such infringement.


 


15.4                                                                         [*] shall forthwith advise Laxdale of any infringement or purported
infringement of the Licensed Patent of which it becomes aware in the Territory.


 


15.4.1                                                                Laxdale shall in its sole discretion decide whether to take any
action at its own expense against any infringement or purported infringement
of the foregoing which comes to its knowledge.  
[*] shall promptly give Laxdale all reasonable assistance in relation to
such action upon being indemnified by Laxdale in respect of any reasonable
costs and, in that event, any damages, profits or other compensation received
from such action shall belong to Laxdale (subject to [*]’s right to be recompensed
for its reasonable costs as aforesaid).  Laxdale shall indemnify [*] in
relation to any costs, claims or damages incurred by [*] as a result of Laxdale
taking such action.


 


15.4.2                                                                In the event Laxdale, in its sole discretion, decides to take no
action [*] shall be entitled to take such action as it sees fit, and Laxdale shall promptly give [*]
all reasonable assistance in relation to such action (including becoming a
party to it if so requested by [*]) upon being indemnified by [*] in respect of
any reasonable costs. 
In the event,
any damages, profits or other compensation received from such proceedings shall
belong to [*] (subject to Laxdale’s right to be recompensed for its reasonable
costs as aforesaid).  To avoid any doubt any action so taken by [*] shall be at its own
expense and [*] shall indemnify Laxdale in relation to any costs, claims or
damages incurred by Laxdale as a result of [*] taking such action.


 


15.5                                                                         In the event of the institution of any suit by a
third party against [*] for patent infringement or warning thereof involving
the manufacture, use, sale, distribution, marketing or other utilisation of the
Licensed Product, [*] shall promptly notify Laxdale in writing.


 


15.5.1                                                                Laxdale shall,
in its sole discretion decide whether to defend, or, at its option, to settle
such suit at its own expense.  Laxdale
shall inform [*] at the earliest practicable opportunity of whether or not it
is going to defend said suit and, upon request from [*], Laxdale shall inform [*]
of the strategy and the progress of such suit. 
[*] shall to the reasonable extent, assist Laxdale and cooperate in such
litigation at the expense of Laxdale.


 


15.5.2                                                                In the
event Laxdale, in its sole discretion, decides not to exercise the first right
to defend, [*] shall, in its sole discretion decide whether to defend, or, at
its option, to settle such suit at its own expense.  [*] shall inform Laxdale at the earliest
practicable opportunity of whether or not it is going to defend said suit and, upon
request from Laxdale, [*] shall inform Laxdale of the strategy and the progress
of such suit.  Laxdale shall, to the
reasonable extent, assist [*] and cooperate in such litigation at the expense
of [*].


 


16.                                                                                 Confidential  Information 


 


16.1                                                                           [*] and Laxdale shall, either during the Term and for five (5) years thereafter:


 


19





















 


(a) keep Confidential Information of the other party, including without
limitation the terms and conditions of this Agreement in strict confidence and
not disclose it to any third party;


 


(b) not use Confidential Information of the other party for any purpose
other than as authorized herein; and


 


(c) prevent its directors, officers and employees from unauthorized use or
disclosure of Confidential Information of the other party.


 


16.2                                                                           The
obligations of confidentiality provided in Clause 16.1 shall not apply to the
extent that the party receiving Confidential Information (the “Receiving Party”)
can establish that such Confidential Information:


 


(a) was available to the public at the time of receipt or thereafter
becomes publicly known through no breach of this Agreement by the Receiving
Party, or its directors, officers, employees or agents;


 


(b) was known to the Receiving Party at the time of disclosure or
thereafter becomes known to the Receiving Party through disclosure by sources
other than the disclosing party of such Confidential Information (“Disclosing
Party”), which was lawfully in possession of the same and that had the right to
disclose the same;


 


(c) is required to be disclosed by law, government agency, court order or
valid discovery request in connection with a legal proceeding, provided that
the Receiving Party provides the Disclosing Party with prior written notice of
any such disclosure so that the Disclosing Party can seek an appropriate protective
order;


 


(d) is approved for release by written authorisation of the Disclosing
Party; or


 


(e) is disclosed by the Receiving Party on a commercially reasonable basis
and in the normal course to a third party who is bound to comply with the
obligations of confidentiality set out in Clause 16.1.


 


17.                                                                                 Press Releases 


 


Neither party
can issue a press release in relation to this
Agreement  without first obtaining the
prior written consent of the other party. Subject to Clause 16, during the Term of this Agreement either Laxdale
or [*] has the right to approve the wording of any
press release relating to the terms of this Agreement or in relation to the
Licensed Product which is intended by the other party, provided
that such approval shall not be unreasonably withheld.
Neither Laxdale nor [*] shall use the
other party’s name without their prior written consent. For the avoidance of
doubt Laxdale do not require the consent of [*] for approval of press releases related to any
Licensed Product outside the Territory that has been licensed to other third parties.


 


20





















 


18.                                                                                 Force majeure


 


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


 


18.2                                                                         The
Defaulting Party shall use its reasonable endeavours to make alternative
arrangements to enable the relevant obligations to be performed and if such
relevant alternative arrangements are not arranged or if they are not arranged
to the satisfaction of the Non-Defaulting Party, the Non-Defaulting Party may
make alternative arrangements to enable such obligations to be performed.


 


19.                                                                                 Termination


 


19.1                                                                         Subject as provided herein, either party may terminate this
Agreement by written notice to the other with immediate effect upon the
occurrence of any of the following events:


 


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


 


19.1.2                                                                the other party commits a material breach of any of the provisions
of this Agreement which cannot be remedied or if it can be remedied remains
unremedied on the expiry of  sixty (60)
days after notice is given by the other party specifying the nature of the
breach and the action required to remedy same.


 


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


 


19.2.1                                                                Change of Control of [*] which shall make it impossible or impracticable for [*] to perform the
obligations hereof; or;


 


19.2.2                                                                  failure by [*] to pay any sum due within forty-five (45) days of
the due date for the payment; or


 


19.2.3                                                                if  [*] challenges and/or
assists any third party to challenge the Licensed Patent in a patent office proceeding or a
court of law.


 


19.3                                                                         Other than where [*] has obtained
approval for the Licensed Product through the relevant regulatory authority
within the Territory, if [*] reasonably decides that it would be difficult to
continue this Agreement for commercial reasons, [*] shall provide Laxdale with
the reasons or rationales in writing, and [*] may terminate this Agreement by
providing three (3) months prior written notice to Laxdale.  For the avoidance of doubt if the relevant
regulatory authority in the Territory removes said approval for the Licensed


 


21





















 


Product and it is not within the control of [*]
using its reasonable endeavours to prevent this removal, [*] may terminate this
Agreement by providing three (3) months prior written notice to Laxdale.  The effective date of such termination shall
be the date falling three (3) month after such written notice or on any later
date detailed by [*] in such written notice.


 


20.                                                                                 Effect of termination


 


20.1                                                                           In the event of expiration or termination of this Agreement for any
reason:-


 


20.1.1                                                                [*]’s rights
and licenses granted hereunder shall automatically terminate; provided, however, that in the
event that [*] has received binding orders on the Licensed Products from its customers,
[*] shall be entitled to fulfil such orders, subject to payment to Laxdale of all Royalties in relation thereto.
;


 


20.1.2                                                                all outstanding
sums due to either party as at the date of termination
shall immediately become due and payable within thirty (30) days;


 


20.1.3                                                                Either party shall destroy, or at the request of the Disclosing Party, shall return to the
Disclosing Party any and all Confidential Information of the Disclosing Party
in tangible form, including, without limitation, all copies and reproductions
thereof, except that one (1) copy thereof may be retained by the Receiving
Party solely for the purpose of determining the scope of its confidentiality
obligations hereunder.


 


20.1.4                                                                Notwithstanding any provision of
this Agreement to the contrary, in the event that this Agreement expires or
terminates (except for the termination in terms of Clause 4.3 or by Laxdale
pursuant to Clause 19.1 or 19.2, or by [*] pursuant to Clause 19.3), [*] may
continue to exercise any rights and licenses granted under this Agreement
without any payment even after such expiration or termination thereof.


 


20.1.5                                                                The following provisions of this
Agreement which by their terms are of a continuing nature, shall survive any termination or expiry of this Agreement: 
Articles 7, 13 (except 13.4 and 13.5), 16, 18, 20, 21 and 22, Clauses
5.2.1, 5.2.2, 12.1, 12.3, 15.5.


 


21.                                                                                 General


 


21.1                                                                         [*] shall not be entitled to transfer, or assign any of its
rights or obligations under this Agreement without the prior written consent of
Laxdale. Laxdale shall be entitled to transfer, assign or sub-license in whole all
of its rights or obligations under this Agreement to a company within its group
of companies as defined by the Companies Act 1985 (the “Act”) or to its holding
company (as defined in the Act) or a company within the group of companies of
its holding company or companies, together with all Licensed Patents, all Laxdale Know-How and any other
rights, interests and information which enable such company to perform any and
all obligations and responsibilities under this Agreement.


 


21.2                                                                         This Agreement constitutes the entire agreement and understanding
between the parties hereto regarding its subject matter and cancels, terminates
and supersedes any and all prior


 


22





















 


agreements and understandings of any nature (written, oral or
otherwise) relating to such subject matter but that without excluding either
party’s liability for fraud or fraudulent misrepresentation.  Any variation or addition to the provisions
of this Agreement shall not be effective unless reduced to writing and signed
by a person of
each party duly authorised to do so.


 


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


 


21.4                                                                         Failure by either party to enforce at any time any of the provisions
of this Agreement provided herein shall not constitute a waiver of such or other provisions hereof,
nor affect the validity of this Agreement or any part thereof, or the right of
the willing party to enforce thereafter each and every such provision.


 


21.5                                                                         If any provision of this Agreement is declared by any court, commission, administrative
body or arbitral tribunal of competent jurisdiction to
be invalid or unenforceable, the remainder of this Agreement shall continue in
full force and effect,
and the parties shall amend this Agreement to the extent feasible to lawfully
include the substance of the excluded term to as fully as possible realize the
intent of the parties and their commercial bargain, unless the invalid
provision is of such essential importance to this Agreement that it is to be
reasonable assumed that the parties would not have entered into this Agreement
without the invalid provision.


 


21.6                                                                         Any notice or other document to be given under this Agreement shall
be in writing and shall be deemed to have been duly given if left at or sent by
hand, or by registered post, or overnight courier, or by facsimile confirmed, by airmail, or by other electronic media to a party at the address set out below or
such other address as the party may from time to time designate by a written notice to the
other.


 


If to Laxdale:


 


Laxdale Limited


Kings Park House,


Laurelhill Business
Park


Stirling, FK7 9JQ


the U.K.


Attention: Managing
Director


Facsimile No.:  +44-0-1786-473137


 


If to [*]:


[*]


[*]


 


23





















 


[*]


Japan


Attention:  Licensing & Business Development


Facsimile No.:  [*]


 


Any such notice or other document shall be
deemed to have been received by the addressee seven (7) working days
following despatch if the notice or other document is sent by registered post,
or three (3) days after
being sent by overnight courier, one (1) day after being sent by facsimile
confirmed by airmail, or simultaneously with the
delivery or transmission if sent by hand or other electronic means.


 


21.7                                                                         The terms, representations,
warranties and agreements of the parties set forth in this Agreement are not
intended for, nor shall they be for the benefit of or enforceable by , any
third party.  Accordingly, except as
otherwise agreed herein, a person who is not a party to this Agreement has no
rights under the United Kingdom Contract (Rights of Third Parties) Act 1999 to
enforce any term of this Agreement but this does not affect any right or remedy
of a third party which exists or is available apart from that Act.


 


22.                                                                                 Applicable law and arbitration


 


22.1                                                                         All matters arising out of or in connection with this Agreement
shall be governed by and construed in accordance with English law.


 


22.2                                                                         All
disputes, controversies, or differences which may arise between the parties out
of, or in relation to, or in connection with this Agreement shall, in the first
instance, be settled amicably between the parties.  In the event that settlement of a dispute is
not reached between the parties within three (3) months from the commencement
of such amicable discussions, such dispute shall be exclusively and finally
settled by arbitration in accordance with the Commercial Arbitration Rules
adopted by the International Chamber of Commerce.  Such arbitration shall be held at the place
of the proposed respondent, i.e., in Tokyo, Japan, if the proposed respondent
is [*], and in London, the U.K., if the proposed respondent is Laxdale, however
it being understood that the arbitration proceedings shall be in English.


 


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


 


	
  Signed
  for and on behalf of

  
	
  LAXDALE
  LIMITED

  
	
   

  
	
   

  
	
   

  	
   

  
	
  Name:

  	
  Sherri Clarkson

  
	
  Title:

  	
  Managing Director

  
	
  Date:

  	
   

  
			



 


24





















 


	
  Signed
  for and on behalf of

  
	
  [*]

  
	
   

  
	
   

  
	
   

  	
   

  
	
  Name:

  	
  [*]

  
	
  Title:

  	
  Senior Executive Managing Director

  
	
  Date:

  	
   

  
			



 


25





















 


Schedule 1


 


1.                                       Licensed Patents: 


 


	
  Scarista Patent

  Reference

  	
   

  	
  Application number

  	
   

  	
  Filing date

  	
   

  	
  Status

  	
   

  
	
  Case
  116

  	
   

  	
  JP518086/98

  	
   

  	
  7.10.97

  	
   

  	
  Pending

  	
   

  
	
  Laxdale Patent

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case 40390

  	
   

  	
  JP2000-595665

  	
   

  	
  21.1.00

  	
   

  	
  Pending

  	
   

  



 


26





















 


Schedule 2


 


1.                                       Royalties:


 


1a; Royalty amount shall be obtained by multiplying
the respective portion of the total Net Sales in each Year by the following
royalty rate (“Basic Royalty Rate”) corresponding thereto:


 


	
  Portion
  of the total Net Sales

  	
   

  	
  Basic Royalty Rate

  	
   

  	
  Case 1c below

  	
   

  	
  Case 1d below

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Less than Yen six billion
  (6,000,000,000)

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Over Yen six
  billion (6,000,000,000)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Less than Yen
  twelve billion (12,000,000,000)

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Over Yen twelve billion (12,000,000,000)

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  



 


1b; The Basic Royalty Rate
shall apply  if the Licensed Product falls within the scope of one or
more of the claims of the granted Licensed Patents and has obtained regulatory approval
by the competent authority in the Territory based upon the Bridging Strategy.


 


1c; If (a) the Licensed Product falls within the scope of one or more of the
claims of the granted Licensed Patents but has obtained regulatory approval by
the competent authority based upon a development strategy other than the
Bridging Strategy or; (b) the Licensed Product has obtained regulatory approval
by the competent authority based upon the Bridging Strategy but does not fall
within any of the claims of the granted Licensed Patents, fifty percent (50%)
of the Basic Royalty Rate shall apply.


 


1d; If the Licensed Product does not fall within the scope of any of the
claims of the granted Licensed Patents and its regulatory approval in the
Territory has been obtained based upon a development strategy other than the
Bridging Strategy, [*] percent ([*]%) shall apply to all portion of the total
Net Sales.   Notwithstanding the
foregoing, [*] shall not be obliged to pay any royalty with respect to a
product containing ethyl EPA for an indication in the Field of Use (a) which
does not fall within any claim of the Licensed Patent and (b) which has
obtained a regulatory approval based upon the [*] Approved Registration Dossier
without containing any part of the Laxdale Know-How.


 


1e;  In the event that the status of
the Licensed Patent is changed after the launch of the Licensed Product in the
Territory, such as grant of a patent from a patent application in the Licensed
Patent, cessation of the existence of the Licensed Patent covering the Licensed
Patent, the applicable royalty rate shall be changed in accordance with the
provision in Part 1 of Schedule 2 hereof.


 


27





















 


The applicable royalty rate is illustrated as follows:


 


	
  Status of the Licensed

  Patent

  	
   

  	
   

  	
   

  	
  Any
  patent application

  	
   

  	
   

  	
   

  
	
  

  Licensed Product

  Approved based upon

  	
   

  	
  Any
  granted patent in

  Licensed Patent covers

  the Licensed Product.

  	
   

  	
  in
  the Licensed Patent

  covers the Licensed

  Product.

  	
   

  	
  No
  Licensed Patent

  covers the Licensed

  Product.

  	
   

  
	
  the Bridging Strategy using
  the Laxdale Approved Registration Dossier

  	
   

  	
  Basic Royalty Rate

  	
   

  	
  50% of the Basic Royalty Rate

  	
   

  	
  50% of the Basic Royalty Rate

  	
   

  
	
  a development strategy other
  than the Bridging Strategy, using a part of Laxdale Know-How *

  	
   

  	
  50% of the Basic Royalty Rate

  	
   

  	
  [*]%

  	
   

  	
  [*]%

  	
   

  
	
  the [*] Registration Dossier
  without containing any Laxdale Know-How *

  	
   

  	
  50% of the Basic Royalty Rate

  	
   

  	
  [*]%

  	
   

  	
  No royalty payment

  	
   

  



 










*  subject to the provision of Clause
7.3 hereof.


 


2.                                       Timetable


 


	
  Milestone

  	
   

  	
  Milestone Payments

  Total
  Amount

  US$[*]

  	
   

  
	
  Milestone 1
  — Licensing Fee within thirty (30) days from the Effective Date

  	
   

  	
  US$

  	
  [*]

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 2 — within
  thirty (30) days from the date on which [*] receives the written notice from
  Laxdale that Laxdale files an application of the first Licensed Product for
  the marketing approval to FDA 

  	
   

  	
  US$

  	
  [*] 

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 3 — within thirty (30) days from the date on
  which Laxdale receives the written notice from [*] that [*] files an
  application of the first Licensed Product for the marketing approval to the
  competent authority in the Territory 

  	
   

  	
  US$

  	
  [*] 

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Milestone 4 — within
  thirty (30) days from the date on which Laxdale receives the written notice
  from [*] that [*] obtains the regulatory approval for the first Licensed
  Product from the competent authority in the Territory

  	
   

  	
  US$

  	
  [*]

  	
   

  



 


28