Exhibit 4.51
DATED
2004
LAXDALE LIMITED
- AND -
SCARISTA LIMITED
EXCLUSIVE PATENT
AND
KNOW-HOW AGREEMENT
EXPLOITATION OF PRODUCTS BY
SCARISTA
AGREED FORM DOCUMENT
THIS AGREEMENT
is made
the day
of
2004
BETWEEN
(1)
LAXDALE LIMITED
a company registered in Scotland
whose registered office is at Kings Park House, Laurelhill Business
Park, Polmaise Road, Stirling FK7 9JQ (“Laxdale”);
and
(2)
SCARISTA LIMITED
a company registered under number
71829 whose registered office is at 1 st 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”).
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TERMS AGREED
1.
Definitions
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In this Agreement:
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“Affiliate”
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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;
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“a
Distributor”
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means a distributor under the terms
of a Distributor Agreement;
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“a Distributor
Agreement”
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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;
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“the Effective
Date”
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means the date of this
Agreement;
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“EMEA”
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means the European Medicines
Evaluation Agency;
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“EU”
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means European Union;
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“European
Union”
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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;
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“FDA”
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means the United States Food and
Drug Agency Administration;
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“the Field of
Use”
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means any and all psychiatric and
Central Nervous System disorders, including pain;
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“the
Improvements”
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means any improvement, enhancement
or modification to a Product or its method of manufacture within
the Field of Use;
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“Intellectual
Property”
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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;
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“Know-how”
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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;
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“LAX-101”
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means ethyl-eicosapentaenoate
(ethyl-EPA) of greater than 90% purity as the active
ingredient
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“the Laxdale
Know-how”
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means all Know-how used by Laxdale
in connection with the Patents set out in the Schedule;
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“the Laxdale
Territory”
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means Canada, the United States of
America, the European Union and Japan;.
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“Licence”
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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;
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“Licensee”
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means a licensee under the terms of
a Licence;
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“the Net Sales
Value”
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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
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(i)
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normal and reasonable discounts
actually granted;
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(ii)
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freight, shipment and insurance
costs directly incurred by Scarista (or a wholly owned subsidiary)
in transporting Products to Customers;
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(iii)
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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);
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(iv)
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customs duties and other
governmental charges incurred in connection with the sale,
exportation or importation of the Products.
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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
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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.
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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.
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“Net Income”
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means all income received by
Scarista with respect to commercial exploitation of the Patents or
Orphan Drug Designation and the associated Scarista
Know-how
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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.
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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.
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“Patents”
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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
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with all Patents which may be
granted pursuant to any such patent applications;
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“Products”
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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;
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“Orphan Drug
Designation”
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means the orphan drug designation of
the approval process for a Product as granted by a Regulatory
Authority;
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“Regulatory
Approval”
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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);
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“Regulatory
Authority”
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the FDA or similar governmental or
other agency in a country having authority to grant a Regulatory
Approval;
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“Regulatory
Dossier”
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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
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information about the chemistry,
formulation, manufacture, toxicology, pharmacology,
pharmacokinetics and clinical studies related to a drug;
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“the Scarista
Know-how”
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means all Know-how used by Scarista
in connection with the Patents set out in the Schedule;
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“the Scarista
Licence”
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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;
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“the Scarista
Territory”
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means world-wide except those
countries which comprise the Laxdale Territory from time to
time;
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“the
Schedule”
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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;
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“Sub-Licence”
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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;
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“Sub-Licensee”
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means any Third Party granted a
Sub-license to sell or otherwise commercialise Product under a
Sub-license;
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“Third Party”
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means any party which is not an
Affiliate or wholly owned subsidiary of the relevant party
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“the Trade
Marks”
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means such trade marks, brands,
signs or logos which are applied to the Products;
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“USA”
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means United States of
America;
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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
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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
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(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.
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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 t
