Exhibit 4.47
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 AND DISTRIBUTION
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
(“Laxdale”);
and
(2)
SCIL BIOMEDICALS GMBH having a place
of business at Fraunhofer Strasse 15 D-82152 Martinsried, Germany
(“Scil”).
WHEREAS
(A)
Laxdale has developed and is the
owner of certain IP Rights (as after defined) including the
Licensed Patent (as after defined) and the Trade Mark (as after
defined) in relation to the Licensed Product (as after defined) for
the treatment inter alia of Huntington’s
Disease;
(B)
Laxdale has agreed to appoint Scil
as its distributor in the Territory (as after defined) on an
exclusive basis and insofar as necessary to perform its obligations
as distributor to license Scil under the Licensed Patent and the
Trade Mark and Scil has agreed to accept such licence and
appointment on the terms and conditions of this
Agreement
NOW THEREFORE IT IS HEREBY AGREED AS
FOLLOWS:
1.
Definitions and
interpretation
1.1
In this Agreement, unless the
context requires otherwise, the following words and expressions
shall bear the following meanings:
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“Additional
Field”
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means the treatment of
depression;
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“Change of
Control”
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means a change of control in
relation to Scil. “Control” for these purposes means
the power of a person to secure:
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(i) by means of holding
shares or the possession of voting power in or in relation to that
or any other body corporate; or
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(ii) by virtue of any
powers conferred by the articles of association or other document
regulating that or any other body corporate
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that the affairs of the first
mentioned body corporate are conducted in accordance with the
wishes of that person;
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“Cost of
Goods”
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means the cost incurred by Laxdale
in relation to a Unit supplied on to Scil pursuant to Purchase
Orders;
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“Effective
Date”
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means the last date of signature
hereof by or on behalf of each of the parties hereto by persons
duly and expressly authorised;
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“EMEA”
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means the European Agency for the
Evaluation of Medical Products or such successor or replacement
body as may from time to time supersede it;
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“Field of
Use”
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means the marketing, distribution
and Sale of Licensed Product for the therapeutic treatment and/or
prevention of Huntington’s Disease it being acknowledged that
in the event Laxdale, in its sole discretion, widens the
development of the Licensed Product to include the treatment of
Spino-cerebellar atrophy; Progressive Supranuclear Palsy; Fragile X
and Friedreich’s ataxia these treatments shall be included in
this definition of Field of Use for the purposes of this Agreement.
To avoid any doubt Laxdale shall be under no obligation to widen
the scope of the development as aforesaid;
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“Group
Company”
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Means any company which is for the
time being a subsidiary or holding company of Scil or any
subsidiary of such holding company;
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“Improvements”
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means all improvements or
modifications or
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adaptations to the Licensed Product
within the Field of Use which may be made or acquired by Laxdale
during the Term (as after defined);
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“Major
Improvement”
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means all improvements or
modifications or adaptations to the Licensed Product by Laxdale
which would render the Licensed Product to be considered by the
relevant regulatory authority as a new and separate Licensed
Product and which (a) obtains it’s own orphan drug
designation and (b) requires completion of a clinical program for
it’s development in order to obtain a Marketing Authorisation
within the Territory To avoid any doubt, the development of
Licensed Product within the Field of Use is not a Major
Improvement
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‘‘Minor
Improvement”
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means all improvements or
modifications or adaptations to the Licensed Product by Laxdale
which only require standard pharmacokinetic, bioequivalence or
similar such studies in order to satisfy its addition to the
Marketing Authorisation of the existing Licensed Product within the
Field of Use;
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“IP Rights”
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means all patents, registered
designs, unregistered design rights, copyrights, topography rights,
trade marks, trade names, logos, trade secrets and know-how, moral
rights, supplementary protection certificates, petty patents,
utility models, applications for any of the above and the right to
make applications and any and all other intellectual or industrial
property rights of any description (and rights of a similar nature)
anywhere in the world,
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(i) existing now or at any time in
the future; and
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(ii) whether or not registered or
registrable;
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related to the Licensed
Product.
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“Launch Date”
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means a date to be agreed between
the parties hereto which shall be no later than three (3) months
following approval of the Licensed Product by the EMEA except for
those countries within the Territory in which the price of the
Licensed Product must be negotiated with the local authorities
where Launch Date shall be no later than nine (9) months following
approval of the Licensed Product by the
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EMEA;
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“Licensed
Patent”
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means:
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(i) the patent applications
referred to in Part 1 of the Schedule including any amended or
divided applications;
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(ii) all patent applications
that may be filed in the Territory by or on behalf of Laxdale which
are based on or claim priority from such patent applications
including any amended or divided applications;
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(iii) all patents actually
granted pursuant to any such patent applications, including any
amended or divided applications;
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“Licensed
Product”
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means the product owned by Laxdale
and sold by Scil pursuant to this Agreement in the Field of Use
which falls within the claims of the Licensed Patent or the Orphan
Drug Designation and which has obtained Marketing Authorisation by
EMEA;
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“Marketing
Authorisation”
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means a marketing authorisation
which enables Scil to sell Licensed Product for the approved
indication in Huntington’s disease being part of the Field of
Use in all countries of the Territory;
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“Milestone
Payments”
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means the sums due to Laxdale
against the performance of the Milestones as more particularly
detailed in Part 1 of the Schedule;
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“Minimum
Sales”
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means the aggregate minimum sales
within all countries of the Territory to be achieved by Scil as set
out in Part 1 of the Schedule;
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“Net Sales
Value”
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means the actual invoiced price of
Units Sold to a third party, net of (i)Value Added Tax or other
equivalent sales taxes or duties; (ii) trade discounts actually
granted, not to exceed 5%;of the list price;
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The Net Sales Value shall also
include any and all lump sums or other benefits whether in cash or
in kind receivable by Scil from any third party in consideration of
the Sale and/or distribution of
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Units;
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In the case of any sale or disposal
of Units which is not an arm’s length sale, the Net Sales
Value shall be the open market price for the Licensed Product in
the country to which the Licensed Product is supplied;
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“Order
Acknowledgement”
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means a written acknowledgement of
any Purchase Order from Laxdale containing details such as price,
delivery dates and quantities agreed by Laxdale;
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“Orphan Drug
Designation”
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means the orphan designation for the
Licensed Product in the treatment of Huntington’s disease
issued by the EMEA Committee for Orphan Medicinal Products on 27
October 2000;
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“Purchase
Order”
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means an irrevocable written order
(and any amendments to the same accepted by Laxdale) from Scil to
Laxdale for the purchase of Licensed Products for sale by Scil in a
format approved in advance by Laxdale;
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“Quarter”
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means each period of 3 months in
each year of the Term, the first quarter commencing at the start of
the month during which the Licensed Product is first sold
(“Quarterly” being construed accordingly);
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“Sale”
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means the sale or other disposal of
Licensed Products (whether or not title is transferred and whether
or not for value) and “Sold” shall be construed
accordingly;
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“Samples”
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means Units to be supplied to Scil
free of charge, labelled as samples ready for distribution to
authorised persons in an amount to be requested and agreed between
Laxdale and Scil. The amount of samples shall not exceed 1000 and
shall not be lower than 500 Units in each of the first and second
years within the total Territory after the Launch Date. Thereafter
the Units of Samples shall be negotiated between the parties in
good faith;
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“Schedule”
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means the schedule in 3 parts
annexed and executed as relative hereto;
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“Term”
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means the term of this Agreement as
detailed in Clause 2.1;
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“Territory”
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means Germany, France, Austria,
Luxembourg, Netherlands and Belgium;
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“Total Net Sales
Value”
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means the aggregate Net Sales Value
of all Sales of Units by Scil to the date of the relevant
calculation;
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“Trade Mark”
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Means the trade mark to be selected
by Laxdale prior to the first Launch Date, and owned solely by
Laxdale, with which Licensed Products shall be branded;
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“Transfer
Price”
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means [ *] percent ([ * ]%) of
the Total Net Sales Value;
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“Unit”
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means the standard pack size (for 28
days treatment) containing 112 capsules (based on 4 per day)each of
which contains 500mg of the Licensed Product of which 485mg is the
active substance ethyl icosapentaenoate (95% e-EPA), finally
packed, labelled and marked with the Trade Mark and being in
compliance with all local regulations and the Marketing
Authorisation, ready for Sale to a customer in the
Territory;
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“Working Day”
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Means Monday to Friday 09:00 till
17:00 excluding all UK and English public holidays.
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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.
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2.
Term
2.1
Subject to Clause 2.2 this Agreement
shall come into force on the Effective Date and subject to
termination in accordance with Clause 24 shall continue until the
later to expire of a period of 10 years or the expiry of the last
of the patent applications referred to in Part 1 of the
Schedule or the expiry of Orphan Drug Designation in the
Territory.
2.2
Notwithstanding Clause 2.1 the
parties may extend the period of this Agreement beyond the Term
provided such extension has been agreed between the parties and
subject always to agreeing a revised Transfer Price being the
actual Cost of Goods plus a percentage of the Net Sales Value to be
negotiated in good faith. The extension to the Term and the revised
Transfer Price shall be notified at least six (6) months prior to
the scheduled expiry of the Term otherwise the Agreement shall
automatically terminate upon expiry of the Term.
3.
Appointment and scope of
rights
3.1
Subject to the terms of this
Agreement, Laxdale hereby grants to Scil an exclusive,
non-transferable licence to market, distribute and sell Licensed
Products , in each country within the Territory (subject always to
Clause 7.1) within the Field of Use only and under the Licensed
Patent and Trade Mark and Orphan Drug Designation. Scil shall not
be entitled to sub-license or sub-contract any of its rights
hereunder without Laxdale’s prior written consent such
consent not to be unreasonably withheld. Such prior written consent
is not needed in case Scil wants to transfer the rights granted
under this Agreement to a Group Company subject always to: (i) said
Group Company being obliged to fulfil all of the obligations of
Scil in terms of this Agreement (including but not limited to
payment obligations); (ii) said Group Company providing Laxdale
with such evidence as Laxdale shall reasonably require to show its
ability to be able to fulfil the obligations of Scil in terms of
this Agreement; (iii) the details of said Group Company being
provided to Laxdale; (iv) said Group Company not being further
entitled to transfer said rights and; (v) said Group Company being
obliged to immediately transfer said rights back to Scil if it
should cease to be a Group Company. It is acknowledged by Scil that
Laxdale hereby expressly reserves the exclusive right to market,
distribute and sell (either itself or by way of licensing a third
party) Licensed Products within the Field of Use in any country in
the World other than the Territory.
3.2
Scil 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 Scil shall be entitled to describe itself as
Laxdale’s authorised distributor for the Licensed Products
within the Territory.
4.
Minimum Sales
4.1
It will be considered a material
breach of this Agreement should Scil fail to achieve Minimum Sales
(as set out in part I of the schedule) in any two years during the
Term whether consecutive or not.
4.2
The Minimum Sales are set out in
Schedule 1.
4.3
For the avoidance of doubt the
provision of Samples by Scil shall not be included in the
calculation of the Minimum Sales.
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4.4
Subject to Clauses 4.1 and 5.2 and,
provided that Scil’s failure is not due to the impact of
parallel imports of the Licensed Product, if Scil fails to achieve
the Minimum Sales Laxdale shall be entitled to terminate this
Agreement with immediate effect and shall be free to appoint new
distributors, agents and/or licensees in the Territory (on a
non-exclusive or exclusive basis) and/or proceed with the
marketing, distribution and sale of the Licensed Products in the
Territory on its own account, as it deems appropriate.
5.
Supply of the Licensed
Products
5.1
With effect from the first Launch
Date, Scil shall provide Laxdale with a forecast of its requirement
of Units for the following 12 month period and shall during every
Quarter of each such year during the Term provide Laxdale with an
updated forecast for the year then following the date of such
forecast. Such forecast shall take the form of a written
schedule and shall specify all details of anticipated sales
and shall be calculated and presented in a true and accurate
manner.
5.2
All orders for the purchase of the
Units shall be made by Scil to Laxdale by submitting a Purchase
Order each quarter for supply in the next six (6) months. Following
the first anniversary of the first Launch Date Laxdale shall be
obliged to comply with Scil’s requirements as set out in
their forecasted quantities in terms of Clause 5.1 together with
such additional quantities of Units if such additional quantities
do not exceed 115% of the forecasted quantity for the delivery
period in question and it being further acknowledged that Scil
shall be obliged to purchase 80% of the forecasted quantities. Any
additional orders to the foregoing shall only become binding once
they have been accepted by Laxdale and an Order Acknowledgement
issued. It is acknowledged by Laxdale that Scil shall not be in
breach of any requirement to make the Minimum Sales if such failure
is due to Laxdale’s rejection of Purchase Orders and/or
defective Licensed Product which would otherwise have allowed Scil
to achieve such Minimum Sales.
5.3
At the time of submitting the
relevant Order Acknowledgement, Laxdale shall inform Scil of
Laxdale’s estimated delivery date for consignments and shall,
subject to Clause 5.2, be obliged to deliver the Units no later
than 6 months following the date of the Order Acknowledgement which
shall be issued by Laxdale within 2(two) weeks of receipt of the
relevant order. Delivery of the Licensed Products shall be made
Ex-Works (Incoterms 2000) from one location within Europe (the
“Delivery Location”) as notified by Laxdale to Scil at
the time of Order Acknowledgement.
5.4
For the avoidance of doubt, at the
end of the first year of this Agreement following the Launch Date
and at the end of each year thereafter the parties may review this
ordering process with a view to modifying or adapting it from time
to time for the benefit of the parties.
6.
Approvals
6.1
Subject to Clauses 6.3 to 6.5 it
shall be Laxdale’s responsibility (at its own cost) to manage
the clinical trials and to obtain regulatory approval of the
Licensed Product in Huntington’s Disease and in this respect
Laxdale shall submit the relevant dossier to EMEA for the purposes
of obtaining Marketing Authorisation in Huntington’s Disease.
For the avoidance of
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doubt, ownership of the results of
all such trials and clinical or other data arising from such
clinical trials shall vest in and remain vested in
Laxdale.
6.2
Laxdale shall be responsible for any
other indications within the Field of Use other than the treatment
of Huntington’s Disease and shall at its sole discretion
prepare and be responsible for the conduct of clinical trials and
at Laxdale’s sole discretion shall be responsible for
securing regulatory approval in the Territory.
6.3
Subject to Clauses 6.1 and 6.2 above
Scil shall be responsible for complying with the laws in the
Territory applicable to marketing, distributing and selling the
Licensed Products pursuant to this Agreement and for paying all
applicable customs duties, taxes and other costs in respect of the
marketing, distribution and sale of the Licensed Products in the
Territory.
6.4
Scil shall be responsible, at its
own cost, for any regulatory matters specific to the Territory, or
any part of it (“Local Regulations”), limited to
obtaining pricing reimbursement or approval with the pricing
authority or other relevant body. Without prejudice to the
foregoing Laxdale shall provide reasonable assistance to Scil free
of charge in gaining approvals under, or otherwise complying with,
the Local Regulations.
6.5
Subject to any Major Improvements
neither party shall at any time nor under any circumstance do
anything (whether directly or indirectly) to interfere with or
prejudice the Orphan Drug Designation of the Licensed Product or
with EMEA’s or any other regulatory body’s approval of
the Licensed Product. Scil shall (at the request of Laxdale from
time to time) do all such acts and things as may be necessary to
assist with maintaining all necessary regulatory approvals of the
Licensed Product with regard to safety aspects thereof. In this
respect, Scil shall promptly provide Laxdale with all information
and data to prepare the periodic safety update reports
(PSUR’s) and other documentation reasonably necessary to be
submitted to EMEA or other regulatory authority from time to
time.
6.6
For the avoidance of doubt,
intentional or negligent failure by either party to comply with any
of the provisions of Clause 6.5 will amount to a material breach of
this Agreement.
7.
Duties of Scil
7.1
Subject to Laxdale complying with
Clause 5.2 and the following provisions of this Clause, Scil shall
be obliged to launch Sales of the Licensed Product in each country
of the Territory by the appropriate Launch Date (as defined).
Failure to so launch shall entitle Laxdale to remove the
appropriate country from the scope of the Territory and the
definition of Territory for the purposes of this Agreement shall be
amended accordingly. For the avoidance of doubt should failure to
launch be directly due to a delay in Scil obtaining pricing
reimbursement caused by acts and/or omissions of the relevant
regulatory authority and not the acts and/or omissions of Scil, the
provisions of this Clause in relation to a removal of a country
from the Territory shall not apply.
7.2
Without prejudice to its obligation
to achieve Minimum Sales and subject to Laxdale complying with the
provisions of Clause 5.2, Scil shall use best endeavours to sell
the Licensed Products in terms of its exclusive appointment under
this Agreement.
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7.3
Scil shall use best endeavours to
enhance the reputation and acceptance of the Licensed Product
amongst customers and prospective customers within the Territory
and in this respect Scil shall jointly agree with Laxdale, after
the Effective Date but prior to the first Launch Date key
promotional messages. Scil shall be consistent in its use of the
agreed messages and shall use them, as appropriate, for all sales
literature, promotional, marketing and other materials in relation
to the Licensed Products. A copy of all sales literature produced
shall be delivered to Laxdale.
7.4
Scil shall refrain from taking any
action that would damage the reputation and sta
