EXHIBIT 10.37.1
"CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE
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BEEN
REDACTED AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION"
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DATE
18 MARCH
2005
PARTIES
(1) INYX PHARMA LIMITED a
company incorporated in England and Wales whose
registered
number is 4573515 and with registered office at 6 Seymour
Court,
Manor Park, Runcorn, Cheshire, WA7 1SY ("INYX"); and
(2) GENERICS [UK] LIMITED a
company incorporated in England and Wales whose
registered
number is 1558756 and with registered office at Station Close,
Potters
Bar, Hertfordshire, EN6 1TL ("GUK").
INTRODUCTION
(A) GUK intends to obtain
Registrations for the Product in the Territory to
enable it
to manufacture, package, market, distribute and sell the
Product
in the
Territory. GUK wishes to appoint INYX as its non-exclusive
manufacturer of the Product.
(B) INYX is willing to assist
GUK in obtaining Registrations and to
manufacture for and exclusively supply GUK with the Product and GUK
is
willing to
purchase the Product on the terms and subject to the conditions
of this
Agreement.
OPERATIVE PROVISIONS
1
Interpretation
1.1 In this Agreement (including
the Introduction and the Schedules), the
following
words and expressions shall, unless the context otherwise
requires,
have the meanings set out opposite them below:
Affiliate
in respect of INYX, shall mean any company which at the
relevant time is the ultimate holding company of that
party or a subsidiary (whether direct or indirect) of
that party's ultimate holding company; a company is a
"subsidiary" of another company, its "holding company",
if that other company (a) holds a majority of the voting
rights in it or (b) is a member of it and has the right
to appoint or remove a majority of its board of
directors,
or (c) is a member of it and controls alone,
pursuant to an agreement with other shareholders or
members, a majority of the voting rights in it, or if it
is a subsidiary of a company which is itself a
subsidiary of that other company;
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in respect of GUK, shall mean the companies set out in
Schedule 1;
Control
means the ability to direct the affairs of another
whether by the ownership of greater than fifty per cent
(50%) of the issued share capital of that other or by
the ability to appoint and maintain a majority of the
executive management board of that other or by contract
or otherwise;
Delivery
Address GUK's premises
at Unit 2 Summit Centre, Summit
Road, Cranborne Industrial Estate, Potters Bar, Herts
EN6 3QW and/or such other premises as GUK may direct;
Device
the devices to be supplied by the Supplier, being (as
the case may be) a pressured metered dose inhaler and a
breath operated metered dose inhaler;
Effective
the date of this Agreement first above written;
Date
Facility
INYX's facility at Astmoor Industrial Site, Runcorn or
such
other facility approved by GUK and used in
connection with the manufacture of the Product;
Intellectual means any
and all rights and interests, vested or
Property
arising out of any patent (including any supplementary
Rights
patent certificates), copyright, design rights (whether
registered or unregistered), trade mark (whether
registered or unregistered), trade secrets, industrial
property rights, rights in data, goodwill or
confidential information whether arising by common law
or by statute, any applications for the same, any
extensions or divisions of the same and/or the right to
apply for registration in respect of the same anywhere
in the world;
MHRA
the Medicines and Healthcare Products Regulatory Agency
of the United Kingdom;
Mutual
the European mutual recognition procedure in relation to
Recognition
Registrations;
Product
Salbutamol Hydrofluoroalkane (HFA) sold in standard
pressurised and/or
breath operated metered dose
inhalation aerosols
And
containing those compounds listed in Schedule 2 in
finished pack form and any improvements thereto
[manufactured and / or sold under GUK's or its
Affiliates' Registration and such other products as the
parties may agree from time to time in writing];
2
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Quarter
any period of three months (or such shorter period as
may be applicable at the commencement or at end of the
Term) ending on the last day of March, June, September
or December (or, in the case of the last Quarter, ending
on the last day of the Term) as the case may be and
"Quarterly" shall be construed accordingly;
Registration the
authorisation necessary to allow GUK (or its
Affiliates) to manufacture, package, market, distribute
and sell the Product in the Territory in accordance with
this Agreement;
Specifications the specifications for
the formulation of the Product in
accordance with any Registrations and any other
specifications agreed by the parties in writing and
listed in Schedule 2;
Technical
a technical agreement as required under EC law and cGMP
Agreement to
be agreed between the parties as part of the
arrangement for ordering initial launch stocks of packed
Product (Schedule 5);
Term
the term of this Agreement as set out in clause 10.1;
Territory
all countries of the world;
Year
each period of twelve months during the Term ending on
31 December provided that the first Year shall be the
period commencing on the Effective Date and ending on
the immediately subsequent 31 December and the last Year
shall be the period ending on the last day of the Term
and commencing on the immediately preceding I January.
1.2 In this Agreement:
(a)
references to
clauses, Schedules and the parties are to clauses of,
and the
Schedules and parties to, this Agreement;
(b)
headings and
captions are for ease of reference only and shall not
affect the interpretation of this Agreement; and
(c)
references to
GUK's rights (including its right to acquire the
Product) under this Agreement shall be construed to include its
Affiliates; for the avoidance of doubt losses suffered by any
Affiliates pursuant to breach by INYX shall be treated as
losses
suffered directly by GUK and recoverable accordingly.
3
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2 Appointment
2.1 Subject to the remaining
terms of this Agreement, GUK appoints INYX as its
non-exclusive manufacturer of the Product in the Territory.
2.2 INYX agrees at all times to
manufacture and supply Product (where Product
is
manufactured by INYX under GUK's Registrations) only for GUK
2.3 GUK shall be free to
purchase Product from third parties (or manufacture
such
Product itself), provided that 52% of GUK's annual requirement
for
the
Product is purchased from INyX.
3 Registration
3.1 GUK shall, at its cost, make
applications for Registration in such
countries
within the Territory as it deems appropriate. It is
acknowledged
that GUK
shall be entitled to take advantage of Mutual Recognition where
appropriate.
3.2 To enable GUK to apply for
Registrations as soon as possible after the
Effective
Date, INYX agrees to provide GUK in a timely manner, with all
the
assistance it reasonably requires from time to time to make the
applications for Registrations and as GUK reasonably requires
thereafter.
In
particular INYX shall, or shall procure that others, regularly
monitor
all
supplies of Product (including Devices and components therefor and
all
ingredients (active and inactive) and compounds with which the
Device is
to be
filled) and to ensure that these are supplied within
Specifications
set by
GUK. INYX will operate only from manufacturing facilities
approved
(or to be
approved prior to production) by an appropriate regulatory
authority
and by GUK.
3.3 All Registrations and
Intellectual Property associated with registrations
obtained
by GUK shall remain the exclusive property of GUK. INYX shall
have the
right to use without limitations all improvements to the
manufacturing process.
4 Manufacture and
Supply
4.1 The Product shall be
manufactured by INYX at the Facility.
4.2 The Product shall be
manufactured by INYX in accordance with the
Specifications and subject to current standards of good
manufacturing
practice
as published from time to time by the relevant authorities in
the
Territory
in relation to medicinal products.
4.3 GUK shall be entitled, at
any time during the Term and without materially
disrupting
the business of INYX, to have access to the Facility during
normal
working hours and on reasonable prior written notice, in order
to
verify
that INYX is adhering to its obligations under this Agreement.
If
GUK is not
reasonably satisfied that INYX is complying with such
obligations then (without prejudice to its other rights) it shall
notify
INYX in
writing of any changes or modifications it reasonably requires
which INYX
shall implement as soon as practically possible.
4.4 The parties recognize that
certain items of equipment (Schedule 4) used by
INYX
belong to GUK. GUK shall (where it elects to purchase Product
from
another,
or manufacture or have manufactured, Product, and in any event,
upon
termination) be entitled to collect such equipment immediately
and
INYX shall
co-operate fully with GUK in this regard. For so long as the
equipment
is used by INYX, INYX shall properly use and maintain the
equipment,
keep the equipment in good repair and condition and obtain
insurance
therefor (for the full replacement cost). All risk of loss or
damage to
the equipment shall be for INYX for so long as it is using the
equipment.
4
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5 Forecasts and
Deliveries
5.1 INYX agrees to maintain
levels of intermediate buffer stocks (filled,
unlabelled
cans) of the Product in such quantities as the parties may
agree from
time to time and INYX shall invoice GUK upon transfer to bulk
stock at
70.0% of the price as agreed in terms of Clause 7.1 GUK shall
provide
INYX on a quarterly basis with non-binding Quarterly rolling
forecasts
of GUK's and its Affiliates (and third party distributors)
likely
requirements of Product for the subsequent 12 month period and
to
place firm
orders for the Packed Product not less than two months before
the
desired delivery date.
5.2 Despatch shall be made by
INYX such as to ensure that deliveries are made
during
GUK's normal business hours.
5.3 Risk in the Product shall
pass to GUK on despatch to the Delivery Address
and title shall pass on
payment in full by GUK.
5.4 Each consignment of the
Product ordered by GUK shall be delivered in full
by the due
date, subject to any changes agreed between the Parties in
writing.
5.5 INYX will despatch the
Product to GUK, ex-works Runcorn (as that term is
defined
Incoterms 1990 Edition), to the Delivery Address on or before
the
date
stipulated in the relevant order.
5.6 Each delivery or consignment
of the Product shall include a packing note
quoting or attaching:
(a)
the batch number
and order number;
(b)
product
documentation should be defined!; and
(c)
a certificate of
analysis
as more
particularly described in the Technical Agreement.
5.7 Time is of the essence in
the delivery by INYX of the Product. If delivery
dates for
the Product cannot be met, INYX shall (without prejudice to
GUK's
rights in respect of such breach) promptly notify GUK of the
earliest
possible date for delivery of the Product. INYX will report
immediately to GUK the occurrence of any event within or beyond
its
control
which is likely to affect delivery of the Product.
5.8 WHERE INYX CANNOT FULFIL
GUK'S ORDER(S) FOR PRODUCT (IN THE QUANTITIES AND
TIME-SCALES SET OUT IN SUCH ORDER(S) FOR ANY REASON, GUK SHALL BE
ENTITLED
WITHOUT
LIABILITY TO CANCEL ALL OR ANY PART
