Exhibit 10.24
SUPPLY AGREEMENT
by and between
AstraZeneca AB
and
INyX Pharma Ltd
DATE: 11 June 2004
TABLE OF CONTENTS
1. Definitions..............................................................1
2. Construction.............................................................4
3. Amendment................................................................4
4. Supply of Products.......................................................4
5. Forecasting..............................................................4
6. Orders...................................................................5
7. Delivery and Title.......................................................5
8. Delay in Delivery........................................................6
9. Price....................................................................6
10. Invoicing and Pavment....................................................6
11. Continuous Improvements..................................................7
12. Shortfalls, Damages & Defects............................................7
13. Quality, Manufacturing and Storage.......................................8
14. Product Recall...........................................................8
15. Responsibilities For Scrapped/Wasted Materials...........................9
16. Printed Packaging and Artwork............................................9
17. Ownership and Use........................................................9
18. Legal and Regulatory Requirements.......................................10
19. Corporate Responsibility................................................10
20. Additional Representations and Warranties...............................10
21. Force Majeure...........................................................11
22. Term and Termination....................................................12
23. Tech Transfer to AstraZeneca or a Second Supplier.......................14
24. Most Favoured Customer..................................................15
25. Confidentiality.........................................................15
26. Improvements............................................................16
27. Insurance...............................................................16
28. Use of Name.............................................................17
29. Notices.................................................................17
30. Relationship of the Parties.............................................17
31. Assignment..............................................................17
32. Expenses................................................................18
33. Waiver and Non-Exclusion of Remedies....................................18
34. Severability............................................................18
35. Governing Law and Disputes..............................................18
36. Counterparts............................................................19
37. Execution...............................................................19
EXHIBIT 1 Product, Product Requirements and Price
EXHIBIT 2 Logistic Arrangement
EXHIBIT 3 Contact People
EXHIBIT 4 Quality Assurance Agreement
EXHIBIT 5 AstraZeneca Property
EXHIBIT 6 General Work Flow For The Artwork Process
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SUPPLY AGREEMENT
This Supply Agreement (the "Agreement") is made on 11 June 2004 ("Effective
Date") by and between
(1) AstraZeneca AB, a company incorporated in Sweden under no. 556011-7482
with offices at ▇-▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ("AstraZeneca"); and
(2) INyX Pharma Ltd, a company incorporated in the United Kingdom under no.
4573515 with offices at ▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇,
▇▇, ▇▇▇ ▇▇▇ ("Inyx")
Recitals
--------
(A) WHEREAS, AstraZeneca intends to outsource the manufacturing,
testing and release of Product (as defined herein).
(B) WHEREAS, Inyx has the ability and desire to manufacture, test
release and supply the Product.
(C) WHEREAS, the Parties have agreed to enter into this Agreement
to set forth the general terms and conditions on which the
supply and additional service of the Product will be carried
out.
Agreement
---------
NOW, THEREFORE, in consideration of the mutual covenants contained in this
Agreement, and other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Parties, intending to be
legally bound, agree as follows:
1. Definitions
-----------
Unless otherwise specifically provided in this Agreement, the following terms
shall have the following meanings:
1.1 "Affiliates" means, with respect to a Person, any Person that controls,
is controlled by or is under common control with such first Person. For
purposes of this definition only, "control" means (a) to possess,
directly or indirectly, the power to direct the management or policies
of a Person, whether through ownership of voting securities, by
contract relating to voting rights or corporate governance or
otherwise, or (b) to own, directly or indirectly, fifty percent (50%)
or more of the outstanding voting securities or other ownership
interest of such Person.
1.2 "Applicable Laws and Regulations" with respect to the Product, has the
meaning defined in the Quality Assurance Agreement and the Product
Requirements.
1.3 "AstraZeneca Information" means all confidential data and information
related to or comprised in Intellectual Property Rights and Know-How,
as well as other information in relation to AstraZeneca's general
business operations, the Product or its manufacture, which is owned by
AstraZeneca or which is in its possession and which AstraZeneca is
entitled to disclose.
1.4 "AstraZeneca Property" means the property owned by AstraZeneca at Inyx'
facilities set out in Exhibit 5, AstraZeneca Property.
1.5 "Change of Control" with respect to any Person, means an event in
which:
(a) any other Person or group of Persons, except Affiliates of
Inyx, acquires beneficial ownership of securities of such
first Person representing more than fifty percent (50%) of the
voting power of the then outstanding securities of such first
Person with respect to the election of directors of such first
Person; or
(b) such Person enters into a merger, consolidation or similar
transaction with another Person in which such first Person is
not the surviving entity in such transaction.
1.6 "Confidential Information" means all AstraZeneca Information or all
Inyx Information, as the context may require, disclosed by or on behalf
of the relevant Party to the other Party pursuant to this Agreement in
written, oral or any other form.
1.7 "Disclosing Party" means the Party disclosing Confidential Information.
1.8 "Price Review Date" means the date on which the then current Price for
a Product will be reviewed as specified in Exhibit 1.
1.9 "Fixed Price Term" means a term for which the Price will remain fixed
as specified in Exhibit 1.
1.10 "Force Majeure Party" means a Party prevented or delayed in its
performance under this Agreement by an event of Force Majeure.
1.11 "Force Majeure" has the meaning defined in the Force Majeure Section.
1.12 "Forecast" has the meaning set forth in Section 5.1.
1.13 "Improvement" means any invention, discovery, upgrading or modification
and all other Intellectual Property Rights (whether patentable or not);
for the Product it shall include any new indication, dosage forms,
formulations or delivery systems.
1.14 "Intellectual Property Rights" means confidential know-how, trade
secrets, patent rights, trade marks, service marks, trade names, design
rights, copyright (including rights in computer software) and any
rights or property similar to any of the foregoing in any part of the
world, whether registered or not, together with the right to apply for
the registration of any such rights, and all rights or forms of
protection having equivalent or similar effect, in any part of the
world.
1.15 "Invoice Currency" means the currency in which the Product will be
invoiced and paid.
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1.16 "Inyx Information" means all confidential data and information related
to or comprised in Intellectual Property Rights and know-how, as well
as other information in relation to Inyx's general business operations
and manufacturing processes, which is owned by Inyx or which is in its
possession and which it is entitled to disclose.
1.17 "Know-How" means (i) all technical information or data relating to the
Products, whether protected by Intellectual Property Rights or not,
including but not limited to technology, processes, specifications,
formulas, procedures, techniques, practices and instructions of, and
scientific, analytical and technical data and studies for, the
synthesis, manufacturing, pharmaceutical processing, formulation,
packaging, labeling storage and transportation of the Products; and
(ii) non-clinical and clinical data and studies relating to the
Products.
1.18 "Lead-Time" means the time from AstraZeneca placing of a purchase order
or a notification requesting delivery under a frame purchase order, as
the case may be, until delivery of Products.
1.19 "Manufacturing Process" means any process (or step in any process,
including packaging, quality control and quality assurance) used or
planned to be used by Inyx (or any of its permitted Affiliates or
subcontractors) for manufacturing the Product.
1.20 "Parties" means AstraZeneca and Inyx and "Party" means either
AstraZeneca or Inyx, as the context requires.
1.21 "Person" means an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust,
incorporated association, joint venture or similar entity or
organization, including a government or political subdivision,
department or agency of a government.
1.22 "Price" means the amount payable from time to time for such Product, as
determined in accordance with the terms hereof.
1.23 "Product" means the finished product to be supplied pursuant to this
Agreement.
1.24 "Product Requirements" means the specifications and requirements for
the Product as specified in an appendix to the QAA and referred to in
Exhibit 1 of this Agreement as the same may be updated from time to
time in accordance with the QAA and the regulatory approved artwork.
1.25 "Product Item" means the smallest unit of Products that can be
purchased by AstraZeneca or its Affiliates and identified by an item
number.
1.26 "Quality Assurance Agreement" or "QAA" means the quality assurance
agreement entered into by the Parties, a copy of which is attached
hereto as Exhibit 4, as the same shall be amended from time to time
1.27 "Receiving Party" means the Party to whom Confidential Information is
disclosed.
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1.28 "Term" means the period beginning on the Effective Date and continuing
until the date upon which this Agreement is terminated in accordance
with Article 22.
2. Construction
------------
2.1 Except where the context requires otherwise, whenever used the singular
includes the plural, the plural includes the singular, the use of any
gender is applicable to all genders and the word "or" has the inclusive
meaning represented by the phrase "and/or". The headings of this
Agreement are for convenience of reference only. The term "including"
or "includes" as used in this Agreement means including, without
limiting the generality of any description preceding such term. The
wording of this Agreement shall be deemed to be the wording mutually
chosen by the Parties and no rule of strict construction shall be
applied against any Party.
2.2 The Exhibits (as amended from time to time by agreement of the Parties
in writing) form part of this Agreement and have the same force and
effect as if expressly set out in the body of the Agreement. Any
reference to the Agreement includes the Exhibits. Any breach of the
Exhibits shall be deemed a breach of this Agreement.
2.3 Save for as set out in Section 13.1, if there is any inconsistency
between the Exhibits and this Agreement, the terms and conditions of
this Agreement shall govern and any inconsistency between the Exhibits,
the Exhibits will take precedence in the order they appear.
3. Amendment
3.1 Any amendment or modification of this Agreement must be in writing and
signed by authorized representatives of both Parties.
4. Supply of Products
4.1 Inyx agrees to manufacture, package, test, release and deliver and
manage stock for the Products under this Supply Agreement exclusively
for AstraZeneca or its Affiliates.
4.2 In addition, Inyx shall perform post marketing stability tests to a
mutually agreed cost and format.
5. Forecasting
-----------
5.1 Forecast: AstraZeneca shall each calendar quarter provide Inyx with a
non-binding forecast for AstraZeneca and its Affiliates requirements of
Products during the following twelve (12) month period ("Forecast").
The Forecast submitted in October each year shall however cover fifteen
(15) months.
5.2 Inyx shall without delay notify AstraZeneca if Inyx does not have the
capacity to deliver Products in accordance with the Forecast.
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6. Orders
------
6.1 Purchase order: AstraZeneca shall place a firm purchase order for each
requested Product to Inyx with a Lead-Time of twenty six (26) weeks.
6.2 AstraZeneca may at its option place frame purchase order for one (1)
year of supply of Products and will in such case notify Inyx on
requested delivery dates. The Lead-Time will in such case be sixteen
(16) weeks from such notification.
6.3 Order confirmation: Inyx shall confirm the purchase orders and the
delivery date within two (2) weeks from the receipt of the purchase
order.
6.4 Time is of essence to this Agreement.
6.5 The delivery performance as to mutually agreed measurement criteria is
to be followed up by Inyx each month and reported to AstraZeneca as
inputs to the Operation Planning Meetings (see below).
6.6 Communication: Any deviation from the delivery plan is to be
communicated to AstraZeneca as soon as possible in order to enable
AstraZeneca to take necessary action to minimize any negative effects
in the market.
6.7 Communication on market changes: AstraZeneca shall inform Inyx of any
major changes in the market or other information, which may have impact
on sales and therefore the supply of Products under this Agreement.
6.8 Operation Planning Meetings shall be held quarterly unless otherwise
agreed upon between the Parties. The agenda shall comprise: (a)
performance report; (b) market intelligence; (c) supply capability; (d)
possible capacity problems and prioritisations; (e) forward planning
including changes, withdrawals. AstraZeneca shall initiate such
meetings.
7. Delivery and Title
------------------
7.1 Inyx shall deliver and supply each Product ordered by AstraZeneca in
accordance with the term Ex Works Runcorn (Incoterms 2000).
7.2 The risk and title to the Products shall pass to AstraZeneca upon
delivery according to the delivery Incoterm in Section 7.1.
7.3 In the event of a delay by AstraZeneca to collect the Products, Inyx
shall have responsibility for ensuring that the Products are stored and
maintained in accordance with the QAA until AstraZeneca has collected
such Products. AstraZeneca shall remunerate Inyx for any direct costs
associated by AstraZeneca's delay to collect Products.
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8. Delay in Delivery
-----------------
8.1 In the event that Inyx discovers that the delivery date cannot be met,
Inyx shall immediately notify AstraZeneca in writing stating the cause
of the delay and present a revised date for delivery or schedule for
delayed deliveries. Inyx shall use commercially best efforts to reduce
such delay. Inyx shall notify AstraZeneca of any delay of the day of
dispatching within five working days.
8.1.1 In case of a delay of delivery, which is due to Inyx or to
circumstances for which Inyx is directly responsible,
AstraZeneca is entitled to liquidated damages. The liquidated
damages shall be payable at a rate of one percent (1%) of the
Price of the Products in delay (the Price in the relevant
purchase order) per completed week of delay up to a maximum of
eight percent (8%) of such Price.
8.1.2 Claims by AstraZeneca for liquidated damages shall not operate
a waiver of any rights to cancel a delayed delivery or any
other rights under this Agreement.
8.2 Inyx is responsible for any delay in transportation or in customs
control due to deficiencies in the documentation supporting the
delivery of Products delivered under this Agreement.
9. Price
-----
9.1 The Price of the Product is specified in Exhibit 1. The Price is
exclusive of Value Added Tax, which, if payable, shall be borne and
paid by AstraZeneca against the provision by Inyx of an appropriate VAT
invoice.
9.2 The Price at the time of signing will remain fixed for the Fixed Price
Term. On the Price Review Date and on each anniversary of such Price
Review Date, the Parties will adjust the Price after agreement. The
Parties shall in such review take into account price review parameters
set out in Exhibit 1.
9.3 If the Parties fail to agree on a revised Price prior to the
commencement of the new Fixed Price Term, then the Price shall be set
according to the price review formula set out in Exhibit 1.
10. Invoicing and Payment
---------------------
10.1 Inyx shall issue an invoice to AstraZeneca for the applicable Price for
all Products delivered to AstraZeneca. The invoice shall contain a
reference identifying the AstraZeneca's purchase order as well as the
relevant AstraZeneca Product article number identifying the Product.
10.2 AstraZeneca shall pay all invoices in full within thirty (30) days from
receipt of the relevant invoice and certificates for the Products,
whichever is later, to Inyx as detailed in Exhibit 2 or Product
Requirements; provided, however, that if AstraZeneca rejects any
Products pursuant to Section 12.1, then payment shall be due within
thirty (30) days of 11 June 2004 receipt by AstraZeneca of (i) notice
from the independent expert (as described in Section 12.4) that the
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Products are conforming or (ii) conforming Products in replacement of
any Non-Conforming Products (as defined herein) or otherwise, as the
case may be.
11. Continuous Improvements
-----------------------
11.1 Inyx shall continuously use its best commercial efforts to make
improvements in purchasing prices of raw material and other materials
as well as in its Manufacturing Process of Product in order to decrease
the Price. After Inyx' recovery of its expenses or write-offs of any
investment made, any cost reduction shall be split between the parties
on a 50/50 basis.
11.2 Any changes in the Manufacturing Process with an impact on the
Chemistry, Manufacturing and Control documentation shall be subject to
AstraZeneca's prior written approval and change control system set out
in the Quality Assurance Agreement.
12. Shortfalls, Damages & Defects
-----------------------------
12.1 If any shipment of Product delivered by Inyx contains any damage,
shortage or defect of the Product, AstraZeneca shall notify Inyx (a)
within sixty (60) days of receipt of such shipment if such damage,
shortage or defect can be ascertained by the exercise of reasonable
diligence upon examination by AstraZeneca on receipt of such shipment,
or (b) within sixty (60) days after discovery of the same if such
damage, shortage or defect cannot be ascertained by the exercise of
reasonable diligence upon examination by AstraZeneca on receipt of such
shipment (including non-conformities relating to stability).
12.2 If there is any defect in or damage to any Product delivered by Inyx or
documentation (collectively, "Non-Conforming Product"), Inyx shall at
AstraZeneca's option without any undue delay either:
12.2.1 replace the Non-Conforming Product with conforming Product, at
Inyx's expense; or
12.2.2 refund to AstraZeneca the cost paid to Inyx by AstraZeneca for
such Non-Conforming Product, or, if the invoice has not been
paid, cancel the invoice; and
12.2.3 in either case, compensate AstraZeneca for any direct costs
incurred as a result of the delivery of Non-Conforming Product
and costs for removal or disposal of Non-Conforming Product.
12.3 If there is any shortfall in any shipment of Product delivered, as
against the relevant order placed by AstraZeneca, Inyx shall at
AstraZeneca's option without any undue delay either:
12.3.1 deliver the quantity of shorted Product to AstraZeneca, at
Inyx's cost; or
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12.3.2 credit or refund AstraZeneca, at AstraZeneca's discretion, for
the amount of shortfall; and
12.3.3 in either case, compensate AstraZeneca for any direct costs
incurred as a result of such shortfall.
12.4 If a dispute arises between the Parties as to any claimed damage or
defect in the Product or shortage of Products delivered, which cannot
be resolved by the Parties within thirty (30) days of a claim being
notified by AstraZeneca to Inyx, either Party may require that the
matter in dispute be referred to an independent expert (such as an
independent testing laboratory) selected by agreement of the Parties
or, failing agreement, appointed by the Stockholm Chamber of Commerce,
at the instigation of either Party. Such referral will be solely for
the purpose of establishing whether or not there is any shortage,
damage or defect (as the case may be) in the Product delivered by Inyx
to AstraZeneca. Except in the case of fraud or manifest error on the
part of such independent expert, the decision of such independent
expert will be binding upon the Parties. If the independent expert
decides there was no shortage, damage or defect in the Product in
question, the costs of the independent expert will be borne by
AstraZeneca. In all other circumstances, the costs of the independent
expert will be borne by Inyx.
12.5 The remedies set forth in this Article 12 shall be in addition to any
other rights that AstraZeneca or Inyx may have hereunder or at law as
specified in this Agreement.
13. Quality, Manufacturing and Storage
----------------------------------
13.1 In manufacturing, testing, storing, releasing and delivering (according
to the agreed Incoterm) Product to AstraZeneca, Inyx shall comply with
all of the provisions and requirements of the Quality Assurance
Agreement and the Product Requirements. Any breach of the Quality
Assurance Agreement or the Product Requirements shall be deemed a
breach of this Agreement as set out in Section 2.2 In the event of a
discrepancy between the Quality Assurance Agreement and this Agreement,
the terms of the Quality Assurance Agreement shall control.
13.2 Inyx and AstraZeneca agree to cooperate in attempting to resolve all
product quality complaints as set out in the Quality Assurance
Agreement.
14. Product Recall
--------------
AstraZeneca shall have sole discretion over whether and under what
circumstances to require the recall of a batch of Product. In the event
that a recall of a batch of Product from sale is necessary as a result
of the willful misconduct or negligence of Inyx, Inyx shall be
responsible for all costs relating thereto. In the event that a recall
is necessary for reasons in addition to the willful misconduct or
negligence of Inyx, then Inyx and AstraZeneca shall be responsible for
a proportionate share of such costs, to be agreed between the Parties.
Subject to the above, AstraZeneca shall bear the costs of any recall in
any other circumstances.
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15. Responsibilities For Scrapped/Wasted Materials
----------------------------------------------
15.1 Inyx shall base the planning and purchasing of raw materials/packaging
components upon purchase orders issued by AstraZeneca.
15.2 If Inyx initiates any change in raw materials/packaging components, as
set out in the QAA between the parties, Inyx shall take all costs
associated with such change, including for scrapped/wasted materials.
15.3 If AstraZeneca initiates a change in raw materials/packaging components
or terminate/withdraw a Product from the market the Parties shall in
good faith plan for the termination in order to minimize Inyx's cost of
waste. AstraZeneca shall take such costs associated therewith,
including for scrapped/wasted materials, at the maximum six (6) months
of need of the stock of raw material/packaging components from the date
of notice of such change or termination/withdraw of Product.
15.4 Products and waste material from Inyx's manufacture of the Product,
which carries the AstraZeneca name or logo or a product name or similar
(below jointly referred to as "Waste") shall be destroyed by Inyx as
soon as possible (without jeopardizing supply) and such destruction
shall be confirmed to AstraZeneca. Until destruction has taken place
the Waste shall be stored and handled in a manner preventing
unauthorized access and possible misuse.
16. Printed Packaging and Artwork
-----------------------------
16.1 Inyx shall be responsible for the handling of artwork on the printed
packaging, in agreement with each Affiliate of AstraZeneca.
16.2 Any change to the artwork shall be initiated by either Party via a
Packaging Administration Form (PAF) or similar and be work processed as
set out in Exhibit 6, General Work Flow for the Artwork Process.
16.3 The costs relating to changes in the artwork are allocated as set out
in Article 15.
17. Ownership and Use
-----------------
17.1 AstraZeneca is the owner of the AstraZeneca Property, including all
drawings (in paper or electronically), including any subsequent
modifications and improvements, and has full right and title thereto.
17.2 The AstraZeneca Property may only be utilized for the sole purpose of
supply of Products to AstraZeneca or its Affiliates.
17.3 Inyx shall provide standard routine maintenance of the AstraZeneca
Property and property purchased by Inyx and used in production of
Products, (if software such as drawings and other related documents
that are stating changes) at the cost of Inyx as required to secure
uninterrupted Product supply. Inyx will perform any other maintenance
or upgrade requested by AstraZeneca at AstraZeneca's expense.
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17.4 AstraZeneca will ensure that all AstraZeneca Property is adequately
covered by appropriate insurance to its full reinstatement value in
case of damages to it outside the control of Inyx. Inyx will ensure
that all AstraZeneca Property and property purchased by Inyx and used
in production of Products is adequately covered by appropriate
insurance to its replacement value to the extent not covered by
AstraZeneca's insurance.
17.5 Inyx will ensure that all AstraZeneca Property owned by AstraZeneca is
clearly marked as such and shall be tagged with an Inyx' identification
number and listed accordingly in Inyx' asset register.
17.6 The condition of AstraZeneca Property shall be reviewed at regular
intervals. In addition, Inyx shall on an annual basis in connection
with the annual price review provide AstraZeneca with an estimate of
usage and forecasts for routine refurbishment, if any, required in the
following twelve (12) months on AstraZeneca Property.
17.7 In the case of termination of this Agreement for any reason, the
Parties shall in good faith negotiate any acquisition by Inyx of any
AstraZeneca Property.
18. Legal and Regulatory Requirements
---------------------------------
18.1 Inyx shall comply with all relevant and applicable local, national, and
international legal requirements ("Applicable Laws") and any other
relevant requirements applicable in respect of the manufacture,
handling, transport and storage of the Product at all times.
19. Corporate Responsibility
------------------------
19.1 AstraZeneca does business with parties conducting in a manner
consistent with AstraZeneca's policies concerning "Corporate
Responsibility" (as in effect from time to time). AstraZeneca shall
provide Inyx with the latest edition of this policy.
19.2 Inyx represents and warrants that Inyx will perform this Agreement in
material compliance with all applicable laws and regulations,
including, without limitations, laws and regulations relating to
Safety, Health and Environment (SHE) relating to the Products and the
raw materials used in connection therewith and relating to fair labor
practices and unlawful discrimination.
19.3 AstraZeneca and Inyx shall, as soon as practicable upon commencement of
the services, meet to discuss the performance of services and sharing
of best practices in order to find opportunities for continuous
improvements in Corporate Responsibility objectives in the context of
this Agreement.
20. Additional Representations and Warranties
-----------------------------------------
20.1 Inyx represents and warrants, to the best of its knowledge, to
AstraZeneca that:
20.1.1 Inyx is the lawful owner, lessee or licensee of all plant,
equipment, machinery, Intellectual Property Rights and
know-how, as well as all permissions required, to enable Inyx
to perform its obligations under this Agreement;
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20.1.2 the performance by Inyx of its obligations to AstraZeneca
under this Agreement will not breach or be in conflict with
any covenant or obligation of Inyx to any third party, and
will not infringe any rights of any third party;
20.1.3 Inyx will inform AstraZeneca promptly in writing of any event,
which in the reasonable judgment of Inyx may adversely affect
(i) Inyx's ability to manufacture or supply the Products or
(ii) the suitability of the Products for AstraZeneca's use;
and
20.1.4 at the time of delivery of each Product to AstraZeneca, (i)
such Product will have been manufactured, handled, stored and
transported in accordance with all Applicable Laws and
applicable regulations and (ii) such Product will have been
manufactured in accordance, and be in conformity, with the
Product Requirements and the Quality Assurance Agreement and
will conform with the certificates provided pursuant to the
Quality Assurance Agreement.
21. Force Majeure
-------------
21.1 Subject to Section 21.3, a Party's obligations under this Agreement
will be suspended to the extent and for the duration that its
performance is delayed, hindered or prevented by circumstances which
are not within its reasonable control ("Force Majeure").
21.2 For the purposes of this Section, Force Majeure includes acts or
restraints of governments or public authorities, war, revolution, riot
or civil commotion, strikes, lock-outs (except relating to a Party's
own employees), blockage or embargo, explosion, fire, flood or natural
disaster, to the extent that any of these events are beyond the
reasonable control of the affected Party.
21.3 A Party affected by any event of Force Majeure shall:
21.3.1 promptly in writing notify the other Party, explaining the
nature, details and expected duration of such event. Such
Party shall also notify the other Party from time to time as
to when the affected Party reasonably expects to resume
performance in whole or in part of its obligations hereunder,
and notify the other Party of the cessation of any such event;
and
21.3.2 use its commercially best efforts to resume full performance
of its obligations under this Agreement as soon as reasonably
practical; and
21.3.3 pending such resumption, use its commercially best efforts to
facilitate any efforts that the other Party may make to
procure an alternative method by which its obligations under
this Agreement may be performed.
21.4 If a Party anticipates that an event of Force Majeure may occur, such
Party shall notify the other Party of the nature, details and expected
duration of such event.
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21.5 If, as a result of Force Majeure, Inyx is unable to manufacture or
supply the full amount of Product ordered by AstraZeneca or which
AstraZeneca would have ordered but for such circumstances, then:
21.5.1 AstraZeneca shall purchase the amount of Products Inyx is able
to supply, but at the Price which would have applied had Inyx
been able to manufacture and supply and had AstraZeneca
purchased the quantities actually required by AstraZeneca, and
the amount AstraZeneca would have ordered but for such Force
Majeure shall be taken into account when calculating any
volume discount as if AstraZeneca had purchased the full
amount from Inyx; and
21.5.2 if such circumstances continue or are forecast to continue for
more than three (3) months, Inyx shall use all reasonable
efforts to offer to AstraZeneca alternative capacity or supply
for Product (at prices and on terms to be agreed) which can be
operable within a further three (3) months, to standards
compliant with the Quality Assurance Agreement; and
21.5.3 Inyx shall allocate all available capacity of Product produced
by Inyx as between AstraZeneca and other customers of Inyx
proportionally in accordance with the amount of Product and
other products supplied to AstraZeneca and other customers
during the twelve (12) months prior to such Force Majeure.
21.6 If, as a result of Force Majeure, AstraZeneca is unable to take or use
the Product which has been ordered, or which would have been ordered
but for AstraZeneca's inability to take or use the Product, AstraZeneca
will only be obliged to purchase such Products under purchase orders it
has placed for the Product.
21.7 If a Force Majeure prevails for a continuous period in excess of three
(3) months, the Party which is to be notified of such circumstances in
accordance with Section 21.3.1 may terminate this Agreement by giving
written notice of termination with immediate effect to the Force
Majeure Party.
22. Term and Termination
--------------------
22.1 This Agreement shall be effective during the Term.
22.2 Either Party may terminate this Agreement without cause by giving the
other party twelve (12) months prior written notice, provided however,
that such notice of termination may not be given during the initial
thirty (30) months of the Term.
22.3 This Agreement will automatically terminate in case the Parties have
not executed a formal QAA by the latest on the 1 September 2004, unless
otherwise agreed in Such QAA shall be appended to this Agreement as
Exhibit 4.
22.4 Notwithstanding Section 22.2, if the tech transfer, validation of
commercial batches or QA inspections by regulatory authorities in
connection therewith are delayed more than sixty (60) days or do not
pass successfully in AstraZeneca's qualified opinion, then this
Agreement may be terminated immediately upon written notice from
AstraZeneca.
12
22.5 Termination by Either Party. In addition to any other provision of this
Agreement expressly providing for termination of this Agreement, this
Agreement may be terminated immediately by either Party upon notice to
the other Party:
22.5.1 in the event of a breach of this Agreement by the other Party,
where such breach is capable of cure and such breach remains
uncured and has not commenced to be cured for twenty (20) days
after notice of such breach and the breach is still not cured
within a reasonable time - such reasonable time shall be set
in relation to the particular circumstances of the relevant
breach - but in no event will the reasonable time last longer
than hundred and eighty (180) days after notice of such
breach;
22.5.2 in the event of a material breach of this Agreement by the
other Party where such breach is not capable of cure;
22.5.3 if the other Party shall file in any court or agency, pursuant
to any statute or regulation of any state or country, a
petition in bankruptcy or insolvency or for reorganization or
for an the appointment of a receiver or trustee of such other
Party or of its assets, or if the other Party proposes a
written agreement of composition or extension of its debts, or
if the other Party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, or if
the other Party shall propose or be a party to any dissolution
or liquidation, or if the other Party shall make an assignment
for the benefit of its creditors;
22.5.4 if any encumbrancer takes possession of any material part of
the assets of the other Party;
22.5.5 if any distress, execution or other such process is levied or
enforced upon or against any of the material assets of the
other Party;
22.5.6 if the other Party ceases or threatens to cease to carry on
the whole or substantially the whole of its business or that
part of its business to which this Agreement relates.
22.6 Notwithstanding Section 22.2, if AstraZeneca, including its Affiliates,
decides not to launch the Product for any reason or ceases the
marketing and sale of the Product for any reason, this Agreement may be
terminated immediately upon written notice from AstraZeneca. In case of
such termination, AstraZeneca will compensate Inyx by paying as
follows:
(a) the Price for any stock of the Product not yet released and
delivered to AstraZeneca in volumes which are ordered by
AstraZeneca and confirmed by Inyx to AstraZeneca.
(b) the direct cost for the volumes of Product in progress which
are ordered by AstraZeneca and confirmed by Inyx to
AstraZeneca.
13
(c) Inyx's direct costs for raw materials and other materials in
Inyx's stock at the date of such termination and purchased for
the use in the manufacture of the Product. The compensation
under this sub-paragraph (c) is given provided that:
(i) the volumes of raw materials and other materials are
within AstraZeneca's latest Forecast and for a period
not exceeding three (3) months from the date of
AstraZeneca's notice;
(ii) the raw materials and other materials cannot
reasonably be used for other purposes by Inyx; and
(iii) AstraZeneca is entitled to collect such raw materials
and other materials for its own use or sale, without
additional charge.
22.7 AstraZeneca may terminate this Agreement immediately upon giving notice
to Inyx in the event of a Change of Control of Inyx.
22.8 Without prejudice to any other rights or remedies which either Party
may have, upon the termination of this Agreement each Party shall:
22.8.1 immediately pay to the other Party all undisputed sums which
at the date of termination are due and payable to the other
Party under this Agreement; and
22.8.2 immediately cease all use of any property of the other Party,
including any Intellectual Property Rights of the other Party
under this Agreement; and
22.8.3 within twenty eight (28) days of such termination, at its own
expense, return to the other Party any property of the other
Party in its possession, custody or control, including all
Confidential Information of that Party and copies of it under
this Agreement; provided, however, that a Party may retain one
(1) copy of the other Party's Confidential Information in
order to ensure compliance with its obligations set forth in
this Agreement; and
22.8.4 at AstraZeneca's request and cost, assist AstraZeneca in
finding an alternative supplier and supply all reasonable
assistance and support in transferring the Supply of
Product(s) to such alternative supplier.
22.9 Articles 1, 2, 14, 25 (as set out in 25), 26, 27 (as set out in 27),
29, 34 and 35, and this Section 22.9 will survive expiry or termination
of this Agreement, howsoever the same occurs.
23. Tech Transfer to AstraZeneca or a Second Supplier
-------------------------------------------------
Upon AstraZeneca's request, Inyx shall provide all necessary and useful
technology transfer documentation and know-how for the manufacturing
process, testing, release and delivery of the Product to AstraZeneca or
such second supplier as AstraZeneca designates at cost at AstraZeneca's
expense.
14
24. Most Favored Customer
---------------------
Notwithstanding anything herein to the contrary, if, at any time during the Term
the Price for the Product exceeds the lowest delivery price at which Inyx (or
any of its Affiliates) offers equal quantities of a similar product on similar
terms and comparable quality to any of its other customers, Inyx shall promptly
notify AstraZeneca of that fact and the Price for such Product will be reduced
for all deliveries of the Product after the date of Inyx's notice of that lowest
delivery price, for so long as it continues to apply.
25. Confidentiality
---------------
25.1 Except as otherwise provided in this Agreement, any Confidential
Information which is disclosed by or on behalf of a Disclosing Party to
the Receiving Party will remain the property of the Disclosing Party.
25.2 The Receiving Party undertakes:
25.2.1 to use the Confidential Information solely and exclusively for
the purposes of this Agreement (or such other purpose as is
agreed in writing between the Parties at the time of
disclosure), and not to use the Confidential Information for
any other purpose whatsoever, including the development,
manufacture, marketing, sale or licensing of any process or
product or any other commercial purpose anywhere in the world,
unless the Parties enter into an agreement specifying
otherwise; and
25.2.2 to maintain the confidentiality of the Confidential
Information and not to disclose it directly or indirectly to
any other company, organization, individual or third Person,
except as permitted by Section 25.3.
25.3 Notwithstanding Section 25.2, the Receiving Party may disclose
Confidential Information to any of its Affiliates, and its and its
Affiliate's directors, employees and professional advisers who need to
know the Confidential Information in order to fulfill the purpose of
this Agreement, provided that the Receiving Party procures that prior
to such disclosure, each such Person to whom Confidential Information
is to be disclosed is made aware of the obligations contained in this
Agreement, and adheres to these terms as if it were a party to this
Agreement.
25.4 Nothing in Section 25.2 will preclude disclosure of any Confidential
Information required by any governmental, quasi-governmental or
regulatory agency or authority or court entitled by law to disclosure
of the same, or which is required by law or the requirements of a
national securities exchange or another similar regulatory body to be
disclosed, provided that the Receiving Party promptly notifies the
Disclosing Party when such requirement to disclose has arisen to enable
the Disclosing Party to seek an appropriate protective order, to make
known to the relevant agency, authority, court or securities exchange
the proprietary nature of the Confidential Information, and to make any
applicable claim of confidentiality. The Receiving Party agrees to
co-operate in any action which the Disclosing Party may decide to take.
If the Receiving Party is required to make a disclosure in accordance
with this clause, it will only make a disclosure to the extent to which
it is obliged.
15
25.5 The provisions of Section 25.2 will not apply to any Confidential
Information which the Receiving Party can demonstrate, to the
reasonable satisfaction of the Disclosing Party:
25.5.1 was already in the possession of the Receiving Party or any of
its Affiliates and at the Receiving Party's or any of its
Affiliates' free use and disposal or in the public domain
(through in each case no fault of the Receiving Party or any
of its Affiliates or no breach of this Agreement by the
Receiving Party) prior to its disclosure by the Disclosing
Party under this Agreement; or
25.5.2 is purchased or otherwise legally acquired by the Receiving
Party or any of its Affiliates at any time from a third Person
having and the right to disclose it; or
25.5.3 comes into the public domain, otherwise than through the fault
of the Receiving Party or any of its Affiliates; or
25.5.4 is independently generated by the Receiving Party or any of
its Affiliates without any recourse or reference to the
Confidential Information.
25.6 The obligations of each Party in this Section will survive for a period
of ten (10) years after the date of expiration or termination of this
Agreement.
26. Improvements
------------
26.1 Inyx shall promptly disclose to AstraZeneca details of all Improvements
which Inyx conceives, reduces to practice, develops, discovers or
otherwise makes during the Term relating to the Product, and the
manufacture and supply thereof.
26.2 AstraZeneca will have exclusive ownership of all right, title and
interest in and to any such Improvements relating to the Products and
Inyx shall and does hereby assign to AstraZeneca any and all right,
title or interest of Inyx in or to such Improvements.
26.3 AstraZeneca grants Inyx a non-exclusive, perpetual, irrevocable
worldwide fully paid up license to any Improvements relating to the
manufacture process.
26.4 Inyx shall, upon AstraZeneca's request and at AstraZeneca's expense,
execute all such documents and do all such things as may be necessary
to vest in AstraZeneca the entire right, title and interest to such
Improvements.
26.5 AstraZeneca at all times shall own the AstraZeneca Information. Inyx at
all times shall own the Inyx Information.
27. Insurance
---------
Inyx shall maintain during the Term and for three (3) years thereafter
insurance coverage of the types and in the amounts typically carried by
companies in the pharmaceutical business. Inyx will exhibit to
AstraZeneca upon written request certificates of insurance evidencing
its insurance coverage and limits.
16
28. Use of Name
-----------
28.1 Except as provided under Section 28.2, neither Party may make any
announcement about the transactions contemplated by this Agreement
without the prior written consent of the other Party.
28.2 Each Party shall not mention or otherwise use the name, insignia,
symbol, trademark, trade name or logotype of the other Party or its
Affiliates in any publication, press release, promotional material or
other form of publicity without the prior written consent of the other
Party in each instance. The restrictions imposed by this Article 28
shall not prohibit either Party from making any disclosure identifying
the other Party that is required by applicable law, rule or regulation
or the requirements of a national securities exchange or another
similar regulatory body, provided that any such disclosure shall be
governed by Article 25.
29. Notices
-------
Any notice, request or other communication permitted or required under
this Agreement shall be in writing, shall refer specifically to this
Agreement and shall be deemed given only if hand delivered or sent by
an internationally recognized overnight delivery service, costs
prepaid, or by facsimile (with transmission confirmed), addressed to
the Parties at their respective addresses first set forth above or to
such other address as the Party to whom notice is to be given may have
provided to the other Party in accordance with this Section 29. Such
notice, shall be deemed to have been given as of the date delivered by
hand or transmitted by facsimile (with transmission confirmed), or on
the second business day (at the place of delivery) after deposit with
an internationally recognized overnight delivery service, whichever is
the earlier. Any notice delivered by facsimile shall be confirmed by a
hard copy delivered as soon as practicable thereafter. This Section is
not intended to govern the day-to-day business communications necessary
between the Parties in performing their obligations under the terms of
this Agreement.
30. Relationship of the Parties
---------------------------
30.1 The status of a Party under this Agreement shall be that of an
independent contractor. Nothing contained in this Agreement shall be
construed as creating a partnership, joint venture or agency
relationship between the Parties.
31. Assignment
----------
31.1 This Agreement may not be assigned by either Party in whole or in part
without the prior written consent of the other Party, which consent
shall not be unreasonably withheld, except that AstraZeneca without
such consent may assign this Agreement and its rights and obligations
hereunder to any of its Affiliates or any successor in interest
(whether by merger, acquisition, asset purchase or otherwise) to all or
substantially all of the business to which this Agreement relates.
31.2 AstraZeneca shall always have the right to perform any or all of its
obligations and exercise any or all of its rights under this Agreement
through any of its Affiliates.
17
32. Expenses
--------
Except as otherwise expressly provided in this Agreement, each Party
shall pay the fees and expenses of its respective lawyers and all other
expenses and costs incurred by such Party incidental to the
negotiation, preparation, execution and delivery of this Agreement.
33. Waiver and Non-Exclusion of Remedies
------------------------------------
33.1 A Party's failure to enforce, at any time or for any period of time,
any provision of this Agreement, or to exercise any right or remedy
shall not constitute a waiver of that provision, right or remedy or
prevent such Party from enforcing any or all provisions of this
Agreement and exercising any rights or remedies. To be effective any
waiver must be in writing. Subject to Section 12.4 and the requirement
that the Parties submit to binding arbitration in accordance with
Section 35, all rights and remedies are cumulative and do not exclude
any other right or remedy provided by law or otherwise available.
33.2 The payment of the invoices by AstraZeneca under Section 10.2 will not
operate as any waiver by AstraZeneca any right, power or remedy
provided by law or under this Agreement.
34. Severability
------------
If any provision of this Agreement is held to be invalid, illegal or
unenforceable, in any respect, then, to the fullest extent permitted by
applicable law and if the rights or obligations of any Party will not
be materially and adversely affected: (a) such provision will be given
no effect by the Parties and shall not form part of this Agreement; (b)
all other provisions of this Agreement shall remain in full force and
effect and (c) the Parties will use their best efforts to negotiate a
provision in replacement of the provision held invalid, illegal or
unenforceable that is consistent with applicable law and achieves, as
nearly as possible, the original intention of the Parties. To the
fullest extent permitted by applicable law, the Parties waive any
provision of law that would render any provision in this Agreement
invalid, illegal or unenforceable in any respect.
35. Governing Law and Disputes
--------------------------
35.1 The interpretation and construction of this Agreement shall be governed
by the laws of Sweden excluding any conflicts or choice of law rule or
principle that might otherwise refer construction or interpretation of
this Agreement to the substantive law of another jurisdiction.
35.2 Except as set forth in Section 12.4, any dispute arising out of or
relating to this Agreement shall be settled by binding arbitration in
accordance with the Stockholm Chamber of Commerce's rules of
arbitration. The number of arbitrators shall be three (3), of whom each
Party shall appoint one (1). The two arbitrators so appointed will
select the third and final arbitrator. The place of arbitration shall
be Stockholm in Sweden. The language used in the arbitration
proceedings shall be English. The proceedings, including any outcome,
shall be confidential. Nothing in this Section will preclude any Party
from seeking interim or provisional relief from a court of competent
jurisdiction, including a temporary restraining order, preliminary
18
injunction or other interim equitable relief, concerning a dispute
either prior to or during any arbitration if necessary to protect the
interests of such Party or to preserve the status quo pending the
arbitration proceeding.
35.3 The Parties agree to use best commercial efforts to mutually resolve
any and al outstanding disputes or issues that may arise as a result of
this Agreement.
36. Counterparts
------------
This Agreement is executed in two (2) counterparts, each of which shall
be deemed an original and all of which taken together shall be deemed
to constitute one and the same instrument.
37. Execution
---------
THIS AGREEMENT IS EXECUTED by the authorized representatives of the Parties as
of the date first written above.
SIGNED for and on behalf of SIGNED for and on behalf of
AstraZeneca AB (publ) Inyx Pharma Ltd
s/s ▇. ▇▇▇▇▇▇▇▇▇▇, ▇. ▇▇▇▇▇▇ s/s ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
---------------------------------- ----------------------------------
Signature Signature
Name: K. Johansson, ▇. ▇▇▇▇▇▇ Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title: VP Supply/CFO, LPS Title: President and Director
19
Exhibit 1
---------
PRODUCT, PRODUCT REQUIREMENTS AND PRICE
1. Product
-------
Pulmicort HFA pMDl
2. Product Requirements
--------------------
Art. no..specified in the QAA.
Art. no..specified in the QAA.
3. Price
-----
Product 100g/ dose - 120 doses -GBP One thousand one
hundred thirty seven 809/1000
((pound)1,137.809) per thousand
(1,000) units for.
Product 200g/ dose - 120 doses - GBP One thousand two hundred
eighty eight 9/1000
((pound)1,288.009) per thousand
(1,000) units for.
Product l00g/ dose - 120 doses without secondary packaging and actuator
packaged product) - (bulk drug GBP Eight hundred
ninety eight 809/1000
((pound)898.809) per thousand
(1,000) units.
Product 200g/ dose - 120 doses without secondary packaging and actuator
packaged product) - (bulk drug GBP One thousand
forty nine 009/1000
((pound)1,049.009) per thousand
(1,000) units.
3.1 The Price includes the components specified in the cost break down
below:
------------------------------- --------------- ---------------- ---------------
PRICE PRICE
((pound))/1000 ((pound))/1000
Characteristic & ref. No. Supplier Product Product
------------------------------- --------------- ---------------- ---------------
100g/ dose 200g/ dose
- 120 doses - 120 doses
------------------------------- --------------- ---------------- ---------------
Filling, Function Testing and Inyx 302.000 302.00
primary packaging of Product
------------------------------- --------------- ---------------- ---------------
Budesonide micronized AstraZeneca 150.200 300.400
------------------------------- --------------- ---------------- ---------------
LIGA Mg-sterate, MF-2-V Tracomme AG 0.009 0.009
------------------------------- --------------- ---------------- ---------------
1-1
------------------------------- --------------- ---------------- ---------------
HFA 134a, HFA Zephex 134a Ineos Limited 90.000 90.000
------------------------------- --------------- ---------------- ---------------
Cans: 12 ml, AL, C1148P, Presspart 36.600 36.600
slimline plain base
------------------------------- --------------- ---------------- ---------------
Valves: DF 31/50 RCU, Inyx Dispray 320.000 320.000
10006319
------------------------------- --------------- ---------------- ---------------
TOTAL PRICE BULK DRUG PRODUCT 898.809 1,049.009
-----------------------------
------------------------------- --------------- ---------------- ---------------
Secondary Packaging: Inyx 88.000 88.000
------------------------------- --------------- ---------------- ---------------
Carton and Leaflet: Inyx' Supplier 32.000 32.000
as approved by
AstraZeneca
------------------------------- --------------- ---------------- ---------------
Actuators: 120D AstraZeneca ▇▇▇▇▇ UK 119.000 119.000
Assy 0.6 mm orif/3.2 stem
FP1157
------------------------------- --------------- ---------------- ---------------
TOTAL PRICE PRODUCT 1,137.809 1,288.009
-------------------
------------------------------- --------------- ---------------- ---------------
4. Minimum remaining shelf life
----------------------------
Inyx shall only deliver Products with a remaining shelf life of
eighteen (18) months at the time of delivery.
5. Invoice address
---------------
AstraZeneca AB
AstraZeneca Sweden Operations
Accounts Payable B416
151 85 Sodertalje
Sweden
6. Fixed Price Term
----------------
The Prices shall be fixed and not subject to variation until and
including 31 December 2005. Thereafter the Prices shall be fixed and
not subject to variation for one (1) year terms beginning 1 January
2006.
1-2
7. Price Review Date
-----------------
Either party may initiate the review of the price at the earliest three
(3) months prior to the expiry of the Fixed Price Term.
8. Price Review Parameters
-----------------------
As the basis for the review of the Price, the Parties shall take into
account labor cost, efficiency improvements, material costs, inflation
rate in the UK and other costs, all according to the indices set out in
the Price Revision Formula and the continuous improvements achieved
under Article 11.
9. Price Review Formula
--------------------
L1
--
P = Po (a x L2 + b x M1 + c)
-- -- --
100 Prod M2
where
P = final price for invoicing
Po= price according to Supply Agreement
Ll = index for average earnings (excluding bonuses) based on
average from preceding year prior delivery.
(▇▇▇.▇▇▇▇▇▇▇▇▇▇.▇▇▇.▇▇/▇▇▇/▇▇▇▇▇▇.▇▇▇?▇▇▇▇▇).
L2 = index for average earnings (excluding bonuses) of the base
month. Base month as defined below.
M1 = index for materials based on average from preceding year prior
delivery. Index for Chemicals, calculated out of
Importprisindex (IMPI), 1990=100 after product group
Prod-SNI97
M2 = index for materials for the base month. Base month as defined
below.
Prod = productivity improvement index for labor Prod = 1,05
a = percentage proportion of wages a = 45%
b = percentage proportion of materials b = 45%
c = percentage proportion of other costs, not index reg. C = 10%
Base month is defined as the Month of June 2004.
Example of how the Price Review Formula is applied:
---------------------------------------------------
Assume wages index goes up by 3%
1-3
Assume material costs go up by 4%
Non intended costs 10% (fixed)
-- --
| |
Price = 1,137.809 | 45% x 1.03 + 45% x 1.04 + 10|
--------- | --- |
100 | 1.05 |
| |
-- --
= 1,137.809 (|44.14285 + 46,8 + 10)
---------
100
New Price = (pound)1,148.537
10. Payment details
---------------
Barclays Bank PLC
Barclays Business Centre
PO Box 100, Leeds LS 1 IPA
Account name Inyx Pharma LTD,
Account number: ▇▇▇▇▇▇▇▇
Sort code 20-48-46
1-4
Exhibit 2
LOGISTIC ARRANGEMENTS
Delivery:
The Products shall be delivered Ex Works (Incoterms 2000).
Means of Transport:
By truck.
Transport Requirements:
Products shall always be transported in rigid box trailers under temperature
control. The temperature shall be between +2-+25 degrees Celsius, unless
AstraZeneca provides Inyx with specific written instructions.
Temperature monitor should be used during transportation i.e. from loading on to
truck until and including receipt at AstraZeneca's central warehouse.
AstraZeneca will provide monitors or other temperature trace recorders.
Carrier:
o The goods shall be packed on EUR-pallet (1200 x 800 mm).
o Maximum height for the loading incl. the pallet is 1150 mm.
o The loading shall be fixed with a sheet on the top and shrink wrapped
or stretch banded.
o No overhang outside the EUR-pallets external dimension.
o The goods shall be marked on both shorter sides.
o Part box / Sample box should be clearly marked.
o Only one product and batch on each pallet.
o The pallet shall be dry, clean and undamaged.
Marking:
The carrier shall be marked with a label on both sides of the load.
The following information shall be stated on the label:
- Inyx's name
- AstraZeneca's article number
- AstraZeneca's purchasing order reference
- Lot no.
2-1
- Quantity (sales unit)
- Pallet/package no. referring to the packing list/delivery note
- Market country
Each shipper (carton) shall be marked with its content:
- AstraZeneca article No.
- Lot no.
- Expiry date
- Name of the Product
- No. of units/shipper
- Market country
Forwarding Agent:
Delivery address:
According to Purchase Order by AstraZeneca.
Exchange of Documents:
Documents shall be sent to Distribution & Nordic Supply Point
Forecast/confirmation
Purchase order/confirmation
Delivery plan/confirmation
Deviation report when necessary
Shipping advice
Shipping advice:
The shipping advice shall be sent by mail or fax to AstraZeneca at the latest
the same day as the Products are shipped from lynx. The advice shall contain the
same information regarding the actual shipment as the delivery note.
Delivery note/Packing list:
Delivery note/Packing list shall always be included in the delivery and clearly
marked.
Following information shall be stated on the note/list:
- AstraZeneca purchase order reference
- AstraZeneca article No.
- Lot no.
- Manufacturing year/month - Expiry date
- Each pallet no and number of units per pallet
- Total number of units (sales unit)
2-2
With Products:
- Delivery note/Packing list
- Forwarding documents
- Certificate of Analysis (except if the Products are managed with QP release)
By Separate Mail:
Invoice
2-3
Exhibit 3
CONTACT PERSONS
Contact persons in matters relating to the supply and manufacture of the
Products are the persons indicated below, or such other persons as subsequently
notified by one party to another:
another:
--------- ----------------- ------------------ ----------------------------------- ------------------
Company Activity Contact Name E-mail Telephone
Number
--------- ----------------- ------------------ ----------------------------------- ------------------
Inyx Commercial ▇▇▇ ▇▇▇▇▇▇ ▇▇▇.▇▇▇▇▇▇@▇▇▇▇-▇▇▇▇▇▇.▇▇.▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
--------- ----------------- ------------------ ----------------------------------- ------------------
Inyx Consecutive ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇▇▇▇▇@inyx- ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇.▇▇.▇▇
--------- ----------------- ------------------ ----------------------------------- ------------------
Inyx Technical ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇.▇▇▇▇▇@▇▇▇▇-▇▇▇▇▇▇.▇▇.▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
Matters/
Packaging/
Material/Artwork
--------- ----------------- ------------------ ----------------------------------- ------------------
Inyx Regulatory ▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇.▇▇▇▇▇▇@▇▇▇▇-▇▇▇▇▇▇.▇▇.▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
--------- ----------------- ------------------ ----------------------------------- ------------------
Inyx Change Control/ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇@▇▇▇▇-▇▇▇▇▇▇.▇▇.▇▇ ▇▇▇ ▇▇▇▇ ▇▇▇ ▇▇▇
Product
Maintenance
--------- ----------------- ------------------ ----------------------------------- ------------------
--------- ----------------- ------------------ ----------------------------------- ------------------
AZ Commercial ▇▇▇▇▇▇▇▇▇ Rudlid ▇▇▇▇▇▇▇▇▇.▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ ▇▇▇ ▇ ▇▇▇ ▇▇▇ ▇▇
--------- ----------------- ------------------ ----------------------------------- ------------------
AZ Consecutive
--------- ----------------- ------------------ ----------------------------------- ------------------
AZ Technical ▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇.▇▇.▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ ▇▇▇ ▇ ▇▇▇ ▇▇▇ ▇▇
Matters/
Packaging/
Material/Artwork
--------- ----------------- ------------------ ----------------------------------- ------------------
AZ Regulatory ▇▇▇▇▇ ▇▇▇▇▇▇▇
--------- ----------------- ------------------ ----------------------------------- ------------------
AZ Change Control/ Ylva ▇▇▇▇.▇▇▇▇▇▇▇▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ ▇▇▇ ▇ ▇▇▇ ▇▇▇ ▇▇
Product Hezekielsson
Maintenance
--------- ----------------- ------------------ ----------------------------------- -------------------
3-1
Exhibit 4
QUALITY ASSURANCE AGREEMENT
to be appended by the latest on I September 2004
4-1
Exhibit 5
AstraZeneca Property
The following list details the assets owned by AstraZeneca at Inyx' facilities
for use in the supply of the Products to AstraZeneca all procured year 2004:
DH Industries
o Double diaphragm pump
o Change parts for filling machine
o Change Parts for can sorting machine
o Propellant metering system
o Suspension flow monitoring system
Kells
o Stainless Steel Vessel and Weighing System
Innerflow Engineering
Fixed product supply and return lines dedicated to the AstraZeneca process
Frymakoruma
o High shear mixer, which will be integrated with the Kells'vessel
Others (estimate - includes)
o Dedicated dispensing equipment for active and magnesium stearate
5-1
Exhibit 6
---------
GENERAL WORK FLOW FOR THE ARTWORK PROCESS
--------------------- -------------------------------------
AstraZeneca <--------- AstraZeneca
Distribution Services / / Marketing Company
--------------------- / /-------------------------------------
/ / |
--------------------------- / / |
For new products/packs: / / -------------------------------------
AZ MC provides / / Supplier
Distribution Services with / / PAF + templates
a PAF for information. / / -------------------------------------
--------------------------- AstraZeneca Marketing Company -
Create artwork and regulatory
approval by concerned authorities
- Provide regulatory approved artwork
(electronic and paper copy) +
PAF to supplier
-------------------------------------
|
|
-------------------------------------
Supplier
Approved artwork
-------------------------------------
|
|
--------------------------------------
Supplier of printed
packaging material
Printed packaging
material
--------------------------------------
|
|
--------------------------------------
Supplier
- Release printed packaging
--------------------- material for production
AstraZeneca <--------- - Distribute printed samples of
Marketing Company packaging material to AstraZeneca
--------------------- Marketing Company for
information
---------------------------------------
6-1
