1
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
September 23, 1997
GLAXO OPERATIONS UK LIMITED (1)
and
CHIREX (XXXXX) LIMITED (2)
and
CHIREX (HOLDINGS) LIMITED (3)
----------------
SUPPLY AGREEMENT
----------------
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
TABLE OF CONTENTS
CLAUSE PAGE NO
1. DEFINITIONS AND INTERPRETATION................................... 1
2. SUPPLY OF PRODUCTS............................................... 4
3. PRICE/PAYMENT.................................................... 7
4. SUPPLY OF RAW MATERIALS.......................................... 9
5. FORECASTS; ORDERS; DELIVERY..................................... 10
6. TITLE/RISK OF LOSS.............................................. 10
7. PREMISES/PLANT.................................................. 10
8. COVENANTS AS TO QUALITY AND QUANTITY............................ 11
9. SAMPLES; INSPECTIONS............................................ 12
10. TECHNICAL ASSISTANCE........................................... 13
11. HAZARDS........................................................ 13
12. INTELLECTUAL PROPERTY; IMPROVEMENTS............................ 13
13. CONFIDENTIALITY................................................ 15
14. CONSENTS....................................................... 16
15. ASSIGNMENT..................................................... 16
16. DURATION....................................................... 17
17. DENIAL OF RIGHTS............................................... 20
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confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
18. PRODUCT COMPLAINTS; ADVERSE EVENT REPORTS...................... 20
19. INDEMNITIES.................................................... 20
20. INSURANCE...................................................... 21
21. FORCE MAJEURE.................................................. 22
22. NOTICES........................................................ 22
23. DISPUTE RESOLUTION............................................. 23
24. PUBLICITY...................................................... 23
25. CONTRACT ADMINISTRATION........................................ 23
26. LIABILITY...................................................... 24
27. WAIVER......................................................... 24
28. CONSENT TO JURISDICTION........................................ 24
29. ENTIRETY....................................................... 24
30. LAW............................................................ 24
31. SUCCESSORS AND ASSIGNS......................................... 24
32. PARTIES........................................................ 24
SCHEDULE 1 - THE PRODUCTS.......................................... 26
SCHEDULE 2 - KEY MATERIALS......................................... 27
SCHEDULE 3 - NOTIONAL CAPACITY REQUIREMENTS........................ 28
SCHEDULE 4 - FORMULA FOR PROFIT SHARE.............................. 30
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
SUPPLY AGREEMENT
THIS AGREEMENT is dated September 23, 1997
BETWEEN:
(1) GLAXO OPERATIONS UK LIMITED registered number 711851 whose registered
office is at Glaxo Xxxxxxxx Xxxxx, Xxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxx
XX0 0XX ('Glaxo Operations')
(2) CHIREX (XXXXX) LIMITED registered number 3417229 whose registered office
is at Dudley, Xxxxxxxxxxx, Xxxxxxxxxxxxxx XX00 0XX ("Chirex Xxxxx")
(3) CHIREX (HOLDINGS) LIMITED whose registered office is at Dudley,
Xxxxxxxxxxx, Xxxxxxxxxxxxxx XX00 0XX ("Chirex Holdings")
WHEREAS:
The Parties have agreed that Chirex Xxxxx or another company within the Chirex
Group would manufacture and supply and Glaxo Operations would purchase certain
active ingredients and intermediates for use in pharmaceutical products under
the terms of this agreement.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS AND INTERPRETATION
1.1. In this agreement the following expressions shall have the following
meanings unless the context otherwise requires:
"Added Value" means, in relation to a Product the price payable (or
which would have been payable for the Product by Glaxo Operations
had Glaxo Operations ordered it) under the terms of this agreement
less (a) Chirex Xxxxx'x cost of raw materials employed (or which
would have been employed had Glaxo Operations ordered the Product)
in Manufacturing that Product (b) any variable costs directly
incurred in respect of the Manufacture of that Product], and the
packaging costs and the cost of disposal of effluent in respect of
the Manufacture of that Product;
"Approved Supplier" means a person designated in the Manufacturing
Instructions which has been approved by Glaxo Operations in writing
for the supply of Raw Materials;
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
"Chirex Group" means Chirex (Holdings) Limited , any parent company
of Chirex Holdings Limited and any company which, in relation to
Chirex (Holdings) Limited and/or any parent company of Chirex
(Holdings) Limited is a subsidiary undertaking from time to time;
"Chirex Holdings" means Chirex (Holdings) Limited, whose registered
office is at Dudley, Xxxxxxxxxxx, Xxxxxxxxxxxxxx XX00 0XX;
"Contract Year" means, in the case of the first Contract Year, the
period from the date of this agreement to 31 December 1997 and in
the case of subsequent Contract Years the respective periods
commencing on 1 January and ending on 31 December of the same year;
"Current Good Manufacturing Practices" or "CGMP's" means all
applicable standards relating to manufacturing practices for fine
chemicals, intermediates, or bulk pharmaceutical products (i)
promulgated by any Governmental Body having jurisdiction over the
manufacture of the Products in the form of laws or regulations, (ii)
promulgated by any Governmental Body having jurisdiction over the
Manufacture of the Products, in the form of guidance documents
(including but not limited to advisory opinions, compliance policy
guides and guidelines) which guidance documents have been
implemented within the pharmaceutical manufacturing industry for
such products in each case as in effect at the date of this
agreement and as amended, promulgated or accepted from time to time
during the term of this agreement;
"Facility" means the manufacturing facility of Chirex (Xxxxx)
Limited located at Xxxxx and/or the manufacturing facility of Chirex
(Xxxxxx) Limited located at Xxxxxx;
"Firm Commitments" means in respect of any Product the quantities of
such Product so identified in Schedule 1;
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
"Force Majeure" means any decree, restraint, order, rule, regulation
or other interference by any government or local authority, war,
strike, lockout, trade dispute, riot, epidemic disease, act of God,
inevitable accident, breakdown of plant or machinery, fire, flood or
any other circumstances whatsoever whether similar to the above
causes or not over which Glaxo Operations or Chirex Xxxxx, as the
case may be, shall have no control;
"Governmental Body" means any government department or agency,
regulatory authority or any entity with legal authority to exercise
executive, legislative, judicial, regulatory or administrative
functions;
"GW Group" means Glaxo Operations, any parent company of Glaxo
Operations and any company which, in relation to Glaxo Operations
and/or any parent company of Glaxo Operations, is a subsidiary
undertaking from time to time;
"Intended Quantities" means the quantities of **** and **** so
identified in Schedule 1;
"Key Materials" means those Raw Materials to be used in the
Manufacture of the Products set out in Column 1 of Schedule 2;
"Manufacture" means all operations in the production and/or
packaging of Products and 'Manufactured' shall be construed
accordingly;
"Manufacturing Instructions" means full descriptions and
instructions concerning Raw Materials usage, operating conditions,
process and quality standards to be employed by Chirex Xxxxx in the
Manufacture of Products, including Product specifications, packaging
instructions and quality control procedures, details of which have
been communicated by Glaxo Operations and agreed by Chirex Xxxxx;
****
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
"Other Materials" means all Raw Materials other than the Key
Materials;
"Parties" means the parties in this agreement;
"Products" means the compounds listed in Column 1 of Schedule 1;
"Quarter" means a period of three months beginning on 1 January, 1
April, 1 July, or 1 October respectively;
"Raw Materials" means all raw and packaging materials used in the
Manufacture of the Products; and
"Replacement Products" means the products identified as such in
Schedule 1 and such other products agreed by the Parties from time
to time.
1.2. The headings in this agreement are for ease of reference only and do
not form part of this agreement for the purposes of interpretation.
1.3 References to persons in this agreement shall mean any individual or
corporation, company, partnership, trust, incorporated or
unincorporated association, joint venture or other entity of any
kind.
2. SUPPLY OF PRODUCTS
2.1 Chirex Xxxxx hereby agrees to Manufacture and sell to Glaxo
Operations in each Contract Year the volumes of Products set out in
Schedule 1 during the term of this agreement at the prices set forth
in Schedule 1, or as adjusted in accordance with the terms of this
agreement, and Glaxo Operations agrees to purchase such Products at
such prices. Schedule 1 sets out Firm Commitments and Intended
Quantities. It is acknowledged by the Parties that Glaxo Operations
is unable, at the date of this agreement, to confirm that it will
purchase the volumes of **** and **** designated as Intended
Quantities in Schedule 1, due to regulatory and market
uncertainties.
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
2.2 While Glaxo Operations is committed to honouring its commitments and
obligations under clause 2.1, the Parties recognise and agree that
the purchase of the Intended Quantities of some volumes of **** in
2000 and thereafter and in all the volumes of **** may be inhibited
due to regulatory and market uncertainties in relation to these
Products or the products manufactured from the Products. In the
event that Glaxo Operations is unable, due to lack of regulatory
approval and/or marketing uncertainties to purchase the Intended
Quantities of **** in 2000 and thereafter or of **** at any time
then the Parties will in good faith negotiate and Glaxo Operations
shall use its best endeavours to purchase Replacement Products to
compensate Chirex Xxxxx in full for any such shortfall. The
principle of such compensation shall be to make up volumes of
Intended Quantities with volumes of Replacement Products which will
result in equivalent Added Value to Chirex Xxxxx and/or any other
company in the Chirex Group. The terms of purchase of such
Replacement Product shall be the same, mutatis mutandis, as under
this agreement.
2.3 The Parties recognise that it may be desirable, particularly at the
beginning or end of any Contract Year for a Product scheduled to be
Manufactured and/or purchased in one Contract Year to be
Manufactured and/or purchased in the following or immediately
preceding Contract Year. The Party proposing any such rescheduling
shall give as much advance notice of its proposals as is reasonably
practicable. Any such rescheduling shall be subject to the agreement
of the Parties.
2.4 In respect of the Product ****, the Firm Commitments shall include
the requirement of **** and its affiliates. If and to the extent
that quantities of such product are purchased by **** and its
affiliates direct from Chirex Xxxxx and/or any other company in the
Chirex Group, such quantities shall be deemed to have been purchased
by Glaxo Operations for the purpose of fulfilling Glaxo Operations'
obligations under this clause 2.
2.5 If Glaxo Operations is unable for any reason (other than due to the
default of Chirex Xxxxx) to purchase any Firm Commitments of any
Product Glaxo Operations shall in that event compensate Chirex Xxxxx
in full in accordance with the terms of this
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
clause but not further or otherwise. Notwithstanding this Chirex
Xxxxx will use its reasonable endeavours to evaluate in good faith
the possibility of the Manufacture of other products including the
Replacement Products or increased volumes of Products for Glaxo
Operations to purchase on the same terms as this agreement.
If, in respect of any Contract Year, Glaxo Operations orders less
Product than the amount set out in Schedule 1 with reference to that
Contract Year as a Firm Commitment, Glaxo Operations shall, on or
before 14 January in the immediately following Contract Year, pay to
Chirex Xxxxx a sum in pounds sterling equal to the Added Value which
would have been generated had Glaxo Operations submitted orders for
such quantity of the Product as represents the difference between
the amount of Product actually ordered by Glaxo Operations in
respect of the Contract Year in question and the Firm Commitment
amount which it undertook to order under the terms of clause 2.
2.6 Without prejudice to Chirex Xxxxx'x obligations under clause 2.1 and
5, Chirex Xxxxx undertakes to have sufficient capacity available at
the Facilities to Manufacture not less than 10% in excess of orders
placed by Glaxo Operations under the terms of this agreement in
accordance with the following procedure:
2.6.1 Glaxo Operations shall advise its proposed Firm Commitment
volumes for the next Contract Year by 30 August of the
previous year;
2.6.2 Chirex Xxxxx will by October of the previous year advise Glaxo
Operations of the production schedule for the following
Contract Year including (a) timing of available capacity to
make up to 10% in excess of the Firm Commitment and (b) any
opportunity to Manufacture in excess of 10% more than the Firm
Commitment;
2.6.3 Glaxo Operations will by November of the previous year advise
Chirex Xxxxx of its wish to reserve available capacity for in
excess of 10% of the Firm Commitment in respect of the
following Contract Year. Chirex Xxxxx
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
shall advise Glaxo Operations whether it is able to reserve
any further capacity but shall be under no obligation to do
so. If such additional capacity is available the Parties will
then negotiate a reservation fee as it is recognised that
Chirex Xxxxx will be holding an under utilised capacity for
Glaxo Operations. Schedule 3 sets out Chirex Xxxxx'x current
estimate of the capacity which it expects to be available at
the Facilities in respect of the Products in the periods set
out.
2.7 It is acknowledged that it is the intention of Glaxo Operations and
Chirex Xxxxx to achieve volumes of Products (not Replacement
Products) in excess of the total number specified in Schedule 1.
2.8 In the event that Chirex Xxxxx is unable to perform its obligations
under this agreement in respect of confirmed orders placed by Glaxo
Operations and accepted by Chirex Xxxxx in accordance with the terms
of this agreement Firm Commitments quantities specified in Schedule
1 shall be reduced to the extent of such shortfall, without
prejudice to any other rights Glaxo Operations may have under this
agreement. For the avoidance of doubt there shall be no obligation
on Glaxo Operations to make up any such shortfall in later Contract
Years.
2.9 This clause shall apply if Glaxo Operations places a confirmed order
under this agreement and Glaxo Operations subsequently gives Chirex
Xxxxx written notice that it is unable to comply with such order. In
this event any savings of fixed costs of Chirex Xxxxx or other
member of the Chirex Group which Chirex Xxxxx can make by using the
capacity which had been reserved for the manufacture of such Product
and which is actually used in the Manufacture, in the same period,
of product for a third party, shall be deducted from any payments
due by Glaxo Operations in respect of such order.
2.10 The **** of **** to be ordered in accordance with Schedule 1 in
respect of 1997 will be reduced, if this agreement is entered into
after 10 October 1997. The reduction will be calculated according to
a formula being the number of days from 1 October
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
1997 to the date this agreement is entered into divided by 92 days
and multiplied by ****.
2.11 Glaxo Operations shall have met its obligations with regard to Firm
Commitments and Intended Quantities if it purchases products from
Chirex Xxxxx irrespective of individual product volumes that will
result in equivalent Added Value to Chirex Xxxxx in respect of any
Contract Year had the quantities specified in Schedule 1 been
ordered in that Contract Year.
3. PRICE/PAYMENT
3.1 3.1. Glaxo Operations shall pay Chirex Xxxxx in accordance with the
sums set out in Schedule 1 for all Products purchased under this
agreement. Chirex Xxxxx shall bear the cost of delivery within the
United Kingdom. Glaxo Operations shall in addition pay to Chirex
Xxxxx any delivery costs and any taxes, or import or export duties
in respect of deliveries outside of the UK.
3.2 Glaxo Operations shall make payment to Chirex Xxxxx not later than
30 days from the date of invoice. In respect of **** and **** and in
respect of such other products as the Parties may agree which are
Manufactured in a campaign Chirex Xxxxx shall be entitled to invoice
monthly during the term of such campaign, the volume actually
available for despatch. Chirex Xxxxx shall invoice Glaxo Operations
upon notifying Glaxo Operations in writing that the Product has been
Manufactured and is available for delivery to Glaxo Operations and
whether or not Glaxo Operations shall have ordered such delivery.
3.3 The prices payable for the Products shall be adjusted annually
before the end of the year immediately preceding the Contract Year
in respect of which such adjusted price is to apply. The adjusted
price shall reflect any material costs variations (upwards or
downwards) since the last adjustment (or, in the case of the first
adjustment since the date of this agreement) in Chirex Xxxxx'x unit
raw materials costs plus direct costs
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
base (including labour and overheads) and usage yields and, in
respect of the Contract Years 2001, and 2002 shall take into account
the ****. The adjusted price in respect of the future supply of any
particular Product shall also reflect any cost savings achieved
through process improvements (achieved in respect of that Product
only) provided that any such adjustments shall only be made if the
Added Value derived from the total volume of Products ordered by
Glaxo Operations for that Contract Year exceeds the Added Value that
would have been derived if Glaxo Operations had ordered the
aggregate volumes of Firm Commitments and Intended Quantities set
out in Schedule 1.
3.4 During August of each Contract Year, or at any other time which the
Parties agree (save for the first Contract Year) in which case the
relevant month shall be November) in the year immediately preceding
the year in relation to which such adjusted price is to apply Chirex
Xxxxx shall deliver to Glaxo Operations a statement showing in
relation to each Product the variations in costs detailing raw
material (usage and conversion)and direct costs.
Within 30 days following delivery of such statement the Parties
shall discuss the statement and endeavour to agree the amount of the
variations and the amount by which the price in respect of each
Product shall be adjusted. Glaxo Operations shall be entitled, as
part of its review, to require Chirex Xxxxx to provide it with such
underlying financial information as is relevant in relation to the
statement produced by Chirex Xxxxx.
If the Parties agree the amount of the variation within the 30 day
period (or such longer period as they may agree) they shall agree,
by exchange of correspondence, the price adjustment to the Product.
If the Parties fail to so agree, either of them may refer the matter
for determination in accordance with the terms of clause 23.
3.5 Any price adjustment agreed or determined under clause 3.4 shall
have effect as from 1 January in each year (or such other date as
the parties may agree), regardless of the date of agreement or
determination.
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
3.6 The Parties acknowledge that it is their intention that orders in
excess of the volumes set out in Schedule 1 both in respect of Firm
Commitments and Intended Quantities identified in Schedule 1 (not
Replacement Products) are placed under this agreement. In this event
any Added Value to which Chirex Xxxxx would be entitled in respect
of such additional orders shall be applied between the Parties in
accordance with the terms of Schedule 4. Any applications under this
clause shall be made at six monthly intervals, or at such other
times as the Parties may agree. The Parties shall review in November
of each year the procedure for such allocation which may, at the
request of Glaxo Operations, be made in respect of the prices to be
paid for ****. The Parties shall agree when to make such
applications.
3.7 All prices are stated exclusive of applicable taxes and VAT and,
where appropriate, taxes and VAT will be added to all invoices at
the rate applicable on the tax point date which shall be the date of
that invoice.
4. SUPPLY OF RAW MATERIALS
4.1. Subject to clauses 4.2 and 4.3 Chirex Xxxxx shall procure at its own
expense all Raw Materials for the Manufacture of the Products.
4.2. Where the Manufacturing Instructions name one or more Approved
Suppliers for Other Materials, Chirex Xxxxx shall obtain that Other
Material only from an Approved Supplier thereof.
4.3 Subject to clause 4.4 in respect of Key Materials Glaxo Operations
shall select each supplier for the Key Materials and shall have the
right to designate to Chirex Xxxxx the quantity, consistent with
contracted volumes, of each Key Material to be purchased from such
designated supplier. The designated supplier may be Glaxo Operations
itself or a member of the GW Group. The initial designated suppliers
for Key Materials are listed in column 2 of Schedule 2.
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
4.4 Chirex Xxxxx shall not utilise any Key Materials purchased under
this agreement for any purposes other than the Manufacture of the
relevant Products in accordance with the terms of this agreement and
to the extent that Glaxo Operations is in breach of its obligations
to order the relevant Product under the terms of this agreement
Glaxo Operations shall reimburse Chirex for the Key Materials
therefor.
4.5 It is acknowledged that Chirex Xxxxx shall be entitled to
Manufacture **** and utilise **** Manufactured by Chirex Xxxxx in
the production of **** under the terms of this agreement. Chirex
Xxxxx understands that Glaxo Operations or another member of the GW
Group may have contractual commitments with third parties to supply
**** to Glaxo Operations or other member of the GW Group and shall
discuss with Glaxo Operations ways in which the production of ****
by Chirex Xxxxx may be reduced to a level consistent with such other
commitments. In this respect Chirex Xxxxx agrees that it will not
without Glaxo Operations' prior written consent Manufacture more
than **** of **** in 1998 nor more than **** of **** in 1999.
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and
have been filed separately with the Commission.
5. FORECASTS; ORDERS; DELIVERY
5.1. For budget purposes Glaxo Operations and Chirex Xxxxx shall meet
prior to 30 August of each year to discuss forecast volumes for the
next full Contract Year.
5.2 Glaxo Operations shall communicate to Chirex Xxxxx by 30 August of
each year a draft order forecast for the next full Contract Year.
The budgeted volume shall be broken down month by month (in respect
of the first six months of any Contract Year) and by Quarter (in
respect of the second six months of any Contract Year) and in
respect of each delivery point. The Parties shall discuss at which
Facility it is appropriate to Manufacture the Product.
5.3 Glaxo Operations shall place with Chirex Xxxxx a firm written
confirmatory order specifying the required quantity of Product, the
date upon which it expects such
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confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
Product to be available for delivery and the appropriate packaging
and labelling instructions. Such confirmatory order shall be placed
at least 30 days prior to the next following Quarter in respect of
all Product to be Manufactured in that Quarter.
5.4 Chirex Xxxxx shall have 10 days from the date of receipt of the
Order to suggest modifications in respect of quantities or delivery
date, based on order forecasts previously communicated to Chirex
Xxxxx.
5.5 Chirex Xxxxx shall deliver or arrange for delivery of Products
Manufactured hereunder to Glaxo Operation's facility (or such other
UK site as Glaxo Operations shall indicate not less than 7 days
before the date of delivery) in accordance with clause 5.3.
6. TITLE/RISK OF LOSS
Chirex Xxxxx shall be responsible for loss of Products until delivery to
Glaxo Operations. Title to Products and risk of loss shall be with Chirex
Xxxxx until delivery to Glaxo Operations or (in the case of deliveries
outside the U.K.) to the delivery agent.
7. PREMISES/PLANT
7.1 Chirex Xxxxx undertakes to Manufacture Products at either Facility.
Manufacture of any Product at either Facility shall be subject to
prior clearance (not to be unreasonably withheld or delayed) by
Glaxo Operations that the Facility, Manufacturing environment
therein, plant and services in which and by which the Portions of
this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and
have been filed separately with the Commission. Products will be
Manufactured meet Glaxo Operations' manufacturing and quality
assurance requirements.
7.2 Subject to the provisions of clause 7.1 Glaxo Operations shall not
be required to approve which Facility Manufactures particular
Products at any one time provided that Glaxo Operations is notified
in advance where particular Products are to be Manufactured. However
if Glaxo Operations reasonably believes that security of
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Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
supply of particular Products is or could be prejudiced by the
quantities of Products being Manufactured at one or other of the
Facilities it shall be entitled to notify Chirex Xxxxx of such
belief. Glaxo Operations shall be entitled, if it is required to do
so by any regulations, to require Chirex Xxxxx to move production
between the Facilities.
8. COVENANTS AS TO QUALITY AND QUANTITY
8.1 Chirex Xxxxx undertakes that the Manufacture of the Products
hereunder shall be carried out in accordance with the Manufacturing
Instructions and that the Products delivered to Glaxo Operations
shall be in compliance with the relevant specifications set out in
the Manufacturing Instructions and (if applicable) approved
reference samples of such Products. Chirex Xxxxx shall not vary the
method of Manufacture of any Product without the prior written
consent of Glaxo Operations. Chirex Xxxxx shall carry out the
Manufacture of the Products in accordance with CGMP.
8.2 Glaxo Operations shall notify any non-compliance with specifications
and/or approved references samples within 30 days of receipt of
Product. Glaxo Operations undertakes not to process the Product
unless and until such Product (or, where appropriate, samples
thereof) have been subject to Glaxo Operations' quality control
tests and approved as meeting the Manufacturing Instructions. Chirex
Xxxxx shall have no liability under the provisions of clause 8.1 if
and to the extent that Glaxo Operations fails to carry out such test
and such tests would have shown that Chirex Xxxxx was not in
compliance with its obligations under this agreement including the
obligation to Manufacture the Products in accordance with the
Manufacturing Instructions. Glaxo Operations shall notify Chirex
Xxxxx of any apparent or chemical defect in the Product of which it
becomes aware whether as a result of its testing requirements for
pharmaceutical ingredients or otherwise within 30 days of receipt of
the Product by Glaxo Operations. If Glaxo Operations has given
notice of any defect in the Product in accordance with this clause
it shall immediately send a sample of such Product to Chirex Xxxxx
for cross-checking.
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confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
8.3 In the event that any batch of any Product Manufactured by Chirex
Xxxxx and delivered to Glaxo Operations shall not comply with the
relevant specification set out in the Manufacturing Instructions
and/or approved reference samples of such Product Chirex Xxxxx shall
make no charge hereunder in respect of that batch provided that
Chirex Xxxxx shall have the right at its option to re-work or
re-process the batch at its own expense in accordance with a
procedure validated by Glaxo Operations if satisfactory recovery or
utilisation of the Product shall thereby be technically feasible.
Chirex Xxxxx shall have the right to have the original non-complying
Product returned to such site as it shall nominate or destroyed.
Chirex Xxxxx shall reimburse Glaxo Operations for all reasonable
expenses incurred by Glaxo Operations in returning the defective
batch to Chirex Xxxxx. Any payment(s) made by Glaxo Operations
pursuant to clause 3 for such Products shall not prejudice Glaxo
Operations' rights under this clause.
8.4 If Glaxo Operations and Chirex Xxxxx do not agree on whether Chirex
has Manufactured any Product in accordance with clause 8 samples of
the Product in question will be submitted for testing to an
independent testing laboratory acceptable to both Parties. The
determination of such independent laboratory will be binding on both
Parties. The cost of the testing by the independent laboratory shall
be borne by the Party whose results differ from those of the
independent laboratory as to whether the Product in question has not
been Manufactured in accordance with this clause 8.
8.5 Glaxo Operations assumes liability for and shall indemnify Chirex
Xxxxx against any loss, liability or expense which Chirex Xxxxx
suffers or incurs to the extent that such loss or liability results
from the Manufacturing Instructions, specifications or other
requirements of Glaxo Operations under this agreement. Provided that
this indemnity shall not extend to physical damage suffered by
Chirex Xxxxx or personal injury to or death of its employees.
9. SAMPLES; INSPECTIONS
9.1. At the request of Glaxo Operations, Chirex Xxxxx shall submit to
Glaxo Operations
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confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
samples of such production batches of Products as Glaxo Operations
shall reasonably request from time to time.
9.2. Glaxo Operations shall have the right at Glaxo Operations' cost
during normal business hours by prior appointment to have an
appropriately qualified observer reasonably approved by Chirex Xxxxx
enter either Facility for the purpose of inspecting the Manufacture
of Products, the storage of Raw Materials and Products in the course
of Manufacture and, insofar as is necessary to determine if the
Product is being Manufactured in accordance with Chirex Xxxxx'x
obligations under this agreement, all records and reports relating
to the Manufacture of the Products. Chirex Xxxxx shall insofar as it
is able procure such rights of entry and inspection in respect of
any suppliers of Raw Materials.
9.3. Glaxo Operations shall have the right to request Chirex Xxxxx to
provide samples of Raw Materials and Products in the course of
Manufacture.
9.4. Chirex Xxxxx shall notify Glaxo Operations of the results of,
observations of, and outcome of all inspections and/or audits of the
Facilities and/or operations conducted by any Governmental Body
which is relevant to the Manufacture of the Products.
10. TECHNICAL ASSISTANCE.
Glaxo Operations shall provide Chirex Xxxxx upon request by Chirex Xxxxx
with such technical assistance and instructions as is reasonably necessary
to enable Chirex Xxxxx to Manufacture Products.
11. HAZARDS
Glaxo Operations will provide Chirex Xxxxx with all information in Glaxo
Operations' possession or which it is obliged to provide by law or under
regulation relating to known hazards relating to the Manufacture and
handling of the Products and the handling of the Raw Materials. The
Parties recognise that Glaxo Operations selected Chirex Xxxxx for the
15
19
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
Manufacture of Products, inter alia, for Chirex Xxxxx'x expertise in
handling chemicals required in the Manufacture of Products. Chirex Xxxxx
shall be solely responsible for compliance with all health, safety and
environmental regulations and guidelines during the Manufacture of
Products and the storage of Raw Materials and Products prior to delivery
to Glaxo Operations.
12. INTELLECTUAL PROPERTY; IMPROVEMENTS
12.1 All intellectual property rights (which shall include patents,
patent applications, know-how, designs, copyright and technical
information) in the Manufacturing Instructions and other information
relating to the Products disclosed by Glaxo Operations in
contemplation of or in accordance with this agreement are and shall
remain the property of Glaxo Operations.
12.2 Glaxo Operations warrants that it or a member of the GW Group is the
owner of all intellectual property rights required for the
Manufacture of the Products under this agreement and that it has the
right to grant a licence of such rights in accordance with the terms
of clause 12.3.
12.3 Under the terms and subject to the conditions of this agreement
Glaxo Operations grants Chirex Xxxxx a non-exclusive, royalty free,
non-transferrable, non-sub-licensable right during the term of this
agreement of all intellectual property rights referred to in clause
12.1. to make, manufacture and supply Products solely to Glaxo
Operations and solely to perform Chirex Xxxxx'x obligations under
this agreement. Chirex Xxxxx will have no right or licence to make,
manufacture, supply, distribute or sell Products, using the
intellectual property rights licensed to it under this clause for
any other purpose or for or to any other person nor to make,
manufacture, supply, distribute or sell any products other than the
Products. To the extent that Chirex Xxxxx and/or any other company
in the Chirex Group enters into a direct Contract with **** or one
of its affiliates in respect of the manufacture and supply of the
Product **** (see clause 2.4) Chirex Xxxxx shall have the right and
licence under all intellectual property rights referred to in clause
12.1 to make, manufacture and supply
16
20
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
such Product to **** or one of its affiliates.
12.4 Each Party shall notify the other of any process improvements that
it discovers or of which it learns (and in each case, which it is
free to disclose) relating to the Manufacture of the Products unless
the party discovering or learning of the improvement has bona fide
commercial reasons for not wishing to disclose such improvements
save as is envisaged under clause 3.3. All intellectual property
rights in such improvements shall (whether or not disclosed) belong
to Glaxo Operations but:
12.4.1 if disclosed shall be licensed to Chirex Xxxxx on the terms
of clause 12.2; and
12.4.2 if discovered, or learned of, by Chirex Xxxxx and not being
specific to the Products Chirex Xxxxx shall have the right to
use such improvements in relation to all products other than
the Products.
13. CONFIDENTIALITY
13.1. Chirex Xxxxx undertakes for itself and any of its employees having
access to any of the Manufacturing Instructions relating to the
Products to use the Manufacturing Instructions only for the purpose
of Manufacturing Products on behalf of Glaxo Operations and to hold
the same in confidence and not to disclose the Manufacturing
Instructions to any other person (other than its affiliates and
their professional advisers, all of whom shall be instructed to keep
such information confidential) during the term of this agreement or
thereafter without the written consent of Glaxo Operations. Chirex
Xxxxx hereby agrees that the Manufacturing Instructions are and
shall at all times remain the property of Glaxo Operations and
Chirex Xxxxx undertakes on the termination of this agreement, unless
otherwise agreed:
13.1.1. to cease using the Manufacturing Instructions; and
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21
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
13.1.2. not to manufacture the Products using intellectual property
rights granted to Chirex Xxxxx under this agreement on
behalf of any third party; and
13.1.3. to return to Glaxo Operations all documents relating thereto
and all copies or reproductions thereof (other than one copy
as proof of receipt).
13.2. Glaxo Operations undertakes for itself and its employees to keep
confidential all information regarding Chirex Xxxxx'x quality
control procedures, documentation, processes, manufacturing
practices and all other information acquired by Glaxo Operations in
connection with this agreement relating to Chirex Xxxxx'x plant or
operations, whether or not relating to Products, not to make any use
of such information except in connection with its purchase of
Products hereunder, and not to disclose any such information to any
other person (other than its affiliates and their professional
advisers, all of whom shall be instructed to keep such information
confidential) during the term of this agreement or thereafter
without the prior written consent of Chirex Xxxxx.
13.3. Clauses 13.1 and 13.2 shall not apply to any information:
13.3.1. that is and can be shown to be already known to any member
of the GW Group or Glaxo, Operations any member of the
Chirex Group, as the case may be, at the time of disclosure
to such Party under the provisions of this agreement; or
13.3.2. that is or has been disclosed to Chirex Xxxxx or Glaxo
Operations as the case may be, without restriction by any
other person entitled to disclose the said information; or
13.3.3. that is in the public domain or is subsequently disclosed to
the public other than by a breach of this agreement; or
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22
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
13.3.4 that is required to be disclosed by any court of competent
jurisdiction or any governmental or regulatory authority.
14. CONSENTS
It is hereby agreed by the Parties that this agreement is made conditional
upon Chirex Xxxxx obtaining all necessary authorisations and consents and
completing such formalities as may be required by any governmental or
ministerial body in order for Chirex Xxxxx to Manufacture and supply the
Products in accordance with the terms of this agreement. The Parties
recognise that Glaxo Operations has selected Chirex Xxxxx to carry out the
Manufacture of Products because inter alia Chirex Xxxxx'x premises, plant
and operations are to a standard that is acceptable to the US Food and
Drug Administration. Without prejudice to the generality of the foregoing,
Chirex Xxxxx undertakes to maintain all necessary FDA approvals.
15. ASSIGNMENT
15.1 The obligations of Chirex Xxxxx under this agreement may be
performed by any company within the Chirex Group. Subject to clause
15.2 Chirex Xxxxx may not at any time delegate, transfer or assign
all or any part of this agreement or the benefits thereof to any
person without the prior written consent of Glaxo Operations, and
Chirex Xxxxx hereby acknowledges that the rights and obligations
contained herein are solely personal to Chirex Xxxxx.
15.2 Chirex Xxxxx may assign this agreement to any company within the
Chirex Group and, upon prior notice to Glaxo Operations to any
funder of Chirex Xxxxx.
15.3 Glaxo Operations may not at any time delegate transfer or assign all
or any part of this agreement or the benefits hereof to any person
without the prior written consent of Chirex Xxxxx and Glaxo
Operations hereby acknowledges that the rights and obligations
contained herein are solely personal to Glaxo Operations. Glaxo
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23
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
Operations may with the prior written consent of Chirex Xxxxx (such
consent not to be unreasonably withheld or delayed) assign this
agreement to any company within the GW Group.
16. DURATION
16.1 Subject to the provisions of clauses 16.2 and 16.3 this agreement
shall commence on the date first above written and shall continue in
force until 31 December 2002. This agreement shall be automatically
renewed by successive periods of 12 months unless terminated by
either Party at the end of its initial term or at the end of any
renewal period (in either such case) by 24 months prior written
notice given to the other Party to that effect and the minimum level
of orders for any such extended period shall be as agreed between
the Parties.
16.2 In addition to any rights to terminate this agreement herein
elsewhere provided:
16.2.1 either Party shall have the right to terminate this agreement
forthwith by giving written notice to the other Party if the
other Party becomes insolvent or goes into liquidation (other
than a voluntary liquidation for the purpose of amalgamation
or reconstruction) or shall have any form of receiver
appointed over the whole or any part of its assets or shall
enter into any arrangement or composition with creditors or
shall cease business;
16.2.2 if either Party shall commit or allow to be committed (other
than by reason of Force Majeure) a material breach of any of
the provisions on its part to be observed and, after written
notice from the other Party indicating if there is another
material breach it intends to terminate this agreement and
such a further material breach arises the other Party shall
have the right to terminate this agreement by giving written
notice to the defaulting Party provided that in the case of a
breach capable of being made good if the defaulting Party
shall make good the said breach within 30 days after the said
notice shall have been given the said notice shall not be
effective;
20
24
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
16.2.3 if either Party shall commit or allow to be committed (other
than by reason of Force Majeure) a material breach of any of
the provisions on its part to be observed and, after written
notice from the other Party indicating if there is another
material breach it intends to terminate this agreement and a
further material breach arises in relation to a Product the
other Party shall have the right to terminate this agreement
in relation to that Product only by giving written notice to
the defaulting party provided that in the case of a breach
capable of being made good if the defaulting Party shall make
good the said breach within 30 days after the said notice
shall have been given the said notice shall not be effective.
16.3 16.3.1 Glaxo Operations may terminate this agreement upon 60 days
notice to Chirex Xxxxx upon the occurrence prior to December
31, 2002 of a Change in Control of Chirex Xxxxx.
16.3.2 A "Change in Control of Chirex Xxxxx" shall mean that a party
(other than a Permitted Owner and other than Chirex Inc. or
any entity controlled by Chirex Inc.) shall have acquired,
directly or indirectly, more than 50%, on a fully diluted
basis, of the voting securities of Chirex Xxxxx or (as the
case may be) Chirex Inc.
16.3.3 A Permitted Owner means any entity (other than an entity
which is itself or through one or more of its affiliates one
of the 30 largest pharmaceutical companies, as determined by
reference to the most current annual revenues as published by
I.M.S.) that
16.3.3.1 is experienced in or has senior and operating
management, including personnel retained at the
Facility (or other facilities permitted to
Manufacture and supply Products hereunder), who are
experienced in pharmaceutical manufacturing under
CGMPs, including fine chemicals, intermediates and
bulk
21
25
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
activities; and
16.3.3.2 has sufficient financial resources and liquidity to
satisfy the requirements for working capital
necessary to operate such facilities as aforesaid
in the manner required to Manufacture and supply
Products and perform all the obligations of Chirex
Xxxxx under this agreement; and
16.3.3.3 is in good standing with the FDA and has for five
years prior to the Change in Control of Chirex had a
satisfactory record of regulatory compliance with
the FDA and the other applicable Governmental
Bodies exercising similar functions except to the
extent any non compliance would not reasonably be
expected to have a material adverse effect on the
ability of such entity to operate facilities of the
type described in clause 16.3.3.1; and
16.3.3.4 is not (and has no affiliate that is) at the time
of the Change of Control of Chirex Xxxxx, or the
five year period prior thereto engaged in any
litigation or arbitration involving a member of the
GW Group or the manufacture of products for the GW
Group, in either case only if such litigation or
arbitration involves significant amounts to the GW
Group.
16.4. On termination of this agreement Glaxo Operations shall in
accordance with the terms of this agreement purchase any and all
stocks of Products which are not defective in the possession of
Chirex Xxxxx (for which Chirex Xxxxx shall invoice Glaxo Operations
in accordance with clause 3) and any Raw Materials and intermediates
purchased by Chirex Xxxxx for the purposes of this agreement and
which is not excessive to meet Chirex Xxxxx'x requirements for stock
to fulfil its expected obligations under this agreement where such
excessive stock has not been purchased in good faith by Chirex Xxxxx
(for which Chirex Xxxxx shall invoice
22
26
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
Glaxo Operations the price paid by Chirex Xxxxx for them) Provided
that Chirex Xxxxx shall be entitled to complete the Manufacture of
any Product which is in process.
16.5. The termination of this agreement shall be without prejudice:
16.5.1. to the obligations of the Parties to remit in full all
payments accrued due and payable at the effective date
of such termination;
16.5.2. to the provisions of Clauses 12, 13, 18 and 19;
16.5.3 to any other right or remedy available to either Party at
such termination.
17. DENIAL OF RIGHTS
Nothing herein contained shall be interpreted as granting or be deemed to
grant Chirex Xxxxx or any member of the Chirex Group any right, title or
interest of any kind whatsoever in or under any patent claiming any of the
Products.
18. PRODUCT COMPLAINTS; ADVERSE EVENT REPORTS
18.1. Chirex Xxxxx acknowledges that Glaxo Operations shall be solely
responsible for receiving, recording and responding to all customer
enquiries and complaints and all reports of alleged adverse events
relating to the final products which are produced from the Products.
In so responding Glaxo Operations shall have due regard to the
reputation and commercial interests of Chirex Xxxxx. Glaxo
Operations shall be solely responsible for reporting all such
matters to Governmental Bodies in accordance with applicable laws.
Chirex Xxxxx shall provide Glaxo Operations with any technical
information relating to investigations, and Manufacture of the
Products reasonably necessary to enable Glaxo Operations to perform
such obligations.
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27
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
18.2 The provisions of clause 18.1 shall survive expiration or
termination of this agreement.
19. INDEMNITIES
19.1. Chirex Xxxxx shall be liable for and shall indemnify Glaxo
Operations against any loss, claim, damage, expense, or liability
arising out of;
19.1.1. any breach of the terms of the agreement by Chirex Xxxxx,
including without limitation any failure to Manufacture the
Products in accordance with this agreement;
19.1.2. any negligence, storage or handling of the Products by
Chirex Xxxxx prior to delivery to Glaxo Operations; and
19.1.3. any wilful act or omission of Chirex Xxxxx or its employees,
agents or other contractors with respect to the Products.
19.2. Glaxo Operations shall be liable for and shall indemnify Chirex
Xxxxx against any loss, claim, damage, expense or liability arising
out of:
19.2.1 any infringement of any third party intellectual property
arising from Chirex Xxxxx'x Manufacture of the Products in
accordance with the provisions of this agreement;
19.2.2 the marketing and the sale of the Products (or products into
which the Products are incorporated) provided that Glaxo
Operations shall not be required to indemnify Chirex Xxxxx in
accordance with the foregoing to the extent that Chirex Xxxxx
is obliged to indemnify Glaxo Operations pursuant to the
provisions of clause 19.1
19.2.3 the handling or use of the Product following delivery by
Chirex Xxxxx.
24
28
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
19.3. Where one Party ("the Indemnifier") is required to indemnify the
other ("the Indemnified") in accordance with clause 8.5 or this
clause 19 it shall be a condition of such Indemnity that:
19.3.1. the Indemnified promptly notifies the Indemnifier in writing
of the claim or the threat of a claim;
19.3.2 the Indemnified accepts and acts upon the reasonable requests
of the Indemnifier as to the manner in which and the means by
which the claim or threat is dealt with; and
19.3.3 the Indemnified shall not have compromised the position by
unnecessary admissions or statements or conduct in a way
which could prejudice the defence of any such claim or
threat.
20. INSURANCE
20.1. Unless otherwise agreed in writing, Chirex Xxxxx shall, at its own
expense, carry and maintain during the term of this agreement the
following insurance's under policies and with companies satisfactory
to Glaxo Operations and in amounts per event no less than that
specified for each type:-
20.1.1. Public Liability Insurance for a sum assured of not less
than (pounds)1,000,000 (one million pounds); and
20.1.2. Product Liability Insurance for sum assured of not less than
(pounds)5,000,000 (five million pounds).
20.2 On request Chirex Xxxxx shall have its insurance carrier or carriers
furnish to Glaxo Operations certificates that all insurance required
under this agreement is in force, such certificates to indicate any
deductible and/or self-insured retention and stipulate
25
29
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
that the insurance will not be cancelled while this agreement is in
effect without (prior written notice to Glaxo Operations. Chirex
Xxxxx shall on request permit Glaxo Operations to examine original
insurance or other protective policies issued in compliance with the
requirements hereof. Should Chirex Xxxxx at any time neglect or
refuse to provide or cause not to be provided the insurance required
herein, or should such insurance be cancelled, Glaxo Operations
shall have the right to procure the same and the cost thereof shall
be deducted from monies then due or thereafter to become due to
Chirex Xxxxx.
21. FORCE MAJEURE
Any failure or delay in performance hereunder shall be excused if and to
the extent such failure or delay is due to Force Majeure; provided that
the Party seeking to excuse its performance shall (a) promptly notify the
other Party of the cause therefor and (b) use its best efforts to remedy
or remove the cause therefor. Neither Party shall have the right or action
against the other for any failure or delay. If the performance of any
material obligation under this agreement is delayed or prevented owing to
Force Majeure for any continuous period of more than 6 months, the Party
not affected by such Force Majeure shall have the right to terminate this
agreement by serving written notice to that effect on the other party.
22. NOTICES
Any notice or consent required to be given by either Party shall be
addressed in writing to the company secretary of the Party for whom it is
intended at the address listed on the first page hereof (or such other
address as a party may from time to time designate by written notice) and
shall be deemed to have been duly served at the time that it would have
been received in the ordinary course of post. Any notice served on Chirex
Xxxxx shall be copied to the Managing Director and Finance Director at
Chirex Dudley Limited, Dudley, Xxxxxxxxxxx, Xxxxxxxxxxxxxx XX00 0XX.
26
30
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
23. DISPUTE RESOLUTION
The Parties shall endeavour to settle amicably any dispute between them of
a financial nature arising in connection with this agreement. If no
amicable settlement can be arrived at within a reasonable time period then
either Party may refer such matter to an independent firm of Chartered
Accountants nominated jointly by them or if no such nomination is made
within 14 days after the expiry of one Party requiring nomination,
nominated at the request of either of them by the President for the time
being of the Institute of Chartered Accountants in England and Wales. The
Accountants so nominated shall be entitled to ask for and inspect the
working papers, records and documents of both Parties as they may
reasonably consider necessary. In making their determination, the said
Accountants shall act as experts and not as arbitrators, their decision
shall (in the absence of manifest error) be final and binding on the
Parties and their fees shall be borne and paid by the Parties in such
proportions as the Accountants determine in the light of the respective
contentions of the Parties, and the Accountants' determination.
24. PUBLICITY
Neither Party shall issue any press release or other publicity materials
or make any representation with respect to the existence of this agreement
or the subject matter thereof without the prior written consent of the
other Party. However, this restriction shall not apply to announcements
required by law or regulation or the regulations of any recognised stock
exchange or under the requirements of the U.S. Securities Xxx 0000 and the
Securities Xxxxxxxx Xxx 0000 except that in such event the Parties shall
co-ordinate to the extent possible with respect to the wording of any such
announcement.
25. CONTRACT ADMINISTRATION
25.1 The Parties shall establish points of contact for, respectively,
matters of a commercial nature and a technical/quality nature
relating to the performance of this agreement to whom matters will
be referred in the first instance. Such points of contact may be
27
31
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
changed at any time by either Party on notification of such change
to the other Party.
25.2 Through their nominated representatives the Parties shall meet on
such basis as shall be agreed from time to time (but no less than
quarterly) to discuss Glaxo Operations' forecast for the Products
and production matters relating to delivery of Products requested by
Glaxo Operations.
26. LIABILITY
In no event shall the aggregate liability of Chirex Xxxxx or any other
member of the Chirex Group under this agreement exceed (pounds)10,000,000
(ten million pounds) in any period of 12 months.
27. WAIVER
The failure on the part of either Party to exercise or enforce any right
conferred upon it shall not be deemed to be a waiver of any such right or
operate to bar the exercise or enforcement thereof at any time or times
thereafter.
28. CONSENT TO JURISDICTION
With respect to any suit, action or proceeding relating to this agreement,
each Party irrevocably submits to the jurisdiction of the English courts
and waives any objection which it may have any time to laying of venue of
any proceedings brought in any such court. Each party irrevocably consents
to service of process given in the manner for notices in clause 22.
29. ENTIRETY
This agreement constitutes the entire agreement between the Parties
relating to Manufacture of the Products, and this agreement shall not be
considered cancelled or amended in any respect unless done so in writing
signed on behalf of the Parties.
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32
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
30. LAW
This agreement shall be construed and have effect in all respects in
accordance with English law.
31. SUCCESSORS AND ASSIGNS
This agreement shall be binding upon and enure for the benefit of both
Parties and their successors and permitted assigns as the case may be.
32. PARTIES
Chirex Holdings is a party to this agreement only to receive the benefit
of clause 15.
As WITNESS the hands of the duly authorised signatories on behalf of the Parties
the day and year first above written.
29
33
SCHEDULE 1
------------------------------------------------------------------------------------------------------------------------------------
1997 1998 2000
---- ---- ----
Products tns (pounds)/kg (pounds)m tns (pounds)/kg (pounds)m tns (pounds)/kg (pounds)m tns
-------- --- ----------- --------- --- ----------- --------- --- ----------- --------- ---
****
2001 2001 2002
---- ---- ----
Products (pounds)/kg (pounds)m tns (pounds)/kg (pounds)m tns (pounds)/kg (pounds)m
-------- ----------- --------- --- ----------- --------- --- ----------- ---------
****
) )
) )
) )
) )
30
34
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
SCHEDULE 2
Key Materials
Material Initial designated supplier
-------- ---------------------------
**** ****
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35
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
SCHEDULE 3
Notional Capacity Requirements (see clause 2.6.3)
Product Contract Year Notional capacity at
------- ------------- Commencement of Contract
Year (tpa)
------------------------
Xxxxx Xxxxxx
----- ------
**** 1998 **** ****
1999
2000
2001
2002
1998
1999
2000
2001
2002
1998
1999
2000
2001
2002
32
36
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
1998
1999
2000
2001
2002
1998
1999
2000
2001
2002
1998
1999
2000
2001
2002
1998
1999
2000
2001
2002
33
37
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
SCHEDULE 4
Formula for Profit Share
In the event of additional volume to that set out in Schedule 1. (Both in
respect of Firm Commitment and Intended Quantities.)
Profit share will be based on:- **** of
Additional turnover less direct cost and engineering and development costs.
Existing Products New Products
----------------- ------------
Direct cost defined as:-
****% Raw Materials ****% Raw Materials
****% Labour ****% Labour
****% Utilities and ****% Utilities and
Consumables Consumables
****% Depreciation
SIGNED by Xxxxx Xxxxxx )
on behalf of ) /s/ X. Xxxxxx
GLAXO OPERATIONS UK )
LIMITED in the presence of: )
/s/ X.X. Xxxxx
X.X. Xxxxx
Solicitor
SIGNED by Xxxx X. Xxxxx )
on behalf of ) /s/ A.R. Xxxxx
CHIREX (XXXXX) LIMITED )
in the presence of: )
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38
Portions of this Exhibit have been omitted pursuant to a request for
confidential treatment. The omitted portions are marked **** and have been filed
separately with the Commission.
SIGNED by Xxxx X. Xxxxx )
on behalf of ) /s/ A.R. Xxxxx
CHIREX (HOLDINGS) )
LIMITED )
in the presence of: )
35
