EXHIBIT 10.22(b)
DATED 18TH JANUARY 2001
astrazeneca ab (1)
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MAILLEFER INSTRUMENTS HOLDINGS
S.A. (2)
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AZLAD PRODUCTS MANUFACTURING
agreement
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THIS AGREEMENT is made on 18TH JANUARY 2001
BETWEEN:
(1) astrazeneca ab a company incorporated under the laws of
Sweden and having its principal office at ▇▇-▇▇▇ ▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ("AZ"), and
(2) MAILLEFER INSTRUMENTS HOLDINGS S.A., a company
incorporated under the laws of Switzerland and having
its principal office at ▇▇▇▇▇▇ ▇▇ ▇▇▇▇▇▇ ▇, ▇▇ - ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇ (the "Purchaser").
BACKGROUND
A. Under the AZLAD Products Agreement, AZ has granted to
the Purchaser on the terms therein stated the permanent
right to use AZ's Technical Information (as therein
defined) for the purpose of manufacturing injectable
dental local anaesthetic products in the Territory and
the permanent right to use certain trade marks in
respect of specific injectable dental local anaesthetic
products.
B. In accordance with the AZLAD Products Agreement, the
Parties are entering into this Agreement relating to
the manufacture of injectable dental local anaesthetic
products by AZ for the Purchaser.
NOW THEREFORE IT IS AGREED as follows:
1. DEFINITIONS
1.1 In this Agreement:
(i) the term "this Agreement" shall mean this
Agreement and any Schedules and amendments
hereto,
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(ii) the terms "AZ" and "Purchaser" and references
to the "Parties" shall, unless the context
otherwise requires, mean AZ and its Affiliates
or any one of them and the Purchaser and its
Affiliates or any one of them and the term
"Party" shall be construed accordingly.
1.2 In this Agreement the following terms shall have the
following meanings:
"Affiliate" means any corporation, partnership, joint
venture, limited liability company or other business
entity now or hereafter controlling, controlled by or
under common control with AZ or the Purchaser as the
case may be and for the purposes of this definition
"control" means the possession, whether direct or
indirect, of the power to direct the management
policies of a business entity, whether through the
ownership of a majority of the voting rights in it or
by contract.
"Agreement Date" means the date of this Agreement as
shown above.
"AZLAD Products" means the LAD Products manufactured
and/or sold by AZ as defined in the AZLAD Products
Agreement.
"AZLAD Products Agreement" means the agreement of even
date herewith between the Parties which is referred to
above.
"AZLAD Products Specifications" means the release
specifications for AZLAD Products.
"Classified Areas" means in respect of each
Manufacturing Site the areas designated by AZ as areas
required to be maintained to appropriate standards of
cleanliness for the manufacture of pharmaceutical
products.
"Competent Authority" means in respect of each Country
the competent regulatory authority for the grant of
Marketing Authorisations and/or manufacturing licences
and approval of applications for the transfer of
Marketing Authorisations.
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"Contract Manufacturers" has the same meaning as in the
AZLAD Products Agreement.
"Contract Manufacturing Agreements" means the
agreements listed in Schedule 5, Part B, paragraphs 1
and 2 of the AZLAD Products Agreement relating (inter
alia) to the manufacture of AZLAD Products for AZ by
the Contract Manufacturers as amended from time to time
in accordance with the terms thereof or with the
Purchaser's written approval.
"Country" means a country within the Territory.
"Effective Date" means 1st March 2001.
"Equipment" means the equipment used by AZ solely in
the manufacture of AZLAD Products as listed in Schedule
2.
"Equipment Transfer Arrangements" means the
arrangements for handover of the Equipment as set out
in Schedule 2, as revised by agreement between the
Parties in writing from time to time.
"Excess Period" means for each Manufacturing Site the
period so described in Schedule 3, Part D calculated
from the expiry of the Initial Period, or such longer
period as may be agreed between the Parties in
writing.
"Existing Contracts" has the same meaning as in the
AZLAD Products Agreement;
"Force Majeure" means any circumstances beyond the
control of a Party, including strikes, lockouts, civil
commotion, accidents, wars, acts of God and
governmental regulations.
"GMP" means the requirement set out in the World Health
Organisation code on "Good Practice for the Manufacture
and Quality Control of Drugs" and/or other applicable
regulations in the Country of manufacture concerning
the manufacture, formulation, processing or packaging
of pharmaceutical products.
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"Initial Period" means for each Manufacturing Site the
period so described in Schedule 3, Part D calculated
from the Effective Date.
"LAD Products" means cartridges containing injectable
dental local anaesthetic drug products, being medicinal
products designed for and placed on the market solely
and specifically for use by dentists, periodontists,
oral surgeons and other practitioners of dentistry.
"LIBOR" means the 30 days US dollar BBA London
Interbank Offered Rate as published by Reuters.
"Manufacturing Charges" means the sums payable by the
Purchaser to AZ for the manufacture and packaging of
AZLAD Products and, upon termination of packaging or
manufacturing, for the sale of stocks of Product Packs,
Product Formulations, raw materials and packaging
components as stated in clause 5.
"Manufacturing Completion Date" means for each
Manufacturing Site the date on which the production of
the last batch of AZLAD Products manufactured at that
Manufacturing Site is completed and released for sale.
"Manufacturing Period" means for each Manufacturing
Site the period from the Effective Date until the
expiry of the Excess Period, or, if there shall be no
Excess Period, until the expiry of the Initial Period.
"Manufacturing Sites" means the sites where AZ
manufactures AZLAD Products namely:
Sodertalje Site, Sweden;
Sydney Site, Australia;
Naucalpan Site, Mexico;
Haedo Site, Argentina;
Westborough Site, USA; and
Mississagua Site, Canada.
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"Marketing Authorisations" has the same meaning as in
the AZLAD Products Agreement.
"Product Formulations" means the pharmaceutical
formulations of AZLAD Products as defined in the AZLAD
Products Agreement.
"Product Packs" means the shelf keeping units of AZLAD
Products as defined in the AZLAD Products Agreement.
"Quality Assurance Agreements" means the documents
referred to in clause 7.1.
"Quarter" means a calendar quarter.
"Technical Information" has the same meaning as in the
AZLAD Products Agreement.
"Territory" means the World, excluding India.
"Transfer Date" has the same meaning as in the AZLAD
Products Agreement.
"Transfer Process" means the arrangements for effecting
the transfer of responsibility for the manufacture and
packaging of AZLAD Products from AZ to the Purchaser,
and the obtaining of all regulatory approvals for such
manufacture and packaging by the Purchaser, all as set
out in Schedule 1, as revised by agreement between the
Parties in writing from time to time.
1.3 In this Agreement, where appropriate, references to
packaging shall include labelling.
1.4 In this Agreement, where appropriate, words denoting
the masculine gender shall include the feminine and
neuter genders and vice versa; words denoting a
singular number shall include the plural and vice
versa; references to the definite article shall include
the indefinite article and vice versa; references to
persons shall include firms, companies and other
organisations and vice versa; words such as "include"
or "including" are to be construed without limiting the
generality of the preceding words and references to
"from" any date shall mean "from and including" such
date.
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2. MANUFACTURE OF AZLAD PRODUCTS
2.1 AZ shall manufacture or have manufactured for the
Purchaser the whole or part of its requirements of
AZLAD Products for sale in the Territory during the
Manufacturing Period in accordance with and subject to
the provisions of this Agreement.
2.2 Except as otherwise agreed, AZLAD Products shall be
shipped by AZ to the Purchaser as finished goods ready
for sale.
2.3 AZ shall not be required to make any changes to the
packaging of the AZLAD Products unless such changes
have been or will be required by a Competent Authority
or are requested by the Purchaser and approved by AZ.
Any such changes shall be carried out as soon as
practicable in accordance with a timetable to be agreed
between the Parties.
2.4 In the event that such changes are made for any reason
other than a decision by AZ to sub-contract its
obligations under this Agreement:
(i) the Purchaser shall supply AZ with all artwork and text
for packaging components (including package
inserts) and shall approve final artwork and
text before printing of packaging components;
(ii) the Purchaser shall compensate AZ for any stock
write-off to the extent that it is not covered
by the purchase of inventory and is within the
shelf life as provided for in the AZLAD
Products Agreement; and
(iii) the Purchaser shall reimburse AZ for all costs
incurred by AZ in implementing such changes.
2.5 In respect of the range of AZLAD Products manufactured
for AZ under the Contract Manufacturing Agreements, AZ
shall not be obliged to manufacture such products for
the Purchaser, but shall provide for the Purchaser the
benefit of such Contract Manufacturing Agreements in
accordance with the provisions of clause 4 of the AZLAD
Products Agreement, provided that if AZ shall be
obliged to continue to
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purchase such products from the Contract Manufacturers,
to provide raw materials to the Contract Manufacturers
or to incur capital or other costs in connection with
the manufacture and supply of such products by the
Contract Manufacturers, the Purchaser shall pay to AZ an
amount equal to the costs so incurred by AZ plus 2%,
insofar as such costs shall not be reimbursed by the
Purchaser to AZ in accordance with the provisions of
clause 9 of the AZLAD Products Agreement, such payments
to be made by the Purchaser within 60 days of the date
of AZ's invoice. The provisions of clauses 3 to 8 shall
not apply in respect of the supply by AZ to the
Purchaser of AZLAD Products manufactured under the
Contract Manufacturing Agreements.
2.6 All forecasting, ordering and shipping shall be dealt
with on a Manufacturing Site by Manufacturing Site
basis and clauses 3, 4 and 6 shall accordingly apply
separately in respect of each Manufacturing Site. All
invoicing shall be dealt with centrally or on a
Manufacturing Site by Manufacturing Site basis as AZ
shall determine.
2.7 Special arrangements with respect to the Westborough
Site, USA are set out in Schedule 3 Part F.
2.8 During the continuance of the Manufacturing Period, the
Parties shall carry out the Transfer Process in
accordance with Schedule 1.
2.9 At the expiry of the Manufacturing Period the Parties
shall effect the transfer and removal of the Equipment
in accordance with the Equipment Transfer
Arrangements.
3. FORECASTS
3.1 Prior to the commencement of each Quarter, the
Purchaser shall deliver to AZ a monthly forecast of its
requirement of AZLAD Products for the period of 18
months commencing at the start of the next succeeding
Quarter or for the duration of the Manufacturing Period
(whichever shall be shorter). In this clause and
clause 4, the expression "Firm Period" shall mean the
first Quarter of the forecasted period, the expression
"Forecast Period" shall mean the second Quarter of the
forecasted period, and the expression "Estimate Period"
shall mean the last 12 months of the forecasted
period. The Purchaser's forecast for the period of 18
months commencing on 1st July 2001 shall be provided to
AZ on or before 31st March 2001.
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3.2 Each forecast shall contain for each Product Pack
details of the Purchaser's requirements for the Firm
Period and estimated requirements for the Forecast
Period and Estimate Period and shall comply with the
conditions contained in clause 4.3. Having provided
such forecasts for the Firm Period and the Forecast
Period, the Purchaser shall be obliged to place firm
production orders for such periods in accordance with
clause 4.1.
3.3 In each forecast the requirements for each month of the
Firm Period for each Product Pack shall not vary by
more than 10% from the quantities for the same months
(then being the Forecast Period) in the preceding
quarterly forecast.
3.4 The Purchaser's forecasts for the Estimate Period shall
be prepared in good faith as best estimates but shall
not be binding.
3.5 Forecasts shall be sent by the Purchaser to such
persons as AZ shall from time to time request.
3.6 The Parties shall have regular meetings to review the
forecasts and forecasting arrangements.
4. PRODUCTION ORDERS
4.1 Prior to the commencement of each Quarter, other than
the final Quarter, the Purchaser shall deliver a firm
production order to AZ for AZLAD Products for the Firm
Period. The quantity of AZLAD Products so ordered
shall be the same as stated for the Firm Period in the
forecast. AZ shall acknowledge receipt of each
production order. A firm production order for delivery
at the commencement or during the continuance of the
Quarter commencing 1st July 2001 shall be delivered by
the Purchaser to AZ on or before 31st March 2001 in
accordance with the forecast for such period. AZ shall
be responsible for deciding what AZLAD Products will be
manufactured for delivery up to 30th June 2001 in
accordance with reasonable expected market demand and
consistent with past practice.
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4.2 The Purchaser's orders shall be sent to such persons as
AZ shall from time to time request.
4.3 The Purchaser acknowledges:
(i) that each Manufacturing Site has restricted
capacity for producing AZLAD Products and that
the orders placed by the Purchaser in each
Quarter shall not exceed such capacity;
(ii) that AZ will manufacture cartridges in full
batch quantities and accordingly AZ shall not
be required to produce cartridges in quantities
other than the full batch quantities set out in
Schedule 3, Part B; and
(iii) that AZ's packaging lines are designed to run
within a certain volume range, that packaging
volumes outside that range may be impossible or
uneconomic, and accordingly that AZ shall be
entitled to place minimum and maximum
quantities, as are reasonable and consistent
with past practice, on orders for Product
Packs. The current minimum is set out in
Schedule 3, Part C.
4.4 AZ shall produce the quantities of Product Packs
ordered by the Purchaser in accordance with clauses 4.1
and 4.3 and in accordance with the AZLAD Products
Specifications and the Marketing Authorisations and
shall deliver such quantities to the Purchaser at the
commencement or during the course of the Firm Period as
agreed between the Parties, provided as follows:
(i) the Parties recognise that the quantity of
AZLAD Products produced in a batch will
fluctuate and the quantity supplied by AZ will
be the amount produced in each batch, but AZ
shall be responsible for ensuring that the
quantity supplied shall not vary from the
quantity ordered by the Purchaser by more than
10%, and
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(ii) if the Purchaser without AZ's written agreement
shall order AZLAD Products in excess of the
quantity permitted under clauses 4.1 and 4.3,
AZ shall endeavour to supply the excess
quantity within the same time frame but shall
not be liable for its failure to do so.
4.5 An order, once acknowledged by AZ, shall be binding on
both Parties (subject to clause 4.4).
5. MANUFACTURING CHARGES
5.1 The prices payable by the Purchaser to AZ for the
manufacture and packaging of AZLAD Products ordered for
delivery in the Initial Period for each Manufacturing
Site are set out in Schedule 3, Part A and the prices
payable for AZLAD Products ordered for delivery in the
Excess Period for each Manufacturing Site will be
calculated in accordance with Schedule 3, Part E. In
addition the Purchaser shall pay transportation costs
(including insurance and brokerage costs) from AZ's
works, and where applicable VAT, sales taxes,
consumption taxes and other similar taxes payable at
the prevailing rate together with any customs duties,
levies and similar taxes payable on importing AZLAD
Products to the delivery points as set out in clause
6.1.
5.2 Upon AZ ceasing to package any category of Product Pack
for the Purchaser, the Purchaser shall purchase from AZ
any stocks of such Product Pack and packaging
components held by AZ, and upon AZ ceasing to
manufacture any category of Product Formulation for the
Purchaser, the Purchaser shall purchase from AZ any
stocks of such Product Formulation and raw materials
and packaging components held by AZ, provided that the
Purchaser shall not be obliged to purchase stocks of
Product Packs having a remaining shelf life of less
than seven months nor to purchase stocks of Product
Formulations having a remaining shelf life of less than
twelve months. The prices payable by the Purchaser for
stocks of Product Packs and Product Formulations shall
be determined in accordance with clause 5.1. The
Purchaser shall purchase the stocks of packaging
components and raw materials at AZ's cost price,
together with transportation and other costs referred
to in clause 5.1.
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5.3 AZ shall deliver an invoice to the Purchaser for the
Manufacturing Charges in respect of each shipment of
AZLAD Products and payment shall be made within 60 days
of the later of the date of invoice or shipment.
5.4 All sums payable under this Agreement shall be paid
without deduction of any bank or transfer charges and
all sums are net of MOMS and other similar sales taxes
which shall be added if appropriate.
5.5 In the event of delay in payment, interest shall be
payable at LIBOR plus 3% calculated from the due date
for payment until the date of payment.
6. TERMS OF SUPPLY
6.1 Each Manufacturing Site shall ship AZLAD Products on
DDU terms (Incoterms 2000) or on such other terms as
shall be customarily used by such Manufacturing Site
and as shall be notified to the Purchaser to one or
more Purchaser distribution centres in the Territory
designated by the Purchaser. The Purchaser, or its
agent, shall take delivery of the AZLAD Products when
tendered. Without affecting any other rights, each
Party shall reimburse the other Party for any costs
incurred (by way of storage, insurance or otherwise) as
a result of any variation or delay in delivery caused
by its act or default.
7. QUALITY ASSURANCE
7.1 The Parties shall enter into Quality Assurance
Agreements which shall govern the obligations and
responsibilities of each Party with respect to the
quality assurance requirements of the manufacture,
analysis and packing by AZ of AZLAD Products and the
supply by AZ to the Purchaser of such products. The
Quality Assurance Agreement for each Manufacturing Site
shall be substantially in the form set out at Schedule
6. Any amendments to such form shall be as agreed
between the Parties in writing with the intention of
ensuring quality of products in accordance with
applicable laws and regulations. Neither Party shall
unreasonably withhold its consent to an amendment
requested by the other Party.
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7.2 In addition to its product recall obligation under the
Quality Assurance Agreements, the Purchaser shall,
after the Transfer Date, if appropriate and at AZ's
request and expense carry out any recall which may be
required by AZ in respect of AZLAD Products released by
AZ prior to the Effective Date.
7.3 AZ shall maintain and manage its manufacturing plants,
facilities and operations and the Purchaser shall
maintain and manage its warehousing and distribution
facilities in compliance with all applicable laws and
regulations and in such manner as not to jeopardise the
validity of the Marketing Authorisations and continuous
supply of AZLAD Products under this Agreement. During
the time that AZ is manufacturing AZLAD Products for
the Purchaser under this Agreement the Purchaser shall
have access on reasonable notice to the Manufacturing
Sites for the purpose of assessing the production and
quality of the AZLAD Products.
7.4 The provisions of clause 7.3 shall not preclude AZ,
from sub-contracting the whole or part of the
manufacture or storage of AZLAD Products but AZ shall
be responsible for ensuring that the changes do not
prejudice the validity of the Marketing Authorisations
and continuous supply of AZLAD Products under this
Agreement and AZ shall give to the Purchaser as much
prior notice of such changes as it shall reasonably
require for regulatory purposes. AZ shall provide the
Purchaser with the manufacturing, technical and quality
assurance data required to prepare and support such
submissions and AZ shall co-operate, at its cost and
expense, as necessary to support such submissions. In
the event of AZ sub-contracting the manufacture or
storage of AZLAD Products, it shall be responsible for
ensuring the due compliance by its sub-contractor with
the terms of this Agreement.
8. DEFECTS
8.1 Any delivery shortage, visible damage or defect in
AZLAD Products shall be reported by the Purchaser to AZ
within 30 days of opening of the transport container
which shall mean the shrink-wrapped pallet container.
All complaints, other than defects which are incapable
of being discovered upon opening of the transport
container, shall be waived unless reported to AZ within
such period of 30 days.
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8.2 In the event that the defect is found to have been
caused by AZ breaching its obligations under the
Quality Assurance Agreement, AZ shall replace free of
charge such quantity of AZLAD Products as are affected
by the defect together with reimbursing or crediting
the Purchaser for either (at AZ's option) the cost of
destruction or the return of the affected Product. No
AZLAD Product may be returned to AZ without AZ's prior
written permission.
8.3 If the Parties are unable to agree on the allocation of
responsibility for a defect in an AZLAD Product, then
the Parties shall refer the matter to a specialised
pharmaceutical laboratory of international repute
acceptable to both Parties (the "Laboratory"). The
Laboratory shall be deemed to act as an expert and not
as an arbitrator and any decision by the Laboratory
shall (in the absence of objection on the grounds of
manifest error within 30 days of the issue of its
decision) be conclusive and binding on the Parties.
The fees and expenses of the Laboratory shall be borne
equally by the Parties.
8.4 In the event that AZLAD Products need to be replaced
due to a defect, regardless of the allocation of
responsibility, AZ shall use its reasonable endeavours
to manufacture replacement AZLAD Products for the
Purchaser as quickly as possible.
9. CONFIDENTIALITY
9.1 All information of a confidential or proprietary nature
received or obtained by either Party under or in
connection with this Agreement shall be treated as
confidential by both Parties and shall not be disclosed
by either Party to any third party or used by either
Party except:
(i) to the extent necessary to fulfil the express
purposes of this Agreement;
(ii) in the case of information disclosed by AZ, as
required for or in connection with its business
relating to medical products or its business
outside the Territory relating to dental
products; or
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(iii) as required by law, or any regulatory or
governmental authority.
9.2 In the event of a Party disclosing confidential
information to a third party in accordance with clause
9.1(i) or (ii), it shall ensure that the recipient is
aware of the confidential nature of such information
and, in the case of information relating solely to
dental products, shall be bound by the same
restrictions on use and disclosure as the disclosing
Party.
9.3 The following information is not subject to the above
confidentiality obligations or restrictions on use:
(i) information which, at the time of acquisition,
is in the public domain;
(ii) information which, after acquisition, becomes
part of the public domain by publication or
otherwise, except by breach of obligation of
the receiving Party;
(iii) information which the receiving Party can
establish by competent proof was in its
possession at the time of acquisition and not
subject to any restriction on disclosure or
use;
(iv) information independently developed by the
receiving Party without the benefit or use of
confidential information; and
(v) information received from third parties,
provided that such information was not obtained
by such third party, indirectly or directly,
from the other Party under obligation of
confidence.
9.4 The obligations and restrictions imposed by this clause
shall continue in force for the duration of 10 years
from the Effective Date.
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10. TERM
10.1 Subject to clause 10.2, this Agreement shall continue
in force until the obligations of the Parties, other
than obligations under the clauses referred to in
clause 10.6, shall have been fulfilled.
10.2 Either Party shall be entitled forthwith to terminate
this Agreement by written notice to the other if:
(i) that other Party commits any breach of any of
the provisions of this Agreement and, in the
case of a breach capable of remedy, fails to
remedy the same within 30 days after receipt of
a written notice giving full particulars of the
breach and requiring it to be remedied;
(ii) an encumbrancer takes possession or a receiver
is appointed over any of the property or assets
of that other Party;
(iii) that other Party makes any voluntary
arrangement with its creditors or becomes
subject to an administration order;
(iv) that other Party goes into liquidation (except
for the purposes of amalgamation or
reconstruction and in such manner that the
company resulting therefrom effectively agrees
to be bound by or assume the obligations
imposed on that other Party under this
Agreement);
(v) anything analogous to any of the foregoing
under the law of any jurisdiction occurs in
relation to that other Party; or
(vi) that other Party ceases, or threatens to cease,
to carry on business.
10.3 For the purposes of clause 10.2(i), a breach shall be
considered capable of remedy if the Party in breach can
comply with the provision in question in all respects
other than as to the time of performance.
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10.4 Any waiver by either Party of a breach of any provision
of this Agreement shall not be considered as a waiver
of any subsequent breach of the same or any other
provision hereof.
10.5 The right to terminate this Agreement given by this
clause shall be without prejudice to any other right or
remedy of either Party in respect of the breach
concerned (if any) or any other breach.
10.6 Notwithstanding the termination of this Agreement, the
provisions of clauses 9, 11, and 12 shall continue in
force.
11. INDEMNIFICATION
11.1 The Purchaser shall indemnify and hold harmless AZ and
each of its officers, employees and agents (each an "AZ
Indemnitee") against any and all losses, damages,
liabilities or expenses in connection with any actions
or demands that may be brought against any AZ
Indemnitee by any non-Affiliate of the Parties arising
out of the manufacture, use or sale of any AZLAD
Product by the Purchaser, or by AZ in accordance with
this Agreement, the Existing Contracts, or clause 9.1
of the AZLAD Products Agreement, including any
investigation by any governmental agency with respect
to the quality of such Product, or any claim for death,
personal injury or property damage asserted by any user
of such Product, provided that the Purchaser shall not
be obliged to indemnify any AZ Indemnitee from any
loss, damage, liability or expense in connection with
any action or demand arising out of any event or
circumstance in which AZ is obliged to indemnify the
Purchaser pursuant to clause 11.2.
11.2
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AZ shall indemnify the Purchaser and each of its officers,
employees and agents (each a "Purchaser Indemnitee")
against any losses, damages, liabilities or expenses in
connection with any actions or demands that may be
brought against any Purchaser Indemnitee by any
non-Affiliate of the Parties to the extent such event
or circumstance: (i) occurred before the Effective Date
or (ii) arises out of the manufacture of AZLAD Products
by AZ otherwise than in accordance with GMP and the
relevant Marketing Authorisation or the sale of AZLAD
Products by AZ otherwise than in accordance with the
relevant Marketing Authorisation.
11.3 As promptly as practicable after any indemnitee
referred to in clauses 11.1 or 11.2 obtains knowledge
of any action or demand as to which it will or may be
entitled to indemnity under such clause, it shall give
notice to the Parties, provided that the failure to
give such notice shall not preclude or bar such claims
but shall reduce such claims to the extent of prejudice
to the indemnifying Party. The indemnifying Party
shall be entitled to participate in any proceedings
relating to such action or demand. The indemnitee shall
obtain the prior approval of the indemnifying Party,
which approval shall not be unreasonably withheld,
before entering into any settlement or compromise of
such action or demand, if as a result thereof the
indemnifying Party's indemnity obligations with respect
to such action or demand will not be discharged.
12. MISCELLANEOUS PROVISIONS
12.1 Neither Party shall be liable on any account for any
failure to fulfil any terms of this Agreement if such
fulfilment has been frustrated by Force Majeure,
provided that the Party which is prevented from
performing exercises diligent efforts to resume its
performance hereunder as soon as practicable.
12.2 Subject to clauses 2.5, 7.4 and 12.13, neither Party
shall be entitled to assign or sub-license any of its
rights or obligations under this Agreement without the
written consent of the other Party, which shall not be
unreasonably withheld.
12.3 If either Party shall assign or sub-license any of its
rights or obligations under this Agreement (other than
under the Contract Manufacturing Agreements):
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(i) it shall give notice of such assignment or
sub-licence to the other Party in writing not
later than seven days after the date of such
assignment or sub-licence,
(ii) if so required by the other Party, it shall be
a condition of such assignment or sub-licence
that the assignee or sub-licensee shall enter
into a direct undertaking with the other Party
to exercise any right and perform any
obligation assigned or sub-licensed in
accordance with the terms of this Agreement,
including the provisions of clause 9 and this
clause, and
(iii) the original Party shall indemnify the other
Party against any loss or damage which it may
suffer as the result of any breach of any
assigned or sub-licensed obligation or of the
terms of this Agreement by an immediate or
subsequent assignee or sub-licensee.
12.4 Notices to be served by either Party on the other shall
be in writing and shall be deemed for the purposes of
this Agreement to be properly given if sent by telefax
with confirmed receipt thereof, by courier service with
evidence of delivery or by registered mail, postage
prepaid, to the other Party at its address as set forth
below. Either Party may change such address for the
purposes of this Agreement by notice in writing to the
other Party. A notice shall be deemed to be served 24
hours after telefax transmission or 4 days after
posting by registered mail, whichever is sooner.
If to AZ:
AstraZeneca AB
For attn of President
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with copy to:
AstraZeneca plc
For attn of Company Secretary
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If to the Purchaser:
Maillefer Instruments Holdings S.A.
For attn of General Manager
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with copy to:
DENTSPLY International Inc
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Attention: Secretary
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12.5 The Parties agree that this Agreement and the
transactions contemplated hereby shall be governed by
and interpreted in accordance with the laws of England
unless otherwise stated herein or in any supplemental
agreement.
12.6 This Agreement and any amendments hereto comprise all
the terms and conditions of the agreement between the
Parties in respect of the subject matter hereof. This
Agreement may not be amended or modified except in
writing duly signed by both Parties.
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12.7 In the event of any conflict between the provisions of
this Agreement and any supplemental agreement, the
provisions of this Agreement shall prevail and in the
event of any conflict between the provisions of the
clauses of this Agreement and the provisions of any
Schedule, the provisions of the clauses shall prevail.
12.8 If the Parties shall execute any document in English
and another language, or if the Parties shall agree the
text of any document in English and the text of the
executed Agreement shall be written in another
language, the English text shall prevail as between the
Parties in the event of there being any discrepancy
between the texts and either Party shall at the request
of the other Party join with it in executing a
supplemental agreement to amend the foreign text to
remove such discrepancy.
12.9 If any provision of this Agreement is held to be
invalid or unenforceable by a competent legal
authority, the Parties shall meet and mutually agree to
amend this Agreement to incorporate new terms which
shall, to the greatest extent possible, restore the
economic balance contemplated by the Parties in
entering into this Agreement.
12.10 The failure by either Party to exercise or enforce any
right conferred upon it hereunder shall not be deemed
to be a waiver of such right or operate to bar the
exercise or enforcement thereof at any time thereafter.
12.11 Completion of the performance of any obligation arising
under this Agreement shall not affect the continuing
validity of any provision of this Agreement.
12.12 It is the intention of the Parties that this Agreement
shall be binding on their respective Affiliates and
accordingly each of them undertakes to procure the
compliance with the provisions of this Agreement of
their respective Affiliates as if signatories hereto.
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12.13 Either Party hereto may transfer any of its rights or
obligations hereunder to any of its Affiliates,
provided that each Party (i) guarantees the performance
of such Party's obligations so transferred pursuant to
this clause, (ii) such transfer shall not relieve the
transferring Party of its obligations under this
Agreement and (iii) prior to such Affiliate ceasing to
be an Affiliate the transferring Party shall procure
that all rights and obligations so transferred are
transferred back to the transferring Party.
12.14 Both Parties hereto agree to execute promptly and shall
compel their respective Affiliates to execute promptly
any separate agreements or other documents,
undertakings, or consents necessary or appropriate to
carry out the provisions of this Agreement. Such
agreements, documents, undertakings and consents shall
neither expand nor contract the rights and obligations
of the Parties hereto.
12.15 Except as otherwise provided for herein, all disputes
arising in connection with this Agreement, including
any amendments, shall be finally settled under the
Rules of Conciliation and Arbitration of the
International Chamber of Commerce by three arbitrators
appointed in accordance with such Rules. The arbitral
proceedings shall be held in English and shall take
place in London. The arbitral tribunal shall conduct
and complete its proceedings and render a final written
opinion within 180 days of the date on which the
arbitral proceedings are initiated. The Parties agree
that any right of appeal against any arbitral award or
order to the Court is hereby waived. The Parties
further agree that it is their expressed intent that
until the tribunal renders its final award, the status
quo of the continuing relationship is to be maintained
to the maximum possible extent and that the arbitrators
are hereby directed to enforce such agreement of the
Parties. In addition, the Parties agree that any
injunctive relief must be sought in such arbitral
proceeding and not in any other proceedings. The
Parties further agree that any award or order issued by
the arbitral tribunal shall be enforceable in
accordance with its terms in any court of competent
jurisdiction.
12.16 Each Party shall be entitled to make such announcements
relating to this Agreement and any supplemental
agreements as shall be appropriate, but each Party
shall first consult in good faith with the other Party
concerning the contents of such announcements.
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IN WITNESS whereof the Parties have caused this Agreement to be
executed the day and year first above written, in duplicate
counterparts, each of which shall constitute an original, by
their respective duly authorised representatives.
SIGNED for and on behalf of SIGNED for and on behalf of
ASTRAZENECA ▇▇ ▇▇▇▇▇▇▇▇▇ INSTRUMENTS
(publ) HOLDINGS S.A.
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