EXHIBIT 10.22(a)
DATED 18TH JANUARY 2001
astrazeneca ab (1)
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MAILLEFER INSTRUMENTS HOLDINGS
S.A. (2)
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AZLAD PRODUCTS 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 XX-000 00
Xxxxxxxxxx, Xxxxxx ("AZ"), and
(2) MAILLEFER INSTRUMENTS HOLDINGS S.A., a company
incorporated under the laws of Switzerland and having
its principal office at Xxxxxx xx Xxxxxx 0, XX-0000
Xxxxxxxxxx, Xxxxxxxxxxx (the "Purchaser").
BACKGROUND
A. AZ has developed and manufactures and sells worldwide a
range of injectable dental local anaesthetic products
and has registered various trade marks in respect
thereof.
B. AZ has agreed with the Purchaser on the terms herein
contained:
(i) to grant to the Purchaser a permanent, fully
paid licence to use the Technical Information
(as hereafter defined) to develop, manufacture
and sell injectable dental local anaesthetic
products in the Territory (as hereafter
defined);
(ii) to grant to the Purchaser a permanent, fully
paid licence to use certain trade marks in
respect of specific injectable dental local
anaesthetic products; and
(iii) to manufacture injectable dental local
anaesthetic products for the Purchaser for a
limited period of time.
C. AZ is also developing but has not yet launched a
non-injectable periodontal anaesthetic product known as
Oraqix intended for use as a local anaesthetic in the
treatment of periodontitis and has agreed with the
Purchaser to grant to the Purchaser rights in respect
of Oraqix products in accordance with the Oraqix
Agreement (as hereafter defined).
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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,
(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.
"Ancilliary Items" means the devices for the
administration of AZLAD Products and the other items
listed in Schedule 1.
"Applicable LIBOR" means the relevant LIBOR rate, which
initially shall be the LIBOR rate published on 28th
February 2001, but if and whenever thereafter the LIBOR
rate published on the last business day of a month
shall vary by at least one percentage point from the
then current Applicable LIBOR, shall be increased or
reduced as the case may be to the LIBOR rate published
on such subsequent date.
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"AZLAD Products" means the LAD Products manufactured
and/or sold by AZ listed in Schedules 8 and 9 and
described in the Marketing Authorisations for such
products.
"AZLAD Products Manufacturing Agreement" means the
agreement relating to the manufacture of AZLAD Products
by AZ for the Purchaser to be entered into by the
Parties on the Agreement Date in accordance with clause
6.1.
"AZ Marketing Authorisations" means the Marketing
Authorisations granted to AZ in the Territory for the
sale of AZLAD Products, including or comprising the
Marketing Authorisations listed in Schedule 10.
"AZ Trade Marks" means the trade marks listed in
Schedule 2, Part A.
"AZ Trade Marks Licence Agreement" means the agreement
relating to the licensing of the AZ Trade Marks by AZ
to the Purchaser to be entered into by the Parties on
the Agreement Date in accordance with clause 3.
"Combined Gross Sales" means the aggregate combined
Gross Sales of LAD Products and Oraqix 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
"Consideration" means the Fixed Consideration and the
Contingent Consideration.
"Contingent Consideration" means the sum determined by
reference to the month in which the Payment Date shall
occur, calculated in accordance with clause 5.3.
"Contract Manufacturers" means Fujisawa and Pierrel.
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"Contract Payment Date" means the earliest of:
(i) the date which is 14 days after the Purchaser
shall have reported to AZ in accordance with
clause 5.5, or the independent accounting firm
referred to in clause 5.6, shall have reported
to AZ and the Purchaser in accordance with
clause 5.6 that the Combined Gross Sales in any
Relevant Period shall have exceeded the
Relevant Target; and
(ii) the date which is 14 days after the date when
the condition contained in clause 5.4(ii) shall
be fulfilled; and
(iii) the date which is 14 days after the date when
AZ shall receive from the bank or other issuer
of the Letter of Credit such notice as is
referred to in clause 5.4(iii).
"Cost of Goods" means
(i) in respect of AZLAD Products manufactured by
AZ, AZ's ex-works prices as shown in the price
lists, by manufacturing location, contained in
Schedule 3;
(ii) in respect of AZLAD Products manufactured by a
Contract Manufacturer, AZ's direct purchase
costs under the contract with the Contract
Manufacturer for the manufacture and supply of
such products plus the cost of the active
ingredient supplied by AZ to the Contract
Manufacturer, the costs applying in 2001 being
shown in Schedule 3;
(iii) in the event of AZ purchasing AZLAD Products
from the Purchaser during the period between
the Effective Date and the Transfer Date, AZ's
direct purchase costs; and
(iv) in respect of Ancilliary Items, AZ's direct
purchase costs under contracts for the purchase
of such items.
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All costs quoted in local currencies shall be converted
into US dollars by AZ in accordance with its standard
accounting policies approved by its independent
auditors for use in its financial statements.
"Country" means a country within the Territory.
"Dental Products" means 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. It is
agreed that LAD Products are Dental Products, but
multi-use vials, glass ampoules and topical
formulations are not Dental Products for the purpose of
this definition.
"Effective Date" means 1st March 2001.
"Existing Contracts" means Existing Dental Contracts
and Existing General Contracts.
"Existing Dental Contracts" means the agreements listed
in Schedule 5, Part A.
"Existing General Contracts" means the agreements
listed in Schedule 5, Part B.
"Fixed Consideration" means the sum of US$96,500,000
(ninety-six million, five hundred thousand US dollars).
"Force Majeure" means any circumstances beyond the
control of a Party, including strikes, lockouts, civil
commotion, accidents, wars, acts of God and
governmental regulations.
"Fujisawa" means Fujisawa Pharmaceutical Company
Limited.
"General Transfer Arrangements" means the arrangements
for the provision of the Regulatory Know-How, Technical
Information and Marketing Data by AZ to the Purchaser
and the transfer of the AZ Marketing Authorisations set
out in Schedule 4.
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"GMP" means the requirements set out in the World
Health Organisation code on "Good Practices 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.
"Gross Sales" means the aggregate sales prices
(excluding VAT or other sales taxes) of LAD Products
and Oraqix Products sold by either Party or its
Affiliates or licensees subsequent to the Effective
Date as shown in its financial statements prepared in
accordance with US GAAP or other applicable accounting
standards.
Any product sold or otherwise transferred (excluding
supplies of clinical trial material or free samples) in
other than an arm's length transaction or for other
property (e.g. barter) shall be deemed sold at its fair
market price in the Country of sale or transfer.
"Gross Sales" shall exclude sales or transfers of a
product between the Purchaser (or, where appropriate,
AZ) and their Affiliates and licensees or between the
Parties unless the receiving party is the consumer or
user of the product; however, the resale or retransfer
of such product to a third party shall be included in
"Gross Sales".
References to "licensees" shall exclude distributors
whose function is to purchase and resell products.
Gross Sales made in a currency other than US dollars
shall be converted from local currency to US dollars by
the Purchaser (or, where appropriate, AZ) in accordance
with its standard accounting policies approved by its
independent auditors for use in its financial
statements.
"LAD Product Category" means a LAD Product category set
out in Schedule 2, Part A.
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"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.
"Letter of Credit" means the letter of credit referred
to in clause 5.10 or any letter of credit issued to AZ
by way of substitution for or renewal of such letter of
credit.
"LIBOR" means the 30 days US dollar BBA London
Interbank Offered Rate as published by Reuters.
"Marketing Authorisations" means the registrations
granted by the Competent Authorities in the Territory
for the sale of LAD Products and, where applicable, for
approval of prices and cost reimbursements, and where
the context admits shall include any modifications or
replacements thereof.
"Marketing Data" means the information relating to
AZLAD Products listed in Schedule 4, Part C.
"Net Sales" means the aggregate gross invoice prices of
products sold by AZ or its Affiliates or licensees
after deducting VAT, consumption tax and other
governmental duties, fees and charges, trade and
quantity discounts, returns and allowances, rebates,
charge backs and other post-sale performance related
rebates, and retroactive price reductions, and less all
transportation, insurance and brokerage costs relating
to the products after release from the manufacturing
site. For the purpose of computing Net Sales sold in a
currency other then US dollars, such currency shall be
converted from local currency to US dollars by AZ in
accordance with its standard accounting policies
approved by its independent auditors for use in its
financial statements.
"Oraqix Agreement" means the agreement relating to the
grant by AZ to the Purchaser of rights in respect of
the non-injectable periodontal anaesthetic product
known as Oraqix to be entered into by the Parties on
the Agreement Date in accordance with clause 11.1.
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"Oraqix Manufacturing Agreement" means the agreement
relating to the manufacture of Oraqix Products by AZ
for the Purchaser to be entered into by the Parties on
the Agreement Date in accordance with the Oraqix
Agreement.
"Oraqix Products" has the same meaning as in the Oraqix
Agreement.
"Payment Date" means the date on which the Purchaser
shall pay the Contingent Consideration to AZ.
"Pierrel" means Pierrel Farmaceutics S.p.A.
"Product Formulations" means the pharmaceutical
formulations of AZLAD Products listed in Schedule 8.
"Product Packs" means the shelf keeping units of AZLAD
Products listed in Schedule 9.
"Regulatory Know-How" means the information contained
in the current approved regulatory dossier for each
Product Formulation as filed in each Country and any
additional information contained in the current core
regulatory dossiers for each Product Formulation held
by AZ.
"Relevant Period" means:
(i) during the first 12 months from the Effective
Date, the number of calendar months (not being
less than 4 months) from such date which shall
have expired; and
(ii) thereafter, any period of 12 calendar months
ending after 28th February 2002.
"Relevant Target" means in respect of a Relevant Period
the amount of Combined Gross Sales for such Relevant
Period as set out in Schedule 13, Part A.
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"Safety Information Exchange Agreement" means the
agreement to be entered into by the Parties in
accordance with clause 8.3.
"Technical Information" means the technical information
required for the manufacture, analysis, packaging and
storage of AZLAD Products contained in the current
manufacturing binders for each Product Formulation held
by each of AZ's production plants and any revisions of
such information made during the term of the AZLAD
Products Manufacturing Agreement.
"Territory" means the World, excluding India, subject
to clause 7.6.
"Transfer Date" means
(i) in the case of each Country and Product Pack
for which AZ shall hold an AZ Marketing
Authorisation, the date when the Competent
Authority shall approve the transfer of the
Marketing Authorisation into the name of the
Purchaser or its nominee or shall grant in
place thereof a new Marketing Authorisation in
the name of the Purchaser or its nominee, or
such earlier date when the Purchaser shall be
able to commence selling the Product Pack in
the Country, whether as AZ's distributor or
otherwise; and
(ii) subject to clause 4 relating to Existing
Contracts, in all other cases, the Effective
Date or such later date when the Purchaser or
its distributor or agent shall be able to
commence selling the Product Pack in the
Country.
"Transferring Employees" means the employees listed in
Schedule 6.
"Warranties" means the warranties contained in clause
13.1.
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"Warranty Claim" means any claim made by the Purchaser
or any person deriving title from the Purchaser against
AZ under the Warranties.
1.3 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.
2. TECHNICAL INFORMATION LICENCE
2.1 With effect from the Effective Date, AZ grants to the
Purchaser a permanent, royalty-free licence to use the
Technical Information for the purpose of developing,
manufacturing, having manufactured, using, selling and
dealing in the Territory in Dental Products, such
licence to be exclusive (subject to clause 4.1) for the
period of ten years and thereafter to be
non-exclusive. After the expiry of such period of 10
years, the restriction on use of the Technical
Information by the Purchaser shall cease. It is agreed
that the rights hereby granted to the Purchaser shall
not at any time preclude AZ from using the Technical
Information in respect of products other than Dental
Products.
3. AZ TRADE MARKS LICENCE AND ASSIGNMENT
3.1 On the Agreement Date, the Parties shall enter into the
AZ Trade Marks Licence Agreement.
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3.2 Within 90 days after the Effective Date, AZ shall
assign to the Purchaser the AZ Trade Marks NUROCAIN(R),
XYLOTOX(R) and LIGNOSTAB(R) and all goodwill therein but
without the goodwill of the business in the goods in
respect of which such trade marks are registered in all
Countries in which they are registered by AZ as listed
in Schedule 2, Part B and shall assign to the Purchaser
its right and interest in such AZ Trade Marks in other
Countries where they are used by AZ in respect of AZLAD
Products as listed in Schedule 2, Part C. Such
assignments shall be in the form set out in Schedule 12
or in such other form to be agreed between the Parties
based so far as practicable on the form set out in such
Schedule as shall be appropriate for assignment and, as
applicable, registration purposes in such Countries.
The Purchaser shall register such assignments in
respect of the registered AZ Trade Marks at the
relevant registries at its own expense.
3.3 To the extent that AZ is able to do so, with effect
from the Effective Date AZ grants to the Purchaser the
right to use the colour coding and trade dress of AZLAD
Products in use at the Effective Date in connection
with the relevant LAD Products manufactured and sold by
the Purchaser.
4. EXISTING CONTRACTS
4.1 The rights granted by AZ to the Purchaser under or
pursuant to this Agreement shall be subject to the
Existing Contracts.
4.2 The Parties recognise that the Existing Dental
Contracts relate to Dental Products only and the
Existing General Contracts relate to Dental Products
and other products. The Parties further recognise that
some or all of the Existing Dental Contracts may not be
assignable by AZ to the Purchaser without the consent
of the other party thereto.
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4.3 In the case of each Existing Dental Contract which is
assignable by AZ to the Purchaser without the consent
of the other party thereto, AZ shall assign the
Existing Dental Contract to the Purchaser with effect
from the Effective Date. Under the terms of such
assignment, all receivables, expenditure and
liabilities arising under the Existing Dental Contract
in respect of any act, omission, event or period up to
the Effective Date shall be payable to or borne by AZ
and all receivables, expenditure and liabilities
arising under the Existing Dental Contract in respect
of any act, omission, event or period on or after the
Effective Date shall be payable to or borne by the
Purchaser.
4.4 In the case of each Existing Dental Contract which is
not assignable by AZ to the Purchaser without the
consent of the other party thereto, AZ shall use its
reasonable endeavours to obtain such consent for the
assignment of the Existing Dental Contract to the
Purchaser on the terms set out in clause 4.3.
4.5 In the case of each Existing General Contract, AZ shall
use its reasonable endeavours to persuade the other
party thereto to enter into new agreements with the
Purchaser and AZ with effect from the Effective Date
relating to Dental Products and other products
respectively in substitution for the Existing General
Contract, the new agreement relating to Dental Products
being on the same terms mutatis mutandis as the
Existing General Contract and in accordance with the
terms set out in clause 4.3.
4.6 In the case of any Existing Dental Contract where AZ
shall fail to obtain the consent of the other party to
the assignment of the Existing Dental Contract on the
terms stated in clause 4.4, and in the case of any
Existing General Contract where AZ shall fail to
persuade the other party to enter into agreements on
the terms stated in clause 4.5, the Parties shall
co-operate with each other so as to provide the
Purchaser with effect from the Effective Date to the
greatest extent possible with the benefit and burden of
the Existing Contract so far as it relates to Dental
Products.
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4.7 The provisions of clause 4.6 shall not preclude AZ from
exercising any right to terminate an Existing Contract,
provided that before exercising such right it shall
consult with the Purchaser as soon as reasonably
practicable and in such consultation each Party shall
have due regard to the commercial interests of the
other Party, provided that significant weight shall be
given to the objective of clause 4.6.
5. CONSIDERATION
5.1 Subject and without prejudice to:
(i) the provisions of clause 8 of the Oraqix
Agreement relating to the payment by the
Purchaser to AZ in the circumstances therein
stated of certain milestone and royalty
payments, and
(ii) any other provisions contained in this
Agreement or any supplemental agreement
requiring the Purchaser to bear any costs or to
pay or reimburse any sums to AZ
the Consideration comprises the entire consideration
payable by the Purchaser to AZ for the rights granted
by AZ to the Purchaser under this Agreement and the
AZLAD Products Manufacturing Agreement, the AZ Trade
Marks Licence Agreement, the Oraqix Agreement and the
Oraqix Manufacturing Agreement, including the
consideration for the sale of the manufacturing
equipment owned by AZ to be transferred by AZ to the
Purchaser in accordance with the AZLAD Products
Manufacturing Agreement and the Oraqix Manufacturing
Agreement when it ceases to manufacture AZLAD Products
or Oraqix Products (as the case may be) for the
Purchaser in accordance with such Agreements. The
proportion of the Consideration attributable to such
manufacturing equipment shall be an amount equal to the
value of such equipment at the date of transfer as
agreed between the Parties or, in default of agreement,
determined by an independent expert and AZ shall render
invoices for such manufacturing equipment to the
Purchaser or its nominee at the date of transfer. It
is recognised that the net purchase price for such
equipment shall have been paid as part of the Fixed
Consideration, but, depending on the identity of the
purchaser and seller, MOMS or other sales taxes may
additionally be payable at the time of transfer.
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5.2 The Fixed Consideration shall be paid in full on the
Effective Date by telegraphic transfer to the following
bank account:
Bank Name: SEB Stockholm
Account No: 5201 0000000
Swift: ESSE SESS.
5.3 The Contingent Consideration shall be a sum which shall
increase on a monthly basis as follows:
(i) In the first calendar month after the Effective
Date, that is in March 2001, the amount of the
Contingent Consideration shall be US$20,000,000
(twenty million US dollars).
(ii) At the start of each succeeding calendar month,
the amount of the Contingent Consideration
shall be increased on a compound basis by
Applicable LIBOR multiplied by 30/360. The
table contained in Schedule 13, Part B
illustrates what the amount of the Contingent
Consideration would be in each month in the
period from the Effective Date until 31st
December 2002 if Applicable LIBOR was at all
times 6.5%.
5.4 The Contingent Consideration shall be payable in full
in any of the following cases:
(i) if in any Relevant Period the Combined Gross
Sales shall exceed the Relevant Target; or
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(ii) if at any time the Purchaser shall dispose of
or discontinue the whole or a material part of
its business of selling LAD Products and Oraqix
Products. For the purpose of this paragraph
(ii), the Purchaser shall be deemed to have
disposed of or discontinued a material part of
such business if in any period of 12 months it
shall cease to sell in one or more Countries
certain Product Packs and/or Oraqix Products
(otherwise than as part of a bona fide product
rationalisation programme designed to increase
sales) and in the preceding period of 12
months, whether falling before or after the
Agreement Date, the Combined Gross Sales of
such Product Packs and Oraqix Products in the
said Countries shall have represented not less
than 5% of Combined Gross Sales of all LAD
Products and Oraqix Products in the Territory
in such period. Until the Contingent
Consideration shall have been paid, the
Purchaser shall inform AZ in writing of each
disposal or discontinuance of any part of its
business of selling LAD Products and Oraqix
Products and shall provide AZ on a monthly
basis with the Gross Sales information required
by AZ to ascertain whether the condition
contained in this clause 5.4(ii) shall have
been fulfilled; or
(iii) if the bank specified in Schedule 13, Part C or
other issuer of the Letter of Credit shall give
to AZ notice in writing that it elects not to
consider the Letter of Credit automatically
extended on the next expiry date, being an
expiry date prior to 1st March 2008.
5.5 Within 60 days after the end of each month, the
Purchaser shall give to AZ a written report of the
Combined Gross Sales during the Relevant Period
expiring at the end of such month.
5.6
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The Purchaser shall keep accurate records in accordance with
applicable generally accepted accounting principles
showing the information which is necessary for the
accurate determination of Gross Sales. Such records
shall be kept at the Purchaser's principal place of
business or other location approved by AZ for at least
5 years from the end of the calendar year to which they
pertain. The Purchaser agrees to permit a certified
public accountant or a person possessing similar
professional status and associated with an independent
accounting firm acceptable to the Parties to inspect
such records during regular business hours to check the
accuracy of the reports given by the Purchaser in
accordance with clauses 5.4(ii) and 5.5. The
accounting firm shall enter into appropriate
obligations with the Purchaser to treat all information
it receives during its inspection in confidence. The
accounting firm shall disclose to AZ and the Purchaser
only whether the Gross Sales' reports of the Purchaser
are correct and details concerning any discrepancies,
but no other information shall be disclosed to AZ. The
charges of the independent accounting firm shall be
paid by AZ, except if the Gross Sales have been
mis-stated by more than 2 per cent in which case the
charges shall be paid by the Purchaser.
5.7 The Purchaser shall pay the Contingent Consideration to
AZ on the Contract Payment Date or on such earlier date
as the Purchaser, by notice in writing given to AZ on
or after 1st July 2001, shall stipulate.
5.8 The Contingent Consideration shall be paid by
telegraphic transfer to the bank account referred to in
clause 5.2 or to such other bank account as AZ by
notice in writing to the Purchaser shall designate.
5.9 The Contingent Consideration shall not be payable if
neither of the conditions contained in clause 5.4 shall
be fulfilled, provided that in no circumstances shall
the Contingent Consideration be repayable if paid by
the Purchaser prior to the fulfilment of such
conditions.
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5.10 As security for the Purchaser's contingent obligation
to pay the Contingent Consideration the Purchaser shall
at its own expense procure for the exclusive benefit of
AZ and shall deliver to AZ on the Effective Date an
irrevocable letter of credit from the bank specified in
Schedule 13, Part C in the form set out in Schedule 13,
Part C.
5.11 All sums payable under this Agreement shall be paid
without deduction of any bank or transfer charges. All
sums are net of MOMS (i.e. Swedish value added tax) and
other similar sales taxes which shall be added if
appropriate. All sums shall be paid without deduction
for any tax or duty levied outside Sweden, unless
applicable laws require that taxes be withheld. Gross
up shall not be made by the Purchaser to the extent
that AZ can obtain relief, including credits or
exemptions, for such taxes under the relevant Double
Taxation Agreement or Swedish law but, if no such
relief is available, the Purchaser shall gross up the
payment so that AZ shall receive the net amount to
which it is entitled. The Purchaser and AZ shall
mutually co-operate to apply any treaty relief that is
available which reduces the level of taxes required to
be withheld. If applicable laws require that taxes be
withheld, the Purchaser will deduct those taxes from
the remittable payments, make timely payment of the
taxes to the proper taxing authority and send proof of
such payment to AZ within sixty days following that
payment. The Purchaser agrees to take all steps
reasonably requested by AZ to minimise such taxes to
AZ.
5.12 Each Party shall reimburse to the other Party within 60
days of receipt of the other Party's invoice any
expenses borne by such other Party which under the
terms of this Agreement the first Party is liable to
reimburse.
5.13 In the event of any delay in payment of the
Consideration or reimbursement of any expenses and
without prejudice to any other remedies available,
interest shall be payable at LIBOR plus 3% or, in the
case of the Contingent Consideration at LIBOR plus 5%.
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5.14 This Agreement shall be conditional upon:
(i) the Purchaser paying the Fixed Consideration to
AZ in full on the Effective Date, and
(ii) the Purchaser delivering the original, duly
executed Letter of Credit to AZ on the
Effective Date.
In the event that any default in payment of the Fixed
Consideration or delivery of the Letter of Credit shall
continue for more than seven days after the Effective
Date, AZ shall be entitled to cancel this Agreement by
written notice to the Purchaser without prejudice to
any other right or remedy of AZ in respect of such
breach. In the event of such cancellation, the AZLAD
Products Manufacturing Agreement, the AZ Trade Marks
Licence Agreement, the Oraqix Agreement and the Oraqix
Manufacturing Agreement shall automatically be
cancelled at the same time and the Parties shall
execute any documents which shall be appropriate to
give effect to such cancellation.
6. AZLAD PRODUCTS MANUFACTURING AGREEMENT
6.1 On the Agreement Date, the Parties shall enter into the
AZLAD Products Manufacturing Agreement relating to the
manufacture and packaging of AZLAD Products by AZ for
the Purchaser.
7. TRANSFER OF AZ MARKETING AUTHORISATIONS
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7.1 The Purchaser, or AZ in co-operation with the
Purchaser, shall make such applications to the
Competent Authorities in the Territory as shall be
necessary for the purpose of transferring the AZ
Marketing Authorisations to the Purchaser or, if
appropriate, for the grant of new Marketing
Authorisations in the name of the Purchaser or its
nominee in place thereof, such applications to be made
to the extent reasonably possible within 90 days after
the Agreement Date. If AZ shall be obliged to make
such application, the Purchaser shall provide it with
such information and assistance as shall be necessary.
The duties of each Party are further detailed in
Schedule 4, Part D. The Party responsible for making
the application shall notify the other Party promptly
of the date when the transfer is effected.
7.2 Pending and until the transfer of the AZ Marketing
Authorisations or the grant of new Marketing
Authorisations in place thereof and subject to the
Purchaser diligently performing its obligations under
clause 7.1, AZ shall maintain the AZ Marketing
Authorisations in force, but AZ's obligations under
this clause 7.2 shall cease upon the expiry of 36
months from the Effective Date.
7.3 All fees payable to the Competent Authorities relating
to the transfer of the AZ Marketing Authorisations or
the grant of new Marketing Authorisations in place
thereof or the maintenance of the AZ Marketing
Authorisations after the Effective Date shall be borne
by the Purchaser.
7.4 The provisions of clauses 7.1 to 7.3 shall be subject,
where applicable, to the provisions of clause 4
relating to the Existing Contracts.
7.5 In the case of any Country and Product Pack for which
the Marketing Authorisation for AZLAD Products shall be
held by a third party at the Effective Date, and where
the provisions of the Existing Contracts shall not
apply, AZ shall provide such assistance to the
Purchaser as it may reasonably require in order to
enable it to sell such Product Packs or to have the
benefit of existing sales arrangements for such Product
Packs in such Country.
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7.6 In the case of Libya and Iraq, the Purchaser may by
notice in writing to AZ given on or before 15th March
2001 decline to accept the grant of any rights under
this Agreement in respect of either or both such
Countries. In such event, this Agreement shall be
construed as if the definition of the Territory
excluded such Country or Countries.
8. GENERAL TRANSFER ARRANGEMENTS
8.1 The transfer of the Regulatory Know-How, Technical
Information and Marketing Data by AZ to the Purchaser
shall be effected on a Country by Country basis in
accordance with the General Transfer Arrangements.
8.2 AZ shall provide the Purchaser with such further
assistance as may reasonably be requested by the
Purchaser in connection with its manufacture and sale
of LAD Products in accordance with the General Transfer
Arrangements.
8.3 The Parties shall enter into the Safety Information
Exchange Agreement in the form set out in Schedule 11
on or as soon as practicable after the Effective Date.
9. INTERIM ARRANGEMENTS
9.1 During the period from the Effective Date until the
Transfer Date, the Parties shall endeavour to enable
the Purchaser to sell each Product Pack in each
Country, including AZ appointing the Purchaser as AZ's
distributor in such Country, if necessary, but if it
shall not be feasible or legally permissible for the
Purchaser to sell a Product Pack in a Country, AZ shall
continue to sell such Product Pack in such Country and
shall account to the Purchaser for an amount equal to
Net Sales less 3% less Cost of Goods. Within 60 days
after the end of each month, AZ shall deliver to the
Purchaser a statement setting forth the calculation of
Net Sales in relevant Countries and the calculation of
the amount owing to the Purchaser and shall at the same
time pay to the Purchaser the amount due to the
Purchaser in respect thereof. Payments by AZ to the
Purchaser shall be effected by telegraphic transfer to
such bank account as the Purchaser may from time to
time specify and until otherwise specified to:
9.2
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Bank Name: Union Banques Suisses
Bank Address: 1400 Yverdon-Les-Bains
Swift: XXXXXXXX00X
Account No: 297-701.047.60A
Account Name: Maillefer Instruments Holdings
S.A.
9.3 During the period from the Effective Date until the
Transfer Date, AZ shall have no obligation to promote
sales of AZLAD Products in the Territory, without
prejudice to AZ's obligation under clause 9.1 to
conduct, but not to promote, sales of AZLAD Products
from the Effective Date until the Transfer Date.
9.4 For avoidance of doubt, it is agreed that if, in
respect of any Product Pack in any Country during the
period from the Effective Date until the Transfer Date,
AZ shall manufacture and release for sale stocks of
such Product Pack in accordance with orders placed by
the Purchaser under the provisions of the AZLAD
Products Manufacturing Agreement, the provisions of
this clause 9 shall apply and the Purchaser shall not
purchase and pay for such stocks under the terms of the
AZLAD Products Manufacturing Agreement.
9.5 At the time when the Purchaser shall be able to
commence selling a Product Pack in a Country, subject
to all relevant regulatory provisions:
(i) the Parties shall at the Purchaser's cost write
to all dealers and major direct customers in
such Country to notify them of the new
distribution arrangements and AZ shall transfer
to the Purchaser and the Purchaser shall take
over from AZ all unfulfilled orders for the
sale of such Product Packs in such Country;
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(ii) AZ shall sell to the Purchaser or its
designated Affiliate and the Purchaser or such
Affiliate shall purchase the marketable stocks
of such Product Pack already packaged and/or
labelled for sale in the Country, including the
stocks referred to in clause 9.3 remaining
unsold, at AZ's normal gross invoice prices for
sale to third parties, provided that the
Purchaser shall not be obliged to purchase
stocks having a remaining shelf life of less
than seven months and shall be obliged to
purchase stocks only to the extent of the level
of inventory, normal and historic, reasonable
to satisfy demand within such shelf life
period; and
(iii) the Parties shall undertake a joint stock count
to verify the volume of AZLAD Products to be
sold under paragraph (ii).
9.6 AZ shall render an invoice to the Purchaser for the
price of the stocks sold in accordance with clause 9.4
promptly after the Parties have conducted the physical
count thereof and the Purchaser shall pay such invoice
within 60 days. Where applicable, VAT, sales taxes and
similar taxes shall be added at the prevailing rate to
the price of the marketable stocks sold in accordance
with clause 9.4.
9.7 For avoidance of doubt, the stocks sold by AZ to the
Purchaser in accordance with clause 9.4(ii) shall be
included in the sales for which AZ shall account to the
Purchaser in accordance with clause 9.1, provided that
there shall be no reduction of three percent (3%) for
such sales and any such sales of stock shall be
specifically identified as to the location from which
such stocks are transferred to the Purchaser.
9.8 During the period in which AZ shall continue to sell
Product Packs under clause 9.1, AZ shall conduct such
activities in the ordinary course of business and
consistent with past practice.
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9.9 In the USA, during the period from the Transfer Date
until the date when the Contingent Consideration shall
be paid by the Purchaser to AZ, the Purchaser shall
reinstate a dual distribution system of LAD Products
whereby it shall sell LAD Products both to dealers and
end users in order to maximise Gross Sales of LAD
Products in the USA.
10. ANCILLIARY ITEMS
10.1 During the period in which AZ shall continue to sell
any Product Pack in a Country under clause 9.1, AZ
shall sell Ancilliary Items on the Purchaser's behalf
in such Country. In respect of such sales and the sale
by AZ to the Purchaser of AZ's marketable stocks of
Ancilliary Items, the provisions of clause 9 shall
apply mutatis mutandis.
10.2 Subject to clause 10.1, AZ shall have no obligation to
sell Ancilliary Items after the Effective Date.
10.3 AZ shall provide the Purchaser with assistance to
enable it to obtain further supplies of Ancilliary
Items in accordance with the General Transfer
Arrangements.
11. ORAQIX AGREEMENT
11.1 On the Agreement Date the Parties shall enter into the
Oraqix Agreement.
12. AZ RESTRICTIONS
12.1 AZ undertakes to the Purchaser that it will not during
the period of ten years from the Effective Date
(otherwise than on behalf of or in co-operation with
the Purchaser or in accordance with the provisions of
this Agreement):
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(i) be engaged or interested in the Territory in
the manufacture or sale of Dental Products, or
(ii) grant to any other person the right to sell or
provide to any other person any assistance for
the purpose of selling Dental Products in the
Territory.
12.2 AZ undertakes to the Purchaser that it will not at any
time after the Agreement Date (otherwise than as
aforesaid):
(i) use or grant to any other person the right to
use the AZ Trade Marks in the Territory for any
purpose except in connection with local
anaesthetic products other than Dental
Products, or
(ii) use or grant to any other person the right to
use the AZ Trade Xxxx ASTRACAINE(R) in the
Territory for any purpose.
12.3 For avoidance of doubt, no breach of the restrictions
contained in clause 12.1 shall be committed by AZ by
reason of another member of any group of companies of
which AZ may hereafter become a member, not being an
Affiliate of AZ at the Agreement Date, being engaged or
interested in the manufacture or sale of Dental
Products, without assistance from AZ.
13. WARRANTIES AND UNDERTAKINGS
13.1 AZ warrants to the Purchaser that in respect of the
Territory, except as disclosed in Schedule 14 and
subject to the Existing Contracts:
(i) it is the owner of and is entitled to license
the AZ Trade Marks as listed on a Country by
Country basis in Schedule 2, Part B and, to the
best of its knowledge, the use of them on or in
relation to AZLAD Products in such Countries
will not infringe the rights of any other
person;
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(ii) it is the owner of and is entitled to transfer
the Technical Information to the Purchaser free
and clear of any liens and claims;
(iii) to the best of its knowledge, it is the owner
of and is entitled to transfer the Regulatory
Know-How and the Marketing Data to the
Purchaser free and clear of any liens and
claims;
(iv) it is the owner of and has the right to
transfer all the AZ Marketing Authorisations
all of which are in force and, to the best of
its knowledge, the regulatory dossiers
presented to each authority for registering
AZLAD Products describe the action of AZLAD
Products and set forth their quality, safety
and efficacy characteristics;
(v) to the best of its knowledge, the financial
information listed in Schedule 15 given by AZ
to the Purchaser in writing with respect to
AZLAD Products was when given true and accurate
in all material respects and no circumstance
has arisen since such information was supplied
which would render such information untrue or
inaccurate in any material respect;
(vi) no action or proceeding, including government
proceedings, having, or that may have, a
material adverse effect on AZ's business of
manufacturing and selling AZLAD Products, has
been commenced or continued during the past two
years, nor is any such action or proceeding
pending against AZ with respect to AZLAD
Products, the Regulatory Know-How, the
Technical Information or the Marketing Data;
(vii) with respect to AZLAD Products and their
manufacture and sale, there is no material
non-compliance or alleged non-compliance by AZ
with any applicable statute, order or
regulation and no material infringement or
alleged infringement by AZ of any proprietary
right of any third party;
202
(viii) it has no commitment to supply AZLAD Products
to customers in the Territory, other than
commitments entered into in the ordinary course
of business, which is not terminable upon no
more than 90 days' notice by it or the
Purchaser without compensation for breach of
contract;
(ix) to the best of its knowledge, the AZ Trade
Marks, the Marketing Authorisations, Regulatory
Know-How and Technical Information comprise all
of such items and information necessary for the
operation of the AZLAD business as conducted by
AZ;
(x) the Existing Contracts, true copies of which
have been made available for review by the
Purchaser, are all of the agreements entered
into by AZ which will impose limitations or
obligations of an onerous or long-term nature
on the Purchaser in connection with its
operation of the business of manufacturing and
selling LAD Products; and
(xi) having regard to the AZLAD Products business of
AZ as a whole and excluding general business
trends, there has been no material adverse
change in such business occurring since 14th
August 2000.
13.2 Each Party hereby warrants to the other that:
(i) it is validly existing and in good standing
under the jurisdiction of its incorporation and
has all requisite power and authority,
corporate or otherwise, to execute, deliver and
perform this Agreement;
(ii) the execution, delivery and performance by it
of this Agreement will not violate any
provision of any law or regulation presently in
effect having applicability to it or any
provision of its charter or by-laws or similar
organisational document or result in a breach
of any obligation or restriction binding it;
203
(iii) this Agreement is a legal, valid and binding
obligation of such party, enforceable against
it in accordance with its terms and conditions;
and
(iv) it is not under any obligation to any person,
contractual or otherwise, or under any court
order or decree which would be violated by or
prevent the entering into of this Agreement and
the consummation of the transactions described
herein or which it knows to be conflicting or
inconsistent in any respect with the terms of
this Agreement or which it knows would impede
the diligent and complete fulfilment of its
obligations hereunder.
13.3 The Purchaser acknowledges:
(i) that the Warranties given by AZ in this clause
are the only representations or warranties
given by or on behalf of AZ upon which the
Purchaser may rely in entering into this
Agreement;
(ii) that no other statement or forecast made by or
on behalf of AZ may form the basis of any claim
by the Purchaser in connection with this
Agreement; and
(iii) that any Warranty Claim shall be subject to the
following provisions of this clause 13.
13.4 The liability of AZ under the Warranties shall be
limited as follows:
(i) there shall be disregarded for all purposes,
except for the purpose of calculating whether
the aggregate sum referred to in clause
13.4(ii) has been reached, any breach of the
Warranties in respect of which the amount of
damages to which the Purchaser would otherwise
be entitled shall be less than US$100,000. For
the purpose of this calculation, all breaches
of a particular Warranty shall be deemed to
constitute a single breach of such Warranty;
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(ii) the Purchaser shall not be entitled to recover
damages in respect of any breach or breaches of
the Warranties unless the amount of damages in
respect of such breach or breaches exceeds in
aggregate the sum of US$1,000,000 in which
event, subject to clause 13.4(i), the Purchaser
may recover the whole of the damages and not
simply the excess over US$1,000,000; and
(iii) the maximum aggregate liability of AZ in
respect of all breaches of the Warranties shall
not exceed the amount of the Consideration.
13.5
(i) If the Purchaser becomes aware of any matter
which is likely to give rise to a Warranty
Claim, it shall within 30 days give notice
thereof in writing to AZ, provided that the
failure to give such notice within 30 days
shall not preclude or bar such claims but shall
reduce such claims to the extent of prejudice
to AZ.
(ii) If the Warranty Claim arises from any liability
to a third party the Purchaser shall take such
action to avoid, dispute or compromise such
liability as AZ may reasonably request and AZ
shall be entitled to have the conduct of any
negotiations and proceedings relating thereto,
subject to AZ indemnifying the Purchaser
against any liability, increased liability,
loss or expense which the Purchaser may incur
as the result of such action.
(iii) Without prejudice to the Purchaser's duty to
mitigate any loss in respect of any breach of
the Warranties, if in respect of any matter
which would otherwise give rise to a breach of
the Warranties the Purchaser is entitled to
claim under any policy of insurance, the amount
of the Purchaser's claim for breach of the
Warranties shall be reduced by the amount of
insurance monies to which the Purchaser shall
be entitled.
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13.6 AZ shall cease to have any liability under the
Warranties contained in clauses 13.1(i) and (ii) on the
tenth anniversary of the Effective Date and shall cease
to have any liability under the other Warranties on the
third anniversary of the Effective Date, except in
respect of any Warranty Claims made by the Purchaser in
writing prior to such dates.
13.7 Any payment made by AZ in respect of a breach of the
Warranties shall be deemed to be a reduction of the
Consideration.
14. [DELETED]
15. EMPLOYEES
15.1 On the Effective Date the Purchaser shall offer to
employ the Transferring Employees with effect from the
relevant Transfer Date or such other date as the
Parties may agree or the laws of the relevant Country
may require ("Employment Transfer Date") on terms in
general regarding compensation and the provision of
health and similar benefits going forward not less
favourable to the Transferring Employees than their
current terms of employment, full details of which have
been supplied by AZ to the Purchaser in writing.
15.2 During the period from the Effective Date to the
Employment Transfer Date the Purchaser shall reimburse
to AZ the employment costs and other direct overheads,
to the extent not covered in the Cost of Goods,
attributable to the Transferring Employees, full
details of which have been supplied by AZ to the
Purchaser in writing.
15.3 Subject to clause 15.1, AZ shall indemnify the
Purchaser against any and all claims, costs and
expenses which are asserted against the Purchaser by
any non-Transferring Employees of AZ.
206
15.4 Subject to clause 15.1, the Purchaser shall not without
AZ's written consent seek to induce any of AZ's
employees engaged in the manufacture or sale of AZLAD
Products to leave AZ's employment, such restriction to
continue until 6 months after the expiry of the AZLAD
Products Manufacturing Agreement in the case of
employees engaged in the manufacture of AZLAD Products
and until 12 months after the Effective Date in the
case of other employees. This provision shall not
apply to or prohibit general employment advertising to
which any such employee may respond, nor prohibit the
Purchaser from responding to unsolicited inquiries.
16. CONFIDENTIALITY
16.1 All information of a confidential or proprietary
nature, including the Regulatory Know-How, the
Technical Information and the Marketing Data, received
or obtained by either Party from the other under or in
connection with this Agreement shall be treated as
confidential ("Confidential Information") 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, or to exercise any
rights granted under 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
(iii) as required by law, or any regulatory or
governmental authority.
16.2 In the event of a Party disclosing Confidential
Information to a third party in accordance with clauses
16.1(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.
207
16.3 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 of the other Party; 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.
16.4 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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17. INDEMNIFICATION
17.1 The Purchaser shall indemnify AZ and each of its
officers, employees and agents (each an "AZ
Indemnitee") against any 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 the AZLAD
Products Manufacturing Agreement, the Existing
Contracts, or clause 9.1 of this 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 17.2.
17.2 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
applicable GMP and the relevant Marketing Authorisation
or the sale of AZLAD Products by AZ otherwise than in
accordance with the relevant Marketing Authorisation.
209
17.3 As promptly as practicable after any indemnitee
referred to in clauses 17.1 or 17.2 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.
18. MISCELLANEOUS
18.1 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.
18.2 Subject to clauses 18.3 and 18.13,
(i) neither Party shall be entitled to assign or
sub-license any of its rights or obligations
under the AZLAD Products Manufacturing
Agreement except in accordance with the
provisions of such Agreement,
(ii) the Purchaser shall not be entitled to assign
or sub-license any of its rights or obligations
under the AZ Trade Marks Licence Agreement
except in accordance with the provisions of
such Agreement, and
(iii) subject to the provisions of paragraphs (i) and
(ii) of this clause, either Party shall be
entitled to assign or sub-license any of its
rights or obligations under this Agreement
without the consent of the other Party.
210
18.3 If either Party shall assign or sub-license any of its
rights or obligations under this Agreement:
(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 16 and this
clause,
(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, and
(iv) in the event of the Purchaser assigning or
sub-licensing any of its rights or obligations
under this Agreement in accordance with the
provisions of clause 18.2(iii), it shall be an
express condition of such assignment or
sub-licence that neither the Purchaser nor the
assignee or sub-licensee shall without AZ's
written consent publish or permit any person to
publish the fact that such rights or
obligations have been obtained directly or
indirectly from AZ.
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18.4 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
XX-000 00 Xxxxxxxxxx
Xxxxxx
Facsimile: x00 0 000 00000
with copy to:
AstraZeneca PLC
For attn of Company Secretary
00 Xxxxxxxx Xxxx
Xxxxxx X0X 0XX
Facsimile: (000) 0000 0000
If to the Purchaser:
Maillefer Instruments Holdings S.A.
For attn of General Manager
Xxxxxx xx Xxxxxx 0
XX-0000 Xxxxxxxxxx
Xxxxxxxxxxx
Facsimile: x00 00 000 0000
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with copy to:
DENTSPLY International Inc
000 Xxxx Xxxxxxx Xxxxxx
Xxxx XX 00000
Attention: Secretary
Facsimile: (000) 000 0000
18.5 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.
18.6 This Agreement and any supplemental agreements 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.
18.7 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.
18.8 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.
18.9 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.
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18.10 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.
18.11 Completion of the performance of any obligation arising
under this Agreement shall not affect the continuing
validity of any provision of this Agreement.
18.12 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.
To the extent any rights or obligations which are part
of the transactions described herein are held by any
Affiliate of a Party, such Party shall obtain all
signatures and documents necessary to fully consummate
and evidence the transactions described herein.
18.13 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.
18.14 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.
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18.15 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.
18.16 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.
18.17 The Parties agree to co-operate to the extent necessary
in connection with the preparation and timely filing of
notifications to relevant competition authorities and,
in the case of the USA, such filing shall be made no
later than 25th January 2001.
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 XX XXXXXXXXX INSTRUMENTS
(publ) HOLDINGS S.A.
===========================
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