EXHIBIT 10.22(c)
(AZ Trade Marks Licence Agreement)
DATE: 18TH JANUARY 2001
PARTIES:
1. ASTRAZENECA AB a company incorporated under the laws of
Sweden and having its principal office at SE-151 85
Sodertalje, Sweden ("AZ")
2. MAILLEFER INSTRUMENTS HOLDINGS S.A., a company
incorporated under the laws of Switzerland and having
its principal office at Chemin du Verger 3, CH-1338
Ballaigues, Switzerland (the "Licensee")
BACKGROUND
(A) AZ is the owner and registered proprietor of the Trade
Marks, each of which is registered and used in respect
of a single LAD Product Category. A list of such
registrations, by LAD Product Category and Country, is
set out in Schedule 2.
(B) By an agreement (the "AZLAD Products Agreement") made
between the Parties on the same date as this Agreement,
AZ granted to the Licensee on the terms and for the
consideration therein stated the permanent right to use
AZ's technical information as therein defined for the
purpose of manufacturing LAD Products and agreed with
the Licensee to enter into this Agreement for the
purpose of granting to the Licensee the right to use
the Trade Marks in respect of LAD Products in the
Territory on the terms herein stated.
OPERATIVE PROVISIONS
1.1 In this Agreement:
(i) the term "this Agreement" shall mean this
Agreement and the Schedules and any amendments
hereto;
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(ii) the terms "AZ" and "Licensee" and references to
the "Parties" shall, unless the context
otherwise requires, mean AZ and its Affiliates
or any one of them and the Licensee 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 Licensee 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.
"Competent Authority" means in respect of each Country
the competent regulatory authority for the grant of
Marketing Authorisations.
"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.
"Effective Date" means 1st March 2001.
"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.
"LAD Product Category" means a LAD Product category set
out in Schedule 1.
"LAD Products" means cartridges containing Dental
Products.
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"Marketing Authorisations" means the registrations
granted by the Competent Authority in each Country for
the sale of LAD Products and, where applicable, for
approval of prices and cost reimbursements.
"Relevant LAD Product" means a LAD Product within the
applicable LAD Product Category.
"Specified Drug Substances" means drug substances used
by AZ at 1st January 2001 in the formulation of LAD
Products.
"Territory" means the World, excluding India and any
other country which under the terms of the AZLAD
Products Agreement shall be excluded from the Territory.
"Trade Marks" means the trade marks listed in Schedule
1.
"Trade Mark Authority" means in respect of each Country
the competent authority for the grant of trade mark
registrations and registration of trade mark
assignments and licences.
2. The Licensee acknowledges that the Trade Marks are used
by AZ in connection with its business of developing,
manufacturing and selling medical products as well as
in connection with LAD Products and that any breach by
the Licensee of its obligations under this Agreement in
relation to the use of the Trade Marks by the Licensee
may cause AZ substantial loss or damage in relation to
its medical business. Likewise, AZ acknowledges that
its use of the Trade Marks in its medical business
shall be in such manner as shall not disparage the use
of the Trade Marks by the Licensee or infringe the
rights in the Trade Marks granted by it to the Licensee
hereunder and that any breach of such obligation may
cause the Licensee substantial loss or damage in its
dental business.
3.1 With effect from the Effective Date, AZ grants to the
Licensee a permanent, exclusive (even as to AZ) and
royalty-free licence in accordance with and subject to
the provisions of this Agreement to use in each Country
in connection with Relevant
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LAD Products each Trade Mark registered in such Country
and used by AZ in such Country in respect of Relevant
LAD Products at the date of this Agreement as listed in
Schedule 2. To the extent that AZ is able to do so, AZ
also grants to the Licensee the same rights to use the
unregistered trade marks listed in Schedule 3 in
respect of Relevant LAD Products in the Countries
listed in Schedule 3. The Licensee shall not be
entitled to use any Trade Mark in connection with
products other than Relevant LAD Products nor (subject
to clause 3.2) to use any Trade Mark in connection with
Relevant LAD Products in Countries other than the
Countries listed in respect of such Trade Mark in
Schedule 2 or 3.
3.2 If the Licensee wishes AZ to grant to it the right to
use any Trade Mark in respect of Relevant LAD Products
in Countries other than the Countries listed for such
Trade Mark in Schedule 2 or 3, it shall apply to AZ for
consent to such extension of its Trade Mark licence
rights and AZ shall not unreasonably withhold its
consent thereto, provided that any costs incurred by AZ
in connection therewith shall be borne by the
Licensee. The Licensee acknowledges that it will be
reasonable for AZ to withhold its consent if it is
determined by AZ that the Licensee's use of the Trade
Mark in a Country will be detrimental to the interests
of AZ's medical business.
4. AZ retains all rights to use the Trade Marks subject to
the rights hereby granted to the Licensee.
5. The Licensee shall use each Trade Mark only upon or in
connection with Relevant LAD Products that have been
manufactured, formulated, processed, packed, marked and
labelled by or on behalf of the Licensee in accordance
with standards, quality control, specifications,
information, formulae and instructions laid down or
approved by AZ from time to time. AZ confirms to the
Licensee that such requirement shall be satisfied in
respect of any Relevant LAD Product if it is
manufactured in accordance with applicable GMP and
complies with the Marketing Authorisation for such LAD
Product in force at the Effective Date or as amended or
replaced from time to time in accordance with the
requirements of the Competent Authority or with the
written approval of AZ which shall not be unreasonably
withheld.
6. The Licensee shall not seek to register itself as the
owner of any Trade Mark in any Country or outside the
Territory without the written consent of AZ.
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7. The Licensee shall, on being given reasonable notice
and without interference with normal operations of the
Licensee, permit AZ and/or its authorised
representatives, at their cost, to inspect the LAD
Products offered for sale under the Trade Marks in
accordance with this Agreement and the methods by which
they are manufactured, formulated, processed, packed,
marked and labelled at the premises of the Licensee or
elsewhere, and the Licensee shall do all such things as
may reasonably be necessary in order to satisfy AZ
and/or its authorised representatives that the LAD
Products conform to the requirements stated in clause
5. AZ and/or its authorised representatives may be
required by the Licensee to enter into appropriate
obligations with the Licensee to treat all information
obtained in the course of such inspection in confidence.
8. The Licensee shall, on request, promptly supply AZ
and/or its authorised representatives with a reasonable
number of random samples of LAD Products manufactured,
formulated or processed for sale under the Trade Marks
in accordance with this Agreement in order that AZ
and/or its authorised representatives may satisfy
themselves that the LAD Products conform to the
requirements stated in clause 5.
9. The Licensee shall promptly comply with all directions
given by AZ and/or its authorised representatives
(provided such directions do not violate requirements
of local laws and are entirely consistent with the
practices and requirements described in this Agreement)
concerning the use of the Trade Marks on LAD Products
and/or on all notepaper, invoices, transfers, labels,
packages, package inserts, advertising matter and other
media of all kinds issued or employed by the Licensee
upon or in connection with LAD Products. If requested,
the Licensee shall submit to AZ and/or its authorised
representatives for inspection samples of items which
incorporate any of the Trade Marks. Wherever possible
the Licensee shall insert on such items a statement to
the effect that the Products are "manufactured and
formulated under licence from AZ".
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10. The Licensee shall ensure that each Trade Mark is used
by it in the Permitted Format and not otherwise. For
the purpose of this clause "Permitted Format" means
with the addition of a prefix or suffix demonstrating
that the Trade Mark is being used in respect of dental
products, such prefix or suffix being approved by AZ in
writing in its first use, such approval not to be
unreasonably withheld. AZ's approval shall be deemed
to be granted if:
(i) the prefix or suffix shall be displayed in a
manner which is more prominent than the Trade
Mark, or
(ii) the prefix or suffix shall be displayed in all
respects in the same manner as the Trade Mark
so as to present the Trade Mark and its prefix
or suffix as an entity in common format, and
(in either case)
(iii) the Licensee receives no comment from AZ within
ten business days of first submission of such
proposed format by the Licensee to AZ for
approval.
11. The use of the Trade Marks shall not be subject to the
payment of any royalties by the Licensee to AZ.
12. The Licensee accepts full responsibility for the
actions of any agent or distributor which it may
appoint for the sale of LAD Products under the Trade
Marks and recognises that such agents or distributors
shall acquire no proprietary rights in the Trade Marks
as the result of their use of the Trade Marks in
connection with the sale of LAD Products.
13. The Licensee hereby acknowledges that the Trade Marks
and the goodwill therein remain the sole property of AZ
and all use thereof by the Licensee shall enure to the
benefit of AZ. The Licensee shall neither acquire nor
be allowed to claim any ownership rights in the Trade
Marks.
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14. The Licensee shall refrain from any act which would
prejudice the distinctiveness or validity of the Trade
Marks or which would adversely affect the rights of AZ
in and to the Trade Marks and undertakes neither to
take any action against the Trade Marks nor directly or
indirectly to assist any third party to do so.
Further, the Licensee undertakes that it will not
adopt, register or use at any time a trade mark
identical with or confusingly similar to any of the
Trade Marks. The provisions of this clause shall apply
mutatis mutandis to AZ with respect to the rights
granted to the Licensee and the use of the Trade Marks
by the Licensee hereunder.
15.1 Upon the request of either Party, the Parties shall
enter into a separate licence agreement for any Country
relating to the grant by AZ to the Licensee of the
right to use the Trade Marks in respect of LAD Products
in such Country, for registration or other purposes.
Such licence agreement shall be in the form set out in
Schedule 4 or in such other form as may be agreed
between the Parties based so far as practicable on the
form set out in Schedule 4. In the event of any
conflict between the provisions of this Agreement and
such separate licence agreement, the provisions of this
Agreement shall prevail. In the event of termination
of this Agreement in its entirety, all such separate
licence agreements shall automatically terminate at the
same time.
15.2 The Licensee shall at its own expense apply as
necessary to the Trade Mark Authority in each Country
for the Licensee to be recorded as a licensee of the
registered Trade Marks for use in connection with the
relevant LAD Product Category, and AZ shall assist the
Licensee, at the Licensee's request and expense in such
activity, including the execution and filing of
documents. All fees and taxes payable in respect of
the registration of the Licensee as licensee of the
Trade Marks and the maintenance of the registration of
the Licensee as licensee of the Trade Marks shall be
borne by the Licensee.
16.1 The Licensee and AZ shall promptly notify each other of
any acts of infringement, suspected infringement or
unfair competition involving the Trade Marks, and of
any allegation that any of the Trade Marks is or may be
invalid or unenforceable, and of any applications or
registrations of confusingly similar marks which may
come to its attention.
16.2 AZ shall be entitled to defend and/or prosecute all
proceedings involving third parties relating to the
infringement or validity of the Trade Marks and the
Licensee shall at the request and expense of AZ do all
such things as may be reasonably requested by AZ to
assist it in taking or resisting any proceedings in
relation to any such infringement or claim.
16.3 If AZ shall for 90 days after the date of notification
referred to in clause 16.1 fail to assume the conduct
of any proceedings referred to in clause 16.2 or fail
to conduct such proceedings in a reasonable commercial
manner, the Licensee shall be authorised, as permitted
by law, to assume the conduct thereof and AZ shall at
the request and expense of the Licensee do all such
things as may be reasonably requested by the Licensee
to assist it in taking or resisting such proceedings.
17.1 This Agreement shall not be terminable by AZ otherwise
than in accordance with the express provisions of this
Agreement.
17.2 This Agreement may be terminated by the Licensee with
respect to any or all Trade Marks by giving notice in
writing to AZ at any time.
17.3
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This Agreement may be terminated by AZ by giving not less than
12 months' notice in writing to the Licensee if during
the period of 10 years from the Effective Date the
Licensee or any other company in the same group of
companies as the Licensee shall be engaged or
interested in the manufacture or sale of injectable
local anaesthetic products based on any of the
Specified Drug Substances, other than Dental Products,
provided that such notice shall be withdrawn by AZ if
during the currency of the notice the Licensee or such
other company in the same group of companies as the
Licensee shall permanently cease to be engaged or
interested in the manufacture or sale of injectable
local anaesthetic products based on any of the
Specified Drug Substances, other than Dental Projects,
and the Licensee shall notify AZ in writing of such
cessation.
17.4 This Agreement may be terminated by AZ by giving notice
in writing to the Licensee if the Licensee shall commit
any serious and wilful breach of any of the terms of
this Agreement and shall fail to remedy such breach, if
capable of remedy, within 60 days of receiving notice
in writing from AZ specifying such breach and requiring
it to be remedied. It is agreed that the use of any
Trade Mark in respect of any product other than
Relevant LAD Products shall constitute a serious breach
of this Agreement.
17.5 Without prejudice to the provisions of clause 17.4,
this Agreement may be terminated by AZ in respect of a
specific Country by giving notice in writing to the
Licensee if the Licensee shall commit any serious and
wilful breach of any of the terms of this Agreement so
far as they relate to such Country and shall fail to
remedy such breach, if capable of remedy, within 60
days of receiving notice in writing from AZ specifying
such breach and requiring it to be remedied. It is
agreed that the use of any Trade Mark in a Country in
respect of Relevant LAD Products shall constitute a
serious breach of this Agreement if AZ shall not have
granted to the Licensee hereunder the right to use such
Trade Mark in such Country.
18.1 Subject to clauses 16 and 18.2 and subject to the
continuing use of the Trade Marks by the Licensee, AZ
undertakes to maintain the Trade Marks in force.
18.2
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If AZ no longer wishes to maintain any Trade Mark in any
Country, it shall offer to transfer such Trade Mark to
the Licensee. If such offer shall be accepted by the
Licensee, AZ shall assign and transfer such Trade Mark
to the Licensee and the Licensee shall register such
transfer with the Trade Mark Authority in such Country
at its own expense. If such offer shall not be
accepted by the Licensee, AZ shall cease to be obliged
to maintain such Trade Mark in such Country.
19. The Licensee shall not be entitled to assign or
sub-license any of its rights or obligations under this
Agreement except to an Affiliate or with the written
consent of AZ which shall not be unreasonably withheld.
20. Upon termination of this Agreement, the Licensee shall
forthwith discontinue all use of the Trade Marks (other
than Trade Marks transferred to the Licensee) and shall
cease to make any reference to AZ in its printed
matter, labels or packages, subject to the disposal of
existing stocks in such manner as may be agreed between
the Parties at the date of termination. The Licensee
shall not thereafter make any use of the Trade Marks or
any colourable imitation thereof and hereby agrees to
join with AZ in applying for cancellation of its
recordal as a licensee of the Trade Marks on
termination of this Agreement and to execute any
documents that may be required to effect such
cancellation. The provisions of this clause shall
apply mutatis mutandis in the event of termination of
this Agreement insofar as it relates to any Country or
Trade Mark.
21. This Agreement shall be governed by and construed and
interpreted in accordance with the laws of England.
22. All disputes which may arise under, out of, or in
connection with, or in relation to this Agreement shall
be 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.
23.
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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 served by telefax shall be
deemed to be served 24 hours after telefax transmission
and a notice served by registered mail shall be deemed
to be served 4 days after posting by registered mail.
If to AZ:
AstraZeneca AB
For attn of President
SE-151 85 Sodertalje
Sweden
Facsimile: +46 8 553 29010
with copies to:
AstraZeneca AB
Global Intellectual Property - Trade Marks
Alderley Park
Macclesfield
Cheshire
SK10 4TG
and to:
AstraZeneca PLC
For attn of Company Secretary
15 Stanhope Gate
London W1Y 6LN
Facsimile: (020) 7304 5151
If to the Purchaser:
Maillefer Instruments Holdings S.A.
For attn of General Manager
Chemin du Verger 3
CH-1338 Ballaigues
Switzerland
Facsimile: +41 21 843 9293
with copy to:
DENTSPLY International Inc
570 West College Avenue
York PA 17404
Attention: Secretary
Facsimile: (717) 849 4753
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IN WITNESS WHEREOF the parties hereto have caused this
Agreement to be executed by their respective duly authorised
representatives the day and year first above written.
For and on behalf For and on behalf of
ofASTRAZENECA AB(publ) MAILLEFER INSTRUMENTS
HOLDINGS S.A.
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