EXHIBIT 10.11
DATED: JUNE, 1ST, 1996
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ICU MEDICAL, INC.
AND
BOC OHMEDA AB
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DISTRIBUTION AGREEMENT
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BOC Group ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
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Tel: ▇▇▇▇▇ ▇▇▇▇▇▇
Fax: ▇▇▇▇▇ ▇▇▇▇▇▇
Page 1: Printed May 28, 1996
TABLE OF CONTENTS
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Clause Page
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1. DEFINITIONS 3
2. APPOINTMENT OF DISTRIBUTOR 4
3. EFFECTIVE DATE AND TERM 5
4. OHMEDA's RESPONSIBILITIES AND UNDERTAKINGS 7
5. ICU's RESPONSIBILITIES AND UNDERTAKINGS 11
6. PRICE 13
7. REGULATORY APPROVALS AND RECALL 13
8. INDEMNITY 15
9. INSURANCE 17
10. LIMITED PRODUCT WARRANTY 17
11. SPECIFICATION AND DESIGN VARIATIONS 18
12. QUALITY CONTROL AND PRODUCT IMPROVEMENTS 19
13. TRADEMARKS 20
14. INSPECTION AND ACCEPTANCE 20
15. MUTUAL UNDERTAKINGS 20
16. CONFIDENTIALITY 21
17. FORCE MAJEURE AND EXCESSIVE DEMAND 22
18. TERMINATION 23
19. MISCELLANEOUS 24
Page 2: Printed May 28, 1996
THIS AGREEMENT DATED THE 1ST DAY OF JUNE, 1996 BETWEEN
1) ICU Medical, Inc., a Delaware corporation with an office and place of
business at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇, ▇▇▇ (referred to
below as "ICU" ) and,
2) ▇▇▇ ▇▇▇▇▇▇ ▇▇, a Swedish company with registered office located at ▇ ▇ ▇▇▇
▇▇▇, ▇-▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ (referred to as "OHMEDA").
IT IS AGREED AS FOLLOWS:
1. DEFINITIONS
1.1 In this Agreement:
"Affiliate" shall mean any person, firm, company or other legal
entity which controls, is controlled by or which is
under common control with ICU or OHMEDA.
"Contract Year" shall mean each sequential twelve (12) month
period during the term of this Agreement
commencing with the Effective Date.
"Effective Date" shall mean the date of execution of this Agreement
by both parties.
"Improvements" shall mean changes to or developments in needleless
connectors together with accessories and components
disclosed by either party to the other and developed by
ICU during the term of this Agreement which technically
or functionally improve upon Products and which ICU
offers to the public to replace one or more of the
existing Products.
"Product' or shall mean ICU's CLAVE needleless injection
"Products" valves, to be sold under the Connecta CLAVE trademark,
and any similar medical devices in the field of
needleless infusion connection (the "Field") which meet
the specifications set forth in Appendix 1.1 below as
amended by mutual written agreement of the parties and
any Improvements.
"Territory" shall mean one or more of the nations listed in Appendix
1.2.
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2. APPOINTMENT OF DISTRIBUTOR
2.1 As the Products are newly developed and have not previously been marketed
in Europe, OHMEDA's representation rights UNDER THIS AGREEMENT ARE TO BE
staggered as follows:
2.1.1 TEST LAUNCH PHASE
As from the Effective Date, OHMEDA is appointed
ICU's exclusive distributor for the Products in each of Great
Britain, France, Belgium and Holland for a fixed period of six (6)
calendar months. During this Test Launch Phase the terms of this
Agreement shall apply to the extent applicable, together with the
arrangements comprised in the Test Launch Program set out in Appendix
2.1.1.
2.1.2 FULL LAUNCH PHASE - DIRECT COUNTRIES
Not less than 30 days prior to the expiration of the Test Launch
Phase, OHMEDA shall have the right to submit to ICU written Business
Plans for each of the Territories listed in Part A of Appendix 1,
such Business Plans to include the information listed in Appendix
4.5. ICU shall accept or reject each of the Business Plans in writing
within 30 days of receipt, unless otherwise agreed. The power to
reject is subject to Clause 5.9 below. On the expiration of the Test
Launch Phase, OHMEDA shall become the exclusive distributor for the
Products with immediate effect, for those Territories listed in Part
A of Appendix 1, as to which OHMEDA has received ICU's written
acceptance of the Business Plan and subject to the terms of this
Agreement.
2.1.3 FULL LAUNCH PHASE - DISTRIBUTOR COUNTRIES
At any time on or after the expiration of the Test Launch Phase,
OHMEDA shall have the right to submit to ICU a Business Plan for any
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one or more of the Territories listed in Part B of Appendix 1 (and in
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the terms provided for in clause 4.5) for which it then wishes to act
as distributor of the Products. ICU shall review and accept or
reject, in writing, all Business Plans within 60 days of receipt
unless otherwise agreed. The power to reject is subject to Clause 5.9
below. Upon written acceptance by ICU of a Business Plan for a
particular Territory, (with or without amendment as applicable),
OHMEDA shall become exclusive distributor for the Products in such
Territory with immediate effect and subject to the terms of this
Agreement.
In the event that any such Business Plans are rejected, the
applicable nations shall be removed from the definition of Territory
for the purposes of OHMEDA's distribution rights.
2.1.4 At any time after the expiration of the Test Launch Phase, ICU shall
have the right, on not less than 60 days written notice, to demand
from
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OHMEDA, a Business Plan for any Territory for which OHMEDA has not then
exercised its rights pursuant to clauses 2.1.2 and 2.1.3. The terms of
clause 2.1.2 or as applicable 2.1.3 shall apply to any Business Plan then
supplied. If OHMEDA fails or elects not to submit any such Business Plans
it shall immediately forfeit any distribution rights for the Products in
the applicable Territory.
2.2 OHMEDA may appoint sub-distributors to sell the Products in any Territory
for which OHMEDA is the exclusive distributor for the Products after
written notification to ICU subject to ICU's written approval of the sub-
distributor. OHMEDA shall include in each agreement appointing a sub-
distributor, provisions to the effect that (i) New York law shall govern
with respect to any dispute or litigation between ICU and sub-distributor,
(ii) the prevailing party in any such litigation shall be entitled to
attorneys fees reasonably incurred, (iii) exclusive jurisdiction and venue
shall be the state courts of the State of Illinois located in ▇▇▇▇ County,
Illinois, USA or United States District Court located in ▇▇▇▇ County,
Illinois, USA., (iv) service of process may be effected by telecopier,
telex, facsimile, mail or courier such provisions to be substantially the
same in substance as set forth in clause 19.
2.3 Notwithstanding OHMEDA's above appointments as exclusive distributor, ICU
shall have the right to sell the Products direct to a customer without
obligation to pay OHMEDA commission, when such customer is an original
equipment manufacturer or pharmaceutical company who will sell the Products
only as a component part of another product.
2.4 Nothing in this Agreement shall preclude ICU from the direct sale or sale
through third parties of individual components comprised in the Products
without obligation to pay OHMEDA commission.
2.5 In the event that ICU sells the Products or individual components as
described in Clauses 2.3 and 2.4, ICU will use reasonable efforts to
facilitate a liaison between OHMEDA and such other parties for the limited
purpose of ensuring that product performance claims and other regulatory
matters are dealt with consistently.
3. EFFECTIVE DATE AND TERM
3.1 The initial term of this Agreement shall be five (5) years commencing on
the Effective Date. This Agreement shall be automatically extended after
the five years, unless and until either party elects to terminate it, upon
not less than 12 months prior written notice to the other party to expire
on or at any time after the fifth anniversary. Notwithstanding the above
termination arrangements, this Agreement may be terminated at any time:
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3.1.1 By mutual consent in writing.
3.1.2 By either party sixty (60) days after the giving of written notice to
the other that the other is in material breach of any of its
obligations under this Agreement and has failed to cure such breach
during such sixty (60) day period except that material breach of
payment obligations must be cured within thirty (30) days of such
written notice.
3.1.3 By either party immediately if any proceeding in bankruptcy, or for
reorganization or arrangement, or for the appointment of a receiver
or trustee, or any other proceeding under any law for the relief of
creditors, shall be instituted by or against the other, or the other
shall make an assignment for the benefit of its creditors.
3.1.4 By ICU where in its reasonable opinion, OHMEDA conducts itself in
such a manner as to be detrimental or harmful to the good name,
goodwill or reputation of ICU and/or the Products.
3.1.5 By ICU if in its reasonable opinion it is unable to comply with
clause 8.1 on a commercially reasonable basis.
3.1.6 By ICU if OHMEDA, any Affiliate of OHMEDA to which this Agreement has
been assigned, or any entity of which OHMEDA or such an Affiliate is
a direct or indirect subsidiary or which directly or indirectly
controls OHMEDA or such an Affiliate is acquired by means of a
merger, consolidation, purchase of assets, purchase of stock or
otherwise.
3.2 In addition to the rights of complete termination provided for above,
either party shall have the right, again on not less than 12 months notice
to expire on or at any time after the fifth anniversary, to terminate any
one or more of the nations of the Territory, whereupon the provisions of
clause 18 shall apply to that Territory only and the rights of any sub-
distributor appointed by OHMEDA shall terminate as to such Territory.
3.3 ICU shall have the right on not less than 90 days written notice to either
terminate OHMEDA's distributorship or convert OHMEDA to a non-exclusive
distributor in a Territory (a) in which OHMEDA has not substantially
achieved the material objectives of its Business Plan for the preceding 12
months or (b) as to which ICU has rejected OHMEDA's annual Business Plan
giving reasonable grounds as provided in clause 5.9, whereupon the
provisions of clause 18 shall apply to that Territory only and the rights
of any sub-distributor appointed by OHMEDA shall terminate as to that
Territory. In the event that OHMEDA's status in a Territory changes to that
of a non-exclusive distributor this Agreement shall be equitably adjusted
to reflect the change of status.
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3.4 Either party may terminate this Agreement in respect of a Territory, in the
event of the commencement of litigation against either party for
infringement of a third party's intellectual property rights in consequence
of the sale of the Products in such Territory.
4. OHMEDA'S RESPONSIBILITIES AND UNDERTAKINGS
4.1 FORECASTS. OHMEDA shall provide ICU each month with a six (6) month rolling
forecast of anticipated Product orders, beginning with the first month for
which ICU is expected to supply OHMEDA with Products, in the form attached
as Appendix 4.1. OHMEDA shall be free from month to month to modify its
forecasts of Product orders.
4.2 ORDERS. OHMEDA shall place irrevocable purchase orders for Products with ICU
for each month 60 days in advance of the desired delivery date. Purchase
orders shall be in writing, and consistent with this Agreement and may be
sent by telex or facsimile machine.
4.3 PROMOTION. OHMEDA shall develop energetically and satisfactorily the
potential for Product sales. OHMEDA shall keep available at all times for
demonstration and evaluation purposes, minimum amounts of each Product as
specified in Appendix 4.3 which shall be in a condition appropriate for
sales promotion. ICU shall review and approve all advertising and marketing
materials prepared by OHMEDA, in advance of their use.
4.4 TRAINING. At its expense, OHMEDA shall train the employees of its customers
to use the Products. OHMEDA sales, customer service and technical service
representatives must be fully trained in the use of the Products and must
have the specific qualifications specified by ICU at the commencement of
this Agreement.
4.5 BUSINESS PLANS. OHMEDA shall prepare a written Business Plan for each nation
in the Territory annually. All Business Plans shall contain the material
listed in Appendix 4.5 and shall be submitted to ICU not less than 90 days
prior to the commencement of such Contract Year.
4.6 CUSTOMER SERVICE. OHMEDA shall render prompt and willing service with
respect to the Products and shall use its best efforts to handle
satisfactorily all matters relating to the sale and servicing of the
Products in the Territory. To facilitate timely customer service,
manufacturer's support may be requested by OHMEDA. If such support is
provided by ICU at ICU's sole direction, it shall be free of charge. If it
is supplied at OHMEDA's request, ICU may ▇▇▇▇ OHMEDA at ICU's then current
rates for time and/or travel expenses.
4.7 PAYMENT. The purchase price for all Product orders and service orders and
all expenses incurred by ICU in the shipment and delivery of ordered
Products and
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the performance of service orders, including without limitation freight
charges, taxes, export and import duties and insurance premiums, shall be
payable by OHMEDA to ICU 60 days after delivery of the Products by ICU to a
carrier (in case of Product orders) or the date of invoice for services
performed. Al1 payments by OHMEDA to ICU shall be made in the currency of
the United States of America.
4.8 TITLE AND RISK OF LOSS. Risk of loss in the Products shall pass to OHMEDA
upon delivery of the Products to the carrier at ICU's manufacturing
facility. ICU shall co-operate with OHMEDA in processing all claims for loss
or damage to the Products. Ownership of the Products shall pass to OHMEDA
upon their acceptance by OHMEDA following receipt.
4.9 DELAY AND STORAGE. OHMEDA shall be responsible for and shall pay for any
delay in accepting delivery, storage and other charges accruing after the
arrival of any shipment at OHMEDA's designated destination where such
shipment conforms in all respects with OHMEDA's order. If OHMEDA shall fail
or refuse to accept delivery of any of the Products ordered by it, and
without good reason, OHMEDA shall pay ICU the amount of all expenses
incurred by ICU in returning the Products to the original shipping point.
4.10 RESTRICTIVE COVENANT.
4.10.1 OHMEDA acknowledges that (i) ICU will provide OHMEDA valuable
Confidential Information (as defined in clause 16 of this Agreement)
and/or trade secrets of ICU, (ii) that the conduct of any
Competitive Activity by OHMEDA while OHMEDA is in possession of such
information and privy to ICU's product development and marketing
strategies could result in the disclosure or use of such
Confidential Information and trade secrets and put ICU at a severe
competitive disadvantage, and (iii) that ICU would not knowingly
disclose such information to any person engaged in any Competitive
Activity.
It is the intention and obligation of the parties to comply with the
limitations on the use and disclosure of Confidential Information
set forth in clause 16 of this Agreement. In order to avoid the
intentional or inadvertent use or disclosure of Confidential
Information and trade secrets and to ensure that OHMEDA can
effectively and credibly promote and represent the Products, OHMEDA
agrees that, during the term of this Agreement and for a period
ending six months after the termination of this Agreement (such
period to be extended to include any period of violation of this
clause 4.10.1) by OHMEDA or period which is required for litigation
to enforce this Agreement and during which OHMEDA is in violation of
this clause 4.10. 1, OHMEDA shall not, without prior written consent
of ICU, engage, directly or indirectly, in any Competitive Activity
in any Territory, or in any country in Europe in which any aspect of
the research,
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design, development, manufacture, clinical testing, marketing,
market research (other than general surveys and analysis),
demonstration or sale of Products has been carried on by or on
behalf of ICU. As used herein the term "Competitive Activity" shall
mean engaging in any business, directly or indirectly, whether as a
manufacturer, DISTRIBUTOR, manufacturer's representative, dealer,
proprietor, partner, joint venturer, employer, agent, employee,
consultant, officer, director, or beneficial or record owner (other
than as a passive investor owning a minority interest in any entity
in which OHMEDA is not involved, directly or indirectly through
representation on the board of directors or otherwise, in running
the business, and which involves the manufacture, clinical testing,
distribution, marketing, demonstration, promotion or sale of
Competitive Products. As used herein, the term "Competitive
Products" means medical connectors which have all of the following
design and performance characteristics: activated by advancing a
male Luer into the valve; closed unless activated by a Luer
advancing in the valve; easily disinfected by swabbing in the same
way as a stretch latex injection site: but expressly excluding
those current OHMEDA products listed in Appendix 4.10 hereto and
Improvements thereto which do not duplicate all of the foregoing
design and performance characteristics. It shall not be a breach of
this restriction for OHMEDA or any OHMEDA Affiliate to acquire a
business which has as incidental activity a Competitive Product
provided OHMEDA demonstrates to ICU that it is taking all reasonable
steps to divest it and does divest it within a reasonable time.
4.10.2 In the event OHMEDA proposes to engage in any Competitive Activity
in any of the geographic areas specified in clause 4.10.1, OHMEDA
shall give ICU 90 days written notice of its intention to do so.
Such notice shall constitute the termination by OHMEDA of this
Agreement, effective when given, unless ICU, in its sole and
absolute discretion, consents to the Competitive Activity. Strict
compliance with this clause 4.10.2 shall relieve OHMEDA of the
obligation under clause 4.10.1 to refrain from Competitive Activity
for six months after any termination of this Agreement and permit
OHMEDA to engage in Competitive Activity 90 days after giving such
written notice. Notwithstanding the foregoing, if during the
aforesaid 90-day period, OHMEDA engages in any Competitive Activity
whatsoever, including any promotion of Competitive Products or any
communication to any customers or prospective customers of OHMEDA of
its intention to engage in Competitive Activity, (except as a
permitted incidental activity of an acquisition) (i) the provisions
of this clause 4.10.2 shall immediately cease to be of any force and
effect, (ii) OHMEDA shall be subject to and deemed to be in
violation of the provisions of clause 4.10.1, and (iii) ICU may take
action to enforce this Agreement and/or recover damages.
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Notwithstanding any provision of this Agreement, ICU is not waiving
its patent rights in any jurisdiction and is not waiving the
obligations of OHMEDA under clause 16 of this Agreement.
4.10.3 The conduct by OHMEDA of any Competitive Activity in any Territory,
or in any country in Europe shall be a material breach of this
Agreement, giving ICU the right to terminate this Agreement under
clause 3.1
4.10.4 OHMEDA acknowledges and agrees that it would be difficult to
compensate ICU fully for damages resulting from the breach or
threatened breach of the foregoing provisions and, accordingly, that
ICU shall be entitled to temporary and injunctive relief (including
temporary restraining orders, preliminary injunctions and permanent
injunctions) and specific performance, to enforce such provisions
upon proving that ICU suffered or that there is a substantial
probability that ICU will suffer irreparable harm and without the
necessity of posting any bond or other undertaking in connection
therewith. This provision with respect to injunctive relief and
specific performance shall not, however, diminish ICU's right to
claim and recover damages.
4.10.5 The provisions of this clause 4.10 are severable and if any one or
more provisions may be determined to be illegal or otherwise
unenforceable, in whole or in part, the remaining provisions, and
any partially unenforceable provisions to the extent enforceable,
shall nevertheless be binding and enforceable. For the purpose of
determining the geographic scope of the covenant such that if the
geographic scope shall be determined by a court of competent
jurisdiction to be excessive and invalid, such area shall be severed
and the covenant relating to the remaining areas shall be deemed
enforceable and remain in full force and effect. In addition, if
this clause 4.10 or any portion hereof shall be determined by a
court of competent jurisdiction to be excessive and invalid by
reason of its extending for too great a period of time or over too
great a range of activities, it shall be interpreted to extend only
over the maximum period of time or range of activities as to which
it may be enforceable.
4.11 COMPLIANCE WITH US EXPORT REGULATIONS. OHMEDA understands that the Products
and Improvements may require a validated export license to be obtained by
ICU from the United States Department of Commerce. OHMEDA agrees to assist
ICU to obtain any such required license by supplying appropriate
documentation requested by ICU. OHMEDA agrees to comply with US Export
Administration Regulations as in effect from time to time and will not re-
export any Products outside the Territory without first gaining approval
from ICU. Until approval is obtained from the United States Department of
Commerce, OHMEDA agrees to obtain similar assurances from its customers.
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OHMEDA will also maintain the necessary records to comply with United
States Export Administration Regulations.
4.12 TERMS OF PURCHASE OF PRODUCTS BY OHMEDA. All purchases of Products by
OHMEDA FROM ICU during the term of this Agreement shall be subject to the
terms and conditions of this Agreement. No other terms including standard
ICU conditions of sale or standard OHMEDA conditions of purchase shall
apply unless expressly agreed in writing by authorized representatives of
both parties.
4.13 TERRITORIAL RESPONSIBILITY. OHMEDA shall refrain from establishing or
maintaining any branch, warehouse or distribution depot for the Products,
or services outside the Territory and shall not engage in any advertising
or promotional activities relating to the Products or services directed
primarily to customers located outside the Territory.
4.14 SALES TRACKING. OHMEDA shall supply to ICU at its request at reasonable
intervals sales tracking information for each Territory in a timely
fashion. Such information shall include, but is not limited to, catalog
number quantities and prices of Products shipped during the period
requested; where possible the facility name and location will also be
provided.
5. ICU'S RESPONSIBILITIES AND UNDERTAKINGS
5.1 CAPACITY. ICU shall maintain manufacturing capacity at the level required to
fulfill OHMEDA's forecasted demand for the Products. ICU will maintain
reasonable raw material inventory consistent with OHMEDA forecasts and
delivery schedules.
5.2 LATEST VERSIONS. ICU shall ensure that Products supplied to OHMEDA are its
most up to date versions unless otherwise requested by OHMEDA, provided
that ICU shall not be required to replace OHMEDA's inventory of earlier
versions of Products.
5.3 ORDERS AND SPECIFICATIONS. ICU shall use all reasonable efforts to fulfill
OHMEDA orders for sterilized Products during the term of this Agreement. ICU
undertakes that the processing of OHMEDA orders shall be handled no less
favorably than any other customer orders. ICU shall manufacture, assemble,
package and label the Products in accordance with the specifications as
described in Appendix 1 below. The content of all labeling of Products shall
be created by OHMEDA and jointly approved by OHMEDA and ICU.
5.4 DELIVERY. ICU shall fulfill all Product orders from OHMEDA so that delivery
of the Products to OHMEDA shall be made FOB ICU's Californian facility
within 45 days of the placement of the order for that Product with ICU,
unless otherwise agreed. If an order cannot be shipped within such time
limits after order acceptance, ICU will notify OHMEDA of the anticipated
shipping date. ICU ▇▇▇▇
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take all necessary actions to minimize down-time of any affected major
equipment. OHMEDA shall be notified by fax, telephone or similar method of
communication promptly as to the date of delivery. In the event that any of
the Products are not shipped as of the scheduled date specified, OHMEDA
shall be given prompt notice by fax, telephone or similar method of
communication. When Products become available, ICU shall ship such delayed
Products by the fastest method of delivery, and the excess of the expedited
delivery charges over normal delivery charges shall be at ICU's expense when
events causing such delay were under ICU control.
ICU shall be responsible for:
5.4.1 putting the Products in possession of Ohmeda's designated carrier and
contracting for their transit,
5.4.2 obtaining any documents necessary to export them from the United
States of America and, so far as it can reasonably do so, to enable
OHMEDA to take possession upon arrival, and
5.4.3 promptly notifying OHMEDA of shipment and delivery to them of any
necessary documents of title.
5.5 INVOICES. ICU shall send all invoices for Products to ▇▇▇▇▇▇ ▇▇ ▇▇▇ ▇▇▇▇▇▇
▇▇, ▇▇ ▇▇▇ ▇▇▇, ▇-▇▇▇ ▇▇, ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇.
5.6 SALES LITERATURE. ICU shall provide initial quantities of such technical
data, drawings, graphic illustrations, artwork and photography as requested
by OHMEDA to enable OHMEDA to prepare adequate selling materials and to
service the Products. Shipping charges incurred on delivery of sales
literature shall be borne by OHMEDA. Large quantities can be ordered from
ICU at ICU's standard prices in effect at the time.
5.7 TRAINING. ICU shall undertake a reasonable number of "train the trainers"
training courses in Europe free of charge for OHMEDA designated personnel.
Such courses shall be in English, shall be of reasonable extent and duration
and shall cover the specifications, uses, selling, marketing and operation
of the Products including any successor and substitute Products launched
from time to time. Both parties shall meet their own travel and
accommodation expenses connected with attendance. ICU shall co-operate with
the provision of such additional and refresher training as OHMEDA may
reasonably require and on terms to be agreed.
5.8 TERRITORIAL RESPONSIBILITY. In the event that OHMEDA does not establish a
branch, warehouse or distribution depot for the Products in one of the
Territories and ICU appoints another distributor in that Territory, ICU
shall impose the same
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territorial responsibility on that distributor as described in Clause 4.13
imposed on OHMEDA.
5.9 BUSINESS PLANS. ICU shall not have the power to reject any Business Plan
which conforms to the Appendix 4.5 requirements. Business Plans shall be
approved or rejected by ICU not more than 60 days after receipt. The first
Business Plan for a Territory shall cover the period up to the next 30th
September or such longer period, ending on a 30th September, as agreed
between the parties. All subsequent Business Plans shall cover an annual
period commencing 1st October.
6. PRICE
6.1 For the Test Launch Phase of this Agreement, the unit price for each Product
shall be as in Appendix 6 attached to this Agreement.
On commencement of the Full Launch Phase and on an annual basis after that
date, the parties shall negotiate in good faith as to the need for a price
change (increase or decrease) for Products. Any price increase shall be
based upon documented total material and direct labor cost increases during
the immediately preceding Contract Year, but capped at the percentage
increase in the US Consumer Price Index for All Urban Consumers (CPI-U") for
Los Angeles-Anaheim-Riverside Average All Items published by the US Bureau
of Labor Statistics for the immediately preceding Contract Year.
6.2 Prices shall be inclusive of the costs of preparing the Products for
shipment FOB California. OHMEDA shall pay for any additional packing and
handling charges for other means of shipment and shall also pay all taxes on
the export, import, use or sale of the Products and all related insurance.
6.3 If the parties fail to agree upon pricing for a following period, they shall
request an independent auditor to be agreed between the parties (such
auditor acting as an expert and not as an arbitrator) to establish an
equitable adjustment to the Purchase Price within thirty (30) days after
such request and the auditor's determination, absent bad faith, shall be
final and binding. The auditor's fees shall be borne in such proportions as
the auditor shall determine. The auditor so appointed shall be entitled to
call for and inspect the working papers of each of the parties insofar as
they affect the pricing dispute only.
7. REGULATORY APPROVALS AND RECALL
7.1 ICU shall be responsible for regulatory approval of the Products and any
applicable sterilization process. ICU shall inform OHMEDA of any Product
data required from the Territory to facilitate any regulatory approvals.
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7.2 The Products shall conform to CE marking requirements of European
legislation as and when in force in the Territory of Product destination.
7.3 ICU may at its sole discretion, institute and fund any recall or field
corrective action. In such circumstances, the actual retrieval of Product
used in the field will be undertaken by the OHMEDA service organization and
reimbursed by ICU. OHMEDA shall maintain adequate records concerning
traceability of Product and in the event that recall, field correction, or
the like procedures are required, OHMEDA shall co-operate fully with ICU for
expeditious completion of the procedure.
7.4 ICU agrees that Products supplied under this Agreement are and will be
manufactured and/or assembled pursuant to the then current US Food and Drug
Administration ("FDA") Good Manufacturing Practices ("GMP") regulations
(i.e. GMP's, 121 U.S.C. 360 et seq.), and all OHMEDA current internal
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regulatory requirements furnished to ICU in writing by OHMEDA as modified
from time to time with ICU's consent. ICU shall be responsible for filing
all Medical Devices Reports ("MDR's") with the FDA and any other applicable
regulatory authority with respect to the Products and handling all follow-
ups.
7.5 ICU shall maintain all records and files required by the FDA regulations and
any other applicable regulatory authority in respect to the Products and
agrees to provide copies of such records and files to OHMEDA as reasonably
requested.
7.6 Both ICU and OHMEDA shall be responsible for complying with all federal,
state and local laws, rules, regulations, guidelines and the like in the
United States and in the Territories as they may apply to the Products and
to the parties respective obligations to perform under this Agreement. This
shall include without limitation, requirements in the United States with
respect to registration of establishments, listing of medical devices,
reporting of deaths, serious injuries and certain malfunctions under 21 CFR
803 and the potential for any such events, tracking of medical devices,
recalls, safety alerts and process controls. In no event shall either party
assume any risk arising out of the other party's failure to comply with such
laws, rules, regulations, guidelines and the like, and each party shall co-
operate with the other in all respects to facilitate and promote strict
compliance with the provisions of this clause.
7.7 Upon ten (10) days prior notice to ICU, OHMEDA shall have the right to
conduct vendor qualification audits and quality audits from time to time at
reasonable intervals at ICU's manufacturing and engineering facilities to
verify, insofar as feasible, ICU's compliance with the above regulatory
requirements. Quality audits will start at the supply phase and be based on
and limited to Products. ICU will not be required to disclose trade secrets
or proprietary processing know-how. If the review of an area of activity
considered proprietary by ICU is regarded as essential by OHMEDA for the
performance of an effective audit, a non-disclosure agreement satisfactory
to ICU will be signed by OHMEDA. ICU
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shall, in good faith, promptly correct any deficiencies discovered during
such audits.
7.8 In the event of any recall of the Products initiated by ICU and conducted by
OHMEDA for safety or efficacy reasons which are directly caused by failure
of the Products to:
7.8.1 conform in all respects to their specifications, or
7.8.2 be free from defects in design, workmanship or materials,
ICU agrees to accept them for repair or replacement at ICU's sole cost and
expense except as provided below.
Except as ordered by a governmental agency or as specified in the above
sentence, no recall or field modification action shall be initiated without
the mutual agreement of the parties unless the initiating party is prepared
to bear the charges on its own. Each party shall notify the other if any
recall or field modification action is contemplated and both parties shall
co-operate in reaching a consistent response. Neither party shall
unreasonably withhold any information involving patient safety or efficacy
or required recall or field modification action.
8. INDEMNITY
8.1 ICU hereby promises to indemnify and hold OHMEDA harmless from and against
any 3rd party claims, liabilities, damages and costs arising from any sale
or use of the Products and Improvements as and when supplied by ICU to
OHMEDA, arising through patent, trademark, (other than OHMEDA trademarks),
or copyright infringements or misappropriation of trade secrets, provided
that ICU is notified promptly in writing and given the necessary authority,
information and assistance to defend such action. Any action taken by ICU
shall not relieve it of a duty to provide to OHMEDA, at substantially
equivalent prices, and otherwise on the same terms as the Products, single
use disposable needleless injection valve products which operate in
functionally the same way as current Products subject to Clause 3.1.5 above.
The above provisions shall not apply to claims based on Products used in a
manner for which they were not designed or which were modified by or for
OHMEDA, its Affiliates or customers in a manner to become infringing.
8.2 If either party becomes aware of any infringement or threatened infringement
in any Territory of any intellectual property rights in the Products, then
such party shall immediately inform the other party. In such event the
parties shall at their joint expense refer the matter to legal counsel
familiar with the law of the
Page 15: Printed May 28, 1996
Territory concerned, for the purpose of obtaining his/her advice on the
chances of success in prosecuting such action. Each party shall make
available to the other all information in its possession concerning the
subject. ICU may, in its sole discretion (unless the parties agree in
writing to the contrary), institute and prosecute such proceedings at its
expense. Should ICU elect not to institute and prosecute such proceedings,
it shall nevertheless do so if OHMEDA agrees to bear the expense of such
proceedings and tenders in advance of each month the estimated cost of
prosecuting such proceedings for such month, provided that ICU shall be
entitled to withdraw from such prosecution if OHMEDA fails to make all such
monthly advances and pay any excess of actual expenses for a month over the
amount advanced promptly after receipt of invoice. Nothing in this clause
shall affect the other rights and obligations of the parties resulting from
such alleged infringement.
8.3 ICU shall indemnify and hold OHMEDA or its affiliates harmless from and
against any and all loss, damage or cost, including reasonable legal
expenses and counsel fees, for which OHMEDA or its affiliates become liable
by reason of third party claims relating to defects in Products including
design or manufacture thereof except to the extent that such liability
arises from conduct described in clauses 8.4.1, 8.4.2, and 8.4.3.
8.4 OHMEDA agrees to indemnify and hold ICU and its Affiliates and its officers,
directors, and employees free and harmless from any loss, damage or cost,
including reasonable legal expenses and counsel fees, incurred by reason of
claims of 3rd parties, for which ICU becomes liable by reason of:
8.4.1 acts of OHMEDA or its Affiliates in marketing the Products including,
but not limited to (a) misrepresenting the terms of any ICU warranty,
(b) misstatements or misrepresentations by OHMEDA's, its Affiliates or
their employees or agents concerning the capabilities or performance
of the Products or availability, delivery dates or any other related
term or condition,
8.4.2 breach of warranties made by OHMEDA, its Affiliates or their
employees or agents regarding the Products or their use or
performance,
8.4.3 personal injury claims or property damages arising out of the actions
of OHMEDA, its Affiliates or their employees or agents in connection
with the Products and which is inconsistent with ICU's advice.
8.5 A party shall have no liability or responsibility of any kind to the other
party or its Affiliates under this clause 8 for any claims, demands, suits,
costs or actions unless the indemnifying party shall have been notified
within a reasonable time of any such claims, demands, suits, costs or
actions and shall have had an adequate opportunity to defend. Should the
indemnified party desire to have its own counsel participate in any such
action or suit, the costs of such counsel
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shall be borne exclusively by the indemnified party. The obligation of the
parties set out in this clause shall continue notwithstanding the
cancellation or termination of this Agreement.
9. INSURANCE
9.1 Each of ICU and OHMEDA shall maintain, at its own expense, general and
product liability policies of not less than $3,000,000. Each party shall
provide certificates of insurance to the other party (and in the case of
ICU, it shall note OHMEDA's and its Affiliates' interest as a named
insured) for information only and such other party shall have no
responsibility to review such policies or to determine their adequacy.
Each party shall promptly advise the other party of any and all such
actions or suits brought against the advising party or its Affiliates
relating to products liability or warranty claims for products sold in the
Territories. This clause shall survive the cancellation or termination of
this Agreement
10. LIMITED PRODUCT WARRANTY
10.1 Limited Product Warranty. Within the expiration date of the Product ICU
warrants all Products sold under the Agreement (i) to be free from defects
of design, material and workmanship when delivered, (ii) to conform
strictly to the applicable published specifications for such Products, as
in effect from time to time, and (iii) to be manufactured and packaged in
accordance with the FDA's then current GMP's and any other laws and
regulations for the time being in force in the United States of America.
These warranties shall survive any inspection delivery, acceptance of
payment for Products but no later than 60 days after OHMEDA becomes aware
of any defect. If any Products sold and delivered by ICU to OHMEDA breach
any of these warranties, ICU in its sole discretion will either replace
the same including if requested by OHMEDA, carriage CIF (Incoterms 1990)
to the end user delivery point of the order being replaced or credit
OHMEDA, within 30 days, the invoice price of the same together with
OHMEDA's incurred transport expenses in delivering the defective Product
to end user if applicable. The design warranty given above shall not apply
in respect of Products manufactured to designs provided by or on behalf of
OHMEDA.
10.2 Disclaimer and Limitation. WITH THE EXCEPTION OF THE WARRANTIES PROVIDED
UNDER CALIFORNIA COMMERCIAL CODE SECTION 2312, WHICH ICU AND OHMEDA AGREE
IS APPLICABLE TO THE PRODUCTS SOLD BY ICU TO OHMEDA, THE FOREGOING
WARRANTIES ARE GIVEN IN LIEU OF ALL OTHER PRODUCT WARRANTIES OR
GUARANTIES, EXPRESSED OR IMPLIED, RESPECTING PRODUCTS DELIVERED AND SOLD
BY ICU TO OHMEDA, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF
MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR COMPLIANCE WITH THE
LAWS AND REGULATIONS OF ANY
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JURISDICTION OTHER THAN THE UNITED STATES OF AMERICA. EXCEPT AS PROVIDED
IN CLAUSE 10.1 ABOVE, ICU SHALL NOT BE LIABLE FOR SPECIAL, INCIDENTAL OR
CONSEQUENTIAL DAMAGES. THE PRECEDING SENTENCE SHALL NOT RELIEVE ICU FOR
TORT LIABILITY FOR PRODUCTS DEFECTS UNDER GOVERNING LAW.
10.3 Subject to the limitations in clause 10.2 above, the representations and
warranties in clause 10.1 shall survive inspection, testing and acceptance
of Products.
10.4 ICU agrees that sub-distributors appointed by OHMEDA with ICU's written
approval shall be entitled to rely upon the representations, warranties
and covenants in clause 10.1 above, subject to the disclaimers and
limitations in clause 10.2 above, to the same extent as if made directly
to sub-distributors.
10.5 ICU shall maintain test records, drawings and serialization lot numbers
and a traceability file of Products sold to OHMEDA. ICU shall provide
OHMEDA with serialization lot numbers and a Certificate of Release for the
Products at shipment as specified in the Vendor Specification shown at
Appendix 1.
10.6 The parties shall co-operate in the exchange of data on all product
complaints in accordance with such complaint handling procedures as
agreed. ICU shall co-operate fully with OHMEDA in performing complaint
investigations and failure analyses as required by FDA GMP regulations or
any regulations applied by regulatory authorities in the countries of the
Territory as applicable.
10.7 All of the provisions of this clause 10 shall survive the cancellation or
termination of this Agreement.
11. SPECIFICATION AND DESIGN VARIATIONS
11.1 Specifications for Products and accessories are listed in Appendix 1
attached. It is recognized that from time to time ICU may, consistent with
such specifications and with quality performance of Products in their
present form, make changes which are deemed Improvements or substitute
components of the Products. OHMEDA shall be notified in writing by means
of a validation package submitted in accordance with ICU's standard
practices prior to the institution of Improvements or substitution of
components unless otherwise agreed and OHMEDA reserves the right to reject
the Improvements if they fail to meet Product specification or if they
adversely affect fit, form, or function or regulatory approvals of the
Products. In such case, OHMEDA may elect to continue to receive Products
meeting the specifications prior to such Improvements or substitution of
components. Should such Improvements or substitution of components or
OHMEDA's election to continue to receive Products meeting the
specifications prior to such Improvements result in either an increase or
decrease in ICU's costs of production of the Products, then the parties
shall
Page 18: Printed May 28, 1996
immediately negotiate in good faith equitable adjustments to the pricing
of the Products.
11.2 OHMEDA may, during the term of this Agreement, request that ICU make such
changes to Products as OHMEDA in its good faith judgment considers are
required, inter alia, by market conditions, customer requirements, or
----------
changes in OHMEDA products. If ICU agrees to make such changes, the
parties shall negotiate an equitable reimbursement for implementing them,
including any adjustment in prices for Products.
11.3 If the parties believe any such revision may require regulatory approval
of the FDA or other regulatory agency, any such submission shall be made
by ICU after consultation with OHMEDA. If the revision is at the request
of OHMEDA, it will bear all costs associated with resubmission to the FDA
and other regulatory agencies.
11.4 ICU shall maintain design responsibility and shall be responsible for
complaint investigation. OHMEDA shall inform ICU of any adverse customer
feedback or complaints in a timely manner.
12. QUALITY CONTROL AND PRODUCT IMPROVEMENTS
12.1 ICU shall maintain a quality assurance program which, without limitation,
shall include incoming component and raw material inspection, inspection
of work in progress and final kit inspection. All criteria for inspection
at each inspection point shall be in writing and kept current with the
requirements provided by OHMEDA and the requirements of the FDA GMP
regulations. Inspection results shall be documented in writing, dated and
maintained as permanent records and subject to audit by OHMEDA.
12.2 The parties recognize that as the Products are innovative and have not
previously been tried and tested in the Territory, there may be scope for
Improvements.
12.3 The parties shall share with each other under conditions of
confidentiality as provided in Section 16 hereof, ideas they generate
during the term hereof that could be used to improve one or more of the
Products. With regard to any Improvements generated by OHMEDA which
improve both the Products and one of OHMEDA's existing products as set
forth in Appendix 4.10 hereto, OHMEDA shall grant to ICU an irrevocable,
worldwide, royalty free, exclusive (except as to OHMEDA, its Affiliates
and customers) right to use such OHMEDA-generated idea, whether patentable
or not, to improve the Products. With regard to OHMEDA-generated ideas
which improve the Products, but do not improve at least one of OHMEDA's
existing products, as set forth in Appendix 4.10 hereto, OHMEDA shall
assign any such OHMEDA-generated idea as well as any intellectual property
rights in the idea to ICU. With regard to any intellectual
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property rights so assigned to ICU, ICU shall grant to OHMEDA an
irrevocable, worldwide, royalty free, non-exclusive right to use such
OHMEDA-generated ideas in future OHMEDA products. In addition, OHMEDA will
execute all documents reasonably necessary to perfect such assignment or
prosecute any patent application filed to protect the idea at ICU's
expense. Any Improvement assigned from OHMEDA to ICU shall be deemed to be
included in the definition of "Products" set forth herein.
13. TRADEMARKS
13.1 Products shall be sold under the "Connecta CLAVE" name. "Connecta" is a
registered trademark of BOC OHMEDA AB. This name shall appear in a clearly
visible place on packaging using the OHMEDA supplied sample labels,
packaging and instructions. Supporting materials and manuals shall bear
the same marking. Such marking is approved by both parties, provided that
no ancillary trademark or service ▇▇▇▇ rights or licenses are conveyed.
Other than the rights specified, and those provided in accordance with
commercial codes or other local laws regarding the sale of goods, this
Agreement provides no separate rights or licenses for either party to use
the trademarks, copyrights, or patents of the other.
13.2 ICU will provide OHMEDA with materials for inclusion into OHMEDA's manuals
for the Product supplied to OHMEDA, provided that ICU shall have a right
to inspect and approve (which approval shall not be unreasonably withheld
or delayed) before publication, that portion of such manuals that relate
to the Products.
13.3 The labels, packaging and instructions for Products shall be incorporated
by ICU into its documentation system and included as official ICU
documents in all government filings required by this Agreement.
14. INSPECTION AND ACCEPTANCE
14.1 OHMEDA shall have the right to inspect Products at the time of their
actual receipt. In the event that no notice of defects is provided to ICU
within five (5) working days of actual receipt, the associated Products
shall be deemed accepted. This acceptance shall not affect the warranty or
indemnity provisions of this Agreement. Upon acceptance, ownership of the
Products shall pass from ICU to OHMEDA. In the event of rejection, risk of
loss shall revert to ICU.
14.2 ICU shall conduct analysis of rejected or returned Products. ICU shall
provide OHMEDA with a written failure analysis report on any rejected or
returned Products within thirty (30) days of return.
15. MUTUAL UNDERTAKINGS
15.1 OHMEDA and ICU represent and warrant one to the other that:
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15.1.1 it is a company duly organized, validly existing, and in good
standing under the laws of the state of its incorporation;
15.1.2 it has the corporate power to own its assets and to carry on the
businesses now being conducted;
15.1.3 execution and delivery of this Agreement have been duly authorized
in accordance with the applicable laws of its state of
incorporation, and its own certificate of incorporation and bye-
laws; and
15.1.4 it is under no legal or equitable restriction or obligation
preventing undertaking or discharging its obligations under this
Agreement.
16. CONFIDENTIALITY
16.1 The parties recognize the necessity of disclosing to one another not only
the basic proprietary technology and information existing at the time of
execution of this Agreement, but further, from time to time, additional
proprietary developments, improvements and business information. For the
purposes of this clause, the term "Confidential Information" shall apply
to data suitably identified and not otherwise excluded from the definition
pursuant to this section concerning research, design, development,
manufacture, use, clinical testing, marketing strategies, market research,
pricing information, production capacity and Improvements of or relating
to Products. The parties agree to the following obligations of
confidentiality, which shall survive expiration of this Agreement.
16.2 For the period of this Agreement and for a period of five (5) years
following the end of this Agreement, neither party shall use nor permit
its Affiliates to use the disclosed Confidential Information except as
necessary for the purposes of this Agreement. Each party shall maintain
confidential to itself and applicable Affiliates with a need to know, and
shall not disclose to third parties, Confidential Information disclosed by
the other party, treating it with the same degree of care as that party
would treat its own Confidential Information. Both parties shall cause
theirs and their Affiliates directors, officers, employees, agents and
representatives to observe the terms of this confidentiality provision.
16.2.1 The confidentiality obligations under this clause shall not apply
to:
a) information which is or becomes part of the public domain
through no fault or act of the party receiving the
information; or
b) information which the receiving party can establish by
written documents was in his possession prior to disclosure;
or
c) information received from a third party which is lawfully in
possession thereof not in breach of any obligation of
confidentiality to the disclosing party; or
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/
d) information any receiving party (the "Recipient") is
required to disclose by law, order or regulation of a
governmental agency or a court of competent jurisdiction;
provided, that the Recipient uses its reasonable efforts,
which shall include timely notice to the other party and
cooperative joint efforts, to obtain protective orders or
other available assurances of confidentiality, and provided
further that except to the extent of such disclosure
contemplated by this sub-paragraph (d) the confidential
obligations of this clause 16 shall continue to apply; or
e) information the Recipient is required to disclose to any
governmental agency for purposes of obtaining approval to
test or market the Products to the extent that such
information thereby becomes part of the public domain. In
such event the Recipient shall provide notice to the other
party of such disclosure.
16.3 In order to implement these confidentiality obligations, both parties
submitting information to the other party which it considers confidential
shall ▇▇▇▇ such information with a proprietary, confidential or similar
notice. If such Confidential Information is disclosed orally by a party it
shall be followed by a writing, within ten (10) days of such oral
disclosure, summarizing details of the disclosure and indicating said
information was confidential.
16.4 ICU and OHMEDA represent and warrant that each has or will have contracts
of secrecy and non-use with any employees, consultants and agents who
shall have access to any of the Confidential Information and in terms
which at least comply with the requirements of this clause. OHMEDA gives
the same warranty on behalf of its Affiliates.
16.5 Upon the termination of this Agreement for any reason, ICU and OHMEDA
shall each deliver to the other (without retaining copies), any and all
documents or other written information containing any Confidential
Information of the other party.
17. FORCE MAJEURE AND EXCESSIVE DEMAND
17.1 In the event that ICU is unable to carry out its obligations under
this Agreement due to acts of God or of the public enemy, war,
insurrection, mob violence, civil commotion or riots, strike, lockouts,
labor disputes, fires, floods, earthquakes, epidemics, quarantine
restrictions, freight embargoes, unusual delays in transportation, lack of
shipping facilities, unavoidable casualty, accidents, abnormal amounts of
inclement weather or unusually severe weather, changes in governmental
policy, laws or regulations (including but not limited to impositions or
quotas of limitations of shipments), or any other cause or causes beyond
the control of ICU or its suppliers, whether herein above specified or
not, ICU shall be permitted to extend the time of performance of its
obligations to
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such extent as may be necessary to enable ICU and its suppliers to complete
performance in the exercise of reasonable diligence after the cause or
causes of delay have been removed. In the event any such delay continues
for a period of more than six months, either party may terminate this
Agreement by so notifying the other party in writing.
17.2 If Force Majeure affects ICU's manufacturing capability for the Products,
ICU shall, at OHMEDA's request, sub-contract manufacture of the Products to
OHMEDA or an OHMEDA Affiliate for the period of the Force Majeure. In such
circumstances, ICU shall co-operate fully with OHMEDA and at ICU's expense,
in the provision of all necessary technology, technical and regulatory
support together with any tooling recoverable from ICU's facility, as may
be required.
17.3 In the event that world-wide demand for the Products exceeds ICU's
manufacturing capacity, ICU shall be excused from supplying OHMEDA's total
requirements for the Products, subject to OHMEDA having entitlement to its
proportionate share of the Products produced. Such share shall be equal to
the ratio that the number of each type of Product purchased by OHMEDA in
the previous Contract Year bears to the total number of that type of
Product produced at ICU's manufacturing facility during the same period.
18. TERMINATION
18.1 OHMEDA'S DUTIES UPON TERMINATION. Upon termination of this Agreement for
any reason whatsoever, OHMEDA shall:
18.1.1 cease immediately from acting as a distributor for ICU and abstain
from making further sales of Products except with the written
approval of ICU except that Ohmeda may continue to sell existing
inventory to then current customers;
18.1.2 immediately cease making use of any sign, printed material,
trademarks or trade name identified with ICU and refrain from
holding itself out as having been formerly connected in any way with
ICU; and
18.1.3 not dispose of any Products purchased from ICU except to ICU or to a
company appointed by ICU, or in a manner approved by ICU.
18.2 ICU'S DUTIES UPON TERMINATION SHALL BE AS FOLLOWS:
18.2.1 ICU may accept at its discretion in accordance with ICU's then
current published Returned Goods Policy the return of certain
Products then held unsold by OHMEDA, in original packaging. The
repurchase price shall be the net ex-works price as invoiced by ICU
for the goods in question. OHMEDA shall meet the costs of their
return CIF ICU facility in California.
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18.2.2 ICU shall cease making use of any packaging, printed materials,
trademarks or trade names identified with OHMEDA.
18.2.3 ICU shall ensure that arrangements are put in place to supply any
outstanding customer orders as notified by OHMEDA and in the case of
the Territories listed in Appendix 1, List A, future customer demand
for the Products, for not less than 12 months after termination. ICU
shall indemnify OHMEDA against all damages, costs and expenses
payable by OHMEDA to customers for non fulfillment of customer
orders outstanding at termination, through breach of this term.
18.3 OHMEDA and ICU acknowledge and agree that upon termination of this
Agreement with due notice, except as provided above, neither party shall be
liable to the other for any damages (whether direct, consequential or
incidental, and including expenditures, loss of profits or prospective
profits of any kind) sustained or arising out of or alleged to have been
sustained or to have arisen out of termination with due notice. However,
such termination shall not excuse either party from any breach of this
Agreement, from amounts owing from one party to the other or from any other
obligations surviving termination of this Agreement, and full legal and
equitable remedies shall remain available for any breach of this Agreement
or any obligation arising from it. This clause 18.3 shall survive the
termination of this Agreement.
19. MISCELLANEOUS
19.1 Any payments, notices, requests, instructions, or other documents to be
given under this Agreement, shall be in writing, and delivered personally
or sent by certified or registered mail, prepaid, unless otherwise
directed, as follows:
If to ICU: President
ICU Medical Inc.
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇,
▇▇▇ ▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ▇▇▇
If to OHMEDA: Managing Director
BOC OHMEDA AB
P O ▇▇▇ ▇▇▇
▇-▇▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇
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WITH COPY TO: The BOC Group pic
▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇
Great Britain
Attention: Legal Department
Either party may change the person or address to which such notices are
being sent by giving written notice to the other in the manner provided in
this Agreement. Any such payments, notices, requests, instructions or other
documents provided for in this Agreement, shall be deemed delivered when
hand delivered or posted prepaid airmail or when sent and received by telex
or telecopy. In the case of posting, delivery shall be deemed effective 5
business days after the date of posting and in the case of telex and
telecopy, 1 business day after the date of transmission.
19.2 Neither party may assign this Agreement, or their rights or obligations,
without prior consent of the other; provided that upon written notice,
OHMEDA shall have the right to assign this Agreement to any of its
Affiliates who agrees in writing to be bound by each and all of OHMEDA's
obligations.
19.3 This Agreement constitutes the entire Agreement between the parties
regarding its subject matter and supersedes all prior understandings of the
parties. There are no promises, terms conditions or obligations of the
parties pertaining to that subject matter other than as contained in this
Agreement. No interpretation, change, termination or waiver of any of the
provisions shall be binding upon either party unless in writing and signed
by its authorized officer. The terms of this clause shall supersede the
Confidence Agreement entered into between ICU and OHMEDA Inc., dated 18
October 1995 which shall have no further force and effect.
19.4 The relationship of the parties is strictly contractual, and is not that of
a joint venture, partnership, agency or employment. Neither party, nor
their agents or Affiliates is authorized to bind the other. No agent of
either party is authorized to make any representations, promise, or
warranty not contained in this Agreement.
19.5 No waiver of any provisions of, or default under this Agreement shall
affect the right of either party to enforce that provision or any other
provision or to exercise any right or remedy in the event of other default,
whether similar or dissimilar.
19.6 All disputes between the parties arising out of this Agreement or as to any
matters related to but not covered by this Agreement shall be governed by
the laws, without regard to the laws as to choice of laws, of the State of
New York. Each party hereto on behalf of themselves and their respective
Affiliates
Page 25: Printed May 28, 1996
consents to the exclusive jurisdiction and venue of State courts of the
State of Illinois located in ▇▇▇▇ County, Illinois, USA and/or the United
States District Court located in ▇▇▇▇ County, Illinois, USA with respect
to all disputes arising out of, or related to but not covered by, this
Agreement and consents to service of process by written notice given as
provided in clause 19.1 of this Agreement.
19.7 This Agreement is binding on the successors and assignees of the parties.
19.8 In the event this Agreement is required to be registered with any
governmental authority, OHMEDA shall cause such registration to be made
and bear any expense or tax payable in respect of such registration.
19.9 Notwithstanding anything to the contrary contained in this Agreement,
neither this Agreement, a modification of any provision of this Agreement,
nor a new provision of this Agreement shall be effected by an order,
acknowledgment or other form submitted by either party containing
different or additional provisions.
19.10 This Agreement may be executed in counterparts, each of which will be an
original, but both of which together shall constitute one instrument.
19.11 The clause and other headings contained in this Agreement are for
reference purposes only and shall not affect in any way the meaning or
interpretation of this Agreement.
19.12 Nothing in this Agreement, expressed or implied, is intended to confer on
any person or entity other than the parties any right or remedy under or
by reason of this Agreement.
19.13 The prevailing party shall be entitled to recover all costs and expenses
reasonably and properly incurred, including attorneys' fees at the hourly
rates usually charged by that party's attorneys, expert witness fees,
court costs and all other costs and expenses incurred in any action or
proceeding arising out of this Agreement or as to any matters related to
but not covered by this Agreement.
19.14 The terms of this Agreement are severable and if for any reason any terms
should be unenforceable or invalid, the rest of the Agreement shall remain
in full force and effect.
19.15 This Agreement has been negotiated by the parties and is to be interpreted
according to its fair meaning as if the parties had prepared it together
and not strictly for or against any party. All reference in this Agreement
to "parties" refer to parties to this Agreement unless expressly indicated
otherwise. References in this Agreement to Articles and Sections are to
Articles and Sections of this Agreement unless expressly indicated
otherwise. References in this Agreement to "provisions" of this Agreement
refer to the terms, conditions and promises contained in this Agreement.
At each place in this Agreement where the context so requires, the
masculine, feminine or neuter gender includes the others and
Page 26: Printed May 28, 1996
the singular or plural number includes the other. "Including" means
"including without limitation." "Or" is inclusive and includes "and."
IN WITNESS the parties have caused this Agreement to be executed by their
respective duly authorized officers, the day and year written below.
ICU Medical, Inc.
By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, M.D.
---------------------------------
▇▇▇▇▇▇ ▇. ▇▇▇▇▇, M.D., President
---------------------------------
Name Title
Name Title
BOC OHMEDA AB
By: /s/ ▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
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▇▇ ▇▇▇▇▇▇, President
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Name Title
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▇▇▇▇▇▇▇▇ 1.2
TERRITORY
Territories shall mean the geographic boundaries of the following nations,
existing as of the date of this Agreement and as they may be from time to time
altered or modified, whether by treaty, conquest, purchase or otherwise, and all
of the political territorial subdivisions within such territories (including any
independent nation, republic or other political or legal jurisdiction, which was
at the date of this Agreement within any such nations):
PART A - Direct Countries:
Andorra, Belgium, Denmark, Finland, France, Germany, Gibraltar, Great Britain,
Ireland, Luxembourg, Monaco, Netherlands, San Marino, Spain, Sweden
PART B - Distributor Countries:
Albania, Austria, Bulgaria, Czech Republic, Greece, Hungary, Iceland, Italy,
Liechtenstein, Malta, Norway, Poland, Portugal, Romania, Slovakia, Switzerland,
Turkey, the former Union of Soviet Socialist Republics ("USSR") (consisting of
Armenia, Azerbaydyhan, Belarus, Estonia, Georgia, Kazakhstan, Kirghizstan,
Latvia, Lithuania, Moldavia, Russia, Tajikistan, Turkmenistan, Ukraine and
Uzbekistan), and the former Yugoslavia (consisting of Bosnia Herzegovina,
Serbia, Montenegro, Kosovo, Macadonia, Vojvodina, Croatia and Slovenia).
Page 29: Printed May 28, 1996
