DISTRIBUTION AGREEMENT by and between GIVEN IMAGING K.K. And SUZUKEN CO., LTD.
by
and
between
GIVEN
IMAGING K.K.
And
SUZUKEN
CO., LTD.
Dated
May
9, 2002
This
Distribution Agreement (the "Agreement")
is
entered into as of May 9, 2002 (the "Execution
Date")
by and
between Given Imaging K.K. ("Given
Japan"),
a
Japanese corporation having its principal office at ▇-▇▇, ▇▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇,
▇▇▇▇▇▇▇-▇▇, ▇▇▇▇▇, and Suzuken Co., Ltd. ("Suzuken"),
a
Japanese corporation having its principal office at ▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇-▇▇▇▇▇,
▇▇▇▇▇▇▇-▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇. Suzuken and Given Japan are sometimes referred to
individually as a "Party"
and
together as the "Parties".
RECITALS
WHEREAS
Given Japan and Given Imaging Ltd. ("Given
Imaging")
are
Parties to that certain Amended Supply Agreement (the "Supply
Agreement")
dated
of even date herewith for supply by Given Imaging to Given Japan of the Given
Diagnostic Imaging System (the "Given System") currently consisting of the
M2ATM
Capsule,
a Data Recorder Kit and the RAPIDTM
Work
Station for the diagnosis of the Gastro-Intestinal Tract, as listed in
Schedule
A,
attached
hereto, and any enhancements, improvements or related product developed by
Given
Imaging (collectively the "Product")
for
distribution in Japan (the "Territory"),
and
WHEREAS,
Suzuken markets, distributes and sells pharmaceutical products and medical
equipment and disposable items throughout the Territory; and
WHEREAS,
subject to the terms and conditions of this Agreement, Given Japan wishes to
appoint Suzuken as its distribution representative for the Product in the
Territory; and
WHEREAS,
Suzuken wishes to accept such appointment and to act as Given Japan's
distribution representative in the Territory for the Product pursuant to the
terms and conditions of this Agreement;
NOW,
THEREFORE, in consideration of the premises and the mutual covenants and
agreements herein contained, and for other good and valuable consideration,
the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:
AGREEMENT
1. Appointment.
1.1 Appointment.
Subject
to the terms hereof, Given Japan hereby appoints Suzuken as its exclusive
distributor of the Product to Customers in the Territory, subject to the
exceptions and restrictions stated herein, and Suzuken accepts this appointment.
To perform its obligations as exclusive distributor, Given Japan grants to
Suzuken the non-transferable (except as provided in Section 15) right to market,
distribute and sell the Product directly to Customers in the Territory.
"Customers"
(each,
individually a "Customer")
means
customers who purchase the Product for their own internal use and not for
further marketing, distribution, sale or resale.
1.2 No
Resellers.
Suzuken
shall not appoint any resellers for the Product without the express prior
written consent of Given Japan other than purchasing agents nominated by
hospitals and other healthcare providers for purchasing medical supplies on
their behalf.
1.3 Restrictions.
Such
appointment as set forth in Section 1.1 is subject to any law and directives
applicable in the Territory. Suzuken shall not use the Product for any purpose
other than the purposes of this Agreement, and Suzuken shall not sell, market
or
distribute the Product, or conduct any marketing activity with respect to the
Product outside the Territory, without the express, prior, written approval
of
Given Japan. Suzuken shall have no distribution rights pursuant to this
Agreement for any Given Imaging products other than the Product. Suzuken shall
not distribute the Product, as such, in integration with other products or
technologies or other than as a stand-alone product, and shall not attempt
to
separate the Product's components or to use a component separately and not
as
part of the Product, without first obtaining Given Japan's prior written
consent.
1.4 Language.
Any and
all correspondence between the Parties hereto, including training and technical
or other documents or notices exchanged between the Parties and with any third
Party relating to this Agreement, shall be in the Japanese; provided that at
Given Japan's reasonable request, Suzuken shall provide English translation
of
its correspondence but shall not bear responsibility for the accuracy of any
translation prepared by a reasonably selected outside translation
service.
1.5 Performance
Standard.
Suzuken
shall and shall cause its employees, agents and independent contractors to
exercise reasonable care in the performance of any and all of its duties under
this Agreement and in taking any other action(s) related thereto, including
without limitation, the handling, installation, demonstration or servicing
of
any Product. Further, Suzuken shall not engage in any illegal, unfair, or
deceptive business practices in connection with its performance under this
Agreement. Suzuken acknowledges that breach of this provision shall be a
material breach of this Agreement.
2. Trademarks
and Domain Names.
2.1 Sublicense.
(a)
Given
Japan hereby grants Suzuken a limited sublicense to use and display the
trademarks GivenTM
,
M2ATM
and
RAPIDTM
owned by
Given Imaging (collectively, the "Given
Marks")
and
licensed to Given Japan pursuant to the Supply Agreement solely for marketing
purposes in publications, articles, advertisements and other promotional
materials in the Territory only in connection with the Product during the
Term.
(b) All
advertising and other materials in which the Given Marks are used shall be
subject to Given Japan's prior written consent, which may be withheld in its
reasonable discretion. Suzuken acknowledges that such advertising and other
materials may be subject to review and approval by Given Imaging under the
Supply Agreement. Upon termination of this Agreement, this limited license
shall
immediately terminate and Suzuken shall cease all use of the Given Marks other
than reasonably necessary to fulfill pending purchase order for
Products.
2
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
(c) Without
limiting the forgoing, all use by Suzuken of the Given Marks (including any
Japanese language translation thereof into katakana
or
otherwise) or domain name shall inure to the benefit of Given Imaging, and
Suzuken shall not obtain any rights with respect to the Given Marks or domain
names, other than any rights expressly set forth herein. Suzuken hereby
irrevocably assigns to Given Imaging in perpetuity all worldwide right, title
and interest, if any, that are owned or obtained by Suzuken in any of the Given
Marks (including any Japanese language translation thereof into katakana
or
otherwise) or domain names.
2.2 Limitations.
Suzuken
agrees not to attach or apply to the Product any other materials (including
packaging) of whatever media, any label, marking or other information that
has
not been approved by Given Japan in writing in advance. Suzuken acknowledges
that all rights in the Given Marks and domain names are and shall remain the
sole property of Given Imaging. Given Japan reserves the right to add to,
change, or discontinue the use of the Given Marks or domain names, on a
selective or general basis, at any time. Suzuken shall not remove, obscure
or
obliterate any Given Imaging patent, trademark or any other proprietary notices
incorporated in, marked on or affixed to the Product, and shall include such
notices in marketing materials in accordance with Given Japan's
instructions.
3. Regulatory
and Marketing Approvals.
Given
Japan shall use its best efforts to obtain and maintain all regulatory and
governmental approvals necessary for the marketing of the Products throughout
the Territory, as well as for health insurance reimbursement. Upon request
by
Given Japan, Suzuken shall, to the extent reasonable, assist Given Japan in
preparing and filing any such requests or applications as well as taking other
actions necessary for obtaining such approvals. Such assistance shall include,
but is not necessarily limited to allocating appropriate professional manpower,
whose costs shall be borne by Suzuken. The approvals will be in Given Japan's
name, and costs for procuring such approvals shall be borne by Given Japan.
The
above shall apply to the existing Product items as well as to new Product items,
as may be announced by Given Imaging from time to time.
4. Given
Japan's Responsibilities.
Given
Japan shall:
(a) subject
to delivery from Given Imaging pursuant to the Supply Agreement, ship Product
within [***Redacted***]
of
receipt of Product purchase order from Suzuken and sell the Products to Suzuken,
pursuant to purchase orders to be placed by Suzuken and at the prices, delivery
dates and otherwise in accordance with this Agreement; provided that (i) Given
Japan shall cause Given Imaging to ship M2A capsules within [***Redacted***]
and (ii)
to assist Suzuken in meeting initial unexpected demand, [***Redacted***]
period
commencing upon receipt of [***Redacted***]
prior
written notice from Suzuken, once [***Redacted***]
(but not
before [***Redacted***]
from
previous Emergency Order (defined below)) Suzuken may submit an emergency order
for up to [***Redacted***]
M2A
capsules (an "Emergency
Order")
and
Given Japan shall cause Given Imaging to deliver such capsules within
[***Redacted***]
of
receipt of such order in accordance with the Supply Agreement; provided further
that Given Japan shall place a purchase order with Given Imaging for the
Products within [***Redacted***]
of
receipt of such order from Suzuken;
3
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
(b) provide
Suzuken with, at no cost, (i) Japanese language Product manuals printed by
Given
Imaging and inserted in the Product package (ii) introductory Japanese language
Product catalogs/brochures printed by Given Japan and (iii) the content and
graphic design for promotional materials and literature to be printed by
Suzuken;
(c) provide
the personnel of Suzuken assigned for the sales and service of the Product
with
adequate training as to the operation, installation, maintenance and
troubleshooting of the Product (training of technical personnel for repairs
of
Product parts shall be provided by Given Imaging in Israel). Suzuken shall
not
be charged for such training other than reimbursement by Suzuken of reasonable
hotel and travel expenses of personnel of Given Imaging or Given Japan, as
the
case may be, who travel to Japan in accommodating Suzuken's request for training
pursuant to this Section 4(c);
(d) assist
Suzuken in its promotion efforts by sending representatives to attend and
lecture in medical meetings, as requested by Suzuken, offer explanations and
answer questions regarding the Product and its use and join conventions and,
trade shows etc., all if coordinated in advance, subject to personnel
availability reimbursement by Suzuken of reasonable hotel and travel expenses
of
personnel of Given Imaging or Given Japan, as the case may be, who travel to
Japan at in accommodating Suzuken's request pursuant to this Section
4(d);
(e) refer
to
Suzuken inquiries coming from the Territory through other international
promotion channels (international advertisements, trade shows etc.) for
purchasing Products for use within the Territory;
(f) subject
to receipt of a prior written notice to such effect from Given Imaging under
the
Supply Agreement, give Suzuken a ninety (90) days minimum prior notice of any
modifications and improvements in the Products (including specifications,
options, features, software upgrades or updates configuration,
etc.);
(g) provide
Suzuken, at not cost, with all the leads and relevant information received
by
Given Japan from Given Imaging coming from the Territory through its Webcentric
marketing and sales system, as soon as practicable after the system is
operational;
(h) at
its
own expense, monitor Suzuken's performance; and
(i) [***Redacted***];
(j) [***Redacted***],
participate in [***Redacted***]
international
gastroenterology congress or convention in the Territory;
(k) [***Redacted***];
(l) during
the Term, not exercise by itself nor grant to or authorize exercises by any
other person or entity in the Territory any of the rights granted to Suzuken
under Sections 1.1 or 1.2; and
4
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange Commission.
(m) during
the Term, not grant to or authorize exercise by any other person or entity
in
the Territory any of the rights granted to Suzuken under Section
2.1.
5. Suzuken
's Responsibilities.
Suzuken
shall:
(a) use
its
best efforts to market and sell the Product in the Territory, in accordance
with
a sales plan (which includes marketing and staffing) that is to be agreed upon
by Given Japan and Suzuken;
(b) [***Redacted***];
(c) [***Redacted***];
(d) maintain
adequate inventory of the Product to meet the market demand and needs of
Customers in the Territory and provide a high level of service to Customers.
("high level" shall mean [***Redacted***]);
(e) [***Redacted***];
(f) [***Redacted***];
(g) make
minor repairs to equipment and provide on-site service and in doing so, Suzuken
shall follow given Japan's reasonable instructions and utilize only such Product
components or spare and service parts, as applicable, for the Product as
approved by or obtained from Given Japan. Accordingly, Suzuken shall maintain
a
stock of Product and spare units in quantity sufficient to provide such
services;
(h) provide
Customers with basic training and education in the use of the Product, in
accordance with Given Japan's guidance;
(i) provide
first level customer and technical support;
(j) handle
warranty claims (subject to reimbursement by Given Japan for defective
Products). [***Redacted***];
(k) [***Redacted***];
(l) print
promotional materials and literature as provided by Given Japan under Section
4(b);
(m) participate
in [***Redacted***]
gastroenterology
congress/convention/exhibit held in the Territory;
(n) [***Redacted***];
(o) notify
Given Japan's designated medical vigilance personnel in writing [***Redacted***]
from the
date that Suzuken becomes aware of the incident or near incident of any incident
or near incident associated with the Product [***Redacted***],
provide
Given Japan all data and information required in order to prepare a medical
device agency vigilance report or to comply with applicable law or requirements
of the Ministry of Health Labor and Welfare of Japan ("MOH") and otherwise
cooperate fully with Given Japan in a timely manner. [***Redacted***].
In this
sub section, "incident" shall include, but is not limited to, [***Redacted***].
A
"serious deterioration in the state of health" shall include, but is not limited
to, [***Redacted***];
5
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
(p) (i)
appoint a representative for implementation of this Agreement, who shall serve
as a point of contact (ii) [***Redacted***]
and
(iii) cause all its staff directly involved in the marketing and sales of the
Product, from the level of regional sales manager and up, to attend a meeting
with representatives of Given Japan [***Redacted***];
(q) not
make
any representations or give any warranties concerning the Product or its
capabilities which are false or misleading in any way [***Redacted***];
(r) notify
Given Japan of all matters of importance coming to its attention, relating
to
the Product and their service, legislative changes, governmental or local
policies, new products and market trends;
(s) refrain
from making any change in the Product (including any part, component or feature
thereof), unless specifically approved by Given Japan in writing;
(t) subject
to any applicable law or directive, refrain from selling Product to any entity
outside the Territory or to any entity who Suzuken reasonably believes may
resell, export or use the Product outside the Territory and refer to Given
Japan
any inquiries regarding the Product coming from outside the
Territory;
(u) reasonably
cooperate with Given Japan on all matters of medical vigilance and report all
Product problems;
(v) [***Redacted***];
(w) sell
the
Product only under Given Japan's limited warranty, as set forth in this
Agreement;
(x) [***Redacted***]
and
provide Customers with basic training and education in the use of the Products,
in accordance with Given Japan's guidance; and
(y) ensure
that all its personnel involved in the marketing and service and distribution
of
the Product are adequately trained.
6
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
6. Terms
and Conditions of Sale.
All
purchases of Products by Suzuken from Given Japan during the term of this
Agreement shall be subject to the terms and conditions attached hereto as
Schedule
B.
The
prices in Schedule
B
relate
only to currently marketable parts and components of the Product, not to future
parts and components of the Product.
7. Proprietary
Rights.
7.1 Reporting
of Third Party Infringement.
Suzuken
undertakes to promptly inform Given Japan in writing of any possible
infringement by third parties in Japan of Given Imaging's proprietary rights
including any duplication of the Product (including any part, component or
feature thereof) or the Given Marks that Suzuken becomes aware of, [***Redacted***].
7.2 Handling
of Infringement Claims.
(a) Suzuken
undertakes to promptly inform Given Japan in writing of any actual or threatened
claim that the Product or part thereof purchased by Suzuken hereunder may
infringe a third party's proprietary rights in the Territory that Suzuken
becomes aware of. In the event that Suzuken notifies Given Japan as aforesaid,
then Given Japan agrees to defend (subject to reasonable assistance by Suzuken
provided that Given Japan shall reimburse all of Suzuken's pre-approved
expenses) and may, in its sole discretion, [***Redacted***].
(b) If
it is
determined by the court of first instance [***Redacted***]
that the
Product or a part thereof purchased by Suzuken hereunder infringes a third
party's proprietary rights in the Territory, Given Japan shall indemnify and
hold harmless Suzuken as well as its shareholders, employees, directors,
representatives, Customers and agents (each an "Indemnified
Party")
from
and against their direct losses, costs and expenses set by such court to the
extent based on such Infringement Claim (as defined below), except to the extent
such losses, costs and expenses result from the Indemnified Party's breach
of
this Agreement, bad faith, willful misconduct or gross negligence. "Infringement
Claim"
means
any third party claim that the Product or a part thereof infringes a third
party's proprietary rights in the Territory.
7.3 [***Redacted***].
7.4 Assignment
of Inventions.
(a) Suzuken
shall inform Given Japan of any Invention (as defined below) relating to the
Product and, at Given Japan's request and expense, Suzuken hereby expressly
assigns all right, titles and interests in and to any Inventions (defined below)
to Given Imaging and shall execute any necessary assignment, patents forms,
trade marks, and the like and will assist in the drafting of any description
or
specification of the Invention as may be required for Given Imaging's records
and in connection with any application for patents. Suzuken shall treat all
information relating to any Invention as Confidential Information. While, where
relevant, the name of the Inventor on the Patent Applications will be that
of
the inventor, Given Imaging shall be the exclusive owner of any invention,
trademark, copyright, improvement know-how or other intellectual property which
shall be developed by Suzuken using any Confidential Information (defined below)
of Given Japan or Given Imaging or with the involvement of any personnel of
Given Japan or Given Imaging ("Inventions"),
and of
any patent, patent application, trademark, copyright and such other rights
therein, without any additional compensation to Suzuken. It is understood that
Given Japan shall pay Suzuken any expense incurred by it in assisting it, at
its
request, in obtaining patent, trademark, copyright or other protection
hereunder. Given Imaging's rights shall be world-wide and shall attach to any
such Invention notwithstanding that it is perfected or reduced to specific
form
after Suzuken has ceased its services hereunder, provided that its conception
during the term hereof.
7
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
(b) Without
derogating from section 7.4(a), Given Imaging shall have sole and exclusive
ownership rights in any results and information relating to, arising out of
or
resulting from the performance of this Agreement by either Party if (i)
developed by Suzuken using any Confidential Information (defined below) of
Given
Japan or Given Imaging or jointly with the involvement of any personnel of
Given
Japan or Given Imaging or in performing its obligations hereunder and (ii)
related to the Product, including, but not limited to all copyrights, and
marketing information and material.
8. Defects
Warranty.
8.1 Limited
Customer Warranty.
Given
Japan shall provide a warranty to Suzuken and Customers warranting that the
Product shall be free from defects in material or workmanship for a period
as
described below:
(i) for
[***Redacted***]
in the
case of the RAPIDTM
Workstation, Data Recorder Kit carrying case, DataRecorderTM,
RecorderBeltTM
and
Battery Charger;
(ii) [***Redacted***]
in the
case of the M2ATM
10-Pak;
and
(iii) for
[***Redacted***]
in the
case of the Rechargeable Battery Packs and SensorArrayTM.
Suzuken
shall make available to Customers a copy of Given Japan's warranty to
Customers.
8.2 Limitation
of Warranty Liability.
The
liability of Given Japan under this warranty is limited to [***Redacted***].
8.3 Exclusions.
This
warranty shall not apply to a Product which has been repaired or altered other
than in accordance with Given Japan's instructions, nor shall it apply to a
Product which has been subject to misuse, unauthorized use, negligence,
accident, (including fire, water, explosion, smoke, vandalism, etc.) or which
has been operated contrary to Given Japan's instructions or any other cause
beyond Given Japan's control. Without derogating from the above, the warranty
is
void, if at any time:
8
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
(i) anyone
other than Given Japan's authorized personnel removes a Product casing and/or
attempts to make or makes any internal changes, removals, attachments or
additions to the Product or components thereof; or
(ii) anyone
installs unauthorized software on to the Product.
8.4 Return/Replacement
of Products Under Warranty.
Products or parts thereof may be returned for repair, replacement or adjustment
to Given Japan. No credit allowances will be given or replacements shipped
unless defects are verified by Given Japan or Given Japan's authorized
personnel.
8.5 Exclusive
Remedy.
THE
FOREGOING WARRANTY IS SUZUKEN'S SOLE AND EXCLUSIVE REMEDY AGAINST ▇▇▇▇ JAPAN
HEREUNDER, AND IS IN LIEU OF ANY AND ALL OTHER WARRANTIES, GUARANTEES, PROMISES,
OR REPRESENTATIONS WHETHER WRITTEN, ORAL OR IMPLIED, INCLUDING WARRANTIES OF
MERCHANTABILITY, SATISFACTORINESS OR FITNESS FOR ANY PARTICULAR PURPOSE OR
USE.
IN NO EVENT SHALL GIVEN JAPAN BE LIABLE FOR LOSS OF USE, LOSS OF PROFITS, OR
OTHER COLLATERAL, SPECIAL OR CONSEQUENTIAL DAMAGES. EXCEPT AS SET FORTH IN
SECTION 7 (Proprietary Rights) AND SECTION 9.1(ii) and 9.2 (Indemnification),
EACH PARTY'S TOTAL LIABILITY ARISING UNDER THIS AGREEMENT SHALL BE LIMITED
TO
THE AMOUNT PAID BY SUZUKEN HEREUNDER IN THE [***Redacted***]
PERIOD
PRECEDING THE DATE OF THE CLAIM UNDER THIS AGREEMENT.
8.6 Response
to Warranty Claims.
Suzuken
shall handle all Customer warranty claims under the warranty set out in Section
8.2 at its expense subject to reimbursement by Given Japan for defective
Products.
9. Indemnification.
9.1 Mutual
Indemnification.
Each
Party shall be liable for and shall indemnify, defend, and hold the other
harmless against any liability, damages, or loss from any claims, actions,
suits, judgments, proceedings, demands, recoveries or expenses, including,
but
not limited to, reasonable attorneys' fees, arising out of, based on, or caused
by (i) any breach of this Agreement or any of its obligations hereunder or
(ii)
violation of any applicable Japanese law, statute, ordinance, rule or regulation
with regard to the Product by the indemnifying Party or any of its respective
employees, agents or independent contractors, except to the extent such damages
arise from the bad faith, willful misconduct or gross negligence of the
indemnified Party or its their respective employees or representatives (whether
authorized or not).
9.2 Indemnification
by Given Japan.
(a) Notwithstanding
anything herein to the contrary, Given Japan shall defend, indemnify and hold
harmless Suzuken, its officers, agents, employees and representatives and any
of
its Customers (each referred to in this Section 9.2 as an "Indemnified
Party")
from
and against any and all direct costs, expenses, losses, damages or liabilities
awarded by a court of first instance (provided that Suzuken will first appeal
such determination if (i) requested by Given Japan and (ii) Given Japan timely
funds the bond necessary to stay execution of such determination) to the extent
based on any Product Liability Claim (defined below), except to the extent
such
damages arise from the bad faith, willful misconduct or gross negligence of
such
Indemnified Party or their respective employees or representatives (whether
authorized or not). Given Japan agrees that, if the Products in the inventory
of
Suzuken, become or are subject of such a determination, Suzuken will be entitled
to return such Products for a refund of the purchase price.
9
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
(b) The
foregoing rights of indemnification shall be conditioned on the Indemnified
Party (i) furnishing prompt notification to Given Japan as soon as it becomes
aware of such claim or action being made, threatened or reasonably expected
(this obligation shall not apply to Customers; provided that Customers shall
be
required to provide such notice to Suzuken), (ii) permitting Given Japan or
its
designee to control defense and settlement of any such third-party claim or
action, and (iii) cooperating in the defense by Given Japan or its designee
at
Given Japan's expense.
(c) "Product
Liability Claim"
means a
third party claim based on any death, bodily injury or property damages
occurring out of the Given System, including, without limitation, a claim based
on the Product
Liability Act of Japan,
Law No.
85 promulgated on July 1, 1994 as it may be amended.
10. Regulatory
Inspections.
Suzuken
shall allow representatives of regulatory agencies or authorities with
jurisdiction over the manufacture, marketing and distribution of the Product
to
tour and inspect all facilities utilized by Suzuken in the marketing,
distribution, or storage, of Product sold under this Agreement, and shall
co-operate with such representatives in every reasonable manner. Suzuken shall
provide Given Japan with a copy of any notices of adverse findings, regulatory
letters or similar notifications it receives from any other governmental
authority setting forth adverse findings or non compliance with any applicable
laws, regulations or standards relating to the items supplied by it hereunder.
Suzuken shall also provide Given Japan with a copy of its proposed written
response to such governmental authority before submission and shall incorporate
all changes thereto which Given Japan requests.
11. Term
and Termination.
11.1 Term.
Subject
to the terms and conditions set forth herein, and unless terminated earlier
in
accordance with Section 11.3, the term of this Agreement shall be as set forth
in Schedule
B
(the
"Term").
11.2 Continuation.
The
Term shall be automatically renewed for consecutive periods of one (1) year
each
so long as Suzuken [***Redacted***]
and (ii)
perform all of its obligations under this Agreement.
11.3 Termination
by Either Party.
This
Agreement and Suzuken 's distribution rights hereunder shall immediately
terminate upon the occurrence of any one of the following:
10
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange Commission.
(a) a
material breach by either Party of its obligations under this Agreement that
has
not been cured (when curable, otherwise this cure period shall not apply) within
ninety (90) days from receipt of written notice of thereof from the
non-breaching Party.
(b) either
Party voluntarily files a petition in bankruptcy or liquidation, or has such
a
petition involuntarily filed against it, which is not discharged within 45
days
after filing, or is placed in receivership, or in the hands of a trustee for
the
benefit of creditors or enters into any analogous situation or position under
the law of any relevant jurisdiction or ceases doing business in the marketing,
distribution, manufacture, sale or lease of Products.
11.4 Termination
by Given Japan.
Given
Japan may, at its sole discretion, upon [***Redacted***]
prior
written notice (unless a shorter time is indicated below), terminate this
Agreement (or make the distribution rights hereunder non-exclusive in the event
that: (i) [***Redacted***];
or (ii)
[***Redacted***];
or
(iii) upon [***Redacted***]
prior
written notice, in the event that [***Redacted***].
11.5 Sale
after Termination.
If the
term of this Agreement expires or this Agreement is terminated by Suzuken due
to
a breach by Given Japan, Suzuken shall at its option, (i) have the rights to
sell the Products in its inventory or (ii) cause Given Japan to purchase the
Products in good and salable condition in its inventory at the purchase price.
Without prejudice to the foregoing, in the event that this Agreement expires
or
is terminated by Suzuken due to a breach by Given Japan, Suzuken may continue
to
sell the Products to its existing Customers until Given Japan or its newly
appointed distributor becomes able to provide such Customers with the Products.
In the event this Agreement is terminated by Given Japan due to breach by
Suzuken or under Section 11.4, the Parties, together with Marubeni and Given
Imaging, shall discuss transfer of Suzuken's Customer accounts to Given Japan
or
its newly appointed distributor to effect continuous sale of the Products to
Suzuken's existing Customers.
12. Non-Compete.
During
the Term and, [***Redacted***],
(the
"Restriction
Period"),
Suzuken shall not without Given Japan's prior written consent:
(i) directly
or indirectly engage, participate or invest in any business whose primary
business is the Restricted Business (defined below) in the Territory, or assist
any business organization or person whose primary business engages in, or
otherwise assist any division or unit of a business organization or person
if
the primary business of such division or unit is in the Restricted
Business;
(ii) directly
or indirectly, on behalf of itself or any other person or entity, approach,
contact or solicit Given Japan's customers in connection with any Restricted
Business; or
(iii) directly
or indirectly, on behalf of itself or any other person or entity, solicit the
services of, employ or agree to employ, engage or otherwise retain the services
of any person who is or was an employee of Given Japan for the purposes of
the
Restricted Business.
11
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
The
"Restricted
Business"
shall
mean [***Redacted***].
13. Confidentiality.
13.1 Confidentiality
Obligation.
(a)
Each
Party shall hold in trust and confidence for the other Party all Confidential
Information (as defined below) disclosed to the receiving Party at any time
during the Term and neither Party shall disclose such Confidential Information
to any person outside of the other Party. Each Party agrees to indemnify the
other Party for any loss resulting from a breach of its duty to maintain such
confidentiality.
(b) "Confidential
Information"
means
any non-public information, data, trade secrets or know-how, or business or
technical information of a Party or other information of a Party related to
the
Product or any Invention, including, but not limited to, ideas, concepts,
strategies, business and marketing plans, financial and operational information,
investment opportunities and investments, research, product plans, customer
and
client lists and names, business contact lists and names, prices and costs,
markets, developments, inventions, processes, marketing, licenses or other
business information of a Party; provided that to be treated as Confidential
Information, the information (whether disclosed in writing or orally) must
be
either (i) marked "Confidential" prior to its disclosure or if any of the
foregoing is not so marked or which is disclosed orally or observed
accidentally, it must be identified in writing as confidential within thirty
(30) days of disclosure or (ii) clearly confidential in nature; provided that
if
there is any doubt as to whether or not the information is clearly confidential
in nature, the receiving Party shall confirm its nature with the disclosing
Party.
(c) Confidential
Information shall not include any information disclosed by a Party hereunder
which (i) is already known to the receiving Party and which the receiving Party
had in its rightful possession in written or physical embodiment prior to the
Execution Date, unless such Confidential Information was previously disclosed
by
the receiving Party, (ii) is rightfully received by the receiving Party in
the
routine course of business from a third party who acquired such Confidential
Information and the right to disclose same from the disclosing Party; (iii)
is
approved for release or publication by written authorization of the disclosing
Party; or (iv) has become generally available to the public through no act
of
the receiving Party.
13.2 Limitations
on Use; Return of Information.
Confidential Information of the other Party shall not be used by either Party
for any purposes except those for which the information was disclosed by or
derived from the disclosing Party. All Confidential Information disclosed to
a
Party hereunder is, and shall remain, the sole property of the disclosing Party.
Upon termination or expiration of this Agreement, the receiving Party shall
cease use of all Confidential Information, and shall promptly destroy or return
to the disclosing Party, all such Confidential Information.
13.3 Need
to Know Basis.
Each
Party agrees that the Confidential Information received from the other Party
shall be disclosed only to such of its respective employees and sales or service
representatives that have a need to know about such Confidential Information
for
a use authorized by this Agreement. Each Party undertakes to bind its respective
employees, officers, sales, technical, maintenance and service representatives,
and other third parties to
12
13.4
whom
Confidential Information is disclosed as permitted hereunder, to the terms
and
conditions contained herein.
13.5 Ongoing
Confidentiality Obligations.
The
obligations respecting Confidential Information imposed on each Party
respectively shall continue during the term of this Agreement and for as long
as
such Party continues to hold any such Confidential Information of the other
Party.
13.6 Limitation
of Rights.
Unless
otherwise specifically stated herein, this Agreement does not grant Suzuken
any
manufacturing, assembly, production, modification or licensing rights, or any
rights in any patents, patent applications, trademarks, and trade names,
copyrights or know-how of Given Japan.
13.7 Injunctive
Relief.
Each
party hereby acknowledges and agrees that in the event of its violation hereof
the other Party shall be authorized and entitled to obtain from any court of
competent jurisdiction, preliminary and permanent injunctive relief, which
rights and remedies shall be cumulative and in addition to any other rights
or
remedies to which each Party shall be entitled under law or under this
Agreement.
14. Independent
Contractors.
The
Parties are independent contractors. Nothing in this Agreement shall be
construed to constitute the Parties as principal and agent, employer and
employee, franchiser and franchisee, partners, joint venturers, corporate
affiliates, co-owners or otherwise as participants in a joint
undertaking.
15. Assignment.
Neither
this Agreement nor any of the rights, interests or obligations hereunder shall
be assigned by either Party without the prior written consent of the other
Party; provided that it is expressly agreed that Suzuken may assign this
Agreement to its wholly-owned subsidiary, provided that (i) Suzuken shall remain
jointly and severally liable for satisfaction of its obligations set forth
in
this Agreement and (ii) this Agreement shall automatically terminate in the
event such subsidiary ceases to be a 100% owned and controlled by
Suzuken.
16. Disputes.
16.1 Resolution
of Disputes.
The
Parties will attempt to resolve all disputes arising out of or in connection
with this Agreement (including any disagreement concerning the validity,
enforceability or interpretation of this Agreement) through amicable and good
faith discussions. If a dispute arises among the Parties then the senior
management of each of the Parties shall engage in amicable and good faith
discussions to attempt to resolve such dispute.
16.2 Arbitration.
In the
event the Parties are unable within thirty (30) days to settle any dispute
amicably as provided in Section 16.1, then, such dispute shall be finally
determined under the Rules of Arbitration of the International Chamber of
Commerce by a single arbitrator fluent in English. The place of such arbitration
shall be London, England unless the claim as submitted, or subsequently amended,
if accepted by the arbitrator shall have no direct or indirect effect on Given
Imaging, other than in its capacity as a shareholder of Given Japan, in which
case the arbitration may be in Tokyo, Japan. The language of the arbitration
shall be English. Judgment upon an arbitral award rendered by the arbitrator
may
be entered in any court having jurisdiction.
13
17. Miscellaneous.
17.1 Governing
Law and Language.
This
Agreement shall be governed by and construed in accordance with the laws of
Japan, without regard to its conflict of laws rules. The English language text
of this Agreement shall be the only binding version. Any translation hereof
shall have no legal effect.
17.2 Publication,
Press releases.
Both
Parties may release press releases that refer to the existence of an agreement
between the Parties, without divulging the commercial details of the agreement,
and subject to their respective confidentiality obligations to each other.
Both
Parties shall send the other Party a copy of any draft press release that refers
to the other Party, for advance approval before release. Approvals will not
be
unreasonably withheld, and shall be provided on a timely basis.
17.3 Recitals
and Schedules.
All
Recitals and all Schedules attached to this Agreement constitute an integral
part of this Agreement. The definitions of this Agreement shall apply to all
Schedules.
17.4 Headings.
The
headings of sections and subsections of this Agreement are inserted only for
the
purposes of convenience and they shall not be construed as to affect the scope,
meaning or intent of the provisions of this Agreement or any part or portion
thereof, nor shall they otherwise be given any legal effect.
17.5 Notices.
Any and
all notices, requests, demands and other communications required or otherwise
contemplated to be made under this Agreement shall be in writing and in English
and Japanese and shall be provided by one or more of the following means and
shall be deemed to have been duly given (i) if delivered personally, when
received; (ii) if transmitted by facsimile, on the date of transmission with
receipt of a transmittal confirmation; or (c) if by international courier
service, on the fourth Business Day following the date of deposit with such
courier service, or such earlier delivery date as may be confirmed in writing
to
the sender by such courier service. Unless otherwise instructed, all such
notices, requests, demands and other communications shall be addressed to
Parties at their addresses as follows:
|
(a)
|
if
to the Suzuken, to
|
Suzuken
Co., Ltd.
8
HigashiKataha – machi
Higashi-ku
Nagoya,
Aichi
JAPAN.
Facsimile:
(▇▇-▇▇) ▇▇▇-▇▇▇▇
Attention:
Senior General Manager, Business Development Department
14
|
(b)
|
if
to the Company, to:
|
Given
Imaging K.K.
▇-▇▇,
▇▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇▇▇
▇▇▇▇▇▇▇-▇▇,
▇▇▇▇▇
▇▇▇▇▇.
Facsimile:
(▇▇-▇) ▇▇▇▇-▇▇▇▇
Attention:
Representative Director
with
copy
to:
▇▇▇
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇
▇▇
▇▇▇
▇▇▇
▇▇▇▇▇▇▇
▇▇▇▇▇, ▇▇▇▇▇▇
Fax:
▇▇▇-▇▇▇▇-▇▇▇▇
Attention:
▇▇▇▇▇ ▇▇▇▇▇▇, Vice President - Business Development and ▇▇▇▇▇ ▇▇▇▇▇▇▇, Vice
President - Global Sales and Marketing
17.6 No
Waiver.
Failure
by either Party to enforce any provision of this Agreement will not be deemed
a
waiver of future enforcement of that or any other provision.
17.7 Force
Majeure.
Neither
Party shall be responsible for any failure to perform due to unforeseen
circumstances or to causes beyond the Party's reasonable control, including
but
not limited to acts of God, war, riot, embargoes, acts of civil or military
authorities, fire, floods, accidents, strikes, or shortages of transportation,
facilities, fuel, energy, labor, or materials. In event of any such delay in
delivery or payment, the Party in delay may defer the performance date for
a
period equal to the time of such delay, provided that the lack of liquidity
by
one Party shall not constitute a Force Majeure.
17.8 Severability.
If any
provision of this Agreement is determined to be invalid or unenforceable, the
provision shall be deemed to be severable from the remainder of this Agreement
and shall not cause the invalidity or unenforceability of the remainder of
this
Agreement. The Parties shall make their best efforts in order to render
effective such provisions of this Agreement not affected thereby and this
Agreement will continue in full force and effect.
17.9 Entire
Agreement.
This
Agreement, including all supplements and Schedules constitutes the entire
agreement between the Parties with respect to the subject matter hereof and
supersedes all prior agreements, understanding or representations, oral or
written between the Parties hereto regarding such matter.
17.10 Amendments.
This
Agreement may be modified or amended only in writing, signed by duly authorized
representatives of both Parties.
17.11 Counterparts.
This
Agreement may be executed in one or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument.
15
17.12 Interpretation.
(i) In
this Agreement, unless the context requires otherwise, the singular shall
include the plural and vice versa, and a reference to one gender shall include
all genders; (ii) A "Section" is a reference to a Section of this Agreement;
(iii) The words "including", "includes" and "include" shall be deemed to be
followed by the words "without limitation" or "but not limited to" or words
of
similar import; (iv) The words "hereof", "herein" and "hereunder" and other
words of similar import used in this Agreement refer to this Agreement as a
whole and not to any particular part of this Agreement; (v) References to
agreements (including, without limitation, this Agreement) and other contractual
instruments shall be deemed to include all appendices, schedules, exhibits,
annexes and attachments attached thereto and all subsequent amendments and
other
modifications to such agreements; (vi) References to Parties include their
respective successors and permitted assigns; and (vii) Reference to a given
applicable law is a reference to that law as amended or modified as of the
date
on which the reference is made.
[Signature
Page Follows]
16
IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement, as of the
Execution Date.
|
GIVEN IMAGING K.K.
|
SUZUKEN CO., LTD.
|
|||
|
By:
|
/s/
▇▇▇▇▇▇ ▇▇▇▇▇▇
|
By:
|
/s/
▇▇▇▇▇▇ ▇▇▇▇▇▇
|
|
|
Name:
|
▇▇▇▇▇▇
▇▇▇▇▇▇
|
Name:
|
▇▇▇▇▇▇
▇▇▇▇▇▇
|
|
|
Title:
|
Representative
Director
|
Title:
|
Director
& Senior General Manager Headquarters of Corporate Planning
Department, General Manager Corporate Planning
Department
|
|
|
Acknowledged:
|
Acknowledged:
|
|||
|
MARUBENI CORPORATION
|
||||
|
By:
|
/s/
▇▇. ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
|
By:
|
/a/
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
|
|
|
Name:
|
▇▇.
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇
|
Name:
|
▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇
|
|
|
Title:
|
President
and Chief Executive Officer
|
Title:
|
Corporate
Vice President, Executive Corporate Officer, Business Incubation
Dept.
|
|
|
By:
|
/s/
▇▇▇▇▇ ▇▇▇▇▇▇▇
|
|||
|
Name:
|
▇▇▇▇▇
▇▇▇▇▇▇▇
|
|||
|
Title:
|
Vice
President, Global Sales and Marketing
|
|||
[Signature
Page to Distribution Agreement]
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
Schedule
A
[***Redacted***]
Portions
of this agreement have been omitted pursuant to a request for confidential
treatment filed with the
Securities
and Exchange Commission. The omissions have been indicated by
“[***Redacted***]”, and the
omitted
text has been filed separately with the Securities and Exchange
Commission.
Schedule
B
[***Redacted***]