[NOTE:
CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL INFORMATION HAS BEEN OMITTED. CONFIDENTIALITY HAS BEEN
REQUESTED FOR THIS CONFIDENTIAL INFORMATION. THE CONFIDENTIAL
PORTIONS HAVE BEEN PROVIDED SEPARATELY TO THE SECURITIES AND
EXCHANGE COMMISSION]
FUKUDA DENSHI CO., LTD. AND
VOLCANO CORPORATION AND VOLCANO JAPAN CO., LTD
AMENDED AND RESTATED JAPANESE
DISTRIBUTION AGREEMENT
THIS AGREEMENT
(“Agreement”), dated as of March 17, 2006 and
which shall be effective on the Effective Date (defined below), is
made and entered into among Volcano Corporation, a Delaware
corporation, with its principal office at 2870 Kilgore Road, Rancho
Cordova, California 95670, U.S.A. (hereinafter referred to as
“Volcano USA”), Volcano Japan Co., LTD, a corporation
of Japan and a wholly-owned subsidiary of Volcano USA, with its
principal office at Ebisu Shimizu Bldg 4F, 1-25-7, Ebisu,
Shibuya-ku, Tokyo (hereinafter referred to as “Volcano
Japan”)(hereinafter Volcano USA and Volcano Japan are
sometimes collectively referred to as “Volcano”) and
Fukuda Denshi Co., Ltd. a corporation of Japan, with its principal
office at 3-39-4 Hongo, Bunkyo-ku, Tokyo 113-8483, Japan
(hereinafter referred to as “Fukuda”), and amends and
restates certain Japanese Distribution Agreement, dated as of
November 30, 2004, by and between Volcano and Fukuda (the
“Original Distribution Agreement”).
In consideration
of the mutual promises contained herein, and for other good and
valuable consideration, the sufficiency of which is hereby
acknowledged, the parties agree as follows:
A. “Act”
shall mean any act, statute, or regulation of any kind governing
the products in the U.S.A. including the Federal Food, Drug and
Cosmetic Act (21 U.S.C. Sections 301-392 (2002)).
B. “Best
Efforts” shall mean every necessary and prudent effort of a
party applied in a prompt, commercially reasonable manner, to the
maximum extent reasonably allowed by such party’s available
financial resources, taking into account all of such party’s
business commitments for such financial resources.
C. “Effective
Date” shall mean the date on which ownership of the Shonins
shall have transferred from Fukuda to Volcano Japan.
D. “EndoSonics
Agreement” shall mean the Japanese Distribution Agreement,
dated August 31, 1998, by and between Fukuda and EndoSonics
Corporation, a Delaware corporation (“EndoSonics”),
which was subsequently assigned to Volcano USA from Jomed, Inc., a
Delaware corporation (formerly EndoSonics), that granted
distribution rights related to certain medical device products to
Fukuda from EndoSonics.
E. “Exclusive
Field” shall mean the cardiology field and does not include
endovascular or peripheral applications fields.
F. “Field”
shall mean the Exclusive Field and the Non-Exclusive
Field.
G. “Fukuda
Accounts” shall mean those accounts listed on
Exhibit A.
H. “Gray
Accounts” shall mean those accounts listed on
Exhibit C .
I. “MOHLW”
shall mean the Ministry of Health, Labour and Welfare for the
country of Japan.
J. “Non-Exclusive
Field” shall mean the endovascular field.
K. “QSR’s”
shall mean the good manufacturing practices for medical devices set
forth by any Act governing the products in the U.S.A. including
United States 21 C.F.R. Section 820 (2004).
L. “s5i
consoles” shall mean a set of individual IVUS imaging system
components (CPU, control stations, monitors, etc.) which are
installed directly into the cath lab on a permanent (non-mobile)
basis or built into mobile angiographic, ultrasound or other
imaging types of equipment. For the avoidance of doubt, the s5i
shall include IVUS systems integrated into the cath lab that have a
control room, a cath lab, and or a bedside control panel of any
number of form factors that is or is not linked to operation of the
basic functions of the cath lab system and gantry.
M. “Shonins”
shall mean the regulatory approvals that are associated with the
Volcano Products and that have been issued by the MOHLW.
N. “Territory”
shall mean the country of Japan, but as defined by the accounts
listed in Exhibit A and Exhibit C. Fukuda shall make best
effort and accept its responsibility to sell to Fukuda Accounts
listed in Exhibit A . From time to time, and no less
than annually, beginning January 1, 2007, the parties agree to
review and modify Exhibit A and Exhibit C. Any
Fukuda Account listed on Exhibit A to which no sales of
any Volcano products have been made by Fukuda over a period of the
prior twelve (12) consecutive months shall be deleted from
Exhibit A and shall be added to Exhibit C
and thereafter be considered a Gray Account.
O. “Volcano
Products” shall mean those products listed on
Exhibit B attached hereto and all successor products
thereto. Volcano Products may be changed, abandoned or added by
Volcano, at its sole discretion, provided that Volcano gives one
hundred twenty (120) days’ prior written notice to
Fukuda.
2.
APPOINTMENT AND AUTHORITY OF FUKUDA
A.
Appointment . Subject to the terms and conditions set forth
herein, for the period commencing on the Effective Date until
June 30, 2012, Volcano hereby appoints Fukuda as:
(i) Volcano’s
exclusive distributor for Volcano Products, other than the s5i
consoles, to Fukuda Accounts within the Exclusive Field within the
Territory; and
(ii) Volcano’s
non-exclusive distributor for:
a. the
s5i consoles to Fukuda Accounts and Gray Accounts within the Field
within the Territory;
b. Volcano
Products, other than the s5i consoles, to Fukuda accounts within
the Non-Exclusive Field within the Territory; and
c. Volcano
Products, other than the s5i consoles, within the Field but limited
to the Gray Accounts.
Subject to the
terms and conditions set forth herein, Fukuda hereby accepts such
appointment.
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B. Use of
Trademarks . Volcano hereby grants to Fukuda a non-exclusive
license to use the Volcano Trademarks (defined herein below) for
the purpose of identifying and marketing the products in Japan for
use in the Field. Any use of the Volcano Trademarks will be in
accordance with such instructions as Volcano may give Fukuda from
time to time. Volcano shall, at its expense, use reasonable efforts
to protect and maintain all registration, filings and issuance of
Volcano Trademarks in full force and effect.
C. Fukuda
Trademarks . Volcano shall not, without the prior written
consent of Fukuda in each instance, use in any manner whatsoever,
Fukuda’s name, its trademarks, logos, symbols or other images
of Fukuda or of any party affiliated therewith.
D.
Territorial Limitation . Fukuda shall not, without the prior
written consent of Volcano USA: (i) promote, advertise, sell,
distribute the Volcano Products in any country outside Japan;
(ii) cause, directly or indirectly, the importation of the
Volcano Products into any country outside Japan; nor
(iii) establish a repair or maintenance facility in any
country outside Japan.
E.
Conflict of Interest . Commencing on the date hereof, Fukuda
shall use its Best Efforts in the promotion and sale of the Volcano
Products and all other products to which it acquires distribution
rights hereunder.
F.
Independent Contractors . The relationship of Volcano and
Fukuda established by this Agreement is that of independent
contractors, and nothing contained in this Agreement shall be
construed to (i) give either party the power to direct and
control the day-to-day activities of the other or (ii) allow
either party to create or assume any obligation on behalf of the
other party for any purpose whatsoever. All financial obligations
associated with each party’s business are the sole
responsibility of such party. All sales and other agreements
between Fukuda and its customers are Fukuda’s exclusive
responsibility and shall have no effect on Volcano’s
obligations under this Agreement. Volcano shall be solely
responsible for, and shall indemnify and hold Fukuda free and
harmless from, any and all claims, damages or lawsuits (including
attorneys’ fees) arising out of the acts of Volcano, its
employees or its agents. Fukuda shall be solely responsible for,
and shall indemnify and hold Volcano free and harmless from, any
and all claims, damages or lawsuits (including attorneys’
fees) arising out of the acts of Fukuda, its employees or its
agents.
3. TERMS OF
PURCHASE OF PRODUCTS BY FUKUDA
A. Terms
and Conditions . All purchases of Volcano Products by Fukuda
from Volcano Japan during the term of this Agreement shall be
subject to the terms and conditions of this Agreement.
B.
Prices . All purchase prices to Fukuda from Volcano Japan
for each of the Volcano Products (“Purchase Price”) are
as set forth on the attached Exhibit B , as such
Purchase Prices shall be amended from time to time during the term
of this Agreement by mutual agreement of the parties.
The Purchase
Prices may be revised from time to time through consultation
between Volcano and Fukuda, taking into account the then prevailing
market prices of the similar products; provided, however
that the Purchase Prices in effect as of the Effective Date shall
not be revised prior to December 31, 2007. Such revisions
shall apply to all orders received after the effective date of
revision. Price increases shall not affect unfulfilled purchase
orders accepted by Volcano Japan prior to the effective date of the
price increase.
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C.
Taxes . The amounts payable by Fukuda under Section 3
shall be calculated at Purchase Price plus the consumption tax (if
applicable) and exclusive of any other tax and government charges
(including, without limitation, interest and penalties), if any,
payable to the Japanese government. Nothing in this
Section 3.C. shall be construed to mean that Fukuda is
responsible for taxes and charges (including, without limitation,
interest and penalties) to the federal or state government of the
U.S.A. which are imposed on Volcano USA and to the Japanese
government which are imposed on Volcano Japan.
D. Order
and Acceptance . All orders for Volcano Products submitted by
Fukuda shall be initiated by written purchase orders sent to
Volcano Japan and requesting a delivery date during the term of
this Agreement; provided, however, that an order may initially be
placed orally or by facsimile if a confirmational written purchase
order is received by Volcano Japan within ten (10) days after said
oral or facsimile order. To facilitate Volcano USA’s
production scheduling, Fukuda shall use reasonable commercial
efforts to submit purchase orders to Volcano Japan at least sixty
(60) days prior to the first day of the requested month of
delivery. No order shall be binding upon Volcano until accepted by
Volcano Japan in writing, and Volcano Japan shall have no liability
to Fukuda with respect to purchase orders that are not accepted.
Volcano Japan shall notify Fukuda of the acceptance or rejection of
an order and of the assigned delivery date for accepted orders
within ten (10) days of receipt of the purchase order, if not
rejected within such period of ten (10) days, the order shall
be deemed accepted. Volcano will use its Best Efforts, consistent
with its obligations to other similarly-situated customers, to
process and ship all orders in accordance with requested delivery
dates by Fukuda.
E. Terms
of Purchase Orders . Fukuda’s purchase orders submitted
to Volcano Japan from time to time with respect to Volcano Products
to be purchased hereunder shall be governed by the terms of this
Agreement, and nothing contained in any such purchase order shall
in any way modify such terms of purchase or add any additional
terms or conditions, unless in writing signed by Fukuda and Volcano
Japan.
F.
Payment . Volcano Japan shall submit an invoice to Fukuda
upon each shipment of Volcano Products ordered by Fukuda. The
invoice shall cover Fukuda’s Purchase Price for the Volcano
Products in any given shipment plus [CONFIDENTIAL] of
Fukuda’s Purchase Price for handling charge incurred by
Volcano Japan. An amount equal to any freight, customs charges,
charge for service of customs clearance agent, insurance fee and
carriage or other applicable costs initially paid by Volcano but to
be borne by Fukuda in Japanese Yen. Payment shall be made in U.S.
dollars and payment shall be by wire transfer, check or other
instrument approved by Volcano Japan. Payment terms shall be the
full invoiced amount due for payment received by Volcano Japan
within sixty (60) days of the date of the invoice. Any invoiced
amount not received within sixty (60) days of the date of
invoice shall be subject to a service charge of one and a half
percent (1.5%) per month or such lesser percentage permitted by
applicable law.
G.
Shipping . All Volcano Products delivered pursuant to the
terms of this Agreement shall be suitably packed for transportation
from Volcano Japan to Fukuda in Volcano’s standard shipping
cartons, marked for shipment at Fukuda’s address set forth
above or any other address in Japan as Fukuda indicates (the
“Fukuda Location”), and delivered by Volcano Japan, or
Volcano Japan’s third-party designee, to Fukuda, at which
time title to such Volcano Products and risk of loss shall pass to
Fukuda. All transportation cost from Volcano Japan to Fukuda,
insurance, and other applicable expenses, as well as any special
packing expense, shall be paid by Fukuda.
-4-
H.
Rejection of Product . Fukuda shall inspect all Volcano
Products, except those Volcano Products which are sterilized and
sealed by Volcano at its plant, promptly upon receipt thereof and
may reject any Volcano Product that fails to meet the
specifications set forth in Volcano’s current product
specifications for that Volcano Product. Any Volcano Product not
properly rejected within sixty (60) days of receipt of that
Volcano Product at Fukuda’s facility (the “Rejection
Period”) shall be deemed accepted. To reject a Volcano
Product, Fukuda shall, within the Rejection Period, notify Volcano
Japan in writing by facsimile of its rejection and request a Return
Material Authorization (“RMA”) number. Volcano Japan
shall provide the RMA number in writing by facsimile to Fukuda
within ten (10) days of receipt of the request. Within ten
(10) days of receipt of the RMA number, Fukuda shall return to
Volcano Japan the rejected Volcano Product, freight collect, in its
original shipping carton with the number displayed on the outside
of the carton. Provided that Volcano Japan has complied with its
obligations in this Agreement, Volcano Japan reserves the right to
refuse to accept any rejected Volcano Products that do not bear an
RMA number on the outside of the carton. As promptly as possible
but no later than fifteen (15) business days after receipt by
Volcano Japan of properly rejected Volcano Products, Volcano Japan
shall, at its expense, replace the Volcano Products and ship such
replacement Volcano Products freight prepaid.
I. Return
of Products After Rejection Period . After the Rejection
Period, Volcano’s Standard Limited Warranty shall be applied.
For sterilized and sealed Volcano Products such as catheters,
however, Volcano shall replace those Volcano Products found
defective with new Volcano Products if such defects should be found
until the date the expiration of the shelf life of such Volcano
Products to Fukuda if a notice with the details of such defects is
given by Fukuda to Volcano Japan within a reasonable period after
Fukuda or the user has discovered defects or ought to have
discovered them. If Volcano tests and inspects these returned
Volcano Products and determines that such Volcano Products perform
according to Volcano’s written specifications, no credit will
be given to Fukuda. If upon such test and inspections, such
returned Volcano Products do not perform to Volcano’s written
specification, these Volcano Products will be replaced at no cost
to Fukuda except in the case that Volcano proves that such defect
was caused after the shipment to Fukuda by Volcano
Japan.
J. No
Time Restriction . Notwithstanding any provision herein to the
contrary, Fukuda’s rights and remedies under this Agreement
or laws of Japan shall not be subject to any time restriction that
may be imposed by any provisions of the laws of non-mandatory
nature so long as Fukuda gives notice specifying the nature of the
lack of conformity within a reasonable time after Fukuda or the
user has discovered it or ought to have discovered it.
4. WARRANTY
TO FUKUDA’S CUSTOMERS
A.
Standard Limited Warranty . Fukuda shall pass on to its
customers Volcano Standard Limited Warranty for the Volcano
Products. This warranty shall cover the Volcano Products for a
period of fifteen (15) months from the date of shipment to
Fukuda. This warranty is contingent upon proper use of a Volcano
Product in the application for which it was intended and does not
cover Volcano Products that were modified without Volcano’s
approval or that were subjected by the customer to unusual physical
stress. If a Volcano Product fails to meet the warranty provided
herein, Volcano’s sole liability and Fukuda and/or the
end-user’s sole remedy shall be either the replacement by
Volcano of the defective unit with another unit of the same product
(or a unit of a substantially equivalent product thereto if the
original model is no longer manufactured) or the refund by Volcano
of the purchase price paid for such defective product.
-5-
B. No
Other Warranty . EXCEPT FOR THE EXPRESS WARRANTY SET FORTH
ABOVE, VOLCANO HEREBY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR
IMPLIED, BY STATUTE OR OTHERWISE, REGARDING THE VOLCANO PRODUCTS,
INCLUDING BUT NOT LIMITED TO THEIR FITNESS FOR A PARTICULAR
PURPOSE, OR THEIR MERCHANTABILITY. OTHER THAN FOR PUNITIVE DAMAGES,
NOTHING IN THIS SECTION 4 SHALL LIMIT THE INDEMNIFICATION
OBLIGATION UNDER SECTION 8.A. WITH RESPECT TO DAMAGE CLAIMS FOR
PERSONAL INJURY AND/OR DEATH CAUSED BY DEFECT OF THE VOLCANO
PRODUCTS.
5.
ADDITIONAL OBLIGATIONS OF VOLCANO AND FUKUDA
A.
Clinical Trials: Management, Product Supply and Regulatory
Approvals . Volcano agrees that it will undertake to manage, at
Volcano Japan’s expense, all animal trials and human clinical
trials required to obtain approval from all Japanese regulatory
authorities to market in the Field throughout the Territory the
Volcano Products and all other products under this Agreement.
Volcano agrees
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