FUKUDA DENSHI CO., LTD. AND VOLCANO CORPORATION AND VOLCANO JAPAN CO., LTD AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT
Exhibit 10.29
[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 0000 Xxxxxxx Xxxx, Xxxxxx Xxxxxxx, Xxxxxxxxxx 00000,
X.X.X. (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 Xxxx 0X,
0-00-0, Xxxxx, Xxxxxxx-xx, Xxxxx (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 0-00-0 Xxxxx, Xxxxxx-xx, Xxxxx 000-0000,
Xxxxx (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:
1. DEFINITIONS
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. “Xxxx 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 X. Xxxxxx 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 Xxxx
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 Xxxx 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 Xxxx
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.
X. Xxxxxx 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.
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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.
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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 to expeditiously submit for Ministry of Health, Labour and Welfare
(“MOHLW’’) approval any Volcano Product.
B. Training. Volcano agrees to train Fukuda in the proper clinical use of all Volcano
Products, and Fukuda shall be responsible in turn for training its customers. Also at Fukuda’s
request, Volcano agrees to make arrangements to send one of Volcano’s major U.S. clinical
investigator physicians to Japan to (i) give lectures on the use of these products and (ii) perform
clinical training of these products to Japanese physicians. Fukuda agrees to reimburse Volcano for
all out-of-pocket expenses for the travel of this physician to Japan.
C. Forecasts. Within the first ten (10) days of every quarter, Fukuda shall provide
Volcano Japan with a four-quarter rolling forecast (“Forecast”) showing prospective orders by
product model and intended purchase order submittal date. The quantities forecasted for the first
quarter of each Forecast (“Binding Quarter”) shall be binding on Fukuda and deemed supported by a
non-cancelable purchase order; provided; however, that if a serious defect in the product is found,
the binding nature of Forecast shall immediately terminate and all purchase orders shall be
cancelable.
D. Promotion of the Products. Fukuda shall, at its own expense, use its Best Efforts
to promote the sale of the Volcano Products in the Field throughout Japan. Such promotion shall
include, but not be limited to, preparing promotional materials in languages appropriate for Japan,
advertising the Volcano Products in trade publications within Japan, participating in appropriate
trade shows to the extent Fukuda thinks fit, and directly soliciting orders from customers for the
Volcano Products.
E. Finances and Personnel. Fukuda shall devote sufficient financial resources,
technically qualified sales personnel, and service personnel to the Volcano Products to fulfill its
responsibilities under this Agreement.
F. Customer and Sales Reporting. Fukuda shall, at its own expense:
(i) place the Volcano Products in Fukuda’s catalogues as soon as possible and feature Volcano
Products in any applicable trade show that it attends to the extent Fukuda thinks fit;
(ii) provide adequate contact with existing and potential customers in the Field throughout
Japan on a regular basis, consistent with good business practice;
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G. Import Requirement. Volcano Japan shall, at its own expense, pay all import
licenses and permits, pay customs charges and duty fees, imposed by any Japanese governmental
authority upon or applicable to any import by Volcano Japan under this Agreement, and take all
other actions required to accomplish the import of the Volcano Products.
X. Xxxxxxx & Xxxxxxx Commercial Relationship. As soon as practicable following the Effective
Date, and in no event more than thirty (30) days following the Effective Date, Fukuda shall provide
Volcano documentation acceptable to Volcano that demonstrates that Xxxxxxx & Xxxxxxx x.x.Cordis
Endovascular System Japan, has been notified of the new fields, territory, accounts, and products
changes as it relates to distribution of Volcano products in the endovascular and peripheral artery
markets.
I. Regulatory Matters. Fukuda shall monitor and track all customer complaints or
issues involving the Volcano Products and to immediately notify Volcano in the event of any
complaints or issues. Fukuda will assist Volcano in the investigation and resolution of these
complaints or issues in a reasonable manner. Fukuda agrees to assist and support Volcano, to the
extent commercially reasonable, in the event that Volcano is required to take action in response to
any such complaints or issues including, but not limited to, recalls, re-labeling, notification of
MOHLW or the like.
Response to Inquiries. Fukuda shall promptly respond to all inquiries from Volcano
concerning matters pertaining to this Agreement.
6. ADDITIONAL OBLIGATIONS OF VOLCANO
A. Supply of Sample Products and Materials. Volcano shall supply Fukuda’s
requirements for the Volcano Products in the Field throughout Japan consistent with the delivery
schedules. Volcano shall promptly provide Fukuda without any charges with marketing and technical
information concerning the Volcano Products as well as reasonable quantities of brochures,
instructional material, advertising literature, and other Volcano product data, with all such
material printed in the English language. Volcano agrees to discuss with Fukuda for supplying
appropriate number of sample Volcano Products or granting a fifty percent (50%) discount for
appropriate number of Volcano Products for assistance of Fukuda’s sales.
B. Response to Inquiries. Volcano shall promptly respond to all inquiries from Fukuda
concerning matters pertaining to this Agreement.
C. Testing. Volcano USA shall test all Volcano Products before shipment to Volcano
Japan under U.S. FDA cGMP or QSR requirements. Volcano warrants to Fukuda that any Volcano
Product sold to Fukuda under this Agreement shall comply with all laws, regulations and any other
orders of Japan.
D. Delivery Time. Volcano Japan shall minimize delivery time as much as possible and
to fulfill delivery obligations as committed in any acceptance.
E. Customer’s Special Requirements. From time to time, Fukuda may encounter requests
from customers for special changes or modifications on Volcano Products so that the Volcano
Products meet their particular usage. In such cases, if Fukuda deems it necessary to comply with
such requirements for its market strategy, Fukuda shall request Volcano to make such changes or
modifications on the Volcano Products and Volcano shall use its reasonable commercial efforts to
meet such requirements.
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F. New Developments. Volcano shall inform Fukuda of new Volcano product developments
during regularly scheduled quarterly reviews.
G. Regulatory Reporting and Analysis of Returned Products. Volcano USA shall file, or
cause to be filed, all reports required of a manufacturer pursuant to the applicable U.S. medical
device reporting regulations. Volcano USA, as the manufacturer of the products, shall perform all
failure analysis on the products within thirty (30) days of receipt of each failed product and
shall file all reports required with the applicable U.S. regulatory agency. Volcano USA shall
further cooperate with and assist Volcano Japan in submitting all reports that Volcano Japan, as
distributor of the products, may be required to file, if any.
7. TERM AND TERMINATION
A. Term. This Agreement shall be effective on the Effective Date and shall continue
in force through June 30, 2012, unless terminated earlier under the provisions of this Section 7.
Six (6) months prior to expiration, the parties will meet to discuss in good faith an extension to
this Agreement. Thereafter the term of the Agreement may be renewed by mutual agreement of the
parties for successive periods of two (2) years.
B. Termination for Cause. If either Fukuda or Volcano materially defaults in the
performance of any obligation in this Agreement, then the non-defaulting party may give written
notice to the defaulting party that if the default is not cured within thirty (30) days after
receipt of such notice, the Agreement will be terminated. If the non-defaulting party gives such
notice and the default is not cured during the thirty (30) day period, then the Agreement shall
automatically terminate at the end of that period.
C. Termination for Insolvency. This Agreement shall terminate, without notice, (i)
upon the institution by or against Fukuda or Volcano of insolvency, receivership or bankruptcy
proceedings or any other proceedings for the settlement of debts; (ii) upon Fukuda’s or Volcano’s
making an assignment for the benefit of creditors; or (iii) upon Fukuda’s or Volcano’s dissolution.
D. Fulfillment of Orders upon Termination. Upon termination of this Agreement,
Volcano shall continue to fulfill, subject to the terms of Section 3 above and if so requested by
Fukuda, all orders accepted by Volcano prior to the date of termination.
E. Return of Materials. All trademarks, trade names, patents, copyrights, designs,
drawings, formulas or other data, photographs, samples, literature and sales aids of every kind
with respect to the Volcano Products shall remain the property of Volcano as long as the objects
still remain in Fukuda’s possession. Within thirty (30) days after the termination of this
Agreement, Fukuda shall prepare all such items in its possession for shipment as Volcano may
direct, at Volcano’s expense. Fukuda shall not make or retain any copies of any confidential items
or information or any product literature which may have been entrusted to it. Effective upon the
termination of this Agreement, Fukuda shall cease to use all trademarks, marks and trade names of
Volcano; provided, however, that Fukuda may continue to use such trademarks to market, distribute
or sell any inventory of the products in Fukuda’s possession at the time of such termination as
permitted pursuant to Section 7.F.
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F. Inventory on Termination. Upon termination of this Agreement due to expiration
(7.A), Fukuda may return to Volcano, or its nominee, its remaining inventory which is new and
unused for credit or refund at the then current selling prices or, upon mutual agreement, for a
period not to exceed one hundred eighty (180) days, sell any remaining inventory. Upon termination
due to Fukuda’s default or insolvency (7.B., 7.C.), Fukuda at Volcano’s option, will return its
remaining inventory which is new and unused for credit or refund at the then current selling prices
or for a period not to exceed one hundred eighty (180) days, sell any remaining inventory. Upon
termination due to Volcano’s default or insolvency (7.B., 7.C.), Fukuda at its option will return
its remaining inventory which is new and unused for credit or refund at the then current selling
prices, or for a period not to exceed one hundred eighty (180) days, sell any remaining inventory.
G. Limitation on Liability. In the event of termination by either party in accordance
with any of the provisions of this Agreement, neither party shall be liable to the other because of
such termination, for compensation, reimbursement or damages on account of the loss of prospective
profits or anticipated sales or on account of expenditures, inventory, investments, leases or
commitments in connection with the business or goodwill of Volcano or Fukuda. Termination shall
not, however, relieve either party of obligations incurred prior to the termination.
H. Survival of Certain Terms. The provisions of Sections 2.F, 3.F, 4, 7, 8, 9, 10, 11
and 12 shall survive the termination of this Agreement for any reason. All other rights and
obligations of the parties shall cease upon termination of this Agreement.
8. LIABILITY COVERAGE AND LIMITATIONS
A. Products Liability. Volcano agrees to carry products liability insurance for all
of its Volcano Products. This liability insurance will cover the design, manufacture and
performance of Volcano Products when these products are promoted, sold and used by customers for
uses specified in Volcano labeling, promotional materials and instructions for use. Fukuda will be
responsible for any liability arising out of (i) Fukuda’s sales of Volcano Products for
applications not included in Volcano’s labeling, promotional material and instructions for use;
(ii) for liability claims arising from Fukuda’s wrongful training of customer users; and (iii)
liability claims arising from wrongful use of Volcano Products by Fukuda’s customers. Volcano
shall indemnify and hold Fukuda free and harmless from all costs, expenses and damages incurred by
Fukuda in connection with third party claims concerning personal injury or death caused by a defect
in the design or manufacture of a Volcano Product or a non-conformance with Volcano’s then current
specifications for Volcano Products existing at the time of delivery of such Volcano Products by
Volcano under Section 3.G.
B. Limitation on Liability. VOLCANO’S LIABILITY ARISING OUT OF THIS AGREEMENT AND/OR
SALE OF THE VOLCANO PRODUCT SHALL BE LIMITED TO THE AMOUNT PAID BY THE CUSTOMER FOR THE VOLCANO
PRODUCTS. IN NO EVENT SHALL VOLCANO BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS. IN NO
EVENT SHALL VOLCANO BE LIABLE TO FUKUDA OR ANY OTHER ENTITY FOR ANY SPECIAL, CONSEQUENTIAL,
INCIDENTAL, OR INDIRECT DAMAGES, HOWEVER CAUSED, ON ANY THEORY OF LIABILITY, AND NOTWITHSTANDING
ANY FAILURE OF ESSENTIAL PURPOSE OR ANY LIMITED PURPOSE OR ANY LIMITED REMEDY, OTHER THAN FOR
PUNITIVE DAMAGES, NOTHING IN THIS SECTION 8.B. 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.
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9. PROPERTY RIGHTS AND CONFIDENTIALITY
A. Property Rights. Fukuda agrees that Volcano USA owns all right, title and interest
in the Volcano product lines that include the Volcano Products now or hereafter subject to this
Agreement and in all of Volcano’s patents, trademarks, trade names, inventions, copyrights,
know-how, and trade secrets relating to the design, manufacture, operation or service of the
Volcano Products. The use by Fukuda of any of these property rights is authorized only for the
purposes herein set forth, and upon termination of this Agreement for any reason, such
authorization shall cease.
B. Sale Conveys No Right to Manufacture or Copy. The Volcano Products are offered for
sale and are sold by Volcano subject in every case to the condition that such sale does not convey
any license, expressly or by implication, to manufacture, duplicate or otherwise copy or reproduce
any of the Volcano Products. Fukuda shall take appropriate steps with its customers, as Volcano
may request, to inform them of and assure compliance with the restrictions contained in this
Section 9.B.
C. Confidentiality. Each party shall maintain in confidence all Confidential
Information, as defined below, of the other party and shall not use, disclose or grant use of such
Confidential Information except as expressly authorized by this Agreement. A party may disclose
Confidential Information, as authorized hereunder, only to those of its employees or agents who
agree to be bound by the terms of this Section 9. Fukuda may disclose the Confidential Information
to MOHLW, if and when it is so required, provided that Fukuda shall make its Best Efforts to avoid
or limit such disclosure. As used in this Agreement, the term “Confidential Information” shall
mean information deemed by a party to be its confidential or proprietary information and disclosed
to the other party in writing and marked “Confidential”, or disclosed orally under confidence,
including without limitation, any confidential engineering designs and drawings, know-how, trade
secret, research, data, process, technique, research project, work in process, future development,
scientific, manufacturing, marketing, business plan, financial or personnel matter relating to the
party, its present or future products, sales suppliers, customers, employees, investors or
business. Upon request of either of the parties hereto, the other party shall advise whether or
not it considers any particular information or materials to be confidential. Fukuda shall not
publish any technical description of the Volcano Products beyond the description published by
Volcano (except to translate that description into appropriate languages for Japan). In the event
of termination of this Agreement, there shall be no use or disclosure by either of the parties
hereto of any Confidential Information of the other party, provided that the restrictions under
Section 9 hereof do not in any manner affect Fukuda’s rights and/or licenses granted under any
other agreements entered into between Volcano and Fukuda.
D. Exclusions. The term “Confidential Information” shall not be deemed to include
information which: (i) is now, or hereafter becomes, through no act or failure to act on the part
of a party receiving such information, generally known or available; (ii) is known by the party
receiving such information at the time of receiving such information, as evidenced by its records;
(iii) is hereafter furnished to the party receiving such information by a third party, as a matter
of right and without restriction on disclosure; (iv) is the subject of a written consent to
disclose provided by the disclosing party, which consent may be withheld in the sole discretion of
such party; or (v) is discovered or developed by a party independent of and without any reference
to Confidential Information of the disclosing party, as evidenced by the written records of the
receiving party.
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10. TRADEMARKS AND TRADE NAMES
A. Use. During the term of this Agreement, Fukuda shall have the right to indicate to
the public that it is an authorized distributor of Volcano Products and to advertise (within Japan)
such Volcano Products under the trademarks, marks and trade names that Volcano may adopt from time
to time (“Volcano Trademarks”). Fukuda shall not alter or remove any Volcano Trademark applied to
the Volcano Products at the factory. Nothing herein shall grant to Fukuda any right, title or
interest in the Volcano Trademarks. At no time during or after the term of this Agreement shall
Fukuda challenge or assist others to challenge the Volcano Trademarks or the registration thereof
or attempt to register any trademarks, marks or trade name confusingly similar to those of Volcano.
B. Approval of Representations. Fukuda shall respect the Volcano Trademarks and
follow the instructions of Volcano as to the usage of Volcano Trademarks. If any of the Volcano
Trademarks are to be used in conjunction with another trademark on or in relation to the Volcano
Products, then the Volcano Trademark shall be presented equally legibly, equally prominently, and
of the same or greater size than the other but nevertheless separated from the other so that each
appears to be a xxxx in its own right, distinct from the other xxxx.
11. PATENT, COPYRIGHT AND TRADEMARK INDEMNITY
A. Indemnification. Fukuda agrees that Volcano has the right to defend, or at its
option to settle, and Volcano agrees, at its own expense, to defend or at its option to settle, any
claim, suit or proceeding brought against Fukuda or its customer on the issue of infringement of
any Japanese patent, or trademark by the Volcano Products sold hereunder, or the use thereof,
subject to the limitations hereinafter set forth. Volcano shall have sole control of any such
action or settlement negotiations, and Volcano agrees to pay, subject to the limitations hereafter
set forth, any final judgment entered against Fukuda or its customer on such issue in any such suit
or proceeding defended by Volcano. Fukuda agrees to notify Volcano promptly in writing of such
claim, suit or proceeding and gives Volcano authority to proceed as contemplated herein, and, at
Volcano’s expense, gives Volcano proper and full information and assistance to settle and/or defend
any such claim, suit or proceeding. If the Volcano Products, or any part thereof, are the subject
of any claim, suit or proceeding for infringement of any Japanese patent, or trademark, or if the
sale or use of the Volcano Products, or any part thereof is, as a result, enjoined, then Volcano
shall, at its expense (i) procure for Fukuda and its customers the right under such patent, or
trademark to sell or use, as appropriate, the Volcano Products or such part thereof; (ii) replace
the Volcano Products, or part thereof, with other suitable Volcano Products or parts; (iii)
suitably modify the Volcano Products, or part thereof; or (iv) if the use of the Volcano Products,
or part thereof is prevented by injunction, remove the Volcano Products, or part thereof and refund
the aggregate payments paid therefor by Fukuda, less a reasonable sum for use and damage.
B. Limitation. Notwithstanding the provisions of Section 11.A above, Volcano assumes
no liability for (i) infringements covering completed equipment or any assembly, circuit,
combination method or process in which any of the Volcano Products may be used but not covering the
Volcano Products standing alone; (ii) any trademark infringement involving any marking or branding
not applied by Volcano or involving any marking or branding applied at the request of Fukuda; or
(iii) the modification of the Volcano Products, or any part thereof, unless such modification or
servicing was done by Volcano.
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C. Entire Liability. The foregoing provision of this Section 11 states the entire
liability and obligations of Volcano and the exclusive remedy of Fukuda and its customers, with
respect to any alleged patent or trademark infringement by the Volcano Products or any part
thereof.
12. GENERAL PROVISIONS
A. Arbitration. All disputes, controversies, or differences which may arise between
the parties hereto, out of, in relation to, or in connection with this Agreement or the breach
thereof, shall be finally settled by arbitration in accordance with the Japan-American Trade
Arbitration Agreement of September 16, 1952 (as amended), by which each party hereto agrees to be
bound. If arbitration is requested by Fukuda, arbitration shall be conducted in Sacramento,
California, U.S.A.; if arbitration is requested by Volcano, arbitration shall be conducted in
Tokyo, Japan. Judgment upon an award rendered may be entered in any court having jurisdiction, or
application may be made to such court for judicial acceptance of the award and an order of
endorsement, as the case may be.
B. Entire Agreement; Termination of Other Agreements. This Agreement sets forth the
entire agreement and understanding of the parties relating to the subject matter herein and merges
all prior discussions between them. Upon the Effective Date, the following agreements shall
immediately and without the necessity of any further action of Fukuda or Volcano, terminate and be
of no further force or effect (except for such provisions which, by their terms survive
termination): the Original Distribution Agreement, the EndoSonics Agreement, and that certain
Non-Exclusive Sub-Distribtuion Agreement, dated as of January 25, 2005, by and between Fukuda and
Xxxxxxx Company, Ltd., a corporation of Japan (“Xxxxxxx”) and which concerns the distribution by by
Xxxxxxx of certain Volcano Products. No modification of or amendment to this Agreement, nor any
waiver of any rights under this Agreement, shall be effective unless in writing signed by the party
to be charged.
C. Notices. Any notice required or permitted by this Agreement shall be in writing
and deemed to be given (i) upon personal delivery to the party be notified; (ii) when sent by
confirmed facsimile if sent during normal business hours of the recipient (if not, then on the next
business day); (iii) ten (10) days after having been sent by registered or certified airmail,
return receipt requested, postage prepaid; or (iv) four (4) business days, after being properly
deposited with an internationally recognized overnight courier, specifying express delivery, with
written verification of receipt addressed to the other party at the address shown at the beginning
of this Agreement or at such other address for which such party gives notice hereunder.
D. Force Majeure. Non-performance of either party shall be excused to the extent that
performance is rendered impossible by strike, fire, flood, governmental acts or orders or
restrictions, failure of suppliers, or any other reason where failure to perform is beyond the
control of and not caused by the negligence of the non-performing party.
E. Change of Control and Assignment. This Agreement, including all terms and
conditions hereof which survive any termination or expiration of this Agreement, shall be binding
upon and inure to the benefit of the parties hereto and their permitted successors and assigns.
Neither Volcano nor Fukuda may assign any of its rights and obligations hereunder without prior
written consent of the other party, and any such assignment or purported assignment shall be void,
except that an assignment pursuant to merger, acquisition or sale of all or substantially all of
the assets of a party shall not require such consent. Notwithstanding the foregoing, Volcano shall
be permitted to assign to Volcano Japan, or any other wholly-owned
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subsidiary of Volcano that is organized under the laws of Japan, the rights and obligations
ascribed to Volcano hereunder, in whole or in part, without the prior written consent of Fukuda.
F. Partial Invalidity. If any provision of this Agreement is held to be invalid by a
court of competent jurisdiction, then the remaining provisions shall nevertheless remain in full
force and effect. The parties agree to renegotiate in good faith any term held invalid and to be
bound by the mutually agreed substitute provision.
G. Legal Expenses. The prevailing party in any legal action brought by one party
against the other and arising out of this Agreement shall be entitled, in addition to any other
rights and remedies it may have, to reimbursement for its expense, including arbitration costs and
reasonable attorneys’ fees.
H. Counterparts. This Agreement shall be executed in three counterparts, each of
which shall be deemed an original, each party retaining one copy thereof.
I. Governing Law. This Agreement shall be governed by the laws of Japan.
[signature page to follow]
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IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed as of the
date first above written by their respective duly authorized representatives.
| VOLCANO CORPORATION | ||||
| By: | /s/ Xxxxx Xxxxxxxxxx | |||
| PRINTED NAME: Xxxxx Xxxxxxxxxx | ||||
| TITLE: President & CEO | ||||
| VOLOCANO JAPAN Co., LTD | ||||
| By: | /s/ Junichi Osawa | |||
| PRINTED NAME: Junichi Osawa | ||||
| TITLE: President and Managing Director | ||||
| FUKUDA DENSHI CO., LTD. | ||||
| By: | /s/ Xxxxxx Xxxxxx | |||
| PRINTED NAME: Xxxxxx Xxxxxx | ||||
| TITLE: President | ||||
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EXHIBIT A
ACCOUNTS
-15-
EXHIBIT B
TO FUKUDA DENSHI CO., LTD. AND
VOLCANO CORPORATION AND VOLCANO JAPAN CO., LTD
AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT
Prices Effective March 20, 2006
Description of VOLCANO Products and Pricing
TO FUKUDA DENSHI CO., LTD. AND
VOLCANO CORPORATION AND VOLCANO JAPAN CO., LTD
AMENDED AND RESTATED JAPANESE DISTRIBUTION AGREEMENT
Prices Effective March 20, 2006
Description of VOLCANO Products and Pricing
Distributor Name:
|
Fukuda Intervention Systems | |||
Distributor Territory:
|
Japan |
| CATALOG | TRANSFER PRICE | |||||
| PRODUCT | NUMBER | (EACH) | ||||
EndoSonics
IVUS Products |
||||||
IVG/VH
|
804908004 | |||||
1-15 Units Purchased Annually
|
[CONFIDENTIAL]USD | |||||
16-24 Units Purchased Annually
|
[CONFIDENTIAL]USD | |||||
25+ Units Purchased Annually
|
[CONFIDENTIAL]USD | |||||
TrakBack II
|
91002 | [CONFIDENTIAL]USD | ||||
Xxxxx Xxx Xxxx Xxxxxxxx
|
00000 | [CONFIDENTIAL]USD | ||||
Avanar Catheter
|
85700 | [CONFIDENTIAL]USD | ||||
PV .018 Catheter
|
86700 | [CONFIDENTIAL]USD | ||||
PV 8.2 Catheter
|
88900 | [CONFIDENTIAL]USD | ||||
Volcano
IVUS Products |
||||||
s5 Console
|
XXX | |||||
x0x Console
|
TBD | |||||
VH IVUS Software Perpetual License Agreement for IVG
|
8044140015 | [CONFIDENTIAL]USD | ||||
VH Software Support and Maintenance Agreement for IVG
|
805698001 | [CONFIDENTIAL]USD | ||||
| per unit Annually | ||||||
VH IVUS Software Perpetual License Agreement for IVG
|
TBD | |||||
VH Software Support and Maintenance Agreement for IVG
|
TBD | |||||
Angio and IVUS Co Registration Hardware and Software |
||||||
• IVG
|
TBD | |||||
• s5 Family
|
TBD | |||||
Revolution Rotational Catheter
|
TBD | |||||
SpinVision Pullback for Rotational Catheters
|
TBD | |||||
R100 Phased Array Pullback Device
|
804547001 | [CONFIDENTIAL]USD | ||||
IVG Rotational Hardware Upgrade
|
TBD | |||||
| • | All prices are quoted “each” and in US Dollars |
| Distributor Authorized Signature and Date | VOLCANO Authorized Signature and Date |
Volcano Corporation CONFIDENTIAL 3/22/2006
EXHIBIT C
“XXXX ACCOUNTS”
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