[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 THERAPEUTICS, INC.
JAPANESE DISTRIBUTION
AGREEMENT
THIS AGREEMENT
(“Agreement”), effective on the Effective Date (defined
below), is made and entered into between Volcano Therapeutics,
Inc., a Delaware corporation, with its principal office at 2870
Kilgore Road, Rancho Cordova, California 95670, U.S.A. (hereinafter
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, Japan (hereinafter referred to as
“Fukuda”).
In consideration
of the mutual promises contained herein, 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 November 30, 2004.
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 from Jomed, Inc., a
Delaware corporation (formerly EndoSonics), that granted
distribution rights related to certain medical device products to
Fukuda from EndoSonics.
E. “Field”
shall mean the cardiology field and does not include endovascular
or peripheral applications fields.
F. “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).
G. “Territory”
shall mean the country of Japan, but as defined by the accounts
listed on Exhibit A . Distributor shall make best
effort and accept its responsibility to sell to the accounts listed
in Exhibit A .
H. “Volcano
Products” shall mean those Volcano phased array versions of
the 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, Volcano hereby appoints Fukuda as Volcano’s
non-exclusive distributor for the Volcano Products in the
Field
throughout the
Territory for the period commencing on the Effective Date until
June 30, 2007. Subject to the terms and conditions set forth
herein, Fukuda hereby accepts such appointment.
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 the
Territory 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: (i) promote, advertise, sell,
distribute the Volcano Products in any country outside the
Territory, (ii) cause, directly or indirectly, the importation
of the Volcano Product into any country outside the Territory; nor
(iii) establish a repair or maintenance facility in any
country outside the Territory.
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 during the term of this Agreement shall be subject to
the terms and conditions of this Agreement.
B.
Prices . All prices are FCA (Incoterms 2000) Volcano’s
plant. The purchase price to Fukuda for each of the Volcano
Products (“Purchase Price”) is set forth on
Exhibit B hereto, 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. Such revisions shall apply
to all orders received after the effective date of
revision.
- 2 -
Price increases
shall not affect unfulfilled purchase orders accepted by Volcano
prior to the effective date of the price increase.
C.
Taxes . The amounts payable by Fukuda under Section 3
are exclusive of all taxes and government charges (including,
without limitation, interest and penalties), if any, payable to the
Japanese government. If Fukuda is required to withhold any taxes on
amounts payable to Volcano in accordance with this Agreement,
pursuant to the laws and regulations of Japan, Fukuda shall
compensate Volcano for any such withholding by paying Volcano an
additional amount equal to such amount withheld. 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.
D. Order
and Acceptance . All orders for Volcano Products submitted by
Fukuda shall be initiated by written purchase orders sent to
Volcano 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 within ten (10) days after said oral or
facsimile order. To facilitate Volcano’s production
scheduling, Fukuda shall use reasonable commercial efforts to
submit purchase orders to Volcano 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 in writing,
and Volcano shall have no liability to Fukuda with respect to
purchase orders that are not accepted. Volcano 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 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.
F.
Payment . Volcano 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 a given shipment plus any freight, taxes or other applicable
costs initially paid by Volcano but to be borne by Fukuda. Payment
shall be made in U.S. dollars and payment shall be by wire
transfer, check or other instrument approved by Volcano. Payment
terms shall be the full invoiced amount due for payment received by
Volcano within sixty (60) days of the date of the invoice.
Fukuda may take a two (2) percent discount as a reduction of
the invoice price if payment is received by Volcano within fifteen
(15) days of the date of 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 air freight
shipment in Volcano’s standard shipping cartons, marked for
shipment at Fukuda’s address set forth above or any other
address in the Territory as Fukuda indicates, and delivered to
Fukuda or its carrier agent FCA (INCOTERMS 2000) Volcano’s
manufacturing plant, at which time title to such Volcano Products
and risk of loss shall pass to Fukuda. Unless otherwise instructed
in writing by Fukuda, Volcano shall select the carrier.
All
- 3 -
freight,
insurance, and other applicable expenses, as well as any special
packing expense, shall be paid by Fukuda.
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 after customs clearance
for import (the “Rejection Period”) shall be deemed
accepted. To reject a Volcano Product, Fukuda shall, within the
Rejection Period, notify Volcano in writing by facsimile of its
rejection and request a Return Material Authorization
(“RMA”) number. Volcano 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 the rejected Volcano
Product, freight collect, in its original shipping carton with the
number displayed on the outside of the carton. Provided that
Volcano has complied with its obligations in this Agreement,
Volcano 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)
working days after receipt by Volcano of properly rejected Volcano
Products, Volcano 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
within fifteen (15) months of shipment of such Volcano
Products to Fukuda if a notice with the details of such defects is
given by Fukuda to Volcano 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 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
FCA (INCOTERMS 2000) point of shipment by Volcano to
Fukuda.
J. No
Time Restriction . Notwithstanding any provision herein to the
contrary, Fukuda’s rights and remedies under this Agreement
or laws of the Territory 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
- 4 -
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.
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 . Fukuda agrees that it will undertake to manage, at
Fukuda’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 to which Fukuda acquires
distribution rights under this Agreement. Fukuda agrees to
expeditiously submit for Ministry of Health, Labour and Welfare
(“MOHLW’’) approval any Volcano Product. Upon
(i) the termination of this Agreement and/or (ii) the
termination of the EndoSonics Agreement, Fukuda shall,
expeditiously transfer to Volcano all regulatory and/or
governmental approvals, permits, licenses and the like of the
Volcano Products and EndoSonics Products (as defined in the
EndoSonics Agreement), to Volcano. Volcano will be responsible to
pay Fukuda only the cost of transferring such approvals, permits,
licenses and the like to Volcano (i.e., labor costs, supplies, and
government fees).
Volcano agrees
that it will supply products to Fukuda to conduct the animal trials
and human clinical trials for free.
Volcano shall
assist Fukuda in obtaining regulatory approvals and registration of
the products in the Field throughout the Territory by providing
Fukuda with:
(i) materials
in Volcano possession necessary to obtain MOHLW approvals and
marketing approvals, licenses, and permits;
(ii) certificates
of analysis, export and compliance;
(iii) trademark
authorizations; and
(iv) such
other information as Fukuda shall reasonably request from time to
time.
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
|