EXHIBITS 10.13
EXCLUSIVE INTERNATIONAL DISTRIBUTOR AGREEMENT
---------------------------------------------
THIS AGREEMENT made as of March 12, 1999, as specified herein, by and between
XXXX Medical Systems, Inc. (and its successors and assigns, the "Seller"), a
California corporation having its principal office at 000 Xxxxx Xxxxxxxxx
Xxxxxxxxx, Xxxxxxxx Xxxx, Xxxxxxxxxx 00000, NISSHO IWAI CORPORATION
("Distributor"), a Japanese corporation having its primary office at 0-0 Xxxxxxx
0-xxxxx, Xxxxxx-xx, Xxxxx 107, and NISSHO IWAI AMERICAN CORPORATION
("Distributor Agent"), a New York corporation with an office at 00 Xxxxxxxxxx
Xxxxxx, Xxxxx 0000, Xxx Xxxxxxxxx, Xxxxxxxxxx 00000-0000 (the Distributor and
Distributor Agent shall be referred to collectively as "Distributors").
WITNESSETH
WHEREAS, Seller has been engaged in the manufacture and marketing of the
Products (as hereinafter defined) and desires to expand the sale of the same;
WHEREAS, among other things, Distributors are collectively engaged in
exporting, distributing and marketing various products in Korea; and
WHEREAS, Distributors desire to act as, and Seller desires to appoint
Distributors as described below;
NOW, THEREFORE, the parties hereto agree as follows:
1. PRODUCTS AND TERRITORY
----------------------
Distributors shall act as Seller 's exclusive distributor in the Territory
(described in Exhibit A) to promote, sell and distribute the Products
(described in Exhibit B) for applications which the Seller approves in
writing, and to provide service with respect to the Products, to customers,
as they are defined below. Further, Seller authorizes, and Distributors
agree to, the prompt appointment of the following entity as Distributors'
exclusive sub-distributor ("Sub-Distributor") within the territory:
Daeyoung Medical Corporation, 0-0, Xxxxxx-Xxx, Xxxx-xx, Xxxxxxx, Xxxxx.
Distributors shall cause Sub-Distributor to be bound by and comply with all
relevant sections of this Agreement, and any breach by Sub-Distributor
shall be deemed a breach by Distributors. Failure to appoint said Sub-
Distributor within sixty (60) days of the date hereof shall be grounds for
immediate termination of this Agreement at the option of the Seller.
"Customers" means medical doctors, institutions such as hospitals and
clinics, and similar institutions which are active in the personal care of
patients. Distributors are not authorized to sell any Products to any of
Distributors' competitors or to any of Seller 's competitors without Seller
's prior written consent. Distributors shall not actively solicit orders
from Customers domiciled outside the Territory, or sell or deliver any
Product to any Customer which is not in the Territory, except as permitted
under the Exclusive Distributorship Agreement between Seller and
Distributors dated November 12, 1997 for the distribution of Products in
Japan. Furthermore, Distributors shall not appoint
any distributor or any agent or maintain any sales, service or stock
facility outside the Territory. Except with the prior written consent of
Seller, Distributors shall not sell or advertise within the Territory,
either on Distributors' own behalf or on behalf of any other person,
company, or corporation, products which are similar to or competitive with
the Products.
2. SALES PROMOTION AND REPORTING RESPONSIBILITIES
----------------------------------------------
Distributors shall be obligated to use commercially reasonable efforts to
promote Seller's products according to Section 1 above, at Distributors'
sole expense. This includes, but is not limited to, the activities
described below in this Section. Distributors shall provide training and
clinical education to all of the Customers in Distributors' Territory.
Distributors shall provide appropriate promotional materials in the
language of Distributors' Territory. Distributors shall be obligated to
provide a sales report to Seller on a monthly basis, by the 15th of the
month following the reporting period, which summarizes unit sales, free
goods and the number of active accounts as well as the current inventory
status of all Products which are in Distributors' possession at the end of
the month. Distributors shall provide to Seller, on request, copies of any
tenders for the Products in Distributors' Territory. Prior to the
commencement of each Sales Year (defined in Section 14) Distributors shall
provide to Seller a business plan which will describe Distributors' results
for the prior year and Distributors' plans for the coming year.
Seller shall be obligated to provide Distributors with such technical
support, advice and information as may be deemed necessary by Seller to
provide Distributors with a full understanding of the Products at no cost
to Distributors. Seller shall also provide Distributors at Seller's cost
with a reasonable number of its then existing catalogs, brochures and other
promotional materials in the English language to facilitate Distributors'
promotion of the Products. Promptly, after this Agreement is signed by both
parties, Seller shall also provide Distributors [***]with [***] Model 500
PA Generators and [***] Model 30 Electrodes which are brand new and not
used or refurbished (or Model 70 electrodes, depending upon availability)
for the exclusive use of Distributors' Sub-Distributor for promoting and
marketing the Products in the Territory provided that Distributors provide
a like quantity of generators and electrodes to Distributors' Sub-
Distributor at no charge as well. Seller agrees to sell the above
mentioned "matching" no charge product to Distributors [***] as described
in Section 5 below.
3. ORDERS AND MINIMUM PURCHASE QUANTITIES
--------------------------------------
The sale and purchase of the Products hereunder shall be based on the terms
and conditions set forth herein and in the applicable Purchase Order,
provided that if any discrepancy should occur between the terms and
conditions of this Agreement and those
_______________________________
*** Material has been omitted pursuant to a request for confidential treatment,
and such Material has been filed separately with SEC.
set out in the printed portion of the Purchase Order, this Agreement shall
prevail. An Individual Contract for the Products shall be deemed to have
been made when Distributor Agent receives Seller's acceptance of the
Purchase Order, such acceptance being indicated by Seller's
countersignature on the Purchase Order, Seller's issuance of a sales
confirmation or similar document, Seller's delivery of the Products or the
like, provided that if any terms in such sales confirmation or similar
document conflict with, or supplement, the terms of this Agreement or the
Purchase Order, such conflicting or supplemental terms shall be deemed null
and void and the provisions of this Agreement and/or the Purchase Order
shall govern. In any case, Seller shall respond to each Purchase Order
within fifteen (15) days after its receipt by Seller, and failure by Seller
to so respond shall be deemed acceptance by Seller. Seller shall endeavor
to timely fill all Purchase Orders. Seller agrees that Nissho Iwai American
Corporation, a wholly owned subsidiary of Nissho Iwai Corporation, shall
act as Distributors' agent specifically in the formal execution of purchase
orders to Seller.
In the first three years of this Agreement, Distributors shall purchase the
minimum quantity of Products set forth on Exhibit C. In (a) succeeding
years or (b) if additional products are added by Seller to the Products
listed in Exhibit B; then, in accordance with Section 14, the parties shall
make best efforts to negotiate commercially reasonable terms regarding the
minimum quantities so as to enable both parties to realize a fair profit on
their sales by taking into consideration the normal practices of the trade,
if any, and competitive circumstances. Such terms shall be considered in
effect only when reduced to writing and signed by both parties. Purchases
in excess of the minimum quantity required in a given Sales Year shall be
credited toward satisfying the minimum quantity required for the following
Sales Year.
For the purpose of securing orderly shipments, Distributors shall submit to
Seller a rolling four quarter forecast, conforming to calendar quarters, of
orders for the Products at the beginning of each quarter. The first and
second quarters of such forecast shall be considered to be a binding
commitment.
Distributors shall have, upon Seller's consent, which consent shall not be
unreasonably withheld, the right to a visual inspection of the Products by
a full-time employee of Distributors at the place of manufacture prior to
final packing for shipment. Seller shall timely notify Distributors of
packing and shipping schedules for the Products. Inspection shall be at
Distributors' expense and shall not cause interruption to Seller's
production or shipping operations. Inspection of Products by Distributors
shall not constitute a waiver of any claim or right which Distributors or
Purchasers may have with respect to Product warranties.
4. RETURNS
-------
A Product may only be returned with the prior written approval of the
Seller, such approval not to be unreasonably withheld. Any such approval
shall reference a return
material authorization number issued by Seller. Repair and direct out-of-
pocket transportation costs for returned Products under warranty and their
replacements shall be for Seller's account, provided, if Seller determines
that the returned Products were not defective, such costs shall be for
Distributors' account.
5. PRICES
------
In the first three years of this Agreement, Distributors shall pay for
Products the prices listed on Exhibit D hereto. In (a) succeeding years or
(b) if additional products are added by Seller to the Products listed in
Exhibit B; then, in accordance with Section 14, the parties shall make best
efforts to negotiate commercially reasonable terms regarding the prices so
as to enable both parties to realize a fair profit on their sales by taking
into consideration the normal practices of the trade, if any, and
competitive circumstances. Such terms shall be considered in effect only
when reduced to writing and signed by both parties.
6. PAYMENT
-------
Full payment of Distributors' purchase price for the Products shall be in
United States of America dollars. Payment terms shall be net sixty (60)
days, and payment shall be made by wire transfer, check or other instrument
approved by Seller. Any invoiced amount not paid when due shall be subject
to a service charge at the lower of the rate of one and one-half percent
(1.5%) per month or the maximum rate permitted by law. If Distributors fail
to make any payment to Seller when due, Seller may, without affecting its
rights under this Agreement, cancel or delay any future shipments of the
Products to Distributors. Further, a failure to pay within twenty (20) days
after the applicable due date shall be considered a failure to fulfill a
material obligation under this Agreement. In the case of the authorized
return of Products under warranty or recall, the sixty (60) day payment
terms for such Products only shall begin upon shipment of replacement
Products from Seller's manufacturing location.
7. COMPLAINTS
----------
If Distributors receive or become aware of any complaints concerning the
Products Distributors shall promptly report them to Seller on copies of the
form attached as Exhibit E to this Agreement (or on such form as Seller may
provide from time to time) and Distributors shall provide all necessary
reasonable assistance in connection with any corrective action with respect
to the Products. Any determination of corrective action shall be made by
Seller in its sole discretion.
8. COMPLIANCE WITH TERRITORIAL REGULATIONS
---------------------------------------
_________________________________
*** Material has been omitted pursuant to a request for confidential treatment,
and such Material has been filed separately with SEC.
Distributors shall comply with all applicable laws, rules and regulations
of the Territory governing the use, sale, distribution, shipment and import
of the Products. With respect to those Products that have not yet received
approval for commercial sale, Distributors shall also comply with the laws,
rules and regulations of the Territory concerning use, sale, distribution,
shipment and import of unapproved products, and with any applicable Seller
clinical trial protocol. In connection with this obligation, Distributors
shall obtain and keep in effect all required licenses, permits and
authorizations (collectively, "Registration(s)") in the name of Seller, or
if this is specifically prohibited by applicable law, in the name of
Distributors or Sub-Distributor.
Seller shall provide Distributors with all necessary assistance in
connection with Distributors or Sub-Distributor obtaining Registrations
which Seller concurs in writing are necessary for the conduct of
Distributors' business. Distributors will advise Seller, upon Seller 's
request, of the status of all Registrations.
Seller shall have the sole authority to cancel or transfer (or direct the
cancellation or transfer of) all such Registrations. If this Agreement is
terminated for any reason, Seller shall make best commercial efforts to
appoint a designee qualified under applicable law to assume distribution of
the Products in the Territory within a period of ninety (90) days following
termination of this Agreement, and Distributors or Sub-Distributor shall,
at Seller's expense, promptly transfer all Registrations held by
Distributors or Sub-Distributor in connection with Distributors' or Sub-
Distributor's distribution of the Products to Seller or its qualified
designee. If such transfer is explicitly prohibited by applicable law, as
confirmed by Seller and Distributors and/or Sub-Distributor in writing,
Distributors and/or Sub-Distributor shall terminate their Registrations
within thirty (30) days following Seller's request and shall use best
commercial efforts to assist Seller, at Seller's expense, in obtaining new
Registrations for the Seller's qualified designee within thirty (30) days
of appointment of said designee.
Distributors and/or Sub-Distributor shall use Distributors' best efforts to
obtain the Registrations necessary to sell the current Products within
sixty (60) days of the effective date of this Agreement provided that if
such Registrations are not obtained by Distributors or Sub-Distributor
within six (6) months for any reason, this shall be grounds for immediate
termination of this Agreement at the option of the Seller.
Whenever possible under specific tender conditions, all activities with
respect to tenders shall be conducted so as to allow, upon termination of
this Agreement for any reason, and upon Seller's written request, transfer
of such tenders to Seller or to such party as Seller designates in writing.
Seller may provide Distributors with information concerning the manufacture
of the Products to increase Distributors' ability to obtain Registrations.
Distributors agree that such information will be disclosed only to those of
Distributors' employees who are authorized by Seller in writing to receive
such information.
9. COMPLIANCE WITH U.S. REGULATIONS
--------------------------------
Seller shall be responsible for compliance with all applicable United
States laws and regulations governing the manufacture and sale of the
Products. Distributors shall comply, and use Distributors' commercially
reasonable efforts to assist Seller in complying, with all United States
laws and regulations applicable to the import and distribution of the
Products in the Territory including the maintenance of all required books,
records and reports. In particular, Distributors shall track the serial
numbers and lot numbers of Products delivered to Distributors' Customers.
The obligation to maintain all legally required records shall survive the
termination of this Agreement.
10. RECALLS
-------
Distributors shall cooperate with Seller in effecting any recall of any
specific lot(s) of the Products which, in Seller's opinion, is necessary,
provided, however, that Seller shall bear all reasonable, direct out-of-
pocket transportation costs relating to the Products under recall and their
replacements. This section of the Agreement shall survive the termination
of this Agreement, provided however that Seller shall reimburse
Distributors and/or Sub-Distributor for all reasonable direct out-of-pocket
costs relating to support provided to Seller in the event of a Recall
following termination of this Agreement.
11. PROPRIETARY PROPERTY OF SELLER
-------------------------------
Seller warrants and represents that, to the best of its knowledge, as of
the date hereof, it is the rightful and legal owner of all Seller's rights,
title and interest to any and all patents, trademarks and trade names used
in connection with the manufacture, sale and promotion of the Products.
Distributors expressly acknowledge that Distributors do not have and shall
not acquire under this Agreement any rights in or to any of Seller 's
patents, trademarks or trade names or to any patents, trademarks or trade
names of any subsidiary or other affiliate of Seller. Distributors further
acknowledge that Distributors shall not at any time use, register, or
obtain in Distributors' own or any other name, Seller 's corporate name, or
any of its other trademarks or trade names without Seller's prior consent
in writing.
Both parties agree at all times during the term of this Agreement to hold
in strictest confidence, and not use, or to disclose to any person, firm,
corporation or any other entity without written authorization of the other
party, any Confidential Information of the other party.
Both parties further agree not to make copies of such Confidential
Information except as authorized by the other party. Distributors
understand that "Confidential
Information" of Seller means any of Seller's proprietary information,
technical data, trade secrets or know-how, including, but not limited to
research, product plans, products, services, suppliers, Customer lists and
Customers, prices and costs, markets, software, developments, inventions,
laboratory notebooks, processes, formulas, technology, designs, drawings,
engineering, hardware configuration information, marketing, licenses,
finances, budgets or other business information disclosed to Distributors
by Seller orally, in writing or by drawings.
Seller understands that "Confidential Information" of Distributors means
any of Distributors' proprietary information including, but not limited
market information, trade secrets or know how, Customer lists and
Customers, prices and costs, finances, budgets or other information
disclosed to Seller by Distributors orally, in writing or by drawings.
Confidential Information shall not in any case include information which is
or becomes generally available or comes to either party's attention through
means which do not involve a violation of this Agreement.
12. WARRANTY
--------
Seller hereby warrants to Distributor, Sub-Distributors, and to
Distributors or Sub-Distributor's Customers that the Products shall (i)
strictly conform to the Product specifications as provided by Seller and
received by Distributor from time to time and all U.S. governmental
regulations therefor, (ii) be free from defects in design, material and
workmanship and (iii) be of merchantable quality and fit for the ordinary
purposes for which the Products are used. This warranty shall survive any
inspection, delivery, acceptance or payment by Distributors. Distributors
shall have no obligation to provide any warranty to the Customers with
respect to the Products, except that Distributor and Sub-Distributor shall
pass on to Customers a copy of Seller's statement of warranty which shall
conform to this Agreement. Seller's liability under these warranties,
subject to Section 13, shall be limited to a refund of the Customer's
purchase price or repair or replacement. In no event shall Seller be liable
for the cost of procurement of substitute goods.
Seller shall promptly repair or replace (i) any Generator which does not
comply with Seller's warranty for a period of twelve (12) months from the
date of delivery by Sub-Distributor to the Customers or eighteen (18)
months after shipment from Seller's manufacturing location to the
Distributors, whichever is earlier, or (ii) any Electrode which does not
comply with Seller's warranty for a period of twenty four (24) months from
the date of delivery by Sub-Distributor to Customers or until the date of
the Electrode expiration date, whichever is earlier, provided, Seller
warrants that the Electrode shall be manufactured with a minimum shelf-life
of twenty-four (24) months, and provided further that Seller shall endeavor
to achieve a shelf-life of thirty-six (36) months for the Electrodes as
soon as commercially reasonable, and shall deliver to
Distributors Electrodes with a manufacture date no more than ninety (90)
days from the date of manufacture/sterilization date, or one hundred eighty
(180) days once a three year shelf-life is obtained. Seller represents that
it shall promptly and diligently comply with all its warranty obligations.
From the date hereof and until two (2) years after the termination of this
Agreement, Seller shall maintain a general comprehensive product liability
insurance policy in the amount of two million U.S. dollars ($2,000,000) per
occurrence and two million U.S. dollars ($2,000,000) in the aggregate per
year. Distributor and Sub-Distributor shall be named as additional
insureds. Within sixty (60) days from the date hereof, Seller shall send
Distributor Agent a copy of such insurance policy. Such policy shall
provide that Distributors and Sub-Distributor must be notified within
thirty (30) days of such policy's expiration, termination or modification.
ALL OTHER GUARANTEES, WARRANTIES, CONDITIONS AND REPRESENTATIONS, EITHER
EXPRESS OR IMPLIED, WHETHER ARISING UNDER ANY STATUTE, COMMON LAW, CASE
LAW, COMMERCIAL USAGE, CUSTOM OR OTHERWISE, INCLUDING IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY EXCLUDED.
13. INDEMNIFICATION
---------------
Seller shall indemnify and hold Distributors, Sub-Distributor, their
parent, subsidiaries and affiliates and their directors, officers and
employees ("Related Parties") harmless from any and all losses,
obligations, liabilities, costs and expenses including, but not limited to,
legal fees and out-of-pocket expenses arising out of or in connection with
(i) any claim of a third party regarding any breach of Seller's warranty,
or any product liability claims arising from the Products that are
otherwise not covered by Seller's general comprehensive product liability
insurance, excluding those claims which arise from the Distributors' or
Sub-Distributor's misconduct or gross negligence and (ii) any claim of a
third party regarding infringement of patent, trademark or tradename rights
with respect to the Products; provided that in either case (i) or (ii)
above, (x) Distributors or Sub-Distributor shall have promptly informed
Seller thereof (y) Distributors and/or Sub-Distributor do not defend
against or settle any claim without the written consent of Seller and (z)
Distributors and/or Sub-Distributor make best efforts to cooperate with
Seller in connection with the defense or settlement of such claim, provided
that Seller shall reimburse Distributors and/or Sub-Distributor for
reasonable expenses associated with such cooperation. In complying with the
provisions of this paragraph, Seller, and not Distributors or Sub-
Distributor, shall actively and at Seller's own expense defend against or
settle any such claim. Notwithstanding the foregoing, Seller's obligations
hereunder shall not extend to special or consequential damage claims of
Distributors, Sub-Distributors, and Related Parties. Seller's obligations
hereunder shall survive the expiration or termination of this Agreement
provided that any claim under this section
was made within ten (10) years of the termination of this Agreement or
until the termination of any applicable statutes of limitations. In the
event of any such claim after such period, Seller shall use its reasonable
commercial efforts to assist Distributors and/or Sub-Distributor in
defending against any such claim.
14. DURATION AND TERMINATION
------------------------
This Agreement shall be for a three (3) year period commencing on the first
full month following Distributors' or Sub-Distributor's obtaining the
Registrations necessary to sell the current Products. This Agreement shall
automatically renew for successive one year periods beginning on the first
day following the end of the initial three year period of this Agreement,
unless notice of termination is given by either party for any reason or no
reason within the ninety (90) days proceeding the commencement of any one
year renewal period. Each one year period, as described in this section,
shall be called a "Sales Year".
Further, this agreement may be terminated or, at the exclusive option of
the Seller, converted to a non-exclusive distributorship:
(1) by Seller, upon thirty (30) days written notice to Distributors, if
minimum quantity of Products, as per Section 3, is not purchased by
Distributors by the end of any Sales Year.
(2) by either party upon thirty (30) days written notice to the other if
the parties fail to reach agreement as to the Minimum Purchase Quantity
(according to Section 3 above) or as to the prices (according to Section 5
above) either (a) prior to the commencement of any one year renewal period
or (b) within sixty (60) days of written notification by Seller of an
addition to the Products.
Should Seller terminate the Agreement or convert the Agreement to a non-
exclusive distributorship according to either (1) or (2) above, Distributor
may, in its sole discretion and without penalty withdraw the most recent
rolling four-quarter forecast for orders submitted to the Seller, the
effect of which shall be to make all purchase commitments by Distributor
and all supply commitments by Seller under this Agreement null and void.
Further, this Agreement may be terminated:
(3) by either party upon written notice to the other if the other party
fails to fulfill its material obligations hereunder and such failure is not
cured within sixty (60) days after its receipt of written notice requesting
a remedy thereof, provided that there shall be no such cure period if
another provision in this Agreement excludes it or specifies another
period.
(4) by either party upon written notice if the other party or the Sub-
Distributor becomes insolvent or any voluntary or involuntary petition in
bankruptcy is filed by or against such party or a trustee is appointed with
respect to any of the assets of such party or a liquidation proceeding is
commenced by or against such party and such proceeding has not been
terminated within ninety (90) days, or if such party discontinues its
business.
(5) by Seller upon sixty (60) days written notice to Distributors if there
is a change of control of Seller.
Upon termination of this Agreement, Seller shall have the following
additional obligations with respect to repurchase of Product inventory held
by Distributors or Sub-Distributor: (i) if the termination arises from (3)
or (4) above, and the Distributors are the terminating party, or
termination arises from (5), Seller shall, upon Distributors' request,
promptly repurchase at Seller's risk and expense and at the original
invoice price any undamaged "Saleable"inventory, defined as inventory in
the Seller's catalog at the time of termination of this Agreement and
having a minimum remaining shelf life of at least eighteen (18) months. If
the termination arises from (3) or (4) above, and the Seller is the
terminating party or if termination arises from (1) or (2) above, Seller
shall have the right, but not the obligation, to repurchase undamaged,
Saleable inventory at the original invoice price.
Only the following Sections of this Agreement shall survive its
termination: Sections 4, 6, 8, 11, 12, 13 and 16.
Other than the specific provisions in this Section, neither party shall
have any remedy upon termination due to such termination, provided that
this shall have no effect on the surviving Sections of this Agreement,
which remain in effect and enforceable along allowing any remedy
specifically associated with them.
15. FORCE MAJEURE
-------------
Neither party shall be responsible to the other party for non-performance
or delay in performance under this Agreement due to acts of God, civil
commotion, war, riots, strikes, lockouts, severe weather, fires,
explosions, governmental actions or other similar causes beyond the control
of such party, provided that the party so affected shall promptly give
notice thereof to the other party and shall continue to take all action
reasonably within its power to comply herewith as fully as possible. In any
event, the time for performance hereunder shall only be extended for the
duration of the delay.
16. GENERAL PROVISIONS
------------------
The validity, interpretation, construction and performance of this
Agreement shall be governed by the laws of the State of California, without
giving effect to the principles
of conflict of laws. Any dispute or claim arising out of or in connection
with any provision of this Agreement will be finally settled by binding
arbitration in Santa Xxxxx County, California in accordance with the rules
of the American Arbitration Association by one arbitrator appointed in
accordance with said rules. The arbitrator shall apply California law,
without reference to rules of conflicts of law or rules of statutory
arbitration, to the resolution of any dispute. Judgment on the award
rendered by the arbitrator may be entered in any court having jurisdiction
thereof. Notwithstanding the foregoing, the parties may apply to any court
of competent jurisdiction for preliminary or interim equitable relief, or
to compel arbitration in accordance with this paragraph, without breach of
this arbitration provision.
Any notice required or permitted by this Agreement shall be in writing and
shall be deemed sufficient upon receipt, when delivered personally or by
courier, overnight delivery service or confirmed facsimile, or forty-eight
(48) hours after being deposited in the regular mail as certified or
registered mail (airmail if sent internationally) with postage prepaid, if
such notice is addressed to the party to be notified at such party's
address or facsimile number as set forth below, or as subsequently modified
by written notice.
XXXX Medical Systems, Inc.
000 X. Xxxxxxxxx Xxxxxxxxx, Xxxxxxxx Xxxx, XX 00000 XXX
Attn: Xxxxx Xxxxxxx - President and CEO
Fax: 000-000-0000
Nissho Iwai Corporation
0-0 Xxxxxxx 0-xxxxx, Xxxxxx-xx, Xxxxx 000, Xxxxx
Attn: Xxxxxxx Xxxxxxx - General Manager
Medical Systems Department
Fax: 00-0000-0000
Nissho Iwai American Corporation
1211 Avenue of the Americas, Xxx Xxxx, XX00000, XXX
Attn: Shin-ichi Kawaratani - Assistant Vise President
Fax: 000-000-0000
The provisions of this Agreement shall be deemed to be severable and the
invalidity of any provision of this Agreement shall not affect the validity
of the remaining provisions of this Agreement.
No amendment or modification of this Agreement shall be binding on the
parties unless made in writing expressly referring to this Agreement and
signed by authorized representatives of each party.
This Agreement is not assignable by either party in whole or in part
without the prior written consent of the other party, and any attempted
assignment without such approval shall be null and void, except that Seller
may assign this Agreement to an individual or entity which acquires a
controlling interest in Seller.
This Agreement constitutes the entire agreement and understanding of the
parties with respect to the subject matter of this Agreement and supersedes
all prior discussions, agreements and understandings.
SIGNATURE PAGE FOLLOWS
Both parties acknowledge and agree to all of the foregoing terms and conditions.
Until so executed by Distributors and Seller and returned to Seller, this
Agreement shall not be binding on either party, and unless executed by
Distributors and returned to Seller within ten days of the date set forth on the
first page hereof, this Agreement shall expire without further notice and shall
be null and void.
The parties executed this Agreement on the respective dates set forth below.
XXXX MEDICAL SYSTEMS, INC.
/s/: Xxxxx Xxxxxxx
-------------------
By: Xxxxx Xxxxxxx
Title: President and CEO
Address: 000 X. Xxxxxxxxx Xxxx.
Xxxxxxxx Xxxx, XX 00000, XXX
NISSHO IWAI CORPORATION
/s/: Xxxxxxx Xxxxxxx
---------------------
By: Xxxxxxx Xxxxxxx
Title: General Manager
Address: 0-0, Xxxxxxx 0-xxxxx,
Xxxxxx-xx, Xxxxx 000, Xxxxx
NISSHO IWAI AMERICAN CORPORATION
/s/: Shin-ichi Kawaratani
-------------------------
By: Shin-ichi Kawaratani
Title: Assistant Vise President
Address: 0000 Xxxxxx xx xxx Xxxxxxxx,
Xxx Xxxx, XX00000, XXX
Exhibit A
Territory
South Korea
Exhibit B
Products
GENERATORS
Model Number Part Number
------------ -----------
Model 500PA 700-101082
ELECTRODES
Model Number Part Number Description
------------ ----------- -----------
Model 30 700-100890 4 array, 3cm, 15cm
Model 30 700-100852 4 array, 3cm, 25cm
Model 70*
ACCESSORIES
Model Number Part Number
------------ ------------
Main Cable 700-101086
Foot Switch 410-100453
Dispersive Electrode 700-100379
Power Cord TBD
At its sole discretion with sixty (60) days prior written notice: (1) Seller
may discontinue any product on this list and (2) Seller may add additional
products to this list, provided that the list shall contain those Seller
products which are direct replacements for the current Products in applications
which the Seller approves in writing.
* When, and if, such product is introduced for Korea
Exhibit C
Minimum Purchase Target
------------------------------------------------------------------------------
Product 1st Sales Year 2nd Sales Year 3rd Sales Year
------- -------------- -------------- --------------
------------------------------------------------------------------------------
Model 500PA Generator [***] [***] [***]
------------------------------------------------------------------------------
Model 30 Electrodes [***] [***] [***]
------------------------------------------------------------------------------
* Each generator is supplied with Power Cord, a Main Cable and a Footswitch
** Each electrode is supplied with one Dispersive Electrode; if, and when the
Model 70 is introduced for Korea, both Model 30 and Model 70 purchases shall be
credited against the minimum purchase target
______________________________________
*** Material has been omitted pursuant to a request for confidential treatment,
and such Material has been filed separately with SEC.
Exhibit D
Pricing Schedule
--------------------------------------------------------------------------------
Product 1st Sales Year 2nd Sales Year 3rd Sales Year
------- -------------- -------------- --------------
--------------------------------------------------------------------------------
Model 500PA Generator* [***] [***] [***]
--------------------------------------------------------------------------------
Model 30 Electrodes** [***] [***] [***]
--------------------------------------------------------------------------------
Main Cable [***] [***] [***]
--------------------------------------------------------------------------------
Foot Switch [***] [***] [***]
--------------------------------------------------------------------------------
Dispersive Electrode [***] [***] [***]
--------------------------------------------------------------------------------
Power Cord [***] [***] [***]
--------------------------------------------------------------------------------
* Each generator is supplied with Power Cord, a Main Cable and a Foot Switch
** Each Model 30 electrode is supplied with one Dispersive Electrode; Model
70 pricing shall be the same as Model 30 pricing in the 1st, 2nd and 3rd
Sales Years
+ Applies to first 1,000 units; quantity discounts for 1st Sales Year only
are as follows (if, and when, the Model 70 is introduced for Korea, both
Model 30 and Model 70 purchases shall be credited against these quantity
discounts):
1,001/st/ - 1,999/th/ units [***]
2,000/th/ - 2,999/th/ units [***]
3,000/th/ + units [***]
Note that all part numbers are per Exhibit B and that terms are F.O.B. Seller's
manufacturing location. All freight, insurance and other direct shipping
expense shall be borne by Distributors from Seller's manufacturing location.
_________________________________
*** Material has been omitted pursuant to a request for confidential treatment,
and such Material has been filed separately with SEC.
Exhibit E
Complaint Form
Complaint Report Form Complaint No._____
--------------------------------------------------------------------------------
1. Date Received:_____________________________________________________
2. Received by:_______________________________________________________
3. Complaint Acknowledgement Letter Sent:_____________________________
4. Product Description:_______________________________________________ Lot No.
_____________________________Model No.______________________
5. Customer Name:_____________________________________________________
6. Contact Person:____________ Telephone:_______________ Fax:_________
7. Hospital/Address:__________________________________________________
__________________________________________________________________
--------------------------------------------------------------------------------
8. Nature of Complaint:
___________________________________________________________________________
___________________________________________________________________________
_______________________________[ ]See Attached
--------------------------------------------------------------------------------
9. Complete Medical Complaint Decision Tree (Form #160-101223).
--------------------------------------------------------------------------------
10. A.
Treatment Date:______________________ C. Device Returned
Indication:__________________________ [ ] Yes, Date Returned:____
Treatment Site:______________________ [ ] No
B. Origin of Complaint D. Confirmed Complaint?:
[ ] Domestic [ ] Clinical Study [ ] Yes
[ ] International [ ] Literature [ ] No
E. RMA Number: ________________
--------------------------------------------------------------------------------
11. Investigation:
[ ] Yes
By who:________________________ Date Complete:_______________________
Results of Investigation :_____________________________________________
_______________________________________________________________________
____________________________________________________[ ]See Attached
12. Corrective Action Number (if assigned): ___________________________________
13. Additional Information:____________________________________________________
--------------------------------------------------------------------------------
Complaint Response Sent:____________________
Approved by:__________________________ __________
Regulatory Affairs or Designated Date
________________ __________
Quality Assurance Date
Date File Closed:_______________________
--------------------------------------------------------------------------------
