exv10w69






Exhibit 10.69




FORM OF OEM SUPPLY AND PURCHASE AGREEMENT




          This OEM Supply and Purchase Agreement (“Agreement”) is made as of January 1, 2008 (the
“Effective Date”) by and between Nihon Kohden Corporation with offices at 31-4 Nishiochiai 1-chome,
Shinjuku-ku, Tokyo 161-8560 Japan (hereinafter referred to as “NK”), and Cardiac Science
Corporation, formerly known as Cardiac Science Inc., with offices at 3303 Monte Villa Parkway,
Bothell, Washington, USA 98021 (hereinafter referred to as “CSC”) (NK and CSC each being a “Party”,
and collectively the “Parties”).




RECITALS




          CSC is a manufacturer of various medical devices including, without limitation, an automated
external defibrillator known as the AED 9231 (the “AED 9231”) and Replacement Electrodes referred
to collectively as “Products” as defined in Appendix 1 below which, among other things, externally
defibrillate a human heart.




          NK develops, manufactures, distributes and sells various medical devices and systems including
patient monitoring systems and defibrillators.




          NK and CSC previously entered into an OEM Supply and Purchase Agreement, dated March 1, 2002,
as amended by Amendment No. 1 dated March 16, 2005 (the “Prior Agreement”) for the purchase and
sale of Products. The term of the Prior Agreement expires on December 31, 2007. NK desires to
continue to purchase from CSC, and CSC desires to continue to sell to NK AED 9231s and Replacement
Electrodes made by CSC for resale under one or more of NK’s trademarks or brand names. CSC
Products sold under the NK trademark or brand name will be sold exclusively by NK.




          NOW THEREFORE, in consideration of the mutual promises and covenants hereinafter contained,
and other consideration the receipt and sufficiency of which is hereby acknowledged, it is hereby
agreed between the parties as follows:




TERMS AND CONDITIONS




1. GRANT OF RIGHTS




          1.1 License. Subject to the terms of this Agreement, CSC grants to NK the
non-assignable and non-transferable right and license to:




               (a) Resell and sub-license the NK-branded AED 9231s to end-users or to other third parties
for sale;




               (b) Resell and sub-license the Replacement Electrodes to end-users or to other third parties
for sale and sub-license to end-users for use only with AED 9231s;




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.






 









 








          (c) Use CSC Marks in connection with the marketing, resale and sublicensing of Products,
pursuant to CSC’s prior written approval, such approval not to be unreasonably withheld; and




          (d) Resell and sub-license the Products as provided herein under NK’s own Marks and using
NK’s own labeling and packaging; provided, however, that NK maintains all CSC Marks and other
proprietary notices contained on the Products.




     1.2 Exclusive Appointment. CSC appoints NK as it exclusive distributor to market,
sell and distribute the AED 9231 to end user customers in Japan during the Term. Throughout the
Term, NK shall use its best efforts to market, sell and distribute AED 9231 in Japan. NK may
supplement, but not replace, its marketing, sales and distribution of AED 9231s in Japan with the
marketing, sales and distribution of AED 1200s that contain circuit boards purchased from CSC under
the OEM Supply and Purchase Agreement dated March 31, 2005 or any successor agreement (the “Parts
Agreement”). For the avoidance of doubt, the AED 1200 is referred to in the Parts Agreement as the
AED 1x.



     1.3 Enforcement. NK shall enforce its obligations under this Agreement with respect
to sublicenses granted by NK pursuant to this Agreement and, upon the request of CSC, shall
enforce, at NK’s cost, the rights of CSC with respect to any such sublicense and shall cooperate
with CSC, at NK’s cost, in any action by CSC to enforce its rights with respect to any such
sublicense, including by providing to CSC all information and assistance that CSC considers
reasonably useful to pursue such action. NK’s sale, distribution or other transfer of Products to
a distributor or a third party for resale to an End-User shall not prevent CSC from enforcing its
rights pursuant to this section.



     1.4 Reservation of Rights. Except as expressly provided herein, CSC does not grant
to NK any license or Intellectual Property Rights, whether by implication, estoppel or otherwise in
and to the Products, CSC Marks and CSC Confidential Information. NK shall not: (a) reverse
engineer, decompile, or otherwise tamper with the Products; (b) permit any third party including
distributors or end user customers to do any of the foregoing.



2. SCOPE OF THE OEM SUPPLY AND PURCHASE AGREEMENT




     2.1 For the term of this Agreement, on the terms and conditions provided herein, CSC agrees
to sell and NK agrees to purchase the Products more closely specified in Appendix 1 hereto in such
quantities as NK orders from time to time pursuant to Section 3.



     2.2 CSC shall supply to NK Products that conform to the technical specifications defined in
Appendix 3 hereto and in accordance with the warranty in Section 9.1.



     2.3 Parties shall cooperate and provide to each other in a timely fashion all information
necessary to facilitate the OEM version of the AED 9231s.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 2 -









 





     2.4 NK agrees to pay CSC for any and all non-recurring engineering (“NRE”) costs and other
expenses associated with any modifications to the Products requested by NK including the NK color
and labeling under one or more of NK’s trademarks or brand names and any modifications to the
casing, internal electronics, software or interfaces of the AED 9231. The Parties will agree in
advance as to the nature and the amount of the NRE costs and expenses associated with the
aforementioned modifications.



     2.5 All artwork, packages and labels (if any) prepared by CSC in connection with the NK name
shall be sent to NK for approval.



     2.6 For convenient reference, certain of the capitalized terms used in this Agreement is
defined in Appendix 4.



     2.7 During the Term, NK shall not, directly or indirectly (e.g., through any Affiliate or
distributor), promote, market, sell or distribute any product that directly competes with the AED
9231. However, for purposes of this Section 2.7 any automated external defibrillator with a lower
specification than AED 9231, including but not limited to an AED 1200 that contains circuit boards
purchased from CSC under the Parts Agreement and any automated external defibrillator equivalent or
similar to the AED 1200, shall not be considered to be a product that competes with the AED 9231.



     2.8 NK shall not, directly or indirectly (e.g., through any Affiliate or distributor),
promote, market, sell or distribute any AED 9231 or AED 1200 in North America.



3. TERM AND TERMINATION




     3.1 Duration. This Agreement becomes effective as of the Effective Date and
continues in full force and effect, unless sooner terminated as set forth below, until [*] (the
“Term”).



     3.2 Termination. Either Party may terminate this Agreement by giving the other Party
written notice of termination at least one (1) year prior to the effective date of such
termination. Either party (the “terminating party”) may immediately terminate this Agreement upon
notice to the other in the event that the other party: (a) breaches any material term of this
Agreement, including the obligation to pay amounts due under this Agreement and such breach is not
cured within thirty (30) days after notice from the terminating party; or (b) immediately upon
written notice to the other party in the event that proceedings in bankruptcy or insolvency are
instituted by or against the other party, or a receiver is appointed, or if any substantial part of
the assets of the other party is the object of attachment, sequestration or other type of
comparable proceeding, and such proceeding is not vacated or terminated within thirty (30) days
after its commencement or institution



     3.3 Effect of Expiration or Termination. Upon any expiration or termination of this
Agreement, the following provisions apply:



 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.






- 3 -









 





          (a) NK will promptly remit to CSC all money due as of the date of expiration or termination;
and if CSC terminates this Agreement pursuant to Section 3.2(a), then NK shall reimburse CSC for
its actual costs of raw materials and components used to manufacture the Products which CSC has
procured in order to supply the Products anticipated by this Agreement, and all work-in-process
related to such Products; provided, however, that (i)NK shall only be required to reimburse CSC for
such volume of raw materials, components and work-in-process that CSC reasonably determines is
unable to utilize for any reasonable period in products other than the Products; and (ii) the
amount of any such reimbursement shall be reduced by any refunds that CSC is able to obtain upon
making reasonable efforts to return such raw materials and components to the vendors thereof. In
the event of termination of this Agreement NK may sell and sublicense the Products existing in its
inventory at expiration or termination.




          (b) For a period of up to nine (9) months after the expiration or termination of this
Agreement, NK may continue to sell Products existing in its inventory at expiration or termination.




          (c) Except in connection with sales under (b) above, NK shall have no further right to use
CSC’s Marks and shall return all promotional materials that contain CSC Marks to CSC.




          (d) NK promptly shall return to CSC all CSC Confidential Information in NK’s possession. NK
shall be entitled to retain, however, copies any data and information that NK may be obligated to
retain for Quality Control and warranty purposes and/or the requirements of any government agency
or applicable law.




          (e) NK shall have a right to keep providing support for the Product to end user customers
after expiration or termination of this Agreement. For that purpose, CSC shall continue to supply
Replacement Electrodes and all other necessary parts and accessories to NK at its standard
published dealer prices under such terms that are mutually agreeable to the parties, and NK may
sell such Replacement Electrodes, parts and accessories to such customers.




          (f) In the event of any termination of this Agreement by NK pursuant to the first sentence of
Section 3.2, then, upon CSC’s request, NK shall cooperate and assist CSC to obtain JMHW and any
other regulatory approval required for CSC to directly or indirectly (e.g., through another
distributor) promote, market, sell and distribute Products in the Territory after the end of the
Term. Such cooperation and assistance may include, without limitation, the transfer of any such
approvals held by NK to CSC or its designee.




          (g) Neither party shall by reason of the termination or expiration of this Agreement in
accordance with its terms be liable to the other for compensation, reimbursement or damages on
account of lost prospective profits or anticipated sales, or on account of expenditures,
investments, leaves or commitments by the other or on any other account.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 4 -









 








4. NK OBLIGATIONS




     4.1 Applicable Laws.



          (a) NK shall comply with all applicable laws, rules and regulations in all of its activities
relating to this Agreement including the U.S. export laws, and to the marketing, sale, lease,
license, promotion, distribution, export, import and transfer of the Products, including without
limitation, obtaining any and all registrations and licenses required for the operation of NK’s
business and the marketing, sale, lease, license, promotion, distribution, export, import and
transfer the Products.




          (b) NK shall be solely responsible for and agrees to provide, in connection with the sale,
offer to sell, license, lease, import, export, transfer or distribution of Products, such labeling,
manuals, or other information as may be required by applicable laws, including but not limited to
instructions, warning and preventions.




          (c) NK shall maintain in effect, pursuant to applicable laws including but not limited to
21CFR 821 of the U.S. Code of Federal Regulations, a system of tracking each of the Products, and
shall provide such information to CSC. Such a system shall, at a minimum enable CSC to promptly:





     (i) identify each Product to its final and/or current location.




     (ii) if appropriate to recall, remedy, repair or modify any or all of the Products,
and/or notify the owners or possessors thereof, in the event of a recall affecting the
Products;



     4.2 Documentation and Models. NK shall provide CSC with one copy of the operations
manuals for each AED 9231 model sold under NK’s trade name. When a manual is revised, a copy of
the revised manual will be provided within 30 days after the revised manual is first issued.



     4.3 Responsibility. NK shall be jointly and severally liable to CSC for the actions
and omissions of its officers, employees, agents, directors, representatives, distributors,
sub-dealers, End-Users and other sublicenses with respect to performance under any license or
sub-license granted or authorized hereunder or related to the subject matter thereof.



5. CSC OBLIGATIONS




     5.1 Supply. CSC shall provide Products to NK pursuant to the terms and conditions
specified herein. Notwithstanding the foregoing, CSC shall be relieved of the obligation to supply
such Products in the event that any of the following circumstances occurs: (i) a third party
claims that any of the Products infringes or misappropriates its intellectual property; and




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 5 -









 




(ii) any product recall involving any of the Products. CSC shall not be required to provide
any direct support to End-users unless mutually agreed upon by CSC and NK in writing.




     5.2 Modifications. NK may request modifications to the Products, which would result
in a deviation from the description of the Products in the Technical Specifications which is
specified in Appendix 3; provided such a request is made at least ninety (90) days prior to the
desired effective date of such modification. The parties shall negotiate in good faith any such
requested modification, including any related amendments to this Agreement to provide for
reimbursement for any non-recurring costs that CSC will incur to effect such modifications and any
adjustments to the prices hereunder to reflect any increased costs of manufacturing the Products as
a result of such modification. If the parties are unable to agree upon such requested modification
and related amendments to this Agreement within such ninety (90) day period, this Agreement and the
Document shall continue in effect without change;



     5.3 Training. CSC shall provide training on the Products for certain NK’s sales
personnel, engineers or its clinical specialists. CSC’s training on the Products will be provided
as reasonably agreed upon by the parties.



     5.4 CSC Product Changes. CSC shall inform NK about any material changes of
specification or any other material changes to the Products at least 180 days prior to their
implementation. If the proposed modification might affect the performance, quality or functioning
of the Products or the approvals, permissions, consents or licenses applicable to them, CSC shall
not modify the Products unless NK has given its consent to the modification in writing. If NK
gives its consent to the proposed modification, the modified Products shall replace the prior
version of the Products and the terms and conditions of this Agreement shall continue to apply. If
the modified Products are not acceptable to NK, CSC shall, if feasible, continue to deliver to NK
unmodified Products. Concerning the Replacement Electrodes, if the modification relates to a
change in the gel material, CSC shall provide NK with the modification notice and biocompatibility
data at least 180 days prior to the proposed date of shipment of the modified Replacement
Electrodes.



     5.5 Out of warranty service. With respect to out-of-warranty product returns, CSC
shall agree to repair the out of warranty Product for a period of at least seven (7) years from the
date of delivery by CSC of the Product. NK shall contact CSC and inform CSC of the relevant
information and request a returned goods authorization and upon approval by CSC, CSC shall give a
return authorization number within two (2) days from receiving the request from NK. As promptly as
possible, but not later than ten (10) working days after CSC’s receipt of the out of warranty
Products, CSC shall to the extent possible repair the out of warranty Product. CSC shall provide a
report together with any product being returned. Each Party shall bear its own shipping costs.
The risk of loss or damage to the product shall pass to the other party upon delivery to the other
party’s carrier. CSC shall apply its standard service rate to such out of warranty repairs, unless
cost of repair is estimated to exceed $200. In such cases, NK shall have




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 6 -









 







the right to approve in advance the nature and the amount of the repair costs and expenses
associated with the out of warranty Product requiring repairs.



     5.6 Product Discontinuation. If CSC plans to discontinue manufacturing of any of the
Product from its product line, it shall notify NK about the intended removal in writing at least
240 days in advance. CSC will make its best commercial effort to provide substitute product if
Product, as defined in Appendix 1, is discontinued.



     5.7 Spare Parts. CSC will make best effort to make compatible spare parts available
on reasonable commercial terms for a period of at least [*] from the delivery by CSC of the Product
in question. NK understands that there may be no spare parts for the Products other than the
Products themselves or their replacements. Accordingly, in such cases where spare parts are
reasonably required for necessary repair of such Products, CSC shall replace the Product in
question with replacements that are reasonably acceptable to NK and on reasonable commercial terms.



     5.8 Applicable Laws and Regulations.



          (a) CSC shall manufacture the Products in compliance with FDA, ISO 9001, the MDD (the Counsel
Directive 93/42/EEC concerning medical devices promulgated by the Counsel of the European
Communities as amended) and all other applicable laws and regulations.




          (b) CSC shall assist and cooperate with NK’s efforts, to the extent reasonably necessary, in
obtaining any regulatory approvals necessary for the use of the Products. In this case of JMHW,
the parties shall cooperate with each other to attain necessary approvals.




     5.9 CSC Notification. Notification of quality control and assurance from CSC to NK
shall be as set forth in Appendix 5. CSC will indemnify and hold NK harmless from and against any
and all direct damages sustained as the result of CSC’s failure to provide timely notice of Product
failure or defect as detailed in the Appendix 5.



6. ORDERS




     Unless expressly otherwise agreed, all sales under this Agreement shall be between CSC as
seller and NK as purchaser.



     6.1 NK shall submit to CSC periodic forecasts every month of its anticipated requirement of
the Products for the subsequent five (5) month period. The purchase forecasts are not binding on
NK. The forecasts shall be provided in good faith. CSC shall notify NK of any inability as a
result of causes beyond CSC’s control (i.e. Force Majeure) to supply according to NK’s forecasts no
later than four (4) weeks prior to the forecast date of shipment and in such case shall inform NK
of the maximum amount it is able to supply and its shipment schedule.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 7 -









 





     6.2 NK shall order Products from CSC by issuing written purchase orders. Purchase orders for
AED 9231s shall be issued at least sixty (60) days in advance of the requested shipment date.
Purchase orders for Electrodes shall be issued at least thirty (30) days in advance of the
requested shipment date.



     6.3 Unless otherwise agreed between the Parties, NK may reschedule in writing, delivery of
any Product on purchase orders with CSC within the following guidelines:



	 	 	 
	Days from Scheduled Shipment Date:	 	Allowed Changes
	AED 9231s [*] days

	 	No changes
	 
	 	 
	AED 9231s –[*] days

	 	[*] percent (plus or minus)
	 
	 	 
	AED 9231s –[*] days

	 	[*] percent (plus or minus)






	 	 	 
	Days from Scheduled Shipment Date	 	Allowed Changes
	Electrodes [*] days

	 	No changes
	 
	 	 
	Electrodes [*] days

	 	[*] percent (plus or minus)
	 
	 	 
	Electrodes [*] days

	 	[*] percent (plus or minus)






     6.4 Every purchase order given by NK will be deemed to be a separate purchase contract under
the terms of this Agreement. Cardiac Science may at its sole discretion refuse to accept or may
cancel any outstanding purchase order in the event that any of the following circumstances occurs:
(i) CSC determines or a third party claims that any of the Products infringes or misappropriates
its intellectual property; and (ii) any product recall or similar corrective action involving any
of the Products which is required to be reported under the FDA’s Medical Device Reporting
requirements such as 21 CFF Part 803.



7. DELIVERIES




     7.1 Delivery and Shipping. Unless expressly otherwise agreed in writing, all orders
shall be delivered by CSC EXW CSC’s manufacturing plant in Deerfield, WI or another location of
CSC’s choosing, interpreted in accordance with INCOTERMS (2000 Edition). CSC shall use its
commercially reasonable efforts to ship the Products with test reports in time for them to arrive
by delivery dates agreed upon in compliance with the ordering procedure described herein. CSC
shall notify NK of any anticipated delivery problems in advance, but CSC shall not be responsible
for any loss or liability suffered by NK as a result of delay in delivery or replacement of any
order. NK agrees, however, that for shipments destined to locations outside the U.S.,




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 8 -









 




where transit time is expected to take more than one week, the minimum lead time for orders
may be appropriately increased by CSC to reasonably account for such additional transit time.
Title and risk of loss to Products purchased under this Agreement shall pass to NK upon delivery
thereof to the carrier.




     7.2 Packaging. Unless NK specifies otherwise, deliveries of the Products shall be
made in CSC’s standard delivery containers, which are reasonably designed to avoid damage during
delivery and inventory phases. Delivery shall be made to such address as NK specifies in a
purchase order. NK shall pay reasonable costs of any special packaging that it requires.



     7.3 Taxes. Except as expressly stated otherwise, prices set forth herein do not
include any existing or future taxes, tariffs, fees, duties, assessments or other charges (other
than income taxes assessed on CSC) that may be applicable to the Products supplied to NK pursuant
to this Agreement. If such additional sums are required to be withheld, collected, or paid, then
CSC shall add them to the price payable by NK.



     7.4 Acceptance and Non-Conforming Products. All sales of Products to NK shall be
deemed accepted upon shipment by CSC and title to the Products shall pass to NK upon delivery to
NK’s carrier. NK shall inspect Products promptly upon receipt at the shipping destination in
accordance with incoming inspection criteria mutually agreed upon by the Parties to determine if
any Products are non-conforming. Upon reasonable request, CSC shall provide reasonable assistance
to NK in order to determine whether any of the Products are non-conforming. Non-conforming
Products may be returned freight prepaid to CSC after receipt of a return authorization number from
CSC. CSC shall issue a return authorization number within two (2) days from receiving information
from NK. No returns will be accepted without a return authorization number. As promptly as
possible, but not later than ten (10) working days after CSC’s receipt of properly rejected goods,
CSC shall, at its option and expense, either repair or replace non-conforming Products. CSC shall
provide a repair/replacement report together with any product being returned. Title and risk of
loss or damage to the products shall pass to the other party upon delivery to the other party’s
carrier. CSC will prepay transportation charges back to NK and shall reimburse NK for any costs of
transportation incurred by NK in connection with the return to CSC of properly rejected goods.
Other than as permitted in this Section or under the terms of the warranty stated herein, goods may
not be returned to CSC.



     7.5 Failure to Pay Duties. NK shall bear all applicable taxes (such as sales, use or
similar taxes); all customs, duties, and similar charges; and all personal property taxes
assessable on Products after delivery to the carrier at CSC’s plant. In the event of NK’s failure
to pay any amounts due CSC within the time herein provided, CSC may, in addition to other remedies
available to it, cease acceptance and /or delivery of orders for Products from NK until such time
as NK’s payments are current and may thereafter condition acceptance and delivery of future orders
on such other or additional payment terms as it shall, in its discretion, determine.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for
confidential treatment filed separately with the Commission.





- 9 -









 





     7.6 Inspection. NK may, by itself or through its appointed representative, during
regular business hours and following reasonable notice to CSC, inspect CSC’s physical facilities
and CSC’s quality control procedures in order to assure compliance with the specifications, quality
requirements and other applicable standards. In the event that NK determines that the quality
procedures applied by CSC are insufficient as to ensure consistent acceptable quality, NK shall
specifically inform CSC thereof and of its recommended corrective measures to be undertaken by CSC.
CSC agrees to evaluate such recommendation in good faith. CSC agrees to take all appropriate
measures in order to ensure compliance of its sub-suppliers with the foregoing. Any circumstance
which might lead to modification or cancellation of CSC’s ISO quality system certificate(s) or
status as an FDA registered manufacturer in good standing, shall be immediately informed to NK in
writing.



8. PRICES AND TERMS OF PAYMENT




     8.1 Prices. The prices for the Products shall be as set forth in Appendix 2 and,
unless expressly otherwise agreed by the Parties, CSC shall sell and NK shall purchase the Products
during the Term from the Effective Date to [*] at those prices. Prices after [*] shall be based
upon mutual agreement of the parties and minimum quantity targets by NK. The Parties shall consult
and cooperate to agree upon the prices and minimum quantity targets for each Product to be
purchased by NK under this Agreement during any NK fiscal year (i.e. April 1 to the following
March 31) commencing after [*] no later than [*] of the prior year.



     8.2 Credit. Any credit terms set forth for NK hereunder shall be subject to the
condition that open account credit is established and maintained to CSC’s satisfaction and that
shipment of any delivery will not cause NK to exceed such credit limit as CSC may from time to time
establish. Unless expressly otherwise agreed in writing, payment for all Products shall be made by
NK in US dollars by wire transfer within thirty (30) days from the date of arrival of the Products
at NK’s premises or such other destination as may have been specified in the purchase order. In
addition to all of the other rights and remedies to which CSC shall be entitled, CSC shall be
entitled to interest on overdue payments at the rate of twelve (12) per cent per annum or highest
rate permitted by the applicable law, whichever is lower. In the event of NK’s failure to pay any
amounts due CSC within the time herein provided, CSC may, in addition to other remedies available
to it, cease acceptance and/or delivery of orders for Products from NK until such time as NK’s
payments are current.



9. CSC REPRESENTATIONS AND WARRANTIES




     9.1 General. CSC’s warranty obligations for the Products supplied by CSC shall be
set forth in subsection (a) — (e) below:



          (a) CSC represents and warrants that the Products supplied by CSC shall be in accordance with
the specifications and quality requirements specified in this Agreement and free from defects or
faults in design workmanship and materials for a period of five (5) years after




 
 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 10 -









 






delivery by CSC of each Product to NK. Batteries shall be supplied in accordance with the
specifications and quality requirements specified in this Agreement and shall be warranted for a
period of two (2) years after delivery by CSC to NK;




          (b) Products as provided by CSC, and as of the Effective Date, are in compliance with all
applicable requirements of U.S. and Japanese law or regulation. As stated in Section 13.3 herein,
CSC will make its best effort to be in compliance with applicable regulatory requirements of other
foreign countries in which the Products may be marketed;




          (c) CSC shall maintain quality control procedures in compliance with the requirements of the
following quality systems ISO 13485:2003, US GMP 21 CFR 820 (“the US GMP”) and the Council
Directive 93/42/EEC concerning medical devices promulgated by the Council of the European
Communities as amended (“the MDD”). If requested by NK, CSC shall provide NK with appropriate
documents evidencing that the Products comply with the essential requirements of the MDD and US GMP
product standards. CSC grants NK the right, by itself or through its appointed representative,
during regular business hours and following reasonable notice to CSC, to inspect CSC’s physical
facilities and CSC’s quality control procedures in order to assure compliance with the
specifications, quality requirements and other applicable standards as required by JMHW ordinances.
In the event that NK determines that the quality procedures applied by CSC are insufficient as to
ensure consistent acceptable quality, NK shall specifically inform CSC thereof and of the
reasonable corrective measures recommended to be undertaken by CSC. CSC agrees to consider in good
faith any such recommended corrective measures without delay. CSC agrees to take all appropriate
measures in order to ensure compliance of its sub-suppliers with the foregoing;




          (d) CSC has good and marketable title, and the right to license or sell the Products free and
clear of all liens, security interests and encumbrances;




          (e) CSC has the legal capacity to execute this Agreement and to perform its obligations
hereunder; and execution and delivery of this Agreement by CSC and performance of its obligations
hereunder shall not violate any applicable U.S. laws.




     9.2 Remedies. (a) If CSC breaches any of its warranties described in Section 9.1,
CSC will, in its sole discretion, either: (i) repair or replace the Product under the applicable
warranty, or (ii) refund any fees already paid for the non-conforming goods. If CSC decides to
repair or replace a Product, NK shall contact CSC and inform CSC of the relevant information and
request a returned goods authorization. If CSC gives a returned goods authorization, CSC will bear
shipping costs in transit in both directions; provided, however, CSC will only bear CSC’s shipping
costs to CSC if NK ships via a carrier designated by NK and directs the carrier bill to CSC. Title
and risk of loss or damage to the Product shall pass to the other party upon delivery to the other
party’s carrier. CSC shall ship the repaired or replacement Product to NK with repair/replacement
report as promptly as possible, but not later than ten (10) working days after CSC’s receipt of the
non-confirming Products.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 11 -









 





     9.3 Limitations.



          (a) THE EXPRESS WARRANTY PROVIDED IN THIS ARTICLE 9 IS THE SOLE AND EXCLUSIVE WARRANTY GIVEN
BY CSC WITH RESPECT TO THE PRODUCTS, AND CSC GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OF
ANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE FOREGOING. WITHOUT LIMITING THE GENERALITY OF THE
FOREGOING, NO IMPLIED WARRANTY OF MERCHANTABILITY, NO IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE, AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR COURSE OF
PERFORMANCE IS GIVEN OR MADE BY CSC OR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR PROVISION
OF THE PRODUCTS BY CSC OR NK’S USE OR SALE OF THE PRODUCTS OR NK’s AND CSC’s CONDUCT IN RELATION
THERETO OR TO EACH OTHER. NO REPRESENTATIVE OF CSC IS AUTHORIZED TO GIVE OR MAKE ANY OTHER
REPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY WAY. THE REMEDIES SET FORTH
IN SUCH EXPRESS WARRANTY ARE THE ONLY REMEDIES AVAILABLE TO ANY PERSON FOR BREACH OF WARRANTY.




          (b) The warranties described in Article 9 do not extend to any Products that have been
subject to misuse, neglect or accident; that have been damaged by causes external to the Products,
including but not limited to failure of or faulty electrical power; that have been used in
violation of CSC’s instructions, inconsistent with the Documentation or outside the scope of the
license granted herein; on which the serial number has been removed or made illegible; or that have
been modified, disassembled, serviced or reassembled by anyone other than CSC or its authorized
agents.




          (c) NK agrees that the warranty, remedies and limitations on liability provided in this
Agreement (subject to the limitations thereon) reflect a bargained-for compromise between CSC and
NK as to the allocation of risk in this Agreement.




10. NK REPRESENTATION AND WARRANTY




     10.1 General. NK represents and warrants:



          (a) As to Products subject to sublicenses granted by NK, NK shall not provide any
representations and warranties to its sublicenses, which exceed in scope the representations and
warranties provided by CSC to NK herein.




          (b) NK has the legal capacity to execute this Agreement and perform its obligations
hereunder;




          (c) Execution and delivery of this Agreement by NK and performance of its obligations
hereunder shall not violate any applicable Japan laws.





 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 12 -









 








11. LIMITATION OF LIABILITY EXCEPT PRODUCT LIABILITY




     IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL,
CONSEQUENTIAL, SPECIAL OR EXEMPLARY DAMAGES OR LOST PROFITS, EVEN IF ADVISED OF THE POSSIBILITY OF
SUCH DAMAGES. THE LIABILITY OF CSC FOR ANY CLAIM CONCERNING PERFORMANCE OR NONPERFORMANCE BY CSC
PURSUANT TO, OR IN ANY WAY RELATED TO, THE SUBJECT MATTER OF THIS AGREEMENT, REGARDLESS OF THE FORM
OF ACTION, WHETHER IN CONTRACT OR IN TORT, EXCEPT PRODUCT LIABILITY DESCRIBED IN SECTION 12 AND
INFRINGEMENT LIABILITY DESCRIBED IN SECTION 16, SHALL BE LIMITED TO THE AMOUNT PAID TO CSC BY NK
FOR THE LICENSED AED 9231s OR REPLACEMENT ELECTRODES, AS APPLICABLE, IN ACCORDANCE WITH THIS
AGREEMENT AND WITH RESPECT TO WHICH LICENSED AED 9231 OR REPLACEMENT ELECTRODES, AS APPLICABLE,
SUCH CLAIM SPECIFICALLY RELATES. IN NO EVENT SHALL CSC BE LIABLE FOR DAMAGES CAUSED BY NK’s OR ANY
END-USER’S ACT OR OMISSION.



12. PRODUCT LIABILITY




     Notwithstanding anything to the contrary contained herein, CSC agrees to indemnify and hold NK
harmless from and against any and all losses, claims, damages, costs and expenses, including
reasonable attorney’s fees, arising out of or relating to personal injury, illness and/or death if
it is established that such damage and/or personal injury resulted from any i) defect with respect
to design, manufacture, workmanship or materials of the Product; or ii) failure of the Product, at
the time of shipment to NK, to comply with the Technical Specifications which is specified in
Appendix 3; provided that NK shall:



          (a) give CSC prompt written notice of the claim;




          (b) tender defense of the claim to CSC;




          (c) cooperate with CSC in connection with the defense and any settlement of the claim; and




          (d) not settle the claim without the prior written consent of CSC, which consent shall not be
unreasonably withheld.




13. REGULATORY REQUIREMENTS, RECALLS




     13.1 The Parties confirm that in relation to the JMHW regulatory approvals or submission that
CSC shall be regarded as the manufacturer of the Products and NK as the in- country caretaker.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 13 -









 





     13.2 The Parties agree to cooperate in order to gain JMHW regulatory approval for the
Products including Cardiac Science’s biphasic AED 9231 product. For shipments outside of Japan,
CSC warrants that the Products conform to the requirements established in the MDD for CE marking
and will affix the CE mark to all the Products.



     13.3 Each Party shall make its best efforts to comply with all applicable laws and
regulations of the competent jurisdiction in which NK sells its Products. In particular, each
Party shall ensure that the Products as well as their respective activities in relation thereto
conform to all legislation, rules, regulations and statutory requirements existing from time to
time.



     13.4 If either Party becomes aware of an event where there is reasonable suspicion that the
Product contributed to or caused a death or serious injury or an event where a Product has
malfunctioned and, if that malfunction occurred again, it could cause death or serious injury, then
such Party shall use its best efforts to (a) give the other Party notice thereof orally within 24
hours from the receipt of such complaint or becoming aware of such event and (b) confirm such
notice by email within 24 hours after giving oral notice. As used herein, “Serious injury” means:
Any injury or illness that i) is life threatening, or ii) result in permanent impairment of a body
function or permanent damage to a body structure, or iii) necessities medical or surgical
intervention to preclude permanent impairment of a body function or permanent damage to a body
structure. To be reported a direct link with the Product and its possible short -comings should be
clearly established.



     13.5 The Parties shall be responsible for reporting under United States reporting
requirements such as 21 CFR Part 803, the Japanese Ministry of Health and Welfare and the European
Union reporting requirements and under the reporting requirements of any other country as may be
applicable. Before submitting a report involving a Product either Party shall use its best efforts
to notify the other Party and to obtain any information it may have relating to any incident
involving a Product. Copies of such reports shall be sent to the other Party without delay. If
JMHW or any governmental authorities require to take any product corrective action (including
notification, recall, removal and correction) involving a Product in Japan, NK shall use its best
efforts to notify CSC by email within 24 hours from the receipt of such information and CSC shall
be responsible to determine the conduction or non-conduction of the corrective action within a
commercially reasonable time and manner after the receipt of the information from NK. In case that
CSC decides to take any corrective action for any product in overseas which is substantially the
same as the Product specified herein, the Product sold or distributed by NK in Japan shall also to
be taken corrective action.



     If FDA or other regulatory authorities contact either Party to inquire about or investigate
the Products sold under this Agreement, the contacted Party, unless required to maintain
confidentiality by such authorities, shall inform the other Party immediately thereof. The Parties
shall co-operate closely to clear any regulatory issues or potential regulatory issues promptly.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 14 -









 





     Notice required by this section 13.4 and 13.5 shall be responsible for each party’s Quality
Assurance Department.



     The information required from NK in case of reporting incidents are including the following:




	 	i)	 	identification of the device including brand name,
	 
	 	ii)	 	description of the incidents,
	 
	 	iii)	 	how the Product was involved and/or contributed to the incident,
	 
	 	iv)	 	identity of the person(s) who were affected by the incidents,
	 
	 	v)	 	identity of the medical personnel who were involved in the incident,
	 
	 	vi)	 	whether a death or serious injury occurred,
	 
	 	vii)	 	identity by name, address, telephone number, email and title of the person submitting
the information to the other Party,
	 
	 	viii)	 	whether the incidents have already been reported to the FDA or other authorities by
the person making the report





     13.6 In the event CSC decides to take any product corrective action in Japan (including
notification, recall, removal and correction) with respect to the Product sold or distributed by
NK, regardless of whether such action is initiated to comply with applicable laws or regulations or
for other reasons, the Parties agrees that: a) NK shall be the point of contact for purchasers of
its Products (whether directly of through its distributors); b) after discussion between the
parties, CSC will “define the action to be taken” and c) during the course of recall of the
Product, CSC shall work with NK to provide replacement Product if required by end user customers to
minimize any downtime of replacement Product. In such cases, CSC shall provide NK with efficient
quantity of replacement Product as soon as possible for NK’s immediate action to end user
customers, and CSC shall reimburse NK for direct costs of the type set forth below which are in
incurred by NK to implement such actions,


As used herein, “define action to be taken” means;





	 	i)	 	In the event of any recall of any Product, CSC shall work with NK to provide
investigation of scope and root cause of the Product failure, and provide a corrective
action plan for any found cause of the Product failure.
	 
	 	ii)	 	Defining the effectiveness check procedure (to establish the corrective action has been
completed).






 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 15 -









 






	 	iii)	 	CSC shall make every effort to pursue any necessary actions against the Vendor or
Supplier responsible for the Product.
	 
	 	iv)	 	If NK submits a corrective action request that accompanies a end user customer returned
Product that requires immediate response, then Seller shall respond with scope of problem
evidence of registration and initial plan for root cause analysis within 72 hours of the
request.






The type of costs reimbursable under this Section  13.6 are: mailing, telephone, telefax and
printing charges for shipment of the Product to NK back to CSC; and direct labor costs to
receive and handle returned Product and to replace the Product to end user customers. In case
that it is necessary for NK to confirm that Product is manufactured under appropriate
manufacturing and quality control, NK has a right to audit such system.



14. INTELLECTUAL PROPERTY RIGHTS




     14.1 Ownership. Except as expressly provided herein, neither Party grants to the
other Party any license or intellectual property right, whether by implication, estoppel or
otherwise in and to its Products, patents, trademarks, documentation and confidential information.
Except in the case of NK’s need to provide authorized service to said Products, NK shall not: (a)
reverse engineer, decompile, disassemble or otherwise tamper with the Products; (b) install,
integrate, adapt or use the Products except as described in CSC’s documentation; and (c) permit any
third party including any of NK’s distributors or end user customers to do any of the foregoing.



     14.2 CSC Trademarks. Subject to NK’s compliance with the terms of this Agreement,
CSC grants to NK the non-transferable and non-assignable right to use the trademarks, service
marks, trade names, logos or other words or symbols of CSC identifying the Products (the
Trademarks”) on NK’s advertising and promotional materials, stationery, signs, labels and packaging
in order to convey that NK is manufacturing Products, equipment or devices which incorporate the
Products. The Trademarks are and shall remain the exclusive property of CSC, whether or not such
ownership is specifically recognized or protected under the laws of the Territory. NK shall
acquire no rights to the Trademarks other than those set forth in this Article, and NK hereby
assigns and transfers to CSC all rights other than those granted pursuant to this Section that it
may acquire in and to the Trademarks, whether by operation of law or otherwise. NK shall comply
with CSC’s guidelines for the use of the Trademarks, and shall allow CSC an opportunity to inspect
the Products to confirm NK’s compliance herewith.



     14.3 NK Trademarks. CSC shall not use or refer to NK’s name or trademarks in any
other form or manner or for any other purpose than what is expressly allowed in this Agreement.
All artwork, packages and labels (if any) prepared by CSC in connection with the NK name shall be
sent to NK for approval.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 16 -









 





     14.4 Infringement. CSC warrants that it is the sole and exclusive owner of, or has
valid licenses, with the right to sublicense, the Products, in each case free and clear of any and
all liens, claims or encumbrances. CSC represents that (i) it has not been determined to be
infringing any patents or other rights with respect to the Products and (ii) no person has asserted
that CSC’s manufacture or sale of the Products anywhere in the world infringes any patent or other
proprietary right of such person.



     14.5 Notification. NK shall promptly notify CSC of (a) any claims, allegations or
notification that NK’s sale, offer to sell, license, lease, importation, export, transfer or
distribution of any Product may or will infringe the Intellectual Property Rights of a third party;
and (b) any determination, discovery, or notification that any person or entity is infringing or
may be infringing the Intellectual Property Rights of CSC.



     14.6 Alteration and Use. NK may not remove or alter any proprietary designs notices
or Marks contained in or on the Products, Documentation or related materials. NK may not make any
reference or claim about CSC or the Products or use any of CSC marks, which have not been approved
or provided by CSC.



15. CONFIDENTIALITY




     15.1 This Agreement and all documents, drawings, manuals and other materials related thereto
and transmitted between the Parties, provided that only if it is designated as “Confidential” in
writing when communicated, or within thirty (30) days of disclose, if disclosed orally, shall be
treated as confidential by the Parties and their employees and such information shall not be
disclosed to any third party. Without the other Party’s prior written consent, this Agreement and
any other materials treated as confidential hereunder may be disclosed by either parties in
compliance with governmental regulations and other corporate reporting requirements; provided that
such Party has notified the other Party and cooperated in good faith to take such steps as may be
reasonably available to protect the confidentiality of the information contained therein to the
extent requested by the other Party and as may be allowable by the applicable law. Confidential
Information does not include information that: a)at the time of disclosure is already known to the
public, b)becomes generally available to the public after disclosure through no fault on the party,
c)Recipient can demonstrate it had rightfully, prior to disclosure to Recipient by the other party,
d)Recipient rightfully obtains from a third party having the right to disclose it, or e) is
independently developed by recipient without the use of Confidential Information; Each Party shall
arrange proper filing for specifications and drawings given by the other Party. Each Party shall
nominate a person who shall be in charge of the filing and shall inform this person of the
confidentiality requirements of this Agreement. The parties agree to hold all Confidential
Information confidential for a period of two (2) years after the expiration and/or termination of
the Agreement.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 17 -









 





16. CSC INDEMNIFICATION




     16.1 Indemnity. Notwithstanding anything to the contrary contained herein and
subject to NK satisfying the conditions of Section 14, CSC shall indemnify and hold NK, its
affiliates and their respective directors, officers, employees and representatives harmless from
and against any suits, actions, losses, damages and other expenses solely arising out of or in
connection with any claim that any authorized use of a Product infringes or violates any
Intellectual Property Right or copyright of a third party.



     16.2 Remedies. If NK’s or any End-User’s use of the Products is prevented by an
injunction or court order because of any claim of infringement, CSC will, at its expense, and in
its sole discretion, use reasonable commercial efforts to: (a) replace or modify the Product, in
such a manner so as to maintain its functionality and compatibility, but nonetheless make the
Products, as applicable, no longer subject to a claim of infringement; or (b) procure for NK’s or
any End-User’s benefit the right to use and resell the Products, as applicable, as provided in this
Agreement. If (a) and (b) above are not commercially viable, CSC shall refund to NK all amounts
paid therefore by NK and shall terminate the rights granted herein.



     16.3 Exclusion. CSC will have no liability for any claim of indemnity if such claim
is based upon: (a) Products that have been modified, disassembled, reassembled, serviced, altered
or changed without the express written authorization of CSC; or (b) the combination, operation, or
use of the Products with software and/or hardware not supplied by CSC, if such liability would have
been avoided in the absence of such combination, operation or use.



     16.4 Entire Liability. This Article 16 states CSC’s entire liability for
infringement of any patent or other intellectual rights with respect to the Products



     16.5 Conditions. NK shall promptly notify CSC of (i) any matter for which NK may
claim indemnification, (ii) any claim against NK that any Products misappropriate any trade secret
or infringe any patent, copyright or other Intellectual Property Right of a third party and (iii)
any suit, action or proceeding brought against NK on the basis of any such claims. CSC shall, in
its sole discretion, defend or settle any such claim, suit, action or proceeding in any manner and
on any terms it shall deem appropriate, and the costs thereof (including any final award of
damages) shall be borne entirely by CSC. If CSC elects to defend any such suit, action or
proceeding, NK shall provide CSC, at CSC’s expense, with all the needed information, assistance and
authority necessary to enable CSC to defend such claim. NK shall not without CSC’s prior written
approval itself defend or settle any such suit, action or proceeding.



17. NK INDEMNITY




     17.1 General. Notwithstanding anything to the contrary contained herein, NK shall
indemnify and hold harmless CSC, its affiliates and their respective directors, officers,




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 18 -









 







employees and representatives harmless from any claims, demands, actions, suits, proceedings,
judgments, damages, expenses and costs (including reasonable attorneys fees) related to:



          (a) Any of its activities under this Agreement, including any third party assertion that the
Products or any component thereof, to the extent they have been modified, disassembled,
reassembled, serviced, altered or changed by NK, infringe or misappropriate any patents or
copyrights of such third parties;




          (b) Death, injury or damage (including death) to any person or property caused by the
Products that have been subject to modification, alteration or change that NK instructed and/or
required to CSC.




     17.2 Conditions. CSC shall promptly notify NK of (i) any claim against CSC that
Products, which have been modified, disassembled, reassembled, serviced, altered or changed by NK
or CSC in accordance to NK’s instruction or requirement, misappropriate any trade secret or
infringe any patent, copyright or other intellectual property right of a third party and (ii) any
suit, action or proceeding brought against CSC on the basis of any such claims. NK shall, in its
sole discretion, defend or settle any such claim, suit, action or proceeding in any manner and on
any terms it shall deem appropriate, and the costs thereof (including any final award of damages)
shall be borne entirely by NK. If NK elects to defend any such suit, action or proceeding, CSC
shall provide NK, at NK’s expense, with all the needed information, assistance and authority
necessary to enable NK to defend such claim. CSC shall not without NK’s prior written approval
itself defend or settle any such suit, action or proceeding.



18. INSURANCE




     Throughout the term of this Agreement, and for a period of at least three (3) years
thereafter, CSC and NK shall each carry a reasonable amount of commercial general liability
insurance. Insurance is to be maintained by parties pursuant to the provisions of this Article and
shall provide for written notice to the other party thirty (30) days in advance of any termination
or cancellation of such insurance. Upon the request of either party from time to time during the
term hereof, each party shall provide the other with a certificate evidencing such insurance
coverage.



19. GENERAL




     19.1 Notices. All notices, requests, demands, waivers and other communications
required or permitted to be given under this Agreement are to be in writing and are deemed to be
duly given (a) upon being delivered either personally or by overnight courier with delivery charges
prepaid, (b) upon the fifth (5th) day from the date such notice was mailed by certified or
registered mail, postage prepaid, receipt requested, or (c) upon being sent by telecopy, to the
people and addresses set forth below or to such other person or address as either party may specify
by notice




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 19 -









 







in writing to the other party. All notices, requests, demands, waivers and communications are
received on the date of delivery.



          If to CSC:



Cardiac Science Corporation.

3303 Monte Villa Parkway

Bothell, Washington 98021

Attention: John Hinson, President and Chief Executive Officer

Facsimile: (425) 402-2020



With a copy to:



Perkins Coie LLP

1201 Third Avenue, Suite 4800

Seattle, Washington 98101

Attention: Richard Rohde

Facsimile: (206) 359-7120




          If to NK:



Nihon Kohden Corporation

31-4 Nishiochiai 1 Chome

Shinjuku-ku, Tokyo 161-8560 JAPAN

Attention:

Facsimile:




     19.2 Force Majeure. If the performance of any obligation under this Agreement is
prevented, restricted or interfered with by reason of war, civil commotion, embargo, strike or any
other act which is beyond the reasonable control of the party affected, then the party so affected
shall, upon giving written notice to the other party, be excused from such performance to the
extent that such prevention, restriction or interference; provided that the party so affected shall
use commercially reasonably efforts to avoid and remove such causes of non-performance, and shall
continue performance hereunder with reasonable dispatch whenever such causes are removed.



     19.3 Successors and Assigns. This Agreement inures to the benefit of and is binding
upon the parties hereto and their successors and permitted assigns. Nothing in this Agreement,
expressed or implied, confers on any person other than the parties hereto (or their successors and
permitted assigns), any rights, remedies, obligations or liabilities.




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 20 -









 





     19.4 Entire Agreement. This Agreement (including the Exhibits) is the entire
agreement between the parties hereto with respect to the subject matter hereof and supersedes all
other prior and contemporaneous agreements and understandings, oral and written.



     19.5 Assignment. Neither party may assign this Agreement without the prior written
approval of the other party.



     19.6 Relations. This Agreement creates no partnership, joint venture, franchise or
agency between the parties. Except as expressly set forth in this Agreement, neither party has the
right to assume or create, either directly or indirectly, any liability or any obligation of any
kind, expressed or implied, in the name of or on behalf of the other party, and neither party shall
represent that it has such authority.



     19.7 Waiver. This Agreement may only be waived or amended, if such waiver or
amendment is in writing, specifically references this Agreement and is executed by the party to be
bound. The waiver by either party of a breach of any provision of this Agreement does not operate
as a waiver of any other breach. A party’s failure or delay to exercise any right hereunder does
not operate as a waiver.



     19.8 Unenforceability. The illegality, invalidity or unenforceability of any part of
this Agreement does not affect the legality, validity or enforceability of the remainder of this
Agreement. If any part of this Agreement is found to be illegal, invalid or unenforceable, this
Agreement will be given such meaning as would make this Agreement legal, valid, and enforceable in
order to give effect to the intent of the parties.



     19.9 Governing Law. This Agreement is governed and construed according to the laws
of Washington, U.S.A. The court of competent jurisdiction shall be exclusively the district court
of Washington located in King County, Washington, U.S.A. if an action is brought by NK, or shall be
exclusively Tokyo district court, Japan if an action is brought by CSC.



     19.10 Dispute Resolution. Prior to taking any legal action, the parties shall
attempt to resolve any claim or controversy arising out of this Agreement by way of amicable
negotiations within a reasonable period not to exceed thirty (30) days after the date of a notice
from either party to the other describing such claim or controversy.



     19.11 Irreparable Harm. CSC and NK acknowledges that, in view of the uniqueness of
the transactions contemplated by this Agreement, a material breach or material failure to comply
with its confidentiality obligations or license restrictions would cause irreparable harm to other
party’s business and that the other party would not have an adequate remedy at law for money
damages. Therefore, CSC and NK agrees that NK and CSC is entitled to specific performance and/or
injunctive relief without the posting of bond or other security in addition to any other remedy to
which it may be entitled hereunder or at law or in equity, in any court of competent jurisdiction
against any such breach or noncompliance. All remedies provided for herein are




 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 21 -









 







cumulative and the exercise of any particular remedy by NK and CSC and does not limit or
preclude the exercise of any other remedy available to it.



     19.12 Survival. Articles and Sections 1, 2.2, 3.2, 3.3, 4.3, 5.5, 5.7, 5.9, 7.5, 9,
10.1, 11, 12, 13, 14, 15, 16 and 17 survive any expiration or termination of this Agreement.



     19.13 Counterparts. This Agreement may be executed in counterparts, each of which
shall be deemed an original and all of which together shall be deemed to be one and the same
instrument.



     19.14 Relation to the Prior Agreement. This Agreement applies to purchase and sale of
Products during the term of this Agreement set forth in Section 3 of this Agreement. The purchase
and sale of Products during the term of the Prior Agreement as set forth in Section 3 thereof shall
be governed by the terms of the Prior Agreement.



* * *




     IN WITNESS WHEREOF, the Parties have caused this OEM Supply and Purchase Agreement to be executed
by their duly authorized representatives.



	 	 	 
	Nihon Kohden Corporation

	 	Cardiac Science Corporation
	 
	 	 
	 

	 	 
	Name:

	 	Name: Allan Criss
	 
	 	 
	Title:

	 	Title: Senior Vice President of Sales and
Marketing






APPENDICES:



1. The Products





 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 22 -









 







2. Prices



3. Technical Specifications



4. Definitions



5. Notification of Quality Control and Assurance from CSC




 
 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 23 -









 








APPENDIX 1




The Products




          The Products consist of the following:




          A.I. The AED 9231 is a portable automated external defibrillator that analyzes a persons’
electrocardiogram and advises an operator to deliver an electric shock(s) using monophasic or
biphasic defibrillation technology to a patient in order to restore normal heart rhythm; and
includes Cardiac Science’s patented RescueReady technology such as one button operation,
pre-connected disposable electrode pads and status indicator. The AED 9231s ordered by NK under
this Agreement will have NK specified coloring and labeling as agreed upon by the Parties




          A.2. The “Electrodes” or “Replacement Electrodes” are single patient use defibrillation
electrodes for use with the AED 9231s. Electrodes ordered by NK under this Agreement will be
labeled under the NK tradename and packaged in such as way to accommodate the RescueReady
capabilities of the AED 9231.




          Technical specifications of the Products are attached hereto as Appendix 3.




          Products include only versions that have been commercially released by CSC, and NK shall not
sell or distribute any pre-released versions provided by CSC for test, evaluation, demonstration,
promotional or other purposes.




          If CSC commercially releases a successor to the AED 9231 during the Term (“Successor
Product”), then CSC shall make the Successor Product available for purchase by NK under this
Agreement; provided that the Parties agree upon pricing and minimum quantity commitments by NK for
the Successor Product. In such event, the Parties shall amend this Appendix 1 and Appendix 2 to
include the Successor Product. For purposes of foregoing, the Successor Product is limited to the
next released portable automated external defibrillator that has a feature set equivalent to or
higher than the feature set in the version of the AED 9231 offered by CSC on the Effective Date and
that is intended to replace the AED 9231 in the applicable market.




          Additional models and other devices, systems, components and/or parts may be added as
“Products” under this Agreement by mutual written agreement of the Parties.






 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 24 -









 








APPENDIX 2




The prices for the Products during the Term from the Effective Date to [*] are as follows (the
Target Number of Units is based upon the prices):



Prices for AED 9231 (without electrode pads)




	 	 	 	 	 
	Month	 	Target Number of Units	 	Price per Unit
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	Total

	 	[*]	 	 






	 	 	 	 	 
	Quarter	 	Target Number of Units	 	Price per Unit
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	[*]

	 	[*]
	 	[*]
	Total

	 	[*]	 	 





A potential additional purchase of up to [*]additional units
above the [*] forecasted or targeted above, at the price points
listed below. The [*] will be a one time only purchase in the
[*] time frame. The price for the additional number of units
is contingent on CSC receiving a purchase order for the [*]
units for [*] and the [*] units forecasted for [*], prior to
receiving an order for the additional [*] units.




	 	 	 	 	 
	Number of Units	 	Price per Unit	 	 
	1 to 1,000

	 	[*]	 	 
	1,001 to 2,000

	 	[*]	 	 
	2,001 and up

	 	[*]	 	 







 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.


- 25 -









 






Prices




	 	 	 	 	 
	Product	 	 	 	Price, $USD
	NK branded AED 9231 Electrodes

	 	any quantity
	 	[*]
	 
	 	 	 	 
	Datacard Adapter

	 	any quantity
	 	[*]
	 
	 	 	 	 
	USB to RS-232 Plug in Adapter
All prices are in US Dollars (USD)

	 	any quantity
	 	[*]






 
 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 26 -









 








APPENDIX 3




Technical Specifications



[*]






 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.




- 27 -









 








APPENDIX 4



Definitions





	 	1.	 	The following is a listing for convenient reference of terms as defined in this
Agreement:
	 
	 	2.	 	Affiliate means with respect to any specified party, any other legal entity that
directly or indirectly controls, is controlled by or is under common control with, such
specified party.
	 
	 	3.	 	CSC means Cardiac Science Corporation.
	 
	 	4.	 	NK means the Nihon Kohden Corporation.
	 
	 	5.	 	Effective Date means January 1, 2008.
	 
	 	6.	 	Replacement Electrode and Electrode mean the electrodes specified in Appendix 1.
	 
	 	7.	 	MDD means the counsel directive 93/42 EEC concerning medical devices promulgated by the
Council of the European Communities as amended.
	 
	 	8.	 	Module means the module specified in Appendix 1.
	 
	 	9.	 	Party or Parties means NK and CSC individually and collectively as applicable.
	 
	 	10.	 	Products means the products specified in Appendix 1.
	 
	 	11.	 	U.S. GMP means the requirements of U.S. GMP 21 CFR 820.






 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 28 -









 











Appendix 5




Notification of Quality Control and Assurance from CSC





	1.	 	CSC shall inform the following of NK in writing.
	 
	 	 	CSC shall inform NK of attentions which NK shall inform to purchaser or installer of products,
if there are some possibilities that product is installed in non-medical institution and
operated by personnel who are not qualified as a doctor or not trained.
	 
	 	 	CSC shall inform NK of the contents of the obligation of purchaser or installer concerning
control or maintenance of products. CSC shall inform NK of the contents of the obligation of NK
concerning control or maintenance of installed products.
	 
	2.	 	In the following cases, CSC shall inform NK in writing immediately (within at least 1 week).
	 
	 	 	After the products are supplied to the customer, if there are any mistakes or omissions which
shall be corrected, or if there are any other additional items concerning safety which are not
described on the operator’s manual, CSC shall inform NK of them in writing.
	 
	3.	 	In the following cases, CSC shall inform NK by fax quickly.
	 
	 	 	CSC shall inform NK by fax, if any adverse events concerning AED 9231 are reported in a medical
congress, in Enforcement Report or MDR by FDA. The information of any adverse events includes
the product of other company. CSC shall not be obligated to notify NK of routine submission of
MDRs to the FDA or routine product complaints.
	 
	 	 	CSC shall inform NK by fax if the failure or the claim concerning safety of products of CSC has
occurred, regardless of whether CSC has the responsibility or not, or whether the product is
failure or not.
	 
	 	 	CSC shall inform NK by fax if software is changed.
	 
	 	 	Where automatic charge and/or internal discharge algorithm or arrhythmia detection algorithm is
changed, or change that affects input and output or the result of arrhythmia detection program
is implemented, CSC shall inform NK of the differences between changed products and previous
products, the purpose or reason of the change, and identify the scope of the change (whether it
is applied to products which has already supplied to the customer, or it limits products which
will be shipped in the future) and explain the reason to NK.
	 
	4.	 	When the circuit or material or structure of the products is improved or changed, CSC shall
inform NK of the outline and serial number, regardless of the details of notification to JMHW.
In the following cases, CSC shall inform NK of them in written quickly.






 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 29 -









 






	1)	 	When parts, related to electrical isolation of applied part from live parts, and creepage
distance, air clearance and construction related to dielectric stress are changed, or these
parts manufacturers are changed.
	 
	2)	 	When exterior material of the products is changed.
	 
	3)	 	When dimension and weight are changed more than +/- 5% greater.
	 
	4)	 	When specification affects the products’ performance, quality and function.
	 
	5)	 	When block diagram is changed.
	 
	6)	 	When testing procedure is changed.







 





[*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.



- 30 -