EXHIBIT 10.66**OEM SUPPLY AND PURCHASE AGREEMENT**          This OEM Supply and Purchase Agreement (“Agreement”) is made as of March 1, 2002 by andbetween Nihon Kohden Corporation with offices at 31-4 Nishiochiai 1-chome, Shinjuku-ku, Tokyo161-8560 Japan (hereinafter referred to as “NK”), and Cardiac Science Inc., with offices at 16931Millikan Avenue, Irvine, California, USA 92606 (hereinafter referred to as “CSI”) (NK and CSI eachbeing a “Party”, and collectively the “Parties”).**RECITALS**          CSI is a manufacturer of various medical devices including automated external defibrillators(“AEDs”) and Replacement Electrodes referred to collectively as (“Products”) as defined in Appendix1 below which, among other things, externally defibrillate a human heart.          NK develops, manufactures, distributes and sells various medical devices and systems includingpatient monitoring systems and defibrillators.          NK desires to purchase from CSI, and CSI desires to sell to NK certain AEDs and ReplacementElectrodes made by CSI for sale under one or more of NK’s trademarks or brand names. CSI Productssold under the NK trademark or brand name will be sold exclusively by NK on a worldwide basis bothinside and outside the Japanese domestic market.          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 herebyagreed between the parties as follows:**TERMS AND CONDITIONS****1. GRANT OF RIGHTS**     1.1 License. Subject to the terms of this Agreement, CSI grants to NK thenon-assignable and non-transferable right and license to:          (a) Resell and sub-license the NK-branded AEDs to End-Users or to other third parties forsale;          (b) Resell and sub-license the Replacement Electrodes to End-Users or to other third partiesfor sale and sub-license to End-Users for use only with AEDs;          (c) Use CSI Marks in connection with the marketing, resale and sublicensing of Products,pursuant to CSI’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 usingNK’s own labeling and packaging; provided, however, that NK maintains all CSI Marks and otherproprietary notices contained on the Products. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
 

 
     1.2 Enforcement. NK shall enforce its obligations under this Agreement with respectto sublicenses granted by NK pursuant to this Agreement and, upon the request of CSI, shallenforce, at NK’s cost, the rights of CSI with respect to any such sublicense and shall cooperatewith CSI, at NK’s cost, in any action by CSI to enforce its rights with respect to any suchsublicense, including by providing to CSI all information and assistance that CSI considersreasonably useful to pursue such action. NK’s sale, distribution or other transfer of Products toa distributor or a third party for resale to an End-User shall not prevent CSI from enforcing itsrights pursuant to this section.     1.3 Reservation of Rights. Except as expressly provided herein, CSI does not grant toNK any license or Intellectual Property Rights, whether by implication, estoppel or otherwise inand to the Products, CSI Marks and CSI Confidential Information. NK shall not: (a) reverseengineer, decompile, or otherwise tamper with the Products; (b) permit any third party includingdistributors or End Users 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, CSI agrees tosell and NK agrees to purchase the Products more closely specified in Appendix 1 hereto in suchquantities as NK orders from time to time pursuant to Section 3.     2.2 CSI shall supply to NK Products that conform to the technical specifications defined inAppendix 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 informationnecessary to facilitate the OEM version of the AEDs.     2.4 NK agrees to pay CSI for any and all non-recurring engineering (“NRE”) costs and otherexpenses associated with any modifications to the Products requested by NK including the NK colorand labeling under one or more of NK’s trademarks or brand names and any modifications to thecasing, internal electronics, software or interfaces of the AED. The Parties will agree in advanceas to the nature and the amount of the NRE costs and expenses associated with the aforementionedmodifications.     2.5 All artwork, packages and labels (if any) prepared by CSI in connection with the NK nameshall be sent to NK for approval.     2.6 For convenient reference, each of the capitalized terms used in this Agreement is definedin Appendix 4.**3. TERM AND TERMINATION**     3.1 Duration. This Agreement becomes effective as of the Effective Date and continuesin full force and effect, unless sooner terminated as set forth below, until [*] (the“Term”), with an automatic one (1) year renewal (the “Renewal Term”) unless either party provides aninety (90) day prior written notice of its intent not to renew the Agreement. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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     3.2 Termination. Either party (the “terminating party”) may immediately terminatethis Agreement upon notice to the other in the event that the other party: (a) breaches anymaterial term of this Agreement, including the obligation to pay amounts due under this Agreementand 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 bankruptcyor insolvency are instituted by or against the other party, or a receiver is appointed, or if anysubstantial part of the assets of the other party is the object of attachment, sequestration orother 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 thisAgreement, the following provisions apply:          (a) NK will promptly remit to CSI all money due as of the date of expiration or termination;and if CSI terminates this Agreement pursuant to Section 3.2(a), then NK shall reimburse CSI forits actual costs of raw materials and components used to manufacture the Products which CSI hasprocured in order to supply the Products anticipated by this Agreement, and all work-in-processrelated to such Products; provided, however, that (i)NK shall only be required to reimburse CSI forsuch volume of raw materials, components and work-in-process that CSI reasonably determines isunable to utilize for any reasonable period in products other than the Products; and (ii) theamount of any such reimbursement shall be reduced by any refunds that CSI is able to obtain uponmaking reasonable efforts to return such raw materials and components to the vendors thereof. Inthe event of termination of this Agreement NK may sell and sublicense the Products existing in itsinventory at expiration or termination;          (b) NK shall have no further right to use CSI’s Marks and shall return all promotionalmaterials that contain CSI Marks to CSI;          (c) NK promptly shall return to CSI all CSI Confidential Information in NK’s possession. NKshall be entitled to retain, however, copies any data and information that NK may be obligated toretain for Quality Control and warranty purposes and/or the requirements of any government agencyor applicable law.          (d) CSI shall continue to supply Licensed Replacement Electrodes to NK for at its standardpublished dealer prices under such terms that are mutually agreeable to the parties and NK shallhave a right to keep providing sales support for the Product to end users customer after expirationand/or termination of the Agreement.          (e) NK shall not by reason of the termination or expiration of this Agreement in accordancewith its terms be liable to CSI for compensation, reimbursement or damages on account of lostprospective profits or anticipated sales, or on account of expenditures, investments, leaves orcommitments by CSI or on any other account. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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**4. NK OBLIGATIONS**     4.1 Applicable Laws.          (a) NK shall comply with all applicable laws, rules and regulations in all of its activitiesrelating 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 withoutlimitation, obtaining any and all registrations and licenses required for the operation of NK’sbusiness and the marketing, sale, lease, license, promotion, distribution, export, import andtransfer 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 toinstructions, warning and preventions.          (c) NK shall maintain in effect, pursuant to applicable laws including but not limited to21CFR 821 of the U.S. Code of Federal Regulations, a system of tracking each of the Products, andshall provide such information to CSI. Such a system shall, at a minimum enable CSI 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 theProducts;     4.2 Documentation and Models. NK shall provide CSI with one copy of the operationsmanuals for each AED model sold under NK’s tradename. When a manual is revised, a copy of therevised 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 CSI for the actionsand omissions of its officers, employees, agents, directors, representatives, distributors,sub-dealers, End-Users and other sublicenses with respect to performance under any license orsub-license granted or authorized hereunder or related to the subject matter thereof.**5. CSI OBLIGATIONS**     5.1 Supply. CSI shall provide Products to NK pursuant to the terms and conditionsspecified herein. Notwithstanding the foregoing, CSI shall be relieved of the obligation to supplysuch Products in the event that any of the following circumstances occurs: (i) a third partyclaims that any of the Products infringes or misappropriates its intellectual property; and (ii)any product recall involving any of the Products. CSI shall not be required to provide any direct supportto End-users unless mutually agreed upon by CSI and NK in writing.     5.2 Modifications. NK may request modifications to the Products, which would resultin a deviation from the description of the Products in the Technical Specifications which isspecified [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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in Appendix 3; provided such a request is made at least ninety (90) days prior to thedesired effective date of such modification. The parties shall negotiate in good faith any suchrequested modification, including any related amendments to this Agreement to provide forreimbursement for any non-recurring costs that CSI will incur to effect such modifications and anyadjustments to the prices hereunder to reflect any increased costs of manufacturing the Products asa result of such modification. If the parties are unable to agree upon such requested modificationand related amendments to this Agreement within such ninety (90) day period, this Agreement and theDocument shall continue in effect without change;     5.3 Training. CSI shall provide training on the Products for certain NK’s salespersonnel, engineers or its clinical specialists. CSI’s training on the Products will be providedas reasonably agreed upon by the parties.     5.4 Development. CSI shall use commercially reasonable efforts to complete agreedupon modification and deliver Licensed AEDs to NK by the earlier date of March 31, 2002 or JMHWapproval date, pursuant to NK’s purchase order.     5.5 CSI Product Changes. CSI shall inform NK about any changes of specification orany other material changes to the Products at least 240 days prior to their implementation. If theproposed modification might affect the performance, quality or functioning of the Products or theapprovals, permissions, consents or licenses applicable to them, CSI shall not modify the Productsunless NK has given its consent to the modification in writing. If NK gives its consent to theproposed modification, the modified Products shall replace the prior version of the Products andthe terms and conditions of this Agreement shall continue to apply. If the modified Products arenot acceptable to NK, CSI shall, if feasible, continue to deliver to NK unmodified Products.     5.6 Out of warranty service. With respect to out-of-warranty product returns, CSIshall agree to repair or replace, but only in case of not repairing, the defective Product. NKshall contact CSI and inform CSI of the relevant information and request a returned goodsauthorization and CSI shall give a return authorization number. As promptly as possible, but notlater than ten (10) working days after CSI’s receipt of the defective Products, CSI shall repair orreplace the defective Product. CSI shall provide a repair/replacement report together with anyproduct being returned. Each Party shall bear own shipping costs. Title and risk of loss ordamage to the product shall pass to the other party upon delivery to the other party’s carrier.The Parties will agree in advance as to the nature and the amount of the repair or replacementcosts and expenses associated with the defective Product.     5.7 Product Discontinuation. If CSI plans to discontinue manufacturing of any of theProduct from its product line, it shall notify NK about the intended removal in writing at least240 days in advance. CS will make its best commercial effort to provide substitute product ifProduct, as defined in Appendix 1, is discontinued.     5.8 Spare Parts. CSI will make best effort to make compatible spare parts will beavailable on reasonable commercial terms for a period of at least [*] from the delivery by CSI ofthe Product in question. NK understands that there may be no spare parts for the Products otherthan [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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the Products themselves or their replacements. Accordingly, in such cases where spare partsare reasonably required for necessary repair of such Products, CSI shall replace the Product inquestion with replacements that are reasonably acceptable to NK and on reasonable commercial terms.     5.9 Applicable Laws and Regulations.          (a) CSI shall manufacture the Products in compliance with FDA, ISO 9001, the MDD (the CounselDirective 93/42/EEC concerning medical devices promulgated by the Counsel of the EuropeanCommunities as amended) and all other applicable laws and regulations.          (b) CSI shall obtain all necessary regulatory clearances and approval for the Productsincluding FDA, UL and CE, and will assist NK’s efforts to the extent reasonably necessary, inobtaining 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.     5.10 CSI Notification. Notification of quality control and assurance from CSI to NKshall be as set forth in Appendix 5. CSI will indemnify and hold NK harmless from and against anyand all direct damages sustained as the result of CSI’s failure to provide timely notice of Productfailure or defect as detailed in the Appendix 5.**6. ORDERS**     Unless expressly otherwise agreed, all sales under this Agreement shall be between CSI asseller and NK as purchaser.     6.1 NK shall submit to CSI periodic forecasts every three (3) months (4 times per year) of itsanticipated requirement of the Products for the subsequent six (6) month period. The purchaseforecasts are not binding on NK. The forecasts shall be provided in good faith. CSI shall notifyNK of any inability as a result of causes beyond CSI’s control (i.e. Force Majeure) to supplyaccording to NK’s forecasts no later than four (4) weeks prior to the forecast date of shipment andin such case shall inform NK of the maximum amount it is able to supply.     6.2 NK shall order Products from CSI by issuing written purchase orders. Purchase orders (a)for AEDs 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 requestedshipment date.     6.3 In order to initiate the Agreement, NK shall order the following Products and quantitiesfrom CSI:   Item to be ordered Minimum Opening Order QuantityNK-branded AED — modified FirstSavemonophasic version (includesaccessories) [*]   NK-branded AED — biphasic version Order quantity to be determined  upon approval by JMHW) [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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     6.4 Unless otherwise agreed between the Parties, NK may reschedule in writing, delivery of anyProduct on purchase orders with CSI within the following guidelines:   Days from Scheduled Shipment Date: Allowed ChangesAEDs [*] days No changes   AEDs [*] days [*] percent (plus or minus)   AEDs [*] days [*] percent (plus or minus)   Days from Scheduled Shipment Date Allowed ChangesElectrodes [*] days No changes   Electrodes [*] days [*] percent (plus or minus)   Electrodes [*] days [*] percent (plus or minus)     6.5 Every purchase order given by NK will be deemed to be a separate purchase contract underthe terms of this Agreement. Cardiac Science may at its sole discretion refuse to accept or maycancel any outstanding purchase order in the event that any of the following circumstances occurs:(i) CSI determines or a third party claims that any of the Products infringes or misappropriatesits intellectual property; and (ii) any product recall or similar corrective action involving anyof the Products which is required to be reported under the FDA’s Medical Device Reportingrequirements such as 21 CFF Part 803.**7. DELIVERIES**     7.1 Delivery and Shipping. Unless expressly otherwise agreed in writing, all ordersshall be delivered by CSI EXW Irvine, CA, interpreted in accordance with INCOTERMS (2000 Edition).CSI shall use its commercially reasonable efforts to ship the Products with test reports in timefor them to arrive by delivery dates agreed upon in compliance with the ordering proceduredescribed herein. CSI shall notify NK of any anticipated delivery problems in advance, but CSIshall not be responsible for any loss or liability suffered by NK as a result of delay in deliveryor replacement of any order. NK agrees, however, that for shipments destined to locations outsidethe U.S., where transit time is expected to take more than one week, the minimum lead time fororders may be appropriately increased by CSI to reasonably account for such additional transittime. Title and risk of loss to Products purchased under this Agreement shall pass to NK upondelivery thereof to the carrier. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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     7.2 Packaging. Unless NK specifies otherwise, deliveries of the Products shall bemade in CSI’s standard delivery containers, which are reasonably designed to avoid damage duringdelivery and inventory phases. Delivery shall be made to such address as NK specifies in apurchase 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 notinclude any existing or future taxes, tariffs, fees, duties, assessments or other charges (otherthan income taxes assessed on CSI) that may be applicable to the Products supplied to NK pursuantto this Agreement. If such additional sums are required to be withheld, collected, or paid, thenCSI shall add them to the price payable by NK.     7.4 Acceptance. NK shall inspect Products promptly upon receipt at the shippingdestination and may reject any non-conforming Products. Any product not rejected by written noticeto CSI within thirty (30) days of NK’s receipt shall be deemed accepted. Upon reasonable request,CSI shall provide reasonable assistance to NK in order to determine whether any of the Products arenon-conforming. Rejected goods shall be returned freight prepaid by CSI within ten (10) days afterreceipt of a return authorization number from CSI. No returns will be accepted without a returnauthorization number. As promptly as possible, but not later than ten (10) working days afterCSI’s receipt of properly rejected goods, CSI shall, at its option and expense, either repair orreplace properly rejected goods. CSI shall provide a repair/replacement report together with anyproduct being returned. Title and risk of loss or damage to the products shall pass to the otherparty upon delivery to the other party’s carrier. CSI will prepay transportation charges back toNK and shall reimburse NK for any costs of transportation incurred by NK in connection with thereturn to CSI of properly rejected goods. Other than as permitted in this Section or under theterms of the warranty stated herein, goods may not be returned to CSI.     7.5 Failure to Pay Duties. NK shall bear all applicable taxes (such as sales, use orsimilar taxes); all customs, duties, and similar charges; and all personal property taxesassessable on Products after delivery to the carrier at CSI’s plant. In the event of NK’s failureto pay any amounts due CSI within the time herein provided, CSI may, in addition to other remediesavailable to it, cease acceptance and /or delivery of orders for Products from NK until such timeas NK’s payments are current and may thereafter condition acceptance and delivery of future orderson such other or additional payment terms as it shall, in its discretion, determine.     7.6 Inspection. NK may, by itself or through its appointed representative, duringregular business hours and following reasonable notice to CSI, inspect CSI’s physical facilitiesand CSI’s quality control procedures in order to assure compliance with the specifications, qualityrequirements and other applicable standards. In the event that NK determines that the qualityprocedures applied by CSI are insufficient as to ensure consistent acceptable quality, NK shallspecifically inform CSI thereof and of its recommended corrective measures to be undertaken by CSI.CSI agrees to evaluate such recommendation in good faith. CSI agrees to take all appropriatemeasures in order to ensure compliance of its sub-suppliers with the foregoing. Anycircumstance which might lead to modification or cancellation of CSI’s quality certificate(s)or status as an FDA registered manufacturer in good standing, shall be immediately informed to NKin writing. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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**8. PRICES AND TERMS OF PAYMENT**     8.1 Prices. The prices for the Products shall be as set forth in Appendix 2 andunless expressly otherwise agreed by the Parties CSI shall sell and NK shall purchase the Productsduring the Term from April 1, 2002 to March 31, 2003 at those prices. Prices after such term shallbe based upon mutual agreement of the parties.     8.2 Credit. Any credit terms set forth for NK hereunder shall be subject to thecondition that open account credit is established and maintained to CSI’s satisfaction and thatshipment of any delivery will not cause NK to exceed such credit limit as CSI may from time to timeestablish. Unless expressly otherwise agreed in writing, payment for all Products shall be made byNK in US dollars by wire transfer within thirty (30) days from the date of arrival of the Productsat NK’s premises or such other destination as may have been specified in the purchase order. Inaddition to all of the other rights and remedies to which CSI shall be entitled, CSI shall beentitled to interest on overdue payments at the rate of twelve (12) per cent per annum or highestrate permitted by the applicable law, whichever is lower. In the event of NK’s failure to pay anyamounts due CSI within the time herein provided, CSI may, in addition to other remedies availableto it, cease acceptance and/or delivery of orders for Products from NK until such time as NK’spayments are current.**9. CSI REPRESENTATIONS AND WARRANTIES**     9.1 General. CSI’s warranty obligations for the Products supplied by CSI shall be setforth in subsection (a) — (e) below:          (a) CSI represents and warrants that the Products supplied by CSI resulting shall be inaccordance with the specifications and quality requirements specified in this Agreement and for aperiod of fifteen (15) months after delivery by CSI of each Product to NK, such Product, (i) willfunction in accordance with the applicable specifications; and (ii) will be free from defects orfaults in design workmanship and materials;          (b) Product as provided by CSI, and as of the Effective Date, are in compliance with allapplicable requirements of U.S. and Japanese law or regulation. As stated in Section 13.3 herein,CSI will make its best effort to be in compliance with applicable regulatory requirements of otherforeign countries in which the Products may be marketed;          (c) CSI shall maintain quality control procedures in compliance with the requirements of thefollowing quality systems ISO 9001, EN 46001 or ISO 13485, US GMP 21 CFR 820 (“the US GMP”) and theCouncil Directive 93/42/EEC concerning medical devices promulgated by the Council of the EuropeanCommunities as amended (“the MDD”). If requested by NK, CSI shall provide NK with appropriatedocuments evidencing that the Products comply with the essential requirements of the MDD and US GMPproduct standards. CSI grants NK the right, byitself or through its appointed representative, during regular business hours and followingreasonable notice to CSI, to inspect CSI’s physical facilities and CSI’s quality control proceduresin order to assure compliance with the specifications, quality requirements and other applicablestandards as required by JMHW ordinances. In the event that NKdetermines that the quality [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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procedures applied by CSI are insufficient as to ensure consistent acceptable quality, NK shallspecifically inform CSI thereof and of the reasonable corrective measures recommended to beundertaken by CSI. CSI agrees to consider in good faith any such recommended corrective measureswithout delay. CSI agrees to take all appropriate measures in order to ensure compliance of itssub-suppliers with the foregoing;          (d) CSI has good and marketable title, and the right to license or sell the Products free andclear of all liens, security interests and encumbrances;          (e) CSI has the legal capacity to execute this Agreement and to perform its obligationshereunder; and execution and delivery of this Agreement by CSI and performance of its obligationshereunder shall not violate any applicable U.S. laws.     9.2 Remedies. (a) If CSI breaches any of its warranties described in Section 9.1, CSIwill, in its sole discretion, either: (i) repair or replace the Product under the applicablewarranty, or (ii) refund any fees already paid for the non-conforming goods. If CSI decides torepair or replace a Product, NK shall contact CSI and inform CSI of the relevant information andrequest a returned goods authorization. If CSI gives a returned goods authorization, CSI will bearshipping costs in transit in both directions; provided, however, CSI will only bear CSI’s shippingcosts to CSI if NK ships via a carrier designated by NK and directs the carrier bill to CSI. Titleand risk of loss or damage to the Product shall pass to the other party upon delivery to the otherparty’s carrier. CSI shall ship the repaired or replacement Product to NK with repair/replacementreport as promptly as possible, but not later than ten (10) working days after CSI’s receipt of thenon-confirming Products.     9.3 Limitations.          (a) THE EXPRESS WARRANTY PROVIDED IN THIS ARTICLE 9 IS THE SOLE AND EXCLUSIVE WARRANTY GIVENBY CSI WITH RESPECT TO THE PRODUCTS, AND CSI GIVES AND MAKES NO REPRESENTATIONS OR WARRANTIES OFANY KIND, EXPRESS OR IMPLIED, OTHER THAN THE FOREGOING. WITHOUT LIMITING THE GENERALITY OF THEFOREGOING, NO IMPLIED WARRANTY OF MERCHANTABILITY, NO IMPLIED WARRANTY OF FITNESS FOR A PARTICULARPURPOSE, AND NO IMPLIED WARRANTY ARISING BY USAGE OF TRADE, COURSE OF DEALING OR COURSE OFPERFORMANCE IS GIVEN OR MADE BY CSI OR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR PROVISIONOF THE PRODUCTS BY CSI OR NK’S USE OR SALE OF THE PRODUCTS OR NK’s AND CSI’s CONDUCT IN RELATIONTHERETO OR TO EACH OTHER. NO REPRESENTATIVE OF CSI IS AUTHORIZED TO GIVE OR MAKE ANY OTHERREPRESENTATION OR WARRANTY OR TO MODIFY THE FOREGOING WARRANTY IN ANY WAY. THE REMEDIES SET FORTHIN 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 subjectto 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 [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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violation of CSI’s instructions, inconsistent with the Documentation or outside the scope of thelicense granted herein; on which the serial number has been removed or made illegible; or that havebeen modified, disassembled, serviced or reassembled by anyone other than CSI or its authorizedagents.          (c) NK agrees that the warranty, remedies and limitations on liability provided in thisAgreement (subject to the limitations thereon) reflect a bargained-for compromise between CSI andNK 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 anyrepresentations and warranties to its sublicenses, which exceed in scope the representations andwarranties provided by CSI 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 obligationshereunder shall not violate any applicable Japan laws.**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 OFSUCH DAMAGES. THE LIABILITY OF CSI FOR ANY CLAIM CONCERNING PERFORMANCE OR NONPERFORMANCE BY CSIPURSUANT TO, OR IN ANY WAY RELATED TO, THE SUBJECT MATTER OF THIS AGREEMENT, REGARDLESS OF THE FORMOF ACTION, WHETHER IN CONTRACT OR IN TORT, EXCEPT PRODUCT LIABILITY DESCRIBED IN SECTION 12, SHALLBE LIMITED TO THE AMOUNT PAID TO CSI BY NK FOR THE LICENSED AEDs OR REPLACEMENT ELECTRODES, ASAPPLICABLE, IN ACCORDANCE WITH THIS AGREEMENT AND WITH RESPECT TO WHICH LICENSED AED OR REPLACEMENTELECTRODES, AS APPLICABLE, SUCH CLAIM SPECIFICALLY RELATES. IN NO EVENT SHALL CSI BE LIABLE FORDAMAGES CAUSED BY NK’s OR ANY END-USER’S ACT OR OMISSION.**12. PRODUCT LIABILITY**     CSI 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 topersonal injury, illness and/or death if it is established that such damage and/or personalinjuryresulted from i) defect with respect to design, manufacturer, workmanship or materials of [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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the Product; or ii) failure of the Product, at the time of shipment to NK, to comply with the TechnicalSpecifications which is specified in Appendix 3.**13. REGULATORY REQUIREMENTS, RECALLS**     13.1 The Parties confirm that in relation to the JMHW regulatory approvals or submission thatCSI shall be regarded as the manufacturer of the Products and NK as the in- country caretaker.     13.2 The Parties agree to cooperate in order to gain JMHW regulatory approval for the Productsincluding Cardiac Science’s biphasic AED product. For shipments outside of Japan, CSI warrantsthat the Products conform to the requirements established in the MDD for CE marking and will affixthe CE mark to all the Products.     13.3 Each Party shall make its best efforts to comply with all applicable laws and regulationsof the competent jurisdiction in which NK sells its Products. In particular, each Party shallensure that the Products as well as their respective activities in relation thereto conform to alllegislation, 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 theProduct contributed to or caused a death or serious injury or an event where a Product hasmalfunctioned and, if that malfunction occurred again, it could cause death or serious injury. Asused 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 orpermanent damage to a body structure. To be reported a direct link with the Product and itspossible short -comings should be clearly established. Party shall use its best efforts to givesuch notice to the other Party orally within 24 hours from the receipt of such complaint orbecoming aware of such event and shall use its best efforts to confirm such notice by telefaxwithin 24 hours after giving oral notice.     13.5 The Parties shall be responsible for reporting under United States reporting requirementssuch as 21 CFR Part 803, the Japanese Ministry of Health and Welfare and the European Unionreporting requirements and under the reporting requirements of any other country as may beapplicable. Before submitting a report involving a Product either Party shall use its best effortsto notify the other Party and to obtain any information it may have relating to any incidentinvolving a Product. Copies of such reports shall be sent to the other Party without delay. IfJMHW or any governmental authorities require to take any product corrective action (includingnotification, recall, removal and correction) involving a Product in Japan, NK shall use its bestefforts to notify CSI by telefax within 24 hours from the receipt of such information and CSI shallbe responsible to determine the conduction or non-conduction of the correctiveaction within 24hours after the receipt of the information from NK. In case that CSI decides to take anycorrective action for any product in overseas which is substantially the sameas the Product specified herein, the Product sold or distributed by NK in Japan shall also tobe taken corrective action. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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     If FDA or other authorities contact either Party to inquire about or investigate the Productssold under this Agreement, the contacted Party, unless required to maintain confidentiality by suchauthorities, shall inform the other Party immediately thereof. The Parties shall co-operateclosely to clear any regulatory issues or potential regulatory issues promptly.     Notice required by this section 13.4 and 13.5 shall be responsible for each party’s QualityAssurance 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, telefax and title of the person submittingthe information to the other Party,  viii) whether the incidents has already been reported to a FDA or otherauthoritiesby theperson making the report     13.6 In the event CSI decides to take any product corrective action in Japan (includingnotification, recall, removal and correction) with respect to the Product sold or distributed byNK, regardless of whether such action is initiated to comply with applicable laws or regulations orfor other reasons, the Parties agrees that: a) NK shall be the point of contact for purchasers ofits Products (whether directly of through its distributors); b) after discussion between theparties, CSI will “define the action to be taken” and c)during the course of recall of the Product,CSI shall work with NK to provide replacement Product if required by end users customers tominimize any downtime of replacement Product. In such cases, CSI shall provide NK with efficientquantity of replacement Product as soon as possible for NK’s immediate action to end userscustomers and d) CSI shall reimburse NK for direct costs of the type set forth below which are inincurred 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, CSI shall work with NK to provideinvestigation of scope and root cause of the Product failure, and provide a correctiveaction plan for any found cause of the Product failure. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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 ii) Defining the effectiveness check procedure (to establish the corrective action has beencompleted).  iii) CSI shall make every effort to pursue any necessary actions against the Vendor orSupplier responsible for the Product.  iv) If NK submits a corrective action request that accompanies a end users customerreturned Product that requires immediate response, then Seller shall respond with scope ofproblem evidence of registration and initial plan for root cause analysis within 72 hoursof the request.The type of costs reimbursable under d) above are: mailing, telephone, telefax and printingcharges for shipment of the Product to NK back to CSI; and direct labor costs to receive andhandle returned Product and to replace the Product to end users customer. In case that it isnecessary for NK to confirm that Product is manufactured under appropriate manufacturing andquality 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 theother Party any license or intellectual property right, other by implication, estoppel or otherwisein and to its Products, patents, trademarks, documentation and confidential information. Except inthe case of NK’s need to provide authorized service to said Products, NK shall not: (a) reverseengineer, decompile, disassemble or otherwise tamper with the Products; (b) install, integrate,adapt or use the Products except as described in CSI’s documentation; and (c) permit any thirdparty including any of NK’s distributors or end users customers to do any of the foregoing.     14.2 CSI Trademarks. Subject to NK’s compliance with the terms of this Agreement, CSIgrants to NK the non-transferable and non-assignable right to use the trademarks, service marks,trade names, logos or other words or symbols of CSI identifying the Products (the Trademarks”) onNK’s advertising and promotional materials, stationery, signs, labels and packaging in order toconvey that NK is manufacturing Products, equipment or devices which incorporate the Products. TheTrademarks are and shall remain the exclusive property of CSI, whether or not such ownership isspecifically recognized or protected under the laws of the Territory. NK shall acquire no rightsto the Trademarks other than those set forth in this Article, and NK hereby assigns and transfersto CSI all rights other than those granted pursuant to this Section that it may acquire in and tothe Trademarks, whether by operation of law or otherwise. NK shall comply with CSI’s guidelinesfor the use of the Trademarks, and shall allow CSI an opportunity to inspect the Products toconfirm NK’s compliance herewith.     14.3 NK Trademarks. CSI shall not use or refer to NK’s name or trademarks in anyother 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 CSI in connection with the NK name shall besent to NK for approval. [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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     14.4 Infringement. CSI warrants that it is the sole and exclusive owner of, or hasvalid licenses, with the right to sublicense, the Products, in each case free and clear of any andall liens, claims or encumbrances. CSI represents that (i) it has not been determined to beinfringing any patents or other rights with respect to the Products and (ii) no person has assertedthat CSI’s manufacture or sale of the Products anywhere in the world infringes any patent or otherproprietary right of such person.     14.5 Notification. NK shall promptly notify CSI of (a) any claims, allegations ornotification that NK’s sale, offer to sell, license, lease, importation, export, transfer ordistribution 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 ormay be infringing the Intellectual Property Rights of CSI.     14.6 Alteration and Use. NK may not remove or alter any proprietary designs noticesor Marks contained in or on the Products, Documentation or related materials. NK may not make anyreference or claim about CSI or the Products or use any of CSI marks, which have not been approvedor provided by CSI.**15. CONFIDENTIALITY**     15.1 This Agreement and all documents, drawings, manuals and other materials related theretoand transmitted between the Parties, provided that only if it is designated as “Confidential” inwriting when communicated, or within thirty (30) days of disclose, if disclosed orally, shall betreated as confidential by the Parties and their employees and such information shall not bedisclosed to any third party. Without the other Party’s prior written consent, this Agreement andany other materials treated as confidential hereunder may be disclosed by either parties incompliance with governmental regulations and other corporate reporting requirements; provided thatsuch Party has notified the other Party and cooperated in good faith to take such steps as may bereasonably available to protect the confidentiality of the information contained therein to theextent requested by the other Party and as may be allowable by the applicable law. ConfidentialInformation does not include information that: a)at the time of disclosure is already known to thepublic, 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) isindependently developed by recipient without the use of Confidential Information; Each Party shallarrange proper filing for specifications and drawings given by the other Party. Each Party shallnominate a person who shall be in charge of the filing and shall inform this person of theconfidentiality requirements of this Agreement. The parties agree to hold all ConfidentialInformation confidential for a period of two (2) years after the expiration and/or termination ofthe Agreement.**16. CSI INDEMNIFICATION**     16.1 Indemnity. Subject to NK satisfying the conditions of Section 14, CSI shallindemnify and hold NK, its affiliates and their respective directors, officers, employees andrepresentatives harmless from and against any suits, actions, losses, damages and other expensessolely arising [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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out of or in connection with any claim (a) that any authorized use of a Productinfringes 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 aninjunction or court order because of any claim of infringement, CSI will, at its expense, and inits sole discretion, use reasonable commercial efforts to: (a) replace or modify the Product, insuch a manner so as to maintain its functionality and compatibility, but nonetheless make theProducts, as applicable, no longer subject to a claim of infringement; or (b) procure for NK’s orany End-User’s benefit the right to use and resell the Products, as applicable, as provided in thisAgreement. If (a) and (b) above are not commercially viable, CSI shall refund to NK all amountspaid therefore by NK and shall terminate the rights granted herein.     16.3 Exclusion. CSI will have no liability for any claim of indemnity if such claimis based upon: (a) Products that have been modified, disassembled, reassembled, serviced, alteredor changed without the express written authorization of CSI; or (b) the combination, operation, oruse of the Products with software and/or hardware not supplied by CSI, if such liability would havebeen avoided in the absence of such combination, operation or use.     16.4 Entire Liability. This Article 16 states CSI’s entire liability for infringementof any patent or other intellectual rights with respect to the Products     16.5 Conditions. NK shall promptly notify CSI of (i) any matter for which NK mayclaim indemnification, (ii) any claim against NK that any Products misappropriate any trade secretor 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. CSI shall, inits sole discretion, defend or settle any such claim, suit, action or proceeding in any manner andon any terms it shall deem appropriate, and the costs thereof (including any final award ofdamages) shall be borne entirely by CSI. If CSI elects to defend any such suit, action orproceeding, NK shall provide CSI, at CSI’s expense, with all the needed information, assistance andauthority necessary to enable CSI to defend such claim. NK shall not without CSI’s prior writtenapproval itself defend or settle any such suit, action or proceeding.**17. NK INDEMNITY**     17.1 General. NK shall indemnify and hold harmless CSI, its affiliates and theirrespective directors, officers, employees and representatives harmless from any claims, demands,actions, suits, proceedings, judgments, damages, expenses and costs (including reasonable attorneysfees) related to:          (a) Any of its activities under this Agreement, including any third party assertion that theProducts or any component thereof, to the extent they have been modified, disassembled,reassembled, serviced, altered or changed by NK, infringe or misappropriate any patents orcopyrights of such third parties; [*] designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the commission.
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     (b) Death, injury or damage (including death) to any person or property caused by the Productsthat have been subject to modification, alteration or change that NK instructed and/or required toCSI.     17.2 Conditions. CSI shall promptly notify NK of (i) any claim against CSI thatProducts, which have been modified, disassembled, reassembled, serviced, altered or changed by NKor CSI in accordance to NK’s instruction or requirement, misappropriate any trade secret orinfringe any patent, copyright or other intellectual property right of a third party and (ii) anysuit, action or proceeding brought against CSI on the basis of any such claims. NK shall, in itssole discretion, defend or settle any such claim, suit, action or proceeding in any manner and onany 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, CSIshall provide NK, at NK’s expense, with all the needed information, assistance and authoritynecessary to enable NK to defend such claim. CSI shall not without NK’s prior written approvalitself 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) yearsthereafter, CSI and NK shall each carry a reasonable amount of commercial general liabilityinsurance. Insurance is to be maintained by parties pursuant to the provisions of this Articleshall provide for written notice to the other party thirty (30) days in advance of any terminationor cancellation of such insurance. Upon the request of either party from time to time during theterm hereof, each party shall provide the other with a certificate evidencing such insurancecoverage.**19. GENERAL**     19.1 Notices. All notices, requests, demands, waivers and other communicationsrequired or permitted to be given under this Agreement are to be in writing and are deemed to beduly given (a) upon being delivered either personally or by overnight courier with delivery chargesprepaid, (b) upon the fifth (5th) day from the date such notice was mailed by certified orregistered mail, postage prepaid, receipt requested, or (c) upon being sent by telecopy, to thepeople and addresses set forth below or to such other person or address as either party may specifyby notice in writing to the other party. All notices, requests, demands, waivers andcommunications are received on the date of delivery.If to CSI:Cardiac Science, Inc.