(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 usingNK’s own labeling and packaging; provided, however, that NK maintains all CSC Marks and otherproprietary 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 theTerm, NK shall use its best efforts to market, sell and distribute AED 9231 in Japan. NK maysupplement, but not replace, its marketing, sales and distribution of AED 9231s in Japan with themarketing, sales and distribution of AED 1200s that contain circuit boards purchased from CSC underthe OEM Supply and Purchase Agreement dated March 31, 2005 or any successor agreement (the “PartsAgreement”). For the avoidance of doubt, the AED 1200 is referred to in the Parts Agreement as theAED 1x.     1.3 Enforcement. NK shall enforce its obligations under this Agreement with respectto sublicenses granted by NK pursuant to this Agreement and, upon the request of CSC, shallenforce, at NK’s cost, the rights of CSC with respect to any such sublicense and shall cooperatewith CSC, at NK’s cost, in any action by CSC to enforce its rights with respect to any suchsublicense, including by providing to CSC all information and assistance that CSC 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 CSC from enforcing itsrights pursuant to this section.     1.4 Reservation of Rights. Except as expressly provided herein, CSC does not grantto NK any license or Intellectual Property Rights, whether by implication, estoppel or otherwise inand to the Products, CSC Marks and CSC Confidential Information. NK shall not: (a) reverseengineer, decompile, or otherwise tamper with the Products; (b) permit any third party includingdistributors 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 agreesto sell 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 CSC 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 AED 9231s. [*]  Designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the Commission.
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     2.4 NK agrees to pay CSC 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 9231. The Parties will agree inadvance as to the nature and the amount of the NRE costs and expenses associated with theaforementioned modifications.     2.5 All artwork, packages and labels (if any) prepared by CSC in connection with the NK nameshall be sent to NK for approval.     2.6 For convenient reference, certain of the capitalized terms used in this Agreement isdefined in Appendix 4.     2.7 During the Term, NK shall not, directly or indirectly (e.g., through any Affiliate ordistributor), promote, market, sell or distribute any product that directly competes with the AED9231. However, for purposes of this Section 2.7 any automated external defibrillator with a lowerspecification than AED 9231, including but not limited to an AED 1200 that contains circuit boardspurchased from CSC under the Parts Agreement and any automated external defibrillator equivalent orsimilar 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 andcontinues 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 Partywritten notice of termination at least one (1) year prior to the effective date of suchtermination. Either party (the “terminating party”) may immediately terminate this Agreement uponnotice to the other in the event that the other party: (a) breaches any material term of thisAgreement, including the obligation to pay amounts due under this Agreement and such breach is notcured within thirty (30) days after notice from the terminating party; or (b) immediately uponwritten notice to the other party in the event that proceedings in bankruptcy or insolvency areinstituted by or against the other party, or a receiver is appointed, or if any substantial part ofthe assets of the other party is the object of attachment, sequestration or other type ofcomparable proceeding, and such proceeding is not vacated or terminated within thirty (30) daysafter its commencement or institution     3.3 Effect of Expiration or Termination. Upon any expiration or termination of thisAgreement, the following provisions apply: [*]  Designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the Commission.
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          (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 forits actual costs of raw materials and components used to manufacture the Products which CSC 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 CSC forsuch volume of raw materials, components and work-in-process that CSC 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 CSC 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) For a period of up to nine (9) months after the expiration or termination of thisAgreement, 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 useCSC’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. 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.          (e) NK shall have a right to keep providing support for the Product to end user customersafter expiration or termination of this Agreement. For that purpose, CSC shall continue to supplyReplacement Electrodes and all other necessary parts and accessories to NK at its standardpublished dealer prices under such terms that are mutually agreeable to the parties, and NK maysell 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 ofSection 3.2, then, upon CSC’s request, NK shall cooperate and assist CSC to obtain JMHW and anyother regulatory approval required for CSC to directly or indirectly (e.g., through anotherdistributor) promote, market, sell and distribute Products in the Territory after the end of theTerm. Such cooperation and assistance may include, without limitation, the transfer of any suchapprovals held by NK to CSC or its designee.          (g) Neither party shall by reason of the termination or expiration of this Agreement inaccordance with its terms be liable to the other for compensation, reimbursement or damages onaccount 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 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 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 theProducts;     4.2 Documentation and Models. NK shall provide CSC with one copy of the operationsmanuals for each AED 9231 model sold under NK’s trade name. When a manual is revised, a copy ofthe 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 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. CSC OBLIGATIONS**     5.1 Supply. CSC shall provide Products to NK pursuant to the terms and conditionsspecified herein. Notwithstanding the foregoing, CSC 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 [*]  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) any product recall involving any of the Products. CSC shall not be required to provideany 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 resultin a deviation from the description of the Products in the Technical Specifications which isspecified 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 CSC 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. CSC shall provide training on the Products for certain NK’s salespersonnel, engineers or its clinical specialists. CSC’s training on the Products will be providedas reasonably agreed upon by the parties.     5.4 CSC Product Changes. CSC shall inform NK about any material changes ofspecification or any other material changes to the Products at least 180 days prior to theirimplementation. If the proposed modification might affect the performance, quality or functioningof the Products or the approvals, permissions, consents or licenses applicable to them, CSC shallnot modify the Products unless NK has given its consent to the modification in writing. If NKgives its consent to the proposed modification, the modified Products shall replace the priorversion of the Products and the terms and conditions of this Agreement shall continue to apply. Ifthe modified Products are not acceptable to NK, CSC shall, if feasible, continue to deliver to NKunmodified Products. Concerning the Replacement Electrodes, if the modification relates to achange in the gel material, CSC shall provide NK with the modification notice and biocompatibilitydata at least 180 days prior to the proposed date of shipment of the modified ReplacementElectrodes.     5.5 Out of warranty service. With respect to out-of-warranty product returns, CSCshall agree to repair the out of warranty Product for a period of at least seven (7) years from thedate of delivery by CSC of the Product. NK shall contact CSC and inform CSC of the relevantinformation and request a returned goods authorization and upon approval by CSC, CSC shall give areturn authorization number within two (2) days from receiving the request from NK. As promptly aspossible, but not later than ten (10) working days after CSC’s receipt of the out of warrantyProducts, CSC shall to the extent possible repair the out of warranty Product. CSC shall provide areport 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 otherparty’s carrier. CSC shall apply its standard service rate to such out of warranty repairs, unlesscost 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 forconfidential treatment filed separately with the Commission.
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the right to approve in advance the nature and the amount of the repair costs and expensesassociated with the out of warranty Product requiring repairs.     5.6 Product Discontinuation. If CSC 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. CSC will make its best commercial effort to provide substitute product ifProduct, as defined in Appendix 1, is discontinued.     5.7 Spare Parts. CSC will make best effort to make compatible spare parts availableon reasonable commercial terms for a period of at least [*] from the delivery by CSC of the Productin question. NK understands that there may be no spare parts for the Products other than theProducts themselves or their replacements. Accordingly, in such cases where spare parts arereasonably required for necessary repair of such Products, CSC shall replace the Product inquestion 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 CounselDirective 93/42/EEC concerning medical devices promulgated by the Counsel of the EuropeanCommunities as amended) and all other applicable laws and regulations.          (b) CSC shall assist and cooperate with 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.     5.9 CSC Notification. Notification of quality control and assurance from CSC to NKshall be as set forth in Appendix 5. CSC will indemnify and hold NK harmless from and against anyand all direct damages sustained as the result of CSC’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 CSC asseller and NK as purchaser.     6.1 NK shall submit to CSC periodic forecasts every month of its anticipated requirement ofthe Products for the subsequent five (5) month period. The purchase forecasts are not binding onNK. The forecasts shall be provided in good faith. CSC shall notify NK of any inability as aresult of causes beyond CSC’s control (i.e. Force Majeure) to supply according to NK’s forecasts nolater than four (4) weeks prior to the forecast date of shipment and in such case shall inform NKof 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 forconfidential treatment filed separately with the Commission.
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     6.2 NK shall order Products from CSC by issuing written purchase orders. Purchase orders forAED 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 therequested shipment date.     6.3 Unless otherwise agreed between the Parties, NK may reschedule in writing, delivery ofany Product on purchase orders with CSC within the following guidelines:   Days from Scheduled Shipment Date: Allowed ChangesAED 9231s [*] days No changes   AED 9231s –[*] days [*] percent (plus or minus)   AED 9231s –[*] 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)     6.4 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) CSC 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 CSC EXW CSC’s manufacturing plant in Deerfield, WI or another location ofCSC’s choosing, interpreted in accordance with INCOTERMS (2000 Edition). CSC shall use itscommercially reasonable efforts to ship the Products with test reports in time for them to arriveby delivery dates agreed upon in compliance with the ordering procedure described herein. CSCshall notify NK of any anticipated delivery problems in advance, but CSC shall not be responsiblefor any loss or liability suffered by NK as a result of delay in delivery or replacement of anyorder. 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 forconfidential treatment filed separately with the Commission.
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where transit time is expected to take more than one week, the minimum lead time for ordersmay 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 deliverythereof to the carrier.     7.2 Packaging. Unless NK specifies otherwise, deliveries of the Products shall bemade in CSC’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 CSC) 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, thenCSC shall add them to the price payable by NK.     7.4 Acceptance and Non-Conforming Products. All sales of Products to NK shall bedeemed accepted upon shipment by CSC and title to the Products shall pass to NK upon delivery toNK’s carrier. NK shall inspect Products promptly upon receipt at the shipping destination inaccordance with incoming inspection criteria mutually agreed upon by the Parties to determine ifany Products are non-conforming. Upon reasonable request, CSC shall provide reasonable assistanceto NK in order to determine whether any of the Products are non-conforming. Non-conformingProducts may be returned freight prepaid to CSC after receipt of a return authorization number fromCSC. CSC shall issue a return authorization number within two (2) days from receiving informationfrom NK. No returns will be accepted without a return authorization number. As promptly aspossible, 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 shallprovide a repair/replacement report together with any product being returned. Title and risk ofloss or damage to the products shall pass to the other party upon delivery to the other party’scarrier. CSC will prepay transportation charges back to NK and shall reimburse NK for any costs oftransportation 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 maynot be returned to CSC.     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 CSC’s plant. In the event of NK’s failureto pay any amounts due CSC within the time herein provided, CSC 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. [*]  Designates portions of this document that have been omitted pursuant to a request forconfidential treatment filed separately with the Commission.
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     7.6 Inspection. NK may, by itself or through its appointed representative, duringregular business hours and following reasonable notice to CSC, inspect CSC’s physical facilitiesand CSC’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 CSC are insufficient as to ensure consistent acceptable quality, NK shallspecifically 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 appropriatemeasures in order to ensure compliance of its sub-suppliers with the foregoing. Any circumstancewhich might lead to modification or cancellation of CSC’s ISO quality system certificate(s) orstatus as an FDA registered manufacturer in good standing, shall be immediately informed to NK inwriting.**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 Productsduring the Term from the Effective Date to **[*]**at those prices. Prices after **[*]**shall be basedupon mutual agreement of the parties and minimum quantity targets by NK. The Parties shall consultand cooperate to agree upon the prices and minimum quantity targets for each Product to bepurchased by NK under this Agreement during any NK fiscal year (i.e. April 1 to the followingMarch 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 thecondition that open account credit is established and maintained to CSC’s satisfaction and thatshipment of any delivery will not cause NK to exceed such credit limit as CSC 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 CSC shall be entitled, CSC 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 CSC within the time herein provided, CSC 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. CSC REPRESENTATIONS AND WARRANTIES**     9.1 General. CSC’s warranty obligations for the Products supplied by CSC shall beset forth in subsection (a) — (e) below:          (a) CSC represents and warrants that the Products supplied by CSC shall be in accordance withthe specifications and quality requirements specified in this Agreement and free from defects orfaults 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.
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delivery by CSC of each Product to NK. Batteries shall be supplied in accordance with thespecifications and quality requirements specified in this Agreement and shall be warranted for aperiod 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 allapplicable 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 otherforeign countries in which the Products may be marketed;          (c) CSC shall maintain quality control procedures in compliance with the requirements of thefollowing quality systems ISO 13485:2003, US GMP 21 CFR 820 (“the US GMP”) and the CouncilDirective 93/42/EEC concerning medical devices promulgated by the Council of the EuropeanCommunities as amended (“the MDD”). If requested by NK, CSC shall provide NK with appropriatedocuments evidencing that the Products comply with the essential requirements of the MDD and US GMPproduct 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 physicalfacilities and CSC’s quality control procedures in order to assure compliance with thespecifications, 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 toensure consistent acceptable quality, NK shall specifically inform CSC thereof and of thereasonable corrective measures recommended to be undertaken by CSC. CSC agrees to consider in goodfaith any such recommended corrective measures without delay. CSC agrees to take all appropriatemeasures 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 andclear of all liens, security interests and encumbrances;          (e) CSC has the legal capacity to execute this Agreement and to perform its obligationshereunder; and execution and delivery of this Agreement by CSC and performance of its obligationshereunder 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 applicablewarranty, or (ii) refund any fees already paid for the non-conforming goods. If CSC decides torepair or replace a Product, NK shall contact CSC and inform CSC of the relevant information andrequest a returned goods authorization. If CSC gives a returned goods authorization, CSC will bearshipping costs in transit in both directions; provided, however, CSC will only bear CSC’s shippingcosts to CSC if NK ships via a carrier designated by NK and directs the carrier bill to CSC. Titleand risk of loss or damage to the Product shall pass to the other party upon delivery to the otherparty’s carrier. CSC 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 CSC’s receipt of thenon-confirming Products. [*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
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     9.3 Limitations.          (a) THE EXPRESS WARRANTY PROVIDED IN THIS ARTICLE 9 IS THE SOLE AND EXCLUSIVE WARRANTY GIVENBY CSC WITH RESPECT TO THE PRODUCTS, AND CSC 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 CSC OR SHALL ARISE BY OR IN CONNECTION WITH ANY SALE OR PROVISIONOF THE PRODUCTS BY CSC OR NK’S USE OR SALE OF THE PRODUCTS OR NK’s AND CSC’s CONDUCT IN RELATIONTHERETO OR TO EACH OTHER. NO REPRESENTATIVE OF CSC 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 beensubject 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 inviolation of CSC’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 CSC 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 CSC 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 CSC to NK herein.          (b) NK has the legal capacity to execute this Agreement and perform its obligationshereunder;          (c) Execution and delivery of this Agreement by NK and performance of its obligationshereunder 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.
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**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 CSC FOR ANY CLAIM CONCERNING PERFORMANCE OR NONPERFORMANCE BY CSCPURSUANT 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 ANDINFRINGEMENT LIABILITY DESCRIBED IN SECTION 16, SHALL BE LIMITED TO THE AMOUNT PAID TO CSC BY NKFOR THE LICENSED AED 9231s OR REPLACEMENT ELECTRODES, AS APPLICABLE, IN ACCORDANCE WITH THISAGREEMENT 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 ANYEND-USER’S ACT OR OMISSION.**12. PRODUCT LIABILITY**     Notwithstanding anything to the contrary contained herein, CSC agrees to indemnify and hold NKharmless from and against any and all losses, claims, damages, costs and expenses, includingreasonable attorney’s fees, arising out of or relating to personal injury, illness and/or death ifit is established that such damage and/or personal injury resulted from any i) defect with respectto design, manufacture, workmanship or materials of the Product; or ii) failure of the Product, atthe time of shipment to NK, to comply with the Technical Specifications which is specified inAppendix 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 beunreasonably withheld.**13. REGULATORY REQUIREMENTS, RECALLS**     13.1 The Parties confirm that in relation to the JMHW regulatory approvals or submission thatCSC 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.
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     13.2 The Parties agree to cooperate in order to gain JMHW regulatory approval for theProducts 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 markingand will affix the CE mark to all the Products.     13.3 Each Party shall make its best efforts to comply with all applicable laws andregulations of the competent jurisdiction in which NK sells its Products. In particular, eachParty shall ensure that the Products as well as their respective activities in relation theretoconform to all legislation, rules, regulations and statutory requirements existing from time totime.     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, thensuch Party shall use its best efforts to (a) give the other Party notice thereof orally within 24hours from the receipt of such complaint or becoming aware of such event and (b) confirm suchnotice 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 bodyfunction or permanent damage to a body structure, or iii) necessities medical or surgicalintervention to preclude permanent impairment of a body function or permanent damage to a bodystructure. To be reported a direct link with the Product and its possible short -comings should beclearly established.     13.5 The Parties shall be responsible for reporting under United States reportingrequirements such as 21 CFR Part 803, the Japanese Ministry of Health and Welfare and the EuropeanUnion reporting 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 CSC by email within 24 hours from the receipt of such information and CSC shallbe responsible to determine the conduction or non-conduction of the corrective action within acommercially reasonable time and manner after the receipt of the information from NK. In case thatCSC decides to take any corrective action for any product in overseas which is substantially thesame as the Product specified herein, the Product sold or distributed by NK in Japan shall also tobe taken corrective action.     If FDA or other regulatory authorities contact either Party to inquire about or investigatethe Products sold under this Agreement, the contacted Party, unless required to maintainconfidentiality by such authorities, shall inform the other Party immediately thereof. The Partiesshall 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.
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     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, email and title of the person submittingthe information to the other Party,  viii) whether the incidents have already been reported to the FDA or other authorities bythe person making the report     13.6 In the event CSC 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, CSC will “define the action to be taken” and c) during the course of recall of theProduct, CSC shall work with NK to provide replacement Product if required by end user customers tominimize any downtime of replacement Product. In such cases, CSC shall provide NK with efficientquantity of replacement Product as soon as possible for NK’s immediate action to end usercustomers, and CSC 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, CSC 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.  ii) Defining the effectiveness check procedure (to establish the corrective action has beencompleted). [*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
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 iii) CSC 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 user customer returnedProduct that requires immediate response, then Seller shall respond with scope of problemevidence of registration and initial plan for root cause analysis within 72 hours of therequest.The type of costs reimbursable under this Section  13.6 are: mailing, telephone, telefax andprinting charges for shipment of the Product to NK back to CSC; and direct labor costs toreceive and handle returned Product and to replace the Product to end user customers. In casethat it is necessary for NK to confirm that Product is manufactured under appropriatemanufacturing 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 theother Party any license or intellectual property right, whether by implication, estoppel orotherwise 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 anythird 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, servicemarks, trade names, logos or other words or symbols of CSC identifying the Products (theTrademarks”) on NK’s advertising and promotional materials, stationery, signs, labels and packagingin order to convey that NK is manufacturing Products, equipment or devices which incorporate theProducts. The Trademarks are and shall remain the exclusive property of CSC, whether or not suchownership is specifically recognized or protected under the laws of the Territory. NK shallacquire no rights to the Trademarks other than those set forth in this Article, and NK herebyassigns and transfers to CSC all rights other than those granted pursuant to this Section that itmay acquire in and to the Trademarks, whether by operation of law or otherwise. NK shall complywith CSC’s guidelines for the use of the Trademarks, and shall allow CSC an opportunity to inspectthe Products to confirm NK’s compliance herewith.     14.3 NK Trademarks. CSC 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 CSC 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 for confidential treatment filed separately with the Commission.
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     14.4 Infringement. CSC 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. CSC 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 CSC’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 CSC 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 CSC.     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 CSC or the Products or use any of CSC marks, which have not been approvedor provided by CSC.**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. [*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
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**16. CSC INDEMNIFICATION**     16.1 Indemnity. Notwithstanding anything to the contrary contained herein andsubject to NK satisfying the conditions of Section 14, CSC shall indemnify and hold NK, itsaffiliates and their respective directors, officers, employees and representatives harmless fromand against any suits, actions, losses, damages and other expenses solely arising out of or inconnection with any claim that any authorized use of a Product infringes or violates anyIntellectual 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, CSC 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, CSC shall refund to NK all amountspaid 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 claimis based upon: (a) Products that have been modified, disassembled, reassembled, serviced, alteredor changed without the express written authorization of CSC; or (b) the combination, operation, oruse of the Products with software and/or hardware not supplied by CSC, if such liability would havebeen avoided in the absence of such combination, operation or use.     16.4 Entire Liability. This Article 16 states CSC’s entire liability forinfringement 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 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. CSC 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 CSC. If CSC elects to defend any such suit, action orproceeding, NK shall provide CSC, at CSC’s expense, with all the needed information, assistance andauthority necessary to enable CSC to defend such claim. NK shall not without CSC’s prior writtenapproval itself defend or settle any such suit, action or proceeding.**17. NK INDEMNITY**     17.1 General. Notwithstanding anything to the contrary contained herein, NK shallindemnify 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.
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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 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;          (b) Death, injury or damage (including death) to any person or property caused by theProducts that have been subject to modification, alteration or change that NK instructed and/orrequired to CSC.     17.2 Conditions. CSC shall promptly notify NK of (i) any claim against CSC thatProducts, which have been modified, disassembled, reassembled, serviced, altered or changed by NKor CSC 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 CSC 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, CSCshall provide NK, at NK’s expense, with all the needed information, assistance and authoritynecessary to enable NK to defend such claim. CSC 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, CSC 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 Article andshall 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 [*]  Designates portions of this document that have been omitted pursuant to a request for confidential treatment filed separately with the Commission.
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in writing to the other party. All notices, requests, demands, waivers and communications arereceived on the date of delivery.          If to CSC:Cardiac Science Corporation.