**Exhibit 10.1**

 

**CONFIDENTIALCERTAIN INFORMATION HAS BEEN REDACTEDCONFIDENTIAL TREATMENT REQUESTED**

 

**ACCELLENT-CONCEPTUS**

 

**SUPPLYAGREEMENT**

 

This SUPPLY AGREEMENT (the “Agreement”) datedas of June 1, 2009 (the “Effective Date”) is between AccellentInc., a Maryland company with its principal office at 100 Fordham Road,Building C, Wilmington, MA 01887 (“Supplier”), and Conceptus Incorporated, withits principal office at 331 East Evelyn Avenue, Mountain View, CA 94041 (the “Purchaser”).

 

WHEREAS, the Purchaser has developed and designed amedical device and seeks to have such device manufactured for it by theSupplier; and

 

WHEREAS, the Supplier has expertise in themanufacture of medical devices and components and desires to providemanufacturing services for the Purchaser.

 

NOW, THEREFORE, in consideration of the mutualcovenants contained herein, and other good and valuable consideration, thereceipt and sufficiency of which is hereby acknowledged, the parties agree asfollows:

 

# **1.****                                   ****Definitions**.  Unless otherwise defined in this Agreement,as used herein, the following defined terms shall have the meanings given thembelow.

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## 1.1           Affiliate.  “Affiliate”means any entity which directly or indirectly controls, is controlled by, or isunder common control with the referenced party.

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## 1.2           Approved Supplier List.  “Approved Supplier List” has the meaninggiven in Section 3.7.

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## 1.3           Bankruptcy Event. “Bankruptcy Event” means the institution of voluntary or involuntaryproceedings by or against a person or entity in bankruptcy or under anyinsolvency law, or the appointment of a receiver or custodian for such personor entity, or the institution of proceedings by or against such person orentity for corporate reorganization or the dissolution of such person orentity, which proceedings, if involuntary, shall not have been dismissed withinsixty (60) days after the date of filing, or an assignment by such person orentity for the benefit of its creditors.

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## 1.4           Competitor.  “Competitor”means any company that sells a non-surgical female tubal sterilization deviceor process.

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## 1.5           Components.  “Components”has the meaning specified in Section 3.6.1.

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## 1.6           Contract Year. “Contract Year” means one of any of the consecutive twelve (12) monthperiods during the Term, the first of which begins on the Effective Date.

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## 1.7           Controlled Environment Room.  “Controlled Environment Room” shall mean aroom that is used to manufacture Products having a controlled environment tolimit particulate and microorganisms.

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## 1.8           Change in Control. “Change in Control” means the direct or indirect (1) sale or otherdisposition of all or substantially all of Supplier’s assets, or (ii) transferof more than fifty percent (50%) of the outstanding voting interests oreconomic interests of Supplier, provided that an initial public offering ofstock by Supplier shall not constitute a “Change in Control.”

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## 1.9           Delivery Date. “Delivery Date” has the meaning given in Section 3.4.

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## 1.10         Delivery Schedule. “Delivery Schedule” has the meaning given in Section 3.4.

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## 1.11         Event of Default. “Event of Default” has the meaning given in Section 13.

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## 1.12         Forecast.  “Forecast”has the meaning given in Section 3.3.

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## 1.13         Incoming Inspection. “Incoming Inspection” means measuring, examining, and testing thatgauges one or more characteristics of a Product component and the comparison ofsuch component with the specified requirements to determine such component’sconformity to the Specifications.

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## 1.14         Intellectual Property.  “Intellectual Property” has the meaning givenin Section 10.1.

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## 1.15         Intellectual Property Rights.  “Intellectual Property Rights” has themeaning given in Section 10.1.

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## 1.16         Procedures.  “Procedures”has the meaning given in Section 2.1.

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## 1.17         Process.  “Process”means the methods and all referenced procedures used in the manufacture of theProduct.

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## 1.18         Product.  “Products”shall mean the Purchaser products listed on Exhibit A attached to thisAgreement.  New products shall be addedto Exhibit A in accordance with Section 2.2 and such productswill thereafter be deemed included within the definition of Products.

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## 1.19         Product Device Master Record.  “Product Device Master Record” means theProduct Device Master Record for the Product required by the RegulatoryAuthorities, as it may be revised and in effect from time to time.

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## 1.20         Purchase Order. “Purchase Order” means a purchase order for Products in a form providedby Purchaser.

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## 1.21         Purchase Price. “Purchase Price” has the meaning given in Section 3.1.

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## 1.22         Qualified Trainer. “Qualified Trainer” shall mean Manufacturer’s designated individual(s) whocan perform training on manufacturing processes, test methods and/or standardoperating procedures as developed and approved by Purchaser.

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## 1.23         Regulatory Authority. “Regulatory Authority” means the Food and Drug Administration of theUnited States (the “FDA”) or, any successor agency or, if applicable in the 

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## context, the government agency performing thesame regulatory function as the FDA in another country.

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## 1.24         Specifications. “Specifications” means the specifications for the Product as provided inthe Product Device Master Record.

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## 1.25         Term.  “Term”has the meaning given in Section 12.1.

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# **2.****                                   ****SupplyRights**.

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## 2.1           Manufacture and Supply.  Supplier agrees, pursuant to the DeliverySchedule, to procure inventory, which includes raw materials, components andother supplies, and to manufacture, test, assemble, inspect and deliver theProducts pursuant to the Specifications for each such Product.  Supplier recognizes and agrees that the specificmanufacturing site employed for the production of the Products must be approvedand accepted by the Purchaser.  Supplieragrees to provide adequate capacity to meet the volumes agreed by the partiesin accordance with Section 3.4. All materials for use in Products, including but not limited to rawmaterials, supplies, and completed Product will be stored by Supplier in asecure, segregated, and controlled area to prevent theft, loss, degradation ordamage of such materials.  Supplier shallmaintain lot traceability of raw materials, work in process and finishedProduct.  All components used in theProducts shall be processed through Incoming Inspection.  All materials and components that do not meetthe applicable Specifications shall be quarantined and investigated through theSupplier’s non-conformance procedure. Supplier’s personnel responsible for manufacturing, testing, andinspecting Product shall be trained in the Procedures (as defined below) by aQualified Trainer.  Supplier’s qualityassurance personnel shall ensure Products meet Specifications.  Supplier agrees to manufacture Products in aControlled Environment Room (CER), which shall be monitored for particulate andmicrobial control on a quarterly basis. The Incoming Inspection, non-conformance procedure, quality assurance proceduresand other manufacturing, testing, and inspection procedures used by Supplier inconnection with the manufacture of the Products are collectively the “Procedures.”All Procedures, and any changes thereto, must be approved by Purchaser prior totheir use by Supplier.  Purchaseracknowledges that Supplier is in the business of providing contractmanufacturing services to the medical device industry and, subject to the termsof this Agreement, reserves the right to supply, develop, manufacture, sell, resell,or carry-on similar activities to any third party, including competitors of thePurchaser.  The Products will be producedin Supplier’s Juarez Mexico facility.

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## 2.2           Purchase Requirements.  Subject to the terms and conditions of thisAgreement, Supplier may terminate this Agreement pursuant to Section 13.1(d)if Purchaser does not purchase a minimum quantity of [***] Products in thefirst Contract Year, [***] Products in the second Contract Year, and [***]Products in the third Contract Year.  NewProducts shall be added to Exhibit A only upon mutual agreement ofpricing for such New Product.

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### [***] Confidential information in this Exhibithas been omitted and filed separately with the Commission.  Confidential treatment has been requestedwith respect to the omitted portions.

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### 2.2.1.       Purchase Requirements for Certain NewProducts.  The terms set forth inthis agreement will apply to the Products listed on Exhibit A as ofthe Effective Date as well as Purchaser’s ESS405 and the ESS505 products addedin accordance with Section 2.2 (“New Products”).  The parties shall use reasonable efforts todetermine the price of the ESS405 and ESS505 products within thirty (30) daysafter Supplier’s receipt of new product specifications from Purchaser (“ReviewPeriod”).  The parties expect that thepurchase price for the New Products will be the same as or similar to thepurchase price for the Products that are set forth on Exhibit A as of theEffective Date (“Existing Products”), subject only to changes in theSpecifications, component manufacturing processes, assembly processes,purchased materials, New Product volumes or testing procedures of the NewProducts from any existing Products.

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# **3.****                                   ****PurchaseOrders, Prices, Terms, Delivery, Forecasts**.

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## 3.1           Purchase Price. The purchase price for each Product purchased from Supplier shall be asset out on Exhibit B (“Purchase Price”) and shall be due andpayable no later than thirty (30) days from the date of the invoice for suchProduct.  Invoices shall be dated thedate the applicable Products are shipped. The price for Products during the Term and assumptions upon which theyare predicated shall be as defined in Exhibit B and the following: (i) atany time, in the event of increases in the amount of five percent (5%) or morein the market price of raw materials, components or packaging materialspurchased by Supplier from vendors on the Approved Supplier List in order tomanufacture the Products (collectively, “Materials”) the Supplier shallnotify Purchaser of such increase and the parties shall discuss methods tomitigate such increase, including the use of alternate vendors, provided thatto the extent the parties are unable to mitigate such increase Supplier maypass the incremental increase through to Purchaser (with no markup); (ii) Suppliershall notify Purchaser of, and pass through to Purchaser, any decreases in theprice of Materials that equal or exceed five percent (5%).  In addition to the Supplier’s other rightsand remedies, Supplier may elect to charge interest at the rate of 10% perannum or the highest rate permitted under applicable law, whichever is lower,on any undisputed amount of the Purchase Price not paid when due under thisAgreement:

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### 3.1.1.       Gainsharing.  Supplier and Purchaser shall use best effortsduring each Contract Year to work together to put forth proposals with respectto Changes (as defined below) that, if implemented, would reduce the price ofthe Product to Purchaser.  The parties’non-binding targeted goal is a [***] percent  Change duringsuch Contract Year.  The parties agree tothe following gainsharing terms: (i) if the parties share the cost of anyProduct engineering changes, process improvements, and procurement or alternatesourcing activities (collectively, “Changes”) that result in a costreduction, the amount of such cost reduction will be shared by the Supplier andPurchaser, with each receiving [***] percent of such cost reduction afterimplementation of the Changes, provided that mutually agreed, nonrecurringexpenses associated with such cost reductions will be retired by the partybearing such expenses prior to sharing, and (ii) if Purchaser (A) paysthe entire cost of any Changes (including the amount of any capital expenses orthe cost of any capital equipment used in the Product assembly process), or (B) suggestsprocess improvements that do not have implementation costs, Purchaser shall realizethe entire amount of any cost reduction resulting from such Change in the formof a lower Product price, and (iii) cost reductions related tomanufacturing, site, process, labor or material improvements undertaken andpaid for independently 

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### by Supplier will benefit Supplier entirely,where allowed by applicable regulation and quality standards.  In all cases where Purchaser is entitled toprice reductions in accordance with this Section 3.1.1, suchreductions will be realized by Purchaser in the form of a lower price(including both the base Product price and the Product price after any rebatesare applied in accordance with Exhibit B).

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### 3.1.2.       Rebates.  Purchaser may be eligible for a rebate asdetailed in Exhibit B.

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## 3.2           Orders, Shipping Terms, and Inconsistencies.  Supplier shall pack all Products for shipmentin accordance with Purchaser’s Specifications and otherwise in a commerciallyreasonable manner to protect against damage. All shipments of Products shall be F.O.B.  Supplier’s facility, and shall be accompaniedby a packing slip which describes the Products and states the Ordernumber.  Title to and all risk of loss ordamage concerning the Products shall pass to Purchaser immediately upon thesooner of delivery of the Products to either (i) the Purchaser, (ii) acommon carrier or (iii) any private carrier designated by Purchaser (ordesignated by Supplier and approved by Purchaser) for shipment to Purchaser’sdesignated point of delivery.  Purchaser’srejection of any Products purchased hereunder shall not shift any risk forthose Products until they are returned to and received by Supplier pursuant toSupplier’s written instructions.  Ifthere is any conflict or inconsistency between this Agreement and any PurchaseOrder confirmation, acceptance or any similar document, the terms of thisAgreement shall govern and control.

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## 3.3           Forecasts. On the first day of each calendar quarter, Purchaser shall provideSupplier with an updated Product forecast (“Forecast”) that reflectsPurchaser’s estimated aggregate purchase requirements of Product for thesubsequent twelve (12) month period.

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## 3.4           Purchase Orders. Purchaser may from time to time provide Supplier with a purchase orderthat covers a three (3) month time frame with specific quantities of Product tobe delivered to Purchaser on specific Delivery Dates (as defined below), whichdates and quantities will be mutually agreed to by the parties, provided thatSupplier shall accept all Purchaser purchase orders (including the deliverydates and quantities specified therein) that specify order quantities that arewithin one hundred and ten percent (110%) of the Product quantities specifiedin the Forecast for the applicable period. The Purchaser shall update such purchase order monthly to maintain atall times a total of three (3) months of Product requirements under a purchaseorder by including, on the first of each new month, an additional one (1) monthof Product requirements to the end of such three (3) month timeframe.  Supplier shall confirm all Product quantitiesand delivery dates specified on purchase orders provided by Purchaser withinthree (3) days after receipt of each such purchase order.  The schedule of agreed upon (subject toSupplier’s obligation to accept purchase orders within one hundred and tenpercent (110%) of the applicable Forecast) Delivery Dates and quantities ofProducts to be delivered on such dates shall become the delivery schedule (“DeliverySchedule”).  Supplier shall supplythe quantities of Product meeting the Specifications on the date detailed inthe Delivery Schedule for such Products (the “Delivery Date”).

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## 3.5           Notice of Anticipated Failure to Make Timely Delivery.  The Supplier will notify the Purchaser in theevent that Supplier becomes aware that the Supplier will not be able to makedelivery of Products by the dates required by Section 3.4.

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## 3.6           Purchaser-Supplied Components.  In the event Supplier has a shortage ofcomponents for Products, Purchaser may, at its discretion, supply components toSupplier at Supplier’s expense upon the written consent of Supplier and only insuch amounts as are necessary for firm orders then placed by Purchaser.  Such components, including provision forfailed parts, shall be delivered to Supplier not later than four (4) weeksprior to the scheduled Delivery Date for the related Products toPurchaser.  Should Purchaser be unable tomeet Purchaser’s requirements for delivery of Products, Purchaser may at itsoption require Supplier to either: (i) ship Products to Purchaser absentthe missing components on or after seven (7) days from the scheduled DeliveryDate; or (ii) hold the Products pending receipt of such components fromPurchaser.  Under these circumstances,Purchaser will give written notification to Supplier prior to the scheduledDelivery Date.  Nothing in this Section relievesSupplier of its other obligations under this Agreement.

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### 3.6.1.       Supplier Component Sales.  Supplier will supply components (“Components”)to Purchaser for use by Purchaser or Purchaser subcontractors at the prices in Exhibit BChart 3.  On the first day of eachcalendar quarter, Purchaser shall provide Supplier with an updated Componentforecast that reflects Purchaser’s estimated aggregate purchase requirements ofComponents for the subsequent twelve (12) month period.  Purchaser may from time to time provideSupplier with a purchase order that covers a three (3) month time frame withspecific quantities of Components to be delivered to Purchaser on specificDelivery Dates, which dates and quantities will be mutually agreed to by theparties, provided that Supplier shall accept all Purchaser purchase orders(including the delivery dates and quantities specified therein) that specifyorder quantities that are within one hundred and ten percent (110%) of theProduct quantities specified in the Component forecast for the applicableperiod.  The Purchaser shall update suchpurchase order monthly to maintain at all times a total of three (3) months ofComponent requirements under a purchase order by including, on the first ofeach new month, an additional one (1) month of Component requirements to theend of such three (3) month timeframe. Supplier shall confirm all Component quantities and delivery datesspecified on purchase orders provided by Purchaser within three (3) days afterreceipt of each such purchase order. Component pricing will be renegotiated annually, at the end of eachContract Year.  If the parties cannotagree on a new price for a Component at the end of a Contract Year, the pricefor such Component shall be the same as the price for such Component during theprevious Contract Year.  Quantitiesavailable to Purchaser at these prices are subject to minimum unit volumerequirements for Products shown in Exhibit B Chart 1, RebateQualification.

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## 3.7           Approved Supplier List.  Purchaser shall provide a bill of materialsand approved supplier list (“Approved Supplier List” or “ASL”)for each Product to be manufactured hereunder. Supplier shall manufacture the Products using components obtained solelyfrom vendors included on the ASL, as it may change from time to time, asapproved by Purchaser.  The ASL shall notbe amended without prior written approval of Purchaser.  If Supplier desires to use a supplier fromSupplier’s own list of approved suppliers, Supplier shall provide Purchaserwith a written proposal describing the reasons to use such supplier.  Purchaser may accept or reject the proposal,which acceptance or rejection shall not be unreasonably withheld.  If Purchaser accepts the proposal, theproposed supplier will be subject to evaluation and approval processes approvedby Purchaser.  Supplier will not orderany materials or components for the Products from such supplier until Purchaserhas provided written approval to make such orders.  Any increased costs associated with acomponent that must be purchased from a supplier on the Approved Supplier List,whether for a 

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## regulated component or not, will be paid byPurchaser (i.e.  a substandard qualitycomponent causes increased scrap rates, inspections, and extra labor for whichSupplier will not be liable); provided that (i) Supplier documents andreasonably demonstrates to Purchaser the cause of the increased cost and howSupplier’s use of an alternate qualified supplier (“Alternate Supplier”)for such component would eliminate such cost, (ii) Purchaser determines inits reasonable discretion that the Alternate Supplier is qualified tomanufacture the component in accordance with the applicable specifications andall regulatory requirements, and (iii) Purchaser chooses not to includethe Alternate Supplier on the Approved Supplier List for such component despitesuch determination.

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## 3.8           Quarterly Review. The parties agree to establish a quarterly business review processpursuant to which the parties will review (either in person, by telephone,video conference or other mutually agreeable means) Product quality, cycletime, manufacturing capacity, delivery, market conditions, and any othermatters or concerns relevant to this Agreement. Each party shall bear its own costs and expenses related to the quarterlybusiness review.

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## 3.9           Excess and Obsolete Inventory.

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### 3.9.1.       If Purchaser cancels a Product orderspecified in the Delivery Schedule less than thirty (30) days prior to theapplicable Delivery Date, Purchaser shall be responsible for the Purchase Priceof the Products specified in such order unless otherwise agreed by the parties.

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### 3.9.2.       Purchaser shall be responsible for anynon-returnable inventory (including finished Products, work-in-process,components, or raw material) or non-cancelable orders for components or rawmaterial that are rendered excess or obsolete (as determined in Supplier’sreasonable discretion) (collectively, “Excess Inventory”) to the extentsuch Excess Inventory is caused by (a) Purchaser’s cancellation of orderswith shipment dates specified in the Delivery Schedule between thirty (30) andone-hundred and twenty (120) days from the date of cancellation, (c) engineeringchange orders agreed by the parties, (d) the end of a Product’s life, or (e) thetermination or expiration of this Agreement (excluding termination of theAgreement by Purchaser in accordance with Section 5.2 or Section 13.1,in which case Purchaser shall not be responsible for any Excess Inventory),provided that in each case (a) through (e) above the Excess Inventorycannot reasonably and without material cost to the Supplier be utilized onother Supplier products or returned to its suppliers.  The cost to Purchaser of the Excess Inventorydescribed above shall be the Purchase Price for finished Products and the Supplier’sburdened cost (including labor (if expended), storage, and documentedrestocking charges paid by Supplier to its suppliers, but excluding a mark-up)for all other items Supplier shall provide Purchaser an invoice that itemizesand describes in reasonable detail the foregoing charges with respect to ExcessInventory and the reasons Supplier cannot avoid such charges within thirty (30)days after the event described in subsections (a) through (e) abovethat gave rise to such charges.  In noevent shall Purchaser’s responsibility for charges with respect to ExcessInventory exceed an amount equal to the total Purchase Price for the quantityof Products on the then current three (3) month purchase order .

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# **4.****                                   ****Changesto Specifications****.**

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## 4.1           Changes by Purchaser.  If the Purchaser desires to change theSpecifications, it will notify the Supplier of such proposed change inwriting.  Within thirty (30) daysfollowing receipt of 

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## such a notice from the Purchaser, theSupplier shall notify the Purchaser of the cost of implementing such change andthe impact such a change would have on the Purchase Price and the manufacturinglead-time.  The Purchaser will then notifythe Supplier in writing whether it wants to implement such change taking intoaccount the implementation costs and the manufacturing lead time and PurchasePrice impact.  Specifications for anychange to the Product shall be finalized by the Purchaser in a mutually agreedto time-frame prior to the placement of the first order for each Product to bemanufactured with such changed Specifications. After approval by the Purchaser, such change shall then become part ofthe Specifications.

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## 4.2           Changes by Supplier to Specifications or Process.  No changes to the Specifications shall bemade by the Supplier without the prior written approval of the Purchaser.  Supplier shall not make any changes to themanufacturing process which may require the submission of any amendment, filingor other documentation with any Regulatory Authority unless such change hasbeen identified, reviewed and approved in writing by the Purchaser.  The Purchaser shall provide a response to anysuch proposed changes as soon as is practicably possible after receipt.

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# **5.****                                   ****Qualityand Regulatory Matters**.

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## 5.1           Facility Reviews. The Purchaser or its designee shall have the right, upon reasonableadvance written notice and during regular business hours, to inspect thefacilities being used by the Supplier for production of the Products solely toconfirm that such facilities are adequate to meet the requirements of thisAgreement, the Regulatory Authority, ISO13485, and any applicable successors tothose ISO requirements.  Supplier shallreasonably cooperate with Purchaser and its designee with respect to suchinspections.  If any such inspectionreveals that the manufacturing facilities do not satisfy such requirements,then the Purchaser shall provide written notice of such fact, which notice shallcontain in reasonable detail the deficiencies found in the manufacturingfacilities and, if practicable, those steps the Supplier should undertake inorder to remedy such deficiencies.  Anyinspection made by the Purchaser under this section shall occur no morefrequently than once each calendar quarter (unless otherwise required by law,including by direction of the Regulatory Authority) and shall be designed tocause the least amount of disruption to the operations of the Supplier as isreasonably possible.  Such inspectionsshall be limited to the manufacture of Products, and shall not include anytrade secrets or other confidential information unless the Purchaser and itsdesignee (if applicable) has signed a confidentiality agreement reasonably satisfactoryto the Supplier.

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## 5.2           Remedying Deficiencies.  The Supplier shall be responsible forremedying any deficiencies identified by the Purchaser under Section 5.1at Supplier’s cost and expense within sixty (60) days following written noticefrom the Purchaser.  With respect to anysuch inspections for which any deficiencies are not capable of being remediedby the Supplier within sixty (60) days of the notification thereof, then theSupplier and the Purchaser shall discuss in good faith a corrective action planwhich will enable the Products to be supplied in accordance with this Agreementuntil such deficiencies are remedied.  Ifthe parties are unable to reach agreement after an additional sixty (60) daysas to such alternative manufacturing arrangements, then the Purchaser shallhave the right to terminate this Agreement upon written notice to the Supplier.

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## 5.3           Records.  TheSupplier will maintain its records with respect to the manufacture of theProducts for ten (10) years after the date of manufacture of the last Productunder this Agreement, after which Supplier shall transfer such records toPurchaser.

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## 5.4           Medical Device Reporting.  Purchaser shall be responsible to reportevents in compliance with FDA Medical Device Reporting Regulation set forth in21 CFR Part 803 and any applicable international regulations.  Purchaser agrees to make Medical DeviceReports available to Supplier within three (3) days of the initial receipt ofany report that reasonably suggests that one of the Products (i) may havecaused or contributed to a death or serious injury or (ii) hasmalfunctioned.

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## 5.5           Notices from Regulatory Authorities.  A party receiving (the “RegulatoryReceiving Party”) communications from any Regulatory Authority, includingany FDA Form 483 Report on Inspectional Observations or equivalent notice,shall provide to the other party within twenty-four (24) hours copies of anysuch communications it receives related to the Products.

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## 5.6           Permits, etc. The Purchaser shall obtain, at the Purchaser’s sole expense, allpermits, licenses, approvals, consents, and authorizations from allgovernmental authorities as may be necessary or appropriate to market, solicitorders for, and sell the Products.

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## 5.7           Product Complaints. In reviewing customer complaints concerning the Products, the Purchasershall be considered the “manufacturer” for regulatory purposes, and shall receiveand log all complaints from customers using the Products.  If after evaluation by the Purchaser of thecomplaints, the Purchaser reasonably believes that a complaint relates to abreach by the Supplier of the warranty contained in Section 6.1,the Purchaser will forward the complaint and the related Product to theSupplier.  The Supplier will thenevaluate the complaint.  If the Productdoes not comply with the warranty contained in Section 6.1, thenthe Supplier shall be responsible to remedy the noncompliance as provided in Section 6.2.  If the Product complies with the warrantycontained in Section 6.1, then (i) the Supplier will returnthe Product to the Purchaser with the Supplier’s evaluation, and the costs ofshipping the Product between the Purchaser, the Supplier, and the customershall be the Purchaser’s responsibility; and (ii) to the extent theSupplier’s investigations of the complaints repeatedly result in Products thatdo not breach the warranty and impose an unreasonable financial burden on theSupplier, then the parties will review the circumstances and attempt to makethe Supplier whole with respect to such burden.

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## 5.8           Sterilization services.  Sterilization services with respect to anyProduct will be provided only if requested by Purchaser and will only beperformed by a third-party supplier approved by Purchaser and solely atPurchaser’s expense.  With respect to anysuch sterilization services, Supplier and Purchaser will jointly review thesterilization protocol and report, which will include the results of thesterilization validation/revalidation. Purchaser will have final approval responsibility for all sterilizationdocumentation (and the services provided thereunder) and is ultimately responsiblefor verification and certification of product sterility.  Supplier and Purchaser will define the termsof the product transfer and mutually agree to the terms of sterile lot release.

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## 5.9           Certain Quality Requirements.  Without limiting its other obligations underthis Agreement, Supplier shall comply with the quality requirements set forthin Exhibit C.

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# **6.****                                     ****ProductWarranty and Limited Remedies; Customer Complaints**.

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## 6.1                                 Warranty.  The Supplier warrants that each Product andeach Component shall materially comply with the Specifications for a period oftwo (2) years following the date of its shipment, provided that thiswarranty shall not apply to non-conformities and shall be void to the extentsuch non-conformities are not caused by Supplier’s or Supplier’s agents’ acts oromissions.

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## 6.2                                 Remedies.  If any Product does not conform to thewarranty stated in Section 6.1 above, the Supplier shall, at Purchaser’soption, within ninety (90) days repair or replace such Product or Component atthe Supplier’s own expense, and ship such repaired or replacement Product orComponent back to either the Purchaser or the applicable customer at theSupplier’s own expense, or credit to the Purchaser the Purchase Price for theProduct or Component.  The foregoingwarranty, and the remedies provided for in this Section 6.2, areexpressly conditioned upon (i) Purchaser providing Supplier with promptwritten notice of any nonconforming Product or Component prior to theexpiration of the warranty period, which notice must identify with particularitythe non-conformity, and (ii) Purchaser’s full cooperation with Supplier inall reasonable respects relating thereto. All defective Products or Components which are covered by the foregoingwarranty shall be shipped to the Supplier at its expense for such repair orreplacement.

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## 6.3                                 Exclusions FromWarranty.  Thewarranty set forth in Section 6.1 above does not include Productsthat have defects or failures resulting from Purchaser’s design of the Products(as such design is described in the design history record of the Product).  Purchaser bears all design responsibility forthe Product.

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## 6.4                                 Product Recalls.  In the event of a Product or Component recallcaused by Supplier’s breach of the warranty provided in Section 6.1,Supplier shall at its cost and expense replace all Product or Component lotsrecalled (regardless of the number of nonconforming Products or Components, ifany, in such lots), and pay any associated transportation costs with respect tosuch lots.  Without limiting Supplier’sliability under Sections 7.1(i) and 7.1(ii), the foregoingrepresents Supplier’s sole obligation with respect to Product or Componentrecalls.

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## 6.5                                 LIMITATIONS.  THE WARRANTY PROVIDED IN SECTION 6.1ABOVE IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS.  ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED,INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY ANDFITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED.  EXCEPT WITH RESPECT TO EACH PARTY’SCONFIDENTIALITY OBLIGATIONS UNDER SECTION 11, NEITHER PARTY WILL UNDER ANYCIRCUMSTANCES BE LIABLE FOR ANY PUNITIVE, SPECIAL, INCIDENTAL, OR CONSEQUENTIALDAMAGES, INCLUDING LOST PROFITS OR REVENUES; AND EXCEPT WITH RESPECT TO EACHPARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 7, NEITHER PARTY’SAGGREGATE LIABILITY UNDER THIS AGREEMENT, WHETHER BASED UPON CONTRACT, TORT, OROTHERWISE, SHALL EXCEED THE ACTUAL AMOUNTS PAID BY PURCHASER FOR PRODUCTSDURING THE IMMEDIATELY PRECEDING TWELVE (12) MONTH PERIOD FROM WHEN THE CLAIMFOR LIABILITY AROSE, REGARDLESS OF WHETHER THE PRODUCTS WERE PURCHASED DURINGSUCH PERIOD UNDER THIS AGREEMENT..

##  

## 10

## 

##  

**CONFIDENTIALCERTAIN INFORMATION HAS BEEN REDACTEDCONFIDENTIAL TREATMENT REQUESTED**

##  

## 6.6                                 Disputes.  If the Supplier disagrees with a claim that aProduct does not conform to the warranty provided in Section 6.1,then the parties agree to submit the disputed Product to an independent partywhich has the capability of testing the Product to determine whether or not itdoes so conform.  In the event theparties cannot agree upon such independent party, or in the event it is notpossible to acquire the services of such an independent party, then suchdispute shall be resolved pursuant to Section 14.11.  The cost of the independent testing partyshall be borne by the party against whom the testing party finds, as directedby the testing party.

##  

# **7.****                                     ****Indemnification**.  In order to distribute between themselves theresponsibility for third party claims arising out of this Agreement, and exceptas otherwise specifically limited or provided for herein, the parties agree asset forth in Sections 7.1  through 7.3below:

#  

## 7.1                                 By Supplier.  The Supplier agrees to indemnify, defend andhold the Purchaser harmless against any and all claims, suits, proceedings,expenses, recoveries and damages of or by third parties, including court costsand reasonable attorneys fees and expenses, to the extent they arise out of,are based on, or are caused by (i) any material breach by the Supplier ofits warranty provided in Section 6.1, which breach causes bodilyharm, death, or property damage, (ii) the willful misconduct or grossnegligence of the Supplier, or (iii) any claim of infringement of anyIntellectual Property Right of any third party based upon or arising out of theSupplier’s manufacturing processes with respect to the Products except for anysuch processes that were provided to Supplier by Purchaser and which Purchaserrequired Supplier to use in writing.  ThePurchaser will promptly notify the Supplier of any such claim or demand whichcomes to its attention.

##  

## 7.2                                 The Purchaser.  The Purchaser agrees to indemnify, defend andhold the Supplier harmless against any and all claims, suits, proceedings,expenses, recoveries, and damages of or by third parties, including court costsand reasonable attorneys fees and expenses, to the extent they arise out of,are based on, or are caused by (i) defects or alleged defects in thedesign of the Products, (ii) any allegation or claim that the design forthe Products infringes upon the Intellectual Property Rights of third parties, (iii) statements,whether written or oral, made or alleged to be made by the Purchaser or itsAffiliates or any other party on the packaging or labeling of any of theProducts, or in the advertising, publicity, promotion, or sale of any of theProducts, (iv) the storage, sale, shipment, promotion, or distribution ofthe Products (except to the extent that such claims are covered by Supplier’sindemnity in Section 7.1), (v) the use or operation of theProducts (except to the extent that such claims are covered by Supplier’sindemnity in Section 7.1), or (vi) any allegation or claimthat the Products are not sterile.  TheSupplier will promptly notify the Purchaser of any such claim or demand whichcomes to its attention.

##  

## 7.3                                 General.  The party claiming indemnity (the “IndemnifiedParty”) shall provide the party from whom indemnity is being sought (the “IndemnifyingParty”) with reasonable assistance, at the Indemnifying Party’s expense, inconnection with the defense of the claim for which indemnity is beingsought.  The Indemnified Party mayparticipate in and monitor such defense with counsel of its own choosing, atthe Indemnified Party’s cost; however, the Indemnifying Party shall have theright to assume and conduct the defense of the claim with counsel of its choiceand shall retain final decision-making authority with respect to the conduct ofthe defense.  The Indemnifying 

##  

## 11

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##  

## Party shall not settle any claim without theprior written consent of the Indemnified Party, not to be unreasonablywithheld, unless the settlement involves only the payment of money by theIndemnifying Party.  So long as theIndemnifying Party is actively defending the claim in good faith, theIndemnified Party shall not settle any such claim without the prior writtenconsent of the Indemnifying Party.  Ifthe Indemnifying Party does not assume and conduct the defense of the claim asprovided above, (i) the Indemnified Party may defend against, and consentto the entry of any judgment or enter into any settlement with respect to theclaim in any manner the Indemnified Party may deem reasonably appropriate (andthe Indemnified Party need not consult with, or obtain any consent from, theIndemnifying Party in connection therewith) and (ii) the IndemnifyingParty will remain responsible to indemnify the Indemnified Party as provided inthis Section 7.

##  

# **8.****                                     ****Insurance**.

#  

## 8.1                                 Each partyagrees to procure and maintain in full force and effect during the term of thisAgreement and for three years thereafter valid and collectible insurancepolicies in connection with the supply and sale of Products pursuant to thisAgreement and provide; (i) for commercial general liability coverage inthe amount of $1,000,000 each occurrence and $2,000,000 general aggregateexcluding Products and Completed Operations coverage and written on anoccurrence basis and, (ii) Products and Completed Operations coverage inthe amount of $5,000,000 per occurrence, $10,000,000 in the aggregate andwritten on a claims made basis.  Suchpolicies shall endeavor to provide for thirty (30) days written notice ofcancellation to the other party.  Uponeither party’s request, the other party shall provide to the requesting party acertificate of insurance coverage.

##  

# **9.****                                     ****Trademarks;Use of Supplier Name**.

#  

## 9.1                                 Trademarks.  For purposes of this Section 9.1,“Trademark” shall mean the Purchaser’s trademarks that are associatedwith the Products and which are approved by Purchaser for use by Supplier inthe manufacture of the Products.  Inconsideration of the fees set forth herein, Purchaser further grants toSupplier a non-exclusive license during the Term to use the Trademarks on andsolely in connection with the manufacture of the Products, and for this purposeto affix, subject to Purchaser’s prior written approval, the Trademarks to oron the Products and to or on any packaging materials used in connection withthe Products.  Any and all uses of theTrademarks shall be subject to the prior written approval of Purchaser.  Supplier shall not remove trademark noticesfrom any Product or component thereof without the prior written consent ofPurchaser.  Supplier shall not use thename, Trademarks or logos associated with the Products in its business name orin any manner other than as specified in this Section.  Purchase shall have and retain ownership ofall Trademarks.  The Purchaser acknowledgesthat such trademark ownership rights do not extend to the Supplier’sproprietary formulae, processes, or other written proprietary information thatSupplier has trademark ownership or rights to as of the Effective Date.

##  

## 9.2                                 Use of Name.  Unless legally required by applicable law,neither party shall use the other party’s name in its advertising or elsewhere,without the prior written approval of the other party.

 

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# **10.****                              ****IntellectualProperty; Tooling**.

#  

## 10.1                           IntellectualProperty Rights Generally.  Eachparty shall retain sole ownership of, and all Intellectual Property Rights to,any Intellectual Property of any kind owned by that party as of the EffectiveDate.

##  

## 10.2                           SupplierTechnology.  “SupplierTechnology” shall mean all Intellectual Property Rights, assembly techniquesand related know-how developed or otherwise owned by Supplier and used in theassembly of the Products.  For theavoidance of doubt, “Supplier Technology” shall not include—and this Agreementshall not confer upon Purchaser any right or license to use—any techniques andrelated know-how associated with any component manufacturing processes that precedethe assembly of the Products.  For thefurther avoidance of doubt, and by way of example and not of limitation, “SupplierTechnology” shall not include—and this Agreement shall not confer uponPurchaser any right or license to use—the following confidential manufacturingtechniques, which shall remain the sole and exclusive property of Supplier:

##  

·                  Nitinol CoilWinding process

·                  Stainless SteelCoil Winding process

·                  Nitinol etching

·                  Core wire(delivery wire) tapering

 

## 10.3                           PurchaserTechnology.  “PurchaserTechnology” shall mean Confidential Information that is the property ofPurchaser and also all inventions, designs, drawings, specifications, andknow-how related to the Products, all improvements to the Products (whetherdeveloped by Purchaser or Supplier, or jointly by the parties), and allIntellectual Property Rights related to any of the foregoing.  Notwithstanding the foregoing provisions ofthis Section 10.3, Purchaser Technology shall not include anytechniques and related know-how developed or otherwise owned by Supplier andassociated with any component manufacturing processes that precede the assemblyof the Products.

##  

## 10.4                           IntellectualProperty.  For thepurposes of this Agreement, the term “Intellectual Property” meansinventions, works of authorship, improvements, developments, or innovations andother creative works (whether or not patentable or copyrightable, conceived ormade or reduced to practice), know-how, technical information, pending patentapplications, registrations, divisions and continuations thereof, registeredand unregistered copyrights, and all associated goodwill, designs, drawings,specifications, manufacturing methods and processes.

##  

## 10.5                           IntellectualProperty Rights.  The term “IntellectualProperty Rights” shall mean all patent rights, copyrights, rights intrademarks, trade names and service marks, trade secret rights, and all otherintellectual property rights of any nature whatsoever arising under the law ofthe United States or any foreign country, or any state or subdivision thereof.

##  

## 10.6                           Grant ofLicense to Supplier.  Purchaserhereby grants to Supplier a non-exclusive license to use all of Purchaser’sIntellectual Property Rights related to the Products solely for the purpose ofSupplier’s manufacture and repair of Products at the request of Purchaser andotherwise carrying out its obligations under this Agreement.  For clarity, nothing in this Agreementprohibits 

 

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## ** **

## Supplier from using in its business generalconcepts, techniques and ideas that are not eligible for protection under anyIntellectual Property Rights whether or not in connection with this Agreement.

##  

## 10.7                           Grant ofLicense to Purchaser.  To theextent that any Supplier Technology or related Intellectual Property Rights arenecessary or useful for the development or assembly of Purchaser products,Supplier hereby grants to Purchaser a non-exclusive, perpetual, irrevocable,royalty free license to use such Supplier Technology and related IntellectualProperty Rights solely for the purpose of assembling and repairing Products andsuccessor Purchaser products, which license includes the right to sublicensethe foregoing rights to third parties to enable such third parties to assembleand repair such products on behalf of Purchaser.  Further, for the avoidance of doubt, suchlicense shall not include any right or license to use and this Agreement shallnot confer upon Purchaser any rights whatsoever regarding pre-assembly componentmanufacturing techniques, as further described in the definition of SupplierTechnology above.

##  

## 10.8                           Retention ofIntellectual Property Rights.  The parties agree that Supplier shall beentitled to retain sole and exclusive ownership rights to the SupplierTechnology, and Purchaser shall be entitled to retain sole and exclusiveownership rights to the Purchaser Technology. Supplier hereby assigns all Intellectual Property Rights it may have oracquire in any Purchaser Technology to Purchaser and shall execute anydocuments reasonably requested by Purchaser and take such other actions as maybe reasonably requested by Purchaser, at Purchaser’s expense, to assign suchrights to Purchaser to perfect Purchaser’s interest in such rights.  Purchaser hereby assigns all IntellectualProperty Rights it may have or acquire in any Supplier Technology (if any) toSupplier and shall execute any documents reasonably requested by Supplier andtake such other actions as may be reasonably requested by Supplier, at Supplier’sexpense, to assign such rights to Supplier to perfect Supplier’s interest insuch rights.

##  

## 10.9                           FutureDevelopment of Finished Goods or Component Processes.  Purchaser may request that Supplier providedevelopment services for Supplier to create new pre-assembly componentmanufacturing techniques (“Pre-Assembly Manufacturing Technology”).  If the parties mutually agree to undertakesuch new development project then Purchaser upon full payment of the agreed tofees shall be granted a non-exclusive, royalty free, perpetual license to usesuch new Pre-Assembly Manufacturing Technology. For clarity, the term “Pre-Assembly Manufacturing Technology” does notinclude any Supplier Technology. Purchaser obtains a limited, restricted license to Supplier Technologywithout payment of any fees in accordance with, and subject to the limitationsand restrictions of Section 10.7.

##  

## 10.10                     General Skills.  Subject to Section 11 of thisAgreement and all of Purchaser’s Intellectual Property Rights, Purchaseracknowledges and agrees that: (i) Supplier is in the business ofdesigning, developing, manufacturing, prototyping and assembling metal andplastic components for specialized medical devices, and that Supplier maydevelop products, devices, instruments or other items for other persons whichare identical or similar in functionality to the Products; (ii) Supplier,its employees and agents shall be free to use and employ their general skills,know-how, and expertise, and to use, disclose, and employ any generalizedideas, concepts, know-how, methods, techniques, processes or skills gained orlearned during the course of this Agreement; and 

##  

## 14

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##  

**CONFIDENTIALCERTAIN INFORMATION HAS BEEN REDACTEDCONFIDENTIAL TREATMENT REQUESTED**

## ** **

## (iii) Supplier may perform similar servicesfor third parties using the same personnel that Supplier may utilize forrendering services for Purchaser hereunder.

##  

## 10.11                     Tooling andEquipment.  Suppliershall provide tooling that is not specific to the Product at its ownexpense.  Purchaser shall pay for orobtain and consign to Supplier for its use any Product-specific tooling andother reasonably necessary non-recurring expenses specific to the Product, assuch tooling and expenses are described on Exhibit B (as updated bythe parties) or otherwise approved in writing by Purchaser (“Set-Up Property”).  Purchaser shall own title to all Set-UpProperty.  Supplier shall hold andmaintain all Set-Up Property for Purchaser and shall exercise reasonable carein the use and custody of such property and shall use such property only inperforming its obligations under this Agreement.  Purchaser will bear responsibility for repairto Set-Up Property resulting from normal wear and tear.  Supplier will bear responsibility for loss ofor damage to Set-Up Property resulting from Supplier’s negligence.  Supplier will mark all Set-Up Property toclearly identify it as being the property of Purchaser.  Supplier shall not grant any securityinterest, incur any liens or any other encumbrances on said Set-Up Property.  Upon any termination or expiration of thisAgreement or upon Purchaser’s written request, Supplier will promptly returnall Set-Up Property in good and workable condition, with the exception ofnormal wear and tear, to a location identified by Purchaser at Purchaser’scost.  Supplier agrees that equipmentused to manufacture Product shall be calibrated and traceable to NISTstandards, and be validated as appropriate.

##  

# **11.****                              ****Confidentiality;Press Releases**.

#  

## 11.1                           Confidentiality.  The Purchaser and the Supplier will beexchanging Confidential Information (as defined herein) relating to theProducts and their manufacture, and relating to the services provided bySupplier pursuant to Exhibit C, at the inception of and from timeto time during the term of this Agreement and the Purchaser may have access toor observe the Confidential Information of Supplier.  For the purposes of this Agreement, “ConfidentialInformation” means any and all information or proprietary materials (inevery form and media) not generally known in the relevant trade or industrymade available by either party (in such case, the “Disclosing Party”) tothe other (in such case, the “Receiving Party”) in connection with theefforts contemplated hereunder and which is marked or otherwise identified asconfidential or which by its nature would reasonably be considered to beconfidential, including (i) all Intellectual Property, (ii) existingor contemplated products, services, designs, inventions, technology, processes,technical data, engineering, techniques, methodologies and concepts and anyinformation related thereto, information relating to business plans, sales orcustomer lists or requirements, manufacturing, financial, marketing ortechnical information such as specifications, manufacturing methods, priceguidelines, future product releases, trade secrets, know-how, inventions,techniques, processes, programs, schematics, data, customer lists, and salesand marketing plans or methods. Notwithstanding the foregoing, each party acknowledges that any and allinformation concerning the other party’s Intellectual Property is confidentialand that no further writing designating it as such is necessary.  The Receiving Party will maintain theinformation in confidence using the same standard of care it uses to maintainits own information in confidence, but in any case, no less than reasonablecommercial diligence, and will not use such information for itself or discloseit to others except as necessary to fulfill its obligations or exercise its rightsunder this Agreement; provided 

##  

## 15

## 

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## ** **

## that the Receiving Party shall not disclosethe Disclosing Party’s Confidential Information to any employee or third partyunless such employee or third party is under a duty of confidentiality withrespect to such information at least as protective as the duty set forth inthis section, except as provided in Exhibit C.  Such obligation of confidentiality andnon-use shall not apply to information which (i) is known to the ReceivingParty prior to the disclosure as demonstrated by documentary evidence, (ii) ispublicly known as of the date of the disclosure, (iii) becomes publiclyknown after the date of disclosure through no fault of the Receiving Party, (iv) isreceived from a third party who has, to the Receiving Party’s knowledge, noobligation of confidentiality to the Disclosing Party or (v) is developedindependently by the Receiving Party as demonstrated by documentaryevidence.  Such obligation ofconfidentiality and non-use shall survive any expiration or termination of thisAgreement.  The restrictions ondisclosure contained in this Section 11.1 shall not apply to anyinformation which is required to be disclosed by court rule orgovernmental law or regulation, provided that the Receiving Party gives theDisclosing Party prompt notice of any such requirement and cooperates with theDisclosing Party, at the Disclosing Party’s expense, in attempting to limitsuch disclosure.

##  

## 11.2                           IntentionallyDeleted

##  

## 11.3                           Publicity.  Unless required by law, neither party willoriginate any publicity, news release, or other public announcement, written ororal, whether to the public, press or otherwise, relating to this Agreement orany amendment hereto or to performance hereunder or the existence of anarrangement between the parties, without the prior written approval of theother party, such approval not to be unreasonably withheld.

##  

## 11.4                           Use of Names inPromotions.  Neitherparty shall use the name of the other for advertising or promotional claimswithout the prior written consent of the other party.

##  

## 11.5                           DamagesInadequate.  The partiesacknowledge that monetary damages may be an inadequate remedy for any breach bya party of its obligations under Section 10.1 and Sections 11.1through 11.3 and that the non-breaching party shall be entitled to seekinjunctive relief and specific performance to enforce the breaching party’sobligations, in addition to whatever remedies the non-breaching party may beentitled to.

##  

## 11.6                           Return.  Each party shall return all ConfidentialInformation of the other party in its possession within ten (10) daysafter any expiration or termination of this Agreement or otherwise upon theother party’s request.

##  

# **12.****                              ****Termand Termination**.

#  

## 12.1                           Term; Renewal.  Unless sooner terminated as provided in Section 12.2below, this Agreement shall have a term commencing on the Effective Date andexpiring on May 31, 2012, and the term of this Agreement shall beautomatically renewed for successive one (1) year terms thereafter.  The initial term together with any renewalterms are the “Term.”

##  

## 16

## 

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#### 12.2                           Termination.  This Agreement may be terminated:

####  

#### (a)                                  upon writtennotice by a party to the other party, if the other party becomes subject to aBankruptcy Event or commits an Event of Default (as defined in Section 13below); or

####  

#### (b)                                 by writtennotice from the Purchaser to the Supplier in accordance with Section 5.2.

####  

#### (c)                                  by 12 monthswritten notice by either party on or after June 1, 2011.

####  

## 12.3                           Effect ofTermination.  Upon anyexpiration or termination of this Agreement the provisions of Sections1,5.3, 5.4, 5.5, 6, 7, 8, 10, 11,12.3, and 14 shall survive such termination and expiration.

##  

# **13.****                              ****Default**.

#  

## 13.1                           Rights Upon anEvent of Default.  Upon theoccurrence of an Event of Default (as defined below) under this Agreement, inaddition to whatever other remedies the non-defaulting party may be entitledto, the non-defaulting party may terminate this Agreement upon written noticeto the defaulting party stating the grounds for such default.  The occurrence of any one or more of thefollowing acts, events or occurrences shall constitute an “Event of Default”under this Agreement:

##  

#### (a)                                  either partybecomes the subject of a Bankruptcy Event; or

####  

#### (b)                                 the Purchaserfails to make undisputed payments of the Purchase Price when due and suchfailure continues for ninety (90) days; provided that Supplier may suspendperformance under this Agreement in the event Purchaser fails to makeundisputed payment of the Purchase Price when due and such failure continue forthirty (30) days; or

####  

#### (c)                                  either partybreaches any other material provision of this Agreement and fails to remedysuch default within sixty (60) days after receipt of written notice thereof,which notice shall state, with particularity, the grounds for such claimeddefault.

####  

#### (d)                                 Purchaser failsto purchase the annual minimum Product volumes as detailed in Section 2.2of this Agreement and does not, within thirty (30) days after Purchaser’sreceipt of written notice from Supplier that Purchaser has failed to make suchpurchases, order the number of Products necessary to remedy such failure.

####  

## 13.2                           Rights UponCertain Supplier Defaults.  Purchaser’sobligation to make the minimum purchase requirements specified in Section 2.2for each Contract Year is subject to Supplier meeting the following criteria:

##  

Supplier has no more than one (I) Delivery Failure (as definedbelow) during 

 

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any rolling twelve (12) month period and no such failure during the six(6) months prior to the beginning of the next Contract Year.  A “DeliveryFailure” occurswhen Supplier delivers less than ninety five (95%) of the Product quantityspecified on a purchase order provided by Purchaser on the Delivery Datespecified on such purchase order with the remaining quantity not deliveredwithin fifteen (15) days after such Delivery Date.

 

If a Delivery Failure occursmore then one (1) time in any rolling twelve (12) month period, or if aDelivery Failure occurs during the three (3) months prior to the beginningof the next Contract Year, such occurrence will be a “Delivery Default.”In the event of a Delivery Default, and without limiting Purchaser’s otherrights and remedies under this Agreement or at law, the minimum purchaserequirements specified in Section 2.2 shall, on a go forward basis afterthe occurrence of a Delivery Default, be reduced on a one-for-one basis by thenumber of Products not delivered by Supplier in accordance with Purchaser’sPurchase Orders during the remainder of the Term, including the PurchaserOrders associated with the Delivery Default. Notwithstanding the foregoing, any Delivery Failure caused by (i) ForceMajeure events per Section 14.6 or (ii) Supplier’s continueduse of an Approved Supplier at the direction of Purchaser, provided that (x) Supplierhad notified Purchaser in accordance with Section 14.7 during thesix (6) month period immediately prior to the applicable Delivery Failurethat such Approved Supplier was not performing adequately and (y) Suppliersought approval from Purchaser to begin the process of seeking an AlternateSupplier, then such Delivery Failure shall not be included in any determinationof whether a Delivery Default has occurred.

 

# **14.****                              ****Miscellaneous**.

#  

## 14.1                           IndependentContractor Status.  Therelationship between the Supplier and the Purchaser established hereby is thatof independent contractors, and nothing contained herein shall be deemed tocreate a relationship of employer and employee, principal and agent, partners,or otherwise.  Neither party shall haveany authority to obligate the other in any respect nor hold itself out ashaving any such authority.  All personnelof the Supplier shall be solely employees of the Supplier and shall notrepresent themselves as employees of the Purchaser, and all personnel of thePurchaser shall be solely employees of the Purchaser and shall not representthemselves as employees of the Supplier.

##  

## 14.2                           Binding Effect;Benefits; Assignment This Agreement shall inure to the benefit of and bebinding upon the parties hereto and their respective permitted successors andassigns.  Nothing contained herein shallgive to any other person any benefit or any legal or equitable right, remedy orclaim.  Any assignment of this Agreementby either party shall require the prior written consent of the other partywhich shall not be unreasonably withheld; provided that (i) a change inownership of a party’s stock or other ownership interest, or of any stock orownership interest in any entity which, directly or through one or moreintermediaries, controls the party, shall not constitute an assignment of thisAgreement or require the other party’s consent, and (ii) either party mayassign this Agreement to a purchaser of such party’s business (whether througha sale of all or substantially all of such party’s assets, merger,consolidation, reorganization, or similar transaction) upon written notice tothe other party; provided further that, in each case, if any such change in 

##  

## 18

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##  

## ownership interests would result in Supplierbeing owned or controlled by a Competitor, Purchaser may elect to terminatethis Agreement in connection with such change in Supplier’s ownership as of thedate specified in Purchaser’s notice of termination.  Any assignment of this Agreement shall besubject to the assignee agreeing in writing to assume the benefits andobligations of this Agreement.  Anyattempt to assign this Agreement in violation of this section shall be null andvoid.

##  

## 14.3                           EntireAgreement; Amendments.  Theparties hereto acknowledge that this Agreement sets forth the entire agreementand understanding of the parties hereto as to the subject matter hereof, andshall not be subject to any change or modification except by the execution of awritten instrument signed by the parties hereto.  To the extent of any conflict orinconsistency between this Agreement and any Purchase Order, confirmation,acceptance or any similar document, the terms of this Agreement shall govern.  The parties agree that this Agreementsupersedes the November 7, 2005 Agreement and that any claims arising withrespect to the Products, regardless of when such Products were purchased byPurchaser, including warranty claims and claims for indemnification, shall besubject to the terms and conditions of this Agreement and shall not be subjectto the terms and conditions of the November 7, 2005 Agreement.

##  

## 14.4                           Severability.  In the event that any provision of thisAgreement would be held in any jurisdiction to be invalid, prohibited orunenforceable for any reason, such provision, as to such jurisdiction, shall beineffective, without invalidating the remaining provisions of this Agreement oraffecting the validity or enforceability of such provision in any otherjurisdiction.  Notwithstanding theforegoing, if such provision could be more narrowly drawn so as not to beinvalid, prohibited or unenforceable in such jurisdiction, it shall, as to suchjurisdiction, be so narrowly drawn, without invalidating the remainingprovisions of this Agreement or affecting the validity or enforceability ofsuch provision in any other jurisdiction.

##  

## 14.5                           Remedies.  Unless otherwise expressly provided, allremedies hereunder are cumulative, are in addition to any other remediesprovided for by law and may, to the extent permitted by law, be exercisedconcurrently or separately, and the exercise of any one remedy shall not bedeemed to be an election of such remedy or to preclude the exercise of anyother remedy.

##  

## 14.6                           Force Majeure.  The obligations of the Supplier and thePurchaser hereunder (except for the Purchaser’s obligations to make payment infill] for Products when due) shall be subject to any delays or non-performancecaused in whole or part by any act of God; extraordinary acts of any governmentor any agency or subdivision thereof; fire; strikes (excluding strikes bySupplier’s workforce); war; transportation delays affecting the general public;riots or acts of a public enemy; terrorist acts; and similar events; in eachcase that are not caused by any act or omission of the affected party and thatare beyond the reasonable control of such party.  The party which is not performing itsobligations under this Agreement as a result of an event of force majeure shalluse diligent efforts to resume compliance with this Agreement as soon aspossible.  Should the event of forcemajeure continue unabated for a period of sixty (60) days or more, the partiesshall enter into good faith discussions with a view to alleviating its affectsor to agreeing upon such alternative arrangements as may be fair and reasonablehaving regard to the circumstances prevailing at that time, provided thatPurchaser may at any time after such sixty (60) day period terminate this 

##  

## 19

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##  

## Agreement, without liability to Supplier,provided that upon such termination Conceptus shall purchase all completedProduct inventory and Product components that exist at the time of terminationand that meet the Specifications.  Forclarity, Conceptus shall not be obligated to purchase an amount of Products (orcomponents thereof) that exceeds the amount of the Product PurchaseRequirement.

##  

## 14.7                           Notices.  Any notice, request, consent or communication(collectively, a “Notice”) under this Agreement shall be effective if itis in writing and (i) personally delivered, (ii) sent by certified orregistered mail, postage prepaid, return receipt requested, (iii) sent byan internationally recognized overnight delivery service, with deliveryconfirmed, or (iv) telexed or telecopied, with receipt confirmed,addressed as set forth in this Section or to such address as shall befurnished by either party hereto to the other party hereto.  A Notice shall be deemed to have been givenas of (i) the date when personally delivered, (ii) when received ifdelivered by the United States Postal Service, certified or registered mail,properly addressed, return receipt requested, postage prepaid, or by overnightdelivery service, or (iii) immediately, upon confirmation of receipt ofthe telex or telecopy, as the case may be. All Notices shall specifically state: the provision (or provisions) ofthis Agreement with respect to which such Notice is given and shall be addressedas follows:

 
| If to the Supplier to:

 

Accellent Inc. 

100 Fordham Road 

Wilmington, MA 01887 

ATTN: Executive VP  Sales & Marketing |   | If to the Purchaser to:  

 

Conceptus, Inc. 

331 East Evelyn Avenue  Building C 

Mountain View, CA 94041     |
|-------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------|
|                                                                                                                                      |   |                                                                                                                       |
| with a copy to:

 

Accellent Inc. 

100 Fordham Road 

Building C 

Wilmington, MA 01887 

ATTN: General Counsel                    |   | with a copy to: 

 

J.D. Marple, Esq. 

Latham &  Watkins LLP 

140 Scott Drive 

Menlo Park, CA 94025 |

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## 14.8                           Waivers.  The failure of either party to assert a righthereunder or to insist upon compliance with any term or condition of thisAgreement shall not constitute a waiver of that right or excuse a similarsubsequent failure to perform any such term or condition by the other party.

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## 14.9                           Counterparts.  This Agreement may be executed in any numberof counterparts, and execution by each of the parties of any one of suchcounterparts will constitute due execution of this Agreement.  Each such counterpart hereof shall be deemed tobe an original instrument, and all such counterparts together shall constitutebut one agreement.

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**CONFIDENTIALCERTAIN INFORMATION HAS BEEN REDACTEDCONFIDENTIAL TREATMENT REQUESTED**

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## 14.10                     Headings.  The article and section headings contained inthis Agreement are for reference purposes only and shall not affect in any waythe meaning or interpretation of this Agreement.

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## 14.11                     Governing Law;Dispute Resolution.  ThisAgreement shall be construed, governed, interpreted and applied in accordancewith the laws of the State of Delaware, without regard to the conflict of lawprinciples of such State.  Anycontroversy or claim arising out of or relating to this Agreement or thevalidity, inducement, or breach thereof (each such controversy or claim ishereinafter referred to as a “Dispute”), shall be settled as follows:

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#### (e)                                  Officers at or above theVice President level of each party shall attempt to resolve any Dispute priorto commencing the procedures set forth in below.

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#### (f)                                    If after 14 calendar daysthe officers are unable to resolve the Dispute, the Chief Executive Officer andfor the highest ranking officer of each party shall submit to non-bindingmediation which shall take place for a period of one day in San Carlos, CAbefore a mediator that is knowledgeable about the subject matter of the Disputeand that is mutually acceptable to the parties. If the parties are unable to agree on the selection of a mediator, amediator will be chosen by an arbitrator selected pursuant to the rules ofthe American Arbitration Association (AAA) who will then select such mediatorfrom a list of distinguished neutral mediators maintained by the AAA.  The mediator shall confer with the parties todesign procedures to conclude the mediation within no more than 30 days afterinitiation.  Under no circumstances shallthe commencement of arbitration under paragraph (c) below be delayed morethan 30 days from the initial notice of a Dispute by the mediation processspecified in this paragraph (b).  Eachparty has the right to pursue any provisional relief from the appropriatecourt, such as attachment, preliminary injunction, replevin, etc.  to avoid irreparable harm, maintain thestatus quo, or preserve the subject matter of the mediation or arbitration,even though mediation or arbitration has not been commenced or completed.  Disputes with respect to a party’sobligations or rights under Section 10 or Section 11shall not be subject to this Section 14.

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#### (g)                                 If during such one-daymediation the parties are unable to resolve the Dispute, the Dispute shall besettled by arbitration before a single arbitrator in accordance with theCommercial Arbitration Rules of the AAA then pertaining, except wherethose rules conflict with this Section 14.11, in which casethis Section 14.11 controls. The parties hereby consent to the jurisdiction of the Federal DistrictCourt in San Francisco, CA and the state courts of California for theenforcement of these provisions and the entry of judgment on any award renderedhereunder.  Should such court for anyreason lack jurisdiction, any court with jurisdiction shall enforce this clauseand enter judgment on any award.  Thearbitrator shall be an attorney specializing in business litigation who has atleast 15 years of experience with a law firm or corporation of over 25 lawyersor was a judge of a court of general jurisdiction.  The arbitration shall be held in San Carlos,CA and the arbitrator shall apply the substantive law of Delaware, except thatthe interpretation and enforcement of this arbitration provision shall begoverned by the Federal Arbitration Act. Within 30 days of initiation of arbitration, the parties shall reachagreement upon and thereafter follow procedures assuring that the arbitrationwill be concluded and the award rendered within no more than three (3) monthsfrom selection of the arbitrator. Failing such agreement, the AAA will design 

 

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**CONFIDENTIALCERTAIN INFORMATION HAS BEEN REDACTEDCONFIDENTIAL TREATMENT REQUESTED**

 

#### and the parties will follow such procedures.  Consistent with the limitations on liabilityprovided in Section 6.3, the parties agree neither to request orseek to enforce any punitive, exemplary or consequential damages from thearbitrator and the arbitrator shall not be empowered to grant any suchdamages.  The arbitrator shall issuewritten findings of fact and conclusions of law.

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#### (h)                                 The arbitrator shall bebound by the express terms of this Agreement and may not amend or modify suchterms in any matter.  Any award renderedby the arbitrator shall be binding on the parties and shall be consistent withthe terms of this Agreement, and such terms shall control the rights andobligations of the parties.  Theproceedings shall be confidential and the arbitrators shall issue appropriateprotective orders to safeguard both parties’ confidential information.  The fees of the arbitrator shall be splitequally between the parties, unless the arbitrator determines that either party’spositions in the dispute were frivolous or based in bad faith, in which casesuch party shall pay the entire arbitrator’s fee.

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IN WITNESS WHEREOF, duly authorized representativesof the parties hereto have duly executed this Supply Agreement as of the datefirst above written.

 
| **SUPPLIER**         | ** **                        | **PURCHASER**        |
|----------------------|-----------------------------------|----------------------|
| ** **           | ** **                        | ** **           |
| Accellent, Inc. |                              | Conceptus, Inc. |
|                 |                              |                 |
| By:                  | /s/ R. Scott Laneve               |                 | By: | /s/ Gregory E.  Lichtwardt |
|                 |                              |                 |   |   |
| Name:                | R. Scott Laneve                   |                 | Name: | Gregory E. Lichtwardt |
|                 |                              |                 |   |   |
| Title:               | Sup., Sales &  Marketing |                 | Title: | Executive Vice President |
|                 |                              |                 |   |   |
| Date:                | June 1, 2009                 |                 | Date: | June 1, 2009 |

 

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**CONFIDENTIALCERTAIN INFORMATION HAS BEEN REDACTEDCONFIDENTIAL TREATMENT REQUESTED**

 

**EXHIBITAPRODUCTS**

 

ESS305With Solder Ball Anchor

 

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**CONFIDENTIAL**

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**EXHIBITB**

 

**PRODUCTPRICES**

 

Pricing: Pricing willbe set at a base price of $[***] per Product as of the Effective Date and willbe further discounted (through a rebate at the end of each Contract Year) basedon purchase volume and share in accordance with this Exhibit B.

 

Cost Savings.  As of the Effective Date and during the Term,with respect to any gainsharing projects that result in a cost savings, suchcost saving will be applied as detailed in Section 3.1.1.  Any such cost reduction implemented shall beapplied to the $[***] base price as well as to the Product price after theimplementation of any rebate in accordance with Chart 2.  (For example, if it is expected that againsharing program may result in a total cost reduction of $[***] per Productand both parties have funded such gainsharing program, each will see a benefitof $[***].  When such a cost reduction isimplemented, the $[***] base price will be adjusted to $[***] and the Year 1rebate price will be adjusted to $[***]. This is an example only.  Actualcost savings will always be used to adjust the applicable base price or rebateprice.)

 

Rebate Qualification: In order toqualify for a rebate, Purchaser must meet the minimum unit volumes (#)describedin Chart 1, Rebate Qualification, as follows:

 

Chart1: Rebate Qualification

 

| **Criteria**         | ** ** | **Contract  Year 1** | ** ** | **Contract  Year 2** | ** ** | **Contract  Year 3** |
|----------------------|------------|----------------------|------------|----------------------|------------|----------------------|
| a. Minimum Units (#) |       | [***]                |       | [***]                |       | [***]                |

 

Rebate to Price: If qualifiedfor a rebate based on meeting the criteria described above, Purchaser will beeligible for a rebate in accordance with chart below based on the volume ofProducts purchased during a Contract Year, The rebate will apply to the entirevolume of Products purchased during the applicable Contract Year, based on thetotal number of Products purchased within such Contract Year, and will yieldthe net prices described in Chart 2, Net Pricing, as follows:

 

Chart2: Net Pricing

AccellentBase Price/Product Price after Rebate

 

| **Volume Purchased**   | ** ** | **Year 1** | ** ** | ** ** |
|------------------------|------------|------------|------------|------------|
| < 85,000 Base Price |       | $          | [***]      |       |   |
| > 85,001            |       | $          | [***]      |       |   |

 

| **Volume Purchased**    | ** ** | **Year 2** | ** ** | **Year 3** |
|-------------------------|------------|------------|------------|------------|
| < 93,000 Base  Price |       | $          | [***]      |       | $ | [***] |
| 93,001-120,000          |       | $          | [***]      |       | $ | [***] |
| > 120,001            |       | $          | [***]      |       | $ | [***] |

 

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Paymentof Rebate.  Suppliershall pay to Purchaser the amount of the rebate owed to Purchaser (i.e., thedifference between (i) the amount Purchaser paid for Products during suchContract Year and (ii) the amount that is equal to the sum of the numberof Products purchased during such Contract Year and the net price of suchProducts after the rebate for such Contract Year has been applied) withinthirty (30) days after the end of the Contract Year for which such rebate isapplicable.

 

**Chart3: Component Prices**

 
| **Part  Number** | ** ** | **Description**       | ** ** | **Price** | ** ** |
|------------------|------------|-----------------------|------------|-----------|------------|
| 101466-02        |       | Inner Coil            |       | $         | [***]      |   |
| 101484           |       | Outer Coil (etched)   |       | $         | [***]      |   |
| 101484           |       | Outer Coil (unetched) |       | $         | [***]      |   |
| 101468           |       | Delivery Wire         |       | $         | [***]      |   |

 

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**CONFIDENTIAL**

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**CONFIDENTIAL TREATMENTREQUESTED**

 

**EXHIBITC**

 

**QUALITYASSURANCE PROCEDURES**

 

Supplier shall manufactureProducts per the requirements specified in the Purchase Orders, theSpecifications, the Agreement, and any inspection and process control criteriaprovided by Purchaser to Supplier.

 

Supplier shall obtainPurchaser’s written approval of all materials, processes, methods, andequipment used to manufacture Products, and shall not deviate from such usewithout Purchaser’s prior written approval. At all times Purchaser shall be required to maintain such information inthe strictest confidence per Section 11, except that the clause in Section 11which would otherwise permit certain disclosures to third parties who are undera duty of confidentiality shall not apply with regard to any ConfidentialInformation related to Supplier’s component manufacturing processes ortechniques (“Component Manufacturing Information”).  By way of example and not of limitation, forthe avoidance of doubt, Purchaser shall not, at any time or for any reason,communicate any Component Manufacturing Information to any third party manufacturer(or its agents, affiliates or contractors), without the prior written approvalof Supplier.  For clarity, ComponentManufacturing Information does not include any Supplier Technology and nothingin this Exhibit C limits Purchaser’s right to exercise its licenseto Supplier Technology set forth in Section 10.7 of the Agreement.

 

Supplier’s manufacturingprocesses shall at all times conform to the current good manufacturingpractices of the Regulatory Authority, as well as all other regulatoryrequirements and guidelines of the Regulatory Authority.  Supplier shall maintain an FDA siteregistration number during the term of the Agreement.

 

Without limiting Supplier’sother obligations under the Agreement, Supplier shall perform the followingfunctions in connection with its manufacture of the Products:

 

2.             Supplier shall ensure component and materialtraceability for Products by establishing and maintaining documented proceduresfor identifying materials from receipt through all stages of production and delivery.

 

3.             Supplier shall ensure that production processes arecarried out under controlled conditions that include:

 

·                  Documented procedures defining the manner ofproduction,

·                  Use of production equipment and a controlledworking environment that meet or exceed industry standards,

·                  Compliance with the Food and DrugAdministration (“FDA”) Quality System Regulations and all applicableinternational Quality Management System Standards,

·                  Monitoring and control of process parametersand Product characteristics,

·                  Approval of all processes and equipment priorto use,

·                  Assignment of only trained, qualifiedpersonnel to perform manufacturing operations,

 

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·                  Specification of workmanship criteria thatmeet or exceed written standards from Purchaser, which criteria shall bespecified and communicated to workers clearly (e.g.  written standards, representative samples, orillustrations),

·                  Maintenance of equipment in a manner thatmeets or exceeds industry standards and ensures continuing process capability.

·                  The inspection and test status of materialsshall be clearly identified, which status shall indicate the conformance ornon-conformance of materials with regard to inspections and testsperformed.  Records of the identificationof inspection and test status shall be maintained as defined in documentedprocedures and the Agreement.

 

4.             Supplier shall establish and maintain documentedprocedures for inspection and testing activities in order to verify that thespecified requirements for the materials are met.  The required inspection and testing, and therecords to be established, shall be detailed in a quality plan or documentedprocedures.

 

5.             Supplier shall ensure that incoming material is not usedor processed until it has been inspected or otherwise verified as conforming tospecified requirements.  Verification ofthe specified requirements shall be in accordance with documented procedures.

 

6.             Supplier shall inspect and test the Products as requiredby the Quality Requirements Specification and documented procedures.

 

7.             Supplier shall not ship completed Products until therequired inspection and tests have been completed or necessary reports havebeen received and verified.

 

8.             Supplier shall carry out all final inspection andtesting in accordance with the Quality Requirements Specification anddocumented procedures to complete the evidence of conformance of the finishedmaterials to the Specifications and other requirements.

 

9.             The documented procedures for final inspection andtesting shall require that all inspections and tests, including those specifiedeither upon completion of Product or in-process, have been carried out and thatthe results meet the Specifications and other requirements.

 

10.           No Products shall be shipped to Purchaser until all theactivities specified in this Exhibit C and the documented procedures havebeen satisfactorily completed and the associated data and documentation areavailable and have been reviewed for compliance with the Specifications andother requirements and authorized.

 

11.           Supplier shall establish and maintain records that provideevidence that the Product has been inspected and tested.  These records shall clearly identify whethera Product has passed or failed the inspections and tests according to definedacceptance criteria.  Where the Productfails to pass any inspection or test, the procedure for control ofnon-conforming Product shall apply.  Theresponsibility for release of Products for shipment shall be identified andrecorded.

 

12.           Supplier shall establish and maintaindocumented procedures to control, calibrate, and maintain inspection, measuringand test equipment used by Supplier’s subcontractors (which subcontractors mustbe approved in writing by Purchaser prior to their use by Supplier) to 

 

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demonstratethe conformance of Products or Product components to the specifiedrequirements.  Inspection, measuring andtest equipment shall be used in a manner which ensures that the measurementuncertainty is known and is consistent with the required measurementcapability.

 

13.           Supplier shall specify, subject to Purchaser’s approval,the measurements to be made and the accuracy required with respect toinspections and testing and shall select, subject to Purchaser’s approval, theappropriate inspections and tests. Supplier shall ensure that all measuring and test equipment is capableof the necessary accuracy and precision. Supplier shall also calibrate all inspection, measuring and testequipment at prescribed intervals as necessary to ensure such equipment canaccurately and correctly inspect, measure and test Products and Productcomponents.

 

14.           Supplier shall establish and maintain documentedprocedures to ensure that Products that do not conform to specifiedrequirements, including the Specifications, are not shipped to Purchaser.  This procedure shall provide for identification,documentation, evaluation, segregation, disposition of non-conforming Product,and for notification of Purchaser with respect to such Products.  The responsibility for review and authorityfor the disposition of non-conforming Product shall be defined in theProcedures.  Non-conforming Products maybe disposed of in accordance with the following procedures:

 

·                  They may be, upon Purchaser’s prior writtenapproval, (a) reworked to meet specified requirements, including theSpecifications, (b) accepted with or without report by concession, (c) regardedfor alternative applications (e.g., DEMO), or (d) scrapped.

·                  Reworked Products shall be re-inspected tooriginal Specifications and in accordance with the documented procedures.

 

15.           Supplier shall adhere to requirements of Purchaser’s Correctiveand Preventive Action Program (CAPA) of identified non-conformances affectingProduct and/or processes under control of Supplier.

 

16.           All procedures, processes, and functions described abovein this Exhibit C (collectively, “Processes”) shall be subject toPurchaser’s review, approval and audit (as described in Section 5.1).  In the event Purchaser discovers a deficiencyin a Process, Purchaser shall provide notice of such deficiency and shallsuggest measures to remedy such deficiency to Supplier in writing.  Supplier shall provide Purchaser with a planto remedy such deficiency within five (5) days after Purchaser’s notice,and Supplier shall remedy such deficiency within fifteen (15) days afterPurchaser’s approval of such plan, such approval not to be unreasonablywithheld, unless another time period is agreed by the parties.

 

17.           Supplier shall provide Purchaser access to the followingin connection with Purchaser’s review of the Processes:

 

·                  Assembly Processes (including SupplierTechnology)

·                  Inspection Procedures

·                  Traceability Records

·                  Test/Inspection Records

 

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·                  Calibration Records

·                  Non-Conformance Records

 

18.           Supplier shall provide the required certifications withall Products and services stating conformance to all applicable specificationsand standards, including the Specifications.

 

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