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

 

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

 

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

 

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

 

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

 

1.13         Incoming Inspection .  “Incoming Inspection” means measuring, examining, and testing that gauges one or more characteristics of a Product component and the comparison of such component with the specified requirements to determine such component’s conformity to the Specifications.

 

1.14         Intellectual Property .  “Intellectual Property” has the meaning given in Section 10.1 .

 

1.15         Intellectual Property Rights .  “Intellectual Property Rights” has the meaning given in Section 10.1 .

 

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

 

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

 

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

 

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

 

1.20         Purchase Order .  “Purchase Order” means a purchase order for Products in a form provided by Purchaser.

 

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

 

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

 

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

 

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

 

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

 

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

 

2.                                     Supply Rights .

 

2.1           Manufacture and Supply .  Supplier agrees, pursuant to the Delivery Schedule, to procure inventory, which includes raw materials, components and other supplies, and to manufacture, test, assemble, inspect and deliver the Products pursuant to the Specifications for each such Product.  Supplier recognizes and agrees that the specific manufacturing site employed for the production of the Products must be approved and accepted by the Purchaser.  Supplier agrees to provide adequate capacity to meet the volumes agreed by the parties in accordance with Section 3.4 .  All materials for use in Products, including but not limited to raw materials, supplies, and completed Product will be stored by Supplier in a secure, segregated, and controlled area to prevent theft, loss, degradation or damage of such materials.  Supplier shall maintain lot traceability of raw materials, work in process and finished Product.  All components used in the Products shall be processed through Incoming Inspection.  All materials and components that do not meet the applicable Specifications shall be quarantined and investigated through the Supplier’s non-conformance procedure.  Supplier’s personnel responsible for manufacturing, testing, and inspecting Product shall be trained in the Procedures (as defined below) by a Qualified Trainer.  Supplier’s quality assurance personnel shall ensure Products meet Specifications.  Supplier agrees to manufacture Products in a Controlled Environment Room (CER), which shall be monitored for particulate and microbial control on a quarterly basis.  The Incoming Inspection, non-conformance procedure, quality assurance procedures and other manufacturing, testing, and inspection procedures used by Supplier in connection with the manufacture of the Products are collectively the “ Procedure s.” All Procedures, and any changes thereto, must be approved by Purchaser prior to their use by Supplier.  Purchaser acknowledges that Supplier is in the business of providing contract manufacturing services to the medical device industry and, subject to the terms of this Agreement, reserves the right to supply, develop, manufacture, sell, resell, or carry-on similar activities to any third party, including competitors of the Purchaser.  The Products will be produced in Supplier’s Juarez Mexico facility.

 

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

 

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

 

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

 

3.                                     Purchase Orders, Prices, Terms, Delivery, Forecasts .

 

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

 

3.1.1.       Gainsharing .  Supplier and Purchaser shall use best efforts during each Contract Year to work together to put forth proposals with respect to Changes (as defined below) that, if implemented, would reduce the price of the Product to Purchaser.  The parties’ non-binding targeted goal is a [***] percent   Change during such Contract Year.  The parties agree to the following gainsharing terms: (i) if the parties share the cost of any Product engineering changes, process improvements, and procurement or alternate sourcing activities (collectively, “ Changes ”) that result in a cost reduction, the amount of such cost reduction will be shared by the Supplier and Purchaser, with each receiving [***] percent of such cost reduction after implementation of the Changes, provided that mutually agreed, nonrecurring expenses associated with such cost reductions will be retired by the party bearing such expenses prior to sharing, and (ii) if Purchaser (A) pays the entire cost of any Changes (including the amount of any capital expenses or the cost of any capital equipment used in the Product assembly process), or (B) suggests process improvements that do not have implementation costs, Purchaser shall realize the entire amount of any cost reduction resulting from such Change in the form of a lower Product price, and (iii) cost reductions related to manufacturing, site, process, labor or material improvements undertaken and paid 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 to price reductions in accordance with this Section 3.1.1 , such reductions will be realized by Purchaser in the form of a lower price (including both the base Product price and the Product price after any rebates are applied in accordance with Exhibit B ).

 

3.1.2.       Rebates .  Purchaser may be eligible for a rebate as detailed in Exhibit B .

 

3.2           Orders, Shipping Terms, and Inconsistencies .  Supplier shall pack all Products for shipment in accordance with Purchaser’s Specifications and otherwise in a commercially reasonable manner to protect against damage.  All shipments of Products shall be F.O.B.  Supplier’s facility, and shall be accompanied by a packing slip which describes the Products and states the Order number.  Title to and all risk of loss or damage concerning the Products shall pass to Purchaser immediately upon the sooner of delivery of the Products to either (i) the Purchaser, (ii) a common carrier or (iii) any private carrier designated by Purchaser (or designated by Supplier and approved by Purchaser) for shipment to Purchaser’s designated point of delivery.  Purchaser’s rejection of any Products purchased hereunder shall not shift any risk for those Products until they are returned to and received by Supplier pursuant to Supplier’s written instructions.  If there is any conflict or inconsistency between this Agreement and any Purchase Order confirmation, acceptance or any similar document, the terms of this Agreement shall govern and control.

 

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

 

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

 

3.5           Notice of Anticipated Failure to Make Timely Delivery .  The Supplier will notify the Purchaser in the event that Supplier becomes aware that the Supplier will not be able to make delivery 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 of components for Products, Purchaser may, at its discretion, supply components to Supplier at Supplier’s expense upon the written consent of Supplier and only in such amounts as are necessary for firm orders then placed by Purchaser.  Such components, including provision for failed parts, shall be delivered to Supplier not later than four (4) weeks prior to the scheduled Delivery Date for the related Products to Purchaser.  Should Purchaser be unable to meet Purchaser’s requirements for delivery of Products, Purchaser may at its option require Supplier to either: (i) ship Products to Purchaser absent the missing components on or after seven (7) days from the scheduled Delivery Date; or (ii) hold the Products pending receipt of such components from Purchaser.  Under these circumstances, Purchaser will give written notification to Supplier prior to the scheduled Delivery Date.  Nothing in this Section relieves Supplier of its other obligations under this Agreement.

 

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 B Chart 3.  On the first day of each calendar quarter, Purchaser shall provide Supplier with an updated Component forecast that reflects Purchaser’s estimated aggregate purchase requirements of Components for the subsequent twelve (12) month period.  Purchaser may from time to time provide Supplier with a purchase order that covers a three (3) month time frame with specific quantities of Components to be delivered to Purchaser on specific Delivery Dates, which dates and quantities will be mutually agreed to by the parties, provided that Supplier shall accept all Purchaser purchase orders (including the delivery dates and quantities specified therein) that specify order quantities that are within one hundred and ten percent (110%) of the Product quantities specified in the Component forecast for the applicable period.  The Purchaser shall update such purchase order monthly to maintain at all times a total of three (3) months of Component requirements under a purchase order by including, on the first of each new month, an additional one (1) month of Component requirements to the end of such three (3) month timeframe.  Supplier shall confirm all Component quantities and delivery dates specified on purchase orders provided by Purchaser within three (3) days after receipt of each such purchase order.  Component pricing will be renegotiated annually, at the end of each Contract Year.  If the parties cannot agree on a new price for a Component at the end of a Contract Year, the price for such Component shall be the same as the price for such Component during the previous Contract Year.  Quantities available to Purchaser at these prices are subject to minimum unit volume requirements for Products shown in Exhibit B Chart 1, Rebate Qualification.

 

3.7           Approved Supplier List .  Purchaser shall provide a bill of materials and approved supplier list (“ Approved Supplier List ” or “ ASL ”) for each Product to be manufactured hereunder.  Supplier shall manufacture the Products using components obtained solely from vendors included on the ASL, as it may change from time to time, as approved by Purchaser.  The ASL shall not be amended without prior written approval of Purchaser.  If Supplier desires to use a supplier from Supplier’s own list of approved suppliers, Supplier shall provide Purchaser with 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, the proposed supplier will be subject to evaluation and approval processes approved by Purchaser.  Supplier will not order any materials or components for the Products from such supplier until Purchaser has provided written approval to make such orders.  Any increased costs associated with a component 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 by Purchaser (i.e.  a substandard quality component causes increased scrap rates, inspections, and extra labor for which Supplier will not be liable); provided that (i) Supplier documents and reasonably demonstrates to Purchaser the cause of the increased cost and how Supplier’s use of an alternate qualified supplier (“ Alternate Supplier ”) for such component would eliminate such cost, (ii) Purchaser determines in its reasonable discretion that the Alternate Supplier is qualified to manufacture the component in accordance with the applicable specifications and all regulatory requirements, and (iii) Purchaser chooses not to include the Alternate Supplier on the Approved Supplier List for such component despite such determination.

 

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

 

3.9           Excess and Obsolete Inventory .

 

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

 

3.9.2.       Purchaser shall be responsible for any non-returnable inventory (including finished Products, work-in-process, components, or raw material) or non-cancelable orders for components or raw material that are rendered excess or obsolete (as determined in Supplier’s reasonable discretion) (collectively, “ Excess Inventory ”) to the extent such Excess Inventory is caused by (a) Purchaser’s cancellation of orders with shipment dates specified in the Delivery Schedule between thirty (30) and one-hundred and twenty (120) days from the date of cancellation, (c) engineering change orders agreed by the parties, (d) the end of a Product’s life, or (e) the termination or expiration of this Agreement (excluding termination of the Agreement 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 Inventory cannot reasonably and without material cost to the Supplier be utilized on other Supplier products or returned to its suppliers.  The cost to Purchaser of the Excess Inventory described above shall be the Purchase Price for finished Products and the Supplier’s burdened cost (including labor (if expended), storage, and documented restocking charges paid by Supplier to its suppliers, but excluding a mark-up) for all other items Supplier shall provide Purchaser an invoice that itemizes and describes in reasonable detail the foregoing charges with respect to Excess Inventory and the reasons Supplier cannot avoid such charges within thirty (30) days after the event described in subsections (a) through (e) above that gave rise to such charges.  In no event shall Purchaser’s responsibility for charges with respect to Excess Inventory exceed an amount equal to the total Purchase Price for the quantity of Products on the then current three (3) month purchase order .

 

4.                                     Changes to Specifications .

 

4.1           Changes by Purchaser .  If the Purchaser desires to change the Specifications, it will notify the Supplier of such proposed change in writing.  Within thirty (30) days following receipt of

 

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such a notice from the Purchaser, the Supplier shall notify the Purchaser of the cost of implementing such change and the impact such a change would have on the Purchase Price and the manufacturing lead-time.  The Purchaser will then notify the Supplier in writing whether it wants to implement such change taking into account the implementation costs and the manufacturing lead time and Purchase Price impact.  Specifications for any change to the Product shall be finalized by the Purchaser in a mutually agreed to time-frame prior to the placement of the first order for each Product to be manufactured with such changed Specifications.  After approval by the Purchaser, such change shall then become part of the Specifications.

 

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

 

5.                                     Quality and Regulatory Matters .

 

5.1           Facility Reviews .  The Purchaser or its designee shall have the right, upon reasonable advance written notice and during regular business hours, to inspect the facilities being used by the Supplier for production of the Products solely to confirm that such facilities are adequate to meet the requirements of this Agreement, the Regulatory Authority, ISO13485, and any applicable successors to those ISO requirements.  Supplier shall reasonably cooperate with Purchaser and its designee with respect to such inspections.  If any such inspection reveals that the manufacturing facilities do not satisfy such requirements, then the Purchaser shall provide written notice of such fact, which notice shall contain in reasonable detail the deficiencies found in the manufacturing facilities and, if practicable, those steps the Supplier should undertake in order to remedy such deficiencies.  Any inspection made by the Purchaser under this section shall occur no more frequently than once each calendar quarter (unless otherwise required by law, including by direction of the Regulatory Authority) and shall be designed to cause the least amount of disruption to the operations of the Supplier as is reasonably possible.  Such inspections shall be limited to the manufacture of Products, and shall not include any trade secrets or other confidential information unless the Purchaser and its designee (if applicable) has signed a confidentiality agreement reasonably satisfactory to the Supplier.

 

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

 

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5.3           Records .  The Supplier will maintain its records with respect to the manufacture of the Products for ten (10) years after the date of manufacture of the last Product under this Agreement, after which Supplier shall transfer such records to Purchaser.

 

5.4           Medical Device Reporting .  Purchaser shall be responsible to report events in compliance with FDA Medical Device Reporting Regulation set forth in 21 CFR Part 803 and any applicable international regulations.  Purchaser agrees to make Medical Device Reports available to Supplier within three (3) days of the initial receipt of any report that reasonably suggests that one of the Products (i) may have caused or contributed to a death or serious injury or (ii) has malfunctioned.

 

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

 

5.6           Permits, etc .  The Purchaser shall obtain, at the Purchaser’s sole expense, all permits, licenses, approvals, consents, and authorizations from all governmental authorities as may be necessary or appropriate to market, solicit orders for, and sell the Products.

 

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

 

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

 

5.9           Certain Quality Requirements .  Without limiting its other obligations under this Agreement, Supplier shall comply with the quality requirements set forth in Exhibit C.

 

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6.                                       Product Warranty and Limited Remedies; Customer Complaints .

 

6.1                                  Warranty .  The Supplier warrants that each Product and each Component shall materially comply with the Specifications for a period of two (2) years following the date of its shipment, provided that this warranty shall not apply to non-conformities and shall be void to the extent such non-conformities are not caused by Supplier’s or Supplier’s agents’ acts or omissions.

 

6.2                                  Remedies .  If any Product does not conform to the warranty stated in Section 6.1 above, the Supplier shall, at Purchaser’s option, within ninety (90) days repair or replace such Product or Component at the Supplier’s own expense, and ship such repaired or replacement Product or Component back to either the Purchaser or the applicable customer at the Supplier’s own expense, or credit to the Purchaser the Purchase Price for the Product or Component.  The foregoing warranty, and the remedies provided for in this Section 6.2 , are expressly conditioned upon (i) Purchaser providing Supplier with prompt written notice of any nonconforming Product or Component prior to the expiration of the warranty period, which notice must identify with particularity the non-conformity, and (ii) Purchaser’s full cooperation with Supplier in all reasonable respects relating thereto.  All defective Products or Components which are covered by the foregoing warranty shall be shipped to the Supplier at its expense for such repair or replacement.

 

6.3                                  Exclusions From Warranty .  The warranty set forth in Section 6.1 above does not include Products that 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 for the Product.

 

6.4                                  Product Recalls .  In the event of a Product or Component recall caused by Supplier’s breach of the warranty provided in Section 6.1 , Supplier shall at its cost and expense replace all Product or Component lots recalled (regardless of the number of nonconforming Products or Components, if any, in such lots), and pay any associated transportation costs with respect to such lots.  Without limiting Supplier’s liability under Sections 7.1(i)  and 7.1(ii) , the foregoing represents Supplier’s sole obligation with respect to Product or Component recalls.

 

6.5                                  LIMITATIONS .  THE WARRANTY PROVIDED IN SECTION 6.1 ABOVE IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS.  ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED.  EXCEPT WITH RESPECT TO EACH PARTY’S CONFIDENTIALITY OBLIGATIONS UNDER SECTION 11, NEITHER PARTY WILL UNDER ANY CIRC