ACCELLENT-CONCEPTUS SUPPLY AGREEMENT

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CONFIDENTIAL
CERTAIN INFORMATION HAS BEEN REDACTED
CONFIDENTIAL TREATMENT REQUESTED

Exhibit 10.34

ACCELLENT-CONCEPTUS

SUPPLY AGREEMENT

        This Supply Agreement (the " Agreement ") dated as of November 7, 2005 (the " Effective Date ") is between Accellent Corp., a Colorado company with its principal office at 100 Fordham Road, Building C, Wilmington, MA 01887 (" Supplier "), and Conceptus Incorporated, with its principal office at 1021 Howard Avenue, San Carlos, CA 94070 (the " Purchaser ").

        WHEREAS, the Purchaser has developed and designed a medical device and seeks to have such device manufactured for it by the Supplier; and

        WHEREAS, the Supplier has expertise in the manufacture of medical devices and components and desires to provide manufacturing services for the Purchaser.

        NOW, THEREFORE, in consideration of the mutual covenants contained herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree as follows:

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

        1.1    Affiliate .    "Affiliate" means any entity which directly or indirectly controls, is controlled by, or is under common control with the referenced party.

        1.2    Approved Supplier List .    "Approved Supplier List" has the meaning given in Section 3.7 .

        1.3    Bankruptcy Event .    "Bankruptcy Event" means the institution of voluntary or involuntary proceedings by or against a person or entity in bankruptcy or under any insolvency law, or the appointment of a receiver or custodian for such person or entity, or the institution of proceedings by or against such person or entity for corporate reorganization or the dissolution of such person or entity, which proceedings, if involuntary, shall not have been dismissed within sixty (60) days after the date of filing, or an assignment by such person or entity for the benefit of its creditors.

        1.4    Competitor .    "Competitor" means any company that sells a non-surgical female tubal sterilization device or process.

        1.5    Controlled Environment Room .    "Controlled Environment Room" shall mean a room that is used to manufacture Products having a controlled environment to limit particulate and microorganisms.

        1.6    Change in Control .    "Change in Control" means the direct or indirect (i) 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."

        1.7    Delivery Date .    "Delivery Date" has the meaning given in Section 3.4 .

        1.8    Delivery Schedule .    "Delivery Schedule" has the meaning given in Section 3.4 .

        1.9    Event of Default .    "Event of Default" has the meaning given in Section 13 .

        1.10  Forecast .    "Forecast" has the meaning given in Section 3.3 .

        1.11  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.

        1.12  Intellectual Property .    "Intellectual Property" has the meaning given in Section 10.1 .

        1.13  Intellectual Property Rights .    "Intellectual Property Rights" has the meaning given in Section 10.1 .

        1.14  Procedures .    "Procedures" has the meaning given in Section 2.1 .

        1.15  Process .    "Process" means the methods and all referenced procedures used in the manufacture of the Product.

        1.16  Product .    "Product" means a kit containing two (2) Essure devices, as further described in Exhibit A hereto.

        1.17  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.

        1.18  Purchase Order .    "Purchase Order" means a purchase order for Products in a form provided by Purchaser.

        1.19  Purchase Price .    "Purchase Price" has the meaning given in Section 3.1 .

        1.20  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.

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

        1.22  Specifications .    "Specifications" means the specifications for the Product as provided in the Product Device Master Record.

        1.23  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

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inspection procedures used by Supplier in connection with the manufacture of the Products are collectively the " Procedures ." 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.

        2.2    Purchase Requirements .    Purchaser is not required to purchase any specific quantity of Products under this Agreement.

        2.3    Essure Catheter Assembly Manufacturing Transfer .     Exhibit C contains the terms and conditions under which Supplier shall transfer the manufacturing capabilities for the next generation of the Essure catheter assembly (i.e., the ESS305 Essure Catheter Assembly, or " ESS305 ") from Purchaser's location in San Carlos, California to Supplier's facility in Juarez, Mexico. Once the transfer has been completed and the manufacturing line has been validated and approved in writing by Purchaser, all ESS305 products manufactured by Supplier after that point will deemed "Products" and be governed by the terms of this Agreement.

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

        3.1.   Purchase Price .    The purchase price (" Purchase Price ") for each Product purchased from Supplier shall be as set out on Exhibit B 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%); (iii) 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 fifty percent (50%) 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 (iv) if Purchaser pays the entire cost of any Changes, Purchaser shall realize the entire amount of any cost reduction resulting from such Change in the form of a lower Product price. In addition to the Supplier's other rights and remedies, Supply 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 (i) of the Purchase Price owed under this Agreement, or (ii) due pursuant to the services provided under Exhibit C , which amounts are not paid when due.

        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

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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 three (3) month period.

        3.4    Purchase Orders .    Purchaser may from time to time provide Supplier 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. The schedule of agreed upon 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 .

        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.

        3.7    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 in its sole discretion. 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.

        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

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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 specified in a Forecast with shipment dates specified in the Delivery Schedule between thirty (30) and one-hundred and twenty (120) days from the date of cancellation, (b) a sustained reduction in Product purchases specified in the Forecast of more than twenty-five (25%) over a three- (3) month period, (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 paid by Purchaser for all Products in the one-hundred and twenty day (120) day period immediately preceding Supplier's initial claim for charges related to Excess Inventory.

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 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

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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.

        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

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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 D .

6.      Product Warranty and Limited Remedies; Customer Complaints .     

        6.1    Warranty .    The Supplier warrants that each Product 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' or contractors' 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 at the Supplier's own expense, and ship such repaired or replacement Product 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. 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 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 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 recall caused by Supplier's breach of the warranty provided in Section 6.1 , Supplier shall at its cost and expense replace all Product lots recalled (regardless of the number of nonconforming Products, if any, in such lots), and pay any associated shipping and handling 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 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 CIRCUMSTANCES BE LIABLE FOR ANY PUNITIVE, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES, INCLUDING LOST PROFITS OR REVENUES; AND EXCEPT WITH RESPECT TO EACH PARTY'S INDEMNIFICATION OBLIGATIONS UNDER SECTION 7, NEITHER PARTY'S AGGREGATE LIABILITY UNDER THIS AGREEMENT, WHETHER BASED UPON CONTRACT, TORT, OR OTHERWISE, SHALL EXCEED THE ACTUAL AMOUNTS PAID BY PURCHASER FOR PRODUCTS DURING THE IMMEDIATELY PRECEDING TWELVE (12) MONTH PERIOD FROM WHEN THE CLAIM FOR LIABILITY AROSE, REGARDLESS OF WHETHER THE PRODUCTS WERE PURCHASED DURING SUCH PERIOD UNDER THIS AGREEMENT OR UNDER THE "CONTRACT MANUFACTURING AGREEMENT" BETWEEN CONCEPTUS AND VENUSA LTD. DATED JUNE 20, 2003 (the " June 20, 2003 Agreement ").

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        6.5    Disputes .    If the Supplier disagrees with a claim that a Product does not conform to the warranty provided in Section 6.1 , then the parties agree to submit the disputed Product to an independent party which has the capability of testing the Product to determine whether or not it does so conform. In the event the parties cannot agree upon such independent party, or in the event it is not possible to acquire the services of such an independent party, then such dispute shall be resolved pursuant to Section 14.11 . The cost of the independent testing party shall be borne by the party against whom the testing party finds, as directed by the testing party.

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

        7.1    By Supplier .    The Supplier agrees to indemnify, defend and hold the Purchaser harmless against any and all claims, suits, proceedings, expenses, recoveries and damages of or by third parties, including court costs and 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 of its warranty provided in Section 6.1 , which breach causes bodily harm, death, or property damage, (ii) the willful misconduct or gross negligence of the Supplier, or (iii) any claim of infringement of any Intellectual Property Right of any third party based upon or arising out of the Supplier's manufacturing processes with respect to the Products. The Purchaser will promptly notify the Supplier of any such claim or demand which comes to its attention.

        7.2    The Purchaser .    The Purchaser agrees to indemnify, defend and hold the Supplier harmless against any and all claims, suits, proceedings, expenses, recoveries, and damages of or by third parties, including court costs and 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 the design of the Products, (ii) any allegation or claim that the design for the 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 its Affiliates or any other party on the packaging or labeling of any of the Products, or in the advertising, publicity, promotion, or sale of any of the Products, (iv) the storage, sale, shipment, promotion, or distribution of the Products (except to the extent that such claims are covered by Supplier's indemnity in Section 7.1 ), (v) the use or operation of the Products (except to the extent that such claims are covered by Supplier's indemnity in Section 7.1 ), or (vi) any allegation or claim that the Products are not sterile. The Supplier will promptly notify the Purchaser of any such claim or demand which comes to its attention.

        7.3    General .    The party claiming indemnity (the " Indemnified Party ") shall provide the party from whom indemnity is being sought (the " Indemnifying Party ") with reasonable assistance, at the Indemnifying Party's expense, in connection with the defense of the claim for which indemnity is being sought. The Indemnified Party may participate in and monitor such defense with counsel of its own choosing, at the Indemnified Party's cost; however, the Indemnifying Party shall have the right to assume and conduct the defense of the claim with counsel of its choice and shall retain final decision-making authority with respect to the conduct of the defense. The Indemnifying Party shall not settle any claim without the prior written consent of the Indemnified Party, not to be unreasonably withheld, unless the settlement involves only the payment of money by the Indemnifying Party . So long as the Indemnifying Party is actively defending the claim in good faith, the Indemnified Party shall not settle any such claim without the prior written consent of the Indemnifying Party. If the Indemnifying Party does not assume and conduct the defense of the claim as provided above, (i) the Indemnified Party may defend against, and consent to the entry of any judgment or enter into any settlement with respect to the claim in any manner the Indemnified Party may deem reasonably appropriate (and the Indemnified Party need not consult with, or obtain any consent from, the Indemnifying Party in connection therewith) and (ii) the Indemnifying Party will remain responsible to indemnify the Indemnified Party as provided in this Section 7 .

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8.      Insurance .     

        8.1   Each party agrees to procure and maintain in full force and effect during the term of this Agreement and for three years thereafter valid and collectible insurance policies in connection with the supply and sale of Products pursuant to this Agreement and provide; (i) for commercial general liability coverage in the amount of $1,000,000 each occurrence and $2,000,000 general aggregate excluding Products and Completed Operations coverage and written on an occurrence basis and, (ii) Products and Completed Operations coverage in the amount of $5,000,000 per occurrence, $10,000,000 in the aggregate and written on a claims made basis. Such policies shall endeavor to provide for thirty (30) days written notice of cancellation to the other party. Upon either party's request, the other party shall provide to the requesting party a certificate 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 associated with the Products and which are approved by Purchaser for use by Supplier in the manufacture of the Products. In consideration of the fees set forth herein, Purchaser further grants to Supplier a non-exclusive license during the Term to use the Trademarks on and solely in connection with the manufacture of the Products, and for this purpose to affix, subject to Purchaser's prior written approval, the Trademarks to or on the Products and to or on any packaging materials used in connection with the Products. Any and all uses of the Trademarks shall be subject to the prior written approval of Purchaser. Supplier shall not remove trademark notices from any Product or component thereof without the prior written consent of Purchaser. Supplier shall not use the name, Trademarks or logos associated with the Products in its business name or in any manner other than as specified in this Section. Purchase shall have and retain ownership of all Trademarks. The Purchaser acknowledges that such trademark ownership rights do not extend to the Supplier's proprietary formulae, processes, or other written proprietary information that Supplier 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.

10.      Intellectual Property; Tooling .    

        10.1  Intellectual Property Rights .    Each party shall retain sole ownership of, and all Intellectual Property Rights to, any Intellectual Property of any kind owned by that party as of the Effective Date. Purchaser shall own any and all Intellectual Property Rights in and to the Products, and to any and all improvements to Products developed during the term of this Agreement, whether such improvements are developed by Supplier or by Purchaser, or jointly by the parties. Supplier shall own any and all Intellectual Property Rights in and to any and all improvements to its manufacturing processes that it develops during the term of this Agreement. Subject to Section 11 of this Agreement and all of Purchaser's Intellectual Property Rights, Purchaser acknowledges and agrees that: (i) Supplier is in the business