DISTRIBUTION AGREEMENT

Exhibit 10.34

DISTRIBUTION AGREEMENT

between

INVATEC S.r.l. (hereinafter referred to as " INVATEC ") having a registered office at Via Martiri della Libertà 7, Roncadelle (BS), Italy, represented by its Chief Executive Officer, Mr. Andrea Venturelli,

and

ev3 Inc. (hereinafter referred to as "EV3") having registered office at 4600 Nathan Lane, Plymouth Minnesota 55442, represented by its President and Chief Executive Officer, Mr. James M. Corbett,

( INVATEC and EV3 are hereinafter also referred to as the " PARTIES ")

WITNESSETH

        WHEREAS, INVATEC operates in the business of designing, developing, manufacturing and selling under the TRADEMARK and/or trade name "INVATEC" the PRODUCTS (as hereinafter defined);

        WHEREAS, EV3 is willing to act as INVATEC 's exclusive distributor in the TERRITORY (as hereinafter defined) as to the PRODUCTS , upon the terms and conditions set forth in this AGREEMENT ;

        NOW, THEREFORE, the PARTIES hereto agree as follows:

ARTICLE 1. DEFINITIONS.

        As used in this AGREEMENT the following words will have the meaning defined hereunder (plural shall include singular and vice versa):

        1.1    " AGREEMENT " shall mean: this DISTRIBUTION AGREEMENT ;

        1.2    " AGGREGATE MINIMUM ANNUAL VALUE OF PURCHASES " shall mean: the aggregate minimum value of orders of the PRODUCTS which EV3 must place during any twelve (12) months period for delivery in the same twelve (12) months period, starting from the FIRST APPROVAL DATE ;

        1.3    " AFFILIATE ": means any entity that, directly or indirectly, now or hereafter controls or is controlled by or is under common control of a PARTY hereto, except that in countries where ownership of a majority or controlling interest by a foreign entity is not permitted by law, rule or regulations, the parent's direct or indirect voting interest may be less than a majority or controlling interest. ("Control"—including the terms "controls", "controlled by", "controlling" and "under common control with"—are understood as meaning the possession, direct or indirect, of the power to direct or cause the direction of the management and policies of a person or entity whether through the ownership of voting security, by contract or otherwise);

        1.4    " ANNUAL TARGETS " shall mean: the targeted orders per each group of PRODUCTS during any twelve (12) months period for delivery in the same twelve (12) months period for EV3 to reach, starting from the FIRST APPROVAL DATE ;

        1.5    " CLINICAL TEST " shall mean: any clinical trial, test and/or whatsoever analysis which is required by the Laws, necessary and/or useful for obtaining from FDA and/or any further competent authority of the TERRITORY the approval to the placement on the market and the REGISTRATION of the PRODUCTS in the TERRITORY ;

        1.6    " EFFECTIVE DATE " shall mean: the date of signature of the AGREEMENT by the latter PARTY hereto;

        1.7    " FDA " shall mean: the United States Food and Drug Administration;

        1.8    " FIRST APPROVAL DATE " shall have the meaning set forth by Article 6.3;

        1.9    " FORCE MAJEURE " shall have the meaning set forth by Article 15;

        1.10    " GROSS MARGIN " shall mean: the difference between, the aggregate amount paid by EV3 to INVATEC for purchasing the PRODUCTS and the manufacturing costs incurred into by INVATEC for the PRODUCTS sold to EV3, during any contractual year;

        1.11    " GROSS PROFIT " shall mean: the difference between the aggregate net amounts invoiced by EV3 to its customers on the sales of the PRODUCTS and the aggregate net amounts charged by INVATEC to EV3 for the sale of the PRODUCTS ;

        1.12    " INFORMATION " shall mean: any data relating to the PRODUCTS ;

        1.13    " INITIAL TERM " shall have the meaning set forth by Article 11.1;

        1.14    " LAWS " shall mean: all the laws, regulations, ordinances and similar legally enforceable requirements applicable in the TERRITORY ;

        1.15    " LOSSES " shall have the meaning set forth by Article 8.2;

        1.16    " MINIMUM ANNUAL VOLUME OF PURCHASES " shall mean: the minimum volume of orders per each group of PRODUCTS that EV3 must place during any twelve (12) months period for delivery in the same twelve (12) months period, starting from the FIRST APPROVAL DATE ;

        1.17    " MINIMUM EV3 STAFF " shall have the meaning set forth by Article 6.5;

        1.18    " OVERLAPPING PRODUCTS " shall mean: PRODUCTS manufactured by INVATEC which are similar to those PRODUCTS which are already manufactured and/or sold also by EV3 under its own brand name at the effective date of this Distribution AGREEMENT ;

        1.19    " PARTIES " shall mean: INVATEC and EV3;

        1.20    " PRICE-LIST " shall have the meaning set forth by Article 5.6;

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        1.21    " PRODUCT " shall mean: any endovascular and cardiology device manufactured by INVATEC , with the sole exclusion of OEM PRODUCTS . The PARTIES expressly agree that this AGREEMENT is to be considered automatically extended to any new cardiology and endovascular device which INVATEC may design, develop and launch after the Effective Date. The list of the PRODUCTS currently manufactured by INVATEC is shown in Exhibit 1;

        1.22    " REGISTRATION " shall mean: the necessary authorizations for placement on the market, marketing, distribution and sale in the TERRITORY of the PRODUCTS granted by any competent authorities of the TERRITORY , including, without limitation, the FDA;

        1.23    " RENEWED TERM " shall mean: both the FIRST RENEWED TERM and any Successive RENEWED TERMS of expiration of the AGREEMENT in case of renewal pursuant to Article 11.1;

        1.24    " ROLLING FORECAST " shall have the meaning set forth by Article 12.2;

        1.25    " SIGN UP FEE " shall have the meaning set forth by Article 2.5;

        1.26    " SPECIFICATION " shall have the meaning set forth by Article 7.1;

        1.27    " TERM " shall mean: the time period commencing on the Effective Date and expiring on the date of expiration or termination as provided for in the AGREEMENT ;

        1.28    " TERRITORY " shall mean: the TERRITORY of the United States of America and Puerto Rico;

        1.29    " TRADEMARKS " shall mean: all INVATEC 's proprietary TRADEMARKS to be used for the REGISTRATIONS .

ARTICLE 1. APPOINTMENT OF EV3 AND GENERAL UNDERTAKINGS OF EV3.

        2.1     INVATEC hereby appoints EV3 and EV3 hereby accepts appointment as its exclusive distributor of the PRODUCTS in the TERRITORY . The PARTIES agree that during the continuance of the AGREEMENT , INVATEC shall not appoint any other distributor for the distribution of the PRODUCTS in the TERRITORY , nor distribute or sell the PRODUCTS in the TERRITORY directly or through its AFFILIATES .

        2.2     INVATEC will retain all distribution rights in the TERRITORY for any product other than the PRODUCTS .

        2.3    EV3 undertakes the following obligations vis-à-vis INVATEC :

• (i)

  EV3 will actively promote, distribute and sell the PRODUCTS in the TERRITORY to the best of its capability and exercising at least the same level of diligence and efforts it exercises for the marketing and distribution of its own PRODUCTS and in accordance with and subject to the terms of this AGREEMENT . EV3 shall not, either directly or indirectly, and shall cause its AFFILIATES not to, (nor assist any third party in) during the Term of this AGREEMENT , either directly

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• • or indirectly, design, develop, register, launch, market, sell, promote or distribute, in the TERRITORY , PRODUCTS which are similar in nature to or which in the reasonable judgment of INVATEC compete with the PRODUCTS , with the exception of the PRODUCTS which are manufactured and/or sold by EV3 listed in Exhibit 2;

  (ii)

  EV3 shall during the continuance of this AGREEMENT diligently and faithfully serve INVATEC as its distributor in the TERRITORY and shall use its best endeavours to improve the goodwill of INVATEC in the TERRITORY and to further increase the sale of the PRODUCTS in the TERRITORY ;
  
  

  (iii)

  EV3 will ensure that it conforms to the Laws in force in the TERRITORY in relation to the PRODUCTS ;
  
  

  (iv)

  EV3 undertakes to store the PRODUCTS under conditions that will prevent deterioration and also (on the instructions of INVATEC ) to store particular PRODUCTS under such special conditions as may be appropriate to their requirements. Where EV3 is responsible for clearing goods through customs and other import formalities into the TERRITORY it shall exercise its best endeavours to ensure that during such clearance the goods are stored as aforesaid. EV3 agrees to allow INVATEC or its authorised representatives to inspect the PRODUCTS when in storage under the control of EV3 from time to time upon reasonable notice;
  
  

  (v)

  EV3 undertakes not to, either directly or indirectly, copy, produce, make, modify or manufacture or assist in any way any other party to copy, produce, make, modify or manufacture the PRODUCTS or any part thereof for use, sale or any other purpose.

        2.4    EV3 shall not, and EV3 shall cause its AFFILIATES , not to (i) solicit orders for the sale of PRODUCTS to any existing or prospective customer outside the TERRITORY , (ii) deliver, tender or sell (or cause to be delivered, tendered or sold) any Product outside the TERRITORY , or (iii) sell any PRODUCT to, or solicit any sales from, a customer if EV3 knows or has reason to know that such customer intends to resell the PRODUCTS outside of the TERRITORY .

        2.5    Upon execution of this AGREEMENT EV3 shall pay to INVATEC a sign up fee of USD 5 million (the "Sign Up Fee") which shall only be recoverable in payment pro rata of 10% of any amount due by EV3 to INVATEC for PRODUCTS purchased during the Initial Term of this AGREEMENT . Amounts of the Sign Up Fee not recovered by EV3 during the INITIAL TERM shall only be payable to EV3 by INVATEC in case of (i) termination of this AGREEMENT for default of INVATEC ; or (ii) no registration of any of the PRODUCTS is obtained; within two (2) years from the Effective Date or all of the REGISTRATIONS obtained are cancelled by FDA or any other competent authority, provided that failure in obtaining the REGISTRATIONS or the cancellation of the REGISTRATIONS , as the case may be, are not attributable to EV3.

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ARTICLE 3. CLINICAL TESTS AND REGISTRATIONS.

        3.1    EV3 undertakes to carry out at its own expense all CLINICAL TESTS and all studies necessary for marketing purposes.

        3.2    EV3 shall, pursuant to the Laws, apply to FDA and/or to any further competent authority in the TERRITORY for the REGISTRATION on behalf of and under the name of INVATEC , provided that INVATEC has presented proper documentation for such application.

        For the purpose of obtaining the REGISTRATION of the PRODUCTS , INVATEC will provide EV3 with all the INFORMATION , documentation and assistance needed in relation to the REGISTRATION process.

        Within thirty (30) days from receipt from INVATEC of the INFORMATION and documentation needed for the REGISTRATION , EV3 shall submit to the FDA and/or any other competent authority in the TERRITORY any applications aimed at obtaining the REGISTRATION of the PRODUCTS in the TERRITORY .

        3.3    Until the REGISTRATION is granted, EV3 will maintain the overall responsibility for the REGISTRATION process and will be the leading interface with the regulatory authorities. It is also agreed that INVATEC and EV3 will co-operate and support each other on technical and regulatory issues and that EV3 will keep INVATEC constantly informed on the relevant REGISTRATION activities. INVATEC will retain in any event the ultimate control of any strategic decision regarding the PRODUCT REGISTRATION strategy.

        3.4    EV3 shall notify INVATEC within one (1) days of any technical complaints that EV3 received from FDA or any other competent authority, in sufficient detail to allow INVATEC to comply with any and all applicable Laws. EV3 shall also advise INVATEC of any regulatory action (e.g. request of INFORMATION on the PRODUCTS , proposed changes in labelling, packaging, storage conditions, and recalls) which would affect the PRODUCTS in the TERRITORY .

        3.5     INVATEC will provide EV3 with the INFORMATION required by any competent authority for the successful outcome of the REGISTRATION process. EV3 acknowledges that INVATEC has exclusive ownership title to the INFORMATION . INVATEC grants to EV3, for the Term of the AGREEMENT , free of charge, the right to use and cite the INFORMATION for the purpose of the successful outcome of the REGISTRATION process. EV3 shall identify INVATEC as the owner of all INFORMATION filed in connection with the aforementioned REGISTRATION .

        3.6    EV3 shall not make any changes to the INFORMATION without the prior written consent of INVATEC . EV3 shall not make any statement and representation in its promotional materials or otherwise with respect to the PRODUCTS that are inconsistent with the INFORMATION .

        3.7    All relevant costs, including without limitation expenses, levies, fees, charges, for all CLINICAL TESTS and for the REGISTRATION of the PRODUCTS will be borne by EV3. In the event of early termination of the AGREEMENT due to the infringement by

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INVATEC of the obligations provided for by the AGREEMENT , INVATEC undertakes to reimburse to EV3 the amount of the expenses (with the exception of internal expenses, e.g. own personnel cost, etc.) incurred for performing the CLINICAL TESTS that were strictly requested for obtaining from FDA and/or any other competent authority in the TERRITORY the REGISTRATION of the PRODUCTS , which exceeds the amount of the aggregate GROSS-PROFIT earned by EV3 by selling the PRODUCTS by the date the termination becomes effective.

        3.8    All experimental protocols, studies and documents that EV3 intends to submit to FDA and/or any other competent authority for the purpose of obtaining any necessary REGISTRATION for the PRODUCTS shall have to be approved in writing in advance by INVATEC before submittal.

        3.9    The PARTIES shall keep each other informed in advance of any scheduled meetings or discussions with FDA and/or any other competent authority in the TERRITORY that involve the safety profile of PRODUCTS .

        3.10    The parties recognize that new market requirements may emerge upon the introduction of any of the PRODUCTS into the U.S. market, or after such introduction, that may require some alterations to the PRODUCT(S) and in such cases, the parties agree to discuss in good faith the appropriate action(s) needed to ensure market acceptance, and to renegotiate in good faith any terms of the AGREEMENT that a reasonable business person would believe should be modified as a result of such market issues. Failure of INVATEC to implement the necessary corrective action, shall give EV3 the right to terminate the AGREEMENT on 180 days notice, and in such case EV3 shall not be liable to INVATEC for any penalties or damages under this AGREEMENT , and INVATEC shall refund to EV3 any balance not yet credited for the Sign-Up Fee, as well as all external costs incurred in designing and conducting CLINICAL TESTS with the limits identified in art. 3.7 above.

ARTICLE 4. TRADEMARKS, LABELS AND OTHER INTELLECTUAL PROPERTY.

        4.1    All TRADEMARKS are the exclusive property of INVATEC .

        4.2    During the Term of this AGREEMENT , and subject to the terms and conditions herein, INVATEC hereby grants to EV3 an exclusive, royalty free, non transferable, licence to use the TRADEMARKS on the PRODUCTS for relevant distribution in the TERRITORY . Such licence will expire automatically, without any prior written notice from INVATEC , upon the termination or expiration of the AGREEMENT for any reason.

        4.3    The TRADEMARKS shall not be used in any manner liable to invalidate the registration thereof and the right to use the TRADEMARKS in connection with the appropriate PRODUCTS is only granted to the extent that INVATEC is able to do so without endangering the validity of the registration.

        4.4    EV3 undertakes not to apply the TRADEMARKS to any item which is not one of the PRODUCTS nor to distribute or sell any such items with the TRADEMARKS so applied or to engage in any other practice or activity likely to mislead potential purchasers into believing that an item is one of the PRODUCTS when in fact it is not.

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        4.5    All PRODUCTS shall be sold under the co-brand of both INVATEC and EV3, provided that the co-brand includes with the same prominence the logo and any detail of both the PARTIES .

        4.6    On all PRODUCTS , containers, advertisements and technical literature for the PRODUCTS the symbol ® shall be used in conjunction with the registered TRADEMARKS or "TM" in conjunction with any Trade Mark applications. All representations of the TRADEMARKS which EV3 intends to use shall first be submitted to INVATEC for approval in writing.

        4.7    EV3 undertakes to send INVATEC prior to the use of any TRADEMARKS or brand names a sample of each letter-head, invoice, price-list, label, brochure and all other advertising material displaying such TRADEMARKS or trade or brand name and only to use items of such printed materials the proofs for which have received in each case the express and specific prior approval of INVATEC .

        4.8    Each parry shall promptly give notice in writing to the other in the event that it becomes aware of:

• (i)

  any infringement or suspected infringement by any third party within the TERRITORY of the TRADEMARKS , any patent or patent application, or any other intellectual property rights of INVATEC in or relating to the PRODUCTS ; and
  
  

  (ii)

  any claim or alleged claim that the PRODUCTS sold by EV3 hereunder or that the TRADEMARKS or trade names or know-how, packaging features or leaflets used by EV3 on or in connection with the PRODUCTS , or any patent or patent application under which the PRODUCTS are manufactured, used or sold, infringes any intellectual property rights of any third party or constitutes an act of unfair competition or parasitism, or any action commenced by a third party in which the declaration of invalidity of any TRADEMARK and/or any patent application under which the PRODUCTS are manufactured, used or sold, is sought, which affect or may affect INVATEC 's and/or EV3's interests.

        4.9     INVATEC shall have the right, in its sole discretion, to bring, defend, control and/or direct, in its own name, any legal proceeding, or other action, including any settlement or negotiation, with respect to the matters described in this Article 4 involving its interests for its own benefit. EV3 shall provide INVATEC with any reasonable support and INFORMATION as INVATEC may request in relation to any such legal proceeding, settlement or negotiation.

        4.10    At the request of INVATEC , EV3 shall take part in or give assistance in respect of any legal proceedings and execute any document and do any things reasonably necessary to protect INVATEC 's intellectual and industrial property rights (including without limitation the TRADEMARKS ) in the TERRITORY . Any relevant cost and expense, including legal fees, related to EV3's assistance will be sustained by EV3.

        4.11    The PARTIES agree to consult each other upon request but, in general, not less frequently than annually, on the need for changes in labelling of the product INFORMATION supplied to end users, the medical professional or patients.

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        4.12    EV3 undertakes that following expiration and/or termination for any reason of the AGREEMENT , it will have no further rights to use and will refrain from further use of TRADEMARKS or of any designs or packaging typical of PRODUCTS .

        EV3 undertakes as well that, in any case of expiration and/or termination may occur, it will not use any marks which are so similar to TRADEMARKS in respect of appearance or meaning that confusion could arise in practice.

        4.13    EV3 agrees to take on the responsibility and cost of securing clearance opinions as EV3 in its sole discretion deems to be advisable for introduction and sale of any and all PRODUCT(S) in the TERRITORY , provided however, that in the event EV3 is unable to secure a satisfactory clearance opinion upon which it can reasonably rely for any PRODUCT , EV3 may decide in its sole discretion that it will not introduce that affected PRODUCT , and the parties will reduce the AGGREGATE MINIMUM ANNUAL VALUE OF PURCHASES and the MINIMUM ANNUAL VOLUME OF PURCHASES accordingly, provided that should the number of PRODUCTS or the AGGREGATE MINIMUM ANNUAL VALUE OF PURCHASES be, as a result of this decision not to introduce the affected PRODUCT(S) , reduced by at least 2/3, INVATEC shall have the right to terminate this AGREEMENT upon 6 month notice in writing.

ARTICLE 5. ORDERS, DELIVERY AND PAYMENTS.

        5.1     INVATEC shall supply EV3 with the PRODUCTS . EV3 shall purchase the PRODUCTS exclusively from INVATEC , or its AFFILIATES , designated by INVATEC and shall not, under any circumstances, purchase any product which is similar in nature to or which competes with the PRODUCTS from any company other than INVATEC or its AFFILIATES .

        5.2    Orders shall be in writing, or if made verbally have to be confirmed in writing by EV3 within forty-eight (48) hours. Otherwise verbally made orders will be considered as not placed by EV3. Under no circumstances, an order shall bind INVATEC unless it is accepted in writing by INVATEC . Notwithstanding the above, it is agreed that orders which are not rejected by INVATEC within five (5) Italian business days from the receipt will be deemed to have been accepted by INVATEC .

        Orders shall be for delivery in not less than sixty (60) days.

        5.3     INVATEC reserves the right to reject in whole or in part the ROLLING FORECASTS pursuant to Article 12.2 below and/or any order without any liability to EV3. It is agreed however that INVATEC may not reject ROLLING FORECASTS and orders which do not exceed the ANNUAL TARGETS and that comply with the provisions of Article 12.2 below and that INVATEC may reject orders only for justifiable business reasons (including insufficient production capacity and overstock by EV3).

        5.4    In case of any discrepancy between the order and INVATEC 's order confirmation, the latter will prevail, unless EV3 contests it in writing within forty eight (48) hours upon receipt of order confirmation.

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        5.5     PRODUCTS will be delivered to EV3 Ex Works INVATEC 's premises in Roncadelle (Brescia), Italy (as defined in INCOTERMS 2000 ) where delivery shall take place. INVATEC shall give EV3 notice of the date on which the PRODUCTS are to be delivered. All dates for delivery of the PRODUCTS are given by INVATEC in good faith but are only estimates and INVATEC shall not be liable for any failure to deliver on the date so given. Collection and transport of the PRODUCTS shall be effected by EV3 on its own responsibility and its own expense. All risks shall pass to EV3 on the date of the delivery of the PRODUCTS under the