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DISTRIBUTION AGREEMENT

Distribution Agreement

DISTRIBUTION AGREEMENT | Document Parties: EV3 INC. | INVATEC TECHNOLOGY CENTER GMBH | ev3 Endovascular, Inc You are currently viewing:
This Distribution Agreement involves

EV3 INC. | INVATEC TECHNOLOGY CENTER GMBH | ev3 Endovascular, Inc

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Title: DISTRIBUTION AGREEMENT
Governing Law: New York     Date: 2/20/2007
Industry: Medical Equipment and Supplies     Sector: Healthcare

DISTRIBUTION AGREEMENT, Parties: ev3 inc. , invatec technology center gmbh , ev3 endovascular  inc
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Exhibit 10.1

DISTRIBUTION AGREEMENT

between

(1)                                   INVATEC TECHNOLOGY CENTER GMBH (hereinafter referred to as Invatec ) having a registered office at Hungerbuelstrasse 12a, 8500 Frauenfeld, Switzerland, represented by its General Manager, Silvio Schaffner,

and

(2)                                   ev3 Endovascular, Inc. (hereinafter referred to as ev3 ) having its registered office at 9600 54 th  Avenue North, 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 non-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:

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 dated 15 February 2007;

1.2                                  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, except in the case of ev3, Warburg Pincus, L.P. and its Affiliates shall not be considered Affiliates under this Agreement);

1.3                                  Clinical Test shall mean: any clinical trial, test and/or whatsoever analysis which is required by the LAWS: (i) for obtaining from FDA IDE approval for Mo.Ma as commenced under the PRIOR AGREEMENT, (ii) for responding to FDA’s letter dated November 15, 2006 regarding the 510(k) submission for CHROMIS Deep and responding to the FDA regarding the 510(k) submission for SKIPPER Deep (the

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“510(k) Responses”), and/or (iii) for continuing valid registration of the PRODUCTS in the TERRITORY;

1.4                                  Effective Date shall mean: the date of signature of the AGREEMENT by the latter PARTY hereto;

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

1.6                                  Force Majeure shall have the meaning set forth by Article 15;

1.7                                  Gross Margin shall mean: the difference between the aggregate amount paid by ev3 to INVATEC for purchasing the PRODUCTS and the manufacturing and other costs incurred into by INVATEC for the PRODUCTS sold to ev3, during any contractual year.

1.8                                  Information shall mean: any data relating to the PRODUCTS, Mo.Ma, CHROMIS Deep, and SKIPPER Deep (including without limitation all data relating to clinical or pre-clinical studies or related to the regulatory approval process);

1.9                                  Initial Rolling Forecast shall have the meaning set forth in Article 12.2;

1.10                            Laws shall mean all the laws, regulations, ordinances and similar legally enforceable requirements applicable in the TERRITORY;

1.11                            Losses shall have the meaning set forth by Article 9.2;

1.12                            Minimum Annual Volume of Purchases shall mean the minimum volume of orders of PRODUCTS that ev3 must place for delivery during each of calendar year 2007 and 2008. For calendar year 2007 such amount shall be [***] units and for the calendar year 2008 such amount shall be [***] units;

1.13                            Mo.Ma . shall mean the Mo.Ma Cerebral Protection System manufactured by INVATEC at the EFFECTIVE DATE of this AGREEMENT.

1.14                            Parties shall mean INVATEC and ev3;

1.15                            Price-List shall have the meaning set forth by Article 3.2;

1.16                            Prior Agreement shall mean the distribution agreement dated 24 June 2004, and as amended by the first amendment to the distribution agreement executed on 10 February 2005 and made effective from 31 December 2004, which was terminated in accordance with the Termination Agreement;

1.17                            Products shall mean the versions of those products set out in Exhibit 1 and currently for sale in the TERRITORY. For the avoidance of doubt, INVATEC shall not discontinue any of the PRODUCTS during the TERM of this AGREEMENT, except where a recall or discontinuance of a PRODUCT is reasonably deemed necessary by INVATEC due to safety or other regulatory reasons; in the event of such discontinuance of any PRODUCT, the MINIMUM ANNUAL VOLUME OF PURCHASESshall be reduced pro-rata as


[***]Confidential treatment has been requested for the bracketed portions.  The confidential redacted portion has been omitted and filed separately with the Securities and Exchange Commission.

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determined by multiplying the MINIMUM ANNUAL VOLUME OF PURCHASES for any future calendar period by a fraction, the numerator of which is the number of units of the discontinued PRODUCT ordered by ev3 in the prior six (6) month period and the denominator of which shall be the overall volume of all PRODUCTS ordered by ev3 during such period.  For the current calendar year in which a PRODUCT is discontinued, the MINIMUM ANNUAL VOLUME OF PURCHASES shall be reduced by an amount equal to the product of (a) the fraction described in the preceding sentence, and (b) a fraction, the denominator of which is the number of days remaining in the calendar year and the denominator of which is 365 and (c) the MINIMUM ANNUAL VOLUME OF PURCHASES for such calendar year immediately prior to such calculation;

1.18                            Relevant Aggregate Volume shall have the meaning set forth in Article 17.1;

1.19                            Rolling Forecast shall have the meaning set forth by Article 12.2;

1.20                            Sign Up Fee shall have the meaning set forth by Article 3.1;

1.21                            Specifications shall have the meaning set forth by Article 8.1;

1.22                            Swiss Business Day shall mean a day (other than a Saturday or a Sunday) on which banks are open for business in Switzerland;

1.23                            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;

1.24                            Termination Agreement shall mean the agreement between the Parties dated 15 February 2007 pursuant to which the PRIOR AGREEMENT was terminated;

1.25                            Territory shall mean: the territory of the United States of America and Puerto Rico;

1.26                            Trademarks shall mean: all INVATEC’s proprietary TRADEMARKS with regard to INVATEC itself and/or the PRODUCTS;

1.27                            Unit Price means the price for one PRODUCT.

2.                                       APPOINTMENT OF ev3 AND GENERAL UNDERTAKINGS OF ev3.

2.1                                  INVATEC hereby appoints ev3 and ev3 hereby accepts appointment as its distributor of the PRODUCTS in the TERRITORY.  ev3 acknowledges (i) that, subject to Article 7.2, it has not been promised (and this AGREEMENT does not grant) an exclusive market by INVATEC (either with respect to INVATEC selling directly to customers or to other distributors) and (ii) that ev3 is not an agent or representative of INVATEC but is an independent entity performing a distribution function in the marketplace.

2.2                                  ev3 undertakes the following obligations vis-à-vis INVATEC:

(a)                                   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.

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(b)                                  Subject to its rights upon effective termination of this AGREEMENT pursuant to Article 14.3, 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 or indirectly, 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; provided, however, that nothing shall preclude ev3 from: (i) designing, developing and registering in the TERRITORY any products that compete with the PRODUCTS, (ii) engaging in any type of competitive activities with regard to any products could not reasonably be considered to be competitive with the PRODUCTS, provided that the PARTIES agree that ev3’s stent products shall not be deemed to be competitive with the PRODUCTS, (iii) engaging in any type of competitive activities outside of the TERRITORY; and (iv) engaging in any type of competitive activities with regard to the X-SIZER ®  Catheter System.

(c)                                   In the event that any business entity which is a competitor of INVATEC merges with ev3 or any Affiliate thereof or acquires a shareholding which exceeds 49% of the entire issued voting share capital in ev3, or any competitor of INVATEC acquires a material amount of assets from ev3 or ev3 acquires a controlling shareholding in such entity or a material amount of such entity’s assets (the “Acquiring Entity”), then the Acquiring Entity must either: (i) continue to operate ev3 independently until the termination of this AGREEMENT and allow any INVATECPRODUCTS to be sold or used only by ev3 and not by the Acquiring Entity; or (ii) must cause ev3 to purchase the MINIMUM ANNUAL VOLUME OF PURCHASES.

(d)                                  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;

(e)                                   ev3 will ensure that it conforms to the LAWS in force in the TERRITORY in relation to the PRODUCTS;

(f)                                     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;

(g)                                  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.

2.3                                  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

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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.

3.                                       PAYMENTS

3.1                                  Within two SWISS BUSINESS DAYS of the date of this Agreement, ev3 shall pay to INVATEC a sign up fee of USD 6.5 million by wire transfer to an account designated by INVATEC.  In addition, the remaining, unamortized portion of the sign up fee under the PRIOR AGREEMENT that exists as of the EFFECTIVE DATEshall constitute additional consideration under this Agreement (collectively, the Sign Up Fee ).

3.2                                  Unless otherwise agreed upon between the PARTIES in writing, during the Term of this Agreement, purchases by ev3 from INVATEC and sales by INVATEC to ev3 shall be made on the basis of the price-list (hereinafter, the Price-List ) agreed by the PARTIES per group of PRODUCTS and attached hereto as Exhibit 2 .

All prices for the purchase of the PRODUCTS will be in Euro. It is understood that payments shall remain in Euros throughout the term of the AGREEMENT, unless the Euro ceases to be the primary legal tender in Europe, in which case the payments under this AGREEMENT will be made in the new primary European currency.

3.3                                  INVATEC agrees that for the TERM of this AGREEMENT, it will not increase the prices for the Products from the prices set out in the Price-List.

3.4                                  The Unit Prices are given in Euro, for delivery EX WORKS (as defined in INCOTERMS 2000).

3.5                                  Unless otherwise agreed upon in writing, all payments of ev3 to INVATEC shall be made within thirty (30) days from the date of invoice. Late payments shall bear an interest calculated at 15% per annum. In the event of a late payment, INVATEC shall notify ev3 in writing and if ev3 does not cure such late payment within ten (10) days of such notice or provide INVATEC with a reasonable basis for dispute of such invoice, such late payment shall entitle INVATEC to cancel orders, although confirmed, and refuse additional orders until such time as all undisputed payment obligations have been remitted to Invatec. The right of ev3 to retain payment in total or in part and/or to set-off against any claims shall be excluded.  No orders cancelled or refused pursuant to this paragraph shall constitute a reduction in the MINIMUM ANNUAL VOLUME OF PURCHASES.

4.                                       CLINICAL TESTS AND REGISTRATIONS.

4.1                                  Unless otherwise instructed by INVATEC, ev3 undertakes to carry out all actions reasonably necessary (including all CLINICAL TESTS) to secure FDA IDE approval for Mo.Ma and to undertake the 510(k) Responses in a complete and timely manner.

4.2                                  ev3 shall conduct the CLINICAL TESTS under the supervision of INVATEC and shall allow reasonably requested access to INVATEC representatives, keep Invatec reasonably informed (including but not limited to responding to information requests from INVATEC) and follow requests from INVATEC in carrying out the CLINICAL TESTS.

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4.3                                  ev3 shall notify INVATEC within one (1) day of any communication from FDA or any other competent authority, in reasonable detail to allow INVATEC to make relevant business decisions and to comply with any and all applicable LAWS.

4.4                                  All actual costs for CLINICAL TESTS (including the costs of operating the Mo.Ma clinical trial) and related regulatory activities incurred following the Mo.Ma IDE approval and the 510(k) Responses will be borne by INVATEC; ev3 shall be responsible for all costs up to such time, provided that INVATEC has provided ev3 proper documentation for such application, and provided further that INVATEC shall be responsible for the costs of any additional Mo.Ma testing requested or required by FDA.  For the purpose of obtaining the Mo.Ma IDE approval and carrying out the Clinical Tests, INVATEC will provide ev3 with all the INFORMATION, documentation, and assistance required by any competent authority or otherwise needed in relation to the registration process.

4.5                                  All experimental protocols, studies and documents that ev3 intends to submit to FDA and/or any other competent authority shall have to be approved in writing in advance by INVATEC before submittal.

4.6                                  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.

4.7                                  Upon receipt of such Mo.Ma IDE approval and completion of the 510(k) Responses (or sooner if requested by INVATEC), ev3 shall cooperate as reasonably requested by INVATEC and in accordance with any FDA requirements to facilitate an orderly transition of the Mo.Ma. clinical work and the 510(k) Responses to INVATEC or a designee of INVATEC, including without limitation, any regulatory transfers necessary for INVATEC or its designee to continue the clinical studies under the IDE (or if transferred prior to approval for INVATEC or its designee to continue the application begun by ev3) as the sponsor of the study (the Clinical Transfer ).  Each party shall bear its own costs in facilitating such Clinical Transfer.

4.8                                  As part of the Clinical Transfer, ev3 shall transfer to INVATEC the INFORMATION in its possession with respect the Mo.Ma., CHROMIS Deep, and SKIPPER Deep devices and the CLINICAL TESTS; following such transfer ev3 shall have no further obligations under this Article 4.

4.9                                  Notwithstanding any provision in any other agreement between the Parties, ev3 may retain such clinical and regulatory data as reasonably required to perform its obligations under this AGREEMENT.

5.                                       TRADEMARKS, LABELS AND OTHER INTELLECTUAL PROPERTY.

5.1                                  All TRADEMARKS are the exclusive property of INVATEC.

5.2                                  During the TERM of this AGREEMENT, and subject to the terms and conditions herein, INVATEC hereby grants to ev3 a non-exclusive, non-sublicensable, royalty free, non transferable, licence to use the TRADEMARKS for relevant distribution in the TERRITORY. Except as provided in Article 16.4 in order to allow ev3 to continue selling any remaining inventory, such licence will expire automatically, without any

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prior written notice from INVATEC, upon the termination or expiration of this AGREEMENT for any reason.

5.3                                  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.

5.4                                  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.

5.5                                  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.

5.6                                  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 and state in the materials that such trademark is owned by INVATEC.  All representations of the TRADEMARKS which ev3 intends to use shall first be submitted to INVATEC for approval in writing.

5.7                                  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, except as provided in Article 11.1(c), 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.  ev3 shall provide to Invatec for approval, within ten (10) business days after the EFFECTIVE DATE, all such printed materials currently being used by ev3.

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

(a)                                   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

(b)                                  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.

5.9                                  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 5

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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.

5.10                            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.

5.11                            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.

5.12                            Except as provided in Article 16.4 (and in such instance, for the period described therein) in order to allow ev3 to continue selling any remaining inventory, 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 of this AGREEMENT 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.

6.                                       ORDERS, DELIVERY AND PAYMENTS.

6.1                                  INVATEC shall supply (or cause an Affiliate to 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 during the TERM of this AGREEMENT, purchase any product which is similar in nature to or which competes with the PRODUCTS from any company other than INVATEC or its AFFILIATES.

6.2                                  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 written orders (or written confirmation of verbal orders) which are not rejected by INVATEC within ten (10) SWISS BUSINESS DAYS from the receipt will be deemed to have been accepted by INVATEC. Once made, orders shall be binding on ev3.

Orders shall be for delivery in not less than sixty (60) days.   Within ten (10) SWISS BUSINESS DAYS from the receipt of the order, Invatec shall either confirm the delivery date(s) requested by ev3 or provide an alternative delivery date.  If Invatec provides an alternative delivery date that is more than ten (10) SWISS BUSINESS DAYS beyond the date requested by ev3, such modification shall not constitute a breach of this AGREEMENT, but ev3 may cancel such order(s) in writing within three (3) SWISS BUSINESS DAYS and the quantity of such order(s) shall constitute a reduction in the MINIMUM ANNUAL VOLUME OF PURCHASES(unless such alteration is due to an event of Force Majeure as defined in Article 15 or such order is subject to Article 6.4

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below).  For purposes of


 
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