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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