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Exhibit 10.11
EUROPEAN MARKET DEVELOPMENT
AGREEMENT
between
Esaote S.p.A.,
a company organized under the laws of the Republic of Italy and
with registered seat in Genova, Italy (hereinafter referred to as
“Esaote”)
— of the one party
—
and
TechniScan,
Inc., a Utah corporation (hereinafter referred to as
“TechniScan”)
— of the other party
—
Esaote and
TechniScan are hereinafter referred to individually as a
“Party” and collectively as the
“Parties”
Recitals
WHEREAS, Esaote
is a leading player in the market of ultrasound systems and has
developed a proprietary technology for such systems;
WHEREAS, Esaote
manufactures and sells, inter alia, ultrasound systems for the
examination of the breast;
WHEREAS,
TechniScan has developed a prototype of a device for the three
dimensional imaging of the whole breast using both reflection and
transmission ultrasound to create tomographic images of the female
breast;
WHEREAS, on
20th November 2007 the Parties executed a term sheet setting
forth inter alia, the basic principles of their possible
co-operation in the field of ultrasound systems for breast
examination (hereinafter referred to as the “Term
Sheet”) ;
WHEREAS,
TechniScan and Esaote on 11 th February 2008 have
consolidated their relationship through (i) the acquisition by
Esaote of an equity ownership interest in TechniScan pursuant to a
Stock Purchase Agreement (the “Stock Purchase
Agreement” or the “SPA”), (ii) through
the execution of an original equipment manufacturing and
engineering support agreement (the “OEM
Agreement”) for the development of a regulatory approved
and usable three dimensional imaging system of the whole breast
using both reflection and transmission ultrasound to create
tomographic images of the female breast and (iii) through the
execution of an exclusive license and distribution Agreement under
which Esaote will distribute the Products (the
“Distribution Agreement”) ;
WHEREAS, Esaote
and TechniScan have been cooperating effectively to develop the
Products and a prototype version of the Product is now installed in
Esaote;
WHEREAS,
TechniScan has not obtained the FDA approval on the Product defined
as the milestone for the Second Closing (as detailed in the SPA)
and has redefined its strategy and planning for FDA
approvals;
WHEREAS,
TechniScan and Esaote have reached a common understanding in how to
redefine the Product strategy and they agree that it is worthwhile
to focalize better the European market, therefore the activities to
obtain the CE mark for the Product and to start the marketing
activities in Europe;
WHEREAS, both
TechniScan and Esaote are willing to integrate the existing
Agreements entering in this European Market Development Agreement
(“the EU Agreement”);
NOW, THEREFORE,
the Parties enter into this EU Agreement as follows:
•
Without prejudice to what is
provided for in this EU Agreement, all terms and conditions of the
previous Agreements shall remain in full force and
effect.
•
Terms which are defined in the
previous Agreements shall have the same meanings when used in this
EU Agreement, unless a different definition is given
herein.
•
TechniScan will provide (including
the system already shipped to Esaote) a total of five Product to
Esaote to be used in the CE marking activities and in order to
establish clinical reference sites in Europe:
- 1
prototype to be used in Esaote to support the development (already
at Esaote)