ORIGINAL EQUIPMENT
MANUFACTURING AGREEMENT
AND ENGINEERING SUPPORT AGREEMENT
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”)
TechniScan,
Inc., a Utah corporation (hereinafter referred to as
“TechniScan”)
Esaote and
TechniScan are hereinafter referred to individually as a
“Party” and collectively as the
“Parties”
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,
TechniScan and Esaote have expressed the interest to solidify their
relationship both (i) through the acquisition by Esaote of an
equity ownership interest in TechniScan pursuant to a Stock
Purchase Agreement dated on or about the date hereof (the
“Stock Purchase Agreement” or the “SPA”),
(ii) through the execution of this original equipment
manufacturing and engineering support agreement (this
“Agreement” or 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, 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, Esaote
has provided and is continuing to provide engineering and design
support and original equipment manufacturing prototype equipment
and supplies to TechniScan which
will be treated
as contribution in kind to TechniScan’s corporate capital for
a value of US$1 million as recognized under the SPA and as
anticipated under the Term Sheet;
WHEREAS, ESAOTE
has provided an open-frame development system (i.e. a system with
production electronics and arrays but without the final covers and
other customer features) to TechniScan as anticipated under the
Term Sheet as well as other components set out in Annex 1
hereto;
NOW, THEREFORE,
the Parties enter into this Original Equipment Manufacturing
Agreement and Engineering Support Agreement as follows:
In addition to
capitalized terms defined elsewhere in this Agreement the following
words in capital shall have the meaning set out below. Words
importing the singular shall include the plural and vice
versa.
1.1. The term
“Bankrupt” shall mean, with respect to either
Party, if any of the following events occurs: such Party
(a) voluntarily becomes the subject of any proceedings
relating to its winding-up, liquidation, insolvency or for the
appointment of a receiver or similar officer for it,
(b) involuntarily becomes the subject of any proceedings
relating to its winding-up, liquidation, insolvency or for the
appointment of a receiver or similar officer for it, which is not
discharged in its favor with prejudice within ninety (90) days
thereafter; (c) makes an assignment for the benefit of all or
substantially all of its creditors, or enters into an agreement for
the extension or readjustment of all or substantially all of its
obligations; (d) has filed against it, a petition or other
document seeking relief under bankruptcy laws, which is not
discharged within ninety (90) days thereafter; or (e) a
temporary or permanent receiver or liquidator is appointed over a
Party or substantially all of such Party’s assets and such
appointment is not cancelled within ninety (90) days
thereafter.
1.2. The term
“Change of Control” shall mean (i) the
consummation of the sale or disposition by a Party of all or
substantial all of such Party’s assets or (ii) the
consummation of a merger or consolidation of a Party with any other
entity, other than a merger or consolidation which would result in
the voting securities of the Party outstanding immediately prior
thereto continuing to represent (either by remaining outstanding or
by being converted into voting securities of the surviving entity
or its parent) at least fifty percent (50%) of the total voting
power represented by the voting securities of the Party or such
surviving entity or its parent outstanding immediately after such
merger or consolidation; and for the purposes of this Agreement, in
the case of Esaote shall mean the above AND, in addition, that such
a change results in a stop of Esaote’s supply and product
development support under the OEM Agreement (for example, a change
in control resulting from a restructuring of ownership that does
not affect the OEM Agreement would NOT be considered “
Change of Control ” for Esaote). Notwithstanding the
foregoing, a “Change of Control” does not
include any Change of
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Control that
occurs as a result of the initial public offering of the stock of
either Party which generates gross proceeds of at least
$10 million.
1.3. The term
“Copyrights” shall mean all copyrights and
copyrightable works, and all applications, registrations and
renewals in connection therewith.
1.4. The term
“Esaote Product” shall mean the ultrasound
system developed by Esaote and supplied by Esaote, as specified in
Annex 1 hereto.
1.5. The term
“Esaote Technology” shall mean all Intellectual
Property that is subject as of the Effective Date, or becomes
subject during the term of this Agreement, to Esaote’s
control. For this definition, Esaote shall be considered to control
an Intellectual Property if Esaote owns or has a license to it and
also has the right to license or sublicense it to
TechniScan.
1.6. The term
“Field of Use” shall mean the imaging of the
whole breast using both reflection and transmission ultrasound to
create tomographic images of the breast.
1.7. The term
“Industrial Designs” shall mean all features of
shape, configuration, pattern, ornament and the like that are or
can be registered as designs or industrial designs and all
applications, registrations and renewals in connection
therewith.
1.8. The term
“Intellectual Property” shall mean, in any
country or territory of the world, all registered and unregistered
Patents, Copyrights, Industrial Designs, Proprietary Information,
and Software, provided, however, that the term
“Intellectual Property” does not include any
Trademarks.
1.9. The term
“Modified Esaote Product” shall mean the Esaote
Product (a) modified by Esaote pursuant to Annex 1 in order to
integrate the Esaote Products into the Products and
(b) supplied by Esaote.
1.10. The term
“Patents” shall mean (a) all patents and
patent applications (including provisional applications and
applications for a certificate of invention); (b) all
reissues, substitutions, confirmations, registrations, validations,
re-examinations, additions, continuations, continued prosecution
applications, continuations-in-part, and divisions of, to or for
any patent or patent application; and (c) all term extensions,
supplementary protection certificates and other governmental
actions that extend exclusive rights to an invention or technology
beyond the original patent expiration date.
1.11. The term
“Products” shall mean any product having a two
and three dimensional imaging system of the whole breast using both
reflection and transmission ultrasound to create tomographic images
of the breast — with a further reference to Annex 2 —
Product Description.
1.12. The term
“Program Technology” shall mean all Intellectual
Property that is created, conceived, discovered, or invented
(i) jointly by employees of TechniScan and
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employees of
Esaote, or other parties under obligation to assign such
Intellectual Property jointly to TechniScan or Esaote, and
(ii) in the course of and in pursuance of the
Program.
1.13. The term
“Proprietary Information” shall mean a
Party’s trade secrets, know-how, data, blue-prints, drawings,
procedures, manuals, technical specifications, business plans,
manufacturing processes, clinical strategies, product
specifications, scientific data, market analyses, formulae,
designs, training manuals and other non-public information (whether
business, financial, commercial, scientific, clinical, regulatory
or otherwise) that the Party treats as proprietary and uses
commercially reasonable efforts to protect.
1.14. The term
“Software” means all computer software programs,
including operating system and applications software,
implementations of algorithms and program interfaces, whether in
source code or object code form, and all documentation, including
design documents, flowcharts, training materials and user manuals,
relating to the foregoing, and all translations thereof.
1.15. The term
“TechniScan Technology” shall mean all
Intellectual Property that is subject as of the Effective Date, or
becomes subject during the term of this Agreement, to
TechniScan’s control. For this definition, TechniScan shall
be considered to control an Intellectual Property if TechniScan
owns or has a license to it and also has the right to license or
sublicense it to Esaote.
1.16. The term
“Trademarks” shall mean all trademarks, service
marks, trade dress, logos, labels, domain names, websites and trade
names, together with all translations, adaptations, derivations and
combinations thereof (including all goodwill associated therewith),
and all applications, registrations and renewals in connection
therewith.
Article 2
Scope of the Agreement
TechniScan and
Esaote mutually acknowledge that the scope of this Agreement is the
development of the Products by:
(a) the
mutual contribution by Esaote and TechniScan of engineering and
design support and the contribution and sale of original equipment
manufacturing prototype and final production equipment and supplies
by Esaote;
(b) the
sharing of technology and Intellectual Property in respect of the
development and starting-up of a process for the industrial
manufacture of the Products to be sold at competitive prices on the
market;
(c) the
setting out of the Parties’ rights and obligations in respect
of the development, manufacturing and supply of the Products to any
third party.
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Article 3
Coordination of activities
3.1. The
Parties agree that Annex 2 sets out the program addressing the
development steps in respect of the realization (e.g., development,
regulatory approval and commercialization) of the Products and the
work required in order to transform the Esaote Products into the
Modified Esaote Products. In particular, such program (hereinafter
referred to as the “Program” ) sets out inter
alia:
• the contribution in terms of technology,
know-how, manpower, materials, assistance, etc. of each of the
Parties;
• the time schedule for development, sample
production, tests and relevant milestones which are necessary to
periodically assess and verify the results from time to time
obtained.
3.2. In the
course of the Program, Esaote and TechniScan will meet at least
every three months to discuss and document specific problems that
are identified with respect to completing the Program. Esaote and
TechniScan will assess the specific problems, consider possible
solutions to identified problems, define mutually agreeable
deadlines to progress the work toward commercialization, and carry
out appropriate developmental work. Esaote and TechniScan will
exchange and evaluate samples on pilot or production versions of
the Product

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