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 Products and the Modified Esaote Product during the development
period and report to each other the results of tests, experiments
or production trials as they determine to be
appropriate.
Article 4
Contribution by Esaote
In the
framework of the Program outlined in Article 3 above
Esaote’s tasks shall be as outlined below:
4.1. Esaote
will provide the following engineering support services, Esaote
Products and Modified Esaote Products:
(a) the
modification of the Esaote Product into the Modified Esaote
Product;
(b) the
supply of the Modified Esaote Product and a non-exclusive license
to the executable version of the related software exclusively for
incorporation by TechniScan into the Products;
(c) the
contribution of engineering and design support and original
equipment manufacturing prototype equipment and supplies necessary
to incorporate the Modified Esaote Products into the Products and
technical assistance related to the completion and manufacture of
the Products incorporating the Modified Esaote Products;
(d) the
supply of spare parts relevant to the Modified Esaote Products as
provided in Article 6;
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(e) the
technical assistance on the Modified Esaote Products and spare
parts including training in the service, installation and
application of Modified Esaote Product, to TechniScan’s
designated technical personnel;
(f) the
provision of seven intermediate prototypes of the Modified Esaote
Product (described as beam formers in the Term Sheet) as per Annex
1.
Article 5
Work incident to the realization of Modified Esaote
Product
5.1. Esaote
shall carry out the work incident to Modified Esaote Product in
accordance with the specifications set out in Annex 1 hereto and
the Program; it being understood that TechniScan shall timely
provide Esaote with all TechniScan Technology — to the extent
such TechniScan Technology has not yet been transferred to Esaote
prior to or upon the coming into force of this Agreement —
and shall proactively extend to Esaote all reasonable
cooperation.
5.2. The work
related to Modified Esaote Product shall be completed upon
successful completion of the last milestone under the
Program.
Article 6
Prices and Terms of Payment; Sole Provider
6.1. During the
development period, the prices for Modified Esaote Products shall
be equal to Esaote’s cost (including shipping, taxes, duties
and tariffs). During the production period, the prices for Modified
Esaote Products shall be equal to Esaote’s cost plus a
mark-up to be agreed in good faith based on the best market price
(estimated at 40% gross margin plus the cost of insurance, freight,
tariffs, duties and all other similar charges). Software from
Esaote that is distributed to end users of the Products shall be
provided on a license (license to use) per completed commercial
version of the Product (generally between 0.5% and 2% per sale
price of each version of the Product). If the Parties do not
otherwise agree, the license fee per unit of the Product shall be
2.0% of the sales price of the Product. In addition to prices for
Esaote Products and Modified Esaote Products, TechniScan shall also
pay Esaote in respect of its engineering fees as provided in
Article 7 and assistance fees as provided in
Article 8.2.
6.2 .
The prices set out in 6.1 above (the “Prices”) are
calculated CIF Incoterms 2000 and shall be denominated in and
payable in Euros. Prices shall include final testing, packaging,
insurance, freight, taxes, duties, tariffs and similar
charges.
6.3. Payment of
the purchase price of Modified Esaote Product, software, units and
spare parts, exchange goods and replaced parts shall be made by
TechniScan within sixty (60) days after product shipment and
invoice from Esaote.
6.4. Esaote
reserves the right to sell Modified Esaote Products and spare parts
therefor to TechniScan through its US subsidiary, in which case the
relevant invoice shall be issued by such US subsidiary.
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6.5. Esaote or
its US subsidiary shall be the sole provider of the Modified Esaote
Product to TechniScan and TechniScan shall not attempt, directly or
indirectly, to procure or develop a replacement or alternative
during the term of this Agreement.
Article 7
Cost of Esaote Contribution
7.1. The prices
for the Esaote contribution relating to engineering services as per
Article 4 and Article 6 will be equal to the cost for Esaote
(and/or its affiliated company), which will include total monthly
salary rate, including base salary, employee benefits, taxes and
other miscellaneous costs of employing the relevant individuals. A
list of relevant billing rates for Esaote personnel is attached
hereto as Annex 3. Esaote shall also be entitled to reimbursement
in respect of its direct out of pocket expenses, including
reasonable travel and lodging and the actual costs of personnel who
are not employed by Esaote or any affiliate.
7.2. Payment of
such fees shall be made by TechniScan (i) first, by deducting
such amount from the initial $1 million in-kind contribution
under the Stock Purchase Agreement and (ii) after such initial
contribution has been fully used, within sixty (60) days after
product shipment or agreed upon engineering assistance and invoice
from Esaote. Once the amount of the Esaote contribution exceeds
$1 million, Esaote shall notify TechniScan and the parties
shall agree on whether Esaote shall provide additional services
and, if so, the pricing and other relevant terms thereof consistent
with the provisions in this Agreement.
8.1. Esaote
agrees to co-operate with TechniScan, free of charge (except for
direct costs), by providing such reasonable documentation,
technical information and data regarding the Modified Esaote
Products as may be requested by TechniScan to secure FDA approval
and a CE Mark for the Product. Esaote’s obligations hereunder
shall not include any filing fees, clinical validation activities
or the hiring of any third party consultants or counsel.
8.2. With
reference to the obtainment of the CE Mark, Esaote agrees to assist
TechniScan to obtain a CE Mark as per MDD 93/42/EEC. The extent of
the assistance by Esaote and the related cost are set out in Annex
4 hereto.
8.3.
Furthermore, Esaote will discuss in good faith with TechniScan how
to cooperate in the product approvals, product registrations and/or
regulatory licenses regarding the Products as may be necessary
under the laws in effect in any part of the world where TechniScan
actually intends to market the Product.
Article 9
Contribution by TechniScan
9.1.
TechniScan’s obligations shall be as follows:
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(a) the
supply of all required engineering and design support and original
equipment manufacturing prototype versions of the Product and
supplies (other than those required of Esaote
hereunder);
(b) the
supply during the development period of a development version of
the Product to Esaote facility in Italy at no cost for Esaote with
the aim of supporting the development program;
(c) provide the TechniScan Technology to
Esaote to facilitate Esaote’s contributions hereunder;
and
(d) use
commercially reasonable efforts to obtain regulatory approval of
Products.
9.2. In the
event Esaote should request OEM support by TechniScan outside the
scope of the Program, TechniScan shall provide it under this
Agreement and article 6 above shall apply, mutatis
mutandi
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