exv10w13






Exhibit 10.13




LETTER OF UNDERTANDINGS

ON POSSIBLE AMENDMENT 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 11th 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, as specified in the European Market Development Agreement;



WHEREAS, both TechniScan and Esaote have discussed possible amendments to the SPA.


NOW, THEREFORE, the Parties agree as follows:





	 	•	 	Without prejudice to what is provided for in this Letter of Understandings, 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 Letter of Understandings, unless a different definition is given herein.
	 
	 	•	 	The SPA Agreement may be amended after consideration and subject to approval by both
the TechniScan and Esaote Boards to be more in line with the new
strategy and development plan along with the following provisions:
	 
	 	 	 	- Second Closing: Esaote shall have the right to purchase up to 3,333,333 additional
Shares and 500,000 additional Warrant for $3,000,000 at a Second Closing (the “Second
Closing”), at the conclusion of at least 30 consecutive examinations performed in Orange
County and 10 tests on volunteers in Esaote with Rev2 (as defined in ANNEX 1 of the
European Market Development Agreement ) of the Product. $2,750,000 shall be paid in
cash and $250,000 shall be paid as an additional account credit under the OEM
Agreement.
	 
	 	 	 	- Third Closing: Esaote shall have the right to purchase up to 3,333,333 additional
Shares and 500,000 additional Warrant for $3,000,000 at a Third Closing (the “Third
Closing”), within 30 days from TechniScan completion of the manufacturing of the first
clinical model of the Product (LRIP as defined in ANNEX 1 of the European Market
Development Agreement) and the shipments of the first three Products to sites for clinical
testing and/or commercial use, provided that Techniscan has also received the CE mark or
the 510(k) approval form FDA on Rev4 of the Product or May 15th, 2009, whichever
is
first. $2,750,000 shall be paid in cash and $250,000 shall be paid as an additional account
credit under the OEM Agreement.
	 
	 	 	 	- Protective Provisions and Right of First Refusal.
	 
	 	 	 	All protective provision and all clauses of the SPA or the Right of First refusal




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	 	 	 	Agreements shall be considered amended to move 31st December 2008 milestone to
May 15th, 2009 with a corresponding extension of all relevant rights.




IN WITNESS WHEREOF, the Parties hereto have caused this Letter of Understandings to be executed in
duplicate by their authorized officers on the dates and the places mentioned below:




	 	 	 	 	 	 	 	 	 	 	 
	Genova,
October 28th 2008

Esaote S.p.A	 	 	 	October 17th 2008
TechniScan, Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By: 

Name:

	 	/s/ Fabrizio Landi
 

Fabrizio Landi
	 	 	 	By:

Name:
	 	/s/ David Robinson
 

David Robinson
	 	 
	Title:

	 	Managing Director and General
Manager
	 	 	 	Title:
	 	President & CEO	 	 







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