EUROPEAN MARKET DEVELOPMENT AGREEMENT between
Exhibit 10.11
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 xxxx 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) | |||
- 1 prototype to be used for CE marking activities (by the end of October 08) | |||
- 3 low rate initial production (LRIP) units to be used to establish clinical reference sites in Europe (as soon as possible and not later than April 09 for the first, May 09 for the second and June 09 for the third system). | |||
These systems will be provided by TechniScan at cost for a total of six hundreds thousands dollars (600,000US$). | |||
These five systems include the development system as per the OEM Agreement, article 9,
provision (c), and the system defined in the Distribution Agreement ANNEX D. Payment terms are: |
|||
- three hundreds thousands dollars (300.000 US$) at the order; | |||
- two hundreds thousands dollars (200.000 US$) at the receipt of the second prototype; |
|||
- one hundred thousands dollars (100.000 US$) at the receipt by Esaote of the last system. |
• | ANNEX 1 here attached is the new strategy and development plan of the Product and is here attached as integration of ANNEX 2 of the OEM Agreement. |
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed in duplicate by
their authorized officers on the dates and the places mentioned below:
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Genova, October 28th 2008 | October 17th 2008 | |||||||||
Esaote S.p.A. | TechniScan, Inc. | |||||||||
By:
|
/s/ Xxxxxxxx Xxxxx | By: | /s/ Xxxxx Xxxxxxxx | |||||||
Name:
|
Xxxxxxxx Xxxxx | Name: | Xxxxx Xxxxxxxx | |||||||
Title:
|
Managing Director and General Manager | Title: | President & CEO |
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ANNEX 1
TechniScan Prototype Characteristics and Plan
Systems characteristics
N. | Function | Rev 0 | Rev 1 | Rev 2 | Rev 3 | Rev 4 | ||||||||
1. | Acquisition Speed in minutes |
45 | 45 | 20 | 8-10 | 8-10 | ||||||||
2. | Tomographic reflection images |
Yes | Yes | Yes | Yes | Yes | ||||||||
3. | Tomographic reflection images (speed corrected) |
No | Yes | Yes | Yes | Yes | ||||||||
4. | Transmission Imaging Speed of sound |
No | Yes | Yes | Yes | Yes | ||||||||
5. | Transmission imaging Attenuation |
No | Yes | Yes | Yes | Yes | ||||||||
6. | Transmission Processing Time in minutes |
N/A | < 20 | < 20 | < 20 | < 10 | ||||||||
7. | Reflection Processing Time in minutes |
Offline | < 20 | < 20 | < 5 | < 5 | ||||||||
8. | UI for automated acquisition |
Yes | Yes | Yes | Yes | Yes | ||||||||
9. | Imaging presentation on workstation — Transmission |
No | DICOM | DICOM | DICOM | DICOM | ||||||||
10. | Imaging presentation on workstation — Reflection |
No | DICOM | DICOM | DICOM | DICOM | ||||||||
11. | Expanded Exam/archive management |
No | No | No | Some | Yes | ||||||||
12. | Chest wall imaging — Reflection |
Yes | Yes | Yes | Yes | Yes | ||||||||
13. | Chest wall imaging — Transmission |
No | No | No | No | No | ||||||||
14. | UI handheld probe and biopsy |
No | No | No | Some | Yes | ||||||||
15. | Final UI and keyboard layout |
No | No | No | Some | Yes |
Configuration definition
Definition | Date | |||
Rev 0
|
Prototype at the stage when it will be installed to Italy | Late July | ||
Rev 1
|
Prototype at the stage when it will be upgraded in Italy and installed at Orange County, (Clinical proof of concept) reduced scan time | Early September | ||
Rev 2
|
Prototype to continue clinical proof of concept (Upgrade: Italy and Orange County) | Late September | ||
Rev 3
|
Prototype to perform full clinical validation of automated scan | Early January | ||
Rev 4
|
LRIP Verified and Validated System final configuration (Hardware and Software) | Early May |
Glossary:
Tomographic reflection images : images produced compounding reflection acquisitions
LRIP low initial rate production = pre-series 7 Units
Esaote 1 = First prototype in Europe
Esaote 2 = Second prototype in Europe
TMS # = Prototype in USA
LRIP low initial rate production = pre-series 7 Units
Esaote 1 = First prototype in Europe
Esaote 2 = Second prototype in Europe
TMS # = Prototype in USA
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Main Milestones
Activities | Prototype, Revision | Date | Notes | |||
First prototype in Italy
|
Esaote 1, Rev 0 | Late July 08 | Shipped | |||
7/11/08 | ||||||
Start clinical evaluation USA (O.C.)
|
TMS #, Rev 1 | September 08 | ||||
Clinical evaluation samples in Europe
|
Esaote 1, Rev 1 | Early October 08 | Uses first proto system |
|||
CE measurements start
|
TMS #, Rev 1 | Early October 08 | ||||
Analysis first clinical results Europe
|
Mid November 08 | RSNA? | ||||
Analysis first clinical results USA
|
Early October 08 | |||||
Second sample in Italy
|
Esaote 2, Rev 2 | Early October 08 | Second system |
|||
Clinical Test Protocol for Europe Start clinical protocol CE |
Mid October 08 | |||||
Clinical Test Protocol for USA Start clinical protocol FDA |
TMS #, Rev 2 | Early October 08 | ||||
Upgrade Rev. 3 (Full speed, some hand
held probe)
|
TMS# — Esaote 1,2 | Mid January 09 | ||||
MKT Plan in European Countries and
necessary investment MKT Plan in USA |
End January 09 | Xxxxxxxx to work with Esaote | ||||
Go-No-Go Review (launch purchasing order for LRIP) |
November 08 | Upon Payment | ||||
LRIP assembly
|
March 09 | Orders placed upon 2nd payment |
||||
Upgrade Rev. 4 (Final release)
|
TMS# — Esaote 1,2 — LRIP | Early April 09 | ||||
LRIP Release
|
Mid May 09 | Upon Payment | ||||
CE xxxx submission
|
Mid September 08 | |||||
CE expected approval
|
End May 09 | |||||
FDA meeting
|
End September 08 | Verify plan after FDA meeting |
||||
FDA submission
|
November 08 | |||||
FDA clearance
|
May 09 | |||||
Start marketing activities in Europe (installing/selling demo units) |
End May 09 |
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Activities | Prototype, Revision | Date | Notes | |||
Start marketing activities in USA (installing/selling demo units) |
End May 09 | |||||
Launch purchasing order for Production
|
Mid April 09 | |||||
Product’ s general availability
|
Late August 09 |
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