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ORIGINAL EQUIPMENT MANUFACTURING AGREEMENT AND ENGINEERING SUPPORT AGREEMENT

Manufacturing Agreement

ORIGINAL EQUIPMENT MANUFACTURING AGREEMENT 
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Title: ORIGINAL EQUIPMENT MANUFACTURING AGREEMENT AND ENGINEERING SUPPORT AGREEMENT
Governing Law: New York     Date: 10/16/2009

ORIGINAL EQUIPMENT MANUFACTURING AGREEMENT 
AND ENGINEERING SUPPORT AGREEMENT, Parties: techniscan  inc
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Exhibit 10.9

Execution Version

ORIGINAL EQUIPMENT MANUFACTURING AGREEMENT
AND ENGINEERING SUPPORT 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, 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:

Article 1
Definitions

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.

Article 8
Approvals

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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